CN119235511B - Valve clamping device with adjustable bearing force and valve clamping system - Google Patents

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

Valve clamping device with adjustable bearing force and valve clamping system

Technical Field

The application relates to the field of implanted medical instruments, in particular to a valve clamping device with adjustable bearing force and a valve clamping system.

Background

Referring to fig. 1, mitral valve 1 is a one-way valve located between left atrium 2 and left ventricle 3 of the heart, and a normally healthy mitral valve 1 can control blood flow from left atrium 2 to left ventricle 3 while avoiding blood flow from left ventricle 3 to left atrium 2. The mitral valve 1 includes a pair of leaflets, called anterior leaflet 1a and posterior leaflet 1b. Anterior leaflet 1a and posterior leaflet 1b are anchored to the papillary muscles of left ventricle 3 by chordae tendineae 4. Normally, the left ventricle 3 of the heart contracts, and the edges of the anterior leaflet 1a and the posterior leaflet 1b are completely coaptated, avoiding blood flow from the left ventricle 3 to the left atrium 2. Referring to fig. 2, when the leaflets of the mitral valve 1 or their associated structures are organically or functionally changed, such as the chordae 4 are partially ruptured, the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are poorly coaptated, whereby the mitral valve 1 cannot be fully closed when the left ventricle 3 of the heart contracts, resulting in regurgitation of blood from the left ventricle 3 to the left atrium 2, thereby causing a series of pathophysiological changes, called "mitral regurgitation".

Transcatheter mitral valve clamping refers to the treatment of mitral regurgitation by implanting a valve clamping device into the mitral valve, using a pair of closable clamp arms to pull the anterior and posterior leaflets toward each other, reducing or eliminating leaflet clearance. In the valve clamping device in the prior art, an elastic body is added in two clamp arms, and the valve leaflet at each side is respectively clamped between one clamp arm at one side and one side of the elastic body, and the interval between the valve leaflets is adapted through the deformation of the elastic body, so that the traction degree of the clamp arms on the valve leaflets is adjusted. The elastic body comprises a deformable net-shaped main body, two ends of the elastic body are fixed by adopting sealing heads such as steel sleeves and the like, and then the elastic body is fixed on a supporting rod between two clamp arms. However, since both ends of the elastic body are fixed through the seal heads, when the clamp arms are closed, the seal heads limit the axial movement of the elastic body, the elastic body can only be radially compressed, and the deformation of the elastic body is influenced, so that the size of the clamping device in a conveying state is increased, the passing performance of the clamping device in a curved blood vessel is not facilitated, the elastic body cannot be completely attached to the valve leaflet after the clamping device is implanted, and the adaptability to the physiological structures of the valve leaflets of different patients is poor.

Disclosure of Invention

To solve or at least partially solve the above technical problems, the present application provides a valve clamping device and a valve clamping system.

In a first aspect, the present application provides an adjustable-bearing valve clasper apparatus comprising:

A support part;

the hollow adjusting part is made of a shape memory material, one end of the adjusting part is sleeved outside the supporting part 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 mode;

The driving part is connected with the clamping part to drive the clamping part to be unfolded or closed around the adjusting part;

When the clamping part is closed relative to the adjusting part, the proximal end of the adjusting part does not exceed the proximal end of the clamping part.

In a second aspect, the application provides a valve clamping system, which comprises the valve clamping device and a conveying device, wherein the conveying device comprises a pushing shaft with a certain axial length and a mandrel movably penetrating through the pushing shaft, the pushing shaft is detachably connected with a supporting part, and the mandrel is connected with a driving part and used for driving the clamping part to be unfolded and closed relative to the supporting part.

Compared with the prior art, the valve clamping device and the valve clamping system comprising the valve clamping device have the advantages that one end of the adjusting part is sleeved on the outer side of the supporting part and connected with the supporting part, the other end of the adjusting part can move along the supporting part, the axial deformation capacity of the adjusting part is improved, and meanwhile, the axial bending deformation capacity of the adjusting part is enhanced, so that when the valve clamping device is radially compressed into the conveyor for in-vivo conveying, the valve clamping device is not only easily compressed into a sheath, but also can adapt to blood vessels with different bending curvatures during conveying in blood vessels, and the conveyor can pass through the blood vessels conveniently, thereby reducing damage to blood vessel walls. In addition, after the valve clamping device is implanted, the valve leaflet and the adjusting part are clamped through the forceps arms, and the axial deformation of the adjusting part is not limited, so that the elastic fit between the valve leaflet and the adjusting part can be improved, and the adaptability of the valve leaflet physiological structures of different patients is improved.

Drawings

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.

In order to more clearly illustrate the embodiments of the invention or the technical solutions of the prior art, the drawings which are used in the description of the embodiments or the prior art will be briefly described, and it will be obvious to a person skilled in the art that other drawings can be obtained from these drawings without inventive effort.

FIG. 1 is a schematic diagram of a mitral valve in a normal state;

FIG. 2 is a schematic illustration of a mitral valve with lesions;

FIG. 3a is a schematic view of the structure of a valve clasper apparatus in accordance with a first embodiment of the present invention;

FIG. 3b is a schematic view of the valve clasper device of FIG. 3a in a configuration for applying a biocompatible film;

FIG. 4 is a schematic view of the combined structure of the adjusting portion and the supporting portion in FIG. 3 a;

FIG. 5 is a schematic view of the valve clasper device of FIG. 3a in a closed configuration;

FIG. 6 is a schematic view of the combined structure of the clamping portion and the driving portion in FIG. 3 a;

FIG. 7 is a schematic view of the structure of the support portion of FIG. 3 a;

FIG. 8 is a schematic view of the support portion of FIG. 3a mated with the base;

FIG. 9 is a schematic view of the support portion of the valve clasper device of FIG. 3a mated with a delivery device;

FIGS. 10-14 are schematic illustrations of delivery of the valve clasper device of FIG. 3a through an antegrade approach to and repair of a mitral valve via a left atrium;

FIG. 15 is a schematic view of a valve clasper apparatus in accordance with a second embodiment of the present application;

FIG. 16 is a schematic view of a valve clasper apparatus in accordance with a second embodiment of the present application in a closed configuration;

FIG. 17 is a schematic view of a valve clasper apparatus in accordance with a third embodiment of the present application;

FIG. 18 is a schematic view of a third embodiment of the valve clasper apparatus in accordance with the present application in combination with a delivery apparatus;

FIG. 19 is a schematic view of a third embodiment of the valve clasper apparatus in accordance with the present application in a closed configuration;

FIG. 20 is a schematic view of a valve clasper apparatus in accordance with a fourth embodiment of the present application;

FIG. 21 is a schematic view of a valve clasper apparatus in accordance with a fourth embodiment of the present application in a closed configuration;

fig. 22 is a schematic view of a structure of a first curved surface side of an adjusting portion of a valve clasping apparatus in accordance with a fifth embodiment of the present application;

FIG. 23 is a top view of the adjustment portion of FIG. 22;

fig. 24 is a schematic view of a structure of the second curved surface side of the regulating portion in fig. 22;

FIG. 25 is a schematic view of a valve clasper apparatus in accordance with a sixth embodiment of the present application;

Fig. 26 is a schematic view of the valve clasper device of fig. 25 partially received within a delivery device after radial compression.

Detailed Description

The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without any inventive effort, are intended to be within the scope of the invention.

In the description of the present invention, it should be noted that the directions or positional relationships indicated by the terms "upper", "lower", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present invention and simplifying the description, and do not indicate or imply that the apparatus or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, in the field of interventional medical devices, proximal refers to the end closer to the operator and distal refers to the end farther from the operator, and axial refers to the direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device. The above definitions are for convenience of description only and are not to be construed as limiting the invention.

Referring to fig. 3 a-14, a valve clamping device 100 with adjustable bearing force according to a first embodiment of the present invention includes a supporting portion 110, the supporting portion 110 includes a connecting end 111 and a free end 112 that are disposed 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 outside the connecting end 111 and connected to the supporting portion 110, the other end of the adjusting portion 120 is suspended, the free end 112 of the supporting portion 110 is suspended in the adjusting portion 120, and a space exists between a proximal end of the adjusting portion 120 and the free end 112, a clamping portion 130, the clamping portion 130 is disposed around the outer side of the adjusting portion 120, and a driving portion 140 is connected to the clamping portion 130 to drive the clamping portion 130 to open or close around the adjusting portion 120.

The one end of the adjusting portion 120 of the valve clamping device 100 is the free suspended end 121b, the free suspended end 121b is not limited by the supporting portion 110 or the delivery device 200 any more, the axial deformability of the adjusting portion 120 is improved, and the axial bending deformability of the adjusting portion is enhanced, so that when the valve clamping device 100 is radially compressed into the delivery device for in-vivo delivery, the valve clamping device is not only easy to be compressed into a sheath, but also can adapt to vessels with different bending curvatures during delivery in the vessel, thereby facilitating the delivery of the delivery device in the vessel, and reducing damage to the vessel wall.

Meanwhile, the free end 112 is connected with or detached from the conveying device in the adjusting part 120, so that the free end 112 is prevented from touching blood vessels or other tissues in the releasing operation process of the instrument, the damage to human tissues is reduced, and the releasing failure caused by hooking tendons of the free end 112 can be prevented.

In addition, after the valve clamping device 100 is implanted, in the process of clamping the valve leaflet and the adjusting portion 120 by the clamp arm 131, the axial deformation of the adjusting portion 120 is not limited, so that the elastic fit between the valve leaflet and the adjusting portion 120 can be improved, and the adaptability of the physiological structures of the valve leaflets of different patients can be improved.

In addition, after the valve clamping device 100 is implanted, the free end 112 is suspended in the adjusting portion 120, and the proximal end of the adjusting portion 120 is spaced from the free end 112, so that interference or winding between the suspended free end 112 and the free suspended end 121b of the adjusting portion 120 can be avoided, and the implantation safety of the apparatus is ensured.

The valve clasper device 100 generally includes two states, one being an expanded state and the other being a closed state. During the closing of the nip portion 130 around the adjustment portion 120, the adjustment portion 120 is radially compressed and the spacing distance h between the proximal end of the adjustment portion 120 and the proximal end of the support portion 110 gradually increases. That is, one end 121a of the adjusting portion 120 is sleeved outside the connection end and connected to the supporting portion 110, the other end of the adjusting portion 120 is a free suspended end 121b, and the free suspended end 121b of the adjusting portion 120 moves toward the proximal end and increases in the interval h with the supporting portion 110 during compression of the adjusting portion 120 by the sandwiching portion 130.

Referring to fig. 6 to 8, the supporting portion 110 may be a circular tube, a square column tube, or a flat circular tube with two end surfaces axially penetrated. In this embodiment, a circular tube body is adopted, and a distal end of the circular tube body is a connection end 111, and a proximal end is a free end 112. At least a portion of the support portion 110 is disposed within the hollow of the adjustment portion 120, for example, the free end 112 of the support portion 110 is disposed within the adjustment portion 120, and the free end 112 is disposed within the adjustment portion 120 in both the closed state and the extended state without exposing the adjustment portion 120. The support portion 110 is further provided with an axial through-hole-shaped penetration passage 113 to be coupled with the driving portion 140 and the conveying device 200. At least two clamping positions 114 are arranged on the pipe wall of the circular pipe body of the supporting part 110 and are used for being detachably connected with the conveying device 200. For example, the clamping table 221 on the conveying device 200 is clamped into the clamping position 114, the conveying device 200 is connected with the supporting portion 110 in a clamping manner, and the conveying device 100 can be conveyed, and when the clamping table 221 is separated from the clamping position 114, the conveying device 200 is separated from the valve clamping device 100. It should be understood that the structure of the supporting portion 110 is only used as an example, and not limiting the present application, and that other structures of the supporting portion 110 adopted by those skilled in the art based on the teachings of the present application are within the scope of protection of the present application.

The valve clasper device 100 of the present application is positioned within the hollow adjustment portion 120 in either the closed or the expanded state of the proximal free end 112 and therefore is not exposed to the delivery device 200 or to the heart at all times, thereby avoiding blood washout and minimizing thrombus formation after implantation. And the implantation is carried out without direct contact with the valve leaflet, and the valve leaflet is prevented from being worn or even perforated along with long-term pulsation of the valve leaflet, so that the implantation safety is improved.

Referring to fig. 4 and 8, the adjusting portion 120 includes a deformable elastic body 123, the elastic body 123 has a natural state and a compressed state, the elastic body 123 has a hollow accommodating cavity, and at least a portion of the supporting portion 110 is disposed in the hollow accommodating cavity. One end 121a of the elastic body 123 is connected to the support portion 110, the other end 121b of the elastic body 123 has an opening 122 and is free to hang, and the size of the opening 122 is smaller than or equal to the size of the free end of the support portion 110 in the compressed state of the elastic body, so that when the valve clamping device 100 is closed, the size of the opening 122 is reduced after the elastic body 123 is pressed, and the support portion 110 can be prevented from being exposed from the opening 122. The elastic body 123 is deformable so as to accommodate the spacing between the different leaflets and adjust the extent to which the valve clamping device 100 is pulled against the leaflets. The opening 122 of the elastic body 123 is used to pass through the distal end of the delivery device 200, and it should be understood that the distal end of the delivery 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 via the opening 122, and the opening 122 of the distal end of the elastic body 123 is not connected to either the distal end of the delivery device 200 or the proximal end (free end) of the support portion 110, i.e., the proximal end 121b of the elastic body 123 is in a free suspended state. Therefore, during the delivery process or the leaflet clamping process, when the clamping portion 130 is closed, the elastic body 123 in the adjusting portion 120 is not limited by the supporting portion 110 or the delivery device 200, and can deform in the radial direction and the axial direction, so that the deformation degree is larger, the delivery is facilitated, the adaptability to the leaflet is stronger, and after the connection between the distal end of the delivery device 200 or the proximal end (free end) of the supporting portion 110 is released, the deformation capability of the free suspended end of the adjusting portion 120 is stronger, and the adaptability to the leaflet is stronger.

The adjusting portion 120 includes a proximal end and a distal end, and in one embodiment, a hollow snare structure (not shown) is sleeved on the proximal edge of the elastic body 123 to form an opening, that is, a seal head is disposed after the proximal end of the elastic body 123 is folded. The snare structure may be ring-shaped or polygonal, and may be made of a hard material such as stainless steel, so that the mesh of the mesh structure or the struts of the frame structure are properly gathered toward the central axis, but are not closed, so that an opening 122 is formed at the center of the snare structure. In another embodiment, the proximal edge of the elastic body 123 encloses the opening 122, and the size of the opening 122 is smaller than or equal to the size of the free end 112, so as to ensure that the free end 112 of the supporting portion 110 does not protrude out of the adjusting portion 120 in both the compressed state and the natural state.

The proximal edge of the elastic body 123 encloses the opening 122, which eliminates the risk of the proximal end closure of the adjusting portion 120 of the valve clamping device 100, when the clamping portion 130 is closed, the elastic body 123 is deformable in both radial and axial directions, the deformation degree is large, and the delivery is facilitated, in addition, the elastic body 123 is not limited by the axial movement of the closure to each mesh wire or strut, so that the elastic body can be moderately curled or bent, thereby completely closing the valve leaflet and adapting to the physiological structures of different patients better, in addition, the risk of the proximal end closure component falling off after implantation for a period of time in the prior art can be avoided, in addition, the distal end of the elastic body 123 is connected with the supporting portion 110, and the opening 122 at the proximal end is opened, so that the center of gravity is always located in the axial direction of the supporting portion 110 (i.e. the axial line of the elastic body 123), and thus the self-centering property is better, and the valve leaflet is not easy to incline.

Referring to fig. 5, the clamping portion 130 includes at least two clamp arms 131, and may generally include at least one set of clamp arms 131, each set of clamp arms 131 including two clamp arms 131 symmetrically disposed with respect to the adjustment portion 120, the clamping portion 130 including one set of clamp arms 131, it being understood that this is by way of example only, and one of ordinary skill in the art may select an appropriate number of clamp arms 131, such as two or more sets of clamp arms, as desired. The driving part 140 is connected to each of the jawarms 131, for example, the driving part 140 is connected to two of the jawarms 131 in a group of the jawarms 131, respectively, to drive each of the jawarms 131 to rotate about the adjusting part 120. It will be appreciated that three or more arms 131 may also be provided in each set as desired, for example, three leaflets of a tricuspid valve may be clamped by three opposed openable and closable arms 131, to treat tricuspid regurgitation.

In the delivery state, the driving part 140 drives the clamp arm 131 to close around the adjusting part 120, so that the outer diameter of the valve clamping device 100 is reduced, delivery is facilitated, and after the valve clamping device 100 is unfolded in a body, the driving part 140 drives the clamp arm 131 to clamp the valve leaflet between the clamp arm 131 and the adjusting part 120, so that the valve leaflet is clamped.

In a preferred implementation of this embodiment, the valve clamping device 100 further includes a gripping portion, which may generally include at least one set of gripping arms 151, each set of gripping arms 151 including two gripping arms 151 symmetrically disposed with respect to the adjustment portion 120, the gripping portion (e.g., gripping arms 151) being disposed between the clamping portion 130 (e.g., forceps arms 131) and the adjustment portion 120 and being expandable or closable with respect to the adjustment portion 120, the gripping portion being at least partially received on an inner surface of the clamping portion 130. Of course, three or more gripping arms 151 may be provided in each set as desired to cooperate with the jawarms 131 to achieve the clamping function.

In the delivery state, the gripping portion is at least partially received in the inner surface of the clamping portion 130, i.e., the gripping arms 151 are at least partially received in the inner surface of the clamp arms 131, thereby reducing the outer diameter of the valve clamping device 100 to facilitate delivery, and the concave inner surface increases the contact area of the clamp arms 131 with the leaflets and allows the gripping arms 151 to grip the leaflets in the inner surface of the clamp arms 131 of the valve She Yaru after the clamp arms 131 are mated with the gripping arms 151 to grip the leaflets.

Referring to fig. 3b, biocompatible films or coatings are applied to the outer portions of the clamp arms 131 and the grasping portion, which provides greater biocompatibility to the valve clamping device 100.

Referring to fig. 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 supporting portion 110, and it should be noted that this portion is defined herein as the term "base" for convenience of description, and the structure for implementing the function of the base 160 may also be the distal end of the supporting portion 110, i.e. an integral structure formed with the supporting portion 110, so that the definition of the term "base" should not limit the scope of the present application. Each of the jawarms 131 in each set are connected together at a base 160 by a pivot 132 such that each of the jawarms 131 cooperate with each other to be able to be opened and closed together about the adjustment member 120 upon actuation of the actuation member 140.

Still referring to fig. 6 and 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, 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 link 143 is connected to one jawarm 131, and the other end is connected to the connection base 142 through a pivot 144, i.e., each jawarm 131 is rotatably connected to the distal end of the connection base 142 of the driving shaft 141 through the link 143 on the corresponding side. The driving shaft 141 movably penetrates through the base 160, and when the driving shaft 141 axially slides relative to the base 160, the connecting rod 143 rotates and drives the jawarms 131 to open and close relative to the base 160.

Specifically, the driving portion 140 includes at least one set of links 143, and the number of links 143 is set in a one-to-one correspondence with the setting of the jawarms 131, for example, two of the jawarms 131 are used in the figure, and two links 143 that cooperate are correspondingly set. The distal end of the link 143 is rotatably coupled to the coupling seat 142 at the distal end of the drive shaft 141 by means of a rotation pin or bolt 144 or the like. When the drive shaft 141 is slid distally in an axial direction relative to the base 160, the link 143 is moved, and the jawarms 131 are rotated about the pin holes 144 to open relative to the base 160 by the pulling of the link 143. When the drive shaft 141 is slid proximally in an axial direction relative to the base 160, the linkage 143 pulls the jawarms 131 to rotate about the pin holes 144 to close relative to the base 160.

The connecting seat 142 is fixedly arranged at the distal end of the driving shaft 141 by welding or the like, and the connecting seat 142 is provided with a pair of pins. The pin hole is used for being hinged with the connecting rod 143 through the pin 144, and the other end of the connecting rod 143 is connected with the clamp arm 131, so that the clamp arm 131 can be opened and closed relative to the base 160. The shape of the connecting seat 142 is any structure such as a hemisphere, a spherical cap or a bullet, so that the valve clamping device 100 is easier to push in the body. The driving shaft 141 and the connecting seat 142 may be integrally formed or may be non-integrally formed. To ensure safety after implantation, the driving shaft 141 and the connecting seat 142 are made of biocompatible materials such as polyester, silicone, stainless steel, cobalt alloy, cobalt-chromium alloy or titanium alloy, preferably stainless steel or cobalt-chromium alloy with high hardness.

Preferably, referring to fig. 6, the valve clasper device 100 further includes a locking portion 170 disposed in the base 160, the locking portion 170 limiting relative movement of the drive shaft 141 and the base 160. In the delivery state, the locking part 170 limits the relative movement of the driving shaft 141 and the base 160, so that the clamping part 130 is kept in a closed state relative to the adjusting part 120 and the supporting part 110 all the time, the unexpected unfolding of the clamping part 130 is avoided, and after the clamping part 130 reaches the vicinity of the mitral valve, the locking part 170 is unlocked to limit the driving shaft 141, so that the clamping part 130 can be driven by the driving part 140 to unfold relative to the adjusting part 120 and the supporting part 110 and support the leaflet. Any suitable locking means may be used, and will not be described in detail here.

Referring to fig. 6 and 9, the valve clamping system of the present embodiment includes the valve clamping device 100 and the delivery device 200, wherein the delivery device 200 includes a pushing shaft 210 having a certain axial length and a mandrel (not shown) movably inserted into the pushing shaft 210, the pushing shaft 210 is detachably connected to the supporting portion 110, and the mandrel is connected to the driving portion 140 and is used for driving the clamping portion 130 to be opened and closed with respect to the supporting portion 110. In this embodiment, the proximal end of the drive shaft 141 is externally threaded and the spindle is threadably coupled to the drive shaft 141 to control axial movement of the drive shaft 141 outside the patient's body via the spindle. It should be appreciated that only a portion of the structure of the delivery device is listed herein, and any other portion may be implemented in any suitable structure that is not described herein.

Specifically, at least one clamping position 114 connected to the lumen of the supporting portion 110 is symmetrically provided on the outer wall of the proximal end of the supporting portion 110, a fixing member 220 is provided on the distal end of the pushing shaft 210, and the fixing member 220 includes two branches, and each branch has a protruding clamping stage 221 at its end. In the natural state, both branches are directed at the central axis of the fixture 220. During assembly, the fixing member 220 is inserted into the supporting portion 110, and then the mandrel of the delivery device 200 is inserted into the pushing shaft 210 until the mandrel is inserted into the fixing member 220, the two branches of the fixing member 220 are lifted outwards, and the clamping blocks 221 at the tail ends of the branches are clamped into the two clamping positions 114 of the supporting portion 110, so that the supporting portion 110 is connected with the fixing member 220, namely, the valve clamping device 100 and the delivery device 200 are connected. When the mandrel is withdrawn from the holder 220 and the pushing shaft 210, the two branches resume their natural state inwards, and the catch 221 is disengaged from the catch 114 of the support 110, so that the valve clamping device 100 and the delivery device 200 are disconnected. The fixing member 220 is made of a material having a certain hardness and elasticity, such as nickel titanium. The pushing shaft 210 may employ a multi-layered composite tube. The mandrel is made of stainless steel material or nickel-titanium alloy material.

The support portion 110 has a through hole as a penetration passage 113 of the driving shaft 141, and the driving shaft 141 is slidably penetrated in the penetration passage 113 of the support portion 110 in the axial direction. The proximal end of the drive shaft 141 is provided with external threads for connection with a spindle of the delivery device 200 to control axial movement of the drive shaft 141 via the spindle. After the clamping part 130 and the grasping part 150 are matched and clamp valve tissues, the mandrel drives the driving shaft 141 to axially and proximally move, the driving shaft 141 drives the connecting rod 143 to rotate, and the connecting rod 143 drives the clamp arm 131 to fold relative to the supporting part 110 until the clamp arm 131 is completely closed relative to the supporting part 110, so that the valve clamping device 100 is in a folded and closed state and falls below a valve. The connection between the mandrel and the drive shaft 141 can then be released, the mandrel is withdrawn from between the fixtures 220, and the catch 221 is separated from the catch 114 of the support 110, thereby releasing the valve clamping device 100 and the delivery device 200. During the disengagement, since the junction (i.e., the disengagement) of the valve clamping device 100 and the delivery device 200 is located within the adjustment portion 120 of the valve clamping device 100, the proximal end of the adjustment portion 120 is provided with an open opening 122, and no component can hook the clamping stand 221 of the branch end of the fixing member 220, facilitating the release of the valve clamping device 100. In addition, the release part is arranged in the adjusting part 120, and is not directly washed by blood, so that the failure of a mechanism of the release part can be avoided, and the risk of thrombus formation can be reduced.

Referring to fig. 9-13, the use of the valve clasper device 100 of the present application is illustrated with respect to the anterograde approach and repair of a mitral valve via the left atrium:

First, as shown in fig. 9, the driving shaft 141 and the valve clamping device 100 connected with the driving shaft are pushed from the left atrium 2, through the mitral valve 1 and to the left ventricle 3 by a guiding device (not shown) such as an adjustable curved sheath;

a second step of adjusting the valvular clamping device 100 to approximate the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1;

Third, as shown in fig. 10, unlocking the locking part in the base 160, pulling the mandrel and the driving shaft 141 to the proximal end, driving the clamp arm 131 to open relative to the supporting part 110, and adjusting the direction of the clamp arm 131, wherein the relative positions of the clamp arm 131 and the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 can be observed by the X-ray equipment, so that the clamp arm 131 is perpendicular to the involution line of the mitral valve 1;

A fourth step, as shown in fig. 11, the whole valve clamping device 100 is retracted proximally, so that the clamp arms 131 support the valve leaflet 1 on the left ventricle 3 side, the two gripping arms 151 are released, and the gripping arms 151 on each side press the valve leaflet 1 on the atrium side and cooperate with the clamp arms 131 on the side to fix the valve leaflet 1, thereby realizing complete clamping of the valve leaflet 1;

Fifth, as shown in fig. 12, when the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are respectively clamped between the pair of forceps arms 131 and the grasping arms 151, the mandrel and the driving shaft 141 are pushed distally, thereby driving the forceps arms 131 to close;

Step six, the threaded connection between the mandrel and the driving shaft 141 is released, the mandrel is withdrawn, the two branches of the fixing piece 220 are restored to the state of being close to the central shaft, the clamping table 221 is separated from the clamping position 114 of the supporting part 110, the connection between the valve clamping device 100 and the conveying device 200 is released, then the conveying device 200 is withdrawn from the body to obtain the implantation state shown in fig. 13, at this time, the valve clamping device 100 pulls the front leaf 1a and the rear leaf 1b of the mitral valve 1 to each other to obtain the double-hole mitral valve, and the edge-to-edge repair of the mitral valve is completed.

After the valve clamping device 100 is implanted, the elastic adjusting part 120 is filled between the front leaflet 1a and the rear leaflet 1b of the clamped mitral valve 1 and abuts against the clamp arm 131, the elastic main body 123 (such as a reticular structure or a porous structure) of the adjusting part 120 has a buffer effect on the beating leaflet 1, so that the pulling degree of the valve clamping device 100 on the leaflet 1 can be adjusted to avoid damaging the leaflet 1, in addition, the elastic main body 123 can be extruded and deformed along with the beating of the leaflet 1, the generated elastic force pushes the part of the leaflet 1 close to the elastic main body 123 in a direction away from the base 160, at the moment, the axial movement of the elastic main body 123 towards the proximal end is not limited due to the opening 122 structure of the adjusting part 120, the clamping angle between the front leaflet and the rear leaflet of the mitral valve is smaller than the opening angle between the clamp arms 131, the pulling degree of the valve clamping device 100 on the leaflet 1 can be reduced, the pulling degree of the valve clamping device 100 on the leaflet 1 is always kept within a reasonable range, in addition, the elastic main body 123 can buffer the beating device can be extruded and deformed along with the beating of the leaflet 1, the beating device can be prevented from directly contacting the leaflet 1, the blood flow C is prevented from being released from the elastic main body 100, and the compression force is prevented from being deformed along with the back to the elastic main body 100, and the blood is prevented from being deformed along with the compression force of the leaflet 1, and the leaflet 1 is prevented from being deformed along with the back to the side of the elastic main body 100, and the clamp arm is prevented from being deformed, and the compression device is directly has a dead angle is prevented from a, and has a compression angle.

Referring to fig. 15 and 16, compared with the valve clasper device 100 of the first embodiment, the valve clasper device 300 according to the second embodiment of the present invention is different in that the adjusting portion 320 is approximately cone-shaped in the unfolded state, the cross-sectional dimension gradually increases in the distal-to-proximal direction, the proximal end face of the adjusting portion 320 forms the bottom face of the cone, and the connecting end of the adjusting portion 320 and the supporting portion 310 forms the vertex of the cone.

The valve clasper device 300 generally includes two states, one being a deployed state and the other being a closed state. When the nip portion 330 is closed around the adjustment portion 320, the proximal end of the adjustment portion 320 is distal to the proximal end of the nip portion 330.

Specifically, the free suspended end 321b of the adjustment portion 320 moves proximally after the clamping portion 330 is radially compressed, but the proximal end of the radially compressed adjustment portion 320 is distally located relative to the proximal end of the clamping portion 330. In this way, the adjusting portion 320 is not exposed from the proximal end face of the clamping portion 330 after closing, so as to ensure that the everted end of the clamping portion 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 thrombus caused by excessive exposure of the adjusting portion 320 to the left atrium.

Referring to fig. 17-19, in contrast to the valve clasper device 100 of the first embodiment, the adjustment portion 420 of the valve clasper device 400 in accordance with the third embodiment of the present invention further includes a cantilevered extension 422 at a proximal end thereof, the extension 422 projecting in a proximal direction, as shown at B in fig. 17. For example, the extension 422 may form a loop around the circumference of the adjustment portion 420 and form a boss structure a near the distal junction, the boss structure a protruding in a direction perpendicular to the distal to proximal direction.

After the clamping portion 430 is closed about the adjustment portion 420, the extension portion 422 extends from the proximal end of the clamping portion 430 without being clamped and wrapped by the clamping portion 430. At this time, there is a space between the proximal end of the clamping portion 430 and the opposite extension portion 422, for example, an axial space length between the distal end face of the extension portion 422 and the proximal end face of the clamping portion 430 may be defined as a space distance L, and a specific value of L may be set by one of ordinary skill in the art according to anatomical structures and the like. In this embodiment, when the clamping portion 430 is closed around the adjusting portion 420, the extending portion 422 protrudes from the clamping portion 430, i.e. the clamping portion 430 does not clamp the extending portion 422, so that the elastic fit between the leaflet and the adjusting portion 420 can be improved.

Specifically, after the valve is clamped by the valve clamping device 400, the extension 422 not clamped and wrapped by the clamping portion 430 may further cooperate with the clamping portion 430 to clamp the leaflet, such as the boss structure a abutting against the leaflet, so as to enhance the clamping force between the valve clamping device 400 and the leaflet, thereby improving the implantation stability of the valve clamping device 400.

Further, the proximal end surface of the adjustment portion 420 is recessed toward the distal end. During the clamping process of the clamping portion 430, the recess portion is beneficial to radial compression of the adjusting portion 420, and the braided wires near the extension portion 422 are not accumulated after compression, so that the compression size is reduced, and meanwhile, the radial reaction force is reduced, and the safety of the compressed instrument is improved. On the other hand, the recessed area also forms a receiving space of the conveying device, and the connection and disconnection of the conveying device 200 is not affected by the arrangement of the extension 422. The extension 422 extends in a direction perpendicular to the proximal to distal direction, and the extension 422 is substantially parallel to the direction perpendicular to the proximal to distal direction, which can improve the elastic fit of the leaflet to the regulating portion 420.

Referring to fig. 20 and 2, in contrast to the valve clasper device 400 of the third embodiment, the adjustment portion 720 of the valve clasper device 700 in accordance with the fourth embodiment of the present invention further includes a depending extension 722 at a proximal end thereof, the extension 722 extending outwardly in a radial direction away from the support portion 710. I.e., the extension 722 extends perpendicularly from the proximal end to the distal end, the extension 722 is substantially parallel to the direction perpendicular from the proximal end to the distal end, forming an approximately flat structure with an approximately straight cross-section, which can improve the elastic fit between the leaflet and the adjusting portion 720.

Specifically, after the valve is clamped by the valve clamping device 700, the extension portion 722 not clamped and wrapped by the clamping portion 730 may further cooperate with the clamping portion 730 to clamp the valve leaflet, for example, the platform structure abuts against the valve leaflet, so that the clamping force between the valve clamping device 700 and the valve leaflet is enhanced, and the implantation stability of the valve clamping device 700 is improved.

The proximal end of the adjustment portion 720 is provided with a steel sleeve 723, the steel sleeve 723 facilitating penetration of the delivery device 200. A steel bushing 723 is provided on the free suspension end 721b of the adjustment portion 720. The extension 722 is arranged around the steel sleeve 723, when the valve clamping device 700 is radially compressed, the extension 722 wraps the steel sleeve 723, so that the steel sleeve 723 is prevented from being in contact with the inner wall of the sheath tube, the steel sleeve 723 can be prevented from being in direct contact with human tissues such as valve leaflets, and the conveying safety and the implantation safety of the apparatus are ensured.

The adjusting part 720 is provided with a biocompatible film as a choke film outside or inside to prevent blood from entering the adjusting part 720, and in specific applications, the adjusting part 720 may be provided with a biocompatible film outside or inside. In this way, the valve clasper device 700 is made more biocompatible and avoids thrombus formation from blood entering the interior of the regulator portion 720.

Referring to fig. 22-24, in comparison 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 adjusting portion 520 has a free hanging end 521B and a distal end cap 521, the free hanging end 521B may have an opening 522, the adjusting 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 are smoothly connected together, i.e., the first curved surfaces 520A are adjacent to the second curved surfaces 520B only, the second curved surfaces 520B are adjacent to the first curved surfaces 520A only, the two first curved surfaces 520A disposed opposite to each other face one clamp arm, and the second curved surfaces 520B have an area smaller than that of the first curved surfaces 520A.

In this embodiment, the first curved surface 520A with a relatively large area is opposite to the forceps arm, the second curved surface 520B with a relatively small area is smoothly connected between the two first curved surfaces 520A, along with the closing of the valve clamping device, the first curved surface 520A of the adjusting portion 520 is extruded by the forceps arm and the valve leaflet, the adjusting portion 520 extends along the direction of the first curved surface 520A and gradually fits the valve leaflet, so as to better adapt to the shape of the valve leaflet, and increase 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 may be greater than the curvature of the second curved surface 520B, so that the adjusting portion has a flat elliptic shape, thereby avoiding affecting the closing of the jawarms. Further, in this embodiment, when the forceps arms are closed, the forceps arms and the leaflets are pressed, the first curved surface 520A of the adjusting portion 520 is pressed, the adjusting portion extends along the axial direction, and the distal end of the delivery system is not hooked due to the open first end of the adjusting portion, so that the valve clamping device can be ensured to be separated from the delivery device connection portion of the valve clamping device under any deformation of the adjusting portion.

Referring to fig. 25 and 26, compared to the valve clamping device of the first embodiment, the structure of the adjusting portion of the valve clamping device 600 according to the sixth embodiment of the present invention is the same as the adjusting portion 120 of the first embodiment, except that the clamping portion 630 and the grasping portion 650 cooperate to grasp the leaflet in a different manner. In the sixth embodiment, the clamping portion 630 includes a set of clamp arms 631 that can be opened and closed with respect to the supporting portion 610 and the adjusting portion, the gripping portion 650 includes a pair of gripping arms 651, and the gripping portion 650 is located between the clamping portion 630 and the adjusting portion.

During delivery, the clamping portion 630, the gripping portion 650 and the adjusting portion are all accommodated in the distal end of the delivery device 200, the delivery device 200 is delivered into the left ventricle through the approach of the apex of the heart and then straddles the orifice of the mitral valve to reach the left atrium, the delivery device 200 is retracted, the adjusting portion and the gripping portion 650 gradually extend out of the delivery device 200 and are deployed in the left atrium, the delivery device 200 is retracted until the clamping portion 630 also extends out of the delivery device 200 and is deployed in the left ventricle, then the clamping portion 630 is pushed distally by the driving portion, the anterior leaflet and the posterior leaflet of the mitral valve are respectively supported on the inner surfaces of the two clamp arms 631 of the clamping portion 630, the gripping portion 650 and the adjusting portion are retracted proximally, namely, the gripping portion 650 is driven to move in the direction of the clamping portion 630, so that the leaflet is captured between the gripping portion 650 and the clamping portion 630, then the clamping portion 631 is driven again to close relative to the adjusting portion and the supporting portion 610, so that the anterior leaflet and the posterior leaflet are respectively fixed between one clamp arm 631 and one clamp arm arranged corresponding to the clamping arm and the clamping arm 651 and deployed in the left ventricle, then the clamping device 200 is pulled back into the sealing device 600 towards each other, and the valve is pulled back into the sealing device is formed, and the valve is gradually pulled into the sealing device between the clamping device and the valve sealing device.

It will be appreciated that a valve clamping system according to the present application comprises any of the valve clamping devices described above 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 leaflets. The above description of the valve clamp is intended to be illustrative only and not to be limiting of the application, and valve clamps and valve clamp systems incorporating same, as would be within the purview of one of ordinary skill in the art based on the teachings herein.

It should be noted that in this document, relational terms such as "first" and "second" and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises an element.

The foregoing is only a specific embodiment of the invention to enable those skilled in the art to understand or practice the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims (9)

1. A valve clamping device with adjustable support force, comprising: 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 clamping device according to claim 1 , wherein a biocompatible film or a biocompatible coating is provided on the outside and/or inside of the regulating part. 3. The valve clamping device according to claim 1 is characterized in that the adjusting part includes an elastic body, the elastic body 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, and 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. 4 . The valve clamping device according to claim 3 , wherein the proximal edge of the elastic body encloses and forms the opening, and a sealing head is provided at the opening. 5. The valve clamping device according to claim 1 is characterized in that the clamping part includes two clamp arms, and the two clamp arms are symmetrically arranged relative to the adjusting part, and the driving part is respectively connected to each of the clamp arms to drive each of the clamp arms to rotate around the adjusting part. 6. The valve clamping device according to claim 5 is characterized in that the clamping part also includes two grasping parts, which are arranged between the two clamp arms and the adjusting part and can be expanded or closed relative to the adjusting part. When the grasping parts and the clamp arms are expanded, the grasping parts are at least partially accommodated on the inner surface of the clamp arms. 7 . The valve clipping device according to claim 6 , wherein a biocompatible film is applied to the exterior of the forceps arm and the grasping portion. 8. The valve clamping device according to claim 6, 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 ends of the clamp arm and the proximal end of the grasping portion. 9. A valve clamping system, characterized in that it comprises the valve clamping device according to any one of claims 1 to 8, and a conveying device, wherein the conveying device comprises: 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.