CN120203876A - Valve clipping device - Google Patents
Valve clipping device Download PDFInfo
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- CN120203876A CN120203876A CN202311806250.XA CN202311806250A CN120203876A CN 120203876 A CN120203876 A CN 120203876A CN 202311806250 A CN202311806250 A CN 202311806250A CN 120203876 A CN120203876 A CN 120203876A
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- Prior art keywords
- clamping
- valve
- arm
- clamping member
- clamping arm
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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
- A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
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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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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The application discloses a valve clamping device, which comprises a main body part, a pair of clamping pieces and a clamping piece arranged between the main body part and the clamping pieces, wherein the clamping pieces are arranged on the outer side of the main body part in a surrounding mode and can be unfolded or closed relative to the main body part by taking one end as a center, the clamping piece comprises two clamping arms which can be operated to move relative to the clamping pieces, the clamping pieces and the clamping arms are respectively provided with a bending part, and the bending parts of the clamping pieces and the bending parts of the clamping arms are matched to clamp valve leaflets of a valve.
Description
Technical Field
The application relates to the technical field of medical equipment, in particular to a valve clamping device.
Background
The atrioventricular valves, such as mitral valve, tricuspid valve, are one-way valves within the heart that allow normal healthy atrioventricular valves to control blood flow from the atrium to the ventricle while avoiding blood flow from the ventricle to the atrium. For example, the mitral valve is a one-way valve located between the left atrium and the left ventricle of the heart that can control the flow of blood from the left atrium to the left ventricle while avoiding the flow of blood from the left ventricle to the left atrium. Specifically, the mitral valve includes a pair of leaflets, anterior and posterior respectively. When the edges of the anterior and posterior leaflet align, the mitral valve may close completely, preventing blood from flowing from the left ventricle to the left atrium. When the leaflets of the mitral valve or their associated structures undergo an organic or functional change, the anterior and posterior leaflets of the mitral valve do not coapt properly, whereby the mitral valve does not close completely when the left ventricle of the heart contracts, resulting in regurgitation of blood from the left ventricle to the left atrium, causing a series of pathophysiological changes known as "mitral regurgitation".
Surgical procedures typically employ surgical approaches such as valve edge-to-edge suturing to treat mitral regurgitation. However, the surgical operation has the defects of complex operation process, high operation cost, high wound degree of patients, high complication risk, long hospitalization time, pain of the recovery process of the patients and the like. Interventional valve pinching refers to treating regurgitation by implanting a valve pinching device into the mitral valve to pull two leaflets of the valve that were otherwise poorly coaptated toward each other, reducing or eliminating leaflet clearance.
The clamp arm structure of the valve clamping device in the prior art for clamping the valve leaflet is usually a single linear structure, the clamping area of the clamp arm of the structure is limited by the length of the clamp arm in the axial direction, so that the clamping effect is not ideal, and long thorns with long length are usually required to be arranged on the inner clamping arm to assist in anchoring the valve leaflet. The presence of long thorns can cause damage to the valve leaflet, increasing the risk of postoperative complications.
Disclosure of Invention
In view of the above, the present application provides a valve clamping device to solve the problems of stable clamping and reduced damage to the valve leaflet.
In one aspect, embodiments of the present application provide a valve clamping device comprising a main body, a pair of clamping members and a clamping member disposed between the main body and the clamping members, the clamping members being disposed around an outer side of the main body and being capable of being opened or closed with respect to the main body about one end, the clamping members comprising two clamping arms operable to move with respect to the clamping members, the clamping members and the clamping arms each having a meandering portion, and the meandering portions of the clamping members and the meandering portions of the clamping arms cooperating with each other to clamp leaflets of a valve.
In a preferred embodiment, the meander of each of the gripping members or gripping arms comprises a convex section and a concave section, and the convex section and the concave section of the surface of the gripping member opposite the gripping arm cooperate.
In a preferred embodiment, the protruding section and the recessed section respectively include a plurality of protruding sections and a plurality of recessed sections are alternately arranged in succession, and extend from one end of the clamping member and the clamping arm near the main body portion in a direction away from the main body portion.
In a preferred embodiment, each of the convex and concave sections is in the shape of a circular arc, and the radius of curvature of the circular arc of each set of cooperating convex and concave sections is the same.
In a preferred embodiment, the arc of each of the convex and concave sections has a length of 1/4 of the circle, and the arc of each of the convex and concave sections has a radius of curvature in the range of 1/8 to 1/5 of the length of the mating surfaces of the clamp and the clamp arm.
In a preferred embodiment, the plurality of raised and recessed sections of the clamp and clamping arm each extend laterally from one side of the width of the clamp and clamping arm to the other.
In a preferred embodiment, the clamping arm is provided with a friction element on the side facing the clamping element and/or the clamping element is provided with a friction element on the side facing the clamping arm, the height of the friction element in the direction away from the clamping arm or clamping element being smaller than the height of the projection section.
In a preferred embodiment, the clamping member comprises a planar portion located in the middle and edge portions located on both sides of the planar portion, the planar portion and the edge portions each being provided with a plurality of the convex sections and concave sections, the width of the clamping arm being smaller than or equal to the width of the planar portion of the clamping member, the plurality of convex sections and concave sections of the clamping arm each extending laterally from one side of the width of the clamping arm to the other side.
In a preferred embodiment, the edge portion is higher than the planar portion such that the cross-section of the clip member is concave in a generally C-shape.
In a preferred embodiment, the body portion comprises a blocking ball, the side of the blocking ball facing the clamping member comprising a meandering portion cooperating with the clamping member.
In a preferred embodiment, the mating meander of each of the clamp and clamp arms comprises at least one mating circular arc.
In a preferred embodiment, the device further comprises a driving part for driving the clamping member to open or close, and a control wire for controlling the movement of the clamping arm relative to the clamping member.
Compared with the prior art, the clamping piece and the clamping arm are respectively provided with the bending parts, the bending parts of the clamping piece and the bending parts of the clamping arm are matched with each other to clamp the valve leaflet of the valve, so that the soft valve leaflet can be clamped between the bending parts, the matched bending parts are used as anchoring elements for clamping the valve She Gajin, long thorns on the clamping arm in the prior art can be avoided, or the requirement on the long thorns is minimized.
Drawings
In order to more clearly illustrate the embodiments of the application 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, it being obvious that the drawings in the description below are only some embodiments of the application, and that other drawings can be obtained from them without inventive faculty for a person skilled in the art.
Fig. 1 is a schematic perspective view of a valve clasper device in accordance with a first embodiment of the present invention.
Fig. 2 is a schematic elevational view of the valve clasper apparatus of fig. 1.
Fig. 3 is a schematic perspective view of the clip of fig. 1.
Fig. 4 is a schematic side view of the clamp of fig. 3.
Fig. 5 is a schematic perspective view of the clamping member of fig. 1.
Fig. 6 is a schematic illustration of the effect of the valve clamping device of fig. 1 clamping the leaflets of a valve.
Fig. 7 is a schematic perspective view of the friction-increasing member of the holder of fig. 1.
Fig. 8 is a schematic perspective view of a clip according to another modified embodiment.
Fig. 9 is a schematic perspective view of a clip according to still another modified embodiment.
Fig. 10 is a schematic perspective view of a clip according to a further modified embodiment.
Fig. 11 is a schematic perspective view of the friction-increasing element of the clip of fig. 1.
Fig. 12 is a schematic perspective view of a clip according to another modified embodiment.
Fig. 13 is a schematic perspective view of a sandwich element according to another embodiment.
Fig. 14 is a schematic view of a threading mode of the clamp of fig. 1.
Fig. 15 is a schematic view of a threading mode of the clip of the alternative variant embodiment of fig. 14.
Fig. 16 is a schematic view of another threading mode of the clamp of fig. 1.
Fig. 17 is a schematic perspective view of a valve clasper apparatus according to a second embodiment of the present invention.
Fig. 18 is a perspective view of the clip of fig. 17.
Fig. 19 is a schematic view of the effect of the clip cross-section of fig. 18 to hold the leaflet.
Fig. 20 is a schematic perspective view of a valve clasper apparatus according to a third embodiment of the present invention.
Fig. 21 is a schematic elevational view of a valve clasper apparatus in accordance with a modified embodiment.
Fig. 22 is a schematic view of a valve clamp device according to an embodiment of the present invention in a mitral valve treatment application state.
Fig. 23 is a schematic view of the valve clasper device of fig. 22 in a closed, clasped configuration.
Fig. 24 is a schematic view of the valve clasper device of fig. 23 in a separated state from the delivery device.
The application will be further described in the following detailed description in conjunction with the above-described figures.
Detailed Description
The following description of the embodiments of the present application will be made clearly and fully with reference to the accompanying drawings, in which it is evident that the embodiments described are only some, but not all embodiments of the application. All other embodiments, based on the embodiments of the application, which a person of ordinary skill in the art would achieve without inventive faculty, are within the scope of the application.
In the interventional medical field, the end of the instrument near the operator is generally referred to as a proximal end and the end of the instrument far from the operator is generally referred to as a distal end along the transport path of the instrument. In particular, for delivery devices used to deliver and release an implantable device into a patient, the distal end refers to the end of the delivery device that is free to be inserted into an animal or human body, and the proximal end refers to the end of the delivery device that is intended for manipulation by a user or machine. The direction of the rotating central shaft of the cylinder, the pipe body and the like is defined as the axial direction, the circumferential direction is the direction (perpendicular to the axis and the cross-section radius) around the axis of the cylinder, the pipe body and the like, and the radial direction refers to the direction along the diameter or the radius. Wherein, the axial direction, the circumferential direction and the radial direction jointly form three orthogonal directions of the column object. It is noted that the term "end" as used in the terms of "proximal", "distal", "one end", "other end", "first end", "second end", "initial end", "terminal", "both ends", "free end", "upper end", "lower end", etc. is not limited to a tip, endpoint or end face, but includes a location extending an axial distance and/or a radial distance from the tip, endpoint or end face over the element to which the tip, endpoint or end face belongs. The above definitions are for convenience of description only and are not to be construed as limiting the application.
It is to be understood that the terminology used in the description and claims of the application and in the above description and drawings is for the purpose of describing particular embodiments only, and is not intended to be limiting of the application. The terms first, second and the like in the description and in the claims and in the above-described figures, are used for distinguishing between different objects and not necessarily for describing a sequential or chronological order. The singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The term "comprising" and any variations thereof is intended to cover a non-exclusive inclusion. Furthermore, the present application may be embodied in many different forms and is not limited to the embodiments described in the present embodiment. The following detailed description is provided to facilitate a more thorough understanding of the present disclosure, in which words of upper, lower, left, right, etc., indicating orientations are used solely for the illustrated structure in the corresponding figures.
It should be noted that, all the above drawings are exemplary illustrations of the present application, and are not intended to represent actual sizes of products, and dimensional relationships among components in the drawings are not intended to limit the actual products of the present application. The description hereinafter sets forth a preferred embodiment for practicing the application, but the above description is not intended to limit the scope of the application, as it is not intended to limit the general principles of the application. The scope of the application is defined by the appended claims.
Referring to fig. 1 and 2 together, a first embodiment of the present application provides a valve clamping device 100, which includes a main body 10, a pair of clamping members 20, a clamping member 30 disposed between the main body 10 and the clamping members 20, and a driving portion 40 for driving the clamping members 20 to open and close. The clamping member 20 is disposed around the outer side of the main body 10, and may be opened or closed with respect to the main body 10 about one end, the clamping member 30 includes two clamping arms 32 that may move with respect to the clamping member 20 under control, the clamping arms 32 cooperate with the clamping member 20 to clamp the valve leaflet of the valve therein, and the left and right groups of clamping arms 32 and the clamping member 20 pull the anterior leaflet and the posterior leaflet of the mitral valve toward each other (see fig. 23), thereby obtaining a double-hole mitral valve, and achieving edge-to-edge repair of the mitral valve.
The main body 10 includes a support 11, and referring to fig. 3, a pair of the clamping members 20 are respectively formed in a sheet shape, each of the clamping members 20 has two opposite legs 22 and a sheet-shaped clamping area 24, and the legs 22 are used to span the front and rear sides of the support 11 and are respectively connected to the support 11 by pins. In this embodiment, the pair of legs 22 of the clip 20, which span the front side of the support base 11, are connected to the front side of the support base 11 by the same pin, and the legs 22, which span the rear side of the support base 11, are connected to the rear side of the support base 11 by the same pin. The pair of the clamping members 20 can be relatively opened or relatively closed by pivoting about a pin. The driving part 40 includes a base 41, a driving shaft 42 connected to the base 41, and two links 43 rotatably connected to left and right sides of the base 41, respectively. The two connecting rods 43 are respectively connected with the pair of clamping members 20, and the supporting seat 11 is provided with a central channel, and the driving shaft 42 passes through the central channel of the supporting seat 11 or is detachably connected with an external driving device extending into the central channel, such as a conveying device, in the central channel. When the drive shaft 42 is driven, the base 41 is simultaneously driven, so that the connecting rod 43 pulls the clamping members 20 to relatively open the pair of clamping members 20, or pushes the clamping members 20 to relatively close the pair of clamping members 20.
Referring also to fig. 4, the nip region 24 of the nip member 20 has a meandering portion 24a, and in this embodiment, the meandering portion 24a extends from an end of the nip member 20 near the main body 10 to an end far from the main body 10.
Specifically, the meandering portion 24a includes a convex section 24b and a concave section 24c, in this embodiment, the convex section 24b and the concave section 24c include a plurality of convex sections 24b and a plurality of concave sections 24c, respectively, and the plurality of convex sections 24b and the plurality of concave sections 24c are alternately and continuously arranged. The plurality of convex sections 24b may be identical, the plurality of concave sections 24c may be identical, or the plurality of convex sections 24b may be different, or the plurality of concave sections 24c may be different, for example, the plurality of convex sections 24b or the plurality of concave sections 24c may be different, and part of the convex sections 24b may be only partial, or part of the concave sections 24c may be partial, that is, part of the incomplete convex sections 24b or the incomplete concave sections 24c may be partial. In a preferred embodiment, the plurality of raised sections 24b and the plurality of recessed sections 24c each have a rounded or arc-like curve such that the nip region 24 of the nip member 20 is undulating.
In this embodiment, the clamping member 20 is rigid, and may be made of stainless steel or the like. The plurality of raised sections 20b and recessed sections 20c extend laterally from one side of the width of the clip 20 to the other.
Referring to fig. 5, the clamping member 30 is a single piece and includes a connecting seat 32 with a substantially U-shaped middle portion, and clamping arms 34 extending from the connecting seat 32 to two sides, wherein one end of the clamping arm 34 away from the connecting seat 32 is a free end. The supporting seat 11 of the main body 10 is accommodated in the connecting seat 32, and the connecting seat 32 can be clamped and fixed with the supporting seat 11.
The clip 30 may be made of an elastic material or a material with shape memory, which deforms when subjected to an external force, and after the external force is removed the free end tends to return to its original shape and position due to the elasticity or shape memory, so that during delivery the free end may be pulled taut and collapsed, and after release the free end is again oriented to an expanded state to capture the leaflets of the valve, which is a common material such as nitinol.
The clamping arm 34 is used as a region for capturing the clamping valve leaflet, the clamping arm 34 has a meandering portion 34a, in this embodiment, the meandering portion 34a extends from one end of the clamping arm 34 near the connection seat 32 to the end far away from the main body 10, and the meandering portion 34a also includes a plurality of convex sections 34b and a plurality of concave sections 34c, the plurality of convex sections 34b and the plurality of concave sections 34c are alternately and continuously arranged, and transversely extend from one side to the other side of the width of the clamping arm 34, and the plurality of convex sections 34b and the plurality of concave sections 34c are each in a circular arc shape or a circular arc-like curve, so that the clamping arm 34 is in a wavy shape.
The clamping arms 34 cooperate with the raised sections 20b, 34b recessed sections 20c, 34c of the opposed surfaces of the clamping member 20, and the cooperating raised sections 20b, 34b and recessed sections 20c, 34c of the opposed surfaces of the clamping member 20 and the clamping arms 34 have the same radius of curvature of the circular arc so that the tortuosity of the tortuosity 24a of the clamping member 20 and the tortuosity 34a of the clamping arms 34 cooperate to clamp the leaflets of the valve.
In this embodiment, the arc length of the convex section 20b of the clamping member 20 facing the clamping arm 34 is greater than the arc length of the concave section 20c of the clamping member 20 facing the clamping arm 34, and correspondingly, the arc length of the concave section 34c of the clamping arm 34 facing the clamping arm 34 is greater than the arc length of the convex section 34b of the clamping member 20 facing the clamping arm 34, so that the anchoring force of the long and short convex and concave opposite flaps She Zengjia is utilized. The longer of the convex and concave sections 20b, 34b, 20c, 34c has a length of about 6mm to about 10mm, preferably about 8mm, and the shorter of the circular arcs has a length of about 2mm to about 4mm, preferably about 3mm, each of which has a length of about 1/4 of a full circle. The radius of the circular arc curvature of each convex section 20b, 34b and concave section 20c, 34c is 1/8 to 1/5 of the overall length of the mating surfaces of the clamp member 20 and the clamp arm 34.
Referring to fig. 6, since the leaflets of the valve, e.g., the anterior leaflet 201 and the posterior leaflet 202 of the mitral valve, are soft, the leaflets 201, 202 will be clamped between the two leaflets in a serpentine shape, and the cooperation of the convex sections 20b, 34b with the concave sections 20c, 34c will cause the leaflets 201, 202 to be held against just as anchor points, but will not damage the leaflets 201, 202.
Referring to fig. 7, in some embodiments, the surface of the clamping arm 34 of the clamping member 30 facing the clamping member 20 is provided with a friction element 342 to hold the leaflet more tightly between the clamping arm 34 and the clamping member 20. The friction element 342 may be provided at a partial section or the entire surface. In this embodiment, the friction element 342 is a hemispherical bump, and the radius of the bump is about 0.02mm-0.05mm.
Referring to fig. 8, in some embodiments, the surface of the clamping arm 34 facing the clamping member 20 is provided with friction elements 344, and the friction elements 344 are elongated semi-cylindrical protrusions, and the radius of the protrusions may be about 0.02mm-0.05mm, and the number of protrusions may be about 10-15.
Referring to fig. 9, in other embodiments, the surface of the clamping arm 34 facing the clamping member 20 is provided with a friction element 346, and the friction element 346 is a barb having a shorter length facing the clamping member 20. Because of the meandering design of the clip 20 and the clamping arm 34, the barb need only have a friction enhancing fixation, and the barb may be triangular or triangular-like in shape, for example, extending at an angle to the surface of the clamping arm 34, and thus have a strong anchoring force, and may have a slightly pointed tip, or may not be too sharp, to achieve a good friction enhancing fixation.
Referring to fig. 10, in other embodiments, the friction element 347 of the retaining arm 34 is in the form of a barb extending obliquely toward the connector 32, and may have an angle of 25-55 degrees with the surface of the retaining arm 34, and the barb may act to pull the leaflet toward the center to prevent the leaflet from slipping after being captured.
Referring to fig. 11, in other embodiments, the surface of the clamping member 20 facing the clamping arm 34 is provided with a friction element 302 to hold the leaflet more tightly between the clamping arm 34 and the clamping member 20. The friction element 302 may be provided at a partial section or the entire surface. In this embodiment, the friction element 302 is a hemispherical bump.
Referring to fig. 12, in other embodiments, a friction element 304 is disposed on a surface of the clamping member 20 facing the clamping arm 34, and the friction element 304 is an elongated semi-cylindrical protrusion.
In other embodiments, one of the gripping arms 34 and the clamp 20 may have friction elements, particularly when the gripping arms 34 have barbs, the clamp 20 may not have friction elements, or both the gripping arms 34 and the clamp 20 may have friction elements, due to the strong anchoring force of the barbs.
In the above embodiments, the friction members 346, 347, 302, 304 on the surface of the clamping arm 34 or clip 20 may have a height in a direction away from the clamping arm 34 or clip 20 that is less than the height of the protrusions of the raised sections 20b, 34b, since the engagement of the raised sections 20b, 34b with the recessed sections 20c, 34c just as the anchor points allows the leaflets 201, 202 to be held down, minimizing the length requirements of the friction members 346, 347, 302, 304.
Referring to fig. 13, in a deformable embodiment, the curved portions 40a of the engaging members 40 and the engaging arms (not shown) have only one circular arc 42, respectively, and the distal ends of the circular arcs 42 include transition sections 43 and flange sections 44. The length of the arc 42 is 3/5 to 4/5 of the length of the mating surfaces of the clamp 40 and the clamping arm, and the radius of curvature of the arc 42 is about 1/2 of the length of the mating surfaces of the clamp 40 and the clamping arm. The contact area between the leaflet and the clamping member 40 and the clamping arm is increased by the larger arc, so that the flexible leaflet She Shunshi is accommodated and clamped between the clamping member 40 and the clamping arm. The transition section 43 and the flange section 44 may function to support the leaflet. The surface of the clamp 40 opposite the clamping arm may still be provided with the friction element described above to enhance clamping.
Referring to fig. 14, in the driving control, the gripping member 30 may control the movement of the gripping arms 34 through the control wire 38, the free ends of the gripping arms 34 away from the connection base 32 may be provided with threading holes 36, and then each gripping arm 34 may pass through the threading hole 36 through one control wire 38 and further extend to the control end (not shown) of the operation handle of the doctor of the delivery device (refer to fig. 22) to control the respective gripping arms 34 through the manipulation of the control wire 38. In this embodiment, the number of threading holes 36 on each clamping arm 34 is two. In other embodiments, referring to fig. 15, the number of threading holes 36 on each clamping arm 34 may be only one.
Referring to fig. 16, the two clamping arms 34 may also share a control line 38, so that both clamping arms 34 are controlled simultaneously. The common control wire 38 is passed through two threading holes 36 on each of the clamp arms 34, respectively, and then both ends are extended to the doctor operation handle control end of the delivery device (see fig. 22), respectively.
Referring to fig. 17 to 19, a second embodiment of the present application provides a valve clamping device 200, wherein the valve clamping device 200 is different from the valve clamping device 100 described above in that the clamping member 60 includes a middle portion 62, edge portions 64 located at both sides of the middle portion 62, and flange portions 66 located at the ends. The intermediate portion 62 and the edge portion 64 have alternating raised sections 62a, 64a and recessed sections 62b, 64b, respectively, the raised section 62a of the intermediate portion 62 corresponding to the raised section 64a of the edge portion 64 and the raised section 64a of the edge portion 64 corresponding to the raised section 64b of the edge portion 64. The intermediate portion 62 is recessed inwardly relative to the edge portion 64 so that the overall clip 60 is a C-shape with slightly higher sides and lower middle.
The width of the clamping arm 45 is less than or equal to the planar portion 62 of the clip 60, and the plurality of raised and recessed sections (see fig. 5) of the clamping arm 45 each extend laterally from one side of the width of the clamping arm 45 to the other.
In the second embodiment described above, the plurality of raised and recessed sections of the clip 60 and the clip arms 45 act as anchoring elements to hold the petals She Ya in the inwardly recessed space of the clip 60, and the substantially C-shaped configuration of the clip 60 encases the leaflets so that they are held more firmly. The edge portion 64 and the cuff portion 66 of the clip 60 may support the edge of the leaflet.
The thickness of the clamping member and the clamping member is generally between 0.15mm and 0.35mm, and the thickness of the clamping member is slightly thicker than the thickness of the clamping member. The nip region of the nip and the gripping arms of the gripping member described above act as an effective area length for capturing the leaflet, which effective area length L1 (see fig. 4) may be between 9mm and 13 mm. The surfaces of the clamping piece and the clamping piece can be respectively applied with active drugs or coated with a layer of polymer film so as to promote the endothelial cells of the valve leaflet tissue to climb and grow on the surfaces of the clamping piece and reduce rejection reaction caused by the direct contact of the metal piece with the valve. The thickness of the coating is preferably between 0.1mm and 0.15 mm.
Referring to fig. 20, a third embodiment of the present application provides a valve clamping device 300, wherein the valve clamping device 300 is different from the valve clamping device 100 in that a sealing ball 110 can be sleeved on a supporting seat 11 of a main body portion to enhance sealing of a blood regurgitation gap between valve blades by the valve clamping device 300. The occlusion ball 110 is made of an elastic material that can be compressed to conform to the shape of the tortuous portion of the gripping arms 34.
Referring to fig. 21, in some embodiments, a curved portion 110b may be disposed on a side of the plugging ball 110a facing the clamping member 20, and the curved portion 110b of the plugging ball 110a cooperates with a clamping arm (see fig. 17) or the curved portion of the clamping member 20 to achieve the maximum close fit, so as to reduce the gap between the clamping members 20 after the clamping members 20 are relatively closed, thereby forming a better plugging reflux effect at the clamping position. In addition, the clamping member 20 may be C-shaped, and the clamping arm may be housed within the clamping member 20. The occlusion ball 110a cooperates with the gripping arms (see fig. 17) or the turns of the clip 20, and the C-wrap design of the clip 20 helps to highly match each other when the clip 20 is closed with the gripping arms and occlusion ring 110a, thereby helping to prevent the clip 20 from being sprung apart.
In addition, referring to the indication of fig. 20, the valve clamping device of the present invention may further provide a locking tab 70 and an unlocking wire 72, and the locking tab is controlled to lock and unlock the driving shaft 42 by the unlocking wire 72, so as to further prevent the adverse event that the clamping member 20 is sprung.
In summary, the clip 20 and the clamping arm 34 of the present application have a meandering portion, respectively, and the meandering portions of the clip 20 and the meandering portions of the clamping arm 34 cooperate to clamp the valve leaflets, such that the flexible leaflets can be clamped between the meandering portions, and the cooperating meandering portions act as anchor elements to hold the valve She Gajin, such that long thorns on the clamping arm 34 can be avoided or the requirement for long thorns can be minimized.
On the basis that the clamping piece 20 and the clamping arm 34 are respectively provided with the bending parts, the bending parts of the blocking ball 110a can be matched with the clamping piece 20 and the clamping arm 34 to form the maximum close fit, so that the better blocking reflux effect is achieved at the clamping position.
The valve clamping device of the present invention may be applied to regurgitation treatment of heart valves, including mitral or tricuspid valves, and referring to fig. 1, 22-24, taking the repair process of the anterior and posterior leaflet of the mitral valve as an example, the valve repair system of the present invention includes a valve clamping device 100 and a delivery device 500, and the operation method of the valve repair of the present invention mainly includes the following steps:
The distal end of the conveying device 500 and the valve clamping device 100 are conveyed to the left atrium through the inferior vena cava in a way of transfemoral puncture, then the valve clamping device 100 is controlled to approach the anterior leaflet and the posterior leaflet of the mitral valve, the driving mandrel 520 is conveyed to the distal end, the driving mandrel 520 drives the driving shaft 42 (see fig. 1) to drive the clamping piece 20 (see fig. 1) to be unfolded, the direction of the clamping piece 20 is adjusted, the relative positions of the clamping piece 20 and the anterior leaflet and the posterior leaflet of the mitral valve can be observed through medical developing or imaging equipment at the moment, so that the clamping piece 20 is approximately perpendicular to the free edges of the anterior leaflet and the posterior leaflet;
Simultaneously or sequentially releasing the clamping arms 34 at the two sides, wherein the clamping arms 34 are matched with the clamping piece 20 to catch the front leaf and the rear leaf; when it is observed that the leaflet is not clamped in place, pulling the drive mandrel 520 proximally brings the drive shaft 50, thereby driving the clip 20 closed such that the anterior and posterior leaflets are clamped between the clamping arms 34 and the clip 20;
The threaded connection between the drive mandrel 520 and the drive shaft 50 is disengaged and the drive mandrel 520 is withdrawn, the delivery sheath 510 is separated from the valve clasping device 100, the connection between the valve clasping device 100 and the delivery device 500 is released, and the delivery device 500 is withdrawn from the body to achieve the implanted condition shown in fig. 24, the valve clasping device 100 pulls the anterior leaflet and the posterior leaflet of the mitral valve toward each other to clamp, and the edge-to-edge repair of the anterior leaflet and the posterior leaflet is completed.
The valve repair system and valve clamping device described above are suitable for use in mitral or tricuspid valve clamping procedures other than the femoral vein-atrial septum-atrial ventricular path described above, which may also be a transapical approach. In the case of tricuspid valve applications, due to the presence of anterior, posterior and septal three leaflets, another or more valve clasper devices 100 may be implanted as needed for treatment.
While the foregoing has been provided to illustrate the principles and embodiments of the present application, specific examples have been provided herein to assist in understanding the principles and embodiments of the present application, and are intended to be in no way limiting, for the purpose of illustrating the application, as long as the principles and embodiments of the present application are modified in accordance with the principles and embodiments of the present application.
Claims (11)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311806250.XA CN120203876A (en) | 2023-12-25 | 2023-12-25 | Valve clipping device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311806250.XA CN120203876A (en) | 2023-12-25 | 2023-12-25 | Valve clipping device |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN120203876A true CN120203876A (en) | 2025-06-27 |
Family
ID=96099717
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202311806250.XA Pending CN120203876A (en) | 2023-12-25 | 2023-12-25 | Valve clipping device |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN120203876A (en) |
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2023
- 2023-12-25 CN CN202311806250.XA patent/CN120203876A/en active Pending
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