Adjustable valve clipping system

Abstract

The present invention provides an adjustable valve clamping system. The adjustable valve clamping system includes a pushing device and a valve clamp. The valve clamp includes a clamp body and a clamp adjustment mechanism. The clamp body includes a fixing seat, a proximal clip, and a distal clip. The fixing seat is used to connect to the pushing device so that the clamp body can be pushed by the pushing device. The proximal clip and the distal clip cooperate to clamp the valve tissue. The clamp adjustment mechanism is located between the pushing device and the fixing seat. The clamp adjustment mechanism includes an adjustment member that can slide axially to be mounted on the fixing seat. When the clamp body is retracted, the adjustment member abuts the proximal clip to adjust the degree of traction of the clamp body on the valve tissue. The adjustable valve clamping system provided by the present invention can ensure that the clamp body has sufficient clamping force to prevent slippage, and the degree of traction of the clamp body on the valve tissue can be adjusted by the clamp adjustment mechanism.

Description

Technical Field

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

[0002] See also Figure 1 The mitral valve 1 is a one-way valve located between the left atrium 2 and the left ventricle 3 of the heart. A healthy mitral valve 1 controls blood flow from the left atrium 2 to the left ventricle 3 while preventing blood from flowing from the left ventricle 3 back to the left atrium 2. The mitral valve 1 consists of a pair of leaflets, called the anterior leaflet 1a and the posterior leaflet 1b. The anterior leaflet 1a and the posterior leaflet 1b are fixed to the papillary muscles of the left ventricle 3 by chordae tendineae 4. Under normal circumstances, when the left ventricle 3 contracts, the edges of the anterior leaflet 1a and the posterior leaflet 1b completely close together, preventing blood from flowing from the left ventricle 3 to the left atrium 2. Figure 2 When the leaflets of the mitral valve 1 or its related structures undergo organic or functional changes, such as partial rupture of the chordae tendineae 4, the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are poorly aligned. As a result, when the left ventricle 3 of the heart contracts, the mitral valve 1 cannot be completely closed, causing blood to flow back from the left ventricle 3 to the left atrium 2, thereby causing a series of pathophysiological changes, called "mitral regurgitation".

[0003] There is a minimally invasive treatment procedure that is based on the principle of edge-to-edge valve surgery. The valve clamp is delivered to the mitral valve through an interventional catheter, and then the relative opening of the clamp simultaneously clamps the anterior and posterior leaflets of the mitral valve, so that the anterior and posterior leaflets of the mitral valve are fixed together, thereby achieving the purpose of narrowing the leaflet gap and reducing mitral regurgitation. However, due to the differences in the physiological structure of the mitral valve and the severity of mitral regurgitation in different patients, the distance between the anterior and posterior leaflets of the mitral valve varies greatly from patient to patient. For patients with a large distance between the anterior and posterior leaflets of the mitral valve, if a valve clamp with a longer clamp arm is used to forcibly clamp the leaflets in order to reduce the difficulty of clamping the leaflets, when the clamp is closed, the anterior and posterior leaflets are forcibly pulled towards each other and fixed together, which can easily pull the leaflets too much, and may lead to serious consequences such as leaflet dysfunction, clamp detachment, or even leaflet tearing.

[0004] Prior art discloses a solution that adds a polymer elastomer to the apposed clamp arms, using the elastomer to adjust the degree of traction applied by the valve clamp to the leaflets. However, because the leaflet tissue is sticky and constantly pulsating, the rigid clamp arms and the elastomer can produce insufficient clamping force to hold the leaflets, causing the clamp to slip. Furthermore, for patients with a narrow interleaflet distance, the presence of the elastomer can result in suboptimal leaflet traction after closure, resulting in inadequate treatment of mitral regurgitation. Summary of the Invention

[0005] In view of this, the present invention provides an adjustable valve clamping system, in which the valve clamp has sufficient clamping force to prevent the valve tissue from slipping when clamping the valve tissue, and the degree of traction of the valve tissue when clamped can be adjusted as needed.

[0006] To solve the above technical problems, the present invention provides an adjustable valve clamping system, including a pushing device and a valve clamp, the valve clamp including a clamp body and a clamp adjustment mechanism, the clamp body including a fixing seat, a distal clip that can be opened and closed relative to the fixing seat, and a proximal clip arranged between the fixing seat and the distal clip; the fixing seat is detachably connected to the pushing device so as to push the clamp body through the pushing device, and the distal clip cooperates with the proximal clip to clamp the valve tissue; the clamp adjustment mechanism is located between the pushing device and the fixing seat, and the clamp adjustment mechanism includes an adjusting member that can slide axially to be sleeved on the fixing seat; when the clamp body is retracted, the adjusting member presses against the proximal clip to adjust the degree of traction of the clamp body on the valve tissue.

[0007] The adjustable valve clamping system provided by the present invention has a clamping body that clamps the valve tissue through the cooperation of the proximal clip and the distal clip, which can ensure that the clamping body has sufficient clamping force to prevent slipping; furthermore, when necessary, the clamping mechanism drives the adjusting member to slide to the proximal clip of the clamping body that is mounted on the fixed seat to resist the closed state, so that the degree of traction of the clamping body on the valve tissue can be adjusted, thereby effectively treating mitral regurgitation in patients with a large interleaflet distance. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for use in the implementation. Obviously, the drawings described below are some implementations of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0009] Figure 1 This is a schematic diagram of the mitral valve in its normal state.

[0010] Figure 2 This is a schematic diagram of a mitral valve disease.

[0011] Figure 3 Schematic diagram of the connection between the valve clipper and the pushing device provided in the first embodiment of the present invention.

[0012] Figure 4 yes Figure 3 Schematic diagram of the adjustment member of the valve clip being released to the fixing seat.

[0013] Figure 5 yes Figure 4 Schematic diagram of the valve clip in the retracted state.

[0014] Figure 6 yes Figure 3 Schematic diagram of the three-dimensional structure of the fixed seat of the valve clipper.

[0015] Figure 7 yes Figure 3 Schematic diagram of the three-dimensional structure of the proximal clip of the valve clip.

[0016] Figure 8 yes Figure 5 Schematic diagram of the valve clip in use when implanted in a patient with a large interleaflet distance.

[0017] Figure 9 yes Figure 8 Schematic diagram of the mitral valve during heart contraction after the valve leaflets are clamped by the valve clip.

[0018] Figure 10 yes Figure 8 Schematic diagram of the mitral valve during diastole after the valve leaflets are clamped by the valve clip.

[0019] Figure 11 yes Figure 3 Schematic diagram of the three-dimensional structure of part of the structure.

[0020] Figure 12 yes Figure 11 Schematic diagram of the three-dimensional structure of the connecting parts.

[0021] Figure 13 yes Figure 11 Schematic diagram of the three-dimensional structure of the adjusting part.

[0022] Figure 14 It is a partial three-dimensional structural schematic diagram of a pushing device of a valve clamping system provided in one embodiment of the present invention.

[0023] Figure 15 yes Figure 14 A cross-sectional view of the pushing device.

[0024] Figures 16 to 20 This is a schematic diagram of the process of using the valve clipper.

[0025] Figure 21 2 is a schematic structural diagram of a valve clipper body and an adjusting member of a valve clipper provided in a second embodiment of the present invention.

[0026] Figure 22 2 is a schematic structural diagram of an adjusting member of a valve clipper provided in a third embodiment of the present invention.

[0027] Figure 23and Figure 24 yes Figure 22 Schematic diagram of other embodiments of the adjusting member. DETAILED DESCRIPTION

[0028] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without creative work are within the scope of protection of the present invention.

[0029] In the description of the present invention, it should be noted that the terms "upper," "lower," "inner," and "outer," etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings and are intended solely to facilitate and simplify the description of the present invention. They are not intended to indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation, and therefore should not be construed as limitations on the present invention. Furthermore, the terms "first," "second," etc., etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0030] In describing the present invention, it should be noted that, in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator; and the axial direction refers to the direction parallel to the line connecting the distal and proximal centers of the medical device. The above definitions are for convenience only and are not to be construed as limitations of the present invention.

[0031] See also Figures 3 to 5 A first embodiment of the present invention provides an adjustable valve clipping system, comprising a valve clipper and a pushing device for delivering the valve clipper. The valve clipper comprises a clipper body 100 for clamping valve tissue and a clipper adjustment mechanism 200 for adjusting the degree of tension exerted by the clipper body 100 on the valve tissue. The clipper body 100 comprises a fixing seat 10, a distal clip 20 that can be opened and closed relative to the fixing seat 10, and a proximal clip 30 disposed between the fixing seat 10 and the distal clip 20. The fixing seat 10 is detachably connected to the pushing device 300, so that the clipper body 100 can be pushed by the pushing device 300. The distal clip 20 cooperates with the proximal clip 30 to clamp the valve tissue. The clamp adjustment mechanism 200 is located between the pushing device 300 and the fixing seat 10. The clamp adjustment mechanism 200 includes an adjustment member 40 that can slide axially to fit on the fixing seat 10. When the clamp body 100 is retracted, the adjustment member 40 abuts against the proximal clip 30 to adjust the degree of traction of the clamp body 100 on the valve tissue.

[0032] In this embodiment, there are two distal clips 20 and two proximal clips 30, each corresponding to a corresponding proximal clip 30 to form two clamps. The two clamps are symmetrically arranged about the mounting base 10. After the valve clip is implanted in the patient, the two clamps can respectively clamp the anterior and posterior leaflets of the mitral valve to alleviate or treat mitral regurgitation. Each clamp, through the cooperation of the proximal clip 30 and the distal clip 20, clamps the valve tissue, ensuring that the clip body 100 has sufficient clamping force to prevent slippage. Furthermore, when necessary, the adjustment member 40 of the clip adjustment mechanism 200 can slide over the mounting base 10 to abut the proximal clip 30 of the clip body 100 in the closed position, thereby reducing the degree of traction on the valve tissue by the clip body 100, thereby effectively treating mitral regurgitation in patients with a large interleaflet distance.

[0033] Among them, in order to ensure safety after implantation, the fixing seat 10, the distal clip 20 and the proximal clip 30 are all made of biocompatible metal materials. The metal materials are selected from commonly used implantable metal materials such as stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy or nickel-titanium alloy, preferably stainless steel or cobalt-chromium alloy with higher hardness.

[0034] For details, please refer to Figure 3 、 Figure 4 and Figure 6 The fixing base 10 includes a first base body 11 at the proximal end, a second base body 12 at the distal end, and a third base body 13 for transitionally connecting the first base body 11 and the second base body 12. In this embodiment, the first base body 11, the second base body 12, and the third base body 13 are an integral structure. Obviously, in other embodiments, the first base body 11, the second base body 12, and the third base body 13 may be non-integral structures.

[0035] In this embodiment, the first base body 11 is a circular tube with axially extending ends. The proximal outer wall of the first base body 11 defines at least one connecting hole 113 that communicates with the tubular lumen of the first base body 11. This at least one connecting hole 113 is used to removably connect the fixing base 10 to the pushing device 300. The distal outer wall of the first base body 11 defines at least one protruding block 115 with an inclined proximal end surface. This at least one protruding block 115 is used to secure the adjusting member 40 mounted on the fixing base 10. There are two connecting holes 113 and two protruding blocks 115.

[0036] In this embodiment, the second base 12 is a block structure. A receiving cavity 14 is defined perpendicularly to the axial direction, extending through two opposing side surfaces of the second base 12. A rectangular block 121 is protruded from each of the other two opposing side surfaces of the second base 12. A through hole is defined axially on the distal inner wall of the receiving cavity 14 of the second base 12. The axis of the through hole is collinear with the axis of the lumen of the first base 11.

[0037] In this embodiment, the third base 13 has a roughly stepped structure. Its cross-section at any position perpendicular to the axial direction is square, and its cross-sectional area gradually increases from the proximal end to the distal end. The outer periphery of the third base 13 includes two opposing flat surfaces and two opposing inclined surfaces. A connecting block 131 is protruded from each of the two opposing flat surfaces of the third base 13, and each connecting block 131 has a pin hole.

[0038] Furthermore, the third seat body 13 is provided with a through hole (not shown) along the axial direction, and the tubular cavity of the first seat body 11, the through hole of the third seat body 13, the accommodating cavity 14 of the second seat body 12 and the through hole located on the distal inner wall of the accommodating cavity 14 are coaxially connected to form a penetration channel 15.

[0039] Please also refer to Figures 3 to 6 The clamp body 100 also includes a push rod 50, which is axially slidably inserted into the passage 15 of the fixed seat 10. In this embodiment, the push rod 50 is a round rod. The proximal end of the push rod 50 is provided with an external thread (not shown) for connecting to the core shaft (not shown) of the pushing device 300. A connecting seat 55 is provided at the distal end of the push rod 50. The connecting seat 55 includes two opposing first flat surfaces and two connecting surfaces connecting the two first flat surfaces. The two connecting surfaces include a curved surface at the distal end and a second flat surface at the proximal end that smoothly transitions to the curved surface. A pair of pin holes are formed at opposite ends of the connecting seat 55, extending through the two first flat surfaces. The cross-sectional dimension of the connecting seat 55, parallel to the second flat surface, gradually decreases from the proximal end to the distal end. In other words, the connecting seat 55 can be shaped like a hemisphere, a spherical cap, or a bullet, making it easier to push the clamp body 100 into the body.

[0040] The push rod 50 and the connecting seat 55 can be an integral structure or a non-integrated structure. In this embodiment, the push rod 50 and the connecting seat 55 are an integral structure, and the outer surfaces of the push rod 50 and the connecting seat 55 are smooth to avoid damaging the valve tissue or hooking the chordae tendineae.

[0041] To ensure safety after implantation, the push rod 50 and the connecting seat 55 are made of biocompatible materials such as polyester, silicone resin, stainless steel, cobalt alloy, cobalt-chromium alloy or titanium alloy, preferably stainless steel or cobalt-chromium alloy with higher hardness.

[0042] It should be noted that a locking member is provided in the accommodating cavity 14 of the fixing seat 10, and the push rod 50 is fixed or unlocked relative to the fixing seat 10 through the locking member. The locking member can be a combination of deformable spring sheets and steel sheets in the prior art. Since it is not related to the improvement and creation of the present invention, it will not be described here.

[0043] Please also refer to Figure 3 and Figure 7The proximal clip 30 includes a connecting end 31 and a free end 32 disposed opposite each other, with the connecting end 31 being fixed relative to the fixing base 10. In this embodiment, the two proximal clips 30 are connected as a whole via a connecting frame 33. The connecting frame 33 defines a through hole 34 for the push rod 50 to pass through. The connecting frame 33 also defines rectangular holes 35 on opposite sides thereof for the rectangular block 121 on the second base body 12 to pass through. The connecting frame 33 is sleeved onto the outer sides of the second base body 12 and the third base body 13 to relatively fix the connecting ends 31 of the two proximal clips 30 to the fixing base 10. Obviously, in other embodiments, the connecting ends 31 of the proximal clips 30 can be directly fixed to the fixing base 10 by welding, crimping, or other connection methods.

[0044] The proximal clips 30 are at least partially made of a shape-memory elastic material and are heat-set. In their natural state, the proximal clips 30 extend radially outward relative to the holder 10, preferably toward the proximal end, to facilitate cooperation with the distal clips 20 to clamp the valve tissue. Specifically, the angle between the two proximal clips 30 in their naturally deployed state is slightly greater than the angle between the two distal clips 20. In other words, the angle between the length of the proximal clips 30 and the axial direction of the holder 10 is greater than or equal to the angle between the corresponding distal clip 20 and the holder 10 when the distal clip 20 is fully extended relative to the holder 10. This ensures that the free end 32 of each proximal clip 30 is in close proximity to the corresponding distal clip 20, providing a certain clamping force and a more stable clamping force. Specifically, in this embodiment, the angle between the length direction of the proximal clip 30 and the axial direction of the fixing seat 10 ranges from 0 to 150 degrees, that is, in the natural state, the angle between the two proximal clips 30 can reach a maximum of 300 degrees, and the angle between the two proximal clips 30 is preferably 240 degrees, and more preferably 160-200 degrees.

[0045] In this embodiment, the proximal clip 30 is entirely made of a superelastic nickel-titanium alloy, providing a spring force to urge the proximal clip 30 toward the distal clip 20 to clamp the valve tissue. Furthermore, in this embodiment, the connecting frame 33 can also be integrally formed with the proximal clip 30 using a resilient nickel-titanium alloy, thereby reducing manufacturing complexity, simplifying the process, and lowering production costs. Furthermore, the resilient connecting frame 33 is more easily attached to the exterior of the second and third base bodies 12, 13.

[0046] It should be noted that the free end 32 of the proximal clip 30 is provided with an adjustment wire hole 36 for connecting to an adjustment wire (not shown) of the push mechanism 300. The free end 32 of the proximal clip 30 can be controlled by an adjustment wire extending outside the patient's body. In the delivery state, the free end 32 of the proximal clip 30 is tightened by the adjustment wire and adheres to the surface of the holder 10. When the adjustment wire releases the control of the free end 32, the proximal clip 30 is released and returns to its natural state due to its elastic memory properties, pressing the valve tissue toward the distal clip 20.

[0047] Furthermore, the proximal clip 30 includes a first surface facing the distal clip 20. A gripping reinforcement is provided on the first surface to increase friction between the proximal clip 30 and the valve tissue, thereby enhancing the grip of the clip body 100 on the valve tissue. Specifically, in this embodiment, the gripping reinforcement comprises two rows of barbs 37 spaced apart on opposite sides of the first surface. The barbs 37 can be integrally formed on the proximal clip 30, or they can be formed from the same or different material as the proximal clip 30 and then attached to the first surface of the proximal clip 30. For example, a nickel-titanium wire or rod can be secured to the first surface via a sleeve. The base of the barbs 37 is connected to the proximal clip 30, and the end of the barbs 37 opposite the base is a free end. In the naturally deployed state, the free end of the barbs 37 faces the distal clip 20. The angle between the extension direction of the barbs 37 and the first surface is less than or equal to 90 degrees, so as to enhance the clamping force of the valve clip on the valve tissue. The free end of each barb 37 is a smooth arc surface to avoid damaging the valve tissue.

[0048] In other embodiments, the clamping reinforcement member may be a ridge, a boss or other irregularly distributed protrusions protruding from the first surface, or a rough surface at least partially covering the first surface, or a combination of the above forms.

[0049] Preferably, active drugs can be applied to the proximal clip 30, and at least one opening 38 can be opened to reduce the weight of the proximal clip 30, to prevent the excessively heavy clamp body 100 from falling under the valve tissue for a long time and causing slippage or damage to the valve tissue, and at the same time, it is also beneficial to the crawling and growth of endothelial cells.

[0050] Please also refer to Figure 4 and Figure 5 In this embodiment, the clamp body 100 also includes a pair of connecting rods 57 arranged opposite to each other. Each distal clip 20 is connected to the connecting seat 55 at the distal end of the push rod 50 through the connecting rod 57 on the corresponding side. When the push rod 50 slides axially in the through-channel 15 of the fixed seat 10, the distal clip 20 can be driven to open and close relative to the fixed seat 10 through the connecting rod 57.

[0051] Specifically, each distal clip 20 includes a connecting section 21 located at the distal end and a clamping section 22 connected to the proximal end of the connecting section 21. The end of the connecting section 21 away from the clamping section 22 is rotatably connected to the connecting block 131 of the third seat body 13 of the fixed seat 10, and the end of the connecting section 21 close to the clamping section 22 is rotatably connected to the proximal end of the connecting rod 57 on the corresponding side. The distal end of the connecting rod 57 is rotatably connected to the connecting seat 55 by rotating a pin or a bolt.

[0052] As mentioned above, the push rod 50 and the fixing seat 10 are unlocked by the locking piece in the accommodating chamber 14, and the push rod 50 can slide axially toward the distal end and move relative to the fixing seat 10. As a result, the connecting seat 55 at the distal end of the push rod 50 moves relative to the fixing seat 10, and the connecting seat 55 drives the connecting rod 57 to move. Under the pulling of the connecting rod 57, the distal clip 20 can rotate around the pin hole on the connecting block 131 and open relative to the fixing seat 10. When the proximal clip 30 located between the fixing seat 10 and the distal clip 20 is released, the proximal clip 30 moves closer to the distal clip 20 and cooperates with the distal clip 20 to clamp the valve tissue located therebetween. After the proximal clip 30 and the distal clip 20 clamp the valve tissue, the push rod 50 is driven to move axially toward the proximal end, and the distal clip 20 is driven to close relative to the fixing seat 10 through the connecting rod 57 until the distal clip 20 is completely closed relative to the fixing seat 10, so that the clip body 100 is in a retracted state. Then, the push rod 50 and the fixing seat 10 are relatively fixed by the locking member to prevent the distal clip 20 from opening relative to the fixing seat 10, and the clip body 100 in the retracted state falls below the valve.

[0053] It is understood that the connecting seat 55 at the distal end of the push rod 50 moves axially to drive the connecting rod 57 to move up and down while opening and closing relative to the fixed seat 10. The connecting rod 57 then drives the distal clip 20 to open and close relative to the fixed seat 10. This motion structure allows the distal clip 20 to open and close relative to the fixed seat 10 over a wide range. In some embodiments, the angle between the clamping sections 22 of the two distal clips 20 can reach a maximum of 300 degrees. That is, after the distal clips 20 are opened relative to the fixed seat 10, they can achieve a certain degree of downward rotation, thereby facilitating the clamping sections 22 to clamp the valve tissue in constant motion and improving the success rate of clamping. In this embodiment, the angle between the clamping sections 22 of the two distal clips 20 is preferably in the range of 0-240 degrees, and more preferably in the range of 120-180 degrees.

[0054] Preferably, a clamping and anti-slip structure (not shown) can be provided on the second surface of the distal clip 20 facing the proximal clip 30 to enhance the friction between the distal clip 20 and the valve tissue, thereby providing a stable clamping force and preventing damage to the valve tissue caused by the distal clip 20. The clamping and anti-slip structure can be a protrusion or groove provided on the second surface, or a gasket made of a biocompatible material with a high friction coefficient and attached to the second surface.

[0055] The second surface of the distal clip 20 can be either flat or curved. Preferably, the curved second surface increases the contact area between the distal clip 20 and the valve tissue, thereby providing a stable clamping force. Furthermore, the curved second surface forms a receiving groove. When the proximal clip 30 moves toward the distal clip 20, the barbs 37 on the first surface of the proximal clip 30 can be received within the receiving groove, thereby compressing the valve tissue and minimizing the volume of the clip body 100 when collapsed, facilitating in-vivo delivery.

[0056] Further preferably, active drugs may be applied on the second surface of the distal clip 20 , or at least one opening may be opened.

[0057] It should be noted that to ensure a stable clamping force and to correspond to the size of the valve, the distal clip 20 has certain size requirements. If the distal clip 20 is too long, it may easily clamp too much of the anterior and posterior leaflets together. When the clip body 100 is retracted, the two leaflets are forcibly pulled toward each other and fixed together. During heartbeat and leaflet movement, the excessive leaflet movement is restricted, which can easily lead to mitral valve dysfunction and may even cause serious consequences such as leaflet tearing. If the distal clip 20 is too short, the clip body 100 can only clamp a small portion of the leaflets, making it easy for the leaflets to slip out and the clamping and fixing effect to be poor. In the present invention, the axial length of the distal clip 20, that is, the distance from the connecting section 21 to the clamping section 22, should be greater than or equal to 4 mm, preferably 6-10 mm. If the distal clip 20 is too narrow, it may easily damage the leaflets. If the distal clip 20 is too wide, it may affect leaflet movement. In the present invention, the width of the distal clip 20, that is, the length in a direction perpendicular to the axial direction of the distal clip 20, should be greater than or equal to 2 mm, preferably 4-6 mm.

[0058] The valve clip provided in this embodiment can be used to alleviate or treat "mitral regurgitation". For details, please refer to Figures 8 to 10The clip body 100 is placed at the position where the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve cannot be normally aligned, so that a corresponding set of proximal clips 30 and distal clips 20 clamp the edge of the anterior leaflet 1a of the mitral valve, and another set of corresponding proximal clips 30 and distal clips 20 clamp the edge of the posterior leaflet 1b of the mitral valve, so as to clamp the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve together. Figure 9 and Figure 10 The arrows in the figure indicate the direction of blood flow. Figure 9 As shown in the figure, when the heart contracts, the anterior leaflet 1a and the posterior leaflet 1b close together, and the parts where the anterior leaflet 1a and the posterior leaflet 1b cannot close normally close together partially or completely. The opening area A of the mitral valve becomes smaller or completely closed, and only a small amount of blood flows back from the opening of the mitral valve into the left atrium, thereby alleviating or treating "mitral regurgitation". Figure 10 As shown, when the heart is in diastole, the anterior leaflet 1a and the posterior leaflet 1b are only clamped together at position B where the valve clamp 100 is clamped, and the other positions of the anterior leaflet 1a and the posterior leaflet 1b are still in normal diastole, allowing blood to flow from the left atrium into the left ventricle, thereby ensuring normal blood circulation.

[0059] Among them, such as Figure 8 As shown, in some embodiments, when the valve clip provided by the present invention is used to alleviate or treat "mitral regurgitation" in patients with a large distance between the leaflets, the operator releases the adjustment member 40 as needed and places it inside the clip body 100 to adjust the degree of traction of the leaflets by the clip body 100 to avoid excessive traction on the leaflets, which may lead to serious consequences such as abnormal leaflet function, detachment of the clip body 100, or even leaflet tearing.

[0060] See also Figures 3 to 5 To effectively treat mitral regurgitation in patients with varying intercuspal spacing, the valve clipper is equipped with a clip adjustment mechanism 200 located between the pushing mechanism 300 and the mounting base 10 of the clipper body 100. The clip adjustment mechanism 200 includes a selectively releasable adjustment member 40. When the operator determines, using medical imaging devices such as ultrasound, that the patient's intercuspal spacing is appropriate, the adjustment member 40 does not need to be released. The distal clip 20 and the proximal clip 30 cooperate to clamp the valve tissue, and the clipper body 100 is collapsed and placed within the patient. When the operator determines that the patient's intercuspal spacing is excessive, the adjustment member 40 is released. The adjustment member 40 slides axially to fit over the mounting base 10. After the clipper body 100 is collapsed, the adjustment member 40 is located within the clipper body 100 and abuts against the proximal clip 30, adjusting the degree of tension applied by the clipper body 100 on the valve tissue.

[0061] For details, please refer to Figure 3 、 Figure 4 、 Figures 11 to 13 A connecting piece 60 is provided at the distal end of the pushing device 300, and the pushing device 300 is detachably connected to the fixing seat 10 through the connecting piece 60. The adjusting piece 40 has a through hole 41 extending through both ends along the axial direction. The adjusting piece 40 is axially slidably sleeved on the outside of the connecting piece 60 and can slide along the connecting piece 60 to be sleeved on the fixing seat 10.

[0062] The connector 60 is generally tubular in shape, with at least one slide rail 61 axially disposed on its outer wall. The slide rail 61 is used to guide the adjustment member 40, which is mounted on the outer portion of the connector 60, along the slide rail 61. At least two connecting rods 63 are disposed at the distal end of the connector 60, each of which has a buckle 65 disposed at the distal end for removable connection to the fixing base 10. In this embodiment, a set of slide rails 61 are axially symmetrically disposed on the outer wall of the connector 60, and a set of connecting rods 63 are axially symmetrically disposed at the distal end of the connector 60.

[0063] Among them, the inner surfaces of the two axially symmetrical connecting rods 63 facing each other are arc surfaces that smoothly transition to the cylindrical surface in the tubular cavity of the connecting piece 60, and the distance from the arc surface of each connecting rod 63 to the axis of the connecting piece 60 gradually decreases from the proximal end to the distal end, that is, the distal end of each connecting rod 63 is inclined toward the axis direction of the connecting piece 60, and the two connecting rods 63 gradually converge and approach from the proximal end to the distal end.

[0064] The connecting rod 63 is made of elastic material. When the connecting rod 63 is pushed outward in the radial direction of the connecting member 60, the distal end of the connecting rod 63 expands outward. Figure 11 As shown, the liner 90 of the pushing device 300 is movably inserted into the tubular cavity of the connecting member 60, driving the liner 90 to move toward the distal end, and the liner 90 pushes the connecting rod 63 radially outward, and the buckle 65 of the connecting rod 63 expands outward and is stuck in the connecting hole 113 of the fixing seat 10, so that the pushing device 300 is in a connected state with the fixing seat 10 through the connecting member 60; it can be understood that when the liner 90 is withdrawn toward the proximal end, the connecting rod 63 rebounds due to its own elasticity, and the distal end of the connecting rod 63 is retracted toward the axial direction of the connecting member 60, and the buckle 65 withdraws from the corresponding connecting hole 113, and the connection state between the pushing device 300 and the fixing seat 10 is released.

[0065] like Figure 3 and Figure 4As shown, the clamp adjustment mechanism 200 further includes a driver 70 and a control wire 80 connected to the adjustment member 40. The driver 70 is used to drive the adjustment member 40 to slide axially toward the distal end, and the control wire 80 is used to pull the adjustment member 40 to slide axially toward the proximal end. In this embodiment, the driver 70 is an elastic member disposed between the pushing mechanism 300 and the adjustment member 40. The elastic member is sleeved onto the exterior of the connector 60. The proximal end of the elastic member is fixedly connected to the pushing mechanism 300 via a detachable or non-detachable connection method such as welding or a snap connection, while the distal end of the elastic member abuts the adjustment member 40. In this embodiment, the control wire 80 passes through the adjustment member 40 and extends outside the patient's body. When the control line 80 is pulled in the proximal direction, the control line 80 drives the adjusting member 40 to slide axially toward the proximal end, and the elastic member is compressed; when the control line 80 is released, the elastic member returns to the extended state and pushes the adjusting member 40 to slide axially toward the distal end to the outside of the first seat body 11 that is sleeved on the fixed seat 10, specifically, the proximal end of the fixed seat 10.

[0066] The inner diameter of the through hole 41 of the adjusting member 40 is at least 0.02 mm larger than the outer diameter of the first base 11 , preferably 0.05-2 mm, so that the adjusting member 40 can slide relative to the first base 11 under the push of the elastic member.

[0067] The elastic member can be compressed or stretched along the axial direction of the pushing device, and is usually selected from elastic elements such as leaf springs, springs or bellows. In this embodiment, the elastic member is a spring.

[0068] The control wire 80 is made of a single wire, such as nickel-titanium wire, stainless steel wire, or a high-strength polymer wire, or a plurality of twisted wires. In this embodiment, the control wire 80 is a single nickel-titanium wire. The control wires 80 are arranged in a group and connected axially symmetrically to the adjustment member 40. This ensures that the tension on both sides of the adjustment member 40 is balanced, thereby preventing the clamp body 100 from swinging due to unbalanced tension.

[0069] Please also refer to Figure 11 and Figure 13 The inner wall of the through hole 41 of the adjusting member 40 is provided with a group of sliding grooves 411 corresponding to the sliding rails 61 of the connecting member 60. When the adjusting member 40 is sleeved on the outside of the connecting member 60, the sliding rails 61 are accommodated in the sliding grooves 411. The adjusting member 40 slides toward the distal end along the sliding rails 61 under the push of the elastic member, or slides toward the proximal end along the sliding rails 61 under the pull of the control line 80.

[0070] The width of the sliding groove 411 is at least 0.02 mm, preferably 0.05-3 mm, greater than the width of the sliding rail 61 to ensure that the adjusting member 40 can slide along the sliding rail 61 .

[0071] The adjusting member 40 includes a sleeve portion 42, a support portion 43, and a fixing portion 44 in sequence from the proximal end to the distal end. In this embodiment, the sleeve portion 42 and the support portion 43 are both cylindrical, and the diameter of the sleeve portion 42 is smaller than the diameter of the support portion 43. A step surface (not shown in the figure) is formed between the sleeve portion 42 and the support portion 43. Figure 3 As shown, the distal end of the elastic member is sleeved on the outside of the clamping sleeve 42 and abuts against the step surface to push the adjusting member 40 to slide toward the distal end along the slide rail 61 .

[0072] In other embodiments, the sleeve portion 42 can have the same diameter as the support portion 43, and the proximal end of the sleeve portion 42 is provided with a circle of slots around the through hole 41, and the elastic member is sleeved in the slot to push the adjustment member 40 to slide axially toward the distal end.

[0073] The support portion 43 defines at least one threading hole 45 for the control wire 80 to pass through. Specifically, in this embodiment, a set of threading holes 45 are axially symmetrically defined at one end of the support portion 43 near the ferrule portion 42. A set of control wires 80 are each threaded through a corresponding threading hole 45 before extending outside the patient's body. In other embodiments, the set of threading holes 45 may be defined at other suitable locations on the support portion 43, for example, in the middle of the support portion 43 or near one end of the fixing portion 44.

[0074] The fixing portion 44 defines at least one fixing groove or at least one fixing hole extending through the outer wall of the fixing portion 44 on the inner wall of the through hole 41. The fixing groove or the fixing hole corresponds one-to-one with the protrusion 115 of the first base body 11 of the fixing seat 10 to secure the adjusting member 40 mounted on the fixing seat 10. Specifically, in this embodiment, a set of fixing holes 46 are axially symmetrically defined at the distal end of the fixing portion 44 and connected to the through hole 41. When the adjusting member 40 slides distally along the slide rail 61 to the exterior of the first base body 11 under the push of the elastic member, the protrusion 115 of the first base body 11 engages with the corresponding fixing holes 46, thereby securing the adjusting member 40 to the fixing seat 10. The edge of the distal end of the fixing portion 44 relative to the through hole 41 may be chamfered to facilitate the engagement of the proximal beveled protrusion 115 with the corresponding fixing holes 46.

[0075] Preferably, the fixing portion 44 is in the shape of an inverted cone, and the diameter of the fixing portion 44 gradually decreases from the proximal end to the distal end, so that after the adjusting member 40 is fixed to the fixing seat 10, it will not affect the relative opening and closing between the proximal clip 30 and the distal clip 20 and the fixing seat 10, thereby avoiding affecting the clamping effect of the clamp body 100.

[0076] The adjusting member 40 is an elastic structure made of a biocompatible polymer material, preferably made of a dense silica gel, etc. It is understandable that the adjusting member 40 can also be made of an elastic porous material such as sponge.

[0077] Please also refer to Figure 3 、 Figure 14 and Figure 15 The adjustable valve clipping system provided in this embodiment includes a pushing device 300 and the aforementioned valve clipper. The pushing device 300 can be used to deliver the valve clipper to the mitral valve and adjust the valve clipper to an appropriate position on the mitral valve. The pushing device 300 includes an operating handle and a pushing assembly. The proximal end of the pushing assembly is connected to the operating handle, and the distal end of the pushing assembly is detachably connected to the valve clipper. Specifically, the pushing assembly includes the aforementioned connector 60, a liner 90 that is movably coaxially sleeved within the lumen of the connector 60, and a core shaft 93 that is movably coaxially sleeved within the liner 90. The operator can drive the liner 90 and the core shaft 93 to move or rotate relative to each other through the operating handle placed outside the patient's body.

[0078] The core shaft 93 is detachably connected to the push rod 50 and is used to drive the push rod 50 to slide axially along the fixing base 10, thereby driving the distal clip 20 to open and close relative to the fixing base 10. In this embodiment, the core shaft 93 is a round rod with an internally threaded hole (not shown) at the distal end. The internally threaded hole is used to threadably connect with the stud at the proximal end of the push rod 50.

[0079] As mentioned above, by driving the liner 90 toward the distal end, the buckle 65 at the distal end of the connector 60 can be pushed to expand outward, so that the buckle 65 is inserted into the corresponding connecting hole 113 of the fixing seat 10, thereby realizing a detachable connection between the connector 60 and the fixing seat 10; by withdrawing the liner 90 toward the proximal end, the connection between the connector 60 and the fixing seat 10 can be released, which will not be repeated here.

[0080] In other embodiments, the pushing assembly may not include the liner 90, and the overall diameter of the core shaft 93 or the diameter of the distal portion of the core shaft 93 is larger, so that the distal portion of the core shaft 93 can directly push the buckle 65 at the distal end of the connecting member 60 to expand outward. In other words, the core shaft 93 can be used to push the buckle 65 at the distal end of the connecting member 60 to expand outward, and can also be used to drive the push rod 50 to slide axially along the fixed seat 10.

[0081] See also Figure 14 and Figure 15 In this embodiment, the pushing assembly also includes a pushing catheter 95 and a fixing member 97 arranged at the distal end of the pushing catheter 95. The connector 60, liner 90 and core shaft 93 that are coaxially sleeved together are sleeved in the pushing catheter 95 through the fixing member 97 so as to be pushed through the pushing catheter 95.

[0082] Among them, the push catheter 95 includes an outer hose, a braided mesh and an inner hose from the outside to the inside. The inner hose has several cavities extending along the axial direction of the push catheter 95. The cavities are used for allowing wires such as the control line 80 to pass through and extend outside the patient's body. The specific structure of the push catheter 95 is similar to that of the existing push catheter and will not be repeated here.

[0083] Furthermore, the pushing device 300 also includes the aforementioned adjustment wire, which is used to fix the free end 32 of the proximal clip 30 to the surface of the fixing base 10. The adjustment wire extends outside the patient's body through the lumen of the pushing catheter 95. The adjustment wire can be made of metal or a polymer material such as PTFE.

[0084] It should be noted that the pushing assembly and the valve clipper can be delivered into the patient's body using an existing adjustable curved sheath tube.

[0085] In other embodiments, the pushing assembly may not include the pushing catheter 95. The connector 60, liner 90 and core shaft 93 with a certain axial length can be directly delivered into the patient's body through the adjustable bend sheath. The adjustment line and control line 80 can also be directly passed through the adjustable bend sheath and extended in the opposite direction to the outside of the patient's body. They will not be elaborated here.

[0086] The following uses the mitral valve repair process as an example to illustrate the operation method of the valve clipping system of the present invention, which mainly includes the following steps:

[0087] Step 1: Place the adjusting member 40 on the outside of the connecting member 60, pull the adjusting member 40 toward the proximal end through the control line 80, so that the adjusting member 40 compresses the elastic member, and then detachably connect the pushing assembly to the clip body 100 of the valve clip, and use the adjusting line to tie the free end 32 of the proximal clip 30 to the surface of the fixing seat 10. Specifically, as mentioned above, the liner 90 is used to push the buckle 65 at the distal end of the connecting member 60 outward so that the buckle 65 is snapped into the connecting hole 113 of the fixing seat 10, so that the fixing seat 10 and the connecting member 60 of the pushing assembly are in a connected state; the core shaft 93 of the pushing assembly is rotated so that the core shaft 93 is screwed and fixed to the push rod 50; the core shaft 93 is moved in the proximal direction by the operating handle to drive the push rod 50 to slide axially in the distal direction, driving the distal clip 20 to close relative to the fixing seat 10, so that the clamp body 100 is in a fully retracted state. At this time, the proximal clip 30 and the distal clip 20 are both close to the surface of the fixing seat 10, keeping the retracted state unchanged.

[0088] Step 2: Using the trans-atrial septal approach, the clipper body 100 connected thereto is pushed forward from the left atrium through the mitral valve to the left ventricle, as shown in FIG. Figure 16 shown.

[0089] Step 3: Adjust the relative position of the clip body 100 and the mitral valve so that the clip body 100 is close to the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve.

[0090] Step 4: Move the core shaft 93 proximally by operating the handle, thereby driving the push rod 50 to slide proximally to drive the distal clip 20 to open relative to the fixed seat 10, and adjust the direction of the clip body 100 so that the distal clip 20 is perpendicular to the mitral valve coaptation line.

[0091] Step 5: Retract the entire clip body 100 toward the proximal end, so that the distal clip 20 supports the valve leaflet on the left ventricle side. Figure 17 shown.

[0092] Step 6: Release the restraint of the adjustment line on the proximal clip 30, and the proximal clip 30 rebounds and opens relative to the fixing seat 10, so that the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve are respectively clamped between the corresponding proximal clip 30 and the distal clip 20. Figure 18 shown.

[0093] Step 7: Through observation of medical imaging such as ultrasound, for patients with a large distance between the anterior and posterior leaflets, loosen the control line 80 of the control adjusting member 40 to release the tension on the adjusting member 40. Under the elastic force of the elastic member, the adjusting member 40 slides toward the distal end until it is fixed on the fixing seat 10. The protrusion 115 on the fixing seat 10 is engaged with the fixing hole 46 of the adjusting member 40. Figure 19 As shown; for patients with a smaller distance between the anterior and posterior leaflets, there is no need to release the adjusting member 40. At this time, the elastic member is kept in a compressed state to prevent the adjusting member 40 from being released.

[0094] Step 8: Move the core shaft 93 toward the distal end again, and the core shaft 93 drives the push rod 50 to slide axially toward the distal end, thereby driving the distal clip 20 to close relative to the fixing seat 10 until the clamp body 100 is completely retracted. Figure 20 As shown;

[0095] Step 9: Use the operating handle to control the rotation of the core shaft 93 to unlock the threaded connection between the core shaft 93 and the push rod 50. Then, withdraw the liner 90 and core shaft 93 proximally until the buckle 65 at the distal end of the connector 60 unlocks and separates from the latch hole 115 of the fixing seat 10, and the clip body 100 is completely separated from the pushing assembly. Finally, the pushing assembly is withdrawn from the patient's body. At this time, the clip body 100 pulls the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve toward each other, forming a double-pore mitral valve and completing the edge-to-edge repair of the mitral valve. In the case of releasing the adjustment member 40, the adjustment member 40 is released inside the clip body 100 and remains in the patient's body with the clip body 100. Figure 8As shown; in the case where there is no need to release the adjusting member 40, the operator can pull the adjusting member 40 and the pushing assembly out of the patient's body through the control line 80, leaving only the clip body 100 in the patient's body to complete the edge-to-edge repair of the mitral valve.

[0096] It is understandable that the valve clipping system of the present invention may also use a transapical route to deliver the valve clipper to the mitral valve.

[0097] The adjustable valve clamping system of the present invention can clamp the valve leaflets through the cooperation of the proximal clip 30 and the distal clip 20, and has sufficient clamping force to prevent the clamp body 100 from slipping; furthermore, according to the spacing of the patient's mitral valve leaflets, the adjustment member 40 can be released or not, thereby being used to treat "mitral regurgitation" in patients with different leaflet spacings. When the adjustment member 40 is released and fixed to the fixing seat 10, the adjustment member 40 is located inside the clamp body 100 when it is retracted. The adjustment member 40 fills between the anterior and posterior leaflets of the clamped mitral valve and presses against the proximal clip 30. The elastic adjustment member 40 can be squeezed and deformed following the pulsation of the leaflets, and the adjustment member 40 generates elastic force to move the part of the leaflet close to the adjustment member 40 away from the adjustment member. The fixing seat 10 is pushed in the direction of the clamping, so that the clamping angle between the anterior and posterior leaflets of the mitral valve is smaller than the opening angle between the distal clips 20, and the elastic adjusting member 40 has a buffering effect on the beating leaflets, thereby reducing the pulling of the leaflets by the clip body 100, so that the pulling degree of the leaflets by the clip body 100 is always kept within a reasonable range, which can effectively treat "mitral regurgitation" in patients with a large interleaflet distance and avoid excessive pulling and damage to the leaflets; in addition, the adjusting member 40 can buffer the direct flushing of blood flow on the interior of the clip body 100, prevent the clip body 100 from being continuously flushed by blood and falling off, and also prevent blood from accumulating and forming thrombus in the dead corner between the proximal clips 30 of the clip body 100.

[0098] See also Figure 21 The structure of the valve clamp provided in the second embodiment of the present invention is similar to that of the valve clamp in the first embodiment, except that: in the second embodiment, at least one of the adjusting member 40, the proximal clip 30 and the distal clip 20 is covered with a coating. Specifically, in this embodiment, the adjusting member 40, the proximal clip 30 and the distal clip 20 are respectively covered with a first coating 410, a second coating 420 and a third coating 430.

[0099] The first coating 410 completely covers the outer surface of the adjusting member 40, the second coating 420 at least partially covers the first surface of the proximal clip 30, and the third coating 430 at least partially covers the second surface of the distal clip 20. Preferably, in this embodiment, the second coating 420 completely covers the first surface of the proximal clip 30 and extends to completely cover the surface of the proximal clip 30 opposite the first surface, allowing only the barbs 37 of the proximal clip 30 to pass through the second coating 420; the third coating 430 completely covers the second surface of the distal clip 20 and extends to completely cover the surface of the distal clip 20 opposite the second surface. Furthermore, the third coating 430 covering both distal clips 20 also covers the outer surface of the connecting portion of the two distal clips 20 (i.e., the portion where the connecting seat 55 and the connecting rod 57 are located).

[0100] The first coating 410, the second coating 420, and the third coating 430 are all secured by suturing, dipping, bonding, fusing, or bundling. In this embodiment, the first coating 410 and the second coating 420 are bonded and secured to the adjusting member 40 and the proximal clip 30, respectively, while the third coating 430 is sutured and secured to the distal clip 20.

[0101] The first, second, and third coatings 410, 420, and 430 are each made of at least one layer of a biocompatible polymer material that is resistant to oxidation and dissolution. The polymer material is selected from at least one of PET, polyester, PTFE, silicone resin, silica gel, or urethane. The materials of the first, second, and third coatings 410, 420, and 430 may be the same or different. In this embodiment, the first, second, and third coatings 410, 420, and 430 are each preferably a single layer of PET.

[0102] Furthermore, the first coating 410, the second coating 420 and the third coating 430 all adopt one or more structures selected from the group consisting of a two-dimensional sieve structure, a porous membrane, a microporous structure, a woven or non-woven mesh structure, and a foaming structure. In this embodiment, the coating adopts a mesh structure, and the first coating 410, the second coating 420 and the third coating 430 are all provided with a plurality of mesh holes, and the opening rate (i.e., the percentage of the opening area to the entire coating area) of the first coating 410, the second coating 420 and the third coating 430 decreases in sequence. Furthermore, the mesh holes of the first coating 410 cannot pass through blood and thrombus, while the mesh holes of the second coating 420 and the third coating 430 can pass through blood and prevent thrombus from passing through.

[0103] In this embodiment, the first coating 410 not only increases the biocompatibility of the regulating member 40, avoids tissue allergies and inflammatory reactions, and improves product safety, but more importantly, the regulating member 40 with the first coating 410 can also form an artificial barrier on the atrial side of the valve leaflet, blocking blood clots in the blood and closing the opening of the entire clamp body 100 facing the atrial side, thereby preventing blood from repeatedly flushing in the internal blind spots of the clamp body 100 to form blood clots, thereby avoiding thrombosis.

[0104] The second coating 420 and the third coating 430 can wrap around the metal surface and / or sharp metal edges of the clip body 100, thereby preventing damage to the clamped valve tissue. Furthermore, the second coating 420 and the third coating 430 can increase the resistance force applied to blood flow, thereby reducing the blood pressure difference between the left atrium and the left ventricle. In addition, the second coating 420 can also increase the contact area between the proximal clip 30 and the blood, thereby providing a buffer for the inflowing blood, thereby minimizing the inflowing blood from impacting the clip body 100 and causing deformation of the proximal clip 30, which could lead to slippage. The third coating 430 can also block a very small amount of thrombus that has entered the clip body 100 through the second coating 420, retaining it within the clip body 100, thereby preventing the thrombus from entering the left ventricle and entering the human blood circulation, potentially causing a stroke.

[0105] The third coating 430 has a large opening rate, which makes the third coating 430 have good elasticity and elongation. When the distal clip 20 covered with the third coating 430 opens and closes relative to the fixing seat 10, the third coating 430 can follow the opening and closing of the distal clip 20 and produce corresponding elastic deformation. The third coating 430 is always attached to the distal clip 20.

[0106] Preferably, in this embodiment, the mesh pores of the third coating 430 covering the proximal region of the distal clip 20 (i.e., the clamping section 22) are relatively small, and the third coating 430 in this region has a high density, so it is not easily worn through by the proximal edge of the distal clip 20 and will not affect the opening and closing of the distal clip 20; while the mesh pores of the third coating 430 covering the distal region of the distal clip 20 (i.e., the connecting section 21) are relatively large, and the elasticity and elongation of the third coating 430 in this region are better. Even in the case of some large opening and closing angles, the third coating 430 close to the fixing seat 10 can deform accordingly with the opening and closing of the distal clip 20, ensuring that the third coating 430 is attached and fixed to the distal clip 20.

[0107] Please also refer to Figures 22 to 24The structure of the valve clipper provided in the third embodiment of the present invention is similar to that of the valve clipper in the first embodiment, except that in the third embodiment, the adjusting member 40c is a mesh cage structure made of a biocompatible metal material selected from stainless steel, nickel-titanium alloy, or cobalt-chromium alloy, which exhibits a certain degree of elasticity. It is also understood that the adjusting member 40c can also be a mesh cage structure woven from an elastic material such as nickel-titanium wire to increase its elasticity, thereby improving its adaptability to the valve leaflets and reducing its outer diameter during delivery. Specifically, the mesh cage adjusting member 40c includes a woven mesh 47, and connecting tubes 48 and fixing tubes 49 connected to opposite ends of the woven mesh 47. The fixing tubes 49 are configured for removable connection to the fixing base 10. In this embodiment, the fixing tube 49 is axially symmetrically defined with a set of fixing holes 491. The fixing holes 491 cooperate with the protrusions 115 of the fixing base 10 to secure the adjusting member 40c to the fixing base 10.

[0108] In order to prevent the adjustment member 40c from affecting the relative opening and closing between the proximal clip 30 and the distal clip 20 and the fixing base 10 after being fixed to the fixing base 10, thereby affecting the clamping effect of the clamp body 100, the diameter of the distal portion of the braided mesh 47 gradually decreases from the proximal end to the distal end. Figure 22 As shown, in this embodiment, the middle portion of the braided mesh 47 is cylindrical, and the two opposite ends are cones, and the cone angles of the cones at the two ends are the same. In other embodiments, the braided mesh 47 can be other reasonable shapes, for example, Figure 23 The spindle-shaped structure with the same cone angle at both ends shown, or Figure 24 The structure shown with different taper angles at both ends is sufficient as long as the diameter of the distal end portion of the braided mesh 47 gradually decreases and does not affect the clamping effect of the clamp body 100.

[0109] Specifically, when making the adjusting part 40c in this embodiment, first, 12-36 nickel-titanium wires with a diameter of 0.05-0.08 mm are wound around the lining rod to weave into a cylindrical woven mesh 47, and one end of the straight woven mesh 47 is inserted into the connecting tube 48 made of a stainless steel tube, and the nickel-titanium wire and the connecting tube 48 are connected together by crimping or welding; then, the open end of the straight woven mesh 47 is inserted into the shaping mold, and the open end is wound into a bundle with stainless steel wire; the woven mesh 47 and the shaping mold are placed in an electrically heated circulating air box furnace and subjected to shaping heat treatment at 450-650°C (preferably 500°C) for 12-18 minutes; after being taken out and cooled to room temperature, the stainless steel wire is removed, and the shaping mold is taken out to obtain the shaping mesh; the nickel-titanium wire at the open end of the shaping mesh is inserted into the fixed tube 49 made of stainless steel, and crimped or welded to obtain the adjusting part 40c with a mesh cage structure.

[0110] In this embodiment, the cage-structured adjusting member 40c has better elastic deformation capability, can better adapt to the anatomical structure of the mitral valve, and avoid leaflet damage caused by excessive pulling of the leaflets.

[0111] It should be noted that the above description uses the example of a valve clipper used to alleviate or treat mitral regurgitation. It is understood that in other embodiments, the valve clipper can also be used to alleviate or treat tricuspid regurgitation. The principles and structure of the valve clipper are substantially similar to those of the valve clipper used to treat mitral regurgitation in the embodiments of the present invention. Multiple sets of proximal and distal clips are used to form multiple clamps, each clamping a valve leaflet. This is not further described here.

[0112] Obviously, in other embodiments, the valve clipper provided by the present invention can also be used in other minimally invasive surgical operations that require clamping three or more pieces of valve tissue together.

[0113] The above is an implementation of the embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the embodiment of the present invention. These improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. An adjustable valve clamping system, characterized in that: The invention comprises a valve clipper and a pushing device for delivering the valve clipper, wherein the valve clipper comprises: a clamp body, the clamp body comprising a distal clip and a proximal clip, the distal clip and the proximal clip cooperating to clamp the valve tissue; a clamp adjustment mechanism, the clamp adjustment mechanism being located between the pushing device and the clamp body, the clamp adjustment mechanism comprising an adjustment member having through holes extending through both ends along the axial direction, the adjustment member being slidable along the axial direction until it is sleeved on the clamp body; when the clamp body is retracted, the adjustment member abuts against the proximal clip to adjust the degree to which the clamp body pulls the valve tissue; Wherein, the pushing device includes a pushing assembly, the distal end of which is detachably connected to the clamp body; and the adjusting member is an elastic structure made of a biocompatible polymer material or a metal material.

2. The adjustable valve clamping system according to claim 1, wherein: The clamp body also includes a fixing base detachably connected to the pushing device, the distal clip can be opened and closed relative to the fixing base, and the proximal clip is arranged between the fixing base and the distal clip; the clamp adjustment mechanism is located between the pushing device and the fixing base.

3. The adjustable valve clamping system according to claim 2, wherein: A connecting piece is provided at the distal end of the pushing device, and the pushing device is detachably connected to the fixing seat through the connecting piece. The adjusting piece is sleeved on the outside of the connecting piece, and the adjusting piece slides along the connecting piece until it is sleeved on the fixing seat to push against the proximal clip.

4. The adjustable valve clamping system according to claim 3, wherein: The clamp adjustment mechanism further includes a driving member, which is used to drive the adjusting member to slide axially.

5. The adjustable valve clamping system according to claim 4, wherein: The clamp adjustment mechanism also includes a control line connected to the adjustment member, and the driving member is an elastic member arranged between the pushing device and the adjustment member; the control line is pulled toward the proximal end to drive the adjustment member to slide axially toward the proximal end, and the elastic member is compressed; when the control line is released, the elastic member stretches and pushes the adjustment member to slide axially toward the distal end to the outside of the proximal end of the fixing seat.

6. The adjustable valve clamping system according to claim 5, wherein: The adjusting member includes a clamping sleeve portion, a supporting portion and a fixing portion in sequence from the proximal end to the distal end, and the distal end of the elastic member is sleeved on the clamping sleeve portion.

7. The adjustable valve clamping system according to claim 6, wherein: The diameter of the clamping sleeve portion is smaller than the diameter of the supporting portion. A step surface is formed between the clamping sleeve portion and the supporting portion, and the distal end of the elastic member abuts against the step surface.

8. The adjustable valve clamping system according to claim 6, wherein: The support portion defines at least one threading hole, and the control line passes through the threading hole.

9. The adjustable valve clamping system according to claim 6, wherein: The diameter of the fixing portion gradually decreases from the proximal end to the distal end.

10. The adjustable valve clamping system according to claim 6, wherein: The fixing portion is provided with at least one fixing groove on the inner wall of the through hole or at least one fixing hole penetrating the outer wall of the fixing portion, and the outer wall of the fixing seat is provided with at least one protrusion, and the protrusion corresponds one-to-one with the fixing groove or the fixing hole to fix the adjusting member sleeved on the fixing seat.

11. The adjustable valve clamping system according to claim 5, wherein: The elastic member is sleeved on the outside of the connecting member, and the proximal end of the elastic member is connected to the pushing device.

12. The adjustable valve clamping system according to claim 5, wherein: The elastic member can be compressed or stretched along the axial direction of the pushing device.

13. The adjustable valve clamping system according to claim 3, wherein: At least one slide rail is axially arranged on the outer wall of the connecting member, and at least one slide groove is arranged on the inner wall of the through hole of the adjusting member corresponding to at least one of the slide rails.

14. The adjustable valve clamping system according to claim 3, wherein: At least two connecting rods are provided at the distal end of the connecting member, and a buckle for detachably connecting to the fixing seat is provided at the distal end of each connecting rod, and a buckle hole corresponding to the buckle is provided at the proximal end of the fixing seat.

15. The adjustable valve clamping system according to claim 14, wherein: The connecting rod is made of elastic material. When the buckle of the connecting rod is pushed outward in the radial direction of the connecting piece, the buckle of the connecting rod expands outward and is locked into the corresponding locking hole.

16. The adjustable valve clamping system according to claim 1, wherein: The polymer material is selected from silica gel or sponge, and the metal material is selected from stainless steel, nickel-titanium alloy or cobalt-chromium alloy.

17. The adjustable valve clamping system according to claim 1, wherein: The adjusting member is a mesh structure, which includes a woven mesh, and a connecting tube and a fixing tube respectively connected to opposite ends of the woven mesh, and the fixing tube is used for detachably connecting to the valve clipper.

18. The adjustable valve clamping system according to claim 2, wherein: At least one of the adjusting member, the proximal clip, and the distal clip is at least partially covered with a membrane.

19. The adjustable valve clamping system according to claim 18, wherein: The adjusting member, the proximal clip and the distal clip are respectively covered with a first coating, a second coating and a third coating.

20. The adjustable valve clamping system according to claim 19, wherein: The coating adopts a mesh structure, and the opening rates of the first coating, the second coating and the third coating decrease in sequence.

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