Valve clamping device with adjustable bearing force and valve clamping system

Abstract

The invention discloses a valve clamping device with adjustable bearing force and a valve clamping system. The valve clamping device comprises a supporting part and a clamping part, the hollow adjusting part is made of a shape memory material, one end of the adjusting part is arranged on the outer side of the supporting part in a sleeving mode and connected with the supporting part, and the other end of the adjusting part can move along the supporting part; the clamping part is arranged on the outer side of the adjusting part in a surrounding manner; the driving part is connected with the clamping part so as to drive the clamping part to be unfolded or folded around the adjusting part; when the clamping part is closed relative to the adjusting part, the near end of the adjusting part does not exceed the near end of the clamping part. Therefore, by means of the valve clamping device, the elastic fitting performance of the valve leaflet and the adjusting part can be improved, and then the adaptability of valve leaflet physiological structures of different patients is improved.

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 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 normal and healthy mitral valve 1 can control the blood flow from the left atrium 2 to the left ventricle 3, while preventing the blood from the left ventricle 3 to the left atrium 2. The mitral valve 1 includes 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 muscle of the left ventricle 3 by chordae tendineae 4. Under normal circumstances, when the left ventricle 3 of the heart contracts, the edges of the anterior leaflet 1a and the posterior leaflet 1b are completely aligned to prevent blood from flowing from the left ventricle 3 to the left atrium 2. Figure 2 When organic or functional changes occur in the leaflets of the mitral valve 1 or its related structures, such as partial rupture of the chordae tendineae 4, the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are not properly 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, known as "mitral regurgitation".

[0003] Transcatheter mitral valve clipping refers to the treatment of mitral valve regurgitation by implanting a valve clipping device into the mitral valve and using a pair of closable clamp arms to pull the anterior leaflet and the posterior leaflet toward each other, reducing or eliminating the leaflet gap. The valve clipping device in the prior art has an elastic body added to the two clamp arms, and the leaflets on each side are clamped between one side of the clamp arm and one side of the elastic body, respectively. The elastic body is deformed to adapt to the spacing of the leaflets, thereby adjusting the degree of pulling of the leaflets by the clamp arms. The elastic body includes a deformable mesh body, and the two ends are fixed with a head such as a steel sleeve, and then fixed on the support rod between the two clamp arms. However, since both ends of the elastic body are fixed by the head, when the clamp arms are closed, the head limits the axial movement of the elastic body, and the elastic body can only be compressed radially, which affects the deformation of the elastic body, thereby increasing the size of the clamping device in the delivery state, which is not conducive to the passability of the clamping device in curved blood vessels, and will cause the elastic body to be unable to completely fit the leaflets after the clamping device is implanted, and the adaptability to the physiological structure of the leaflets of different patients is poor. 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 supporting force, comprising:

[0006] Supporting part;

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

[0008] A clamping portion, the clamping portion is arranged around the outer side of the adjusting portion;

[0009] a driving portion, the driving portion being 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 conveying device, wherein the conveying 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 supporting part are detachably connected, and the core shaft is connected to the driving part for driving the clamping part to expand and close relative to the supporting part.

[0012] The above technical solution provided by the embodiment of the present application has the following advantages compared with the prior art: for the valve clamping device and the valve clamping system including the valve clamping device, one end of the regulating part is sleeved on the outside of the support part and connected to the support part, and the other end of the regulating part is movable along the support part, which improves the axial deformation ability of the regulating part and enhances its axial bending deformation ability. Therefore, when the valve clamping device is radially compressed into the conveyor 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 being delivered in the blood vessel, so as to facilitate the conveyor to pass through the blood vessel, thereby reducing damage to the blood vessel wall. In addition, after the valve clamping device is implanted, in the process of clamping the valve leaflet and the regulating part by the forceps arm, the axial deformation of the regulating part is not limited, which can improve the elastic fit between the valve leaflet and the regulating part, thereby improving the adaptability of the valve leaflet physiological structure of 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 drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, for ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[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 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 A schematic diagram of the structure of the valve clamping device applying the biocompatible film;

[0019] Figure 4 yes Figure 3a A 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 A schematic diagram of the structure after the middle clamping part and the driving part are combined;

[0022] Figure 7 yes Figure 3a A schematic diagram of the structure of the middle support portion;

[0023] Figure 8 yes Figure 3a A schematic diagram of the structure of the middle support part cooperating with the base;

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

[0025] Figure 10-Figure 14 Is adopted Figure 3a Schematic diagram of the delivery process of the mid-valve clipping device to approach and repair the mitral valve via the left atrium in an antegrade manner;

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

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

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

[0029] Fig.18 It is a schematic structural diagram of the valve clamping device and the delivery device in the third embodiment of the present application;

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

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

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

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

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

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

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

[0037] Fig.26 yes Fig.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 be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field 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", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", etc., are only used for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0040] In the description of 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; the axial direction refers to the direction parallel to the line connecting the distal center and the proximal center of the medical device. The above definitions are only for the convenience of expression and cannot be understood as limitations of the present invention.

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

[0042] One end of the adjusting portion 120 of the above-mentioned valve clamping device 100 is a free suspended end 121b, and the free suspended end 121b is no longer restricted by the supporting portion 110 or the conveying device 200, thereby improving the axial deformation ability of the adjusting portion 120 and enhancing its axial bending deformation ability. Therefore, when the valve clamping device 100 is radially compressed into the conveyor 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 being transported in the blood vessel, thereby facilitating the passage of the conveyor 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 device, reducing damage to human tissues, and also 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 valve leaflet and the regulating part 120 by the clamp arm 131, the axial deformation of the regulating part 120 is not restricted, so the elastic fit between the valve leaflet and the regulating part 120 can be improved, thereby improving the adaptability of the valve 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 mainly includes two states, one is the unfolded state, and the other is the closed state. In the process of the clamping part 130 closing around the adjusting part 120, the adjusting part 120 is radially compressed, and the spacing h between the proximal end of the adjusting part 120 and the proximal end of the supporting part 110 gradually increases. That is, one end 121a of the adjusting part 120 is sleeved on the outside of the connecting end and connected to the supporting part 110, and the other end of the adjusting part 120 is a free suspended end 121b. In the process of the clamping part 130 compressing the adjusting part 120, the free suspended end 121b of the adjusting part 120 moves toward the proximal end, and the spacing h between the adjusting part 120 and the supporting part 110 increases.

[0047] See also Figure 6-Figure 8 , the support portion 110 can be a circular tube, a square column tube or an oblate tube, etc., with both end faces axially penetrated. 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 disposed 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. 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, after the clamping platform 221 on the delivery device 200 is clamped into the clamping position 114, the delivery device 200 is clamped and connected with the support portion 110, and the valve clamping device 100 can be delivered. When the clamping platform 221 is separated from the clamping position 114, the delivery device 200 is separated from the valve clamping device 100. It should be known that the structure of the support portion 110 here is only used as an example and is not a limitation of the present application. Other structures of the support portion 110 adopted by ordinary technicians in this field based on the teachings of the present application are all within the protection scope of the present application.

[0048] The free end 112 of the valve clamping device 100 of the present application is located in the hollow regulating part 120 in either the closed or expanded state, so it will never be exposed in the delivery device 200 or the heart, thereby avoiding the flushing of blood and minimizing the formation of thrombus after implantation. After implantation, it also avoids direct contact with the leaflets, and with the long-term pulsation of the leaflets, it avoids the wear and even perforation of the leaflets, thereby improving the safety of implantation.

[0049] See also Figure 4 and Figure 8The adjusting part 120 includes a deformable elastic body 123, which has a natural state and a compressed state. The elastic body 123 has a hollow accommodating cavity, and at least a part of the supporting part 110 is arranged in the hollow accommodating cavity. One end 121a of the elastic body 123 is connected to the supporting part 110, and the other end 121b of the elastic body 123 has an opening 122 and is freely suspended. When the elastic body is in a compressed state, the size of the opening 122 is smaller than or equal to the size of the free end of the supporting part 110. Therefore, when the valve clamping device 100 is closed, after the elastic body 123 is squeezed, the size of the opening 122 becomes smaller, which can prevent the supporting part 110 from being exposed from the opening 122. The elastic body 123 is deformable, so as to adapt to the spacing between different leaflets and adjust the pulling degree of the leaflets by the valve clamping device 100. The opening 122 of the elastic body 123 is used to penetrate 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 penetrating into 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 the radial and axial directions. The degree of deformation is relatively large, 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, a hollow snare structure (not shown in the figure) is sleeved on the proximal edge of the elastic body 123 to form an opening, that is, a head is provided after the proximal end of the elastic body 123 is folded. The snare structure can be annular or polygonal, and can be made of hard materials such as stainless steel, so that the mesh wire of the mesh structure or the support rod of the frame structure is appropriately gathered toward the central axis, but not closed, so as to form 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, so as to ensure that the free end 112 of the support portion 110 will 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, and the proximal head of the adjustment part 120 of the valve clamping device 100 is eliminated. 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 head on the axial movement of each mesh wire or support rod, 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 axis of the elastic body 123), so it has good self-centering and is not easy to tilt.

[0052] See also Figure 5 The clamping part 130 includes at least two clamp arms 131, and generally includes at least one group of clamp arms 131. Each group of clamp arms 131 includes two clamp arms 131 symmetrically arranged relative to the adjusting part 120. The clamping part 130 in the figure includes a group of clamp arms 131. It should be known that this is only used as an example. Ordinary technicians in this field can select a suitable number of clamp arms 131 as needed, such as two or more groups of clamp arms. The driving part 140 is respectively connected to each clamp arm 131, for example, the driving part 140 is respectively connected to two clamp arms 131 in a group of clamp arms 131 to drive each clamp arm 131 to rotate around the adjusting part 120. It can be understood that three or more clamp arms 131 can be set in each group as needed. For example, three clamp arms 131 that can open and close relatively can be used to clamp the three leaflets of the tricuspid valve, thereby treating tricuspid valve regurgitation.

[0053] In the conveying 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 conveying; 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, thereby achieving leaflet clamping.

[0054] In a preferred implementation of this embodiment, the valve clamping device 100 further includes a grasping portion, which generally may 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 adjusting portion 120, the grasping portion (e.g., grasping arm 151) is arranged between the clamping portion 130 (e.g., clamp arm 131) and the adjusting portion 120 and can be opened or closed relative to the adjusting portion 120, and the grasping portion is at least partially accommodated on the inner surface of the clamping portion 130. Of course, three or more grasping arms 151 may be arranged in each group as needed, so as to cooperate with the clamp arm 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 also Figure 3b A biocompatible film or a biocompatible coating is applied to the outside of the forceps arm 131 and the grasping portion, so that the valve clipping device 100 has stronger biocompatibility.

[0057] See also 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 the convenience of explanation, this part is defined as the term "base" here. The structure that realizes the function of the base 160 can also be the distal end of the support portion 110, that is, an integral structure formed 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 through a pivot 132, so that under the drive of the drive portion 140, each clamp arm 131 cooperates with each other to expand and close together around the adjustment portion 120.

[0058] Still reading Figure 6 and Figure 8 The driving part 140 includes: a driving shaft 141, a connecting seat 142 and two connecting rods 143; wherein one end of each connecting rod 143 is connected to the clamping part 130, and the other end is pivoted to the connecting seat 142; one end of the driving shaft 141 is connected to the connecting seat 142, and the other end is movably installed in the base 160. Specifically, one end of each connecting rod 143 is connected to a clamp arm 131, and the other end is connected to the connecting seat 142 through a pivot 144, that is, each clamp arm 131 is rotatably connected to the distal end of the connecting seat 142 of the driving shaft 141 through the connecting rod 143 on the corresponding side. The driving shaft 141 movably passes through the base 160, and when the driving 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 driving part 140 includes at least one group of connecting rods 143, and the number of connecting rods 143 is set to correspond to the setting of the clamp arms 131. For example, if two clamp arms 131 are used in the figure, two connecting rods 143 are set to work in cooperation. The distal end of the connecting rod 143 is rotatably connected to the connecting seat 142 at the distal end of the driving shaft 141 by rotating a pin or a bolt 144. When the driving shaft 141 slides toward the distal end relative to the base 160 in the axial direction, the connecting rod 143 is driven to move. Under the pull of the connecting rod 143, the clamp arm 131 rotates around the pin hole 144 and opens relative to the base 160. When the driving shaft 141 slides toward the proximal end relative to the base 160 in the axial direction, the connecting rod 143 pulls the clamp arm 131 to rotate around the pin hole 144 and closes relative to the base 160.

[0060] The connecting seat 142 is fixedly arranged at the distal end of the driving shaft 141 by welding or the like, and a pair of pins are provided on the connecting seat 142. 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, so as to realize 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 driving shaft 141 and the connecting seat 142 can be an integral structure or a non-integrated structure. In order to ensure safety after implantation, the driving 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 clamping device 100 further includes a locking portion 170 disposed in the base 160, and the locking portion 170 limits the relative movement of the driving shaft 141 and the base 160. In the delivery state, the locking portion 170 limits the relative movement of the driving shaft 141 and the base 160, thereby ensuring that the clamping portion 130 always remains in a closed state relative to the adjusting portion 120 and the supporting portion 110, thereby preventing the clamping portion 130 from accidentally unfolding; after reaching the vicinity of the mitral valve, the restriction of the locking portion 170 on the driving shaft 141 is unlocked, and the clamping portion 130 can be driven by the driving portion 140 to unfold and support the valve leaflet relative to the adjusting portion 120 and the supporting portion 110. Any existing suitable locking portion can be used, which will not be described in detail here.

[0062] See also Figure 6 and 9The valve clamping system of this embodiment includes the above-mentioned valve clamping device 100 and a conveying device 200, wherein the conveying 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, an external thread is provided at the proximal end of the driving shaft 141, and the core shaft is threadedly connected to the driving shaft 141, so that the axial movement of the driving shaft 141 is controlled by the core shaft outside the patient's body. It should be known that only part of the structure of the conveying device is listed here, and 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 clamping position 114 connected to the lumen of the support portion 110, and the distal end of the push shaft 210 is provided with a fixing member 220, and the fixing member 220 includes two branches, and the end of each branch is a protruding clamping 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 mandrel of the conveying device 200 is inserted into the pushing shaft 210 until the mandrel is inserted into the fixing member 220, and the two branches of the fixing member 220 are pushed outward, and the clamping platform 221 at the end of the branch is clamped into the two clamping positions 114 of the support portion 110, thereby connecting the support portion 110 with the fixing member 220, that is, connecting the valve clamping device 100 and the conveying device 200. When the mandrel is withdrawn from the fixing member 220 and the pushing shaft 210, the two branches return to their natural inward state, and the clamping platform 221 is disengaged from the clamping position 114 of the support portion 110, so that the valve clamping device 100 and the conveying device 200 are disconnected. The fixing member 220 is made of a material with a certain hardness and elasticity such as nickel titanium. The pushing shaft 210 can adopt a multi-layer composite tube body. The mandrel is made of stainless steel or nickel-titanium alloy material.

[0064] The support portion 110 is provided with a through hole inside as a passage 113 for the drive shaft 141, and the drive shaft 141 is axially slidably penetrated in the passage 113 of the support portion 110. The proximal end of the drive shaft 141 is provided with an external thread for connecting with the mandrel of the delivery device 200, so that the axial movement of the drive shaft 141 is controlled by the mandrel. After the clamping portion 130 and the gripping portion 150 cooperate and clamp the valve tissue, the drive shaft 141 is driven by the mandrel to move axially toward the proximal end, the drive shaft 141 drives the connecting rod 143 to rotate, and the connecting rod 143 drives the clamp arm 131 to close relative to the support portion 110, until the clamp arm 131 is completely closed relative to the support portion 110, so that the valve clamping device 100 is in a retracted and closed state and falls below the valve. After that, the connection between the core shaft and the driving shaft 141 can be released, the core shaft is withdrawn from between the fixing member 220, and the clamping platform 221 is separated from the clamping position 114 of the support part 110, thereby realizing the release of the valve clamping device 100 and the conveying device 200. In the release process, since the connection point (i.e., the release point) between the valve clamping device 100 and the conveying device 200 is located in the adjustment part 120 of the valve clamping device 100, and the proximal end of the adjustment part 120 is provided with an open opening 122, no parts will hook the clamping platform 221 at the branch end of the fixing member 220, which facilitates the release of the valve clamping device 100. In addition, the release point is located inside the adjustment part 120 and is not directly flushed by blood, which can avoid the failure of the mechanism of the release point and reduce the risk of thrombosis.

[0065] See also Figure 9-13 Taking the antegrade 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 Fig. 9 As shown, the driving shaft 141 and the valve clamping device 100 connected thereto are pushed from the left atrium 2 through the mitral valve 1 to the left ventricle 3 through a guiding device such as an adjustable curved sheath tube (not shown in the figure);

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

[0068] Step 3: If Fig.10 As shown, unlock the locking part in the base 160, pull the core shaft and the driving shaft 141 toward the proximal end, drive the clamp arm 131 to open relative to the support part 110, and adjust the direction of the clamp arm 131. At this time, the relative position of the clamp 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 clamp arm 131 is perpendicular to the coaptation line of the mitral valve 1;

[0069] Step 4: If Fig.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 atrium 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 Fig.12 As shown, when the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are clamped between a pair of clamp arms 131 and the grasping arm 151, respectively, 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 mandrel and the drive shaft 141, and withdraw the mandrel. 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 portion 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. Fig.13 In the implantation state shown, the valve clamping device 100 pulls the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 toward each other to obtain a double-pore mitral valve, thereby 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 abuts against the clamp arm 131. The elastic body 123 (e.g., a mesh structure or a porous structure, etc.) of the regulating portion 120 has a buffering effect on the pulsating leaflet 1, so that the degree of pulling of the leaflet 1 by the valve clamping device 100 can be adjusted to avoid damaging the leaflet 1. In addition, the elastic body 123 can be squeezed and deformed following the pulsation of the leaflet 1, and the elastic force generated pushes the portion of the leaflet 1 close to the elastic body 123 away from the base 160. 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 to the inside of the valve clamping device 100, prevent the valve clamping device 100 from falling off due to continuous flushing of the blood, and also prevent the blood from being 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, so as to avoid that after the leaflet 1 is grasped, the elastic body 123 is squeezed by the forceps arm 131 and acts on the forceps arm 131 in turn, so as to ensure that the grasping effect of the valve leaflet 1 by the valve clamping device 100 after release is consistent with that before release.

[0073] See also Fig.15 and Fig.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 cone-shaped 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 cone, and the connecting end of the adjustment portion 320 and the supporting portion 310 constitutes the apex of the above-mentioned cone.

[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 end side relative to the proximal end of the clamping portion 330.

[0075] Specifically, after the clamping part 330 is radially compressed, the free suspended end 321b of the regulating part 320 will move toward the proximal end, but the proximal end of the regulating part 320 after radial compression is on the distal side relative to the proximal end of the clamping part 330. In this way, the regulating part 320 will not be exposed on the proximal surface of the clamping part 330 after closing, ensuring that the everted end of the clamping part 330 abuts against the leaflet to increase the contact area of ​​the leaflet, conform to the angle and direction of the leaflet, and avoid the risk of thrombosis caused by excessive exposure of the regulating part 320 in the left atrium.

[0076] See also 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 the proximal end thereof, and the extension portion 422 extends toward the proximal direction, such as Fig.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, and the boss structure A extends in a direction perpendicular 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 according to 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, which 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 leaflets. For example, the boss structure A contacts the leaflets, thereby enhancing the clamping force between the valve clamping device 400 and the leaflets, 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 wires near the extension portion 422 will not be accumulated. While reducing the compression size, the radial reaction force can also be reduced, thereby improving 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 also Fig. 20 and Figure 2 Compared with the valve clamping device 400 of the third embodiment, the regulating portion 720 of the valve clamping device 700 according to the fourth embodiment of the present invention further includes a suspended extension portion 722 located at the proximal end thereof, and the extension portion 722 extends outward in a radial direction away from the support portion 710. That is, the extension portion 722 extends in a direction perpendicular to the direction from the proximal end to the distal end, and the extension portion 722 is substantially parallel to the direction perpendicular to the direction from the proximal end to the distal end, forming an approximate platform structure, and the cross-section of the platform structure is approximately in a straight line shape, so that the elastic fit between the leaflet and the regulating portion 720 can be improved.

[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] The proximal end of the adjusting portion 720 is provided with a steel sleeve 723, which facilitates the penetration of the delivery device 200. The steel sleeve 723 is provided on the free suspended end 721b of the adjusting portion 720. The extension portion 722 is provided around the steel sleeve 723. When the valve clamping device 700 is radially compressed, the extension portion 722 wraps the steel sleeve 723, which not only prevents the steel sleeve 723 from contacting the inner wall of the sheath, but also prevents the steel sleeve 723 from directly contacting the human tissue such as the leaflets, thereby ensuring the safety of the delivery and implantation of the device.

[0083] A biocompatible film is provided outside or inside the regulating part 720 as a flow-blocking film to prevent blood from entering the regulating part 720. In a specific application, a biocompatible film may be provided outside and inside the regulating part 720. In this way, the valve clamping device 700 has stronger biocompatibility and prevents blood from entering the regulating part 720 to form a thrombus.

[0084] See also 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 regulating portion 520 has a free suspended end 521b and a distal end cap 521, and the free suspended end 521b may have an opening 522. The regulating portion 520 includes a plurality of first curved surfaces 520A and a plurality of 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 first curved surfaces 520A arranged opposite to each other 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, the first curved surface 520A with a relatively large area faces the forceps arm, and the second curved surface 520B with a relatively small area is smoothly connected between the two first curved surfaces 520A. As the valve clamping device is closed, the first curved surface 520A of the adjusting portion 520 is squeezed by the forceps arm and the valve leaflet, and the adjusting portion 520 extends along the direction of the first curved surface 520A and gradually fits the valve leaflet, thereby better adapting to the shape of the valve leaflet and increasing the contact area between the first curved surface 520A and the valve leaflet, thereby reducing the gap between the valve clamping device and the valve leaflet, slowing down the blood flow and preventing the blood flow from scouring the valve clamping device. Preferably, the curvature of the first curved surface 520A can also be greater than the curvature of the second curved surface 520B, so that the adjusting portion presents a flat ellipsoid shape to avoid affecting the closing 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 subjected to pressure due to the squeezing of 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 also Fig.25 and Fig.26 Compared with the valve clamping device of the first embodiment, the structure of the adjustment part of the valve clamping device 600 according to the sixth embodiment of the present invention is the same as the structure of the adjustment part 120 of the first embodiment, and the difference lies in the different ways in which the clamping part 630 and the grasping part 650 cooperate to grasp the valve leaflet. In the sixth embodiment, the clamping part 630 includes a group of clamp arms 631 that can be opened or closed relative to the support part 610 and the adjustment part, and the grasping part 650 includes a pair of grasping arms 651, and the grasping part 650 is located between the clamping part 630 and the adjustment part.

[0087] During delivery, the clamping part 630, the gripping part 650 and the regulating part 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 withdrawn, so that the regulating part and the gripping part 650 gradually extend out of the delivery device 200 and are deployed in the left atrium. The delivery device 200 is continuously withdrawn until the clamping part 630 also extends out of the delivery device 200 and is deployed in the left ventricle. Then, the driving part pushes the clamping part 630 to the distal end, and the anterior and posterior leaflets of the mitral valve are respectively supported on the inner surfaces of the two clamp arms 631 of the clamping part 630. The gripping part 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 respectively between a clamp arm 631 and a grasping arm 651 corresponding to the clamp arm 631, 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 is understood that the valve clamping system according to the present application includes any of the above-mentioned valve clamping devices and a delivery device capable of delivering the valve clamping device from outside the body to the vicinity of the mitral valve and clamping the valve leaflets. The above description of the valve clamping device is only used as an example and is not a limitation of the present application. The valve clamping device and the valve clamping system including the valve clamping device obtained by a person of ordinary skill in the art based on the teachings of the present application are within the protection scope of the present application.

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

[0090] The foregoing is merely a specific embodiment of the present invention, which enables those skilled in the art to understand or implement the present invention. Various modifications to these embodiments will be 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 will not be limited to the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features claimed herein.

Claims

1. A valve clamping device with adjustable supporting force, characterized in that: include: Supporting part; A hollow adjusting portion, wherein the adjusting portion is made of a shape memory material, one end of the adjusting portion is sleeved outside the supporting portion and connected to the supporting portion, and the other end of the adjusting portion is movable along the supporting portion; A clamping portion, the clamping portion is arranged around the outer side of the adjusting portion; a driving portion, the driving portion being 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 exceed the proximal end of the clamping portion.

2. The valve clamping device according to claim 1, characterized in that: 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.

3. The valve clamping device according to claim 1, characterized in that: The adjusting portion includes a plurality of first curved surfaces and a plurality of second curved surfaces, wherein the first curved surfaces are adjacent to the second curved surfaces, two oppositely disposed first curved surfaces face the clamping portion respectively, and an area of ​​the first curved surface is greater than an area of ​​the second curved surface.

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

5. The valve clamping device according to claim 1, characterized in that: The adjusting part includes an elastic body, which has a natural state and a compressed state. One end of the elastic body is connected to the supporting part, 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 part.

6. The valve clamping device according to claim 5, characterized in that: The proximal edge of the elastic body encloses the opening, and a sealing head is arranged at the opening.

7. The valve clamping 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 respectively connected to each of the clamp arms to drive each of the clamp arms to rotate around the adjusting portion.

8. The valve clamping device according to claim 7, characterized in that: The clamping portion further comprises two gripping portions, which are arranged between the two clamp arms and the adjusting portion and can be opened or closed relative to the adjusting portion. When the gripping portions and the clamp arms are both opened, the gripping portions are at least partially accommodated in the inner surface of the clamp arms.

9. The valve clamping device according to claim 8, characterized in that: The outsides of the forceps arm and the gripping portion are both coated with a biocompatible film.

10. The valve clamping device according to claim 8, 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.

11. A valve clamping system, characterized in that: It comprises the valve clamping device according to any one of claims 1 to 10, 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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