Disclosure of Invention
The invention aims to provide a valve clamp which can improve the rigidity of an inner capturing arm, so that the inner capturing arm is prevented from deforming, the stability of the valve clamp in the use process is improved, and the success rate of an operation is improved.
In order to achieve the above object, the present invention provides a valve clamp, including a transmission assembly and a clamping portion, where the transmission assembly includes a support member, an inner capturing arm, an outer capturing arm and a connecting member sequentially connected from a proximal end to a distal end, the connecting member is used to drive all the outer capturing arms to move, and the outer capturing arm moves to drive the inner capturing arm to move, so that the valve clamp is in a deployed state, a capturing state or a clamping state;
The transmission assembly further comprises a reinforcing part, the reinforcing part and the clamping part are respectively connected with the inner capturing arm, the clamping part is used for clamping target tissues, and the reinforcing part is used for preventing the inner capturing arm from deforming after being stressed.
Optionally, the transmission assembly further includes a compression ring, one end of the compression ring is connected with the connecting piece or the outer capturing arm, and the other end of the compression ring is connected with the inner capturing arm and/or the reinforcing part; the compression ring is configured to apply a closing force to the inner capture arm to assist in transitioning the valve clip from the grasping state to the clamping state.
Optionally, the number of the inner capturing arms, the outer capturing arms, the reinforcing part and the pressing ring is at least two, and all the inner capturing arms and all the outer capturing arms are arranged at intervals in the circumferential direction of the supporting rod; the reinforcing part and the clamping part are respectively connected with a corresponding one of the inner capturing arms; one end of the compression ring is connected with the connecting piece, and the other end of the compression ring is connected with a corresponding reinforcing part.
Optionally, the reinforcing part is a reinforcing plate, and the clamping part and the reinforcing plate are respectively fixed at two sides of a corresponding inner capturing arm; the clamping portion is secured to the proximal end of the reinforcement plate when the valve clamp is in the deployed state.
Optionally, the clamping portion is fixed to a proximal end of a corresponding one of the inner capturing arms, and the reinforcing plate is fixed to a distal end of a corresponding one of the inner capturing arms.
Optionally, one end of the reinforcing plate is connected with the inner capturing arm and the clamping part, and the other end of the reinforcing plate is connected with the compression ring.
Optionally, the reinforcement plate comprises a first section and a second section, a distal end of the first section being connected to a proximal end of the second section; a dimension of the first section in the width direction of the inner catch arm is less than or equal to a dimension of the second section in the width direction of the inner catch arm; a dimension of the first section in a width direction of the inner catch arm is smaller than or equal to a width of the inner catch arm, the first section being connected with the nip and the inner catch arm; the second section is connected with the pressure ring.
Optionally, a dimension of the second section in a width direction of the inner capturing arm is greater than or equal to a width of the inner capturing arm; the portion of the second section extending beyond the inner catch arm is connected to the compression ring.
Optionally, the dimension of the reinforcing plate in the length direction of the inner capturing arm is smaller than the length of the inner capturing arm.
Optionally, the clamping portion includes an elastic member and a fixing member connected to each other, and the elastic member is configured to cooperate with the fixing member to clamp the target tissue; the fixing piece is respectively connected with the inner capturing arm and the reinforcing plate.
Optionally, the reinforcing plate is provided with a first fixing hole, and the fixing piece is provided with a second fixing hole; the first fixing hole is used for being aligned with the second fixing hole, and the reinforcing plate, the inner capturing arm and the fixing piece are stitched through the first fixing hole and the second fixing hole.
The valve clamp comprises a transmission assembly and a clamping part, wherein the transmission assembly comprises a supporting piece, an inner capturing arm, an outer capturing arm and a connecting piece which are sequentially connected from a proximal end to a distal end, the connecting piece is used for driving all the outer capturing arms to move, and the outer capturing arms after moving drive the inner capturing arms to move so as to enable the valve clamp to be in an unfolding state, a grabbing state or a clamping state. The transmission assembly further comprises a reinforcing part, the reinforcing part and the clamping part are respectively connected with the inner capturing arm, the clamping part is used for clamping target tissues, and the reinforcing part is used for preventing the inner capturing arm from deforming after being stressed.
The valve clamp can increase the rigidity of the inner capturing arm through the reinforcing part, so that the inner capturing arm is prevented from deforming, the inner capturing arm is ensured to always keep a capturing form in the capturing process of the valve clamp, the stability of the valve clamp in the using process is improved, and the success rate of an operation is improved.
Detailed Description
The invention is described in further detail below with reference to the drawings and the specific examples. The advantages and features of the present invention will become more apparent from the following description. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for convenience and clarity in aiding in the description of embodiments of the invention.
The terms "center," "longitudinal," "transverse," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counter-clockwise," "axial," "radial," "circumferential," etc. refer to an orientation or positional relationship based on that shown in the drawings, merely for convenience of description and to simplify the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be construed as limiting the invention.
In the present invention, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly and include, for example, either fixedly attached, detachably attached, or integrally formed; may be mechanically connected, may be electrically connected or may be in communication with each other; either directly, or through an intermediary, may be internal to the two elements or in an interactive relationship with the two elements, unless explicitly defined otherwise. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances. In the description of the present invention, "plurality" means at least two, for example, two or three or more, etc.
As used in this specification, "distal" generally refers to the end of the valve clip that is distal to the operator; the term "proximal" as opposed to "distal" generally refers to the end of the valve clip that is proximal to the operator; the term "axial" refers to the direction along the axis of the drive rod; the term "circumferential" refers to the circumferential direction of the axis of the drive rod; the term "radial" refers to a direction perpendicular to the axis of the drive rod.
Heart valves are membranous structures that can be opened and closed in the organs of humans or some animals. Four valves are located in each human heart, specifically an aortic valve separating the left ventricle from the aorta, a pulmonary valve separating the right ventricle from the pulmonary artery, a mitral valve separating the left atrium from the left ventricle, and a tricuspid valve separating the right atrium from the right ventricle. The heart valve corresponds to a check valve, so that blood can only flow from one direction to the other and cannot flow back. The aortic valve or the pulmonary valve can ensure that the blood of the ventricle enters the aorta or the pulmonary artery through the aortic valve or the pulmonary valve, so that the blood rich in oxygen and nutrient substances flows into the whole body through the aorta, and meanwhile, the blood recovered by the vena cava can exchange oxygen to the lung, so that the blood becomes arterial blood rich in oxygen. Both the mitral and tricuspid valves function to isolate the atria from the ventricles to prevent blood in the ventricles from regurgitating back into the atria. If the heart valve is not tightly closed, reflux phenomenon can be caused, heart failure of a patient is caused, normal life quality of the patient is affected, and if reflux is serious and even life is dangerous.
The invention will now be described in detail with reference to the drawings and a preferred embodiment. The following embodiments and features of the embodiments may be complemented or combined with each other without conflict.
As shown in fig. 1-4, a preferred embodiment of the present invention provides a valve clip that can be delivered to a predetermined location within the body and grasp target tissue (i.e., native leaflets) to treat regurgitation caused by adjacent leaflets being under-closed.
It should be understood that the predetermined location refers to the in vivo target location to which the valve clip is delivered. In this embodiment, the predetermined position refers to the position of the mitral valve or tricuspid valve. The target tissue refers to the clamping location after implantation of the valve clip. In this embodiment, the target tissue is the native leaflet of the mitral or tricuspid valve.
Referring to fig. 3, the valve clip comprises a transmission assembly and a clip portion, the transmission assembly comprising a support 11, an inner capturing arm 12, an outer capturing arm 13 and a connector 14 connected in sequence from a proximal end to a distal end. The connecting piece 14 is used for driving all the outer capturing arms 13 to move, and the outer capturing arms 13 move to drive the inner capturing arms 12 to move so as to enable the valve clamp to be in a unfolding state, a grabbing state or a clamping state.
Further, the transmission assembly further comprises a reinforcing part 15, the reinforcing part 15 and the clamping part 2 are respectively connected with the inner capturing arm 12, the clamping part 2 is used for clamping target tissues (namely, native valve leaflets), and the reinforcing part 15 is used for preventing the inner capturing arm 12 from deforming after being stressed. That is, after the reinforcement portion 15 is connected to the inner catch arm 12, the shape of the inner catch arm 12 can be maintained to increase the strength of the inner catch arm 12, thereby preventing the inner catch arm 12 from being deformed.
The valve clamp can increase the rigidity of the inner capturing arm 12 through the reinforcing part 15, so that the inner capturing arm 12 is prevented from deforming, the inner capturing arm 12 is ensured to always maintain the capturing form in the capturing process of the valve clamp, the stability of the valve clamp in the using process is improved, and the success rate of an operation is improved.
With continued reference to fig. 3, the transmission assembly 1 further includes a pressure ring 16, one end of the pressure ring 16 is connected to the connecting member 14 or the outer capturing arm 13, and the other end of the pressure ring 16 is connected to the inner capturing arm 12 or the reinforcing portion 15. The compression ring 16 is used to apply a closing force to the inward catch arms 12 to assist in transitioning the valve clip from the grasping state to the clamping state.
Further, the number of the inner capturing arms 12, the outer capturing arms 13, the reinforcing portion 15 and the pressing ring 16 is the same, and at least two, all the inner capturing arms 12 and all the outer capturing arms 13 are arranged at intervals in the circumferential direction of the support rod 11 (i.e., the circumferential direction of the connection line of the support rod 11 and the connecting member 14). The reinforcement portion 15 and the nip portion 2 are connected to a corresponding one of the inner catch arms 12, respectively.
It will be appreciated that when the predetermined location is the mitral or tricuspid valve, the number of inner capturing arms 12, outer capturing arms 13 and clamping portions 2 is 2, in which case each clamping portion 2 can clamp one leaflet.
As shown in fig. 3, in a preferred embodiment, the number of inner capturing arms 12 and outer capturing arms 13 is two; the distal end of each outer capturing arm 13 is connected to a connector 14, and the proximal end of each outer capturing arm 13 is connected to a corresponding one of the inner capturing arms 12. The connecting piece 14 can synchronously drive the two outer capturing arms 13 to synchronously rotate after moving, and the corresponding inner capturing arm 12 is driven to gradually rotate towards the direction approaching or separating from the supporting piece 11 after the outer capturing arms 13 rotate.
With continued reference to fig. 3, the transmission assembly 1 further comprises a driving rod 17, the support 11 has a through hole (not numbered) extending axially therethrough, the driving rod 17 movably extends through the through hole of the support 11, and the driving rod 17 is connected to the connecting member 14. All the inner catch arms 12 and all the outer catch arms 13 are symmetrically arranged about the axis of the drive rod 17 (i.e. the line connecting the support 11 with the connection 14). The driving rod 17 is used for driving the connecting piece 14 to move in the axial direction of the driving rod 17, the connecting piece 14 is used for driving all the outer capturing arms 13 to synchronously rotate after moving, and the corresponding inner capturing arm 12 is driven to rotate after the outer capturing arms 13 rotate, so that the inner capturing arm 12 bends relative to the outer capturing arm 13, and then the valve clamp is in an unfolding state, a grabbing state or a clamping state.
Specifically, the link 14 can be driven to move in the axial direction of the drive rod 17. The valve clamp is in the deployed state when the inner and outer catch arms 12, 13 are moved to a substantially co-linear position, i.e. when the connector 14 is moved to the most distal end. During proximal movement of the connector 14 under the drive of the drive rod 17, the inner catch arm 12 is rotated in the direction of the support 11 under the drive of the outer catch arm 13, and when the inner catch arm 12 is moved to a position substantially perpendicular to the support 11 (i.e. the position shown in fig. 3), the valve clamp is in a grasped state, in which the valve clamp can capture the native leaflets. After the valve clamp is in the grabbing state, the inner capturing arm 12 can be driven by the outer capturing arm 13 to rotate continuously towards the direction of the supporting piece 11, and the pressing ring 16 can provide closing force for approaching the supporting piece 11 to the inner capturing arm 12 so as to enable the inner capturing arm 12 to move towards the direction of the supporting piece 11. When the inner catch arm 12 is moved to a position closest to the support 11, i.e. when the inner catch arm 12 is in a substantially parallel position with the support 11, the valve clamp is in a clamped state in which it can clamp and secure the native leaflet.
In one embodiment, one end of the compression ring 16 is connected to the connector 14, and the other end of the compression ring 16 is connected to the inner catch arm 12. Because the inner capturing arm 12 is connected with the reinforcing part 15, and further has higher rigidity, the arrangement can avoid the inner capturing arm 12 from deforming under the closing force of the compression ring 16, so that the inner capturing arm 12 keeps the original flat shape, and the capturing efficiency of the clamping part 21 on the native valve leaflet is improved.
Referring to fig. 3, in another embodiment, one end of the pressing ring 16 is connected to the connecting member 14, and the other end of the pressing ring 16 is connected to the reinforcing portion 15. After the pressing ring 16 is connected with the reinforcing portion 15, the reinforcing portion 15 has high rigidity, so that the closing force of the pressing ring 16 is not transmitted to the inner capturing arm 12, and the inner capturing arm 12 is kept in an original flat shape.
Referring to fig. 4 and 5, in a preferred embodiment, the reinforcing portion 15 is a reinforcing plate, which is connected to the pressure ring 16, and preferably has a shape matching that of the inner catch arm 12 so as to enhance the strength of the inner catch arm 12. It should be understood that the reinforcement 15 is not limited to a plate-like structure, and in another preferred embodiment, the reinforcement 15 may be provided in other suitable structures, for example, the reinforcement 15 may be provided in a structure such as a reinforcing bar or a reinforcing block.
In the following description, a reinforcing plate is schematically illustrated as the reinforcing portion 15.
With continued reference to fig. 3, as an alternative embodiment, the nip 2 and the reinforcing plate are each fixed to both sides of a corresponding one of the inner catch arms 12. When the valve clamp is in the expanded state, the clamping portion 2 is fixed at the proximal end of the reinforcement plate, i.e. the clamping portion 2 is arranged at the proximal end of a corresponding one of the reinforcement plates. That is, the clamping portion 2 is closer to the support 11 relative to the reinforcement plate when the valve clamp is in the expanded state. As an alternative embodiment, the clamping part 2 and the reinforcing plate may be fixed to one side of the inner capturing arm 12, for example, the clamping part 2 and the reinforcing plate may be fixed to the outer wall of the inner capturing arm 12.
Referring to fig. 3, in a preferred embodiment, the nip 2 is secured to the proximal end of a corresponding one of the inner catch arms 12 and the reinforcement plate is secured to the distal end of a corresponding one of the inner catch arms 12.
In an exemplary embodiment, one end of the reinforcing plate is respectively connected to the inner capturing arm 12 and the clamping portion 2, that is, one end of the reinforcing plate, which is close to the supporting member 11, is fixedly connected to the inner capturing arm 12 and the clamping portion 2 at the same time, and the other end of the reinforcing plate is connected to the pressing ring 16, so as to raise the rigidity of the distal end of the inner capturing arm 12 and prevent the inner capturing arm 12 from being deformed under the closing force of the pressing ring 16.
In another exemplary embodiment, the reinforcing plate and the nip 2 may also be connected to the inner catch arm 12, respectively, while the reinforcing plate and the nip 2 are not connected.
Referring to fig. 5, the reinforcing plate includes a first section 151 and a second section 152, and a distal end of the first section 151 is connected to a proximal end of the second section 152 in an extending direction of the inner capturing arm 12 (i.e., a length direction of the inner capturing arm 12). The reinforcing plate has a T-shaped structure, and the dimension of the first section 151 in the width direction of the inner capturing arm 12 is smaller than or equal to the dimension of the second section 152 in the width direction of the inner capturing arm 12.
Preferably, the dimension of the first section 151 in the width direction of the inner catch arm 12 is smaller than or equal to the width of the inner catch arm 12, so as to promote the rigidity of the inner catch arm 12, in which case the first section 151 may be connected to both the nip 2 and the inner catch arm 12, and the second section 152 is connected to the pressure ring 16.
More preferably, the second section 152 has a dimension in the width direction of the inner capturing arm 12 that is greater than or equal to the width of the inner capturing arm 12. When the dimension of the second section 152 in the width direction of the inner catch arm 12 is larger than the width of the inner catch arm 12, the portion of the second section 152 that protrudes out of the inner catch arm 12 is connected with the pressing ring 16.
Further, the dimension of the reinforcing plate in the length direction of the inner catch arm 12 (i.e., the extending direction of the inner catch arm 12) is smaller than the length of the inner catch arm 12, preferably slightly smaller than the length of the inner catch arm 12, so that the reinforcing plate can be fixed to the inner wall of the inner catch arm 12.
Referring to fig. 5 and 6, and in combination with fig. 3, the clamping portion 2 includes an elastic member 21 and a fixing member 22 connected to each other, and the elastic member 21 is configured to be driven to rotate and to cooperate with the fixing member 22 to clamp a target tissue. The fixing members 22 are connected to the inner catch arms 12 and the reinforcing plate, respectively.
Specifically, the elastic member 21 is capable of deforming and rotating in a direction away from the fixing member 22 by an external force so as to be away from the fixing member 22; the elastic member 21 is also capable of recovering its shape after the external force is removed and rotating in a direction approaching the fixing member 22 to clamp the target tissue in cooperation with the fixing member 22.
With continued reference to fig. 5 and 6, in the present embodiment, the reinforcing plate is provided with a first fixing hole 153 and the fixing member 22 is provided with a second fixing hole 221. The first fixing hole 153 is used to align with the second fixing hole 221, i.e., the positions of the reinforcing plate and the fixing member 22 correspond to each other, so that the first fixing hole 153 and the second fixing hole 221 can communicate through the inner catch arm 12. The reinforcement plate, the inner catch arm 12 and the fixing member 22 are sewn through the first fixing hole 153 and the second fixing hole 221.
In practice, the reinforcing plate may be placed on the inner wall of the inner catch arm 12, and the nip 2 placed on the outer wall of the inner catch arm 12 with the first fixing holes 153 in the reinforcing plate aligned with the second fixing holes 221 in the fixing member 22. Then, the suture thread sequentially passes through the first fixing hole 153 and the second fixing hole 221 to fix the clamping part 2, the reinforcing plate and the inner capturing arm 12.
Referring to fig. 5, a third fixing hole 154 is further formed in the reinforcing plate, and after the reinforcing plate is fixed to the inner capturing arm 12, the third fixing hole 154 extends out of the inner capturing arm 12, and the pressing ring 16 may be sewn to the reinforcing plate through the third fixing hole 154.
Referring back to fig. 3, the valve clip further comprises a moving member 18 and a control wire 19, the moving member 18 is disposed at the proximal end of the supporting member 11, one end of the driving rod 17 is connected to the moving member 18, and the other end is connected to the connecting member 14 after penetrating through the through hole of the supporting member 11. The moving member 18 is used to push and pull the connecting member 14 so as to move the connecting member 14 in the axial direction of the supporting member 11. The number of the control wires 19 corresponds to the number of the clamping parts 2, one end of the control wires 19 is connected with the moving member 18, and the other end is connected with the corresponding clamping part 2.
As shown in fig. 6, the elastic member 21 includes a fourth fixing hole 211, and the fourth fixing hole 211 is provided on an end of the elastic member 21 remote from the fixing member 22. The control wire 19 is used to connect with a corresponding one of the elastic members 21 through the fourth fixing hole 211. In actual use, the moving member 18 drives the connecting member 14 to move proximally, and the control wire 19 can pull the elastic member 21 to move the elastic member 21 away from the fixing member 22 (as shown in fig. 3), so as to separate the elastic member 21 and the fixing member 22. After the valve clamp is implanted in place, when the native valve leaflet enters between the elastic member 21 and the fixing member 22, an operator can relax the control wire 19 to remove the constraint of the control wire 19 on the elastic member 21, and the elastic member 21 can automatically rotate towards the direction of the fixing member 22 after the external force is removed, so that the elastic member 21 is matched with the fixing member 22 to clamp the native valve leaflet.
With continued reference to fig. 6, and in combination with fig. 3, the elastic member 21 further includes a plurality of barbs 212, one end of the barbs 212 being connected to the elastic member 21 and the other end extending toward the securing member 22, the barbs 212 being adapted to be inserted into the native leaflet to secure the native leaflet.
In summary, in the valve clamp provided by the invention, the rigidity of the inner capturing arm 12 can be increased by the reinforcing part 15, so that the inner capturing arm 12 is prevented from deforming, the inner capturing arm 12 is ensured to always maintain the capturing form in the capturing process of the valve clamp, the stability of the valve clamp in the use process is improved, and the success rate of the operation is improved.
The above description is only illustrative of the preferred embodiments of the present invention and is not intended to limit the scope of the present invention, and any alterations and modifications made by those skilled in the art based on the above disclosure shall fall within the scope of the present invention.