KR20170133422A - Eustachian tube expansion balloon with ventilation path - Google Patents

Abstract

The apparatus includes a shaft, an expandable expander 1850, and at least one vent path 1855. The shaft defines a longitudinal axis and includes distal and proximal ends with at least one shaft lumen 1853. The expandable expander includes a body having its proximal and distal ends (1856, 1851). The body is configured to transition between the retracted and expanded states. The body is configured to expand the patient's eustachian tube in an enlarged state. The at least one vent path is configured to provide venting from the distal end of the body to the proximal end of the body when the body is in an enlarged state. In some examples, the vent path includes a set of laterally oriented vent openings formed through the shaft. In some other examples, the vent path includes a space defined between at least one radially outwardly projecting feature of the expandable expander.

Description

Eustachian tube expansion balloon with ventilation path

The present invention relates to methods and systems for accessing, diagnosing and treating target tissue regions in the middle ear and Eustachian tube.

Referring to Figures 1 and 2, the ear 10 is divided into three parts: an external ear 12, a middle ear 14 and an inner ear 16. The ear canal 12 includes an ear canal 18 and an ear canal 20 for collecting sound and directing it towards the eardrum 22 (also referred to as auditory) located at the inward end 24 of the ear canal 20 ). The middle ear 14 lies between the outer ear 12 and the inner ear 16 and is connected to the back of the throat by a eustachian tube 26 serving as a pressure equalization valve between the ear 10 and the sinus . The eustachian tube 26 terminates in a distal opening 28 in the nasopharynx region 30 of the throat 32. In addition to the hearing aid 22, the middle ear 14 also includes three small ear bones (the ossicles) 34 (hammer), an orbital 36 (anvil), and a spine 38 (Stirrup). These bones 34 to 38 transmit sound vibrations to the inner ear 16 and thereby act as a transducer so that the sound vibrations in the ear canal 20 of the outer ear 12 are converted into a fluid wave in the inner ear 16 . These fluid waves stimulate some nerve endings (40), the nerve endings then deliver sound energy to the brain, and the sound energy in the brain is interpreted.

The eustachian tube 26 is a narrow channel 1.5 inches long that connects the nasopharynx 30 and the middle ear 14, which is the upper throat area just above the palate, behind the nose. The eustachian tube 26 functions as a pressure equalization valve for the middle ear 14, filled with air in a steady state. When properly functioning, the eustachian tube 26 is opened briefly in response to swallowing or yawn periodically (about once every three minutes). In doing so, it causes air to enter the middle diaphragm 14 to replace the air absorbed by the inner lining (mucous membrane), or to equalize the pressure changes that occur upon altitude change. Anything that interferes with this periodic opening and closing of the eustachian tube 26 can cause hearing loss or other ear symptoms.

Occlusion or clogging of the eustachian tube 26 causes a negative middle ear 14 pressure with contraction (sucking) of the hearing aid 22. In the case of an adult, this usually involves some ear discomfort, fullness, or a sense of pressure, and can cause mild hearing loss and head echo (tinnitus). Children may have no symptoms. When the occlusion is prolonged, the fluid can flow out from the mucous membrane of the middle ear 14, causing a state called serous otitis media (middle ear fluid). This frequently occurs in children in relation to upper respiratory tract infections and causes hearing impairment related to these conditions.

The lining membrane (mucosa) of the middle ear 14 and the eustachian tube 26 is connected to the mucous membrane of the nose 42, the sinus 44 and the throat 32, and is the same as that of the mucosa. Infection of these areas causes mucosal dilatation, which in turn can result in occlusion of the eustachian tube 26. This is referred to as serous otitis media, i.e., within the middle ear 14, which can be acute or chronic, which is the result of clogging of the distal opening 28 of the eustachian tube 26, which typically causes fluid to accumulate in the middle ear 14 Of the fluid. In the presence of bacteria, these fluids can be infected, causing acute, purulent otitis media (infected or boils). In the absence of infection, the fluid remains until the eustachian tube 26 begins to function normally again, where the fluid is absorbed or flows through the eustachian tube opening 28 along the eustachian tube into the throat 32 .

Chronic serous otitis media may result from prolonged eustachian tube clogging or fluid thickening to such an extent that the fluid can not be absorbed or discharged along the eustachian tube 26. This chronic condition is usually associated with hearing impairment. Especially when a person has a cold, ear pain can recur. Fortunately, serous otitis media can persist for many years without causing any permanent damage to the middle ear mechanism. However, the presence of fluid in the middle ear 14 is very likely to cause an acute infection to recur. These recurrent infections can cause serious injury.

If the eustachian tube 26 includes accumulation of fluid, a lot of things will happen. First, the body absorbs air from the middle ear 14 and pulls the inner membrane and the hearing aid 22 inwardly to form a vacuum that tends to cause pain. Next, the body replaces this vacuum with more fluid, which tends to relieve pain, but the patient can experience fullness in the ear 10. [ Treating this condition with antihistamines and decongestants may take several weeks to be fully effective. Finally, fluids can be infected, which can be painful and deteriorate the patient's feelings and can make the patient unreadable. If the inner ear 14 becomes diseased, the patient may feel dizziness or dizziness. Infection is typically treated with antibiotics.

However, although antihistamines, decongestants, and antibiotics are used to treat infections or other causes of fluid build up in the middle ear 14, these treatments are typically pain and / or pain caused by accumulation of fluid within the middle ear 14, The patient will feel the most immediate relief if the fluid can be removed from the eustachian tube 26.

Antibiotic treatment of middle ear infections typically results in normal middle ear function within 3 to 4 weeks. During the treatment period, the patient may experience varying degrees of ear pressure, popping, clicking, and auditory fluctuations with occasional painful ears. The resolution of the infection sometimes leaves the patient with an uninfected fluid in the middle ear 14 localized in the eustachian tube 26.

Fluid accumulation caused by these types of infections has been treated surgically in the past. The primary goal of surgical treatment of chronic serous otitis media is to restore ventilation of the middle ear, to maintain normal hearing levels and to prevent recurrent infections that can damage the eardrum and middle ear bone.

For example, as shown in FIG. 3, eardrum dissection may be performed to remove fluid in the middle ear 14. The eardrhythmia is an incision 42 in the hearing aid 22 performed to remove fluid in the middle ear 14. A hollow plastic tube 44, referred to as a vent tube, is inserted into the cut-out 42 to prevent any incision 42 and to ensure the ventilation of the middle ear 14. The vent tube 44 temporarily replaces the eustachian tube 26 in equalizing the pressure in the middle ear 14. The vent tube 44 is usually held in place for three to nine months during which the blockage of the eustachian tube 26 is settled. When the tube 44 is removed, the hearing aid 22 heals and then the eustachian tube 26 regains its normal pressure equalization function.

Another method of relieving the pressure in the middle ear 14 is shown in Figure 4 where the hypodermic syringe 46 is pushed through the hearing aid 22 and through the hypodermic syringe any accumulated fluid is typically injected through the eustachian Can be taken out only from the upper part of the pipe (26).

The method of Figures 3 and 4 involves rupturing the hearing aid 22 in order to alleviate heavy fluid accumulation and pressure buildup. None of these methods is particularly effective at removing all of the fluid in the eustachian tube 26 because it is often the case that its lower end 28 is in fluid communication with the fluid It is blocked because it is blocked.

With regard to the surgical treatment described above in FIGS. 3 and 4, expansion of the eustachian tube 26 is also employed to relieve pressure buildup and fluid buildup, as shown in FIG. The hypodermic syringe 46 (shown as having a flexible tip 48) is inserted into the distal opening 28 of the eustachian tube 26 in the nasopharynx region 30 of the throat 32 Is inserted into the nostril or into the mouth until it is positioned adjacent. Air is blown through the syringe 46 through the tip 48 into the occluded eustachian tube 26 and thus into the middle ear 14 to help relieve congestion and restore middle ear venting. This procedure is often referred to as politzerization. Polymeric ventilation is most effective when the patient is swallowing one of the nostrils tightly (as shown in FIG. 6) and at the same time swallowing the patient. As a result, air is pressurized into the eustachian tube 26 and the middle ear 14. While this technique is suitable for opening the eustachian tube 26, this technique does not remove the accumulated fluid.

Another way to (at least temporarily) clear the middle ear 14 is referred to as the " valsalva "maneuver, which forces air into the middle ear 14 while holding the nose Quot; popping "). While this method is also suitable for opening the eustachian tube 26, this method does not remove the accumulated fluid.

Typical diseases associated with the middle ear and eustachian tube include perforated hearing loss, acyl sclerosis, osteoporosis, otitis media, middle ear cholesteatoma, mastoiditis, open eustachian tube, and full-tone hearing loss. To treat some of these diseases, ear surgery may be performed. Most ear surgery is a microsurgery performed with an operating microscope. Types of ear surgery include lobectomy, ossiculoplasty, tympanotomy and ear tube surgery.

One of the simplest ear surgeries is evisceration of the eardrum or hearing. However, ear surgery may also require removal of the eardrum for visualization of the middle ear space. Often the surgeon will attempt to preserve the integrity of the eardrum by making an incision in the skin of the ear canal and removing the eardrum as a complete unit. Alternatively, a middle ear approach is achieved through the mastoid process. This approach approaches the middle ear space from the back of the ear and pierces the middle ear through the mastoid air cell. Whether or not the bony partition between the external auditory canal and the mastoid process is removed depends on the degree of disease. The canal-wall-down refers to the removal of such an osseous bulkhead. Canal-wall-up refers to maintaining these osseointegration walls intact. The term " modified radical mastoidectomy "refers to a surgical procedure in which the ossicular barrier is removed and the hearing and ossicles are reconstructed. Curative mastoidectomy is an operation that removes the osseous bony wall and permanently removes the cortex, bone, and orbits so that the inner lining of the large middle ear pyloric sac can be safely removed. This surgery is performed in the case of a middle ear cholesteatoma or a middle ear cholesteatoma adhered to the inner ear or facial nerve.

The pain of middle ear and eustachian tube is a very widespread and serious medical problem, which afflicts millions of people and causes pain, discomfort and even hearing loss or permanent ear damage. Although a number of therapies have been developed, each of these has its drawbacks, as described above. Thus, there is a need for improved methods and systems for accessing, diagnosing, and treating target tissue regions in the middle ear and eustachian tubes. Ideally, such methods and systems would be minimally invasive and would hardly involve the risk of damage to healthy ear tissue.

Embodiments of the present invention are directed to methods and systems for accessing, diagnosing, and treating target tissue regions in middle ear and eustachian tubes.

In one aspect, the present invention provides a method for accessing a patient's eustachian tube. The method includes the steps of inserting a guide catheter having a distal tip with a bend having an angle of 30 to 90 degrees into a patient's nasal passage, Advancing the guide catheter within the nasal passageway toward the opening of the eustachian tube and placing the distal tip adjacent the eustachian tube opening.

In one embodiment, the method may also include advancing the diagnostic device through the guide catheter to place the distal tip of the diagnostic device adjacent the Eustachian tube opening. The diagnostic device may be a catheter or an endoscope.

In another embodiment, the method can include directly assessing eustachian tube function by introducing a diagnostic probe into the eustachian tube. The diagnostic probe may be made of a flexible and eustachic tube-compatible material. The diagnostic probe may be a pressure transducer located on a guidewire. The method may also include monitoring the pressure in the eustachian tube while the patient is swallowing, and evaluating the open function of the patient's eustachian tube using this monitoring.

In one embodiment, the method may also include removing the guide catheter after the diagnostic probe is deployed into the eustachian tube.

In one embodiment, the diagnostic probe may comprise an ultrasonic probe.

In another embodiment, the method may also include advancing the treatment device through the guide catheter toward the eustachian tube to position the distal tip of the treatment device adjacent the Eustachian tube opening. The treatment device may comprise a radiopaque distal member. The treatment device may comprise a catheter. The treatment device may also include a fluid introduction device for introducing fluid into the patient ' s ear space. The method may also include scanning the mid-space using an ultrasonic device. The fluid may be air, contrast agent, aspiration fluid, or drug.

In another embodiment, the treatment device may comprise a suction device for suctioning material from the middle ear space.

In another embodiment, the method can also include the step of introducing a guard device adjacent to the eustachian tube and monitoring the advancement of the treatment device using a guard device. In one aspect, the guard device may include a sensor positioned adjacent to the eardrum to sense the position of the therapy device during advancement. The safeguard can include an endoscope that visualizes the advancement.

In another aspect, the invention provides a method for indirectly evaluating a patient's eustachian tube function. The method includes positioning an energy emitter in a nasopharynx adjacent to the eustachian tube; Positioning an energy receiver adjacent the eardrum through the ear canal; Directing energy from the emitter to the receiver; Generating an emitter signal representative of energy from the emitter; Generating a receiver signal representative of the energy received by the emitter; Performing a comparison between the emitter signal and the receiver signal; And indirectly assessing the function of the eustachian tube during swallowing using this comparison.

In one embodiment, the step of indirectly evaluating may include evaluating the physical properties of the eustachian tube.

In another embodiment, the energy emitter may emit energy in the form of pressure waves or electromagnetic energy.

In another aspect, the invention provides a method for treating a patient's eustachian tube. The method includes positioning a guide wire through a patient's nasopharynx into a patient's eustachian tube; Introducing a debulking device into the patient's eustachian tube along the guide wire; And removing the edematous tissue comprising the hypertrophic mucosa from the surface along one side of the eustachian tube.

In one embodiment, the guide wire may include marking, and the method may also include providing feedback related to introducing into the eustachian tube.

In another aspect, the invention provides a method for treating a patient's eustachian tube. Introducing the guide wire through the nasopharynx of the patient submucosally between the mucosal surface of the eustachian tube and the cartilage; Introducing the debilking device into the submucosal tissue of the eustachian tube between the cartilage and mucosal surface along the guide wire; And removing a portion of the submucosal tissue.

In another aspect, the invention provides a method for treating a muscle dysfunction or anatomical disorder in a patient's eustachian tube. The method may include the step of creating lesions in at least one of the stretch muscular palpebral palatal muscles or the lumbar muscle palatal muscles to influence the rigidity of the muscle (s) upon absorption of the lesion.

In one embodiment, the stiffness may include shortening or straining of the muscles of the muscular palate of the palate or the muscularis muscles of the lumbar muscle.

In another embodiment, the generation of lesions may comprise applying treatment from a group including mechanical therapy, laser therapy, radiofrequency therapy and chemotherapy.

In another aspect, the invention provides a method for treating a patient's eustachian tube. The method includes disposing a dual lumen pressure equalization tube through a patient's eardrum with a distal extension for localization of the eustachian tube; Providing a drug to a region of the eustachian tube through a first lumen of a dual lumen tube in fluid communication with the distal extension; And providing venting through the eardrum through the second lumen of the dual lumen tube.

In one embodiment, the drug may be configured to reduce edema in the eustachian tube area. The drug may comprise a surfactant configured to alter the surface tension of the mucosal layer of the eustachian tube to achieve enhanced wetting of the mucosal surface by the drug.

In one embodiment, the drug may comprise particles configured to be captured by mucosal tissues of the eustachian tube to achieve sustained release of the drug.

In one aspect, the invention provides an apparatus for treating a patient's eustachian tube. The device may comprise a dual lumen tube for insertion into the eardrum of a patient's ear, the duct comprising a distal extension for intra-area placement of the eustachian tube; A first lumen for providing drug to a region of the eustachian tube via a distal extension; And a second lumen for providing venting over the eardrum.

In one embodiment, the first lumen may be disposed within the second lumen. In another aspect, the second lumen may be disposed within the first lumen. In another aspect, the first lumen may be disposed adjacent to the second lumen.

In another embodiment, the dual lumen tube may be made of biodegradable bioabsorbable material.

In another aspect, the invention provides a method for treating a patient's eustachian tube. The method includes the steps of accessing the eustachian tube region through the nasopharynx using a lumen guide; Introducing a guide wire through the lumen of the guide to position the guide wire under the mucosa between the mucosal surface of the Eustachian tube and the cartilage; Passing a transient lumen implant with a drug delivery reservoir along a guide wire to position the implant under the mucosa in a posterior cushion of the area of the ustacity tube between the lumen and the cartilage; And delivering the drug from the drug delivery storage to the eustachian tube area.

In one embodiment, the method may also comprise simultaneously delivering the drug from the drug delivery reservoir to the pharyngeal adenoids and the eustachian tube region.

In one embodiment, the drug delivery reservoir may comprise a coating layer disposed on the implant.

In another embodiment, the guide may be made of a biodegradable bioabsorbable material.

In another aspect, the invention provides a method for treating a patient's eustachian tube. The method comprising: achieving access to the eustachian tube region through the nasopharynx; Introducing a hollow guide wire dimensioned to reach into the eustachian tube area and including a plurality of holes disposed at or near the distal end through the patient's nasopharynx; And delivering the drug to at least one of the middle ear region or eustachian tube of the patient's ear through the hole.

In another aspect, the present invention provides a system for accessing a patient's eustachian tube. The system includes a guide having a distal tip configured to pass into a patient ' s nasal passage for positioning the distal tip of the catheter in or near the eustachian tube and having a bend at an angle of 30 to 90 degrees; And a guide wire configured to pass through the guide and into the eustachian tube.

In one embodiment, the guide may comprise a catheter.

In other embodiments, the guide may comprise a dual lumen tube.

In another embodiment, the system may also include a diagnostic device configured to pass the guide.

In another embodiment, the system may also include a treatment device configured to pass the guide.

In another aspect, the invention provides an apparatus for treating a eustachian tube. The device may include a long rigid shaft. The device may also include a long flexible insert coupled to the shaft, wherein the insert includes a treatment device for treating a long portion of the eustachian tube, the insert having lateral stiffness biased according to the eustachian tube and / Includes column stiffness that allows the insert to be pushed into the eustachian tube without buckling.

In one embodiment, the long stiffness shaft may include a distal end having a bend in the range of 30 to 90 degrees.

In one embodiment, the long rigid shaft may include a proximal end that may include at least one fluid fitting for supplying fluid to the insert.

In one embodiment, the long rigid shaft may include a lumen for passage of the guide wire.

In one embodiment, the insert may comprise a flexible core wire.

In one embodiment, the flexible core wire may be composed of a superelastic alloy.

In one embodiment, the flexible core wire may include a non-traumatic tip at the topmost portion of the insert.

In one embodiment, the treatment device may comprise a balloon.

In one embodiment, the balloon may include a microporous structure.

In one embodiment, the balloon may be expandable into a preformed shape that matches the profile of the eustachian tube.

In one embodiment, the balloon may comprise a drug coating.

In one embodiment, the drug coating can be one of steroids, antibiotics, antifungal agents, nonsteroidal anti-inflammatory agents, steroidal anti-inflammatory agents, surfactants, or anti-mucus materials.

In one embodiment, the treatment device may be separable from the rigid shaft.

In one embodiment, the treatment device may comprise a lumen.

In one embodiment, the treatment device can be biodegradable and can include therapeutic materials.

In one embodiment, the therapeutic substance can be one of steroids, antibiotics, antifungal agents, non-steroidal anti-inflammatory agents, steroidal anti-inflammatory agents, surfactants, or anti-mucus materials.

In one embodiment, the treatment device may include an expandable stent.

In one embodiment, the expandable stent may comprise a therapeutic substance.

In another aspect, the present invention provides a method for expanding a patient's eustachian tube. The guide catheter may be advanced through the patient ' s nasal passage to position the distal end of the guide catheter at or near the opening of the patient's eustachian tube. The distal portion of the guide catheter may include a bend having an angle of 30 to 90 degrees. The distal portion may be more flexible than the proximal portion of the guide catheter. The guidewire may be advanced through the guide catheter such that the distal end of the guidewire enters the eustachian tube. The expanding catheter may be advanced over the guide wire to position the expander of the expanding catheter within the eustachian tube. The expander can be expanded to expand the Eustachian tube. The expanding catheter and guide wire can be removed from the patient.

In one embodiment, the distal portion of the guide catheter may be malleable and the bend of the distal portion may be formed by a user of the guide catheter.

In one embodiment, the opening of the eustachian tube may include the pharyngeal pore of the eustachian tube, and the expanding catheter may be advanced to position the expander in the pharyngeal pore.

In one embodiment, the guide wire may be an illumination guide wire. The light can be emitted from the illumination guide wire, and the emitted light can be observed.

In one embodiment, the emitted light can be viewed using an endoscope positioned in the head of the patient.

In one embodiment, the guide catheter may be removed from the patient prior to advancing the expanding catheter over the guide wire.

In one embodiment, the expanding catheter can be advanced over the guide wire and through the guide catheter. The removing step may include removing the guide catheter from the patient.

In one embodiment, the expanding catheter may include a balloon expanding catheter, and expanding the expander may include inflating the balloon of the balloon expanding catheter.

In one embodiment, expanding the balloon can expand the stent in the eustachian tube.

In one embodiment, the expanding catheter may include a lateral wing, and expanding the expander may include maintaining the position of the balloon using the lateral wing.

In one embodiment, the balloon can be configured to conform to the conical hole of the pharyngeal pore of the eustachian tube (ET) when inflated, and the step of expanding the expander can include expanding the balloon within the pharyngeal pore of the eustachian tube (ET) . ≪ / RTI >

In one embodiment, the balloon may be shaped to have a cross section that does not occupy the entirety of the eustachian tube, and the step of expanding the expander may include maintaining the balloon in place to relieve the pressure in the eustachian tube.

In one embodiment, the balloon may include a cutting member, and the step of expanding the expander may include cutting the wall of the eustachian tube with a cutting member.

In one embodiment, the endoscope can be advanced through the nasal passage, and the expandable catheter can be observed using an endoscope.

In one embodiment, observing the expanding catheter includes observing a marker on the shaft of the catheter. The position of the expander relative to the opening of the eustachian tube can be approximated based on the distance of the marker from the proximal end of the expander.

In one embodiment, at least one material may be applied to the eustachian tube using an expander.

In one embodiment, the expander may include a porous balloon for delivering the substance.

In one embodiment, the expander may include a balloon having a plurality of needles for delivering a substance.

In one embodiment, the expanding catheter may exert a force against the eustachian tube to maintain the position of the expander during enlargement.

In another aspect, the present invention provides a method for expanding a patient's eustachian tube. The guide catheter may be advanced through the patient ' s nasal passage to position the distal end of the guide catheter at or near the opening of the patient's eustachian tube. The distal portion of the guide catheter may include a bend having an angle of 30 to 90 degrees. The distal portion may be more flexible than the proximal portion of the guide catheter. The delivery catheter may be advanced through the guide catheter to place the delivery catheter within the eustachian tube. A long mass transfer device can be delivered into the eustachian tube using a delivery catheter. The expanding catheter and guide wire may be removed from the patient while the long drug delivery device remains within the eustachian tube.

In one embodiment, the long mass transfer device may be a long string configured to elute at least one therapeutic substance.

In one embodiment, delivering a long mass transfer device may include separating the long string from the delivery catheter internally.

In one embodiment, delivering the elongate mass transfer device may include separating the elongate polymer string from the externally from the delivery catheter.

In one embodiment, the long mass transfer device may be a balloon configured to elute a substance over a period of time.

In one embodiment, delivering a long drug delivery device can include inflating the balloon within the eustachian tube and disengaging the balloon from the delivery catheter.

In one embodiment, the balloon may be configured to allow pressure equalization within the eustachian tube.

In one embodiment, the elongate drug delivery device may be an expandable stent.

In one embodiment, delivering a long drug delivery device includes inserting an expandable stent into the eustachian tube and releasing the proximal end of the expandable stent to expand the proximal end of the expandable stent within the eustachian tube . ≪ / RTI >

In one embodiment, the long drug delivery device may be a long insert comprising a long central member connected to a plurality of braces, each brace being connectable to a long outer member.

In one embodiment, the brace may provide and maintain an open space within the eustachian tube to maintain pressure equalization within the eustachian tube.

In another aspect, a method for expanding a patient's eustachian tube comprises advancing an expanding device through the patient ' s nasal passage and locating the expander of the device at least partially within the patient's eustachian tube; Expanding the expander to expand a portion of the eustachian tube; Disrupting the expander; And removing the expanding device from the patient, wherein the expanded portion of the eustachian tube is at least partially expanded and maintained after removal of the device. In one embodiment, the distal portion of the expanding device may be malleable and the method may further comprise the step of the user of the expanding device forming a bend in the distal portion. In this or an alternative embodiment, the distal portion of the expanding device may include a bend of about 30 degrees to about 90 degrees. In some embodiments, the opening of the eustachian tube is the pharyngeal cavity of the eustachian tube, and the expanding device is advanced to place the expander into the pharyngeal pore.

In one embodiment, the expansion device may include a guide portion that is slidably engaged with the expander. In such an embodiment, advancing the expanding device may include advancing the expanding device into the nasal cavity to position the distal end of the device at or near the opening of the eustachian tube and advancing the expander relative to the guide portion, And < / RTI > In one embodiment, the guide portion may include an inner shaft extending in a distal direction past the outer tube and the outer tube, and the expander may be advanced through the tube and on the inner shaft. In one embodiment, the inner shaft may be malleable and the method further comprises the step of the user of the expansion device forming a bend in the inner shaft.

In some embodiments, the expander may be a balloon, and expanding the expander may include inflating the balloon. In one embodiment, expanding the balloon can expand the stent in the eustachian tube. In one embodiment, the balloon may include a cutting member, and the step of expanding the expander may further include the step of cutting the wall of the eustachian tube with a cutting member.

Optionally, the method may further comprise the step of advancing the endoscope through the nasal passage and the step of observing at least one of the advancing, expanding, collapsing or removing steps using the endoscope. In one embodiment, the observing step may include observing the marker on the expanding device. In this embodiment, the method may further include approximating the position of the expander relative to the opening of the eustachian tube based on the distance of the marker from the proximal end of the expander.

In one embodiment, the method may further comprise applying at least one substance to the eustachian tube using an expander. In one embodiment, the expander may be a porous balloon for delivering the substance. In another embodiment, the expander may be a balloon having a plurality of needles for delivering material.

In another aspect, an apparatus for expanding a patient's eustachian tube includes a handle, a guide member coupled with the handle, an expander that is slidably engaged with the handle and disposed over at least a portion of the guide member, a handle for advancing the expander along the guide member, And an enlarged member associated with the handle to allow enlargement of the expander. In one embodiment, the expander can include a balloon catheter including an inflatable balloon, and the enlarged member can include an inflation port in fluid communication with the expansion lumen of the balloon catheter. In one embodiment, the balloon may include a plurality of holes through which one or more drugs may pass to contact the eustachian tube. In these or other embodiments, the balloon may include at least one cutting member for cutting tissue within the eustachian tube upon enlargement.

In some embodiments, the guide member may include a shaft, and the expander slides thereon. In some embodiments, the shaft is malleable. In these or other embodiments, the shaft may have a bend having an angle of about 30 degrees to about 90 degrees. In some embodiments, the distal end of the shaft may have a ball tip.

In some embodiments, the advancing member comprises a slide. In some embodiments, the expander may include a rigid proximal portion and a flexible distal portion. In one embodiment, the rigid proximal portion may comprise a hypotube. In one embodiment, the guide member may include a tubular shaft, through which the expander slides. In one embodiment, such a shaft may be malleable. Additionally or alternatively, the shaft may have a bend having an angle of between about 30 degrees and about 90 degrees.

Optionally, the device may further include a suction port disposed on the handle and in fluid communication with a suction member or lumen passing through the guide member or dilator. Optionally, the apparatus may further comprise an endoscope connection member for coupling the endoscope to the device.

For a further understanding of the nature and advantages of the present invention, reference should be made to the following description taken in connection with the accompanying drawings. Each of the figures is provided for purposes of illustration and description only, and is not intended to limit the scope of the embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a cross-sectional view of the human ear showing the inner ear, middle ear, and outer ear portions and the eustachian tube connecting the middle ear and throat non-pharyngeal regions through the distal opening.
Figure 2 is a cross-sectional view of a human head showing the nasopharyngeal region of the throat shown in Figure 1, including the distal opening of the eustachian tube shown in Figure 1;
Fig. 3 is a cross-sectional view of the human ear of the orientation shown in Fig. 1, wherein the vent is deployed within the cul-de-sac, illustrating a prior art surgical procedure for removing fluid in the middle ear;
4 is a cross-sectional view of the human ear of the orientation shown in FIG. 1, wherein a syringe is shown having a needle perforating the pericardium, illustrating a prior art surgical procedure for removing fluid in the middle ear.
Figures 5 and 6 are cross-sectional views of the human head of orientation shown in Figure 2, showing a prior art polychiping method for removing fluid in the middle ear, wherein the flexible tip Extending into the nose and / or throat region so that the tip abuts the pharyngeal pores of the eustachian tube).
Figure 7 is a cross-sectional view of a human head showing the nasopharyngeal region and the guide catheter in the nasal passageway, wherein the distal tip of the guide catheter is adjacent to the eustachian tube opening.
Figure 8 shows a section of an anatomical region around the eustachian tube (ET).
Figure 9 shows a section of an anatomical region around the eustachian tube showing diagnostic or therapeutic procedures for debubbling edematous tissue around the ET.
Figure 10 shows a section of an anatomical region around the eustachian tube showing an alternative therapeutic procedure for debubbling edematous tissue around the ET.
Figure 11 illustrates an exemplary drug delivery system for delivering a medicament to treat ET inflammation or edema.
Figure 12 depicts an alternative drug delivery system for delivering a medicament for treating ET inflammation or edema, which may be provided via the nasopharynx.
13 shows a section of the anatomical region around the ET showing the diagnostic or therapeutic procedure performed by the device inserted through the pharyngeal cavity of the eustachian tube.
13A is an enlarged view of an area surrounded by a broken line in Fig.
13B is a front view of a human head in which a portion of the face is removed to illustrate an embodiment of a method of introducing the guide wire into the eustachian tube.
Figures 14a-14d illustrate various examples of actuating elements that may be located on the diagnostic or treatment device of Figure 13;
15A and 15B are side views of an exemplary apparatus for providing treatment to the eustachian tube.
Figs. 15c-15e are cross-sectional views of an exemplary apparatus for providing therapy to the eustachian tube. Fig.
Figure 15f is a side view of an expansion device that provides treatment to the eustachian tube.
16A and 16B are partial cross-sectional views of a device used in a method for treating a patient's eustachian tube.
17A is a front view of an illuminated guide wire for treating a eustachian tube, in use in a patient.
Figures 18a and 18b are partial cross-sectional views of a device used in a method for treating a patient's eustachian tube.
18c is a partial cross-sectional view of an apparatus used in a method for treating a patient's eustachian tube.
18D is a partial cross-sectional view of a device used in a method for treating a patient's eustachian tube.
18E is a side view of an expander for providing therapy to a patient's eustachian tube.
Figure 18f is a perspective view of the expander of Figure 18e.
18g is a cross-sectional view of the expander of FIG. 18e within the patient's eustachian tube, with the expander in an enlarged state;
Figure 18h is a side view of an expander for providing treatment to a patient's eustachian tube.
Figure 18i is a perspective view of an expander for providing therapy to a patient's eustachian tube.
Figure 18j is a cross-sectional view of the expander of Figure 18i in the patient's eustachian tube, with the expander in an enlarged state.
Figure 18k is a side view of an expander for providing treatment to a patient's eustachian tube.
Figure 18l is a perspective view of the expander of Figure 18k.
Figure 18m is a side view of the expander to provide therapy to the patient's eustachian tube.
Figure 18n is a perspective view of the expander of Figure 18m.
Figure 18o is a side view of the expander to provide treatment to the patient's eustachian tube.
Figure 18p is a perspective view of the expander of Figure 18o.
Figure 18q is a side view of the expander to provide therapy to the patient's eustachian tube.
Figure 18r is a perspective view of the expander of Figure 18q.
18s is a side view of an expander disposed within the patient's eustachian tube to provide therapy to the patient's eustachian tube.
Figure 18t is a cross-sectional view of the expander of Figure 18s within the patient's eustachian tube, with the expander in an enlarged state.
Figure 18u is a side view of the expander for providing treatment to the patient's Eustachian tube, disposed within the patient's eustachian tube, with the expander in a contracted state.
Figure 18v is a side view of the expander of Figure 18u disposed within the patient's eustachian tube with the expander in a semi-expanded state.
Figure 18w is a side view of the expander of Figure 18u disposed in the patient's eustachian tube with the expander in a fully expanded state.
Figure 18x is a side view of the expander to provide therapy to the patient's eustachian tube.
Figures 18 (a) and 18 (z) are cross-sectional views before and after treatment of the eustachian tube treated by the dilator of Figure 18x, respectively.
Figures 19a and 19b are side views of a stent for providing treatment to a patient's eustachian tube.
Figures 19c and 19d are side views of a stent in different magnification stages to provide treatment to the patient's eustachian tube.
Figures 20a, 20b and 20c are cross-sectional views of a distal tip of a guide catheter for interfacing with an opening in a patient's eustachian tube.
Figures 21a and 21b are perspective and cross-sectional views, respectively, of a long insert for providing treatment to a patient's eustachian tube.
Figure 22a is a side view of a string insert for providing treatment to a patient's eustachian tube.
Figures 22b, 22c and 22d are partial cross-sectional views of a delivery catheter for delivering the string insert of Figure 22a.
Figures 22e and 22f are partial cross-sectional views of the string insert of Figure 22a used in a method for providing treatment to a patient's eustachian tube.
Figures 23A-23C are various views of two embodiments of a guide tube access guide device coupled with an endoscope.
24A-24C are various views of two embodiments of a Eustachian tube balloon dilatation catheter associated with an endoscope.
25 is a side view of an Eustachian tube access guide according to an embodiment;
26 is a side view of a Eustachian tube balloon dilatation catheter according to one embodiment.
FIG. 27 is a side view of a balloon expander catheter disposed within the guide and a guide to a eustachian tube, in accordance with one embodiment; FIG.
28A-28D are side views of a balloon catheter and a pre-shaped curved stylet that bends the balloon catheter, according to one embodiment.
29A and 29B are side views of an extendible inflatable balloon catheter with a guide, according to one embodiment.
Figure 30 is a side view of an exemplary light guide wire suitable for use with a balloon expanding catheter.
31 is a side cross-sectional view of the illumination guide wire of Fig.
32 is a side view of an exemplary light guide wire suitable for use with a balloon expanding catheter, with an enlarged distal tip;
33 is a side sectional view of the illumination guide wire of Fig. 32;

Embodiments of the present invention are directed to methods and systems for accessing, diagnosing, and treating target tissue regions in middle ear and eustachian tubes.

Access

One embodiment of the present invention relates to obtaining access to middle ear through a Eustachian tube using minimally invasive techniques. In one embodiment, the middle ear space can be accessed through the eustachian tube (ET). To achieve this approach to the eustachian tube orifice, a guide catheter having a bend on the distal tip of greater than about 30 degrees and less than about 90 degrees may be used. Once approached, a diagnostic or interventional device may be introduced into the eustachian tube. Optionally, a safety mechanism may be employed to prevent damage to the delicate heavy duty structure. In one embodiment, the safety mechanism may include a probe and / or sensor that is introduced into the middle ear through the eardrum as shown in Fig. For example, the probe may be an endoscope and the sensor may be an electromagnetic transducer.

FIG. 7 is a cross-sectional view showing the guide catheter 100 in the nasopharynx area and the nasal passage, wherein the distal tip 102 of the guide catheter 100 is adjacent to the Eustachian tube opening. FIG. 7 shows a guide catheter 100 having a bend on the distal tip 102 that is greater than about 30 degrees and less than about 90 degrees, located adjacent to the eustachian tube orifice. A sensor 104 positioned adjacent to the eardrum may be used to monitor the advancement of the guide catheter 100. The sensor 104 is an example of a safety mechanism.

In various alternative embodiments, the guide catheter 100 may have any suitable length, diameter, angle of bend, and position of the bend along the length of the catheter 100 to facilitate access to the Eustachian tube openings. have. In some embodiments, for example, the guide catheter 100 may have a length of from about 10 cm to about 20 cm, and more preferably from about 12 cm to about 16 cm. In various embodiments, the guide catheter 100 may have a bend having an angle from about 0 degrees to about 180 degrees, more preferably from about 30 degrees to about 90 degrees. In one embodiment, for example, the guide catheter 100 may have a length, bend angle and overall configuration for accessing the eustachian tube through entry through the nostril at the same head side as the one approaching the eustachian tube . In an alternative embodiment, the guide catheter 100 has a length, bend angle and overall configuration for accessing the eustachian tube through entry through the nostril on the opposite side (opposite side) of the head of the approaching eustachian tube . The bend angle of this latter embodiment may be greater than, for example, the angle of bend of the guide catheter 100 used for the same approach.

In one embodiment, the guide catheter 100 may be malleable so that the user can bend the guide catheter 100 into a desired shape that at least partially retains the guide catheter 100 during use. In another embodiment, the guide catheter 100 may be steerable. For example, at least a portion of the guide catheter 100 may be partially flexible, and such portion may be manipulated by a manipulation mechanism, such as one or more pull wires, coupled to the proximal end of the catheter 100 have. Various embodiments may include one steerable portion or a plurality of steerable portions. The various embodiments may also include any suitable angle of maneuverability. For example, one steerable portion may be bent at an angle of about 30 degrees, and the other steerable portion may be bent at an angle of about 45 degrees. Any combination of angle and steerable portion may be included in various embodiments.

In some embodiments, the guide catheter 100 may be combined with or combinable with a flexible or rigid endoscope. In one embodiment, for example, a flexible endoscope can be embedded within the body of the guide catheter 100. [ In another embodiment, the guide catheter 100 may include an endoscopic lumen and the flexible endoscope may be advanced therethrough. In yet another embodiment, the guide catheter may include a lumen, clip or other attachment member (or members) for attaching to the rigid endoscope. For example, in some embodiments, the guide catheter 100 may be attached to a variable field of view rigid endoscope, such as a swing prism endoscope.

Some embodiments of the guide catheter 100 may include an optional suction port on or near the proximal end and thus the catheter 100 may be connected to a vacuum / suction source. In these embodiments, the guide catheter 100 may include a separate suction lumen, or alternatively, the suction power may be directed through the same lumen through which the device is passed. Some embodiments may include a one-way valve to allow passage of the device through the guide catheter 100 while maintaining suction pressure.

In use, the guide catheter 100 may be advanced into the nostril and through the nasal cavity to position the distal end of the catheter 100 into the eustachian tube, into or near the opening. In one embodiment, the guide catheter 100 may be moved through the nostril to the eustachian tube on the east side (the same side) of the head. In an alternative embodiment, the guide catheter 100 may be moved through the nostril to the eustachian tube on the opposite side (opposite side) of the head. Once access to the eustachian tube is achieved using the guide catheter 100, any of a number of procedures may be performed in the eustachian tube using any of a number of different devices. Alternatively, in some embodiments, the guide catheter 100 may be used to inhale and withdraw blood and / or other fluid / material from the eustachian tube and / or nascent during and / or after advancement of the catheter 100. In an alternative embodiment described more fully below, the guide catheter 100 may be excluded from the procedure, and the Eustachian tube may be accessed and treated with one or more devices without the use of the catheter 100.

Diagnosis

Another embodiment of the invention relates to the diagnosis of middle ear condition and middle ear condition. In one embodiment, the diagnosis may include the use of an endoscope that has been advanced through the guide catheter 100 to an appropriate position and incorporated into the guide catheter 100. The design of the endoscope will allow for Y-axis visualization of over 90 degrees and 360 degree rotation. Such endoscopes may be used for evaluation of middle ear cholesteatoma, osseous function and / or condition, and surgical follow-up. An exemplary endoscope that can be configured as described above can use an IntroSpicio 115 1.8 mm camera developed by Medigus. Such a camera is approximately 1.8 mm x 1.8 mm, and its small stiffness permits maximum flexibility at the endoscope tip.

Alternatively, ultrasonic waves can be used by injecting fluids into the middle ear space and into the ET and scanning the middle ear and the ET and its structure with ultrasonic waves. After the procedure, the fluid may be aspirated or vented through the eustachian tube. An ultrasound tipped catheter can be advanced to a position in the middle ear over the ET. The ultrasound catheter can then be pulled under the ET and the surgeon can use an external video monitor to observe the structure in and near the ET.

Functional diagnosis of the eustachian tube can be achieved through direct or indirect evaluation. In one embodiment, in the case of a direct evaluation, the diagnostic system may allow dynamic monitoring of the eustachian tube during swallowing by a diagnostic probe inserted through the nasopharynx. Since such a diagnostic system can be used dynamically during swallowing, the probe can be made of a flexible and durable material configured to be non-traumatic. In one embodiment, the guide catheter (s) 100 used for the nasopharynx approach can be removed once the diagnostic probe is in or near the ET area and before swallowing.

In one embodiment, the diagnostic probe may include an endoscope that visualizes the ET structure and function. Alternatively, the diagnostic probe may include a pressure transducer located on the catheter or wire. When a pressure transducer is used, the pressure in the ET can be monitored during swallowing, and the pressure measurements can be interpreted for the ET open function. Alternatively, an ultrasonic probe may be inserted into the ET lumen to scan the structure of the ET region. Fluids can be introduced into the ET to facilitate ultrasound diagnosis. In the case of any of the above diagnostic systems, a single transducer having a short length that changes position after each swallow can be used. Alternatively, an array of transducers may be used to facilitate mapping of all or part of the ET.

The techniques described above can be used to diagnose and access the patient's eustachian tube directly. In one embodiment, a method for accessing a patient's eustachian tube comprises the steps of inserting a guide catheter having a distal tip with a bend having an angle of about 30 to about 90 degrees into a patient ' s nasal passage; And advancing the guide catheter in the nasal passage toward the opening of the eustachian tube in the nasopharynx to position the distal tip adjacent the eustachian tube opening. Additionally, the method may also include advancing the diagnostic device through the guide catheter to place the distal tip of the diagnostic device adjacent the Eustachian tube opening. The diagnostic device may comprise a diagnostic catheter. The diagnostic device may include an endoscope, a pressure transducer, or an ultrasonic catheter.

Additionally, the method may also include directly assessing eustachian tube function by introducing a diagnostic probe into the eustachian tube. The diagnostic probe is preferably made of a flexible and eustachic tube-compatible material. Alternatively, the diagnostic probe may include a pressure transducer located on the guidewire, whereby the method comprises monitoring the pressure in the eustachian tube while the patient is swallowing; And evaluating the open function of the patient's eustachian tube using this monitoring. The method may also include the step of removing the guide catheter after the diagnostic probe has been placed into the eustachian tube. Additionally or alternatively, the diagnostic probe may comprise an ultrasonic probe.

In the case of an indirect functional diagnosis of the eustachian tube, in some embodiments, an external energy source may be used to evaluate the opening of the eustachian tube. For example, a possible source of energy may include, but is not limited to, pressure, sound, light or other electromagnetic energy. In one embodiment of the indirect evaluation, the emitter can be positioned in the nasopharynx and the receiver can be placed in the eardrum. The correlation between the emitted signal and the received signal can be interpreted as the physical property of the ET during swallowing.

The techniques described above can be used to indirectly access and diagnose the patient's eustachian tube. The indirect evaluation method includes positioning an energy emitter in the nasopharynx adjacent to the eustachian tube; Positioning an energy receiver adjacent the eardrum through the ear canal; Directing energy from the emitter to the receiver; Generating an emitter signal representative of energy from the emitter; Generating a receiver signal representative of the energy received by the emitter; Performing a comparison between the emitter signal and the receiver signal; And indirectly assessing the function of the eustachian tube during swallowing using this comparison. The energy emitter may be a device that emits energy in the form of pressure waves or electromagnetic energy. The indirect evaluation may also include a step of evaluating the physical properties of the eustachian tube.

cure

Another embodiment of the invention relates to the treatment of Eustachian tube disease. In some cases, for example, eustachian tube disease may be associated with structural occlusion of the eustachian tube. The structural disease of the eustachian tube is often the result of anatomical malformations or excess or edematous tissue in or around the eustachian tube, as shown in Fig. Figure 8 shows a section of the anatomical region around the eustachian tube (ET). Figure 8 shows some common anatomical landmarks, including the anatomy (TM), carotid artery, and ET cartilage, as well as the location of the myotonic palatal and carpal tunnel muscles. Figures 9 and 10 illustrate diagnostic or therapeutic procedures performed in the area around the ET.

Figure 9 shows a section of the anatomical region around the eustachian tube showing diagnostic or therapeutic procedures for debubbling the edematous tissue around the ET. 9 includes accessing the ET lumen using the guide wire 202 and removing tissue from one side of the ET using the deblocking tool 204. [ 9, deblocking tool 204 may have a retractable deblocking tip 206 projecting from one side to allow the tip to remove tissue from one side of the ET lumen, as shown in FIG. 9 . This treatment procedure preferably allows controlled access and positioning within the ET and prevents damage to the opposing surfaces. It should be understood that the above-described treatment procedure can be performed with the aid of ultrasound guidance or visualization, for example, by using a visualization catheter in the ET. Ultrasound may be used for diagnosis before treatment as described above. Ultrasound can also be used for guidance and / or assistance during treatment. In an alternative embodiment, the deblocking tool 204 may be advanced into the eustachian tube without the use of a guidewire and advanced without the use or use of a guide catheter.

Figure 10 shows a section of the anatomical region around the eustachian tube showing an alternative therapeutic procedure for debubbling edematous tissue around the ET. 10, a debulling device 304 may be introduced submucosally between the cartilage 330 and the mucosal surface at its tip or distal end 306 to preserve the mucosal surface. In this alternative procedure, the guide wire 302 and / or debubbling device may pass between the lumen and the cartilage, thereby protecting both the mucosal surface and the carotid artery. As shown in FIG. 10, the guide wire 302 may be inserted between the ET cartilage and the mucosal surface at the submucosal entry point. Subsequently, a deblocking tool 304 may be introduced along the guide wire 302 to debond the tissue area without affecting the mucosal surface. Ultrasound, such as low-power, high-efficiency ultrasound, can be used as a debuggling tool to remove, reduce or deb debate tissue under mucosal tissue. As with the previously described device, in an alternative embodiment, the deblocking tool 304 may be advanced into the eustachian tube without the use of a guide wire and advanced without the use or use of a guide catheter.

The aforementioned treatment techniques include placing the guide wire through the patient's nasopharynx into the patient's eustachian tube; Introducing a debulling device into the patient's eustachian tube along the guide wire; Can be used to treat a patient's eustachian tube by removing edematous tissue, including the hypertrophic mucosa, from the surface along one side of the eustachian tube. The guide wire may include a marking to provide feedback related to introduction into the eustachian tube. Alternatively, the deblocking tool may be introduced into the ET without first placing the guide wire in the ET. In either case (i.e., with or without a guidewire), in some embodiments the treatment device may be advanced through the guide catheter into the eustachian tube, while in alternative embodiments the treatment device may be advanced without the use of a guide catheter . Indeed, in various alternative embodiments of the device, any of the treatment devices described herein may have a guidewire or be without a guide wire and with or without a guide catheter.

Alternatively, a method for treating a patient's eustachian tube comprises introducing a guide wire through the nasopharynx of a patient submucosally between the mucosal surface of the eustachian tube and the cartilage; Introducing a debarking device into the submucosal tissue of the eustachian tube between the cartilage and the mucosal surface along the guide wire; And removing a portion of submucosal tissue.

In addition to the treatment procedures described above and shown in Figures 9 and 10, tissue removal or remodeling (e.g., reduction) can be achieved using mechanical treatment, laser treatment, radiofrequency treatment, and / or chemotherapy. For example, if a muscle dysfunction or an anatomical disorder is a contributing factor, the muscles (tension myocardial palsy muscle or lumbar muscle palatal muscle) may be shortened or strained. One way to make or shorten muscles is to create lesions in the muscles. Over time, these lesions are absorbed and the muscles become taut due to reabsorbed muscle mass in a manner similar to high frequency hyperthermia (somnoplasty).

Another embodiment of the invention relates to the treatment of Eustachian tube disease caused by inflammation or edema. In addition to the surgical procedures described above, edema can also be reduced through pharmacotherapy. Delivery of therapeutic agents, particularly steroids, into the ET mucosa may be facilitated locally using a variety of methods including direct aspiration into the ET using a micro-catheter designed to enter the medial or non-pharyngeal side of the ET. Alternatively, the formulation may be delivered from the surface of the expanding balloon. In such cases, the agent may be deposited into the mucosal layer, not on the surface of the mucosal layer. Continuous delivery may be facilitated by depositing the drug into the reservoir and burying the reservoir into the mucosa. Prolonging the residence time of the therapeutic agent can be achieved by including the agent as particles and filling the reservoir particles to cause it to stick to the mucosal surface. Alternatively, the residence time of the therapeutic agent can be controlled by implanting the reservoir into the ET or its substructure.

An exemplary drug delivery system according to one embodiment is shown in FIG. As shown in Fig. 11, the pressure equalization tube 400 can be inserted into the eardrum. The pressure equalization tube includes an extension 402 that resides in the region of the eustachian tube, wherein the extension has drug delivery capability. As shown in FIG. 11, the pressure equalization tube 400 may be a dual-lumen providing drug delivery and venting functions. The pressure equalization tube 400 with the extension 402 can be designed to slide between the radial fibers of the eardrum TM. When in position, the tube may be oriented to minimize the travel path.

Alternatively, a drug delivery system may be provided through the nasopharynx as shown in FIG. As shown in FIG. 12, drug delivery may be provided from the transient lumen implant 500. The transient nature of the implant 500 may require a removal system or may provide for natural removal through decomposition and / or extinguishment. Similar to the debubbling device described above, the drug delivery system can also be implanted submucosally, with the benefit of not interfering with the surface mucosa. In one embodiment, the implant can be deployed into the posterior elevation of the ET between the lumen and cartilage. This method can benefit from the use of consistent anatomical landmarks and can minimize the possibility of trauma to the middle ear or carotid artery. The implant 500 may include an anchored drug delivery reservoir in the form of a coil with a reduced diameter from the distal portion 502 to the proximal portion 504, respectively.

Figure 13 shows a section of the anatomical region around the eustachian tube showing the diagnostic or therapeutic procedure performed by the device inserted through the pharyngeal pore of the eustachian tube (ET). Fig. 13 shows a diagnostic or therapeutic procedure performed by a guide wire GW inserted into a desired area in the ET through the nasopharynx, and a device introduced into the eustachian tube by a guide wire GW.

FIG. 13A shows an enlarged view of the area 33A of FIG. 13, showing an anatomical area around the eustachian tube ET and showing the diagnostic or therapeutic procedure performed by the device inserted through the pharyngeal cavity of the eustachian tube . In one embodiment, the guide wire GW includes an anchoring balloon 3200 located in the distal region of the guide wire GW. Fixed balloon 3200 is inflated after placing guide wire GW at the target position. The fixed balloon 3200 fixes the guide wire GW to the adjacent anatomical structures and prevents accidental repositioning of the guide wire GW during diagnostic or therapeutic procedures. Fixed balloon 3200 may be made of any suitable flexible or semi-flexible material such as, but not limited to, cross-linked polyethylene or other polyolefin, polyurethane, flexible polyvinyl chloride, nylon and the like. In various alternative embodiments, the guide wire GW may include, in addition to the stationary balloon 3200, at least one stationary element, for example, a notch on the guide wire GW, a bent area on the guide wire GW, Elements, hooks, coil-like elements, and the like. In another embodiment, the guide wire GW may comprise a sensor 3202 located in the distal region of the guide wire GW. The sensor 3202 may enable the guide wire GW to be used with a suitable surgical navigation system. In one embodiment, the sensor 3202 may include an electromagnetic sensor for use with a navigation system for electromagnetic surgery, such as the GE lnstaTrak (TM) 3 500 Plus system. One or more sensors 3202 or other types of surgical navigation sensors or transmitters may also be located on other diagnostic or therapeutic devices as described herein. The sensor 3202 may be used with an immobile sensor 3204 located thereon. The combination of the sensor 3202 and the stationary sensor 3204 can facilitate positioning the guide wire GW within the target area.

In some embodiments, the guide wire GW may include one or more stop members (not shown) at its distal end, proximal end, or both. Such a stop member may be other than fixed balloon 3200 and may be included in embodiments that do not have fixed balloon 3200. The stop member helps to prevent the distal end of the guide wire GW from being moved too far into the eustachian tube and therefore can not cause any damage to the structure that can result from moving the guide wire GW too far It helps to prevent. In one embodiment, for example, the guide wire GW may include a distal bend or bend, which prevents the guide wire from passing through the narrow portion of the eustachian tube. These or other embodiments may also include a proximal stop member adjacent the proximal portion of the guide catheter through which the guidewire passes and preventing the proximal portion from moving too far. In any of the embodiments described above, the guide wire may also have a non-traumatic tip.

In another embodiment, the radiopaque plug 3206 may be inserted into the area adjacent to the auditory canal from the external auditory canal. The radiopaque plug 3206 may serve as a fiducial marker during pre-operative scanning of the patient, thereby allowing the physician to position the diagnostic or therapeutic device closely to the hearing. Other image guidance methods and devices may also be used with the diagnostic or therapeutic procedures disclosed herein. 13A also shows a diagnostic or treatment device 3208 including an expanding balloon introduced by a shaft 3210 and an actuating element 3212, e.g., a guide wire GW. The diagnostic or therapeutic device 3208 may comprise a radiopaque marker 3214.

13B shows a front view of a human head in which a portion of the face is removed to illustrate an embodiment of a method of introducing the guide wire GW into the eustachian tube. In Fig. 13B, guide catheter 3250 is introduced into the nasopharynx through the nostril. The distal portion of the guide catheter 3250 may include a curved or angled region. For example, in one embodiment, such bent or angled region may form an interior angle in the range of about 45 degrees to about 150 degrees. The guide catheter 3250 may be constructed using any of the various designs disclosed in the assignee's co-pending U.S. Patent Application No. 11 / 926,565 (Attorney Docket No. 83529.0066), which is incorporated herein by reference. Guide catheter 3250 is positioned within the nasopharynx such that the distal tip of guide catheter 3250 is positioned proximate the nasopharyngeal opening of the ustacity tube. Thereafter, a guide wire GW is introduced through the guide catheter 3250 into the eustachian tube. The guide wire GW can then be used to advance one or more diagnostic or therapeutic devices into the eustachian tube to perform one or more diagnostic or therapeutic procedures.

14A-14D illustrate various embodiments of actuating elements that may be positioned on a diagnostic or therapeutic device, such as catheter 3210, which may be advanced over a guidewire 3208 in some embodiments. 14A shows a balloon dilatation catheter 3210 with an actuating element including an expanding balloon 3312 advanced over a guide wire 3208. Fig. The expanding balloon 3312 can be made of a suitable non-compliant material such as, but not limited to, polyethylene terephthalate, nylon and the like. In various alternative embodiments, the balloon catheter 3210 may be placed on the guide wire 3208, without the use of a guide catheter, on the guide catheter or without the use of the guide wire 3208, (E. G., Into a partially rigid balloon catheter) without the use of a catheter, or using a guide wire 3208 or a guide catheter. Also, in various embodiments, the balloon catheter 3210 may be used for inflation / contraction of the balloon 3312, cleaning and / or inhalation, drug delivery, passage of a visualization device such as a flexible endoscope, And may include multiple lumens.

14B shows an example of a actuating element including an expanding balloon 3314 loaded with a balloon-expandable stent 3316. Fig. In some embodiments, the expanding balloon 3314 may be made of a suitable non-compliant material such as, but not limited to, polyethylene terephthalate, nylon, and the like. Several types of stent designs may be used to construct the stent 3316, including, but not limited to, metal tube designs, polymer tube designs, chain-connected designs, helical designs, rolled sheet designs, single wire designs, These designs can have open-cell or closed-cell structures. Various manufacturing methods, including but not limited to laser cutting of metal or polymer elements, welding metal elements, etc., may be used to fabricate the stent 3316. A variety of materials can be used to fabricate the stent 3316, including but not limited to metals, polymers, foam-type materials, plastic deformation materials, superelastic materials, and the like. Various features may be added to the stent 3316, including, but not limited to, drug eluting devices that elute radiation-impermeable coatings, anti-inflammatory agents, antibiotics, and the like. In one embodiment, the stent 3316 may be bioabsorbable. The actuating element may also include a self-expanding stent instead of a pressure-expandable stent.

14C illustrates an alternative embodiment that includes a cleaning catheter 3120 with a working element including a lavage element 3318. [ The cleaning element 3318 may include a plurality of cleaning openings 3320. The cleaning opening 3320 can be connected to a cleaning lumen in the shaft of the catheter 3210 through which the contrast agent, a pharmaceutically acceptable salt or an antimicrobial agent in a dosage form (e.g., an antibiotic, an antiviral agent, (E.g., xylocaine with or without epinephrine, tetracaine with or without epinephrine), analgesics, corticosteroids, or the like, with or without a vasoconstrictor (E. G., An expectorant or a mucolytic agent), an agent that prevents or alleviates an allergic reaction (e. G., An anti-inflammatory agent For example, antihistamines, cytokine inhibitors, leukotriene inhibitors, IgE inhibitors, immunomodulators), mucus secretion by allergens or tissues A solution containing a biological agent such as other substances to stop bleeding, a hemostatic agent to stop bleeding, an antiproliferative agent, a cytotoxic agent (for example, alcohol), a protein molecule, a stem cell, May be delivered. In one embodiment, some of the cleaning openings 3320 may be connected to the suction lumen to suck the cleaning media from the eustachian tube.

FIG. 14D shows an example of a working element including mass transfer storage 3322. FIG. Mass transfer storage 3322 may be wholly or partially biodegradable or non-biodegradable. In one embodiment, mass transfer storage 3322 is made of a suitable biocompatible material, such as a hydrogel (e.g., collagen hydrogel). In another embodiment, mass transfer storage 3322 includes a porous matrix formed of a porous material such as a flexible or rigid polymer foam, cotton wadding, gauze, and the like. Examples of biodegradable polymers that can be foamed or otherwise porous include polyglycolide, poly-L-lactide, poly-D-lactide, poly (amino acid), polydioxanone, polycaprolactone, polygluconate, Polylactic acid-polyethylene oxide copolymer, modified cellulose, collagen, polyorthoester, polyhydroxybutyrate, polyanhydride, polyphosphoester, poly (alpha-hydroxy acid) and combinations thereof. Examples of non-biodegradable polymers which can be foamed or otherwise porous include polyurethanes, polycarbonates, silicone elastomers, and the like. Mass transfer storage 3322 also includes an implantable device and method for transferring drugs and other materials to treat sinusitis and other diseases (Implantable Device and Methods), filed August 4, 2004, for example, one or more embodiments disclosed in U.S. Patent Application No. 10 / 912,578, entitled " Delivering Drugs and Other Substances to Treat Sinusitis and Other Disorders, " the entire disclosure of which is expressly incorporated herein by reference. Mass transfer storage 3322 or any mass transfer device described in this application may be used to deliver various types of therapeutic or diagnostic agents. As used herein, the term "diagnostic or therapeutic substance" is used broadly to include any feasible drug, prodrug, protein, gene therapy form, cell, diagnostic, contrast or imaging agent, Should be interpreted. Such a material may be in the form of a combined or free form, a liquid or solid, a colloid or other suspension, a solution, or a gas or other fluid or non-fluid form. For example, in some applications where it is desired to treat or prevent a microbial infection, the delivered substance may be an antimicrobial agent (e.g., an antibiotic, an antiviral agent, an anti-parasitic agent, an antifungal agent, etc.), a corticosteroid or other anti- (E.g., antihistamines, cytokine inhibitors, anti-inflammatory agents, anti-inflammatory agents, anti-inflammatory agents, ≪ / RTI > quatraene inhibitors, IgE inhibitors), and the like.

Some non-limiting examples of antimicrobial agents that may be used in the present invention include acyclovir, amantadine, aminoglycosides (e.g., amikacin, gentamicin and tobramycin), amoxicillin, amoxicillin / clavulanate, The present invention relates to a pharmaceutical composition comprising amphotericin B, ampicillin, ampicillin / sulfamant, atobakuon, azithromycin, cephazoline, cephipim, cell taxidermis, cytetan, cephodoxim, ceftazidime, ceftioxan, ceftriaxone, , Cefuroxime axetil, cefalexin, chloramphenicol, clothiramazole, ciprofloxacin, clarithromycin, clindamycin, suzone, dicloxacin, doxycycline, erythromycin, fluconazole, foscamet, gancyclovir, Cilastatin, isoniazid, itraconazole, ketoconazole, metronidazole, nafcillin, nafcillin, nystatin, penicillin, penicillin G, (E. G., ≪ RTI ID = 0.0 > lysine / lysine / lysine / lysophosphatidylcholine) (Bactroban, Glaxo SmithKline, Research Triangle Park, North Carolina), nystatin, triamcinolone / nystatin, clotrimazole / betamethasone, clotrimazole, ketoconazole, butoconazole , Myconezol, thioconazole, detergent-like chemicals (e.g., nonoxynol-9, octoxynol-9, benzalkonium chloride, mennegolol, and N-doxanone) that disrupt or disable microorganisms, ; (Such as PC-515 (carrageenan), Pro (Pro) -2000, and dextrin 2 sulfate) that block and / or block the attachment of microorganisms to target cells or inhibit the entry of infectious agents Nitrated polymers); Antiretroviral agents (e. G., PMPA gels) that prevent the retrovirus from replicating in cells; A genetically engineered or naturally occurring antibody against a pathogen, for example, a plant-derived genetically engineered antiviral antibody, known as a "plantibody "; (E. G., Substances that alter mucosal pH (e. G., Buffer gels and acid forms)); Pathogenic or "friendly" microorganisms (e. G., Lactobacillus) that cause hydrogen peroxide or other substances that kill pathogenic microorganisms or inhibit its growth; Antimicrobial proteins or peptides such as those described in U.S. Patent No. 6,716,813 (Lin et al.), Which are expressly incorporated herein by reference, or antimicrobial metals (such as colloidal silver).

Additionally or alternatively, in some applications where it is desired to treat or prevent inflammation, the substance delivered in the present invention may include a variety of steroids or other anti-inflammatory agents (e.g., non-steroidal anti-inflammatory or NSAIDS), analgesics or antipyretics . For example, corticosteroids previously administered by intranasal (10) administration, such as beclomethasone (Vancenase (R) or Beconase), fluney solid ( (Nasalide (R)), fluticasone propionate (Flonase (R)), triamcinolone acetonide (Nasacort (R)), busesonide (Rhinocort Aqua (R) (registered trademark)), rottenol nethonate (Locort), and Mometasone (Nasonex (R)). Other salt forms of the above-described corticosteroids may also be used. Other non-limiting examples of steroids that may be used in the present invention include, but are not limited to, clomethasone, desonide, hydrocortisone, betamethasone, crocortolone, daciximethone, fluocinolone, plurandreenolide, But are not limited to, but are not limited to, imatinos, mometasone, prednicarbate, amcinonide, dexamethasone, diflorasone, fluorocinolone, fluorocinonide, halcinonide, clobetasol, But are not limited to, prednisone, dexamethasone, and methylprednisolone. Other anti-inflammatory, analgesic or antipyretic agents that may be used include non-selective COX inhibitors such as salicylic acid derivatives, aspirin, sodium salicylate, choline magnesium trisalicylate, salvate, dipyrunic, sulfasalazine and olsalazine; Indole and indene acetic acid such as indomethacin and sulindadac, heteroaryl acetic acids such as tolmetin, dicofenac and keto-rolac, ibuprofen, naproxen, fluvifroprofen, ketoprofen, Aryl propionic acids such as naprofen and oxaprofen; anthranilic acids (phenamates) such as mefenamic acid and meloxicam; ethanols such as oxycomb (piroxicam, meloxicam) and alkanones such as nabumetone; and Selective COX-2 inhibitors (e.g., diaryl-substituted furans such as rofecoxib, diaryl-substituted pyrazoles such as celecoxib, Indole acetic acid, such as lac, and sulphonanilides, such as nimesulide).

Additionally or alternatively, in some applications, such as those in which it is desired to treat or prevent allergies or immune reactions and / or cell proliferation, the substances delivered in the present invention include a) a humanized anti-cytokine antibody, an anti-cytokine receptor Antibodies, various recombinant (new cell derived from recombinant) antagonists, or soluble cytokine inhibitors such as soluble receptors; b) various leukotriene modulators such as zafirlukast, montelukast and ziluton; c) immunoglobulin E (Ig E) inhibitors and secretory leukocyte protease inhibitors, such as omalizumab (an anti-lgE monoclonal antibody formerly termed rhu Mab-E25); And d) a SYK kinase inhibitor such as a formulation designated "R-112 ", manufactured by Rigel Pharmaceuticals, Inc. of South San Francisco, Calif.

Additionally or alternatively, in some applications, such as contraction of mucosal tissues, induction of congestion relief, or achievement of hemostasis, the substance delivered in the present invention is selected from the group consisting of pseudoephedrine, xylomethazoline, Including, but not limited to, corticosteroids, corticosteroids, corticosteroids, corticosteroids, zolin, phenylphrine, epinephrine, and the like.

Additionally or alternatively, in some applications, such as where it is desired to facilitate the flow of mucus, the substance delivered in the present invention may include various mucolytic agents, including but not limited to acetylcysteine, or mucilage or mucoid And may include other agents that alter the viscosity or consistency of secretions. In one particular embodiment, the substance delivered by the present invention comprises a combination of an anti-inflammatory agent (e.g., a steroid or an NSAID) and a mucolytic agent.

Additionally or alternatively, in some applications, such as where it is desired to prevent or inhibit histamine release, the substance delivered in the present invention may be selected from the group consisting of chromolin (e.g., Nasal Chroma) The same, various mast cell stabilizers, or drugs that prevent the release of histamine.

Additionally or alternatively, in some applications, such as where it is desired to prevent or inhibit the effect of histamine, the substance delivered in the present invention may be combined with various antihistamines, such as, for example, azelastine (e.g., Astylin), diphenhydramine, lauratidine, and the like.

Additionally or alternatively, in some embodiments, such as where dissolution, disassembly, cutting, fracture, or modification of the bone or cartilage is required, the material delivered in the present invention may be modified, reshaped, fractured, Gt; and / or < / RTI > the cartilage to facilitate other procedures of the present invention. An example of such a formulation would be a calcium chelating agent such as EDTA that can be injected or delivered into a mass transfer implant next to the area of the bone to be modified or altered. Another example would be a formulation consisting of or containing bone-degrading cells, such as osteoclasts. Other examples include various enzymes of substances capable of softening or comminuting bone or cartilage components such as collagenase (CGN), trypsin, trypsin / LEDTA, hyaluronidase and tocylisylchloromethane (TLCM) something to do.

Additionally or alternatively, in some applications, the substance delivered in the present invention may include other classes of substances used in the treatment of rhinitis, non-inflammatory, non-inflammatory, and other disorders of the ears, nose and throat, This includes, but is not limited to, an anticholinergic agent that tends to dry nasal secretion, such as ipratropium (Atrovent Nasal < (R) >), and other agents not listed herein Do not.

Additionally or alternatively, in some applications, such as where suction of fluid from a polyp or edematous tissue is desired, the substance delivered in the present invention may be administered topically or topically in a diuretic, such as furosemide and / Or hyperosmotic agents such as sodium chloride gel or other salt formulations which aspirate moisture from the tissue or directly or indirectly change the osmotic contents of the mucus to allow more water to be released from the tissue, Lt; RTI ID = 0.0 > directly < / RTI > contracted at the site.

Additionally or alternatively, in some applications, such as those where it is desired to treat a tumor or a cancerous lesion, the substance delivered in the present invention may be administered in combination with an anti-tumor agent (e.g., a cancer chemotherapeutic agent, a biological response modifier, Other agents that directly kill cancer cells by attacking the DNA of, for example, an alkylating agent or cancer cells (e. G., Cyclosporine, < RTI ID = 0.0 & (BCNU) and rhomustine (CCNU)) that kill cancer cells by inhibiting the changes necessary for DNA repair of the cells, the anti-inflammatory drugs (e.g., Other agents that block cancer cell growth by inhibiting the metabolism and certain cellular functions, usually DNA synthesis (e. G., 6 mercaptopurine and 5- (5FU), antitumor antibiotics, and other compounds that act by binding or inserting DNA and preventing RNA synthesis (such as doxorubicin, daunorubicin, epirubicin, dirubicin, mitomycin (E.g., vincristine and vinblastine), steroid hormones, hormone inhibitors, hormone receptor antagonists and hormone-reactive cancers (e.g., vincristine and vincristine) (For example, tamoxifen, herceptin, aromatase inhibitors such as aminoglutethamide and formestan, triazole inhibitors such as letrozole and anastrazole, steroids, Inhibitors such as exemestane), antiangiogenic proteins, small molecules, gene therapy agents and / or other agents that inhibit angiogenesis or angiogenesis of tumors (Eg, meth-1, met-2, thalidomide), bevacizumab (Avastin), squalamine, endostatin, angiostatin, Angiozyme, AE-941 Neovastat), CC-5013 (Revimid), medi-522 (Vitaxin), 2-methoxyestradiol (2ME2, Panzem), carboxyamido (CAI), combretastatin A4 prodrug (CA4P), SU6668, SU11248, BMS-275291, COL-3, EMD 121974, IMC-1C11, 1M862, TNP-470, celecoxib (Celebrex) ), Rofecoxib (Vioxx), interferon alfa, interleukin-12 (IL-12), or those described in Science Vol. (Eg, interferon, bacillus calmetteguerin, BCG, monoclonal antibody, interleukin-1, interleukin-1, interleukin-1, Granulocyte colony stimulating factor (GCSF), etc.), PGDF receptor antagonist, Herceptin, asparaginase, epidermal growth factor, carboplatin, cisplatin, carmustine, chlorambucil, cytarabine Methotrexate, thioguanine, thiotepa, tamoxifen, thiotepa, tamoxifen, erythropoietin, erythropoietin, erythromycin, As well as analogues / derivatives (congeners) and derivatives of such compounds, as well as the compounds of formula (I), as well as the compounds of formula May include other anti-tumor agents not listed herein.

Additionally or alternatively, in some applications, such as where it is desired to grow new cells or to modify existing cells, the material delivered in the present invention can be used to treat cells (mucosal cells, fibroblasts, stem cells, A gene delivery vehicle such as a plasmid, adenoviral vector or naked DNA, mRNA or the like, which is injected with a gene encoding a gene as well as a gene, a gene, and an anti-inflammatory substance, and the like, and as described above, An osteoclast that alters or softens the bone, a cell that participates in or causes mucus production or ciliogenesis, and the like.

In addition to, or in addition to being combined with the device and / or substance release pattern, it may be ideal to position the device in a specific position (i.e., frontal or fulgic bar) upstream of the mucus flow path. This allows for the deployment of fewer drug release devices and allows for "bathing " of all of the downstream tissues by the desired drug. The use of this mucus as a carrier for the drug may be ideal, in particular because the concentration on the drug may be highest in the region where the mucus is retained, while the unblocked region with a good mucus flow Because it will be less affected by drugs. This may be particularly useful in tumors or chronic sinusitis where higher concentrations of the drug at these particular sites may have a greater therapeutic benefit. In all such cases, local delivery will enable these drugs to have a much less systemic effect. It may also be ideal to construct a composition or delivery system of the drug so as to maintain a weak affinity for mucus and to be uniformly distributed during flow. Also, in some applications, a solute, such as a salt or other mucolol-soluble substance, rather than a drug, may be placed in place, whereby the mucus will contact the substance and a large amount of the substance will dissolve in the mucus, For example, pH, osmolality, etc.). In some cases, this technique can be used to make the mucus hyperosmotic so that flowing mucus pulls water and / or other fluids from the polyp, edematous mucosal tissue, etc. to provide a drying or dehumidifying therapeutic effect.

The aforementioned treatment of the patient's eustachian tube allows the treatment device to be advanced through the guide catheter towards the eustachian tube to position the distal tip of the treatment device adjacent the eustachian tube opening. It may be desirable for the treatment device to have a radiopaque distal member. The treatment device may comprise a catheter.

Alternatively or additionally, the treatment device may include a fluid introduction device for introducing fluid into the patient's ear space. The fluid may be air, a contrast agent, a suction fluid, or a drug as described above. The method of treatment may also include scanning the mid-space using an ultrasonic device. Alternatively or additionally, the treatment device may comprise a suction device for suctioning the material from the middle space.

Alternatively or additionally, the treatment may also include the step of introducing the protective device adjacent to the eustachian tube and monitoring the advancement of the treatment device using a protective device. The protection device may be a sensor positioned adjacent to the eardrum to sense the position of the therapy device during advancement. Alternatively, the protective device may include an endoscope that visualizes the advancement.

Alternatively or additionally, a method for treating a patient's eustachian tube comprises disposing a dual lumen pressure equalization tube through a patient's eardrum, the dual lumen pressure equalization tube having a distal extension for localization of the eustachian tube; Providing a drug to a region of the eustachian tube through a first lumen of a dual lumen tube in fluid communication with the distal extension; And providing venting through the eardrum through the second lumen of the dual lumen tube. Drugs are used to reduce edema in the eustachian tube area.

The drug may also comprise a surfactant configured to alter the surface tension of the mucosal layer of the eustachian tube to achieve improved wetting of the mucosal surface by the drug. The drug may also include particles that are trapped by mucosal tissues of the eustachian tube and used to achieve sustained release of the drug. Exemplary surfactants are disclosed in U.S. Patent No. 6,616,913, entitled " Composition and Method for Treatment of Otitis Media, " the disclosure of which is incorporated herein by reference. do.

In another embodiment, the invention is directed to an apparatus for treating a patient's eustachian tube. The device includes a dual lumen tube for insertion into the eardrum of a patient ' s ear. The tube may include a distal extension for intra-zone deployment of the eustachian tube, a first lumen for providing drug to the area of the eustachian tube via the distal extension, and a second lumen for providing venting over the eardrum.

The first lumen may be disposed within the second lumen. Alternatively, the second lumen is disposed within the first lumen. Additionally or alternatively, the first lumen is disposed adjacent to the second lumen. The dual lumen tube may be made of or comprise a biodegradable bioabsorbable material.

In another embodiment, the present invention relates to the treatment of the eustachian tube by delivering the drug to the eustachian tube. The method includes the steps of accessing the eustachian tube region through the nasopharynx using a guide having a lumen; Introducing a guide wire through the lumen of the guide to position the guide wire under the mucosa between the mucosal surface of the Eustachian tube and the cartilage; Passing transient lumen implants with drug delivery storage along the guide wire to position the implant under the submucosa in the posterior elevation of the eustachian tube area between the lumen and cartilage; And transferring the drug from the drug delivery storage to the eustachian tube area.

Additionally, the method may also include simultaneously delivering the drug from the drug delivery reservoir to the pharyngeal and eustachian tube regions. In one embodiment, the drug delivery reservoir may comprise a coating layer disposed on the implant. In another embodiment, the guide comprises a biodegradable bioabsorbable material.

In another embodiment, the treatment of the patient's eustachian tube includes achieving access to the eustachian tube area through the nasopharynx, including a plurality of holes dimensioned to be located within the eustachian tube area and disposed at or near the distal end Introducing a hollow guide wire through the nasopharynx of the patient and delivering the drug to at least one of the middle ear region or the eustachian tube of the patient's ear through the hole.

In another embodiment, the drug can be delivered to tissue within the eustachian tube via iontophoresis. In such an embodiment, the drug fluid may be moved into the eustachian tube and an electrical current may be applied to the fluid to cause ions of the drug to cross the tissue, such as mucosa or eardrum.

In another embodiment, the present invention is directed to a system for accessing a patient's eustachian tube. The system includes a guide having a distal tip configured to pass into a patient ' s nasal passage for positioning the distal tip of the catheter in or near the eustachian tube and having a bend with an angle of 30 to 90 degrees; And a guide wire configured to pass through the guide and into the eustachian tube.

In one embodiment, the guide includes a catheter. In another embodiment, the guide includes a dual lumen tube. In another embodiment, the system may also include a diagnostic device configured to pass the guide. In another embodiment, the system may also include a treatment device configured to pass the guide.

Non-guide wire device

15A illustrates an apparatus 1500 for treating a eustachian tube according to one embodiment. Apparatus 1500 includes a long rigid shaft 1502. The stiffness shaft may be comprised of semi-flexible metal or plastic. "Rigidity" used in connection with apparatus 1500 means that shaft 1502 will not be deformed when inserting shaft 1502 into the nasal cavity. The rigid shaft 1502 can be formed of a malleable material and can be bent on demand for field use. In this example, a treatment device, which is a long flexible insert 1504, is coupled to the distal portion of the rigid shaft 1502. A stop may be placed at the insert 1504 / shaft 1502 junction to prevent the shaft from entering the eustachian tube. The insert 1504 preferentially includes lateral stiffness such that when the insert 1504 is inserted into the eustachian tube, it conforms to the path of the eustachian tube and does not cause significant deformation of the eustachian tube. The insert 1504 may also include a preformed shape (not shown) that is preformed, for example, in accordance with the anatomical structure of the eustachian tube. Insert 1504 preferentially includes column rigidity that is strong enough to be inserted into the eustachian tube without collapsing or buckling on itself. This example of insert 1504 includes a core wire 1506 and an expandable balloon 1508. The core wire 1506 may be composed of a metal such as stainless steel or a superelastic alloy such as nickel-titanium. A core wire 1508 having a diameter in the range of 0.05 to 0.25 mm may be suitable. The balloon 1508 may have a flexible, semi-flexible, or non-flexible configuration. The balloon 1508 may include a preformed feature that matches the profile of the eustachian tube. The balloon 1508 may include a micropore to deliver any of the therapeutic materials described herein when partially or fully expanded. Balloon 1508 may include a coating to deliver any of the therapeutic materials described herein. The device 1500 may include a ball-shaped non-traumatic tip 1510 that may be integral with the core wire 1506. The device 1500 may include a fitting 1511 in the proximal portion of the shaft 1502 for supplying fluid, energy, and electrical signals to the insert 1504. Thus, the apparatus 1500 may include a lumen for passage of fluid. The device 1500 does not require a guide wire for insertion into the eustachian tube, but a guide wire may optionally be used.

The device 1500 can be inserted manually by grasping the shaft 1502 and guiding the insert into the nasal passages and nasopharynx and into the eustachian tube by scope, fluoroscopy, or transillumination have. Accordingly, portions of device 1500 may include a radiopaque coating or material. The insert 1504 may include an optical fiber for transmitting light for transmission. Examples of transfer devices are disclosed in commonly assigned U.S. Patent Applications 10 / 829,917 and 11 / 522,497, both of which are incorporated herein by reference in their entirety. The insert 1504 may also include a CCD or CMOS camera for endoscopic observation, and associated wiring, without a separate scope. Device 1500 may also be coupled to a 3-D tracking system.

The illustrated insert 1504 is merely an example and may include other configurations such as bare wire. The uncovered wire may deliver energy, such as resistance heat, ultrasound, or electrosurgical energy (e.g., RF). The energy can also be delivered by the balloon 1504, for example by a hot fluid or a gas.

Insert 1504 may also deliver a stent for supporting or expanding the eustachian tube. The stent may comprise a polymeric material capable of eluting any of the therapeutic agents disclosed herein.

The insert 1504 may also be removable from the shaft 1504 for delivery into the eustachian tube. In one embodiment, the insert 1504 may be constructed from biodegradable polymers, such as polylactic acid, which may also include any of the therapeutic materials disclosed herein. The insert 1504 is then disassembled over time and can deliver the therapeutic material as needed. The biodegradable insert 1504 may also include a lumen for discharge of fluid within the eustachian tube.

FIG. 15B shows an alternative device 1512 for treating a eustachian tube according to one embodiment. The apparatus 1512 is generally constructed as shown in FIG. 15A, but this embodiment includes a rigid shaft 1514 that includes distinctive bends 1516. The bend 1516 may range from 30 to 90 degrees. The bend 1516 allows easier access to the eustachian tube within a given anatomical structure.

FIG. 15C shows an in-use device 1500 or 1512 in accordance with one embodiment. Apparatus 1500 is shown with insert 1504 disposed within eustachian tube ET. The insert 1504 is preferentially deformed to match the profile of the eustachian tube (ET), thus delivering the treatment without modifying or damaging the eustachian tube (ET). Alternatively, the insert 1504 is preformed to match the profile of the eustachian tube and slightly deformed during positioning. The insert 1504 also includes significant post stiffness sufficient to prevent buckling of the insert during insertion into the eustachian tube (ET), thereby preventing damage to the device or the eustachian tube (ET).

FIG. 15D shows an in-use device 1500 or 1512 in accordance with one embodiment. In this embodiment, the device 1500 includes a stent 1518 that can be expanded within the eustachian tube (ET). The stent may include a deformable configuration or a shape-memory alloy configuration that is expanded by balloon 1508.

15D illustrates an in-use device 1500 or 1512 in accordance with one embodiment. In such an embodiment, the apparatus 1500 includes a detachable insert 1520. The detachable insert may be detached at the junction 1522. In this example, the insert 1520 includes a lumen. The insert 1520 can be biodegradable and can deliver the therapeutic material over a period of time. In one embodiment, the insert 1520 may include an attachment member for attaching the insert 1520 to mucosal tissue within the nasal cavity, such that the insert 1520 will not move from the region in which it is placed. This attachment member (or a number of members) may be attached to the insert 1520 at or near the proximal end of the insert 1520 such that when the insert 1520 is positioned within the eustachian tube, And may be attached to mucosal tissue by a physician. In various embodiments, any suitable attachment member, such as, but not limited to, a sealing loop, clip, barb, etc., may be used.

15F illustrates another alternative embodiment of a guide wire extensions 1530 without a guide wire. In this embodiment, the expansion device 1530 includes a handle 1532 that engages a slide balloon catheter 1540 and a malleable guide member (or "shaft") 1544 on which the balloon catheter 1540 slides do. A slide actuator 1538 for advancing and retracting the suction port 1534, the inflation port 1536 and the balloon catheter 1540 along with the guide member 1544 is also engaged with the handle 1532. In this embodiment, the balloon catheter includes a rigid proximal portion 1541, a flexible distal portion 1546, and an inflatable balloon 1548. The guide member 1544 may include a ball tip 1542 similar to that found at the distal end of a ball-tip seeker frequently used by ENT physicians during sinus surgery. Proximal shaft portion 1541 may be made of any suitable material. For example, in one embodiment, proximal shaft portion 1541 may be a stainless steel hypotube. The flexible distal shaft portion 1546 may be made of any flexible material, such as a flexible polymer, and the balloon 1548 may be made of any suitable material including, but not limited to PET, nylon or Pebax May be made of suitable non-flexible, semi-flexible or flexible materials. In various embodiments, the guide member 1544 can be flexible, malleable or rigid and can be made of stainless steel, Nitinol or any other suitable material.

In use, the expanding device 1530 can be advanced into the nostril, and the guide member 1544 can be advanced by its ball tip 1542 in substantially the same manner as the ENT physician uses the ball tip seeker to find the opening of the sinus, Can be used to locate and locate the opening of the eustachian tube. Once the eustachian tube opening is located, guide member 1544 can be advanced through the opening and slide actuator 1538 is advanced along a slot (not visible in FIG. 15F) in handle 1532 to engage balloon catheter 1540 Can be advanced along the guide member 1544. Fig. The balloon catheter 1546 is advanced to place the balloon 1548 at a desired position in the eustachian tube. The balloon 1548 can then be expanded through the expansion port 1536 to expand / extend a portion of the eustachian tube, and then the balloon 1548 can be retracted. The balloon 1548 may subsequently be removed from the patient or repositioned in the same eustachian tube to expand the additional portion or reposition to the opposite side of the eustachian tube to expand such a tube. Such an operation may be performed as many times as desired to the patient and in any combination of positions. In some embodiments, the dilator 1530 may also be used to expand the opening (or a plurality of sinus openings) into the sinus. The sinus opening extension may be performed before and / or after expansion of the eustachian tube and may be associated with an opening into the frontal sinus, sphenoid sinus, maxillary sinus or ethmoid sinus. In some embodiments, the expansion device 1530 is removed from the patient between expansions to allow the user to bend the malleable portion of the guide member 1544 at different angles to facilitate access to different sinuses and / or Eustachian tube openings .

In an alternative embodiment, the guide member 1544 may be an external vessel through which the balloon catheter 1540 advances. Such tubing may be primarily rigid, partially stiff / partially flexible, or mostly flexible. In another alternative embodiment, guide member 1544 may include both an inner shaft and an outer tube. In another embodiment, the balloon catheter 1540 may be securely attached to the guide member 1544 (or shaft). In another embodiment, there may be only a rigid or partially rigid and / or malleable balloon catheter 1540 without a guide member, which may be advanced alone into the eustachian tube without the use of a guide. In other embodiments, any other suitable expanding device, such as but not limited to a mechanical expander, such as an expandable metal basket, including a plurality of tines, may replace the balloon catheter 1540.

16A and 16B illustrate methods for providing treatment to a patient's eustachian tube according to one embodiment. Before the treatment method is performed, the physician may apply local anesthesia to the nasal cavity and / or the eustachian tube. If performed under general anesthesia, the physician may choose not to apply local anesthesia, while local anesthesia may be applied if performed in a conscious patient. In general, the method may include any required preparation / anesthesia technique. In some embodiments, for example, the physician may choose to wash the nasal and / or eustachian tubes prior to performing the treatment. This can be done in addition to or in the absence of local anesthesia.

After any desired preparation of the nasal and / or eustachian tubes, the guide catheter 1600 may be routed through the nasal passages of the patient and placed adjacent to the opening of the eustachian tube (ET). In various embodiments, the guide catheter 1600 can be advanced through the east or opposite nostrils to the eustachian tube, and generally the guide catheter 1600 will have a different bending angle depending on the approach. In the illustrated embodiment, the distal portion 1602 of the guide catheter 1600 includes a bend having an angle of 30 to 90 degrees (or any other angle in alternative embodiments). In one embodiment, the distal portion 1602 may be more flexible than the proximal portion of the guide catheter 1600. In one embodiment, the distal portion 1602 of the guide catheter may be malleable. Thus, the user can flex the distal portion 1602 to position the guide catheter 1600 at a desired position relative to the eustachian tube ET.

After the guide catheter 1600 is in the desired position, the guide wire 1604 can then be advanced through the guide catheter 1600 and into the eustachian tube ET. In the illustrated embodiment, the guide wire 1604 includes a ball tip 1603 to prevent passage of the guide wire 1604 through the distal portion of the small diameter of the eustachian tube. Other embodiments may include curved distal tips or other stop mechanisms to achieve the same purpose. As mentioned above, although this embodiment of the method for treating the eustachian tube includes the guide catheter 1600 and the guide wire 1604, an alternative treatment method is to use only the guide catheter 1600, only the guide wire 1604 Or may be performed without any guide device.

In Fig. 16B, an expanding catheter 1606 is advanced over the guide wire 1604 and through the guide catheter 1600 to place the expander 1608 of the expanding catheter 1606 within the eustachian tube ET. In an alternative embodiment, the guide catheter 1600 may be selectively removed from the patient prior to advancing the expanding catheter 1606 over the guide wire 1604. In another alternative embodiment, the expanding catheter 1606 may be advanced through the guide catheter 1600 into the eustachian tube without using the guide wire 1604. The expansion catheter 1606 generally includes an elongate shaft and an expander 1608. The expander 1608 can be a polymer balloon (flexible, semi-flexible or non-flexible). In some embodiments, the balloon may be porous to deliver a therapeutic or diagnostic agent when pressurized. Alternatively, the expander 1608 may be any of a number of other suitable mechanical expansion devices or a mechanically expandable basket constructed from a plurality of metal or polymer tines. Expansion catheter 1606 generally includes a proximal positioned connection / dispensing portion for expanding / actuating expander 1608. The therapeutic or diagnostic agent may be applied to the interior of the eustachian tube (ET) before or after insertion of the expanding catheter 1606, e.g., via a spray lumen or spray catheter of the guide catheter 1600. In one embodiment, for example, the expanding catheter 1606 can include a fluid introduction lumen (or multiple lumens) for introducing a cleaning fluid, an anesthetic fluid, a therapeutic drug, or other material into the eustachian tube. In one embodiment, this same lumen or separate lumen may be used to inhale fluid / material from the eustachian tube.

The expander 1608 may be enlarged to expand the eustachian tube after it has been placed at the desired location within the eustachian tube (ET). For example, the opening area of the eustachian tube (ET) may include a pharyngeal pore, and an expanding catheter 1606 may be advanced to place the expander 1608 in the pharyngeal pore. An endoscope can be used to help locate the expanding catheter 1606. [ The endoscope can be advanced through the nasal passage to observe the expanding catheter 1606. [ A marker on the shaft of the expanding catheter 1606 is observed from the endoscope to roughly grasp the position of the expander 1608 relative to the opening of the eustachian tube ET based on the distance of the marker from the proximal end of the expander 1608 . Thus, the expanding catheter 1606 can be moved to place the marker in the desired position prior to enlargement of the expander 1608 in the eustachian tube (ET).

The expander 1608 may remain in that position while being in the expanded state for a long period of time (e.g., seconds or minutes). Expander 1608 may also deliver a substance such as one or more of the therapeutic or diagnostic agents described herein to the eustachian tube (ET). The expander 1608 may also carry an expandable stent for delivery into the eustachian tube upon expansion of the expander 1608. The expanding catheter 1606, the guide catheter 1600 and the guide wire 1604 can be removed from the patient after the expander 1608 is contracted / unexpanded.

As noted above, in an alternative embodiment, the balloon expanding catheter may be advanced into the eustachian tube and occasionally used in the eustachian tube without the use of a guide wire, a guide catheter or other guiding device. Such a balloon catheter would need to have sufficient overall stiffness to allow it to move through the nasal cavity and into the eustachian tube without a guide device, but ideally also at least the distal portion of the catheter would have to be meandered It will be sufficiently flexible to advance into the mold of the Eustachian tube and conform to its shape. In some embodiments, such a balloon expanding catheter may have an adjustable stiffness along at least a portion of its length. For example, in one embodiment, the catheter may have a malleable portion that the pseudo-user can adjust with his or her hand before insertion. However, it may be even more advantageous to have a catheter that can be advanced into the eustachian tube with any positive stiffness and then be adjusted to a different amount of stiffness. For example, it may be desirable to have the catheter, which is relatively rigid until the distal end of the catheter is moved into the eustachian tube, and may become more flexible to move further into the eustachian tube. In one embodiment, this adjustable stiffness is achieved by a proximal portion of the catheter that extends into the distal portion of the catheter where rigidity adjustment is desired and which the user uses to perform the adjustment, or a proximal portion of the catheter, Can be accomplished using a sliding stiffening mandrel. In other embodiments, the reinforcing member (or members) may include one or more core wires, ribbons, compressible fluids, and the like. The proximal member used to control the stiffness may include a slide, a dial, a button or other actuator.

Figure 17 shows an illuminated guide wire 1700 in use according to one embodiment. The illuminated guide wire 1700 is used in the same manner as the guide wire 1604 described above. However, the illuminated guidewire 1700 provides illumination at the distal tip 1702, which is visible to the user on the external surface of the patient or through the eardrum (commonly referred to as "urge"). The user can position the distal tip 1702 at a desired location based on the location of the light spot 1704 passing through the tissue of the patient. The light spot 1704 can be used as a reference point for placement of other devices based on the relative distance from the light spot 1704. The light spot 1704 may also provide a secondary or primary light source for an endoscope that is observing the pharyngeal pores of the eustachian tube (ET). The illuminated guide wire 1700 may include a fiber optic channel for passing light from the light source to the distal tip 1702. Examples of illuminated guidewires and scopes that can be used with the present invention are shown and described in commonly assigned U.S. Patent Application No. 11 / 522,497, which is incorporated herein by reference in its entirety.

18A and 18B illustrate an expanding catheter 1800 according to an alternative embodiment. The expanding catheter 1800 includes a detachable expander 1802. The detachable expander 1802 can be detached from the expanding catheter 1800 after the detachable expander 1802 is enlarged within the eustachian tube ET. Detachable expander 1802 may include a one-way valve that causes detachable expander 1802 to remain expanded after separation from expanding catheter 1800. A fracture joint may connect the expandable catheter 1800 with the detachable expander 1802. Detachable expander 1802 may include at least one lumen that allows passage of pressurized fluid. In use, the expanding catheter 1800 may be positioned and enlarged to expand a portion of the eustachian tube as described for the previous embodiment. After the detachable expander 1802 is inflated, it can be disengaged from the fracture joint through a torsional force or a tensile force applied at the proximal portion of the expanding catheter 1800. The one-way valve prevents the detachable expander 1802 from being retracted after removal from the expansion catheter 1800. Detachable expander 1802 may include a therapeutic or diagnostic agent for treating the eustachian tube (ET). The pressure in the eustachian tube (ET) can be balanced through the lumen while the detachable expander 1802 remains expanded within the eustachian tube. The detachable expander 1802 can be removed by pulling it out of the eustachian tube ET, and in some embodiments also by puncturing the detachable expander 1802.

18C illustrates an expanding catheter 1804 in accordance with an alternative embodiment. The expanding catheter 1804 includes a plurality of extendable needles 1806 that can extend through the passageways in the expander 1808. Each needle 1806 may be fluidly connected to a therapeutic or diagnostic agent such as a syringe. Different needles 1806 can be connected to different types of therapeutic or diagnostic agents. In use, the expanding catheter 1800 may be positioned and enlarged to expand a portion of the eustachian tube as described for the previous embodiment. After the expander 1808 is inflated, the needle 1806 may be advanced through the expander 1808 and into the tissue of the eustachian tube (ET). The needle 1806 can then be injected with one or more therapeutic or diagnostic agents into the tissue of the eustachian tube (ET), as shown by the material plume (P). After the substance is injected into the tissue of the eustachian tube (ET), the needle may be retracted back into the expanding catheter 1804, and the expanding catheter 1804 may be removed from the eustachian tube (ET).

18D shows an expanding catheter 1810 in accordance with an alternative embodiment of the expanding catheter 1606. As shown in Fig. The expanding catheter 1810 includes at least a pair of opposed lateral wings 1812, which help maintain the position of the expander 1814 in the eustachian tube ET. More than one pair of opposing lateral wings 1812 may be used. The lateral wings 1812 do not have to be positioned opposite to each other and the configuration of the odd number of lateral wings 1812 may be used. The lateral wing 1812 can be configured as a long tine that is spring biased to expand when advanced out of the shaft 1816 of the expanding catheter 1810. Retracting the slidably received lateral wings 1812 will cause them to collapse within the shaft 1816. The lateral wing 1812 can be manipulated at the proximal end of the expanding catheter 1810, for example, through operation of a slider mechanism. The lateral wings 1812 may include spikes or grips that help maintain non-mobile contact with the eustachian tube ET. In use, the expander 1814 and the lateral wing 1812 are advanced simultaneously or simultaneously out of the shaft 1816 (i.e., the lateral wing 1812 is advanced before or after the expander 1814) . The lateral wing portion 1812 applies a force to the wall of the opening of the eustachian tube (ET), which helps maintain the expander 1814 in the desired position. The lateral wings 1812 may be retracted back into the shaft 1816 after the expander 1814 has applied the desired treatment to the eustachian tube ET.

Figures 18e-18t show various views of an alternative embodiment of the expander 1608. [ For example, FIGS. 18e-18g illustrate expander 1817 with a tapered conical shape that compensates for the tapered geometry of the eustachian tube (ET) and improves its expansion. The tapered conical shape of the expander 1817 is formed by a proximal end 1832, a tapered proximal surface 1830, a maximum diameter portion 1831, a tapered distal surface 1818, and a distal end 1833. In this example, the tapered distal surface 1818 has a longitudinal length of about 12 to 18 millimeters, the largest diameter portion 1831 has a diameter of about 6.5 millimeters, and the proximal end 1832 and the distal end 1833 have a diameter Has a diameter of about 4.5 millimeters. Alternatively, any other suitable dimension may be used. The expander 1820 may also have a variable shape, such as the stepped shape shown in Figure 18h. In the case of this stepped configuration, the expander 1820 includes at least two different outer diameter portions, a first outer diameter portion extending along the proximal length of the expander 1820 and a second outer diameter portion 1860 extending along the distal length of the expander 1820. [ And an oblique transition portion between the outer diameter portion and the outer diameter portion.

Problems may arise from expanders 1817 and 1820 that extend the eustachian tube (ET) by contacting uniformly along the entire circumference of the eustachian tube (ET). When the expanders 1817 and 1820 are expanded in the eustachian tube, air is evacuated due to an increase in the volume of the expanders 1817 and 1820. If air moves toward the middle ear 14 rather than the throat non-throat region 30, pressure may be created in the middle ear 14 and damage to the eardrum 22 may result. The pressure may partially cause expanders 1817 and 1820 to act as seals in the eustachian tube (ET). Providing a fluid communication between the proximal end 1832 and the distal end 1833 of the expanders 1817 and 1820 may result in a pressure rise that may occur in the middle ear 14 due to the expanding expanders 1817 and 1820 It can help you get rid of it. In other words, as the expanding expanders 1817 and 1820 begin to occupy space in the lateral area of the eustachian tube ET, a vent path is provided to allow air to escape from the lateral area of the eustachian tube ET Can be beneficial. In addition, controlling the direction of exhaust air due to enlargement of the expanders 1817, 1820 can also help prevent possible pressure buildup in the middle diaphragm 14. The following are only illustrative examples of different devices and methods that may be used to prevent pressure buildup in middle ear 14 and that may also provide an extension of the eustachian tube (ET). Other examples of devices and methods will be apparent to those skilled in the art in light of the teachings herein. It should be understood that the method and expander features described below may be combined in various ways to help prevent unwanted pressure buildup in the middle ear 14.

Extenders 1817 and 1820 may be attached to a shaft 1822 that extends through both the proximal and distal ends 1832 and 1833 of the expanders 1817 and 1820 as shown in Figures 18e and 18h. have. The shaft 1822 includes a vent lumen 1834 extending through the expanders 1817 and 1820, a set of proximal pressure relief holes 1824 located proximal to the proximal end 1832, 1833 located on the source of the pressure relief hole. The pressure relief holes 1824 are oriented laterally through the shaft 1822. The pressure relief aperture 1824 can provide fluid communication between the proximal end 1832 and the distal end 1833 of the expanders 1817 and 1820 through the vent lumen 1834. This fluid communication path may be used to provide pressure equalization in the eustachian tube ET by preventing the pressure rise in the middle diaphragm 14 from being provided by enlargement of the expanders 1817, 1820. In other words, when the expanders 1817 and 1820 are inflated, the air in the region of the eustachian tube ET above the circle of the expanders 1817 and 1820 is expanded by the expanders 1817 and 1820, And can be exhausted through the pressure relief hole 1824 as occupying the distal area. The number of pressure relief holes 1824 shown in Figures 18e and 18h is merely exemplary. The shaft 1822 may include additional or fewer pressure relief holes 1824 if desired. It should also be appreciated that the shaft 1822 includes a separate expansion lumen (not shown) that may be used to expand / contract the expanders 1817, 1820. Such an expansion lumen will be fluidly isolated from the vent lumen 1834. Moreover, the expandable portion of the expanders 1817, 1820 will be fluidly isolated from the vent lumen 1834.

181 to 18n have a cross-sectional geometric structure that does not contact and occupy the entire circumference of the eustachian tube ET, thereby providing a seal between the proximal and distal ends of the expanders 1850, 8900, 9000, 9100, 9200 when inflated. Illustrate exemplary expanders 1850, 8900, 9000, 9100, and 9200 that enable fluid communication of a fluid. Thus, as discussed in more detail below, the cross-sectional geometry of the expanders 1850, 8900, 9000, 9100, and 9200 prevents the sealing effect from occurring all the time.

Figs. 18i and 18j illustrate one exemplary cross-sectional geometry for the expander 1850. Fig. The expander 1850 includes a proximal end 1856, a distal end 1851, a lumen 1853, a plurality of lobes 1854 separated by a plurality of recesses 1855, and a tapered surface 1852 . In this example, a tapered surface 1852 is located at both the proximal end 1856 and the distal end 1851. However, the tapered surface 1852 is only optional, and may or may not be present on one end. In this example, the lobes 1854 are angularly spaced equidistantly about a longitudinal axis defined by the shaft 1822. The cross-sectional shape of the expander 1850 is formed by successive spaced lobes 1854 and recesses 1855; This is generally similar to the "+" sign. The cross-sectional shape of the expander 1850 provides limited contact with the eustachian tube ET when the expander 1850 is inflated, thereby preventing the sealing effect from occurring. In other words, the groove 1855 provides a vent path along the length of the expander 1850. Optionally, as in expanders 1817 and 1820, pressure relief holes may be used past proximal end 1856 and distal end 1851 to provide additional pressure relief. Additionally, the tapered surface 1852 does not need to be uniform, but has a dimensional change similar to the tapered surfaces 1818, 1830 of the expander 1817 so that the patient's eustachian tube (ET) Lt; / RTI >

Figures 18k-18p illustrate examples of expanders 8900, 9000, 9100; This has a cross-sectional geometry that varies along the length of the expanders 8900, 9000, 9100, while still providing fluid communication between the proximal and distal ends of the expanders 8900, 9000, 9100 when inflated.

For example, FIGS. 18k and 18l illustrate a rib 8901 separated by a proximal end 8904, a distal end 8907, an annular groove 8902, a distal end 8907 from a proximal end 8904, And a shaft 8903 with a lumen 8904 extending through the expander 8900. The expander 8900 includes an elongate groove 8905 extending through the elongate groove 8905, The rib 8901 is an aspect of the expander in contact with the eustachian tube ET while the annular groove 8902 and the longitudinal groove 8905 are in fluid communication with the proximal end 8904 and the distal end 8905, Thereby preventing any sealing effect that would otherwise result in an undesired pressure rise in the middle diaphragm 14 of the expander 8900 when inflated. Optionally, as in expanders 1817 and 1820, pressure relief holes may be used in shaft 8903 past proximal end 8904 and distal end 8907 of expander 8900 to provide additional pressure relief have. Additionally, the dimensions along the length of the expander 8900 do not need to be uniform, but have a dimensional change similar to the tapered surfaces 1818, 1830 of the expander 1817, whereby the patient's eustachian tube (ET) It is possible to allow complementary alignment of the second region 8900.

Figures 18m and 18n illustrate that the expander 9000 is a lumen extending through the proximal end 9004, the distal end 9005, the expander body 9002, the separate bump 9001, 9006, which includes a shaft 9003. Separate bumps 9001 may be disposed symmetrically or randomly along the expander body 9002. When the expander 9000 is inflated, a separate bump 9001 may contact the patient's eustachian tube ET. The separate bump 9001 has sufficient stiffness to serve as a spacer between the eustachian tube ET of the patient and the expander body 9002. By providing a space between the expander body 9002 and the eustachian tube ET, a separate bump 9001 can be formed in such a space when the expander 9000 is inflated by providing a proximal end 9004 and a distal end 9005). As such, fluid communication between the proximal end 9004 and the distal end 9005 prevents any sealing effect, which would otherwise result in an undesired pressure rise in the middle ear 14 when the expander 8900 is inflated . Optionally, as in expanders 1817 and 1820, pressure relief holes may be used in shaft 9003 past proximal end 9004 and distal end 9005 of expander 9000 to provide additional pressure relief have. Additionally, the dimensions along the length of the expander 9000 do not need to be uniform, but have a dimensional change similar to the tapered surfaces 1818, 1830 of the expander 1817 so that the patient's eustachian tube (ET) (9000). ≪ / RTI >

Figures 18O and 18P illustrate that the expander 9100 includes a proximal end 9102, a distal end 9104, a body 9103, a helical rib 9101 along the body 9103, and a lumen RTI ID = 0.0 > 9105 < / RTI > Helical ribs 9101 provide contact with the patient's eustachian tube (ET) when the expander 9100 is inflated, thereby preventing the expander body 9103 from providing a sealing effect. In other words, the helical ribs 9101 provide a helical vent path along a space defined between the wall of the eustachian tube ET and the body 9103. Thus, helical rib 9101 provides a vent path between proximal end 9102 and distal end 9104 of dilator 9100. Optionally, as in expanders 1817 and 1820, pressure relief holes may be used on shaft 9105 past proximal end 9102 and distal end 9104 of expander 9100 to provide additional pressure relief have. Additionally, the dimensions along the length of the expander 9100 do not need to be uniform, but have a dimensional change similar to the tapered surfaces 1818, 1830 of the expander 1817 so that the patient's eustachian tube (ET) (9100). It should be noted that more than one helical rib 9101 may be used.

Figures 18q and 18r show a proximal end 9402, a distal end 9205, a body 9202, a fin 9201 extending longitudinally along the exterior of the body 9202, and a proximal end 9204, And a shaft 9203 with a lumen 9206 extending between the distal end 9205 and the distal end 9205 of the expander 9200. [ When expander 9000 is inflated, pin 9201 may contact the patient's eustachian tube ET. The pin 9201 has sufficient rigidity to serve as a spacer between the patient's eustachian tube (ET) and the expander body 9202 to prevent the wall of the eustachian tube from being sealed to the body 9202. The pin 9201 thus has a vent path 9204 between the proximal end 9204 and the distal end 9205 of the expander 9200 as the expander 9200 is inflated and the pin 9201 is brought into contact with the eustachian tube ET. Lt; / RTI > Such an aeration path may prevent unwanted pressure buildup, which may otherwise occur in the middle ear 14 due to the expansion of the expander 9200. Optionally, as in expanders 1817 and 1820, pressure relief holes may be used in shaft 9203 past proximal end 9204 and distal end 9205 of expander 9200 to provide additional pressure relief have. Additionally, the dimensions along the length of the expander 9020 do not need to be uniform, but have a dimensional change similar to the tapered surfaces 1818, 1830 of the expander 1817 so that the patient's eustachian tube (ET) It is possible to allow complementary alignment of the second lens 9200.

Figures 18s and 18t illustrate that a proximal end 9302, a distal end 9304, a body 9307, a vent tube 9301 that is not coaxial to the body 9307, and a proximal end 9302 of the expander 9300, And includes a shaft 9303 with a lumen 9306 extending through the end portion 9304 of the expander 9300. The vent tube 9301 can be attached to the body 9307 and thus can be inserted into the patient's eustachian tube ET simultaneously with the body 9307. Alternatively, the vent tube 9301 may be detached from the body 9307 to allow insertion of a vent lumen into the patient's eustachian tube ET before or after inserting the body 9307 into the patient's eustachian tube ET . The vent tube 9301 has an open distal end and an open proximal end, and the lumen extends between these ends. Thus, the vent tube 9301 effectively provides a vent path between the proximal end 9302 and the distal end 9304 of the expander 9300. Through the inner lumen of the vent tube 9301 through the space S (Figure 18t) between the wall of the eustachian tube ET and the area of the wall of the vent tube 9301 and the body 9307, Venting is achieved through the combination. The venting prevents the sealing effect, which can otherwise result in an undesired pressure rise in the middle diaphragm 14 when the expander 9300 is inflated.

Providing a path for venting through the geometry of the expanders 1818, 1820, 1850, 8900, 9000, 9100, 9200, 9300 avoids pressure buildup in the middle ear 14 during expansion of the eustachian tube (ET) Is just one example. 18E through 18W illustrate controlled expansion of the expander 9500 which pressurizes the air into the nasopharyngeal region of the throat 30 towards the inner region of the patient's eustachian tube ET, . In Fig. 18U, the expander 9500 is in the contracted state in the eustachian tube (ET). 18V, air is first introduced into the expander 9500 such that the distal end 9501 of the expander 9500 is inflated. First, inflating the distal end 9501 of the expander 9500 pressurizes the air in the proximal or medial direction, as indicated by the arrows in Figs. 18u-18w. The distal end 9501 of the expander 9500 provides a sealing effect to block the pressurized air from the middle ear 14. As additional fluid is delivered to the expander 9500, the expander 9500 extends from the distal / outer end 9501 of the expander 9500 toward the proximal / medial end 9502 of the expander 9500 toward the distal end of the expander 9500 It continues to expand gradually along its length. FIG. 18w shows both the proximal end 9502 and the distal end 9501, which are expanded to extend the eustachian tube ET.

Advancing the distal end 9501 first and then toward the proximal end 9502 can be accomplished in a number of ways. Distal expansion can be achieved, for example, by designing the distal end 9501 of the dilator 9500 to have a smaller wall thickness than the proximal end 9502 of the dilator 9500. Alternatively, the distal end 9501 may include a material having a density that is less than the material of the proximal end 9502 such that the distal end 9501 is first inflated. In yet another alternative, there may be a retractable outer sheath around the outer surface of the expander 9500. [ This sheath can initially be placed in a distal position and then slowly retracted in the proximal direction as the expander 9500 is inflated. Other methods of expanding the distal end 9501 of the expander first and then toward the proximal end 9502 will be apparent to those skilled in the art in light of the teachings herein.

Figure 18x illustrates a cutting (or "scoring") balloon expander 1826 in accordance with an alternative embodiment. The balloon expander 1826 includes a cutting member 1828 disposed circumferentially about its outer surface. In various embodiments, cutting member 1828 may be wires, sharp blades, one wire or sharp blade, small barbs or raised sharpened protrusions, and the like. The cutting member may be configured to transmit energy (e.g., RF). In use, the cutting member 1828 is enlarged with the expander and impinges on the eustachian tube ET, which causes the expander to open and extend along the controlled positions. Figures 18 (a) and 18 (z) show plots of the treated eustachian tube (ET) before treatment and after treatment. Cutting the eustachian tube ET along the controlled sections 1829 causes the eustachian tube ET to maintain its enlarged shape by at least partially disrupting the elastic response of the eustachian tube (ET) wall.

In an alternative embodiment of the cutting balloon dilator 1826, the cutting member 1828 may be disposed along only a portion of the circumference of the balloon 1826. This may be advantageous because in some cases it may be desirable to score only a fraction of the circumference of the eustachian tube. In some cases, it may be desirable, for example, to simply score the posterior aspect of the eustachian tube, perhaps because such portions will respond in the manner required for such treatment. In addition, in various embodiments, cutting member 1828 may have a variety of suitable heights, sharpness, or other cutting characteristics to provide a different level / depth of cut. This may be advantageous because different depths of cut in different eustachian tubes may be desirable.

In various embodiments of the method for treating a eustachian tube, the stent may be used to prop open the expanded portion of the eustachian tube, deliver the drug to the eustachian tube, or both. 19A illustrates a stent 1900 in accordance with one embodiment. The stent 1900 is configured as a tapered coil whose diameter gradually increases from the distal portion 1902 to the proximal portion 1904. The shape of the coil is similar to that of the pharyngeal pore of the eustachian tube (ET), so that its expansion can be improved. The stent 1900 may be comprised of a malleable or shape-memory alloy. Alternatively, the stent 1900 may be constructed of a biodegradable polymer. Stent 1900 can be configured to deliver and deliver a substance such as any of the therapeutic agents or diagnostic agents disclosed herein, for example, through a biodegradable polymer coating comprising such a substance. The polymeric coating may be formed from a polymeric material comprising a poly (dioxanone), a poly (trimethylene carbonate) copolymer, and a poly (caprolactone) homopolymer, a copolymer polyanhydride, a polyorthoester, , A matrix of lactose or glycolic acid or a blended material with a biodegradable polymer based on another material. The stent 1900 may be carried and delivered by an expanding catheter, such as any of the expansion catheters disclosed herein. In use, the stent 1900 maintains mechanical enlargement of the opening of the eustachian tube (ET) as shown. Alternatively, the stent 1900 may be configured to exert minimal force on the eustachian tube (ET) wall to provide mechanical assistance. The stent may be permanently placed in the eustachian tube (ET) or removed later. The open coiled configuration of the stent 1900 allows the stent 1900 to provide a substantially unobstructed path for venting through the eustachian tube ET while the stent 1900 is located in the eustachian tube ET. It should be understood.

19B shows a stent 1906 according to another embodiment. The stent includes a connecting member 1908 connecting a plurality of expandable tines 1910. The tines 1910 may be composed of a malleable or shape-memory alloy. Alternatively, the tines 1910 may be comprised of a biodegradable polymer. The others 1910 can be configured to transport and deliver materials such as any of the therapeutic agents or diagnostic agents described herein, for example, through a biodegradable polymer coating that includes the material. The polymeric coating may be formed from a polymeric material comprising a poly (dioxanone), a poly (trimethylene carbonate) copolymer, and a poly (caprolactone) homopolymer, a copolymer polyanhydride, a polyorthoester, , Lactic acid or glycolic acid, or a matrix of materials blended with biodegradable polymers based on other materials. The tines 1910 may be carried and delivered by an expanding catheter, such as any of the expansion catheters disclosed herein. The tines 1910 can be configured to self-expand radially upon removal from the constricting shaft or through force from the balloon. In use, the stent 1906 maintains mechanical expansion of the eustachian tube (ET) as shown. Alternatively, the stent 1906 may be configured to exert minimal force on the eustachian tube (ET) wall to provide mechanical assistance. The stent 1906 may be permanently placed in the eustachian tube (ET) or may be removed later. The open configuration of the stent 1910 allows the stent 1910 to provide a substantially unobstructed path for venting through the eustachian tube ET while the stent 1910 is located in the eustachian tube ET. It should be understood.

Figures 19c and 19d illustrate a stent 1910 according to another embodiment. The stent includes a distal connecting member 1912 connecting a plurality of expandable tines 1916 and a removable proximal connecting member 1914. The tines 1916 may comprise a shape-memory alloy. Alternatively, the tines 1916 may be comprised of a biodegradable polymer. The others 1916 can be configured to transport and deliver materials such as any of the therapeutic agents or diagnostic agents described herein, for example, through a biodegradable polymer coating that includes the materials. The polymeric coating may be formed from a polymeric material comprising a poly (dioxanone), a poly (trimethylene carbonate) copolymer, and a poly (caprolactone) homopolymer, a copolymer polyanhydride, a polyorthoester, , Lactic acid or glycolic acid, or a matrix of materials blended with biodegradable polymers based on other materials. The tines 1916 may be carried and delivered by an expanding catheter, such as any of the expansion catheters disclosed herein. The tines 1916 can be configured to self-expand in the radial direction upon removal from the retraction shaft. In use, the stent 1906 is delivered through a delivery catheter. The removable proximal connecting member 1914 is then removed to enlarge the proximal portion of the stent 1910, thereby enlarging the pharyngeal pores of the eustachian tube ET. Once in position, the stent 1906 maintains mechanical expansion of the eustachian tube (ET). Alternatively, the tines 1916 may be configured to exert minimal force on the eustachian tube (ET) wall to provide mechanical assistance. The stent 1910 may be permanently placed in the eustachian tube ET or removed later. The open configuration of the stent 1910 allows the stent 1910 to provide a substantially unobstructed path for venting through the eustachian tube ET while the stent 1910 is located in the eustachian tube ET. It should be understood.

FIGS. 20A, 20B and 20C illustrate a distal configuration of the guide catheter 1600 according to various embodiments. The illustrated distal tip can be configured to enter the eustachian tube to enable another device to advance into the eustachian tube (ET). 20A shows a tilted tip 2002 that allows for easier entry into the eustachian tube ET through the reduced forward edge. 20B shows a tapered tip 2004 that allows easier entry into the eustachian tube ET through the reduced forward edge. 20C shows a bulb-shaped tip 2006 that allows the guide catheter 1600 to seal the eustachian tube ET through an increased sealing area. The tip may be comprised of a flexible material, such as silicone or rubber, that provides a good sealing capability to the eustachian tube (ET). In use, the tip may seal the eustachian tube (ET) for treatment, such as application of pressure, suction, and / or material to the eustachian tube (ET).

21A and 21B illustrate an insert 2100 according to one embodiment. The insert includes a long central shaft 2102 from which a plurality of braces 2104 extend in a circumferential direction. Each brace 2104 is connected to an outer member 2106 that is rounded for placement against the eustachian tube (ET). Although the insert 2100 as shown includes three triangulated braces 2104, two or more braces 2104 may be used in an alternative embodiment. The insert 2100 may be composed of a flexible polymer extruded from a die. Alternatively, the insert 2100 may be constructed of a biodegradable polymer. The outer member 2106 can be configured to transport and deliver materials such as any of the therapeutic agents or diagnostic agents disclosed herein. The insert 2100 may be carried and delivered by an expanding catheter, such as any of the expansion catheters disclosed herein. The insert 2100 can be configured to self-expand upon removal from the retraction shaft. In use, the stent 1906 is delivered through a delivery catheter. Once in place, the insert 2100 maintains mechanical expansion of the eustachian tube (ET) as shown in Figure 21B. The insert 2100 provides and maintains an open space 2108 in the eustachian tube to maintain pressure equalization within the eustachian tube (ET). The insert 2100 may be permanently disposed in the eustachian tube (ET) or removed later. The open configuration provided by the open space 2108 of the insert 2100 allows the insert 2100 to be substantially in contact with the stent 1910 for venting through the eustachian tube ET while the stent 1910 is positioned within the eustachian tube ET. Lt; / RTI > can provide a barrier-free path.

22A shows a string insert 2200 according to one embodiment. String insert 2200 can be a long alloy or polymer string configured to carry and deliver materials such as any of the therapeutic agents or diagnostic agents described herein to the eustachian tube (ET). The string insert 2200 may be made from a poly (di-oxanone), a poly (trimethylene carbonate) copolymer, and a poly (caprolactone) homopolymer, a copolymer polyanhydride, a polyorthoester, , Or a biodegradable polymer based on lactic acid or glycolic acid or other materials. The string insert may be flexible to conform to the path of the Eustachian tube (ET). The string insert 2200 can be made of several strings in a braided form. The string insert may include a proximal loop 2201 to assist in removal from the eustachian tube (ET).

22B, 22C and 22D illustrate a delivery catheter for delivering the string insert 2200 to the Eustachian tube ET according to various embodiments. The delivery catheter 2202 is configured as a shaft and includes a snare 2204 for holding the string insert 2200 externally. The delivery catheter 2202 may be configured to slide on the guide wire 1604. In use, the snare 2204 can be actuated to release tension on the string insert 2200 and enable its removal from the delivery catheter 2202.

The delivery catheter 2204 is configured as a shaft that externally holds the string insert 2200, wherein the distal portion of the string insert 2200 is positioned internally. A slideable cutting member 2206 is movably received within the delivery catheter 2204. The delivery catheter 2204 may be configured to slide over the guide wire 1604. In use, the slidable cutting member 2206 moves in a distal direction to separate the string insert 2200 for separation from the delivery catheter 2204.

The delivery catheter 2208 is configured as a shaft that externally holds the string insert 2200 on the outer surface of the delivery catheter 2208. The delivery catheter 2208 may be configured to slide on the guide wire 1604. The connection 2210 between the delivery catheter 2208 and the string insert 2200 may be electrically fused. In use, connection 2210 is destroyed when a suitable current passes therethrough.

22E and 22F illustrate a string insert 2200 in use in accordance with one embodiment. String insert 2200 is delivered through delivery catheter 2212 and guide catheter 1600. A guidewire 1604 may also be used to aid delivery. Delivery catheter 2212 may be any of the delivery catheters described above. Once the string insert 2200 is placed in the eustachian tube (ET), the string insert can deliver the material over a sustained period of time. The string insert 2200 may remain permanently in the eustachian tube (ET) or may be removed later.

As previously mentioned, any implantable embodiment described herein, such as but not limited to those described in Figs. 21 and 22, may optionally include at least one fixation member for securing the implant within the eustachian tube or nasal cavity . Such anchoring members may help prevent unwanted movement of the implant out of the eustachian tube and may include, for example, a seaming loop, barb or clip.

In various alternative embodiments, any of a number of different endoscopes may be included as part of the methods and systems described above. For example, in some embodiments, a standard ENT endoscope, i.e., a zero degree endoscope, an angled endoscope, or a combination of both may be used. In another embodiment, a variable field endoscope such as a swing prism endoscope may be used. In another embodiment, a flexible endoscope such as an optical fiber or a CMOS scope may be used.

In some embodiments, an endoscope may be attached to or integrated within an expanding catheter (or other treatment catheter) or guide catheter. 23A-23C illustrate two embodiments of an endoscope attached to a guide catheter. Figure 23A shows a guide catheter 2300 placed in the nasal cavity (NC) with the distal end in the vicinity of the eustachian tube (ET). The guide catheter 2300 includes a side-mounted endoscope channel 2302 through which an endoscope, such as a flexible fiber scope, can be advanced or permanently disposed. 23B is an end-on cross-sectional view of guide catheter 2300 including instrument channel 2304 and endoscope channel 2303. FIG. Endoscopic channel 2302 may include optical fibers within core portion 2306 (or alternatively, chip) and illumination fibers within outer portion 2038, or vice versa. 23C shows two side channels that also include a mechanism channel 2312 but include a first channel 2314 for an optical fiber or chip and a second channel 2316 for the illumination fiber (or vice versa) Sectional view of an alternative embodiment of a guide catheter 2310 additionally provided. In various embodiments, any suitable combination and arrangement of channels may be used. In an alternative embodiment, the illumination fibers and / or optical fiber scope may be embedded within the walls of the guide catheter.

24A-24C show two alternative embodiments in which an endoscope is integrated into a balloon catheter. 24A, the balloon catheter 2400 may generally include a shaft 2402 and a balloon 2404. As shown in FIG. Figure 24B shows the balloon catheter 2400 in a sectional view from the perspective of line A-A of Figure 24A. In this embodiment, the outer ring is the balloon 2404, the middle ring 2406 is the channel through which the illuminating fibers pass, and the inner circle 2408 is the channel through which the visible fibers or chips pass. 24C, the balloon catheter 2410 may include an outer balloon 2414 that surrounds the channel 2416 for the passage of the illuminating fibers. In the alternative embodiment shown in FIG. There is also a helical support member 2418 (such as a wire) in the channel 2416 and an inner channel 2412 through which the visualized fibers or chips pass. In various embodiments, any combination and configuration of channels may be used.

In yet another alternative embodiment (not shown), any of the devices described herein can be combined with an endoscope using a sheath, some of which are known in the art and some that can be invented in the future have. The sheath may be disposable and may cover a portion of any suitable endoscope, such as, but not limited to, a standard endoscope, a variable vision endoscope, an inclined endoscope, etc., used by the ENT physician. The sheath may be placed on the endoscope (or a portion of the endoscope) and may include side channels through which one or more actuating devices, such as a guide catheter, a balloon dilation catheter, another therapeutic or diagnostic catheter, etc., may pass.

Referring now to Figure 25, in one embodiment, the eustachian tube access guide 2500 may include a hub 2502, a proximal shaft portion 2510, and a distal shaft portion 2512. The hub 2502 includes a stop 2504 on the proximal end, a suction port 2506 for connection to a suction source, such as a suction tube (not shown), and a finger to apply suction through the device 2500 And a finger hole 2508 for the finger. The distal shaft portion 2512 may include a bent portion 2516 and a distal tip 2514. In one embodiment, the eustachian tube access guide 2500 is a Lilie Baffex ™ sinus guide catheter (Relieva Flex ™ Such as a Sinus Guide Catheter (Acclarent, Inc., Menlo Park, Calif.).

The access guide 2500 may have any suitable length, diameter, and bend angle. For example, in various embodiments, the access guide 2500 may have an angle from about 0 degrees to about 180 degrees, and more preferably from about 30 degrees to about 90 degrees. In one embodiment, the proximal shaft portion 2510 can be made of hypotube, the distal shaft portion 2512 can be made of nylon, and the distal tip 2514 can be made of pellet. In various embodiments, the distal portion 2512 can be about 4 cm to about 8 cm, and more preferably about 6 cm, the proximal portion 2510 can be about 5 cm to about 15 cm, and more preferably, About 8 cm to about 12 cm.

Referring now to Figure 26, a balloon expanding catheter 2600 for expanding the eustachian tube includes, in some embodiments, a proximal hub 2602 including a finger hold 2603, a shaft 2604, and a balloon (not shown) 2606). The balloon dilatation catheter (2600) can be used to deliver the same features, dimensions and many of the other characteristics of the Lily Bar Solo Pro ™ Sinus Balloon Catheter or Lily Bar Solo ™ Sinus Balloon Catheter (Accraint, Inc., Menlo Park, Calif. . In some embodiments, one or more features, dimensions, etc. of such a catheter may be altered to facilitate use of the balloon catheter 2600 in the eustachian tube.

27, in one embodiment, a system 2700 for expanding the eustachian tube may include a guide device 2710 and a balloon dilatation catheter 2720. In one embodiment, The guide device 2710 may have any of the features or characteristics discussed with respect to the embodiments described above. In addition, the guide device 2710 may include a handle 2712 with a finger grip 2714. The handle 2710 can be coupled to the shaft 2716 and the balloon catheter 2720 can pass through the handle 2712 and the shaft 2716. [

Referring now to Figures 28A-28D, in one embodiment, a balloon dilatation catheter 2800 (Figure 28A) for expanding the eustachian tube comprises a stylet with a curved portion 2812 and a handle 2814 ). ≪ / RTI > As shown in FIG. 28C, when stylet 2810 is advanced into balloon catheter 2800, stylet 2810 has sufficient stiffness to maintain its original shape, so that the curved portion 2812 The curvature is imparted on the balloon catheter 2800. 28D, as the curved portion 2812 of the stylet 2810 turns the distal portion of the balloon catheter 2800 in the other direction by turning the handle 2814, the balloon catheter 2800 2800) can be steered. This is just one example of how balloon catheters 2800 can be steered in various embodiments.

In another embodiment, and now referring to Figures 29A and 29B, the balloon expander 2900 may include a throat shaft 2902 and an inflatable balloon portion 2904. As shown in Figure 29A, in one configuration, the traversing shaft 2902 may be elongated to advance the balloon portion 2904 into the eustachian tube. As shown in Figure 29B, in other configurations, the traversing shaft 2902 may be shortened to retract the balloon portion 2904 and / or initially advance the device 2900 into the nasal cavity. This embodiment is just one example of a way in which the expanding device can be advanced into the eustachian tube following the nasal cavity to expand the eustachian tube.

The various embodiments herein include an expansion mechanism that relies on inflation of the balloon to provide an extension of the eustachian tube (ET) (or any other anatomical passage). However, it should be understood that a variety of different types of instruments may be used to provide an extension of the eustachian tube (ET) (or any other anatomical passage). Such an alternative instrument may rely on the mechanical expansion of the instrument to provide an extension in addition to or instead of relying on the inflation of the balloon or other inflatable member to provide an extension. By way of example only, the mechanical extension is incorporated herein by reference in its entirety, filed March 16, 2015, entitled " Mechanical Dilation of the Paranasal Sinuses and Other Passageways of the Sinus, the Ear, Nose and Throat), the disclosures of which are incorporated herein by reference. Other suitable ways in which mechanical expansion may be provided will be apparent to those skilled in the art in light of the teachings herein.

30 and 31 illustrate an exemplary guide wire 50 that may be used with the above-described procedure. The guide wire 50 includes a coil 52 positioned around the core wire 54. The illumination fibers 56 extend along the interior of the core wire 54 and terminate in the non-traumatic lens 58. A connector 55 at the proximal end of the guide wire 50 enables optical coupling between the illumination fiber 56 and the light source. The illumination fibers 56 may comprise one or more optical fibers. The lens 58 is configured to project light when the illumination fiber 56 is illuminated by the light source such that the illumination fiber 56 transmits light from the light source to the lens 58. In some aspects, the distal end of the guide wire 50 is more flexible than the proximal end of the guide wire 50. By way of example only, guide wire 50 may be constructed in accordance with at least some of the teachings of U.S. Publication No. 2012/0078118, the disclosure of which is incorporated herein by reference. In some aspects, the guide wire 50 is configured similar to a Lily Barma Sentry ™ sinus illumination system by Accurant, Inc. of Menlo Park, CA, USA. Other suitable forms that guide wire 50 may take will be apparent to those skilled in the art in light of the teachings herein.

In some situations, particularly when approaching the eustachian tube (ET), the guide wire (50) is prevented from passing through the shoulder of the eustachian tube (ET) such that the guide wire (50) It can be beneficial to prevent it from happening. This can be solved by the exemplary alternative guide wire 51 shown in Figures 32 and 33. The guide wire 51 is similar to the guide wire 50 in all respects except for the addition of the distal tip 9700. [ The distal tip 9700 is sized in such a manner that the guide wire 51 stops at the shoulder before it is further advanced into the middle ear 14. [ In this example, the outer diameter of the distal tip 9700 is about 2 mm. Alternatively, any other suitable outer diameter may be used. Distal tip 9700 includes channel 9702 to allow light projected by lens 58 to illuminate eustachian tube ET. Light illuminated into the eustachian tube (ET) through the channel (9702) can serve as an indicator that the eustachian tube (ET) has been sufficiently expanded by the tug of the eardrum. Additionally or alternatively, the distal tip 9700 may be made of an optically transparent material 9701 (e.g., transparent or translucent plastic or glass, etc.) so that light is transmitted through the optic- The material 9701 may be illuminated by itself.

In any of the methods described herein, the operator may first perforate or perforate the hearing aid 22 to provide a temporary aeration path through the middle ear 14, via the ear canal 20. For example, the operator may push a needle or other perforation mechanism (e.g., as shown in FIG. 4) through the eardrum 22 before inserting the expander into the eustachian tube (ET) 26. Alternatively, the operator may first insert the expander into the eustachian tube (ET) 26 and then puncture the hearing aid 22 before expanding the expander. In either case, the opening formed through the hearing aid 22 will allow air to flow through the eustachian tube (ET) 26 while inserting the expander into the eustachian tube (ET) 26 and / 20 to be evacuated from the middle ear 14. However, the opening formed through the hearing aid 22 may be sufficiently small such that the opening can self-heal without requiring any kind of adhesive or suture after the expansion process is completed. A variety of suitable ways in which the hearing aid 22 can be perforated before inserting the expander into the eustachian tube (ET) 26 or before expanding the expander in the eustachian tube (ET) 26 is well within the scope of the teachings herein, .

The present invention may be embodied in other specific forms without departing from the essential characteristics thereof. These other embodiments are intended to be included within the scope of the invention as described in the following claims.

Claims (20)

As the expander assembly
(a) a shaft defining a longitudinal axis, the shaft
(i) the distal end,
(ii) a proximal end, and
(iii) at least one shaft lumen;
(b) an expandable expander located on said shaft, said expandable expander being located between said distal end of said shaft and said proximal end of said shaft, said expandable expander being between a retracted and expanded state Wherein the body is configured to expand a patient's eustachian tube in the expanded state, and wherein the body further comprises a distal end and a proximal end; And
(c) at least one vent path configured to provide venting from the distal end of the body to the proximal end of the body when the body is in the expanded state,
(i) a set of laterally oriented vent openings formed through the shaft, wherein at least one vent opening is on a circle at the distal end of the body, and at least one other vent opening defines a proximal The set of laterally oriented vent openings in the vicinity of the end, or
(ii) a space defined by one or more radially outwardly projecting features of the expandable expander, the at least one vent path
. ≪ / RTI > The expander assembly of claim 1, wherein the body comprises a conical shape and the conical shape is configured to complement the conical geometry of the eustachian tube. 2. The expander assembly of claim 1, wherein the shaft lumen is in fluid communication with the vent openings. The expander assembly of claim 1, wherein the expander has a stepped shape. 2. The expander assembly of claim 1, wherein the at least one outwardly projecting features comprise a plurality of longitudinally extending lobes separated by grooves. 6. The expander assembly of claim 5, wherein the lobes are configured to support a wall of the eustachian tube while the grooves are configured to define the space providing the aeration path. 7. The expander assembly of claim 6, wherein the lobes are angularly spaced equidistantly about the longitudinal axis of the shaft. 2. The apparatus of claim 1, wherein the at least one outwardly projecting features include a plurality of ribs extending in an angular direction about the longitudinal axis of the shaft, the ribs being longitudinally spaced from one another, Expander assembly. 9. The expander assembly of claim 8, wherein the body further comprises a plurality of annular grooves positioned between the ribs, the annular grooves providing a longitudinal spacing of the ribs spaced from one another. 9. The expander assembly of claim 8, wherein the body further comprises a plurality of longitudinal grooves across the ribs. 2. The expander assembly of claim 1, wherein the at least one outwardly projecting features comprise a plurality of discrete bumps extending radially outwardly from the body. 12. The expander assembly of claim 11, wherein the discrete bumps are located in an array positioned along the length of the body and angularly about the longitudinal axis of the shaft. 2. The expander assembly of claim 1, wherein the at least one outwardly projecting features include a helical rib extending spirally along the body. The expander assembly of claim 1, wherein the at least one outwardly projecting features include fins extending along the length of the body. The vent tube of claim 1, wherein the diverter assembly further comprises a vent tube, the vent tube being positioned adjacent an outer region of the body, the vent tube extending along an axis parallel to the longitudinal axis of the shaft / RTI > The expander assembly of claim 1, wherein the expander is configured to mechanically expand without expansion. CLAIMS 1. A method for expanding a patient's eustachian tube,
(a) advancing an expander including a distal end and a proximal end through the nasal passageway of the patient, thereby positioning at least the distal end of the expander within the eustachian tube of the patient;
(c) expanding a portion of the eustachian tube by enlarging the distal end of the expander while the proximal end of the expander remains unexpanded;
(d) expanding the proximal end of the expander to expand a portion of the eustachian tube after the distal end of the expander has been enlarged and while the distal end of the expander is maintained in an enlarged state;
(e) disrupting the expander; And
(f) removing the expanding device from the patient
Gt; a < / RTI > eustachian tube of a patient. 18. The method of claim 17, wherein the method further comprises puncturing the eardrum at the head of the subject to expand the eustachian tube, wherein puncturing the eardrum is performed prior to advancing the ears , A method for expanding a patient's eustachian tube. As guide wires,
(a) a body having a length sufficient to extend from the exterior of the patient through the patient ' s nares and into the patient's eustachian tube;
(b) a flexible distal end portion,
(i) a coil having a first outer diameter, and
(ii) a tip having a second outer diameter, the second outer diameter being greater than the outer diameter of the coil, and the second outer diameter of the tip being small enough to fit the tip within the eustachian tube, The second outer diameter being sufficiently large that the tip is not fit within the canal of the eustachian tube, thereby preventing insertion of the tip into the middle region; And
(c) at least one optical fiber extending through the body, the at least one optical fiber being configured to transmit light, the at least one optical fiber
Lt; / RTI >
Wherein the tip is configured to transmit light transmitted from the optical fiber. 20. The method of claim 19, wherein the tip
(i) a hole configured to provide a path for transmission of light from the optical fiber, or
(ii) an optically transmissive material configured to transmit light from the optical fiber
One or both of
And a guide wire.

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