CN114010918B

CN114010918B - Balloon catheter system for intravertebral astride eccentric plaque denudation operation

Info

Publication number: CN114010918B
Application number: CN202111310379.2A
Authority: CN
Inventors: 焦力群; 杨斌; 王亚冰; 马妍; 王韬; 徐然
Original assignee: Xuanwu Hospital
Current assignee: Xuanwu Hospital
Priority date: 2021-11-05
Filing date: 2021-11-05
Publication date: 2022-06-24
Anticipated expiration: 2041-11-05
Also published as: CN114010918A; CN115253035A; CN115253035B

Abstract

The invention relates to a balloon catheter system, in particular to a balloon catheter system for plugging blood vessels in a vertebral artery internal straddling eccentric plaque denudation operation, which comprises: a first balloon portion with a controllable form; and a positioning guide wire for guiding the first balloon part to correspond to a bifurcation cavity formed by communicating one end part of the vertebral artery with the outer tube wall of the subclavian artery and located between the vertebral artery and the subclavian artery, wherein the bifurcation cavity is formed by communicating one end part of the vertebral artery with the outer tube wall of the subclavian artery, the first balloon part comprises a waist balloon and a first shoulder balloon and a second shoulder balloon which are respectively formed at two ends of the waist balloon along the extension direction of the positioning guide wire, the waist balloon and the shoulder balloons can be expanded by injecting fluid into the first balloon part, and the expanded shoulder balloons have larger expansion diameters than the waist balloon, so that the first balloon part can avoid the wall surface of the bifurcation eccentric plaque in the bifurcation cavity while blocking the subclavian artery.

Description

Balloon catheter system for intravertebral astride eccentric plaque denudation operation

Technical Field

The invention relates to the technical field of medical instruments, in particular to a balloon catheter system for a straddle eccentric plaque denudation operation in a vertebral artery.

Background

Post-circulating ischemic stroke (TIA) accounts for 25% -40% of stroke, 70% of post-circulating ischemic stroke is caused by vertebral artery-basal atheromatous plaque formation or arterial occlusion caused by an arterial interlayer, TIA has the characteristics of high morbidity, high mortality, high disability rate and high recurrence rate, and can cause heavy burden to families and society of patients. On the other hand, the Vertebral Artery Origin (VAO) is one of the most important causes of the occurrence of post-circulatory ischemia, because it is the most likely site to develop atherosclerosis due to its hemodynamic disturbance or the like. Studies have shown that 9% to 33% of patients with posterior ischemic disease have either a Vertebral Artery Origin Stenosis (VAOS) or occlusion. The annual incidence of post-circulatory ischemic enrollment in New England was used to measure the incidence of VAOS-induced post-circulatory ischemic events in 1-2 million patients per year in the United states.

At present, drugs for treating vertebral atherosclerotic stenosis are mainly platelet aggregation resistant drugs, statin lipid lowering drugs and other drugs for controlling risk factors of cerebrovascular diseases, and the like, and can inhibit lipid metabolism, reduce lipid substance deposition and help stabilize plaques. When plaque develops to block the vertebral artery lumen, it causes stenosis of the vessel, and may even cause ischemia or necrosis of the tissue or organ. Vertebral Endarterectomy (VAE) is a common minimally invasive treatment method and can effectively prevent stroke caused by vertebral artery stenosis. The vertebral artery intimal denudation operation is specifically implemented by the steps of exposing the vertebral artery, temporarily blocking the far-end blood flow and the near-end blood flow of a vertebral artery plaque, then cutting the vertebral artery, stripping the intima containing the plaque, then suturing the vertebral artery, and ending the operation.

The most common occurrence of vertebral atherosclerosis is the opening of the vertebral artery, i.e., where the vertebral artery meets the subclavian artery (or innominate artery), where Plaque usually accumulates inside the opening of the vertebral artery, and the Plaque extends beyond the vertebral opening to form a Straddling Plaque (Straddling Plaque). When an endomesenteric denudation operation is performed on a plaque in the vicinity of the site, it is necessary to block blood flow in a subclavian artery (or innominate artery) to perform the operation. However, the position of the isolated surface at the vertebral artery opening is deep, the clavicle is arranged in front of the isolated surface and is shielded, the vertebral artery opening and the surrounding structures are not easily and fully exposed in the operation, the exposure is difficult, and the blocking difficulty is high. Especially, when the vertebral artery intimal stripping operation is carried out, if the vertebral artery opening and the surrounding structures are not sufficiently exposed, the anterior and posterior blood flow can not be well blocked, and the difficulty of the operation is greatly increased.

In this regard, prior art proposes solutions in combination with interventional therapy, by placing a temporary occlusion balloon into the proximal subclavian artery, the subclavian artery can be temporarily occluded after balloon expansion. However, most of the existing plugging balloons are of a circumferential expansion type, namely, the plugging balloon plugs the subclavian artery after expansion, but also plugs the opening of the vertebral artery, so that the plaque to be treated is shielded, and the operation space of the intimal stripping operation is also obstructed. For example, a balloon proposed in patent document No. CN108310594A in the prior art includes a balloon body and a catheter connected to the balloon body, wherein a catheter extension portion is provided at a front end of the balloon body, a first flow guide hole is provided on the catheter extension portion, and a second flow guide hole communicated with the first flow guide hole is provided on the catheter at a rear end of the balloon body. Therefore, in the field of the current vertebral artery endarterectomy technology, a device which can block the subclavian artery blood flow and does not obstruct the endarterectomy is needed.

Furthermore, on the one hand, due to the differences in understanding to the person skilled in the art; on the other hand, since the applicant has studied a great deal of literature and patents when he or she made the present invention, but not limited to the details and contents listed in the section, this invention is by no means free of the features of the prior art, but instead the invention has been provided with all the features of the prior art, and the applicant has retained the right to increase the related art in the background.

Disclosure of Invention

In order to solve the problem of difficulty in blocking blood flow at the anterior and posterior vertebral artery openings in the vertebral endarterectomy, a solution combining interventional therapy is proposed in the prior art, for example, a balloon proposed in patent document CN108310594A is used for temporarily blocking the subclavian artery after the balloon is expanded by placing a temporary blocking balloon in the proximal subclavian artery. However, the blocking balloon proposed by the above technical scheme is mostly of a circumferential expansion type at present, namely, the blocking balloon blocks the subclavian artery after expansion, but simultaneously blocks the opening of the vertebral artery, thereby blocking not only the plaque to be treated, but also the operation space of the inner membrane denudation operation.

In view of the above-mentioned deficiencies of the prior art, the present invention provides a balloon catheter system which can not only block the subclavian artery blood flow, but also does not interfere with the intimal stripping operation, especially a balloon catheter system for blocking the blood vessel in the vertebral artery straddling eccentric plaque stripping operation, comprising at least: a first balloon portion with a controllable form; and a positioning guide wire for guiding the first balloon portion to correspond to a bifurcation cavity formed by communicating one end portion of the vertebral artery with the outer tube wall of the subclavian artery and located between the vertebral artery and the subclavian artery, wherein the bifurcation cavity is formed by communicating one end portion of the vertebral artery with the outer tube wall of the subclavian artery.

In the balloon catheter system that this application provided, through improving conventional sacculus structure and then making it can be applicable to better in the vertebral artery straddle type eccentric plaque and peel off the operation, whole sacculus structure similar to dumbbell type can fully expose to the eccentric plaque of straddling that extends to the position outside the vertebral artery opening, and the blood flow of artery front and back end under the clavicle has fully been blocked at sacculus both ends simultaneously. Compared with the catheter balloon proposed in the prior art, such as the patent document with publication number CN104582780A, the catheter balloon summarizes most of the balloon structures similar to the dumbbell shape in the prior art, however, such balloon structures need to be prepared by an integral molding process, the molding process is complicated, and in contrast, the dual-balloon structure proposed in the present application can be molded step by step, so that the difficulty of the molding process is greatly reduced, and the cost is reduced.

According to a preferred embodiment, each shoulder balloon continuously extends around the circumferential direction of the waist balloon and is arranged on the end part of the waist balloon in an encircling manner, and the shoulder balloon and/or the waist balloon are sleeved on the positioning guide wire in a manner that the positioning guide wire is positioned on the eccentric position of the balloon body of the shoulder balloon and/or the waist balloon, so that the positioning guide wire moves towards the direction departing from the striding eccentric patch when the first balloon part is expanded to avoid the wall surface of the bifurcation cavity where the striding eccentric patch is positioned.

The application also provides an intervention method of the balloon catheter system for the intraspinal straddling eccentric plaque peeling operation, in particular to a balloon catheter method for plugging blood vessels in the intraspinal straddling eccentric plaque peeling operation, which is characterized by at least comprising the following steps: moving the first balloon part into a bifurcation cavity where the straddling eccentric plaque is located by using a positioning guide wire; the first shoulder sacculus and the second shoulder sacculus which are formed at two ends of the first sacculus part are respectively positioned in the proximal subclavian artery and the distal subclavian artery; injecting fluid into the first balloon portion to expand the waist balloon and the shoulder balloon of the first balloon portion; the shoulder sacculus after the expansion has the expansion diameter that is bigger than waist sacculus to this realizes that first sacculus portion blocks the artery under the clavicle, dodges the wall of striding eccentric plaque place in the forked type cavity simultaneously.

The present application also proposes a balloon catheter system for use in a vertebras intra-arterial straddle eccentric plaque denudation procedure, in particular for use in a vertebras intra-arterial straddle eccentric plaque denudation procedure for sealing a blood vessel, comprising at least: a first balloon portion with a controllable form; and a positioning guide wire for guiding the first balloon part to correspond to a bifurcation cavity formed by communicating one end part of the vertebral artery from the outer tube wall of the subclavian artery to the inside of the subclavian artery, wherein the bifurcation cavity is positioned between the vertebral artery and the subclavian artery, and the positioning guide wire is characterized by further comprising: and the expansion limiting part is arranged on the middle balloon body of the first balloon part to limit the expansion of the middle balloon body at the position of the middle balloon body when the first balloon part is expanded, so that the expansion degree of the middle balloon body is smaller than that of the end balloon bodies at the two ends of the first balloon part.

According to a preferred embodiment, the system further comprises a guiding component, wherein the guiding component is configured to apply a triggering event to the expansion limiting part to change the form of the expansion limiting part, so that the expansion limiting part is arranged on the middle balloon body of the first balloon part in a first posture close to the positioning guide wire, and the intervention size of the positioning guide wire carrying at least the first balloon part and the expansion limiting part is reduced.

According to a preferred embodiment, the guide assembly is further configured such that, when the first balloon portion is expanded, the expansion restricting portion is caused to shift to and be held in the second posture by an external force applied thereto by the expanded first balloon portion by changing the form of the expansion restricting portion, thereby causing the degree of expansion of the intermediate balloon to be smaller than the degree of expansion of the end balloons located at both ends of the first balloon portion.

According to a preferred embodiment, the system further comprises a second balloon portion arranged on the positioning guide wire, a first developing mark and a second developing mark are pre-configured on the first balloon portion or the second balloon portion, and a plugging position relation formed by the first balloon portion and the vertebral artery on a wall surface where the striding eccentric plaque is located in the bifurcation cavity can be obtained by obtaining a developing position relation of the first developing mark and the second developing mark on a two-dimensional interface so as to assist the first balloon portion to avoid the bifurcation cavity.

The present application also proposes a balloon catheter system for use in a vertebras intra-arterial straddle eccentric plaque denudation procedure, in particular for use in a vertebras intra-arterial straddle eccentric plaque denudation procedure for sealing a blood vessel, comprising at least: a first balloon portion with a controllable form; and the positioning guide wire is used for guiding the first balloon part to correspond to a bifurcation cavity formed by communicating one end part of the vertebral artery with the outer tube wall of the subclavian artery to the inside of the subclavian artery, the bifurcation cavity is positioned between the vertebral artery and the subclavian artery, the first balloon part comprises a first shoulder balloon and a second shoulder balloon which are respectively formed at different positions along the extension direction of the positioning guide wire, and the shoulder balloons can be expanded by injecting fluid into the first balloon part, so that the first balloon part can avoid the wall surface of the bifurcation plaque in the bifurcation cavity while blocking the subclavian artery.

The application also provides an intervention method of the balloon catheter system for the intraspinal straddling eccentric plaque peeling operation, in particular to a balloon catheter method for plugging blood vessels in the intraspinal straddling eccentric plaque peeling operation, which is characterized by at least comprising the following steps: moving the first balloon part into a bifurcation cavity where the straddling eccentric plaque is located by using a positioning guide wire; injecting fluid into the first balloon part to expand the first balloon part, and limiting the expansion of the middle balloon body of the first balloon part by the expansion limiting part on the middle balloon body; the expansion degree of the middle utricule after the expansion is less than the expansion degree that is located the tip utricule at first sacculus portion both ends to this realizes that first sacculus portion is to the shutoff of artery under the clavicle, dodges simultaneously and rides the eccentric plaque place wall of nature of striding in the forked type cavity.

The present application also proposes a balloon catheter system for use in a vertebras intra-arterial straddle eccentric plaque denudation procedure, in particular for use in a vertebras intra-arterial straddle eccentric plaque denudation procedure for sealing a blood vessel, comprising at least: a first balloon portion with a controllable form; the positioning guide wire is used for guiding the first balloon portion to correspond to a bifurcation cavity formed by communicating one end portion of a vertebral artery with the outer tube wall of the subclavian artery and located between the vertebral artery and the subclavian artery, wherein the bifurcation cavity is located between the subclavian artery and the subclavian artery, the positioning guide wire is used for guiding the first balloon portion and the straddling eccentric plaque, and the bifurcation cavity is characterized by further comprising an expansion limiting portion and a guiding assembly, wherein the guiding assembly is used for changing the shape of the expansion limiting portion so that the expansion limiting portion can be arranged on a middle balloon body of the first balloon portion in a first posture close to the positioning guide wire, so that the intervention size of the positioning guide wire at least carrying the first balloon portion and the expansion limiting portion is reduced, and/or the expansion limiting portion can be converted to and kept in a second posture under the action of external force applied to the expansion limiting portion by the expanded first balloon portion, and accordingly the expansion degree of the middle balloon body is smaller than the expansion degree of end portion balloons located at two ends of the first balloon portion.

The application also provides an intervention method of the balloon catheter system for the intraspinal straddling eccentric plaque peeling operation, in particular to a balloon catheter method for plugging blood vessels in the intraspinal straddling eccentric plaque peeling operation, which is characterized by at least comprising the following steps: arranging a first balloon part with a limited expansion part on the positioning guide wire; before the positioning guide wire intervenes in the blood vessel, the shape of the expansion limiting part is changed, so that the expansion limiting part is arranged on the middle capsule body of the first capsule part in a first posture close to the positioning guide wire; expanding the first balloon portion after the positioning guidewire is inserted into the blood vessel; the expanded first balloon part exerts an external force effect on the expansion limiting part to enable the expansion limiting part to be converted into a second posture; the form of the expansion restricting portion is changed to be maintained in the second posture, thereby restricting the degree of expansion of the local region on the first balloon portion.

Drawings

FIG. 1 is a simplified schematic diagram of a preferred balloon catheter system for intravertebral astride eccentric plaque ablation provided by the present invention;

FIG. 2 is a simplified schematic structural view of a balloon catheter system for intravertebral astride eccentric plaque denudation in accordance with another preferred embodiment of the present invention;

fig. 3 is a simplified structural schematic diagram of a balloon catheter system for a vertebral artery straddle eccentric plaque denudation operation according to another preferred embodiment of the invention.

List of reference numerals

1: the vertebral artery; 2: a proximal subclavian artery; 3: the distal subclavian artery; 4: a first balloon portion; 5: positioning a guide wire; 6: a lumbar balloon; 7: a first shoulder balloon; 8: a second shoulder balloon; 9: no diseased surface; 10: the surface of the plaque; 11: a limiting expansion part; 12: a striding eccentric plaque; 13: a bifurcated cavity.

Detailed Description

The following detailed description is made with reference to the accompanying drawings.

Reference herein to a straddling plaque (straddling eccentricplacque) or atherosclerotic plaque at the opening of a vertebral artery, particularly to a straddling plaque at the opening of a vertebral artery, or other lesion whose anatomical structure resembles the opening of a vertebral artery. Atherosclerotic plaques at the vertebral artery openings are different from conventional lesions existing on the inner wall of blood vessels, the most common position of atherosclerosis of the vertebral artery 1 is at the vertebral artery openings, namely the openings of the vertebral artery 1 extending towards the subclavian artery, the openings are of a bifurcation structure rather than a conventional strip structure, and the astride plaques usually cross the vertebral artery 1 and the subclavian artery, so that the technical schemes which are applied to atherosclerotic plaques in a large amount in the prior art cannot be applied to the astride plaques. In addition, the striding plaque is usually accumulated at the inner side of the vertebral artery opening, the outer side is usually a normal blood vessel intima without pathological changes, but most of the technical schemes applied to the blood vessel occlusion at the vertebral artery opening in the prior art are of a circumferential expansion type, namely, although the subclavian artery is occluded after the occlusion balloon is expanded, the vertebral artery opening can be occluded at the same time, so that the plaque to be treated is shielded, and the operation space of an intima stripping operation is also hindered.

The application provides a balloon catheter system for a straddling eccentric plaque peeling operation in a vertebral artery, in particular to a balloon catheter system for blocking a blood vessel in the straddling eccentric plaque peeling operation in the vertebral artery, or an auxiliary system for interventional operation on an opening which extends towards a subclavian artery on a vertebral artery 1 and is only formed with a straddling eccentric plaque 12 on one side. The balloon catheter system provided by the application can also be used in the interventional operation of cutting plaques, when the normal vascular wall is accidentally injured, the condition of vertebral artery 1 intimal denudation needs to be implemented.

For the sake of understanding, the location and connection between the vertebral artery 1 and the subclavian artery will be described first, and the vertebral artery 1 starts from the upper wall of the first segment of the subclavian artery and extends generally upward along the cervical spine after exiting. The subclavian artery can be divided into a proximal subclavian artery 2 and a distal subclavian artery 3 from the location of the junction between the vertebral artery 1 and the subclavian artery. The proximal subclavian artery 2, the distal subclavian artery 3 and the vertebral artery 1 form a bifurcated structure or lumen with three passageways therebetween. The guidewire can be placed from the proximal subclavian artery 2 and moved into the vertebral artery 1 or into the distal subclavian artery 3. The straddling eccentric plaque 12 is usually located at the opening of the vertebral artery at the corner of the proximal subclavian artery 2 extending towards the vertebral artery 1.

In the present application, the cavity of the bifurcated lumen may be referred to as a lumen or a vessel lumen, and the inner wall surface of the portion of the bifurcated lumen where the straddling eccentric plaque 12 is formed is the plaque-located surface 10, and correspondingly, the inner wall surface opposite to the plaque-located surface 10 is the non-diseased surface 9. The plaque-bearing surface 10 is relative to the non-diseased surface 9 and does not absolutely refer to a fixed wall surface within the cavity.

Example 1

The balloon catheter system comprises a first balloon portion 4 and a positioning guide wire 5, the first balloon portion 4 being positioned on the positioning guide wire 5.

The first balloon portion 4 has a cavity and its form is controllable. The inflation or deflation of the first balloon portion 4 may be achieved by injecting or withdrawing fluid into or from the cavity of the first balloon portion 4. The fluid may be a gas or a liquid.

The first balloon portion 4 can be placed in a blood vessel together with the positioning guide wire 5 and moved to a specified position corresponding to the plaque to be treated. Whether the first balloon portion 4 is located at a specified position or not can be determined by angiography. The designated location is the location of the plaque or bifurcated lumen to be treated.

The positioning guide wire 5 is a strip-shaped structure and is mainly used for leading the first balloon part 4 in a contraction state to be close to a bifurcation cavity where the striding eccentric plaque 12 is located. One end of the vertebral artery 1 communicates from the outer tubular wall of the subclavian artery to the inside thereof to form the bifurcated lumen which is located between the vertebral artery 1 and the subclavian artery.

Preferably, as shown in fig. 1, the first balloon portion 4 includes a waist balloon 6 and a shoulder balloon. The shoulder balloon comprises a first shoulder balloon 7 and a second shoulder balloon 8 which are respectively formed at two ends of the waist balloon 6 along the extending direction of the positioning guide wire 5.

When fluid is injected into the first balloon portion 4, the lumbar balloon 6 and the shoulder balloon can be expanded. The shoulder balloon after inflation has a larger inflation diameter than the waist balloon 6. The expanded diameter may refer to the dimension of the expansion in a cross-section perpendicular to the direction of extension of the length of the positioning guidewire 5.

With this arrangement, the shoulder balloon of the first balloon portion 4 expands to block the anterior-posterior blood flow of the subclavian artery, and the narrow waist balloon 6 allows avoidance of the wall surface of the bifurcated cavity where the striding eccentric plaque 12 is located.

Preferably, the lumbar balloon 6 may have a lower extensibility than the shoulder balloon. The degree of extensibility may refer to a degree to which the balloon is resistant to deformation when fluid is injected into the balloon, and a higher degree of extensibility indicates a greater hardness of the material of the balloon. When fluid is injected to expand the balloon, the expansion degree of the waist balloon 6 is certain and smaller than the diameter of a blood vessel close to the bifurcation cavity on the subclavian artery, so that the bifurcation cavity cannot be blocked by the first balloon part 4, the straddling eccentric plaque 12 is fully exposed in the operation, and a better operation view field can be realized. The shoulder balloon has larger expansible degree, so that the shoulder balloon can be better matched with the diameter of a blood vessel close to the bifurcation cavity on the subclavian artery, and the reliable plugging effect on the subclavian artery is realized. The expansion of the shoulder saccule also leads the waist saccule 6 to be far away from the wall surface of the straddling eccentric plaque 12 in the bifurcation cavity, and the waist saccule 6 can not shield the stripping operation of the plaque in the operation.

Preferably, each shoulder balloon extends continuously around the circumferential direction of the lumbar balloon 6 and is provided around the end of the lumbar balloon 6. The lumbar balloon 6 may be of conventional construction which is elongate after expansion. The lumbar balloon 6 is communicated with the shoulder balloon by opening an opening at a partial position of the lumbar balloon 6, which is provided at the shoulder balloon.

Preferably, the shoulder balloon and/or the lumbar balloon 6 is sleeved on the positioning guide wire 5 in such a way that the positioning guide wire 5 is positioned at an eccentric position of the balloon thereof. With this arrangement, when the first balloon portion 4 is expanded, the positioning guide wire 5 is moved in a direction away from the striding eccentric patch 12 to avoid the wall surface of the bifurcated lumen where the striding eccentric patch 12 is located.

The positioning wires 5 are located at eccentric positions of the balloon, which means that the distance between the balloon and the guide wires at each position in the circumferential direction is different or the same when the balloon is expanded.

Preferably, the first balloon portion 4 in the expanded state has a first region having the largest distance from the guide wire and a second region having the smallest distance from the guide wire, the first region and the second region being disposed opposite to each other. Thus, when the balloon is expanded, the lumbar balloon 6 is laterally directed to the non-diseased surface 9 within the bifurcated lumen, substantially exposing the site of the plaque.

The application provides an intervention method of a balloon catheter system for a vertebral artery internal straddling eccentric plaque peeling operation, in particular to a balloon catheter method for plugging a blood vessel in the vertebral artery internal straddling eccentric plaque peeling operation. The first balloon portion 4 is placed on the positioning guide wire 5 before the balloon is inserted. The positioning guidewire 5 is placed from the proximal subclavian artery 2. The first balloon portion 4 is displaced at the location of the bifurcated lumen. At this time, the first shoulder balloon 7 and the second shoulder balloon 8 are located in the proximal subclavian artery 2 and the distal subclavian artery 3, respectively. The fluid is injected into the first balloon portion 4 to expand the lumbar balloon 6 and the shoulder balloon. The shoulder balloon is expanded until the subclavian artery is sealed off. The waist balloon 6 is in an inward concave shape relative to the shoulder balloon, so that the wall surface of the straddling eccentric plaque 12 in the bifurcation cavity is avoided.

As a preferred embodiment, as shown in fig. 1, the shoulder balloon is formed on the waist balloon 6 such that the shoulder balloon after expansion forms an expanded size relative to the positioning guide wire 5 which is the sum of the expanded size of the shoulder balloon and the expanded size of the waist balloon 6 at the position of the shoulder balloon.

As a preferred embodiment, as shown in fig. 2, shoulder balloons are formed at both ends of the lumbar balloon 6 so that the expanded size formed by positioning the guide wire 5 relative to the shoulder balloon after the shoulder balloon is expanded is the expanded size of the shoulder balloon itself. With this arrangement, the shoulder balloon and the lumbar balloon 6 may be integrally formed.

Reference herein to an expanded dimension may refer to an expanded diameter or radius of expansion of the balloon in an expanded position relative to the positioning guidewire in a direction perpendicular to the direction of expansion of the positioning guidewire.

As a preferred embodiment, as shown in fig. 3, the first balloon portion 4 is composed of a first shoulder balloon 7 and a second shoulder balloon 8 which are provided separately. The first shoulder balloon 7 and the second shoulder balloon 8 are respectively positioned on different positions of the positioning guide wire 5, and both can be expanded by injecting fluid to block corresponding blood vessels. The expansion of the first shoulder balloon 7 and the second shoulder balloon 8 may be set synchronously or asynchronously.

Preferably, the system further comprises a second balloon portion provided on the positioning guide wire 5. The second balloon portion is mainly used to assist the positioning of the first balloon portion 4 within the vessel.

Preferably, the second balloon portion is provided with a first developing mark and a second developing mark in advance. By obtaining the development position relationship of the first development mark and the second development mark on the two-dimensional interface, the blocking position relationship formed by the first balloon part 4 relative to the vertebral artery 1 on the wall surface where the striding eccentric patch 12 is located for assisting the first balloon part 4 to avoid the bifurcation cavity can be obtained. The visualization position relationship on the two-dimensional interface referred to in the present application may refer to a position relationship between the first visualization marker and the second visualization marker in a picture obtained by contrast.

The second balloon portion enters the vessel segment in a contracted posture and is convertible to a preset first expanded posture so that the first visualization marker and the second visualization marker can be recognized. Preferably, the first developing mark extends continuously in the circumferential direction of the second balloon portion with a constant distance from both ends of the second balloon portion. Preferably, the second developing marks extend continuously along the circumferential direction of the second balloon portion, and the distance between the second developing marks and the two ends of the second balloon portion has a changing trend. Preferably, the first development marks may be arranged in a manner similar to a hoop belt, and the second development marks may be arranged in a manner similar to a spiral belt. With this arrangement, the distance between the first development mark and the second development mark is different as viewed at different positions in the circumferential direction of the second balloon portion, and this distance can be obtained by the development positional relationship of the first development mark and the second development mark with each other on the two-dimensional interface.

Preferably, the inner wall of the balloon portion is provided with a through channel, and the through channel can be formed into a first developing mark and a second developing mark on the inner wall of the balloon portion by introducing a developer to fill the through channel. The through passage includes a first through passage and a second through passage connected to each other, the first through passage extending along an annular shape of the second balloon portion, the second through passage extending spirally upward around a circumferential direction of the second balloon portion.

Preferably, the first and second developing marks may be provided in a manner of being applied to the outer side or the inner wall of the balloon portion in advance.

Preferably, the first balloon portion 4 may be assisted by a precise twisting mechanism disposed outside the human body to complete the positioning of the first balloon portion 4 in the blood vessel, and the positioning accuracy of the first balloon portion 4 may be improved in this configuration.

Preferably, the distance between the first shoulder balloon 7 and the second shoulder balloon 8 may be set to 30mm to 50 mm. Wherein the distance between the first shoulder balloon 7 and the second shoulder balloon 8 is preferably 40mm or 45 mm.

Preferably, the expanded size of the expanded first balloon portion 4 may be set to 9mm to 16 mm. The expanded size of the expanded first balloon portion 4 is preferably 10mm to 12 mm.

Example 2

This embodiment is a further improvement of the foregoing embodiment, and repeated contents are not described again.

The balloon catheter system further includes a limiting expansion portion 11. The first balloon portion 4 is formed with end balloons located at both ends thereof in the length extending direction of the guide wire, and an intermediate balloon located between the two end balloons, and the expansion limiting portion 11 is provided on the intermediate balloon of the first balloon portion 4.

Preferably, the intermediate balloon and the end balloon are merely the divisions of the area of the first balloon portion 4 for the convenience of description, and do not absolutely indicate that the first balloon portion 4 is composed of different balloons.

When the first balloon portion 4 is expanded, the expansion of the middle balloon body where the first balloon portion is located is limited through the expansion limiting portion 11, so that the expansion degree of the middle balloon body is smaller than that of the end balloon bodies located at the two ends of the first balloon portion 4. The expansion degree here may refer to an expansion area formed on a cross section perpendicular to a length extending direction of the guide wire after the balloon expansion is completed.

In the present embodiment, the expansion limiting portion 11 has a configuration that is not changeable. For example, the expansion restricting portion 11 is a wire-shaped structure made of metal, and a wire is provided on the intermediate balloon portion 4 so as to surround the same. The expansion of the mid-balloon surrounded by the wire is limited. In practice, the wire with different specifications or lengths can be selected according to actual requirements, and the expansion limiting area or the expansion degree can be changed correspondingly. For example, the expansion restricting portion 11 may be a metal collar that is fitted over the middle bag body. The shape is not changeable, which means that the rigidity or flexibility of the material is determined, but not absolutely that the material cannot be deformed due to high rigidity.

In this arrangement, the end balloon of the first balloon portion 4 expands to block the anterior-posterior blood flow of the subclavian artery, while the narrower middle balloon enables avoidance of the wall surface of the bifurcated lumen where the straddling eccentric plaque 12 is located.

Example 3

In the present embodiment, the expansion limiting portion 11 has a controllable configuration. The expansion restricting section 11 has at least a first form and a second form. The first and second configurations of the expansion-limiting portion 11 may be referred to as flexible and rigid, respectively. The shape of the expansion limiting part 11 is controllable, which means that the expansion limiting part 11 can be switched between flexibility and rigidity without influencing the use of the expansion limiting part.

In the present embodiment, the expansion limiting portion 11 may be a strip-shaped structure, and the expansion limiting portion 11 of the strip-shaped structure is spirally wound on the middle bag body.

The controllable form of the first balloon portion 4 may be such that the first balloon portion 4 is switched between inflation and deflation by charging and discharging fluid into the cavity of the first balloon portion 4.

The flaring 11 in the first configuration has some flexibility to accommodate a guidewire to be placed more easily within a vessel segment or to extend between different vessel segments. In the first state, the expansion limiting part 11 is in a first posture close to the positioning guide wire 5, the expansion limiting part 11 is in a closed posture, and the expansion limiting part 11 is positioned on the middle balloon body of the first balloon part 4. With this arrangement, the size of the intervention of the positioning guide wire 5 carrying at least the first balloon portion 4 and the expansion limiter 11 is reduced, since the expansion limiter 11 is folded onto the guide wire.

The expansion restricting portion 11 in the second form has a certain rigidity for providing an effective expansion restricting effect on the first balloon portion 4. The expansion restricting portion 11 can restrict the degree of expansion of the intermediate bladder on the first bladder portion 4 in the second posture in which it is formed in the second form.

When the first balloon portion 4 is expanded, since the expansion restricting portion 11 surrounds the first balloon portion 4, the expanded first balloon portion 4 exerts a force on the expansion restricting portion 11, and the expansion restricting portion 11 in the first state is forced to expand outward, and then shifts to the second posture. The expansion restricting part 11 in the second posture has a larger accommodation space than the first posture. At this time, the form of the expansion limiter 11 is switched to the second form, and the expansion limiter 11 is held in the second posture with increased rigidity. The expansion of the balloon is continued so that the expansion degree of the intermediate balloon is smaller than the expansion degree of the end balloons positioned at both ends of the first balloon portion 4.

In order to avoid the expansion restricting portion 11 from sliding on the unexpanded first balloon portion 4, a partial region of the expansion restricting portion 11 may be fixed to the first balloon portion 4.

The balloon catheter system of the present application further includes a guide assembly. The guiding component is used for executing a triggering event on the expansion limiting part 11 entering the cavity in the first form so as to change the form of the expansion limiting part 11 or make the expansion limiting part 11 convert to the second form.

The posture of the expansion restricting portion 11 formed in the second form refers to a certain posture which is formed by an external force in the first form and is fixed by its conversion to the second form. The posture of the expanding restriction portion 11 formed in the second posture may be made different by different external forces. The external force action referred to herein may refer to the force exerted by the first balloon portion 4 on the expansion restricting portion 11. Specifically, the expansion restricting portion 11 in the first form may vary according to the degree of expansion of the first balloon portion 4.

Under this setting, on the one hand, the expansion limiting part 11 of different postures can guide the expansion form of the first balloon part 4, so that the shape of the first balloon part 4 can be more suitable for the bifurcation cavity where the striding eccentric plaque 12 is located, and a better plugging effect is achieved. On the other hand, the form conversion timing of the expansion limiting part 11 is controllable, that is, the form conversion timing of the expansion limiting part 11 can be regulated and controlled according to different expansion requirements.

Preferably, the expansion limiter 11 is a material with shape memory effect. The shape memory effect is a phenomenon that after an alloy which undergoes martensite phase transformation is deformed, the alloy is heated to a temperature higher than a final temperature, so that low-temperature martensite is inverted into a high-temperature parent phase to return to an original shape before deformation, or the martensite returns to the shape of the martensite through the release of internal elastic energy in a subsequent cooling process. The material with shape memory effect is solid material with certain shape, and after certain plastic deformation and heating to certain temperature, the material returns to the original shape before deformation.

The guiding component can be a long-strip-shaped flexible heating wire, the deformation capacity of the guide wire is not affected, and the guiding component can heat after being electrified, so that the form of the thermotropic phase change composite material filled in the cavity of the expansion limiting part 11 is changed. Preferably, the guide assembly may have an electrically conductive section disposed along the guide wire and a heating section disposed on the enlarged limit 11. In order to protect the blood vessel, the heating section and the outside of the expansion limiting part 11 can be wrapped with a heat insulating layer so as to avoid the adverse effect of the temperature change in the expansion limiting part 11 on the blood vessel. The heating section may heat the expansion limiting part 11, or may cool the expansion limiting part 11.

In the present application, the parent phase of the expansion limiting part 11 is set to be a spiral structure with a large winding degree, and when the expansion limiting part 11 is heated to a certain temperature, the expansion limiting part 11 enters the first form, and the flexibility of the expansion limiting part 11 in the first form is increased. Before the balloon is inserted, the expansion limiting part 11 is wound on the first balloon part 4, and the expansion limiting part 11 is heated by the guide assembly and then cooled, so that the expansion limiting part is fixed on the first balloon part 4 in the wound posture of the parent phase.

When the balloon is inserted, the expansion restricting portion 11 is heated by the guide member, the expansion restricting portion 11 enters the first form, and the flexibility of the expansion restricting portion 11 in the first form is increased.

Fluid is injected into the balloon to expand the balloon, and the expanded balloon exerts force on the expansion limiting part 11 to drive the expansion limiting part 11 to deform along with the expanded balloon.

When the balloon is expanded to a certain extent, the heating is removed, and the expansion restricting portion 11 enters the second form, whereby the expansion restricting portion 11 can be maintained in the current posture.

The balloon is continuously expanded, and the expansion degree of the middle balloon body is not longer than that of the end balloon bodies positioned at the two ends of the first balloon part 4.

After the operation is finished, the fluid in the saccule is led out, and the first saccule is contracted. Meanwhile, the expansion limiting part 11 is heated through the guide assembly, and the expansion limiting part 11 can be restored to the parent phase, so that the interventional size of the balloon is reduced again. The guide wire can be smoothly withdrawn at this time.

Preferably, when the paramedic opens the bifurcated lumen from outside the body, the release of blood flow there may cause a sudden pressure change between the two end balloons, which may cause the balloons to move and the vessel occlusion to fail. In addition, the operation of medical care personnel in the operation can also cause the capsule body to move, so that the blood vessel blockage fails. In contrast, in the present application, the shape of the expansion restricting portion 11 can be changed by applying a trigger event to the expansion restricting portion 11 by the guide member, so that the expansion restricting portion 11 can exert a force on the first balloon portion 4 against a reverse force exerted on the first balloon portion 4 by a pressure change when the medical staff opens the bifurcated lumen from the outside of the human body. Since the enlargement restricting portion 11 is spirally provided on the first balloon portion 4, the enlargement restricting portion 11 in the first posture has a shorter width formed in the guide wire extending direction than the enlargement restricting portion 11 in the second posture. In the art, limit and expand portion 11 and heat through the guide assembly, make it oppress middle utricule, the fluid in the middle utricule removes in the tip utricule, forces the effort increase between tip utricule and the subclavian artery, and the stabilization is strengthened. Wherein, the heating rate of the expansion limiting part 11 can be controlled by the guiding component, and the pressure action of the expansion limiting part 11 on the middle capsule body can be regulated and controlled.

In order to avoid the damage of the saccule caused by the sharp part formed by the end part of the strip-shaped structure on the saccule after expansion, the end part of the strip-shaped structure can be designed into an arc shape or other shapes capable of protecting the saccule.

Example 4

Preferably, the expansion limiting portion 11 may comprise several strips, which are arranged on the middle balloon body of the first balloon portion 4 in parallel with each other. Several strip-shaped portions are spaced apart from each other in the circumferential direction of the first balloon portion 4. The provision of the strip portion on a single side of the intermediate bag body enables the first bag portion 4 to expand in a single-sided concave manner. Or the strip-shaped parts are arranged on the periphery of the middle balloon body, so that the first balloon part 4 can expand in a dumbbell shape.

The strip part has certain extension strength, namely the middle capsule body has certain deformation resistance. In contrast, the end balloon portion of the first balloon portion 4, which is not provided with a wire, has less resistance to deformation. In this arrangement, the first balloon portion 4 is inflated in a non-uniform manner and is formed to be recessed inwardly towards the region where the intermediate balloon is located. Preferably, the expansion restricting portion 11 forms a central expansion restriction of the first balloon portion 4 in the lengthwise extending direction of the positioning guide wire 5 such that the first balloon portion 4 expands in a direction away from the straddling eccentric plaque 12. The expanded first balloon portion 4 assumes an inwardly depressed posture.

Preferably, when the paramedic opens the bifurcated lumen from outside the body, the release of blood flow there may cause a sudden pressure change between the two end balloons, which may cause the balloons to move and the vessel occlusion to fail. In this regard, the shape of the expansion-limiting portion 11 can be changed by applying a triggering event to the expansion-limiting portion 11 through the guiding means, so that the expansion-limiting portion 11 can exert a limiting action on the first balloon portion 4 against a reaction force exerted on the first balloon portion 4 by a pressure change when the medical staff opens the bifurcated lumen from outside the human body. Under this setting, be different from the great metal material of hardness, limit expansion portion 11 can intervene the blood vessel along with the guide wire with the first form that the flexibility is better this moment, and the guarantee is intervened smoothly, also can play the effect of limiting expansion to first sacculus portion 4 simultaneously.

Preferably, the cavity of the expansion limiting part 11 is filled with a thermotropic phase change composite material, so that the form change of the expansion limiting part 11 can be controlled by temperature. In this arrangement, the guiding component is a heat conducting component and is disposed in the cavity of the expansion limiting portion 11, and is configured to perform a triggering event on the expansion limiting portion 11 entering the cavity in the first form so as to switch the expansion limiting portion 11 to the second form, where the triggering event is a change in temperature. The guiding component can be a strip-shaped flexible heating wire, the deformation capacity of the guide wire is not affected, and the guiding component can heat after being electrified, so that the form of the thermotropic phase change composite material filled in the cavity of the expansion limiting part 11 is changed. Preferably, the thermotropic phase change composite may be a composite composed of high latent heat Paraffin (PA), Olefin Block Copolymer (OBC), Expanded Graphite (EG). Wherein, PA is used as PCM for absorbing heat, OBC is used as a supporting material, and EG is used for improving heat conduction performance. When the PA is below the phase transition temperature, the PA is in a solid phase crystallization state, and the molecular chain segment of the OBC soft segment is frozen. As the temperature increases, the PA changes from a solid to a liquid state and the molecular segments of the soft segments of the OBC are "thawed" and free to move. Meanwhile, the existence of the liquid phase PA can play a role in lubrication in the movement of the chain segment, so that the storage modulus is rapidly reduced, and the material obtains flexibility. Good flexibility can be obtained by triggering the phase change of the PA, so that various deformation modes such as bending and compression are obtained. When the external stress for deforming the material is cancelled, the molecular chain of the soft segment gradually reaches a thermodynamic equilibrium state under the action of entropy elasticity, and the macroscopic expression is the shape recovery. Preferably, each end face of the expansion restricting part 11 may be made of a heat insulating material to avoid adverse effects of temperature changes in the expansion restricting part 11 on the blood vessel.

Preferably, the cavity of the expansion limiter 11 is filled with a magnetic transition composite material, so that the form change of the expansion limiter 11 can be controlled by a magnetic field. In this arrangement, the guiding component is a current conductor and is disposed in the cavity of the expansion limiting part 11, and is configured to apply a triggering event to the expansion limiting part 11 entering the cavity in the first form so as to switch the expansion limiting part 11 to the second form, where the triggering event is a change in the magnetic field. The guiding component can be a long flexible electrified conductor, the deformation capability of the guide wire is not affected, and the guiding component can generate a magnetic field after being electrified so as to change the form of the magnetic phase change material filled in the cavity of the expansion limiting part 11. Preferably, the magneto-rheological material may be a magneto-rheological fluid which exhibits low viscosity newtonian fluid characteristics in the absence of an external magnetic field. Magnetorheological fluids are typically suspensions of micron or nanoscale ferromagnetic particles (typically carbonyl iron particles) immersed in a non-magnetic carrier liquid, with small amounts of other auxiliary solutions. Exhibits a high viscosity, low flow Bingham fluid (Bingham) upon application of a magnetic field. The viscosity of the liquid is in corresponding relation with the magnetic flux. This conversion is low in energy consumption, easy to control, and fast in response (milliseconds). Preferably, each end face of the expansion limiter 11 may be made of an insulating material.

Preferably, the cavity of the expansion limiting part 11 is filled with a photo-induced phase change material, so that the form change of the expansion limiting part 11 can be controlled by light. In this arrangement, the guiding component is a light emitting component and is disposed in the cavity of the expansion limiting portion 11, and is configured to perform a triggering event on the expansion limiting portion 11 entering the cavity in the first form so as to switch the expansion limiting portion 11 to the second form, where the triggering event is a change in light intensity. The guiding component can be a long flexible transparent optical fiber, the deformation capability of the guide wire is not affected, and the guiding component can emit light after being electrified, so that the shape of the photoinduced phase change material filled in the cavity of the limited expansion part 11 is changed. Preferably, the light-induced phase change material can change the structure thereof according to light with different wavelengths, and can be changed from a rigid substance to a soft substance. The photo-phase change material may be composed of a polymer attached to photosensitive molecules that can alter chemical bonds formed within the material. When a magnetic field is present in the fluid, the magnetic particles align in chains along the magnetic field lines, increasing the stiffness of the fluid and thus simultaneously the overall structure. When the magnetic field is removed, the fluid behaves as a liquid, being able to flow freely.

Preferably, the cavity of the expansion limiting part 11 is filled with an electric signal induced phase change material, so that the form change of the expansion limiting part 11 can be controlled by an electric signal. In this arrangement, the guiding component is an electrical conductor and is disposed in the cavity of the expansion-limiting portion 11, and is configured to apply a triggering event to the expansion-limiting portion 11 entering the cavity in the first form so as to convert the expansion-limiting portion 11 into the second form, where the triggering event is a change of an electrical signal. The guiding component can be a long strip-shaped electric conductor, the deformation capability of the guide wire is not influenced, and the guiding component can transmit an electric signal to the electric signal phase-change material after being electrified, so that the form of the electric signal phase-change material filled in the cavity of the limited expansion part 11 is changed. Preferably, the electric signal induced phase change material can change the strength of the material in a few seconds from hard and fragile to soft and flexible, and the whole quality change process is controlled by the electric signal. The phase change material caused by electric signals can be a metal and liquid mixed material formed by putting a noble metal material such as gold or platinum into an acid solution for corrosion, forming tiny pipelines and holes in the material, then pouring a nano-structure material into the whole pore channel frame, and filling each micropore with a conductive liquid. The electric signal induced phase change material can be called as metal water conjunct, and can be excited by an electric signal to rapidly change the material form. Preferably, in the presence of an external current, atomic bonds on the surface of the metal are strengthened, and the hardness of the material is increased; when the current is cut off, the atomic bonds are weakened, and the material can also become softer, has stronger damage resistance and better ductility. The mechanical property of the phase-change material caused by the electric signal can be switched back and forth between a soft state and a hard state. Preferably, each end face of the expansion limiter 11 may be made of an insulating material.

It should be noted that the above-mentioned embodiments are exemplary, and that those skilled in the art, having benefit of the present disclosure, may devise various arrangements that are within the scope of the present disclosure and that fall within the scope of the invention. It should be understood by those skilled in the art that the present specification and figures are illustrative only and are not limiting upon the claims. The scope of the invention is defined by the claims and their equivalents. The present description contains a plurality of inventive concepts such as "preferably", "according to a preferred embodiment" or "optionally" each indicating that the respective paragraph discloses a separate concept, the applicant reserves the right to apply for divisional applications according to each inventive concept. Throughout this document, the features referred to as "preferably" are only an optional feature and should not be understood as necessarily requiring that such applicant reserves the right to disclaim or delete the associated preferred feature at any time.

Claims

1. Balloon catheter system for intravertebral straddling eccentric plaque denudation, comprising at least:

a first balloon portion (4) with a controllable form; and

a positioning guide wire (5) used for guiding the first saccule part (4) to correspond to a bifurcation cavity which is formed by communicating one end part of the vertebral artery (1) with the inside of the outer tube wall of the subclavian artery and is positioned between the vertebral artery (1) and the subclavian artery and is provided with a striding eccentric plaque (12),

it is characterized in that the preparation method is characterized in that,

the first balloon part (4) comprises a waist balloon (6) and a first shoulder balloon (7) and a second shoulder balloon (8) which are respectively formed at two ends of the waist balloon (6) along the extension direction of the positioning guide wire (5), the waist balloon (6) and the shoulder balloons can be expanded by injecting fluid into the first balloon part (4), the expanded shoulder balloons have larger expansion diameters than the waist balloon (6), so that the first balloon part (4) can avoid the wall surface where the striding eccentric plaque (12) is located in a bifurcation type cavity while blocking the subclavian artery,

each shoulder sacculus respectively around waist sacculus (6) circumference extend in succession and encircle locate waist sacculus (6) on the tip, shoulder sacculus and/or waist sacculus (6) with location seal wire (5) locate at the mode on the eccentric position of its utricule cover locate on location seal wire (5) to when first sacculus portion (4) expand location seal wire (5) move in order to dodge the wall of straddling nature eccentric plaque (12) place in the forked type cavity towards the direction that deviates from straddling nature eccentric plaque (12).

2. Balloon catheter system for use in a vertebro-arterial straddle eccentric plaque ablation procedure, comprising at least:

a first balloon portion (4) with a controllable form; and

a positioning guide wire (5) used for guiding the first balloon part (4) to correspond to a bifurcation cavity formed by communicating one end part of the vertebral artery (1) with the inside of the subclavian artery from the outer tube wall of the subclavian artery, wherein the straddling eccentric plaque (12) is positioned on the bifurcation guide wire, and the bifurcation cavity is positioned between the vertebral artery (1) and the subclavian artery,

it is characterized by also comprising:

an expansion limiting part (11) which is arranged on the middle capsule body of the first capsule part (4) to limit the expansion of the middle capsule body when the first capsule part (4) expands, so that the expansion degree of the middle capsule body is smaller than the expansion degree of the end capsule bodies at the two ends of the first capsule part (4),

the system further comprises a guiding assembly, wherein the guiding assembly is configured to implement a triggering event on the expansion limiting part (11) so as to change the shape of the expansion limiting part (11), so that the expansion limiting part (11) is arranged on the middle capsule body of the first balloon part (4) in a first posture close to the positioning guide wire (5), and the intervention size of the positioning guide wire (5) carrying at least the first balloon part (4) and the expansion limiting part (11) is reduced.

3. The system of claim 2, wherein the guide assembly is further configured to cause the expansion limiter (11) to transition to and remain in the second position under the external force applied thereto by the expanded first balloon portion (4) by changing the configuration of the expansion limiter (11) when the first balloon portion (4) is expanded, such that the degree of expansion of the intermediate balloon is less than the degree of expansion of the end balloons at both ends of the first balloon portion (4).

4. Balloon catheter system for intravertebral straddling eccentric plaque denudation, comprising at least:

a first balloon portion (4) with a controllable form; and

characterized in that the device also comprises a limiting expansion part (11) and a guide component, wherein,

the guiding component is used for changing the form of the expansion limiting part (11) so that the expansion limiting part (11) can be arranged on the middle capsule body of the first capsule part (4) in a first posture close to the positioning guide wire (5) to reduce the intervention size of the positioning guide wire (5) at least carrying the first capsule part (4) and the expansion limiting part (11), and

the expansion limiting part (11) can be converted to and kept at the second posture under the action of external force applied to the expansion limiting part by the expanded first balloon part (4), so that the expansion degree of the middle balloon is smaller than that of the end balloons at the two ends of the first balloon part (4).