CN115105252B - Valve clamping device with plugging function and valve clamping system - Google Patents

Valve clamping device with plugging function and valve clamping system Download PDF

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Publication number
CN115105252B
CN115105252B CN202110310895.9A CN202110310895A CN115105252B CN 115105252 B CN115105252 B CN 115105252B CN 202110310895 A CN202110310895 A CN 202110310895A CN 115105252 B CN115105252 B CN 115105252B
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China
Prior art keywords
clamping
valve
clamping arm
piece
base
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Active
Application number
CN202110310895.9A
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CN115105252A (en
Inventor
李立光
张伟伟
张庭超
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Hangzhou Valgen Medtech Co Ltd
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Hangzhou Valgen Medtech Co Ltd
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Priority to CN202110310895.9A priority Critical patent/CN115105252B/en
Publication of CN115105252A publication Critical patent/CN115105252A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466Delivery devices therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12122Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136Balloons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12177Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246Devices for obstructing a leak through a native valve in a closed condition
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205Introduction devices

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Cardiology (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Reproductive Health (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Prostheses (AREA)

Abstract

The application provides a valve clamping device with a plugging function and a valve clamping system. The valve clamping device comprises at least two groups of clamping pieces, blocking pieces and a driving assembly; each group of clamping pieces comprises a first clamping arm and a second clamping arm, and the first clamping arms are positioned on the inner sides of the corresponding second clamping arms; the blocking piece is made of elastic materials and is arranged on the inner side of each first clamping arm; the driving component comprises a base, a movable piece and a locking piece; one end of each second clamping arm is fixedly connected with the base, one end of each first clamping arm is fixedly connected with the movable piece, and the movable piece can axially move relative to the base so as to drive the first clamping arm and the corresponding second clamping arm to be relatively far away from or close to each other; the locking piece is arranged outside the base and can axially move relative to the base so as to drive each second clamping arm and each first clamping arm to retract inwards; when the first clamping arms are folded inwards, the blocking piece is extruded, so that the blocking piece is deformed and the space between the inner sides of the first clamping arms is filled.

Description

Valve clamping device with plugging function and valve clamping system
Technical Field
The application relates to the technical field of medical equipment, in particular to a valve clamping device with a plugging function and a valve clamping system.
Background
The mitral valve is a one-way valve located between the left atrium and the left ventricle of the heart, and a normally healthy mitral valve can control blood flow from the left atrium to the left ventricle while avoiding blood flow from the left ventricle to the left atrium. The mitral valve includes a pair of leaflets, called anterior and posterior, to which chordae tendineae, which are secured to the papillary muscles of the left ventricle, act to pull. Normally, when the left ventricle of the heart contracts, the edges of the anterior and posterior lobes are completely apposed, 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, such as a partial rupture of the chordae tendineae, the anterior and posterior leaflets of the mitral valve do not coapt properly, whereby when the left ventricle of the heart contracts, the mitral valve does not close completely, resulting in regurgitation of blood from the left ventricle to the left atrium, causing a series of pathophysiological changes known as "mitral regurgitation".
Interventional mitral valve clamping refers to the treatment of mitral regurgitation by implanting a valve clamping device into the mitral valve to pull the anterior and posterior leaflets toward each other, reducing or eliminating leaflet clearance.
Referring to fig. 1 to 3, a conventional valve clamping device includes two first clamping arms 02, two second clamping arms 03, a movable member 01 and a locking member 04. Wherein, the two first clamping arms 02 and the two second clamping arms 03 are in one-to-one correspondence. The first clamping arms 02 and the second clamping arms 03 have elasticity, in an initial state, the two first clamping arms 02 are relatively opened to form a V shape, the two second clamping arms 03 are relatively opened to form a V shape, and the two first clamping arms 02 can be driven by the movable piece 01 to axially move away from or approach the corresponding two second clamping arms 03 so as to capture the valve leaflet; after the valve leaflet is successfully captured (that is, the valve leaflet is captured between the first clamping arm and the second clamping arm), the operation locking piece 04 moves far relative to the two second clamping arms 03, and as the first clamping arm 02 and the second clamping arm 03 can elastically deform, the locking piece 04 drives the two second clamping arms 03 to retract and deform towards the middle along with the movement of the locking piece 04 far, and the two first clamping arms 02 also retract and deform towards the middle under the action of the two second clamping arms 03, so that the anterior leaflet and the posterior leaflet of the mitral valve are respectively clamped and locked between the first clamping arms 02 and the second clamping arms 03 on the corresponding sides, and the leaflet clearance is reduced, thereby reducing the mitral valve regurgitation. However, as shown in fig. 3, after the valve clamping device is closed, because the two first clamping arms 02 are hollowed out, an open gap still exists between the valve leaflets, and a central reflux phenomenon is easy to occur in the central part of the valve clamping device, so that the reflux treatment effect is affected.
Disclosure of Invention
In view of the above, the present application provides a valve clamping device and a valve clamping system with a plugging function, which can effectively plug blood flowing back from a center and improve the therapeutic effect on the regurgitation.
In order to achieve the above object, according to one aspect of the present application, there is provided a valve clamping device with a plugging function, including at least two sets of clamping members, a plugging member and a driving assembly; each group of clamping pieces comprises a first clamping arm and a second clamping arm, and the first clamping arms are positioned on the inner sides of the corresponding second clamping arms; the blocking piece is made of elastic materials and is arranged on the inner side of each first clamping arm; the driving assembly comprises a base, a movable piece and a locking piece; one end of each second clamping arm is fixedly connected with the base, one end of each first clamping arm is fixedly connected with the movable piece, and the movable piece can axially move relative to the base so as to drive the first clamping arm and the second clamping arm in each group of clamping pieces to be relatively far away or close to each other; the locking piece is arranged outside the base and can axially move relative to the base so as to drive each second clamping arm and each first clamping arm to retract inwards; and when the first clamping arms are folded inwards, the blocking piece is extruded, so that the blocking piece is deformed and the space between the inner sides of the first clamping arms is filled.
The application also provides a valve clamping system, which comprises the valve clamping device with the plugging function and a conveying device, wherein the distal end of the conveying device is detachably connected with the valve clamping device, and the conveying device is used for conveying the valve clamping device and controlling the driving assembly.
According to the valve clamping device with the plugging function and the valve clamping system, the first clamping arms and the second clamping arms in the clamping pieces are driven to clamp the valve leaflets through the axial movement of the movable pieces relative to the base, and then the second clamping arms and the first clamping arms are driven to retract inwards through the axial movement of the locking pieces relative to the base, so that the valve She Jianju is reduced, the plugging pieces made of elastic materials are extruded by the first clamping arms to deform and fill and plug the space between the inner sides of the first clamping arms, the first clamping arms are not hollowed any more, the opening gaps between the valve leaflets corresponding to the first clamping arms are plugged by the plugging pieces, the phenomenon of central reflux of the valve clamping device can be avoided, and the treatment effect on the reflux is improved.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present application, and other drawings can be obtained according to these drawings without inventive effort for a person skilled in the art.
Fig. 1-3 are schematic views of the prior art valve clasper apparatus in use.
Fig. 4 is a schematic structural view of a valve clasper device with occlusion function according to a first embodiment of the present application.
Fig. 5 is a schematic view of the valve clasper device of fig. 4 in a clasped condition with the leaflets therebetween.
Fig. 6 is a schematic structural view of a valve clasper device with occlusion function according to a second embodiment of the present application.
Fig. 7 is an enlarged schematic view of the VII portion of fig. 6.
Fig. 8 is a schematic view of the valve clasper device of fig. 6 in a clasped condition with the leaflets therebetween.
Fig. 9 is a schematic structural view of a valve clasper device with occlusion function provided in a third embodiment of the present application.
Fig. 10 is a schematic view of the valve clasper device of fig. 9 in a clasped condition with the leaflets therebetween.
Fig. 11 is a schematic structural view of a valve clasper device with a blocking function provided in accordance with a fourth embodiment of the present application.
Fig. 12 is a schematic view of the valve clamping device of fig. 11 with leaflets received in the clamping spaces of each clamp.
Fig. 13 is a schematic view of the valve clasper device of fig. 12 in a clasped condition with the leaflets therebetween.
Fig. 14 is a schematic structural view of a valve clasper device with occlusion function provided in a fifth embodiment of the present application.
Fig. 15 is a schematic cross-sectional view of the movable member of fig. 14 perpendicular to the axial direction.
Fig. 16 is a schematic view of the valve clasper of fig. 14 with the first clasper arms on either side controlled by a pull wire and with the leaflet received in the leaflet-receiving space of the one-sided clip.
Fig. 17 is a schematic view of the valve clamping device of fig. 16 with the first clamping arm on one side released and the second clamping arm on the corresponding side clamping the leaflet, and with the leaflet received in the leaflet receiving space of the other side clamping member.
Fig. 18 is a schematic view of the valve clamping device of fig. 17 with the first clamping arm on the other side released and clamping the leaflet with the second clamping arm on the corresponding side.
Description of main reference numerals:
Valve clamping device 100
Clamping member 10
First clamping arm 11
Second clamping arm 12
Anchoring structure 13
Tooth form construction 14
Closure 30
First blocking portion 301
Second blocking portion 302
First section 31
Second section 32
Third section 33
Drive assembly 50
Base 52
Moving part 54
Elastic sheet 542
Threading cavity 545
Locking member 56
Closure head 70
Flow blocking film 90
Limit part 20
Traction wire 40
First included angle A
Second included angle B
First axial distance D1
Second axial interval D2
Third axial spacing D3
The application will be further illustrated by the following specific examples in conjunction with the above-described figures.
DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION
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, which can be made by a person skilled in the art based on the embodiments of the application without any inventive effort, are intended to fall within the scope of the application.
Furthermore, the following description of the embodiments refers to the accompanying drawings, which illustrate specific embodiments in which the application may be practiced. Directional terms, such as "upper", "lower", "front", "rear", "left", "right", "inner", "outer", "side", etc., in the present application are merely referring to directions of the attached drawings, and thus, the directional terms are used for better, more clear explanation and understanding of the present application, rather than indicating or implying that the apparatus or element being 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 application.
In order to more clearly describe the structure of the valve clasper device with the occlusion function, the terms "proximal" and "distal" are used in the specification to define the terms of the interventional medical field. Specifically, "distal" refers to the end that is distal to the operator during a surgical procedure, and "proximal" refers to the end that is proximal to the operator during a surgical procedure; the direction of the rotation central axis of the column body, the tube body and other objects is defined as an axial direction; the circumferential direction is the direction (perpendicular to the axis and the radius of the section) around the axis of the cylinder, the pipe body and the like; radial is the direction along the diameter or radius. 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. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.
Referring to fig. 4 and 5, a valve clamping device 100 with a plugging function according to a first embodiment of the present application includes at least two first clamping arms 11, at least two second clamping arms 12, a plugging member 30, and a driving assembly 50. Wherein, a first clamping arm 11 and a second clamping arm 12 are correspondingly formed into a group of clamping members 10, and the first clamping arm 11 is located at the inner side of the corresponding second clamping arm 12. The blocking member 30 is made of an elastic material and is provided inside each first clamping arm 11. It should be noted that, for any element of the valve clasper device 100, the inner side refers to the side of the element that is relatively close to the central axis of the valve clasper device 100, and the outer side refers to the opposite side of the element.
As shown in fig. 4 and 5, the driving assembly 50 includes a base 52, a movable member 54, and a locking member 56. One end of each second clamping arm 12 is fixedly connected with the base 52, one end of each first clamping arm 11 is fixedly connected with the movable piece 54, and the movable piece 54 can axially move relative to the base 52 so as to drive the first clamping arms 11 and the second clamping arms 12 in each group of clamping pieces 10 to be relatively far away or close to each other so as to clamp the valve leaflet. The locking member 56 is disposed outside the base 52 and is axially movable relative to the base 52 to drive each of the second clamping arms 12 and each of the first clamping arms 11 inwardly to retract the petals She Jianju. As each first clamping arm 11 is folded inwards, the blocking piece 30 is deformed by extrusion of each first clamping arm 11 and fills and blocks the space between the inner sides of each first clamping arm 11, so that the open gap between the valve leaflets corresponding to each first clamping arm 11 is blocked, the blood flowing back from the center of the valve clamping device 100 can be effectively blocked, and the improvement or improvement of the treatment effect on the regurgitation is facilitated.
It should be noted that, a limiting structure is disposed between the movable member 54 and the base 52, and after the movable member 54 drives the first clamping arm 11 of each group of clamping members 10 to approach the corresponding second clamping arm 12 to clamp the valve leaflet, the limiting structure can prevent the movable member 54 from driving the first clamping arm 11 to depart from the corresponding second clamping arm 12, thereby preventing the clamped valve leaflet from sliding between the first clamping arm 11 and the corresponding second clamping arm 12. In addition, a locking structure is arranged between the locking piece 56 and the base 52 and/or a locking structure is arranged between the locking piece 56 and the second clamping arms 12, and after the locking piece 56 drives each second clamping arm 12 and each first clamping arm 11 to retract inwards to reduce the petals She Jianju, the locking structure can prevent the locking piece 56 from moving along the axial direction relative to the base 52 so as to prevent the locking piece 56 from being far away from each second clamping arm 12, so that each second clamping arm 12 and each first clamping arm 11 which are retracted inwards are outwards opened, and the phenomenon that hollow parts between each first clamping arm 11 cannot be effectively blocked because the blocking piece 30 is not extruded by each first clamping arm 11 is avoided, and central reflux still exists.
Specifically, as shown in fig. 4 and 5, in the first embodiment, the base 52 has a truncated cone structure and is provided with through holes (not labeled) penetrating through two ends along the axial direction, and external threads (not shown) are further provided on the outer wall of the base 52; the locking member 56 has a cylindrical structure and is provided with a receiving chamber penetrating both ends in the axial direction, and an inner wall of the receiving chamber is provided with an internal thread (not shown) at least at a distal end portion. Wherein, the external screw thread of the base 52 is matched with the internal screw thread of the locking piece 56, and the base 52 is arranged in the accommodating cavity of the locking piece 56 and is in threaded connection with the locking piece 56. It will be appreciated that when the base 52 is fixed, the locking member 56 is axially movable relative to the base 52 while rotating relative to the base 52; when the locking member 56 stops rotating, the external thread of the base 52 and the internal thread of the locking member 56 form a locking structure, so that self-locking between the base 52 and the locking member 56 can be realized, and the locking member 56 is prevented from moving axially relative to the base 52. Preferably, in the present embodiment, the inner wall of the accommodating cavity of the locking member 56 is provided with an internal thread from the proximal end to the distal end, so that the base 52 has a larger axial movement space in the accommodating cavity of the locking member 56.
As shown in fig. 4 and 5, the movable member 54 has a rod-like or tubular structure, and the proximal end of the movable member 54 is movably inserted through the through-hole of the base 52. In this embodiment, the movable member 54 has a rod-like structure including a large-diameter section and a small-diameter section extending from a distal end of the large-diameter section, and a proximal end portion of the large-diameter section is movable through the through hole of the base 52. In other embodiments, the moveable member 54 may be a shaft structure having a constant proximal-to-distal dimension, or a shaft structure having a distal dimension greater than a proximal dimension. Of course, in other embodiments, the moveable member 54 may be a tubular structure that moves proximally through the base 52, the dimensions of which are not limited from proximal to distal.
Further, in the present embodiment, at least one elastic piece 542 is further disposed on the outer wall of the proximal end of the movable member 54, and one end of each elastic piece 542 is connected to the outer wall of the movable member 54, and the other end is a free end. In a natural state, each elastic piece 542 extends toward the distal end and toward the outside of the movable member 54. As shown in fig. 4, in the present embodiment, the proximal end of the movable member 54 penetrates into the through hole of the base 52 from the distal end of the base 52, and each elastic sheet 542 is pressed by the inner wall of the through hole to elastically deform and fit the outer wall of the movable member 54. As shown in fig. 5, when the movable member 54 moves axially and proximally relative to the base 52 until the elastic piece 542 extends out of the proximal end surface of the base 52, the elastic piece 542 is not pressed by the inner wall of the through hole and returns to deform, and the free end of the elastic piece 542 abuts against the proximal end surface of the base 52, so that the movable member 54 can be prevented from moving axially and distally relative to the base 52. The proximal end surface of the base 52 and the elastic piece 542 on the movable member 54 form a limiting structure between the base 52 and the movable member 54. Preferably, in the present embodiment, the outer wall of the movable member 54 is symmetrically provided with a pair of elastic sheets 542, so that the movable member 54 is stressed and balanced.
In other embodiments, at least one elastic piece extending toward the proximal end and simultaneously toward the interior of the through hole may be disposed at the edge of the proximal end port of the through hole of the base 52, a ring of annular groove is formed on the proximal outer wall of the movable piece 54, and when the movable piece 54 moves axially and proximally relative to the base 52 until the elastic piece is snapped into the annular groove, the elastic piece disposed on the base 52 and the annular groove formed on the movable piece 54 form a limiting structure between the base 52 and the movable piece 54, so that the movable piece 54 can be prevented from moving axially and distally relative to the base 52. It is understood that in other embodiments, the limiting structure between the base 52 and the movable member 54 may be other types of structures, such as a combination structure of a spring and a clip hole, which will not be described herein.
Alternatively, to avoid rotation during axial movement of moveable member 54 relative to base member 52, the cross-section of moveable member 54 at least at the proximal portion is of a shape that is not easily rotated (including, but not limited to, rectangular, oval, or diamond-shaped), and the cross-sectional shape of the through-hole of base member 52 matches the cross-sectional shape of the proximal portion of moveable member 54. In this embodiment, the cross section of the large diameter section of the movable member 54 is rectangular, and the through hole of the base 52 is a rectangular through hole. It will be appreciated that rotation of the movable member 54 during axial movement relative to the base 52 may also be avoided by providing the through-hole of the base 52 and the proximal portion of the movable member 54 with axially extending guide grooves and guide protrusions adapted to the guide grooves, respectively. It should be noted that, to ensure safety after implantation, the base 52, the movable member 54, and the locking member 56 are made of biocompatible metal materials or polymer materials, wherein the metal materials include, but are not limited to, stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy, or nickel-titanium alloy, and the polymer materials include, but are not limited to, polyester, silicone, and the like. In this embodiment, the base 52, the movable member 54 and the locking member 56 are preferably made of stainless steel or cobalt-chromium alloy with high hardness.
Further, as shown in fig. 4 and 5, one end of the first clamping arm 11 is fixedly connected to the movable member 54, and the other end is a free end; one end of the second clamping arm 12 is fixedly connected to the base 52, and the other end is a free end. In this embodiment, one end of each first clamping arm 11 is connected to the distal end of the large-diameter section of the movable member 54 and uniformly distributed around the movable member 54, and one end of each second clamping arm 12 is connected to the distal end of the base 52 and uniformly distributed around the through hole of the base 52. It will be appreciated that as the moveable member 54 moves axially relative to the base 52, each first clamping arm 11 follows the movement of the moveable member 54 axially relatively toward or away from the corresponding second clamping arm 12; as the locking member 56 moves axially relative to the base 52, the locking member 56 simultaneously moves axially relative to each of the second clamping arms 12.
The first clamping arm 11 and the second clamping arm 12 are made of a metal material with biocompatibility and elasticity, including but not limited to stainless steel, cobalt alloy, cobalt chromium alloy, titanium alloy or nickel titanium alloy, etc. In this embodiment, the first clamping arm 11 and the second clamping arm 12 are preferably made of nitinol, and the first clamping arm 11 and the second clamping arm 12 may be fixedly connected to the movable member 54 and the base 52 by welding, crimping, riveting, or the like, respectively. In other embodiments, the first clamping arm 11 and the movable member 54 may be integrally formed of the same material, and the second clamping arm 12 and the base 52 may be integrally formed of the same material. It will be appreciated that the materials of the first clamping arm 11 and the second clamping arm 12 may be the same or different.
As shown in fig. 4 and 5, in the present embodiment, the number of the first clamping arms 11 and the second clamping arms 12 is two, that is, the number of the clamping members 10 is two, and the two clamping members 10 are symmetrically disposed about the central axis of the valve clamping device 100. Specifically, in the present embodiment, in a natural state (i.e. in a state of not being subjected to an external force), the two first clamping arms 11 are relatively opened in a V-shape, the two second clamping arms 12 are also relatively opened in a V-shape, and the opening angle between the two second clamping arms 12 is equal to or slightly larger than the opening angle between the two first clamping arms 11. Preferably, in this embodiment, the opening angle between the two second clamping arms 12 is slightly larger than the opening angle between the two first clamping arms 11, so that a leaflet accommodating space with a flared opening is formed between the first clamping arms 11 and the corresponding second clamping arms 12, and the flared opening facilitates the leaflet entering the leaflet She Rongna space.
Preferably, in this embodiment, the first clamping arm 11 and the second clamping arm 12 are both in a sheet-like structure, and the first clamping arm 11 and the corresponding second clamping arm 12 have a larger clamping area, which is beneficial to clamping the leaflet.
Further, at least one of the first clamping arm 11 and the corresponding second clamping arm 12 is provided with an anchoring structure 13 at one side for clamping the leaflet. The anchoring structures 13 may be protrusions, grooves or pads made of biocompatible materials with a high friction coefficient. Preferably, as shown in fig. 4 and 5, in this embodiment, the opposite sides of the first clamping arm 11 and the corresponding second clamping arm 12 are provided with the anchoring structures 13 with tooth-like protruding structures, and when the first clamping arm 11 and the corresponding second clamping arm 12 clamp the leaflet, the leaflet can be fixed by using the anchoring structures 13 with tooth-like protruding structures, so as to prevent the leaflet She Huatuo or unstable fixation.
It will be appreciated that when the locking member 56 moves distally in the axial direction relative to the base 52, the base 52 gradually moves proximally in the receiving cavity of the locking member 56, thereby driving each second clamping arm 12 to move proximally relative to the locking member 56 until the outer side of each second clamping arm 12 contacts the distal end of the locking member 56, and the distal end of the locking member 56 presses each second clamping arm 12 inwardly, so that each second clamping arm 12 deforms elastically to retract inwardly, and further driving the clamped leaflet and each first clamping arm 11 to retract inwardly. The greater the distance the locking member 56 moves axially distally relative to the base 52, the greater the inward extent to which each second clamping arm 12 is drawn, and the proximal portion of each second clamping arm 12 is gradually received in the receiving cavity of the locking member 56.
Optionally, as shown in fig. 4 and 5, a tooth-shaped structure 14 is disposed on the outer side of at least one second clamping arm 12 of the valve clamping device 100, and each tooth-shaped structure 14 includes a stop surface and a sliding guide surface connected to the stop surface, where the stop surface is a plane disposed on the distal end of the tooth-shaped structure 14 and protruding outwards from the outer side of the second clamping arm 12, and the sliding guide surface is a slope extending from the stop surface towards the proximal end and towards the outer side of the second clamping arm 12. As shown in fig. 5, when the locking member 56 drives each second clamping arm 12 to retract inward and the proximal end portion of each second clamping arm 12 is gradually accommodated in the accommodating cavity of the locking member 56, at least part of the tooth-shaped structure 14 is also gradually accommodated in the accommodating cavity, and the sliding guide surface of the tooth-shaped structure 14 is in sliding contact with the distal end opening of the accommodating cavity of the locking member 56, so that the proximal end portion of the second clamping arm 12 can smoothly enter the accommodating cavity; the stop surface of the tooth-shaped structure 14 accommodated in the accommodating cavity stops the internal thread of the inner wall of the accommodating cavity to prevent the locking piece 56 from moving axially and proximally relative to the base 52, and the tooth-shaped structure 14 of the second clamping arm 12 and the internal thread in the locking piece 56 form a locking structure between the second clamping arm 12 and the locking piece 56 together to prevent the locking piece 56 from being far away from each second clamping arm 12 so that each second clamping arm 12 and each first clamping arm 11 which are folded inwards are outwards opened. Preferably, in this embodiment, the tooth-shaped structures 14 are disposed on the outer sides of the two second clamping arms 12, which is beneficial to ensuring the stress balance of the valve clamping device 100. In other embodiments, the valve clasper apparatus 100 may have the tooth formation 14 on the outside of only one of the second clasper arms 12, and may also be configured to form the locking formation with the internal threads of the locking member 56.
In this embodiment, a locking structure is disposed between the second clamping arm 12 and the locking member 56, and a locking structure (i.e. an external thread of the base 52 and an internal thread of the locking member 56) is also disposed between the base 52 and the locking member 56, and the two locking structures have dual safety functions, so that if one locking structure fails, the other locking structure can still prevent the locking member 56 from being away from the second clamping arm 12, so as to prevent the second clamping arms 12 and the first clamping arms 11 that have been folded inwards from being opened outwards, so as to avoid the blocking failure of the blocking member 30 caused by the outward opening of the clamping member 10. Of course, in other embodiments, the valve clasper apparatus 100 may provide a locking structure only between the second clasper arm 12 and the locking member 56, or only between the base 52 and the locking member 56, without limitation.
Referring to fig. 4 and 5 again, in the present embodiment, the plugging member 30 is a mesh structure with elastic self-expansion property, and is preferably made of a wire material with shape memory function (including but not limited to nickel-titanium alloy wire) woven and heat-set, or a tube material with shape memory function (including but not limited to nickel-titanium alloy tube) cut and heat-set. As shown in fig. 4, in the natural state, the blocking member 30 is in an expanded state; as shown in fig. 5, when the blocking member 30 is pressed by each of the first clamping arms 11, the blocking member 30 is deformed in a compressed state to fill and block the space between the inner sides of each of the first clamping arms 11, thereby blocking the open gap between the clamped leaflets corresponding to the positions of each of the first clamping arms 11.
In other embodiments, the occluding member 30 may be other structures having elastic self-expanding properties including, but not limited to, a dense structure, wherein the occluding member 30 may be a silica gel, or a porous structure, wherein the occluding member 30 may be a sponge.
The shape of the plugging member 30 in the expanded state of any of the above structures includes, but is not limited to, a cone shape, an inverted cone shape, a sphere shape, a flat sphere shape, an ellipsoid shape, a gourd shape, and the like. In this embodiment, the shape of the occluding component 30 is approximately balloon-shaped. The distal end of the occluding member 30 is free and in a closed position, and the proximal end of the occluding member 30 is fixedly attached to the moveable member 54. Specifically, in this embodiment, the proximal ends of the nickel-titanium alloy wires used for braiding the plugging member 30 are gathered, and the seal head 70 with the connecting sleeve-like structure is fixed by welding, crimping or riveting, and the seal head 70 is fixedly connected to the distal end of the small-diameter section of the movable member 54, so that the proximal end of the plugging member 30 is fixedly connected to the distal end of the movable member 54. The distal end of the movable member 54 may or may not extend into the blocking member 30, and is not limited to this. In other embodiments, the proximal end of the occluding member 30 may be fixedly attached to the distal end of the moveable member 54 directly by welding or the like, thereby eliminating the need for the closure head 70.
In other embodiments, the proximal end of the blocking member 30 may be fixedly connected to the inner side of any of the first clamping arms 11, as long as the blocking member 30 is disposed between the inner sides of the respective first clamping arms 11.
Preferably, in this embodiment, as shown in fig. 5, the radial dimension of the blocking member 30 from the middle section to the proximal end thereof is gradually reduced, that is, the portion from the middle section to the proximal end of the blocking member 30 is in an inverted cone shape, which is beneficial for the first clamping arms 11 to be folded inwards to a greater extent, so that the first included angle a between the two first clamping arms 11 is smaller, and is more beneficial for reducing the interval between the valve leaflets. In this embodiment, when the valve clamping device 100 is in the folded state, the first included angle a between the two first clamping arms 11 may range from 5 degrees to 20 degrees, and the second included angle B between the second clamping arm 12 and the undamped portion of the leaflet may be greater than 100 degrees. In contrast to fig. 3, in the conventional valve clamping device, since no blocking member is provided, the two second clamping arms 03 can be nearly parallel, the second clamping arms 03 are nearly perpendicular to the portion of the valve leaflet that is not clamped, and the second included angle B between the second clamping arm 12 of the valve clamping device 100 and the portion of the valve leaflet that is not clamped can be greater than 100 degrees, so that the impact of the distal end of the second clamping arm 12 on the valve leaflet during the swing of the valve leaflet can be reduced, the distal end of the valve leaflet is prevented from being perforated by the distal end of the second clamping arm 12, and the implantation safety of the valve clamping device 100 is improved. In addition, in this embodiment, the distal end of the second clamping arm 12 is designed to have no sharp angle, preferably, the distal end of the second clamping arm 12 is designed to have a smoothly rounded spherical structure, so that damaged leaflets can be further weakened.
To enhance the sealing effect of the seal 30 on blood, the seal 30 may also be coated with a barrier film 90 on the inner and/or outer surfaces. The choke film 90 is made of at least one layer of a polymeric material having biocompatibility, oxidation resistance, dissolution resistance, including but not limited to PTFE, EPTFE, polyester, silicone, PET, silicone, urethane, or the like. In this embodiment, the outer surface of the blocking member 30 is coated with a barrier film 90 made of PET material.
As shown in fig. 4, there is a first axial space D1 between the connection of the proximal end of the blocking member 30 and the movable member 54 and the connection of the first clamping arm 11 and the movable member 54, i.e., there is a first axial space D1 between the proximal end of the blocking member 30 and the connection end of the first clamping arm 11. It will be appreciated that if the first axial distance D1 is too large, when the first clamping arms 11 are folded relatively, the attaching area between the plugging member 30 and the inner side surface of each first clamping arm 11 is smaller, so that the plugging effect of the plugging member 30 is reduced; if the first axial distance D1 is too small, the blocking member 30 will prevent the first clamping arms 11 from being folded to a smaller angle when the first clamping arms 11 are folded relatively, so the first axial distance D1 should be controlled within a reasonable range of values. In this embodiment, the value range of the first axial interval D1 is controlled to be 12mm-15mm, so that on one hand, the blocking piece 30 and the inner side surface of the first clamping arm 11 can be ensured to have enough attaching area, and on the other hand, the blocking piece 30 can be prevented from blocking the two first clamping arms 11 to be folded to a smaller angle relatively.
The valve clasper device 100 provided in this embodiment is capable of being used to treat mitral regurgitation. Specifically, after the valve clamping device 100 is pushed to a position where the anterior leaflet and the posterior leaflet of the mitral valve cannot be normally closed by the corresponding conveying device, the first clamping arms 11 are driven by the movable piece 54 to approach the corresponding second clamping arms 12, so that one group of clamping pieces 10 clamps the anterior leaflet edge of the mitral valve, the other group of clamping pieces 10 clamps the posterior leaflet edge of the mitral valve, and then the two groups of clamping pieces 10 are driven by the locking piece 56 to be folded together, so that the position where the anterior leaflet and the posterior leaflet of the mitral valve cannot be normally closed can be folded together, the interval between the anterior leaflet and the posterior leaflet of the mitral valve is reduced, and the blocking piece 30 is deformed and fills and blocks the space between the inner sides of the first clamping arms 11 due to the extrusion of the first clamping arms 11, that is, the open gap between the anterior leaflet and the posterior leaflet of the mitral valve corresponding to the positions of the first clamping arms 11 is blocked (as shown in fig. 5). When the heart contracts, the valve clamping device 100 enables the mitral valve to be completely closed or the gap to be reduced, so that mitral regurgitation is treated, the blocking piece 30 effectively blocks the open gap between the anterior leaflet and the posterior leaflet of the mitral valve corresponding to the positions of the first clamping arms 11, and can block blood flowing back from the center, thereby being beneficial to improving or enhancing the treatment effect on mitral regurgitation.
It can be understood that, in the process of driving the two sets of clamping members 10 to fold together to clamp the valve leaflet by the locking member 56 and extruding the sealing member 30, the folding states of the two sets of clamping members 10 are different along with different distances of the locking member 56 moving distally relative to the base 52, so that the sealing member 30 is extruded to have different degrees of elastic deformation, that is, the sealing member 30 can be deformed adaptively to different degrees, so as to ensure the sealing effect. Furthermore, when the valve clamping device 100 is in the folded state, the extruded blocking member 30 generates an outward reaction force to the two first clamping arms 11, so that the excessive pulling force to the valve leaflet caused by the excessive folding of the two first clamping arms 11 can be avoided, and meanwhile, the clamping force of the first clamping arms 11 and the corresponding second clamping arms 12 to the valve leaflet can be increased.
Further, the present application provides a valve clamping system comprising a delivery device and the valve clamping device 100, wherein the distal end of the delivery device is detachably connected with the valve clamping device 100, and the delivery device is used for delivering the valve clamping device 100 and controlling the driving assembly 50 of the valve clamping device 100, namely controlling the axial movement of the movable member 54 relative to the base 52 and controlling the axial movement of the locking member 56 relative to the base 52.
Wherein, the conveying device can comprise an operating handle and a pushing component, the proximal end of the pushing component is connected with the operating handle, and the distal end of the pushing component is detachably connected with the driving component 50. Specifically, the pushing assembly comprises a mandrel, a liner tube and an outer tube which are movably coaxially sleeved together, wherein the liner tube is positioned between the mandrel and the outer tube. The operating handle can drive the mandrel, the liner tube and the outer tube to rotate and move axially respectively.
The distal end of the spindle is removably connected, such as by a threaded connection, to the proximal end of the moveable member 54, and the spindle is used to control the movement of the moveable member 54 in the axial direction. The distal end of the sleeve is removably connected, such as snap-fit, to the proximal end of the base 52, and the sleeve is adapted to limit rotation of the base 52. The distal end of the outer tube is removably coupled to the proximal end of the locking member 56, such as a snap fit connection, and the outer tube is used to control rotation of the locking member 56 relative to the base 52, i.e., to control axial movement of the locking member 56 relative to the base, when rotation of the base 52 is limited. It will be appreciated that the detachable connection of the mandrel to the movable member 54, the detachable connection of the liner to the base 52, and the detachable connection of the outer tube to the locking member 56 may be conventional, and will not be described in detail herein.
The following describes the use of the valve clamping system of the present application, taking as an example a mitral valve repair procedure, which essentially comprises the steps of:
The first step: the pushing assembly of the delivery device is connected to the valve clasper device 100. Specifically, the base 52 is disposed in the receiving cavity of the locking member 56 and is in threaded connection with the same, the proximal end of the movable member 54 is disposed in a through hole of the base 52 in a penetrating manner, the elastic sheet 542 of the movable member is received in the through hole, the distal end of the mandrel is in threaded connection with the proximal end of the movable member 54, the distal end of the liner tube is in snap connection with the proximal end of the base 52, and the distal end of the outer tube is in fit connection with the proximal end of the locking member 56 through the elastic sheet and the snap hole.
And a second step of: accommodating the push assembly and the valve clasper device 100 in a catheter such that each set of clips 10 and plugs 30 of the valve clasper device 100 are in a compressed state; the valve clamping device 100 is advanced to the left ventricle through the advancing assembly, following a transapical path, and then across the mitral valve orifice to the left atrium.
And a third step of: the valve clamping device 100 in the catheter is brought close to the anterior and posterior leaflet of the mitral valve, and then the valve clamping device 100 is gradually pushed out of the distal end of the catheter by the pushing assembly, the occluding member 30 and the two first clamping arms 11 are deployed in the left atrium first, and the two second clamping arms 12 are deployed in the left ventricle.
Fourth step: the whole valve clamping device 100 is pushed distally, so that the two second clamping arms 12 respectively support the anterior leaflet and the posterior leaflet of the mitral valve at one side of the left ventricle, and then the mandrel control movable part 54 is retracted proximally along the axial direction relative to the base 52, so as to drive the two first clamping arms 11 to respectively approach the corresponding second clamping arms 12, thereby capturing the anterior leaflet and the posterior leaflet of the mitral valve and respectively clamping the two first clamping arms 11 and the corresponding two second clamping arms 12.
Fifth step: through the rotation of the liner tube limiting base 52, the locking piece 56 is driven by the outer tube to rotate and move towards the far end along the axial direction relative to the base 52, so that the two second clamping arms 12 are gathered relatively, the two first clamping arms 11 are driven to gather relatively at the same time, the blocking piece 30 is gradually subjected to the extrusion action of the two first clamping arms 11 to generate adaptive deformation, so that the space between the inner sides of the two first clamping arms 11 is filled and blocked, at the moment, the anterior leaflet and the posterior leaflet of the mitral valve are respectively fixed between the corresponding first clamping arms 11 and the second clamping arms 12, and the blocking piece 30 blocks the open gap between the valve leaflets corresponding to the positions of the two first clamping arms 11, so that the blood with the back flow in the center is effectively blocked.
Sixth step: the detachable connection of the pushing assembly and the driving assembly 50 is released through the operation handle, the pushing assembly and the catheter are withdrawn from the patient, and the edge-to-edge repair of the mitral valve is completed.
In addition to applying the transapical approach described above, the interventional approach to edge-to-edge repair of the mitral valve may be: femoral artery-abdominal aorta-thoracic aorta-aortic arch-left ventricle-left atrium.
It will be appreciated that in other embodiments, the valve clasper device 100 provided by the present application may include three first clasper arms 11 and corresponding three second clasper arms 12, i.e., the claspers 10 may be arranged in three groups, such that the three leaflets are simultaneously gathered together by the three groups of claspers 10, such that the valve clasper device 100 is also capable of being used to treat tricuspid regurgitation.
In other embodiments, two of the leaflets of the tricuspid valve may also be clamped by one valve clamping device 100; or three valve clamping devices 100 are implanted to clamp the front and rear leaves, rear and partition leaves and front leaves of the tricuspid valve respectively, and the purpose of reducing or treating the regurgitation of the tricuspid valve can be achieved. Wherein, the margin-to-margin repair is performed on the tricuspid valve, and only a corresponding intervention path, such as a transapical intervention path, is needed. Of course, in other embodiments of the present application, the valve clamping device 100 can be applied to other minimally invasive operations requiring clamping together several pieces of tissue, and the number of the clamping members 10 can be varied according to the actual requirement, which will not be described in detail.
Referring to fig. 6 to 8, a valve clamping device 100b with a plugging function according to a second embodiment of the present application has a similar structure to the valve clamping device 100 of the first embodiment, except that: in the second embodiment, the blocking member 30 has an inverted cone structure, the distal end of the blocking member 30 is fixedly connected to the distal end of the movable member 54 through the sealing head 70, and the proximal end is axially slidably sleeved on the movable member 54.
In the second embodiment, the plugging member 30 includes a first section 31, a second section 32 and a third section 33 connected in sequence. Specifically, as shown in fig. 6 and 7, in a natural state, one end of the first section 31 is fixedly connected to the distal end of the movable member 54, the other end is connected to the second section 32, and the first section 31 is recessed inward relative to the second section 32 to form a bowl-like shape; the second section 32 extends radially outwardly from the other end of the first section 31, and the third section 33 extends proximally from the end of the second section remote from the first section 31 and radially inwardly to the proximal end of the blocking member 30, and the proximal end of the blocking member 30 is slidably disposed on the movable member 54.
As shown in fig. 8, in this embodiment, when the valve clamping device 100b is in the collapsed state, the axial movement of the first section 31 and the second section 32 is limited, the sealing member 30 is axially elongated toward the proximal end thereof when being pressed by each first clamping arm 11, and is radially contracted, the recessed first section 31 resists inward deformation of the second section 32, the second section 32 further transfers the resisting action to the corresponding portion of the third section 33 connected thereto, and the sealing member 30 is in an elongated inverted cone-shaped structure as a whole along with the proximal end of the sealing member 30 sliding along the movable member 54 in the proximal direction, the shape of the inverted cone-shaped sealing member 30 complements the shape of each first clamping arm 11 after being relatively gathered, so that the elastic fit between the sealing member 30 and each first clamping arm 11 is improved, and the sealing member 30 can be more fully attached to the center of the sealing member 11, thereby achieving a better sealing effect of reverse flow. In addition, the plugging piece 30 with a slidable end deforms elastically to a greater extent when being pressed, so that a greater radial supporting force can be provided for each first clamping arm 11, and the clamping force is further improved to firmly clamp the valve leaflet.
In this embodiment, when the valve clamping device 100 is in the folded state, the first included angle between the two first clamping arms 11 may range from 5 degrees to 30 degrees, and the second included angle between the second clamping arm 12 and the undamped portion of the valve leaflet may be greater than 120 degrees.
It will be appreciated that in other embodiments, the blocking member 30 may be fixedly connected to the movable member 54 at a proximal end thereof by the sealing head 70, and the movable member 54 is slidably sleeved at a distal end thereof, so that the blocking member 30 may extend toward the distal end thereof in the axial direction when being pressed by the respective first clamping arms 11, and may be contracted in the radial direction, thereby achieving the same effects as described above. It should be noted that, when the distal end of the blocking member 30 is slidably sleeved on the movable member 54, in order to prevent the distal end of the blocking member 30 from sliding off from the distal end of the movable member 54, optionally, a limiting portion may be disposed on the distal end of the movable member 54 to prevent the distal end of the blocking member 30 from being separated from the movable member 54.
Referring to fig. 9 and 10 together, a third embodiment of the present application provides a valve clamping device 100c with a plugging function, which has a similar structure to the valve clamping device 100b of the second embodiment, and is different in that: in the third embodiment, both ends of the blocking member 30 are slidably sleeved on the movable member 54. When the valve clamping device 100c is folded, the proximal end and the distal end of the blocking member 30 can both move axially relative to the movable member 54, so that the blocking member 30 has a stronger elastic deformation capability, and the adaptability of the blocking member 30 to the relative gathering degree between the two first clamping arms 11 is further enhanced.
Optionally, to prevent the distal end of the blocking member 30 from sliding off the distal end of the movable member 54, in this embodiment, the distal end of the movable member 54 is provided with a radially boss-shaped limiting portion 20. As shown in fig. 9, in the present embodiment, the second axial interval between the limiting portion 20 and the connecting end of the first clamping arm 11 (i.e. the end connected to the movable member 54) is D2; in a natural state, the third axial spacing between the distal and proximal ends of the occluding component 30 is D3. It will be appreciated that in this embodiment the blocking member 30 is only slidable over the area between the stop 20 and the connection end of the first clamping arm 11, and therefore the sum of the maximum sliding distances d=d2-D3 of the proximal and distal ends of the blocking member 30. In order to effectively control the closing angle between the two first clamping arms 11 and to ensure the blocking effect of the blocking element 30, the sum D of the maximum sliding distances should be within a reasonable range. In this embodiment, the value of D is in the range of 6mm to 10mm.
Referring to fig. 11 to 13 together, a valve clasper device 100d with a sealing function according to a fourth embodiment of the present application has a similar structure to the valve clasper device 100 of the first embodiment, except that: in the fourth embodiment, the blocking member 30 includes the first blocking portion 301 and the second blocking portion 302, the first blocking portion 301 and the second blocking portion 302 respectively correspond to one of the first clamp arms 11, and opposite sides of the first blocking portion 301 and the second blocking portion 302 are respectively provided with complementary concave-convex shapes.
As shown in fig. 11, in this embodiment, the proximal end of the first blocking portion 301 and the proximal end of the second blocking portion 302 are fixedly connected to the distal end of the movable member 54 by the same head 70, and the distal ends of the first blocking portion 301 and the second blocking portion 302 are both closed. The shape of the opposite side of the first and second plugging portions 301, 302 is substantially complementary, in particular, the side of the first plugging portion 301 facing the second plugging portion 302 has a concave region and the side of the second plugging portion 302 facing the first plugging portion 301 has a convex region. As shown in fig. 13, in this embodiment, when the two first clamping arms 11 gather together and squeeze the first blocking portion 301 and the second blocking portion 302, two opposite sides of the first blocking portion 301 and the second blocking portion 302 are respectively attached to the inner sides of the two first clamping arms 11, and two opposite sides of the first blocking portion 301 and the second blocking portion 302 are attached together, so as to fill and block the space between the inner sides of the two first clamping arms 11, and play a role in blocking the blood flowing back from the center.
Wherein, optionally, the middle part of the first blocking portion 301 and/or the middle part of the second blocking portion 302 may be fixedly connected to the corresponding first clamping arm 11 by crimping, riveting or by means of a fixing member (e.g. a steel sleeve), so as to prevent the first blocking portion 301 and the second blocking portion 302 from being misplaced during the relative gathering of the two first clamping arms 11, thereby ensuring that the first blocking portion 301 and the second blocking portion 302 can be accurately attached together. In addition, the first blocking portion 301 and the second blocking portion 302 are respectively and fixedly connected with the corresponding first clamping arms 11, which is also beneficial to improving radial supporting force of the first blocking portion 301 and the second blocking portion 302 to the two first clamping arms 11.
In this embodiment, when the valve clamping device 100d is in the folded state, the first included angle between the two first clamping arms 11 may be 15 degrees to 25 degrees, and the second included angle between the second clamping arm 12 and the part of the leaflet that is not clamped may be greater than 100 degrees, so that damage to the leaflet caused by the distal end of the second clamping arm 12 can be reduced, and the safety of long-term implantation of the product is improved. In addition, after the opposite sides of at least two plugging parts forming the plugging piece 30 are attached, the plugging parts are mutually propped against each other, and the pushing force is transmitted to each first clamping arm 11, so that the clamping force is improved to firmly clamp the valve leaflet.
It will be appreciated that in other embodiments, the blocking member 30 may be formed by 3 or more blocking portions, where each first clamping arm 11 is correspondingly connected to at least one blocking portion, and when the first clamping arms 11 are gathered together, the blocking portions can be attached together, so as to fill and block the space between the two first clamping arms 11, and function to block the blood flowing back from the center.
Referring to fig. 14 to 18, a valve clamping device 100e with plugging function according to a fifth embodiment of the present application has a similar structure to the valve clamping device 100b of the second embodiment, except that: in the fifth embodiment, the valve clamping device 100e further includes the same number of pulling wires 40 as the first clamping arms 11, each pulling wire 40 corresponds to a first clamping arm 11, a plurality of threading cavities 545 are correspondingly disposed in the movable member 54, and each pulling wire 40 passes out of the distal end of the movable member 54 from the corresponding threading cavity 545 and is movably connected to the free end of the corresponding first clamping arm 11, so as to control the free end of the first clamping arm 11 to be relatively far from or near to the free end of the corresponding second clamping arm 12.
Specifically, as shown in fig. 14, in the present embodiment, the number of the pull wires 40 is two. Each traction wire 40 is folded in U-shaped, and comprises a folding section and two connecting sections respectively connected to two sides of the folding section. The folded section of each pulling wire 40 is sleeved on the distal end of the ball structure of a corresponding first clamping arm 11, and the two connecting sections of each pulling wire 40 are respectively movably arranged in the threading cavities 545 of the movable parts 54 in a penetrating manner. As shown in fig. 15, in the present embodiment, the movable member 54 is provided with a pair of threading cavities 545 corresponding to each pulling wire 40, and each connecting section of each pulling wire 40 is respectively threaded into one threading cavity 545, so as to avoid the two connecting sections of the pulling wires 40 from being entangled. Of course, in other embodiments, the movable member 54 may also have a threading cavity 545 corresponding to each pulling wire 40, and two connecting sections of each pulling wire 40 are disposed in the same threading cavity 545. It should be noted that, the pushing assembly of the aforementioned conveying device is provided with a plurality of penetrating channels correspondingly communicated with the threading cavity 545 of the movable member 54, and the free end of each connecting section of the pulling wire 40 extends out of the patient through a corresponding one of the penetrating channels, so as to facilitate the pulling by the operator. The penetrating channel may be disposed in a mandrel of the pushing assembly, or may be disposed between the mandrel and a liner tube of the pushing assembly, which is not limited thereto.
As shown in fig. 16, the operator can control the free end of each first clamping arm 11 relatively far from the free end of the corresponding second clamping arm 12 by pulling the two pulling wires 40 outside the body, and each first clamping arm 11 abuts or presses the blocking member 30, so that the opening of the leaflet receiving space between each first clamping arm 11 and the corresponding second clamping arm 12 becomes large, facilitating the leaflet to enter the leaflet receiving space. As shown in fig. 16 to 18, the first clamping arm 11 on the corresponding side is released by loosening the pull wire 40 on the side, the first clamping arm 11 is engaged with the corresponding second clamping arm 12 to capture the anterior leaflet of the mitral valve, after confirming that the anterior leaflet is captured, the position of the valve clamping device 100e is adjusted so that the posterior leaflet of the mitral valve enters the leaflet receiving space on the other side, and then the first clamping arm 11 on the other side is released by loosening the pull wire 40 on the other side, and the first clamping arm 11 is engaged with the corresponding second clamping arm 12 to capture the posterior leaflet. It will be appreciated that during the capture process, if the leaflet capture position is found to be inadequate, the corresponding pull wire 40 may be pulled taut and the leaflet capture resumed. Finally, the locking pieces 56 drive the second clamping arms 12 and the first clamping arms 11 to retract inwards, so that the plugging pieces 30 are extruded by the first clamping arms 11 to deform and fill and plug the spaces between the first clamping arms 11, and the plugging of the central reflux blood is realized. It should be noted that, after the mitral valve edge-to-edge repair operation is completed, the pull wire 40 may be withdrawn from the body through the threading cavity 545 and the corresponding threading channel by withdrawing any one of the connecting sections of the pull wire 40.
The material of the pulling wire 40 may be stainless steel wire, nickel titanium wire, polymer wire, etc., preferably nickel titanium wire with good elasticity and toughness, and the pulling wire 40 made of nickel titanium wire will not break.
It can be appreciated that by manipulating the single traction wire 40, the first clamping arms 11 on the corresponding side can be released independently to capture the valve leaflet on the corresponding side, so that the capturing and clamping difficulty of the movable valve leaflet is reduced; of course, the two traction wires 40 can be simultaneously operated to simultaneously release the two side first clamping arms 11 to capture the two side valve leaflets, so that the flexibility and convenience of operation are improved.
The foregoing is a description of embodiments of the present application, and it should be noted that, for those skilled in the art, modifications and variations can be made without departing from the principles of the embodiments of the present application, and such modifications and variations are also considered to be within the scope of the present application.

Claims (12)

1. The valve clamping device with the plugging function is characterized by comprising at least two groups of clamping pieces, plugging pieces and a driving assembly; each group of clamping pieces comprises a first clamping arm and a second clamping arm, and the first clamping arms are positioned on the inner sides of the corresponding second clamping arms; the blocking piece is made of elastic materials and is arranged on the inner side of each first clamping arm; the driving assembly comprises a base, a movable piece and a locking piece;
One end of each second clamping arm is fixedly connected with the base, one end of each first clamping arm is fixedly connected with the movable piece, and the movable piece can axially move relative to the base so as to drive the first clamping arm and the second clamping arm in each group of clamping pieces to be relatively far away or close to each other; the locking piece is arranged outside the base and can axially move relative to the base so as to drive each second clamping arm and each first clamping arm to retract inwards; when the first clamping arms are folded inwards, the blocking piece is extruded, so that the blocking piece is deformed and the space between the inner sides of the first clamping arms is filled;
A locking structure is arranged between the locking piece and the base, and/or a locking structure is arranged between the locking piece and the second clamping arm; and a limiting structure is arranged between the movable part and the base, and the movable part drives the first clamping arm to be close to the second clamping arm so as to clamp the valve leaflet, and the limiting structure prevents the movable part from driving the first clamping arm to be far away from the second clamping arm.
2. The valve clasper with occlusion of claim 1 wherein the proximal end of said occlusion member is fixedly attached to said moveable member and the distal end of said occlusion member is free.
3. The valve clamping device with plugging function according to claim 2, wherein the plugging piece comprises at least two plugging portions, the at least two plugging portions are in one-to-one correspondence with the at least two first clamping arms, and opposite sides of two adjacent plugging portions are respectively provided with complementary concave-convex shapes.
4. A valve clamping arrangement with occlusion function according to claim 2 or 3, wherein there is an axial spacing between the connection of the proximal end of the occluding member to the moveable member to the connection of the first clamping arm to the moveable member.
5. The valve clasper with plugging function of claim 1, wherein one end of the plugging member is fixedly connected to the movable member, and the other end of the plugging member is slidably sleeved or fixedly connected to the movable member;
or both ends of the blocking piece are sleeved on the movable piece in a sliding way.
6. The valve clasper with occlusion function of claim 5, wherein said occlusion member comprises a first section, a second section, and a third section connected in sequence;
In a natural state, one end of the first section is fixedly connected or sleeved on the movable piece, the other end of the first section is connected with the second section, the first section is recessed inwards relative to the second section, the second section extends outwards radially from the other end of the first section, the third section extends inwards radially from one end, away from the first section, of the second section towards the proximal end and simultaneously towards the proximal end, of the plugging piece to the proximal end of the plugging piece, and the proximal end of the plugging piece is fixedly connected or sleeved on the movable piece in a sliding mode.
7. The valve clasper with occlusion of claim 5 wherein the distal end of the occlusion member is slidably disposed over the moveable member, the distal end of the moveable member having a stop for preventing the distal end of the occlusion member from exiting the moveable member.
8. The valve clamping device with plugging function according to claim 1, further comprising at least two pulling wires corresponding to at least two first clamping arms one by one, wherein at least two threading cavities are arranged in the movable piece, and each pulling wire penetrates out of the distal end of the movable piece from the corresponding threading cavity and is movably connected to the free end of the corresponding first clamping arm so as to control the free end of the first clamping arm to be relatively far away from or close to the free end of the corresponding second clamping arm.
9. The valve clasper with occlusion function of claim 1 wherein said occlusion member has elastic self-expanding properties, said occlusion member being at least one of a mesh structure, a dense structure and a porous structure.
10. The occlusion valve clasper of claim 1, wherein the occlusion member tapers in radial dimension from its middle section to its proximal end.
11. The valve clasper with occlusion of claim 1 wherein the inner surface and/or the outer surface of the occlusion member is coated with a fluid blocking membrane.
12. A valve clamping system comprising a valve clamping device with a plugging function according to any one of claims 1 to 11, and a delivery device, the distal end of which is detachably connected to the valve clamping device, the delivery device being adapted to deliver the valve clamping device and to control the drive assembly.
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