CN113456295A - Heart valve clamping device - Google Patents

Abstract

The invention provides a heart valve clamping device which comprises a fixing arm mechanism, a clamping arm mechanism and a driving mechanism, wherein the fixing arm mechanism comprises a fixing arm main body and at least two fixing arms extending outwards from the fixing arm main body, and the fixing arms and the fixing arm main body are integrally formed; the clamping arm mechanism comprises a clamping arm main body connected to the bottom of the fixed arm main body and at least two clamping arms extending outwards from the clamping arm main body, and the clamping arms and the clamping arm main body are integrally formed; the driving mechanism comprises a second driving component for driving the fixing arm and the clamping arm to open or close. The fixing arm mechanism and the clamping arm mechanism of the whole heart valve clamping device are respectively a whole, so that the risk of disengaging the fixing arm or the clamping arm can be avoided, the stability of the whole structure is better, the valve leaflets are clamped by the fixing arm and the clamping arm under three-dimensional ultrasound and radiography navigation, the regurgitation area is reduced, and the regurgitation treatment of the mitral valve or the tricuspid valve can be realized without the continuous heartbeat.

Description

Heart valve clamping device

Technical Field

The invention relates to the technical field of medical instruments, in particular to a heart valve clamping device.

Background

The mitral valve is a one-way valve located between the left atrium and the left ventricle of the heart, and a normal healthy mitral valve can control the flow of blood from the left atrium to the left ventricle while avoiding the flow of blood from the left ventricle to the left atrium. With the development of society and the aging population, the incidence rate of Mitral Regurgitation (MR) is in a significantly rising situation, and is now a common heart valve disease.

The mitral valve regurgitation treatment is currently in the era of traditional sternal median incision surgery and recent minimally invasive small incision surgery, and is beginning to come in the era of transcatheter interventional therapy. The mitral regurgitation interventional minimally invasive treatment technology has become one of the most popular research directions in interventional cardiology, and the interventional treatment MR method with small trauma, less complications and less cost has made great progress.

In mitral regurgitation, the interventional treatment techniques for mitral regurgitation can be divided into two categories: one is transcatheter mitral valve repair, such as MitraClip, pasal, valleclam, Cardioband, Mitralign, and NeoChord, and the other is transcatheter mitral valve placement, which is currently the primary treatment for repair. However, the current technology has some problems, such as that MitralClip achieves the purpose of treatment by clamping anterior and posterior mitral valve leaflets and changing a large single hole into a small double hole, but the implantation path is too far away, the operation is too complicated, and the improvement is still needed.

There is a valve clamping device and a valve clamping system in the prior art, the valve clamping system comprises a valve clamping device and a pushing device. The valve clamping device comprises a push rod, at least two clamps, at least one extension arm and a driving component for driving the clamps to open and close and the extension arms to stretch. Each clamp comprises a first clamp arm and a second clamp arm which can be opened and closed relatively, and at least one extension arm is arranged on the surface of the first clamp arm in a telescopic mode. When the operation is performed, the first forceps arm and the second forceps arm can be opened and closed, and the valve leaflet positioned between the first forceps arm and the second forceps arm can be clamped.

However, in the valve clamping device, the number of the first clamping arm and the second clamping arm is 2 or more than 2, and each first clamping arm or each second clamping arm is arranged independently, namely each clamping arm is assembled with the push rod or the driving assembly in the middle for connection in production and processing, the integrity of the clamp is weak, the risk of partial disconnection exists, and the connection is not stable enough.

Disclosure of Invention

The invention aims to provide a heart valve clamping device, which solves the technical problem that the clamp arms in the prior art are separately arranged, so that the connection is not stable enough and the risk of disconnection exists.

In order to achieve the purpose, the invention adopts the technical scheme that: there is provided a heart valve binder comprising: the fixing arm mechanism comprises a fixing arm main body and at least two fixing arms extending outwards from the fixing arm main body, and the fixing arm main body are integrally formed; the clamping arm mechanism comprises a clamping arm main body connected to the bottom of the fixing arm main body and at least two clamping arms extending outwards from the clamping arm main body, and the clamping arms and the clamping arm main body are integrally formed; the driving mechanism comprises a first driving component for driving the fixing arm to open or close relative to the fixing arm main body and a second driving component for driving the clamping arm to open or close relative to the clamping arm main body.

Furthermore, the fixing arm main body is of a pipe body structure, a first strip-shaped groove is formed in the side wall of the pipe body structure, and the pipe wall located in the first strip-shaped groove is the fixing arm.

Further, still include the transportation sheath pipe of being fixed in the top of fixed arm main part.

Further, fixed arm mechanism still including being located the sheath pipe hanging head at fixed arm main part top, the sheath pipe hanging head with carry sheath pipe detachably fixed connection.

Furthermore, the sheath pipe hanging head is at least one T-shaped hook protruding out of the top of the fixed arm main body, a fixing groove for accommodating the sheath pipe hanging head is formed in the bottom of the conveying sheath pipe, and the fixing groove is clamped with the sheath pipe hanging head and can be bent to separate from the clamping.

Furthermore, the fixed arm is pre-shaped to be opened towards a direction far away from the fixed arm main body, the first driving assembly comprises at least two pulling wires, and the end of each pulling wire is fixedly connected with one fixed arm and drives one or more fixed arms to be opened or closed.

Furthermore, a fixing hole for fixing the traction line is formed in one end, far away from the fixing arm main body, of the fixing arm.

Furthermore, a barb structure is arranged on one side face, facing the clamping arm, of the fixed arm.

Furthermore, the clamping arm mechanism further comprises a traction arm base and at least two traction arms extending outwards from the traction arm base, the traction arm base is located at the bottom of the clamping arm main body, the traction arms are fixedly connected with the clamping arms or integrally formed, and connecting points of the traction arms and the clamping arm main body are arranged at intervals.

Furthermore, the base of the pulling arm is of a pipe body structure, a second strip-shaped groove is formed in the side wall of the pipe body structure, the pipe wall located in the second strip-shaped groove is the pulling arm, a third strip-shaped groove is formed in the pipe wall located outside the second strip-shaped groove, and the pipe wall in the third strip-shaped groove forms the clamping arm and the clamping arm main body.

Furthermore, the second driving component comprises a pushing rod, and the pushing rod penetrates through the fixing arm main body and the clamping arm main body in a sliding mode and is abutted to the traction arm base.

Furthermore, the clamp arm is pre-shaped to be attached to the clamp arm main body, and the push rod can drive the traction arm base to move towards one side far away from the clamp arm main body and drive the clamp arm to open.

Furthermore, the number of the fixed arms and the number of the clamping arms are two, the two fixed arms are symmetrical, the two clamping arms are symmetrical, and the fixed arms are opposite to the clamping arms.

Further, the maximum opening angle of the fixing arm is larger than or equal to the maximum opening angle of the clamping arm.

Furthermore, the fixed arm mechanism and the clamping arm mechanism are both made of shape memory alloy.

Furthermore, the outer edges of the fixed arm and the clamping arm are provided with round corners or chamfers.

Furthermore, the outer sides of the fixing arm mechanism and the clamping arm mechanism are coated with fiber sewing cloth.

The heart valve clamping device provided by the invention has the beneficial effects that: compared with the prior art, the heart valve clamping device has the advantages that the fixing arm mechanism and the clamping arm mechanism of the whole heart valve clamping device are respectively integrated, the fixing arm mechanism and the clamping arm mechanism are fixedly connected, the risk of separation of the fixing arm or the clamping arm can be avoided, the stability of the whole structure is better, the fixing arm and the clamping arm are driven to be opened or closed through the first driving assembly and the second driving assembly independently, and the fixing arm and the clamping arm clamp valve leaflets under three-dimensional ultrasonic and radiography navigation, so that the regurgitation area is reduced, the repair of the regurgitation area through the opposite edges of the catheter is realized, the treatment of regurgitation of the mitral valve or the regurgitation of the tricuspid valve can be realized without heartbeat, the structure is simpler, and the production and the manufacture are more convenient.

Drawings

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 that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

FIG. 1 is a schematic drawing of a closed heart valve binder according to an embodiment of the present invention;

FIG. 2 is a schematic view of a heart valve clamp according to an embodiment of the present invention in an expanded configuration;

FIG. 3 is a schematic diagram of a side view of a fixed arm mechanism of the present invention in a collapsed configuration;

FIG. 4 is a schematic view of an expanded fixing arm mechanism according to an embodiment of the present invention;

FIG. 5 is a schematic diagram of a deployed holding arm mechanism according to an embodiment of the present invention;

FIG. 6 is a schematic side view of a clamping arm mechanism according to an embodiment of the present invention;

FIG. 7 is another side view of the clamping arm mechanism of the present invention in a closed position;

FIG. 8 is a schematic view of the clamp arm mechanism used in the embodiment of the present invention in an open configuration;

FIG. 9 is a schematic view of the deployed clamp arm mechanism employed in the embodiments of the present invention;

FIG. 10 is a schematic view of a heart valve clip device according to an embodiment of the present invention in an inserted configuration;

FIG. 11 is a schematic view of a heart valve clamp according to an embodiment of the present invention showing the clamp arms open;

FIG. 12 is a schematic view of a heart valve clamp according to an embodiment of the present invention showing the deployed bilateral fixation arms;

FIG. 13 is a schematic view of a heart valve clamp according to an embodiment of the present invention, with one of the securing arms being expanded;

fig. 14 is a schematic structural view of a heart valve binder according to an embodiment of the present invention after completion of fixation.

Description of reference numerals:

100. a fixed arm mechanism; 200. a clamping arm mechanism; 300. a push rod; 400. a delivery sheath; 500. a pulling wire; 600. a leaflet; 110. a fixed arm main body; 120. a fixed arm; 130. a first bar-shaped groove; 140. hanging a sheath tube; 121. a fixing hole; 122. a barb structure; 210. a clamp arm body; 220. a clamping arm; 230. a pulling arm base; 240. a pulling arm; 250. a second strip-shaped groove; 260. a third strip-shaped groove; 410. and fixing the grooves.

Detailed Description

The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" 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, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

In addition, the technical features involved in the different embodiments of the present invention described below may be combined with each other as long as they do not conflict with each other.

Referring to fig. 1 and 2 together, a heart valve clamping device according to the present invention will now be described. The heart valve clamping device comprises a conveying sheath 400, a fixing arm mechanism 100 fixed at the bottom of the conveying sheath 400, a clamping arm mechanism 200 sleeved at the bottom of the fixing arm main body 110, and a driving mechanism for driving the clamping arm 220 and the fixing arm 120 to open and close, wherein the fixing arm mechanism 100 comprises a fixing arm main body 110 fixedly connected with the bottom of the conveying sheath 400 and at least two fixing arms 120 extending outwards from the fixing arm main body 110, and the fixed ends of the fixing arms 120 are integrally formed with the fixing arm main body 110; the clamping arm mechanism 200 comprises a clamping arm main body 210 sleeved at the bottom of the fixing arm main body 110 and at least two clamping arms 220 extending outwards from the clamping arm main body 210, wherein the fixed ends of the clamping arms 220 are integrally formed with the clamping arm main body 210; the driving mechanism includes a first driving component for driving the fixing arm 120 to open or close towards the clamping arm 220 and a second driving component for driving the clamping arm 220 to open or close towards the fixing arm 120.

Compared with the prior art, the whole heart valve clamping device can enter the left atrium under the driving of the conveying sheath tube 400, the fixing arm mechanism 100 and the clamping arm mechanism 200 are respectively integrated, and the fixing arm mechanism 100 and the clamping arm mechanism 200 are fixedly connected, so that the risk of disengaging the fixing arm 120 or the clamping arm 220 can be avoided, the whole structure has better stability, and can be driven to open or close independently through the first driving component and the second driving component, the fixing arm 120 and the clamping arm 220 clamp the valve leaflet 600 under three-dimensional ultrasonic and radiography navigation, so that the regurgitation area is reduced, the transductal edge-to-edge repair is realized, the treatment of mitral regurgitation or tricuspid regurgitation can be realized under the heart beating, the structure is simpler, and the production and the manufacture are more convenient.

Further, referring to fig. 3 to 5, as an embodiment of the heart valve clamping device provided by the present invention, the fixing arm main body 110 is a tube structure, a first strip-shaped groove 130 is formed on a side wall of the tube structure, and a tube wall located in the first strip-shaped groove 130 is the fixing arm 120. Specifically, the first strip-shaped groove 130 is a groove formed in the tube structure, and the groove is elongated and can be enclosed into the shape of the fixing arm 120, so that the top end of the fixing arm 120 and the fixing arm main body 110 are separated from each other, and the bottom end of the fixing arm 120 is still connected to the fixing arm main body 110, that is, the fixing arm 120 has a fixed end fixedly connected to the fixing arm main body 110, and an open free end capable of rotating around the fixing arm main body 110. The whole fixed arm mechanism 100 is integrally formed by a pipe body structure, the integrity is better, the production, the processing and the assembly are more convenient, and the assembly flow is greatly saved. Of course, according to practical situations and specific needs, in other embodiments of the present invention, it is also possible to use only the fixing arm main body 110 as a tube structure, and the fixing arm 120 as an extension part disposed at the top end of the tube structure, which is not limited herein.

Further, referring to fig. 1 to 5, as an embodiment of the heart valve clamping device provided by the present invention, the fixing arm mechanism 100 further includes a sheath hanging head 140 located at the top of the fixing arm main body 110, and the sheath hanging head 140 is detachably and fixedly connected to the delivery sheath 400. Specifically, the sheath hanging head 140 is used for being connected with the delivery sheath 400, wherein the delivery sheath 400 is one of the guide catheters and can be inserted into the left ventricle, the sheath hanging head 140 is arranged at the top end of the fixing arm mechanism 100, the detachable connection between the whole fixing arm mechanism 100 and the delivery sheath 400 can be realized through the sheath hanging head 140, and further, the fixed connection between the clamping arm mechanism 200 and the delivery sheath 400 can be realized, so that the fixing arm mechanism 100 and the clamping arm mechanism 200 can be ensured to move together with the delivery sheath 400, and after the fixing arm 120 and the clamping arm 220 respectively clamp the leaflet 600, the fixing arm mechanism 100 and the delivery sheath 400 can be detached, and only the fixing arm mechanism 100 and the clamping arm mechanism 200 are reserved in the ventricle.

Further, referring to fig. 1 to 5, as an embodiment of the heart valve clamping device provided by the present invention, the sheath hanging head 140 is at least one T-shaped hook protruding from the top of the fixing arm main body 110, and the bottom of the delivery sheath 400 is provided with a fixing groove 410 for accommodating the sheath hanging head 140. Specifically, sheath pipe hanging head 140 is a "T" shape couple, fixed slot 410 is a "T" shape recess promptly, this "T" shape couple can be arranged in this "T" shape recess, thereby realize sheath pipe hanging head 140 and carry the connection between sheath pipe 400, and push rod 300 can insert to this inside of carrying sheath pipe 400 and sheath pipe hanging head 140 this moment, push rod 300 can restrict the relative buckling between carrying sheath pipe 400 and sheath pipe hanging head 140, sheath pipe hanging head 140 can block in the inside of fixed slot 410 all the time promptly. After the completion of work, push rod 300 can be taken out from carrying sheath pipe 400, carry and can buckle relatively between sheath pipe 400 and the sheath pipe string head 140 this moment, remove and carry sheath pipe 400 and make and buckle between the sheath pipe string head 140, both can deviate from sheath pipe string head 140 from fixed slot 410, thereby realize carrying the separation between sheath pipe 400 and the sheath pipe string head 140, its separation mode is simple, and can cooperate with push rod 300 and realize breaking away from, can effectually avoid the maloperation, thereby realize carrying the phenomenon of separation between sheath pipe 400 and the sheath pipe string head 140, and convenient operation, the operation time has been shortened, the operation degree of difficulty and operation risk have been reduced. Of course, according to practical situations and specific needs, in other embodiments of the present invention, threads may be formed on both the outer side surface of the sheath hanging head 140 and the inner side surface of the delivery sheath 400, and then the detachable connection between the delivery sheath 400 and the sheath hanging head 140 is realized by a threaded connection, which is not limited herein.

Preferably, the outer diameter of the push rod 300 matches the inner wall of the delivery sheath 400 and the fixed arm main body 110, such that the push rod 300 can slide within the delivery sheath 400 and the fixed arm main body 110 and completely fill the interior of the delivery sheath 400 and the fixed arm main body 110, i.e., the outer diameter of the push rod 300 is less than or equal to the inner diameter of the delivery sheath 400 and the outer diameter of the push rod 300 is less than or equal to the inner diameter of the fixed arm main body 110.

Further, referring to fig. 1 to 5, as an embodiment of the heart valve clamping device provided by the present invention, the fixing arm 120 is pre-shaped to open towards a side away from the fixing arm main body 110, the first driving assembly includes at least two pulling wires 500, and ends of the pulling wires 500 are fixedly connected to free ends of the fixing arm 120. Specifically, the fixing arm 120 needs to be opened toward a side away from the fixing arm main body 110 in a use state, needs to be folded at two sides of the fixing arm main body 110 in a transportation state, and presets the fixing arm 120 at a certain angle, and the angle needs to be larger than the maximum opening angle of the clamping arm 220, so that the fixing arm 120 can be matched with the clamping arm 220 to clamp the leaflet 600 when being naturally opened, and can ensure that the leaflet 600 can be normally fixed when the clamping arm 220 is unfolded at the maximum angle, when the leaflet 600 is delivered into the sheath, the left and right fixing arms 120 are kept in a closed state under the tightening action of the pulling wire 500, and after the fixing arm reaches the designated position, the fixing arm 120 is unfolded at a certain angle by loosening the pulling wire 500, and then the unfolding of the fixing arm 120 is realized. The pre-shaping unfolding angle of the fixing arm 120 is generally 120 to 240 degrees, and the width, structure, wall thickness of the tube and the like of the fixing arm 120 determine the force value of the fixing leaflet 600 after the fixing arm 120 is unfolded, and can be adjusted according to different lesions.

The stretching or furling driving structure of the fixing arm 120 is realized by adopting the pulling line 500, so that each fixing arm 120 can be separately unfolded, the functions of single-side adjustment and complete recovery can be realized, various different operation requirements can be met, and the structure is simple and the operation is convenient.

Further, referring to fig. 5, as a specific embodiment of the heart valve clamping device provided by the present invention, the fixing arm 120 is provided with a fixing hole 121 at an end away from the fixing arm main body 110 for fixing the pulling wire 500. Specifically, the fixing hole 121 is formed at the free end of the fixing arm 120, and one end or the middle portion of the pulling line 500 may pass through the fixing hole 121, so as to realize the connection between the pulling line 500 and the fixing hole 121. The end of the pulling wire 500 can be directly tied or fixed inside the fixing hole 121, and the other end of the pulling wire 500 extends outside the body through the inside of the conveying sheath 400, so that a doctor can pull the other end of the pulling wire 500 to control the fixing arm 120, and then cut off the pulling wire 500 through scissors after the operation is completed, or adopt the easily-dissolved pulling wire 500; the middle part of the pulling line 500 can also penetrate through the inside of the fixing hole 121, two ends of the pulling line 500 penetrate through the inside of the conveying sheath tube 400 and extend to the outside of the body, a doctor can simultaneously pull two ends of the pulling line 500 to control the fixing arm 120, after the operation is completed, one end of the pulling line 500 is pulled by the doctor, and the other end of the pulling line 500 can penetrate through the conveying sheath tube 400 and then is loosened from the inside of the fixing hole 121, so that the pulling line 500 can be removed, the operation is simpler, the operation time is shorter, and the operation risk is lower.

Further, referring to fig. 3 to 5, as an embodiment of the heart valve clamping device provided by the present invention, a side of the fixing arm 120 facing the clamping arm 220 is provided with a barb structure 122. Specifically, the barb structures 122 are a plurality of protrusions disposed on the bottom surface of the fixing arm 120, and when the fixing arm 120 is in the furled state, the tips of the protrusions are inclined downward, that is, inclined toward the clamping arm 220; when the fixing arm 120 is in the opened state, the tip of the protrusion is also inclined downward, which may increase the friction force of the fixing leaflet 600. The number of the convex parts can be adjusted according to the actual situation, and can be 1 or more.

Further, referring to fig. 2, 6 to 9, as an embodiment of the heart valve clip device provided by the present invention, the clip arm mechanism 200 further includes a pulling arm base 230 and at least two pulling arms 240 extending from the pulling arm base 230, the pulling arm base 230 is located at the bottom of the clip arm main body 210, and the pulling arms 240 are fixedly connected to or integrally formed with the bottoms of the free ends of the clip arms 220. Specifically, the pulling arm base 230 is located at the bottom of the clamping arm main body 210, the pulling arm 240 is formed by extending the pulling arm base 230 upwards, and the pulling arm 240 is connected with the pulling arm base 230, the pulling arm 240 can also extend or retract around the pulling arm base 230, so that the pulling arm 240 drives the clamping arm 220 to extend or retract, and the extending or retracting of the clamping arm 220 is controlled by the position of the pulling arm base 230. Wherein, the pulling arm base 230, the pulling arm 240, the clamping arm 220 and the clamping arm main body 210 can be integrally formed; alternatively, the clamping arm 220 and the clamping arm body 210 may be integrally formed, the pulling arm base 230 and the pulling arm 240 may be integrally formed, and the clamping arm 220 and the pulling arm 240 are fixedly connected, which is not limited herein.

Further, referring to fig. 9, as a specific embodiment of the heart valve clamping device provided by the present invention, the base 230 of the pulling arm is a tube structure, a second strip-shaped groove 250 is formed on a sidewall of the tube structure, a tube wall located in the second strip-shaped groove 250 is the pulling arm 240, a third strip-shaped groove 260 is formed on the tube wall located outside the second strip-shaped groove 250, and an inner tube wall of the third strip-shaped groove 260 forms the clamping arm 220 and the clamping arm main body 210. Specifically, the second strip-shaped groove 250 is a groove formed in the tube structure, and the groove is elongated and can be enclosed into the shape of the pulling arm 240, so that the top end of the pulling arm 240 is separated from the pulling arm base 230, and the bottom end of the pulling arm 240 is still connected to the pulling arm base 230, i.e., the pulling arm 240 also has a fixed end fixedly connected to the pulling arm base 230, and can rotate around the pulling arm base 230 to open the free end. And a third strip-shaped groove 260 is continuously formed in the rest of the tube wall, is in a strip shape and can be enclosed into the shapes of the clamping arm 220 and the clamping part main body, so that the top end of the traction arm 240 is connected with the top end of the clamping arm 220, the bottom end of the clamping arm 220 is fixedly connected with the clamping arm main body 210, and the outer edge of the clamping arm main body 210 is separated from the traction arm 240 and the traction arm base 230. At this moment, the whole clamping arm mechanism 200 is integrally formed by a pipe body structure, the integrity is better, the production, the processing and the assembly are more convenient, and the assembly flow is greatly saved. Of course, according to the actual situation and the specific requirement, in other embodiments of the present invention, the clamping arm body 210 may also be a tube structure, and the clamping arm 220 is an extending component disposed at the top end of the tube structure; the pulling arm base 230 is a tube structure, and the pulling arm 240 is an extension part disposed at the top end of the tube structure, and the pulling arm 240 and the clamping arm 220 are fixedly connected, which is not limited herein.

Further, referring to fig. 2, as an embodiment of the heart valve clamping device provided in the present invention, the second driving component includes a pushing rod 300 disposed in the delivery sheath 400, and the pushing rod 300 is slidably disposed through the fixing arm main body 110 and the clamping arm main body 210 and abuts against the pulling arm base 230. Specifically, the pushing rod 300 is disposed in the conveying sheath 400, and can be abutted or detachably connected to the pulling arm base 230, and the pushing rod 300 drives the pulling arm base 230 to move, so that the pushing rod 300, the pulling arm 240 and the clamping arm 220 can form a link mechanism, and then the pushing rod 300 moves to drive the pulling arm 240 and the clamping arm 220 to open and close. The pushing rod 300 can move in the fixing arm mechanism 100 and the clamping arm mechanism 200, when the pushing rod 300 moves towards the far end, the pushing rod pushes the pulling arm base 230 to move, so as to drive the pulling arm 240 to unfold at a certain angle gamma, and finally the clamping arm 220 unfolds at a corresponding angle beta of about 0-210 degrees, wherein the unfolding angle beta can be adjusted in real time through the relative position of the pulling arm 240, and the angle beta is larger than the angle gamma. The amount of clamping force applied to the clamping arms 220 can be adjusted by the rod width of the clamping arms 220 and the pulling arms 240, the wall thickness of the tubing, and the structure.

Further, as a specific embodiment of the heart valve clipping device provided by the present invention, the clipping arm 220 is pre-shaped to be attached to the clipping arm main body 210, and the pushing rod 300 can drive the pulling arm base 230 to move towards a side away from the clipping arm main body 210, and drive the clipping arm 220 to open. Specifically, when the clamping arm 220 is in a use state, the clamping arm 220 needs to be drawn close to one side close to the clamping arm main body 210, when the leaflet 600 needs to be clamped, the clamping arm 220 is drawn close to two sides of the clamping arm main body 210 in a natural state, when the leaflet 600 needs to be clamped, the clamping arm 220 is stretched by the drawing arm 240, so that the clamping arm 220 is located on the inner side surface of the leaflet 600, after the fixing arm 120 is fixed, the drawing arm 240 does not have the pulling force for stretching the clamping arm 220 after the push rod 300 is detached, the clamping arm 220 has a larger aligning force for drawing close towards the clamping arm main body 210, and the fixing arm 120 also has an aligning force far away from the fixing arm main body 110, so that the clamping force between the clamping arm 220 and the fixing arm 120 can be better ensured, and the clamping effect on the leaflet 600 is further ensured.

Further, referring to fig. 2, 6 to 9, as a specific embodiment of the heart valve clamping device provided by the present invention, the number of the fixing arms 120 and the clamping arms 220 is two, the two fixing arms 120 are symmetrical, the two clamping arms 220 are symmetrical, and the fixing arms 120 are opposite to the clamping arms 220. When the number of the fixing arms 120 and the clamping arms 220 is two, the fixing arms 120 and the clamping arms 220 can be applied to treatment of mitral regurgitation, the fixing arms 120 and the clamping arms 220 are symmetrically arranged, so that the uniformity of force applied to the valve leaflets 600 by the whole heart valve clamping device can be ensured, and the accurate clamping of the valve leaflets 600 can also be ensured when the fixing arms 120 and the clamping arms 220 are over against each other. Of course, according to practical situations and specific needs, in other embodiments of the present invention, the arrangement of the fixing arm 120 and the clamping arm 220 may also be asymmetric, and the number of the fixing arm 120 and the clamping arm 220 may also be three or more, which may be applied to the treatment of tricuspid regurgitation or multiple tricuspid regurgitations, and is not limited herein.

Further, as a specific embodiment of the heart valve clamping device provided by the present invention, the fixing arm mechanism 100 and the clamping arm mechanism 200 are both made of shape memory alloy. Specifically, the shape memory alloy is a metal capable of keeping memory of an initial shape, that is, the fixing arm 120 is pre-shaped to open towards a side away from the fixing arm main body 110, and the clamping arm 220 is pre-shaped to be attached to the clamping arm main body 210, so that a good aligning effect between the clamping arm 220 and the fixing arm 120 can be ensured, and a clamping force between the clamping arm 220 and the fixing arm 120 can be further ensured. Among them, NiTi alloy and the like are generally used for forming the memory alloy.

Further, as a specific embodiment of the heart valve clamping device provided by the present invention, the outer edges of the fixing arm 120 and the clamping arm 220 are provided with a round angle or a chamfer. Specifically, the outer edges of the fixing arm 120, the clamping arm 220 and the pulling arm 240 may touch the heart, and chamfers are formed on the edges of the fixing arm 120, the clamping arm 220 and the pulling arm 240, and the chamfers are formed at the corners, so that the outer edge of the whole heart valve clamping device is smoother, and the degree of trauma is effectively reduced. Wherein the round angle or chamfer angle can be obtained by adopting a polishing process during production.

Further, as a specific embodiment of the heart valve clamping device provided by the present invention, the outer sides of the delivery sheath 400, the fixing arm mechanism 100 and the clamping arm mechanism 200 are covered with a fabric sewing cloth (not shown). Particularly, fiber sewing cloth is arranged on the parts of the heart valve clamping device, which are possibly contacted with a human body, and can be used for endothelial tissues to climb, so that the damage to organ tissues in the operation process is reduced, and the clamping of the valve is more tightly completed.

Referring to fig. 10-14, the heart valve clip provided by the present invention will be described in detail by taking the example of treating mitral regurgitation as an example, and the surgical approach is a transcatheter approach, in which a delivery sheath 400 is delivered to the left atrium, and the subsequent operations are based on this.

Firstly, after the heart valve clamping device is placed at the left atrium position through the conveying sheath tube 400, the heart valve clamping device is pushed to the lower part of the valve, the pulling arm base 230 is pushed through the pushing rod 300, then the clamping arm 220 is unfolded to a certain angle through the pulling arm 240, the heart valve clamping device is lifted upwards to enable the clamping arm 220 to hold the valve leaflet 600 from the bottom, then the pulling wire 500 is released to enable the fixing arm 120 to be unfolded and firmly press the valve leaflet 600 on the clamping arm 220, after the clamping position of the valve leaflet 600 is determined to be proper and the regurgitation treatment effect is achieved, a section of the pushing rod 300 is retracted to complete the closing step of the heart valve clamping device, the clamping effect is determined again, and if the regurgitation is reduced to an acceptable degree, the pushing rod 300 can be continuously retracted to the proximal end of the sheath tube hanging head 140 to complete the releasing step of the heart valve clamping device. The above steps may be repeated, if necessary, until the desired effect is achieved.

Wherein, the pulling wire 500 of the clamping device is respectively connected with the two fixing arms 120, and the unfolding angle of the single fixing arm 120 can be independently controlled by adjusting. When the pushing rod 300 is not yet retracted to the sheath hanging head 140, the heart valve clamping device can be opened, the fixed valve leaflets 600 are released, and the implantation step is carried out again, so that the fully-recoverable operation is achieved, and the implantation risk can be greatly reduced.

It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications therefrom are within the scope of the invention.

Claims (17)

1. Heart valve clamping ware which characterized in that: comprises that

The fixing arm mechanism (100) comprises a fixing arm main body (110) and at least two fixing arms (120) extending outwards from the fixing arm main body (110), and the fixing arms (120) and the fixing arm main body (110) are integrally formed;

the clamping arm mechanism (200) comprises a clamping arm main body (210) connected to the bottom of the fixing arm main body (110) and at least two clamping arms (220) extending outwards from the clamping arm main body (210), and the clamping arms (220) and the clamping arm main body (210) are integrally formed; and

a drive mechanism including a first drive assembly that drives the stationary arm (120) to open or close relative to the stationary arm body (110) and a second drive assembly that drives the clamping arm (220) to open or close relative to the clamping arm body (210).

2. The heart valve binder of claim 1, wherein: the fixing arm main body (110) is of a pipe body structure, a first strip-shaped groove (130) is formed in the side wall of the pipe body structure, and the pipe wall located in the first strip-shaped groove (130) is the fixing arm (120).

3. The heart valve binder of claim 1, wherein: also comprises a conveying sheath (400) fixed on the top of the fixing arm main body (110).

4. The heart valve binder of claim 3, wherein: the fixing arm mechanism (100) further comprises a sheath tube hanging head (140) positioned at the top of the fixing arm main body (110), and the sheath tube hanging head (140) is detachably and fixedly connected with the conveying sheath tube (400).

5. The heart valve binder of claim 4, wherein: the sheath pipe hanging head (140) is at least one T-shaped hook protruding out of the top of the fixed arm main body (110), a fixing groove (410) for accommodating the sheath pipe hanging head (140) is formed in the bottom of the conveying sheath pipe (400), and the fixing groove (410) is clamped with the sheath pipe hanging head (140) and can be bent to be disengaged from the clamping.

6. The heart valve binder of any one of claims 1 to 5, wherein: the fixing arm (120) is pre-shaped to be opened towards a direction far away from the fixing arm main body (110), the first driving assembly comprises at least two pulling wires (500), and the end of each pulling wire (500) is fixedly connected with one fixing arm (120) respectively and drives one or more fixing arms (120) to be opened or closed.

7. The heart valve binder of claim 6, wherein: and one end of the fixing arm (120) far away from the fixing arm main body (110) is provided with a fixing hole (121) for fixing the traction line (500).

8. The heart valve binder of any one of claims 1 to 5, wherein: and a barb structure (122) is arranged on one side of the fixing arm (120) facing the clamping arm (220).

9. The heart valve binder of any one of claims 1 to 5, wherein: the clamping arm mechanism (200) further comprises a drawing arm base (230) and at least two drawing arms (240) extending outwards from the drawing arm base (230), the drawing arm base (230) is located at the bottom of the clamping arm main body (210), the drawing arms (240) are fixedly connected with the clamping arms (220) or integrally formed, and connecting points of the drawing arms (240) and the clamping arms (220) are arranged at intervals with the clamping arm main body (210).

10. The heart valve binder of claim 9, wherein: the traction arm base (230) is of a pipe body structure, a second strip-shaped groove (250) is formed in the side wall of the pipe body structure, the pipe wall in the second strip-shaped groove (250) is the traction arm (240), a third strip-shaped groove (260) is formed in the pipe wall outside the second strip-shaped groove (250), and the inner pipe wall of the third strip-shaped groove (260) forms the clamping arm (220) and the clamping arm main body (210).

11. The heart valve binder of claim 9, wherein: the second driving component comprises a pushing rod (300), and the pushing rod (300) penetrates through the fixing arm main body (110) and the clamping arm main body (210) in a sliding mode and is abutted to the traction arm base (230).

12. The heart valve binder of claim 11, wherein: the clamping arm (220) is pre-shaped to be attached to the clamping arm main body (210), and the push rod (300) can drive the traction arm base (230) to move towards one side far away from the clamping arm main body (210) and drive the clamping arm (220) to open.

13. The heart valve binder of any one of claims 1 to 12, wherein: the number of the fixed arms (120) and the number of the clamping arms (220) are two, the two fixed arms (120) are symmetrical, the two clamping arms (220) are symmetrical, and the fixed arms (120) are opposite to the clamping arms (220).

14. The heart valve binder of any one of claims 1 to 12, wherein: the maximum opening angle of the fixing arm (120) is larger than or equal to the maximum opening angle of the clamping arm (220).

15. The heart valve binder of any one of claims 1 to 12, wherein: the fixing arm mechanism (100) and the clamping arm mechanism (200) are both made of shape memory alloy.

16. The heart valve binder of any one of claims 1 to 12, wherein: the outer edges of the fixing arm (120) and the clamping arm (220) are provided with round corners or chamfers.

17. The heart valve binder of any one of claims 1 to 12, wherein: the outer sides of the fixing arm mechanism (100) and the clamping arm mechanism (200) are coated with fiber sewing cloth.

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