CN115813629B

CN115813629B - Breach saccule

Info

Publication number: CN115813629B
Application number: CN202310151107.5A
Authority: CN
Inventors: 唐航; 崔巍; 段华磊; 王秀文; 王锐; 刘昊; 王金磊; 韩雪倩
Original assignee: Beijing Taijieweiye Technology Co ltd
Current assignee: Beijing Taijieweiye Technology Co ltd
Priority date: 2023-02-22
Filing date: 2023-02-22
Publication date: 2023-07-21
Anticipated expiration: 2043-02-22
Also published as: CN115813629A

Abstract

The invention discloses a breach saccule, which comprises: the balloon body is provided with an expansion state and a contraction state, a radial deformation area extending axially is constructed on the balloon body, when the balloon body is in the contraction state, the radial deformation area contracts radially inwards to form a radial inward contraction part, and the radial inward contraction part is provided with an accommodating space extending axially and a contraction opening corresponding to the accommodating space and positioned at the outer side of the accommodating space in the radial direction; the rupture part is arranged in the accommodating space of the radial inward shrinkage part and is axially arranged, and the bottom of the rupture part is bonded with the balloon body corresponding to the bottom of the accommodating space; when the balloon body is in a contracted state, the balloon body is hidden in the radial inward contracted part; when the balloon body is switched from the contracted state to the expanded state, the radial inward contracted part deforms to drive the opening part to move radially outwards, so that the opening part protrudes radially out of the balloon body in the expanded state.

Description

Breach saccule

Technical Field

The invention relates to the technical field of medical instruments, in particular to a breach balloon applied to angioplasty.

Background

Myocardial infarction and stroke events caused by atherosclerosis are more and more frequent, and atherosclerosis is typically characterized by the accumulation and attachment of thrombus on the inner wall of a blood vessel to form a diseased tube segment that results in a substantial stenosis within the blood vessel, which may be blocked by free thrombus, thereby burst myocardial infarction or stroke.

Angioplasty is directed to dilating a stenosed vessel segment so that the pore size of the lumen of the diseased vessel segment is greatly increased, even closer to the pore size of the normal vessel segment. Balloon and stent are key core components in angioplasty, and the delivery of the balloon and/or stent to the lesion by means of associated operative components (e.g., catheter) effects the expansion of the lesion by mechanical forces. Well known and easily understood are: the balloon is used to temporarily dilate the diseased tube section and the stent is used to dilate the diseased tube section and form a permanent support.

The balloon may be used in conjunction with the stent or the balloon may be used alone, for example, when the lesion segment obtained by the prognosis is still highly likely to be restored to restenosis after the balloon is temporarily expanded, the stent is usually fed into the lesion segment after the balloon is expanded to permanently support the lesion segment by expanding the stent to prevent restenosis, and when the probability of restenosis of the lesion segment obtained by the prognosis after the balloon is temporarily expanded is not large or the degree of restoration is not large, the stent may be expanded only by the balloon and then the stent is not required to be permanently supported.

Conventional balloons expand a lesion segment by only the mechanical forces generated by inflation, however, this way of forcing vasodilation by only mechanical inflation forces does not achieve the best results in some special lesion situations and under some higher therapeutic requirements. These special pathological conditions include severe calcification of the thrombotic surface (wall) of the diseased tube segment, and these higher therapeutic demands include thrombolytic demands on the diseased tube segment. On the one hand, due to the severe calcification of the thrombus wall, it is impossible (or difficult) to expand the tube section by mechanical expansion force, or even if the tube section can be temporarily expanded by means of a balloon, the tube section is still easily re-stenosed after the balloon expansion, resulting in the invasive stent having to be implanted. On the other hand, because the wall of the thrombus is seriously calcified, thrombolytic drugs are not easy to enter the thrombus, and the thrombolysis effect is poor.

In order to solve the above-mentioned problems caused by serious calcification of the inner wall of a thrombus in a lesion tube section, there is provided in the prior art a balloon having a rupture member attached to the surface thereof (by bonding or heat-melting), such as a triangular blade-like rupture member, the head of which is invaded into the thrombus from the wall of the thrombus after the balloon is inflated, and further to rupture the thrombus, so that vasodilation of the tube section is easier, thrombolytic drug is easier to enter into the inside of the thrombus, and then the balloon expands the tube section by inflation (or alternatively expands the tube section of the ruptured thrombus with another balloon).

However, the above-mentioned balloon capable of breaking thrombus in the prior art has the following drawbacks when in use:

in order to operate, the balloon is delivered to the region near the lesion tube segment by the catheter, the balloon is first removed from the front end of the catheter before penetrating the lesion tube segment, then the balloon is extended into the lesion tube segment by the guidewire, and then the balloon is inflated to perform the breach.

From the above operation sequence, the possibility that the balloon is in contact with the inner wall of the non-diseased tube section inevitably exists, however, as the rupture part on the balloon is always exposed on the surface of the balloon, the possibility that the rupture part is in contact with the inner wall of the non-diseased tube section is increased, and then the rupture part can cut the inner wall of the non-diseased tube section, so that the inner wall of a normal blood vessel is damaged, and even the blood vessel is ruptured.

For non-compliant balloons (the effect of elastic deformation is only a small fraction of the expansion process), the balloon is typically held in a contracted state by rolling to facilitate the delivery of the balloon, and then inflated by unrolling the rolled region. In the prior art, although the purpose of shielding the opening part and avoiding the contact with the inner wall of the blood vessel of the non-lesion tube section can be achieved by arranging the opening part at the inner side of the rolling region, in the process of expanding the balloon, the opening part can prevent the rolling region from overturning and unfolding because of being positioned at the inner side of the rolling region, and particularly, under the condition that the thrombus thickness of the lesion tube section is larger, the opening part has higher possibility of preventing the rolling region from unfolding, so that the balloon is difficult to expand smoothly.

Disclosure of Invention

Aiming at the technical problems in the prior art, the embodiment of the invention provides a breach balloon.

In order to solve the technical problems, the technical scheme adopted by the embodiment of the invention is as follows:

a breach balloon, comprising:

the balloon comprises a balloon body, a pressure sensor and a pressure sensor, wherein the balloon body is provided with an expansion state and a contraction state, a radial deformation area extending axially is constructed on the balloon body, when the balloon body is in the contraction state, the radial deformation area contracts radially inwards to form a radial inward contraction part, and the radial inward contraction part is provided with an accommodating space extending axially and a contraction opening corresponding to the accommodating space and positioned at the outer side of the accommodating space in the radial direction;

the rupture part is arranged in the accommodating space of the radial inward shrinkage part and is axially arranged, and the bottom of the rupture part is bonded with the balloon body corresponding to the bottom of the accommodating space;

when the balloon body is in a contracted state, the balloon body is hidden in the radially inward contracted part;

when the balloon body is switched from a contracted state to an expanded state, the radial inward contracted part deforms to drive the rupture part to move radially outwards so that the rupture part protrudes radially out of the balloon body in the expanded state.

Preferably, the method comprises the steps of,

the opening part is a cutting edge part with a triangular section;

the radially inward constriction is configured such that the constriction is offset relative to the edge of the edge member such that the edge is offset from the constriction.

Preferably, the method comprises the steps of,

the balloon body is a compliant or semi-compliant balloon body;

the length of the radial deformation zone extending axially is limited to the main area of the balloon body;

in the process of switching from the contracted state to the expanded state, the balloon body is radially expanded to the outside of the balloon body by the radially inward contracted part to form a radially outward part.

Preferably, the method comprises the steps of,

the balloon body is a non-compliant balloon body;

the radial deformation area axially penetrates through the main area of the balloon body;

the balloon body on two sides in the circumferential direction of the radial deformation area is provided with a plurality of bending parts so that the balloon body is in a contracted state;

the balloon body is switched to the inflated state by flattening the radially inward pinch portion and the bend portion.

Preferably, the radial deformation area comprises a plurality of circumferentially and uniformly distributed parts, when the balloon body is in a contracted state, each radial deformation area correspondingly forms the radially inward contracted part, and each radially inward contracted part is uniformly distributed with the break part.

Preferably, the break-out part comprises a plurality of axially arranged in sequence and separated from each other.

Preferably, the break-out part comprises a cutting edge part or a spinous process part; the cutting edge part breaks thrombus through the cutting edge part.

Preferably, the ratchet part comprises a substrate and convex needles which are formed on the substrate and are distributed in a matrix; wherein:

the protruding needle is formed by welding a needle body part on the substrate

Or alternatively

The convex needle is engraved on the substrate by laser.

Preferably, the compliant balloon or the semi-compliant balloon is made of a polymer and the non-compliant balloon body is made of a polymer compounded with a fiber yarn; wherein the polymer comprises one or more of polyurethane, polyvinyl fluoride and elastic polyamide.

Preferably, the radially deformed region is shaped by a thermoplastic process.

Compared with the prior art, the beneficial effects of the breach saccule provided by the embodiment of the invention are as follows:

when the rupture balloon in the contracted state is released from the catheter and is exposed in the normal blood vessel near (far side of) the lesion tube section, the rupture member is accommodated in the radially inward contracted part and is difficult to protrude out of the radial outer side of the balloon body, so that the possibility that the rupture member is contacted with the inner wall of the normal blood vessel is reduced, and the possibility that the inner wall of the normal blood vessel is damaged by the rupture member is further reduced.

During the inflation of the balloon body, the balloon body in the region at both sides of the reduction opening is expanded substantially circumferentially outwards, and at the same time, the opening part is moved substantially radially outwards, so that the inflation of the balloon body is less interfered by the opening part, and the posture of the opening part is also less affected by the inflation of the balloon body, thereby enabling the opening part to be embedded into thrombus substantially vertically.

Other key advantages of the present invention are set forth directly and implicitly in the detailed description which follows.

An overview of various implementations or examples of the technology described in this disclosure is not a comprehensive disclosure of the full scope or all of the features of the technology disclosed.

Drawings

Fig. 1 is a front view of a breach balloon provided by an embodiment of the present invention.

Fig. 2 is a view from section A-A of fig. 1 (the balloon body is in a contracted state, the balloon body being a compliant or semi-compliant balloon body).

Fig. 3 is a cross-sectional view of a breach balloon (balloon body in an inflated state) provided by an embodiment of the present invention.

Fig. 4 is a cross-sectional view of a mold used in the thermoplastic shaping process.

Fig. 5 is a cross-sectional view of a breach balloon (the reduction of the radially inward reduction of the balloon body being in an offset state) provided by a preferred embodiment of the present invention.

Fig. 6 is a cross-sectional view of a rupture balloon (the rupture member being configured as an ratchet member) provided by an embodiment of the present invention.

Fig. 7 is a cross-sectional view of a non-compliant breach balloon provided by an embodiment of the invention (balloon body in a contracted state).

Fig. 8 is a cross-sectional view of a non-compliant breach balloon provided by an embodiment of the invention (balloon body in an inflated state).

Fig. 9 is a cross-sectional view showing a state where a thrombus is ruptured by a rupture balloon according to an embodiment of the present invention.

Fig. 10 is a longitudinal cross-sectional view of an embodiment of the present invention providing a first use condition of a breach balloon.

Fig. 11 is a longitudinal cross-sectional view of an embodiment of the present invention providing a second use condition of the breach balloon.

Fig. 12 is a longitudinal cross-sectional view of an embodiment of the present invention providing a third use condition of the breach balloon.

In the figure:

10-a balloon body; 11-a body region; 12-proximal end; 13-distal; 14-a conical region; 15-radial deformation zone; 151-radially outer lugs; 16-a radially inward constriction; 161-accommodating space; 162-necking; 17-a bending part; 20-a breach component; 21-a cutting edge part; 211-blade part; 22-spinous process component; 221-a substrate; 222-protruding needles; 30-a main body mold; 31-a bar-shaped cavity; 40-inserting a column; 50-a central heating rod; 100-breach balloon; 200-a guidewire; 300-catheter; 1000-lesion tube segments; 1001-thrombosis.

Description of the embodiments

Unless defined otherwise, technical or scientific terms used herein should be given the ordinary meaning as understood by one of ordinary skill in the art to which this invention belongs. The terms "first," "second," and the like, as used herein, do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. The word "comprising" or "comprises", and the like, means that elements or items preceding the word are included in the element or item listed after the word and equivalents thereof, but does not exclude other elements or items. The terms "connected" or "connected," and the like, are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "upper", "lower", "left", "right", etc. are used merely to indicate relative positional relationships, which may also be changed when the absolute position of the object to be described is changed.

In order to keep the following description of the embodiments of the present invention clear and concise, the detailed description of known functions and known components thereof have been omitted.

The invention discloses a rupture balloon 100, which is used for rupturing a thrombus 1001 in a lesion tube section 1000 to obtain a better expansion effect on the lesion tube section 1000 and facilitate injection of thrombolytic drugs into the thrombus 1001, wherein the rupture balloon 100 can be used alone to temporarily expand the lesion tube section 1000 only or the rupture balloon 100 is matched with a drug balloon to be used, the thrombus 1001 is ruptured by the rupture balloon 100, then the lesion tube section 1000 is expanded again by the drug balloon and the thrombolytic drugs are injected into the thrombus 1001 through the rupture, or the rupture balloon 100 is matched with a bracket to be used, the lesion tube section 1000 is temporarily expanded by the rupture balloon 100 and then the stent is used to permanently support the lesion tube section 1000.

As shown in fig. 1 to 8, the rupture balloon 100 includes a balloon body 10 and a plurality of rupture members 20.

As shown in fig. 1, the balloon body 10 includes a main body region 11 in the middle, proximal and distal ends 12 and 13 on both sides of the main body region 11, and a tapered region 14 between the proximal end 12 (distal end 13) and the main body region 11. The guide wire 200 (an operation part of the balloon component is conveyed) for conveying and pulling the balloon body 10 axially passes through the balloon body 10, and the proximal end 12 and the distal end 13 of the balloon body 10 are coated on the guide wire 200 in a bonding and hot melting mode.

The balloon body 10 has two states, i.e., a contracted state and an expanded state, the balloon body 10 being in the contracted state during the process for inputting the balloon member from the incision of the blood vessel to the vicinity of the lesion segment 1000, which serves to house the balloon body 10 in the catheter 300 (another operation member for conveying the balloon member) so as to facilitate conveying the balloon member to the lesion segment 1000, and when the balloon member is required to expand the lesion segment 1000, the balloon body 10 is switched to the expanded state by introducing a fluid into the balloon body 10. Noteworthy are: the balloon body 10 is inflated mainly in the main body region 11.

The balloon body 10 provided by the present invention may be made of conventional polymeric materials, for example, one or more of polyurethane, polyvinyl fluoride, and elastic polyamide.

The appearance structure of the balloon body 10 provided by the invention can be molded in a traditional integral injection molding mode.

The key structure of the balloon body 10 provided by the invention is as follows:

as shown in fig. 1 to 3, a plurality of radially deformed regions 15 extending in the axial direction and uniformly distributed in the circumferential direction are formed on the main region 11 of the balloon body 10, and each radially deformed region 15 has the following structural features: when the balloon body 10 is in the contracted state, the radial deformation region 15 is contracted radially inwards, so that a radially inward contracted part 16 is formed on the balloon body 10, the radially inward contracted part 16 is positioned on the inner side of the outer periphery enveloped by the balloon body 10 in the contracted state, an accommodating space 161 which is consistent with the extension of the radially inward contracted part 16 is formed inside the radially inward contracted part 16, and the radially inward contracted part 16 is also formed with a contraction opening 162 which is positioned on the radially outer side of the accommodating space 161 and corresponds to the accommodating space 161 and has a cross-sectional width which is far smaller than that of the accommodating space 161.

The rupture member 20 is used to invade from the calcified wall of the thrombus 1001 into the inside of the thrombus 1001 to form a rupture of the wall of the thrombus 1001, and in the present invention, the rupture member 20 includes a plurality of groups, each group of the rupture members 20 is respectively provided in the accommodation space 161 of the radially inward contracted part 16 and is arranged in the axial direction, and the bottom of the rupture member 20 is bonded to the surface of the balloon body 10 corresponding to the bottom of the accommodation space 161 by bonding or heat fusion. Thus, when the balloon body 10 is in the contracted state as shown in fig. 2, the rupture member 20 is located in the radially inward contracted portion 16 so as not to be exposed to the outside of the outer periphery enveloped by the balloon body 10, as shown in fig. 3, and when the balloon body 10 is switched to the expanded state by the fluid, the radially inward contracted portion 16 drives the rupture member 20 to move radially outward and radially protrude out of the balloon body 10 in the expanded state through the expanded contracted port 162.

The above-structured breach balloon 100 has advantages in that:

as shown in fig. 10, when the rupture balloon 100 in the contracted state is withdrawn from the catheter 300 to be exposed in the normal blood vessel in the vicinity (distal side) of the lesion tube section 1000, the rupture member 20 is received in the radially inward contracted portion 16 so as to be hardly protruded radially outward of the balloon body 10, thereby reducing the possibility that the rupture member 20 is in contact with the inner wall of the normal blood vessel, and further reducing the possibility that the rupture member 20 damages the inner wall of the normal blood vessel.

As shown in fig. 11 and 12, after the balloon body 10 is inflated by pulling the lesion tube segment 1000 by the guide wire 200, the rupture member 20 radially protrudes outside the balloon body 10 in the inflated state, so as to invade the thrombus 1001 and form a rupture in the thrombus 1001, thereby effectively reducing the probability and degree of rebound after the lesion tube segment 1000 is expanded and facilitating the injection of the thrombolytic drug into the thrombus 1001 through the rupture.

The particular key and important advantages are: during inflation of the balloon body 10, the balloon body 10 in the regions on both sides of the stoma 162 expands substantially circumferentially outwardly, while at the same time the rupture member 20 moves substantially radially outwardly, whereby the inflation of the balloon body 10 is less subject to interference by the rupture member 20 and the attitude of the rupture member 20 is less subject to the inflation of the balloon body 10, thereby enabling a substantially vertical embedding of the rupture member 20 into the thrombus 1001.

The plurality of the rupture members 20 are arranged to be separated from each other at each radially inward tapered portion 16 in the axial direction of the balloon body 10, and the length of each of the rupture members 20 is short, which is advantageous in that the rupture balloon 100 can be bent into a large curvature to smoothly pass through a bent blood vessel when being delivered.

The present invention provides two structural forms of the breach member 20.

The break-away part 20 of the first construction: as shown in fig. 2, the rupture member 20 is a cutting edge member 21 having a triangular cross section, and the tip angle of the cutting edge member 21 has a cutting edge portion 211, and the cutting edge portion 211 is adapted to intrude into the thrombus 1001 during inflation of the balloon body 10. The breach member 20 having such a structure is suitable for breach of a thrombus 1001 having a relatively large thickness of the thrombus 1001.

The break-away part 20 of the second construction: as shown in fig. 6, the breach member 20 is an thorn member 22, the thorn member 22 includes a substrate 221, and protruding pins 222 arranged in a matrix are provided on an outer surface of the substrate 221, and the protruding pins 222 may be formed by welding a needle member to the substrate 221, or may be engraved on the substrate 221 by laser. The substrate 221 may be made of a titanium alloy or the like. The protruding needle 222 is used to invade the interior of the thrombus 1001 during inflation of the balloon body 10. The breach member 20 having such a structure is suitable for breach of a thrombus 1001 having a small thickness of the thrombus 1001.

The present invention provides two specific configurations of balloon bodies 10 having radially inward tapers 16, the two configurations of balloon bodies 10 being usable as compliant balloon bodies 10 or semi-compliant balloon bodies 10, or as non-compliant balloons.

Compliant or semi-compliant balloon:

as shown in fig. 2 and 3, the balloon body 10 of the present type achieves the purpose of inflation by using elastic deformation and partial plastic deformation, and when the balloon body 10 is manufactured, the thickness of the balloon body 10 is made slightly larger so as to satisfy a certain stability of the balloon body 10 after the thickness is reduced due to inflation of the balloon body 10. When the balloon body 10 is in the contracted state, the other regions are in the flattened state except for the radially deformed region 15 having the radially inward contracted portion 16.

In the balloon body 10 of the present type, the length of the radially deformed region 15 is limited to the main body region 11, and thus, as shown in fig. 1, the radially inward-contracted portion 16 is located in the main body region 11, and thus, after the balloon body 10 is inflated, as shown in fig. 3, the radially inward-contracted portion 16 is not flattened, but rather, the radially outward-protruded portion 151 is formed by protruding radially outward, which protrudes beyond the outer periphery enveloped by the balloon body 10, so that the amount of protruding the rupture member 20 radially beyond the balloon body 10 is further increased, and as shown in fig. 9, after the balloon body 10 is inflated and the rupture member 20 invades the thrombus 1001, the balloon body 10 is not in contact with or in contact with the inner wall of the thrombus 1001 but exerts only a small force on the thrombus 1001, and further, it is possible to effectively avoid the balloon body 10 from severely squeezing the thrombus 1001 to cause the thrombus 1001 to fall off as a whole.

The breach balloon 100 of this type is suitable for breach of thrombus 1001 having a small thickness and being easily entirely detached.

A non-compliant balloon:

as shown in fig. 7 and 8, the balloon body 10 of the present type is not inflated by elastic deformation and plastic deformation, but is inflated by switching the balloon body 10 from the folded state to the flattened state, and the balloon body 10 of the present type has an advantage of stable overall appearance after inflation. The balloon body 10 can be formed by compounding the polymer and the fiber yarn so as to improve the tensile property of the balloon body 10 and reduce the elastic and plastic deformation, thereby achieving the purpose of using the non-compliant balloon.

The radially deformed region 15 of the present type extends axially through the main body region 11, which causes the radially inward constriction 16 to extend entirely through the main body region 11, which causes the radially inward constriction 16 and the other regions of the balloon body 10 to lie on the outer periphery of the envelope of the balloon body 10 after inflation without forming the radially outward projection 151. In addition, the balloon body 10 on both sides in the circumferential direction of the radially deforming region 15 is formed with a plurality of bending portions 17 so that the balloon body 10 is in a contracted state, and when inflation of the balloon body 10 is required, the fluid expands both the bending portions 17 and the radially inward contracting portions 16 to switch to an inflated state.

The balloon body 10 of this type is capable of being entirely in contact with the inner wall of the thrombus 1001 after inflation, and of pressing the thrombus 1001, and simultaneously breaking the thrombus 1001. The breach balloon 100 of this type is suitable for expanding and breaching a thrombus 1001 with a large thickness and serious calcification.

The radially deformed region 15 in both types of balloon bodies 10 may be formed by a thermoplastic shaping process, which provides a mold and thermoplastic shaping process for the thermoplastic shaping process.

The mold includes a body mold 30, a plunger 40, and a central heating rod 50. The body mold 30 has a plurality of bar-shaped cavities 31 circumferentially arranged and conforming to the outer shape of the radially inward shrinking portion 16, the cross section of the insert pin 40 is matched with the bar-shaped cavities 31 and smaller than the bar-shaped cavities 31, the insert pin 40 is used for being axially inserted into the bar-shaped cavities 31, the insert pin 40 is configured to be capable of generating elastic bending deformation, and the insert pin 40 is beneficial to being adaptively inserted into the bar-shaped cavities 31 which do not axially penetrate the body mold 30. The central heating rod 50 is inserted into the body mold 30 along the center of the body mold 30 for heating the body mold 30, and the body mold 30 is placed in the heating space.

The thermoplastic shaping process comprises the following steps: the injection molded balloon body 10 is set on the main body mold 30, then, the insertion column 40 is axially inserted into the strip-shaped cavity 31 from the end of the strip-shaped cavity 31, and then, the area corresponding to the balloon body 10 is brought into the strip-shaped cavity 31, so that the area is positioned in the shape of the radially inward shrinking portion 16, then, the main body mold 30 is heated from the periphery and the inside, so that the balloon body 10 in the strip-shaped cavity 31 is shaped, after the shaping, the insertion column 40 is taken out, and the balloon body 10 is detached from the main body mold 30, so that the balloon body 10 is thermoplastic-shaped into the radially inward shrinking portion 16.

As shown in fig. 7, the bending portion 17 of the non-compliant balloon body 10 may be formed by forming a structure substantially identical to that of the strip-shaped cavity 31 in the main body mold 30.

The following describes the use of the breach balloon 100.

First, the breach balloon 100 in a contracted state received in the catheter 300 is delivered to the vicinity of the lesion segment 1000, and as the catheter 300 passes through the lesion segment 1000, the breach balloon 100 is delivered to a normal blood vessel area on the right side of the lesion segment 1000.

Then, as shown in fig. 10, the catheter 300 is retracted to the left side of the lesion segment 1000, so that the breach balloon 100 is detached.

Then, as shown in fig. 11, the breach balloon 100 is pulled to the lesion segment 1000 using the guidewire 200.

Then, the fluid is introduced into the rupture balloon 100 to expand the balloon body 10, and as shown in fig. 12, the rupture member 20 ruptures the thrombus 1001 and the balloon body 10 expands the lesion segment 1000.

Then, the fluid is withdrawn, the breach balloon 100 is switched to a contracted state, and the breach balloon 100 is re-housed in the catheter 300, and finally withdrawn from the human blood vessel with the catheter 300.

The above embodiments are only exemplary embodiments of the present invention and are not intended to limit the present invention, the scope of which is defined by the claims. Various modifications and equivalent arrangements of this invention will occur to those skilled in the art, and are intended to be within the spirit and scope of the invention.

Claims

1. A rupture balloon, comprising:

when the balloon body is switched from a contracted state to an expanded state, the radial inward contraction part deforms to drive the rupture part to move radially outwards so that the rupture part protrudes radially out of the balloon body in the expanded state;

the balloon body is a compliant or semi-compliant balloon body;

the balloon body comprises a main body area positioned in the middle, a proximal end and a distal end positioned at two sides of the main body area, and a conical area between the proximal end and the main body area and between the distal end and the main body area;

the length of the axial extension of the radial deformation area is limited in the main body area of the balloon body, so that the radial inward shrinkage part is radially expanded to the outside of the balloon body to form a radial outward shrinkage part in the process of switching the balloon body from a contracted state to an expanded state, and the radial outward shrinkage part is used for reducing or avoiding the contact between the balloon body and the inner wall of the thrombus after the balloon body is expanded and the rupture part invades the thrombus, so as to avoid the balloon body from excessively extruding the thrombus.

2. The rupture balloon as set forth in claim 1, wherein,

the opening part is a cutting edge part with a triangular section;

3. The rupture balloon of claim 1, wherein the radially deformable region comprises a plurality of circumferentially equispaced sections, each of the radially deformable regions correspondingly defining the radially inward pinch portion when the balloon body is in the contracted state, each of the radially inward pinch portions being equispaced with the rupture member.

4. The rupture balloon of claim 1, wherein the rupture member comprises a plurality of axially aligned in sequence and separated from one another.

5. The rupture balloon of claim 1, wherein the rupture member comprises a cutting edge member or a spinous process member; the cutting edge part breaks thrombus through the cutting edge part.

6. The rupture balloon of claim 5, wherein the ratchet member comprises a base plate and a matrix arrangement of protruding pins formed on the base plate; wherein:

the protruding needle is formed by welding a needle body part on the substrate

Or alternatively

The convex needle is engraved on the substrate by laser.

7. The rupture balloon as set forth in claim 1, wherein,

the compliant balloon or semi-compliant balloon body is made of a polymer;

wherein the polymer comprises one or more of polyurethane, polyvinyl fluoride and elastic polyamide.

8. The rupture balloon of claim 1, wherein the radially deformed region is shaped by a thermoplastic process.