Valve clamping device with adjustable support force and valve clamping system

Abstract

The present invention discloses a valve clamping device and a valve clamping system with adjustable supporting force. The valve clamping device includes: a support portion; a hollow adjustment portion, the adjustment portion is made of shape memory material, one end of the adjustment portion is sleeved on the outside of the support portion and connected to the support portion, and the other end of the adjustment portion is movable along the support portion; a clamping portion, the clamping portion is surrounded on the outside of the adjustment portion; a driving portion, the driving portion is connected to the clamping portion to drive the clamping portion to expand or close around the adjustment portion; when the clamping portion is closed relative to the adjustment portion, the proximal end of the adjustment portion does not exceed the proximal end of the clamping portion. In this way, the valve clamping device of the present invention can improve the elastic fit between the leaflet and the adjustment portion, thereby improving the adaptability of the leaflet physiological structure to different patients.

Description

Technical Field

[0001] The present application relates to the field of implantable medical devices, and in particular to a valve clamping device and a valve clamping system with adjustable supporting force. Background Art

[0002] See 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 valve regurgitation."

[0003] Transcatheter mitral valve clipping involves implanting a valve clipping device into the mitral valve, using a pair of closable clamping arms to pull the anterior and posterior leaflets toward each other, reducing or eliminating the interleaflet gap and thereby treating mitral regurgitation. Prior art valve clipping devices incorporate an elastic body between the two clamping arms. Each leaflet is clamped between one clamping arm and one side of the elastic body. The elastic body deforms to adjust the distance between the leaflets, thereby regulating the degree of retraction applied by the clamping arms. The elastic body comprises a deformable mesh body secured at both ends by caps, such as steel sleeves, which are then secured to a support rod between the two clamping arms. However, because both ends of the elastic body are secured by caps, when the clamping arms are closed, the caps restrict the axial movement of the elastic body, forcing it to be compressed radially. This affects its deformation, increases the size of the clipping device during delivery, and hinders its ability to pass through curved vessels. Furthermore, after implantation, the elastic body may not fully conform to the leaflets, resulting in poor adaptability to the leaflet anatomy of different patients. Summary of the Invention

[0004] In order to solve the above technical problems or at least partially solve the above technical problems, the present application provides a valve clamping device and a valve clamping system.

[0005] In a first aspect, the present application provides a valve clamping device with adjustable support force, comprising:

[0006] Support part;

[0007] a hollow adjusting portion, the adjusting portion being made of a shape memory material, one end of the adjusting portion being sleeved on the outside of the supporting portion and connected to the supporting portion, and the other end of the adjusting portion being movable along the supporting portion;

[0008] a clamping portion, the clamping portion being arranged around the outer side of the adjusting portion;

[0009] a driving portion connected to the clamping portion to drive the clamping portion to expand or close around the adjusting portion;

[0010] Wherein, when the clamping portion is closed relative to the adjusting portion, the proximal end of the adjusting portion does not exceed the proximal end of the clamping portion.

[0011] In the second aspect, the present application provides a valve clamping system, including the above-mentioned valve clamping device and a delivery device, wherein the delivery device includes: a pushing shaft with a certain axial length and a core shaft movably installed in the pushing shaft, the pushing shaft and the support part are detachably connected, and the core shaft is connected to the driving part for driving the expansion and closing of the clamping part relative to the support part.

[0012] The technical solution provided by the embodiments of the present application has the following advantages over the prior art: For a valve clamping device and a valve clamping system including the same, one end of the regulating portion is sheathed outside the support portion and connected to the support portion, while the other end of the regulating portion is movable along the support portion, thereby improving the axial deformation capability of the regulating portion and enhancing its axial bending deformation capability. Therefore, when the valve clamping device is radially compressed into a delivery device for in vivo delivery, it is not only easily compressed into the sheath, but also can adapt to vessels of varying curvatures during delivery within a blood vessel, thereby facilitating the delivery device's passage through the vessel and reducing damage to the vessel wall. Furthermore, after implantation of the valve clamping device, the clamp arms clamp the valve leaflets and the regulating portion, and since the axial deformation of the regulating portion is unrestricted, the elastic fit between the valve leaflets and the regulating portion can be improved, thereby improving the adaptability of the valve leaflet physiological structure to different patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention.

[0014] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, for ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0015] Figure 1This is a schematic diagram of the mitral valve in its normal state;

[0016] Figure 2 This is a schematic diagram of a mitral valve disease.

[0017] Figure 3a 1 is a schematic structural diagram of a valve clamping device according to a first embodiment of the present invention;

[0018] Figure 3b yes Figure 3a Schematic diagram of the structure of the valve clamping device applying the biocompatible film;

[0019] Figure 4 yes Figure 3a Schematic diagram of the structure after the middle adjustment part and the support part are combined;

[0020] Figure 5 yes Figure 3a A schematic diagram of the structure of the middle valve clamping device in a closed state;

[0021] Figure 6 yes Figure 3a Schematic diagram of the structure after the middle clamping part and the driving part are combined;

[0022] Figure 7 yes Figure 3a Schematic diagram of the structure of the middle support part;

[0023] Figure 8 yes Figure 3a Schematic diagram of the structure of the middle support part and the base;

[0024] Figure 9 yes Figure 3a A schematic diagram of the structure of the support portion of the mid-valve clamping device cooperating with the delivery device;

[0025] Figure 10-14 It is adopted Figure 3a Schematic diagram of the delivery process of the mid-valve clipping device through the left atrium to approach and repair the mitral valve;

[0026] Figure 15 2 is a schematic structural diagram of a valve clamping device according to a second embodiment of the present application;

[0027] Figure 16 is a structural schematic diagram of the valve clamping device in the second embodiment of the present application in a closed state;

[0028] Figure 17 2 is a schematic structural diagram of a valve clamping device according to a third embodiment of the present application;

[0029] Figure 18 This is a schematic structural diagram of the valve clamping device and the delivery device in cooperation with each other in the third embodiment of the present application;

[0030] Figure 19 is a schematic structural diagram of the valve clamping device in a closed state according to the third embodiment of the present application;

[0031] Figure 20 2 is a schematic structural diagram of a valve clamping device according to a fourth embodiment of the present application;

[0032] Figure 21 is a schematic structural diagram of the valve clamping device of the fourth embodiment of the present application in a closed state;

[0033] Figure 22 is a schematic structural diagram of the first curved surface side of the adjustment portion of the valve clamping device according to the fifth embodiment of the present application;

[0034] Figure 23 yes Figure 22 A top view of the middle adjustment portion;

[0035] Figure 24 yes Figure 22 A schematic structural diagram of the second curved surface side of the middle adjustment portion;

[0036] Figure 25 1 is a schematic structural diagram of a valve clamping device according to a sixth embodiment of the present application;

[0037] Figure 26 yes Figure 25 Schematic diagram of the structure in which the valve clamping device is partially retracted into the delivery device after radial compression. DETAILED DESCRIPTION

[0038] 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.

[0039] 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.

[0040] 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.

[0041] See Figure 3a-Figure 14 The first embodiment of the present invention provides a valve clamping device 100 with adjustable supporting force, which includes: a support part 110, the support part 110 includes a connecting end 111 and a free end 112 arranged opposite to each other; a hollow adjusting part 120, the adjusting part 120 is made of shape memory material, one end of the adjusting part 120 is sleeved on the outside of the connecting end 111 and connected to the support part 110, and the other end of the adjusting part 120 is suspended, and the free end 112 of the support part 110 is suspended in the adjusting part 120, and there is a gap between the proximal end of the adjusting part 120 and the free end 112; a clamping part 130, the clamping part 130 is surrounded by the outside of the adjusting part 120; and a driving part 140, the driving part 140 is connected to the clamping part 130 to drive the clamping part 130 to expand or close around the adjusting part 120.

[0042] One end of the adjustment portion 120 of the above-mentioned valve clamping device 100 is a free suspended end 121b. The free suspended end 121b is no longer restricted by the support portion 110 or the delivery device 200, thereby improving the axial deformation ability of the adjustment portion 120 and enhancing its axial bending deformation ability. Therefore, when the valve clamping device 100 is radially compressed into the delivery device for in vivo delivery, it is not only easy to be compressed into the sheath, but also can adapt to blood vessels with different curvatures when delivered in the blood vessel, thereby facilitating the passage of the delivery device in the blood vessel, thereby reducing damage to the blood vessel wall.

[0043] At the same time, the free end 112 is connected to or detached from the delivery device in the adjustment portion 120, avoiding contact between the free end 112 and blood vessels or other tissues during the release operation of the instrument, reducing damage to human tissue, and preventing the free end 112 from hooking the tendon cord and causing release failure.

[0044] In addition, after the valve clamping device 100 is implanted, during the process of clamping the leaflet and the regulating part 120 by the clamp arm 131, the axial deformation of the regulating part 120 is not restricted, which can improve the elastic fit between the leaflet and the regulating part 120, thereby improving the adaptability of the leaflet physiological structure to different patients.

[0045] In addition, after the valve clamping device 100 is implanted, the free end 112 is suspended in the adjustment part 120, and there is a gap between the proximal end of the adjustment part 120 and the free end 112, which can avoid interference or entanglement between the suspended free end 112 and the free suspended end 121b of the adjustment part 120, thereby ensuring the safe implantation of the device.

[0046] The valve clamping device 100 primarily operates in two states: an expanded state and a closed state. As the clamping portion 130 closes around the regulating portion 120, the regulating portion 120 is radially compressed, and the spacing h between the proximal end of the regulating portion 120 and the proximal end of the support portion 110 gradually increases. Specifically, one end 121a of the regulating portion 120 is sheathed outside the connecting end and connected to the support portion 110, while the other end of the regulating portion 120 is a free, suspended end 121b. As the clamping portion 130 compresses the regulating portion 120, the free, suspended end 121b of the regulating portion 120 moves toward the proximal end, increasing the spacing h between the regulating portion 120 and the support portion 110.

[0047] See Figure 6-Figure 8 , the support portion 110 can be a circular tube, a square tube or an oblate tube, etc., with both end faces axially connected. This embodiment adopts a circular tube, the distal end of which is a connecting end 111, and the proximal end is a free end 112. At least a portion of the support portion 110 is arranged in the hollow of the adjustment portion 120. For example, the free end 112 of the support portion 110 is located in the adjustment portion 120. The free end 112 is located in the adjustment portion 120 in both the closed state and the expanded state, and the adjustment portion 120 is not exposed to the outside. The support portion 110 is also provided with an axial through-hole-shaped penetration channel 113 to cooperate with the drive portion 140 and the conveying device 200. At least two latching positions 114 are provided on the tube wall of the circular tube of the support portion 110 for detachable connection with the conveying device 200. For example, when the platform 221 on the delivery device 200 is engaged with the engagement position 114, the delivery device 200 is engaged and connected with the support portion 110, and the valve clamping device 100 can be delivered. When the platform 221 is disengaged from the engagement position 114, the delivery device 200 is separated from the valve clamping device 100. It should be understood that the structure of the support portion 110 herein is merely an example and does not limit the present application. Other structures of the support portion 110 adopted by persons of ordinary skill in the art based on the teachings of this application are all within the scope of protection of this application.

[0048] The proximal free end 112 of the valve clipping device 100 of the present application is located within the hollow adjustment portion 120, whether in the closed or expanded state. Therefore, it is never exposed to the delivery device 200 or the heart, thereby preventing blood flushing and minimizing the formation of thrombi after implantation. Furthermore, after implantation, direct contact with the valve leaflets is avoided, which, along with the long-term pulsation of the valve leaflets, prevents abrasion or even perforation of the leaflets, thereby improving implant safety.

[0049] See Figure 4 and Figure 8The adjustment portion 120 includes a deformable elastic body 123, which has a natural state and a compressed state. The elastic body 123 has a hollow housing, within which at least a portion of the support portion 110 is disposed. One end 121a of the elastic body 123 is connected to the support portion 110, while the other end 121b of the elastic body 123 has an opening 122 that is freely suspended. In the compressed state, the size of the opening 122 is smaller than or equal to the size of the free end of the support portion 110. Therefore, when the valve clipping device 100 is closed, the elastic body 123 is squeezed, and the size of the opening 122 decreases, preventing the support portion 110 from being exposed through the opening 122. The elastic body 123 is deformable, thereby adapting to the spacing between different leaflets and adjusting the degree of traction on the leaflets by the valve clipping device 100. The opening 122 of the elastic body 123 is used to pass the distal end of the conveying device 200. It should be understood that the distal end of the conveying device 200 is connected to the proximal end (free end) of the support portion 110 after passing through the hollow accommodating cavity of the elastic body 123 through the opening 122, while the opening 122 at the distal end of the elastic body 123 is not connected to the distal end of the conveying device 200 or the proximal end (free end) of the support portion 110, that is, the proximal end 121b of the elastic body 123 is in a freely suspended state. Therefore, during the delivery process or the process of clamping the leaflets, when the clamping part 130 is closed, the elastic body 123 in the adjustment part 120 is not restricted by the support part 110 or the delivery device 200, and can be deformed in both radial and axial directions. The degree of deformation is greater, which is more conducive to delivery and has a stronger adaptability to the leaflets; when the connection between the distal end of the delivery device 200 or the proximal end (free end) of the support part 110 is released, the deformation ability of the freely suspended end of the adjustment part 120 is stronger, and the adaptability to the leaflets is stronger.

[0050] The adjustment portion 120 includes a proximal end and a distal end. In one embodiment, the proximal edge of the elastic body 123 is provided with a hollow snare structure (not shown in the figure) to form an opening, that is, the proximal end of the elastic body 123 is provided with a head after being folded. The snare structure can be annular or polygonal and can be made of a hard material such as stainless steel, so that the mesh wires of the mesh structure or the support rods of the frame structure are appropriately gathered toward the central axis, but not closed, thereby forming an opening 122 at the center of the snare structure. In another embodiment, the proximal edge of the elastic body 123 encloses the above-mentioned opening 122, and the size of the opening 122 is less than or equal to the size of the free end 112, thereby ensuring that the free end 112 of the support portion 110 does not extend out of the adjustment portion 120 in both the compressed state and the natural state.

[0051] The proximal edge of the elastic body 123 encloses the opening 122, eliminating the proximal head of the adjustment part 120 of the valve clamping device 100. When the clamping part 130 is closed, the elastic body 123 can be deformed not only in the radial direction but also in the axial direction, and the deformation degree is large, which is more conducive to transportation. In addition, the elastic body 123 is not restricted by the axial movement of each mesh or support rod of the head, so it can curl or bend moderately, so as to completely fit the leaflet and better adapt to the physiological structure of the leaflet of different patients. In addition, the risk of the proximal head component in the prior art falling off after being implanted for a period of time can also be avoided. In addition, the distal end of the elastic body 123 is connected to the support part 110, and the opening 122 at the proximal end is open, so the center of gravity is always located in the axial direction of the support part 110 (that is, the axial center line of the elastic body 123), so it has good self-centering and is not easy to tilt.

[0052] See Figure 5 The clamping portion 130 includes at least two arms 131, and generally may include at least one group of arms 131. Each group of arms 131 includes two arms 131 symmetrically arranged relative to the adjustment portion 120. The clamping portion 130 shown in the figure includes one group of arms 131. It should be understood that this is merely an example, and one skilled in the art can select an appropriate number of arms 131 as needed, such as two or more groups of arms. The driving portion 140 is connected to each arm 131, for example, the driving portion 140 is connected to two arms 131 in a group of arms 131, to drive each arm 131 to rotate around the adjustment portion 120. It is understood that three or more arms 131 can be provided in each group as needed. For example, three relatively openable arms 131 can be used to clamp the three leaflets of the tricuspid valve, thereby treating tricuspid regurgitation.

[0053] In the transport state, the driving unit 140 drives the clamp arm 131 to close around the adjusting unit 120, thereby reducing the outer diameter of the valve clamping device 100 and facilitating transport; after the valve clamping device 100 is deployed in the body, the driving unit 140 drives the clamp arm 131 to clamp the leaflet between the clamp arm 131 and the adjusting unit 120 to achieve leaflet clamping.

[0054] In a preferred embodiment of this embodiment, the valve clamping device 100 further includes a grasping portion, which may generally include at least one group of grasping arms 151. Each group of grasping arms 151 includes two grasping arms 151 symmetrically arranged relative to the adjustment portion 120. The grasping portion (e.g., the grasping arms 151) is disposed between the clamping portion 130 (e.g., the clamp arms 131) and the adjustment portion 120 and can be expanded or closed relative to the adjustment portion 120. The grasping portion is at least partially accommodated within the inner surface of the clamping portion 130. Of course, three or more grasping arms 151 may be provided in each group as needed to cooperate with the clamp arms 131 to achieve the clamping function.

[0055] In the conveying state, the grasping portion is at least partially accommodated in the inner surface of the clamping portion 130, that is, the grasping arm 151 is at least partially accommodated in the inner surface of the clamp arm 131, thereby reducing the outer diameter of the valve clamping device 100 and facilitating conveying; after the clamp arm 131 and the grasping arm 151 cooperate to clamp the leaflet, the concave inner surface can increase the contact area between the clamp arm 131 and the leaflet, and enable the grasping arm 151 to press the leaflet into the inner surface of the clamp arm 131, thereby increasing the clamping force on the leaflet.

[0056] See Figure 3b A biocompatible film or a biocompatible coating is applied to the exterior of the forceps arm 131 and the gripping portion, thereby making the valve clipping device 100 more biocompatible.

[0057] See Figure 8 The valve clamping device 100 further includes a base 160 fixedly connected to the support portion 110, and the clamping portion 130 is rotatably connected to the base 160. Specifically, the proximal end of the base 160 is fixedly connected to the distal end 121a of the support portion 110. It should be noted that for ease of explanation, this portion is defined as the "base" herein. The structure that implements the function of the base 160 may also be the distal end of the support portion 110, that is, a structure formed integrally with the support portion 110. Therefore, the definition of the term "base" should not limit the scope of this application. Each clamp arm 131 in each group is connected together on the base 160 via a pivot 132. Therefore, under the drive of the drive portion 140, each clamp arm 131 cooperates with each other to expand and close around the adjustment portion 120.

[0058] Still see Figure 6 and Figure 8 The drive unit 140 includes a drive shaft 141, a connecting base 142, and two connecting rods 143. Each connecting rod 143 has one end connected to the clamping portion 130 and the other end pivotally connected to the connecting base 142. The drive shaft 141 has one end connected to the connecting base 142 and the other end movably mounted in the base 160. Specifically, each connecting rod 143 has one end connected to a clamp arm 131 and the other end connected to the connecting base 142 via a pivot 144. That is, each clamp arm 131 is rotatably connected to the distal end of the connecting base 142 of the drive shaft 141 via the corresponding connecting rod 143. The drive shaft 141 movably passes through the base 160. When the drive shaft 141 slides axially relative to the base 160, the connecting rod 143 rotates and drives the clamp arm 131 to open and close relative to the base 160.

[0059] Specifically, the drive unit 140 includes at least one set of connecting rods 143. The number of connecting rods 143 corresponds to the number of clamp arms 131. For example, if two clamp arms 131 are used in the figure, two corresponding connecting rods 143 are provided. The distal ends of the connecting rods 143 are rotatably connected to the connecting base 142 at the distal end of the drive shaft 141 by rotating pins or bolts 144. When the drive shaft 141 slides axially toward the distal end relative to the base 160, it drives the connecting rods 143 to move. Under the pull of the connecting rods 143, the clamp arms 131 rotate about the pin holes 144 and open relative to the base 160. When the drive shaft 141 slides axially toward the proximal end relative to the base 160, the connecting rods 143 pull the clamp arms 131 to rotate about the pin holes 144 and close relative to the base 160.

[0060] The connecting seat 142 is fixedly arranged at the distal end of the drive shaft 141 by welding or other means, and the connecting seat 142 is provided with a pair of pins. The pin hole is used to hinge the connecting rod 143 through the pin 144, and the other end of the connecting rod 143 is connected to the clamp arm 131, thereby realizing the opening and closing of the clamp arm 131 relative to the base 160. The shape of the connecting seat 142 is any structure such as a hemisphere, a spherical crown or a bullet shape, so that the valve clamping device 100 is easier to push in the body. The drive shaft 141 and the connecting seat 142 can be an integral structure or a non-integrated structure. To ensure safety after implantation, the drive shaft 141 and the connecting seat 142 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.

[0061] Preferably, see Figure 6 As shown, the valve clipping device 100 further includes a locking portion 170 disposed within the base 160. The locking portion 170 limits relative movement between the drive shaft 141 and the base 160. During delivery, the locking portion 170 limits relative movement between the drive shaft 141 and the base 160, thereby ensuring that the clipping portion 130 remains closed relative to the adjustment portion 120 and the support portion 110, preventing accidental deployment of the clipping portion 130. Upon reaching the vicinity of the mitral valve, the locking portion 170 is released from the drive shaft 141, allowing the drive portion 140 to drive the clipping portion 130 to deploy relative to the adjustment portion 120 and the support portion 110, thereby supporting the valve leaflets. Any suitable existing locking portion may be employed, and further description thereof will not be given here.

[0062] See Figure 6 and 9The valve clamping system of this embodiment includes the above-mentioned valve clamping device 100 and a delivery device 200, wherein the delivery device 200 includes: a push shaft 210 with a certain axial length and a core shaft (not shown in the figure) movably installed in the push shaft 210, the push shaft 210 is detachably connected to the support part 110, and the core shaft is connected to the driving part 140, which is used to drive the expansion and closure of the clamping part 130 relative to the support part 110. In this embodiment, the proximal end of the drive shaft 141 is provided with an external thread, and the core shaft and the drive shaft 141 are threadedly connected, so that the axial movement of the drive shaft 141 is controlled by the core shaft outside the patient's body. It should be known that what is listed here is only a part of the structure of the delivery device, and the other parts can adopt any existing suitable structure, which will not be repeated here.

[0063] Specifically, the proximal outer wall of the support portion 110 is symmetrically provided with at least one latching position 114 that is connected to the tubular cavity of the support portion 110. The distal end of the push shaft 210 is provided with a fixing member 220. The fixing member 220 includes two branches, each of which ends in a raised latching platform 221. In a natural state, both branches point to the central axis of the fixing member 220. During assembly, the fixing member 220 is inserted into the support portion 110, and then the core shaft of the delivery device 200 is inserted into the push shaft 210 until the core shaft is inserted into the fixing member 220. The two branches of the fixing member 220 are pushed outward, and the latching platforms 221 at the ends of the branches are snapped into the two latching positions 114 of the support portion 110, thereby connecting the support portion 110 and the fixing member 220, that is, connecting the valve clamping device 100 and the delivery device 200. When the core shaft is withdrawn from the fixing member 220 and the push shaft 210, the two branches return to their natural inward position, and the clamping platform 221 disengages from the locking position 114 of the support portion 110, thereby disconnecting the valve clipping device 100 from the delivery device 200. The fixing member 220 is made of a material with a certain hardness and elasticity, such as nickel titanium. The push shaft 210 can be made of a multi-layer composite tube. The core shaft is made of stainless steel or nickel titanium alloy.

[0064] The support portion 110 has a through hole inside that serves as a passage 113 for the drive shaft 141. The drive shaft 141 is axially slidably inserted into the passage 113 of the support portion 110. The proximal end of the drive shaft 141 is provided with external threads for connection to the core shaft of the delivery device 200, thereby controlling the axial movement of the drive shaft 141 via the core shaft. After the clamping portion 130 and the gripping portion 150 engage and clamp the valve tissue, the core shaft drives the drive shaft 141 to move axially proximally. The drive shaft 141 drives the connecting rod 143 to rotate, which in turn drives the clamp arm 131 to close relative to the support portion 110 until the clamp arm 131 is fully closed relative to the support portion 110, placing the valve clamping device 100 in a retracted and closed state and dropping it below the valve. The connection between the core shaft and the drive shaft 141 can then be released, the core shaft withdrawn from between the fixing members 220, and the latch 221 separated from the latching position 114 of the support portion 110, thereby achieving the release of the valve clamping device 100 and the delivery device 200. During the release process, because the connection between the valve clamping device 100 and the delivery device 200 (i.e., the release point) is located within the adjustment portion 120 of the valve clamping device 100, and the proximal end of the adjustment portion 120 is provided with an open opening 122, no parts can hook onto the latch 221 at the branch end of the fixing member 220, thereby facilitating the release of the valve clamping device 100. In addition, the release point is located within the adjustment portion 120 and is not directly exposed to blood, which can prevent mechanical failure of the release point and reduce the risk of thrombosis.

[0065] See Figures 9-13 Taking the anterograde approach to and repair of the mitral valve through the left atrium as an example, the use process of the valve clipping device 100 of the present application is described:

[0066] Step 1: If Figure 9 As shown, the drive shaft 141 and the valve clamping device 100 connected thereto are advanced from the left atrium 2 through the mitral valve 1 to the left ventricle 3 via an adjustable sheath or other guiding device (not shown).

[0067] Step 2: Adjust the valve clipping device 100 to be close to the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1;

[0068] Step 3: If Figure 10 As shown, the locking portion in the base 160 is unlocked, the core shaft and the drive shaft 141 are pulled proximally, the forceps arm 131 is driven to open relative to the support portion 110, and the direction of the forceps arm 131 is adjusted. At this time, the relative position of the forceps arm 131 and the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 can be observed by X-ray equipment, so that the forceps arm 131 is perpendicular to the coaptation line of the mitral valve 1;

[0069] Step 4: If Figure 11As shown, the entire valve clamping device 100 is withdrawn proximally, so that the clamp arm 131 holds the valve leaflet 1 on the left ventricle 3 side, and the grasping arms 151 on both sides are released. The grasping arms 151 on each side press the valve leaflet 1 on the atrial side and cooperate with the clamp arm 131 on that side to fix the valve leaflet 1, thereby achieving complete clamping of the valve leaflet 1;

[0070] Step 5: If Figure 12 As shown, when the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are respectively clamped between a pair of clamp arms 131 and the grasping arm 151, the core shaft and the driving shaft 141 are pushed distally, thereby driving the clamp arms 131 to close;

[0071] Step 6: Release the threaded connection between the core shaft and the drive shaft 141, and withdraw the core shaft. The two branches of the fixing member 220 are restored to the state of being close to the central axis. The clamping platform 221 is separated from the clamping position 114 of the support part 110. The connection between the valve clamping device 100 and the delivery device 200 is released. Then, the delivery device 200 is withdrawn from the body, and the valve is obtained. Figure 13 In the implanted state shown, the valve clipping device 100 pulls the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 toward each other, obtaining a double-pore mitral valve and completing the edge-to-edge repair of the mitral valve.

[0072] After the valve clamping device 100 is implanted, the elastic regulating portion 120 is filled between the anterior leaflet 1a and the posterior leaflet 1b of the clamped mitral valve 1 and presses against the clamp arm 131. The elastic main body 123 (such as a mesh structure or a porous structure, etc.) of the regulating portion 120 has a buffering effect on the pulsating leaflet 1, thereby achieving the adjustable pulling degree of the valve clamping device 100 on the leaflet 1 to avoid damaging the leaflet 1; in addition, the elastic main body 123 can be squeezed and deformed following the pulsation of the leaflet 1, and the elastic force generated pushes the part of the leaflet 1 close to the elastic main body 123 away from the base 160, and at this time, due to the The opening 122 structure of 120 makes the axial movement of the elastic body 123 toward the proximal end no longer restricted, and the clamping angle between the anterior leaflet and the posterior leaflet of the mitral valve is smaller than the opening angle between the clamp arms 131, which can reduce the pulling of the valve leaflet 1 by the valve clamping device 100, so that the pulling degree of the valve leaflet 1 by the valve clamping device 100 is always kept within a reasonable range; in addition, the elastic body 123 can buffer the direct flushing of the blood flow on the interior of the valve clamping device 100, thereby preventing the valve clamping device 100 from being continuously flushed by the blood and falling off, and also preventing blood from being trapped in the dead angle between the clamping parts 130 of the valve clamping device 100 ( Figure 3aIn addition, when the elastic body 123 is subjected to the pressure of the valve, it will produce a certain degree of deformation, and the degree of deformation increases with the increase of pressure, thereby preventing the elastic body 123 from being squeezed by the clamp arm 131 and acting on the clamp arm 131 after grasping the leaflet 1, thereby ensuring that the grasping effect of the valve clamping device 100 on the leaflet 1 after release remains consistent with that before release.

[0073] See Figure 15 and Figure 16 Compared with the valve clamping device 100 of the first embodiment, the difference of the valve clamping device 300 according to the second embodiment of the present invention is that the adjustment portion 320 is approximately conical in the expanded state, and the cross-sectional size gradually increases from the distal end to the proximal end. The proximal end surface of the adjustment portion 320 constitutes the bottom surface of the vertebral body, and the connecting end of the adjustment portion 320 and the support portion 310 constitutes the apex of the above-mentioned vertebral body.

[0074] The valve clamping device 300 mainly includes two states, one is an expanded state and the other is a closed state. When the clamping portion 330 is closed around the adjusting portion 320, the proximal end of the adjusting portion 320 is at the distal side relative to the proximal end of the clamping portion 330.

[0075] Specifically, after the clamping portion 330 is radially compressed, the free end 321b of the regulating portion 320 moves toward the proximal end, but the proximal end of the regulating portion 320 after radial compression is distal to the proximal end of the clamping portion 330. In this way, the regulating portion 320 is not exposed at the proximal end surface of the clamping portion 330 after closure, ensuring that the outward-facing end of the clamping portion 330 abuts against the leaflets to increase the contact area between the leaflets, conform to the angle and direction of the leaflets, and avoid the risk of thrombosis caused by excessive exposure of the regulating portion 320 in the left atrium.

[0076] See Figure 17-Figure 19 Compared with the valve clamping device 100 of the first embodiment, the regulating portion 420 of the valve clamping device 400 according to the third embodiment of the present invention further includes a suspended extension portion 422 located at its proximal end, and the extension portion 422 extends toward the proximal end, such as Figure 17 As shown at B in FIG. For example, the extension portion 422 may form a circle around the outer circumference of the adjustment portion 420 and form a boss structure A near the distal connection, the boss structure A extending perpendicularly to the direction from the distal end to the proximal end.

[0077] After the clamping portion 430 is closed around the regulating portion 420, the extension portion 422 is exposed and extends out from the proximal end of the clamping portion 430 and is not clamped and wrapped by the clamping portion 430. At this time, there is a gap between the proximal end of the clamping portion 430 and the extension portion 422. For example, the axial gap length between the distal end surface of the extension portion 422 and the proximal end surface of the clamping portion 430 can be defined as the gap spacing L. A person skilled in the art can set a specific L value based on factors such as the anatomical structure. In this embodiment, when the clamping portion 430 is closed around the regulating portion 420, the extension portion 422 protrudes from the clamping portion 430, that is, the clamping portion 430 does not clamp the extension portion 422. This can improve the elastic fit between the leaflet and the regulating portion 420.

[0078] Specifically, after the valve clamping device 400 clamps the valve, the extension portion 422 that is not clamped and wrapped by the clamping portion 430 can further cooperate with the clamping portion 430 to clamp the leaflet. For example, the boss structure A contacts the leaflet, thereby enhancing the clamping force between the valve clamping device 400 and the leaflet, thereby improving the implantation stability of the valve clamping device 400.

[0079] Furthermore, the proximal end face of the regulating portion 420 is recessed toward the distal end. During the clamping process of the clamping portion 430, the recessed portion is conducive to the radial compression of the regulating portion 420, and after compression, the braided wire near the extension portion 422 will not be accumulated. While reducing the compression size, it can also reduce the radial reaction force and improve the safety of the device after compression. On the other hand, the recessed area also forms a accommodating space for the conveying device, and the connection and disassembly of the conveying device 200 will not be affected by the setting of the extension portion 422. The extension portion 422 extends in a direction perpendicular to the direction from the proximal end to the distal end, and the extension portion 422 is substantially parallel to the direction perpendicular to the direction from the proximal end to the distal end, which can improve the elastic fit between the leaflet and the regulating portion 420.

[0080] See Figure 20 and Figure 2 Compared to the valve clipping device 400 of the third embodiment, the regulating portion 720 of the valve clipping device 700 according to the fourth embodiment of the present invention further includes a suspended extension portion 722 located at its proximal end. The extension portion 722 extends radially outward away from the support portion 710. Specifically, the extension portion 722 extends perpendicularly to the direction from the proximal end to the distal end and is substantially parallel to the direction perpendicular to the proximal end to the distal end, forming a platform-like structure with a substantially straight cross-section. This improves the elastic fit between the leaflet and the regulating portion 720.

[0081] Specifically, after the valve clamping device 700 clamps the valve, the extension portion 722 that is not clamped and wrapped by the clamping portion 730 can further cooperate with the clamping portion 730 to clamp the leaflets. For example, the platform structure contacts the leaflets, thereby enhancing the clamping force between the valve clamping device 700 and the leaflets, thereby improving the implantation stability of the valve clamping device 700.

[0082] A steel sleeve 723 is provided at the proximal end of the adjustment portion 720 to facilitate the insertion of the delivery device 200. The sleeve 723 is positioned at the free, suspended end 721b of the adjustment portion 720. An extension portion 722 surrounds the sleeve 723. When the valve clamping device 700 is radially compressed, the extension portion 722 wraps around the sleeve 723, preventing it from contacting the inner wall of the sheath and directly contacting the valve leaflets and other human tissue, thereby ensuring safe delivery and implantation of the device.

[0083] A biocompatible film is provided on the outside or inside of the regulating portion 720 as a flow barrier to prevent blood from entering the regulating portion 720. In specific applications, the biocompatible film can also be provided on both the outside and inside of the regulating portion 720. This makes the valve clipping device 700 more biocompatible and prevents blood from entering the regulating portion 720 and forming thrombi.

[0084] See Figure 22-Figure 24 Compared with the valve clamping device 100 of the first embodiment, according to the valve clamping device of the fifth embodiment of the present invention, the adjustment portion 520 has a free suspended end 521b and a distal head 521, and the free suspended end 521b may have an opening 522. The adjustment portion 520 includes multiple first curved surfaces 520A and multiple second curved surfaces 520B. The first curved surfaces 520A and the second curved surfaces 520B are adjacent to each other and smoothly connected together, that is, the first curved surface 520A is only adjacent to the second curved surface 520B, and the second curved surface 520B is also only adjacent to the first curved surface 520A. The two oppositely arranged first curved surfaces 520A face one clamp arm respectively, and the area of ​​the second curved surface 520B is smaller than the area of ​​the first curved surface 520A.

[0085] In this embodiment, a relatively large first curved surface 520A faces the forceps arm, while a relatively smaller second curved surface 520B smoothly connects the two first curved surfaces 520A. As the valve clamping device closes, the first curved surface 520A of the adjusting portion 520 is squeezed by the forceps arm and the valve leaflets. The adjusting portion 520 extends along the direction of the first curved surface 520A, gradually conforming to the valve leaflets, thereby better adapting to the shape of the valve leaflets and increasing the contact area between the first curved surface 520A and the valve leaflets. This reduces the gap between the valve clamping device and the valve leaflets, slowing blood flow and preventing blood flow from eroding the valve clamping device. Preferably, the curvature of the first curved surface 520A can be greater than that of the second curved surface 520B, so that the adjusting portion assumes a flattened ellipsoidal shape, thereby preventing interference with the closure of the forceps arm. Furthermore, in this embodiment, when the forceps arm is closed, the first curved surface 520A of the adjustment portion 520 is squeezed by the forceps arm and the leaflet, and the adjustment portion extends axially. Since the first end of the adjustment portion is open, it will not hook the distal end of the delivery system, thereby ensuring that the valve clamping device will be detached from the delivery device connection of the valve clamping device in the event of any deformation of the adjustment portion.

[0086] See Figure 25 and Figure 26 Compared to the valve clipping device of the first embodiment, the valve clipping device 600 according to the sixth embodiment of the present invention has an adjustment portion structure identical to the adjustment portion 120 of the first embodiment, differing in the manner in which the clipping portion 630 and the grasping portion 650 cooperate to grasp the valve leaflets. In the sixth embodiment, the clipping portion 630 includes a set of clamping arms 631 that can be expanded or closed relative to the support portion 610 and the adjustment portion. The grasping portion 650 includes a pair of grasping arms 651, and the grasping portion 650 is located between the clipping portion 630 and the adjustment portion.

[0087] During delivery, the clamping portion 630, the gripping portion 650 and the regulating portion are all housed in the distal end of the delivery device 200. The delivery device 200 is delivered into the left ventricle through the transapical approach and then crosses the mitral valve orifice to reach the left atrium. The delivery device 200 is then withdrawn, so that the regulating portion and the gripping portion 650 gradually extend out of the delivery device 200 and unfold in the left atrium. The delivery device 200 is further withdrawn until the clamping portion 630 also extends out of the delivery device 200 and unfolds in the left ventricle. The driving portion then pushes the clamping portion 630 toward the distal end, supporting the anterior and posterior leaflets of the mitral valve on the inner surfaces of the two clamp arms 631 of the clamping portion 630, and the gripping portion 650 is withdrawn toward the proximal end. 0 and the adjusting portion, that is, driving the grasping portion 650 to move in the direction of the clamping portion 630, thereby capturing the leaflet between the grasping portion 650 and the clamping portion 630, and then driving the clamping portion 630 to close relative to the adjusting portion and the supporting portion 610, thereby fixing the anterior leaflet and the posterior leaflet between a clamp arm 631 and a grasping arm 651 corresponding to the clamp arm 631, respectively, and then pushing the conveying device 200 toward the distal end until the valve clamping device 600 is gradually retracted and closed; releasing the connection between the valve clamping device and the conveying device 200, thereby implanting the valve clamping device on the mitral valve, and pulling the anterior leaflet and the posterior leaflet of the mitral valve toward each other to form a double-hole structure.

[0088] It will be understood that the valve clipping system according to the present application includes any of the aforementioned valve clipping devices and a delivery device capable of delivering the valve clipping device from outside the body to the vicinity of the mitral valve and clipping the valve leaflets. The above description of the valve clipping device is provided for illustrative purposes only and is not intended to limit the present application. Any valve clipping device and valve clipping system including the valve clipping device that can be obtained by a person of ordinary skill in the art based on the teachings of the present application are within the scope of protection of the present application.

[0089] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variations thereof are intended to cover non-exclusive inclusion, so that a process, method, article, or device comprising a series of elements includes not only those elements, but also other elements not explicitly listed, or elements inherent to such process, method, article, or device. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of other identical elements in the process, method, article, or device comprising the element.

[0090] The foregoing description is intended only to provide specific embodiments of the present invention, which will enable those skilled in the art to understand and implement the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention is not intended to be limited to the embodiments shown herein, but is intended to be accorded the widest scope consistent with the principles and novel features claimed herein.

Claims

1. A valve clamping device with adjustable support force, characterized in that: include: Support part; a hollow adjusting portion, the adjusting portion being made of a shape memory material, one end of the adjusting portion being sleeved on the outside of the supporting portion and connected to the supporting portion, and the other end of the adjusting portion being movable along the supporting portion; a clamping portion, the clamping portion being arranged around the outer side of the adjusting portion; a driving portion connected to the clamping portion to drive the clamping portion to expand or close around the adjusting portion; Wherein, when the clamping portion is closed relative to the adjusting portion, the proximal end of the adjusting portion does not extend beyond the proximal end of the clamping portion; The adjusting portion is approximately in the shape of a cone in a natural state, the proximal end surface of the adjusting portion constitutes the bottom surface of the cone, and the connection between the adjusting portion and the supporting portion constitutes the apex of the cone.

2. The valve clipping device according to claim 1, characterized in that: The outside and / or inside of the regulating part is provided with a biocompatible film or a biocompatible coating.

3. The valve clipping device according to claim 1, characterized in that: The adjusting portion includes an elastic body, which has a natural state and a compressed state. One end of the elastic body is connected to the supporting portion, and the other end of the elastic body has an opening. When the elastic body is in the compressed state, the size of the opening is smaller than or equal to the size of the supporting portion.

4. The valve clipping device according to claim 3, characterized in that: The proximal edge of the elastic body encloses the opening, and a sealing head is provided at the opening.

5. The valve clipping device according to claim 1, characterized in that: The clamping portion includes two clamp arms, which are symmetrically arranged relative to the adjusting portion. The driving portion is connected to each clamp arm respectively to drive each clamp arm to rotate around the adjusting portion.

6. The valve clipping device according to claim 5, characterized in that: The clamping portion further includes two gripping portions, which are disposed between the two clamp arms and the adjusting portion and can be expanded or closed relative to the adjusting portion. When the gripping portions and the clamp arms are expanded, the gripping portions are at least partially accommodated in the inner surface of the clamp arms.

7. The valve clipping device according to claim 6, characterized in that: The exteriors of the forceps arm and the gripping portion are both coated with a biocompatible film.

8. The valve clipping device according to claim 6, characterized in that: When the clamping portion is closed relative to the adjusting portion, the proximal end of the adjusting portion does not exceed the proximal ends of the clamp arms and the proximal ends of the grasping portion.

9. A valve clipping system, characterized in that: The invention comprises a valve clamping device according to any one of claims 1 to 8, and a conveying device, wherein the conveying device comprises: a pushing shaft having a certain axial length and a core shaft movably installed in the pushing shaft, the pushing shaft and the supporting portion are detachably connected, and the core shaft is connected to the driving portion for driving the clamping portion to expand and close relative to the supporting portion.

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