CN114073602A

CN114073602A - Valve clamping device with adjustable supporting force and valve clamping system

Info

Publication number: CN114073602A
Application number: CN202010827144.XA
Authority: CN
Inventors: 张庭超; 张伟伟; 郑贤章; 梁华光
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2020-08-17
Filing date: 2020-08-17
Publication date: 2022-02-22

Abstract

The invention discloses a valve clamping device with adjustable bearing force and a valve clamping system. Wherein, this holding power adjustable valve clamping device includes: the supporting part comprises a connecting end and a free end which are oppositely arranged; the adjusting part is made of shape memory materials, one end of the adjusting part is sleeved outside the connecting end and is connected with the supporting part, and the other end of the adjusting part is suspended in the air; the clamping part is arranged around the outer side of the adjusting part; the driving part is connected with the clamping part so as to drive the clamping part to open or close around the adjusting part; the free end of the supporting part is positioned in the adjusting part, and the near end of the adjusting part is spaced from the near end of the supporting part. Therefore, the valve clamping device with adjustable supporting force provided by the embodiment of the invention can improve the elastic fitting property of the valve leaflet and the adjusting part, and further improve the adaptability of the physiological structures of the valve leaflets of different patients.

Description

Valve clamping device with adjustable supporting force and valve clamping system

Technical Field

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

Background

Referring to fig. 1, the mitral valve 1 is a one-way valve between the left atrium 2 and the left ventricle 3 of the heart, and a normal, healthy mitral valve 1 can control the flow of blood from the left atrium 2 to the left ventricle 3 while preventing the flow of blood from the left ventricle 3 to the left atrium 2. The mitral valve 1 includes a pair of leaflets, referred to as an anterior leaflet 1a and a posterior leaflet 1 b. The anterior leaflet 1a and the posterior leaflet 1b are fixed to papillary muscles of the left ventricle 3 by chordae tendineae 4. Normally, when the left ventricle 3 of the heart contracts, the edges of the anterior leaflet 1a and the posterior leaflet 1b are completely apposed, preventing blood from flowing 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 tendineae 4 are partially broken, the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are poorly coaptated, and thus, when the left ventricle 3 of the heart contracts, the mitral valve 1 cannot be completely closed, causing blood to regurgitate from the left ventricle 3 to the left atrium 2, thereby causing a series of pathophysiological changes, called "mitral regurgitation".

Transcatheter mitral valve coaptation refers to the treatment of mitral regurgitation by implanting a valve coaptation device into the mitral valve, using a pair of closable forceps arms to pull the anterior and posterior leaflets toward each other, reducing or eliminating the leaflet gap. The valve clamping device in the prior art adds an elastic body in two clamp arms, wherein the valve leaflet on each side is respectively clamped between one clamp arm and one side of the elastic body, and the distance between the valve leaflets is adapted through the deformation of the elastic body, so that the pulling degree of the clamp arms to the valve leaflets is adjusted. The elastic body comprises a deformable net-shaped main body, two ends of the elastic body are fixed by seal 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 by the sealing heads, when the forceps arms are closed, the sealing heads limit the axial movement of the elastic body, and the elastic body can only be radially compressed, which affects the deformation of the elastic body, thereby increasing the size of the clamping device in a delivery state, being not beneficial to the trafficability of the clamping device in a bent blood vessel, and causing the elastic body not to completely fit the valve leaflets after the clamping device is implanted, which has poor adaptability to the physiological structures of the valve leaflets of different patients.

Disclosure of Invention

To address 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 with adjustable support force.

In a first aspect, the present application provides a force-bearing adjustable valve clamping device comprising:

the supporting part comprises a connecting end and a free end which are oppositely arranged;

the adjusting part is made of shape memory materials, one end of the adjusting part is sleeved on the outer side of the connecting end and is connected with the supporting part, and the other end of the adjusting part is suspended in the air;

the clamping part is arranged around the outer side of the adjusting part;

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

the free end of the support portion is located within the adjustment portion, and the proximal end of the adjustment portion is spaced from the proximal end of the support portion.

In a second aspect, the present application provides a valve clamping system, comprising the above-mentioned valve clamping device with adjustable supporting force, and a delivery device, wherein the delivery device comprises: the pushing shaft is connected with the supporting part in a detachable mode, and the mandrel is connected with the 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 technical scheme provided by the embodiment of the application has the following advantages: for the valve clamping device with adjustable supporting force and the valve clamping system comprising the valve clamping device with adjustable supporting force, one end of the adjusting part is sleeved outside the connecting end and is connected with the supporting part, the other end of the adjusting part is freely suspended, the freely suspended end is not connected with the supporting part and the conveying device and is not limited by the supporting part or the conveying device, the axial deformation capacity of the adjusting part is improved, and meanwhile, the bending deformation capacity along the axial direction is enhanced. In addition, after the valve clamping device with adjustable supporting force is implanted, in the process of clamping the valve leaflets and the adjusting part through the clamp arms, the axial deformation of the adjusting part is not limited, so that the elastic fitting performance of the valve leaflets 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 present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious for those skilled in the art that other drawings can be obtained according to the drawings without inventive exercise.

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

FIG. 2 is a schematic representation of a diseased mitral valve;

FIG. 3a is a schematic structural view of a first embodiment of an adjustable-support-force valve clamping device of the present application;

FIG. 3b is a schematic diagram of the adjustable-support valve clasping device of FIG. 3a showing the structure of the applied biocompatible thin film;

FIG. 4 is a schematic view of the combined structure of the adjustment part and the support part in FIG. 3 a;

FIG. 5 is a schematic diagram of the adjustable force valve clamping device of FIG. 3a in a closed position;

FIG. 6 is a schematic view of the combination of the clamping portion and the driving portion of FIG. 3 a;

FIG. 7 is a schematic structural view of the support part of FIG. 3 a;

FIG. 8 is a schematic view of the support part and the base of FIG. 3 a;

FIG. 9 is a schematic view of the adjustable support portion of the valve clamping device of FIG. 3a engaged with a delivery device;

FIGS. 10-14 are schematic illustrations of a delivery procedure for anterograde approximation and repair of a mitral valve via the left atrium using the adjustable-force valve clamping device of FIG. 3 a;

FIG. 15 is a schematic structural view of a second embodiment of the adjustable-support-force valve clamping device of the present application;

FIG. 16 is a schematic view of a second embodiment of the adjustable-support valve clamping device of the present application in a closed position;

FIG. 17 is a schematic view of a third embodiment of the adjustable support force valve clamping device of the present application;

FIG. 18 is a schematic view of a third embodiment of the adjustable-support valve clamping device of the present application in conjunction with a delivery device;

FIG. 19 is a schematic diagram of a third embodiment of the adjustable-support valve clamping device of the present application in a closed position;

FIG. 20 is a schematic view of a fourth embodiment of the adjustable support force valve clamping device of the present application;

FIG. 21 is a schematic view of a fourth embodiment of the adjustable-support valve clamping device of the present application in a closed position;

FIG. 22 is a schematic view of a fifth embodiment of the present application showing a first curved side of an adjustment portion of an adjustable-support valve clamping device;

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

FIG. 24 is a schematic view of the second curved side of the adjustment part of FIG. 22;

FIG. 25 is a schematic view of a sixth embodiment of the adjustable support force valve clamping device of the present application;

FIG. 26 is a schematic view of the adjustable-support-force valve clasping device of FIG. 25 partially retracted into the delivery device after radial compression.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without inventive effort based on the embodiments of the present invention, are within the scope of the present invention.

In the description of the present invention, it should be noted that the terms "upper", "lower", "inside", "outside", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience in describing the present invention and simplifying the description, but do not indicate or imply that the referred device or element must have a specific orientation, be constructed in a specific orientation, and be operated, 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, it should be noted that, in the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; axial refers to a direction parallel to the line joining the center of the distal end and the center of the proximal end of the medical device. The foregoing definitions are for convenience only and are not to be construed as limiting the present invention.

Referring to fig. 3 a-14, a first embodiment of the present invention provides a valve clamping device 100 with adjustable supporting force, comprising: a support portion 110, the support portion 110 including a connection end 111 and a free end 112 disposed opposite to each other; the adjusting part 120 is hollow, the adjusting part 120 is made of shape memory material, one end of the adjusting part 120 is sleeved outside the connecting end 111 and is connected with the supporting part 110, the other end of the adjusting part 120 is suspended, the free end 112 of the supporting part 110 is suspended in the adjusting part 120, and a gap exists between the near end of the adjusting part 120 and the free end 112; the clamping part 130, the clamping part 130 is arranged around the outer side of the adjusting part 120; and the driving part 140, the driving part 140 being connected with the clamping part 130 to drive the clamping part 130 to open or close around the adjusting part 120.

One end of the adjusting part 120 of the valve clamping device 100 with adjustable supporting force is a free hanging end 121b, the free hanging end 121b is not limited by the supporting part 110 or the conveying device 200 any more, the axial deformation capacity of the adjusting part 120 is improved, and the bending deformation capacity along the axial direction is enhanced, so that when the valve clamping device 100 with adjustable supporting force is radially compressed into a conveyor for conveying in vivo, the valve clamping device is not only easily compressed into a sheath, but also can adapt to blood vessels with different bending degrees during conveying in the blood vessel, thereby being beneficial to the conveyor to pass through the blood vessel, and reducing the damage to the blood vessel wall.

Meanwhile, the free end 112 is connected or detached with the delivery device in the adjusting portion 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 release failure caused by the hooking of the chordae tendineae on the free end 112 can also be prevented.

In addition, after the valve clamping device 100 with adjustable supporting force is implanted, in the process of clamping the valve leaflets and the adjusting part 120 through the clamp arms 131, the axial deformation of the adjusting part 120 is not limited, so that the elastic fitting performance of the valve leaflets and the adjusting part 120 can be improved, and the adaptability of the valve leaflet physiological structures of different patients is further improved.

In addition, after the valve clamping device 100 with adjustable supporting force is implanted, the free end 112 is suspended in the adjusting part 120, and the proximal end of the adjusting part 120 is spaced from the free end 112, so that the suspended free end 112 and the free suspended end 121b of the adjusting part 120 can be prevented from interfering or winding, and the implantation safety of the device can be ensured.

The adjustable-support-force valve clamping device 100 mainly comprises two states, namely a deployed state and a closed state. During the closing of the nip 130 around the adjustment part 120, the adjustment part 120 is radially compressed, and the interval h between the proximal end of the adjustment part 120 and the proximal end of the support part 110 gradually increases. That is, one end 121a of the adjusting portion 120 is sleeved on the outer side of the connecting end and connected to the supporting portion 110, and the other end of the adjusting portion 120 is a free hanging end 121b, and in the process of compressing the adjusting portion 120 by the clamping portion 130, the free hanging end 121b of the adjusting portion 120 moves towards the proximal end, and the interval h between the free hanging end 121b and the supporting portion 110 increases.

Referring to fig. 6-8, the supporting portion 110 may be a circular tube, a square tube, or an oblate tube with two axially-through end faces. The embodiment adopts a round tube body, the far end of which is a connecting end 111 and the near end of which is a free end 112. At least a portion of the supporting portion 110 is disposed in the hollow of the adjusting portion 120, for example, the free end 112 of the supporting portion 110 is disposed in the adjusting portion 120, and the free end 112 is disposed in the adjusting portion 120 in both the closed state and the open state, and does not expose the adjusting portion 120. The support portion 110 is further provided with an axial through-hole shaped through-passage 113 for cooperating with the driving portion 140 and the delivery device 200. At least two clamping positions 114 are arranged on the pipe wall of the round pipe body of the supporting part 110 and are used for being detachably connected with the conveying device 200. For example, after the retainer 221 of the delivery device 200 is engaged with the retainer 114, the delivery device 200 is engaged with the support 110 to deliver the valve clamping device 100, and when the retainer 221 is disengaged from the retainer 114, the delivery 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 a limitation of the present application, and those skilled in the art can adopt other structures of the supporting portion 110 based on the teaching of the present application within the protection scope of the present application.

The valve clamping device 100 with adjustable supporting force of the first embodiment is located in the hollow adjusting part 120 in the proximal free end 112 in both the closed state and the expanded state, so that the valve clamping device is not exposed in the delivery device 200 or the heart all the time, thereby avoiding blood scouring and minimizing thrombus formation after implantation. And the direct contact with the valve leaflets is avoided after implantation, the valve leaflets are prevented from being worn and even perforated along with the long-term pulsation of the valve leaflets, and 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 part 110, the other end 121b of the elastic body 123 has an opening 122 and is freely suspended, and the size of the opening 122 is smaller than or equal to the size of the free end of the support part 110 in a 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, thereby preventing the support part 110 from being exposed from the opening 122. The elastic body 123 can deform to accommodate the spacing between the different leaflets, adjusting the degree of pull of the valve clamping device 100 on the leaflets. The opening 122 of the elastic body 123 is used for penetrating 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 penetrating into the hollow accommodating cavity of the elastic body 123 through the opening 122, and the opening 122 of the distal end of the elastic body 123 is not connected to the distal end of the delivery 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 free-floating state. Therefore, in the process of delivering or clamping the valve leaflets, when the clamping part 130 is closed, the elastic main body 123 in the adjusting part 120 is not limited by the support part 110 or the delivery device 200, can be deformed in the radial direction and the axial direction, has larger deformation degree, is more beneficial to delivery and has stronger adaptability to the valve leaflets; when the connection between the distal end of the delivery device 200 or the proximal end (free end) of the support portion 110 is released, the free, suspended end of the adjustment portion 120 is more deformable and more adaptable to the leaflets.

The adjustment portion 120 includes a proximal end and a distal end, and in one embodiment, the proximal edge of the elastic body 123 is sleeved with a hollow snare structure (not shown) to form an opening, i.e., the proximal end of the elastic body 123 is closed and provided with a seal. The snare structure may be ring-shaped or polygonal, and may be made of a hard material such as stainless steel, so that the wires of the mesh structure or the struts of the frame structure are suitably gathered toward the central axis, but are not closed, thereby forming an opening 122 at the center of the snare structure. In another embodiment, the proximal edge of the elastic body 123 encloses the 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 extend beyond the adjusting portion 120 in both the compressed state and the natural state.

The proximal edge of the elastic body 123 encloses to form an opening 122, the proximal end closure of the adjustment portion 120 of the valve clamping device 100 is eliminated, and when the clamping portion 130 is closed, the elastic body 123 can deform in both the radial direction and the axial direction, so that the degree of deformation is greater, and the delivery is facilitated; in addition, the elastic body 123 is not limited by the axial movement of each mesh wire or strut of the sealing head, so that the elastic body can be moderately curled or bent, thereby completely fitting the valve leaflet and better adapting to the physiological structures of the valve leaflets of different patients; in addition, the risk that the near-end sealing head part in the prior art falls off after being implanted for a period of time can be avoided; in addition, the distal end of the elastic body 123 is connected to the support portion 110, and the opening 122 at the proximal end is open, so that the center of gravity is always located in the axial direction of the support portion 110 (i.e., the axial line of the elastic body 123), and therefore, the self-centering performance is good and the inclination is not easy.

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

In the delivery state, the driving part 140 drives the forceps arms 131 to close around the adjusting part 120, so as to reduce the outer diameter of the valve clamping device 100 and facilitate delivery; after the valve clamping device 100 is deployed in vivo, the driving portion 140 drives the clamp arms 131 to clamp the valve leaflets between the clamp arms 131 and the adjusting portion 120, so as to clamp the valve leaflets.

In a preferred embodiment of the present embodiment, the valve clamping device 100 further comprises a gripping portion, which generally comprises at least one set of gripping arms 151, each set of gripping arms 151 comprises two gripping arms 151 symmetrically disposed with respect to the adjustment portion 120, the gripping portion (e.g. the gripping arms 151) is disposed between the clamping portion 130 (e.g. the clamp arms 131) and the adjustment portion 120 and can be opened or closed with respect to the adjustment portion 120, and the gripping portion is at least partially received in 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 achieve a clamping function in cooperation with the jawarms 131.

In the delivery state, the grip is at least partially received in the inner surface of the clamp 130, i.e., the grip arms 151 are at least partially received in the inner surface of the clamp arms 131, thereby reducing the outer diameter of the valve clamp device 100 for delivery; after the clamp arms 131 engage the grasping arms 151 to grasp a leaflet, the concave inner surfaces can increase the contact area of the clamp arms 131 with the leaflet and cause the grasping arms 151 to press the leaflet into the inner surfaces of the clamp arms 131, increasing the grasping force on the leaflet.

Referring to fig. 3b, a biocompatible film or coating is applied to the exterior of both the clamp arms 131 and the grip portion, which makes the valve clamping device 100 more biocompatible.

Referring to fig. 8, the valve clamping device 100 further includes a base 160 fixedly connected to the supporting 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, for convenience of explanation, this portion is defined as the term "base", and the structure for realizing the function of the base 160 may also be the distal end of the supporting portion 110, i.e. the integral structure formed with the supporting portion 110, so that the definition of the term "base" should not form a limitation to the scope of the present application. Each of the jawarms 131 in each set are connected together by a pivot 132 on the base 160 so that each of the jawarms 131, in cooperation with each other, can be opened and closed together about the adjustment portion 120 upon actuation of the actuation portion 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 with the clamping part 130, and the other end is pivoted with the connecting seat 142; one end of the driving shaft 141 is connected to the connecting seat 142, and the other end is movably inserted into the base 160. Specifically, each link 143 has one end connected to one of the forceps arms 131 and the other end connected to the connecting section 142 by a pivot 144, i.e., each forceps arm 131 is rotatably connected to the distal end of the connecting section 142 of the driving shaft 141 by the link 143 on the corresponding side. The driving shaft 141 movably passes through the base 160, and when the driving shaft 141 slides in the axial direction 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.

Specifically, the driving portion 140 includes at least one set of connecting rods 143, and the number of the connecting rods 143 is set to correspond to the number of the forceps arms 131, for example, two forceps arms 131 are used in the figure, and two connecting rods 143 are correspondingly set. The distal end of the link 143 is rotatably coupled to the coupling seat 142 at the distal end of the driving shaft 141 by means of a rotating pin or bolt 144. When the driving shaft 141 slides in the axial direction toward the distal end with respect to the base 160, the link 143 is moved, and the jawarms 131 are rotated about the pin holes 144 to be opened with respect to the base 160 by the pulling of the link 143. As drive shaft 141 slides axially proximally relative to base 160, linkage 143 pulls jawarm 131 to rotate about pin hole 144 to close relative to base 160.

The connecting base 142 is fixedly disposed at a distal end of the driving shaft 141 by welding or the like, and the connecting base 142 is provided with a pair of pins. The pin hole is used for connecting the connecting rod 143 through a pin 144, and the other end of the connecting rod 143 is connected with the clamp arm 131, so that the clamp arm 131 is opened and closed relative to the base 160. The connecting seat 142 is shaped as any one of a hemisphere, a spherical cap, or a bullet, so that the valve clamping device 100 can be pushed in the body more easily. The driving shaft 141 and the connecting seat 142 may be an integral structure or a non-integral structure. In order to ensure the safety after implantation, the driving shaft 141 and the connecting seat 142 are made of a biocompatible material 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 clamping device 100 further comprises a locking portion 170 provided in the base 160, the locking portion 170 limiting the relative movement of the drive shaft 141 and the base 160. In the delivery state, the locking part 170 limits the relative movement between the driving shaft 141 and the base 160, so as to ensure that the clamping part 130 is always kept in a closed state relative to the adjusting part 120 and the supporting part 110, and avoid the accidental unfolding of the clamping part 130; after reaching the vicinity of the mitral valve, the restriction of the drive shaft 141 by the unlock lock 170 is such that the drive unit 140 drives the clamping unit 130 to unfold and support the leaflet with respect to the adjustment unit 120 and the support unit 110. Any suitable locking portion may be used as is known in the art and will not be described further herein.

Referring to fig. 6 and 9, the valve clamping system of the present embodiment includes the valve clamping device 100 and a 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, wherein the pushing shaft 210 is detachably connected to the supporting portion 110, and the mandrel is connected to the driving portion 140 for driving the clamping portion 130 to open and close relative to the supporting portion 110. In this embodiment, the proximal end of the drive shaft 141 is externally threaded, and the spindle is threadedly coupled to the drive shaft 141 such that axial movement of the drive shaft 141 is controlled by the spindle outside the patient's body. It should be understood that only a portion of the structure of the delivery device is shown, and any other portion may be any suitable structure that is known in the art, and will not be described herein.

Specifically, the outer wall of the proximal end of the supporting portion 110 is symmetrically provided with at least one retaining portion 114 communicated with the lumen of the supporting portion 110, the distal end of the pushing shaft 210 is provided with a fixing member 220, the fixing member 220 includes two branches, and the end of each branch is a convex retaining platform 221. In the natural state, both branches point towards the central axis of the fixture 220. During assembly, the fixing member 220 is inserted into the supporting portion 110, and 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 platforms 221 at the 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, that is, the valve clamping device 100 and the delivery device 200 are connected. When the mandrel is withdrawn from the fixing element 220 and the pushing shaft 210, the two branches return to the inward natural state, and the clamping platform 221 is disengaged from the clamping position 114 of the supporting part 110, so that the connection between the valve clamping device 100 and the delivery device 200 is released. The fixing member 220 is made of a material having a certain hardness and elasticity, such as nickel titanium. The pusher shaft 210 may be a multi-layer composite tube. The mandrel is made of stainless steel materials or nickel-titanium alloy materials.

The support portion 110 has a through hole as a passage 113 for the driving shaft 141, and the driving shaft 141 is axially slidably inserted into the passage 113 of the support portion 110. The proximal end of the drive shaft 141 is externally threaded for connection to a spindle of the delivery device 200, whereby axial movement of the drive shaft 141 is controlled by the spindle. After the clamping portion 130 and the grasping portion 150 are engaged to clamp the valve tissue, the driving shaft 141 is driven by the mandrel to move axially and proximally, the driving shaft 141 drives the connecting rod 143 to rotate, the connecting rod 143 drives the forceps arms 131 to close relative to the supporting portion 110 until the forceps arms 131 are completely closed relative to the supporting portion 110, so that the valve clamping device 100 is in a closed state and falls below the valve. The mandrel can then be disconnected from the drive shaft 141, withdrawn from the fastener 220, and the locking platform 221 separated from the locking position 114 of the support 110, thereby releasing the valve clamping device 100 and the delivery device 200. During the release process, since the connection point (i.e., the release point) of the valve clamping device 100 and the delivery device 200 is located in the adjusting part 120 of the valve clamping device 100, and the proximal end of the adjusting part 120 is provided with the open opening 122, there is no part that can hook the clamping table 221 at the branch end of the fixing member 220, so as to facilitate the release of the valve clamping device 100. In addition, the release site is provided inside the regulating part 120, and is not directly washed by blood, so that the mechanism failure at the release site can be avoided, and the risk of thrombosis can be reduced.

Referring to fig. 9-13, the use of the valve clamping device 100 of the present application is illustrated, for example, to access and repair a mitral valve anterogradely through the left atrium:

the first step is as follows: as shown in fig. 9, the drive shaft 141 and the valve clamping device 100 connected thereto are advanced from the left atrium 2, through the mitral valve 1 to the left ventricle 3, by means of a guiding device (not shown) such as an adjustable curved sheath;

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

the third step: as shown in fig. 10, the locking portion in the base 160 is unlocked, the mandrel and the driving shaft 141 are pulled proximally, the forceps arms 131 are driven to open relative to the supporting portion 110, and the directions of the forceps arms 131 are adjusted, so that the relative positions of the forceps arms 131 and the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 can be observed through an X-ray device, and the forceps arms 131 are perpendicular to the coaptation line of the mitral valve 1;

the fourth step: as shown in fig. 11, the entire valve clamping device 100 is withdrawn proximally, so that the forceps arms 131 hold the leaflet 1 at the left ventricle 3 side, the grasping arms 151 at both sides are released, the grasping arm 151 at each side presses the leaflet 1 at the atrium side and cooperates with the forceps arms 131 at the side to fix the leaflet 1, and complete clamping of the leaflet 1 is realized;

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

and a sixth step: the threaded connection between the mandrel and the driving shaft 141 is released, the mandrel is withdrawn, the two branches of the fixing member 220 return to the state of approaching 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 delivery device 200 is released, then the delivery device 200 is withdrawn out of the body, the implantation state shown in fig. 13 is obtained, at the moment, the valve clamping device 100 pulls the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 to each other, a bicuspid mitral valve is obtained, and the edge-to-edge repair of the mitral valve is completed.

After the valve clamping device 100 is implanted, the adjusting part 120 with elasticity is filled between the anterior leaflet 1a and the posterior leaflet 1b of the clamped mitral valve 1 and abuts against the clamp arms 131, and the elastic main body 123 (such as a mesh structure or a porous structure) of the adjusting part 120 has a buffering effect on the pulsating leaflet 1, so that the valve clamping device 100 can adjust the pulling degree of the leaflet 1 to avoid damaging the leaflet 1; in addition, the elastic body 123 can be squeezed and deformed along with the pulsation of the valve leaflet 1, the generated elastic force pushes the part of the valve leaflet 1 close to the elastic body 123 to the direction away from the base 160, at this time, the axial movement of the elastic body 123 towards the proximal end is not limited due to the structure of the opening 122 of the adjusting part 120, 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, the pulling of the valve clamping device 100 on the valve leaflet 1 can be reduced, and the pulling degree of the valve clamping device 100 on the valve leaflet 1 is always kept in 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, so as to prevent the valve clamping device 100 from falling off due to the continuous flushing of the blood, and prevent the blood from accumulating at the dead angle (position C in fig. 3 a) between the clamping parts 130 of the valve clamping device 100 to form thrombus; in addition, when the elastic main body 123 is under the pressure action of the valve, a certain degree of deformation is generated, and the degree of deformation increases along with the increase of the pressure, so that after the valve leaflet 1 is prevented from being grabbed, the extrusion force of the clamp arms 131 on the elastic main body 123 is reversely acted on the clamp arms 131, and the grabbing effect of the valve leaflet 1 by the valve leaflet clamping device 100 after release is ensured to be consistent with the grabbing effect before release.

Referring to fig. 15 and 16, compared to the valve clamping device 100 of the first embodiment, the valve clamping device 300 with adjustable supporting force according to the second embodiment of the present invention is different in that the adjusting portion 320 has a substantially conical shape in a natural state, the cross-sectional dimension of the adjusting portion increases gradually from the distal end to the proximal end, the proximal end face of the adjusting portion 320 forms the bottom surface of the conical body, and the connecting end of the adjusting portion 320 and the supporting portion 310 forms the apex of the conical body.

The valve clamping 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 regulating portion 320, the proximal end of the regulating portion 320 is on the distal side with respect to the proximal end of the nip portion 330.

Specifically, after the clamping part 330 is radially compressed, the free end 321b of the adjusting part 320 moves towards the proximal end, but the proximal end of the radially compressed adjusting part 320 is at the distal side relative to the proximal end of the clamping part 330. Thus, the adjustment portion 320 is not exposed to the proximal surface of the clamping portion 330 after closing, ensuring that the everted end of the clamping portion 330 abuts against the valve leaflet to increase the contact area of the valve leaflet, conform to the angle and direction of the valve leaflet, and avoiding the risk of thrombus caused by too much of the adjustment portion 320 being exposed to the left atrium.

Referring to fig. 17-19, in comparison with the valve clamping device 100 of the first embodiment, the adjusting part 420 of the valve clamping device 400 with adjustable supporting force according to the third embodiment of the invention further includes a suspending extension 422 at its proximal end, and the extension 422 extends in the proximal direction, as shown at B in fig. 17. For example, extension 422 may form a ring of adjustment portion 420 around the outer circumference and form a ledge structure A near the distal junction that extends in a direction perpendicular to the direction from the distal end to the proximal end.

After the clamping portion 430 is closed around the adjustment portion 420, the extension portion 422 is exposed from the proximal end of the clamping portion 430 and is not clamped and wrapped by the clamping portion 430. At this time, the proximal end of the clamping portion 430 is spaced from the extending portion 422, for example, the axial spacing length between the distal end surface of the extending portion 422 and the proximal end surface of the clamping portion 430 may be defined as a spacing distance L, and a specific value of L may be set by one skilled in the art according to factors such as the anatomical structure. In this embodiment, when the clamping portion 430 is closed around the adjusting portion 420, the extension 422 protrudes from the clamping portion 430, that is, the clamping portion 430 does not clamp the extension 422 therein, so that the elastic fit between the leaflet and the adjusting portion 420 can be improved.

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

Further, the proximal end surface of the regulating portion 420 is recessed toward the distal end. In the clamping process of the clamping part 430, the concave part is beneficial to radial compression of the adjusting part 420, and the braided wires near the extending part 422 cannot be accumulated after compression, so that the compression size is reduced, the radial reaction force can be reduced, and the safety of the compressed instrument is improved. On the other hand, the recessed area also forms a containing space of the conveying device, and the connection and the disassembly of the conveying device 200 cannot be influenced by the arrangement of the extension part 422. Extensions 422 extend in a direction perpendicular to the proximal-to-distal direction, and extensions 422 are substantially parallel to the direction perpendicular to the proximal-to-distal direction, which can improve the elastic fit of the leaflet to the accommodating section 420.

Referring to fig. 20 and 2, compared to the valve clamping device 400 of the third embodiment, the adjusting portion 720 of the valve clamping device 700 with adjustable supporting force according to the fourth embodiment of the present invention further includes a suspending extension portion 722 at its proximal end, and the extension portion 722 extends outward in a radial direction away from the supporting portion 710. That is, the extension 722 extends perpendicularly from the proximal end to the distal end, and the extension 722 is substantially parallel to the perpendicular direction from the proximal end to the distal end, so as to form an approximate platform structure having an approximately straight cross section, thereby improving the elastic fit between the leaflet and the adjustment part 720.

Specifically, after the valve clamping device 700 clamps the valve, the extensions 722 not clamped and wrapped by the clamping portions 730 can further cooperate with the clamping portions 730 to clamp the valve leaflets, for example, the platform structure abuts against the valve leaflets, so that the clamping force between the valve clamping device 700 and the valve leaflets 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 sleeve 723 is provided on the free hanging end 721b of the regulating portion 720. The extension part 722 is arranged around the steel sleeve 723, and after the valve clamping device 700 is radially compressed, the extension part 722 wraps the steel sleeve 723, so that the steel sleeve 723 is prevented from contacting the inner wall of the sheath, the steel sleeve 723 is prevented from directly contacting human tissues such as valve leaflets and the like, and the delivery safety and the implantation safety of the device are ensured.

The exterior or interior of the regulating part 720 is provided with a biocompatible film as a flow blocking film to prevent blood from entering the regulating part 720, and in a specific application, the exterior and interior of the regulating part 720 can also be provided with a biocompatible film. In this way, the valve clamping device 700 is made more biocompatible and prevents blood from entering the interior of the regulating portion 720 to form thrombus.

Referring to fig. 22-24, compared to the valve clamping device 100 of the first embodiment, according to the valve clamping device with adjustable supporting force 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, that is, the first curved surfaces 520A are only adjacent to the second curved surfaces 520B, the second curved surfaces 520B are also only adjacent to the first curved surfaces 520A, two oppositely disposed first curved surfaces 520A respectively face one clamp arm, and the area of the second curved surfaces 520B is smaller than the area of the first curved surfaces 520A.

In this embodiment, the first curved surface 520A with a relatively large area faces the forceps arms, 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 squeezed by the forceps arms and the valve leaflets, the adjusting portion 520 extends along the direction of the first curved surface 520A and gradually fits the valve leaflets, so as to better adapt to the shapes of the valve leaflets, and increase the contact area between the first curved surface 520A and the valve leaflets, thereby reducing the gap between the valve clamping device and the valve leaflets, slowing down the blood flow and blocking the blood flow from washing the valve clamping device. Preferably, the curvature of the first curved surface 520A may be larger than that of the second curved surface 520B, so that the adjusting portion is shaped like a flat ellipsoid to avoid affecting the closing of the forceps arms. Further, in this embodiment, when the clamp arms are closed, the clamp arms and the valve leaflets press against the first curved surface 520A of the adjustment portion 520, the adjustment portion 520 extends in the axial direction, and the first end of the adjustment portion 520 is open and does not hook the distal end of the delivery system, so that the valve clamping device can be ensured to be separated from the delivery device connection of the valve clamping device under the condition that the adjustment portion 520 is deformed arbitrarily.

Referring to fig. 25 and 26, in comparison with the valve clamping device of the first embodiment, the adjustable-support-force valve clamping device 600 according to the sixth embodiment of the present invention has the same structure as the adjustable part 120 of the first embodiment, except that the clamping part 630 and the grasping part 650 cooperate to grasp the valve leaflet. In the sixth embodiment, the nip portion 630 includes a set of clamp arms 631 that can be opened and closed with respect to the support portion 610 and the adjustment portion, the grip portion 650 includes a pair of grip arms 651, and the grip portion 650 is located between the nip portion 630 and the adjustment portion.

During delivery, the clamping portion 630, the grasping 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 transapical route and then crosses the mitral valve orifice to reach the left atrium, and the delivery device 200 is retracted, so that the adjusting portion and the grasping portion 650 gradually extend out of the delivery device 200 and are deployed in the left atrium; continuing to withdraw the delivery device 200 until the nip 630 also extends from the delivery device 200 and deploys into the left ventricle; then, the clamping part 630 is pushed to the far end by the driving part, 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 part 630, the gripping part 650 and the adjusting part are withdrawn to the near end, namely, the gripping part 650 is driven to move towards the clamping part 630, so that the leaflet is captured between the gripping part 650 and the clamping part 630, then the clamping part 630 is driven to close relative to the adjusting part and the supporting part 610, so that the anterior leaflet and the posterior leaflet are respectively fixed between one clamp arm 631 and one clamp arm 651 correspondingly arranged with the clamp arm 631, and then the conveying device 200 is pushed to the far end until the valve clamping device 600 is gradually folded and closed; the connection between the valve clamping device and the delivery device 200 is released, thereby implanting the valve clamping device on the mitral valve, drawing the anterior and posterior leaflets of the mitral valve toward each other into a bi-porous configuration.

It will be appreciated that a valve coaptation system according to the present application includes any of the valve coaptation devices described above, as well as a delivery device capable of delivering the valve coaptation device from outside the body to the vicinity of the mitral valve and coapting the leaflets. The above description of the valve clamping device is provided by way of example and not by way of limitation, and valve clamping devices and valve clamping systems incorporating the same, as taught herein, by one of ordinary skill in the art are within the scope of the present application.

It is noted that, in this document, relational terms such as "first" and "second," and the like, may be 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. Also, 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 an … …" does not exclude the presence of other identical elements in a process, method, article, or apparatus that comprises the element.

The foregoing are merely exemplary embodiments of the present invention, which enable those skilled in the art to understand or practice the present 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

1. A force-bearing adjustable valve clamping device, comprising:

the clamping part is arranged around the outer side of the adjusting part;

2. The adjustable-support-force valve clamping device according to claim 1, wherein the adjusting portion is substantially conical in shape in a natural state, a proximal end face of the adjusting portion forms a bottom surface of the conical body, and a connecting end of the adjusting portion and the support portion forms an apex of the conical body.

3. The adjustable-support-force valve clamping device according to claim 1, wherein the adjustment portion comprises a cantilevered extension that protrudes in a proximal direction, the extension forming a ring around the circumference of the adjustment portion.

4. The adjustable-support-force valve clamping device according to claim 1, wherein the adjusting portion comprises a cantilevered extension portion that projects in a radial direction away from the support portion, the extension portion forming a ring around the circumference of the adjusting portion.

5. The adjustable-support-force valve clamping device as claimed in claim 1, wherein the adjusting portion comprises a plurality of first curved surfaces and a plurality of second curved surfaces, the first curved surfaces and the second curved surfaces are adjacent to each other, two oppositely arranged first curved surfaces respectively face the clamping portion, and the area of the first curved surfaces is larger than that of the second curved surfaces.

6. The adjustable-support-force valve clamping device according to claim 1, wherein the adjusting portion is externally and/or internally provided with a biocompatible film or a biocompatible coating.

7. The adjustable-support-force valve clamping device according to claim 1, wherein the adjusting portion comprises an elastic body, the elastic body has a natural state and a compressed state, one end of the elastic body is connected to the support portion, the other end of the elastic body has an opening, and the size of the opening is smaller than or equal to the size of the free end of the support portion in the compressed state of the elastic body.

8. The adjustable-support-force valve clamping device according to claim 7, wherein the proximal edge of the elastic body is configured to enclose the opening.

9. The adjustable-support valve clipping device of claim 7, wherein the proximal end of the resilient body is closed and provided with a seal.

10. The adjustable-support-force valve clamping device according to claim 1, wherein the clamping portion comprises at least two clamping arms, the at least two clamping arms are symmetrically arranged relative to the adjusting portion, and the driving portion is connected with each clamping arm respectively so as to drive each clamping arm to rotate around the adjusting portion.

11. The adjustable support force valve clamping device according to any one of claims 1 to 10, further comprising a gripping portion disposed between the clamping portion and the adjustment portion and capable of being opened or closed relative to the adjustment portion, wherein the gripping portion is at least partially received within an inner surface of the clamping portion when both the gripping portion and the clamping portion are opened.

12. The adjustable-support-force valve clamping device according to any one of claims 1 to 10, wherein a biocompatible thin film is applied to the outside of the forceps arms and the grip portion.

13. The adjustable-support-force valve clamping device according to any one of claims 1 to 10, further comprising a base fixedly connected to the support portion, wherein the clamping portion is rotatably connected to the base.

14. The adjustable-support-force valve clamping device according to claim 13, wherein the driving portion comprises: the connecting device comprises a driving shaft, a connecting seat and at least two connecting rods; one end of each connecting rod is connected with the clamping part, and the other end of each connecting rod is pivoted with the connecting seat; one end of the driving shaft is connected with the connecting seat, and the other end of the driving shaft is movably arranged in the base in a penetrating mode.

15. The adjustable-support-force valve clamping device of claim 14, further comprising a locking portion disposed in the base, the locking portion restricting relative movement of the drive shaft and the base.

16. A valve clamping system comprising the adjustable-support-force valve clamping device of any one of claims 1-15 and a delivery device, the delivery device comprising: the pushing shaft is provided with a certain axial length, and the mandrel is movably arranged in the pushing shaft in a penetrating mode, the pushing shaft is detachably connected with the supporting portion, and the mandrel is connected with the driving portion and used for driving the clamping portion to be unfolded and closed relative to the supporting portion.