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CN113456295B - Heart valve clip - Google Patents

Heart valve clip
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Publication number
CN113456295B
CN113456295BCN202010238347.5ACN202010238347ACN113456295BCN 113456295 BCN113456295 BCN 113456295BCN 202010238347 ACN202010238347 ACN 202010238347ACN 113456295 BCN113456295 BCN 113456295B
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Prior art keywords
arm
clamping
fixing
arms
clip
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CN202010238347.5A
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CN113456295A (en
Inventor
赵洋
刘小建
张昱昕
蒲忠杰
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Lepu Medical Technology Beijing Co Ltd
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Lepu Medical Technology Beijing Co Ltd
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Publication of CN113456295ApublicationCriticalpatent/CN113456295A/en
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Abstract

Translated fromChinese

本发明提供了一种心脏瓣膜夹合器,包括固定臂机构、夹合臂机构和驱动机构,固定臂机构包括固定臂主体和至少两个由固定臂主体向外延伸的固定臂,固定臂与固定臂主体一体成型;夹合臂机构包括连接于固定臂主体底部的夹合臂主体以及至少两个由夹合臂主体向外延伸的夹合臂,夹合臂与夹合臂主体一体成型;驱动机构包括驱动固定臂和夹合臂张开或收拢的第二驱动组件。整个心脏瓣膜夹合器的固定臂机构和夹合臂机构分别为一个整体,能够避免固定臂或夹合臂脱开的风险,整个结构的稳固性更好,在三维超声和造影导航下使得固定臂和夹合臂夹合住瓣叶,从而使反流面积减小,能够在心脏不停跳下实现对二尖瓣反流或三尖瓣反流的治疗。

The present invention provides a heart valve clamp, including a fixed arm mechanism, a clamping arm mechanism and a driving mechanism, wherein the fixed arm mechanism includes a fixed arm body and at least two fixed arms extending outward from the fixed arm body, wherein the fixed arm and the fixed arm body are integrally formed; the clamping arm mechanism includes a clamping arm body connected to the bottom of the fixed arm body and at least two clamping arms extending outward from the clamping arm body, wherein the clamping arm and the clamping arm body are integrally formed; and the driving mechanism includes a second driving component for driving the fixed arm and the clamping arm to open or close. The fixed arm mechanism and the clamping arm mechanism of the whole heart valve clamp are respectively an integral whole, which can avoid the risk of the fixed arm or the clamping arm being disengaged, and the stability of the whole structure is better. Under three-dimensional ultrasound and angiography navigation, the fixed arm and the clamping arm clamp the valve leaflet, thereby reducing the regurgitation area, and can achieve the treatment of mitral valve regurgitation or tricuspid valve regurgitation without stopping the heart beating.

Description

Cardiac valve clamp
Technical Field
The invention relates to the technical field of medical appliances, in particular to a heart valve clamp.
Background
The mitral valve is a one-way valve located between the left atrium and the left ventricle of the heart, and a normally healthy mitral valve can control blood flow from the left atrium to the left ventricle while avoiding blood flow from the left ventricle to the left atrium. With the development of society and the aging of population, the incidence of mitral regurgitation (mitral regurgitation, MR) is in a markedly rising state, and has become a common heart valve disease.
Current mitral regurgitation treatment has undergone the age of traditional surgical sternal median incision surgery and recent minimally invasive small incision surgery, coming into the age of transcatheter intervention. Mitral regurgitation mediated minimally invasive therapy has become one of the most popular directions of investigation in interventional cardiology, and the MR method of interventional therapy with little trauma, few complications and low cost has made great progress.
Among mitral regurgitation, mitral regurgitation interventional techniques can be divided into two categories, one category is transcatheter mitral valve repair, such as MITRACLIP, PASCAL, VALVECLAM, CARDIOBAND, MITRALIGN and NeoChord, and the other category is transcatheter mitral valve implantation, which is currently the primary treatment for repair. However, the existing technology has some problems, such as MITRALCLIP changing a large single hole into a small double hole by clamping anterior and posterior valve leaflets of the mitral valve, so as to achieve the purpose of treatment, but the implantation route is too far, the operation is too complex, and the improvement is still needed.
There is a valve clamp and a valve clamp system in the prior art, the valve clamp system comprising a valve clamp and a pushing device. The valve clamp comprises a push rod, at least two clamps, at least one extension arm and a driving assembly 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 telescopically arranged on the surface of the first clamp arm. When in operation, 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 clip, the number of the first clamp arms and the second clamp arms is 2 or more, and each first clamp arm or each second clamp arm is separately arranged, that is, each clamp arm is assembled with a middle push rod or a driving assembly to realize connection during production and processing, the integrity is weaker, the risk of partial disconnection may exist, and the connection is not stable enough.
Disclosure of Invention
The invention aims to provide a heart valve clamp for solving the technical problem that the clamp arms in the prior art are arranged independently, so that the connection is not stable enough and the risk of disconnection exists.
The heart valve clamp 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 which extend outwards from the fixing arm main body, 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 fixing arm main body and at least two clamping arms which extend outwards from the clamping arm main body, the clamping arms and the clamping arm main body are integrally formed, and the driving mechanism comprises a first driving component for driving the fixing arms to open or close relative to the fixing arm main body and a second driving component for driving the clamping arms to open or close relative to the clamping arm main body.
Further, 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, a delivery sheath secured to the top of the fixed arm body is included.
Further, the fixed arm mechanism further comprises a sheath hanging head positioned at the top of the fixed arm main body, and the sheath hanging head is detachably and fixedly connected with the conveying sheath.
Further, the sheath hanging head is at least one T-shaped hook protruding out of the top of the fixing arm main body, a fixing groove for accommodating the sheath hanging head is formed in the bottom of the conveying sheath, and the fixing groove is clamped with the sheath hanging head and can be bent to be separated from the clamping.
Further, the fixing arm is preformed to be opened towards a direction away from the fixing arm main body, the first driving assembly comprises at least two traction wires, and the end part of each traction wire is fixedly connected with one fixing arm and drives a single fixing arm or a plurality of fixing arms to be opened or closed.
Further, the fixing arm is provided with a fixing hole for fixing the traction wire at one end far away from the fixing arm main body.
Further, a barb structure is arranged on one side face, facing the clamping arm, of the fixing arm.
Further, the clamping arm mechanism further comprises a pulling arm base and at least two pulling arms extending outwards from the pulling arm base, wherein the pulling arm base is positioned at the bottom of the clamping arm main body, the pulling arms are fixedly connected with the clamping arms or integrally formed, and the connecting points of the pulling arms and the clamping arms are arranged at intervals with the clamping arm main body.
Further, the pulling arm base 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 inner pipe wall of the third strip-shaped groove forms the clamping arm and the clamping arm main body.
Further, the second driving assembly comprises a pushing rod, and the pushing rod is slidably arranged in the fixed arm main body and the clamping arm main body in a penetrating manner and is abutted to the traction arm base.
Further, the clamping arm is preformed to be attached to the clamping arm main body, and the pushing rod can drive the pulling arm base to move towards one side away from the clamping arm main body and drive the clamping arm to open.
Further, the number of the fixing arms and the clamping arms is two, the two fixing arms are symmetrical, the two clamping arms are symmetrical, and the fixing arms are opposite to the clamping arms.
Further, the maximum opening angle of the fixed arm is greater than or equal to the maximum opening angle of the clamping arm.
Further, the fixed arm mechanism and the clamping arm mechanism are both made of shape memory alloy.
Further, the outer edges of the fixing arm and the clamping arm are respectively provided with a round angle or a chamfer angle.
Further, the outer sides of the fixed arm mechanism and the clamping arm mechanism are respectively coated with fiber sewing cloth.
Compared with the prior art, the heart valve clamp has the advantages that the fixing arm mechanism and the clamping arm mechanism of the whole heart valve clamp are respectively integrated, the fixing arm mechanism and the clamping arm mechanism are fixedly connected, the risk of detachment 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 clamp the valve leaflet under three-dimensional ultrasonic and radiography navigation independently through the first driving component and the second driving component, the reflux area is reduced, edge-to-edge repair through the catheter is realized, the treatment of mitral regurgitation or tricuspid regurgitation can be realized under the condition that the heart does not stop, 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 that are needed in the description of the embodiments or the prior art will be briefly described, and it is obvious that the drawings in the description below are some embodiments of the present invention, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic view of a heart valve clip according to an embodiment of the present invention when in a collapsed configuration;
FIG. 2 is a schematic view of a heart valve clip according to an embodiment of the present invention when deployed;
FIG. 3 is a schematic side view of a fixed arm mechanism according to an embodiment of the present invention when the fixed arm mechanism is folded;
FIG. 4 is a schematic view of a fixed arm mechanism according to an embodiment of the present invention when opened;
FIG. 5 is a schematic view of a fixed arm mechanism according to an embodiment of the present invention when deployed;
FIG. 6 is a schematic side view of a clip arm mechanism according to an embodiment of the present invention when folded;
FIG. 7 is a schematic diagram of another side view of a clip arm mechanism according to an embodiment of the present invention when the clip arm mechanism is retracted;
FIG. 8 is a schematic view of a mechanism of a clamping arm used in an embodiment of the present invention when opened;
FIG. 9 is a schematic view of a mechanism for unfolding a clamping arm according to an embodiment of the present invention;
FIG. 10 is a schematic view of a heart valve clip according to an embodiment of the present invention as inserted;
FIG. 11 is a schematic view of the structure of a heart valve clamp according to an embodiment of the present invention with the arms open;
FIG. 12 is a schematic view of a heart valve clip according to an embodiment of the present invention with two side fixation arms open;
FIG. 13 is a schematic view of a heart valve clip according to an embodiment of the present invention with one side of the fixation arm open;
fig. 14 is a schematic view of the structure of the heart valve clip according to the embodiment of the present invention when the fixation is completed.
Reference numerals illustrate:
100. The device comprises a fixed arm mechanism, 200 parts of clamping arm mechanism, 300 parts of pushing rod, 400 parts of conveying sheath tube, 500 parts of traction wire, 600 parts of valve leaf, 110 parts of fixed arm main body, 120 parts of fixed arm, 130 parts of first strip-shaped groove, 140 parts of sheath tube hanging head, 121 parts of fixed hole, 122 parts of barb structure, 210 parts of clamping arm main body, 220 parts of clamping arm, 230 parts of traction arm base, 240 parts of traction arm, 250 parts of second strip-shaped groove, 260 parts of third strip-shaped groove, 410 parts of fixed groove.
Detailed Description
The following description of the embodiments of the present invention will be made apparent and fully in view of the accompanying drawings, in which some, but not all embodiments of the invention are shown. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
In the description of the present invention, it should be noted that the directions or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific 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, unless explicitly stated or limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected, mechanically connected, electrically connected, directly connected, indirectly connected via an intervening medium, or in communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.
In addition, the technical features of the different embodiments of the present invention described below may be combined with each other as long as they do not collide with each other.
Referring to fig. 1 and 2 together, a heart valve clip according to the present invention will now be described. The heart valve clamp comprises a delivery sheath 400, a fixing arm mechanism 100 fixed at the bottom of the delivery 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 the fixing arm main body 110 fixedly connected with the bottom of the delivery sheath 400 and at least two fixing arms 120 extending outwards from the fixing arm main body 110, 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, fixed ends of the clamping arms 220 are integrally formed with the clamping arm main body 210, and the driving mechanism comprises a first driving component for driving the fixing arms 120 to open or close towards the clamping arms 220 and a second driving component for driving the clamping arms 220 to open or close towards the fixing arms 120.
Compared with the prior art, the heart valve clamp provided by the invention has the advantages that the whole heart valve clamp can enter the left atrium under the drive of the delivery sheath 400, the fixed arm mechanism 100 and the clamp arm mechanism 200 are respectively integrated, the fixed arm mechanism 100 and the clamp arm mechanism 200 are fixedly connected, the risk of disengaging the fixed arm 120 or the clamp arm 220 can be avoided, the stability of the whole structure is better, the first driving assembly and the second driving assembly are independently used for driving the valve blade 600 to open or close, the three-dimensional ultrasonic and radiography navigation enables the fixed arm 120 and the clamp arm 220 to clamp the valve blade 600, so that the reflux area is reduced, the edge-to-edge repair through the catheter is realized, the treatment of mitral regurgitation or tricuspid regurgitation can be realized under the condition that the heart is not stopped, the structure is simpler, and the production and the manufacture are more convenient.
Further, referring to fig. 3 to 5, as a specific embodiment of the heart valve clip provided by the present invention, the fixing arm main body 110 is a tube structure, a first bar-shaped groove 130 is formed on a side wall of the tube structure, and a tube wall located in the first bar-shaped groove 130 is the fixing arm 120. Specifically, the first strip-shaped groove 130 is a groove formed on the pipe body 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 is separated from the fixing arm main body 110, the bottom end of the fixing arm 120 is still connected with the fixing arm main body 110, that is, the fixing arm 120 has a fixed end fixedly connected with the fixing arm main body 110, and a free end capable of rotating and expanding around the fixing arm main body 110. The whole fixed arm mechanism 100 is integrally formed by a pipe body structure, so that the whole fixed arm mechanism is better in integrity and more convenient to produce, process and assemble, and the assembling process is greatly saved. Of course, according to practical situations and specific requirements, in other embodiments of the present invention, only the fixing arm main body 110 may be a tube structure, and the fixing arm 120 may be an extension member disposed at a top end of the tube structure, which is not limited only.
Further, referring to fig. 1 to 5, as an embodiment of the heart valve clip 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 with the delivery sheath 400. Specifically, the sheath hanging head 140 is used for realizing connection with the delivery sheath 400, wherein the delivery sheath 400 is one of guide-in catheters and can be inserted into the left ventricle, the sheath hanging head 140 is arranged at the top end of the fixed arm mechanism 100, the whole fixed arm mechanism 100 and the delivery sheath 400 can be detachably connected through the sheath hanging head 140, and then the fixed connection between the clamping arm mechanism 200 and the delivery sheath 400 can be realized, the fixed arm mechanism 100 and the clamping arm mechanism 200 can be ensured to move along with the delivery sheath 400, and after the valve leaf 600 is respectively clamped by the fixed arm 120 and the clamping arm 220, the fixed arm mechanism 100 and the delivery sheath 400 can be detached, and only the fixed 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 clip 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 a fixing groove 410 for accommodating the sheath hanging head 140 is formed at the bottom of the delivery sheath 400. Specifically, the sheath hanging head 140 is a "T" shaped hook, the fixing groove 410 is a "T" shaped groove, and the "T" shaped hook can be placed in the "T" shaped groove, so as to realize connection between the sheath hanging head 140 and the delivery sheath 400, and the push rod 300 can be inserted into the delivery sheath 400 and the sheath hanging head 140 at this time, the push rod 300 can limit relative bending between the delivery sheath 400 and the sheath hanging head 140, i.e. the sheath hanging head 140 can be always clamped in the fixing groove 410. After the work is completed, the pushing rod 300 can be pulled out of the conveying sheath 400, at this time, the conveying sheath 400 and the sheath hanging heads 140 can be bent relatively, the conveying sheath 400 is moved to bend the sheath hanging heads 140, and the sheath hanging heads 140 can be separated from the fixing grooves 410, so that separation between the conveying sheath 400 and the sheath hanging heads 140 is realized, the separation mode is simple, the separation can be realized by being matched with the pushing rod 300, misoperation can be effectively avoided, separation between the conveying sheath 400 and the sheath hanging heads 140 is realized, the operation is convenient, the operation time is shortened, and the operation difficulty and the operation risk are reduced. Of course, according to practical situations and specific requirements, 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 may be implemented by means of threaded connection, which is not limited only herein.
Preferably, the outer diameter of the pushing rod 300 is matched with the inner wall of the delivery sheath 400 and the fixing arm body 110, so that the pushing rod 300 can slide in the delivery sheath 400 and the fixing arm body 110 and is completely filled in the delivery sheath 400 and the fixing arm body 110, that is, the outer diameter of the pushing rod 300 is smaller than or equal to the inner diameter of the delivery sheath 400, and the outer diameter of the pushing rod 300 is smaller than or equal to the inner diameter of the fixing arm body 110.
Further, referring to fig. 1 to 5, as an embodiment of the heart valve clip provided by the present invention, the fixing arm 120 is preformed to be opened toward a side away from the fixing arm body 110, and the first driving assembly includes at least two pulling wires 500, and ends of the pulling wires 500 are fixedly connected with the free ends of the fixing arm 120. Specifically, the fixing arm 120 needs to be opened toward a side far 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 transport state, and is preset with a certain angle for the fixing arm 120, and the angle needs to be larger than a 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 in a natural opening state, the leaflet 600 can be ensured to be still normally fixed when the clamping arm 220 is unfolded by the maximum angle, the left fixing arm 120 and the right fixing arm 120 are kept in a closed state under the tightening action of the traction wire 500 when the fixing arm 120 is conveyed in a sheath, and the fixing arm 120 is unfolded to a certain angle by loosening the traction wire 500 after reaching a designated position, so that the fixing arm 120 is unfolded. The pre-shaped deployment angle of the fixing arm 120 is generally 120 ° to 240 °, and the rod width, the structure, the wall thickness of the tube, etc. of the fixing arm 120 determine the magnitude of the force value of the fixing leaflet 600 after the fixing arm 120 is deployed, and can be adjusted according to different lesions.
The driving structure for opening or closing the fixing arms 120 is realized by adopting the mode of the traction wire 500, so that each fixing arm 120 can be respectively and independently unfolded, the unilateral adjustment and complete recycling functions can be realized, the requirements of various different operations are met, and the device is simple in structure and convenient to operate.
Further, referring to fig. 5, as an embodiment of the heart valve clip provided by the present invention, the fixing arm 120 is provided with a fixing hole 121 for fixing the pull wire 500 at an end far from the fixing arm main body 110. 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 wire 500 may pass through the fixing hole 121, thereby achieving connection between the pulling wire 500 and the fixing hole 121. The end of the pull wire 500 may be tied directly or fixed inside the fixing hole 121, at this time, the other end of the pull wire 500 passes through the inside of the delivery sheath 400 and extends to the outside, a doctor may pull the other end of the pull wire 500 to control the fixing arm 120, after the operation is completed, the pull wire 500 is cut off by scissors, or the pull wire 500 which is soluble may be adopted, or the middle part of the pull wire 500 passes through the inside of the fixing hole 121, both ends of the pull wire 500 pass through the inside of the delivery sheath 400 and extend to the outside, a doctor may pull both ends of the pull wire 500 at the same time to control the fixing arm 120, after the operation is completed, a doctor pulls one end of the pull wire 500, and the other end of the pull wire may pass through the delivery sheath 400 and then be released from the inside of the fixing hole 121, thereby realizing the removal of the pull wire 500.
Further, referring to fig. 3 to 5, as an embodiment of the heart valve clip provided in the present invention, a side of the fixing arm 120 facing the clip arm 220 is provided with a barb structure 122. Specifically, the barb structure 122 is a plurality of protruding portions disposed on the bottom surface of the fixing arm 120, and when the fixing arm 120 is in a folded state, the tips of the protruding portions incline downward, i.e. incline toward the clamping arm 220, and when the fixing arm 120 is in an open state, the tips of the protruding portions also incline downward, so as to play a role in increasing friction force of the fixing leaflet 600. The number of the protruding parts can be adjusted according to actual conditions and can be 1 or more.
Further, referring to fig. 2 and 6 to 9, as an embodiment of the heart valve clip provided by the present invention, the clip arm mechanism 200 further includes a pull arm base 230 and at least two pull arms 240 extending outwards from the pull arm base 230, the pull arm base 230 is located at the bottom of the clip arm body 210, and the pull arms 240 are fixedly connected or integrally formed with the bottom of the free ends of the clip arms 220. Specifically, the pulling arm base 230 is located at the bottom of the clamping arm 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, and the pulling arm 240 can also be opened or closed around the pulling arm base 230, so that the pulling arm 240 drives the clamping arm 220 to open or close, and the opening or closing of the clamping arm 220 is controlled by the position of the pulling arm base 230. The pulling arm base 230, the pulling arm 240, the clamping arm 220 and the clamping arm body 210 may be formed integrally, or the clamping arm 220 and the clamping arm body 210 may be formed integrally, the pulling arm base 230 and the pulling arm 240 may be formed integrally, and the clamping arm 220 and the pulling arm 240 may be fixedly connected, which is not limited herein.
Further, referring to fig. 9, as a specific embodiment of the heart valve clip provided by the present invention, the pulling arm base 230 is a tube structure, a second bar-shaped groove 250 is formed on a side wall of the tube structure, the pulling arm 240 is disposed on a tube wall located in the second bar-shaped groove 250, a third bar-shaped groove 260 is formed on the tube wall located outside the second bar-shaped groove 250, and the inner tube wall of the third bar-shaped groove 260 forms the clip arm 220 and the clip arm main body 210. Specifically, the second strip-shaped groove 250 is a groove formed on the pipe body 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 with the pulling arm base 230, i.e. the pulling arm 240 also has a fixed end fixedly connected with the pulling arm base 230 and a free end capable of rotating and expanding around the pulling arm base 230. The third strip-shaped groove 260 is formed on the remaining tube wall, and the groove is elongated and can be enclosed into the shape of the clamping arm 220 and the clamping part main body, so that the top end of the pulling 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 pulling arm 240 and the pulling arm base 230. At this time, the whole clamping arm mechanism 200 is integrally formed by a pipe body structure, so that the integrity is better, the production, processing and assembly are more convenient, and the assembly flow is greatly saved. Of course, according to practical situations and specific requirements, in other embodiments of the present invention, the clamping arm main body 210 may be a tube structure, the clamping arm 220 is an extension member disposed at the top end of the tube structure, the pulling arm base 230 is a tube structure, the pulling arm 240 is an extension member 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 only.
Further, referring to fig. 2, as an embodiment of the heart valve clip provided by the present invention, the second driving assembly includes a pushing rod 300 disposed in the delivery sheath 400, and the pushing rod 300 is slidably disposed in the fixing arm body 110 and the clip arm body 210 and abuts against the pulling arm base 230. Specifically, the pushing rod 300 is disposed in the delivery sheath 400 and can be abutted against or detachably connected with 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 fixed arm mechanism 100 and the clamping arm mechanism 200, and when the pushing rod 300 moves distally, it pushes the pulling arm base 230 to move, so as to drive the pulling arm 240 to be unfolded to a certain angle γ, and finally, the clamping arm 220 is unfolded to a corresponding angle β, which is about 0 ° -210 °, the unfolding angle β can be adjusted in real time by the relative position of the pulling arm 240, and the angle β is larger than the angle γ. The amount of clamping force on the clamping arm 220 can be adjusted by the rod widths of the clamping arm 220 and the pulling arm 240, the wall thickness of the tubing, and the configuration.
Further, as an embodiment of the heart valve clip provided by the present invention, the clip arms 220 are preformed to fit on the clip arm body 210, and the pushing rod 300 can drive the pulling arm base 230 to move toward a side away from the clip arm body 210, and drive the clip arms 220 to open. Specifically, when the clamping arm 220 is in the use state, the clamping arm 220 needs to be drawn close to one side close to the clamping arm main body 210, when in the transportation state, 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 spread by the pulling arm 240, so that the clamping arm 220 is positioned on the inner side surface of the leaflet 600, after the fixing arm 120 is also fixed, the pulling arm 240 does not have the pulling force for stretching the clamping arm 220 after the pushing rod 300 is removed, the clamping arm 220 has a larger return force towards the clamping arm main body 210, and the fixing arm 120 also has a return force 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 then the clamping effect on the leaflet 600 is ensured.
Further, referring to fig. 2 and fig. 6 to fig. 9, as an embodiment of the heart valve clamp 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, uniformity of force applied to the valve leaflet 600 by the whole heart valve clamp can be guaranteed, and accurate clamping of the valve leaflet 600 can be guaranteed due to the fact that the fixing arms 120 and the clamping arms 220 are opposite to each other. Of course, according to the actual situation and specific requirements, in other embodiments of the present invention, the arrangement of the fixing arm 120 and the clamping arm 220 may be asymmetric, and the number of the fixing arm 120 and the clamping arm 220 may be three or more, which may be applied to the treatment of tricuspid regurgitation or tricuspid regurgitation, which is not limited herein.
Further, as an embodiment of the heart valve clip provided by the present invention, the fixing arm mechanism 100 and the clip arm mechanism 200 are both made of shape memory alloy. Specifically, the shape memory alloy refers to a metal capable of maintaining memory of an initial shape, that is, the fixing arm 120 is preformed to open toward a side far away from the fixing arm main body 110, and the clamping arm 220 is preformed to be attached to the clamping arm main body 210, so that a better aligning effect between the clamping arm 220 and the fixing arm 120 can be ensured, and then a clamping force between the clamping arm 220 and the fixing arm 120 is ensured. Among them, niTi alloy and the like are generally used for forming the memory alloy.
Further, as an embodiment of the heart valve clip provided by the present invention, the outer edges of the fixing arm 120 and the clip arm 220 are provided with rounded corners or chamfers. Specifically, the outer edges of the fixing arm 120, the clamping arm 220 and the pulling arm 240 may touch the heart, and the edges of the fixing arm 120, the clamping arm 220 and the pulling arm 240 are provided with chamfers, and the corners are rounded, so that the outer edge of the whole heart valve clamp is smoother, and the trauma degree is effectively reduced. Wherein, the fillet or chamfer can be obtained by adopting a polishing process during production.
Further, as a specific embodiment of the heart valve clip provided by the present invention, the outer sides of the delivery sheath 400, the fixing arm mechanism 100 and the clip arm mechanism 200 are all covered with a fiber suture cloth (not shown). Specifically, the parts of the heart valve clamp which are possibly contacted with the human body are all provided with fiber cloth, and the fiber cloth can climb endothelial tissues, reduce the damage to organ tissues in the operation process and simultaneously more tightly finish clamping the valve.
For the heart valve clip provided by the present invention, reference is made to fig. 10-14, which illustrate an example of treating mitral regurgitation, the surgical approach is transcatheter, and the delivery sheath 400 is delivered to the left atrium, on which the subsequent operations are based.
After the heart valve clamp is placed at the left atrium position through the delivery sheath 400, the heart valve clamp is pushed to the lower part of the valve, the pulling arm base 230 is pushed by the pushing rod 300, then after the clamping arm 220 is unfolded to a certain angle through the pulling arm 240, the heart valve clamp 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, the fixing arm 120 is unfolded and the valve leaflet 600 is firmly pressed on the clamping arm 220, after the proper clamping position of the valve leaflet 600 is determined and the reflux treatment effect is achieved, the pushing rod 300 is retracted for a certain period of time, the closing step of the heart valve clamp is completed, the clamping effect is determined again, and if the reflux is reduced to an acceptable degree, the pushing rod 300 can be retracted to the proximal end of the sheath hanging head 140 continuously, and the releasing step of the heart valve clamp is completed. If necessary, the above steps can be repeated until the desired effect is achieved.
The pull wires 500 of the clamp are 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 retracted to the position of the sheath hanging head 140, the heart valve clamp can be opened to release the fixed valve leaflet 600, and the implantation step is performed again, so that the operation of complete recovery is achieved, and the implantation risk can be greatly reduced.
It is apparent that the above examples are given by way of illustration only and are not limiting of the embodiments. Other variations or modifications of the above teachings will be apparent to those of ordinary skill in the art. It is not necessary here nor is it exhaustive of all embodiments. While still being apparent from variations or modifications that may be made by those skilled in the art are within the scope of the invention.

Claims (12)

The clamping arm mechanism (200) further comprises a pulling arm base (230) and at least two pulling arms (240) which extend outwards from the pulling arm base (230), the pulling arm base (230) is located at the bottom of the clamping arm main body (210), the pulling arms (240) are fixedly connected with the clamping arms (220) or integrally formed, connecting points of the pulling arms (240) and the clamping arms (220) are arranged at intervals with the clamping arm main body (210), the pulling arm base (230) is of a tube body structure, the side wall of the tube body structure is provided with a second bar-shaped groove (250), the tube wall located in the second bar-shaped groove (250) is provided with a third bar-shaped groove (260), and the tube wall located outside the second bar-shaped groove (250) is provided with a third bar-shaped groove (260), so that the inner tube wall of the third bar-shaped groove (260) forms the clamping arms (220) and the clamping arm main body (210).
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