Artificial valve conveying device and system

Abstract

The utility model relates to an artificial valve conveying device and system, the structure of the conveying device comprises a conveying catheter, a supporting element and element pushing cavities, the conveying catheter is used for conveying and releasing an artificial valve to the far end, a plurality of element pushing cavities are distributed along the circumferential direction of the conveying catheter, each element pushing cavity is axially through, and the supporting element is used for supporting the artificial valve. The supporting element is made of shape memory metal, the far end of the supporting element can extend outwards in the radial direction after penetrating out of the element pushing cavity and is used for abutting against the near end of an anchoring instrument of the artificial valve, the anchoring instrument is a fishing ring capable of being matched with the artificial valve, and after the fishing ring is installed in place, the anchoring instrument is used for anchoring the artificial valve. The fishing ring can be jacked to the root of the valve ring through the far end of the supporting element, then the artificial valve is released, it is guaranteed that the fishing ring cannot fall down in the artificial valve releasing process, and finally stable connection of the artificial valve and the fishing ring is achieved.

Description

Technical Field

[0001] The utility model relates to the field of medical instruments for cardiac surgery, in particular to an artificial valve delivery device and system. Background Art

[0002] Mitral regurgitation is the most common heart valve disease. In recent years, the successful advancement of aortic valve replacement has stimulated the exploration of transcatheter mitral valve replacement to treat regurgitation.

[0003] An existing transcatheter heart valve replacement system includes two components: an artificial valve and an anchoring device. The working principle of the system is as follows: the anchoring device (fishing ring) is implanted under the patient's valve ring through a transcatheter method, and the fishing ring passes through the gap between the chordae tendineae under the valve ring and the ventricular wall, and is fixed to the patient's valve ring by winding the chordae tendineae, forming a valve anchoring device; the artificial valve is implanted into the patient's heart through a transcatheter method, and is released and unfolded in the anchoring device. The artificial valve is fixed in the anchoring device and eventually replaces the patient's valve.

[0004] After the above-mentioned transcatheter heart valve replacement system is implanted in the patient's body, the anchoring device may fall into the papillary muscle, causing the artificial valve to be unable to be stably connected to the anchoring device, or the artificial valve and the anchoring device may clamp the chordae tendineae. Ultimately, as the patient's heart beats, the two will continuously squeeze and rub the chordae tendineae, causing the chordae tendineae to rupture and the anchoring device and the artificial valve to shift. Utility Model Content

[0005] The utility model discloses an artificial valve delivery device and a system, aiming to solve the technical problems existing in the prior art.

[0006] The utility model adopts the following technical solutions:

[0007] In one aspect, the utility model provides an artificial valve delivery device, comprising:

[0008] A delivery catheter, which is axially penetrated and used for delivering and releasing the artificial valve to the distal end;

[0009] The component pushing cavity is axially connected and is axially arranged on the conveying conduit;

[0010] The support element can be pushed toward the distal end along the inner cavity of the element pushing cavity, and the distal end of the support element extends radially outward to abut against the proximal end of the anchoring device of the artificial valve.

[0011] As a preferred technical solution, the support element comprises a shape memory alloy material, the support element can be pushed in the element pushing cavity in a rod shape, and the distal end of the support element can restore its shape to extend radially outward after passing through the element pushing cavity.

[0012] As a preferred technical solution, the length of the supporting element is greater than the length of the element pushing cavity.

[0013] As a preferred technical solution, the distal end of the support element includes a radial extension portion and an axial limiting portion; the radial extension portion extends radially outward, and the axial limiting portion extends axially distally, for abutting against the proximal end of the artificial valve anchoring device.

[0014] As a preferred technical solution, the radially extending portion extends straight outward in the radial direction;

[0015] Alternatively, the radially extending portion extends obliquely toward the proximal end in the radial direction;

[0016] Alternatively, the radially extending portion extends radially and obliquely toward the distal end.

[0017] As a preferred technical solution, there is a bend between the axial limiting portion and the radial extending portion;

[0018] The axial limiting portion extends straight toward the distal end along the axial direction;

[0019] Alternatively, the axial limiting portion is radially inclined and extends to the distal end;

[0020] Alternatively, the axial limiting portion extends toward the distal end in an arc shape;

[0021] Alternatively, the axial limiting portion is in the shape of a bent hook, which is bent concave toward the distal end.

[0022] As a preferred technical solution, multiple element pushing cavities are circumferentially distributed on the inner side or outer side of the delivery catheter;

[0023] Alternatively, the delivery catheter is a multi-lumen tube, and the peripheral lumen of the multi-lumen tube is configured as the element pushing lumen.

[0024] As a preferred technical solution, the number of component pushing cavities matches the number of supporting elements, and the number of component pushing cavities is not less than 2.

[0025] As a preferred technical solution, the length of the element pushing cavity is not longer than the length of the delivery catheter.

[0026] On the other hand, the utility model also provides an artificial valve delivery system, comprising an artificial valve delivery device as described in any one of the above items, and also comprising an artificial valve and an anchoring device, wherein the anchoring device comprises a fishing ring.

[0027] The technical solution adopted by the utility model can achieve the following beneficial effects:

[0028] The utility model mainly provides an artificial valve delivery device, the structure of which includes a delivery catheter, a support element and an element pushing cavity. The delivery catheter is used to deliver and release the artificial valve to the distal end. A plurality of element pushing cavities are distributed along the circumference of the delivery catheter, and each element pushing cavity is axially penetrated so that the support element can be pushed to the distal end. The support element is made of shape memory metal, and its distal end can extend radially outward after passing through the element pushing cavity, so as to abut against the proximal end of the anchoring device of the artificial valve, wherein the anchoring device refers to a fishing ring that can cooperate with the artificial valve. After the fishing ring is installed in place, the distal end of the support element can push the fishing ring to the root of the valve ring, and then release the artificial valve, to ensure that the fishing ring will not fall during the release of the artificial valve, and finally achieve a stable connection between the artificial valve and the fishing ring. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In order to more clearly illustrate the technical solution of the embodiment of the utility model, the following is a brief introduction to the drawings required for the description of the embodiment, which constitute a part of the utility model. The schematic embodiment of the utility model and its description explain the utility model and do not constitute an improper limitation of the utility model. In the drawings:

[0030] Figure 1 This is a schematic structural diagram of an artificial valve delivery device in a preferred embodiment disclosed in Example 1 of the utility model;

[0031] Figure 2 — Figure 4 This is a schematic structural diagram of an artificial valve delivery device in a preferred embodiment disclosed in Example 1 of the utility model during the delivery process of the support element and after the release;

[0032] Figure 5 This is a schematic diagram of the structure of a fishing ring after it is released in the heart in a preferred implementation manner disclosed in Example 1 of the utility model;

[0033] Figure 6 This is a schematic diagram showing abutment between the distal end of an artificial valve delivery device and the proximal end of a fishing ring in a preferred embodiment disclosed in Example 1 of the utility model;

[0034] Figure 7 This is a schematic diagram of the structure of a supporting element supporting a fishing ring after being released in the heart in a preferred embodiment disclosed in Example 1 of the utility model;

[0035] Figure 8 for Figure 7 Schematic diagram without the heart structure;

[0036] Fig. 9 This is a schematic diagram of the structure of starting to release an artificial valve in the heart in a preferred implementation manner disclosed in Example 1 of the utility model;

[0037] Fig.10 for Fig. 9 Schematic diagram without the heart structure;

[0038] Fig.11 This is a schematic structural diagram of an artificial valve after it is fully released in a preferred implementation manner disclosed in Example 1 of the utility model;

[0039] Fig.12 This is a schematic structural diagram of the distal end of a support element in a preferred implementation manner disclosed in Example 1 of the utility model;

[0040] Fig.13 This is a schematic structural diagram of the distal end of the support element in another preferred embodiment disclosed in Example 2 of the utility model;

[0041] Fig.14 This is a schematic structural diagram of the distal end of the support element in another preferred implementation manner disclosed in Example 2 of the utility model.

[0042] Description of reference numerals:

[0043] Delivery catheter 10, element pushing cavity 20, support element 30, radial extension portion 31, axial limiting portion 32, artificial valve 40, capture ring 50, valve ring 60. DETAILED DESCRIPTION

[0044] In order to make the purpose, technical solution and advantages of the utility model clearer, the technical solution of the utility model will be clearly and completely described below in combination with the specific embodiments of the utility model and the corresponding drawings. In the description of the utility model, it should be noted that the term "or" is usually used in the sense of including "and / or", unless the content clearly indicates otherwise.

[0045] In the description of the present utility model, 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 in the text 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. As described in this article, the "arc-shaped", "bent hook-shaped" and the like are not absolute or standard shapes, but can also be roughly related shapes, etc. Those skilled in the art can know that in order to achieve their respective functions and meet the requirements of surgical operations, the specific shapes / sizes / angles of each structure can be adaptively adjusted.

[0046] Obviously, the described embodiments are only some embodiments of the utility model, not all embodiments. Based on the embodiments of the utility model, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the utility model.

[0047] In order to solve the problems existing in the prior art, an embodiment of the utility model provides an artificial valve delivery device, including: a delivery catheter 10, an element pushing cavity 20 and a support element 30, wherein the delivery catheter 10 is axially through-connected and is used to deliver and release an artificial valve 40 to the distal end; the element pushing cavity 20 is axially through-connected and is axially arranged on the delivery catheter 10; the support element 30 can be pushed toward the distal end along the inner cavity of the element pushing cavity 20, and the distal end of the support element 30 extends radially outward for abutting against the proximal end of the anchoring device of the artificial valve 40.

[0048] Example 1

[0049] The present embodiment provides an artificial valve delivery device, which is preferably suitable for the delivery and release of an artificial mitral valve, and is used in conjunction with an anchoring device of an artificial valve 40; in the present embodiment, when performing valve replacement, the anchoring device first wraps around the body's own tendineae on the outside, and then releases the artificial valve 40 in the valve ring 60. After the release, the artificial valve 40 can radially self-expand and be stably connected to the anchoring device to replace the native valve and replace its physiological function.

[0050] For ease of explanation, the delivery device will be explained in this embodiment in conjunction with the structure of the artificial valve 40 and its anchoring device. However, it should be emphasized that since the artificial valve delivery device itself does not include the artificial valve 40 and its anchoring device, the structure of the artificial valve 40 and the anchoring device is not specifically limited in this embodiment. Technical personnel in this field can apply the delivery device to existing artificial valves 40 and anchoring devices of other structures based on the structure of the delivery device.

[0051] In a preferred embodiment, the artificial valve 40 is a self-expanding valve, and its valve stent is made of shape memory alloy, which can complete automatic radial expansion after losing radial constraint and be anchored at the native valve ring 60; preferably, the artificial valve 40 is divided into a main body and a skirt portion along the axial direction, and the main body is located in the valve ring 60, and its cross-section is generally circular, elliptical or other shapes, and the channel defined by the interior of the main body is the blood flow channel of the artificial valve 40; preferably, the outer surface of the main body can be further provided with a connecting structure, such as a barb, a thorn or a boss, etc., which is used to cooperate with the anchoring device to achieve a stable connection between the two; preferably, the skirt portion is located in the inflow section of the main body, and its shape is a flange disc, which is used to prevent paravalvular leakage.

[0052] In a preferred embodiment, the anchoring device of the artificial valve 40 is a capture ring 50, and the cross-section of the capture ring 50 is generally annular. Optionally, the capture ring 50 can be configured as a spiral open-loop structure, or as one or more coaxial closed-loop structures; preferably, the capture ring 50 is implanted into the patient's body via a catheter, and during the implantation process, the capture ring 50 is wrapped around the body's own tendinous cords to ensure that the capture ring 50 can be fixed on the patient's heart valve.

[0053] Specifically, the stable connection between the artificial valve 40 and the anchoring device means that the fishing ring 50 wraps around the chordae tendineae and is located at the root of the valve ring 60. The artificial valve 40 and the fishing ring 50 are connected at the root of the valve ring 60. The two cooperate to clamp the native leaflets, thereby minimizing damage to the patient's chordae tendineae while replacing the valve.

[0054] Due to the continuous beating of the heart, the fishing ring 50 may fall to the papillary muscle after being wrapped around the chordae tendineae, resulting in failure to connect with the artificial valve 40, or accidentally squeeze the chordae tendineae and cause the chordae tendineae to break, affecting the anchoring position of the artificial valve 40 and the fishing ring 50. In order to solve the above problems, the embodiment of the utility model provides an artificial valve delivery device, such as Figure 1-4 The delivery device includes a delivery catheter 10, a support element 30 and an element pushing cavity 20. The delivery catheter 10 is used to deliver an artificial valve 40. The support element 30 can pass through the distal end of the element pushing cavity 20 and extend radially, thereby supporting the capture ring 50 at the root of the valve ring 60, and then releasing the artificial valve 40, ultimately achieving a stable connection among the artificial valve 40, the native valve leaflets and the capture ring 50, while avoiding friction damage to the tendons caused by the artificial valve 40 and the capture ring 50.

[0055] Preferably, the delivery catheter 10 is axially penetrated and can enter the patient's body through the apical approach under the guidance of a medical guidewire and reach the expected position. Since the artificial valves 40 of different manufacturers have different sizes, the specifications of the delivery catheter 10 can be adaptively adjusted according to the actual size of the artificial valve 40, which is not limited here.

[0056] In a preferred embodiment, the length of the delivery catheter 10 is at least sufficient to allow its distal end to reach the heart, while the proximal end is located outside the body for proximal operations.

[0057] In a preferred embodiment, the delivery catheter 10 is a flexible tube, which can have a multi-layer structure from the inside to the outside to take into account its flexibility and circumferential rigidity to avoid squeezing the artificial valve 40; specifically, the material and structure of the delivery catheter 10 can be selected from any embodiment disclosed in the prior art, and this embodiment does not make specific limitations.

[0058] Preferably, the component pushing cavity 20 is axially through and axially arranged on the surface of the delivery catheter 10, and can be specifically arranged on the inner surface or the outer surface of the delivery catheter 10; preferably, the length of the component pushing cavity 20 is not longer than the length of the delivery catheter 10, and more preferably, at least the distal end of the component pushing cavity 20 is flush with the distal end of the delivery catheter 10. Specifically, the material of the component pushing cavity 20 can be the same as that of the delivery catheter 10, or a different material can be selected, which is not limited here.

[0059] In a preferred embodiment, the element pushing cavity 20 is arranged on the inner surface of the delivery catheter 10. The element pushing cavity 20 itself can be fixedly connected to the inner surface of the delivery catheter 10 as a separate pipeline, or the delivery catheter 10 can be configured as a multi-lumen tube, in which the central lumen is used to deliver the artificial valve 40, and the peripheral lumen is used as the element pushing cavity 20.

[0060] In another preferred embodiment, the element pushing cavity 20 is disposed on the outer surface of the delivery catheter 10, and the element pushing cavity 20 itself is fixedly connected to the outer surface of the delivery catheter 10 as a separate pipeline, and the two can be fixedly connected by bonding, hot melting, etc.

[0061] In a preferred embodiment, the number of the element pushing cavities 20 is equal to the number of the supporting elements 30 , and the number can be configured as one or more. When multiple element pushing cavities 20 are provided, the element pushing cavities 20 are evenly distributed along the circumference of the delivery catheter 10 .

[0062] Preferably, the inner diameter of the element pushing cavity 20 satisfies that the supporting element 30 can freely move axially therein.

[0063] Preferably, the support element 30 can be pushed toward the distal end along the inner cavity of the element pushing cavity 20. The support element 30 is preferably made of a shape memory alloy material, such as nickel-titanium alloy. When pushed in the element pushing cavity 20, the support element 30 is rod-shaped, such as Figure 2 , Figure 3 After passing through the component pushing cavity 20, the distal end thereof returns to the prefabricated shape during in vitro heat setting, such as Figure 4 The prefabricated shape is configured so that the distal end of the support element 30 extends radially outward and can abut against the proximal end of the capture ring 50 to support it at the root of the valve ring 60 to prevent the capture ring 50 from being displaced before and during the release of the artificial valve 40.

[0064] In a preferred embodiment, the length of the support element 30 is greater than the length of the element pushing cavity 20, so as to ensure that the distal end of the support element 30 can pass through the distal end of the element pushing cavity 20, and the proximal end can still be exposed at the proximal end of the element pushing cavity 20, so as to achieve the operation of pushing and retracting the support element 30 by the proximal end. Specifically, the pushing and retracting method of the support element 30 is similar to that of the guide wire. The operator can hold the proximal end of the support element 30 and then operate it in vitro to achieve the pushing and retracting of the support element 30. When retracting, the support element 30 is limited circumferentially by the element pushing cavity 20 and returns to a rod shape.

[0065] In a preferred embodiment, the distal end of the support element 30 includes a radial extension portion 31 and an axial limiting portion 32, and the axial limiting portion 32 is located at the farthest end of the entire support element 30, and the radial extension portion 31 extends radially outward, and there is a bend between the axial limiting portion 32 and the radial extension portion 31. The axial limiting portion 32 extends axially toward the distal end. On the one hand, it is used to abut the proximal end of the capture ring 50, and on the other hand, it can prevent the axial limiting portion 32 from radially piercing the ventricular wall after it returns to the prefabricated shape to cause damage.

[0066] In a preferred embodiment, the radially extending portion 31 extends straight outward in the radial direction. Fig.12 .

[0067] In a preferred embodiment, the radially extending portion 31 extends radially and obliquely toward the proximal end, such as Fig.13 .

[0068] In a preferred embodiment, the radially extending portion 31 extends radially and obliquely toward the distal end, such as Fig.14 .

[0069] In a preferred embodiment, the axial limiting portion 32 extends axially straight toward the distal end. Fig.12 .

[0070] In a preferred embodiment, the axial limiting portion 32 is radially inclined and extends to the distal end. Fig.13 .

[0071] In a preferred embodiment, the axial limiting portion 32 extends toward the distal end in an arc shape.

[0072] In a preferred embodiment, the axial limiting portion 32 is in the shape of a bent hook, which is bent concave toward the distal end. Fig.14 , used to accommodate the proximal end of the fishing ring 50.

[0073] refer to Figure 5 — Fig.11 In this embodiment, the method of using the artificial valve delivery device is as follows:

[0074] refer to Figure 5First, the capture ring 50 is implanted into the patient's valve annulus 60. Due to its own gravity and the beating of the heart, the capture ring 50 will gradually slide down to the papillary muscle, away from the root of the valve annulus 60. The artificial valve delivery device is delivered into the patient's body through the apical approach and reaches the desired position, such as Figure 6 At this time, the support element 30 is located inside the element pushing cavity 20. Through proximal operation, the distal end of the support element 30 is pushed out of the element pushing cavity 20, and the distal end of the support element 30 is restored to a predetermined shape. The radial extension portion 31 and the axial limit portion 32 are both supported at the proximal end of the fishing ring 50 (that is, the bottom of the fishing ring 50). The support element 30 is continued to be transported, and the fishing ring 50 is pushed upward to move the fishing ring 50 from the papillary muscle to the root of the valve ring 60, and then the fishing ring 50 is kept at the root of the valve ring 60 through the support element 30. Figure 7 and Figure 8 , and then release the artificial valve 40 normally, such as Fig. 9 and Fig.10 , achieving a stable connection between the artificial valve 40 and the fishing ring 50, at which time the native valve leaflet is clamped between the artificial valve 40 and the fishing ring 50, such as Fig.11 After the artificial valve 40 is completely released, the support element 30 is withdrawn into the cavity of the element pushing cavity 20, and then the artificial valve delivery device is withdrawn.

[0075] Example 2

[0076] This embodiment provides an artificial valve delivery system, including the artificial valve delivery device as described in Example 1, and also including an artificial valve 40 and an anchoring device, the anchoring device is a fishing ring 50, and the various features already included in Example 1 are naturally inherited in this embodiment.

[0077] In this embodiment, the method of using the artificial valve delivery system is the same as the method of using the artificial valve delivery device in Example 1, and will not be repeated here.

[0078] The embodiments of the utility model are described above in conjunction with the accompanying drawings, but the utility model is not limited to the above-mentioned specific implementation methods. The above-mentioned specific implementation methods are merely illustrative and not restrictive. Under the enlightenment of the utility model, ordinary technicians in this field can also make many forms without departing from the scope of protection of the utility model and the claims, all of which are within the protection of the utility model.

Claims

1. An artificial valve delivery device, characterized in that: include: A delivery catheter, which is axially connected and used for delivering and releasing the artificial valve to the distal end; An element pushing cavity, which is axially continuous and axially arranged on the delivery conduit; A support element, wherein the support element can be pushed toward the distal end along the inner cavity of the element pushing cavity, and the distal end of the support element extends radially outward to abut against the proximal end of the anchoring device of the artificial valve.

2. The artificial valve delivery device according to claim 1, characterized in that: The support element comprises a shape memory alloy material, and the support element can be pushed in the element pushing cavity in a rod shape, and the distal end of the support element can restore its shape to extend radially outward after passing through the element pushing cavity.

3. The artificial valve delivery device according to claim 2, characterized in that: The length of the supporting element is greater than the length of the element pushing cavity.

4. The artificial valve delivery device according to claim 2, characterized in that: The distal end of the support element includes a radial extension portion and an axial limiting portion; the radial extension portion extends radially outward, and the axial limiting portion extends axially distally for abutting against the proximal end of the artificial valve anchoring device.

5. The artificial valve delivery device according to claim 4, characterized in that: The radially extending portion extends straight outward in the radial direction; Alternatively, the radially extending portion extends obliquely toward the proximal end in the radial direction; Alternatively, the radially extending portion extends radially and obliquely toward the distal end.

6. The artificial valve delivery device according to claim 4, characterized in that: There is a bend between the axial limiting portion and the radial extending portion; The axial limiting portion extends straight toward the distal end along the axial direction; Alternatively, the axial limiting portion is radially inclined and extends to the distal end; Alternatively, the axial limiting portion extends toward the distal end in an arc shape; Alternatively, the axial limiting portion is in the shape of a bent hook, which is bent concave toward the distal end.

7. The artificial valve delivery device according to claim 1, characterized in that: A plurality of the element pushing cavities are circumferentially distributed on the inner side or the outer side of the delivery catheter; Alternatively, the delivery catheter is a multi-lumen tube, and the peripheral lumen of the multi-lumen tube is configured as the element pushing lumen.

8. The artificial valve delivery device according to claim 7, characterized in that: The number of the component pushing cavities matches the number of the supporting elements, and the number of the component pushing cavities is not less than 2.

9. The artificial valve delivery device according to claim 7, characterized in that: The length of the element pushing cavity is not longer than the length of the delivery catheter.

10. An artificial valve delivery system, characterized in that: It comprises an artificial valve delivery device as described in any one of claims 1-9, and also comprises an artificial valve and an anchoring device, wherein the anchoring device comprises a fishing ring.

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