CN111904660A - Valve clamping device and valve clamping system - Google Patents

Valve clamping device and valve clamping system Download PDF

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Publication number
CN111904660A
CN111904660A CN202010192630.9A CN202010192630A CN111904660A CN 111904660 A CN111904660 A CN 111904660A CN 202010192630 A CN202010192630 A CN 202010192630A CN 111904660 A CN111904660 A CN 111904660A
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CN
China
Prior art keywords
valve
clamping device
clamping
valve clamping
elastic body
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN202010192630.9A
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Chinese (zh)
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CN111904660B (en
Inventor
张庭超
张伟伟
王泽涛
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hangzhou Valgen Medtech Co Ltd
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Hangzhou Valgen Medtech Co Ltd
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Publication date
Application filed by Hangzhou Valgen Medtech Co Ltd filed Critical Hangzhou Valgen Medtech Co Ltd
Priority to CN202310195744.2A priority Critical patent/CN116211543A/en
Priority to CN202010192630.9A priority patent/CN111904660B/en
Publication of CN111904660A publication Critical patent/CN111904660A/en
Priority to EP21770911.2A priority patent/EP4122426A4/en
Priority to PCT/CN2021/081606 priority patent/WO2021185324A1/en
Priority to BR112022018791A priority patent/BR112022018791A2/en
Priority to US17/906,641 priority patent/US20230157819A1/en
Application granted granted Critical
Publication of CN111904660B publication Critical patent/CN111904660B/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466Delivery devices therefor

Abstract

The application relates to a valve clamping system, which comprises a valve clamping device and a conveying device, wherein the valve clamping device comprises a supporting part, and the supporting part comprises a connecting end and a free end which are oppositely arranged; at least one part of the supporting part is arranged in the adjusting part, one end of the adjusting part is sleeved outside the connecting end and is connected with the supporting part, and the other end of the adjusting part is provided with an opening; the clamping part is arranged around the outer side of the adjusting part; the driving part is connected with the clamping part to drive the clamping part to unfold or close around the adjusting part. The regulating part is provided with an open free end which is not limited by the sealing head, the axial deformation capacity of the regulating part is improved, the bending deformation capacity along the axial direction is enhanced, the regulating part is easily compressed into the sheath, the regulating part can adapt to blood vessels with different bending degrees during conveying, and the damage to the blood vessel wall is reduced. After the valve leaflet is implanted, the axial deformation of the adjusting part is not limited, so that the elastic fitting performance of the valve leaflet and the adjusting part is improved, and the adaptability of the physiological structures of the valve leaflets of different patients is improved.

Description

Valve clamping device and valve clamping system
Technical Field
The present application relates to the field of implantable medical devices, and in particular, to a valve clamping device and a valve clamping system including the same.
Background
Referring to fig. 1, the mitral valve 1 is a one-way valve between the left atrium 2 and the left ventricle 3 of the heart, and a normal, healthy mitral valve 1 can control the flow of blood from the left atrium 2 to the left ventricle 3 while preventing the flow of blood from the left ventricle 3 to the left atrium 2. The mitral valve 1 includes a pair of leaflets, referred to as an anterior leaflet 1a and a posterior leaflet 1 b. The anterior leaflet 1a and the posterior leaflet 1b are fixed to papillary muscles of the left ventricle 3 by chordae tendineae 4. Normally, when the left ventricle 3 of the heart contracts, the edges of the anterior leaflet 1a and the posterior leaflet 1b are completely apposed, preventing blood from flowing from the left ventricle 3 to the left atrium 2. Referring to fig. 2, when the leaflets of the mitral valve 1 or their associated structures are organically or functionally changed, such as the chordae tendineae 4 are partially broken, the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are poorly coaptated, and thus, when the left ventricle 3 of the heart contracts, the mitral valve 1 cannot be completely closed, causing blood to regurgitate from the left ventricle 3 to the left atrium 2, thereby causing a series of pathophysiological changes, called "mitral regurgitation".
The prior art treats mitral regurgitation by implanting a valve clamping device into the mitral valve, pulling the anterior and posterior leaflets toward each other with a pair of closable clamping arms, reducing or eliminating the leaflet gap. Referring to fig. 3 and 4, in the conventional valve clamping device, an elastic body 20 is added to two clamp arms 30, and the leaflet of each side is clamped between one clamp arm 30 and one side of the elastic body 20, so that the distance between the leaflets is adjusted by the deformation of the elastic body 20, thereby adjusting the degree of the leaflet pulled by the clamp arms 30. The resilient body 20 comprises a deformable mesh body 21 secured at either end by end caps 24 such as steel sleeves, and then secured to the support bar between the two jawarms 30. However, since both ends of the elastic body 20 are fixed by the sealing heads 24, when the forceps arms 30 are closed, the sealing heads 24 limit the axial movement of the elastic body, and the elastic body can only be radially compressed, which affects the deformation of the elastic body, thereby increasing the size of the clamping device in a delivery state, being unfavorable for the passing performance of the clamping device in a bent blood vessel, and causing the elastic body not to completely fit the valve leaflet after the clamping device is implanted, which is poor in adaptability to the physiological structure of the valve leaflet of different patients.
Disclosure of Invention
In order to solve the above technical problem or at least partially solve the above technical problem, the present application provides a valve clamping device and a valve clamping system including the same.
In a first aspect, the present application provides a valve clamping device comprising:
the supporting part comprises a connecting end and a free end which are oppositely arranged;
at least one part of the supporting part is arranged in the adjusting part, one end of the adjusting part is sleeved outside the connecting end and is connected with the supporting part, and the other end of the adjusting part is freely suspended in the air;
the clamping part is arranged around the outer side of the adjusting part;
the driving part is connected with the clamping part to drive the clamping part to unfold or close around the adjusting part.
In a second aspect, the present application provides a valve clamping system comprising a valve clamping device of any one of the above, and a delivery device, wherein the delivery device comprises: the pushing shaft is connected with the supporting part in a detachable mode, and the mandrel is connected with the driving part and used for driving the clamping part to be unfolded and closed relative to the supporting part.
Compared with the prior art, the technical scheme provided by the embodiment of the application has at least the following advantages: for the valve clamping device and the valve clamping system comprising the valve clamping device, at least one part of the supporting part is arranged in the hollow of the adjusting part, one end of the adjusting part is sleeved outside the connecting end and is connected with the supporting part, the other end of the adjusting part is freely suspended, the freely suspended end is not connected with the supporting part and the conveying device and is not limited by the supporting part or the conveying device, the axial deformation capacity of the adjusting part is improved, and meanwhile, the bending deformation capacity of the adjusting part along the axial direction is enhanced. In addition, after the valve clamping device is implanted, the valve leaflet and the adjusting part are clamped by the clamp arms, and the elastic fitting performance of the valve leaflet and the adjusting part can be improved due to the fact that the axial deformation of the adjusting part is not limited, and then the adaptability of the valve leaflet physiological structures of different patients is improved.
Drawings
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the invention and together with the description, serve to explain the principles of the invention.
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious for those skilled in the art that other drawings can be obtained according to the drawings without inventive exercise.
FIG. 1 is a schematic view of a mitral valve in a normal state;
FIG. 2 is a schematic representation of a diseased mitral valve;
figures 3 and 4 are schematic structural views of a prior art valve clamping device;
FIG. 5 is a schematic view of a valve clamping device according to a first embodiment of the present application;
FIG. 6 is a schematic view of the combined structure of the adjusting part and the supporting part in FIG. 5;
FIG. 7 is a schematic structural view of the support part of FIG. 5;
FIG. 8 is a schematic view showing the structure of the regulating part of FIG. 5;
FIG. 9A is a schematic view of an example of a tubular body for preparing the regulating part of FIG. 5;
FIG. 9B is a schematic structural diagram of the frame structure after the tube body in FIG. 9A is cut and shaped;
FIG. 9C is a schematic diagram of an exemplary elastomeric body prepared by cutting;
FIG. 9D is a schematic diagram of another example elastomeric body prepared by cutting;
FIG. 9E is a partial schematic view of the proximal portion of the resilient body of FIG. 9D;
FIG. 9F is a schematic representation of a structure of yet another example elastomeric body prepared by cutting;
FIG. 10A is a schematic view of an exemplary mesh structure of the regulating part of FIG. 5;
FIG. 10B is a schematic view of another example mesh structure of the regulating part of FIG. 5;
FIG. 11 is a partial schematic view of an adjustment portion having a ring-like configuration as illustrated in FIG. 5;
FIG. 12 is a schematic view of the combination of the clamping portion and the driving portion of FIG. 5;
FIG. 13 is a schematic view of the support portion of FIG. 5 engaged with the base;
FIG. 14 is a schematic view of the valve clamping device of FIG. 5 in cooperation with a delivery device;
FIG. 15 is a schematic view of the valve clamping device of FIG. 5 with the support portion engaged with the delivery device;
FIGS. 16-20 are schematic illustrations of a delivery procedure for accessing and repairing a mitral valve anterograde through the left atrium using the valve clamping device of FIG. 5;
FIG. 21 is a schematic view of a valve clamping device according to a second embodiment of the present application;
FIG. 22 is a schematic view showing the structure of the regulating portion of FIG. 21;
FIG. 23 is a partial schematic view of the distal end of the adjustment member of FIG. 22;
FIG. 24A is a schematic view of a valve clamping device according to a third embodiment of the present application;
FIG. 24B is a schematic view of a preferred valve clasping device of FIG. 24A;
FIG. 25A is a schematic view of a first curved side of an adjustment portion of a valve clamping device according to a fourth embodiment of the present application;
FIG. 25B is a schematic view of the second curved side of the adjustment part of FIG. 25A;
FIG. 25C is a top view of the adjustment portion of FIG. 25A;
FIG. 26A is a schematic view of a valve clasping device according to a fifth embodiment of the present application;
fig. 26B is a schematic view of the valve clasping device of fig. 26A partially retracted into the delivery device after radial compression.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without inventive effort based on the embodiments of the present invention, are within the scope of the present invention.
In the description of the present invention, it should be noted that the terms "upper", "lower", "inside", "outside", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience in describing the present invention and simplifying the description, but do not indicate or imply that the referred device or element must have a specific orientation, be constructed in a specific orientation, and be operated, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
In the description of 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, and the distal end refers to the end farther from the operator; axial refers to a direction parallel to the line joining the center of the distal end and the center of the proximal end of the medical device. The foregoing definitions are for convenience only and are not to be construed as limiting the present invention.
Referring to fig. 5 to 20, a valve clamping device 100 according to a first embodiment of the present invention includes: a support portion 110, the support portion 110 including a connection end 111 and a free end 112 disposed opposite to each other; a hollow adjusting part 120, at least a part of the supporting part 110 is arranged in the adjusting part 120, one end 121a of the adjusting part 120 is sleeved outside the connecting end 111 and connected with the supporting part 110, and the other end 121b of the adjusting part 120 is freely suspended; the clamping part 130, the clamping part 130 is arranged around the outer side of the adjusting part 120; and the driving part 140, the driving part 140 being connected with the clamping part 130 to drive the clamping part 130 to open or close around the adjusting part 120.
For the valve clamping device 100, at least a part of the supporting part 110 is arranged in the hollow of the adjusting part 120, one end 121a of the adjusting part 120 is sleeved outside the connecting end 111 and connected with the supporting part 110, and the other end 121b of the adjusting part 120 is freely suspended, and the freely suspended end is not limited by the supporting part 110 or the conveying device 200, so that the axial deformation capacity of the adjusting part 120 is improved, and the bending deformation capacity along the axial direction is enhanced. In addition, after the valve clamping device 100 is implanted, in the process of clamping the valve leaflets and the adjusting part 120 through the clamp arms 131, the elastic fitting performance of the valve leaflets and the adjusting part 120 can be improved because the axial deformation of the adjusting part 120 is not limited, and then the adaptability of the valve leaflet physiological structures of different patients is improved.
Referring to fig. 6 and 7, the supporting portion 110 may be a circular tube with two end surfaces axially penetrating, a distal end of the circular tube is a connecting end 111, and a proximal end of the circular tube is a free end 112. At least a part of the supporting portion 110 is disposed in the hollow of the adjusting portion 120, for example, the free end 112 of the supporting portion 110 is disposed in the adjusting portion 120, and the free end 112 is disposed in the adjusting portion 120 in both the delivery state and the deployed state, without exposing the adjusting portion 120. The support portion 110 is further provided with an axial through-hole shaped through-passage 113 for cooperating with the driving portion 140 and the delivery device 200. At least two clamping positions 114 are arranged on the pipe wall of the round pipe body of the supporting part 110 and are used for being detachably connected with the conveying device 200. For example, after the clamping platform 221 (see fig. 14) of the delivery device 200 is clamped into the clamping position 114, the delivery device 200 is connected to the supporting portion 110 in a clamping manner, so as to deliver the valve clamping device 100, and when the clamping platform 221 is separated from the clamping position 114, the delivery device 200 is separated from the valve clamping device 100 and released in vivo. It should be understood that the structure of the supporting portion 110 is only used as an example and not a limitation of the present application, and those skilled in the art can adopt other structures of the supporting portion 110 based on the teaching of the present application within the protection scope of the present application.
The valve clamping device 100 of the present application is positioned within the hollow regulating portion 120 in both the delivery and release deployment states of the proximal free end 112, and therefore is not exposed to the delivery device 200 or to the heart at all times, thereby avoiding blood washout and minimizing thrombus formation after implantation. And after the valve is implanted, the valve is prevented from being directly contacted with the valve leaflets, the valve leaflets are prevented from being abraded and even perforated along with the long-term pulsation of the valve leaflets, and the safety of an implanted patient is improved.
Referring to fig. 6 and 8, the adjusting portion 120 includes a deformable elastic body 123, the elastic body 123 has a hollow accommodating cavity, and at least a portion of the supporting portion 110 is disposed in the hollow accommodating cavity. One end 121a of the elastic body 123 is connected to the supporting portion 110, and the other end 121b of the elastic body 123 has an opening 122 and is freely suspended. The elastic body 123 can deform to accommodate the spacing between the different leaflets, adjusting the degree of pull of the valve clamping device 100 on the leaflets. The opening 122 of the elastic body 123 is used for threading the distal end of the delivery device 200, and it should be understood that the distal end of the delivery device 200 is connected to the proximal end (free end) of the support portion 110 after penetrating into the inner cavity of the elastic body 123 through the opening 122, and the opening 122 of the distal end of the elastic body 123 is not connected to the distal end of the delivery device 200 or the proximal end (free end) of the support portion 110, that is, the proximal end 121b of the elastic body 123 is in a free-floating state. Therefore, in the process of delivering or clamping the valve leaflets, when the clamping part 130 is closed, the elastic main body 123 in the adjusting part 120 is not limited by the support part 110 or the delivery device 200, can be deformed in the radial direction and the axial direction, has larger deformation degree, is more beneficial to delivery and has stronger adaptability to the valve leaflets; when the connection between the distal end of the delivery device 200 or the proximal end (free end) of the support portion 110 is released, the free, suspended end of the adjustment portion 120 is more deformable and more adaptable to the leaflets.
In one embodiment, the elastic body 123 is a mesh structure that can be woven from a shape memory material, such as a superelastic nitinol, and heat set to a compressed state and an expanded state, and is held in the delivery device 200 in the compressed state and released in vivo to hold the expanded state. In one embodiment, the elastic body 123 of the net structure is woven by first winding 12-36 Ni-Ti wires with a diameter of 0.02-0.15mm around a backing rod to form a tubular woven mesh having opposite proximal and distal ends. At the proximal end, the plurality of mesh wires 124 are bent back into a plurality of loops that encircle to form the proximal edge, and then one wire is passed through all of the loops of the proximal end in sequence and then tightened appropriately, but leaving an opening of moderate size. Then inserting the shaping die into the far end of the woven net, and winding the nickel-titanium wires at the far end into a bundle by using metal wires; placing the woven net and the shaping mold into an electric heating type circulating air box furnace, and carrying out heat-shaping treatment for 10-20 minutes under the conditions of 450-650 ℃ (preferably 500 ℃); and (3) after taking out and cooling to room temperature, detaching the metal wires at the near end and the far end, taking out the shaping mold, plugging all the nickel-titanium wires at the far end into a seal head made of stainless steel, and performing compression joint or welding to obtain the elastic main body 123 with the net-shaped structure.
Referring to fig. 9A and 9B, the elastic body 123 may also be a frame structure, which is cut from a relatively hard metal or polymer material such as stainless steel, alloy, polyvinyl chloride, etc. The cut elastic body 123 has a smooth and flat inner surface to prevent thrombus from forming inside the elastic body 123 and to ensure that the fixing member 220 (see fig. 14) can be smoothly withdrawn from the opening 122 of the elastic body 123. The cutting mode can adopt linear cutting or laser cutting, preferably adopting the laser cutting mode. When manufacturing, the nickel-titanium tube 126 is cut into a desired shape by a laser cutting machine. Pressing the nickel-titanium piece obtained by cutting into a shaping mould with a certain shape. Then putting the nickel-titanium piece and the shaping mold into an electric heating type circulating air chamber furnace, and carrying out shaping heat treatment for 10-20 minutes under the conditions of 450-650 ℃ (preferably 500 ℃); and taking out and cooling to room temperature, and removing the shaping mold to obtain a shaped elastic main body 123 which is of a frame structure and comprises a plurality of supporting rods 127 which are radially arranged at intervals and axially extend, wherein the proximal ends of the supporting rods 127 are gathered to form a free suspended proximal edge. The distal ends of the plurality of struts 127 are gathered and welded to the support portion 110. The nickel-titanium pipe is a pipe with certain wall thickness, and particularly, the wall thickness of the nickel-titanium pipe is less than 1mm, preferably 0.02-0.15mm, and the nickel-titanium pipe has certain flexibility and rigidity.
Referring to fig. 9C, the elastic body 123 is a frame structure formed by cutting and connecting a plurality of struts 127, the proximal end 121b of the elastic body 123 is an open structure, and the frame structure encloses the proximal edges of all the struts 127 at the proximal end 121b to form the opening 122.
Referring to fig. 9D and 9E, the elastic body 123 is still a frame structure, and is formed by a plurality of struts 127 cooperatively connected, the proximal end 121b of the elastic body 123 is an open structure, each strut 127 at the proximal end 121b may further be provided with a through hole 127a, and the through holes 127a are connected in series by a flexible wire 129 to form an opening 122.
Referring to fig. 9F, the elastic body 123 is still a frame structure formed by a plurality of struts 127 connected together, the proximal end 121b of the elastic body 123 is an open structure, and adjacent struts 127 of the frame structure can be cut and cross-linked with each other, for example, adjacent struts 127 at the edge of the proximal end 121b can be cut and cross-linked with each other to form a ring structure 129.
Of course, the elastic body 123 of the adjusting portion 120 may also be another hollow structure having elasticity, for example, the elastic body 123 may be a compact structure or a porous structure, the compact structure is a silica gel body, the porous structure is a sponge body, and the proximal edge of the compact structure or the porous structure forms an opening 122 for the distal end of the delivery device 200 to penetrate into the inner cavity of the elastic body 123.
The shape of the elastic body 123 is selected from at least one of a cylindrical shape, a conical shape, a spherical shape, an oblate spherical shape, an ellipsoidal shape, a fan-shaped spherical shape, and a gourd-shaped spherical shape, and may be a combination of a plurality of shapes. To avoid the elastic body 123 affecting the relative opening and closing between the grasping arms 151 and the forceps arms 131 and the support 110, and the grasping effect on the leaflets, the diameter of the portion of the elastic body 123 near the distal end should be smaller than the diameter of the other portions of the elastic body 123. For example, in the embodiment shown in fig. 8, the middle portion of the elastic body 123 is cylindrical, the two ends are tapered, and the taper angles of the tapered ends are the same. It will be appreciated that in other embodiments, the resilient body 123 may have any other shape, as long as the diameter of the distal end does not affect the gripping effect. For example, a spindle-shaped structure shown in fig. 10A in which the taper angles at both ends are the same, or a structure shown in fig. 10B in which the taper angles at both ends are different.
The adjustment portion 120 includes a proximal end and a distal end, and in one embodiment, the proximal edge of the elastic body 123 is sleeved with a hollow snare structure (not shown) to form an opening, which can be an existing seal structure. The snare structure may be ring-shaped or polygonal, and may be made of a hard material such as stainless steel, so that the wires of the mesh structure or the struts of the frame structure are suitably gathered toward the central axis, but are not closed, thereby forming an opening 122 at the center of the snare structure. In another embodiment, the proximal edge of the elastic body 123 encloses the opening 122, and the size of the opening 122 is smaller than or equal to the size of the free end 112, so as to ensure that the free end 112 of the supporting portion 110 does not extend beyond the adjusting portion 120 in the compressed state and the expanded state.
In a specific embodiment of this embodiment, the mesh structure 123 is formed by braiding and heat-setting nitinol wires, and the mesh wires 124 of the mesh structure 123 are bent and wrapped back at the proximal end to form the proximal end edge, that is, all the mesh wires 124 are wrapped around the wrapped portion of the proximal end edge to form the opening 122, and the wrapped shape may be set according to the need, for example, one-time wrapped or wrapped multiple times to form at least one ring and then wrapped back, and so on, which is not described herein again.
The proximal edge of the elastic body 123 encloses to form an opening 122, the proximal end closure of the adjustment portion 120 of the valve clamping device 100 is eliminated, and when the clamping portion 130 is closed, the elastic body 123 can deform in both the radial direction and the axial direction, so that the degree of deformation is greater, and the delivery is facilitated; in addition, the elastic body 123 is not limited by the axial movement of each mesh wire or strut of the sealing head, so that the elastic body can be moderately curled or bent, thereby completely fitting the valve leaflet and better adapting to the physiological structures of the valve leaflets of different patients; in addition, the risk that the near-end sealing head part in the prior art falls off after being implanted for a period of time can be avoided; in addition, the distal end of the elastic body 123 is connected to the support portion 110, and the opening 122 at the proximal end is open, so that the center of gravity is always located in the axial direction of the support portion 110 (i.e., the axial line of the elastic body 123), and therefore, the self-centering performance is good and the inclination is not easy.
Further, referring to fig. 11, the adjusting portion 120 may further include a ring-shaped structure 125 disposed at the proximal edge to stabilize the shape of the opening 122, and all the mesh wires 124 of the mesh-shaped structure 123 at the proximal end are wound around the ring-shaped structure 125. The loop structure 125 is made of a flexible or elastic material with a larger diameter than the mesh of the woven mesh structure 123, so as to provide a certain supporting force to the openings 122 of the mesh structure 123, but not to affect the axial deformability and bending capability of the mesh structure 123.
The distal end of the adjustment part 120 is fixedly connected to the support part 110. Specifically, a hollow snare structure is sleeved outside the distal edge of the elastic body 123, and the snare structure is fixedly sleeved on the support portion 110. The snare structure of the distal end 121a (e.g., a head at the distal end 121a in fig. 8) and the support 110 are secured together by a common detachable or non-detachable connection, such as welding, gluing, screwing, crimping, bolting, etc., for example, a welded connection may be preferred.
Referring to fig. 12 and 13, the clamping portion 130 includes at least two clamping arms 131, and may generally include at least one set of clamping arms 131, each set of clamping arms 131 includes two clamping arms 131 symmetrically disposed with respect to the adjustment portion 120, and the clamping portion 130 includes one set of clamping arms 131, it should be understood that, by way of example only, one skilled in the art can select an appropriate number of clamping arms 131, such as two or more sets of clamping arms, as desired. A drive portion 140 is coupled to each of the jawarms 131, such that the drive portion 140 is coupled to each of two jawarms 131 of the set of jawarms 131 to drive each of the jawarms 131 to rotate about the adjustment portion 120. It will be appreciated that three or more clamp arms 131 may also be provided in each group as desired, for example, three leaflets of the tricuspid valve may be clamped by the three relatively openable and closable clamp arms 131 to treat tricuspid regurgitation.
In the delivery state, the driving part 140 drives the forceps arms 131 to close around the adjusting part 120, so as to reduce the outer diameter of the valve clamping device 100 and facilitate delivery; after the valve clamping device 100 is deployed in vivo, the driving portion 140 drives the clamp arms 131 to clamp the valve leaflets between the clamp arms 131 and the adjusting portion 120, so as to clamp the valve leaflets.
In a preferred embodiment of the present embodiment, the valve clamping device 100 further includes a gripping portion, which generally includes at least one set of gripping arms 151, each set of gripping arms 151 includes two gripping arms 151 symmetrically disposed with respect to the adjustment portion 120, the gripping portion (e.g., the gripping arms 151) is disposed between the clamping portion 130 (e.g., the clamp arms 131) and the adjustment portion 120 and can be opened or closed with respect to the adjustment portion 120, and the gripping portion is at least partially received in an inner surface of the clamping portion 130 when the gripping portion and the clamping portion 130 are both opened. Of course, three or more gripping arms 151 may be provided in each set as desired to achieve a clamping function in cooperation with the jawarms 131.
In the delivery state, the grip is at least partially received in the inner surface of the clamp 130, i.e., the grip arms 151 are at least partially received in the inner surface of the clamp arms 131, thereby reducing the outer diameter of the valve clamp device 100 for delivery; after the clamp arms 131 engage the grasping arms 151 to grasp a leaflet, the concave inner surfaces can increase the contact area of the clamp arms 131 with the leaflet and cause the grasping arms 151 to press the leaflet into the inner surfaces of the clamp arms 131, increasing the grasping force on the leaflet.
Still referring to fig. 12 and 13, the valve clamping device 100 further includes a base 160 fixedly connected to the support portion 110, and the clamping portion 130 is rotatably connected to the base 160. Specifically, the proximal end of the base 160 is fixedly connected to the distal end 121a of the supporting portion 110, and it should be noted that, for convenience of explanation, this portion is defined as the term "base", and the structure for realizing the function of the base 160 may also be the distal end of the supporting portion 110, i.e. the integral structure formed with the supporting portion 110, so that the definition of the term "base" should not form a limitation to the scope of the present application. Each of the jawarms 131 in each set are connected together by a pivot 132 on the base 160 so that each of the jawarms 131, in cooperation with each other, can be opened and closed together about the adjustment portion 120 upon actuation of the actuation portion 140.
Still referring to fig. 12 and 13, the driving part 140 includes: a driving shaft 141, a connecting seat 142 and two connecting rods 143; wherein, one end of each connecting rod 143 is connected with the clamping part 130, and the other end is pivoted with the connecting seat 142; one end of the driving shaft 141 is connected to the connecting seat 142, and the other end is movably inserted into the base 160. Specifically, each link 143 has one end connected to one of the forceps arms 131 and the other end connected to the connecting section 142 by a pivot 144, i.e., each forceps arm 131 is rotatably connected to the distal end of the connecting section 142 of the driving shaft 141 by the link 143 on the corresponding side. The driving shaft 141 movably passes through the base 160, and when the driving shaft 141 slides in the axial direction relative to the base 160, the connecting rod 143 rotates and drives the clamp arm 131 to open and close relative to the base 160.
Specifically, the driving portion 140 includes at least one set of connecting rods 143, and the number of the connecting rods 143 is set to correspond to the number of the forceps arms 131, for example, two forceps arms 131 are used in the figure, and two connecting rods 143 are correspondingly set. The distal end of the link 143 is rotatably coupled to the coupling seat 142 at the distal end of the driving shaft 141 by means of a rotating pin or bolt 144. When the driving shaft 141 slides in the axial direction toward the distal end with respect to the base 160, the link 143 is moved, and the jawarms 131 are rotated about the pin holes 144 to be opened with respect to the base 160 by the pulling of the link 143. As drive shaft 141 slides axially proximally relative to base 160, linkage 143 pulls jawarm 131 to rotate about pin hole 144 to close relative to base 160.
The connecting base 142 is fixedly disposed at a distal end of the driving shaft 141 by welding or the like, and the connecting base 142 is provided with a pair of pins. The pin hole is used for connecting the connecting rod 143 through a pin 144, and the other end of the connecting rod 143 is connected with the clamp arm 131, so that the clamp arm 131 is opened and closed relative to the base 160. The connecting seat 142 is shaped as any one of a hemisphere, a spherical cap, or a bullet, so that the valve clamping device 100 can be pushed in the body more easily. The driving shaft 141 and the connecting seat 142 may be an integral structure or a non-integral structure. In order to ensure the safety after implantation, the driving shaft 141 and the connecting seat 142 are made of a biocompatible material such as polyester, silicone, stainless steel, cobalt alloy, cobalt-chromium alloy, or titanium alloy, preferably stainless steel or cobalt-chromium alloy with high hardness.
Preferably, referring to fig. 12, the valve clamping device 100 further comprises a locking portion 170 provided in the base 160, the locking portion 170 limiting relative movement of the drive shaft 141 and the base 160. In the delivery state, the locking part 170 limits the relative movement between the driving shaft 141 and the base 160, so as to ensure that the clamping part 130 is always kept in a closed state relative to the adjusting part 120 and the supporting part 110, and avoid the accidental unfolding of the clamping part 130; after reaching the vicinity of the mitral valve, the restriction of the drive shaft 141 by the unlock lock 170 is such that the drive unit 140 drives the clamping unit 130 to unfold and support the leaflet with respect to the adjustment unit 120 and the support unit 110. Any suitable locking portion may be used as is known in the art and will not be described further herein.
Referring to fig. 14 and 15, the valve clamping system of the present embodiment includes the valve clamping device 100 and the delivery device 200, wherein the delivery device 200 includes: a pushing shaft 210 having a certain axial length and a mandrel (not shown) movably inserted into the pushing shaft 210, wherein the pushing shaft 210 is detachably connected to the supporting portion 110, and the mandrel is connected to the driving portion 140 for driving the clamping portion 130 to open and close relative to the supporting portion 110. In this embodiment, the proximal end of the drive shaft 141 is externally threaded, and the spindle is threadedly coupled to the drive shaft 141 such that axial movement of the drive shaft 141 is controlled by the spindle outside the patient's body. It should be understood that only a portion of the structure of the delivery device is shown, and any other portion may be any suitable structure that is known in the art, and will not be described herein.
Specifically, the outer wall of the proximal end of the supporting portion 110 is symmetrically provided with at least one retaining portion 114 communicated with the lumen of the supporting portion 110, the distal end of the pushing shaft 210 is provided with a fixing member 220, the fixing member 220 includes two branches, and the end of each branch is a convex retaining platform 221. In the natural state, both branches point towards the central axis of the fixture 220. During assembly, the fixing member 220 is inserted into the supporting portion 110, and the mandrel of the delivery device 200 is inserted into the pushing shaft 210 until the mandrel is inserted into the fixing member 220, the two branches of the fixing member 220 are lifted outwards, and the clamping platforms 221 at the ends of the branches are clamped into the two clamping positions 114 of the supporting portion 110, so that the supporting portion 110 is connected with the fixing member 220, that is, the valve clamping device 100 and the delivery device 200 are connected. When the mandrel is withdrawn from the fixing element 220 and the pushing shaft 210, the two branches return to the inward natural state, and the clamping platform 221 is disengaged from the clamping position 114 of the supporting part 110, so that the connection between the valve clamping device 100 and the delivery device 200 is released. The fixing member 220 is made of a material having a certain hardness and elasticity, such as nickel titanium. The pusher shaft 210 may be a multi-layer composite tube. The mandrel is made of stainless steel material.
The support portion 110 has a through hole as a passage 113 for the driving shaft 141, and the driving shaft 141 is axially slidably inserted into the passage 113 of the support portion 110. The proximal end of the drive shaft 141 is externally threaded for connection to a spindle of the delivery device 200, whereby axial movement of the drive shaft 141 is controlled by the spindle. After the clamping portion 130 and the grasping portion 150 are engaged to clamp the valve tissue, the driving shaft 141 is driven by the mandrel to move axially and proximally, the driving shaft 141 drives the connecting rod 143 to rotate, the connecting rod 143 drives the forceps arms 131 to close relative to the supporting portion 110 until the forceps arms 131 are completely closed relative to the supporting portion 110, so that the valve clamping device 100 is in a closed state and falls below the valve. The mandrel can then be disconnected from the drive shaft 141, withdrawn from the fastener 220, and the locking platform 221 separated from the locking position 114 of the support 110, thereby releasing the valve clamping device 100 and the delivery device 200. During the release process, since the connection point (i.e., the release point) of the valve clamping device 100 and the delivery device 200 is located in the adjusting part 120 of the valve clamping device 100, and the proximal end of the adjusting part 120 is provided with the open opening 122, there is no part that can hook the clamping table 221 at the branch end of the fixing member 220, so as to facilitate the release of the valve clamping device 100. In addition, the release site is provided inside the regulating part 120, and is not directly washed by blood, so that the mechanism failure at the release site can be avoided, and the risk of thrombosis can be reduced.
Referring to fig. 16-20, the use of the valve clamping device 100 of the present application is illustrated, for example, to access and repair a mitral valve anterogradely through the left atrium:
the first step is as follows: as shown in fig. 16, the drive shaft 141 and the valve clamping device 100 connected thereto are advanced from the left atrium 2, through the mitral valve 1 to the left ventricle 3, through a guiding device (not shown) such as an adjustable curved sheath;
the second step is that: adjusting the valve clamping device 100 to approximate the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1;
the third step: as shown in fig. 17, the locking portion in the base 160 is unlocked, the mandrel and the driving shaft 141 are pulled proximally, the forceps arms 131 are driven to open relative to the supporting portion 110, and the directions of the forceps arms 131 are adjusted, so that the relative positions of the forceps arms 131 and the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 can be observed through an X-ray device, and the forceps arms 131 are perpendicular to the coaptation line of the mitral valve 1;
the fourth step: as shown in fig. 18, the entire valve clamping device 100 is withdrawn proximally, so that the forceps arms 131 hold the leaflet 1 at the left ventricle 3 side, the grasping arms 151 at both sides are released, the grasping arm 151 at each side presses the leaflet 1 at the atrium side and cooperates with the forceps arms 131 at the side to fix the leaflet 1, and complete clamping of the leaflet 1 is realized;
the fifth step: as shown in fig. 19, when the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are clamped between the pair of forceps arms 131 and the grasping arm 151, respectively, the mandrel and the drive shaft 141 are pushed distally, thereby driving the forceps arms 131 to close;
and a sixth step: the threaded connection between the mandrel and the driving shaft 141 is released, the mandrel is withdrawn, the two branches of the fixing member 220 return to the state of approaching to the central shaft, the clamping table 221 is separated from the clamping position 114 of the supporting part 110, the connection between the valve clamping device 100 and the delivery device 200 is released, then the delivery device 200 is withdrawn out of the body, the implantation state shown in fig. 20 is obtained, at the moment, the valve clamping device 100 pulls the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 to each other, a bicuspid mitral valve is obtained, and the edge-to-edge repair of the mitral valve is completed.
After the valve clamping device 100 is implanted, the adjusting part 120 with elasticity is filled between the anterior leaflet 1a and the posterior leaflet 1b of the clamped mitral valve 1 and abuts against the clamp arms 131, and the elastic main body 123 (such as a mesh structure or a porous structure) of the adjusting part 120 has a buffering effect on the pulsating leaflet 1, so that the valve clamping device 100 can adjust the pulling degree of the leaflet 1 to avoid damaging the leaflet 1; in addition, the elastic body 123 can be squeezed and deformed along with the pulsation of the valve leaflet 1, the generated elastic force pushes the part of the valve leaflet 1 close to the elastic body 123 to the direction away from the base 160, at this time, the axial movement of the elastic body 123 towards the proximal end is not limited due to the structure of the opening 122 of the adjusting part 120, the clamping angle between the anterior leaflet and the posterior leaflet of the mitral valve is smaller than the opening angle between the clamp arms 131, the pulling of the valve clamping device 100 on the valve leaflet 1 can be reduced, and the pulling degree of the valve clamping device 100 on the valve leaflet 1 is always kept in a reasonable range; in addition, the elastic body 123 can buffer the direct flushing of the blood flow to the inside of the valve clamping device 100, so as to prevent the valve clamping device 100 from falling off due to the continuous flushing of the blood, and prevent the blood from accumulating at the dead angle (position C in fig. 5) between the clamping parts 130 of the valve clamping device 100 to form thrombus; in addition, when the elastic main body 123 is under the pressure action of the valve, a certain degree of deformation is generated, and the degree of deformation increases along with the increase of the pressure, so that after the valve leaflet 1 is prevented from being grabbed, the extrusion force of the clamp arms 131 on the elastic main body 123 is reversely acted on the clamp arms 131, and the grabbing effect of the valve leaflet 1 by the valve leaflet clamping device 100 after release is ensured to be consistent with the grabbing effect before release.
Referring to fig. 21-23, compared to the valve clamping device of the first embodiment, the mesh structure of the adjustment part 320 of the valve clamping device 300 according to the second embodiment of the present invention is fixed on the support part 310 by all the mesh wires 324 at the distal end 321. That is, both ends 322 and 321 of the adjusting portion 320 are open structures without end sockets, and the adjusting portion 320 directly fixes the mesh 324 at the distal end 321 of the adjusting portion 322 on the supporting portion 310 by common detachable or non-detachable connection manners such as welding, bonding, crimping, and the like, and the welding connection is preferred in this embodiment.
The opening or closing of the clamping portion 330 (e.g., jawarms) is caused to pivot about a pivot 332 (e.g., a pin) near the distal side of the adjustment portion 320. When the clamping part 330 is closed, the closer to the pivot 332, the smaller the space. When the valve leaflets are clamped by the clamping part 330, part of the valve leaflets 1 can fill the space accumulated at the position D, which not only affects the closing of the valve clamping device, but also causes the valve leaflets 1 at the position to be seriously damaged when the valve leaflet 1 filling condition at the position cannot be found in time and the valve clamping device is forcibly closed. In this embodiment, since the distal end 321 of the adjustment portion 320 is also in an open structure without a seal head, the adjustment portion 320 can better conform to the deformation of the leaflet 1 during the closing process of the valve clamping device 300. Meanwhile, the adjustment part 320 reduces the hard end socket, so that the space at the position is increased, and the whole valve clamping device 300 can be better closed after the valve leaflet 1 is grabbed.
Referring to fig. 24A, in contrast to the valve clamping device of the first embodiment, at least a portion of the outer surface of the mesh structure of the adjustment portion 420 of the valve clamping device 400 according to the third embodiment of the present invention is coated with a film. In addition, a coating film may be applied to at least a part of the outer surfaces of the nip portion 430 and the grip portion 450. The film can be a woven net structure and is provided with a plurality of meshes. The regulator 420, the clamping part 430 and the grip 450 after being coated with the film have higher biocompatibility and enhanced friction force, so the clamping effect on the valve leaflet is better.
For example, referring to fig. 24B, the grasping arm 451 and the forceps arm 431 are externally covered with a first coating and a second coating, respectively, and the elastic body of the adjustment portion 420 is externally covered with a third coating. The aperture ratio of the three is: the aperture ratio of the third coating film is less than the aperture ratio of the first coating film and less than the aperture ratio of the second coating film. The open porosity is the percentage of open area in the entire film area. The aperture ratio of the second coating is larger, so that the second coating has better elasticity and elongation compared with the first coating, when the clamp arm covered with the second coating is opened relative to the fixed base, the second coating can generate corresponding elastic deformation along with the opening and closing of the clamp arm, and the second coating is always attached to the clamp arm. The third cover film has a minimal open porosity such that the elastomeric body substantially obstructs blood flow therethrough.
The meshes of the first and second coatings can pass blood and prevent thrombus from passing through, and the meshes of the third coating can not pass blood or thrombus. The first covering film can allow blood to permeate through the first covering film, normal flow of the blood from the left atrium to the left ventricle is not affected, and the blood is prevented from being retained in the left atrium, so that damage of blood pressure to a left atrial cavity is reduced; the first cover film can also increase the contact area of the grasping arm and blood so as to buffer the inflowing blood flow, thereby avoiding the phenomenon that the grasping arm is deformed to cause slippage when the inflowing blood flow impacts the valve clamping device as far as possible. The second coating can ensure that blood flows normally in the left atrium and between the left ventricles, so that the blood pressure difference between the left atrium and the left ventricles is reduced; the second coating can also block a small amount of thrombus entering the interior of the valve clamping device through the first coating and retain the thrombus in the valve clamping device, so that the thrombus is prevented from entering the left ventricle and entering the blood circulation of a human body to induce stroke.
The elastic main body with the third covering film can not only increase biocompatibility, avoid tissue allergy and inflammatory reaction and improve product safety, but also form an artificial barrier on the atrium side of the valve leaflet to block thrombus in blood, close the opening of the whole valve clamping device towards the atrium side and avoid repeated washing of blood at the internal dead angle of the valve clamping device to form thrombus, thereby avoiding thrombus.
The first, second and third coating films may be made of polyethylene terephthalate, polypropylene, polytetrafluoroethylene, polyurethane, or other polymer materials, and the materials of the first, second and third coating films may be the same or different.
Referring to fig. 25A-25C, compared to the valve clamping device of the first embodiment, the adjusting portion 520 of the valve clamping device according to the fourth embodiment of the present invention has a free end and a distal end cap 521, the free end may have an opening 522, the adjusting portion 520 includes a plurality of first curved surfaces 520A and a plurality of second curved surfaces 520B, the first curved surfaces 520A and the second curved surfaces 520B are adjacent to each other and are connected smoothly, that is, the first curved surfaces 520A are only adjacent to the second curved surfaces 520B, the second curved surfaces 520B are only adjacent to the first curved surfaces 520A, two opposite first curved surfaces 520A face one clamp arm, and the area of the second curved surfaces 520B is larger than the area of the first curved surfaces 520A.
In this embodiment, the first curved surface 520A with a relatively small area faces the forceps arms, the second curved surface 520B with a relatively large area is smoothly connected between the two first curved surfaces 520A, along with the closing process of the valve clamping device, the first curved surface 520A of the adjusting portion is squeezed by the forceps arms and the valve leaflets, the adjusting portion extends along the direction of the second curved surface 520B and gradually fits the valve leaflets, so as to better adapt to the shapes of the valve leaflets, and increase the contact area between the first curved surface 520A and the valve leaflets, thereby reducing the gap between the valve clamping device and the valve leaflets, slowing down the blood flow and preventing the blood flow from washing the valve clamping device. Preferably, the curvature of the first curved surface 520A may be larger than that of the second curved surface 520B, so that the adjusting portion is shaped like a flat ellipsoid to avoid affecting the closing of the forceps arms. Further, in this embodiment, when the clamp arms are closed, the first curved surface 520A of the adjustment portion is pressed by the clamp arms and the valve leaflets, and the adjustment portion extends along the second curved surface 520B, and since the first end of the adjustment portion is open, the distal end of the delivery system is not hooked, thereby ensuring that the valve clamping device can be detached from the delivery device connection of the valve clamping device when the adjustment portion is deformed arbitrarily.
Referring to fig. 26A and 26B, in comparison with the valve clamping device of the first embodiment, the structure of the adjustment part 620 of the valve clamping device 600 according to the fifth embodiment of the present invention is the same as that of the adjustment part 120 of the first embodiment, except that the clamping part 630 and the grip part 650 cooperate to grasp the valve leaflet. In the fifth embodiment, the nip portion 630 includes a set of clamp arms 631 that can be opened and closed with respect to the support portion 610 and the adjustment portion 620, the grip portion 650 includes a pair of grip arms 651, and the grip portion 650 is located between the nip portion 630 and the adjustment portion 620.
During delivery, the clamping portion 630, the gripping portion 650 and the adjusting portion 620 are all accommodated in the distal end of the delivery device 200, the delivery device 200 is delivered into the left ventricle through the transapical route and then reaches the left atrium by crossing the mitral valve orifice, and the delivery device 200 is retracted, so that the adjusting portion 620 and the gripping portion 650 gradually extend out of the delivery device 200 and are deployed in the left atrium; continuing to withdraw the delivery device 200 until the nip 630 also extends from the delivery device 200 and deploys into the left ventricle; then, the clamping part 630 is pushed to the far end by the driving part, the anterior leaflet and the posterior leaflet of the mitral valve are respectively supported on the inner surfaces of the two clamp arms 631 of the clamping part 630, the gripping part 650 and the adjusting part 620 are withdrawn to the near end, namely, the gripping part 650 is driven to move towards the clamping part 630, so that the leaflet is captured between the gripping part 650 and the clamping part 630, then the clamping part 630 is driven to be closed relative to the adjusting part 620 and the supporting part 610, so that the anterior leaflet and the posterior leaflet are respectively fixed between one clamp arm 631 and one clamp arm 651 corresponding to the clamp arm 631, and then the conveying device 200 is pushed to the far end until the valve clamping device 600 is gradually folded and closed; the connection between the valve clamping device and the delivery device 200 is released, thereby implanting the valve clamping device on the mitral valve, drawing the anterior and posterior leaflets of the mitral valve toward each other into a bi-porous configuration.
It will be appreciated that a valve coaptation system according to the present application includes any of the valve coaptation devices described above, as well as a delivery device capable of delivering the valve coaptation device from outside the body to the vicinity of the mitral valve and coapting the leaflets. The above description of the valve clamping device is provided by way of example and not by way of limitation, and valve clamping devices and valve clamping systems incorporating the same, as taught herein, by one of ordinary skill in the art are within the scope of the present application.
It is noted that, in this document, relational terms such as "first" and "second," and the like, may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising an … …" does not exclude the presence of other identical elements in a process, method, article, or apparatus that comprises the element.
The foregoing are merely exemplary embodiments of the present invention, which enable those skilled in the art to understand or practice the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims (20)

1. A valve clamping device, comprising:
the supporting part comprises a connecting end and a free end which are oppositely arranged;
at least one part of the supporting part is arranged in the adjusting part, one end of the adjusting part is sleeved outside the connecting end and is connected with the supporting part, and the other end of the adjusting part is freely suspended in the air;
the clamping part is arranged around the outer side of the adjusting part;
the driving part is connected with the clamping part to drive the clamping part to expand or close around the adjusting part.
2. The valve clamping device of claim 1, wherein the free end of the support portion is located within the adjustment portion.
3. The valve clamping device of claim 1, wherein the adjustment portion comprises an elastic body, one end of the elastic body is connected with the support portion, and the other end of the elastic body is provided with an opening and is freely suspended.
4. The valve clamping device of claim 3, wherein the opening has a size less than or equal to a size of the free end.
5. The valve clamping device of claim 3, wherein the proximal edge of the resilient body is sleeved with a hollow snare structure to form the opening.
6. The valve clipping device of claim 3, wherein the proximal edge of the resilient body is enclosed to form the opening.
7. The valve clamping device of claim 3, wherein the elastic body is selected from at least one of a mesh structure, a frame structure, a dense structure, or a porous structure.
8. The valve clamping device of claim 7, wherein at least a portion of an outer surface of said resilient body is coated with a covering when said resilient body is said mesh or frame structure.
9. The valve clamping device of claim 7, wherein when the resilient body is the mesh or frame structure, the resilient body is woven or cut from a shape memory material.
10. The valve clipping device of claim 9, wherein when the resilient body is the mesh structure, the mesh of the mesh structure is folded back proximally to form the proximal edge.
11. The valve clipping device of claim 9, wherein when the resilient body is the frame structure, adjacent struts of the frame structure are spaced apart or cross-linked with one another, the struts of the frame structure being gathered proximally to form the proximal edge.
12. The valve clipping device of claim 9, wherein when the elastic body is the dense structure, the dense structure is a silicone body; when the elastic main body is the porous structure, the porous structure is a sponge body; the proximal edge of the dense or porous structure forms the opening.
13. The valve clamping device of claim 3, wherein the distal end of the elastic body is fixedly sleeved on the supporting portion, or a hollow snare structure is sleeved outside the distal end edge of the elastic body, and the snare structure is fixedly sleeved on the supporting portion.
14. The valve clamping device of claim 1, wherein the clamping portion comprises at least two clamping arms symmetrically disposed with respect to the adjustment portion, and the driving portion is connected to each of the clamping arms to drive each of the clamping arms to rotate about the adjustment portion.
15. The valve clamping device of any one of claims 1 to 14, wherein the adjustment portion comprises a plurality of first curved surfaces and a plurality of second curved surfaces, the first curved surfaces and the second curved surfaces are adjacent to each other, two first curved surfaces which are oppositely arranged face one of the clamp arms, and the area of the second curved surfaces is larger than that of the first curved surfaces.
16. The valve clamping device of any one of claims 1 to 14, further comprising a gripping portion disposed between the clamping portion and the adjustment portion and being expandable or closable relative to the adjustment portion, wherein the gripping portion is at least partially received by an inner surface of the clamping portion when both are expanded.
17. The valve clamping device of any one of claims 1 to 14, further comprising a base fixedly attached to the support portion, the clamping portion being pivotally attached to the base.
18. The valve clamping device of claim 17, wherein the actuation portion comprises: the connecting device comprises a driving shaft, a connecting seat and at least two connecting rods; one end of each connecting rod is connected with the clamping part, and the other end of each connecting rod is pivoted with the connecting seat; one end of the driving shaft is connected with the connecting seat, and the other end of the driving shaft is movably arranged in the base in a penetrating mode.
19. The valve clamping device of claim 18, further comprising a locking portion disposed in the base, the locking portion restricting relative movement of the drive shaft and the base.
20. A valve clamping system comprising the valve clamping device of any one of claims 1 to 19, and a delivery device, the delivery device comprising: the pushing shaft is provided with a certain axial length, and the mandrel is movably arranged in the pushing shaft in a penetrating mode, the pushing shaft is detachably connected with the supporting portion, and the mandrel is connected with the driving portion and used for driving the clamping portion to be unfolded and closed relative to the supporting portion.
CN202010192630.9A 2020-03-18 2020-03-18 Valve clamping device and valve clamping system Active CN111904660B (en)

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CN202310195744.2A CN116211543A (en) 2020-03-18 2020-03-18 Valve clamping device and valve clamping system
CN202010192630.9A CN111904660B (en) 2020-03-18 2020-03-18 Valve clamping device and valve clamping system
EP21770911.2A EP4122426A4 (en) 2020-03-18 2021-03-18 Valve clamping device and valve clamping system
PCT/CN2021/081606 WO2021185324A1 (en) 2020-03-18 2021-03-18 Valve clamping device and valve clamping system
BR112022018791A BR112022018791A2 (en) 2020-03-18 2021-03-18 VALVE FIXING DEVICE AND VALVE FIXING SYSTEM
US17/906,641 US20230157819A1 (en) 2020-03-18 2021-03-18 Valve clamping device and valve clamping system

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