Valve clip recovery device

Abstract

The present invention relates to the field of interventional medical devices, and specifically to a valve clip retrieval device for cutting valve leaflets and retrieving valve clips, comprising: a capturing member, which is used to capture the valve clip; a retrieving member, which is used to reclaim the valve clip and detached valve leaflet tissue; a first cutting member, which is used to cut the valve leaflet; the capturing member, the retrieving member, and the first cutting member are arranged as a coaxial rotating body kit, the retrieving member is arranged on the outside of the capturing member, and the first cutting member is arranged on the outside of the retrieving member, and the relative movements of the capturing member, the retrieving member, and the first cutting member in the axial direction on their shared axial direction are independent of each other, and the circumferential rotation of the first cutting member around the axis is not affected.

Description

Technical Field

[0001] The present invention relates to the field of interventional medical devices, and in particular to a valve clip recovery device. Background Art

[0002] Heart valves are valves that connect the atria and ventricles, or between the ventricles and arteries or veins. They act like one-way valves. Heart valve disease can cause regurgitation, or abnormal backflow of blood. Mitral regurgitation is common. When the heart's ventricles contract, some blood flows from the left ventricle back into the left atrium instead of the aorta. Similar regurgitation can occur with the tricuspid valve, allowing blood to flow from the right ventricle back into the right atrium.

[0003] Clinically, valve repair or replacement is the most common treatment for heart valve disease. For example, edge-to-edge repair of the mitral valve using a clip device is a common procedure. Specifically, an implanted clip clamps the anterior and posterior leaflets of the mitral valve together. By sacrificing the opening area of ​​the mitral valve, the mitral valve changes from a single-orifice structure to a double-orifice structure, thereby reducing regurgitation caused by leaflet regurgitation and improving clinical outcomes. However, several years after survival, patients may experience recurrent regurgitation or stenosis due to ventricular enlargement, rheumatic mitral valve disease, inflammatory valvular disease, severe valvular calcification, or valve tissue hyperplasia caused by clip compression, necessitating secondary repair. Prior to secondary repair, the sutured valve tissue must be removed, or the valve clip and the valve tissue held together by the clip must be removed.

[0004] CN116407265A discloses a leaflet cutting device and a leaflet cutting system that are quite representative. However, in the prior art, the leaflets and valve clips are mainly locked by stretching, and the control over the stretching force is weak, causing greater damage to the valve tissue; the retrieval device is not reliable, and the valve clip is prone to fall off during the process of retrieval and withdrawal from the body, resulting in serious consequences; the cutting tool lacks protective action when entering the heart, and is prone to causing unexpected damage when entering the human body; the number of catheter devices is too large, and the required incision is relatively large. Summary of the Invention

[0005] The purpose of the present invention is to solve the shortcomings in the prior art.

[0006] In order to achieve the above object, the present invention adopts the following technical solutions:

[0007] A valve clip retrieval device for cutting a valve leaflet and retrieving the valve clip, comprising:

[0008] a capture member, the capture member being used to capture the valve clip;

[0009] A recovery component, used for recovering the valve clip and the detached valve leaflet tissue;

[0010] a first cutting member, the first cutting member being used for cutting the leaflet;

[0011] The capturing member, the recovery member and the first cutting member are arranged as a coaxially matched rotating body kit, the recovery member is arranged on the outside of the capturing member, and the first cutting member is arranged on the outside of the recovery member. The relative movements of the capturing member, the recovery member and the first cutting member in the axial direction on their shared axial direction are independent of each other, and the circumferential rotation of the first cutting member around the axis is not affected.

[0012] As a preferred technical solution, the capturing member includes a capturing wire and a capturing rod, wherein the capturing wire is arranged at the distal end of the capturing rod, or the capturing wire is arranged inside the capturing rod, and the capturing wire has an active state and a locked state that can be manually switched repeatedly.

[0013] As a preferred technical solution, the capturing wire is configured as a ring structure with two fixed connection points with the distal end of the capturing rod. When the distal end of the capturing rod extends out of the distal end of the recovery component, the capturing wire is in an expanded active state; when the distal end of the capturing rod is retracted into the distal end of the recovery component, the capturing wire is in a contracted locked state.

[0014] As a preferred technical solution, the capturing rod is configured as a hollow structure, and the capturing wire is configured as a long line structure that shuttles through the hollow structure of the capturing rod. When the portion of the capturing wire in the hollow structure is a single strand, the capturing wire is in an expanded active state; when the portion of the capturing wire in the hollow structure is a double strand, the capturing wire is in a contracted locked state.

[0015] As a preferred technical solution, the distal end of the recovery member is configured as an opening structure with a diameter increasing toward the distal end, with a maximum inner diameter greater than the outer diameter of the circumscribed circle of the cross section of the leaflet clip, and a minimum inner diameter less than or equal to the outer diameter of the circumscribed circle of the cross section of the leaflet clip.

[0016] As a preferred technical solution, the distal end of the recovery member is set as an expandable elastic structure of a certain length, the maximum inner diameter of which in the unexpanded state is larger than the outer diameter of the circumscribed circle of the cross section of the leaflet clip, and the minimum inner diameter is smaller than the outer diameter of the circumscribed circle of the cross section of the leaflet clip.

[0017] As a preferred technical solution, it also includes a second cutting piece, which is a hollow rotating body coaxially matched with the capturing piece and the recovering piece, and the distal end of the second cutting piece is provided with a blade facing the distal end; the relative movements of the capturing piece, the recovering piece and the second cutting piece in the axial direction on their shared axial direction are independent of each other, and the circumferential rotation of the second cutting piece around the axis is not affected.

[0018] As a preferred technical solution, the first cutting member includes a catheter and at least one cutter, the cutter is arranged on the inner wall of the catheter, and the cutter includes a retracted state in which the blade points to the axial direction of the catheter and a cutting state in which the blade points to the center along the radial direction of the catheter; the retracted state and cutting state of the cutter can be switched repeatedly.

[0019] As a preferred technical solution, the blade of the cutter points to the proximal end in the retracted state, and the cutter is configured to be sharpened on one side of the proximal end of the blade in the cutting state.

[0020] As a preferred technical solution, it also includes a control member, which is arranged on the inner wall of the first cutting member. The control member is used to control the repeated switching of the cutter between a retracted state and a cutting state. When the distal end of the control member exceeds the position of the cutter, the cutter is in a retracted state. When the distal end of the control member is retracted to the position of the cutter, the cutter is in a cutting state.

[0021] As a preferred technical solution, an elastic structure is provided between the cutter and the catheter, and the cutter has a tendency to automatically turn into a cutting state under the action of the elastic structure. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] 1-capturing piece, 11-capturing wire, 12-capturing rod, 2-recovery piece, 3-first cutting piece, 31-catheter, 32-cutter, 4-control piece, 51-valve leaflet, 52-valve clip, 6-second cutting piece, 7-delivery catheter.

[0023] Figure 1 A schematic cross-sectional view of a heart with a valve clip implanted at the mitral valve position;

[0024] Figure 2 Schematic diagram of the mitral valve without valve clip implantation;

[0025] Figure 3 Schematic diagram of the mitral valve with a valve clip implanted;

[0026] Figure 4 This is a schematic structural diagram of a valve clip recovery device provided in an embodiment;

[0027] Figure 5 This is a schematic diagram of the structure of a capture element provided in an embodiment;

[0028] Figure 6 This is a schematic diagram of the structure of a capture element provided in an embodiment;

[0029] Figure 7 is a schematic structural diagram of a first cutting member and a control member provided in an embodiment;

[0030] Figure 8is a schematic structural diagram of a first cutting member and a control member provided in an embodiment;

[0031] Figure 9 is a schematic structural diagram of a first cutting member and a control member provided in an embodiment;

[0032] Figure 10-13 This is a schematic diagram of the working principle of a valve clip retrieval device provided in an embodiment;

[0033] Figure 14 is a schematic structural diagram of a second cutting member provided in an embodiment;

[0034] Figure 15-20 This is a schematic diagram of the working principle of a valve clip retrieval device provided in an embodiment;

[0035] Figure 21 A schematic diagram of the structure of a valve clip recovery device provided in an embodiment

[0036] Figure 22-24 This is a schematic structural diagram of a first cutting member and a control member provided in an embodiment. DETAILED DESCRIPTION

[0037] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the 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.

[0038] In addition, the following descriptions of the embodiments refer to the accompanying drawings to illustrate specific embodiments in which the present invention may be implemented. Directional terms used in the present invention, such as "upper," "lower," "front," "back," "left," "right," "inner," "outer," and "side," are used solely with reference to the directions in the accompanying drawings. Therefore, the use of directional terms is intended to better and more clearly illustrate and understand the present invention, and is not intended to indicate or imply that the device or component referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limiting the present invention.

[0039] In the description of the present invention, it should be noted that, unless otherwise clearly stipulated and limited, the terms "installed", "connected", "connected", and "set on..." 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; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be internal communication between two components.

[0040] In the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator. The axial direction refers to the direction parallel to the line connecting the distal and proximal centers of the medical device. The radial direction refers to the direction along the diameter or radius, with the radial and axial directions being perpendicular to each other. The circumferential direction refers to the direction around the central axis. Those skilled in the art will understand the specific meanings of the above terms in the present invention.

[0041] The present invention will be further described in detail below with reference to the accompanying drawings.

[0042] like Figure 1 The valve leaflets and valve clip shown need to be removed after long-term use for the next treatment. The present invention is used to cut the valve leaflets and recycle the valve clip, thereby providing a valve clip recycle device, such as Figure 4 As shown, including:

[0043] a capture member, the capture member being used to capture the valve clip;

[0044] A recovery component, used for recovering the valve clip and the detached valve leaflet tissue;

[0045] a first cutting member, the first cutting member being used for cutting the leaflet;

[0046] The capturing member, the recovery member and the first cutting member are arranged as a coaxially matched rotating body kit, the recovery member is arranged on the outside of the capturing member, and the first cutting member is arranged on the outside of the recovery member. The relative movements of the capturing member, the recovery member and the first cutting member in the axial direction on their shared axial direction are independent of each other, and the circumferential rotation of the first cutting member around the axis is not affected.

[0047] As a preferred embodiment, the capturing member includes a capturing wire and a capturing rod, wherein the capturing wire is arranged at the distal end of the capturing rod, or the capturing wire is arranged inside the capturing rod, and the capturing wire has an active state and a locked state that can be manually switched repeatedly.

[0048] As a preferred embodiment, Figure 5 As shown, the capturing wire is configured as a ring structure with two fixed connection points with the distal end of the capturing rod. When the distal end of the capturing rod extends out of the distal end of the recovery component, the capturing wire is in an expanded active state. When the distal end of the capturing rod is retracted into the distal end of the recovery component, the capturing wire is in a contracted locked state.

[0049] Preferably, the capture wire is configured as an elastic member that has a tendency to expand in a free state;

[0050] Preferably, the capture wire is configured as a soft thin wire structure;

[0051] Preferably, the capturing wire is configured as a shape memory alloy.

[0052] The distal end of the capture rod extends out of the recovery part, and the capture wire is unfolded. Since the valve clip is usually a relatively complex mechanical structure, the capture wire can be easily hung on the valve clip, or hung in the gap between the valve clip and the leaflet to capture the valve clip.

[0053] As a preferred embodiment, Figure 6 As shown, the capturing rod is configured as a hollow structure, and the capturing wire is configured as a long line structure that shuttles through the hollow structure of the capturing rod. When the portion of the capturing wire in the hollow structure is a single strand, the capturing wire is in an expanded active state; when the portion of the capturing wire in the hollow structure is a double strand, the capturing wire is in a contracted locked state.

[0054] like Figure 2 As shown, the gap between the valves resembles a large hole when not treated, as Figure 3 As shown, the anterior and posterior leaflets of the mitral valve will become two small holes after being clamped by the valve clamp. When the capture wire is set to a long-line structure, one active end of the long-line structure first enters the left atrium from the left ventricle through one of the holes, and then returns to the left ventricle from the left atrium through the other hole. Then, through extracorporeal operation, the active end is made to re-enter the hollow structure of the capture rod, and then pass through the capture rod back to the body. Then, the operator can pull the two ends of the capture wire, and the middle part of the capture wire completes the crossing of the two holes near the valve clamp, thereby completing the capture and locking of the valve clamp. This capture method can not only make the capture of the valve clamp by the capture wire more stable, ensure the stability of the cutting process, but also ensure the safe recovery of the valve clip after the cutting is completed.

[0055] Preferably, it also includes a delivery catheter, which is arranged in the outermost layer and is used to deliver the capture piece, the recovery piece, and the first cutting piece to the target position while avoiding unnecessary damage to human tissue during the delivery process.

[0056] As a preferred embodiment, the distal end of the recovery member is configured as an opening structure with a diameter increasing toward the distal end, the maximum inner diameter is larger than the outer diameter of the circumscribed circle of the cross section of the leaflet clip, and the minimum inner diameter is less than or equal to the outer diameter of the circumscribed circle of the cross section of the leaflet clip.

[0057] The distal end of the recovery part with an open structure is more conducive to the stable position control of the valve clip. Under the pull of the capture part, the valve clip can be stabilized in the cavity of the recovery part, avoiding radial position movement and making the operation process safer.

[0058] As a preferred embodiment, the distal end of the recovery member is configured as an expandable elastic structure of a certain length, the maximum inner diameter of which in the unexpanded state is larger than the outer diameter of the circumscribed circle of the cross section of the leaflet clip, and the minimum inner diameter is smaller than the outer diameter of the circumscribed circle of the cross section of the leaflet clip.

[0059] The elastic wrapping method makes the valve clip more stable during the retrieval process to prevent it from falling.

[0060] As a preferred technical solution, Figure 14 As shown, it also includes a second cutting piece, which is a hollow rotating body coaxially matched with the capturing piece and the recovering piece, and the distal end of the second cutting piece is provided with a blade facing the distal end; the relative movements of the capturing piece, the recovering piece and the second cutting piece in the axial direction on their shared axial direction are independent of each other, and the circumferential rotation of the second cutting piece around the axis is not affected.

[0061] like Figure 15-20 As shown, in some cases, the valve clip is not necessarily clamped at the tip of the valve leaflet, or the valve clip is surrounded by the valve leaflet tissue under the body's own defense mechanism. The valve leaflet cannot be cut only by the first cutting member in its radial direction. The present invention also provides a second cutting member, such as Figure 17 As shown, first, an axial cutting edge is cut out of the leaflet by an axial cutter, and then the first cutting member enters the axial cutting edge, and the cutter is released to complete the radial cutting, thereby achieving complete acquisition of the valve clip.

[0062] As a preferred embodiment, the first cutting member includes a catheter and at least one cutter, the cutter is arranged on the inner wall of the catheter, and the cutter includes a retracted state in which the blade points to the axial direction of the catheter and a cutting state in which the blade points to the center along the radial direction of the catheter; the retracted state and cutting state of the cutter can be switched repeatedly.

[0063] By arranging the blade on the inner wall of the catheter and setting it to a retracted state, unexpected damage to internal organs during the movement is avoided, thereby ensuring the absolute safety of the surgical process.

[0064] Preferably, Figure 7 As shown, the cutter blade points to the proximal end in the retracted state, and the cutter is configured to have the proximal end of the blade sharpened on one side in the cutting state.

[0065] Optional, such as Figure 8 As shown, the cutter blade points to the distal end in the retracted state, and the cutter is configured to have a single-sided sharp edge at the distal end of the blade in the cutting state.

[0066] The direction of the blade is coordinated with the direction of the blade, and the blade directly pierces the valve tissue after it pops out to achieve a better cutting effect.

[0067] As a preferred embodiment, it also includes a control member, which is arranged on the inner wall of the first cutting member. The control member is used to control the repeated switching of the cutter between a retracted state and a cutting state. When the distal end of the control member exceeds the position of the cutter, the cutter is in a retracted state. When the distal end of the control member is retracted to the position of the cutter, the cutter is in a cutting state.

[0068] In this solution, only three layers of cannula are needed to achieve good technical effects, effectively reducing the required wound size.

[0069] As a preferred embodiment, an elastic structure is provided between the cutter and the catheter, and the cutter has a tendency to automatically turn into a cutting state under the action of the elastic structure.

[0070] Preferably, the elastic structure is configured as a coil of spring arranged around the inner wall of the catheter.

[0071] As a preferred embodiment, the first cutting member includes a catheter and at least one cutter, the cutter is arranged on the inner wall of the catheter, and the cutter includes a retracted state in which the blade points to the axial proximal end of the catheter, a radial cutting state in which the blade points to the center along the radial direction of the catheter, and an axial cutting state in which the blade points to the axial distal end of the catheter.

[0072] like Figure 22-24 As shown, when the cutter is in the axial cutting state, the first cutting member is rotated to complete the axial cutting, and the control member is withdrawn. The cutter is in the radial cutting state, and the first cutting member is rotated to complete the radial cutting, thereby completing the acquisition of the valve clip.

[0073] The present invention is described in detail below through an embodiment of application in the recovery process of a mitral valve clip. It should be noted that the technical solution provided by the present invention can also be applied to the recovery process of a tricuspid valve clip.

[0074] Working principle: The valve clip retrieval device provided by the present invention is used to enter the left ventricle from the apex of the heart. The first thing to enter is the capture part and the retrieval part, such as Figure 10 As shown, in this embodiment, the capture wire is configured as a ring structure made of elastic material with an expansion tendency. When the capture rod extends out of the distal end of the recovery member, the capture wire expands into an active state, forming an open ring. Due to the complex shape and structure of the valve clip, the operator only needs to pull the capture wire back and forth a few times to hook the valve clip and immediately feel the change in resistance. Figure 11 As shown in FIG, the retractor is extended forward to press against the valve clip, thereby forming a stable control on the valve to avoid unnecessary pulling on the valve during subsequent operations, which may cause accidental damage; Figure 12As shown, the first cutting part is then entered, the control part is retracted, and the cutter pops out. At this time, the valve unfolds an inclined plane under the stable control of the capture part and the recovery part, and the cutter blade just touches the valve tissue. The first cutting part is rotated to cut the valve clip and a small part of the valve tissue together; once the valve clip falls off, it is held by the recovery part, and the valve clip locked by the capture part is fixed at both ends, which greatly reduces the risk of falling and ensures the smooth progress of the next operation.

[0075] The technical means disclosed in the solutions of the present invention are not limited to those disclosed in the above-mentioned embodiments, but also include technical solutions composed of any combination of the above-mentioned technical features. It should be noted that those skilled in the art may make various improvements and modifications without departing from the principles of the present invention, and such improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. A valve clip retrieval device for cutting a valve leaflet (51) and retrieving a valve clip (52), characterized in that: include: A capture member (1), the capture member (1) being used to capture the valve clip (52); A recovery member (2), the recovery member (2) being used to recover the valve clip (52) and the detached valve leaflet (51) tissue; a first cutting member (3), the first cutting member (3) being used for cutting the leaflet (51), the first cutting member (3) comprising a catheter (31) and at least one cutter (32), the cutter (32) being arranged on the inner wall of the catheter (31), the cutter (32) comprising a contracted state in which the blade points axially to the catheter (31) and a cutting state in which the blade points radially to the center of the catheter (31); The capturing member (1), the recovery member (2), and the first cutting member (3) are configured as a coaxially matched rotary body kit, the recovery member (2) is configured on the outside of the capturing member (1), and the first cutting member (3) is configured on the outside of the recovery member (2), and the relative movements of the capturing member (1), the recovery member (2), and the first cutting member (3) in the axial direction on their shared axial direction are independent of each other, and the circumferential rotation of the first cutting member (3) around the axis is not affected; The invention also includes a control member (4), which is arranged on the inner wall of the first cutting member (3). The control member (4) is used to control the repeated switching of the cutter (32) between the contraction state and the cutting state. An elastic structure is arranged between the cutter (32) and the catheter (31). Under the action of the elastic structure, the cutter (32) has a tendency to automatically switch to the cutting state; when the distal end of the control member (4) exceeds the position of the cutter (32), the cutter (32) is in the contraction state, and when the distal end of the control member (4) is retracted to the position of the cutter (32), the cutter (32) is in the cutting state.

2. A valve clip retrieval device according to claim 1, characterized in that: The catching member (1) comprises a catching wire (11) and a catching rod (12); the catching wire (11) is arranged at the distal end of the catching rod (12), or the catching wire (11) is arranged inside the catching rod (12); and the catching wire (11) has an active state and a locked state that can be switched manually and repeatedly.

3. A valve clip retrieval device according to claim 2, characterized in that: The catching wire (11) is configured as a ring structure having two fixed connection points with the distal end of the catching rod (12); when the distal end of the catching rod (12) extends beyond the distal end of the recovery member (2), the catching wire (11) is in an extended active state; and when the distal end of the catching rod (12) is retracted into the distal end of the recovery member (2), the catching wire (11) is in a contracted locked state.

4. A valve clip retrieval device according to claim 2, characterized in that: The capturing rod (12) is configured as a hollow structure, and the capturing wire (11) is configured as a long-line structure that shuttles through the hollow structure of the capturing rod (12). When the portion of the capturing wire (11) in the hollow structure is a single strand, the capturing wire (11) is in an extended active state; when the portion of the capturing wire (11) in the hollow structure is a double strand, the capturing wire (11) is in a contracted locked state.

5. The valve clip retrieval device according to claim 1, characterized in that: The distal end of the recovery member (2) is configured as an open structure with a diameter that increases toward the distal end, wherein the maximum inner diameter is greater than the outer diameter of the circumscribed circle of the cross section of the leaflet (51) clip, and the minimum inner diameter is less than or equal to the outer diameter of the circumscribed circle of the cross section of the leaflet (51) clip.

6. The valve clip retrieval device according to claim 1, characterized in that: The distal end of the recovery member (2) is configured as an expandable elastic structure of a certain length, wherein the maximum inner diameter in the unexpanded state is larger than the outer diameter of the circumscribed circle of the cross section of the leaflet (51) clip, and the minimum inner diameter is smaller than the outer diameter of the circumscribed circle of the cross section of the leaflet (51) clip.

7. The valve clip retrieval device according to claim 1, characterized in that: The invention also includes a second cutting member (6), which is a hollow rotating body coaxially matched with the capturing member (1) and the recovering member (2), and a distal end of the second cutting member (6) is provided with a blade facing the distal end; the relative movements of the capturing member (1), the recovering member (2) and the second cutting member (6) in the axial direction on their shared axial direction are independent of each other, and the circumferential rotation of the second cutting member (6) around the axis is not affected.

8. The valve clip retrieval device according to claim 1, characterized in that: The blade of the cutter (32) points to the proximal end in the retracted state, and the cutter (32) is configured to be sharpened on one side of the proximal end in the cutting state.

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