CN116211543A - Valve clamping device and valve clamping system - Google Patents
Valve clamping device and valve clamping system Download PDFInfo
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- CN116211543A CN116211543A CN202310195744.2A CN202310195744A CN116211543A CN 116211543 A CN116211543 A CN 116211543A CN 202310195744 A CN202310195744 A CN 202310195744A CN 116211543 A CN116211543 A CN 116211543A
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- Prior art keywords
- valve
- clamping
- adjusting part
- opening
- elastic body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2466—Delivery devices therefor
Abstract
The application relates to a valve clamping system comprising 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; the hollow adjusting part is arranged in the supporting part, one end of the adjusting part is sleeved outside the connecting end and connected with the supporting part, and the other end of the adjusting part is provided with an opening; the clamping part is arranged on the outer side of the adjusting part in a surrounding mode; and the driving part is connected with the clamping part to drive the clamping part to open or close around the adjusting part. The free end of the adjusting part with the opening is not limited by the sealing head, so that the axial deformation capacity of the adjusting part is improved, the axial bending deformation capacity of the adjusting part is enhanced, the adjusting part is easy to be compressed into a sheath, and the adjusting part can adapt to blood vessels with different bending curvatures during conveying, and reduces the damage to the blood vessel walls. After implantation, the axial deformation of the adjusting part is not limited, so that the elastic fit between 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
Technical Field
The present application relates to the field of implanted medical devices, and in particular to a valve clamping device and a valve clamping system comprising the same.
Background
Referring to fig. 1, mitral valve 1 is a one-way valve located between left atrium 2 and left ventricle 3 of the heart, and a normally healthy mitral valve 1 can control blood flow from left atrium 2 to left ventricle 3 while avoiding blood flow from left ventricle 3 to left atrium 2. The mitral valve 1 includes a pair of leaflets, called anterior leaflet 1a and posterior leaflet 1b. Anterior leaflet 1a and posterior leaflet 1b are anchored to the papillary muscles of left ventricle 3 by chordae tendineae 4. Normally, the left ventricle 3 of the heart contracts, and the edges of the anterior leaflet 1a and the posterior leaflet 1b are completely coaptated, avoiding blood flow 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 4 are partially ruptured, the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are poorly coaptated, whereby the mitral valve 1 cannot be fully closed when the left ventricle 3 of the heart contracts, resulting in regurgitation of blood 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 a pair of closable clamp arms toward each other, pulling the anterior and posterior leaflets toward each other, reducing or eliminating leaflet clearance. Referring to fig. 3 and 4, a valve clamping device of the prior art adds an elastic body 20 to two clamp arms 30, and the leaflet on each side is clamped between one clamp arm 30 and one side of the elastic body 20, and the interval between the leaflets is adapted by deformation of the elastic body 20, so as to adjust the pulling degree of the clamp arms 30 on the leaflets. The elastic body 20 comprises a deformable net-shaped main body 21, and two ends of the main body are fixed by seal heads 24 such as steel sleeves and the like and then fixed on a supporting rod between two clamp arms 30. However, since both ends of the elastic body 20 are fixed by the sealing heads 24, when the clamp 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, so that the deformation of the elastic body is influenced, thereby increasing the size of the clamping device in a delivery state, being unfavorable for the passing of the clamping device in a curved blood vessel, and causing the failure of the elastic body to completely adhere to the valve leaflet after the implantation of the clamping device, and having poor adaptability to the physiological structures of the valve leaflets of different patients.
Disclosure of Invention
To solve or at least partially solve the above technical problems, the present application provides a valve clamping device and a valve clamping system comprising the valve clamping device.
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;
the hollow adjusting part is arranged in the supporting part, one end of the adjusting part is sleeved outside the connecting end and connected with the supporting part, and the other end of the adjusting part is provided with an opening and is freely suspended;
the clamping part is arranged on the outer side of the adjusting part in a surrounding mode;
and the driving part is connected with the clamping part to drive the clamping part to open 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 with a certain axial length and a mandrel movably penetrating the pushing shaft are detachably connected with the supporting part, 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 valve clamping device and contain this valve clamping device's valve clamping system, the cavity of regulation portion is located to at least a portion of supporting part, the one end cover of regulation portion is established in the link outside and is connected with the supporting part, the other end of regulation portion is unsettled freely, all be connected between this end of unsettled and supporting part and the conveyor, no longer be limited by supporting part or conveyor, the axial deformability of regulation portion has been improved, the bending deformation ability along the axial has been strengthened simultaneously, therefore when this valve clamping device is compressed into the conveyer by radial direction and carries out the internal transport in vivo, not only easily compressed into the sheath, moreover when carrying in the blood vessel, can adapt to the blood vessel of different bending curvature, thereby do benefit to the conveyer and pass through in the blood vessel, thereby reduced the damage to the blood vessel wall. In addition, after the valve clamping device is implanted, the valve leaflet and the adjusting part are clamped through the forceps arms, and the axial deformation of the adjusting part is not limited, so that the elastic fit between the valve leaflet and the adjusting part can be improved, and 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 invention or the technical solutions of the prior art, the drawings which are used in the description of the embodiments or the prior art will be briefly described, and it will be obvious to a person skilled in the art that other drawings can be obtained from these drawings without inventive effort.
FIG. 1 is a schematic diagram of a mitral valve in a normal state;
FIG. 2 is a schematic illustration of a mitral valve with lesions;
FIGS. 3 and 4 are schematic structural views of a prior art valve clasper apparatus;
FIG. 5 is a schematic view of a valve clamping apparatus according to a first embodiment of the present application;
FIG. 6 is a schematic view of the combined structure of the adjusting portion and the supporting portion in FIG. 5;
FIG. 7 is a schematic view of the structure of the support of FIG. 5;
FIG. 8 is a schematic view of the structure of the adjustment portion of FIG. 5;
FIG. 9A is a schematic view of a tube body for preparing the adjustment portion of FIG. 5 in an example;
FIG. 9B is a schematic view of the frame structure after the tube body in FIG. 9A is cut and formed;
FIG. 9C is a schematic structural view of an exemplary elastic body prepared by cutting;
FIG. 9D is a schematic structural view of another example elastic body prepared by cutting;
FIG. 9E is a partial schematic view of the proximal portion of the elastomeric body of FIG. 9D;
FIG. 9F is a schematic structural view of yet another example elastic body prepared by cutting;
FIG. 10A is a schematic view of an example mesh structure of the conditioning portion of FIG. 5;
FIG. 10B is a schematic view of another example mesh structure of the conditioning portion of FIG. 5;
FIG. 11 is a partial schematic view of an exemplary adjustment portion of FIG. 5 having a ring-like structure;
FIG. 12 is a schematic view of the combined structure of the clamping portion and the driving portion of FIG. 5;
FIG. 13 is a schematic view of the support portion of FIG. 5 mated with a base;
FIG. 14 is a schematic view of the valve clasper device of FIG. 5 mated with a delivery device;
FIG. 15 is a schematic view of the support portion of the valve clasper device of FIG. 5 mated with a delivery device;
FIGS. 16-20 are schematic illustrations of delivery of the valve clasper device of FIG. 5 through an antegrade approach to and repair of a mitral valve via a left atrium;
FIG. 21 is a schematic view of a valve clasper apparatus in accordance with a second embodiment of the present application;
FIG. 22 is a schematic view of the adjustment portion of FIG. 21;
FIG. 23 is a partial schematic view of the distal end of the adjustment portion of FIG. 22;
FIG. 24A is a schematic view of a valve clasper apparatus in accordance with a third embodiment of the present application;
FIG. 24B is a schematic view of a preferred valve clasper apparatus of FIG. 24A;
fig. 25A is a schematic view of a structure of a first curved surface side of an adjusting portion of a valve clasping device in accordance with a fourth embodiment of the present application;
fig. 25B is a schematic view of the structure of the second curved surface side of the adjusting portion in fig. 25A;
FIG. 25C is a top view of the adjustment portion of FIG. 25A;
FIG. 26A is a schematic illustration of a valve clasper apparatus in accordance with a fifth embodiment of the present application;
fig. 26B is a schematic view of the valve clasper device of fig. 26A partially collapsed into a delivery device.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without any inventive effort, are intended to be within the scope of the invention.
In the description of the present invention, it should be noted that the directions or positional relationships indicated by the terms "upper", "lower", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present invention and simplifying the description, and do not indicate or imply that the apparatus or element referred to must have a specific orientation, be constructed and operated in a specific orientation, 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 connecting the distal center and the proximal center of the medical device. The above definitions are for convenience of description only and are not to be construed as limiting the invention.
Referring to fig. 5-20, a valve clasper apparatus 100 in accordance with 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 is 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 enclosed on the outer side of the adjusting part 120; and a driving part 140, wherein the driving part 140 is connected with the clamping part 130 to drive the clamping part 130 to open or close around the adjusting part 120.
With the valve clamping device 100, at least a part of the supporting portion 110 is disposed in the hollow of the adjusting portion 120, one end 121a of the adjusting portion 120 is sleeved outside the connecting end 111 and is connected with the supporting portion 110, the other end 121b of the adjusting portion 120 is free to hang, the free end is not limited by the supporting portion 110 or the conveying device 200 any more, the axial deformation capability of the adjusting portion 120 is improved, and the axial bending deformation capability of the adjusting portion is enhanced, so that when the valve clamping device 100 is radially compressed into the conveyor for in-vivo conveying, the valve clamping device is not only easily compressed into a sheath, but also can adapt to blood vessels with different bending curvatures during conveying in the blood vessels, thereby facilitating the conveyor to pass in the blood vessels, and reducing the damage to the blood vessel walls. In addition, after the valve clamping device 100 is implanted, in the process of clamping the valve leaflet and the adjusting portion 120 by the clamp arm 131, the axial deformation of the adjusting portion 120 is not limited, so that the elastic fit between the valve leaflet and the adjusting portion 120 can be improved, and the adaptability of the physiological structures of the valve leaflets of different patients can be improved.
Referring to fig. 6 and 7, the supporting portion 110 may be a circular tube with two axially penetrating end surfaces, and a distal end of the circular tube is a connection end 111 and a proximal end is a free end 112. At least a part of the supporting portion 110 is provided in the hollow of the adjusting portion 120, for example, the free end 112 of the supporting portion 110 is provided in the adjusting portion 120, and the free end 112 is provided in the adjusting portion 120 in both the transport state and the expanded state without exposing the adjusting portion 120. The support portion 110 is further provided with an axial through-hole-shaped penetration passage 113 to be coupled with the driving portion 140 and the conveying device 200. At least two clamping positions 114 are arranged on the pipe wall of the circular pipe body of the supporting part 110 and are used for being detachably connected with the conveying device 200. For example, after the clamping table 221 (see fig. 14) on the delivery device 200 is clamped into the clamping position 114, the delivery device 200 is in clamping connection with the supporting portion 110, so that the delivery device 100 can be delivered, and when the clamping table 221 is separated from the clamping position 114, the delivery device 200 is separated from the valve clamping device 100 and released in the body. It should be understood that the support portion 110 structure herein is only used as an example and not limiting, and that other support portion 110 structures adopted by those of ordinary skill in the art based on the teachings of the present application are within the scope of the present application.
The valve clasper device 100 of the present application is positioned within the hollow adjustment portion 120 in either the delivery state or the release deployment state of the proximal free end 112, and therefore is not exposed to the delivery device 200 or the heart all the time, thereby avoiding blood washout and minimizing thrombus formation after implantation. And after implantation, direct contact with the valve leaflet is avoided, long-term pulsation of the valve leaflet is accompanied, abrasion and even perforation of the valve leaflet are avoided, and the safety of implantation of a patient is improved.
Referring to fig. 6 and 8, the adjusting portion 120 includes a deformable elastic body 123, the elastic body 123 having 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 suspended freely. The elastic body 123 is deformable so as to accommodate the spacing between the different leaflets and adjust the extent to which the valve clamping device 100 is pulled against the leaflets. The opening 122 of the elastic body 123 is used to insert 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 passing through the lumen 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 either the distal end of the delivery device 200 or the proximal end (free end) of the support portion 110, i.e., the proximal end 121b of the elastic body 123 is free to hang. Therefore, in the conveying process or the process of clamping the valve leaflet, when the clamping part 130 is closed, the elastic body 123 in the adjusting part 120 is not limited by the supporting part 110 or the conveying device 200, and can deform in the radial direction and the axial direction, so that the deformation degree is larger, the conveying is facilitated, and the adaptability to the valve leaflet is stronger; when the distal end of the delivery device 200 or the proximal end (free end) of the support portion 110 is disconnected, the free-floating end of the adjustment portion 120 is more deformable and more adaptable to the valve leaflet.
In one embodiment, the elastic body 123 is a mesh structure that may be woven from shape memory materials, such as a superelastic nickel titanium alloy material, and may be heat set to form a compressed state and an expanded state, and may be held in the delivery device 200 in the compressed state and may be released in vivo to hold the expanded state. In one embodiment, the elastic body 123 of the mesh structure is formed by braiding, and 12-36 nickel titanium wires with diameters of 0.02-0.15mm are wound on the backing rod during manufacturing, so that a tubular braided net is formed by braiding, and the tubular braided net is provided with a proximal end and a distal end which are oppositely arranged. At the proximal end, the plurality of wires 124 are folded back into a plurality of loops, the plurality of loops are looped around to form the proximal edge, and then one wire is threaded through all loops of the proximal end in sequence followed by a moderate tightening of the wires, but leaving an opening of moderate size. Then, the shaping mould is plugged from the far end of the woven net, and then the nickel titanium wires at the far end are wound into a bundle by using metal wires; placing the woven mesh and the shaping mould into an electric heating type circulating air box furnace to perform heat shaping treatment for 10-20 minutes under the condition of 450-650 ℃ (preferably 500 ℃); and taking out and cooling to room temperature, removing the metal wires at the proximal end and the distal end, taking out the shaping die, plugging all the nickel titanium wires at the distal end into a seal head made of stainless steel, and crimping 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, prevents thrombus from forming inside the elastic body 123 and ensures 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 adopts a laser cutting mode. In the process of manufacturing, the nickel-titanium tube 126 is cut into a required shape by a laser cutting machine. And pressing the nickel-titanium piece obtained by cutting into a shaping die with a certain shape. Then placing the nickel-titanium piece and the shaping mould into an electric heating type circulating air box furnace for shaping heat treatment for 10-20 minutes under the condition of 450-650 ℃ (preferably 500 ℃); after being taken out and cooled to room temperature, the shaping die is removed to obtain a shaped elastic main body 123 which is of a frame structure and comprises a plurality of support rods 127 which are radially arranged at intervals and axially extend, and the proximal ends of the support rods 127 are gathered to form free suspended proximal edges. Distal ends of the plurality of struts 127 converge and are welded to the support 110. The nickel-titanium tube is a tube with a certain wall thickness, in particular, the wall thickness of the nickel-titanium tube is less than 1mm, preferably 0.02-0.15mm, and has certain flexibility and rigidity.
Referring to fig. 9C, the elastic body 123 is a frame structure formed by cutting, and is formed by connecting a plurality of struts 127 in a matching manner, the proximal end 121b of the elastic body 123 is an open structure, and the proximal edges of all struts 127 at the proximal end 121b of the frame structure are enclosed 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 being cooperatively connected, the proximal end 121b of the elastic body 123 is an open structure, and 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 with each other by flexible wires 129 to form openings 122.
Referring to fig. 9F, the elastic body 123 is still a frame structure formed by a plurality of struts 127 cooperatively connected, and 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 then crosslinked with each other, for example, adjacent struts 127 at the edge of the proximal end 121b are cut and then crosslinked with each other to form an annular structure 129.
Of course, the elastic body 123 of the adjusting portion 120 may also be other hollow structures with elasticity, for example, the elastic body 123 may be a compact structure or a porous structure, the compact structure is a silica gel, the porous structure is a sponge, and the proximal edge of the compact structure or the porous structure forms the 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 cylinder, a cone, a sphere, a oblate sphere, an ellipsoid, a sphere of a fan, or a gourd shape, and may be a combination of various shapes. To avoid the elastic body 123 from affecting the relative opening and closing between the clamping arms 151 and the jawarms 131 and the support 110, and from affecting the clamping 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, both ends are tapered, and taper angles of the tapered portions of both ends are the same. It will be appreciated that in other embodiments, the resilient body 123 may be of any other shape, provided that the diameter of the distal end does not affect the gripping effect. For example, a spindle structure in which taper angles at both ends are the same as shown in fig. 10A, or a structure in which taper angles at both ends are different as shown in fig. 10B.
The adjustment portion 120 includes a proximal end and a distal end, and in one embodiment, a hollow snare structure (not shown) is sleeved on the proximal edge of the elastic body 123 to form an opening, and the snare structure may be an existing end closure 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 mesh of the mesh structure or the struts of the frame structure are properly gathered toward the central axis, but are not closed, so that an opening 122 is formed 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 protrude out of the adjusting portion 120 in both the compressed state and the expanded state.
The proximal edge of the elastic body 123 is wrapped to form the opening 122 in various manners, in a specific embodiment of the present invention, the mesh structure 123 is formed by braiding and heat setting nickel-titanium alloy wires, and the wires 124 of the mesh structure 123 are bent and wrapped around at the proximal end to form the proximal edge, that is, all the wires 124 are wrapped around the wrapped portion of the proximal edge to form the opening 122, and the shape of the wrapping may be set as required, for example, one wrapping, or multiple wrapping to form at least one ring-shaped back wrapping, and so on, which will not be repeated herein.
The proximal edge of the elastic body 123 is surrounded to form an opening 122, so that the proximal end socket of the adjusting part 120 of the valve clamping device 100 is eliminated, and when the clamping part 130 is closed, the elastic body 123 can deform in both the radial direction and the axial direction, so that the deformation degree is high, and the conveying is facilitated; in addition, the elastic body 123 is not limited by the axial movement of the end enclosure to each mesh or strut, so that the elastic body can be moderately curled or bent, thereby completely attaching the valve leaflet and better adapting to the physiological structures of the valve leaflets of different patients; in addition, the risk that the proximal end socket 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 supporting 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 supporting portion 110 (i.e., the axial line of the elastic body 123), and therefore, the self-centering property is good, and the inclination is not easy.
Further, referring to fig. 11, the adjusting portion 120 may further include an annular structure 125 disposed at the proximal edge to stabilize the shape of the opening 122, and all the wires 124 of the mesh structure 123 at the proximal end are wound around the annular structure 125. The ring structure 125 is made of a flexible or elastic material having a wire diameter greater than the wire diameter of the mesh wires of the woven mesh structure 123, thereby providing a certain supporting force to the openings 122 of the mesh structure 123, but without affecting the axial deformability and bending capability of the mesh structure 123.
The distal end of the adjustment portion 120 is fixedly connected to the support portion 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 supporting portion 110. The snare structure of distal end 121a (e.g., the closure head at distal end 121a in fig. 8) is secured to support portion 110 by welding, adhesive, threaded connection, crimping, bolting, etc. as is commonly known in the art, and may be preferably welded.
Referring to fig. 12 and 13, the clamping portion 130 includes at least two clamp arms 131, and may generally include at least one set of clamp arms 131, each set of clamp arms 131 including two clamp arms 131 symmetrically disposed with respect to the adjustment portion 120, the clamping portion 130 including one set of clamp arms 131, it being understood that this is by way of example only, and one of ordinary skill in the art may select an appropriate number of clamp arms 131, such as two or more sets of clamp arms, as desired. The driving part 140 is connected to each of the jawarms 131, for example, the driving part 140 is connected to two of the jawarms 131 in a group of the jawarms 131, respectively, to drive each of the jawarms 131 to rotate about the adjusting part 120. It will be appreciated that three or more arms 131 may also be provided in each set as desired, for example, three leaflets of a tricuspid valve may be clamped by three opposed openable and closable arms 131, to treat tricuspid regurgitation.
In the delivery state, the driving part 140 drives the clamp arm 131 to close around the adjusting part 120, so that the outer diameter of the valve clamping device 100 is reduced, and the delivery is facilitated; after the valve clamping device 100 is deployed in the body, the driving part 140 drives the clamp arms 131 to clamp the valve leaflet between the clamp arms 131 and the adjusting part 120, so that the valve leaflet is clamped.
In a preferred implementation of this embodiment, the valve clamping device 100 further includes a gripping portion, which may generally include at least one set of gripping arms 151, where each set of gripping arms 151 includes two gripping arms 151 symmetrically disposed with respect to the adjustment portion 120, and the gripping portion (e.g., gripping arms 151) is disposed between the clamping portion 130 (e.g., the clamp arm 131) and the adjustment portion 120 and can be opened or closed with respect to the adjustment portion 120, and when both the gripping portion and the clamping portion 130 are opened, the gripping portion is at least partially accommodated on an inner surface of the clamping portion 130. Of course, three or more gripping arms 151 may be provided in each set as desired to cooperate with the jawarms 131 to achieve the clamping function.
In the delivery state, the gripping portion is at least partially received in the inner surface of the clamping portion 130, i.e. the gripping arms 151 are at least partially received in the inner surface of the clamp arms 131, thereby reducing the outer diameter of the valve clamping device 100, facilitating delivery; after the clamp arm 131 cooperates with the gripping arm 151 to grip the leaflet, the concave inner surface can increase the contact area of the clamp arm 131 with the leaflet and allow the gripping arm 151 to grip the leaflet in the inner surface of the clamp arm 131 of the flap She Yaru to increase the gripping force against the leaflet.
Still referring to fig. 12 and 13, the valve clamping device 100 further includes a base 160 fixedly coupled to the support portion 110, and the clamping portion 130 is rotatably coupled 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 this portion is defined herein as the term "base" for convenience of description, and the structure for implementing the function of the base 160 may also be the distal end of the supporting portion 110, i.e. an integral structure formed with the supporting portion 110, so that the definition of the term "base" should not limit the scope of the present application. Each of the jawarms 131 in each set are connected together at a base 160 by a pivot 132 such that each of the jawarms 131 cooperate with each other to be able to be opened and closed together about the adjustment member 120 upon actuation of the actuation member 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; 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 connection seat 142, and the other end is movably installed in the base 160. Specifically, one end of each link 143 is connected to one jawarm 131, and the other end is connected to the connection base 142 through a pivot 144, i.e., each jawarm 131 is rotatably connected to the distal end of the connection base 142 of the driving shaft 141 through the link 143 on the corresponding side. The driving shaft 141 movably penetrates through the base 160, and when the driving shaft 141 axially slides relative to the base 160, the connecting rod 143 rotates and drives the jawarms 131 to open and close relative to the base 160.
Specifically, the driving portion 140 includes at least one set of links 143, and the number of links 143 is set in a one-to-one correspondence with the setting of the jawarms 131, for example, two of the jawarms 131 are used in the figure, and two links 143 that cooperate are correspondingly set. The distal end of the link 143 is rotatably coupled to the coupling seat 142 at the distal end of the drive shaft 141 by means of a rotation pin or bolt 144 or the like. When the drive shaft 141 is slid distally in an axial direction relative to the base 160, the link 143 is moved, and the jawarms 131 are rotated about the pin holes 144 to open relative to the base 160 by the pulling of the link 143. When the drive shaft 141 is slid proximally in an axial direction relative to the base 160, the linkage 143 pulls the jawarms 131 to rotate about the pin holes 144 to close relative to the base 160.
The connecting seat 142 is fixedly arranged at the distal end of the driving shaft 141 by welding or the like, and the connecting seat 142 is provided with a pair of pins. The pin hole is used for being hinged with the connecting rod 143 through the pin 144, and the other end of the connecting rod 143 is connected with the clamp arm 131, so that the clamp arm 131 can be opened and closed relative to the base 160. The shape of the connecting seat 142 is any structure such as a hemisphere, a spherical cap or a bullet, so that the valve clamping device 100 is easier to push in the body. The driving shaft 141 and the connecting seat 142 may be integrally formed or may be non-integrally formed. To ensure safety after implantation, the driving shaft 141 and the connecting seat 142 are made of biocompatible materials 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 clasper device 100 further includes a locking portion 170 disposed in the base 160, the locking portion 170 limiting relative movement of the drive shaft 141 and the base 160. In the conveying state, the locking part 170 limits the relative movement of 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 unexpected unfolding of the clamping part 130; after reaching the vicinity of the mitral valve, the clamping portion 130 is driven by the driving portion 140 to expand and support the leaflet with respect to the adjusting portion 120 and the supporting portion 110 by unlocking the restriction of the driving shaft 141 by the locking portion 170. Any suitable locking means may be used, and will not be described in detail here.
Referring to fig. 14 and 15, the valve clamping system of the present embodiment includes the valve clamping device 100 described above, and a delivery device 200, wherein the delivery device 200 includes: a pushing shaft 210 having a certain axial length, and a mandrel (not shown) movably installed in the pushing shaft 210, wherein the pushing shaft 210 is detachably connected with the supporting portion 110, and the mandrel is connected with the driving portion 140 for driving the clamping portion 130 to be opened and closed relative to the supporting portion 110. In this embodiment, the proximal end of the drive shaft 141 is externally threaded and the spindle is threadably coupled to the drive shaft 141 to control axial movement of the drive shaft 141 outside the patient's body via the spindle. It should be appreciated that only a portion of the structure of the delivery device is listed herein, and any other portion may be implemented in any suitable structure that is not described herein.
Specifically, at least one clamping position 114 connected to the lumen of the supporting portion 110 is symmetrically provided on the outer wall of the proximal end of the supporting portion 110, a fixing member 220 is provided on the distal end of the pushing shaft 210, and the fixing member 220 includes two branches, and each branch has a protruding clamping stage 221 at its end. In the natural state, both branches are directed at the central axis of the fixture 220. During assembly, the fixing member 220 is inserted into the supporting portion 110, and then 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 blocks 221 at the tail 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, namely, the valve clamping device 100 and the delivery device 200 are connected. When the mandrel is withdrawn from the holder 220 and the pushing shaft 210, the two branches resume their natural state inwards, and the catch 221 is disengaged from the catch 114 of the support 110, so that the valve clamping device 100 and the delivery device 200 are disconnected. The fixing member 220 is made of a material having a certain hardness and elasticity, such as nickel titanium. The pushing shaft 210 may employ a multi-layered composite tube. The mandrel is made of stainless steel materials.
The support portion 110 has a through hole as a penetration passage 113 of the driving shaft 141, and the driving shaft 141 is slidably penetrated in the penetration passage 113 of the support portion 110 in the axial direction. The proximal end of the drive shaft 141 is provided with external threads for connection with a spindle of the delivery device 200 to control axial movement of the drive shaft 141 via the spindle. After the clamping part 130 and the grasping part 150 are matched and clamp valve tissues, the mandrel drives the driving shaft 141 to axially and proximally move, the driving shaft 141 drives the connecting rod 143 to rotate, and the connecting rod 143 drives the clamp arm 131 to fold relative to the supporting part 110 until the clamp arm 131 is completely closed relative to the supporting part 110, so that the valve clamping device 100 is in a folded and closed state and falls below a valve. The connection between the mandrel and the drive shaft 141 can then be released, the mandrel is withdrawn from between the fixtures 220, and the catch 221 is separated from the catch 114 of the support 110, thereby releasing the valve clamping device 100 and the delivery device 200. During the disengagement, since the junction (i.e., the disengagement) of the valve clamping device 100 and the delivery device 200 is located within the adjustment portion 120 of the valve clamping device 100, the proximal end of the adjustment portion 120 is provided with an open opening 122, and no component can hook the clamping stand 221 of the branch end of the fixing member 220, facilitating the release of the valve clamping device 100. In addition, the release part is arranged in the adjusting part 120, and is not directly washed by blood, so that the failure of a mechanism of the release part can be avoided, and the risk of thrombus formation can be reduced.
Referring to fig. 16-20, the use of the valve clamping device 100 of the present application is illustrated with respect to the anterograde approach and repair of the mitral valve via the left atrium:
the first step: as shown in fig. 16, the drive shaft 141 and the valve clasper device 100 connected thereto are advanced from the left atrium 2, through the mitral valve 1, and to the left ventricle 3 by a guiding device (not shown) such as an adjustable curved sheath;
and a second step of: adjusting the valve clamping device 100 to approximate the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1;
and a third step of: as shown in fig. 17, the locking part in the base 160 is unlocked, the mandrel and the driving shaft 141 are pulled proximally, the clamp arm 131 is driven to open relative to the supporting part 110, and the direction of the clamp arm 131 is adjusted, at this time, the relative positions of the clamp arm 131 and the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 can be observed by the X-ray device, so that the clamp arm 131 is perpendicular to the involution line of the mitral valve 1;
fourth step: as shown in fig. 18, the whole valve clamping device 100 is retracted proximally, so that the clamp arms 131 hold the valve leaflet 1 on the left ventricle 3 side, the two holding arms 151 are released, and the holding arms 151 on each side press the valve leaflet 1 on the atrial side and cooperate with the clamp arms 131 on the side to fix the valve leaflet 1, thereby realizing complete clamping of the valve leaflet 1;
fifth step: as shown in fig. 19, when the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are respectively clamped between the pair of forceps arms 131 and the grasping arm 151, the mandrel and the driving shaft 141 are pushed distally, thereby driving the forceps arms 131 to close;
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 piece 220 are restored to a state of being close 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 conveying device 200 is released, the conveying device 200 is withdrawn from the body to obtain the implantation state shown in fig. 20, at this time, the valve clamping device 100 pulls the front leaf 1a and the rear leaf 1b of the mitral valve 1 to each other to obtain a double-hole mitral valve, and the edge-to-edge repair of the mitral valve is completed.
After the valve clamping device 100 is implanted, the elastic adjusting part 120 is filled between the front leaflet 1a and the rear leaflet 1b of the clamped mitral valve 1 and is propped against the clamp arm 131, and the elastic main body 123 (such as a net structure or a porous structure) of the adjusting part 120 has a buffering effect on the beating leaflet 1, so that the adjustable pulling degree of the valve clamping device 100 on the leaflet 1 is realized, and the leaflet 1 is prevented from being damaged; in addition, the elastic body 123 can be extruded 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, and at the moment, the axial movement of the elastic body 123 towards the proximal end is not limited due to the opening 122 structure 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 forceps arms 131, so that the traction of the valve clamping device 100 to the valve leaflet 1 can be reduced, and the traction degree of the valve clamping device 100 to the valve leaflet 1 is always kept within a reasonable range; in addition, the elastic body 123 can buffer the direct scouring 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 scouring of the blood, and can also prevent the blood from being deposited at dead corners (at C in fig. 5) between the clamping parts 130 of the valve clamping device 100 to form thrombus; in addition, when the elastic body 123 receives 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 grasped, the elastic body 123 receives the extrusion force of the clamp arm 131 to act on the clamp arm 131 in turn, and the grasping effect of the valve clamping device 100 on the valve leaflet 1 after release is ensured to be consistent with that before release.
Referring to fig. 21-23, in contrast to the valve clasper device of the first embodiment, the mesh structure of the adjustment portion 320 of the valve clasper device 300 in accordance with the second embodiment of the present invention is such that all of the mesh wires 324 at the distal end 321 are fixedly positioned over the support portion 310. That is, both ends 322 and 321 of the adjusting portion 320 are open structures without sealing heads, and the adjusting portion 320 directly fixes the mesh 324 of the distal end 321 of the adjusting portion 322 on the supporting portion 310 through common detachable or non-detachable connection modes such as welding, bonding, crimping and the like during assembly, and the welding connection is preferred in this embodiment.
As the clamping portion 330 (e.g., jawarms) is opened or closed, it is rotated about a pivot 332 (e.g., pin) near the distal side of the adjustment portion 320. As the nip 330 closes, the closer to the pivot 332, the less space there is. When the leaflet is clamped by the clamping portion 330, a part of the leaflet 1 fills the space accumulated at the position D, which not only affects the closing of the valve clamping device, but also causes serious damage to the leaflet 1 at the position when the leaflet 1 at the position cannot be found in time to forcibly close the valve clamping device. In this embodiment, since the distal end 321 of the adjustment portion 320 is also an open structure without a sealing head, the adjustment portion 320 can better conform to the deformation of the leaflet 1 during the closing of the valve clasper 300. At the same time, the adjustment 320 reduces the hard head, thereby increasing the space there, which is advantageous for better closure of the entire valve clasper device 300 after grasping the leaflet 1.
Referring to fig. 24A, in comparison with the valve clamping device of the first embodiment, the valve clamping device 400 according to the third embodiment of the present invention has a coating applied to at least a portion of the outer surface of the mesh structure of the adjustment portion 420. In addition, a coating may be applied to at least part of the outer surfaces of the nip portion 430 and the grip portion 450. The coating film can be in a woven net structure and is provided with a plurality of meshes. The coated adjusting part 420, the clamping part 430 and the grasping part 450 have higher biocompatibility and enhanced friction force, so that the clamping effect on the valve leaflet is better.
For example, referring to fig. 24B, the grip arm 451 and the clamp arm 431 are covered with a first coating and a second coating, respectively, and the elastic body of the adjustment portion 420 is covered with a third coating. The relation of the opening ratios of the three is as follows: the third coating has an aperture ratio < that of the first coating and < that of the second coating. The aperture ratio is the percentage of the open area to the whole covered area. The aperture ratio of the second coating is larger, so that the second coating has better elasticity and elongation than the first coating, and when the clamp arm covered with the second coating is opened relative to the fixed base, the second coating can follow the opening and closing of the clamp arm to generate corresponding elastic deformation, and the second coating is always attached to the clamp arm. The third coating has a minimal open cell content such that the elastomeric body substantially blocks blood flow therethrough.
The mesh openings on the first and second membranes pass through blood and prevent thrombus from passing through, and the mesh opening on the third membrane passes through neither blood nor thrombus. The first covering film can allow blood to permeate through, normal flow of blood from the left atrium to the left ventricle is not affected, blood is prevented from being detained in the left atrium, and therefore damage of blood pressure to a cavity of the left atrium is reduced; the first covering film can also increase the contact area between the holding arms and blood so as to buffer the inflow blood flow, thereby avoiding the slipping caused by the deformation of the holding arms due to the impact of the inflow blood flow on the valve clamping device as much as possible. The second coating can enable blood flow to normally circulate 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 valve clamping device through the first coating and stay in the valve clamping device, so that the thrombus is prevented from entering the left ventricle and entering the blood circulation of the human body to induce stroke.
The elastic body with the third coating not only increases biocompatibility, avoids tissue allergy and inflammatory reaction and improves product safety, but also can form an artificial barrier on the atrial side of the valve leaflet to block thrombus in blood, close the opening of the whole valve clamping device towards the atrial side, and avoid repeated scouring of blood at the internal dead angle of the valve clamping device to form thrombus, thereby avoiding thrombus.
The first film, the second film and the third film can be made of polymer materials such as polyethylene terephthalate, polypropylene, polytetrafluoroethylene, polyurethane and the like, and the materials of the first film, the second film and the third film can be the same or different, and in the embodiment, all the three films are made of PET.
Referring to fig. 25A-25C, compared with 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 hanging end and a distal end cap 521, the free hanging 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 smoothly connected together, i.e., the first curved surfaces 520A are adjacent to the second curved surfaces 520B, the second curved surfaces 520B are adjacent to the first curved surfaces 520A, two first curved surfaces 520A disposed opposite to each other face one clamp arm, and the second curved surfaces 520B have an area larger than that of the first curved surfaces 520A.
In this embodiment, the first curved surface 520A with a relatively smaller area faces the forceps arm, the second curved surface 520B with a relatively larger 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 part is extruded by the forceps arm and the valve leaflet, and the adjusting part extends along the direction of the second curved surface 520B and gradually fits the valve leaflet, so that the shape of the valve leaflet is better adapted, the contact area between the first curved surface 520A and the valve leaflet is increased, the gap between the valve clamping device and the valve leaflet is reduced, and the blood flow is slowed down and the scouring of the valve clamping device by the blood flow is hindered. Preferably, the curvature of the first curved surface 520A may be greater than the curvature of the second curved surface 520B, so that the adjusting portion has a flat elliptic shape, thereby avoiding affecting the closing of the jawarms. Further, in this embodiment, when the forceps arms are closed, the forceps arms and the valve leaflets are pressed, the first curved surface 520A of the adjusting portion is pressed, the adjusting portion extends along the direction of the second curved surface 520B, and the distal end of the delivery system is not hooked due to the open arrangement of the first end of the adjusting portion, so that the valve clamping device can be ensured to be separated from the connection position of the delivery device of the valve clamping device under the condition that the adjusting portion is deformed arbitrarily.
Referring to fig. 26A and 26B, compared with the valve clamping device of the first embodiment, the structure of the adjusting portion 620 of the valve clamping device 600 according to the fifth embodiment of the present invention is the same as that of the adjusting portion 120 of the first embodiment, except that the clamping portion 630 and the grasping portion 650 are engaged to grasp the leaflet. In the fifth embodiment, the clamping portion 630 includes a set of clamp arms 631 that can be opened and closed with respect to the supporting portion 610 and the adjusting portion 620, the gripping portion 650 includes a pair of gripping arms 651, and the gripping portion 650 is located between the clamping portion 630 and the adjusting portion 620.
During delivery, the clamping portion 630, the gripping portion 650 and the adjustment portion 620 are all housed within the distal end of the delivery device 200, the delivery device 200 is delivered through the transapical approach to the left ventricle and then passed across the mitral valve orifice to the left atrium, and the delivery device 200 is retracted such that the adjustment portion 620 and the gripping portion 650 gradually extend out of the delivery device 200 and deploy within the left atrium; continued withdrawal of the delivery device 200 until the nip 630 also extends from the delivery device 200 and deploys within the left ventricle; then pushing the clamping part 630 to the distal end through the driving part, respectively supporting the anterior leaflet and the posterior leaflet of the mitral valve on the inner surfaces of two clamp arms 631 of the clamping part 630, retracting the grasping part 650 and the adjusting part 620 to the proximal end, namely, driving the grasping part 650 to move towards the clamping part 630 so as to capture the leaflet between the grasping part 650 and the clamping part 630, and then driving the clamping part 630 to close relative to the adjusting part 620 and the supporting part 610, thereby respectively fixing the anterior leaflet and the posterior leaflet between one clamp arm 631 and one grasping arm 651 corresponding to the clamp arm 631, and pushing the conveying device 200 to the distal 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, pulling the anterior and posterior leaflets of the mitral valve toward each other to form a double-porous structure.
It will be appreciated that a valve clamping system according to the present application includes any of the valve clamping devices described above and a delivery device capable of delivering the valve clamping device from outside the body to the vicinity of the mitral valve and clamping the leaflets. The above description of the valve clamp device is intended to be illustrative only and not limiting of the present application, and valve clamp devices and valve clamp systems incorporating the same, as would be within the purview of one of ordinary skill in the art based on the teachings herein.
It should be noted that in this document, relational terms such as "first" and "second" and the like are 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. Moreover, 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 one … …" does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises the element.
The foregoing is only a specific embodiment of the invention to enable those skilled in the art to understand or practice the 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 (10)
1. A valve clasper apparatus, comprising:
the support part comprises a connecting end and a free end which are oppositely arranged;
the hollow adjusting part is arranged in the supporting part, one end of the adjusting part is sleeved outside the connecting end and connected with the supporting part, and the other end of the adjusting part is provided with an opening and is freely suspended;
the clamping part is arranged on the outer side of the adjusting part in a surrounding mode;
and the driving part is connected with the clamping part to drive the clamping part to open or close around the adjusting part.
2. The valve clasper device of claim 1, wherein the size of the opening is less than or equal to the size of the free end of the support portion.
3. The valve clasper device of claim 1, wherein the opening is for threading a distal end of a delivery device.
4. A valve clamping device according to claim 3, wherein the other end of the adjustment portion is deformable both radially and axially relative to the support portion or the delivery device through the opening.
5. The valve clasper of claim 1, wherein the adjustment portion further comprises an annular structure disposed at the proximal edge to stabilize the morphology of the opening.
6. The valve clasper of claim 1, wherein the other end of the adjustment portion having the opening and free to hang has a greater deformability than the one end of the adjustment portion that is sleeved outside the connection end and connected to the support portion.
7. The valve clasper of claim 1, wherein the adjustment portion is an elastic body, one end of the elastic body is connected to the support portion, and the other end of the elastic body has the opening and is free to hang.
8. The valve clasper of claim 7, wherein the free end of the support is located within the elastomeric body.
9. The valve clasper of claim 7, wherein the adjustment portion comprises a plurality of first curved surfaces surrounding the opening and a plurality of second curved surfaces, the first curved surfaces and the second curved surfaces being adjacent to each other, the two first curved surfaces disposed opposite each other facing one of the clamp arms, the second curved surfaces having an area greater than an area of the first curved surfaces.
10. A valve clamping system comprising the valve clamping device of any one of claims 1 to 9, and a delivery device comprising: the pushing shaft is detachably connected with the supporting part, and the mandrel is connected with the driving part and is used for driving the clamping part to be unfolded and closed relative to the supporting part.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN202310195744.2A CN116211543A (en) | 2020-03-18 | 2020-03-18 | Valve clamping device and valve clamping system |
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| Application Number | Priority Date | Filing Date | Title |
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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 |
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| CN202010192630.9A Division CN111904660B (en) | 2020-03-18 | 2020-03-18 | Valve clamping device and valve clamping system |
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| CN116211543A true CN116211543A (en) | 2023-06-06 |
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| CN202010192630.9A Active CN111904660B (en) | 2020-03-18 | 2020-03-18 | Valve clamping device and valve clamping system |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8449599B2 (en) | 2009-12-04 | 2013-05-28 | Edwards Lifesciences Corporation | Prosthetic valve for replacing mitral valve |
| EP3226810A4 (en) | 2014-12-04 | 2018-08-15 | Edwards Lifesciences Corporation | Percutaneous clip for repairing a heart valve |
| US10517726B2 (en) | 2015-05-14 | 2019-12-31 | Edwards Lifesciences Corporation | Heart valve sealing devices and delivery devices therefor |
| US10799675B2 (en) | 2016-03-21 | 2020-10-13 | Edwards Lifesciences Corporation | Cam controlled multi-direction steerable handles |
| US10653862B2 (en) | 2016-11-07 | 2020-05-19 | Edwards Lifesciences Corporation | Apparatus for the introduction and manipulation of multiple telescoping catheters |
| ES2906137T3 (en) | 2017-04-18 | 2022-04-13 | Edwards Lifesciences Corp | Heart valve sealing devices and delivery devices therefor |
| US11224511B2 (en) | 2017-04-18 | 2022-01-18 | Edwards Lifesciences Corporation | Heart valve sealing devices and delivery devices therefor |
| US11051940B2 (en) | 2017-09-07 | 2021-07-06 | Edwards Lifesciences Corporation | Prosthetic spacer device for heart valve |
| US11040174B2 (en) | 2017-09-19 | 2021-06-22 | Edwards Lifesciences Corporation | Multi-direction steerable handles for steering catheters |
| US10111751B1 (en) | 2018-01-09 | 2018-10-30 | Edwards Lifesciences Corporation | Native valve repair devices and procedures |
| EP3964175A1 (en) | 2018-01-09 | 2022-03-09 | Edwards Lifesciences Corporation | Native valve repair devices and procedures |
| US10231837B1 (en) | 2018-01-09 | 2019-03-19 | Edwards Lifesciences Corporation | Native valve repair devices and procedures |
| US10945844B2 (en) | 2018-10-10 | 2021-03-16 | Edwards Lifesciences Corporation | Heart valve sealing devices and delivery devices therefor |
| CN114206264A (en) | 2019-02-14 | 2022-03-18 | 爱德华兹生命科学公司 | Heart valve sealing device and delivery device thereof |
| US20230157819A1 (en) * | 2020-03-18 | 2023-05-25 | Hangzhou Valgen Medtech Co., Ltd | Valve clamping device and valve clamping system |
| WO2022083027A1 (en) * | 2020-10-21 | 2022-04-28 | 江苏臻亿医疗科技有限公司 | Adjustable and removable valve clamping device |
| CN113230001B (en) * | 2021-06-28 | 2024-03-01 | 广东脉搏医疗科技有限公司 | Valve clamping device |
| CN113244031B (en) * | 2021-07-15 | 2021-09-24 | 上海御瓣医疗科技有限公司 | Medical self-locking structure |
| CN113662713A (en) * | 2021-08-18 | 2021-11-19 | 复旦大学附属中山医院 | Valve backflow blocking device |
| CN115919507A (en) * | 2021-08-19 | 2023-04-07 | 深圳市健心医疗科技有限公司 | tissue clamping system |
| WO2023091520A1 (en) * | 2021-11-19 | 2023-05-25 | Edwards Lifesciences Corporation | Heart valve repair devices |
| CN116250965A (en) * | 2021-12-10 | 2023-06-13 | 杭州德晋医疗科技有限公司 | Tissue clamping device and tissue clamping system |
| CN117323066B (en) * | 2023-12-01 | 2024-03-19 | 杭州德晋医疗科技有限公司 | Valve clamping device |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106491245B (en) * | 2015-09-06 | 2018-08-07 | 先健科技(深圳)有限公司 | Valve clamping device |
| ES2906137T3 (en) * | 2017-04-18 | 2022-04-13 | Edwards Lifesciences Corp | Heart valve sealing devices and delivery devices therefor |
| US10898180B2 (en) * | 2017-07-31 | 2021-01-26 | Hangzhou Valgen Medtech Co., Ltd. | Heart valve repair method |
| CN110495972A (en) * | 2018-05-17 | 2019-11-26 | 杭州德晋医疗科技有限公司 | Valve clamping machine and valve clamping system |
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| CN111904660A (en) | 2020-11-10 |
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