CN120837819B - Multi-balloon catheter with dilation, drug delivery, and nutrient supply functions - Google Patents

Abstract

The invention belongs to the technical field of medical instruments, and discloses a multi-balloon catheter with functions of expansion, drug delivery and nutrition supply. The multi-balloon device comprises at least three balloons which are respectively communicated with different through cavities, wherein a first balloon is used for dilating a narrow part, and a second balloon is used for slow release administration. The second sacculus wall is of a porous and microporous structure. And a third balloon for adjusting the expanded state. The first balloon surface is provided with array protrusions or degradable microneedle patches to increase friction or local administration. The first balloon can support three-stage staged expansion, the outer surface of the catheter is provided with a hydrophilic coating, and a depth marking part is arranged. Each through cavity is connected with a one-way valve and a pressure display device, and the internal pressure of the saccule is monitored and controlled in real time. A third three-way cavity is additionally arranged for nutrition supply or guide wire positioning. The invention integrates the functions of expansion, drug administration and nutrition, and is safe and controllable in operation.

Description

Multi-balloon catheter with functions of expansion, administration and nutrition supply

Technical Field

The invention relates to the technical field of medical instruments, in particular to a multi-balloon catheter with functions of expansion, drug delivery and nutrition supply.

Background

Esophageal stenosis refers to a pathological state of symptoms such as dysphagia caused by narrowing of esophageal lumen, and the occurrence mechanism of the pathological state is mostly related to factors such as scar fibrosis after tissue injury, inflammation repair abnormality and the like.

In the healing process of esophageal mucosa wounds, the main means for preventing and treating esophageal stenosis at present comprise two types of drug treatment and mechanical intervention. Drug therapy is usually carried out by local or systemic administration, using anti-inflammatory, immunosuppressive or anti-fibrotic drugs to suppress excessive inflammatory response and fibrous tissue proliferation, and mechanical intervention is often dependent on balloon dilation or stent implantation to physically dilate the stricture.

However, the prior art has obvious defects that in the aspect of drug treatment, the traditional administration mode often causes the problems of uneven drug distribution, difficult maintenance of local effective concentration, short acting time and the like, the treatment effect is seriously affected, in the aspect of mechanical intervention, the restenosis and scar formation after operation cannot be effectively inhibited by purely relying on dilatation or stent implantation without synchronous drug support, and the stent may have risks of displacement, foreign body stimulation and the like, and even ulcer or hemorrhage is caused.

Thus, there is a need in the art for a medical device that can integrate mechanical dilation with localized slow release delivery to achieve safer, more effective treatment of esophageal stricture.

Disclosure of Invention

The invention aims to provide a multi-balloon catheter with functions of expansion, drug delivery and nutrition supply, which can realize mechanical expansion, drug slow release and nutrition supply of a narrow part of esophagus simultaneously in one-time catheterization operation, and improve the treatment effect and the safety of patients.

In order to achieve the above purpose, the present invention provides the following technical solutions:

A multi-balloon catheter with functions of expanding, drug administration and nutrition supply comprises a catheter main body and a multi-balloon device. The multi-balloon device is arranged at one axial end of the catheter body and comprises at least two balloons which are arranged in series and are respectively communicated with the through cavities, wherein the through cavities comprise a first balloon through cavity and a second balloon through cavity, one end of the first balloon through cavity is communicated with the first balloon, the other end of the first balloon through cavity is communicated with the first balloon inlet, one end of the second balloon through cavity is communicated with the second balloon, and the other end of the second balloon through cavity is communicated with the second balloon inlet. Micropores penetrating through the wall of the balloon are distributed on the second balloon, and an array bulge (9) or a microneedle structure is arranged on the surface of the first balloon (2).

Besides the technical characteristics, the invention also optimizes and improves the following aspects:

As a preferable technical scheme of the invention, the device further comprises a third balloon, one end of the first balloon through cavity is communicated with the third balloon and the first balloon, and the other end is communicated with the third balloon inlet.

As a preferable technical scheme of the invention, the device further comprises a fourth balloon, one end of the second balloon through cavity is communicated with the fourth balloon and the second balloon, and the other end of the second balloon through cavity is communicated with the fourth balloon inlet.

As a preferable technical scheme of the invention, a third through cavity which is mutually separated from the first balloon through cavity and the second balloon through cavity is also arranged in the catheter main body, and the third through cavity extends along the length direction of the catheter main body.

As a preferable technical scheme of the invention, the inlets of the first balloon through cavity and the second balloon through cavity are respectively connected with a one-way valve, and a pressure display device is connected with the one-way valve.

As a preferable technical scheme of the invention, the first balloon and the second balloon are any one of a compliant balloon, a semi-compliant balloon and a non-compliant balloon, and the third balloon and the fourth balloon are non-compliant balloons.

As a preferable technical scheme of the invention, the first balloon and the second balloon are made of at least one of latex, silica gel, rubber, polyurethane, polyvinyl chloride, polyethylene, polyamide and polyether block polyamide, and the third balloon and the fourth balloon are made of at least one of polyvinyl chloride, polyethylene, polyamide and polyether block polyamide.

As a preferable technical scheme, the first balloon has a diameter of 5 mm-30 mm after expansion, a volume of 0.05 ml-15 ml after expansion and a pressure-resistant range of 1-20 atm, the second balloon (3) has a diameter of 5 mm-20 mm after expansion, a volume of 0.05 ml-8 ml after expansion and a pressure-resistant range of 1-16 atm.

As a preferable technical scheme of the invention, the display density of the bulges or the micro-needles is gradually reduced from the central area of the surface of the first balloon (2) to the two side edges, and the height of the bulges or the micro-needles is gradually increased from the central area of the surface of the first balloon to the two side edges.

As a preferable technical scheme of the invention, the diameter range of the array protrusions is 0.1-3 mm, and the height range of the protrusions is 0.05-1 mm.

As a preferable technical scheme of the invention, the wall of the second balloon (3) presents an expandable porous micropore structure, the pore diameter range is 50-500 micrometers, and the porosity is 5% -50%.

In combination with the description of the technical content, the application realizes the remarkable optimization of the structure of the multi-balloon catheter through a series of technical improvements, and has the advantages in various aspects, namely the following aspects:

1. multifunctional integration and co-therapy

The structure integration innovation is that a plurality of independent through cavities are arranged in the same catheter main body, so that the physical integration and the cooperative operation of three functions of mechanical expansion, local slow release drug delivery and nutrition supply are realized. The through cavities are mutually separated, so that interference among functions is avoided, and the efficiency and convenience of treatment operation are remarkably improved.

Therapeutic synergy the first balloon (the dilation balloon) mechanically dilates the stricture site while the second balloon (the administration balloon) can be administered simultaneously locally. The physical space formed after expansion is beneficial to intercepting the liquid medicine, so that the medicine is gathered at the lesion part and maintains the effective concentration, and the technical problems that the targeting of systemic administration is poor and the local medicine concentration is difficult to maintain are solved. Meanwhile, the third saccule is additionally arranged for adjusting the scaling of the first saccule, so that tissue relaxation can be realized to a certain extent, the blood circulation is promoted, and the condition of long-time ischemia necrosis of esophageal mucosa compression is further avoided.

By arranging the bulges or the micro-needles with different specifications on the surface of the first balloon (the expansion balloon) and irregularly arranging the bulges or the micro-needles, namely, the display density of the bulges or the micro-needles is gradually decreased from the central area of the surface of the first balloon (the expansion balloon) to the two side edges, and the height of the bulges or the micro-needles is gradually increased from the central area of the surface of the first balloon to the two side edges. The medicine liquid can smoothly flow to the expansion affected part and prolong the residence time of the medicine on the affected part, and in addition, the stability of the first saccule (expansion saccule) is improved.

2. Accurate and controllable medicine slow-release system

The controllable drug release mechanism is that the wall of the second saccule is designed into a porous and microporous structure (the aperture is 50-500 mu m, the porosity is 5-50%), and the release rate and the dosage of the drug can be accurately controlled by adjusting the pressure of the infused liquid medicine through the fluid mechanics principle.

Simultaneously, the surface of the first saccule (the expansion saccule) is combined with the bulges or the micro-needles with different specifications and the micro-needles are irregularly arranged, so that the medicine can smoothly pass through the saccule to be close to the proximal end of the joint, gather in the middle of the saccule and be accurately and slowly released to the affected part, and the medicine can be prevented from flowing back.

The drug release enhancement design is that by adding a fourth balloon communicated with the second balloon, medical staff can increase the instantaneous pressure in the second balloon by manually squeezing the fourth balloon, thereby actively accelerating the drug release, basically evacuating the residual liquid medicine in the balloon at the end of treatment, obviously improving the utilization rate of the drug and reducing waste.

3. Safe and progressive mechanical expansion

The staged expansion capability, the first balloon can be designed as a three-stage expansion balloon, which allows a clinician to perform staged and progressive expansion according to patient tolerance and stenosis severity, avoiding the risk of tissue damage caused by a single over-expansion.

The real-time pressure monitoring is that the through cavity is connected with the one-way valve and the pressure display device, so that the internal pressure of the saccule can be monitored and fed back in real time, the expansion process is always in a safe and controllable pressure range, and the operation safety is greatly improved.

4. Stable anchoring and anti-displacement capabilities

The friction-increasing structural design is that the array bulges or the degradable microneedles are arranged on the surface of the first saccule, so that the friction force between the saccule and the wall of the food tube is obviously increased. This not only ensures the positional stability of the catheter during treatment, preventing its displacement from affecting the treatment effect or causing damage, but also provides a more uniform radial support force upon expansion. And meanwhile, the effects of relieving tissues and promoting blood circulation can be improved.

Degradable and safe, the micro needle is made of biodegradable material and is attached by water-soluble adhesive. After the treatment is finished, the in-vivo treatment of the microneedle has two conditions that the degradation is completed in the body, and the two conditions are separated from the saccule along with the patch and finally discharged, so that the secondary damage caused when the traditional stent or the instrument with the non-degradable structure is taken out is thoroughly avoided.

5. Convenience of operation

The independent third through cavity can be used for retaining the guide wire to assist in accurately placing the tube, can also be used for nasal feeding nutrition during treatment, ensures energy intake of a patient and supports overall rehabilitation.

In summary, the multi-balloon catheter is realized through the innovative integrated design and intelligent controllable functions, so that the core problems of insufficient curative effect, complex operation, higher risk, poor patient experience and the like in the existing esophageal stenosis treatment scheme are effectively solved in the technical aspect, and a safer, more effective and more convenient integrated treatment solution is provided.

Drawings

FIG. 1 is a schematic view of the overall structure of a multiple balloon catheter with dilatation, drug delivery and nutrient delivery functions of the present invention;

FIG. 2 is a schematic view of a partial structure of a first balloon surface with array projections according to the present invention;

FIG. 3 is an enlarged view of A in FIG. 2;

FIG. 4 is a schematic view of a partial structure of a first balloon surface with a degradable microneedle patch;

FIG. 5 is an enlarged view of B in FIG. 4;

FIG. 6 is a cross-sectional view of a first balloon surface with array projections according to the present invention;

fig. 7 is a cross-sectional view of a first balloon surface with a degradable microneedle patch of the present invention.

Reference numerals illustrate:

1. The catheter comprises a catheter main body, a first balloon, a second balloon, a third balloon, a fourth balloon, a first balloon through cavity, a second balloon through cavity, a third balloon through cavity, an array bulge, a degradable microneedle patch, a one-way valve and a one-way valve, wherein the catheter main body comprises a catheter main body, the first balloon, the second balloon, the third balloon, the fourth balloon, the first balloon through cavity, the second balloon through cavity, the third balloon through cavity, the 9 array bulge, the 10 degradable microneedle patch and the 11 one-way valve.

Detailed Description

The preferred embodiments of the present invention will be described below with reference to the accompanying drawings, it being understood that the preferred embodiments described herein are for illustration and explanation of the present invention only, and are not intended to limit the present invention.

1. Description of descriptive terms in the invention

The embodiments of the present invention are presented in connection with the technical proposal in order to make the present invention more thorough and complete, and fully express the scope of the present invention to those skilled in the art. It should be noted that the relative arrangement of the components set forth in these embodiments should be construed as merely illustrative, and not a limitation of the present disclosure unless specifically indicated otherwise.

In the present invention, directional terms such as "upper", "lower", "left", "right", "bottom", "top" and the like are defined with respect to directions in the drawings, and are merely used to indicate relative positional relationships, and when the absolute position of a subject to be described is changed, the relative positional relationships may be changed accordingly. These and other directional terms should not be construed as limiting terms.

In the present invention, references to "a," "an," "the," and the like are not intended to be limiting, as singular or plural numbers may be represented. The terms "comprising," "including," "having," and any variations thereof, as used herein, are intended to cover a non-exclusive inclusion, as the term "first," "second," "third," etc., merely distinguish between similar objects and do not represent a particular ordering of objects.

In the present invention, when it is described that a specific device is located between a first device and a second device, an intervening device may or may not be present between the specific device and the first device or the second device. When a particular device is described as being connected to another device, the particular device may be directly connected to the other device without intervening devices, or may be directly connected to the other device without intervening devices.

In addition, the present invention is not discussed in detail with respect to techniques, apparatus known to those of ordinary skill in the relevant art, but where appropriate, the techniques and apparatus should be considered part of the specification.

2. The technical proposal of the application aims to solve the core technical problems

At present, clinical prevention and treatment of esophageal stenosis mainly depend on two means of drug treatment and mechanical intervention, but still have significant limitations. In the aspect of drug treatment, the traditional local or systemic administration mode has the problems of uneven drug distribution, short effective concentration maintenance time of target sites, limited duration of action and the like, so that inflammation and fibrosis processes are difficult to continuously inhibit, and the treatment effect is limited. In the aspect of mechanical intervention, although the balloon expansion or the stent implantation can physically expand a narrow section, the synchronous drug intervention function is lacking, the restenosis and scar tissue regeneration after operation cannot be effectively inhibited, in addition, the stent implantation is easy to generate displacement, mucous membrane stimulation, even ulcer or bleeding and other complications, and the treatment safety and the long-term effect are poor. Therefore, the prior art lacks an integrated therapeutic means capable of cooperatively realizing mechanical expansion and local sustained release administration.

3. Based on the above problems, the present invention particularly provides a technical solution for solving the above problems, and the following details of the technical solution, the working principle and the technical effects of the present invention are described with reference to fig. 1 to 7 by combining specific embodiments.

Example 1

As shown in fig. 1 and 2, the multi-balloon catheter in the present embodiment includes a catheter main body 1, a multi-balloon device, a check valve 11, and a pressure display device.

The multi-balloon device consists of a first balloon 2, a second balloon 3, a third balloon 4 and a fourth balloon 5 which are arranged in series, and both ends of each balloon are connected with the surface of the catheter main body 1 in a sealing way.

The catheter body 1 is internally provided with a first balloon through cavity 6, a second balloon through cavity 7 and a third balloon through cavity 8 which are mutually separated, one end of the first balloon through cavity 6 is communicated with the first balloon 2 and the third balloon 4, and the other end is sequentially connected with a one-way valve 11 and a pressure display device.

One end of the second balloon through cavity 7 is communicated with the second balloon 3 and the fourth balloon 5, and the other end is also connected with a one-way valve 11 and a pressure display device in sequence.

The outer surface of the catheter body 1 is coated with a hydrophilic coating, and the catheter body 1 is provided with a marking part for marking the insertion depth.

Specifically, the catheter body 1 is made of polyurethane (TPU) material, has good flexibility and strength, and has a pipe diameter of 4.7mm and a length of 120cm according to the conventional size of an adult esophagus. The first saccule through cavity 6, the second saccule through cavity 7 and the third through cavity 8 in the catheter main body 1 are mutually independent and separated, the inner diameters of the through cavities are all 1mm, and the third through cavity 8 can be used for nasal feeding nutrition supply or guide wire positioning.

The hydrophilic coating on the outer surface of the catheter main body 1 is made of polyvinylpyrrolidone, the thickness of the coating is 5 mu m, and the friction coefficient between the catheter and esophageal tissue can be effectively reduced.

The marking part can be annular scale marks, each 1cm of the marking part is provided with one scale mark by taking the far end of the catheter as a starting point, the scale marks are made of barium strips which are impermeable to X-rays, and the developing rings can be arranged in the middle of the first balloon or at the two ends of the first balloon, and can be made of platinum, gold, stainless steel, platinum iridium alloy and the like, so that the insertion depth of the catheter can be conveniently observed under X-ray perspective.

The first balloon 2 is used as an expansion balloon for expanding a narrow part, is made of polyether block Polyamide (PEBAX) materials, has a diameter of 15mm, a thickness of 150 mu m and a volume of 10ml after expansion, has a pressure-resistant range of 10atm, and can be a three-stage expansion balloon to realize staged expansion.

The surface of the first balloon 2 is provided with array bulges 9, the bulges can be in any shape such as spherical, hemispherical and conical, and the bulges can be arranged in any mode such as rectangular array, annular array and the like, and the friction force on the surface of the balloon can be increased. As shown in fig. 2,3 and 6, the array protrusions 9 on the surface of the first balloon 2 are hemispherical protrusions, the diameter of each protrusion is 1mm, the height of each protrusion is 0.5mm, the protrusions are arranged in an annular array mode, the center-to-center distance between adjacent protrusions is 2mm, the friction force between the balloon and the inner wall of the esophagus can be increased, and the catheter is prevented from being displaced.

The second saccule 3 is used for slow release drug delivery, and also adopts polyether block Polyamide (PEBAX) materials, the wall of the second saccule is of a porous micropore structure, and the whole circumferential direction of the wall of the second saccule can be provided with a micropore structure, so that the liquid medicine can seep along the whole circumference, and the uniformity and the efficiency of drug delivery are improved. As shown in FIG. 2, the diameter after expansion was 10mm, the thickness was 100 μm, the volume was 3ml, and the pressure-resistant range was 8atm. The pore diameter is 200 micrometers, the porosity is 25%, and the liquid medicine can be uniformly oozed out through micropores and flows to a lesion part.

The third balloon 4 is communicated with the first balloon 2 through the first balloon through cavity 6, is made of Polyamide (PA) material, has the diameter of 8mm, the thickness of 100 mu m, the volume of 1.5ml and the pressure-resistant range of 6atm after expansion, and can adjust the expansion state of the first balloon 2 through the extrusion-release cycle operation of the third balloon 4, thereby realizing tissue relief, promoting blood circulation and avoiding the condition of long ischemia necrosis of esophageal mucosa compression time.

The fourth balloon 5 is communicated with the second balloon 3 through the second balloon through cavity 7, is made of Polyamide (PA) material, has the diameter of 8mm, the thickness of 100 mu m and the volume of 1.5ml after expansion, has the pressure-resistant range of 6atm, can accelerate the release rate of the liquid medicine in the second balloon 3 by extruding the fourth balloon 5, and can discharge the residual liquid medicine in the balloon as far as possible by extruding the fourth balloon after the drug delivery is finished.

The third balloon and the fourth balloon can be separated outside the tube body, and can also be fixedly and serially arranged on the tube body.

The one-way valve 11 and the pressure display device are that the one-way valve 11 adopts a medical silica gel one-way valve, so that the pressure leakage in the balloon can be prevented, the use stability of the balloon is ensured, the pressure display device is a miniature digital pressure gauge, the measurement range is 0-25 atm, the precision is 0.1atm, the pressure value in the balloon can be displayed in real time, the monitoring of medical staff is facilitated, and the balloon is prevented from being excessively expanded to damage the esophageal mucosa.

In order to more clearly illustrate the application, the following further description of the application is provided in connection with the working principle and the operation steps:

and (3) preoperative preparation, namely checking whether all parts of the catheter are intact, ensuring good sealing performance of the one-way valve 11 and normal operation of the pressure display device. According to the condition of the esophageal stenosis of a patient, the liquid medicine required by treatment, such as anti-inflammatory medicine, anti-fibrosis medicine and the like, is prepared.

The catheter is inserted, wherein a patient adopts a proper position, and medical staff refers to a marking part on the catheter main body 1 under the assistance of X-ray fluoroscopy, so that the distal end of the catheter is slowly inserted into the esophagus of the patient until the first balloon 2 reaches the stricture part of the esophagus, and the distal end of the catheter is ensured to enter the stomach.

Balloon dilation, namely, normal saline is injected into the first balloon 2 and the third balloon 4 through the first balloon through cavity 6 for pressurization, the pressure of the first balloon 2 is slowly increased to 3atm according to the reading of the pressure display device, the first-stage dilation is carried out for 5 minutes, the pressure is increased to 6atm for the second-stage dilation for 5 minutes, the pressure is increased to 10atm for the third-stage dilation, and the staged dilation treatment of esophageal stenosis is realized.

The third balloon 4 can be operated by the extrusion-release cycle during treatment to relieve esophageal mucosa compression and promote blood circulation.

And slow release drug delivery, namely, the prepared liquid medicine is injected into the second balloon 3 and the fourth balloon 5 through the second balloon through cavity 7, and the total amount of the liquid medicine is determined according to the illness state of a patient and is generally 2ml. After the injection of the liquid medicine, the pressure display device is observed, the pressure in the second balloon 3 is maintained at 5atm, the liquid medicine uniformly seeps out through the micropores of the balloon wall of the second balloon 3 and flows downwards to the affected part, and the trapped liquid medicine is gathered at the affected part due to the expansion of the first balloon at the affected part. When the drug delivery is near the end, the retraction state of the second balloon can be adjusted by repeatedly squeezing the fourth balloon 5, so that the liquid medicine in the second balloon 3 is discharged as much as possible, and the drug loss is reduced. According to the requirements of the lesion sites, the release speed and the dosage of the medicine can be accurately controlled through pressure regulation, so that the medicine can maintain effective local concentration for a long time, and the treatment effect is improved. The release speed of the liquid medicine can be further controlled by designing the number of the holes of the micropores.

During treatment, if the patient cannot eat autonomously, nutrient substances such as liquid nutrient solution can be infused into the stomach of the patient in a nasal feeding mode through the third three-way cavity 8, and the infusion rate is generally 50-100 ml/h according to the tolerance condition of the patient.

And after the treatment is finished, the pressure in the first balloon 2 and the third balloon 4 is released firstly, then the pressure in the second balloon 3 and the fourth balloon 5 is released, all the balloons are in a retracted state, and then the catheter is slowly taken out from the esophagus of the patient.

Through the structure and the working principle, the embodiment can realize the cooperation of three functions of expansion, drug administration and nutrition supply.

When the first saccule 2 is a three-stage expansion saccule, the expansion can be gradually and stepwise carried out according to the degree of esophageal stenosis, the expansion pressure of the saccule can be properly reduced to reduce the stimulation to the esophagus for a patient with mild stenosis, and the expansion force can be increased to achieve better treatment effect for a patient with severe stenosis, so that the damage to the esophagus caused by one-time over expansion is avoided. And the surface array bulges 9 can effectively prevent the catheter from shifting, ensure the expansion effect, and simultaneously can promote the effect of relieving the tissue of the affected part and promoting the blood circulation.

The porous and microporous structure of the second balloon 3 enables the medicine to be released uniformly, and the medicine in the balloon can be further discharged after the medicine delivery is finished by combining the regulation effect of the fourth balloon 5, so that the medicine loss is reduced, and the medicine utilization rate is improved.

The nutrition supplying function of the third lumen 8 can ensure the nutrition intake during the treatment of the patient and promote rehabilitation.

Simultaneously, the setting of check valve 11 and pressure display device can real-time supervision sacculus pressure, and greatly reduced sacculus excessive expansion leads to patient's risk of injury, hydrophilic coating and the mark portion of pipe surface have improved convenience and the location accuracy that catheterization took out respectively, have wholly promoted security, validity and the patient's of treatment comfort level.

Example 2

The difference between this embodiment and embodiment 1 is that the surface structure of the first balloon 2 is different, in embodiment 1, the surface of the first balloon 2 is an array protrusion 9, in this embodiment, the surface of the first balloon 2 is provided with a degradable microneedle patch 10, as shown in fig. 4, 5 and 7, and the degradable microneedle patch 10 is attached to the surface of the first balloon 2 by a water-soluble adhesive, and the surface of the degradable microneedle patch 10 is also covered with a water-soluble film.

The degradable microneedle patch 10 comprises a patch base and a plurality of degradable microneedles, wherein the patch base is made of polylactic acid material, has a thickness of 200 μm, and is circular with a diameter of 15mm, and the size of the patch base is matched with the surface bonding area of the first saccule 2.

The degradable micro-needles are in a cone shape, the diameter of the bottom surface is 200 mu m, the height is 500 mu m, the degradable micro-needles are arranged in a rectangular array mode, and the center-to-center distance between every two adjacent micro-needles is 500 mu m. The degradable microneedle is prepared by mixing gelatin and polyvinyl alcohol according to the mass ratio of 1:1, and has good biocompatibility and degradability.

The water-soluble adhesive adopts a carboxypropyl methyl cellulose aqueous solution as the water-soluble adhesive, the thickness of the adhesive coating is 10 mu m, the dissolution period is 24 hours, and the dissolution period is shorter than the conventional esophageal stricture dilation treatment period (generally 3-7 days).

The water-soluble film adopts a polyvinyl alcohol film with the thickness of 5 mu m, the degradable microneedle patch 10 is completely wrapped, and the film can be dissolved within 30 minutes after contacting with liquid in esophagus.

Differences between the procedure and example one:

in the catheterization process, as the surface of the degradable microneedle patch 10 is covered with the water-soluble film, the microneedle can be prevented from scratching the esophageal mucosa during insertion, and after the microneedle is inserted in place, the film is dissolved under the action of liquid in the esophagus;

in the treatment process, along with the expansion of the first saccule 2, the degradable microneedle is pressed into the mucosa of the stricture affected part of the esophagus, so that the friction force between the first saccule 2 and the inner wall of the esophagus is further increased, the catheter is prevented from shifting, and meanwhile, the microneedle can assist in drug permeation, so that the drug absorption effect is improved;

In the later stage of treatment, as the esophageal wound heals, the degradable microneedle gradually degrades, if the microneedle is not completely degraded at the end of treatment, the water-soluble adhesive is dissolved, the degradable microneedle patch 10 is separated from the first balloon 2, and the fallen patch can be automatically degraded in a human body or discharged along with the alimentary canal.

As the surface of the first saccule 2 adopts the degradable microneedle patch 10, compared with the array protrusion 9 of the embodiment 1, the friction force between the array protrusion and the inner wall of the esophagus is larger, the catheter positioning is more stable, and the array patch is particularly suitable for the conditions that the stricture degree of the esophagus is more serious and the catheter is easy to shift.

After the degradable micro-needle is penetrated into the mucous membrane, the drug permeation can be assisted, so that the drug can enter the pathological tissues more easily, and compared with the embodiment 1, the drug absorption efficiency is improved through experimental verification.

The water-soluble adhesive has a dissolution period shorter than a treatment period, can ensure that the microneedle patch is separated from the saccule in the later treatment period, avoid secondary damage to esophageal mucosa caused by micro-alignment when the catheter is taken out, and solves the problem of scratching the esophagus by the microneedle in the catheter insertion process by the arrangement of the water-soluble film, thereby further improving the safety of treatment and the comfort of patients.

In addition, the biodegradable characteristic of the microneedle can be degraded, the risk of foreign body residues in the body is avoided, and the occurrence probability of postoperative complications is reduced.

Example 3

The difference between this embodiment and embodiment 1 is that the material of the catheter main body 1 and the dimensional parameters of the balloon are different, in embodiment 1, the catheter main body 1 is made of polyurethane (TPU) material, in this embodiment, the catheter main body 1 is made of silica gel and polyamide mixed according to a mass ratio of 3:1, and meanwhile, parameters such as the diameter, the volume, the pressure-resistant range and the like of the first balloon 2 and the second balloon 3 after expansion are also adjusted.

The catheter main body 1 is made of a mixed material of silica gel and polyamide, has a pipe diameter of 3.3mm and a length of 80cm, and is suitable for children patients. The mixed material has the flexibility of silica gel and the strength of polyamide, can be better suitable for thinner and fragile esophagus structures of children, and reduces the irritation to esophagus mucous membranes of children.

Balloon size parameter adjustment:

The first balloon 2 was still a three-stage dilatation balloon, using polyether block Polyamide (PEBAX) material, having a diameter of 8mm, a thickness of 100 μm, a volume of 1.5ml, and a pressure-resistant range of 6atm after dilatation.

The second balloon 3 had a diameter of 6mm, a thickness of 80 μm, a volume of 1ml, a pressure-resistant range of 5atm, a pore diameter of 100 μm on the balloon, and a porosity of 15%.

The third balloon 4 had a diameter of 5mm, a thickness of 60 μm, a volume of 0.8ml and a pressure-resistant range of 5atm after inflation.

The fourth balloon 5 had a diameter of 5mm, a thickness of 60 μm, a volume of 0.8ml and a pressure-resistant range of 5atm after inflation.

The difference between the operation steps and the first embodiment is that the first stage expansion pressure is 1.5atm for 3 minutes, the second stage expansion pressure is 3atm for 3 minutes, the third stage expansion pressure is 6atm for 3 minutes, and the expansion pressure and the maintenance time of each stage are lower than those of the first embodiment 1 due to the small size of the balloon and the low pressure resistant range in the balloon expansion process, so as to adapt to the bearing capacity of the esophagus of children.

When in administration, the total amount of the liquid medicine is regulated to 0.8ml, the pressure in the second saccule 3 is maintained at 3atm, the burden of excessive medicine on the body of children is avoided, and when in nutrition supply, the special liquid nutrition liquid for children is infused through the third cavity 8, the infusion rate is regulated to 20-50 ml/h, and the regulation is further refined according to the age and the weight of the children.

The embodiment adjusts the material and the size of the catheter main body 1 and the parameters of the balloon according to the physiological characteristics of the child patient, the catheter made of the mixed material of the silica gel and the polyamide is softer, the irritation and the damage to the esophagus of the child can be reduced, the balloon with the smaller size and the lower expansion pressure and the administration dosage accord with the tolerance range of the body of the child, and the treatment risk is reduced.

Clinical application proves that in the treatment of the esophageal stenosis of the children, compared with the embodiment 1 (applicable to adults), the embodiment reduces the complication rate, can better meet the treatment requirements of children patients, and widens the applicable crowd range of the multi-balloon catheter.

The foregoing description of the preferred embodiments of the invention is not intended to be limiting, but rather is intended to cover all modifications, equivalents, alternatives, and improvements that fall within the spirit and scope of the invention.

In addition, the technical solutions of the embodiments can be combined with each other, but must be based on the realization of those of ordinary skill in the art, and when the technical solutions are contradictory or cannot be realized, the combination of the technical solutions should be considered to be absent and not within the protection scope of the invention.

Claims (8)

1. A multi-balloon catheter having functions of dilating, administering and supplying nutrients, comprising:

a catheter main body (1) provided with at least two mutually separated through cavities inside;

the multi-balloon device is arranged at one axial end of the catheter main body (1) and comprises at least three balloons which are respectively communicated with the through cavity;

The through cavity comprises a first balloon through cavity (6) and a second balloon through cavity (7), one end of the first balloon through cavity (6) is communicated with the first balloon (2), the other end of the first balloon through cavity is communicated with the first balloon inlet, one end of the second balloon through cavity (7) is communicated with the second balloon (3), and the other end of the second balloon through cavity is communicated with the second balloon inlet;

the surface of the first balloon (2) is provided with an array bulge (9) or a microneedle structure, and micropores penetrating through the balloon wall are distributed on the second balloon (3);

One end of the first balloon through cavity (6) is communicated with the third balloon (4) and the first balloon (2), and the other end is communicated with the third balloon inlet;

the device also comprises a fourth balloon (5), wherein one end of the second balloon through cavity (7) is communicated with the fourth balloon (5) and the second balloon (3), and the other end is communicated with the fourth balloon inlet;

the catheter is characterized in that a third through cavity (8) which is mutually separated from the first saccule through cavity (6) and the second saccule through cavity (7) is further arranged in the catheter main body (1), and the third through cavity (8) extends along the length direction of the catheter main body (1).

2. The multi-balloon catheter according to claim 1, wherein the inlets of the first balloon through cavity (6) and the second balloon through cavity (7) are respectively connected with a one-way valve (11), and a pressure display device is connected with the one-way valve (11).

3. The multi-balloon catheter according to claim 1, wherein the first balloon (2) and the second balloon (3) are any one of a compliant balloon, a semi-compliant balloon, a non-compliant balloon, and the third balloon (4) and the fourth balloon (5) are non-compliant balloons.

4. A multi-balloon catheter according to claim 3, wherein the first balloon (2) and the second balloon (3) are made of at least one of latex, silica gel, rubber, polyurethane, polyvinyl chloride, polyethylene, polyamide and polyether block polyamide, and the third balloon (4) and the fourth balloon (5) are made of at least one of polyvinyl chloride, polyethylene, polyamide and polyether block polyamide.

5. The multi-balloon catheter according to claim 1, wherein the first balloon (2) has a diameter of 5mm to 30mm after expansion, a volume of 0.05ml to 15ml after expansion, a pressure-resistant range of 1 to 20atm, and the second balloon (3) has a diameter of 5mm to 20mm after expansion, a volume of 0.05ml to 8ml after expansion, and a pressure-resistant range of 1 to 16atm.

6. The multi-balloon catheter according to claim 1, wherein the array density of the protrusions or microneedles decreases from the central region of the first balloon (2) surface to the two side edges and the height of the protrusions or microneedles increases from the central region of the first balloon surface to the two side edges.

7. The multi-balloon catheter of claim 1, wherein the array bump diameter ranges from 0.1 to 3 millimeters and the bump height ranges from 0.05 to 1 millimeter.

8. The multi-balloon catheter according to claim 1, wherein the balloon wall of the second balloon (3) presents an expandable porous microporous structure with a pore size ranging from 50 to 500 microns and a porosity ranging from 5% to 50%.