Retrievable valve clip and valve clip retrieval system
By designing a recyclable valve clamp and recycling system, the valve clamp is recovered by interventional means, the problem of surgical removal in the prior art is solved, and a simple recycling process and secondary repair with low damage is achieved.
Patent Information
- Application Number
- CN201910742196.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2019-08-12
- Publication Date
- 2025-08-12
- Estimated Expiration
- 2039-08-12
AI Technical Summary
Existing valve clamps cannot be removed from the patient through an interventional catheter and require secondary repair through high-cost and high-risk surgical procedures.
A recyclable valve clamp is designed, equipped with a recovery part, a capture device and a cutting device, and the valve clamp is retrieved through interventional means, including a main body part and a distal recovery part, and the valve clamp contact position is captured and cut by a capture device.
A simple interventional recovery process is realized, reducing damage to patients and facilitating secondary repair.
Smart Images

Figure CN112386367B_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the field of medical devices, and in particular to a recyclable valve clipper and a valve clipper recovery system. Background Art
[0002] See also Figure 1 The mitral valve 1 is a one-way valve located between the left atrium 2 and the left ventricle 3 of the heart. A healthy mitral valve 1 controls blood flow from the left atrium 2 to the left ventricle 3 while preventing blood from flowing from the left ventricle 3 back to the left atrium 2. The mitral valve 1 consists of a pair of leaflets, called the anterior leaflet 1a and the posterior leaflet 1b. The anterior leaflet 1a and the posterior leaflet 1b are fixed to the papillary muscles of the left ventricle 3 by chordae tendineae 4. Under normal circumstances, when the left ventricle contracts, the edges of the anterior leaflet 1a and the posterior leaflet 1b completely close together, preventing blood from flowing from the left ventricle 3 to the left atrium 2. Figure 2 When organic or functional changes occur in the leaflets of the mitral valve or its related structures, such as partial rupture of the chordae tendineae 4, the anterior leaflet 1a and posterior leaflet 1b of the mitral valve 1 are poorly aligned. As a result, when the left ventricle 3 of the heart contracts, the mitral valve 1 cannot be completely closed, causing blood to flow back from the left ventricle 3 to the left atrium 2, thereby causing a series of pathophysiological changes, called "mitral regurgitation."
[0003] There is a minimally invasive treatment procedure that uses the principle of edge-to-edge valve surgery to deliver a valve clamp to the mitral valve via an interventional catheter. The clamp then opens and closes the anterior and posterior leaflets of the mitral valve, securing them in place. This narrows the intercuspal gap and reduces mitral regurgitation. However, patients who have had a valve clamp implanted via minimally invasive surgery may experience valve stenosis or malapposition several years later due to ventricular enlargement, rheumatic mitral valve disease, inflammatory valvular disease, severe valve calcification, or clamp compression stimulating valve tissue hyperplasia, leading to recurrent regurgitation or stenosis. This necessitates a secondary repair. Before the secondary repair can be performed, the implanted valve clamp and the valve tissue secured by the clamp must be removed. However, existing valve clamps cannot be removed from the patient's body via an interventional catheter and can only be removed surgically. This procedure is costly and difficult, and some patients cannot tolerate the procedure, resulting in high risks. Summary of the Invention
[0004] In view of this, the present invention provides a recyclable valve clipper and a valve clipper recovery system. After the valve clipper is implanted in the patient's body, it can be recovered in an interventional manner through the valve clipper recovery system as needed. The surgical procedure is simple, causes little damage to the patient, and is conducive to secondary repair.
[0005] To solve the above technical problems, the present invention provides a retrievable valve clipper, comprising a main body and a retrieving portion disposed at the distal end of the main body, wherein the retrieving portion is used to connect to a capture device to retrieve the valve clipper by intervention.
[0006] The present invention also provides a valve clamp recovery system for recovering the aforementioned valve clamp, the valve clamp recovery system comprising a capture device and a cutting device, the distal end of the capture device being detachably connected to the recovery portion of the valve clamp; the cutting device being used to cut the position where the valve contacts the valve clamp to remove the valve clamp, and the capture device being capable of capturing the valve clamp.
[0007] The valve clamp and valve clamp recovery system provided by the present invention provide a recovery portion at the distal end of the valve clamp. After the valve clamp is implanted in the patient's body, it can be recovered in an interventional manner through the valve clamp recovery system as needed. The recovery process is simple, causes little damage to the patient, and is conducive to secondary repair. BRIEF DESCRIPTION OF THE DRAWINGS
[0008] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for use in the implementation. Obviously, the drawings described below are some implementations of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.
[0009] Figure 1 This is a schematic diagram of the mitral valve in its normal state.
[0010] Figure 2 This is a schematic diagram of a mitral valve disease.
[0011] Figure 3 1 is a schematic structural diagram of the valve clipper provided by the first embodiment of the present invention in a closed state.
[0012] Figure 4 yes Figure 3 Schematic diagram of the three-dimensional structure of the valve clip from another perspective.
[0013] Figure 5 yes Figure 3 Schematic diagram of the structure of the valve clip in the open state.
[0014] Figure 6 yes Figure 5 Schematic diagram of the three-dimensional structure of the connecting seat of the valve clip.
[0015] Figure 7 yes Figure 5 Schematic diagram of the connection between the proximal clip of the valve clip and the fixing seat.
[0016] Figure 8 yes Figure 7 Schematic diagram of the three-dimensional structure of the fixing seat.
[0017] Figure 9 yes Figure 3 Schematic diagram of the mitral valve after the valve clip is implanted.
[0018] Figure 10 yes Figure 9 A partial enlarged schematic diagram of part XI.
[0019] Figure 11 yes Figure 9 Schematic diagram of the mitral valve during heart contraction after the valve clip in the figure clamps the valve leaflets.
[0020] Figure 12 yes Figure 9 Schematic diagram of the mitral valve during diastole after the valve clip has clamped the leaflets.
[0021] Figure 13 Is the capture device will be with Figure 3 Schematic diagram of the valve clip connection in .
[0022] Figure 14 FIG. 1 is a schematic diagram of a valve clipper recovery system provided in one embodiment of the present invention.
[0023] Figure 15 yes Figure 14 Schematic diagram of the intervention channel in one embodiment of the valve clip retrieval system.
[0024] Figure 16 yes Figure 14 Schematic diagram of an interventional channel of another embodiment of a valve clipper retrieval system.
[0025] Figure 17 yes Figure 16 Schematic diagram of the capture device docking with the valve clipper.
[0026] Figure 18 yes Figure 16 Schematic diagram of the cutting device removing the valve clip.
[0027] Figure 19 Schematic diagram of a valve clipper and a capture device provided in a second embodiment of the present invention.
[0028] Figure 20 yes Figure 19 Schematic diagram of the structure of the connecting seat of the valve clip.
[0029] Figure 21Schematic diagram of a valve clipper and a capture device provided in a third embodiment of the present invention.
[0030] Figure 22 yes Figure 21 Schematic diagram of the structure of the connecting seat of the valve clip.
[0031] Figure 23 Schematic diagram of a valve clipper and a capture device provided in a fourth embodiment of the present invention.
[0032] Figure 24 Schematic diagram of a valve clipper and a capture device provided in a fifth embodiment of the present invention.
[0033] Figure 25 yes Figure 24 Schematic diagram of the structure of the connecting seat of the valve clip.
[0034] Figure 26 Schematic diagram of a valve clipper and a capture device provided in accordance with a sixth embodiment of the present invention.
[0035] Figure 27 Schematic diagram of a valve clipper and a capture device provided in accordance with a seventh embodiment of the present invention.
[0036] Figure 28 yes Figure 27 Schematic diagram of another embodiment of the retrieval portion of the valve clipper. 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. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without creative work are within the scope of protection of the present invention.
[0038] In the description of the present invention, it should be noted that the terms "upper," "lower," "inner," and "outer," etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings and are intended solely to facilitate and simplify the description of the present invention. They are not intended to indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation, and therefore should not be construed as limitations on the present invention. Furthermore, the terms "first," "second," etc., etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance.
[0039] In the description of the present invention, it should be noted that, unless otherwise specified or limited, the terms "mounted," "connected," and "connected" should be understood broadly. For example, they may refer to fixed connections, detachable connections, or integral connections; and they may refer to direct connections or indirect connections through an intermediary. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on the specific circumstances.
[0040] In describing the present invention, it should be noted that, 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; and the axial direction refers to the direction parallel to the line connecting the distal and proximal centers of the medical device. The above definitions are for convenience only and are not to be construed as limitations of the present invention.
[0041] See also Figures 3 to 5 The present invention provides a retrievable valve clipper 100, comprising a main body 130 and a retrieving portion 150 disposed at the distal end of the main body 130, wherein the retrieving portion 150 is used to connect with a capture device to retrieve the valve clipper 100 through an interventional manner.
[0042] In this embodiment, the main body 130 includes a distal connector 10, a push rod 20 connected to the connector 10, a fixed base 30 sleeved around the push rod 20, two proximal clips 40 and two distal clips 50 extending radially from the push rod 20, and two opposing connecting rods 60. Specifically, the two proximal clips 40 and the two distal clips 50 are symmetrically arranged about the axis of the push rod 20, with the proximal clips 40 corresponding to the distal clips 50. One end of the proximal clip 40 is fixedly connected to the fixed base 30 and disposed between the distal clip 50 and the fixed base 30. The other end of the proximal clip 40, which is opposite to the distal clip 50, can move toward the distal clip 50 due to its own elastic force, forming a valve-accommodating space 45 between the corresponding proximal clips 40 and distal clips 50. One end of the distal clip 50 is rotatably connected to the fixed base 30, and the distal clip 50 is movably connected to the connector 10 via a connecting rod 60. When the push rod 20 moves axially relative to the fixing seat 30, the connecting seat 10 moves relative to the fixing seat 30. Under the pull of the connecting rod 60, the distal clip 50 opens and closes relative to the fixing seat 30. When the proximal clip 40 fixed on the fixing seat 30 moves closer to the distal clip 50, it can cooperate with the distal clip 50 to clamp the valve located in the valve accommodating space 45.
[0043] Specifically, the proximal end of the valve clipper 100 is detachably connected to a corresponding pushing device, and the valve clipper 100 can be pushed to the patient's mitral valve through the pushing device. Then, the valve clipper 100 is operated remotely to clamp the anterior and posterior leaflets of the mitral valve together. Once the leaflets of the mitral valve are aligned edge to edge, the operator can release the connection between the pushing device and the valve clipper 100, so that the valve clipper 100 is released from the distal end of the pushing device and remains in the patient's body as an implant, thereby alleviating or treating "mitral regurgitation".
[0044] Among them, the pushing device includes an adjustment line for controlling the release of the proximal clip 40, a pushing assembly for driving the push rod 20 to move axially and for detachably connecting with the valve clamp 100, and an operating handle connected to the proximal end of the pushing assembly, which will not be repeated here.
[0045] To ensure safety after implantation, both the proximal clip 40 and the distal clip 50 are made of biocompatible metal materials, selected from commonly used implantable metal materials such as stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy, or nickel-titanium alloy. Specifically, the proximal clip 40 is made of an elastic material with shape memory, while the distal clip 50 is made of a rigid material to ensure that the two can work together to clamp and secure the valve. In this embodiment, the proximal clip 40 is made of a superelastic nickel-titanium alloy, while the distal clip 50 is made of stainless steel or a cobalt-chromium alloy with a relatively high hardness.
[0046] In the present invention, a recovery portion 150 is provided at the distal end of the main body 130 of the valve clipper 100. After the valve clipper 100 is implanted in the patient's body, the recovery portion 150 can be connected to a capture device according to the patient's condition or the need for secondary repair, thereby recovering the valve clipper 100 in an interventional manner. The recovery process is simple, causes little damage to the patient, and is conducive to secondary repair.
[0047] For details, please refer to Figure 5 and Figure 6, the connecting seat 10 and the push rod 20 can be an integral structure or a non-integrated structure. In the present embodiment, the connecting seat 10 and the push rod 20 are non-integrated structures. In the present embodiment, the push rod 20 is a round rod, the distal end of the push rod 20 is provided with an external thread, and the push rod 20 is screwed and fixed to the connecting seat 10. In other embodiments, the push rod 20 can be connected to the connecting seat 10 by other detachable or non-detachable connection methods such as snap-fit. In the present embodiment, the connecting seat 10 includes two opposite first surfaces 11 and two connecting surfaces connecting the two first surfaces 11, the two connecting surfaces include a second surface 12 located at the distal end and a third surface 13 located at the proximal end and smoothly transitioned to the second surface 12, wherein the first surface 11 and the third surface 13 are planes, and the second surface 12 is a curved surface. Pin holes 14 are respectively provided at the opposite ends of the connecting seat 10, which pass through the two first surfaces 11 and are used to connect the connecting rod 60. A connecting hole 15 for connecting to the push rod 20 is provided in the central axial direction of the third surface 13 of the connecting seat 10, and an internal thread corresponding to the external thread at the far end of the push rod 20 is provided in the connecting hole 15.
[0048] Among them, the cross-sectional dimension of the connecting seat 10 parallel to the third surface 13 gradually decreases from the proximal end to the distal end, that is, the shape of the connecting seat 10 can be a hemisphere, a spherical crown, a bullet-shaped structure, etc., so that the valve clipper 100 is easier to push into the patient's body.
[0049] The outer surfaces of the connecting seat 10 and the push rod 20 are smooth to avoid damaging the valve or hooking the chordae tendineae.
[0050] The connecting seat 10 and the push rod 20 are made of biocompatible materials such as polyester, silicone resin, stainless steel, cobalt alloy, cobalt-chromium alloy or titanium alloy, preferably stainless steel or cobalt-chromium alloy.
[0051] Please also refer to Figure 5 、 Figure 7 and Figure 8 The fixed base 30 includes a first base body 31 and a second base body 32 connected to the distal end of the first base body 31. Specifically, the first base body 31 and the second base body 32 are transitionally connected by a third base body 33. The first base body 31, the second base body 32, and the third base body 33 can be an integral structure or a non-integrated structure. In this embodiment, the first base body 31, the second base body 32, and the third base body 33 are an integral structure.
[0052] When the cam 33 is in the closed position, the cam 33 is in the closed position, and the cam 33 is in the open position, so that the cam 33 is in the closed position.
[0053] Furthermore, the fixing seat 30 is provided with a through-hole 35 axially extending through the first seat body 31, the second seat body 32, and the third seat body 33. When the fixing seat 30 is sleeved on the outside of the push rod 20, the push rod 20 is received in the through-hole 35. When the push rod 20 is received in the through-hole 35, the push rod 20 passes through the steel sheet 343 and the deformable spring piece 345 disposed in the accommodating cavity 34. The steel sheet 343 and the deformable spring piece 345 are provided with corresponding through-holes, the area of which is slightly larger than the cross-sectional area of the push rod 20.
[0054] It can be understood that the push rod 20 passes through the steel sheet 343 and the deformable spring sheet 345. Under the elastic force of the deformable spring sheet 345, the steel sheet 343 tilts and forms a certain angle with the push rod 20 and contacts the edge of the through hole. When there is a tendency of relative movement between the push rod 20 and the fixing seat 30, the steel sheet 343 generates friction to prevent the push rod 20 from moving relative to the fixing seat 30.
[0055] Among them, in order to ensure safety after implantation, the fixing seat 30 is made of biocompatible metal material, and the metal material is selected from commonly used implantation metal materials such as stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy or nickel-titanium alloy, preferably stainless steel or cobalt-chromium alloy with higher hardness.
[0056] The steel sheet 343 and the deformable spring piece 345 are also made of biocompatible materials. The steel sheet 343 is preferably made of stainless steel or cobalt-chromium alloy with high hardness, and the deformable spring piece 345 is made of elastic nickel-titanium alloy.
[0057] It is understandable that only one embodiment of the fixing base 30 is provided here. In fact, the fixing base 30 may also have other structures, which will not be described in detail here.
[0058] Further, such as Figure 8As shown in FIG, control members 36 are provided on opposite sides of the fixing base 30. The control members 36 are metal wires made of nickel-titanium alloy or the like. The control members 36 are attached to the fixing base 30, and the distal end of the control member 36 is bent toward the axis of the fixing base 30 and received within the accommodating cavity 34. Specifically, the distal end of the control member 36 has two branches, one of which abuts the distal end plane of the boss 341, and the other abuts the distal end surface of the steel sheet 343 and is close to the end of the steel sheet 343 away from the boss 341. When the control member 36 is pulled toward the proximal direction to abut the branch on the distal surface of the steel sheet 343, the branch can drive the steel sheet 343 to move away from one end of the boss 341 with the end of the steel sheet 343 abutting on the inclined surface of the boss 341 as the support point and rotate toward the proximal direction until the steel sheet 343 is 90 degrees to the axis of the push rod 20. At this time, the through hole of the steel sheet 343 is coaxial with the axis of the push rod 20, the connection locking state between the push rod 20 and the fixing seat 30 is released, and the push rod 20 can move axially.
[0059] The two control members 36 disposed on opposite sides of the fixing base 30 may be an integral structure or a non-integrated structure. In this embodiment, the two control members 36 are an integral structure, specifically, they may be formed by a single metal wire passing through the bottom of the accommodating cavity 34 and then being bent.
[0060] Please also refer to Figure 5 and Figure 7 The proximal clip 40 includes a connecting end 41 and a free end 42 disposed opposite each other, with the connecting end 41 being fixed to the fixing base 30. In this embodiment, the connecting ends 41 of the two proximal clips 40 are connected as a whole via a connecting frame 43. The connecting frame 43 defines a through hole for the push rod 20 to pass through. Opposite sides of the connecting frame 43 also define rectangular holes for the protrusions 321 on the second base 32 to pass through. The connecting frame 43 is sleeved onto the second base 32 and the third base 33 to secure the connecting ends 41 of the two proximal clips 40 relative to the fixing base 30. In other embodiments, the connecting ends 41 of the proximal clips 40 can be directly fixed to the fixing base 30 by welding or other connection methods.
[0061] The proximal clip 40 is at least partially made of an elastic material with shape memory and undergoes heat setting. In its natural state, the proximal clip 40 is in an unfolded U-shape, i.e., the proximal clip 40 is angled relative to the retaining seat 30 to facilitate cooperation with the distal clip 50 to clamp the valve. The angle between the two extension directions of the proximal clip 40 ranges from 0 to 200 degrees. In this embodiment, the proximal clip 40 is cut from nickel-titanium alloy and placed in a shaping mold. The shaping mold is then placed in an electrically heated circulating air box furnace and subjected to a shaping heat treatment at 300-650°C. The proximal clip 40 is then removed and quickly cooled in purified water. The shaping mold is then removed to obtain the shaped proximal clip 40. In this embodiment, the proximal clip 40 is entirely made of superelastic nickel-titanium alloy, which provides the proximal clip 40 with a spring force that drives it toward the distal clip 50 to clamp the valve. In addition, in this embodiment, the connecting frame 43 is also made of elastic nickel-titanium alloy, so that the connecting frame 43 can be easily sleeved on the second base body 32 and the third base body 33 .
[0062] In other embodiments, the connecting end 41 of the proximal clip 40 is made of elastic material, and the free end 42 of the proximal clip 40 can be made of non-elastic material such as aluminum alloy. The elastic force of the connecting end 41 drives the proximal clip 40 to move closer to the distal clip 50.
[0063] It should be noted that the free end 42 of the proximal clip 40 extending outward and radiating toward the proximal end relative to the push rod 20 can be controlled by an adjustment line. In the conveying state, the free end 42 of the proximal clip 40 is tightened by the adjustment line and fits against the surface of the fixing seat 30. After the control of the adjustment line on the free end 42 is released, the proximal clip 40 rebounds due to its own elastic memory properties, and the proximal clip 40 returns to its natural state and presses the valve toward the distal clip 50. Preferably, the angle between the two side extension directions of the proximal clip 40 in the naturally expanded state should be slightly larger than the angle between the two distal clips 50 to provide a more stable clamping force, that is, the angle between the extension direction of each side of the proximal clip 40 and the fixing seat 30 is greater than or equal to the angle between the distal clip 50 and the fixing seat 30 when the distal clip 50 corresponding to that side is opened to the maximum state, thereby ensuring that there is a certain clamping force between the distal clip 50 and the proximal clip 40 to clamp the valve located between the distal clip 50 and the proximal clip 40.
[0064] Furthermore, the proximal clip 40 includes a first surface facing the valve-receiving space 45. A gripping reinforcement is provided on the first surface to increase friction between the proximal clip 40 and the valve held within the valve-receiving space 45, thereby enhancing the gripping force of the valve clip 100 on the valve. Specifically, in this embodiment, the gripping reinforcement comprises two rows of barbs 46 spaced apart on opposite sides of the first surface. The barbs 46 can be integrally formed on the proximal clip 40, or they can be formed from the same or different material as the proximal clip 40 and then attached to the first surface of the proximal clip 40. For example, a nickel-titanium wire or rod can be secured to the first surface via a sleeve. The base of the barbs 46 is connected to the proximal clip 40, and the end of the barbs 46 opposite the base is a free end. In the naturally deployed state, the free end of the barbs 46 faces the distal clip 50. The angle between the extension direction of the barbs 46 and the first surface is less than or equal to 90 degrees, so as to enhance the clamping force of the valve clip 100 on the valve. Furthermore, the free end of each barb 46 is a smooth arc surface to avoid damaging the valve tissue.
[0065] In other embodiments, the number of barbs 46 may be 1, 2, or other reasonable numbers.
[0066] In other embodiments, the clamping reinforcement may be a ridge, a boss or other irregularly distributed protrusions protruding from the first surface, or a rough surface at least partially covering the first surface to increase the clamping force on the valve.
[0067] Among them, multiple openings are opened on the proximal clip 40 to reduce the weight of the proximal clip 40, to prevent the overweight valve clamp 100 from falling under the leaflet for a long time and causing slippage or damage to the leaflet, and at the same time it is also beneficial for endothelial cells to crawl and grow.
[0068] See also Figure 5 The distal clip 50 includes a connecting segment 51 at the distal end and a clamping segment 52 connected to the proximal end of the connecting segment 51. The distal end of the connecting segment 51 is rotatably connected to the connecting block 331 of the fixing base 30. The proximal end of the connecting segment 51 is rotatably connected to the proximal end of the connecting rod 60 on the corresponding side. The distal end of the connecting rod 60 is rotatably connected to the connecting base 10. In this embodiment, the rotatable connection is achieved by corresponding rotating pins. Obviously, in other embodiments, the rotating pins can be replaced by bolts.
[0069] As mentioned above, by pulling the control part 36 against the branch on the distal surface of the steel sheet 343, the steel sheet 343 can be driven to rotate in the proximal direction with one end of the steel sheet 343 abutting against the inclined surface of the boss 341 as the support point until the steel sheet 343 is 90 degrees to the axis of the push rod 20. The connection locking state between the push rod 20 and the fixing seat 30 is released, and the push rod 20 can move axially relative to the fixing seat 30. As a result, the fixing seat 30 and the connecting seat 10 move relative to each other. Under the pulling of the connecting rod 60, the distal clip 50 can rotate around the rotating pin on the connecting block 331 and open and close relative to the fixing seat 30. When the proximal clip 40 is released and freely unfolded due to its own elastic memory function, the proximal clip 40 can move closer to the distal clip 50 to clamp the valve in the valve accommodating space 45. Furthermore, after the proximal clip 40 and the distal clip 50 clamp the valve, the connecting seat 10 moves axially toward the proximal direction until the valve clamp 100 is in a folded state, and then releases the control part 36 to control the end of the steel sheet 343 away from the boss 341. Under the elastic force of the deformed spring piece 345, the steel sheet 343 contacts the push rod 20 and forms a certain angle. The connection between the push rod 20 and the fixing seat 30 is locked to prevent the distal clip 50 from opening relative to the fixing seat 30, and the valve clamp 100 in the folded state falls below the leaflet.
[0070] Preferably, a structure similar to the clamping reinforcement of the proximal clip 40 may also be provided on the second surface of the distal clip 50 facing the valve accommodating space 45 , or active drugs may be applied or multiple openings may be provided.
[0071] Preferably, the second surface is curved to increase the contact and clamping area between the distal clip 50 and the valve, thereby providing a stable clamping force. Furthermore, the curved second surface forms a receiving groove. When the proximal clip 40 moves toward the distal clip 50, the barbs 46 on the first surface of the proximal clip 40 can be received in the receiving groove, thereby compressing the valve within the leaflet-accommodating space 45. This also minimizes the collapsed volume of the valve clip 100, facilitating in-vivo delivery.
[0072] It should be noted that to ensure a stable clamping force and to correspond to the size of the valve leaflets, the distal clip 50 has certain size requirements. Specifically, the length of the distal clip 50 must be within a certain range. If the distal clip 50 is too long, it is easy for the distal clip 50 to clamp too much of the anterior and posterior leaflets together. When the valve clip 100 is closed, the two leaflets are forcibly pulled toward each other and fixed together. During heartbeat and leaflet movement, the excessive leaflet movement is restricted, which can not only easily lead to mitral valve dysfunction, but also cause serious consequences such as leaflet tearing. If the distal clip 50 is too short, the valve clip 100 can only clamp a small portion of the leaflets, making it easy for the leaflets to slip out, resulting in poor clamping and fixing effect. In this embodiment of the present invention, the axial length of the distal clip 50, that is, the distance from the connecting section 51 to the clamping section 52, should be greater than or equal to 4 mm, preferably 6-10 mm. Furthermore, the width of the distal clip 50 is also limited to prevent damage to the valve leaflets caused by an excessively narrow distal clip 50. Furthermore, the clip 50 is also limited to prevent the valve clip 100 from affecting the movement of the valve leaflets if the distal clip 50 is too wide. The width of the distal clip 50, i.e., the length perpendicular to the axial direction of the distal clip 50, should be greater than or equal to 2 mm, preferably 4-6 mm.
[0073] The valve clipper 100 provided in this embodiment can be used to alleviate or treat "mitral regurgitation". For details, please refer to Figures 9 to 12 The valve clipper 100 is placed at the position where the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve cannot be normally coapted, so that one distal clip 50 and one side of the proximal clip 40 clamp the edge of the anterior leaflet 1a of the mitral valve, and the other distal clip 50 and one side of the proximal clip 40 clamp the edge of the posterior leaflet 1b of the mitral valve, so as to clamp the position where the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve cannot be normally coapted together. Figure 11 and Figure 12 The arrows in the figure indicate the direction of blood flow. Figure 11 As shown in , when the heart contracts, the anterior leaflet 1a and the posterior leaflet 1b close together, and the parts where the anterior leaflet 1a and the posterior leaflet 1b cannot close normally are partially or completely closed together, and the area A of the mitral valve opening becomes smaller or the mitral valve can be completely closed, and only a small amount of blood flows back from the mitral valve opening into the left atrium, thereby alleviating or treating "mitral regurgitation". Figure 12 As shown in FIG, when the heart is in diastole, the anterior leaflet 1a and the posterior leaflet 1b are only clamped together at position B of the valve clamp 100, while the other positions of the anterior leaflet 1a and the posterior leaflet 1b are still in normal diastole, allowing blood to flow from the left atrium into the left ventricle, thereby ensuring normal blood circulation.
[0074] Please also refer to Figure 3 and Figure 13In the present invention, in order to facilitate secondary repair of the mitral valve, a retrieval portion 150 is provided at the distal end of the main body 130 of the valve clipper 100, and the retrieval portion 150 is used to connect with the capture device 210 to retrieve the valve clipper 100 through intervention.
[0075] In this embodiment, a retraction portion 150 is provided at the distal end of each connecting rod 60. The retraction portion 150 is a groove formed on the outer side of each connecting rod 60. Specifically, the connecting rod 60 includes a connecting portion 62 rotatably connected to the distal clip 50, an extension bar 64 extending obliquely from the distal end of the connecting portion 62 toward the centerline of the valve clip 100, and a protrusion 66 disposed on the outer side of the distal end of the extension bar 64. The extension bar 64 and the protrusion 66 form the groove. Specifically, the groove is located at the distal end of the outer side of the connecting rod 60. The distance from the proximal surface of the groove to the centerline of the valve clip 100 is greater than the distance from the distal surface of the groove to the centerline of the valve clip 100, thereby forming a groove with its distal end inclined toward the centerline of the valve clip 100.
[0076] like Figure 13 As shown in FIG, the capture device 210 includes a capture catheter 212 having a certain axial length and a capture device 214 disposed at the distal end of the capture catheter 212. The capture device 214 is configured to be detachably connected to the retrieval unit 150 to capture the valve clip 100. Specifically, in this embodiment, the capture device 214 is a gooseneck snare. By fitting the gooseneck snare onto the grooves of two opposing connecting rods 60, the retrieval unit 150 is connected to the capture device 210, thereby capturing the valve clip 100. Once the valve clip 100 is removed from the valve, it can be retrieved.
[0077] In order to ensure that the gooseneck snare can be stably sheathed in the groove without falling off, preferably, the ratio of the minimum outer diameter of the valve clip 100 at the groove to the outer diameter of the distal end of the valve clip 100 adjacent to the groove is in the range of 0.5-0.95.
[0078] In other embodiments, the recovery portion 150 may be a protrusion protruding from the outer side of each connecting rod 60. Specifically, the distance that the protrusion protrudes outward from the outer side of the connecting rod 60 gradually decreases from the proximal end to the distal end. The gooseneck snare of the capture device 210 is sheathed on the protrusions of the two opposing connecting rods 60 and connected to the recovery portion 150. Similarly, to ensure that the gooseneck snare is stably sheathed in the groove and does not fall off, the ratio of the maximum outer diameter of the valve clipper 100 at the protrusion to the outer diameter of the proximal portion of the valve clipper 100 adjacent to the protrusion is preferably in the range of 1.05-1.25.
[0079] For further information, see Figure 3 and Figure 4The valve clipper 100 also includes an isolation portion 170, which is arranged between the main body 130 and the recovery portion 150. An anti-cell proliferation drug coating or an isolation layer is applied to at least a portion of the recovery portion 150 and the isolation portion 170 to prevent the recovery portion 150 from being completely covered by endothelial cells, thereby ensuring that the capture device 210 can be connected to the recovery portion 150 to facilitate the recovery of the valve clipper 100.
[0080] Specifically, in this embodiment, the isolation portion 170 is disposed on the outer side surface and two opposing side surfaces of each connecting rod 60 adjacent to the proximal end of the recovery portion 150, i.e., the distal end of the connecting portion 62 adjacent to the extension strip 64. The entire area of the isolation portion 170 is coated with an anti-cell proliferation drug selected from at least one of rapamycin and its derivatives, and paclitaxel and its derivatives.
[0081] The isolation portion 170 extends along the axial direction and covers a range of 5-10 mm.
[0082] In other embodiments, the entire area of the isolation portion 170 can be covered with an isolation layer to prevent endothelial growth, wherein the isolation layer is a sleeve or coating made of a biocompatible polymer material, and the polymer material is selected from at least one of PET, polyester, silicone, PTFE, silicone or urethane.
[0083] In other embodiments, the isolation portion 170 may be coated with an anti-cell proliferation drug coating or an isolation layer only in a partial area. For example, the anti-cell proliferation drug coating or the isolation layer may be applied only in a partial area of the isolation portion 170 located on the outer side surface of each connecting rod 60 adjacent to the proximal end of the recovery portion 150, as long as the endothelial cells can be prevented from completely crawling over the recovery portion 150.
[0084] In other embodiments, the recovery portion 150 may also be coated with an anti-cell proliferation drug coating or an isolation layer to prevent endothelial cells from completely covering the recovery portion 150 .
[0085] In other embodiments, the portion of the connecting seat 10 of the valve clip 100 adjacent to the distal end of the retrieving portion 150 may also be configured as the isolation portion 170 .
[0086] It is understood that the thickness of the anti-cell proliferation drug coating or the isolation layer should avoid affecting the overall outer diameter of the valve clip 100 to facilitate the delivery of the valve clip 100 in the patient's body.
[0087] Please also refer to Figure 13 and Figure 14The present invention also provides a valve clip retrieval system 200 for retrieving the aforementioned valve clip 100. Specifically, the valve clip retrieval system 200 includes a capture device 210 and a cutting device 230. The cutting device 230 is used to cut the contact area between the valve and the valve clip 100 to remove the valve clip 100. As previously described, the capture device 210 is detachably connected to the retrieval portion 150 of the valve clip 100 via a distal capture device 214 to capture the valve clip 100. Specifically, in this embodiment, the capture device 214 is a gooseneck snare. The retrieval portion 150 of the valve clip 100 is a groove provided on the outer surface of each connecting rod 60. The gooseneck snare is inserted into the groove to capture the valve clip 100. In other embodiments, the capture device 214 may be a trilobate snare, a vascular foreign body capturer, a ligation device, a claw, a magnetic connector, or other forms.
[0088] The cutting device 230 uses at least one of mechanical cutting and electric knife cutting. The electric knife is selected from at least one of radio frequency electric knife, high frequency electric knife, ultrasonic scalpel, plasma scalpel, laser scalpel or low temperature freezing scalpel.
[0089] Mechanical cutting refers to direct cutting using surgical instruments, such as a pair of scissors or separate lancets or biopsy forceps. In this embodiment, mechanical cutting is employed. The distal end of the cutting device 230 is provided with two opposing blades 231. Blades 231 are made of metal and are developable, facilitating real-time observation and cutting of the valve by the operator.
[0090] In other embodiments, a conductive portion may be circumferentially provided on the outer peripheral surface of the distal end of the cutting device 230, and the conductive portion conducts electricity on the surface in contact with the valve to enable electric knife cutting of the valve. Specifically, taking the radio frequency electric knife as an example, the conductive portion includes exposed metal or metal electrodes. In order to ensure safety, the outer surface of the remaining parts of the cutting device 230 except the conductive portion is insulated, and the insulation method may be coating an insulating coating or providing an insulator. In order to further ensure safety, when using the electric knife cutting method, the cutting device 230 may also be provided with a temperature sensor electrically connected to the conductive portion, and the temperature sensor is in contact with the valve to indicate the local temperature of the part of the valve in contact with the conductive portion, thereby preventing the local temperature of the valve from being too high and causing damage.
[0091] Preferably, at least one developing portion is provided at the distal end of the cutting device 230 , and the operator can adjust the distal end position of the cutting device 230 according to the position of the developing portion, thereby accurately cutting the position where the valve contacts the valve clip 100 .
[0092] The developing unit can be in the form of a developing wire, developing dots, or developing film. It is made of a corrosion-resistant and biocompatible developing material, such as gold, platinum, tantalum, osmium, rhenium, tungsten, iridium, rhodium, or alloys or composites of these metals. In this embodiment, the developing unit is a nickel-titanium alloy sheet containing tantalum, which is attached to the distal end of the cutting device 230.
[0093] like Figure 14 As shown in , the valve clip retrieval system 200 further includes a removal device 250, which is used to remove the resected valve clip 100 from the patient's body. Specifically, the removal device 250 includes a positioning member 251, which is movably disposed at the distal end of the removal device 250. The positioning member 251 comprises a radially contractible and expandable elastic frame. When the positioning member 251 extends from the distal end of the removal device 250, the elastic frame expands and unfolds to support the valve below, thereby reducing the pulsation amplitude of the valve, thereby facilitating the removal of the valve by the resection device 230. Furthermore, the positioning member 251 can be used to accommodate the resected valve clip 100 and allow the valve clip 100 to be accommodated in the removal device 250 along with the positioning member 251.
[0094] The radial dimension of the elastic frame of the positioning member 251 gradually decreases from the distal opening to the proximal end, that is, the positioning member 251 is cup-shaped, cage-shaped or funnel-shaped. In this embodiment, the positioning member 251 is cup-shaped.
[0095] Furthermore, an adjustment mechanism is provided at the distal opening of the positioning member 251. The adjustment mechanism includes at least one control wire, which is used to adjust the radial size of the distal opening of the positioning member 251. Specifically, the control wires simultaneously pass through different circumferential positions of the distal end of the positioning member 251. By controlling the length of the control wires passing through different circumferential positions of the positioning member 251, the size of the distal opening of the positioning member 251 can be adjusted. As a result, when the resected valve clip 100 and valve tissue fall into the cup-shaped positioning member 251, the operator can tighten the control wires to tighten the distal opening of the positioning member 251, thereby enclosing the valve clip 100 and preventing it from falling out, thereby facilitating its recovery.
[0096] It should be noted that the capture device 210 is movably arranged in the removal device 250 and can be extended from the distal opening of the positioning member 251 to capture the valve clamp 100. After capturing the valve clamp 100, the capture device 210 is retracted into the removal device 250. At this time, the distal opening of the positioning member 251 is tightened to prevent the valve clamp 100 from falling off.
[0097] Further, such as Figure 14As shown in the figure, the valve clipper recovery system 200 also includes a guide device 270 and an adjustable curved sheath tube 290. The guide device 270 can be movably set in the adjustable curved sheath tube 290 and can also be used alternately in sequence. The guide device 270 and the adjustable curved sheath tube 290 are used to establish an interventional channel from outside the patient's body to inside the body.
[0098] The guide device 270 includes a puncture guidewire (not shown) and a conical dilator. Once a channel is established and the puncture guidewire reaches the vicinity of the valve, the operator can direct the distal end of the puncture guidewire into the left atrium, past the valve clip 100, and extend it outward from the patient's body. The puncture guidewire then applies tension to the valve clip 100, reducing its fluctuations and facilitating connection between the capture device 210 and the retrieving portion 150 of the valve clip 100.
[0099] Among them, the adjustable curved sheath tube 290, the dilator and the puncture guide wire are similar in structure to the existing adjustable curved sheath tube, the dilator and the puncture guide wire, and are not described in detail here.
[0100] It is understood that at least one of the capture device 210, the cutting device 230 and the removal device 250 can be delivered to the patient's mitral valve through the corresponding intervention channel by using the adjustable curved sheath tube 290 of corresponding specifications. Figure 15 and Figure 16 , which illustrates different intervention channels of the valve clipper recovery system 200 of the present invention. Figure 15 As shown in FIG, in this embodiment, the capture device 210 is placed in the removal device 250 and reaches the mitral valve through the path of the apex-left ventricle through the adjustable bend sheath tube 290a, while the resection device 230 reaches the mitral valve through the path of the femoral vein-right atrium-atrial septum-left atrium-mitral valve through the adjustable bend sheath tube 290b. Figure 16 As shown in , in other embodiments, the capture device 210 and the removal device 250 can reach the mitral valve through the adjustable bend sheath 290a via the femoral artery-aortic arch-aortic valve-left ventricle path, and the resection device 230 can reach the mitral valve through the adjustable bend sheath 290b via the jugular vein-atrial septum-left atrium path.
[0101] Of course, in other embodiments, the capturing device 210, the cutting device 230, and the removing device 250 may take the same path to reach the mitral valve, thereby avoiding damage to the patient caused by multiple punctures.
[0102] Preferably, in some embodiments, the valve clip retrieval system 200 further includes a detection device, which is movably disposed within the adjustable sheath 290 and can extend from the distal end of the adjustable sheath 290 and into the left atrium to provide real-time feedback on intracardiac pressure, thereby promptly confirming the presence of mitral regurgitation and determining whether resection is complete. Specifically, the detection device can be a pressure sensor.
[0103] The following uses the recovery process of the valve clipper 100 of the first embodiment of the present invention as an example to illustrate the steps of using the valve clipper recovery system 200 provided by the present invention. Figures 16 to 18 As shown:
[0104] Step 1: Use the guide device 270 and the corresponding adjustable curved sheath 290 to establish an interventional pathway for the retrieval device (i.e., the capture device 210 and the removal device 250) and the cutting device 230. The retrieval device's interventional pathway is through the aortic arch into the left ventricle, while the cutting device 230's interventional pathway is through the atrial septum into the left atrium.
[0105] Step 2: withdraw the guide device 270, push the removal device 250 and the capture device 210 that are installed together into the left ventricle through the adjustable curved sheath tube 290a, and push the cutting device 230 into the left atrium through the adjustable curved sheath tube 290b. Figure 16 As shown in;
[0106] Step 3: The capturer 214 at the distal end of the capture device 210 docks with the retrieving portion 150 of the valve clip 100 to capture the valve clip 100 and maintain the capture state, such as Figure 17 As shown in;
[0107] Step 4: Use the two blades 231 of the cutting device 230 to cut the attachment points of the valve clip 100 on the anterior leaflet and the posterior leaflet, thereby removing the valve clip 100 from the valve. Figure 18 As shown in;
[0108] Step 5: Retract the capturing device 210 into the removing device 250 to receive the removed valve clip 100 into the removing device 250;
[0109] Step 6: withdraw the cutting device 230, the removal device 250, the capture device 210 housed in the removal device 250, and the valve clipper 100 through the corresponding adjustable curved sheath tube 290; finally, withdraw the adjustable curved sheath tube 290 to complete the operation.
[0110] Optionally, after the first step is completed, the distal end of the puncture guidewire of the guide device 270 can be passed over the valve clip 100 and extended back out of the patient's body. This allows the puncture guidewire to exert tension on the valve clip 100, reducing the amplitude of the valve clip 100's fluctuations due to leaflet pulsation, thereby facilitating the docking of the capture device 210 with the retractor 150 of the valve clip 100.
[0111] After the fifth step is completed, the operator can temporarily leave the adjustable sheath 290 in the patient's body after withdrawing the cutting device 230, the removal device 250, the capture device 210 and the valve clamp 100, so as to perform a secondary interventional repair surgery through the interventional channel, such as implanting an artificial heart valve.
[0112] It should be noted that the capture device 210, cutting device 230, removal device 250, guide device 270 and adjustable bending sheath 290 respectively have operating handles close to the operator. The operator controls the corresponding device through the corresponding operating handles to achieve capture, cutting, bending and other actions. The details will not be repeated here.
[0113] Please also refer to Figure 19 and Figure 20 The structure of the valve clipper 100b provided in the second embodiment of the present invention is similar to that of the valve clipper 100 in the first embodiment, except that in the second embodiment, the retrieval portion 150b is disposed on the connecting seat 10b. Specifically, the retrieval portion 150b is at least one hook protruding from at least one first surface 11 of the connecting seat 10b. In this embodiment, a hook is protruding from each first surface 11 of the connecting seat 10b. When retrieving the valve clipper 100b, depending on the position of the valve clipper 100b and the extent of endothelial coverage, the operator can attach the capturer 214 of the capture device 210 to one hook for unilateral capture, or to two hooks for simultaneous bilateral capture. In this embodiment, the capturer 214 is a gooseneck snare.
[0114] Wherein, the shape of the hook includes but is not limited to a right-angle hook, a semicircular ring hook, etc. In the present embodiment, the hook is a right-angle hook.
[0115] The hook and the connecting base 10b can be an integral structure or a non-integrated structure. In this embodiment, the hook and the connecting base 10b are integrally formed. In other embodiments, the hook can be formed separately and fixed to the first surface 11 of the connecting base 10b by welding or other methods.
[0116] Furthermore, in this embodiment, the two hooks are symmetrically arranged about the central axis of the connecting base 10b. When the snare of the capture device 210 is attached to the two hooks, the capture force on the valve adapter 100b is always directed along its center of mass, making it easier for the valve adapter 100b to enter the removal device, thereby improving surgical efficiency.
[0117] It is understandable that the outward protrusion distance of the hook relative to the first surface 11 of the connecting seat 10b should avoid affecting the overall outer diameter of the valve clipper 100b, so as to facilitate delivery within the patient's body.
[0118] Furthermore, unlike the first embodiment, in the second embodiment, the isolation portion 170b of the valve clipper 100b is disposed on the connecting seat 10b. Specifically, the isolation portion 170b may be disposed only on the first surface 11 of the connecting seat 10b, or may be disposed throughout the entire connecting seat 10b. That is, the isolation portion 170b may be disposed at least on the portion of the connecting seat 10b adjacent to the hook. In this embodiment, the isolation portion 170b is disposed on the entire outer surface of the connecting seat 10b.
[0119] Please also refer to Figure 21 and Figure 22 The structure of the valve clipper 100c provided in the third embodiment of the present invention is similar to that of the valve clipper 100b of the second embodiment, except that in the third embodiment, the retrieving portion 150c is a through-hole formed in the connecting seat 10c and extending through the two first surfaces 11. In this embodiment, the capture members 214c of the capture device 210c are a pair of claws, which are inserted into the two ends of the through-hole to retrieve the valve clipper 100c. Preferably, the through-hole is located in the middle of the connecting seat 10c so that the capture force applied to the valve clipper 100c is always directed at its center of mass, making it easier for the valve clipper 100c to be inserted into the removal device, thereby improving surgical efficiency. Furthermore, the through-hole in this embodiment reduces the weight of the valve clipper 100c, preventing the excessive weight of the valve clipper 100c from being left under the valve for an extended period of time and causing damage to the valve.
[0120] In order to reduce the outer diameter of the capture device 210c, the proximal ends of a pair of claws are staggered.
[0121] It is understood that in other embodiments, the retrieval portion 150c may be at least one blind hole defined on at least one first surface 11 of the connector 10c, into which the claws of the capture device 210c are inserted to retrieve the valve clip 100c. Preferably, a blind hole is defined on each of the two opposing first surfaces 11 of the connector 10c, and the two blind holes are symmetrically arranged about the central axis of the connector 10c, so that the capture force applied to the valve clip 100c is always directed along its center of mass. Furthermore, an auxiliary component may be provided within the blind hole to assist in connecting the claws of the capture device 210c. Specifically, the auxiliary component may be a magnetic sheet that attracts the claws to prevent them from falling out of the blind hole.
[0122] See also Figure 23 The structure of the valve clipper 100d provided in the fourth embodiment of the present invention is similar to that of the valve clipper 100b in the second embodiment, except that in the fourth embodiment, the retrieval portion 150d is at least one barb or at least one ring disposed on the second surface 12 of the connector 10d. In this embodiment, the retrieval portion 150d is a barb protruding outward from the second surface 12, and the capture portion 214d of the capture device 210d is a catch ring. The valve clipper 100d is retrieved by hooking the catch ring of the capture device 210d onto the barb.
[0123] The shape of the barb includes but is not limited to a right-angle hook, a semicircular hook, etc. In this embodiment, the barb is a semicircular hook.
[0124] Among them, the barb is set at the axial position of the valve clamp 100d. When the capture ring of the capture device 210d is hooked on the barb, the capture force exerted on the valve clamp 100d is always on its center of mass line, making it easier for the valve clamp 100d to enter the removal device, thereby improving the efficiency of the operation.
[0125] In other embodiments, two barbs may be provided, with the capture ring of the capture device 210d being hooked onto both barbs simultaneously. Thus, if the capture ring of the capture device 210d falls off one barb, it remains hooked onto the other barb, ensuring that the capture device 210d remains connected to the retraction portion 150d of the valve clip 100d. Similarly, the two barbs are symmetrically arranged about the connecting base 10d so that the capture force applied to the valve clip 100d is always directed along its center of mass.
[0126] In other embodiments, the recovery portion 150d can be at least one annular body made of biocompatible metal or polymer material, and the capturer 214d of the capture device 210d is correspondingly configured as a claw, and the valve clipper 100d is recovered by inserting the claw of the capture device 210d into at least one annular body.
[0127] Please also refer to Figure 24 and Figure 25 The structure of the valve clipper 100e provided in the fifth embodiment of the present invention is similar to that of the valve clipper 100d in the fourth embodiment, except that in the fifth embodiment, the retracting portion 150e is a connecting hole formed on the second surface 12 of the connecting base 10e, within which is disposed a connector for docking with the capture device 210e. In this embodiment, the connecting hole is a blind hole 153e formed in the middle of the second surface 12, within which is disposed a magnetic member. In this embodiment, the capture member of the capture device 210e is a magnetic conduit connector 214e. Docking the magnetic conduit connector 214e into the connecting hole allows magnetic docking of the capture device 210e with the valve clipper 100e.
[0128] The magnetic component may be a magnetic gasket disposed in the blind hole 153e.
[0129] Furthermore, to enhance connection reliability, a threaded member is provided at the center of the blind hole 153e for threaded connection with the capture device 210e. In this embodiment, the threaded member is a threaded hole 155e formed in the inner bottom of the connection hole. A threaded connector 216e is provided at the distal end of the capture device 210e, which is movably disposed within the magnetic conduit connector 214e. Once the magnetic conduit connector 214e of the capture device 210e is magnetically docked with the blind hole 153e of the connector 10e, the threaded connector 216e can be extended from the magnetic conduit connector 214e and threadedly engaged with the threaded hole 155e within the blind hole 153e, thereby threading and locking the capture device 210e to the valve clipper 100e.
[0130] In other embodiments, the threaded member can be a stud protruding from the connecting hole, and a connecting tube with an internal thread is provided at the distal end of the capture device 210e. The connecting tube is movably provided in the magnetic catheter joint and can be extended to be threadedly connected to the stud in the connecting hole.
[0131] In other embodiments, the magnetic conduit connector 214e may be disposed at the distal end of the removal device 250e, or the threaded connector 216e may be disposed at the distal end of the removal device 250e.
[0132] Of course, in other embodiments, the connection hole may only be provided with a magnetic member or a threaded member.
[0133] See also Figure 26 The structure of the valve clipper 100f provided in the sixth embodiment of the present invention is basically similar to the structure of the valve clipper 100 in the first embodiment, except that: in the sixth embodiment, a through groove for connecting with the claw 214f of the capture device 210f is provided at the distal end of the main body, and the through groove extends in a direction perpendicular to the axial direction of the valve clipper 100f, and the through groove forms a recovery portion 150f.
[0134] Specifically, in this embodiment, the connecting section 51f of each distal clip 50f is hollowed out, and the connecting section 51f of each distal clip 50f includes two connecting pieces, each connecting piece is provided with a slide groove extending from the distal end to the proximal end, and the two distal clips 50f are located on the same side of the connecting seat 10f. The two connecting pieces are stacked on each other, and the slide grooves of the two connecting pieces are connected. One end of a first pin passes through the slide grooves on the two connecting pieces on the same side of the connecting seat 10f of the two distal clips 50f in sequence, and then passes through the pin hole on the connecting seat 10f, and finally is plugged into the two distal clips 50f at the connecting seat. The two second pins pass through the pin holes on the two distal clips 50f and are inserted into the corresponding fixing holes on the fixing seat 30f, thereby rotating the proximal ends of the connecting segments 51f of the two distal clips 50f to connect them to the opposite ends of the fixing seat 30f. At this time, the connecting seat 10f, the fixing seat 30f and the two distal clips 50f are located between the two groups of connecting plates on the opposite sides of the connecting seat 10f and the fixing seat 30f, forming the through groove. The through groove passes through the opposite sides of the valve clamp 100f, and the claw 214f of the capture device 210f can be inserted into the through groove and abut against the third surface 13 of the connecting seat 10f to recover the valve clamp 100f.
[0135] Furthermore, different from the first embodiment, in the sixth embodiment, the isolation portion 170f of the valve clip 100f is disposed at the distal end of the clamping section 52f of the distal clip 50f.
[0136] See also Figure 27 The structure of the valve clipper 100g provided in the seventh embodiment of the present invention is basically similar to the structure of the valve clipper 100 of the first embodiment, except that: in the seventh embodiment, the valve clipper 100g includes two V-shaped clamping members that can be relatively overlapped, wherein the two clamping members are both fixed on the fixing seat 30g, and a recovery portion 150g is provided at the distal end of the fixing seat 30g. The capturer 214g of the capture device 210g is connected to the recovery portion 150g to recover the valve clipper 100g.
[0137] Specifically, in this embodiment, the recovery portion 150g is a groove circumferentially opened at the distal end of the fixing seat 30g, and the capture device 214g is a gooseneck snare, and the valve clipper 100g is recovered by fitting the snare into the groove.
[0138] See also Figure 28It can be understood that in other embodiments, the recovery portion 150g' can be a hook, barb or annular body protruding from the distal end of the fixing seat 30g', or a blind hole, through hole or connecting hole opened on the surface of the fixing seat 30g', which will not be repeated here.
[0139] Furthermore, unlike the first embodiment, in the seventh embodiment, the isolation portion 170g of the valve clipper 100g is provided at least on the portion of the fixing seat 30g adjacent to the recovery portion 150g. In this embodiment, the isolation portion 170g is provided on the outer surface of the entire fixing seat 30g.
[0140] It should be noted that the above description uses the example of a valve clipper used to alleviate or treat mitral regurgitation. It is understood that in other embodiments, the valve clipper can also be used to alleviate or treat tricuspid regurgitation. The principles and structure of the valve clipper are substantially similar to those of the valve clipper used to treat mitral regurgitation in the embodiments of the present invention. Multiple sets of proximal and distal clips are used to form multiple clamps, each clamping a valve leaflet. This is not further described here.
[0141] Obviously, in other embodiments, the valve clipper provided by the present invention can also be used in other minimally invasive surgical operations that require clamping three or more pieces of valve tissue together.
[0142] The above is an implementation of the embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the embodiment of the present invention. These improvements and modifications are also considered to be within the scope of protection of the present invention.
Claims
1. A recyclable valve clip, characterized in that: The valve clipper comprises a main body and a recovery portion, wherein the recovery portion is used to connect with a capture device to recover the valve clipper in an interventional manner; The main body includes a connecting seat at the distal end, a push rod connected to the connecting seat, a fixing seat sleeved on the outside of the push rod, and two distal clips radiating relative to the push rod; The fixing seat is provided with an accommodating cavity, a boss is provided on one inner wall of the accommodating cavity, a steel sheet and a deformable spring sheet abutting the proximal end surface of the steel sheet are provided in the accommodating cavity, the steel sheet is obliquely arranged in the accommodating cavity and one end abuts the proximal end of the boss, the push rod passes through the steel sheet and the deformable spring sheet, and the push rod is used to perform axial movement under the drive of the pushing assembly; the steel sheet is used to rotate in the proximal direction with one end abutting the boss as a support point under the control of the control component, so that the connection and locking state between the push rod and the fixing seat is released, the push rod moves axially relative to the fixing seat, and then the fixing seat and the connecting seat move relative to each other, and the distal clip can be opened and closed relative to the fixing seat; when the valve clipper is in the retracted state, the control of the control component on the steel sheet is released; In which, the main body also includes two relatively arranged connecting rods, each of the distal clips is rotatably connected to the fixing seat and movably connected to the connecting seat through a connecting rod, and the recovery portion is arranged at the distal end of the connecting rod or the connecting seat; or, each of the distal clips is rotatably connected to the fixing seat and movably connected to the connecting seat, and a through groove is formed between the connecting seat, the fixing seat and the two distal clips, and the through groove is used to connect with the capture device and extends in a direction perpendicular to the axial direction of the valve clamper, and the through groove forms the recovery portion.
2. The valve clipper according to claim 1, characterized in that: The recovery portion is a groove provided on the outer side surface of each of the connecting rods or a protrusion provided on the outer side surface of each of the connecting rods.
3. The valve clipper according to claim 2, characterized in that: The ratio of the minimum outer diameter of the valve clip at the groove to the outer diameter of the distal end of the valve clip adjacent to the groove is in the range of 0.5-0.95; the ratio of the maximum outer diameter of the valve clip at the protrusion to the outer diameter of the proximal end of the valve clip adjacent to the protrusion is in the range of 1.05-1.
25.
4. The valve clipper according to claim 1, characterized in that: The connecting seat includes two opposite first surfaces and a second surface located at the distal end.
5. The valve clipper according to claim 4, characterized in that: The recovery portion is at least one hook, barb or ring-shaped body protruding from at least one of the first surface or the second surface.
6. The valve clip according to claim 4, characterized in that: The recovery portion is at least one blind hole or through hole opened on at least one of the first surface or the second surface.
7. The valve clip according to claim 6, characterized in that: The through hole passes through the two first surfaces.
8. The valve clipper according to claim 6, characterized in that: The blind hole is a connection hole opened on the second surface, and a connector for docking with the capture device is arranged in the connection hole.
9. The valve clip according to claim 8, characterized in that: The connecting member includes a magnetic member and / or a threaded member.
10. The valve clip according to claim 5 or 6, characterized in that: There are two recovery parts, and the two recovery parts are symmetrically arranged about the central axis of the connecting seat.
11. The valve clipper according to claim 1, characterized in that: The valve clipper further includes an isolation portion, which is disposed between the main body and the recovery portion. An anti-cell proliferation drug coating or an isolation layer is applied to at least a portion of the recovery portion and the isolation portion.
12. The valve clip according to claim 11, characterized in that: The anti-cell proliferation drug is selected from at least one of rapamycin and its derivatives, paclitaxel and its derivatives; the isolation layer is a sleeve or coating made of a biocompatible polymer material, and the polymer material is selected from at least one of PET, polyester, silicone resin, PTFE, silica gel or urethane.
13. A valve clip recovery system for recovering the valve clip according to any one of claims 1 to 12, characterized in that: The valve clipper recovery system includes a capture device and a cutting device; the cutting device is used to cut the position where the valve contacts the valve clipper to remove the valve clipper; the distal end of the capture device is detachably connected to the recovery part of the valve clipper to capture the valve clipper.
14. The valve clip retrieval system according to claim 13, characterized in that: The capturing device includes a capturing catheter and a capturing device arranged at the distal end of the capturing catheter, and the capturing device is used to be detachably connected to the recovery part.
15. The valve clip retrieval system according to claim 14, characterized in that: The capture device is at least one of a snare, a capture ring, a claw, a magnetic joint, and a threaded joint.
16. The valve clip retrieval system according to claim 13, characterized in that: The cutting device is provided with at least one developing portion, and the at least one developing portion is provided at the distal end of the cutting device.
17. The valve clip retrieval system according to claim 13, wherein: The cutting method of the cutting device is selected from at least one of mechanical cutting and electric knife cutting.
18. The valve clip retrieval system according to claim 17, characterized in that: The electric knife is selected from at least one of a radio frequency electric knife, a high frequency electric knife, an ultrasonic scalpel, a plasma scalpel, a laser scalpel or a low temperature freezing scalpel.
19. The valve clip retrieval system according to claim 18, characterized in that: A conductive portion is circumferentially provided on the outer peripheral surface of the distal end of the cutting device. The conductive portion conducts electricity on the surface in contact with the valve, so as to cut the valve with an electric knife.
20. The valve clip retrieval system according to claim 19, wherein: The cutting device further includes a temperature sensor electrically connected to the conductive portion, wherein the temperature sensor is in contact with the valve; the temperature sensor is used to indicate the temperature of the portion of the valve in contact with the conductive portion.
21. The valve clip retrieval system according to claim 13, wherein: The valve clip recovery system further includes a removing device, which is used to remove the excised valve clip from the patient's body.
22. The valve clip retrieval system according to claim 21, characterized in that: The removal device includes a positioning member, which is movably arranged at the distal end of the removal device. The positioning member is used to support the valve to reduce the pulsation amplitude of the valve.
23. The valve clip retrieval system according to claim 22, characterized in that: The positioning member includes an elastic frame that can be radially contracted and expanded. When the positioning member extends from the distal end of the removal device, the elastic frame expands and unfolds to support the bottom of the valve.
24. The valve clip retrieval system according to claim 23, wherein: The radial dimension of the elastic frame gradually decreases from the distal opening to the proximal end.
25. The valve clip retrieval system according to claim 22, wherein: The distal opening of the positioning member is provided with an adjustment mechanism, and the adjustment mechanism includes at least one control line, and the at least one control line is used to adjust the radial size of the distal opening of the positioning member.
26. The valve clip retrieval system according to claim 13, wherein: The valve clip retrieving system further includes a guide device, which is used to approach the valve clip and extend in the opposite direction after passing over the valve clip to reduce the amplitude of the undulation of the valve clip.
Citation Information
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