WO2025118704A1 - Prosthetic valve delivery apparatus and system - Google Patents

Abstract

The present invention relates to a prosthetic valve delivery apparatus and system. The prosthetic valve delivery apparatus comprises a pushing assembly (1). The pushing assembly (1) comprises a capsule part (11), a catheter part (12), and a control part (13). The capsule part (11) is in a capsule shape and consists of a distal capsule member (111), a loading member (112), and a proximal capsule member (113), which are connected to a first control tube (121), a second control tube (122), and a third control tube (123) in the catheter part (12), respectively. The three control tubes are sequentially arranged from inside to outside. The control part (13) enables the control tubes to move axially. By means of the movement of the first control tube (121) and the third control tube (123), the proximal capsule member (113) can be separated from the distal capsule member (111), thereby achieving the release of a prosthetic valve (4). The prosthetic valve (4) can self-expand after being released, so as to achieve the purpose of valve replacement.

Description

Artificial valve delivery device and system Technical Field

The present invention relates to the field of medical instruments for cardiac surgery, and in particular to an artificial valve delivery device and system.

Background Art

Mitral regurgitation is the most common heart valve disease. Although surgical treatment of mitral regurgitation is the primary criterion, these patients may refuse or be judged as unsuitable for traditional open surgery due to high risk.

In recent years, the successful advancement of aortic valve replacement has stimulated the exploration of transcatheter mitral valve replacement for the treatment of regurgitation. However, mitral valve replacement is much more difficult than aortic replacement in many aspects. For example, the spatial structure of the mitral valve is "saddle-shaped" instead of the traditional circular shape, and the mitral valve has a more complex tissue structure (valve ring, leaflets, chordae tendineae, papillary muscles), etc. The treatment of valvular disease can be achieved by implanting an artificial valve to replace the diseased native mitral valve.

Among the methods of implanting artificial valves, the transapical method is currently the main one. However, the transapical valve replacement method has disadvantages such as greater trauma and slow postoperative recovery of patients. Compared with the transapical replacement method, the heart valve replacement method using femoral vein puncture through the atrial septum has smaller device specifications and does not require thoracotomy. It also causes less trauma to the patient's heart and is conducive to the patient's rapid recovery after surgery.

Although there are many advantages to the scheme of puncturing the atrial septum via the femoral vein, the size of the vascular lumen and the multiple physiological bends in the blood vessels and the heart place higher requirements on the device structure applicable to this scheme.

Summary of the invention

The invention discloses an artificial valve delivery device and a system, aiming to solve the technical problems existing in the prior art.

The present invention adopts the following technical solutions:

In one aspect, the present invention provides an artificial valve delivery device, comprising a push assembly, the push assembly comprising a capsule portion, a catheter portion and a control portion;

The capsule part comprises a proximal capsule part, a loading part and a distal capsule part which are sequentially arranged axially. The proximal capsule part and the distal capsule part are in a capsule shape after being axially connected. The loading part is arranged between the two and is used for connecting the artificial valve.

The catheter part includes a first control tube, a second control tube and a third control tube which are sequentially sleeved from the inside to the outside, the distal end of the first control tube is fixedly connected to the distal capsule part, the distal end of the second control tube is fixedly connected to the loading part, and the distal end of the third control tube is fixedly connected to the proximal capsule part;

The control part includes a first actuating part, a first driving member, a second actuating part, and a second driving member;

The first drive member is connected to the proximal end of the third control tube, and the first drive member is threadedly matched with the first actuating part, and the circumferential rotation of the first actuating part is used to drive the axial movement of the proximal capsule part; the second drive member is connected to the proximal end of the first control tube, and the second drive member is threadedly matched with the second actuating part, and the circumferential rotation of the second actuating part is used to drive the axial movement of the distal capsule part.

As a preferred technical solution, the first actuating part includes a first rotating member and a first threaded member, the first threaded member is fixed to the inner side of the first rotating member, and the first threaded member is threadedly matched with the first driving member;

The second actuating portion includes a second rotating member and a second threaded member. The second threaded member is fixedly connected to the inner side of the second rotating member, and the second threaded member is threadedly matched with the second driving member.

As a preferred technical solution, the control part further includes a first fixing member and a second fixing member, the proximal end of the first fixing member is fixedly connected to the distal end of the second fixing member, and the interiors of the first fixing member and the second fixing member are axially connected.

As a preferred technical solution, the first fixing member is provided with a first rectangular window along the axial direction, and the external thread of the first driving member is exposed in the first rectangular window and matched with the internal thread of the first threaded member;

The second fixing member is provided with a second rectangular window along the axial direction, and the external thread of the second driving member is exposed in the second rectangular window and matched with the internal thread of the second threaded member.

As a preferred technical solution, the control part also includes a handle shell, and the first rotating member and the second rotating member are respectively arranged on the outer side of the distal end and the outer side of the proximal end of the handle shell, and the two rotate circumferentially on the handle shell.

As a preferred technical solution, a control tube fixing member is fixedly connected to the distal end of the first fixing member, the third control tube passes through the control tube fixing member, and limiting grooves are provided on the control tube fixing member and the second fixing member for axial limiting with the first rotating member and the second rotating member respectively.

As a preferred technical solution, the proximal end of the first control tube is also connected to a connecting tube for emptying, and a first seal is provided between the connecting tube and the second driving member; a second seal is provided between the first control tube and the proximal end of the first fixing member; and a third seal is provided between the second control tube and the first driving member.

As a preferred technical solution, the axial length of the proximal capsule part is smaller than the axial length of the distal capsule part.

As a preferred technical solution, the compliance of the proximal capsule part is greater than the compliance of the distal capsule part.

As a preferred technical solution, the proximal capsule component includes Pebax material, and the distal capsule component includes stainless steel material.

As a preferred technical solution, the distal end of the proximal capsule member is configured as a diameter-changing structure, the diameter-changing structure matches the proximal end of the distal capsule member, and the proximal capsule member is connected to the distal capsule member via the diameter-changing structure.

As a preferred technical solution, it also includes a first bending adjustment device, which is sleeved outside the third control tube and includes an axially connected first bending adjustment catheter and a first bending adjustment handle. The first bending adjustment handle is used to adjust the bending direction of the distal end of the first bending adjustment catheter.

As a preferred technical solution, it also includes a second bending adjustment device, which is sleeved outside the first bending adjustment catheter and includes an axially connected second bending adjustment catheter and a second bending adjustment handle. The second bending adjustment handle is used to adjust the bending direction of the distal end of the second bending adjustment catheter.

On the other hand, the present invention also provides an artificial valve delivery system, comprising an artificial valve delivery device as described in any one of the above items and an artificial valve.

The technical solution adopted by the present invention can achieve the following beneficial effects:

The present invention mainly provides an artificial valve delivery device and system, wherein the artificial valve delivery device includes a pushing component, a first bending adjustment component and a second bending adjustment component, the distal ends of the bending adjustment catheters of the first bending adjustment component and the second bending adjustment component can be bent in different directions to adapt to the physiological curvature of the human body's lumen and heart, and the pushing component includes a capsule part, a catheter part and a control part, wherein the capsule part is capsule-shaped, and consists of a distal capsule part, a loading part and a proximal capsule part, and the three are respectively connected to a first control tube, a second control tube and a third control tube in the catheter part, and the three control tubes are arranged in sequence from the inside to the outside, and the control part can make the control tube move axially, and the proximal capsule part and the distal capsule part can be separated by moving the first control tube and the third control tube, thereby realizing the release of the artificial valve, and the artificial valve can self-expand after release to achieve the purpose of valve replacement.

An operating handle is provided at the proximal end of the control part. When releasing the artificial valve, the proximal capsule part and the distal capsule part can be controlled by only rotating the rotating part on the operating handle, without the need for complicated operations. In addition, the proximal capsule part and the distal capsule part only undergo relative axial movement without displacement or rotation in other directions. The distal volume of the pushing assembly can be effectively controlled, which is beneficial for delivery through the femoral vein. At the same time, the spatial constraints inherent in the anatomical limitations of the heart are overcome, and the damage to the patient's heart structure caused by the excessive size of the capsule part during the release of the artificial valve is reduced.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for describing the embodiments, which constitute a part of the present invention. The exemplary embodiments of the present invention and their descriptions explain the present invention and do not constitute improper limitations on the present invention. In the drawings:

FIG1 is a schematic structural diagram of an artificial valve delivery device in a preferred embodiment disclosed in Example 1 of the present invention;

FIG2 is a schematic diagram of the structure decomposition of a capsule portion in a preferred embodiment disclosed in Example 1 of the present invention;

FIG3 is a schematic diagram of the structure decomposition of a control unit in a preferred implementation manner disclosed in Example 1 of the present invention;

FIG4 is a cross-sectional view of a control unit in a preferred embodiment disclosed in Example 1 of the present invention;

FIG5 is a schematic diagram of the structure of the control unit in a preferred implementation mode disclosed in Example 1 of the present invention;

FIG6 is a cross-sectional view taken along line AA of FIG5 ;

FIG7 is a schematic diagram of the structure of the interior of the control unit, the catheter unit, and the capsule unit in a preferred implementation manner disclosed in Example 1 of the present invention;

Fig. 8 is a cross-sectional view taken along line B-B of Fig. 7;

FIG9 is a schematic diagram of the operation of the artificial valve delivery device during installation of an artificial valve in a preferred embodiment disclosed in Example 1 of the present invention;

FIG10 is a schematic diagram of the operation of the artificial valve delivery device when releasing the artificial valve in a preferred implementation manner disclosed in Example 1 of the present invention;

FIG11 is a schematic structural diagram of an artificial valve delivery device in a preferred embodiment of the present invention disclosed in Example 2;

FIG12 is a schematic structural diagram of a first bending adjustment device in a preferred implementation manner disclosed in Example 2 of the present invention;

FIG13 is a schematic structural diagram of a second bending adjustment device in a preferred embodiment disclosed in Example 2 of the present invention;

Figures 14, 15 and 16 are working state diagrams of an artificial valve delivery device when releasing an artificial valve in a preferred implementation manner disclosed in Example 2 of the present invention.

Description of reference numerals:
Pushing assembly 1, capsule part 11, distal capsule part 111, loading part 112, proximal capsule part 113, catheter part 12,
The first control tube 121, the second control tube 122, the third control tube 123, the control part 13, the handle shell 131, the first rotating member 132, the first threaded member 133, the first driving member 134, the third sealing member 1341, the first fixing member 135, the first rectangular window 1351, the second sealing member 1352, the control tube fixing member 1353, the second rotating member 136, the second threaded member 137, the second driving member 138, the first sealing member 1381, the second fixing member 139, the second rectangular window 1391, the connecting tube 14, the first bending adjustment device 2, the first bending adjustment catheter 21, the first bending adjustment handle 22, the second bending adjustment device 3, the second bending adjustment catheter 31, the second bending adjustment handle 32, the artificial valve 4, the left atrium 5, the atrial septum 6, and the mitral valve ring 7.

DETAILED DESCRIPTION

In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be clearly and completely described below in conjunction with the specific embodiments of the present invention and the corresponding drawings. In the description of the present invention, it should be noted that the term "or" is usually used in the sense of including "and/or", unless the content clearly indicates otherwise.

In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected" and "connected" should be understood in a broad sense. In addition, in the description of the present application, the terms "first", "second" and the like are only used to distinguish the description and cannot be understood as indicating or implying relative importance. The "proximal end" mentioned herein refers to the end close to the operator along the length direction of the artificial valve delivery device, and the "distal end" refers to the end away from the operator along the length direction of the artificial valve delivery device. The "capsule-shaped", "disc-shaped", "conical" and the like described in this article are not absolute or standard shapes, but may also be roughly related shapes, etc. It can be known by those skilled in the art that in order to achieve various In order to realize its own functions and meet the requirements of surgical operations, the specific shape/size/angle of each structure can be adaptively adjusted.

Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

In order to solve the problems existing in the prior art, the embodiment of the present application provides an artificial valve delivery device, including a push assembly 1, the push assembly 1 includes a capsule part 11, a catheter part 12 and a control part 13; the capsule part 11 includes a proximal capsule part 113, a loading part 112 and a distal capsule part 111 arranged in sequence in the axial direction, the proximal capsule part 113 and the distal capsule part 111 are in a capsule shape after being axially connected, and the loading part 112 is arranged between the two and is used to connect the artificial valve 4; the catheter part 12 includes a first control tube 121, a second control tube 122 and a third control tube 123 which are sequentially sleeved from the inside to the outside, and the distal end of the first control tube 121 is fixed to the distal capsule part 111 The distal end of the second control tube 122 is fixedly connected to the loading member 112, and the distal end of the third control tube 123 is fixedly connected to the proximal capsule member 113; the control unit 13 includes a first actuating unit, a first driving member 134, a second actuating unit, and a second driving member 138; the first driving member 134 is connected to the proximal end of the third control tube 123, the first driving member 134 is threadedly matched with the first actuating unit, and the circumferential rotation of the first actuating unit is used to drive the axial movement of the proximal capsule member 113; the second driving member 138 is connected to the proximal end of the first control tube 121, the second driving member 138 is threadedly matched with the second actuating unit, and the circumferential rotation of the second actuating unit is used to drive the axial movement of the distal capsule member 111.

Example 1

This embodiment provides an artificial valve delivery device, which is preferably suitable for delivery and release of an artificial mitral valve; in this embodiment, the artificial valve 4 is in a compressed cylindrical shape during delivery, and expands radially after being released at the native valve ring. The artificial valve 4 in the expanded state can support and fix at the native valve ring to replace the physiological function of the native valve. Preferably, the artificial valve 4 described in this embodiment is a self-expanding artificial valve, and its valve stent is made of shape memory alloy, which can complete radial automatic expansion after losing radial constraints and anchor at the native valve ring.

It should be noted that the artificial valve delivery device described in this embodiment does not include the artificial valve itself, and since the artificial valves 4 of different manufacturers have certain differences in structure after expansion, the specific structure of the artificial valve 4 is no longer specifically limited in this embodiment.

As shown in Figures 1-10, the artificial valve delivery device includes a pushing component 1, which is provided with a capsule part 11, a catheter part 12 and a control part 13 from the distal end to the proximal end, wherein the capsule part 11 is loaded with an artificial valve 4 in a compressed state, the capsule part 11 is in a capsule shape, and can be axially opened and release the artificial valve 4, the catheter part 12 connects the capsule part 11 and the control part 13, and the opening or closing of the capsule part 11 can be controlled by the axial movement of multiple pipes in the catheter part 12. The control part 13 is arranged outside the body when in use, and the control of the capsule part 11 is achieved through manual operation of the doctor.

As shown in Figures 1, 2, 7 and 8, in a preferred embodiment, the capsule portion 11 is in a capsule shape during transportation, and the capsule portion 11 includes a proximal capsule part 113, a distal capsule part 111 and a loading part 112 arranged inside the two, the loading part 112 is used to connect the compressed artificial valve 4, and the catheter portion 12 includes a first control tube 121, a second control tube 122 and a third control tube 123 arranged in sequence from the inside to the outside, the distal end of the first control tube 121 is fixedly connected to the distal capsule part 111, the distal end of the second control tube 122 is fixedly connected to the loading part 112, and the distal end of the third control tube 123 is fixedly connected to the proximal capsule part 113, and the proximal ends of the three control tubes are all penetrated and installed in the control portion 13, and the axial movement of the first control tube 121 and the second control tube 122 is achieved by operating the control portion 13.

As shown in Figure 10, preferably, when the artificial valve 4 is released, the second control tube 122 and the loading part 112 connected thereto remain in a fixed position, and the third control tube 123 moves proximally relative to the second control tube 122, driving the proximal capsule part 113 connected thereto to withdraw proximally, and the inflow end of the artificial valve 4 is exposed first, and then the first control tube 121 moves distally relative to the second control tube 122, driving the distal capsule part 111 connected thereto to withdraw distally, and the main body of the artificial valve 4 is released, completing the valve replacement.

Preferably, the distal capsule 111 is roughly in the shape of a circular tube, and a conical guide head is provided at its distal end. An axially penetrating cavity is provided in the guide head, and the cavity is connected with the first control tube 121 for the guide wire to pass through.

In a preferred embodiment, the distal capsule member 111 is made of a material with high structural strength to provide sufficient supporting force, while being able to provide radial limitation for the compressed artificial valve 4, so as to facilitate the axial transportation of the entire delivery device in the human body, while avoiding radial pressure of the delivery device caused by the intravascular blood pressure, and avoiding harmful decomposition products caused by the instability of the material.

Preferably, the distal capsule member 111 is made of metal such as stainless steel or a polymer material with high hardness, and the distal capsule member 111 is fastened to the distal end of the first control tube 121 by bonding, hot melting or threading.

Preferably, since the height of the atrium of an average patient is significantly smaller than that of the ventricle, the axial length of the distal capsule component 111 is greater than that of the proximal capsule component 113 .

In a preferred embodiment, the proximal capsule member 113 and the distal end of the third control tube 123 are fastened together by bonding, hot melting or threading, and the two are axially connected to allow the second control tube 122 to penetrate therein.

Preferably, the proximal capsule part 113 is made of a material with high compliance, preferably Pebax. When the capsule part 11 enters through the femoral vein and crosses the atrial septum 6, sufficient lateral space is required. At this time, after the distal capsule part 111 enters, the highly compliant proximal capsule part 113 can provide good bending performance, so that the distal capsule part 111 can bend downward and enter the atrium. Since the skirt of the proximal end of the artificial valve 4 is softer, it can bend synchronously with the proximal capsule part 113.

In a preferred embodiment, the distal end of the proximal capsule member 113 has a variable diameter design, which can match the proximal end of the distal capsule member 111. When the two are connected, the distal variable diameter structure of the proximal capsule member 113 can be inserted into the proximal end of the distal capsule member 111 to achieve a stable connection between the two and avoid the proximal capsule member 113 and the distal capsule member 111 from bending. Misalignment may cause the capsule part 11 to separate and damage the artificial valve 4, scratch the heart tissue, and affect the smoothness of the delivery process.

Preferably, the loading member 112 is disc-shaped and has a plurality of grooves circumferentially provided therein for connecting the connector at the distal end of the artificial valve 4 and limiting the axial movement of the artificial valve 4. Preferably, the groove is configured as an axially through groove that is radially open outward. When the artificial valve 4 loses the radial constraint of the distal capsule member 111, it can directly detach radially outward from the loading member 112.

Specifically, the number and size of the grooves on the loading component 112 should match the connectors on the artificial valve 4. Since artificial valves 4 of different specifications, structures and manufacturers have connectors with different structures, the shape, number and size of the grooves on the loading component 112 can be adaptively adjusted according to specific conditions, which will not be repeated here.

Preferably, the loading component 112 is fastened to the distal end of the second control tube 122 by bonding, hot melting or threading. Since the artificial valve 4 in the compressed state still maintains its axial penetration state, after the distal end of the artificial valve 4 is connected to the loading component 112, its main body is sleeved and loaded on the outer periphery of the second control tube 122, and the two are coaxially arranged. Preferably, the distal end of the second control tube 122 passes through the third control tube 123 and the proximal capsule component 113 and then comes out, and the first control tube 121 passes out from the distal end of the second control tube 122.

Preferably, the axial lengths of the first control tube 121 , the second control tube 122 , and the third control tube 123 decrease in sequence.

Preferably, the inner diameters of the first control tube 121 , the second control tube 122 and the third control tube 123 increase sequentially, and gaps are reserved between adjacent tubes to ensure that the two adjacent tubes can move axially relative to each other.

Preferably, the inner lumen of the first control tube 121 should at least allow a medical guide wire to pass through. Since medical guide wires have different rules, medical guide wires of different specifications have different diameters to cope with different patients or different lesions. On the premise of meeting intraoperative requirements, the inner lumen diameter of the first control tube 121 can be adaptively adjusted according to specific conditions, and the optional inner lumen diameters are not listed one by one here.

Preferably, the first control tube 121 can be made of a sheath or a catheter. Those skilled in the art should understand that when selecting guide wires of different specifications, a catheter or sheath that matches them should be selected. Therefore, the wall thickness of the first control tube 121 is no longer limited in this embodiment.

Preferably, the inner diameter and wall thickness of the second control tube 122 and the third control tube 123 may refer to the first control tube 121 , and those skilled in the art may adjust them according to actual needs, which will not be described in detail here.

3-8 , in a preferred embodiment, the control unit 13 includes a handle housing 131, a first rotating member 132, a first threaded member 133, a first driving member 134, a first fixing member 135, a second rotating member 136, a second threaded member 137, a second driving member 138, and a second fixing member 139, wherein the first rotating member 132 is disposed on the distal outer side of the handle housing 131, the second rotating member 136 is disposed on the proximal outer side of the handle housing 131, and the remaining components are disposed inside the handle housing 131, and the handle housing 131 has an axially through inner cavity for the guide wire and the catheter portion 12 to pass therethrough.

Preferably, the proximal end of the first fixing member 135 is axially fixed to the distal end of the second fixing member 139 , and both are axially fixed in the handle housing 131 , and the interiors of both are axially connected to the handle housing 131 .

Preferably, the first fixing member 135 and the second fixing member 139 are fastened to each other by bonding or screws, and the two are fastened to the handle housing 131 by bonding or screws, respectively.

Preferably, the first driving member 134 is axially arranged in the first fixing member 135 and can move axially in the first fixing member 135. The first driving member 134 is connected to the proximal end of the third control tube 123. Therefore, the axial movement of the first driving member 134 can drive the movement of the third control tube 123, and finally realize the axial movement of the proximal capsule member 113.

Preferably, the first rotating member 132 disposed on the outside of the handle housing 131 is fixedly connected to the first threaded member 133 disposed inside the handle housing 131, and the two are combined to form a first actuating portion, the first threaded member 133 is provided with an internal thread, the first driving member 134 is provided with an external thread, and the first fixing member 135 is provided with a first rectangular window 1351 along the axial direction, and the external thread of the first driving member 134 is exposed in the first rectangular window 1351, and cooperates with the internal thread of the first threaded member 133. When the first rotating member 132 is rotated, the first rotating member 132 rotates circumferentially on the handle housing 131, and at the same time drives the first threaded member 133 to rotate circumferentially together, at this time, the first driving member 134 is driven by the thread to move axially, and finally drives the axial movement of the proximal capsule member 113.

Preferably, the distal end of the first fixing member 135 is fixedly connected to a control tube fixing member 1353, and the third control tube 123 axially passes through the control tube fixing member 1353. A limiting groove is provided in the control tube fixing member 1353 for axially limiting the first rotating member 132 to ensure that the first rotating member 132 does not move axially when the doctor rotates it.

Preferably, the proximal end of the first driving member 134 is also fixedly connected with a third sealing member 1341. Optionally, the third sealing member 1341 is threadedly connected to the first driving member 134, and the proximal end of the third control tube 123 is inserted into the first driving member 134. Glue is injected through the glue dispensing hole on the first driving member 134 to achieve the connection between the third control tube 123 and the first driving member 134. Since the proximal end of the second control tube 122 is passed out from the inside of the third control tube 123, after the third sealing member 1341 is set, the gap between the second control tube 122 and the first driving member 134 can be filled by the third sealing member 1341.

Preferably, the second driving member 138 is axially arranged in the second fixing member 139 and can move axially in the second fixing member 139. The second driving member 138 is connected to the proximal end of the first control tube 121. Therefore, the axial movement of the second driving member 138 can drive the movement of the first control tube 121, and finally realize the axial movement of the distal capsule member 111.

Preferably, the second rotating member 136 disposed on the outside of the handle housing 131 is fixedly connected to the second threaded member 137 disposed inside the handle housing 131, and the two are combined to form a second actuating portion, the second threaded member 137 is provided with an internal thread, the second driving member 138 is provided with an external thread, and the second fixing member 139 is provided with a second rectangular window 1391 along the axial direction, and the external thread of the second driving member 138 is exposed in the second rectangular window 1391, and cooperates with the internal thread of the second threaded member 137. When the second rotating member 136 is rotated, the second rotating member 136 rotates circumferentially on the handle housing 131, and at the same time drives the second threaded member 137 to rotate circumferentially together, at this time, the second driving member 138 is driven by the thread to move axially, and finally drives the axial movement of the distal capsule member 111.

Preferably, a limiting groove is provided at the proximal end of the second fixing member 139 for axially limiting the second rotating member 136 to ensure that the second rotating member 136 does not move axially when the doctor rotates it.

Preferably, a second sealing member 1352 is further provided at the proximal end of the first fixing member 135 , and after the proximal end of the first control tube 121 passes through the proximal end of the first fixing member 135 , the gap between the two is filled and sealed by the second sealing member 1352 .

Preferably, a connecting tube 14 for emptying is provided at the proximal end of the handle housing 131, the connecting tube 14 is passed through the second fixing member 139 of the handle housing 131, and is connected to the proximal end of the first control tube 121, and a first sealing member 1381 is provided between the connecting tube 14 and the second driving member 138. Through the first sealing member 1381, the second sealing member 1352, and the third sealing member 1341, the integrated emptying of the entire artificial valve delivery device can be achieved.

In this embodiment, the method of using the artificial valve delivery device is as follows:

When the first rotating member 132 is rotated, since the first rotating member 132 and the first threaded member 133 are fixed and in synchronous rotation, the first driving member 134 can be driven to move axially in the first fixed member 135 through the action of the thread. Since the proximal end of the third control tube 123 is connected to the first driving member 134, the axial movement of the proximal capsule member 113 can be achieved. Similarly, rotating the second rotating member 136 can drive the axial movement of the distal capsule member 111, thereby finally achieving the opening and closing of the capsule portion 11.

As shown in Figure 9, when the artificial valve 4 is placed into the capsule part 11, the connector at the distal end of the artificial valve 4 is inserted into the groove of the loading part 112, and the second rotating part 136 is rotated first, and the distal capsule part 111 is withdrawn to receive the main part of the artificial valve 4 therein, and then the skirt at the proximal end of the artificial valve 4 is compressed into the inner cavity of the proximal capsule part 113, and the first rotating part 132 is rotated, and the proximal capsule part 113 receives the proximal end of the artificial valve 4 therein.

As shown in Figure 10, when the artificial valve 4 is released, the first rotating member 132 is rotated first, the proximal capsule member 113 is withdrawn, and the proximal end of the artificial valve 4 is exposed first, and then the second rotating member 136 is rotated, the distal capsule member 111 moves toward the distal end, and the main part of the artificial valve 4 is released. During the entire releasing process, the second control tube 122 and the loading member 112 connected thereto always remain in a fixed position.

Example 2

The present embodiment provides an artificial valve delivery device, which is preferably suitable for the delivery and release of an artificial mitral valve; in the present embodiment, the basic structure of the artificial valve delivery device includes a pushing component 1, and the technical features of the pushing component 1 already included in the above-mentioned embodiment 1 are naturally inherited in the present embodiment and will not be repeated.

Referring to Figures 11-16, in a preferred embodiment, the artificial valve delivery device includes a first bending adjustment device 2 and a second bending adjustment device 3 in addition to the pushing component 1.

As shown in Figure 12, preferably, the first bending adjustment device 2 is arranged outside the third control tube 123, and includes an axially connected first bending adjustment catheter 21 and a first bending adjustment handle 22. Several control wires are axially arranged in the first bending adjustment catheter 21. By controlling the first bending adjustment handle 22, the bending direction of the distal end of the first bending adjustment catheter 21 can be adjusted.

As shown in Figure 13, preferably, the second bending adjustment device 3 is arranged outside the first bending adjustment catheter 21, and includes an axially connected second bending adjustment catheter 31 and a second bending adjustment handle 32. A plurality of control wires are axially arranged in the second bending adjustment catheter 31. By controlling the second bending adjustment handle 32, the bending direction of the distal end of the second bending adjustment catheter 31 can be adjusted.

Preferably, the length of the first bending-adjusting catheter 21 is greater than that of the second bending-adjusting catheter 31 , and the first bending-adjusting catheter 21 passes through the second bending-adjusting catheter 31 , so as to achieve three-dimensional bending of the distal end of the conveying device in different sections and directions.

Specifically, the first bending adjustment device 2 and the second bending adjustment device 3 have the same bending adjustment principle, and their structures can adopt any specific implementation method disclosed in the prior art. The structure itself is not the invention point of this embodiment, so the specific structure of the first bending adjustment device 2 and the second bending adjustment device 3 will not be described in detail.

In this embodiment, the method of using the artificial valve delivery device is as follows:

According to the intraoperative requirements, the femoral vein of the patient is punctured, and the artificial valve delivery device enters the right atrium through the inferior vena cava. Since the left and right atrial septum 6 and the inferior vena cava form an angle of about 90 degrees, it is necessary to operate the second bending handle 32 to bend the second bending catheter 31 to 90 degrees or more, and enter the left atrium 5 from the puncture point of the atrial septum 6. In order to accurately deliver the capsule part 11 to the mitral valve ring 7, the atrial septum 6 and the plane of the mitral valve ring 7 form an angle of about 90 degrees, so it is necessary to operate the first bending handle 22 to bend the first bending catheter 213121 When the angle reaches 90° or above, the pushing assembly 1 is transported toward the distal end. The proximal capsule member 113 can bend synchronously and approach the mitral valve annulus 7 due to its good compliance. The artificial valve 4 is released at this time. The first rotating member 132 is rotated first, and the proximal capsule member 113 is withdrawn. The proximal skirt of the artificial valve 4 is exposed first. Then the second rotating member 136 is rotated, and the distal capsule member 111 is advanced. The main body of the artificial valve 4 is released. During the entire releasing process, the second control tube 122 and the loading member 112 connected thereto always keep their positions fixed.

Example 3

This embodiment provides an artificial valve delivery system, including the artificial valve delivery device as described in Example 1 or Example 2, and also including an artificial valve 4; various features already included in Example 1 or Example 2 are naturally inherited in this embodiment.

In this embodiment, the artificial valve 4 at least includes a valve stent and valve leaflets.

Preferably, the valve stent is roughly in the shape of a cylindrical mesh tube, and the inflow end of the valve stent is also provided with a trumpet-shaped or funnel-shaped skirt that expands radially outward. Preferably, a connecting piece is provided at the distal end of the valve stent, and the connecting piece matches the groove of the loading piece 112; in a preferred embodiment, the valve stent is a self-expanding valve stent, and the valve stent is made of nickel-titanium alloy with shape memory effect. When the artificial valve 4 is loaded onto the conveying device, it can be radially compressed and maintained in its compressed state by the radial constraints of the proximal capsule piece 113 and the distal capsule piece 111; when the artificial valve 4 reaches the diseased native valve, it is released from the proximal capsule piece 113 and the distal capsule piece 111, and can undergo radial self-expansion, and finally gradually detach from the loading piece 112.

Preferably, the valve leaflets are made of commercial porcine aortic valves, bovine pericardial valves or porcine pericardial valves to replace the physiological functions of native valve leaflets; the valve leaflets are sutured into the valve stent and extend from the proximal end to the distal end.

In other preferred embodiments, a skirt sealing film may be sewn on the surface of the valve stent to prevent complications such as paravalvular leakage after valve replacement surgery.

In this embodiment, the method of using the artificial valve 4 delivery system is the same as the method of the artificial valve delivery device in Example 1 or Example 2, and will not be repeated here.

The embodiments of the present invention are described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementation modes, which are merely illustrative rather than restrictive. Under the guidance of the present invention, ordinary technicians in this field can also make many forms without departing from the scope of protection of the present invention and the claims, all of which are within the protection of the present invention.

Claims (14)

An artificial valve delivery device, characterized in that it comprises a pushing assembly, wherein the pushing assembly comprises a capsule part, a catheter part and a control part; The capsule part comprises a proximal capsule part, a loading part and a distal capsule part which are sequentially arranged axially, the proximal capsule part and the distal capsule part are in a capsule shape after being axially connected, and the loading part is arranged between the two and is used for connecting the artificial valve; The catheter portion includes a first control tube, a second control tube and a third control tube which are sequentially sleeved from the inside to the outside, the distal end of the first control tube is fixedly connected to the distal capsule component, the distal end of the second control tube is fixedly connected to the loading component, and the distal end of the third control tube is fixedly connected to the proximal capsule component; The control part includes a first actuating part, a first driving member, a second actuating part, and a second driving member; The first drive member is connected to the proximal end of the third control tube, and the first drive member is threadedly matched with the first actuating part, and the circumferential rotation of the first actuating part is used to drive the axial movement of the proximal capsule part; the second drive member is connected to the proximal end of the first control tube, and the second drive member is threadedly matched with the second actuating part, and the circumferential rotation of the second actuating part is used to drive the axial movement of the distal capsule part. The artificial valve delivery device according to claim 1, characterized in that the first actuating portion comprises a first rotating member and a first threaded member, the first threaded member is fixedly connected to the inner side of the first rotating member, and the first threaded member is threadedly matched with the first driving member; The second actuating portion includes a second rotating member and a second threaded member, the second threaded member is fixedly connected to the inner side of the second rotating member, and the second threaded member is threadedly matched with the second driving member. The artificial valve delivery device according to claim 2 is characterized in that the control part also includes a first fixing member and a second fixing member, the proximal end of the first fixing member is fixedly connected to the distal end of the second fixing member, and the interiors of the two are axially connected. The artificial valve delivery device according to claim 3, characterized in that the first fixing member is provided with a first rectangular window along the axial direction, and the external thread of the first driving member is exposed in the first rectangular window and matched with the internal thread of the first threaded member; The second fixing member is provided with a second rectangular window along the axial direction, and the external thread of the second driving member is exposed in the second rectangular window and matched with the internal thread of the second threaded member. The artificial valve delivery device according to claim 4 is characterized in that the control part also includes a handle shell, and the first rotating member and the second rotating member are respectively arranged on the distal outer side and the proximal outer side of the handle shell, and the two rotate circumferentially on the handle shell. The artificial valve delivery device according to claim 5 is characterized in that a control tube fixing part is fixedly connected to the distal end of the first fixing part, the third control tube passes through the control tube fixing part, and the control tube fixing part and the second fixing part are both provided with limiting grooves for axially limiting the first rotating part and the second rotating part respectively. The artificial valve delivery device according to claim 6, characterized in that the proximal end of the first control tube is further connected to a connecting tube for emptying, and a first sealing member is provided between the connecting tube and the second driving member; A second sealing member is provided between the first control tube and the proximal end of the first fixing member; A third sealing member is provided between the second control tube and the first driving member. The artificial valve delivery device according to claim 1, characterized in that the axial length of the proximal capsule member is smaller than the axial length of the distal capsule member. The artificial valve delivery device according to claim 1 is characterized in that the compliance of the proximal capsule member is greater than the compliance of the distal capsule member. The artificial valve delivery device according to claim 9, characterized in that the proximal capsule component comprises Pebax material, and the distal capsule component comprises stainless steel material. The artificial valve delivery device according to claim 1 is characterized in that the distal end of the proximal capsule member is configured as a variable diameter structure, the variable diameter structure matches the proximal end of the distal capsule member, and the proximal capsule member is connected to the distal capsule member via the variable diameter structure. The artificial valve delivery device according to any one of claims 1-11 is characterized in that it also includes a first bending adjustment device, which is arranged outside the third control tube and includes an axially connected first bending adjustment catheter and a first bending adjustment handle, and the first bending adjustment handle is used to adjust the bending direction of the distal end of the first bending adjustment catheter. The artificial valve delivery device according to claim 12 is characterized in that it also includes a second bending adjustment device, which is arranged outside the first bending adjustment catheter, and includes an axially connected second bending adjustment catheter and a second bending adjustment handle, and the second bending adjustment handle is used to adjust the bending direction of the distal end of the second bending adjustment catheter. An artificial valve delivery system, characterized in that it comprises an artificial valve delivery device as described in any one of claims 1-13 and an artificial valve.