CN114681143A

CN114681143A - Self-adaptive valve clamping device and valve clamping system

Info

Publication number: CN114681143A
Application number: CN202011621758.9A
Authority: CN
Inventors: 王建安; 刘先宝; 郑贤章; 张伟伟; 张庭超
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2020-12-31
Filing date: 2020-12-31
Publication date: 2022-07-01

Abstract

The invention discloses a self-adaptive valve clamping device and a valve clamping system. The adaptive valve clamping device comprises a clamping assembly, a transmission assembly and an elastic self-locking piece. The clamping assembly includes a pair of openable and closable jawarms. The transmission assembly comprises a fixed base and a driving shaft movably arranged in the fixed base in a penetrating mode, each clamp arm is movably connected with the fixed base and the driving shaft, and the clamp arms are driven to open or close relative to the fixed base through axial movement of the driving shaft. The outer peripheral face of drive shaft is located to elasticity from the latch fitting cover, and elasticity is located between the distal end of fixed baseplate and the near-end of drive shaft from the both ends of latch fitting under natural state. According to the valve clamping device, in the valve leaflet clamping process, the deformation of the elastic self-locking piece is automatically adjusted in real time along with the stress change of the valve leaflets, so that the clamp arms keep applying flexible clamping force on the valve leaflets, and the valve leaflets are prevented from being torn due to excessive traction; and can automatically adjust the clamping force along with the change of the valve leaflet gap to adapt to the new valve leaflet gap.

Description

Self-adaptive valve clamping device and valve clamping system

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a self-adaptive valve clamping device 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 normal healthy mitral valve can control the flow of blood from the left atrium to the left ventricle while avoiding the flow of blood from the left ventricle to the left atrium. The mitral valve includes a pair of leaflets, referred to as the anterior leaflet and the posterior leaflet, and as shown in fig. 1, when the edges of the anterior leaflet and the posterior leaflet are brought together, the mitral valve is completely closed to prevent blood from flowing from the left ventricle to the left atrium. When the leaflets of the mitral valve or their associated structures undergo organic or functional changes, the anterior and posterior leaflets of the mitral valve coapt poorly, whereby when the left ventricle of the heart contracts, the mitral valve fails to close completely, resulting in blood backflow from the left ventricle to the left atrium, causing a series of pathophysiological changes known as "mitral regurgitation".

Surgery typically employs surgical approaches such as valve edge-to-edge suturing to treat mitral regurgitation. However, the surgical operation has the defects of complicated operation process, high operation cost, high trauma degree of patients, high risk of complications, long hospitalization time, pain in the recovery process of the patients and the like. The prior art discloses a minimally invasive treatment operation, which is based on the edge-to-edge operation principle of a valve, a valve clamping device is conveyed to a mitral valve through an interventional catheter, and an anterior leaflet and a posterior leaflet of the mitral valve are clamped simultaneously through relative opening and closing of clamps, so that the aims of fixing the leaflets and reducing the backflow of the mitral valve are fulfilled.

However, such a valve coaptation device is in a fixed, locked state after coaptation of the leaflets, and relative displacement between the coaptation parts cannot occur. When the valve clamping device is closed, the valve clamping device falls off from the valve leaflets due to the over-loose clamping force, and the two valve leaflets are forcibly pulled towards each other and fixed together due to the over-tight clamping force, so that the valve leaflets are excessively restricted to move, the function of the mitral valve is abnormal, and the valve leaflets are possibly torn due to the over-tight clamping force when the heart beats and moves; in addition, after the valve clamping device is implanted, as the implantation time is prolonged, regurgitation is relieved, the valve shape is changed correspondingly, and when the valve leaflet gap is changed, the clamping force of the valve clamping device can be expected to be adjustable, so that the valve clamping device can gradually adapt to the new valve leaflet gap.

Disclosure of Invention

The invention mainly aims to overcome the defect that the clamping force of the conventional valve clamping device cannot be adjusted in real time along with the movement of valve leaflets or the gap between the valve leaflets, and provides a self-adaptive valve clamping device and a valve clamping system.

The invention provides an adaptive valve clamping device, comprising:

the clamping assembly comprises a pair of openable clamp arms;

the transmission assembly comprises a fixed base and a driving shaft movably penetrating through the fixed base, each clamp arm is movably connected with the fixed base and the driving shaft, and the axial movement of the driving shaft drives the clamp arms to open or close relative to the fixed base; and the number of the first and second groups,

elasticity is located from the latch fitting, the cover the outer peripheral face of drive shaft, just elasticity is located from the both ends of latch fitting under natural state the distal end of fixed baseplate with between the near-end of drive shaft.

The invention also provides a valve clamping system, which comprises a conveying assembly and the self-adaptive valve clamping device with the structure, wherein the conveying assembly comprises a limiting pipe and a pushing shaft movably arranged in the limiting pipe in a penetrating mode, the far end of the pushing shaft is detachably connected with the near end of the driving shaft, and the far end of the limiting pipe is detachably connected with the near end of the fixed base.

Compared with the prior art, the self-adaptive valve clamping device and the valve clamping system have the following beneficial effects: the drive shaft slides and locates in the fixed baseplate, but the tong arm forms the structure that opens and shuts along with the removal of drive shaft relatively fixed baseplate, and the degree of opening and shutting of tong arm is directly decided to the sliding distance of drive shaft, realizes the locking of tong arm at a certain angle of opening and shutting for fixed baseplate through the deformation degree of elasticity self-locking piece simultaneously. In the process of clamping the valve leaflets, the elastic self-locking piece receives the driving force of the driving shaft on one hand and the pulling force transmitted to the far end of the fixed base by the clamp arms on the other hand, and the pulling force of the clamp arms comes from the valve leaflets, so that the deformation of the elastic self-locking piece is automatically adjusted in real time along with the stress change of the valve leaflets, the clamp arms keep applying flexible clamping force on the valve leaflets, excessive clamping force is prevented from forcibly pulling the valve leaflets, and secondary damage to the valve leaflets is prevented. Therefore, the elastic self-locking piece can realize the locking of the clamp arms relative to the fixed base and can also adjust the clamping force of the clamp arms to the valve leaflets in a self-adaptive manner, so that the flexible clamping force is provided for the valve leaflets, the valve leaflets are prevented from being torn due to excessive traction, and the valve leaflets are accelerated to recover the normal involution level; and after the valve clamping device is implanted, the clamping force can be automatically adjusted along with the change of the valve leaflet gap to adapt to the new valve leaflet gap.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the invention and together with the description, serve to explain the principles of the invention.

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious for those skilled in the art that other drawings can be obtained according to the drawings without inventive exercise.

Fig. 1 is a perspective view of a valve clamping device according to a first embodiment of the invention in an open state.

Fig. 2 is a front view of a valve clamping device according to a first embodiment of the invention in an open state.

Fig. 3 is a perspective view of a valve clamping device according to a first embodiment of the invention in an open state.

Fig. 4 is a longitudinal cross-sectional view of a valve clamping device according to a first embodiment of the invention in an expanded state.

Fig. 5 is a perspective view of a valve clamping device according to a first embodiment of the invention in a closed state.

Fig. 6 is a front view of a valve clamping device according to a first embodiment of the invention in a closed state.

Fig. 7 is a longitudinal cross-sectional view of a valve clamping device according to a first embodiment of the invention in a closed state.

Fig. 8 is a perspective view of a fixing base according to a first embodiment of the invention.

Fig. 9 is a longitudinal sectional view of a fixing base according to a first embodiment of the invention.

Fig. 10 is an exploded view of a drive pin according to a first embodiment of the invention.

Fig. 11 is a perspective view of a fixing base of another structure according to an embodiment of the invention.

Fig. 12 is a longitudinal sectional view of a fixing base of another structure according to the first embodiment of the present invention.

Fig. 13 is a perspective view of a resilient self-locking element in accordance with an embodiment of the present invention.

Fig. 14 is a perspective view of another construction of a resilient self-locking element in accordance with an embodiment of the present invention.

Fig. 15 is a perspective view of a drive shaft according to a first embodiment of the present invention.

Fig. 16 is a longitudinal sectional view of a drive shaft according to a first embodiment of the present invention.

Fig. 17 is a partial perspective view of a valve clamping system according to a first embodiment of the invention.

Fig. 18 is a perspective view of a valve clamping device according to a second embodiment of the invention in an open position.

Fig. 19 is an elevation view of a valve clamping device according to a second embodiment of the invention in an expanded state.

Fig. 20 is a longitudinal cross-sectional view of a valve clamping device according to a second embodiment of the invention in an expanded state.

Fig. 21 is a perspective view of a valve clasping device of a second embodiment of the present invention in a closed state.

Fig. 22 is a longitudinal cross-sectional view of a valve clasping device of a second embodiment of the present invention in a closed state.

Fig. 23 is a perspective view of a fixing base according to a second embodiment of the invention.

Fig. 24 is a longitudinal sectional view of a fixing base according to a second embodiment of the present invention.

Fig. 25 is a perspective view of a drive shaft according to a second embodiment of the present invention.

Fig. 26 is a longitudinal sectional view of the drive shaft of the second embodiment of the present invention.

Fig. 27 is a perspective view of a third valve clamping device according to an embodiment of the invention in an open state.

Fig. 28 is a front view of a third valve clamping device according to an embodiment of the invention in an open state.

Fig. 29 is a perspective view of a valve clasping device of a third embodiment of the present invention in a closed state.

Fig. 30 is a front view of a valve clasping device of a third embodiment of the present invention in a closed state.

Fig. 31 is a perspective assembly view of a fixed base, a driving shaft and a resilient self-locking member according to a third embodiment of the present invention.

Fig. 32 is a front assembly view of the fixed base, the actuating shaft and the resilient self-locking member of the third embodiment of the present invention.

Fig. 33 is a perspective assembly view of the fixing base, the driving shaft and the elastic self-locking member in the state where the elastic self-locking member is stretched according to the third embodiment of the present invention.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

It should be understood that the directions or positional relationships indicated by "front", "back", "upper", "lower", "left", "right", "longitudinal", "lateral", "vertical", "horizontal", "top", "bottom", "inner", "outer", "head", "tail", etc. are configured and operated in specific directions based on the directions or positional relationships of the drawings, and are only for convenience of describing the technical solution, but not for indicating that the device or element referred to must have a specific direction, and thus, cannot be construed as limiting the present invention.

It is also noted that, unless expressly stated or limited otherwise, the terms "mounted," "connected," "secured," "disposed," and the like are intended to be inclusive and mean, for example, that they may be fixedly connected, detachably connected, or integrally formed; either directly or indirectly through intervening media, either internally or in any other relationship. When an element is referred to as being "on" or "under" another element, it can be "directly" or "indirectly" on the other element or intervening elements may also be present. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

In the description of the present invention, it is still to be noted that the proximal end refers to the end of the instrument or component close to the operator, and the distal end refers to the end of the instrument or component away from the operator; axial refers to a direction parallel to the center line connecting the distal end and the proximal end of the instrument or component, radial refers to a direction perpendicular to the axial direction, and circumferential refers to a direction around the axial direction.

In order to overcome the defect that the clamping force of a valve clamping structure in the prior art cannot be adjusted in real time, the invention discloses a self-adaptive valve clamping device 1000 and a valve clamping system, which apply flexible force to valve leaflets to automatically adjust the clamping force of a clamp arm 110 to the valve leaflets in real time. The invention is explained in detail below with reference to specific embodiments and the drawing.

Example one

Referring to fig. 1-4, an embodiment of the present invention discloses an adaptive valve clamping device 1000, which comprises a clamping assembly 100, a transmission assembly 200 and an elastic self-locking member 300. The clamping assembly 100 includes a pair of openable and closable jawarms 110. The transmission assembly 200 includes a fixed base 210 and a driving shaft 220 movably disposed in the fixed base 210, each of the plurality of clamp arms 110 is movably connected to the fixed base 210 and the driving shaft 220, and the axial movement of the driving shaft 220 drives the plurality of clamp arms 110 to open or close relative to the fixed base 210. The elastic self-locking element 300 is sleeved on the outer circumferential surface of the driving shaft 220, and two ends of the elastic self-locking element 300 in a natural state are located between the distal end of the fixing base 210 and the proximal end of the driving shaft 220.

In the technical scheme of the present invention, the driving shaft 220 is slidably disposed in the fixing base 210, the forceps arm 110 forms an openable structure with respect to the fixing base 210 along with the movement of the driving shaft 220, the opening degree of the forceps arm 110 is directly determined by the sliding distance of the driving shaft 220, and the locking of the forceps arm 110 at a certain opening degree with respect to the fixing base 210 is achieved by the deformation degree of the elastic self-locking member 300. In the process of clamping the valve leaflet, the elastic self-locking piece 300 receives the driving force of the driving shaft 220 on one hand and the pulling force transmitted to the far end of the fixed base 210 by the forceps arm 110 on the other hand, and the pulling force of the forceps arm 110 comes from the valve leaflet, so the deformation of the elastic self-locking piece 300 is automatically adjusted in real time along with the stress change of the valve leaflet, thereby the forceps arm 110 keeps applying a flexible clamping force to the valve leaflet, the excessive clamping force is prevented from forcibly pulling the valve leaflet, and the secondary damage to the valve leaflet is prevented. Therefore, the elastic self-locking element 300 of the present invention not only can lock the forceps arm 110 with respect to the fixed base 210, but also can adaptively adjust the clamping force of the forceps arm 110 on the leaflet, thereby providing a flexible clamping force on the leaflet, avoiding the leaflet from being torn due to excessive pulling, and accelerating the leaflet to recover to a normal coaptation level; and after the valve coaptation device 1000 is implanted, the coaptation dynamics can also be automatically adjusted along with the leaflet clearance change, adapt to new leaflet clearance.

The adaptive valve clamping device 1000 of the present invention can be delivered by a delivery assembly 2000. The self-adaptive valve clamping device 1000 is simple in structure, does not need a complex self-locking mechanism, does not need additional unlocking control operation, is easy to operate, shortens the operation time, and improves the operation success rate; meanwhile, an unlocking control mechanism is not required to be added in the conveying assembly 2000, the assembly difficulty of the conveying assembly 2000 is reduced, and the stability of the conveying system is ensured. In addition, the overall weight of the valve clamping device 1000 can be reduced, the load on the valve leaflets can be reduced, and the fatigue resistance of the valve clamping device 1000 can be improved.

The clamping assembly 100 further includes a pair of clamping arms 120, each clamping arm 120 is disposed opposite to one of the clamping arms 110, one end of each clamping arm 120 is connected to the fixed base 210, and the other end of each clamping arm 120 is opened and closed relative to the fixed base 210. When the forceps arms 110 are closed relative to the fixed base 210, the anterior leaflet and the posterior leaflet of the mitral valve are clamped between one forceps arm 110 and one side of the clamping arm 120, respectively.

In this embodiment, the distal end of the jawarm 110 is provided with a coupling slot 111, and a driving pin 2201 is inserted into the coupling slot 111 to couple the jawarm 110 and the driving shaft 220 together. When the driving shaft 220 is pulled proximally, the driving pin 2201 moves proximally and slides relative to the connecting slot 111 of the forceps arm 110, so as to drive the forceps arm 110 to rotate around the driving pin 2201, thereby opening the forceps arm 110 and the fixed base 210. When the driving shaft 220 is pulled distally, the driving pin 2201 moves distally and slides relative to the connecting slot 111 of the forceps arm 110, so as to drive the forceps arm 110 to rotate around the driving pin 2201, thereby closing the forceps arm 110 and the fixed base 210.

Referring to fig. 5-7, the inner surface of the jawarms 110 opposite to the fixed base 210 serves as a leaflet holding surface, and thus in order to better accommodate the structure of the leaflets and to ensure a proper leaflet contact area and holding area, thereby providing a stable holding force, the jawarms 110 are preferably sheets having a concave inner surface and have a width and an axial length, and specifically, the width of the jawarms 110 should be greater than or equal to 2mm, preferably 4-6mm, and the axial length of the jawarms 110 should be greater than or equal to 4mm, preferably 6-12 mm. To ensure safety after implantation, the forceps arms 110 should be made of a biocompatible material and have some flexibility and rigidity. And an active agent may also be applied to the inner surface of the forceps arms 110 to promote endothelial cell coverage and growth of the leaflet tissue on the inner surface of the forceps arms 110.

It will also be appreciated that to increase the gripping force of the

gripper arms

120 and 110 on the leaflets, the surface of the gripper arms 120 facing the gripper arms 110 can also be provided with at least one row of barbs to prevent the leaflets from slipping out of the inner surface of the gripper arms 110.

Each clamp arm 120 includes an oppositely disposed attachment end and a free end, the attachment end being fixed relative to the fixed base 210. In this embodiment, the two clamping arms 120 are connected into a whole by a connection frame, the connection frame is provided with a through hole for the driving shaft 220 to pass through, and the connection frame is sleeved on the outer side of the fixing base 210. In other embodiments, the connecting end of the clamping arm 120 can be directly fixed to the fixing base 210 by welding, crimping, or the like.

The gripper arms 120 are at least partially made of an elastic material having a shape memory function and are heat-set. In its natural state, the grasping arms 120 extend radially outward relative to the fixed base 210, and preferably extend proximally to facilitate engagement with the forceps arms 110 to grasp valve tissue. In this embodiment, the gripping arms 120 are made entirely of a super elastic nickel titanium alloy, thereby providing a greater spring force to the gripping arms 120 to urge the gripping arms 120 toward the forceps arms 110 to grip the valve tissue.

It should be noted that the free end of the holding arm 120 is provided with a control wire hole for connecting a control wire (not shown) of the pushing device, and the free end of the holding arm 120 can be controlled by the control wire extending to the outside of the patient body. In the delivery state, the free end of the gripper arm 120 is tensioned by the control wire and adheres to the surface of the fixed base 210; after the control of the free end by the control wire is released, the grasping arm 120 is released, and the grasping arm 120 restores its natural state due to its elastic memory property and presses the leaflet toward the caliper arm 110.

It is understood that, in order to increase the biocompatibility between the valve clamping device 1000 and the valve leaflet and facilitate the endothelial cell to cover, the clamping surface of the clamp arm 110 (i.e., the surface facing the clamp arm 120) and the clamping surface of the clamp arm 120 (i.e., the surface facing the clamp arm 110) may be further coated with a biocompatible polymer coating, the polymer coating is selected from polyethylene terephthalate (PET), Polytetrafluoroethylene (PTFE), and the like, and the materials of the coatings applied on the clamp arm 110 and the clamp arm 120 may be the same or different.

Preferably, referring to fig. 8 and 9, the fixing base 210 includes a base body 211 and a tube 212 disposed at a proximal end of the base body 211, the base body 211 is movably connected to the forceps arm 110, and a shaft hole 213 for passing the driving shaft 220 is disposed in the base body 211 and the tube 212. In this embodiment, the seat 211 is pivotally connected to the jawarm 110 by a pivot pin 112. The shaft hole 213 serves to limit and guide the driving shaft 220. The shaft hole 213 is formed as a circular hole to be fitted to the outer circumferential surface of the driving shaft 220. Two pin holes are formed at both sides of the distal end of the fixing base 210 for receiving the rotation pins 112.

Referring to fig. 10, in the present embodiment, one end of the driving pin 2201 is a smooth hemispherical protrusion, and the other end is provided with a radially protruding pin collar, so that after the driving pin 2201 is inserted into the connecting groove 111, the driving pin 2201 and the forceps arm 110 do not need to be welded, the driving pin 2201 and the forceps arm 110 rotate relative to each other, and the hemispherical protrusion and the pin collar cooperate to prevent the driving pin 2201 from falling off from the connecting groove 111 of the forceps arm 110. The structure of the rotation pin 112 may be the same as that of the driving pin 2201.

Preferably, referring to fig. 9, the shaft hole 213 is provided with a step 2130 protruding inward, and one end of the elastic locking member 300 abuts against or is connected to the step 2130. The step surface 2130 has a circumferential limiting effect on the elastic self-locking piece 300, and avoids the failure of the device caused by the backward withdrawing of the elastic self-locking piece 300 along with the driving shaft 220, thereby ensuring the stability of the elastic force.

Further, the shaft hole 213 includes a first hole 2131 and a second hole 2132 connected, and the diameter of the first hole 2131 is smaller than the diameter of the second hole 2132. A stepped surface 2130 is formed at the junction of the first hole 2131 and the second hole 2132, and the elastic self-locking member 300 is received in the second hole 2132. The first hole 2131 is used for accommodating and guiding the driving shaft 220, the second hole 2132 is used for accommodating the elastic self-locking piece 300, and the first hole 2131 and the second hole 2132 are respectively matched with the driving shaft 220 and the elastic self-locking piece 300 in size so as to realize limiting and guiding effects and avoid axial deflection of the driving shaft 220 and the elastic self-locking piece 300 from affecting the closing of the jawarms 110 and the transmission of elastic force.

Preferably, the first hole 2131 and the second hole 2132 are sequentially opened from the proximal end to the distal end of the fixing base 210, and the elastic self-locking element 300 is interposed between the distal end of the driving shaft 220 and the stepped surface 2130. Of course, the positions of the first and

second holes

2131 and 2132 may be adjusted according to the positions of the driving shaft 220 and the elastic self-locking member 300. In this embodiment, the distal end of the resilient self-locking element 300 at least partially protrudes through the second hole 2132, and the resilient self-locking element 300 reaches a maximum protruding length when the two forceps arms 110 of the valve clamping device 1000 are clamped. This structure can shorten the overall length of the fixing base 210, and make the size of the fixing base 210 smaller and the self weight smaller.

Further, referring to fig. 11 and 12, to reduce the weight of the valve clamping device 1000, lightening holes 215 or lightening slots 2111 may be added to the fixation base 210. The fixed base 210 may be made of a biocompatible material having certain hardness and rigidity, and stainless steel is used in this embodiment.

Preferably, referring to fig. 13, the elastic self-locking member 300 is a spring 310, and the driving shaft 220 is inserted into the spring 310. The elastic self-locking member 300 is in the form of a spring 310, which is simple and convenient. The spring 310 may be made by winding stainless steel material with good elasticity or by winding nickel titanium wire with super elasticity and heat setting. The spring 310 of the present embodiment is a compression spring, that is, the external force applied to the spring 310 from the initial state to the deformed state is a pressure. It will be appreciated that when the jawarms 110 are in the closed condition, the spring 310 is in an initial condition, and the spring 310 is slightly compressed in the initial condition. The spring 310 compresses more when the drive shaft 220 is pulled proximally, leaving the jawarms 110 in an open position; when the drive shaft 220 is pushed distally, the spring 310 returns to its initial state, i.e., is slightly compressed, and the jawarms 110 are in a closed position and locked relative to the stationary base 210.

Referring to fig. 14, in another embodiment, the elastic self-locking member 300 includes a plurality of stacked elastic pieces 320, and a through hole 321 is formed in the middle of the elastic pieces 320 for the driving shaft 220 to pass through. Specifically, a plurality of elastic pieces 320, which are sequentially overlapped end to end, may be made of an elastic material as the elastic self-locking member 300, for example, a stainless steel material with good elasticity is bent, or a superelastic nickel-titanium sheet is heat-set, or a spring steel is coated to obtain the elastic self-locking member 300. The operation principle of the stacked resilient sheets 320 is the same as that of the compression spring 310, and will not be described herein.

It can be understood that when the valve clamping device 1000 is in the closed state, the elastic self-locking piece 300 is slightly compressed and provides a certain elastic force as the self-locking force of the valve clamping device 1000, and when the pulling force of the valve leaflet to the forceps arms 110 exceeds the self-locking force, the forceps arms 110 will overcome the self-locking force provided by the elastic self-locking piece 300 to generate a self-adaptive adjusting function, so as to prevent the forceps arms 110 from excessively pulling the valve leaflet. Under the pushing force of the pushing shaft 2200 or the pulling force of the valve leaflet, along with the increase of the opening angle of the forceps arms 110, the compression deformation amount of the elastic self-locking piece 300 gradually increases, and when the valve clamping device 1000 is opened to the maximum angle, the elastic self-locking piece 300 reaches the compression limit position, and the self-locking force (the elastic force of the elastic self-locking piece 300) which needs to be overcome by the forceps arms 110 is maximum.

The self-locking force provided by the resilient self-locking element 300 is tested by the following method: by adopting an HY-0580 electronic type universal tensile testing machine produced by Shanghai Lianfeng precision instruments Co., Ltd, the valve clamping device 1000 is connected with the simple handle, the testing shaft is connected with the driving shaft 220 and penetrates out of the near end of the simple handle, the simple handle is fixed on a machine table of a tensile machine, the moving end of the tensile machine is hooked on the tail end of the testing shaft, the moving end is moved at a constant speed of 4.5mm/min, and the force value of the clamp arm 110 moving from an initial closed state and the force value of the clamp arm 110 required by the maximum angle are recorded. The valve clamping device 1000 has a self-locking force of 15-20N in an initial state and 40-50N when the valve clamping device 1000 is expanded to a maximum angle. Therefore, in order to clamp the valve well and maintain the clamping effect, and ensure that the self-adaptive adjustment function can be generated when a large pulling force is applied, the self-locking force value range required to be provided by the elastic self-locking piece 300 is 15-50N, and the self-locking force range is the elastic force range of the elastic self-locking piece 300.

Preferably, the elastic self-locking member 300 has an elastic coefficient ranging from 1.5 to 10N/mm, which can be obtained through experiments and calculations. The method specifically comprises the following steps: the resilient self-locking element 300 is a compression spring 310, and the resilient self-locking element 300 is not assembled in the valve clamping device 1000 at its original length. When the elastic self-locking piece 300 is slightly compressed and assembled in the valve clamping device 1000, the two side clamp arms 110 of the valve clamping device 1000 are closed, the elastic self-locking piece 300 is slightly compressed in the axial direction, the length after slight compression is the axial distance between the limiting surface of the driving shaft 220 and the step surface 2130 of the inner shaft hole 213 of the fixed base 210, the first axial deformation amount of the elastic self-locking piece 300 is the difference value between the original length and the length after installation and compression, the range is 1-5 mm, and at this time, the self-locking force provided by the elastic self-locking piece 300 is 15-20N. The driving shaft 220 is gradually pushed to drive the forceps arm 110 to open towards two sides relative to the fixed base 210, the elastic self-locking piece 300 is further axially compressed, when the forceps arm 110 is at the maximum opening angle, the elastic self-locking piece 300 reaches the limit compression position, the length after compression is the axial distance between the limit surface of the driving shaft 220 and the step surface 2130 of the inner shaft hole 213 of the fixed base 210, namely the second axial deformation of the elastic self-locking piece 300 is the difference value between the original length and the limit compression length, the range is 5-10 mm, and at the moment, the self-locking force provided by the elastic self-locking piece 300 is 40-50N. According to Hooke' S law F ═ KS, F is the elasticity of elasticity self-locking piece 300, K is the elastic coefficient of elasticity self-locking piece 300, S is the compressive capacity of elasticity self-locking piece 300, can calculate the elastic coefficient K [ N/mm, lb/in ] scope of elasticity self-locking piece 300 and be 1.5 ~ 10N/mm.

In the present embodiment, a compression spring 310 made of stainless steel is used as the elastic self-locking member 300, and the calculation formula of the spring coefficient K of the compression spring 310 is known as

Wherein K is the elastic coefficient [ N/mm, lb/in]G ═ shear modulus of elasticity [ MPa, psi](ii) a d-wire diameter [ mm, in](ii) a n is effective circle-](ii) a D-center diameter [ mm, in]The shear elastic modulus G is 7000MPa, the wire diameter D is 0.30mm, the total number of turns is 9 circles, the effective number of turns N is 7 circles, the center diameter D is 1.20mm, and the elastic coefficient K is 5.74N/mm 300. It is understood that in other embodiments, the material, wire diameter, shear modulus of elasticity, center diameter, effective number of turns, total length of spring, etc. of the elastic self-locking member 300 may be changed, as long as the elastic coefficient of the elastic self-locking member 300 is within the range of 1.5-10N/mm, so as to satisfy the self-locking force requirement of the present invention.

Preferably, referring to fig. 15 and 16, the distal end of the driving shaft 220 is provided with a support seat 221, and one end of the elastic self-locking member 300 abuts or is connected to the support seat 221. The supporting seat 221 is used to provide an abutting position or a connecting (welding) position for the elastic self-locking piece 300, and provide a stable supporting surface for the elastic self-locking piece 300. In this embodiment, the support seat 221 is provided with a driving pin hole 222, and the driving pin 2201 is disposed in the driving pin hole 222 of the support seat 221. The driving pin hole 222 is provided in the support seat 221, so that it is possible to prevent the driving pin hole 222 from adversely affecting the overall strength of the driving shaft 220.

Further, the clamp arm 110 is pivotally connected to the fixed base 210, and the clamp arm 110 is slidably or pivotally connected to the drive shaft 220. In this embodiment, the forceps arm 110 is pivotally connected to the fixed base 210, the forceps arm 110 is slidably connected to the drive shaft, and the combination of the pivotal and slidable movements converts the axial movement of the drive shaft 220 into the pivotal opening and closing movement of the forceps arm 110. In other embodiments, the positions of the rotatable connection and the slidable connection can be adjusted to achieve the same operational effect.

Referring to fig. 17, the present invention also discloses a valve clamping system comprising a delivery assembly 2000 and an adaptive valve clamping device 1000 of the above-described construction. The delivery assembly 2000 comprises a limiting tube 2100 and a pushing shaft 2200 movably inserted in the limiting tube 2100. The distal end of the push shaft 2200 is detachably connected to the proximal end of the drive shaft 220, and the distal end of the stop tube 2100 is detachably connected to the proximal end of the fixed base 210.

It will be appreciated that the proximal end of the valve clamping device 1000 is releasably attached to the push shaft 2200 and the stop tube 2100, that the operator pushes the valve clamping device 1000 to the patient's mitral valve, and then remotely operates the valve clamping device 1000 to clamp the anterior and posterior leaflets of the mitral valve together, and that once the leaflets of the mitral valve are aligned edge to edge, the operator can disengage the connection between the push shaft 2200 and the valve clamping device 1000, such that the valve clamping device 1000 is disengaged from the distal end of the push shaft 2200 and remains in the patient as an implant to hold the apposition of the leaflets together to mitigate mitral regurgitation in the patient.

The driving shaft 220 is slidably disposed in the shaft hole 213 of the fixed base 210 in an axial direction, and a driving pin hole 222 is formed at a distal end of the driving shaft 220, and a driving pin 2201 is inserted into the driving pin hole 222 and coupled to the caliper arm 110 to drive the caliper arm 110 to open and close with respect to the fixed base 210. The proximal end of the drive shaft 220 is provided with a threaded segment 223 for detachable connection to the pusher shaft 2200 of the delivery assembly 2000 for remotely controlling the axial advancement or retraction of the drive shaft 220 relative to the stationary base 210 outside the patient's body.

The limiting tube 2100 is detachably connected to the valve clamping device 1000, the pushing shaft 2200 is movably disposed in the limiting tube 2100, and a distal end of the pushing shaft 2200 is detachably connected to the driving shaft 220 by a screw thread. The push shaft 2200 is used to control the driving shaft 220 to advance or retreat in the axial direction with respect to the fixed base 210, i.e., to drive the opening or closing of the caliper arm 110 with respect to the fixed base 210. The push shaft 2200 is also used to control the connection and disconnection between the stop tube 2100 and the valve clamping device 1000, and when the push shaft 2200 is withdrawn from the stop tube 2100, the connection between the valve clamping device 1000 and the stop tube 2100 is disconnected.

The delivery assembly 2000 also includes adjustment lines for controlling the release and tensioning of the free ends of the gripper arms 120. The stop tube 2100, the push shaft 2200, and the adjustment wire each have a certain axial length and extend outside the patient's body, so that an operator can remotely operate outside the patient's body to control the valve clamping device 1000 to clamp, release, and release the valve leaflets. The proximal ends of the stop tube 2100 and the push shaft 2200 may also be provided with handles to facilitate manipulation by the operator.

Preferably, referring to fig. 8-12 again, the proximal end of the fixing base 210 is provided with at least one locking groove 214, and the distal end of the limiting tube 2100 is provided with a locking piece 2110 corresponding to and matching with the locking groove 214. In this way, the fastening base 210 and the stopper tube 2100 form a detachable fastening structure by engaging the engaging groove 214 with the engaging piece 2110. Before the clamping is completed, the fixed base 210 and the limiting tube 2100 maintain a clamping state, the pushing shaft 2200 slides in the limiting tube 2100, and the driving shaft 220 slides through a thread, so that the opening and closing of the forceps arm 110 are controlled; after clamping is completed, the fixed base 210 and the limiting tube 2100 are separated from a clamping state and switched into two independent components, so that the conveying assembly 2000 can be conveniently withdrawn.

Preferably, the free end of the engaging piece 2110 is caught in the fixing base 210, and the depth of the engaging piece 2110 is greater than the gap between the pushing shaft 2200 and the limiting tube 2100, which is caught in the fixing base 210. The engaging piece 2110 is engaged with the fixing base 210 and pressed by the outer circumferential surface of the pushing shaft 2200, so that the engaging state between the limiting tube 2100 and the fixing base 210 can be maintained, and the connection relationship between the limiting tube 2100 and the fixing base 210 can be changed by controlling the position of the pushing shaft 2200. In this embodiment, the engaging piece 2110 is a T-shaped elastic piece. Specifically, two T-shaped elastic pieces 320 are symmetrically arranged at the distal end of the limiting tube 2100, and each T-shaped elastic piece 320 is radially biased inwards in a natural state. When the pushing shaft 2200 is inserted into the limiting tube 2100, the pushing shaft 2200 pushes up the T-shaped elastic pieces 320 to the outside in the radial direction, so that each T-shaped elastic piece 320 is embedded into one T-shaped groove of the fixing base 210, and at this time, the fixing base 210 and the limiting tube 2100 are in a connected state. When the pushing shaft 2200 is retracted from the limiting tube 2100, the T-shaped spring 320 of the limiting tube 2100 is deformed inward and separated from the T-shaped groove because it is separated from the interference of the pushing shaft 2200, and the fixing base 210 and the limiting tube 2100 are unlocked.

The following is the operation of the valve clamping device 1000:

after the valve clamping device 1000 reaches the leaflet site, the drive shaft 220 is axially moved by rotating the push shaft 2200 to open the clamp arms 110, and when the leaflet enters between the clamp arms 110 and the clamp arms 120, the clamp arms 120 are released to naturally draw the clamp arms 120 toward the clamp arms 110 and clamp the leaflet tissue.

The pushing shaft 2200 is rotated in the opposite direction to move the driving shaft 220 in the opposite direction in the axial direction and to clamp the leaflet by driving the clamp arms 110.

After the valve clamping device 1000 clamps the valve leaflets, the screw connection between the pushing shaft 2200 and the driving shaft 220 of the valve clamping device 1000 is released, then the pushing shaft 2200 is withdrawn from the limiting tube 2100, the T-shaped spring 320 on the limiting tube 2100 is biased inwards to separate from the fixed base 210 of the valve clamping device 1000, the whole valve clamping device 1000 is disconnected from the delivery assembly 2000 and quickly released, and then the valve clamping device 1000 can maintain the flexible clamping effect under the elastic force of the elastic self-locking piece 300.

When the pulling force of the valve leaflet reaches a certain force value, the forceps arms 110 overcome the elastic force of the elastic self-locking piece 300 and adjust the closing state, and the whole closing process is a flexible self-adaptive process, so that the valve leaflet is prevented from being torn. In addition, from the long-term effect after the valve clamping device 1000 is implanted, along with the recovery of cardiac function, the ventricular structure recovery and the leaflet coaptation effect are gradually improved, the forceps arm 110 can automatically adjust the closing angle under the effect of the flexible clamping force provided by the elastic self-locking piece 300, thereby preventing the leaflet from tearing and accelerating the leaflet to recover the normal coaptation level, and further ensuring the operation effect.

Example two

Referring to fig. 18 to 22, a valve clamping device 1000 according to a second embodiment of the present invention has substantially the same structure as the first embodiment, in that the forceps arm 110 is rotatably connected to the fixed base 210, and the forceps arm 110 is slidably connected to the driving shaft 220, except that: the rotating pin 112 and the driving pin 2201 are located at different positions in the forceps arm 110, and are sequentially arranged from the proximal side to the distal side in the axial direction of the valve clamping device 1000. When the drive shaft 220 is pushed distally, the jawarms 110 are in an open state; when the drive shaft 220 is pulled proximally, the jawarms 110 are in a closed position. In this embodiment, the elastic self-locking element 300 is also a pressure spring 310, that is, the external force from the initial state to the deformed state is a pressure, and the elastic force of the elastic self-locking element 300 acts between the fixed base 210 and the driving shaft 220.

The structure advantage of this embodiment: (1) the fixed base 210 has a small size and a compact structure; (2) the fixed base 210 is provided with a guide groove 113 for driving a pin 2201, so that the valve clamping device 1000 can move more stably in the opening and closing process; (3) the elastic self-locking member 300 is integrally received in the fixing base 210, and the flexible clamping effect is more stable.

Referring to fig. 23 and 24, the second hole 2132 and the first hole 2131 are sequentially opened from the proximal end to the distal end of the fixing base 210, and the elastic self-locking element 300 is interposed between the proximal end of the driving shaft 220 and the step surface 2130. The elastic self-locking element 300 is disposed in the second hole 2132 and contained inside the fixed base 210, which further contributes to improving the stability of the elastic self-locking element 300.

Referring to fig. 25 and 26, preferably, the proximal end of the drive shaft 220 is provided with a boss 224, and one end of the resilient self-locking element 300 abuts or is connected to the boss 224. Unlike the first embodiment, the elastic self-locking element 300 abuts between the proximal end of the driving shaft 220 (in the first embodiment, the distal end of the driving shaft 220) and the step surface 2130, and the structure of the driving shaft 220 and the structure of the fixing base 210 are adapted to each other, which is beneficial to the stability of the whole structure.

Optionally, the proximal end of the drive shaft 220 is provided with an internal threaded section 225 that is threadably coupled to the push shaft 2200.

EXAMPLE III

Referring to fig. 27 to 30, a third embodiment of the valve clamping device 1000 of the present invention has substantially the same structure as the first embodiment, and the clamp arm 110 is rotatably connected to the fixed base 210, except that: a connecting arm 130 is disposed between the jawarms 110 and the fixed base 210. the connecting arm 130 causes the jawarms 110 to open or close relative to the fixed base 210 when the drive shaft 220 is axially moved relative to the fixed base 210. The difference is that: the jawarm 110 is rotatably coupled to the drive shaft 220.

Referring to fig. 31 to 33, the elastic self-locking member 300 is disposed outside the driving shaft 220, and a proximal end surface of the elastic self-locking member 300 is welded to the fixing base 210 and a distal end surface thereof is welded to the driving shaft 220, thereby applying elasticity between the fixing base 210 and the driving shaft 220. In this embodiment, the elastic self-locking member 300 is an extension spring 310, and its initial state is a compressed state. When the drive shaft 220 is pushed distally, the spring 310 is stretched, and the forceps arms 110 of the valve clamping device 1000 are spread apart relative to the fixed base 210; when the drive shaft 220 is withdrawn proximally, the spring 310 returns to the initial state of axial compression, and the forceps arms 110 of the valve clamping device 1000 close relative to the fixed base 210, thereby clamping the leaflets between the forceps arms 110 and achieving locking of the forceps arms 110 to the fixed base 210.

The structure of this embodiment has the advantage: (1) a complex self-locking mechanism is not needed; (2) the elastic self-locking member 300 provides an adaptive flexible clamping force; (3) the weight is light; the operation is simple; the structure is simple.

In summary, according to the structural difference of the valve clamping device 1000, the compression or tension deformation of the elastic self-locking member 300 has a large difference, that is, the corresponding installation axial deformation and the extreme compression axial deformation, or the installation axial deformation and the extreme tension axial deformation have a large difference, and different spring coefficient ranges can be selected according to the structural characteristics.

Claims

1. An adaptive valve clamping device, comprising:

the clamping assembly comprises a pair of openable clamp arms;

2. The adaptive valve clamping device according to claim 1, wherein the fixing base comprises a base body and a tube body disposed at a proximal end of the base body, the base body is movably connected to the forceps arm, and a shaft hole is formed in the base body and the tube body for the driving shaft to pass through.

3. The adaptive valve clamping device according to claim 2, wherein the axial bore is inwardly provided with a step surface, and one end of the elastic self-locking member abuts against or is connected to the step surface.

4. The adaptive valve clamping device of claim 3, wherein the axial bore comprises a first bore and a second bore connected, the first bore having a diameter smaller than the second bore, a step surface is formed at the junction of the first bore and the second bore, and the resilient self-locking element is received in the second bore.

5. The adaptive valve clamping device according to claim 4, wherein the first and second holes are sequentially opened from a proximal end to a distal end of the fixed base, and the resilient self-locking member is interposed between the distal end of the driving shaft and the step surface.

6. The adaptive valve clamping device according to claim 4, wherein the second hole and the first hole are sequentially opened from the proximal end to the distal end of the fixed base, and the elastic self-locking member is disposed between the proximal end of the driving shaft and the step surface.

7. The adaptive valve clamping device of claim 1, wherein the resilient self-locking member is a spring, the drive shaft being disposed through the spring.

8. The adaptive valve clamping device according to claim 1, wherein the elastic self-locking member comprises a plurality of stacked elastic pieces, and a through hole for the driving shaft to pass through is formed in the middle of each elastic piece.

9. The adaptive valve clamping device according to claim 1, wherein the elastic self-locking piece has an elastic coefficient in the range of 1.5-10N/mm.

10. The adaptive valve clamping device according to claim 1, wherein the distal end of the driving shaft is provided with a support seat, and one end of the elastic self-locking piece abuts against or is connected to the support seat.

11. The adaptive valve clamping device according to claim 1, wherein the proximal end of the drive shaft is provided with a boss, and one end of the elastic self-locking member abuts against or is connected to the boss.

12. The adaptive valve clamping device of any one of claims 1 to 11, wherein the clamping assembly further comprises a pair of clamping arms, each clamping arm being disposed opposite one of the clamp arms, one end of the clamping arm being connected to the fixed base and the other end of the clamping arm being open and closed relative to the fixed base.

13. The adaptive valve clamping device according to any one of claims 1 to 11, wherein the clamp arm is rotatably connected to the fixed base, and the clamp arm is slidably or rotatably connected to the drive shaft.

14. A valve clamping system, comprising a delivery assembly and the adaptive valve clamping device of any one of claims 1-13, wherein the delivery assembly comprises a limiting tube and a pushing shaft movably arranged in the limiting tube in a penetrating manner, the distal end of the pushing shaft is detachably connected with the proximal end of the driving shaft, and the distal end of the limiting tube is detachably connected with the proximal end of the fixed base.

15. The valve clamping system of claim 14, wherein the proximal end of the fixing base is provided with at least one clamping groove, and the distal end of the limiting tube is provided with a clamping piece which is matched with and corresponds to the clamping groove in shape.

16. The valve clamping system of claim 15, wherein the free ends of the tabs snap into the fixation base, the tabs snap into the fixation base to a depth greater than a gap between the push shaft and the stop tube.