CN116138940A - Support system - Google Patents

Abstract

The invention relates to a medical instrument, in particular to a bracket system, which comprises a balloon catheter assembly, a bracket and an outer tube assembly, wherein the balloon catheter assembly comprises a balloon part and a catheter part, the balloon part comprises a balloon body, the catheter part comprises a catheter body, a fixed seat arranged on the catheter body and a catheter seat arranged at the proximal end of the catheter body, the catheter body is at least partially communicated with the balloon body, and the bracket is arranged in an annular space formed by the catheter body and the outer tube assembly. The stent system integrates the balloon expansion and the stent release device, ensures that the balloon does not damage the stent, can avoid frequent replacement of exchange instruments, reduces operation cost, reduces operation time, and avoids secondary injury to patients.

Description

Support system

Technical Field

The present invention relates to medical devices, and more particularly to a stent system.

Background

PTA (percutaneous transluminal angioplasty) is used to pass stenosed vessels and restore blood flow to the vessels. Balloon dilation catheters commonly used in percutaneous transluminal angioplasty are of the type of both the total and rapid exchange type, and commonly used surgical instruments include vascular stents, balloons, and delivery devices (including guidewires). The whole exchange type full length is provided with an inner cavity which can pass through the guide wire, the saccule slides along the guide wire, and an assistant is needed to assist operation, so that the guide wire can be exchanged and the guide wire support can be enhanced. The rapid exchange type single-track balloon is mainly provided with a single-track balloon, only the 15-30cm near section of the balloon can coaxially slide along the guide wire, other pushing rods have no inner cavity for the guide wire to pass through, the guide wire with standard length is matched, and the rapid exchange type single-track balloon can be rapidly and simply operated by a single person, and has the defects that the guide wire cannot be exchanged and the support for the guide wire is weaker when complex lesions are treated. During operation, the carrier is loaded with the stent with high rigidity, so that the carrier cannot directly pass through a severely stenosed vessel, the balloon is required to be used for pre-expanding the stenosed part, the diameter of the stenosed vessel is restored after the balloon is expanded, and the carrier is introduced and the self-expandable vascular stent is released for expanding the stenosed vessel, so that the long-term shaping of the vessel is ensured. After the stent is released, the balloon is often required to be used for post-expansion, so that the diameter of the blood vessel is further recovered, and the long-term smoothness is ensured.

Percutaneous transluminal angioplasty using self-expanding stents is often performed by sequentially feeding a balloon, stent, balloon along a guidewire as a track, and thus frequently exchanging different instruments. When there are calcifications, thrombi and other lesions on the blood vessel along the way, the frequent exchange of the apparatus is easy to bring down tiny particles, and the particles flow along with blood to the distal blood vessel, thus increasing the risk of embolism of the distal blood vessel. In addition, multiple exchanges of instruments also greatly extend the procedure time and increase the cost of the procedure. There is therefore a need to develop a system that avoids multiple exchanges of instruments without damaging the stent.

Disclosure of Invention

In view of the above-mentioned drawbacks of the prior art, an object of the present invention is to provide a stent system for solving the problems of the prior art.

To achieve the above and other related objects, the present invention provides a stent system comprising a balloon catheter assembly including a balloon portion and a catheter portion, the balloon portion including a balloon body, a fixing seat provided on the catheter body and a catheter seat provided at a proximal end of the catheter body, the catheter body being at least partially in communication with the balloon body, and a stent provided in an annular space formed by the catheter body and the outer tube assembly.

Specifically, the balloon body both ends are equipped with distal end conical head and proximal end conical head respectively.

Specifically, the axial length and the maximum radial length of the balloon body are smaller than or equal to the corresponding lengths of the released stent.

Specifically, the catheter body is of a double-layer tube structure, the catheter body comprises an inner catheter and an outer catheter, the outer catheter is sleeved on the outer layer of the inner catheter, a cavity in the inner catheter is a guide wire cavity, and a cavity formed between the inner catheter and the outer catheter is a filling cavity; the inner catheter axially penetrates through the balloon body, and the proximal end of the inner catheter is connected with the catheter seat; the outer catheter is communicated with the balloon body; the proximal end of the outer catheter is connected with the catheter seat, and the bracket is arranged in an annular space formed by the outer catheter and the outer catheter component.

Specifically, the catheter body is of a single-tube structure, and a guide wire cavity and a filling cavity are axially formed in the catheter body; the guide wire cavity is connected with the catheter seat, and the distal end extends to the distal conical head; the filling cavity is communicated with the catheter seat and the balloon body.

Specifically, the catheter seat is provided with a catheter seat cavity, a first inlet, a second inlet and an outlet, the catheter seat cavity is communicated with the outer catheter through the outlet, the second inlet is communicated with the catheter seat cavity, and the inner catheter penetrates through the catheter seat cavity through the first inlet and the outlet.

Specifically, the catheter seat is provided with a catheter seat cavity, a first inlet and an outlet, the catheter seat cavity is communicated with the outer catheter through the outlet, and the inner catheter extends to the proximal end of the conical head at the distal end of the fixed seat.

Specifically, the support is located between the proximal conical head and the fixing base.

Specifically, the stent is a covered stent, a bare stent, a degradable stent or a drug stent.

Specifically, the outer tube assembly comprises an outer tube and an outer tube seat, the outer tube and the outer tube seat are sleeved on the outer layer of the outer catheter, the outer tube seat is connected with the proximal end of the outer tube, the outer tube seat comprises a third inlet, a fourth inlet and an outer tube seat cavity, and the third inlet and the fourth inlet are arranged on the outer tube seat cavity.

Specifically, the distal end of the catheter body and/or the outer tube is provided with a developing mark.

As described above, the stent system of the present invention has the following advantageous effects:

1. the stent system can be used for pre-expanding a blood vessel stenosis by using the saccule, so that the whole trafficability of the stent system is ensured when the blood vessel is severely stenosed.

2. The bracket system can continuously provide supporting force for a narrow blood vessel and ensure long-term shaping of the blood vessel.

3. The stent system can utilize the saccule to post-dilate the stenosed vessel after the stent is released, so that the diameter of the stenosed vessel is further restored.

4. The invention integrates the functions of balloon pre-expansion, stent release and balloon post-expansion, avoids the risk caused by frequent instrument exchange in the operation, and saves the operation time and the operation cost.

5. Avoiding damaging the stent in the conveying process.

Drawings

Fig. 1 shows a schematic view of the stent system of the present invention in a released state.

Fig. 2 is a schematic view of the stent system of the present invention in a compressed state.

Fig. 3 shows a schematic view of a balloon catheter assembly of the present invention.

Fig. 4 shows a cross section of a catheter body of a double-layered tube structure of the present invention.

Fig. 5 shows a cross section of a catheter body of a single tube construction according to the invention.

Fig. 6 shows a cross section of a catheter body of another single tube construction of the invention.

Fig. 7 shows a cross-sectional view of a catheter hub in the total exchange stent system of the present invention.

Fig. 8 shows a cross-section of the stent system of the present invention in a compressed state.

Fig. 9 shows a schematic view of a laser cut stent of the present invention.

Fig. 10 shows a schematic view of a braided stent of the present invention.

Fig. 11 shows a cross-sectional view of an outer tube assembly of the present invention.

Fig. 12-18 are schematic views of the stent system in use.

Description of element reference numerals

1. Balloon catheter assembly

11. Balloon portion

111. Balloon body

112. Distal cone

113. Proximal cone head

12. Catheter section

121. Catheter body

a guide wire cavity

b filling cavity

1211. Inner catheter

1212. Outer catheter

122. Fixing seat

123. Catheter hub

1231. Catheter hub

1232. A first inlet

1233. A second inlet

1234. An outlet

124. Guide wire tube

2. Support frame

3. Outer tube assembly

31. Outer tube

32. Outer tube seat

321. Third inlet

322. Fourth inlet

323. Outer tube seat cavity

Detailed Description

Further advantages and effects of the present invention will become apparent to those skilled in the art from the disclosure of the present invention, which is described by the following specific examples.

Please refer to fig. 1 to 18. It should be understood that the structures, proportions, sizes, etc. shown in the drawings are for illustration purposes only and should not be construed as limiting the invention to the extent that it can be practiced, since modifications, changes in the proportions, or otherwise, used in the practice of the invention, are not intended to be critical to the essential characteristics of the invention, but are otherwise, required to achieve the objective and effect taught by the invention. Also, the terms such as "upper," "lower," "left," "right," "middle," and "a" and the like recited in the present specification are merely for descriptive purposes and are not intended to limit the scope of the invention, but are intended to provide relative positional changes or modifications without materially altering the technical context in which the invention may be practiced.

As shown in fig. 1 to 3, the present invention provides a stent system comprising a balloon catheter assembly 1, a stent 2 and an outer tube assembly 3, the balloon catheter assembly 1 comprising a balloon portion 11 and a catheter portion 12, the balloon portion 11 comprising a balloon body 111, the balloon body 111 primarily serving to pre-dilate a stenotic lesion and post-dilate the released stent 2; the catheter portion 12 includes a catheter body 121, a fixing seat 122 disposed on the catheter body 121, and a catheter seat 123 disposed at a proximal end of the catheter body 121, at least a portion of the catheter body 121 is in communication with the balloon body 111, the stent 2 is disposed in an annular space formed by the catheter body 121 and the outer tube assembly 3, the outer tube assembly 3 can release the stent 2 at a lesion site when moving, and the stent 2 and the balloon body 111 are disposed in tandem in an axial direction of the stent system.

The stent system may be of the whole exchange type or the rapid exchange type, the most important difference between the whole exchange type and the rapid exchange type being the different arrangement of the components forming the guidewire lumen. The components are described below by way of example in terms of a total exchange unless otherwise specified.

As shown in fig. 3, the two ends of the balloon body 111 are respectively provided with a distal conical head 112 and a proximal conical head 113. The distal end is the end near the lesion (i.e., the left end in fig. 1-3) and the proximal end is the end near the operator (i.e., the right end in fig. 1-3).

The diameter of distal cone 112 is at a maximum that is smaller than the diameter of proximal cone 113. This ensures that the balloon body 111 is more easily passed through stenosed vessels.

The balloon body 111 has a columnar shape in an expanded state, and a circular or nearly circular cross section. The diameter of balloon body 111 in the expanded state approximates the maximum diameter of distal cone 112. The axial length and the maximum radial length of the balloon body 111 are less than or equal to the corresponding dimensions of the stent 2 after release to ensure that the balloon can be post-expanded after release of the stent 2 and withdrawn through the stent 2. The material of the balloon body 111 is a single polymer material or a mixed polymer material. The material of the balloon body 111 may be, for example, any one or more of polyether block amide, thermoplastic polyurethane elastomer rubber, nylon, or silicone rubber. The balloon body 111 may be a common balloon or a drug balloon, and is not limited herein.

The proximal tapered head 113 has a smaller diameter proximal to the balloon body end, corresponding to the compressed size of the balloon body 111. The proximal tapered head 113 has a diameter dimension near the outer tube 31 at the distal balloon body end.

The fixing base 122 is cylindrical. The anchor mount 122 is adhered or welded to the conduit portion 12. The fixing base 122 is used for supporting the bracket 2 when the bracket 2 is not released so as to keep the position of the bracket fixed. The fixing base 122 may be provided with a groove matched with the hanging ear of the bracket 2, so as to serve as a hanging ear seat.

The catheter section 12 is primarily used to inflate the balloon body 111 and as a guidewire lumen. The catheter body 121 has a chamber formed therein, which communicates with the balloon body 111.

The distal end of the catheter body 121 is provided with a developing mark. The developing marks are used to mark the positions of the balloon body 111 and the stent 2.

In the embodiment shown in fig. 4, the catheter body 121 has a double-layered tube structure. The catheter body 121 includes an inner catheter 1211 and an outer catheter 1212, the outer catheter 1212 being sleeved on the outer layer of the inner catheter 1211. As shown in fig. 3 and 4, the inner catheter 1211 extends axially through the balloon body 111. In the integral exchange, the inner catheter 1211 extends distally to the distal conical head 112 and proximally to the catheter hub 123. The outer catheter 1212 communicates with the balloon body 111. The distal end of the outer catheter 1212 extends to the proximal tapered head 113, which is connected to the catheter hub 123. The stent 2 is disposed in the distal section of the outer conduit 1212 and in the annular space formed by the outer conduit 1212 and the outer tube assembly 3. I.e. the stent 2 and balloon body 111 are arranged in tandem in the axial direction of the stent system. The distal segment is a segment near the lesion (i.e., the left segment in fig. 1-3) in the present invention.

In the whole exchange, the chamber formed by the inner catheter 1211 is used for passing a guide wire, thus called a guide wire lumen, and the chamber formed between the outer catheter 1212 and the inner catheter 1211 communicates with the balloon body 111 for filling the balloon body 111, thus called a filling lumen.

The inner tube 1211 and the outer tube 1212 may be made of a polymer material, or may be made of a polymer mixed with a metal, and the materials may be the same or different.

In the embodiment shown in fig. 5 and 6, the catheter body 121 is of a single tube construction. The catheter body 121 is axially provided with a guidewire lumen a and a filling lumen b. The guidewire lumen and the filling lumen can have a variety of cross-sectional shapes, and the two lumens can be coaxial or non-coaxial. The portion of guidewire lumen a protruding from filling lumen b may extend outwardly alone. As shown in fig. 3, 5 and 6, the guidewire lumen a extends axially through the balloon body 111. Guidewire lumen a extends proximally to catheter hub 123 and distally to distal cone 112. The inflation lumen b communicates with the balloon body 111. Filling lumen b extends proximally to catheter hub 123 and distally to proximal conical head 113. The support 2 is arranged at the far section of the filling cavity b and is arranged in an annular space formed by the common part of the guide wire cavity a and the filling cavity b and the outer tube assembly 3. I.e. the stent 2 and balloon body 111 are arranged in tandem in the axial direction of the stent system.

In the integrated exchange stent system as shown in fig. 7, the catheter hub 123 is provided with a catheter hub cavity 1231, a first inlet 1232, a second inlet 1233 and an outlet 1234, the catheter hub cavity 1231 being in communication with the outer catheter 1212 via the outlet 1234, the second inlet 1233 being in communication with the catheter hub cavity 1231, the inner catheter 1211 extending through the catheter hub cavity 1231 via the first inlet 1232 and the outlet 1234.

In one embodiment, luer connectors are provided at the first inlet 1232 and the second inlet 1233.

In the whole exchange stent system, the first inlet 1232 is the same size as the outer diameter of the inner catheter 1211 or the guidewire lumen a. Such that the first inlet 1232 can only be used with the inner catheter 1211 exiting the catheter hub 1231. In a total exchange stent system, the luer fitting at the first inlet 1232 is used for evacuation of the guidewire lumen.

In the integral exchange stent system, the second inlet 1233 and its luer connector are used to inject water or developer into the catheter hub cavity 1231. Water or developer enters the balloon body 111 along the filling cavity through the outlet 1234, thereby achieving the purpose of filling the balloon body 111.

In another embodiment, the stent system is a rapid exchange type, as shown in fig. 8, the balloon catheter assembly 1 includes a balloon portion 11 and a catheter portion 12. The balloon part 11 comprises a balloon body 111, and a distal conical head 112 and a proximal conical head 113 are respectively arranged at two ends of the balloon body 111; the catheter section 12 includes a catheter body 121, a fixed base 122 disposed on the catheter body 121, a catheter base 123 disposed on the proximal end of the catheter body 121, and a guidewire tube 124. The fixing base 122 has a cylindrical shape and is adhered or welded to the pipe portion 12. The catheter section 12 is primarily used to inflate the balloon body 111 and as a guidewire lumen. The catheter body 121 has a chamber formed therein, which communicates with the balloon body 111. The catheter body 121 has a single-layer tube structure. The catheter body 121 is comprised of an inner catheter 1211 disposed at a proximal end and an outer catheter 1212 disposed at a distal end. The distal end of the inner conduit 1211 extends to the proximal end of the outer conduit 1212, and the inner conduit 1211 is connected to the opposite end of the outer conduit 1212. The proximal end of inner catheter 1211 is coaxially disposed within catheter hub 123 and connected in a suitable manner. The outer catheter 1212 is connected end-to-end with the balloon body 111 or the outer catheter 1212 is integral with the balloon body 111. Guidewire lumen a is formed by a separate guidewire tube 124 having a proximal inlet disposed distally of inner catheter 1211 and introduced through the side wall of outer catheter 1212 and an outlet disposed distally of distal cone 112. The proximal end of inner conduit 1211 extends to an outlet 1234 of conduit mount 123. The stent system has an inner catheter 1211 as part of the filling lumen b at the proximal end and an outer catheter 1212 as another part of the filling lumen at the distal end.

In a rapid exchange stent system, the catheter hub 123 is provided with a catheter hub lumen 1231, a first inlet 1232 and an outlet 1234, the catheter hub lumen 1231 being in communication with the inner catheter 1211 via the outlet 1234. In the rapid exchange stent system, the first inlet 1232 and its luer fitting are used to inject water or developer into the catheter hub cavity 1231. Water or developer enters the balloon body 111 along the filling cavity b through the outlet 1234, so as to fill the balloon body 111.

In the stent system, the stent 2 is positioned between the proximal conical head 113 and the anchor 122. The stent 2 is a self-expanding stent and can be made of alloy or polymer. Preferably, the bracket 2 is made of nitinol. The stent can be in the form of a covered stent, a bare stent, a degradable stent or a drug stent. As shown in fig. 9 and 10, the structure of the stent 2 may be any of laser cutting type, braiding type, and the like, and is not limited herein.

As shown in fig. 11, the outer tube assembly 3 includes an outer tube 31 and an outer tube seat 32, the outer tube 31 and the outer tube seat 32 are sleeved on the outer layer of the outer catheter 1212, the outer tube seat 32 is disposed on the proximal end of the outer tube 31, the outer tube seat 32 includes a third inlet 321, a fourth inlet 322 and an outer tube seat cavity 323, and the third inlet 321 and the fourth inlet 322 are disposed on the outer tube seat cavity 323.

The distal end of the outer tube 31 extends to the proximal end of the distal conical head 112, and may also extend to the proximal end of the proximal conical head 113, i.e.: the outer tube 31 may cover the balloon body 111 and the stent 2, or may not cover the balloon body 111.

A luer connector is arranged on the third inlet 321. The third inlet 321 and luer fitting thereon are used for evacuation between the outer tube 31 and the outer conduit 1212.

The outer tube 31 is a polymer tube or a polymer reinforced tube, and the reinforcement is formed by knitting reinforcement, spring reinforcement, or the like, and is not limited thereto.

The distal end of the outer tube 31 may be provided with a visualization mark (not shown) for intraoperative visualization alignment.

When the stent system is a rapid exchange type, the outer tube 31 may be tapered with a large proximal stent diameter and a small distal stent diameter. The outer tube 31 is provided with a guidewire outlet at the reducing point.

Taking an integral exchange type stent system as an example, the use method of the stent system of the invention is described as follows:

as shown in fig. 12, the guidewire orbits through the stenosis (i.e., the shaded portion of the figure). As shown in fig. 13, the stent system is advanced along a guidewire and the distal cone 112 and balloon body 111 are passed through the stenotic lesion, with the care being taken that the balloon body 111 completely covers the stenotic lesion. The balloon body 111 is inflated and expanded by injecting a liquid or a developing solution into the catheter seat cavity 1231 through the second inlet 1233, and the diameter of the narrowed blood vessel becomes larger after an external force is applied thereto (as shown in fig. 14). As shown in fig. 15, the balloon body 111 is depressurized, the diameter becomes smaller after the depressurization, the stent system is continuously pushed, the stent 2 is sent into the dilated vascular stenosis, and the position of the stent 2 is confirmed according to the development. The catheter hub 123 is secured and the outer hub 32 is slowly pulled back, at which time the stent 2 is gradually released (as shown in fig. 16), continuing to withdraw the outer hub 32 until the image confirms that the stent 2 has been fully opened. The whole stent system is withdrawn, the balloon body 111 is overlapped with the release position of the stent 2 according to the position of the development point (as shown in figure 17), the balloon body 111 is inflated again at the moment, the diameter of the lumen at the narrow part is further restored, and the long-term normal rate is improved. The released stent 2 is shown in fig. 18. And (5) withdrawing the system to complete the whole operation. The stent system integrates the functions of balloon front expansion, stent release and balloon rear expansion, avoids risks caused by frequent instrument exchange in operation, saves operation time and cost, and also avoids risks of compression damage to the stent caused by the balloon body when the balloon body is full.

In summary, the present invention effectively overcomes the disadvantages of the prior art and has high industrial utility value.

The above embodiments are merely illustrative of the principles of the present invention and its effectiveness, and are not intended to limit the invention. Modifications and variations may be made to the above-described embodiments by those skilled in the art without departing from the spirit and scope of the invention. Accordingly, it is intended that all equivalent modifications and variations of the invention be covered by the claims, which are within the ordinary skill of the art, be within the spirit and scope of the present disclosure.

Claims (11)

1. The stent system is characterized by comprising a balloon catheter assembly (1), a stent (2) and an outer tube assembly (3), wherein the balloon catheter assembly (1) comprises a balloon portion (11) and a catheter portion (12), the balloon portion (11) comprises a balloon body (111), the catheter portion (12) comprises a catheter body (121) and a fixing seat (122) arranged on the catheter body (121) and a catheter seat (123) arranged at the proximal end of the catheter body (121), the catheter body (121) is at least partially communicated with the balloon body (111), and the stent (2) is arranged in an annular space formed by the catheter body (121) and the outer tube assembly (3).

2. The stent system according to claim 1, wherein the balloon body (111) is provided with a distal conical head (112) and a proximal conical head (113) at both ends, respectively.

3. The stent system according to claim 1, characterized in that the axial length and the maximum radial length of the balloon body (111) are smaller than or equal to the corresponding length of the stent (2) after release.

4. The stent system according to claim 1, wherein the catheter body (121) is a double-layer tube structure, the catheter body (121) comprises an inner catheter (1211) and an outer catheter (1212), the outer catheter (1212) is sleeved on the outer layer of the inner catheter (1211), the cavity in the inner catheter (1211) is a guide wire cavity (a), and the cavity formed between the inner catheter (1211) and the outer catheter (1212) is a filling cavity (b); the inner catheter (1211) axially penetrates through the balloon body (111), and the proximal end of the inner catheter (1211) is connected with the catheter seat (123); the outer catheter (1212) is communicated with the balloon body (111); the proximal end of the outer catheter (1212) is connected with the catheter seat (123), and the stent (2) is arranged in an annular space formed by the outer catheter (1212) and the outer catheter assembly (3).

5. The stent system according to claim 2, characterized in that the catheter body (121) is of a single tube structure, the catheter body (121) being axially provided with a guidewire lumen (a) and a filling lumen (b); the guide wire cavity (a) is connected with the catheter seat (123), and the distal end extends to the position of the distal conical head (112); the filling cavity (b) is communicated with the catheter seat (123) and the balloon body (111).

6. The stent system according to claim 4, wherein the catheter hub (123) is provided with a catheter hub lumen (1231), a first inlet (1232), a second inlet (1233) and an outlet (1234), the catheter hub lumen (1231) being in communication with the outer catheter (1212) via the outlet (1234), the second inlet (1233) being in communication with the catheter hub lumen (1231), the inner catheter (1211) extending through the catheter hub lumen (1231) via the first inlet (1232) and the outlet (1234).

7. The stent system according to claim 1, wherein the catheter hub (123) is provided with a catheter hub lumen (1231), a first inlet (1232) and an outlet (1234), the catheter hub lumen (1231) being in communication with the catheter body (121) via the outlet (1234).

8. The stent system according to claim 2, characterized in that the stent (2) is located between the proximal conical head (113) and the fixation seat (122).

9. The stent system according to claim 1, characterized in that the stent (2) is a covered stent, a bare stent, a degradable stent or a drug stent.

10. The stent system according to claim 4, wherein the outer tube assembly (3) comprises an outer tube (31) and an outer tube holder (32), the outer tube (31) and the outer tube holder (32) are sleeved on the outer layer of the outer catheter (1212), the outer tube holder (32) is connected with the proximal end of the outer tube (31), the outer tube holder (32) comprises a third inlet (321), a fourth inlet (322) and an outer tube holder cavity (323), and the third inlet (321) and the fourth inlet (322) are arranged on the outer tube holder cavity (323).

11. The stent system according to claim 1, characterized in that the catheter body (121) and/or the distal end of the outer tube (31) are provided with a visualization mark.

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