An adaptive valve clamping device and valve clamping system

Abstract

The invention discloses an 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 member. The clamping assembly comprises a pair of openable and closable clamp arms. The transmission assembly comprises a fixed base and a driving shaft movably arranged in 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 arm to open or close relative to the fixed base. The elastic self-locking member is sleeved on the outer peripheral surface of the driving shaft, and the two ends of the elastic self-locking member in a natural state are located between the distal end of the fixed base and the proximal end of the driving shaft. In the valve clamping device of the present invention, during the leaflet clamping process, the deformation of the elastic self-locking member is automatically adjusted in real time as the force applied to the leaflet changes, so that the clamp arm maintains a flexible clamping force applied to the leaflet to avoid tearing caused by excessive pulling of the leaflet; and the clamping force can also be automatically adjusted as the leaflet gap changes to adapt to the new leaflet gap.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular, relates to an adaptive valve clamping device and a valve clamping system. Background Art

[0002] The mitral valve is a one-way valve located between the left atrium and the left ventricle of the heart. A healthy mitral valve can control the flow of blood from the left atrium to the left ventricle, while preventing blood from flowing from the left ventricle to the left atrium. The mitral valve consists of a pair of leaflets, called the anterior leaflet and the posterior leaflet. Figure 1 As shown in the figure, when the edges of the anterior leaflet and the posterior leaflet are in apposition, the mitral valve can be completely closed to prevent blood from flowing from the left ventricle to the left atrium. When the mitral valve leaflets or their related structures undergo organic or functional changes, the anterior and posterior leaflets of the mitral valve are not in apposition. As a result, when the left ventricle of the heart contracts, the mitral valve cannot be completely closed, causing blood to flow back from the left ventricle to the left atrium, thereby causing a series of pathological and physiological changes, known as "mitral regurgitation."

[0003] Surgery usually uses surgical methods such as valve edge-to-edge suture to treat mitral regurgitation. However, this type of surgical procedure has the disadvantages of complex surgical procedures, high surgical costs, high degree of patient trauma, high risk of complications, long hospital stay, and painful recovery process for patients. The prior art discloses a minimally invasive treatment surgery, which is based on the principle of valve edge-to-edge surgery, delivers a valve clamping device to the mitral valve through an interventional catheter, and then clamps the anterior and posterior leaflets of the mitral valve at the same time through the relative opening of the clamp, thereby achieving the purpose of fixing the valve leaflets and reducing mitral regurgitation.

[0004] However, this valve clamping device is in a fixed locked state after clamping the leaflets, and relative displacement cannot occur between the clamping parts. When the valve clamping device is closed, too loose clamping force will cause the valve clamping device to fall off the leaflets, while too tight clamping force will cause the two leaflets to be forcibly pulled toward each other and fixed together, which will not only cause the leaflets to be excessively restricted from moving and thus cause mitral valve dysfunction, but also when the heart beats and the leaflets move, too tight clamping force may also cause leaflet tearing and other serious consequences; in addition, after the valve clamping device is implanted, as the implantation time increases, the regurgitation is alleviated, and the valve morphology will also change accordingly. When the leaflet gap changes, it may be desirable that the clamping force of the valve clamping device be adjustable so that it can gradually adapt to the new leaflet gap. Summary of the invention

[0005] A main purpose of the present invention is to overcome the defect of the existing valve clamping device that the clamping force cannot be adjusted in real time with the movement of the valve leaflets or the valve leaflet gap, and to provide an adaptive valve clamping device and a valve clamping system.

[0006] The present invention provides an adaptive valve clamping device, comprising:

[0007] A clamping assembly, comprising a pair of openable and closable clamp arms;

[0008] A transmission assembly, comprising a fixed base and a drive shaft movably disposed in the fixed base, each of the clamp arms being movably connected to the fixed base and the drive shaft, and the axial movement of the drive shaft drives the clamp arms to open or close relative to the fixed base; and,

[0009] The elastic self-locking member is sleeved on the outer circumferential surface of the driving shaft, and the two ends of the elastic self-locking member in a natural state are located between the distal end of the fixed base and the proximal end of the driving shaft.

[0010] The present invention also provides a valve clamping system, including a conveying component and an adaptive valve clamping device of the above structure, wherein the conveying component includes a limiting tube and a pushing shaft movably installed in the limiting tube, the distal end of the pushing shaft is detachably connected to the proximal end of the driving shaft, and the distal end of the limiting tube is detachably connected to the proximal end of the fixed base.

[0011] Compared with the prior art, the adaptive valve clamping device and valve clamping system of the present invention have at least the following beneficial effects: the drive shaft is slidably arranged in the fixed base, the clamp arm forms an openable and closable structure relative to the fixed base as the drive shaft moves, and the sliding distance of the drive shaft directly determines the opening and closing degree of the clamp arm, and at the same time, the clamp arm is locked at a certain opening and closing angle relative to the fixed base through the deformation degree of the elastic self-locking member. In the process of clamping the leaflets, the elastic self-locking member is subjected to the driving force of the drive shaft on the one hand, and the pulling force transmitted to the far end of the fixed base by the clamp arm on the other hand, and the pulling force of the clamp arm comes from the leaflets, so the deformation of the elastic self-locking member is automatically adjusted in real time as the force applied to the leaflets changes, so that the clamp arm maintains a flexible clamping force on the leaflets, preventing excessive clamping force from forcibly pulling the leaflets, thereby preventing secondary damage to the leaflets. Therefore, the elastic self-locking part of the present invention can not only lock the clamp arm relative to the fixed base, but also adaptively adjust the clamping force of the clamp arm on the leaflet, thereby providing a flexible clamping force to the leaflet, avoiding tearing caused by excessive pulling of the leaflet, and accelerating the leaflet to return to a normal level of occlusion; and after the valve clamping device is implanted, the clamping force can be automatically adjusted as the leaflet gap changes to adapt to the new leaflet gap. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] 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.

[0013] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, for ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0014] Figure 1 This is a three-dimensional view of the valve clamping device in the open state according to the first embodiment of the present invention.

[0015] Figure 2 This is a front view of the valve clamping device in the open state according to the first embodiment of the present invention.

[0016] Figure 3 This is a perspective view of the valve clamping device according to Embodiment 1 of the present invention in an open state.

[0017] Figure 4 This is a longitudinal cross-sectional view of the valve clamping device in the first embodiment of the present invention in an open state.

[0018] Figure 5 This is a three-dimensional view of the valve clamping device in the closed state according to the first embodiment of the present invention.

[0019] Figure 6 This is a front view of the valve clamping device in the closed state according to the first embodiment of the present invention.

[0020] Figure 7 This is a longitudinal cross-sectional view of the valve clamping device in the closed state according to the first embodiment of the present invention.

[0021] Figure 8 It is a three-dimensional view of the fixed base according to the first embodiment of the present invention.

[0022] Fig. 9 It is a longitudinal cross-sectional view of the fixed base according to the first embodiment of the present invention.

[0023] Fig.10 This is an exploded view of the driving pin of the first embodiment of the present invention.

[0024] Fig.11 This is a three-dimensional view of a fixed base with another structure according to the first embodiment of the present invention.

[0025] Fig.12 It is a longitudinal cross-sectional view of another structure of a fixed base according to the first embodiment of the present invention.

[0026] Fig.13 This is a three-dimensional view of the elastic self-locking member according to the first embodiment of the present invention.

[0027] Fig.14 This is a three-dimensional view of another elastic self-locking member of the first embodiment of the present invention.

[0028] Fig.15 This is a three-dimensional view of the drive shaft of the first embodiment of the present invention.

[0029] Fig.16 It is a longitudinal cross-sectional view of the drive shaft of the first embodiment of the present invention.

[0030] Fig.17 It is a partial stereoscopic view of the valve clamping system according to the first embodiment of the present invention.

[0031] Fig.18 This is a three-dimensional view of the valve clamping device according to the second embodiment of the present invention in an open state.

[0032] Fig.19 This is a front view of the valve clamping device of the second embodiment of the present invention in an open state.

[0033] Fig. 20 It is a longitudinal cross-sectional view of the valve clamping device of the second embodiment of the present invention in the open state.

[0034] Fig.21 This is a three-dimensional view of the valve clamping device in the second embodiment of the present invention in a closed state.

[0035] Fig. 22 It is a longitudinal cross-sectional view of the valve clamping device in the second embodiment of the present invention in a closed state.

[0036] Fig.23 It is a three-dimensional view of the fixed base of the second embodiment of the present invention.

[0037] Fig.24 It is a longitudinal cross-sectional view of the fixed base according to the second embodiment of the present invention.

[0038] Fig.25 This is a three-dimensional view of the drive shaft of the second embodiment of the present invention.

[0039] Fig.26 It is a longitudinal cross-sectional view of the drive shaft of the second embodiment of the present invention.

[0040] Fig. 27 This is a three-dimensional view of the valve clamping device of embodiment 3 of the present invention in an open state.

[0041] Fig.28 This is a front view of the valve clamping device of embodiment 3 of the present invention in an open state.

[0042] Fig.29 This is a three-dimensional view of the valve clamping device in the closed state according to the third embodiment of the present invention.

[0043] Fig.30 This is a front view of the valve clamping device in the closed state according to the third embodiment of the present invention.

[0044] Fig.31 It is a three-dimensional assembly diagram of the fixed base, the driving shaft and the elastic self-locking member of the third embodiment of the present invention.

[0045] Fig.32 This is a forward assembly diagram of the fixed base, the drive shaft and the elastic self-locking member of the third embodiment of the present invention.

[0046] Fig.33 It is a three-dimensional assembly diagram of the fixed base, the driving shaft and the elastic self-locking member of the third embodiment of the present invention when the elastic self-locking member is in a stretched state. DETAILED DESCRIPTION

[0047] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0048] It should be understood that the directions or positional relationships indicated by “front”, “back”, “up”, “down”, “left”, “right”, “longitudinal”, “horizontal”, “vertical”, “horizontal”, “top”, “bottom”, “inside”, “outside”, “head”, “tail”, etc. are based on the directions or positional relationships in the drawings, are constructed and operated in a specific direction, and are only for the convenience of describing the technical solution, and do not indicate that the device or element referred to must have a specific direction, and therefore should not be understood as a limitation on the present invention.

[0049] It should also be noted that, unless otherwise clearly specified and limited, the terms such as "installed", "connected", "connected", "fixed", "set" and the like should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral one; it can be directly connected, or indirectly connected through an intermediate medium, and it can be the internal connection of two elements or the interaction relationship between two elements. When an element is referred to as being "on" or "under" another element, the element can be "directly" or "indirectly" located on the other element, or there may be one or more intervening elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances.

[0050] In the description of the present invention, it still needs to be explained 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; the axial direction refers to the direction parallel to the line connecting the distal and proximal centers of the instrument or component, the radial direction refers to the direction perpendicular to the axial direction, and the circumferential direction refers to the direction surrounding the axial direction.

[0051] In order to overcome the defect that the clamping force of the valve clamping structure in the prior art cannot be adjusted in real time, the present invention discloses an adaptive valve clamping device 1000 and a valve clamping system, which applies a flexible force to the valve leaflets to automatically and in real time adjust the clamping force of the clamp arm 110 on the valve leaflets. The present invention is described in detail below through specific embodiments and drawings of the specification.

[0052] Embodiment 1

[0053] See also Figure 1-4 The first embodiment of the present invention discloses an adaptive valve clamping device 1000, including 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 clamp arms 110. The transmission assembly 200 includes a fixed base 210 and a drive shaft 220 movably inserted into the fixed base 210. Each clamp arm 110 is movably connected to the fixed base 210 and the drive shaft 220. The axial movement of the drive shaft 220 drives the clamp arm 110 to open or close relative to the fixed base 210. The elastic self-locking member 300 is sleeved on the outer circumference of the drive shaft 220, and the two ends of the elastic self-locking member 300 in a natural state are located between the distal end of the fixed base 210 and the proximal end of the drive shaft 220.

[0054] According to the technical solution of the present invention, the drive shaft 220 is slidably arranged in the fixed base 210, and the clamp arm 110 forms an openable and closable structure relative to the fixed base 210 as the drive shaft 220 moves, and the sliding distance of the drive shaft 220 directly determines the opening and closing degree of the clamp arm 110, and at the same time, the clamp arm 110 is locked relative to the fixed base 210 at a certain opening and closing angle through the deformation degree of the elastic self-locking member 300. In the process of clamping the leaflets, the elastic self-locking member 300 is subjected to the driving force of the drive shaft 220 on the one hand, and the pulling force transmitted to the far end of the fixed base 210 by the clamp arm 110 on the other hand, and the pulling force of the clamp arm 110 comes from the leaflets, so the deformation of the elastic self-locking member 300 is automatically adjusted in real time as the force applied to the leaflets changes, so that the clamp arm 110 maintains a flexible clamping force on the leaflets, preventing the excessive clamping force from forcibly pulling the leaflets, thereby preventing secondary damage to the leaflets. Therefore, the elastic self-locking part 300 of the present invention can not only lock the clamp arm 110 relative to the fixed base 210, but also adaptively adjust the clamping force of the clamp arm 110 on the leaflet, thereby providing a flexible clamping force to the leaflet, avoiding tearing caused by excessive pulling of the leaflet, and accelerating the leaflet to return to a normal level of occlusion; and after the valve clamping device 1000 is implanted, the clamping force can be automatically adjusted as the leaflet gap changes to adapt to the new leaflet gap.

[0055] The adaptive valve clamping device 1000 of the present invention can be delivered through the delivery assembly 2000. The adaptive valve clamping device 1000 has a simple structure and does not require a complex self-locking mechanism, so that no additional control unlocking operation is required, which is easy to operate, shortens the operation time, and improves the success rate of the operation; at the same time, there is no need to add an unlocking control mechanism in the delivery assembly 2000, which reduces the assembly difficulty of the delivery assembly 2000 and ensures the stability of the delivery system. 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.

[0056] The clamping assembly 100 further includes a pair of clamping arms 120, each clamping arm 120 is disposed opposite to a clamp arm 110, one end of the clamping arm 120 is connected to the fixed base 210, and the other end of the clamping arm 120 opens and closes relative to the fixed base 210. When the clamp arm 110 is closed relative to the fixed base 210, the anterior leaflet and the posterior leaflet of the mitral valve are clamped between one clamp arm 110 and the clamp arm 120 on one side, respectively.

[0057] In this embodiment, the distal end of the clamp arm 110 is provided with a connecting groove 111, and the driving pin 2201 is inserted into the connecting groove 111, so as to connect the clamp arm 110 with the driving shaft 220. When the driving shaft 220 is pulled toward the proximal end, the driving pin 2201 moves toward the proximal end and relatively slides with the connecting groove 111 of the clamp arm 110, thereby driving the clamp arm 110 to rotate around the driving pin 2201 as the center, thereby realizing the opening between the clamp arm 110 and the fixed base 210. When the driving shaft 220 is pulled toward the distal end, the driving pin 2201 moves toward the distal end and relatively slides with the connecting groove 111 of the clamp arm 110, thereby driving the clamp arm 110 to rotate around the driving pin 2201 as the center, thereby realizing the closing between the clamp arm 110 and the fixed base 210.

[0058] See also Figure 5-Figure 7 The inner surface of the clamp arm 110 opposite to the fixed base 210 serves as the leaflet clamping surface. Therefore, in order to better adapt to the structure of the leaflet and ensure an appropriate leaflet contact area and clamping area, thereby providing a stable clamping force, the clamp arm 110 is preferably a sheet with a concave inner surface and has a certain width and axial length. Specifically, the width of the clamp arm 110 should be greater than or equal to 2 mm, preferably 4-6 mm, and the axial length of the clamp arm 110 should be greater than or equal to 4 mm, preferably 6-12 mm. In order to ensure safety after implantation, the clamp arm 110 should be made of a biocompatible material and have a certain flexibility and rigidity. In addition, active drugs can also be applied to the inner surface of the clamp arm 110 to promote the crawling and growth of endothelial cells of the leaflet tissue on the inner surface of the clamp arm 110.

[0059] It can also be understood that in order to increase the clamping force of the clamp arm 120 and the clamp arm 110 on the valve leaflet, at least one row of barbs can be provided on the surface of the clamp arm 120 facing the clamp arm 110 to prevent the valve leaflet from slipping off the inner surface of the clamp arm 110.

[0060] Each clamping arm 120 includes a connecting end and a free end that are arranged opposite to each other, and the connecting end is fixed relative to the fixed base 210. In this embodiment, the two clamping arms 120 are connected as a whole through a connecting frame, and the connecting frame is provided with a through hole for the driving shaft 220 to pass through, and the connecting frame is sleeved on the outer side of the fixed base 210. In other embodiments, the connecting end of the clamping arm 120 can be directly fixed to the fixed base 210 by welding, crimping, or other connection methods.

[0061] The clamping arm 120 is at least partially made of an elastic material with shape memory function and is heat-set. In a natural state, the clamping arm 120 extends radially outward relative to the fixed base 210, and preferably extends toward the proximal end so as to cooperate with the clamp arm 110 to clamp the valve tissue. In this embodiment, the clamping arm 120 is made of a superelastic nickel-titanium alloy as a whole, thereby providing a greater elastic force for the clamping arm 120 to drive the clamping arm 120 to move closer to the clamp arm 110 to clamp the valve tissue.

[0062] It should be noted that the free end of the clamp arm 120 is provided with a control wire hole for connecting the control wire (not shown) of the pushing device, and the free end of the clamp arm 120 can be controlled by the control wire extending outside the patient's body. In the delivery state, the free end of the clamp arm 120 is tightened 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 clamp arm 120 is released, and the clamp arm 120 returns to the natural state due to its own elastic memory performance, and presses the valve leaflet toward the clamp arm 110.

[0063] It is understandable that in order to increase the biocompatibility between the valve clamping device 1000 and the valve leaflet and facilitate the crawling of endothelial cells, 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) can also be coated with a biocompatible polymer coating. The polymer coating is selected from materials such as polyethylene terephthalate (PET) and polytetrafluoroethylene (PTFE). The materials of the coating applied to the clamp arm 110 and the clamp arm 120 can be the same or different.

[0064] Preferably, see Figure 8 and Fig. 9The fixed base 210 includes a base body 211 and a tube body 212 disposed at the proximal end of the base body 211. The base body 211 is movably connected to the clamp arm 110. A through shaft hole 213 is provided in the base body 211 and the tube body 212 for the drive shaft 220 to pass through. In this embodiment, the base body 211 and the clamp arm 110 are rotatably connected through the rotating pin 112. The shaft hole 213 serves to limit and guide the drive shaft 220. The shaft hole 213 is specifically configured as a circular hole, which is adapted to the outer peripheral surface of the drive shaft 220. Two pin holes are provided on both sides of the distal end of the fixed base 210 for accommodating the rotating pin 112.

[0065] See also Fig.10 In this 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. When the driving pin 2201 is inserted into the connecting groove 111, the driving pin 2201 and the clamp arm 110 do not need to be welded. The driving pin 2201 and the clamp 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 clamp arm 110. The structure of the rotating pin 112 can be the same as that of the driving pin 2201.

[0066] Preferably, see Fig. 9 The shaft hole 213 is provided with a step surface 2130 protruding inwardly, and one end of the elastic self-locking member 300 abuts or is connected to the step surface 2130. The step surface 2130 serves as a circumferential limit for the elastic self-locking member 300, preventing the elastic self-locking member 300 from retreating with the driving shaft 220, causing the device to fail, thereby ensuring the stability of the elastic force.

[0067] Furthermore, the shaft hole 213 includes a first hole 2131 and a second hole 2132 connected to each other, and the diameter of the first hole 2131 is smaller than the diameter of the second hole 2132. A step surface 2130 is formed at the connection between the first hole 2131 and the second hole 2132, and the elastic self-locking member 300 is accommodated in the second hole 2132. The first hole 2131 is used to accommodate and guide the drive shaft 220, and the second hole 2132 is used to accommodate the elastic self-locking member 300. The sizes of the first hole 2131 and the second hole 2132 are matched with the drive shaft 220 and the elastic self-locking member 300, respectively, to achieve the limiting and guiding effects, and avoid the drive shaft 220 and the elastic self-locking member 300 from axially skewing, which affects the closing of the clamp arm 110 and the transmission of the elastic force.

[0068] Preferably, the first hole 2131 and the second hole 2132 are sequentially opened from the proximal end to the distal end of the fixed base 210, and the elastic self-locking member 300 is placed between the distal end of the drive shaft 220 and the step surface 2130. Of course, the positions of the first hole 2131 and the second hole 2132 can be adjusted according to the positions of the drive shaft 220 and the elastic self-locking member 300. In this embodiment, at least part of the distal end of the elastic self-locking member 300 extends out of the second hole 2132, and when the two clamp arms 110 of the valve clamping device 1000 are clamped, the elastic self-locking member 300 reaches the maximum extension length. This structure can shorten the overall length of the fixed base 210, making the fixed base 210 smaller in size and lighter in weight.

[0069] Further, see Fig.11 and Fig.12 In order to reduce the weight of the valve clamping device 1000, a weight-reducing hole 215 or a weight-reducing groove 2111 may be added to the fixed base 210. The fixed base 210 may be made of a biocompatible material with a certain hardness and rigidity, and stainless steel is used in this embodiment.

[0070] Preferably, see Fig.13 , the elastic self-locking member 300 is a spring 310, and the drive 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 can be wound with a stainless steel material with good elasticity, or can be wound with a nickel-titanium wire with superelasticity and made by heat setting. The spring 310 of this embodiment is a compression spring, that is, the external force on the spring 310 from the initial state to the deformed state is pressure. It can be understood that when the clamp arm 110 is in a closed state, the spring 310 is in an initial state, and the spring 310 is slightly compressed in the initial state. When the drive shaft 220 is pulled toward the proximal end, the compression amount of the spring 310 increases, and the clamp arm 110 is in an open state; when the drive shaft 220 is pushed toward the distal end, the spring 310 returns to the initial state, that is, it is slightly compressed, and the clamp arm 110 is in a closed state and locked relative to the fixed base 210.

[0071] See also Fig.14 In other embodiments, the elastic self-locking member 300 includes a plurality of stacked spring sheets 320, and a through hole 321 is provided in the middle of the spring sheets 320 for the drive shaft 220 to pass through. Specifically, a plurality of spring sheets 320 connected end to end and stacked in sequence can be made of elastic material as the elastic self-locking member 300, for example, a stainless steel material with good elasticity can be bent, a superelastic nickel-titanium sheet can be heat-set, or a spring steel can be coated to obtain the elastic self-locking member 300. The working principle of the plurality of stacked spring sheets 320 is consistent with the working principle of the compression spring 310, and will not be repeated here.

[0072] It can be understood that when the valve clamping device 1000 is in a closed state, the elastic self-locking member 300 is slightly compressed and provides a certain elastic force as the self-locking force of the valve clamping device 1000. When the pulling force of the valve leaf on the clamp arm 110 exceeds the self-locking force, the clamp arm 110 will overcome the self-locking force provided by the elastic self-locking member 300 and produce an adaptive adjustment effect to prevent the clamp arm 110 from excessively pulling the valve leaf. Under the thrust of the push shaft 2200 or the pulling force of the valve leaf, as the opening angle of the clamp arm 110 increases, the compression deformation of the elastic self-locking member 300 gradually increases. When the valve clamping device 1000 is opened to the maximum angle, the elastic self-locking member 300 reaches the compression limit position, and the self-locking force (elastic force of the elastic self-locking member 300) that the clamp arm 110 needs to overcome is the maximum.

[0073] The self-locking force provided by the elastic self-locking member 300 is tested by the following method: the valve clamping device 1000 is connected to the simple handle by using the HY-0580 electronic universal tensile testing machine produced by Shanghai Hengyi Precision Instrument Co., Ltd. The test shaft is connected to the drive shaft 220 and passes through the proximal end of the simple handle, and the simple handle is fixed on the machine table of the tensile machine. The moving end of the tensile machine hooks the end of the test shaft, and the moving end is moved at a constant speed of 4.5mm / min. The force value of the clamp arm 110 moving from the initial closed state and the force value required for the clamp arm 110 to open to the maximum angle are recorded. After measurement, the self-locking force of the valve clamping device 1000 in the initial state is 15-20N, and the self-locking force of the valve clamping device 1000 when it is opened to the maximum angle is 40-50N. Therefore, in order to better clamp the valve and maintain the clamping effect on the one hand, and to ensure that an adaptive adjustment function can be generated when subjected to a large pulling force on the other hand, the elastic self-locking component 300 needs to provide a self-locking force value range of 15-50N, which is the elastic force range of the elastic self-locking component 300.

[0074] Preferably, the elastic coefficient of the elastic self-locking member 300 is in the range of 1.5-10N / mm, which can be obtained through experiments and calculations. Specifically, the elastic self-locking member 300 is a compression spring 310, and at the original length, the elastic self-locking member 300 is not assembled in the valve clamping device 1000. When the elastic self-locking member 300 is slightly compressed and assembled in the valve clamping device 1000, the clamp arms 110 on both sides of the valve clamping device 1000 are closed, and the elastic self-locking member 300 is slightly compressed axially. The length after slight compression is the axial distance between the limiting surface of the drive shaft 220 and the step surface 2130 of the inner shaft hole 213 of the fixed base 210. The first axial deformation of the elastic self-locking member 300 is the difference between the original length and the length after installation compression, which ranges from 1 to 5 mm. At this time, the self-locking force provided by the elastic self-locking member 300 is 15-20N. The drive shaft 220 is gradually pushed to drive the clamp arm 110 to open to both sides relative to the fixed base 210, and the elastic self-locking member 300 is further axially compressed. When the clamp arm 110 is at the maximum opening angle, the elastic self-locking member 300 reaches the limit compression position. The compressed length is the axial distance between the limit surface of the drive shaft 220 and the step surface 2130 of the inner shaft hole 213 of the fixed base 210, that is, the second axial deformation of the elastic self-locking member 300 is the difference between the original length and the limit compression length, ranging from 5 to 10 mm. At this time, the self-locking force provided by the elastic self-locking member 300 is 40-50 N. According to Hooke's law F=KS, F is the elastic force of the elastic self-locking member 300, K is the elastic coefficient of the elastic self-locking member 300, and S is the compression of the elastic self-locking member 300. It can be calculated that the elastic coefficient K [N / mm, lb / in] of the elastic self-locking member 300 ranges from 1.5 to 10 N / mm.

[0075] This embodiment uses a stainless steel compression spring 310 as the elastic self-locking member 300. The calculation formula of the spring coefficient K of the compression spring 310 is known to be: Wherein, K = elastic modulus [N / mm, lb / in], G = shear elastic modulus [MPa, psi]; d = wire diameter [mm, in]; n = effective number of turns [-]; D = center diameter [mm, in], shear elastic modulus G is 7000MPa, wire diameter d is 0.30mm, total number of turns is 9 turns, effective number of turns n is 7 turns, center diameter D is 1.20mm, elastic modulus K = 5.74N / mm300. It can be understood that in other embodiments, the material, wire diameter, shear elastic modulus, center diameter, effective number of turns, total length of the spring and other parameters of the elastic self-locking member 300 can be changed, as long as the elastic modulus of the elastic self-locking member 300 is within the range of 1.5 to 10N / mm, the self-locking force requirement of the present invention can be met.

[0076] Preferably, see Fig.15 and Fig.16, a support seat 221 is provided at the distal end of the drive shaft 220, and one end of the elastic self-locking member 300 abuts or is connected to the support seat 221. The support seat 221 is used to provide an abutting position or a connection (welding) position for the elastic self-locking member 300, and to provide a stable support surface for the elastic self-locking member 300. Moreover, in this embodiment, the support seat 221 is provided with a driving pin hole 222, and the driving pin 2201 is arranged in the driving pin hole 222 of the support seat 221. The driving pin hole 222 is arranged in the support seat 221, so as to avoid the driving pin hole 222 from causing adverse effects on the overall strength of the drive shaft 220.

[0077] Furthermore, the clamp arm 110 is rotatably connected to the fixed base 210, and the clamp arm 110 is slidably connected or rotatably connected to the drive shaft 220. In this embodiment, the clamp arm 110 is rotatably connected to the fixed base 210, and the clamp arm 110 is slidably connected to the drive shaft, and the axial movement of the drive shaft 220 is converted into a rotatable opening and closing action of the clamp arm 110 by combining the rotation and sliding actions. In other embodiments, the positions of the rotation connection and the sliding connection can be adjusted to achieve the same operating effect.

[0078] See also Fig.17 The present invention also discloses a valve clamping system, including a delivery assembly 2000 and the adaptive valve clamping device 1000 of the above structure. The delivery assembly 2000 includes a stop tube 2100 and a push shaft 2200 movably installed in the stop tube 2100. The distal end of the push shaft 2200 is detachably connected to the proximal end of the driving shaft 220, and the distal end of the stop tube 2100 is detachably connected to the proximal end of the fixed base 210.

[0079] It can be understood that the proximal end of the valve clamping device 1000 is releasably connected to the push shaft 2200 and the limiting tube 2100. 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 leaflet and the posterior leaflet of the mitral valve together. Once the leaflets of the mitral valve are aligned edge to edge, the operator can release the connection between the push shaft 2200 and the valve clamping device 1000, so that the valve clamping device 1000 is released from the distal end of the push shaft 2200 and remains in the patient's body as an implant to keep the leaflets in the aligned position together and reduce the patient's mitral regurgitation.

[0080] The driving shaft 220 is located in the shaft hole 213 of the fixed base 210 and can slide in the axial direction. The distal end of the driving shaft 220 is provided with a driving pin hole 222. The driving pin 2201 is inserted into the driving pin hole 222 and connected to the clamp arm 110, thereby driving the clamp arm 110 to open and close relative to the fixed base 210. The proximal end of the driving shaft 220 is provided with a threaded section 223, which is used to be detachably connected to the push shaft 2200 of the conveying assembly 2000, so as to remotely control the driving shaft 220 to move forward or backward in the axial direction relative to the fixed base 210 outside the patient's body.

[0081] The limiting tube 2100 is used to be detachably connected to the valve clamping device 1000, the pushing shaft 2200 is movably arranged in the limiting tube 2100, and the distal end of the pushing shaft 2200 is detachably connected to the driving shaft 220 via a thread. The pushing shaft 2200 is used to control the driving shaft 220 to advance or retreat axially relative to the fixed base 210, that is, to drive the clamp arm 110 to open or close relative to the fixed base 210. The pushing shaft 2200 is also used to control the connection and release between the limiting tube 2100 and the valve clamping device 1000. When the pushing shaft 2200 is withdrawn from the limiting tube 2100, the valve clamping device 1000 and the limiting tube 2100 are released from the connection.

[0082] The delivery assembly 2000 also includes an adjustment line for controlling the release and tension of the free end of the clamping arm 120. The position-limiting tube 2100, the pushing shaft 2200 and the adjustment line each have a certain axial length and extend outside the patient's body, so that the operator can remotely operate outside the patient's body to control the valve clamping device 1000 to clamp, disengage and release the valve leaflets. A handle can also be provided at the proximal end of the position-limiting tube 2100 and the pushing shaft 2200 to facilitate the operator's operation.

[0083] Preferably, refer again to Figure 8-Figure 12 , at least one slot 214 is provided at the proximal end of the fixed base 210, and a snap-fitting piece 2110 that matches and corresponds to the slot 214 is provided at the distal end of the position-limiting tube 2100. In this way, through the cooperation between the slot 214 and the snap-fitting piece 2110, the fixed base 210 and the position-limiting tube 2100 form a detachable snap-fitting structure. Before the clamping is completed, the fixed base 210 and the position-limiting tube 2100 maintain a snap-fitting state, the push shaft 2200 slides in the position-limiting tube 2100, and the drive shaft 220 slides through the thread, thereby controlling the opening and closing of the clamp arm 110; after the clamping is completed, the fixed base 210 and the position-limiting tube 2100 are out of the snap-fitting state and switched to two independent components, which facilitates the withdrawal of the conveying assembly 2000.

[0084] Preferably, the free end of the snap-fitting piece 2110 is snapped into the fixed base 210, and the depth of the snap-fitting piece 2110 being snapped into the fixed base 210 is greater than the gap between the push shaft 2200 and the limiting tube 2100. The snap-fitting piece 2110 is snapped into the fixed base 210, and is subjected to the resistance pressure of the outer peripheral surface of the push shaft 2200, so as to maintain the snap-fitting state of the limiting tube 2100 and the fixed base 210, and the connection relationship between the limiting tube 2100 and the fixed base 210 is changed by controlling the position of the push shaft 2200. In the present embodiment, the snap-fitting piece 2110 is configured as a T-shaped spring piece. Specifically, two T-shaped spring pieces 320 are symmetrically provided at the far end of the limiting tube 2100, and each T-shaped spring piece 320 is radially biased inward in a natural state. When the push shaft 2200 is inserted into the limiting tube 2100, the push shaft 2200 pushes the T-shaped spring piece 320 radially outward, so that each T-shaped spring piece 320 is embedded in a T-shaped slot of the fixed base 210, and the fixed base 210 and the limiting tube 2100 are in a connected state. When the push shaft 2200 is withdrawn from the limiting tube 2100, the T-shaped spring piece 320 of the limiting tube 2100 is deformed inward and separated from the T-shaped slot because it is free from the interference of the push shaft 2200, and the fixed base 210 and the limiting tube 2100 are in an unlocked state.

[0085] The following is the operation process of the valve clipping device 1000:

[0086] After the valve clamping device 1000 reaches the leaflet position, the push shaft 2200 is rotated to make the drive shaft 220 move axially and drive the clamp arm 110 to open. When the leaflet enters between the clamp arm 110 and the clamp arm 120, the clamp arm 120 is released, so that the clamp arm 120 naturally moves toward the clamp arm 110 and clamps the leaflet tissue.

[0087] The pushing shaft 2200 is rotated in the reverse direction, so that the driving shaft 220 moves in the reverse direction along the axial direction and drives the clamp arm 110 to clamp, thereby clamping the leaflet.

[0088] After the valve clamping device 1000 clamps the valve leaflets, the threaded connection between the push shaft 2200 and the driving shaft 220 of the valve clamping device 1000 is released, and then the push shaft 2200 is withdrawn from the limiting tube 2100. The T-shaped spring piece 320 on the limiting tube 2100 is biased inward and separated from the fixed base 210 of the valve clamping device 1000. The entire valve clamping device 1000 is disconnected from the conveying component 2000 and released quickly. Afterwards, the valve clamping device 1000 can maintain a flexible clamping effect under the elastic force of the elastic self-locking member 300.

[0089] When the leaflet tension reaches a certain force value, the clamp arm 110 overcomes the elastic force of the elastic self-locking member 300 and adjusts the closed state. The entire closing process is a flexible adaptive process, thereby avoiding leaflet tearing. In addition, from the long-term effect of the valve clamping device 1000 after implantation, as the heart function recovers, the ventricular structure recovers and the leaflet coaptation effect gradually improves, the clamp arm 110 will automatically adjust the closing angle under the action of the flexible clamping force provided by the elastic self-locking member 300, avoiding leaflet tearing and accelerating the leaflet to return to a normal coaptation level, thereby ensuring the surgical effect.

[0090] Embodiment 2

[0091] See also Figure 18-Figure 22 The valve clamping device 1000 of the second embodiment of the present invention has a structure that is basically the same as that of the first embodiment. The clamp arm 110 is rotatably connected to the fixed base 210, and the clamp arm 110 is slidably connected to the drive shaft 220. The difference is that the rotating pin 112 and the drive pin 2201 are located at different positions on the clamp arm 110, and are sequentially arranged from near to far along the axial direction of the valve clamping device 1000. When the drive shaft 220 is pushed toward the distal end, the clamp arm 110 is in an open state; when the drive shaft 220 is pulled toward the proximal end, the clamp arm 110 is in a closed state. In this embodiment, the elastic self-locking member 300 is also a pressure spring 310, that is, the external force from the initial state to the deformed state is pressure, and the elastic force of the elastic self-locking member 300 acts between the fixed base 210 and the drive shaft 220.

[0092] The structural advantages of this embodiment are as follows: (1) The fixed base 210 is small in size and compact in structure; (2) A guide groove 113 for the driving pin 2201 is provided on the fixed base 210, and the movement of the valve clamping device 1000 during the opening and closing process is more stable; (3) The elastic self-locking member 300 is integrally accommodated inside the fixed base 210, and the flexible clamping effect is more stable.

[0093] See also Fig.23 and Fig.24 The second hole 2132 and the first hole 2131 are sequentially opened from the proximal end to the distal end of the fixed base 210, and the elastic self-locking member 300 is placed between the proximal end of the driving shaft 220 and the step surface 2130. The elastic self-locking member 300 is arranged in the second hole 2132 and contained in the fixed base 210, which is more conducive to improving the stability of the elastic self-locking member 300.

[0094] See also Fig.25 and Fig.26Preferably, a boss 224 is provided at the proximal end of the drive shaft 220, and one end of the elastic self-locking member 300 abuts against or is connected to the boss 224. Different from the first embodiment, the elastic self-locking member 300 abuts between the proximal end of the drive shaft 220 (abuts against the distal end of the drive shaft 220 in the first embodiment) and the step surface 2130, and the structure of the drive shaft 220 and the structure of the fixed base 210 are adapted to each other, which is conducive to the stability of the overall structure.

[0095] Optionally, the proximal end of the driving shaft 220 is provided with an internal thread section 225 to form a threaded connection with the pushing shaft 2200 .

[0096] Embodiment 3

[0097] See also Figure 27-Figure 30 The valve clamping device 1000 of the third embodiment of the present invention has a substantially similar structure to that of the first embodiment, wherein the clamp arm 110 is rotatably connected to the fixed base 210, and the difference is that a connecting arm 130 is provided between the clamp arm 110 and the fixed base 210, and when the driving shaft 220 moves relatively axially in the fixed base 210, the connecting arm 130 drives the clamp arm 110 to open or close relative to the fixed base 210. The difference is also that the clamp arm 110 is rotatably connected to the driving shaft 220.

[0098] See also Figure 31-Figure 33 , the elastic self-locking member 300 is arranged outside the driving shaft 220, the proximal end surface of the elastic self-locking member 300 is welded and fixed to the fixed base 210, and the distal end surface is welded and fixed to the driving shaft 220, so that the elasticity acts between the fixed base 210 and the driving shaft 220. In this embodiment, the elastic self-locking member 300 is a tension spring 310, and its initial state is a compressed state. When the driving shaft 220 is pushed to the distal end and the spring 310 is stretched, the clamp arm 110 of the valve clamping device 1000 is opened relative to the fixed base 210; when the driving shaft 220 is withdrawn to the proximal end, the spring 310 returns to the initial state of axial compression, and the clamp arm 110 of the valve clamping device 1000 is closed relative to the fixed base 210, so that the leaflet is clamped between the clamp arm 110, and the clamp arm 110 and the fixed base 210 are locked.

[0099] The structure of this embodiment has the following advantages: (1) no complicated self-locking mechanism is required; (2) the elastic self-locking member 300 provides an adaptive flexible clamping force; (3) it is light in weight; easy to operate; and has a simple structure.

[0100] In summary, according to the structural differences of the valve clamping device 1000, there are also large differences in the compression or tension deformation of the elastic self-locking part 300, 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 large differences. Different spring coefficient ranges can be selected according to the structural characteristics.

Claims

1. An adaptive valve clamping device, characterized in that: include: A clamping assembly, comprising a pair of openable and closable clamp arms; A transmission assembly, comprising a fixed base and a drive shaft movably disposed in the fixed base, each of the clamp arms being movably connected to the fixed base and the drive shaft, and the axial movement of the drive shaft drives the clamp arms to open or close relative to the fixed base; and, An elastic self-locking member is sleeved on the outer circumference of the driving shaft, and both ends of the elastic self-locking member in a natural state are located between the distal end of the fixed base and the proximal end of the driving shaft, and the elastic coefficient of the elastic self-locking member is in the range of 1.5-10N / mm; The clamp arm is rotatably connected to the fixed base, and the clamp arm is slidably connected or rotatably connected to the drive shaft. The fixed base includes a seat body and a tube body arranged at the proximal end of the seat body, the seat body is movably connected to the clamp arm, and a through axial hole for the drive shaft to pass through is provided in the seat body and the tube body, and the axial hole is provided with a step surface protruding inwardly, and one end of the elastic self-locking member abuts or is connected to the step surface, and the axial hole includes a first hole and a second hole that are connected, the diameter of the first hole is smaller than the diameter of the second hole, and a step surface is formed at the connection between the first hole and the second hole, and the elastic self-locking member is accommodated in the second hole.

2. The adaptive valve clamping device according to claim 1, characterized in that: The first hole and the second hole are opened sequentially from the proximal end to the distal end of the fixed base, and the elastic self-locking member is placed between the distal end of the driving shaft and the step surface.

3. The adaptive valve clamping device according to claim 1, characterized in that: The second hole and the first hole are opened sequentially from the proximal end to the distal end of the fixed base, and the elastic self-locking member is placed between the proximal end of the driving shaft and the step surface.

4. The adaptive valve clamping device according to claim 1, characterized in that: The elastic self-locking member is a spring, and the driving shaft is inserted into the spring.

5. The adaptive valve clamping device according to claim 1, characterized in that: The elastic self-locking member comprises a plurality of stacked spring sheets, and a through hole for the driving shaft to pass through is arranged in the middle of the spring sheets.

6. The adaptive valve clamping device according to claim 1, characterized in that: A support seat is provided at the distal end of the driving shaft, and one end of the elastic self-locking member abuts against or is connected to the support seat.

7. The adaptive valve clamping device according to claim 1, characterized in that: A boss is provided at the proximal end of the driving shaft, and one end of the elastic self-locking member abuts against or is connected to the boss.

8. The adaptive valve clamping device according to any one of claims 1 to 7, characterized in that: The clamping assembly also includes a pair of clamping arms, each clamping arm is arranged opposite to one of the clamp arms, one end of the clamping arm is connected to the fixed base, and the other end of the clamping arm opens and closes relative to the fixed base.

9. A valve clamping system, characterized in that: It comprises a conveying component and an adaptive valve clamping device as described in any one of claims 1 to 8, wherein the conveying component comprises a limiting tube and a pushing shaft movably installed in the limiting tube, the distal end of the pushing shaft is detachably connected to the proximal end of the driving shaft, and the distal end of the limiting tube is detachably connected to the proximal end of the fixed base.

10. The valve clipping system according to claim 9, characterized in that: The proximal end of the fixed base is provided with at least one clamping groove, and the distal end of the limiting tube is provided with a clamping piece that matches and corresponds to the shape of the clamping groove.

11. The valve clipping system according to claim 10, characterized in that: The free end of the locking piece is locked in the fixed base, and the depth of the locking piece in the fixed base is greater than the gap between the pushing shaft and the limiting tube.

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