An integral exchangeable balloon stent installation device and stent installation method

Abstract

The present invention relates to the technical field of stent delivery of integral exchangeable balloon dilatation catheters, and discloses an integral exchangeable balloon stent installation device and a stent installation method. The integral exchangeable balloon stent installation device is used to install a self-expanding stent on a lesion site of a blood vessel, and includes a balloon dilatation catheter and a stent release tube. The balloon dilatation catheter is provided with a first through hole along the length direction, an inlet is provided at the proximal end of the first through hole, and an outlet is provided at the distal end of the first through hole; an expansion portion is provided at the distal end of the balloon dilatation catheter, and the self-expanding stent can be slidably installed in the first through hole, and the self-expanding stent is located at the distal end of the balloon dilatation catheter; the stent release tube is passed through the first through hole through the inlet, the stent release tube is slidably set in the first through hole of the balloon dilatation catheter, and the distal end of the stent release tube abuts against the self-expanding stent; the stent release tube is provided with a second through hole along the length direction, and a micro guidewire is sequentially passed through the outlet of the first through hole, the self-expanding stent, and the second through hole.

Description

Technical Field

[0001] The present invention relates to the technical field of stent delivery of an integral exchange balloon dilatation catheter, and in particular to an integral exchange balloon stent installation device and a stent installation method. Background Art

[0002] Vascular stenosis is a common vascular disease and an important cause and risk factor for ischemic vascular disease. Currently, vascular stent implantation is one of the important technologies for treating vascular stenosis. The implantation of self-expanding stents usually involves pre-dilation with a balloon catheter, and then delivering the stent to the lesion site to release and automatically expand the blood vessel.

[0003] During the current surgery, doctors need to first deliver the microcatheter and microguidewire to the lesion site, then remove the microcatheter, insert the balloon catheter to pre-dilate the lesion, then withdraw the balloon catheter, insert the microcatheter, and then deliver the stent to the lesion site through the microcatheter to release and automatically expand the blood vessel. During the above process, the microcatheter and balloon catheter need to be inserted into the blood vessel alternately multiple times, which is prone to complications and increases the operation time.

[0004] Based on this, there is an urgent need for an integrally exchangeable balloon stent installation device and a stent installation method to solve the above-mentioned problems. Summary of the invention

[0005] Based on the above, the purpose of the present invention is to provide an integrally exchangeable balloon stent installation device and a stent installation method, which can realize the delivery and installation of a self-expanding stent by installing a balloon dilatation catheter once to dilate the blood vessels, reduce surgical steps, reduce the number of instrument exchanges in the patient's body and the operation time, and improve the success rate of the operation.

[0006] To achieve the above object, the present invention adopts the following technical solutions:

[0007] On the one hand, an integral exchangeable balloon stent installation device is provided, which is used to install a self-expanding stent on a lesion site of a blood vessel, and the integral exchangeable balloon stent installation device comprises:

[0008] A balloon dilatation catheter, wherein the balloon dilatation catheter is provided with a first through hole along the length direction, an inlet is provided at the proximal end of the first through hole, and an outlet is provided at the distal end of the first through hole;

[0009] The distal end of the balloon dilatation catheter is provided with an expansion portion, the self-expanding stent can be slidably installed in the first through hole, and the self-expanding stent is located at the distal end of the balloon dilatation catheter;

[0010] A stent release tube, the stent release tube is passed through the inlet and is disposed in the first through hole, the stent release tube is slidably disposed in the first through hole of the balloon dilatation catheter, and the distal end of the stent release tube abuts against the self-expanding stent;

[0011] A micro guide wire, wherein the stent release tube is provided with a second through hole along the length direction, and the micro guide wire is sequentially passed through the outlet of the first through hole, the self-expanding stent and the second through hole.

[0012] As a preferred technical solution for an integrally exchangeable balloon stent installation device, it also includes a limiting assembly, wherein a first handle is provided at the proximal end of the balloon dilatation catheter, and a second handle is provided at the proximal end of the stent release tube. Two slots are provided inside the limiting assembly at intervals, and a cavity is provided between the two slots. The limiting assembly can be detachably mounted on the first handle and the second handle respectively through the two slots, and a portion of the side wall of the stent release tube is located in the cavity. The spacing between the two slots is not less than the length of the self-expanding stent.

[0013] As a preferred technical solution of an integrally exchangeable balloon stent installation device, the spacing between the two slots is the same as the distance that the stent release tube pushes the self-expanding stent.

[0014] As a preferred technical solution for an integrally exchangeable balloon stent installation device, the limit assembly includes two connectable limit blocks, and the side walls of the two limit blocks are provided with relative grooves. After the two limit blocks are spliced ​​together, the relative grooves are spliced ​​to form the two card slots and the cavity.

[0015] As a preferred technical solution for an integrally exchangeable balloon stent installation device, the side wall of the balloon dilatation catheter includes an inner wall and an outer wall, a fluid channel is provided between the inner wall and the outer wall, the expansion portion is an expansion membrane connected to the outer wall, the proximal end of the fluid channel is connected to a fluid source, the distal end of the fluid channel is connected to the expansion membrane, and the fluid source can control the contraction and expansion of the expansion membrane.

[0016] As a preferred technical solution for an integrally exchangeable balloon stent installation device, a connection port is provided on the outer side wall of the balloon dilatation catheter close to the proximal end, and the connection port is used to connect to the fluid source.

[0017] As a preferred technical solution of an integrally exchangeable balloon stent installation device, the fluid released by the fluid source is liquid.

[0018] As a preferred technical solution for an integrally exchangeable balloon stent installation device, a developing ring or a developing winding is installed on the outer side of the self-expanding stent.

[0019] As a preferred technical solution for an integrally exchangeable balloon stent installation device, a developing ring or a developing winding is installed at the distal end of the balloon dilatation catheter.

[0020] On the other hand, a stent installation method is provided, using the integral exchangeable balloon stent installation device described in any of the above schemes, comprising the following steps:

[0021] Installing the compressed self-expanding stent at the distal end of the balloon dilatation catheter, and installing the stent release tube in the first through hole;

[0022] The micro-guidewire is sequentially inserted into the outlet of the first through hole, the self-expanding stent and the second through hole, and the balloon dilatation catheter cooperates with the micro-guidewire to push the expansion part of the balloon dilatation catheter to the lesion site;

[0023] The expansion part expands to expand the diseased part;

[0024] The expansion portion contracts and the balloon dilatation catheter is withdrawn until the stent release tube pushes the self-expanding stent out of the first through hole;

[0025] The balloon dilatation catheter and the stent release tube are withdrawn simultaneously.

[0026] The beneficial effects of the present invention are:

[0027] During operation, the compressed self-expanding stent is installed at the distal end of the balloon dilatation catheter, and the stent release tube is installed in the first through hole through the inlet; the micro-guidewire is sequentially inserted into the outlet of the first through hole, the self-expanding stent, and the second through hole. The balloon dilatation catheter cooperates with the micro-guidewire to push the expansion part of the balloon dilatation catheter to the lesion site; the expansion part is pressurized positively to expand the lesion site; the expansion part is pressurized negatively to withdraw the balloon dilatation catheter, and at this time, the stent release tube slides relative to the balloon dilatation catheter in the first through hole until the stent release tube pushes the self-expanding stent out of the first through hole; after the self-expanding stent is separated from the first through hole, it automatically expands to achieve blood vessel expansion. Then the balloon dilatation catheter and the stent release tube are withdrawn at the same time to complete the delivery and installation of the self-expanding stent. The present invention can achieve the delivery and installation of the self-expanding stent by installing the balloon dilatation catheter once, so as to expand the blood vessels, reduce the surgical steps, reduce the number of instrument exchanges in the patient's body and the surgical time, and improve the success rate of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in the description of the embodiments of the present invention. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the contents of the embodiments of the present invention and these drawings without paying any creative work.

[0029] Figure 1 is a cross-sectional view of a stent installation device of an integral exchangeable balloon stent installation device provided in a specific embodiment of the present invention;

[0030] Figure 2 yes Figure 1 A local enlarged view at point A;

[0031] Figure 3 is a cross-sectional view of a balloon dilatation catheter provided in a specific embodiment of the present invention;

[0032] Figure 4 is a cross-sectional view of a first state of installation of a self-expanding stent provided by a specific embodiment of the present invention;

[0033] Figure 5 It is a cross-sectional view of a second state of installation of a self-expanding stent provided by a specific embodiment of the present invention.

[0034] The following are marked in the figure:

[0035] 100, self-expanding stent; 200, lesion site;

[0036] 1. Balloon dilatation catheter; 11. First through hole; 12. Inlet; 13. Outlet; 14. First handle; 15. Connecting port; 151. Fluid channel; 16. Expansion portion; 161. Expansion membrane; 2. Stent release tube; 21. Second through hole; 22. Second handle; 3. Limiting assembly; 31. Limiting block. DETAILED DESCRIPTION

[0037] The present invention will be further described in detail below in conjunction with the accompanying drawings and embodiments. It is to be understood that the specific embodiments described herein are only used to explain the present invention, rather than to limit the present invention. It should also be noted that, for ease of description, only parts related to the present invention, rather than all structures, are shown in the accompanying drawings.

[0038] In the description of the present invention, unless otherwise clearly specified and limited, the terms "connected", "connected", and "fixed" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0039] In the present invention, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may include that the first and second features are in direct contact, or may include that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, a first feature being "above", "above" and "above" a second feature includes that the first feature is directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being "below", "below" and "below" a second feature includes that the first feature is directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.

[0040] In the description of this embodiment, the terms "upper", "lower", "left", "right" and other directions or positional relationships are based on the directions or positional relationships shown in the drawings, and are only for the convenience of description and simplification of operation, rather than indicating or implying that the device or element referred to must have a specific direction, be constructed and operate in a specific direction, and therefore cannot be understood as limiting the present invention. In addition, the terms "first" and "second" are only used to distinguish in the description and have no special meaning.

[0041] During the current surgery, doctors need to first deliver the microcatheter and microguidewire to the lesion site, then remove the microcatheter, insert the balloon catheter to pre-dilate the lesion, then withdraw the balloon catheter, insert the microcatheter, and then deliver the stent to the lesion site through the microcatheter to release and automatically expand the blood vessel. During the above process, the microcatheter and balloon catheter need to be inserted into the blood vessel alternately multiple times, which is prone to complications and increases the operation time.

[0042] To solve the above problems, Figure 1-Figure 5 As shown, this embodiment provides an integrally exchangeable balloon stent installation device, which includes a balloon dilatation catheter 1, a stent release tube 2 and a micro guidewire (not shown in the figure), and is used to install a self-expanding stent 100 in a diseased area 200 of a blood vessel.

[0043] Specifically, Figure 1-Figure 3As shown, the balloon dilatation catheter 1 is provided with a first through hole 11 along the length direction, an inlet 12 is provided at the proximal end of the first through hole 11, and an outlet 13 is provided at the distal end of the first through hole 11; an expansion portion 16 is provided at the distal end of the balloon dilatation catheter 1, a self-expanding stent 100 can be slidably installed in the first through hole 11, and the self-expanding stent 100 is located at the distal end of the balloon dilatation catheter 1; a stent release tube 2 is passed through the first through hole 11 through the inlet 12, the stent release tube 2 is slidably set in the first through hole 11 of the balloon dilatation catheter 1, and the distal end of the stent release tube 2 abuts against the self-expanding stent 100; a second through hole 21 is provided along the length direction of the stent release tube 2, and a micro guide wire is sequentially passed through the outlet 13 of the first through hole 11, the self-expanding stent 100 and the second through hole 21.

[0044] During operation, the compressed self-expanding stent 100 is installed at the distal end of the balloon dilatation catheter 1, and the stent release tube 2 is installed in the first through hole 11 through the inlet 12; the micro-guide wire is sequentially inserted into the outlet 13 of the first through hole 11, the self-expanding stent 100, and the second through hole 21, and the balloon dilatation catheter 1 cooperates with the micro-guide wire to push the expansion part 16 of the balloon dilatation catheter 1 to the lesion site 200; the expansion part 16 is pressurized positively to expand the lesion site 200; the expansion part 16 is pressurized negatively to withdraw the balloon dilatation catheter 1, and at this time, the stent release tube 2 slides relative to the balloon dilatation catheter 1 in the first through hole 11 until the stent release tube 2 pushes the self-expanding stent 100 out of the first through hole 11; after the self-expanding stent 100 is separated from the first through hole 11, it automatically expands to achieve vascular dilation. Then the balloon dilatation catheter 1 and the stent release tube 2 are withdrawn at the same time to complete the delivery and installation of the self-expanding stent 100. In this embodiment, the balloon dilatation catheter 1 is installed once to achieve the delivery and installation of the self-expanding stent 100 to dilate the blood vessels, reduce the surgical steps, reduce the number of instrument exchanges in the patient's body and the surgical time, and improve the success rate of the surgery.

[0045] Preferably, if Figure 1 and Figure 4 As shown, the integral exchangeable balloon stent installation device also includes a limit assembly 3. A first handle 14 is provided at the proximal end of the balloon dilatation catheter 1, and a second handle 22 is provided at the proximal end of the stent release tube 2. Two slots are provided at intervals in the limit assembly 3, and a cavity is provided between the two slots. The limit assembly 3 is detachably mounted on the first handle 14 and the second handle 22 through the two slots, and part of the side wall of the stent release tube 2 is located in the cavity. The spacing between the two slots is not less than the length of the self-expanding stent 100. The limit assembly 3 is installed on the first handle 14 and the second handle 22. During the process of the balloon dilatation catheter 1 entering the blood vessel, the limit assembly 3 ensures that the balloon dilatation catheter 1 and the stent release tube 2 remain relatively still, and prevents the stent release tube 2 from sliding relative to the balloon dilatation catheter 1 and pushing out the self-expanding stent 100 in advance. Figure 5As shown, when the expansion portion 16 of the balloon dilatation catheter 1 reaches the lesion site 200, the stopper assembly 3 is disassembled, and the balloon dilatation catheter 1 is withdrawn. Since the stent release tube 2 remains stationary, the stent release tube 2 can push out the self-expanding stent 100. The distance between the two slots is not less than the length of the self-expanding stent 100, so as to prevent the stent release tube 2 and the balloon dilatation catheter 1 from sliding relative to each other insufficiently, and thus preventing the self-expanding stent 100 from being completely pushed out.

[0046] Preferably, the spacing between the two slots is the same as the distance that the stent release tube 2 pushes the self-expanding stent 100. By reasonably setting the spacing between the two slots, in the early stage of withdrawing the balloon dilatation catheter 1, the balloon dilatation catheter 1 slides relative to the stent release tube 2, and the stent release tube 2 remains unchanged until the first handle 14 and the second handle 22 contact, and then the balloon dilatation catheter 1 and the stent release tube 2 are withdrawn at the same time, providing a preset distance for the push-out distance of the stent release tube 2, thereby improving the withdrawal efficiency of the integral exchangeable balloon stent installation device.

[0047] Preferably, the limit assembly 3 includes two limit blocks 31 that can be spliced, and the side walls of the two limit blocks 31 are provided with opposite grooves. After the two limit blocks 31 are spliced, the opposite grooves are spliced ​​into two slots and a cavity. The two limit blocks 31 are assembled in a splicing manner, and the first handle 14 and the second handle 22 provide positioning for the assembly of the two limit blocks 31, which is simple to operate, easy to disassemble and assemble, and highly practical.

[0048] Preferably, the side wall of the balloon dilatation catheter 1 includes an inner wall and an outer wall, a fluid channel 151 is provided between the inner wall and the outer wall, the expansion portion 16 is an expansion membrane 161 connected to the outer wall, the proximal end of the fluid channel 151 is connected to the fluid source, and the distal end of the fluid channel 151 is connected to the expansion membrane 161. When the fluid source releases the fluid, the fluid in the expansion membrane 161 increases, positive pressure is generated, and the expansion membrane 161 expands outward to expand the lesion 200; when the fluid source recovers the fluid, the fluid in the expansion membrane 161 decreases, negative pressure is generated, and the expansion membrane 161 retracts, which facilitates the withdrawal of the balloon dilatation catheter 1. In this embodiment, the fluid released by the fluid source is liquid. Of course, in other embodiments, the fluid can also be gas. Preferably, a connection port 15 is provided on the outer side wall near the proximal end of the balloon dilatation catheter 1, and the connection port 15 is used to connect the fluid source, which is convenient for connecting the fluid source.

[0049] Furthermore, in order to facilitate the operator to understand the distal position of the balloon dilatation catheter 1 and the position of the self-expanding stent 100 in the blood vessel, a developing ring or a developing winding is installed at the distal end of the balloon dilatation catheter 1, and a developing ring or a developing winding is also installed on the outside of the self-expanding stent 100. Under the radiation, the distal position of the balloon dilatation catheter 1 can be understood by the instrument, and the position and state of the self-expanding stent 100 can be detected by the instrument. Among them, the developing ring can be fixed by bonding, and the developing winding can be fixed by winding.

[0050] This embodiment also provides a stent installation method, using the above-mentioned integral exchangeable balloon stent installation device, including the following steps:

[0051] Step 1: Install the compressed self-expanding stent 100 at the distal end of the balloon dilatation catheter 1, and install the stent release tube 2 in the first through hole 11;

[0052] Step 2: The micro-guidewire is sequentially passed through the outlet 13 of the first through hole 11, the self-expanding stent 100 and the second through hole 21, and the balloon dilatation catheter 1 cooperates with the micro-guidewire to push the expansion part 16 of the balloon dilatation catheter 1 to the lesion site 200;

[0053] Step 3: the expansion part 16 expands to expand the diseased part 200;

[0054] Step 4: the expansion portion 16 contracts, and the balloon dilatation catheter 1 is withdrawn until the stent release tube 2 pushes the self-expanding stent 100 out of the first through hole 11, and the self-expanding stent 100 automatically expands to expand the lesion 200;

[0055] Step 5: The balloon dilatation catheter 1 and the stent release tube 2 are withdrawn simultaneously to complete the installation operation of the self-expanding stent 100 .

[0056] Furthermore, when the limiting assembly 3 is used, in step two, after the stent release tube 2 is installed in the first through hole 11, the limiting assembly 3 is installed on the first handle 14 and the second handle 22 to improve the stability of the delivery of the balloon dilatation catheter 1; in step four, after the expansion part 16 is contracted, the limiting assembly 3 is removed.

[0057] Note that the above are only preferred embodiments of the present invention and the technical principles used. Those skilled in the art will understand that the present invention is not limited to the specific embodiments described herein, and that various obvious changes, readjustments and substitutions can be made by those skilled in the art without departing from the scope of protection of the present invention. Therefore, although the present invention has been described in more detail through the above embodiments, the present invention is not limited to the above embodiments, and may include more other equivalent embodiments without departing from the concept of the present invention, and the scope of the present invention is determined by the scope of the appended claims.

Claims

1. An integral exchangeable balloon stent installation device, used to install a self-expanding stent (100) on a lesion site (200) of a blood vessel, characterized in that: The integral exchangeable balloon stent installation device comprises: A balloon dilatation catheter (1), wherein the balloon dilatation catheter (1) is provided with a first through hole (11) along its length direction, an inlet (12) is provided at the proximal end of the first through hole (11), and an outlet (13) is provided at the distal end of the first through hole (11); The distal end of the balloon dilatation catheter (1) is provided with an expansion portion (16), the self-expanding stent (100) can be slidably installed in the first through hole (11), and the self-expanding stent (100) is located at the distal end of the balloon dilatation catheter (1); a stent release tube (2), the stent release tube (2) being inserted into the first through hole (11) through the inlet (12), the stent release tube (2) being slidably disposed in the first through hole (11) of the balloon dilatation catheter (1), and the distal end of the stent release tube (2) being in contact with the self-expanding stent (100); A micro guide wire, wherein the stent release tube (2) is provided with a second through hole (21) along the length direction, and the micro guide wire is sequentially passed through the outlet (13) of the first through hole (11), the self-expanding stent (100) and the second through hole (21); The integral exchangeable balloon stent installation device further comprises a limiting assembly (3); a first handle (14) is provided at the proximal end of the balloon dilatation catheter (1); a second handle (22) is provided at the proximal end of the stent release tube (2); two slots are provided in the limiting assembly (3); a cavity is provided between the two slots; the limiting assembly (3) is detachably mounted on the first handle (14) and the second handle (22) through the two slots; and a part of the side wall of the stent release tube (2) is located in the cavity; The limiting assembly (3) comprises two limit blocks (31) that can be spliced ​​together. The side walls of the two limit blocks (31) are provided with opposite grooves. After the two limit blocks (31) are spliced ​​together, the opposite grooves are spliced ​​together to form two slots and the cavity. The spacing between the two slots is the same as the distance that the stent release tube (2) pushes the self-expanding stent (100).

2. The integral exchangeable balloon stent installation device according to claim 1, characterized in that: The side wall of the balloon dilatation catheter (1) includes an inner wall and an outer wall, a fluid channel (151) is provided between the inner wall and the outer wall, the expansion portion (16) is an expansion membrane (161) connected to the outer wall, the proximal end of the fluid channel (151) is connected to a fluid source, the distal end of the fluid channel (151) is connected to the expansion membrane (161), and the fluid source can control the contraction and expansion of the expansion membrane (161).

3. The integral exchangeable balloon stent installation device according to claim 2, characterized in that: A connection port (15) is provided on the outer side wall of the balloon dilatation catheter (1) near the proximal end, and the connection port (15) is used to connect to the fluid source.

4. The integral exchangeable balloon stent installation device according to claim 2, characterized in that: The fluid released by the fluid source is liquid.

5. The integral exchangeable balloon stent installation device according to claim 1, characterized in that: A developing ring is installed on the outer side of the self-expanding stent (100).

6. The integral exchangeable balloon stent installation device according to claim 2, characterized in that: The distal end of the balloon dilatation catheter (1) is provided with a developing ring.

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