CN113907718B

CN113907718B - Miniature OCT (optical coherence tomography) imaging catheter for nerve intervention

Info

Publication number: CN113907718B
Application number: CN202111528961.6A
Authority: CN
Inventors: 吕怡然; 郑竣译; 梁栋; 高洪亮
Original assignee: Aike Medical Devices Beijing Co ltd
Current assignee: Accumedical Inc
Priority date: 2021-12-15
Filing date: 2021-12-15
Publication date: 2022-06-17
Anticipated expiration: 2041-12-15
Also published as: CN114869235A; CN114869235B; CN113907718A

Abstract

The application provides a miniature OCT imaging catheter for neural intervention, it includes optical assembly, outer tube subassembly, the outer tube subassembly, emollient and catheter head end, the outer tube subassembly includes interior tube socket and the outer tube of connecting each other, outer tube subassembly near-end and optical assembly near-end cup joint, the outer tube covers optical assembly and outer tube subassembly is at outer tube subassembly end and catheter head end sealing connection, the outer tube forms the chamber with catheter head end sealing with near inner tube socket and optical assembly are sealed, emollient holds in the sealing chamber, the outer tube subassembly cup joints in outer tube subassembly near-end outside and sealing connection. The miniature OCT imaging catheter has the advantages that: smaller catheter diameters, more flexibility, ease of insertion into smaller sized, smaller turn radius vessels, and complex tortuous vessels.

Description

Miniature OCT (optical coherence tomography) imaging catheter for nerve intervention

Technical Field

The application relates to the field of medical instruments, in particular to a miniature OCT imaging catheter for nerve intervention.

Background

Intravascular devices such as catheters are often used in the medical field. Catheters are commonly navigated through blood vessels of patients to reach the heart, brain, or other target anatomical structures. Typically, a guidewire is first guided to the target anatomy, and one or more catheters are then passed over the guidewire and guided to the target anatomy. Once in place, the catheter can be used to deliver devices, substances, energy or signals for treating, detecting lesions in a desired manner. In other cases, the catheter and guidewire are delivered simultaneously toward the target anatomy while the guidewire is within the catheter, and then the guidewire is further delivered into the anatomy by translation within the catheter.

Optical Coherence Tomography (OCT) imaging, a high resolution imaging diagnostic technique, has matured in recent years to develop and apply in coronary intervention. In the coronary intervention operation, a doctor enters an artery lumen by means of an OCT imaging catheter, emits near infrared light to lesion vascular tissues through an optical microprism with the front end of the catheter rotating at a high speed, receives optical signals reflected by the vascular tissues, performs image processing by using computer software, and finally obtains a clear and complete image in the lumen. OCT imaging can accurately provide the tissue structure, pathological change form and reference value in blood vessels, and provides accurate and efficient diagnosis and treatment means for preoperative evaluation, intraoperative guidance and postoperative follow-up of coronary artery interventional operation.

The working principle of the OCT imaging catheter is as follows: the light beam is transmitted to the micro prism through the optical fiber, the micro prism changes the light beam transmission direction and focuses the light beam on the vascular wall, meanwhile, the micro prism and the optical fiber rotate at a high speed at a certain frequency and retract at a constant speed for a certain distance, the light beam scans the whole inner wall of a section of blood vessel with a corresponding length, corresponding reflection optical signals are obtained, the reflection optical signals are processed through computer software, and finally complete images and information of the section of blood vessel are obtained.

At present, an OCT imaging catheter used in coronary artery interventional therapy is structured by forming an optical component by a microprism, an optical fiber and an optical fiber connector, wherein the optical component is coated with a protective sleeve to prevent the optical fiber and the microprism from being damaged; the outermost layer is an outer tube assembly which directly contacts the vessel wall and serves as a track for the movement of the optical assembly, and the position of the outer tube assembly is kept still during the scanning process. The whole optical component protective sleeve is driven to rotate and retract together by a motor on the external equipment. The outer tube assembly also performs the function of contrast injection, including a contrast inlet and a contrast outlet, requiring a space for contrast to pass through. In addition, such catheters require the use of guide wires which are threaded through side holes in the catheter tip and threaded out through a top hole in the catheter tip.

The structural design causes the coronary OCT imaging catheter to have the following problems: (1) the outer diameter size is great, and the three-layer nested structure of optics subassembly, protective sheath and outer tube subassembly is complicated, still additionally increases the external diameter of seal wire simultaneously, can't be used for small-size blood vessel. (2) The multilayer structure stack, in addition the bending modulus of optic fibre itself is great, leads to the pipe body harder, can't pass through the less blood vessel of turning radius and the blood vessel of complicated circuitous. (3) The fiber structure itself is sensitive to bending and is prone to breakage when used in vessels with small bend radii. The above problems limit the application and development of OCT imaging techniques in neuro-interventional therapy.

The application aims to provide a miniature OCT imaging catheter for neural intervention, the small size of the catheter can adapt to small-size blood vessels, and the head end of a flexible catheter can adapt to the blood vessels with smaller turning radius and more complicated tortuosity, so that the application range of the OCT imaging technology is expanded to the field of neural intervention treatment.

Disclosure of Invention

The present application is directed to a novel micro OCT imaging catheter for neuro-intervention to solve the problems of the prior art. The purpose of the application is achieved through the following technical scheme.

One embodiment of the present application provides a miniature OCT imaging catheter for neural intervention, wherein miniature OCT imaging catheter includes an optical assembly, an outer tube assembly, an outer sleeve assembly, a lubricant, and a catheter tip, the outer tube assembly includes an inner tube seat and an outer tube connected to each other, the outer tube assembly proximal end and the optical assembly proximal end are sleeved, the outer tube covers the optical assembly and the outer tube assembly is in sealed connection at the outer tube assembly distal end and the catheter tip, the outer tube is sealed with the optical assembly near the inner tube seat and forms a sealed cavity with the catheter tip, the lubricant is contained in the sealed cavity, the outer sleeve assembly is sleeved outside the outer tube assembly proximal end and is in sealed connection.

According to the micro OCT imaging catheter for nerve intervention provided in the above-mentioned one embodiment of the present application, the optical assembly includes a protective sleeve, a micro prism, an optical fiber coating layer, an optical fiber connector housing and an optical fiber ferrule, the micro prism is connected with the optical fiber, the protective sleeve is sleeved around the micro prism, the optical fiber ferrule is installed in the optical fiber connector housing, the optical fiber proximal end is installed in the optical fiber ferrule, and the optical fiber is covered with the optical fiber coating layer from the optical fiber connector housing to the optical fiber distal end.

According to the micro OCT imaging catheter for the neural intervention provided by the above one embodiment of the application, the outer tube assembly comprises an inner tube seat and an outer tube which are connected with each other, the outer tube comprises an outer tube proximal end reinforcing section, an outer tube pushing section, an outer tube distal end transition section and an outer tube scanning window section which are connected with each other, the inner tube seat is clamped and sleeved on the distal end of the optical fiber connector shell, and the outer tube assembly is close to the outer tube proximal end reinforcing section so that the outer tube pushing section is connected to the optical fiber coating layer in a sealing mode to form an optical assembly sealing part.

According to the micro OCT imaging catheter for the neural intervention provided by one embodiment of the application, the outer tube scanning window section is a transparent structure, the light beam from the optical fiber irradiates on the blood vessel wall after passing through the micro prism and receives the optical signal reflected by the blood vessel tissue, and the optical component can realize the scanning of the blood vessel wall irradiated by the light beam.

According to the micro OCT imaging catheter for nerve intervention provided by one embodiment of the application, the outer sleeve assembly comprises an outer tube seat and an outer sleeve which are connected in sequence, the optical fiber connector shell, the optical fiber inserting core, the inner tube seat and a part of the outer tube proximal end reinforcing section are contained in the outer tube seat, the outer sleeve covers a part of the outer tube proximal end reinforcing section and a part of the outer tube pushing section and is connected with the outer tube proximal end reinforcing section in a sealing mode at the position adjacent to the inner tube seat, an outer sleeve sealing piece is formed, and a contrast medium channel is formed between the outer sleeve sealing piece and the part of the outer tube proximal end reinforcing section and the part of the outer tube pushing section by the outer sleeve.

According to the micro OCT imaging catheter for the neural intervention provided by the above one embodiment of the application, the outer sleeve comprises an outer sleeve seat shell and an outer sleeve seat cover arranged at the tail end of the outer sleeve seat shell, the outer sleeve seat shell is in a cavity structure, and the optical assembly and the outer sleeve assembly are inserted through the outer sleeve from the tail end of the outer sleeve seat shell.

According to one embodiment of the present application, a micro OCT imaging catheter for neuro-intervention is provided, wherein the micro OCT imaging catheter further includes a contrast agent injection port disposed on the outer cannula away from the outer cannula sealing member and communicating with the contrast agent channel, and when the micro OCT imaging catheter is required to inject a contrast agent to reach a treatment site during intervention in a blood vessel, the contrast agent is injected through the contrast agent injection port and flows to the treatment site through the contrast agent channel.

According to the micro OCT imaging catheter for the neural intervention provided by the embodiment of the application, the catheter tip of the micro OCT imaging catheter is in a flexible and shapeable structure.

According to the micro OCT imaging catheter for the neural intervention provided by the embodiment of the application, the inner tube seat comprises a connecting part and a buckling part which are connected with each other.

A micro OCT imaging catheter for neural intervention is provided according to an embodiment of the present application as described above, wherein the outer cannula assembly and the outer cannula assembly are sealingly connected to form an outer cannula seal, the outer cannula seal being adjacent the outer cannula distal end.

A micro OCT imaging catheter for neural intervention is provided according to one of the above-described embodiments of the present application, wherein the catheter tip is a seal.

According to the micro OCT imaging catheter for the neural intervention provided by the embodiment of the application, the inner tube seat comprises a buckling part.

According to the micro OCT imaging catheter for the neural intervention provided by one embodiment of the application, the outer diameter of the part of the distal end of the catheter extending out of the outer sleeve component is 0.014 inches to 0.018 inches, and the length is 30cm to 130 cm.

According to the micro OCT imaging catheter for the neural intervention provided by the embodiment of the application, the minimum bending radius of the micro OCT imaging catheter is 8 mm-15 mm, and the effective length of the micro OCT imaging catheter is 135 cm-190 cm.

According to the micro OCT imaging catheter for the nerve intervention provided by the embodiment of the application, the maximum retracting distance of the micro OCT imaging catheter is 80 cm-150 cm, the maximum retracting speed of the micro OCT imaging catheter is 50 mm/s-120 mm/s, and the scanning frequency of the microprism is 100 Hz-300 Hz.

A micro OCT imaging catheter for neural intervention is provided according to one of the above-described embodiments of the present application, wherein the microprisms are gradient index (GRIN) microprisms or are thermally expanded and angled reflective surface machined directly to the distal end of the optical fiber.

According to the micro OCT imaging catheter for the neural intervention provided by the above one embodiment of the application, the optical fiber is a bending insensitive optical fiber, the diameter of the optical fiber is 80 um-120 um, and the minimum bending radius of the optical fiber is 5-12 mm.

According to the micro OCT imaging catheter for nerve intervention provided in the above embodiment of the present application, the optical fiber coating layer is made of polyimide, resin, acrylate or aluminum, and a joint with the optical fiber connector is reinforced by recoating and sleeving, and the reinforcing layer is made of polyimide, nylon, modified nylon, resin or acrylate.

According to the micro OCT imaging catheter for nerve intervention provided in one of the above-mentioned embodiments of the present application, the protective sheath is a covering film made of nylon, modified nylon, polyethylene or polyimide.

A micro OCT imaging catheter for neural intervention is provided according to one of the above-described embodiments of the present application, wherein a lubricant fills the sealed lumen and encapsulates the microprisms, the protective sheath and the optical fiber, the lubricant being a silicone oil, a gel or a shear-thinning fluid.

According to the micro OCT imaging catheter for neural intervention provided by one embodiment of this application, the catheter tip is a sealing element, and the sealing element is a spot-gluing curing or direct melting sealing.

A micro OCT imaging catheter for neurological intervention is provided according to one of the above-described embodiments of the present application, wherein the outer tube distal transition section is a stainless steel or nitinol spring coil tube, a spring tube, a braided tube, a laser engraved tube, a nylon tube, or a modified nylon tube.

A micro OCT imaging catheter for neurological intervention is provided according to one of the above-described embodiments of the present application, wherein the outer tube pushing section is stainless steel or nitinol and covered with a hydrophobic coating, nylon, modified nylon, polyimide, or polyetheretherketone.

According to the micro OCT imaging catheter for the neural intervention provided by the above one embodiment of the application, the catheter head is in a flexible and shapeable configuration, and the catheter head is a spring coil tube, a spring tube, nylon or a modified nylon tube made of stainless steel or nickel-titanium alloy.

According to the micro OCT imaging catheter for the nerve intervention provided by the above one embodiment of the application, the length of the outer sleeve is 60 cm-160 cm, and the outer sleeve is made of nylon or modified nylon, polyimide, polyether ether ketone or polytetrafluoroethylene.

According to the micro OCT imaging catheter for the neural intervention provided by the above one embodiment of the application, the outer sleeve sealing piece is made of silica gel.

A micro OCT imaging catheter for neural intervention is provided according to one of the above-described embodiments of the present application, wherein the optical assembly seal is a gel or a shear-thinning fluid.

A micro OCT imaging catheter for neuro-intervention is provided according to one embodiment of the present application, where the outer tube proximal reinforcement segment is a stainless steel or nitinol tube, a spring coil tube, a spring tube, a braided tube, a laser engraved tube, a polyimide tube, a polyetheretherketone tube, or a teflon tube.

A micro OCT imaging catheter for neural intervention is provided according to one of the above-described embodiments of the present application, in which the optical assembly is rotated alone in the outer tube assembly while the optical assembly is withdrawn together with the outer tube assembly in the outer sleeve assembly, thereby completing a scan of the beam-irradiated segment of the blood vessel.

The miniature OCT imaging catheter for the neural intervention according to the embodiment of the application has the advantages that: 1) the head end of the catheter is of a flexible and shapeable structure, so that the catheter can be conveniently inserted into a blood vessel without damaging the blood vessel. 2) The optical fiber adopts a bending insensitive optical fiber and an optical fiber coating layer is arranged outside the optical fiber, so that the optical fiber with smaller diameter can be conveniently inserted into a blood vessel with smaller size and smaller turning radius and a complicated tortuous blood vessel. 3) The lubricant fills the sealed cavity and wraps the microprism, the protective sleeve and the optical fiber, so that the microprism, the protective sleeve and the optical fiber are prevented from being damaged due to friction in the rotating process. 4) The inclusion of only one layer of the outer tube assembly reduces the size and is suitable for insertion into smaller sized blood vessels.

Drawings

Other features, objects and advantages of the present application will become more apparent upon reading of the following detailed description of non-limiting embodiments thereof, made with reference to the accompanying drawings.

Fig. 1 shows a schematic view of a micro OCT imaging catheter for neural intervention according to a first embodiment of the present application.

Fig. 2 shows a cross-sectional view of a micro OCT imaging catheter for neural intervention according to a first embodiment of the present application.

Fig. 3 shows a partially enlarged view of the distal end and microprism portion of a micro-OCT imaging catheter for neuro-intervention according to a first embodiment of the present application.

Fig. 4 shows a partially enlarged view of the outer tube and outer sleeve portion of a micro OCT imaging catheter for neural intervention according to a first embodiment of the present application.

Fig. 5 shows a partially enlarged view of the outer hub and inner hub portions of a micro OCT imaging catheter for neurological interventions according to a first embodiment of the present application.

Fig. 6 shows a cross-sectional view of a micro-OCT imaging catheter for neural intervention according to a second embodiment of the present application.

Fig. 7 shows a cross-sectional view of a micro OCT imaging catheter for neural intervention according to a third embodiment of the present application.

Fig. 8 shows a cross-sectional view of a micro OCT imaging catheter for neural intervention according to a fourth embodiment of the present application.

Fig. 9 shows a cross-sectional view of a micro OCT imaging catheter for neural intervention according to a fifth embodiment of the present application.

Reference numbers and designations in the drawings: 100-optical assembly, 200-outer tube assembly, 300-outer tube assembly, 1-catheter tip, 2-outer tube scanning window section, 3-outer tube distal transition section, 4-outer tube pushing section, 5-lubricant, 6-protective sleeve, 7-microprism, 8-optical fiber, 9-optical fiber coating, 10-outer tube, 11-outer tube seal, 12-optical assembly seal, 13-outer tube proximal reinforcement section, 14-outer tube seat, 15-inner tube seat, 16-optical fiber connector housing, 17-optical fiber ferrule, 18-contrast agent injection port, 140-outer tube seat shell, 142-outer tube seat cover, 150-connecting part, 152-snap part, 180-contrast agent channel.

Detailed Description

The following description of the embodiments of the present application with reference to the drawings and examples will make it apparent to those skilled in the art that the technical problems, technical solutions and technical effects of the present application can be easily solved through the contents described in the present specification. It is to be understood that the specific embodiments described herein are merely illustrative of the relevant invention and not restrictive of the invention. In addition, for convenience of description, only portions related to the related invention are shown in the drawings.

It should be noted that the structures, proportions, sizes, and other elements shown in the drawings are only used for understanding and reading the contents of the specification, and are not used for limiting the conditions under which the present application can be implemented, so they do not have the technical significance, and any structural modifications, changes in proportion, or adjustments of sizes, which do not affect the efficacy and achievement of the purposes of the present application, shall still fall within the scope of the technical content disclosed in the present application.

Reference herein to words such as "first," "second," "the," and the like do not denote a limitation of quantity, but rather denote the singular or plural. The terms "comprises," "comprising," "has," "having," and any variations thereof, as referred to herein, are intended to cover a non-exclusive inclusion; for example, a process, method, system, article, or apparatus that comprises a list of steps or modules (elements) is not limited to the listed steps or elements, but may include other steps or elements not expressly listed or inherent to such process, method, article, or apparatus. Reference to "connected," "coupled," and the like in this application is not intended to be limited to physical or mechanical connections, but rather can include electrical connections, whether direct or indirect.

In this application proximal end F1 represents the proximal end of the micro-OCT imaging catheter and distal end F2 represents the distal end of the micro-OCT imaging catheter.

Fig. 1 shows a schematic view of a micro OCT imaging catheter for neural intervention according to a first embodiment of the present application. Fig. 2 shows a cross-sectional view of a micro OCT imaging catheter for neural intervention according to a first embodiment of the present application. Fig. 3 shows a partially enlarged view of the distal end and microprism portion of a micro-OCT imaging catheter for neurological intervention according to a first embodiment of the present application. Figure 4 shows a partial enlarged view of the outer tube and outer sleeve portion of a micro OCT imaging catheter for neurological interventions according to a first embodiment of the present application. Fig. 5 shows a partially enlarged view of the outer hub and inner hub portions of a micro OCT imaging catheter for neurological interventions according to a first embodiment of the present application. As shown in fig. 1 to 5, a micro OCT imaging catheter for nerve intervention according to an embodiment of the present application includes a micro OCT imaging catheter including an optical assembly 100, an outer tube assembly 200, an outer sleeve assembly 300, a lubricant 5, and a catheter tip end 1, the outer tube assembly 100 includes an inner tube base 15 and an outer tube connected to each other, the outer tube assembly proximal end and the optical assembly proximal end are sleeved, the outer tube covers the optical assembly and the outer tube assembly is hermetically connected to the catheter tip end 1 at the outer tube assembly distal end, the outer tube is sealed to the optical assembly near the inner tube base 15 and forms a sealed cavity with the catheter tip end 1, the lubricant 5 is contained in the sealed cavity, and the outer sleeve assembly 300 is sleeved to the outer side of the outer tube assembly proximal end and is hermetically connected.

As shown in fig. 1 to 5, the optical assembly 100 includes a protective sleeve 6, a micro prism 7, an optical fiber 8, an optical fiber coating layer 9, an optical fiber connector housing 16 and an optical fiber ferrule 17, wherein the micro prism 7 is connected with the optical fiber 8, the protective sleeve 6 is sleeved around the micro prism 7, the optical fiber ferrule 17 is installed in the optical fiber connector housing 16, the optical fiber proximal end is installed in the optical fiber ferrule 17, and the optical fiber 8 is covered with the optical fiber coating layer 9 from the optical fiber connector housing 16 to the optical fiber distal end.

As shown in fig. 1-5, the outer tube assembly 200 includes an inner tube mount 15 and an outer tube connected to each other, the outer tube including an outer tube proximal reinforcement section 13, an outer tube pushing section 4, an outer tube distal transition section 3 and an outer tube scanning window section 2 connected to each other, the inner tube mount 15 being snap-fit onto the distal end of the fiber optic connector housing 16, the outer tube assembly 200 being adjacent to the outer tube proximal reinforcement section 13 such that the outer tube pushing section 4 is sealingly connected to the optical fiber coating layer 9, forming an optical assembly seal 12. The outer tube scanning window section 2 is a transparent structure, light beams from the optical fibers 8 irradiate the blood vessel wall after passing through the microprism 7 and receive optical signals reflected by blood vessel tissues, and computer software is used for image processing to finally obtain clear and complete images in the blood vessel cavity. The optical assembly 100 enables scanning of the vessel wall to which the light beam is directed.

As shown in fig. 1-5, the outer sleeve assembly 300 includes an outer tube socket 14 and an outer sleeve 10 connected in sequence, the optical fiber connector housing 16, the optical fiber ferrule 17, the inner tube socket 15 and a portion of the outer tube proximal end reinforcing section 13 are accommodated in the outer tube socket 14, the outer sleeve 10 covers a portion of the outer tube proximal end reinforcing section 13 and a portion of the outer tube pushing section 4 and is hermetically connected with the outer tube proximal end reinforcing section 13 adjacent to the inner tube socket 15 to form an outer sleeve seal 11, and the outer sleeve 10 forms a contrast medium channel 180 from the outer sleeve seal 11 and between the portion of the outer tube proximal end reinforcing section 13 and the portion of the outer tube pushing section 4. The outer sleeve 10 includes an outer socket shell 140 and an outer socket cap 142 disposed at an end of the outer socket shell, the outer socket shell 140 being of a hollow configuration. The optical assembly 100 and the outer tube assembly 200 are inserted through the outer sleeve 10 from the end of the outer tube mount housing.

As shown in fig. 1 to 5, the micro OCT imaging catheter for nerve intervention according to an embodiment of the present application further includes a contrast agent injection port 18, and the contrast agent injection port 18 is disposed on the outer cannula 10 away from the outer cannula seal 11 and communicates with the contrast agent passage 180. When a contrast agent is injected into a blood vessel to reach a treatment site by a micro OCT imaging catheter for nerve intervention, the contrast agent may be injected through the contrast agent injection port 18, and the contrast agent flows to the treatment site through the contrast agent passage 180.

As shown in fig. 1-5, a catheter tip 1 of a micro OCT imaging catheter for neurological intervention according to one embodiment of the present application is of a flexible, shapeable configuration.

As shown in fig. 1 to 5, the inner tube base 15 of the micro OCT imaging catheter for nerve intervention according to an embodiment of the present application includes a connecting portion 150 and a hooking portion 152 connected to each other.

Figure 6 shows a cross-sectional view of a micro OCT imaging catheter for neurological interventions, according to a second embodiment of the present application. As shown in fig. 6, the micro OCT imaging catheter for neural intervention according to the second embodiment of the present application is different from the micro OCT imaging catheter for neural intervention according to the first embodiment of the present application shown in fig. 1 to 5 in that: the length of the catheter tip 1 is short, and as shown in fig. 6, the catheter tip 1 is a seal.

Fig. 7 shows a cross-sectional view of a micro OCT imaging catheter for neural intervention according to a third embodiment of the present application. As shown in fig. 7, the micro OCT imaging catheter for neural intervention according to the third embodiment of the present application is different from the micro OCT imaging catheter for neural intervention according to the first embodiment of the present application shown in fig. 1 to 5 in that: the third embodiment of the miniature OCT imaging catheter for neuro-intervention does not include a contrast injection port 18, and the outer cannula seal 11 is adjacent the outer cannula distal end.

Fig. 8 shows a cross-sectional view of a micro OCT imaging catheter for neural intervention according to a fourth embodiment of the present application. The difference between the micro OCT imaging catheter for neural intervention according to the fourth embodiment of the present application and the micro OCT imaging catheter for neural intervention according to the first embodiment of the present application as shown in fig. 1 to 5 is that: the length of the catheter tip 1 is short, and the catheter tip 1 is a seal. The fourth embodiment of the miniature OCT imaging catheter for neuro-intervention does not include a contrast injection port 18, and the outer cannula seal 11 is adjacent the outer cannula distal end.

Fig. 9 shows a cross-sectional view of a micro OCT imaging catheter for neural intervention according to a fifth embodiment of the present application. The micro OCT imaging catheter for nerve intervention according to the fifth embodiment of the present application is different from the micro OCT imaging catheter for nerve intervention according to the first embodiment of the present application shown in fig. 1 to 5 in that: the catheter tip 1 is short in length, the catheter tip 1 is a seal, and the inner hub 15 does not include the connection 150.

According to the micro OCT imaging catheter for the neural intervention of the above embodiments of the application, the outer diameter of the part of the distal end of the catheter extending out of the outer sleeve component is 0.014 inch-0.018 inch, the length is 30 cm-130 cm, and the micro OCT imaging catheter is suitable for blood vessels with the diameter of 1 mm-7 mm.

According to the micro OCT imaging catheter for the neural intervention of the above embodiment of the application, the minimum bending radius of the micro OCT imaging catheter is 8 mm-15 mm, and the effective length of the micro OCT imaging catheter is 135 cm-190 cm.

According to the micro OCT imaging catheter for the nerve intervention of the embodiment of the application, the maximum retraction distance of the micro OCT imaging catheter is 80 cm-150 cm, the maximum retraction speed of the micro OCT imaging catheter is 50 mm/s-120 mm/s, and the scanning frequency of the microprism is 100 Hz-300 Hz.

According to the micro OCT imaging catheter for nerve intervention of the above-described embodiment of the present application, the micro-prism 7 is a gradient index (GRIN) micro-prism or a hot-core-expanding and inclined reflective surface processing is directly performed on the distal end of the optical fiber 8. Optical fiber 8 is bending insensitive type optical fiber, and the optical fiber diameter is 80um ~120um, and the minimum bend radius of optical fiber is 5~12 mm.

According to the micro OCT imaging catheter for nerve intervention of the above embodiment of the present application, the optical fiber coating layer 9 is made of polyimide, resin, acrylate or aluminum, and the joint with the optical fiber connector housing 16 is reinforced by recoating or sleeving, and the reinforcing layer is made of polyimide, nylon, modified nylon, resin, acrylate or the like.

According to the micro OCT imaging catheter for nerve intervention of the above-described embodiment of the present application, the protective sheath 6 is a coating film, and may be nylon, modified nylon, polyethylene, polyimide, or the like.

According to the micro OCT imaging catheter for nerve intervention of the above embodiment of the application, the lubricant 5 fills the sealed cavity and wraps the micro prism 7, the protective sheath 6 and the optical fiber 8, and the lubricant 5 can be silicone oil, gel, shear thinning fluid and the like.

According to the micro OCT imaging catheter for nerve intervention of the above embodiments of the present application, the catheter tip 1 is a sealing member, and the sealing member can be a spot-gluing curing or direct melting sealing.

According to the micro OCT imaging catheter for nerve intervention of the above embodiments of the present application, the outer tube distal end transition section 3 may be a stainless steel or nitinol spring coil tube, a spring tube, a braided tube, a laser engraved tube, a nylon tube or a modified nylon tube, etc.

According to the micro OCT imaging catheter for nerve intervention of the above-mentioned embodiment of the present application, the outer tube pushing section 4 may be a stainless steel or nitinol tube covered with a hydrophobic coating, or a nylon or modified nylon tube, a polyimide tube, a polyetheretherketone tube, or the like.

According to the micro OCT imaging catheter for nerve intervention of the above embodiments of the present application, the catheter tip 1 is of a flexible and moldable structure, and the catheter tip 1 may be a spring coil tube or a spring tube made of stainless steel or nitinol, or a nylon tube or a modified nylon tube.

According to the micro OCT imaging catheter for the neural intervention of the above embodiments of the application, the length of the outer sleeve 10 is 60 cm-160 cm, and the outer sleeve can be made of nylon or modified nylon, polyimide, polyether ether ketone, polytetrafluoroethylene and the like. The outer sleeve sealing member 11 is made of silica gel.

According to the micro OCT imaging catheter for neural intervention of the above-described embodiment of the present application, the optical assembly seal 12 is a gel or a shear-thinning fluid.

According to the micro OCT imaging catheter for nerve intervention of the above-mentioned embodiment of the present application, the outer tube proximal reinforcement section 13 is a stainless steel or nitinol tube, a spring coil tube, a spring tube, a braided tube, a laser engraved tube, or a polyimide tube, a polyetheretherketone tube, or a teflon tube.

According to the micro OCT imaging catheter for nerve intervention of the above-described embodiment of the present application, the optical assembly 100 is rotated alone in the outer tube assembly 200 while the optical assembly 100 is withdrawn together with the outer tube assembly 200 in the outer tube assembly 300, thereby completing the scanning of the optically illuminated segment of the blood vessel.

The miniature OCT imaging catheter for the neural intervention according to the above embodiment of the application has the advantages that: 1) the head end of the catheter is of a flexible and shapeable structure, so that the catheter can be conveniently inserted into a blood vessel without damaging the blood vessel. 2) The optical fiber adopts a bending insensitive optical fiber and an optical fiber coating layer is arranged outside the optical fiber, so that the optical fiber with smaller diameter can be conveniently inserted into a blood vessel with smaller size and smaller turning radius and a complicated tortuous blood vessel. 3) The lubricant fills the sealed cavity and wraps the microprism, the protective sleeve and the optical fiber to prevent the microprism, the protective sleeve and the optical fiber from being damaged. 4) The inclusion of only one layer of the outer tube assembly reduces the size and is suitable for insertion into smaller sized blood vessels.

While the present application has been described and illustrated with reference to particular embodiments thereof, these descriptions and illustrations do not limit the present application. It will be apparent to those skilled in the art that various changes may be made and equivalents may be substituted in the embodiments without departing from the true spirit and scope of the application as defined by the appended claims. The illustrations may not necessarily be drawn to scale. There may be a difference between the technical reproduction in the present application and the actual device due to variables in the manufacturing process and the like. There may be other embodiments of the application that are not specifically illustrated. The specification and drawings are to be regarded in an illustrative rather than a restrictive sense. Modifications may be made to adapt a particular situation, material, composition of matter, method, or process to the objective, spirit and scope of the application. All such modifications are intended to be within the scope of the claims appended hereto. Although the methods disclosed herein have been described with reference to particular operations performed in a particular order, it should be understood that these operations may be combined, sub-divided, or reordered to form equivalent methods without departing from the teachings of the present application. Accordingly, unless specifically indicated herein, the order and grouping of the operations is not a limitation of the present application.

Claims

1. A miniature OCT imaging catheter for nerve intervention, characterized in that the miniature OCT imaging catheter comprises an optical assembly (100), an outer tube assembly (200), an outer sleeve assembly (300), a lubricant (5) and a catheter The head end (1), the outer tube assembly (200) includes an inner tube base (15) and an outer tube connected to each other, and the optical assembly (100) includes an optical fiber (8), an optical fiber coating layer (9), an optical fiber connector housing ( 16) and the optical fiber ferrule (17), the outer tube includes a reinforcing section (13) at the proximal end of the outer tube, a pushing section (4) at the outer tube, a transition section at the distal end of the outer tube (3), and a scanning window section ( 2), the outer sleeve assembly (300) includes an outer sleeve (14) and an outer sleeve (10) connected in sequence, and the outer sleeve (10) includes an outer sleeve (140) and an outer sleeve arranged at the end of the outer sleeve the cover (142), the proximal end of the outer tube assembly (200) and the proximal end of the optical assembly (100) are sleeved, the outer tube covers the optical assembly (100) and the outer tube assembly is sealed at the end of the outer tube assembly and the catheter head end (1), The outer tube is sealed with the optical assembly (100) near the inner tube seat and forms a sealing cavity with the catheter head end (1), the lubricant (5) is accommodated in the sealing cavity, and the outer sleeve assembly (300) is sleeved on the proximal end of the outer tube assembly The outer side is sealed and connected, the inner tube seat (15) is snap-sleeved on the distal end of the optical fiber connector housing (16), and the outer tube assembly (200) is adjacent to the proximal reinforcing section (13) of the outer tube to push the outer tube The segment (4) is hermetically connected to the optical fiber coating (9) to form the optical assembly seal (12), the optical fiber ferrule (17) is installed in the optical fiber connector housing assembly (16), and the optical fiber proximal end is installed in the optical fiber ferrule. In the core (17), the optical fiber (8) is covered with an optical fiber coating layer (9) from the optical fiber connector housing (16) to the distal end of the optical fiber, the optical fiber connector housing (16), the optical fiber ferrule (17), the inner tube The seat (15) and part of the reinforcement section (13) at the proximal end of the outer tube are accommodated in the outer tube seat (14), and the outer sleeve (10) covers part of the reinforcement section (13) at the proximal end of the outer tube and part of the pushing section (4) of the outer tube and Close to the inner tube seat (15) and sealingly connect with the reinforcing section (13) at the proximal end of the outer tube to form an outer casing seal (11), and the outer casing (10) from the outer casing seal (11) and a part of the outer tube are close to each other. A contrast medium channel (180) is formed between the end reinforcement section (13) and part of the outer tube pushing section (4), the outer tube seat shell (140) is of a cavity structure, and the optical assembly (100) and the outer tube assembly (200) are connected from The end of the outer tube base housing is inserted through the outer tube (10), the optical assembly (100) is rotated in the outer tube assembly (200) alone, and the optical assembly (100) is together with the outer tube assembly (200) in the outer tube assembly (300) Retraction in the middle, thus completing the scanning of the blood vessels in the beam irradiation segment.

2. The miniature OCT imaging catheter for nerve intervention as claimed in claim 1, wherein the optical assembly further comprises a protective cover (6) and a microprism (7), and the microprism (7) is connected with an optical fiber (8) , the protective cover (6) is sleeved around the microprism (7).

3. The miniature OCT imaging catheter for nerve intervention as claimed in claim 1, wherein the outer tube scanning window segment (2) is a transparent structure, and the light beam from the optical fiber (8) is irradiated after passing through the microprism (7) The optical component (200) can scan the blood vessel wall irradiated by the light beam by reaching the blood vessel wall and receiving the optical signal reflected back by the blood vessel tissue.

4. The micro-OCT imaging catheter for nerve intervention according to claim 1, characterized in that, the micro-OCT imaging catheter further comprises a contrast agent injection port (18), and the contrast agent injection port (18) is disposed away from the outer sleeve to seal The outer sleeve (10) of the component (11) is connected to the contrast medium channel (180). When the micro-OCT imaging catheter is inserted into the blood vessel to reach the treatment site and needs to inject contrast medium, the contrast medium is injected through the contrast medium injection port (18). And flow to the treatment site through the contrast medium channel (180).

5. The micro-OCT imaging catheter for nerve intervention according to claim 1 or 4, characterized in that the catheter tip (1) of the micro-OCT imaging catheter is in a flexible and plastic configuration.

6. The miniature OCT imaging catheter for nerve intervention according to claim 1, characterized in that, the inner tube seat (15) comprises a connecting part (150) and a buckling part (152) which are connected to each other.

7. The miniature OCT imaging catheter for nerve intervention according to claim 1, characterized in that, the catheter tip (1) is a seal.

8. The miniature OCT imaging catheter for nerve intervention according to claim 7, wherein the outer sleeve assembly (300) and the outer sleeve assembly (200) are sealed and connected to form an outer sleeve seal (11), and the outer sleeve seals Piece (11) is adjacent to the distal end of the outer sleeve.

9. The miniature OCT imaging catheter for nerve intervention according to claim 4, characterized in that, the catheter tip (1) is a seal.

10. The miniature OCT imaging catheter for nerve intervention according to claim 1, characterized in that, the inner tube seat (15) comprises a buckle portion (152).

11 . The micro-OCT imaging catheter for nerve intervention according to claim 1 , wherein the outer diameter of the portion extending from the outer sleeve assembly at the distal end of the catheter is 0.014 inches to 0.018 inches and the length is 30 cm to 130 cm. 12 .

12 . The micro-OCT imaging catheter according to claim 1 , wherein the minimum bending radius of the micro-OCT imaging catheter is 8mm˜15mm, and the effective length of the micro-OCT imaging catheter is 135cm˜190cm. 13 .

13. The miniature OCT imaging catheter for neurointervention according to claim 2, wherein the miniature OCT imaging catheter has a maximum retraction distance of 80 cm to 150 cm, and the miniature OCT imaging catheter has a maximum retraction speed of 50 mm/s to 120 mm/s. , Microprism scanning frequency 100Hz ~ 300Hz.

14 . The micro-OCT imaging catheter for nerve intervention according to claim 2 , wherein the micro-prism is a gradient-index micro-prism or directly performs thermal expansion and inclined reflection surface processing on the distal end of the optical fiber. 15 .

15 . The miniature OCT imaging catheter for nerve intervention according to claim 2 , wherein the optical fiber is a bend-insensitive optical fiber, the diameter of the optical fiber is 80 μm to 120 μm, and the minimum bending radius of the optical fiber is 5 to 12 mm. 16 .

16. The miniature OCT imaging catheter for nerve intervention according to claim 2, wherein the optical fiber coating layer is made of polyimide, resin, acrylate or aluminum, and the connection with the optical fiber connector is reinforced Treatment, the reinforcement process is recoating, casing coating, and the reinforcement layer material is polyimide, nylon, modified nylon, resin, acrylate.

17. The miniature OCT imaging catheter for nerve intervention as claimed in claim 2, wherein the protective sheath is a coating film made of nylon, modified nylon, polyethylene or polyimide.

18. The miniature OCT imaging catheter for nerve intervention according to claim 2, wherein the lubricant fills the sealed cavity and wraps the microprism, the protective sleeve and the optical fiber, and the lubricant is silicone oil, gel or shear thinning fluid.

19. The miniature OCT imaging catheter for neurointervention according to claim 1, wherein the catheter head end is a sealing member, and the sealing member is glue-cured or directly melt-sealed.

20. The miniature OCT imaging catheter for nerve intervention according to claim 1, wherein the outer tube distal transition section is a spring coil tube, a spring tube, a braided tube, a laser engraved tube, a stainless steel or a nickel-titanium alloy. Nylon tube or modified nylon tube.

21. The miniature OCT imaging catheter for nerve intervention as claimed in claim 1, wherein the outer tube pushing section is stainless steel or nickel-titanium alloy and is covered with a hydrophobic coating, nylon, modified nylon, polyimide or Polyetheretherketone.

22. The miniature OCT imaging catheter for nerve intervention according to claim 1, wherein the catheter tip is in a flexible and plastic structure, and the catheter tip is a spring coil tube, spring tube, nylon, stainless steel or nickel-titanium alloy. or modified nylon tube.

23. The miniature OCT imaging catheter for nerve intervention according to claim 1, wherein the length of the outer cannula is 60cm-160cm, and the outer cannula is made of nylon or modified nylon, polyimide, polyetheretherketone or Made of Teflon.

24. The miniature OCT imaging catheter for neurointervention of claim 1, wherein the outer sleeve seal is made of silicone.

25. The micro-OCT imaging catheter for neurointervention of claim 1, wherein the optical assembly seal is a gel or a shear thinning fluid.

26. The miniature OCT imaging catheter for nerve intervention as claimed in claim 1, wherein the reinforcing section at the proximal end of the outer tube is a stainless steel or nickel-titanium alloy tube, a spring coil tube, a spring tube, a braided tube, a laser engraved tube , polyimide tube, polyether ether ketone tube or teflon tube.