CN113230001B - Valve clamping device - Google Patents

Valve clamping device Download PDF

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Publication number
CN113230001B
CN113230001B CN202110720766.7A CN202110720766A CN113230001B CN 113230001 B CN113230001 B CN 113230001B CN 202110720766 A CN202110720766 A CN 202110720766A CN 113230001 B CN113230001 B CN 113230001B
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CN
China
Prior art keywords
piece
closing
valve
control rod
clamping
Prior art date
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Active
Application number
CN202110720766.7A
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Chinese (zh)
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CN113230001A (en
Inventor
阮成民
肖建平
林育坤
曾杰
姜小飞
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Guangdong Pulse Medical Technology Co ltd
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Guangdong Pulse Medical Technology Co ltd
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Priority to CN202110720766.7A priority Critical patent/CN113230001B/en
Publication of CN113230001A publication Critical patent/CN113230001A/en
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Classifications

    • 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
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466Delivery devices therefor

Abstract

The invention relates to the field of medical instruments, in particular to a valve clamping device. A valve clasper device including a lever, a first support, a clamp, at least one pair of pairs of fasteners, and at least one pair of closures; the closing part is respectively arranged at two sides of the control rod and corresponds to the closing part; one end of the opposite-closing member is rotationally connected with the control rod, the other end of the opposite-closing member is movably connected with the first supporting member, and the first supporting member slides on the control rod; the closing piece is connected with the involution piece; the clamping piece is arranged between the involution piece and the control rod. The opening and closing degree of the clamping device is adjusted by automatically adjusting the opening and closing angle through the driving of the blood pressure, so that the opening and closing degree of a valve is achieved; thereby achieving the effect of reducing blood reflux during systole and reducing resistance to blood flow through the valve during diastole.

Description

Valve clamping device
Technical Field
The invention relates to the field of medical instruments, in particular to a valve clamping device.
Background
Heart valves (aortic valve, pulmonary valve, mitral valve, tricuspid valve) are an important part of the cardiovascular system. The heart valve plays a role of a one-way passing valve in the heart blood vessel, and blood passing through the heart valve can only pass along the flowing direction of the valve and cannot reversely flow back, so that the blood in the blood vessel system can flow in a fixed direction under the action of the systolic and diastolic movements of the heart.
Mitral regurgitation is a common valve disorder. Some prior art techniques for treating mitral regurgitation in patients include surgically replacing a prosthetic valve or suturing the native mitral valve leaflet edge to edge (Alfiery flap), or clamping the mitral valve leaflet edge using a catheter delivery clip, or the like.
At present, the surgical intervention is mainly used for treating mitral regurgitation: surgical replacement and surgical repair, including annulus repair, leaflet repair and tendinous lock repair, have gained clinical acceptance in recent years with the development of minimally invasive interventional techniques, a percutaneous minimally invasive interventional mitral valve She Gage procedure based on edge-to-edge techniques.
The surgical treatment method for mitral regurgitation has the defects of multiple complications, long recovery period, high surgical risk and the like.
When the end portions of the mitral valve leaflets are clamped together at the sides of the leaflets by using the catheter delivery clamp, the end portions of the mitral valve leaflets overlap partially, and then under the action of the tension of suturing or clamping, the opening and closing movement of the mitral valve can be limited to a certain extent, so that the stretching degree is high, and the mitral valve leaflets with high stress also have high risk of leaflet pull-apart.
That is, how to provide a clamping force for the valve to adapt to the opening and closing movement of the valve is a technical problem to be solved in the prior art.
Disclosure of Invention
The present invention aims to provide a valve clamping device which can provide clamping force for a valve, wherein the clamping force is suitable for valve opening and closing movement.
Embodiments of the present invention are implemented as follows:
a valve clasper device comprising a lever, a first support, a clamp, at least one pair of opposed members, and at least one pair of closure members;
the involution pieces in each pair are respectively arranged on two opposite sides of the control rod, and the involution pieces are arranged in one-to-one correspondence with the closing pieces;
one end of the involution piece is rotationally connected with the control rod, the other end of the involution piece is movably connected with the first support piece, and the first support piece is arranged on the control rod in a sliding way;
the closing piece is connected with the involution piece and can position the opening state of the involution piece and the closing state of the involution piece;
the clamping piece is arranged between the involution piece and the control rod and used for clamping the valve leaflet.
In an alternative embodiment, the apposition member comprises a first connection portion and a second connection portion;
one end of the first connecting part is connected with the control rod, and the other end of the first connecting part is connected with one end of the second connecting part;
the other end of the second connecting part is connected with the first supporting piece;
the first and second connection portions can be formed into a folded state or an unfolded state by relative rotation.
In an alternative embodiment, the closure comprises a fixed portion and a resilient portion;
one end of the fixing part is arranged on the control rod, and the other end of the fixing part is connected with one end of the elastic part;
the connecting part of the first connecting part and the second connecting part or the second connecting part is movably connected with the other end of the elastic part;
the elastic part is used for always providing power for the connecting part towards the direction of the control rod.
In an alternative embodiment, the elastic portion is an elastic bending structure.
In an alternative embodiment, the closing member and the matching member are hinged, connected in a mating manner, connected in a spring or connected in a binding manner.
In an alternative embodiment, the clamp comprises a first clamp arm and a second clamp arm;
one end of the first clamping arm is rotationally connected with one end of the second clamping arm;
one side of the first clamping arm far away from the second clamping arm is connected with the involution piece.
In an alternative embodiment, a clamping tooth is arranged on one side of the first clamping arm, which is close to the second clamping arm;
and/or, a clamping tooth is arranged on one side, close to the first clamping arm, of the second clamping arm.
In an alternative embodiment, the clamping device further comprises a second support and a connecting sleeve;
the first supporting piece and the second supporting piece are respectively arranged at two ends of the connecting sleeve, and the first supporting piece, the second supporting piece and the connecting sleeve are all arranged on the control rod in a sliding manner;
the two ends of the elastic supporting piece are respectively connected with the first supporting piece and the second supporting piece, and the elastic supporting piece is sleeved on the connecting sleeve.
In an alternative embodiment, the clamping device further comprises a third support member, the third support member is disposed at one end of the control rod, and one end of the abutting member is rotatably connected with the third support member.
The embodiment of the invention has the beneficial effects that:
the first support piece slides on the control rod, so that the closing piece can conduct opening and closing actions on the clamping piece, then a closing piece with certain elasticity provides closing power for the closing piece, and further the opening and closing degree of the clamping device is adjusted by automatically adjusting the opening and closing angle through the driving of blood pressure, so that the opening and closing degree of the valve is achieved; thereby achieving the effect of reducing blood reflux during systole and reducing resistance to blood flow through the valve during diastole.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings that are needed in the embodiments will be briefly described below, it being understood that the following drawings only illustrate some embodiments of the present invention and therefore should not be considered as limiting the scope, and other related drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic view of a valve clasper apparatus according to an embodiment of the present invention in a stowed configuration;
FIG. 2 is a schematic view of a valve clasper apparatus according to an embodiment of the present invention in a deployed state;
FIG. 3 is a schematic view of an embodiment of an elongated valve clasper apparatus;
FIG. 4 is a front view of a closure member of a valve clasper apparatus provided in accordance with an embodiment of the present invention;
FIG. 5 is a side view of a closure member of a valve clasper apparatus provided in accordance with an embodiment of the present invention;
FIG. 6 is a top view of a closure member of a valve clasper apparatus provided in accordance with an embodiment of the present invention;
FIG. 7 is a diagram showing a comparison of an initial state and an assembled state of a closure member of a valve clasper apparatus provided in accordance with an embodiment of the present invention;
FIG. 8 is a schematic illustration of a valve clasper closure member in accordance with an embodiment of the present invention from an initial state to an assembled state;
FIG. 9 is a schematic view of a first connection between a commissure cap and a closing member of a valve clasper according to an embodiment of the present invention;
FIG. 10 is a schematic view of a second connection between a commissure cap and a closing member of a valve clasper according to an embodiment of the present invention;
FIG. 11 is a schematic view of a third connection between a commissure cap and a closing member of a valve clasper according to an embodiment of the present invention;
FIG. 12 is a schematic perspective view of a valve clasper apparatus according to an embodiment of the present invention;
FIG. 13 is a front view of a valve clasper apparatus provided in accordance with an embodiment of the present invention;
FIG. 14 is a side view of a valve clasper apparatus provided in accordance with an embodiment of the present invention;
FIG. 15 is a top view of a valve clasper apparatus provided in accordance with an embodiment of the present invention;
FIGS. 16-18 are schematic views of several states of a valve clasper apparatus provided in accordance with embodiments of the present invention;
FIG. 19 is a schematic view showing the closing state of the closing member of the valve clasper device according to the embodiment of the present invention;
FIG. 20 is a schematic view of a valve clasper apparatus according to an embodiment of the present invention in use;
FIG. 21 is a schematic view of a valve clasper apparatus in accordance with an embodiment of the present invention in a diastole state;
FIG. 22 is a schematic view of a valve clasper apparatus in accordance with an embodiment of the present invention in a contracted state;
fig. 23 and 24 are reference diagrams showing the use state of the valve clasper device in the implanted state according to the embodiment of the present invention.
Icon: 1-a control rod; 2-a closure; 3-a involution member; 4-a third support; 5-a first support; 6-clamping piece; 7-an elastic part; 8-a fixing part; 9-a first connection; 10-a second connection; 11-protrusions; 12-shrapnel; 13-suture; 14-a second support; 15-an elastic support; 16-leaflet; 17-valve clamping means; 18-opening.
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments of the present invention. The components of the embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.
Thus, the following detailed description of the embodiments of the invention, as presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
It should be noted that: like reference numerals and letters denote like items in the following figures, and thus once an item is defined in one figure, no further definition or explanation thereof is necessary in the following figures.
In the description of the present invention, it should be noted that, directions or positional relationships indicated by terms such as "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., are directions or positional relationships based on those shown in the drawings, or are directions or positional relationships conventionally put in use of the inventive product, are merely for convenience of describing the present invention and simplifying the description, and are not indicative or implying that the apparatus or element to be referred to must have a specific direction, be constructed and operated in a specific direction, and thus should not be construed as limiting the present invention. Furthermore, the terms "first," "second," "third," and the like are used merely to distinguish between descriptions and should not be construed as indicating or implying relative importance.
Furthermore, the terms "horizontal," "vertical," "overhang," and the like do not denote a requirement that the component be absolutely horizontal or overhang, but rather may be slightly inclined. As "horizontal" merely means that its direction is more horizontal than "vertical", and does not mean that the structure must be perfectly horizontal, but may be slightly inclined.
In the description of the present invention, it should also be noted that, unless explicitly specified and limited otherwise, the terms "disposed," "mounted," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.
Some embodiments of the present invention are described in detail below with reference to the accompanying drawings. The following embodiments and features of the embodiments may be combined with each other without conflict.
The present invention provides a valve clasper device, as shown in fig. 1-3, comprising a lever 1, a first support 5, a clamp 6, at least one pair of opposed members 3, and at least one pair of closure members 2; the involution pieces 3 in each pair are respectively arranged on two opposite sides of the control rod 1, and the involution pieces 3 are arranged in one-to-one correspondence with the closing pieces 2; one end of the involution piece 3 is rotationally connected with the control rod 1, the other end of the involution piece 3 is movably connected with the first support piece 5, and the first support piece 5 is arranged on the control rod 1 in a sliding way; the closing piece 2 is connected with the closing piece 3, and can position the opening state of the closing piece 3 and the closing state of the closing piece 3; the clamping piece 6 is arranged between the involution piece 3 and the control rod 1, and the clamping piece 6 is used for clamping the valve leaflet.
In this embodiment, the closing member 2 may be covered with a film, woven or textile to increase the contact area of the valve leaflet 16, reduce the difficulty of capturing, reduce the clamping stress, increase the blood flow blocking effect, and provide closing power to the closing member 3 for clamping the valve.
The clamping member 6 is used for clamping the valve leaflet 16, and the valve leaflet 16 is fixed on the apposition member 3, so that the blood flow resistance can be increased by covering a braid or the like.
Specifically, in this embodiment, when the first supporting member 5 is a fixing member, the operating rod 1 is pushed to move axially to drive the closing member 3 to open and close, and at this time, the closing member 2 provides the closing power for the closing member 3, so that the closing member 3 forms a self-locking function.
In an alternative embodiment, the apposition member 3 comprises a first connecting portion 9 and a second connecting portion 10, one end of the first connecting portion 9 is connected with the control rod 1, and the other end of the first connecting portion 9 is connected with one end of the second connecting portion 10; the other end of the second connecting part 10 is connected with the first supporting piece 5; the first and second connection parts 9 and 10 can be formed in a folded state or an unfolded state by relative rotation.
Specifically, in this embodiment, the first connecting portion 9 and the second connecting portion 10 are respectively in a plate-like structure, one end of the first connecting portion 9 is rotatably connected to the lower end of the control lever 1, the other end of the first connecting portion 9 is rotatably connected to one end of the second connecting portion 10, and the other end of the second connecting portion 10 is connected to the linkage member to form a rocker slider structure on the control lever 1.
More specifically, in this embodiment, the above-mentioned arrangement mode of the rotation connection may be a hinge connection, a ball connection or other rotation connection modes, or may be a connection through an elastic material, as long as the relative rotation of the first connection portion 9 and the second connection portion 10 around the connection portion thereof as a central axis can be achieved.
More specifically, in the present embodiment, the first connection portion 9 and the second connection portion 10 are integrally provided, and the connection portion of the first connection portion 9 and the second connection portion 10 is an elastic material.
More specifically, in the present embodiment, the first connecting portion 9 and the second connecting portion 10 are made of super-elastic materials, and the deformation amount of the repeated alternating operation is small, so that the materials can be kept within the elastic deformation range, and no slippage and excessive heat are generated, so that no fatigue weakness is caused.
In an alternative embodiment, as shown in fig. 4-6, the closure 2 comprises a fixed portion 8 and an elastic portion 7; one end of the fixing part 8 is arranged on the control rod 1, and the other end of the fixing part 8 is connected with one end of the elastic part 7; the joint of the first connecting part 9 and the second connecting part 10, or the second connecting part 10 is movably connected with the other end of the elastic part 7; the elastic portion 7 is used to always provide a force to the joint in the direction of the lever 1.
Specifically, in this embodiment, the fixing portion 8 and the elastic portion 7 are integrally provided, and are formed into a rod-like structure having elasticity, and after being bent, are formed into a shape as shown in fig. 4 to 6.
It should be noted that, in the present embodiment, the fixing portion 8 and the elastic portion 7 are integrally provided as a bent portion, but the present invention is not limited to a bent portion, and may be provided by other means such as cutting, pouring, etc., that is, the present invention is not limited to the above-described embodiment, as long as the space structure shown in fig. 3 to 6 can be formed, and the elastic force can be provided to the mating member 3.
Wherein, the one end of fixed part 8 is connected at the tip of control rod 1, and the one end that elastic part 7 kept away from fixed part 8 is connected on closure member 2.
Specifically, as shown in fig. 7, when the initial state of the closing tool 2 is the left-hand state, the assembled state with the mating tool 3 is the right-hand state, that is, the elastic portion 7 in the initial state is biased to the left, and when the assembly is performed, the elastic portion 7 at the upper end of the closing tool 2 is biased to bend rightward to connect with the mating tool 3.
At this time, the assembled closing member 2 is elastically deformed to a certain extent, and thus the closing member 2 tends to return to the original state, and thus a force to move the mating member 3 to the left is always generated, as shown in fig. 8.
After the whole device is assembled, the trend of the closure member 2 to the initial state drives the closure member 3 to be further closed, and a certain clamping force is provided for the closure of the closure member 3, and indirectly, the clamping force is provided for the valve closure.
The coupling of the closure part and the apposition member 3 not only requires the relative position of the two coupling parts to be determined, but also requires a certain degree of rotational freedom of the closure member 2 to avoid twisting of the clamping device during opening and closing of the apposition member 3.
In alternative embodiments, the closure member 2 and the apposition member 3 are hinged, connected in a mating manner, connected by a spring 12 or connected in a binding manner.
Specifically, the connection between the closing member 2 and the mating member 3 may be as follows:
the first connection mode is as follows: and (5) mating and connecting.
Specifically, as shown in fig. 9, in this embodiment, a protrusion 11 is disposed in the middle of the connection portion between the first connection portion 9 and the second connection portion 10 of the apposition member 3 by cutting and shaping, and after the closing member 2 passes through the protrusion 11, both ends of the closing member are fixed on the control rod 1, at this time, the apposition member 3 can freely move within the range constrained by the closing member 2.
And the connection mode II is as follows: the spring 12 is coupled.
Specifically, as shown in fig. 10, in this embodiment, a connecting elastic sheet 12 is cut at the connection position of the first connecting portion 9 and the second connecting portion 10 of the mating member 3 by cutting, and after the free end of the elastic sheet 12 is shaped by bending, the free end is fixedly connected with the closing member 2 by welding, bonding or the like, at this time, the degree of freedom of rotation of the closing member 2 is provided by the elasticity of the elastic sheet 12.
And the connection mode is three: suture 13 is coupled.
Specifically, as shown in fig. 11, in this embodiment, a hollowed structure is provided at the connection position of the first connection portion 9 and the second connection portion 10 of the apposition member 3, or a suture hole is provided, and then the apposition member 3 and the closure member 2 are bound and connected together by using a suture 13, and the closure member 2 at this time has a certain degree of rotational freedom with the apposition member 3 within the range of wire constraint.
It should be noted that the connection between the closing element 2 and the mating element 3 may be several connection modes described above, but is not limited to the above-mentioned modes, and may be other connection modes, as long as a certain degree of rotational freedom of the closing element 2 relative to the mating element 3 can be achieved.
As shown in fig. 12-15, the valve clasper device further includes a resilient support 15, one end of the resilient support 15 is connected to the first support 5, and the resilient support 15 is slidably connected to the control rod 1; the clamping pieces 6 are respectively connected with the outer wall of the elastic supporting piece 15 and the involution piece 3.
In this embodiment, the elastic support 15 acts as a spacer between the leaflets 16 after implantation, and also acts as a support for the coaptation member 3 after closure of the coaptation member 3; the angle self-adaptation function is realized by matching the involution piece 3 and the closure piece 2 in the systole and diastole processes, and the blood choking effect can be increased by covering the braided fabric, weaving and the like; the closing piece 2 in the clamping device can be used for covering a film or weaving and weaving fabrics to increase the contact area of the valve leaflet 16, reduce the catching difficulty, reduce the clamping stress, increase the blood flow blocking effect, provide closing power for the closing piece 3 and can be matched with the elastic supporting piece 15 to realize the angle self-adaption function; the involution piece 3 is used for anchoring the valve leaflet 16, and is matched with the clamping piece 6 to capture the valve leaflet 16 and close the valve leaflet 16, and the blood flow resistance of the involution piece can be increased by covering a braided fabric and the like; the control rod 1 is used for controlling the folding member 3 to switch between the open state and the extended state (as shown in fig. 16 to 18); the first supporting element 5 is used for fixing the elastic supporting element 15 to prevent the elastic supporting element 15 from being deformed axially, and is in the vertical direction in fig. 11-14, so as to ensure that the elastic supporting element 15 has a certain supporting force, and the elastic supporting element 15 plays a role in rigid supporting when being compressed to a certain degree, so that excessive compression of the elastic supporting element 15 is prevented from generating excessive tensile force on the valve leaflet 16, and a pushing channel is provided for the control rod 1.
Specifically, in the present embodiment, the clamping member 6 abuts against the elastic support member 15 only when the leaflet 16 is clamped, so that a connection relationship is formed, and there may be no connection relationship between the clamping member 6 and the elastic support member 15 when the leaflet 16 is not clamped.
In an alternative embodiment, a second support 14 and a connecting sleeve are also included; the first supporting piece 5 and the second supporting piece 14 are respectively arranged at two ends of the connecting sleeve, and the first supporting piece 5, the second supporting piece 14 and the connecting sleeve are all arranged on the control rod 1 in a sliding way; the two ends of the elastic supporting piece 15 are respectively connected with the first supporting piece 5 and the second supporting piece 14, and the elastic supporting piece 15 is sleeved on the connecting sleeve.
In this embodiment, the distance between the two ends of the elastic support member 15 is unchanged by the arrangement of the second support member 14 and the connecting sleeve, so that the elastic support member has a certain elastic support function, if the second support member 14 and the first support member 5 can move relatively, the second support member 14 can move relatively to the first support member 5 under the action of elastic deformation of the elastic support member 15, and then the elastic support member 15 loses the support function.
In this embodiment, the second support 14 functions in conjunction with a delivery sheath for delivering and releasing the valve clasping apparatus.
Specifically, in the present embodiment, the second supporting member 14 is fixed above the first supporting member 5 through a connecting sleeve, the left and right sides of the first supporting member 5 are respectively connected with one ends of the two opposite connecting members 3, the other ends of the opposite connecting members 3 are connected with the third supporting member 4, the closing member 2 is also connected to the third supporting member 4, and the third supporting member 4 is fixedly disposed at the end of the control lever 1. The involution piece 3 and the closure piece 2 are connected by a rotating pair, and can be connected by a metal wire, a buckle or a braided wire; the fixed end of the clamping piece 6 is arranged on the involution piece 3; the two ends of the elastic supporting piece 15 are respectively fixed on the first supporting piece 5 and the second supporting piece 14; the lower end of the control rod 1 is connected with the third support piece 4 after passing through a hole in the middle of the first support piece 5; the third support 4 is connected to the control rod 1, and controls the folding member 3 to switch between the open and closed states and the extended states (as shown in fig. 1 to 3). The blood barrier properties may be increased by covering the braid or the like.
As can be seen from the above, the valve clasping apparatus of the present invention includes the first support 5, the second support 14, the elastic support 15, the pair of the closing members 2, the pair of the counter members 3, the third support 4, the operating lever 1, and the pair of the holding members 6. Wherein the first support 5, the second support 14, the third support 4 and the control rod 1 are rigid components which do not deform; the elastic support 15 is woven by super-elastic material wires, and has good shape adaptability when stressed; the bending and hollowed-out parts of the closing piece 2, the apposition piece 3 and the clamping piece 6 have better bending and deforming capacity, and other parts have better rigidity, so that the function of stabilizing the whole structure is achieved.
In an alternative embodiment, the clamp 6 comprises a first clamp arm and a second clamp arm; one end of the first clamping arm is rotationally connected with one end of the second clamping arm; one side of the first clamping arm far away from the second clamping arm is connected with the involution piece 3, and one side of the second clamping arm far away from the first clamping arm is connected with the elastic supporting piece 15.
The first and second clamping arms are rotatable relative to each other, and when the first and second clamping arms are brought together in a stacked arrangement by relative rotation, they provide a clamping action to the leaflet 16.
The second clamping arm may be in contact with the elastic support 15 in the working state, but it is not necessarily always in contact, and in this embodiment, a side of the second clamping arm away from the first clamping arm is connected to the elastic support 15, which mainly refers to contact connection between the second clamping arm and the elastic support when the elastic support 15 has elastic support to the clamping member 6.
In an alternative embodiment, the side of the first clamping arm, which is close to the second clamping arm, is provided with clamping teeth; and/or, one side of the second clamping arm, which is close to the first clamping arm, is provided with clamping teeth.
To ensure stability of the clamping member 6 when clamping the leaflet 16, clamping teeth are provided on both the first and second clamping arms in this embodiment.
It should be noted that the clamping teeth may be provided only on the first clamping arm, or may be provided only on the second clamping arm, so long as the stability of the clamping of the leaflet 16 by the clamping member 6 can be ensured by the clamping teeth.
It should also be noted that in the present embodiment, the shape of the gripping teeth is shown in fig. 12 to 20, but it is not limited to the shape shown in the drawings only as long as the gripping stability of the gripping member 6 against the leaflet 16 can be increased.
From the above, the movement mode of the valve clamping device provided by the invention is as follows:
the initial state is shown as 1. The second support 14 is fixed and the lever is pushed downwards in the orientation shown in fig. 12-14, pushing the third support 4, the movement of the third support 4 will open the apposition member 3, as shown in fig. 16. In this state the clamp 6 can be opened by means of a wire or the like as shown in fig. 17. This state is the leaflet 16 capturing state. Continuing to push the lever downwardly, the apposition member 3 continues to be elongated, as shown in fig. 18. This state is the delivery state within the catheter.
The valve clamping device provided by the invention has the working mode that:
the valve clasper device is delivered to the right atrium of the heart in the delivery system in the state shown in fig. 18, and is controlled to close by the joystick 1 in the right atrium, as shown in the state of fig. 12 and 13; after delivery over the heart valve in the state of fig. 12, the clamping device is opened by the operating rod 1 and the valve clamping device is pushed between the valve leaflets 16 continuously, confirming that after the valve leaflets 16 are properly anchored by the apposition member 3, the closing clamp 6 (shown in fig. 16) clamps the valve leaflets 16; after confirming that the leaflet 16 is firmly clamped, the clamping device is closed by the operating rod 1, and at this time, the deformation stress of the preload of the closing member 2 causes the closing member 3 to be tightly clamped on the elastic support member 15.
By manipulating the third support 4 by the manipulation lever 1 to close the apposition member 3 (see fig. 19), the closing member 2 will further provide a clamping force. As shown in fig. 8, the original shape of the closing member 2 is shown by a broken line in the drawing, and the closing member 2 has an elastic restoring force due to the elastic deformation of the assembly, and the restoring force can tighten the closing member 3 in the axial direction. Acting to close the clamping means. The closure member 2 has a relatively wide outline, can be covered by various materials in the modes of knitting, sewing, laminating and the like, obtains a wide clamping area and increases the effect of blocking flow.
After the valve clamping device is implanted into the heart, the closing piece 2, the closing piece 3 and the elastic supporting piece 15 which are positioned between valves are in a stress balance state (as shown in fig. 20), and the elastic supporting piece 15, the closing piece 2 and the closing piece 3 are elastic closing elements.
During diastole, blood flows from the left atrium to the left ventricle, and the pressure Pd applied to the valve and valve clamping device 17 will increase the angle of closure of the coaptation member 3 with the closure member 2 (as shown in FIG. 21), and the area of the openings 18 of the leaflets 16 through which blood can flow (as shown in FIG. 24) will correspondingly increase, to reduce the resistance to flow of blood from the left atrium to the left ventricle during diastole. If the closing angle of the valve clasper 17 is a fixed angle, the blood flow resistance is large as shown in fig. 23, compared to the size of the opening 18 of the leaflet 16 when the valve clasper 17 is contracted.
When the heart contracts, blood tends to flow from the left ventricle to the left atrium, and the blood pressure Ps acting on the valve and the clamping device will reduce the closing angle of the closing member 3 and the closing member 2, as shown in fig. 22, and increase the holding force of the elastic support member 15, so as to increase the effect of preventing the blood from flowing back in the scope and periphery of the apparatus. Under the effect of the reduced closing angle of the apposition member 3 and the closure member 2, the openings on both sides of the leaflet 16 will also be more tightly closed by pulling, thereby further reducing regurgitation of the openings of the other leaflets 16.
The embodiment of the invention has the beneficial effects that:
the first support piece 5 slides on the control rod 1, so that the closing piece 3 can guide the opening and closing actions of the clamping piece 6, then the closing piece 3 is provided with closing power through the closing piece 2 with certain elasticity, and the opening and closing degree of the clamping device is adjusted by automatically adjusting the opening and closing angle through the driving of the blood pressure, so that the opening and closing degree of the valve is achieved; thereby achieving the effect of reducing blood reflux during systole and reducing resistance to blood flow through the valve during diastole.
The above is only a preferred embodiment of the present invention, and is not intended to limit the present invention, but various modifications and variations can be made to the present invention by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (9)

1. A valve clasper comprising a handle, a first support, a clasp, at least one pair of opposed members, and at least one pair of closure members;
the involution pieces in each pair are respectively arranged on two opposite sides of the control rod, and the involution pieces are arranged in one-to-one correspondence with the closing pieces;
one end of the involution piece is rotationally connected with the control rod, the other end of the involution piece is movably connected with the first support piece, and the first support piece is arranged on the control rod in a sliding way;
the closing piece is connected with the involution piece and can position the opening state of the involution piece and the closing state of the involution piece;
the clamping piece is arranged between the involution piece and the control rod and is used for clamping the valve leaflet;
the closing piece and the matching piece are hinged, connected in a crossed mode, connected by a spring piece or connected in a binding mode.
2. The valve clasper device of claim 1, wherein the apposition member comprises a first connection portion and a second connection portion,
one end of the first connecting part is connected with the control rod, and the other end of the first connecting part is connected with one end of the second connecting part;
the other end of the second connecting part is connected with the first supporting piece;
the first and second connection portions can be formed into a folded state or an unfolded state by relative rotation.
3. The valve clasper device of claim 2, wherein the closure member includes a securing portion and a resilient portion;
one end of the fixing part is arranged on the control rod, and the other end of the fixing part is connected with one end of the elastic part;
the connecting part of the first connecting part and the second connecting part or the second connecting part is movably connected with the other end of the elastic part;
the elastic part is used for always providing power for the connecting part towards the direction of the control rod.
4. A valve clasper device in accordance with claim 3 wherein the resilient portion is a resilient flexure structure.
5. The valve clasper device of claim 1, wherein the clip comprises a first clip arm and a second clip arm;
one end of the first clamping arm is rotationally connected with one end of the second clamping arm;
one side of the first clamping arm far away from the second clamping arm is connected with the involution piece.
6. The valve clasper of claim 5, wherein a side of the first clasper arm adjacent to the second clasper arm is provided with clasper teeth;
and/or, a clamping tooth is arranged on one side, close to the first clamping arm, of the second clamping arm.
7. The valve clasper device of claim 1, further comprising a resilient support;
one end of the elastic support piece is connected with the first support piece, and the elastic support piece is connected with the control rod in a sliding mode.
8. The valve clasper of claim 7, further comprising a second support and a connection sleeve;
the first supporting piece and the second supporting piece are respectively arranged at two ends of the connecting sleeve, and the first supporting piece, the second supporting piece and the connecting sleeve are all arranged on the control rod in a sliding manner;
the two ends of the elastic supporting piece are respectively connected with the first supporting piece and the second supporting piece, and the elastic supporting piece is sleeved on the connecting sleeve.
9. The valve clasper of claim 1, further comprising a third support member disposed at an end of the lever, wherein an end of the clasp member is rotatably coupled to the third support member.
CN202110720766.7A 2021-06-28 2021-06-28 Valve clamping device Active CN113230001B (en)

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CN114081674B (en) * 2021-09-28 2023-08-15 四川大学华西医院 Valve leaf segmentation device
CN113907918B (en) * 2021-09-30 2023-02-28 杭州端佑医疗科技有限公司 Valve clamping system

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