CN219126881U - Valve clamping device with reliable locking and valve repair system - Google Patents

Abstract

The present application provides a reliably locked valve clasper device and valve repair system. The valve clasper device includes a fixed base, at least one pair of jawarms, a drive assembly, and a locking mechanism. Wherein, at least a pair of forceps arms are connected with the fixed base and can be opened and closed relative to the fixed base; the driving assembly comprises a driving shaft movably inserted into the fixed base, the driving shaft moves along the axial direction to drive the clamp arm to open and close relative to the fixed base, the outer peripheral surface of the driving shaft is provided with a positioning part, and the positioning part comprises a plurality of clamping grooves which are arranged at intervals; the locking mechanism comprises a locking piece and an elastic piece, and the locking piece is provided with a locking hole; the driving shaft is inserted into the locking hole, and the elastic piece can selectively push against the locking piece, so that the locking piece is obliquely arranged in the fixed base, and the edge of the locking hole is clamped in the clamping groove; the edge of the locking hole moves at least 0.01mm in the radial direction compared with the outer edge of the clamping groove; the ratio of the slot width of the clamping slot to the interval between two adjacent clamping slots is in the range of 0.5-2.0.

Description

Valve clamping device with reliable locking and valve repair system

Technical Field

The application relates to the field of interventional medical instruments, in particular to a valve clamping device with reliable locking and a valve repair system.

Background

The atrioventricular valves, such as mitral valve, tricuspid valve, are one-way valves within the heart that allow normal healthy atrioventricular valves to control blood flow from the atrium to the ventricle while avoiding blood flow from the ventricle to the atrium. For example: the mitral valve is a one-way valve located between the left atrium and the left ventricle of the heart that can control the flow of blood from the left atrium to the left ventricle while avoiding the flow of blood from the left ventricle to the left atrium; the tricuspid valve is a one-way valve located between the right atrium and right ventricle of the heart that controls the flow of blood from the right atrium to the right ventricle while avoiding the flow of blood from the right ventricle to the right atrium.

The mitral valve includes anterior and posterior lobes, and the tricuspid valve includes anterior, posterior and septal lobes. Normally, when the left or right ventricle contracts, the edges of any two adjacent leaflets of the mitral or tricuspid valve should be fully coaptated, avoiding blood flow from the ventricle to the atrium. If the mitral or tricuspid valve is not properly coaptated, the mitral or tricuspid valve cannot be fully closed when the left or right ventricle contracts, resulting in regurgitation of blood from the ventricle to the atrium, causing a series of pathophysiological changes known as "mitral regurgitation" or "tricuspid regurgitation.

The interventional valve clamping operation is based on the principle of valve edge-to-edge operation, and by implanting a valve clamping device into the atrioventricular valve such as the mitral valve, the tricuspid valve and the like, two valve leaflets which are originally ill-coaptated are pulled towards each other, and valve leaflet gaps are reduced or eliminated, so that regurgitation is treated.

Some existing valve clasper devices are provided with a locking mechanism to prevent premature opening of the valve clasper during delivery, or accidental opening during grasping of the leaflets, and valve clip detachment after implantation. However, the locking effect of the locking mechanism in the existing valve clamping device is not reliable, especially when the locking mechanism is applied to the edge-to-edge repair of the tricuspid valve leaflet, as the tricuspid valve regurgitation is mainly functional regurgitation and is usually accompanied by a certain degree of valve annulus expansion, larger valve She Zhangli can be continuously generated, and the valve She Zhangli can exert larger external force on the locking mechanism, so that higher requirements are placed on the locking reliability of the valve clamping device; in addition, since the leaflets of the tricuspid valve are weaker, the locking mechanism in the existing valve clamping device lacks sensitivity for locking the clamping angle, on one hand, the tricuspid valve leaflets are easily clamped by too much to cause perforation or tearing, on the other hand, the too much clamping can also aggravate the external force applied by the valve She Zhangli to the locking mechanism, and the risk of falling off the valve clamping device is increased.

Disclosure of Invention

In view of this, the present application provides a valve clasper device that can improve the reliability of the locking mechanism.

The application provides a valve clamping device with a locking mechanism, which comprises a fixed base, at least one pair of clamp arms, a driving assembly and the locking mechanism. The at least one pair of forceps arms are connected with the fixed base and can be opened and closed relative to the fixed base; the driving assembly comprises a driving shaft movably inserted into the fixed base, the driving shaft moves along the axial direction to drive the clamp arm to open and close relative to the fixed base, the outer circumferential surface of the driving shaft is provided with a positioning part, and the positioning part comprises a plurality of clamping grooves which are arranged at intervals; the locking mechanism comprises a locking piece and an elastic piece, and the locking piece is provided with a locking hole; the driving shaft is inserted into the locking hole, and the elastic piece can selectively prop against the locking piece, so that the locking piece is obliquely arranged in the fixed base, and the edge of the locking hole is clamped in the clamping groove; the edge of the locking hole is at least 0.01mm inward in the radial direction compared with the outer edge of the clamping groove; the ratio of the groove width of the clamping groove to the distance between two adjacent clamping grooves is in the range of 0.5-2.0.

The application also provides a valve repair system comprising a valve clamping device and a conveying device detachably connected with the valve clamping device, wherein the conveying device comprises an operation wire, and the distal end of the operation wire is detachably connected with the unlocking control piece.

According to the valve clamping device and the valve repair system, the clamping grooves are formed in the peripheral surface of the driving shaft at intervals, the driving shaft is inserted into the locking piece, the elastic piece abuts against the locking piece and is obliquely arranged in the fixed base, the edge of the locking hole is clamped in the clamping groove, compared with the outer edge of the clamping groove, the edge of the locking hole moves inwards by 0.01mm in the radial direction, the locking force is improved by utilizing the double effects of mechanical engagement and friction to realize firm locking of the driving shaft, even if the edge of the locking hole is worn due to friction, the elastic piece is adapted to further abut against the locking piece due to enough mechanical engagement between the clamping groove and the locking piece, and tighter engagement is formed between the locking piece and the clamping groove, so that the locking reliability of the locking mechanism is greatly improved; meanwhile, the ratio range of the groove width of the clamping groove to the interval between two adjacent clamping grooves is 0.5-2.0, when the edge of the locking hole is clamped at the position of the adjacent clamping grooves, the clamping angle of the clamp arm to the valve leaflet is changed slightly, the sensitivity of the locking mechanism to the locking control of the clamping angle is improved, and finally the valve leaflet can be clamped at a proper clamping angle, so that perforation or tearing caused by the fact that the tricuspid valve leaflet is clamped too tightly is avoided, and on the other hand, the valve clamping device is also beneficial to reducing the falling risk of the valve clamping device due to proper clamping.

Drawings

In order to more clearly illustrate the technical solutions of the examples of the present application, the drawings that are needed in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present application, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

Fig. 1 is a schematic perspective view of a valve repair system according to a first embodiment of the present application.

Fig. 2 is a side view of a valve clasper apparatus provided in accordance with a first embodiment of the present application.

Fig. 3 is a schematic perspective view of the stationary base, part of the drive assembly and locking mechanism of the valve clasper apparatus of fig. 1.

Fig. 4 is a side view of the stationary base, part of the drive assembly and locking mechanism of the valve clasping apparatus of fig. 3.

Fig. 5 is an enlarged view of the VII part in fig. 4.

Fig. 6 is a cross-sectional view corresponding to fig. 5, with the elastic member omitted and the unlocking control member.

Fig. 7 is a schematic perspective view of the drive shaft and the connecting seat of the valve clasping device of fig. 1.

FIG. 8 is an enlarged schematic view of a portion of the drive shaft of FIG. 7;

FIG. 9 is a schematic view of another configuration of a drive shaft and a clamping slot;

fig. 10 is a schematic perspective view of the locking member of fig. 5.

Fig. 11 is a schematic perspective view of the elastic member of fig. 5.

Fig. 12 is a schematic view showing a state in which the locking member is engaged with the locking groove on the driving shaft.

Fig. 13 is a schematic view of another embodiment of the locking element.

Fig. 14 is a schematic view showing a state in which the locking member shown in fig. 13 is engaged with the locking groove on the driving shaft.

Fig. 15 is a perspective view of an unlocked state of a locking mechanism of a valve clasping device in accordance with the first embodiment of the present application.

Fig. 16 is a side view of the unlocked state of the locking mechanism of the valve clasping device of the first embodiment of the present application.

Fig. 17 is an enlarged view of a portion XVI in fig. 16.

Fig. 18 is a schematic perspective view of the unlocking control of fig. 17.

Fig. 19 is a schematic perspective view of the fixing base, part of the driving assembly, and the locking mechanism and the clamping arm in fig. 1.

Fig. 20 is a schematic view of the valve clasper device of fig. 1 in one use configuration.

Fig. 21 is a schematic view of the valve clasper apparatus of fig. 1 in a closed configuration.

Fig. 22 is a schematic structural view of a valve clasper apparatus provided in accordance with a second embodiment of the present application.

Fig. 23 is a schematic structural view of a valve clasper apparatus provided in accordance with a third embodiment of the present application.

Detailed Description

The following description of the embodiments of the present application will be made clearly and fully with reference to the accompanying drawings, in which it is evident that the embodiments described are only some, but not all, of the embodiments of the present application. All other embodiments, which can be made by one of ordinary skill in the art based on the embodiments herein without undue burden, are within the scope of the present application.

Furthermore, the following description of the embodiments refers to the accompanying drawings, which illustrate specific embodiments that can be used to practice the present application. Directional terms referred to in this application, such as "upper", "lower", "front", "rear", "left", "right", "inner", "outer", "side", etc., are merely directions referring to the attached drawings, and thus, directional terms are used for better, more clear description and understanding of the present application, rather than indicating or implying that the apparatus or element being referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the present application.

In the description of the present application, it should be noted that, in the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; the axial direction refers to a direction parallel to the line connecting the distal center and the proximal center of the medical device in a natural state, the radial direction refers to a direction perpendicular or substantially perpendicular to the axial direction and along the radius or diameter of the device or element, and the circumferential direction refers to a direction around the axial direction. The term "proximal", "distal", "one end", "another end", "first end", "second end", "initial end", "terminal", "both ends", "free end", "upper end", "lower end", "connected end", and the like, is intended to refer to "an end" and is not limited to a tip, endpoint or end face, but includes a portion extending an axial distance and/or a radial distance from the tip, endpoint or end face onto the device or element to which the tip, endpoint or end face belongs.

Referring to fig. 1-7, a first embodiment of the present application provides a valve repair system comprising a valve clamping device 100 and a delivery device 500 detachably connected to the valve clamping device 100. The valve clasping apparatus 100 includes a fixed base 20, at least one pair of arms 40 hinged to the fixed base 20, a clip 60 disposed between the fixed base 20 and the arms 40, a drive assembly 70 for driving the arms 40 to open and close relative to the fixed base 20, and a locking mechanism 80 disposed within the fixed base 20. At least one pair of jawarms 40 are openable and closable relative to the fixed base 20. The clip 60 includes at least one pair of clip arms 64, each clip arm 64 being released to draw toward the clamp arm 40 and cooperate with the clamp arm 40 on a corresponding side to clip valve tissue therebetween.

Specifically, the driving assembly 70 includes a driving shaft 72 movably inserted into the fixed base 20, the driving shaft 72 moves in an axial direction to drive the jawarms 40 to open and close relative to the fixed base 20, a positioning portion 720 is disposed on an outer peripheral surface of the driving shaft 72, and the positioning portion 720 includes a plurality of clamping grooves 722 disposed at intervals. The locking mechanism 80 includes a locking member 82 and an elastic member 84, the locking member 82 is provided with a locking hole 820 along an axial direction, the driving shaft 72 is inserted into the locking hole 820, the elastic member 84 is obliquely disposed in the fixed base 20 against the locking member 82, so that an edge 821 of the locking hole 820 is clamped in the clamping groove 722, so that the driving shaft 72 and the fixed base 20 are relatively fixed, and the relative opening and closing between the jawarms 40 and the fixed base 20 are limited.

The conveying device 500 comprises a tube body assembly, an operation wire 501 and a control wire 801, wherein the operation wire 501 and the control wire 801 are arranged in the tube body assembly in a penetrating mode, the operation wire 501 is connected with the clamping arm 64, the control wire 801 is connected with the locking mechanism 80, and the operation wire 501 and the control wire 801 extend out of a patient body respectively. In use, the proximal end of the valve clasper device 100 is releasably connected to the distal end of the tube assembly, and the two clamping arms 64 of the valve clasper device 100 are pulled up to be relatively close by the operating wire 501 (as shown in fig. 19), with the resilient member 84 disposed obliquely to the fixed base 20 against the locking member 82 such that the edge 821 of the locking aperture 820 is snapped into the snap groove 722, limiting relative movement between the drive shaft 72 and the fixed base 20 and thus locking relative movement between the clamp arm 40 and the fixed base 20; then the locking piece 82 is pulled by the control wire 801 for a long distance, so that the edge 821 of the locking hole 820 and the driving shaft 72 can move relatively, at the moment, the locking piece 82 applies pressure to the elastic piece 84 to enable the elastic piece 84 to bend and deform, then the driving shaft 72 is operated to enable the clamp arm 40 to be folded to the outer surface of the fixed base 20, the locking piece 82 is released again, the elastic piece 84 is restored to an initial state and is propped against the locking piece 82 to be obliquely arranged on the fixed base 20, the edge 821 of the locking hole 820 is clamped in the clamping groove 722, and the clamp arm 40 and the fixed base 20 are locked; after that, the valve clamping device 100 can be pushed to the tricuspid valve or the mitral valve of the patient, the locking mechanism 80 is unlocked again to the driving shaft 72 after being adjusted to a proper position, and the driving shaft 72 is operated to open the clamp arms 40 relative to the fixed base 20; then, the pulling force of the operation wire 501 on the two clamping arms 64 is released, the clamping arms 64 rebound and move towards the clamp arms 40 so as to clamp the valve She Yaxiang clamp arms 40, when two adjacent valve leaflets of the mitral valve or tricuspid valve are clamped together by the clamp arms 40 and the corresponding clamping arms 64 respectively, the clamping of the locking piece 82 to the driving shaft 72 is released, the driving shaft 72 is operated so that the clamp arms 40 are closed relative to the fixed base 20 so as to pull the two adjacent valve leaflets towards each other, then the connection between the tube assembly and the valve clamping device 100 is released, the conveying device 500 is withdrawn, and the valve clamping device 100 is used as an implant to remain in a patient so as to keep the involuted positions of the valve leaflets together, so that the 'edge-to-edge repair' of the mitral valve or tricuspid valve is realized, and the mitral regurgitation or tricuspid valve regurgitation of the patient is relieved.

Notably, given that tricuspid regurgitation is primarily functional regurgitation, often accompanied by a degree of valve annulus dilation, there is a continuing need for a more reliable lock to produce larger petals She Zhangli; and because the valve leaflet of the tricuspid valve is more fragile, the clamping angle needs to be sensitively locked, as shown in fig. 7, 8 and 12, in order to be suitable for edge-to-edge repair of the tricuspid valve, the application particularly sets the edge 821 of the locking hole 820 to be at least 0.01mm (denoted by C1 and C2 in fig. 12) radially inward compared with the outer edge E of the clamping groove 722, and the ratio of the groove width a of the clamping groove 722 to the interval B between two adjacent clamping grooves 722 ranges from 0.5 to 2.0.

Since the outer circumferential surface of the driving shaft 72 of the valve clamping device 100 is provided with the clamping groove 722, the driving shaft 72 is inserted into the locking hole 820 of the locking piece 82, the elastic piece 84 is obliquely arranged in the fixed base 20 against the locking piece 82, so that the edge 821 of the locking hole 820 is clamped in the clamping groove 722, the clamping groove 722 on the driving shaft 72 and the edge of the locking hole 820 have a clamping amount of at least 0.01mm, the locking force is improved by the double effects of mechanical clamping and friction to realize firm locking of the driving shaft 72, and the clamping force is tightly clamped under the action of stress; meanwhile, since the edge of the locking hole 820 moves at least 0.01mm in the radial direction compared with the outer edge of the locking groove 722, even if the edge of the locking hole 820 is worn due to friction, the elastic member 84 adaptively further abuts against the locking member 82 due to a sufficient mechanical engagement amount between the locking groove 722 and the locking member 82, and a tighter engagement is formed between the locking member 82 and the locking groove 722, thereby greatly improving the locking reliability of the locking mechanism 80. In addition, the ratio of the groove width of the locking groove 722 to the interval between two adjacent locking grooves 722 is set to be in the range of 0.5-2.0, when the edge of the locking hole 820 is clamped between the two adjacent locking grooves 722 in a position changing manner, the change of the clamping angle of the clamp arm 40 to the valve leaflet is small, the sensitivity of the locking mechanism 80 to lock and control the clamping angle is improved, finally the valve leaflet can be clamped at a proper clamping angle, on one hand, perforation or tearing caused by the fact that the tricuspid valve leaflet is clamped too tightly is avoided, and on the other hand, the proper clamping also helps to reduce the risk of falling off of the valve clamping device.

Preferably, the inner diameter of the locking hole 820 of the locking piece 82 may be appropriately increased, and after the driving shaft 72 is inserted into the locking hole 820, a gap between the outer circumferential surface of the driving shaft 72 and the inner surface of the locking hole 820 may be increased; therefore, the outer peripheral surface of the driving shaft 72 and the inner surface of the locking hole 820 can be prevented from interfering with each other due to the overall displacement of the locking member 82 during unlocking of the locking member 82.

As shown in fig. 3 and 4, in the present embodiment, the valve clamping device 100 includes a pair of clamp arms 40 disposed opposite to each other, and each clamp arm 40 can be opened and closed relative to the fixed base 20. Each of the jawarms 40 includes a connecting frame 42 and a clamping frame 44 connected to an end of the connecting frame 42 away from the fixed base 20, and the connecting frames 42 of the two jawarms 40 are hinged to the fixed base 20 after being stacked on each other at the end of the connecting frame 42 away from the clamping frame 44. A leaflet receiving space is formed between the clamping arm 64 and the jawarm 40; specifically, the surface of each clamp arm 40 facing the clamp arm 64 is recessed inward to form a receiving groove 45, so that in the delivery state of the valve clamping device 100, the clamp arms 64 are at least partially received in the receiving grooves 45 of the clamp arms 40 to reduce the outer diameter and volume of the valve clamping device 100, facilitating delivery in vivo. After the clamping arms 40 and the clamping arms 64 are matched to clamp the valve leaflet, the valve leaflet is clamped in the accommodating groove 45, so that the contact area between the clamping arms 40 and the valve leaflet can be increased, and the valve leaflet is pressed into the accommodating groove 45 of the clamping arms 40 by the clamping arms 64, so that the clamping force on the valve leaflet 300 can also be increased.

The clamp arms 40 are driven by the driving component 70 to open and close relative to the fixed base 20, and the included angle between the two clamp arms 40 can reach 300 degrees at maximum, namely, after the clamp arms 40 are opened relative to the fixed base 20, a certain degree of downward overturning can be realized, so that the clamp arms are beneficial to clamping a valve in motion, the success rate of clamping is improved, and after clamping, if an undesirable effect is found, the clamp arms 40 can be overturned downwards to loosen the valve leaflet, and the clamp is clamped again. In this embodiment, the angle between the two jawarms 40 in the open position is preferably in the range of 0-240 degrees, more preferably 120-180 degrees. In the closed position, the included angle between the two jawarms 40 (which may be referred to as the clamping angle) is preferably in the range of 0-60 degrees, more preferably 5-45 degrees.

The drive assembly 70 further includes a connecting seat 74 disposed at the distal end of the drive shaft 72 and a pair of links 76 movably coupled to opposite sides of the connecting seat 74. The driving shaft 72 movably passes through the fixed base 20 and is connected to the connection seat 74. One end of each link 76 is connected to a corresponding one of the jawarms 40 and the other end is pivotally connected to the link 74, i.e., each jawarms 40 is pivotally connected to the link 74 of the drive assembly 70 via a link 76 on a respective side.

In this embodiment, one end of the connecting frame 42 of each jawarm 40 far from the clamping frame 44 is rotatably connected to the same position of the fixed base 20, and the portion of the connecting frame 42 of each jawarm 40 near to the clamping frame 44 is rotatably connected to the proximal end of the connecting rod 76 on the corresponding side, and the distal end of the connecting rod 76 is rotatably connected to the connecting seat 74 on the distal end of the driving shaft 72 by means of pins or bolts. When the drive shaft 72 is slid distally in an axial direction relative to the fixed base 20, the link 76 is moved, and the jawarms 40 are pivoted about the pin holes to open relative to the fixed base 20 by the pulling of the link 76. As the drive shaft 72 slides proximally in an axial direction relative to the fixed base 20, the linkage 76 pulls the jawarms 40 to rotate about the pin holes to close relative to the fixed base 20.

The connecting seat 74 and the driving shaft 72 may be of an integral structure or a non-integral structure. In this embodiment, the driving shaft 72 is a round rod body, and an external thread is provided at the distal end of the round rod body, and the driving shaft 72 is screwed with the connecting seat 74 and then welded and fixed. In other embodiments, the drive shaft 72 may be fixedly coupled to the connection base 74 by other removable or non-removable couplings such as a snap fit. The diameter d of the drive shaft 72 has a value in the range of 0.5 to 1.0mm, preferably 0.65 to 0.85mm. The material of the drive shaft 72 may be stainless steel, cobalt chrome alloy, nickel titanium alloy, etc., with cobalt chrome alloy being preferred in this embodiment. The surface hardness of the drive shaft 72 is preferably 300-1000HV, and more preferably 350-800HV, which is a hardness range that ensures that the surface of the drive shaft 72 is not easily scratched and that avoids embrittlement of the drive shaft 72, thereby achieving high locking strength and fatigue resistance. The drive shaft 72 may also be further enhanced in hardness and wear resistance by surface treatments such as nitriding, ceramic coating, and the like.

Specifically, the outer peripheral surface of the driving shaft 72 is provided with a positioning portion 720, the positioning portion 720 includes a plurality of radially inward recessed clamping grooves 722 opposite to the outer peripheral surface of the driving shaft 72, and the edges 821 of the locking holes 820 are embedded into the corresponding clamping grooves 722, so that the two functions similar to mechanical engagement, and locking stability is ensured.

The shape of the clamping groove 722 may be a semicircle, a rectangle, a trapezoid or a triangle, as shown in fig. 8, the clamping groove 722 of the embodiment has a triangular clamping groove structure, the clamping groove 722 includes two opposite inclined annular surfaces P1, P2, and the edges 821 of the two opposite inclined annular surfaces P1, P2, which are arranged as the locking holes 820, provide a larger clamping area, which is beneficial to improving the firmness of the clamping.

The width a of the card slot 722 should be sized in the range of 0.02-0.20 mm, preferably 0.05-0.10 mm. Too small a width a of the clamping groove 722 cannot guarantee the amount of overlap of the edge 821 of the locking hole 820 embedded therein, and too large a width a affects the locking sensitivity of the valve clamping device. In this embodiment, each of the clamping grooves 722 is disposed in a circle along the circumferential direction of the driving shaft 72, and a plurality of clamping grooves 722 are axially arranged at the distal end of the driving shaft 72. Preferably, in the present embodiment, a plurality of the clamping grooves 722 are arranged in parallel, that is, arranged along the axial direction of the driving shaft 72, and any of the clamping grooves 722 is perpendicular to the axial direction of the driving shaft 72. Further, the distance B between two adjacent clamping grooves 722 is in the range of 0.04-0.16 mm, preferably 0.05-0.12 mm, if the value of B is too small, it is difficult to ensure the locking strength, and if the value of B is too large, the gradient of the clamping angle of the valve clamping device will be increased (i.e. the corresponding clamping angle changes too much every one clamping groove 722), so as to reduce the locking sensitivity. On this basis, the ratio of the groove width a of the clamping groove 722 to the interval B between two adjacent clamping grooves 722 is further set to be in the range of 0.5-2.0, more preferably 0.8-1.6, so that when the edge of the locking hole 820 is clamped between two adjacent clamping grooves 722 in a position changing manner, the change of the clamping angle of the clamp arm 40 to the valve leaflet is small, the sensitivity of the locking mechanism 80 to lock and control the clamping angle is improved, and finally the valve leaflet can be clamped at a proper clamping angle.

As shown in fig. 7, the plurality of the clamping grooves 722 may have a uniform distribution density in the axial direction on the driving shaft 72, and more preferably, the plurality of clamping grooves may have different distribution densities in the sectional areas. Specifically, the driving shaft 72 includes a first section 721 and a second section 723 sequentially from a proximal end to a distal end thereof, wherein the distribution density of the clamping grooves 722 on the second section 723 is greater than the distribution density of the clamping grooves 722 on the first section 721. The axial length H1 of the first section 721 is about 1.0-3.0 mm, the distribution of the clamping grooves 722 in the section is sparse, for example, the ratio of the groove width a of the clamping groove 722 to the spacing B between two adjacent clamping grooves 722 is 1.2-1.6, and the corresponding clamping angle is about 20-45 degrees when the locking member 82 is clamped with the different clamping grooves 722 in the section. The second section 723 has a corresponding axial length H2 of about 0.4-2.0 mm, and the clamping grooves 722 are densely distributed in the section, for example, the ratio of the groove width a of the clamping groove 722 to the spacing B between two adjacent clamping grooves 722 is 0.8-1.2, and the corresponding clamping angle is about 0-20 degrees when the locking member 82 is engaged with the different clamping grooves 722 in the section. On the second section 723, there is a small variation in the corresponding clamping angle with each slot 722, and the lock sensitivity is high, so that a proper flap She Gage effect is easily obtained.

As shown in fig. 8, the depth T of the slot 722 is in the range of 0.02 mm to 0.10 mm, preferably 0.03mm to 0.06 mm. The value of T should be reasonably set so as not to affect the amount of engagement of the edges of the locking aperture 820 with the detents 722 nor to weaken the overall strength of the drive shaft 72.

As shown in fig. 3 to 6, the fixing base 20 includes a rectangular fixing frame 21, a connecting block 22 disposed at a proximal end of the fixing frame 21, clamping blocks 23 disposed at opposite sides of the fixing frame 21, and a boss 25 disposed in an inner cavity of the fixing base 20. The fixing base 20 is provided with a through hole 24 penetrating the connection block 22 and the fixing frame 21 in the axial direction, and the through hole 24 is used for inserting the driving shaft 72. The opposite ends of the connecting block 22 are respectively provided with a pin hole 26, the axial lead of the pin hole 26 is mutually perpendicular to the axial lead of the through hole 24, and the pin hole 26 is used for being connected with the connecting part 42 of the clamp arm 40 through pins. The boss 25 is disposed on one side wall of the inner cavity of the fixed frame 21, a slope 251 is disposed at a proximal end of the boss 25, a first end 823 of the locking member 82 abuts against the boss 25, a gap 826 is formed between a second end 825 of the locking member 82 and the inner cavity of the fixed base 20, so that the second end 825 of the locking member 82 rotates along the first end 823, and the locking member 82 is prevented from interfering with the fixed base 20 during unlocking, thereby affecting the unlocking effect. The locking piece 82 of the application is lapped on the surface of the boss 25 of the fixed base 20, so that the pulling force required for unlocking can be reduced. A first rounded corner 253 is provided between the proximal end of the inclined surface 251 and the inner surface of the fixed frame 21, and a second rounded corner 255 is provided between the distal end of the inclined surface 251 and the side of the boss 25. Specifically, the first end 823 of the locking member 82 overlaps the first rounded corner 253, when the first end 823 of the locking member 82 abuts against the inclined surface 251, the elastic member 84 abuts against the proximal end surface of the locking member 82 so that the distal end surface of the first end 823 abuts against the inclined surface 251, the locking member 82 is inclined to the driving shaft 72, and the locking hole 820 of the locking member 82 is clamped to the clamping groove 722 of the driving shaft 72, so that the driving shaft 72 and the fixing base 20 are relatively fixed.

As shown in fig. 10 and 15 to 17, in the present embodiment, the locking member 82 is a plate structure, and the locking member 82 includes a first end 823 and a second end 825 opposite to each other, the first end 823 abuts against the inner cavity of the fixed base 20, and the second end 825 can rotate around the first end 823 until the axis of the locking hole 820 is coaxial with the axial direction of the fixed base 20, so as to facilitate the driving shaft 72 to move along the axial direction. When the locking member 82 is inclined relative to the driving shaft 72, such that the edge 821 of the locking hole 820 is clamped to the clamping groove 722 of the driving shaft 72, the axial line of the locking hole 820 is inclined to the axial direction of the fixed base 20, the elastic member 84 abuts against the proximal end surface of the locking member 82, and the locking member 82 defines the driving shaft 72 to move in the axial direction; when the second end 825 of the lock member 82 is rotated about the first end 823 until the axial line of the locking hole 820 is coaxial or parallel with the axial direction of the fixed base 20, the lock member 82 releases the locking of the drive shaft 72, and at this time, the drive shaft 72 can move in the axial direction within the locking hole 820.

As shown in fig. 4, 5 and 11, the elastic member 84 includes a first side 841 and a second side 843 opposite to each other, the first side 841 abuts against the inner wall of the fixed base 20, and the second side 843 abuts against the proximal end surface of the locking member 82. The elastic member 84 elastically abuts against the locking member 82 to enable the locking member 82 to incline relative to the driving shaft 72, so as to ensure that the edge 821 of the locking hole 820 is clamped with the clamping groove 722 of the driving shaft 72. Specifically, the elastic member 84 is a sheet structure made of an elastic material, and the elastic member 84 further includes a middle portion connected between the first side 841 and the second side 843, and the middle portion of the elastic member 84 is bent proximally and gradually abuts against the inner wall of the fixing base 20 to provide the elastic member 84 with stable elastic force. In the initial state, the elastic member 84 is in a bent deformed state, thereby restricting the proximal movement of the locking member 82. The first side 841 of the elastic member 84 is provided with a clamping piece 845, and a connecting groove 27 communicating with the inner cavity of the fixing frame 21 is formed at the proximal end of the inner wall of the fixing frame for fixing the elastic member 84, and the connecting groove 27 is closer to the proximal end than the boss 25 so that the elastic member 84 bends and abuts against the locking member 82. The locking piece 845 of the elastic member 84 is locked in the connecting slot 27 of the fixed base 20, so that the elastic member 84 is fixedly connected to the fixed base 20, and the elastic member 84 is prevented from being deflected. The middle portion of the elastic member 84 is axially provided with a through hole 846, and the driving shaft 72 is axially inserted into the through hole 846. In this application, since only one side of the elastic member 84 abuts against the proximal end surface of the locking member 82, the resistance to be overcome to press the elastic member 84 is small, i.e., the pulling force required for unlocking is small. It is understood that in other embodiments, the first side 841 of the resilient member 84 may be directly snapped, welded or glued to the inner wall of the stationary base 20.

As shown in fig. 5 and 12, in the present embodiment, when the elastic member 84 elastically abuts against the locking member 82 to enable the locking member 82 to incline relative to the driving shaft 72, the edge 821 of the locking hole 820 is clamped to two adjacent clamping grooves 722 to form two clamping parts, wherein one clamping part (the clamping part located at the upper side as shown in fig. 12) is positioned at one clamping part, the edge 821 of the locking hole 820 moves inward by C1 in the radial direction (i.e. the clamping amount of the locking hole 820 and the clamping groove 722 is C1) compared with the outer edge E of the clamping groove 722, and the other clamping part (the clamping part located at the lower side as shown in fig. 12) moves inward by C2 in the radial direction compared with the outer edge E of the clamping groove 722 (i.e. the clamping amount of the locking hole 820 and the clamping groove 722 is C2), wherein the value range of C1 is preferably 0.01-0.03mm, and the value range of C2 is preferably 0.01-0.04mm, on the one hand, the clamping amount is ensured to be sufficient, and the locking reliability is ensured; on the other hand, even if the edge 821 of the locking hole 820 is worn by friction, the elastic member 84 adaptively further abuts against the locking member 82 due to a sufficient mechanical engagement amount greater than 0.01mm between the locking groove 722 and the locking member 82, so that a tighter engagement can be formed between the locking member 82 and the locking groove 722, thereby improving the locking reliability and breaking through the defect that the existing locking mechanism cannot be locked after wear occurs.

Specifically, referring to fig. 12, in order to ensure that two adjacent clamping grooves 722 can be simultaneously clamped in the inclined state of the locking member 82, the following relationship should be satisfied:

(B+A/2)≤Dsinθ≤(B+A3/2)

where D denotes the aperture of the locking hole 820, θ denotes the inclination angle of the locking piece 82, a denotes the groove width of the locking groove 722, and B denotes the pitch between two adjacent locking grooves 722. The inclination angle θ of the locking member 82 is an angle of an included angle between the locking member 82 and a cross section of the driving shaft 72 perpendicular to the axial direction, the value of θ ranges from 3 to 20 degrees, more preferably from 5 to 15 degrees, an excessively large value of θ causes an increase in unlocking force, and an excessively small value of θ causes an insufficient locking strength.

Referring to fig. 9, in other embodiments, the clamping grooves 722 may be inclined relative to the axial direction of the driving shaft 72 but are parallel to each other. The inclination angle of the locking groove should be smaller than the inclination angle of the locking piece 82 relative to the axial direction of the driving shaft 72 when locking, so as to obtain two locking parts, and the upper side and the lower side of the locking hole 820 of the locking piece 82 can be simultaneously locked in one inclined locking groove 722. The spacing between two adjacent slots 722 may be smaller, so that the valve clamping device 100 may have less variation in the clamping angle and higher sensitivity to locking when one slot 722 is locked at each interval.

Referring to fig. 13 and 14, in other embodiments, the edge of the locking hole 820 may be provided with a chamfer 827, so that the clamping contact between the locking hole 820 and the clamping groove 722 is changed from line contact to surface contact, which can reduce the contact stress, delay the abrasion of the edge of the locking hole 820, further improve the locking stability, and increase the friction between the locking hole 820 and the clamping groove 722.

Referring to fig. 3-5 and fig. 15-19, the locking mechanism 80 further includes an unlocking control member 86, wherein the unlocking control member 86 in the present embodiment is a one-sided unlocking, and the one-sided unlocking means that the unlocking control member 86 is connected to a single side (second end 825) of the locking member 82. Specifically, the unlocking control member 86 is connected to the second end 825 of the locking member 82, and pulling the unlocking control member 86 proximally causes the second end 825 of the locking member 82 to rotate proximally about the first end 823, and the elastic member 84 elastically deforms, such that the outer circumferential surface of the driving shaft 72 is spaced from the locking hole 820 and the through hole 846 of the elastic member 84, and the driving shaft 72 can move in the axial direction. When the pulling force on the unlocking control member 86 is released, the elastic member 84 returns to the initial state to push the second end 825 of the locking member 82 to rotate distally about the first end 823 until the locking member 82 is locked to the positioning portion 720 of the driving shaft 72, so that the driving shaft 72 is relatively fixed to the fixed base 20.

In this embodiment, the unlocking control member 86 includes a double-wire structure that is sleeved on the second end 825 of the locking member 82. Specifically, the two-wire structure is disposed side by side and is sleeved on the second end 825 of the locking member 82. Each of the two-wire structures includes a connecting section 862 connected to the second end 825 of the locking member 82, and an extending section 864 extending proximally from opposite ends of the connecting section 862, the connecting section 862 and the extending section 864 enclosing a U-shaped structure disposed at the second end 825; the proximal end of each extension 864 is integrally connected to the proximal end of an adjacent extension 864 by an arcuate coupling segment 866. The unlocking control 86 in this embodiment is made of nickel titanium wire by heat setting and stainless steel sleeve crimping.

To facilitate remote control of the unlocking control 86 outside the body, the proximal end of the unlocking control 86 is detachably connected to the control wire 801. The distal end of control wire 801 extends outside the patient through the tube assembly of delivery device 500. The control wire 801 is generally made of a polymer material. In this embodiment, the control wire 801 is a double-wire structure that is U-shaped and passes through the unlocking control member 86, that is, a gap is provided between two adjacent extension sections 864 of the double-wire structure adjacent to the combining section 866, and the control wire 801 sequentially passes through the two gaps.

As shown in fig. 1, 2, and 19 to 21, the clip 60 is at least partially made of a material having a shape memory function, and is subjected to a heat setting process. When in manufacture, the shape memory material is cut into a required shape by a laser cutting mode, and then is placed in a die and subjected to heat setting at about 550 ℃ to form the shape memory material into a specific shape. In a natural state, the clamping arms 64 on both sides of the clamping member 60 are radially extended outward from the connection frame 62.

Preferably, the angle between the two clamping arms 64 in the naturally unfolded state should be slightly larger than the angle between the two clamping arms 40, i.e. the angle between the length direction of the clamping arms 64 and the axial direction of the fixed base 20 is larger than or equal to the angle between the clamping arm 40 and the fixed base 20 when the clamping arm 40 corresponding to that side is fully unfolded relative to the fixed base 20, so that the free end of each clamping arm 64 and the corresponding clamping arm 40 are close to each other and have a certain clamping force to provide a more stable clamping force. Specifically, in the present embodiment, the angle between the length direction of the clamping arms 64 and the axial direction of the fixed base 20 is in the range of 0-150 degrees, i.e. the angle between the two clamping arms 64 can reach 300 degrees at maximum in a natural state, and is preferably 160-200 degrees. In this embodiment, the clip 60 is made entirely of superelastic nickel-titanium alloy.

In this embodiment, two opposite side walls of the connection frame 62 are respectively provided with a clamping groove 622 (as shown in fig. 19) for being matched and clamped with the clamping block 23 of the fixed base 20. The shape of the clamping groove 622 can be rectangular, elliptic, prismatic or other, and the embodiment is preferably rectangular, so that the matching stability is higher. The fixed base 20 is accommodated in the inner cavity of the connecting frame 62, and the driving shaft 72 is inserted into the fixed base 20 and the connecting frame 62 through the proximal opening of the connecting frame 62. The connecting frame 62 can prevent the fixed base 20 from moving left and right after being matched with the fixed base 20, namely, plays a role of left and right limiting; the clamping block 23 and the clamping groove 622 are mutually buckled to prevent the clamping piece 60 and the fixed base 20 from moving forwards and backwards, i.e. play a role of front and rear limiting.

As shown in fig. 19 and 20, the free end of each clamping arm 64 is provided with a wire hole 644 for connecting the operation wire 501 of the delivery device 500, and the free end of the clamping arm 64 can be controlled by the operation wire 501 extending outside the patient. In the transport state, the free end of the clamp arm 64 is pulled by the operation wire 501 and is attached to the surface of the fixed base 20; and after releasing the control of the free end by the operating wire 501, the holding arm 64 is released, the holding arm 64 is restored to a natural state due to its own elastic memory property, and the valve tissue is pressed toward the clamp arm 40. The operation wire 501 may be a wire made of nitinol or the like.

To ensure safety after implantation, the fixed base 20 and the clamp arm 40 are respectively made of biocompatible metal materials such as stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy or nickel-titanium alloy; the driving assembly 70 is made of biocompatible polymer materials or metal materials such as polyester, silicone, stainless steel, cobalt alloy, cobalt-chromium alloy or titanium alloy. In this embodiment, the fixed base 20, the jawarms 40 and the drive assembly 70 are all made of stainless steel. The locking member 82 and the elastic member 84 are also made of biocompatible materials, and the locking member 82 is preferably made of stainless steel or cobalt-chromium alloy with high hardness, and the elastic member 84 is made of nickel-titanium alloy with elasticity.

Referring to fig. 22, a valve clamping device 100b according to a second embodiment of the present application has a similar structure to the valve clamping device 100 according to the first embodiment, except that: the valve clasper device 100b in the third embodiment further includes an adjustment member 90, the adjustment member 90 being disposed around the exterior of the fixed base 20; when the valve clamping device 100b clamps a valve, the adjusting member 90 is elastically clamped between the pair of clamping arms 64, and the adjusting member 90 is used for adjusting the pulling degree of the valve tissue at both sides when the pair of forceps arms 40 are closed.

In this embodiment, the adjusting member 90 is made of an elastic material, the distal end of the adjusting member 90 is fixedly connected to the fixed base 20, and the proximal end of the adjusting member 90 is suspended. Specifically, the adjustment member 90 includes a first end 91 and a second end 93 disposed opposite the first end 91, the first end 91 being located at a proximal end of the adjustment member 90 and the second end 93 being located at a distal end of the adjustment member 90. Wherein the first end 91 is an open end, and the second end 93 is folded by the sealing head. The seal head of the second end 93 is fixed to the fixing base 20 by welding, bonding, screwing, crimping, locking by bolts, or other common detachable or non-detachable connection methods, and in this embodiment, a welded connection is adopted.

The regulator 90 comprises a resilient body which fills between the anterior and posterior leaflet of the clamped mitral valve and abuts against the jawarms 40 when the valve clamping device 100b is closed, thus providing the following advantages: (1) The elastic body has a buffering effect on the beating valve leaflet, so that the traction degree of the valve clamping device 100b on the valve leaflet can be adjusted to avoid damaging the valve leaflet; (2) The elastic body can be extruded and deformed along with the pulsation of the valve leaflet, and the generated elastic force pushes the part of the valve leaflet close to the elastic body to a direction away from the fixed base 20, so that the clamping angle between the anterior leaflet and the posterior leaflet of the mitral valve is smaller than the opening angle between the forceps arms 40, the traction of the valve clamping device 100b on the valve leaflet can be reduced, and the traction degree of the valve clamping device 100b on the valve leaflet is always kept within a reasonable range; (3) The elastic body can buffer the direct scouring of blood flow to the inside of the valve clamping device 100b, so that the valve clamping device 100b is prevented from falling off due to continuous scouring of blood, and thrombus can be prevented from being formed by blood accumulation at dead corners between clamping parts of the valve clamping device 100 b; (4) When the elastic body is acted by the pressure of the valve, the elastic body can deform to a certain extent, and the deformation degree is increased along with the increase of the pressure, so that the elastic body is prevented from being reversely acted on the forceps arms 40 by the extrusion force of the forceps arms 40 after the valve is grasped, and the grasping effect of the valve clamping device 100b on the valve is ensured to be consistent with that before the valve is released

Referring to fig. 23, a third embodiment of the present application provides a valve clamping device 100c similar to the valve clamping device 100b provided in the second embodiment, except that: the outer and/or inner portions of the adjustment member 90, the clamping arm 64 and/or the jawarm 40 are provided with a biocompatible mesh film 92. The mesh film 92 is a woven mesh structure having a plurality of openings. Wherein, the adjusting member 90 with the reticular membrane 92 not only can increase biocompatibility, avoid tissue allergy and inflammatory reaction and improve product safety, but also can form an artificial barrier on the atrial side of the valve leaflet to block thrombus in blood, close the opening of the whole valve clamping device 100c towards the atrial side, and avoid repeated scouring of blood at the inner dead angle of the valve clamping device 100c to form thrombus, thereby avoiding thrombus.

The mesh film 92 may be made of a polymer material such as polyethylene terephthalate, polypropylene, polytetrafluoroethylene, polyurethane, etc., and the mesh film material covering the outside and/or inside of the adjusting member 90, the holding arm 64, and the jawarms 40 may be the same or different, and in this embodiment, all three are made of PET and all cover the outside of the adjusting member 90, the holding arm 64, and the jawarms 40.

The foregoing is a description of embodiments of the present application, and it should be noted that, for those skilled in the art, several improvements and modifications can be made without departing from the principles of the embodiments of the present application, and these improvements and modifications are also considered as the protection scope of the present application.

Claims (14)

1. A valve clasper apparatus, comprising:

a fixed base;

the at least one pair of clamp arms are connected with the fixed base and can open and close relative to the fixed base;

the driving assembly comprises a driving shaft movably inserted into the fixed base, the driving shaft moves along the axial direction to drive the clamp arm to open and close relative to the fixed base, the outer circumferential surface of the driving shaft is provided with a positioning part, and the positioning part comprises a plurality of clamping grooves which are arranged at intervals; and

the locking mechanism comprises a locking piece and an elastic piece, wherein the locking piece is provided with a locking hole;

the driving shaft is inserted into the locking hole, and the elastic piece can selectively prop against the locking piece, so that the locking piece is obliquely arranged in the fixed base, and the edge of the locking hole is clamped in the clamping groove;

the edge of the locking hole is at least 0.01mm inward in the radial direction compared with the outer edge of the clamping groove; the ratio of the groove width of the clamping groove to the distance between two adjacent clamping grooves is in the range of 0.5-2.0.

2. The valve clasper of claim 1 wherein a plurality of said detents are disposed in parallel, any of said detents being perpendicular or oblique to the axial direction of said drive shaft.

3. The valve clasper of claim 2 wherein the drive shaft comprises a first section and a second section in sequence from a proximal end thereof to a distal end thereof; wherein the distribution density of the clamping grooves on the second section is greater than the distribution density of the clamping grooves on the first section.

4. The valve clamping device of claim 1, wherein edges of the locking hole are snapped into two snap-fit locations formed in adjacent two of the snap-fit slots.

5. The valve clasper of claim 4 wherein the aperture of the locking aperture, the angle of inclination of the locking member, the slot width of the slot and the spacing between adjacent slots satisfy the following relationship:

(B+A/2)≤Dsinθ≤(B+A3/2)

wherein D represents the aperture of the locking hole, theta represents the inclination angle of the locking piece, A represents the groove width of the clamping groove, and B represents the interval between two adjacent clamping grooves.

6. The valve clamping device of any one of claims 1-5, wherein an edge of the locking aperture is provided with a chamfer.

7. The valve clamping device of claim 1, wherein the locking member includes opposite first and second ends, the inner cavity of the fixation base being provided with a boss, the first end of the locking member abutting the boss, a gap being provided between the second end of the locking member and the inner cavity of the fixation base, the second end being rotatable about the first end until an axis of the locking aperture is coaxial with an axis of the fixation base.

8. The valve clamping device of claim 1, wherein the resilient member includes opposing first and second sides, the first side abutting an inner wall of the fixation base and the second side abutting a proximal surface of the locking member.

9. The valve clasper of claim 8 wherein said resilient member further comprises a central portion connected between said first side and said second side, said central portion being proximally curved and abutting an inner wall of said fixed base; the middle part of the elastic piece is provided with a through hole along the axial direction, and the driving shaft is inserted into the through hole along the axial direction.

10. The valve clasper of claim 7, wherein the locking mechanism further comprises an unlocking control, the unlocking control coupled to the second end of the locking member, and wherein pulling the unlocking control proximally causes the second end of the locking member to rotate about the first end.

11. The valve-clamping device of claim 1, further comprising at least one pair of clamping arms disposed between the fixed base and the at least one pair of clamp arms, each of the clamping arms cooperating with a corresponding one of the clamp arms to clamp the valve.

12. The valve clasper of claim 11, further comprising an adjustment member that is disposed about an exterior of the fixed base; the regulating member is made of an elastic material.

13. The valve clamping device of claim 12, wherein the outer and/or inner portions of the adjustment member, the clamping arm and/or the clamp arm are provided with a biocompatible mesh membrane.

14. A valve repair system comprising the valve clasper device of any one of claims 1-13, further comprising a delivery device removably coupled to the valve clasper device, the delivery device comprising an operating wire, a distal end of the operating wire being removably coupled to the unlocking control.

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