CN116407347A - Tissue clamping device and tissue clamping system - Google Patents

Abstract

The application relates to a tissue clamping device and a tissue clamping system, wherein the tissue clamping device comprises a clamping mechanism and an expanding mechanism; the clamping mechanism comprises at least two clamping arms which can be relatively unfolded and closed, each clamping arm comprises a connecting end and a suspension end which are movably connected with other clamping arms, and the clamping arms extend along a first direction from the connecting end to the suspension end; the expansion mechanism comprises an elastic piece and at least one expansion assembly connected with the elastic piece, the elastic piece is configured to elastically compress or elastically return along a second direction, one part of the expansion assembly is movably connected with the clamping arm, the other part of the expansion assembly is arranged to retract or expand along the second direction relative to the clamping arm under the elastic drive of the elastic piece, and an included angle between the first direction and the second direction is larger than 0 degree and smaller than 180 degrees. The elastic piece elastically drives the expansion assembly to retract or expand relative to the clamping arm, so that the clamping width of tissues can be remarkably increased, and the clamping effect is enhanced.

Description

Tissue clamping device and tissue clamping system

Technical Field

The present application relates to the field of medical devices, and more particularly to a tissue clamping device and tissue clamping system.

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. The mitral valve includes a pair of leaflets, called anterior and posterior, that when aligned at their edges, should be fully closed to avoid blood flow from the left ventricle to the left atrium. When the leaflets of the mitral valve or their associated structures undergo an organic or functional change, the anterior and posterior leaflets of the mitral valve do not coapt properly, whereby the mitral valve does not close completely when the left ventricle of the heart contracts, resulting in regurgitation of blood from the left ventricle to the left atrium, causing a series of pathophysiological changes known as "mitral regurgitation".

At present, a minimally invasive interventional therapy method can be used for performing edge-to-edge repair on a valve, for example, a valve clamp is conveyed to the mitral valve through an interventional catheter, and the anterior leaflet and the posterior leaflet of the mitral valve are clamped through relative opening and closing of the valve clamp, so that the purposes of fixing the valve leaflet and reducing mitral regurgitation are achieved. In the interventional operation process, the valve clips are required to be taken into the interventional catheter and conveyed to the lesion position through the catheter, the size of the catheter is limited, the width of the valve clips is limited, therefore, the clamping range of the valve leaflets is also limited relatively, and for patients with wider reverse flow streams, if the clamping range of one valve clip is smaller, the reverse flow cannot be effectively eliminated, and two or more valve clips are often implanted to achieve better reverse flow reduction effect. If a plurality of valve clamps are implanted at the mitral valve, the stenosis of the valve orifice is easy to be caused, the activity of the valve leaflet is limited, and the postoperative effect is poor.

Disclosure of Invention

The application provides a tissue clamping device and tissue clamping system to solve the not enough technical problem that leads to postoperative effect of centre gripping width.

The tissue clamping device comprises a clamping mechanism and an expanding mechanism;

the clamping mechanism comprises at least two clamping arms which can be relatively unfolded and closed, each clamping arm comprises a connecting end and a suspension end which are movably connected with other clamping arms, and the clamping arms extend along a first direction from the connecting end to the suspension end;

the expansion mechanism comprises an elastic piece and at least one expansion assembly connected with the elastic piece, the elastic piece is configured to elastically compress or elastically return along a second direction, one part of the expansion assembly is movably connected with the clamping arm, the other part of the expansion assembly is arranged to retract or expand along the second direction relative to the clamping arm under the elastic drive of the elastic piece, and an included angle between the first direction and the second direction is larger than 0 degree and smaller than 180 degrees.

The tissue clamping system comprises the tissue clamping device and a conveying device, wherein the clamping mechanism is detachably connected to the distal end of the conveying device.

In the tissue clamping device, the elastic piece elastically drives the expansion assembly to retract or expand relative to the clamping arm, so that the clamping width of the tissue clamping device to tissues can be increased, or the clamping arm is widened, so that the clamping range is enlarged, and the clamping effect is enhanced; when the tissue clamping device is used for clamping the valve leaflet, the instrument with the same size can clamp the valve leaflet in a larger range, reflux can be remarkably reduced or eliminated, and particularly for patients with wider reflux beams, an ideal reflux reduction effect can be realized by adopting a small number of tissue clamping devices, so that the narrow valve orifice caused by using a plurality of tissue clamping devices is avoided, the limited activity of the valve leaflet is avoided, and the operation effect is improved.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the invention and together with the description, serve to explain the principles of the invention.

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

FIG. 1 is a schematic view of a tissue clamping device according to a first embodiment of the present application after deployment;

FIG. 2 is a schematic view of the tissue clamping device of FIG. 1 after it has been closed;

FIG. 3 is a schematic view of the tissue clamping device of FIG. 1 from another perspective;

FIG. 4 is a top view of FIG. 1;

FIG. 5 is a schematic illustration of the tissue gripping device of FIG. 1 gripping a leaflet;

FIG. 6 is a schematic view of the clamping arm of FIG. 1;

FIG. 7 is a top view of FIG. 6;

FIG. 8 is an exploded view of the clamping arm and expansion unit of FIG. 1;

FIG. 9 is a schematic view of the expansion unit of FIG. 1 retracted into the clamping arm;

FIG. 10 is a schematic view of the expansion unit of FIG. 1 expanding out of the clamping arms;

FIG. 11 is a schematic view of a structural form of the elastic member in FIG. 1;

FIG. 12 is a schematic view of another structural form of the elastic member in FIG. 1;

FIG. 13 is a schematic view of two expansion units;

FIG. 14 is a schematic view of a clamping arm of a tissue clamping device in combination with an expansion unit according to a second embodiment of the present application;

FIG. 15 is a schematic view of another clamping arm of a tissue clamping device in combination with another expansion unit according to a second embodiment of the present application;

FIG. 16 is a schematic view of a tissue clamping device according to a third embodiment of the present application;

FIG. 17 is a schematic view of a tissue clamping device according to a fourth embodiment of the present application after closing;

FIG. 18 is a schematic view of the tissue clamping device of FIG. 17 after deployment;

FIG. 19 is a schematic view of the expansion unit of FIG. 17 expanding out of the clamping arms;

FIG. 20 is a schematic view of the expansion unit of FIG. 17 retracted into the clamping arm;

fig. 21 is a schematic view of the structure of the stent of fig. 17.

Detailed Description

For the purposes of making the objects, technical solutions and advantages of the embodiments of the present application more clear, the technical solutions of the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is apparent that the described embodiments are some embodiments of the present application, but not all embodiments. All other embodiments, which can be made by one of ordinary skill in the art without undue burden from the present disclosure, are within the scope of the present application based on the embodiments herein.

In the description of the present invention, it should be noted that, in the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; straight line refers to the direction parallel to the line connecting the distal center and the proximal center of the medical instrument; radial refers to a direction perpendicular or substantially perpendicular to a straight line; the circumferential direction refers to a direction around a straight line. It is noted that the term "end" as used in terms of "proximal", "distal", "one end", "other end", "first end", "second end", "initial end", "terminal", "both ends", "free end", "upper end", "lower end", etc. is not limited to a tip, endpoint or end face, but includes a portion extending a linear distance and/or a radial distance from the tip, endpoint or end face to the element to which the tip, endpoint or end face belongs. The above definitions are for convenience of description only and are not to be construed as limiting the invention.

Referring to fig. 1-5, a tissue clamping device 00 according to a first embodiment of the present application includes a clamping mechanism 1 and an expansion mechanism 2. The clamping mechanism 1 comprises at least two clamping arms 11 which can be opened and closed relatively, as indicated by the arrow direction A1. The clamping arm 11 includes a connection end 11b movably connected to the other clamping arm 11 and a suspension end 11a, and the clamping arm 11 extends in a first direction H1 from the connection end 11b toward the suspension end 11 a. The expansion mechanism 2 comprises an elastic piece 21 and at least one expansion component 22 connected with the elastic piece 21, the elastic piece 21 is configured to elastically compress or elastically return along a second direction H2, one part of the expansion component 22 is movably connected with the clamping arm 11, and the other part of the expansion component 22 is configured to retract or expand along the second direction H2 relative to the clamping arm 11 under the elastic drive of the elastic piece 21, and an included angle theta between the first direction H1 and the second direction H2 is larger than 0 degree and smaller than 180 degrees.

In the tissue clamping device 00, the elastic piece 21 elastically drives the expansion assembly 22 to retract or expand relative to the clamping arm 11, which is equivalent to widening the clamping arm 11, so that the clamping width of the tissue clamping device 00 to tissues can be increased, the clamping range is enlarged, and the tissue clamping effect is enhanced. When the tissue clamping device 00 is used for clamping the valve leaflet, the instrument with the same size can clamp a larger range of valve leaflet, reflux can be remarkably reduced or eliminated, and particularly for patients with wider reflux beams, an ideal reflux reduction effect can be realized by adopting a small number of tissue clamping devices 00, so that the narrow orifice caused by using a plurality of tissue clamping devices 00 is avoided, the limited activity of the valve leaflet 01 is avoided, and the operation effect is improved.

In addition, the elastic member 21 elastically compresses or elastically returns along the second direction H2, the second direction H2 is a linear direction, and the first direction H1 is not parallel to the second direction H2, so that the expansion assembly 22 does not need to bend or turn over relative to the clamping arm 11 during the linear retraction or expansion along the second direction H2, and therefore, the compressed size of the whole device is not increased, and thus, a higher requirement on the size of the delivery catheter is not provided. Meanwhile, compared with the existing expansion assembly which is provided with a device for retracting through bending or overturning, or compared with the device for directly fixedly connecting the elastic expansion assembly on the clamping arm, the expansion assembly is expanded and unfolded, the stress direction of the tissue (such as the valve leaflet) at the clamped position is consistent with the bending or overturning retracting direction, if the stress at the tissue is large enough, the expansion assembly is pushed to bend or overturn and retract in clamping, so that the expansion width cannot be stably maintained, and the effect of widening the clamping arm cannot be effectively and reliably achieved. In this application, the expansion assembly 22 is retracted or expanded along the second direction H2 under the driving of the elastic element 21, and when the expansion assembly 22 is easy to expand or retract, the pressure direction received by the tissue is not associated with the retraction direction, so that the increase effect on the clamping width after the expansion assembly 22 is expanded is not affected, the width after the expansion assembly 22 is expanded can be stably maintained, the clamping reliability is improved, and the clamping width of the clamping arm 11 is effectively widened.

Referring to fig. 5, when the expansion assembly 22 is in the unexpanded state, the tissue gripping device 00 grips the leaflet 01 with a width that is no greater than the maximum width W1 of the gripping arms 11; if the expansion member 22 expands relative to the clamping arms 11, the extended expansion member 22 widens the clamping width of the device, which is typically the sum of the clamping width of the clamping arms 11 and the extended length of the expansion member 22, e.g., W2 > W1, thereby achieving the effect of increasing the clamping width.

In addition, during clamping, the device is subjected to the pressure of the valve leaflet 01 along the pressing direction H3, and the pressing direction H3 is basically perpendicular to the second direction H2, so that the pressure of the valve leaflet 01 on the device cannot influence the elastic expansion or retraction of the elastic piece 21, the expanded width of the expansion assembly 22 can be ensured to be stably maintained, and the clamping width of the valve leaflet 01 can be effectively increased.

Referring to fig. 6-8, the clamping arm 11 has a clamping face, which may be generally referred to as the clamping face at the maximum area of the clamping arm 11 that contacts tissue. For example, the clamping arm 11 in the drawing includes a bottom 111 and a side 112 vertically connected to the bottom 111, and both the side 112 and the bottom 111 contact and clamp the tissue during clamping, but the bottom 111 has a relatively large contact area, so that the clamping surface of the clamping arm 11 of this example is a plane in which the bottom 111 lies. Referring to fig. 8, the second direction H2 in which the elastic member 21 is retracted or expanded is parallel to the plane in which the bottom 111 is located, i.e., the second direction H2 is parallel to the clamping surface. With the above arrangement, the elastic member 21 is retracted or expanded in a straight line in the second direction H2 in parallel with the clamping surface, so that even if the elastic member 21 is pressed between the clamping surface and the tissue during clamping, the pressing force is generally perpendicular to the clamping surface, so that the pressing action of the tissue does not affect the elastic retraction or expansion of the elastic member 21, and the reliability of enlarging the clamping width is ensured.

In order to ensure that the expansion assembly 22 can expand to widen under the driving of the elastic member 21, the second direction H2 in which the expansion assembly 22 expands is not parallel to the first direction H1 in which the clamping arm 11 extends, and the included angle θ between the two directions is only greater than 0 ° and less than 180 °, preferably, the included angle θ between the first direction H1 and the second direction H2 is in the range of [45 °,135 ° ], and more preferably, in this embodiment, the first direction H1 is perpendicular to the second direction H2, and θ is 90 °.

By the above-mentioned angular arrangement, the portion of the expansion member 22 that can retract or expand in the second direction H2 relative to the clamp arm 11 under the elastic drive of the elastic member 21 includes a portion parallel to the first direction H1, which corresponds to widening the clamp arm 11 after the expansion member 22 expands and deploys relative to the clamp arm 11. When the included angle θ is 90 °, the overall expansion extension length of the expansion assembly 22 relative to the clamping arm 11 is the increased clamping width, and the widening effect is optimal. When θ is other angle, the increased holding width is smaller than the overall expanding and extending length of the expansion member 22 with respect to the holding arm 11, and the widening effect is relatively weakened. For example, referring to fig. 9 and 10, in this embodiment, where the first direction H1 and the second direction H2 are perpendicular, i.e., the included angle θ is 90 °, the portion of the expansion assembly 22 parallel to the first direction H1 is expanded and extended by a length L1 relative to the entire clamping arm 11, and the clamping width of the tissue clamping device is increased from the width L2 of the clamping arm 11 along the second direction H2 to at least l1+l2.

To ensure that the elastic member 21 is elastically retractable or expandable in the second direction H2, the elastic member 21 includes at least one spring extending in the second direction H2. Referring to fig. 11, in one embodiment, the elastic member 21 may be a single spring. Referring to FIG. 12, spring 21 may further include a spring 210 and sleeves 2101, 2102 and 2103 disposed about the spring 210, wherein when spring 21 is compressed, sleeves 2101 and 2103 may telescope into sleeve 2102 from opposite sides, respectively, and the arrangement of each sleeve may assist in compressing or expanding spring 210 in its axial direction only. It will be appreciated that the elastic member 21 may also comprise two or more springs arranged in parallel along said second direction H2.

Referring to fig. 8-10, and 13, the expansion assembly 22 includes at least one expansion unit 221 or 222 including a connection 2211 or 2221, and an expansion 2212 or 2222; the connection member 2211 or 2221 is slidably connected to the clamping arm 11, and the expansion member 2212 or 2222 is connected to the elastic member 21 and the connection member 2211 or 2221, so that the expansion member 2212 or 2222 is slidably retracted or expanded relative to the clamping arm 11 by elastic compression or elastic recovery of the elastic member 21. For example, in this embodiment, the first expansion unit 221 and the second expansion unit 222 are correspondingly disposed on each clamping arm 11, the 2 expansion units are disposed on two opposite sides of the clamping arm 11 along the second direction H2, the expansion of the 2 expansion units is overlapped, and the expansion pieces 2212 or 2222 clamp the valve leaflet together with the clamping arm 11, so that the widening effect on the clamping arm 11 can be further enhanced.

Notably, the expansion member 2212 or 2222, like the clamp arm 11, is made of a rigid material such as stainless steel, nitinol, cobalt chrome, or Polyetheretherketone (PEEK).

Referring specifically to fig. 8 and 13, the first connection member 2211 of the first expansion unit 221 includes a first pin, and the first expansion member 2212 includes a first bottom plate 2212b and a first side plate 2212a vertically connected to the first bottom plate 2212b at one side of the first bottom plate 2212 b; the clamping arm 11 is correspondingly provided with a plurality of sliding grooves 113 extending along the second direction H2, the first bottom plate 2212b is slidably connected with the clamping arm 11 through a first pin 2211 arranged in the first sliding groove 1131, the first side plate 2212a is connected with one end of the elastic member 21, for example, a first connecting column 2214 is radially inwards protruding on the first side plate 2212a, and one end of the elastic member 21 is sleeved on the first connecting column 2214 and fixedly connected with the first side plate 2212 a.

Correspondingly, the second connector 2221 of the second expansion unit 222 includes a second pin, and the second expansion element 2222 includes a second bottom plate 2222b and a second side plate 2222a vertically connected to the second bottom plate 2222b at one side of the second bottom plate 2222 b; the second bottom plate 2222b is slidably connected to the clamping arm 11 through a second pin 2221 provided in the second sliding groove 1132, the second side plate 2222a is connected to one end of the elastic element 21, for example, a second connection column 2224 is protruding radially inward on the second side plate 2222a, and the other end of the elastic element 21 is sleeved on the second connection column 2224 and is fixedly connected to the second side plate 2222 a.

Preferably, the first bottom plate 2212b of the first expansion unit 221 and the second bottom plate 2222b of the second expansion unit 222 are disposed at an inner side or an outer side of the clamping arm 11 in a staggered manner, and as shown in fig. 3 and 5, the first bottom plate 2212b and the second bottom plate 2222b are disposed at the outer side of the clamping arm 11. It is understood that in other embodiments, the first bottom plate 2212b and the second bottom plate 2222b may be disposed on the inner sides of the clamping arms 11. After retraction of expansion assembly 22, first base plate 2212b may be nested with second base plate 2222b to reduce space occupation. The clamping arm 11 is correspondingly provided with a first chute 1131 and a second chute 1132 which extend along the second direction H2 and are staggered relatively. For example, the clamping arm 11 shown in fig. 8 includes 2 parallel first sliding grooves 1131, and 2 parallel second sliding grooves 1132 are provided between the 2 first sliding grooves 1131, and the sliding grooves may be disposed at equal intervals. The first bottom plate 2212b and the second bottom plate 2222b are nested in a staggered manner, the length of the first bottom plate 2212b and the length of the second bottom plate 2222b are at least greater than half of the length of the clamping arm 11 along the second direction H2, the length of the corresponding first sliding groove 1131 and the length of the second sliding groove 1132 are also at least greater than half of the length of the clamping arm 11 along the second direction H2, and then the total width of the combined widening of the 2 expansion units can be greater than the self length of the clamping arm 11 along the second direction H2, so that the widening effect is further enhanced. The length of the bottom plate and the length of the chute refer to the length of each chute along the second direction H2, and the length along which the expansion unit can move along the chute determines the length by which the expansion unit can expand and extend in the second direction H2, thereby determining the extent to which the clamping arm 11 can widen.

In some embodiments, the thickness of the portion of the base 111 of the clamping arm 11 that overlaps the base of the expansion member is less than the thickness of the other portions of the base 111, and more preferably, the sum of the thickness of the portion of the base 111 that overlaps the base of the expansion member and the thickness of the base of the expansion member is equal to the thickness of the other portions of the base 111 to ensure that retraction of the expansion assembly 22 does not increase the thickness of the device as a whole, thereby eliminating the need to increase the inner diameter of the delivery catheter. Specifically, the bottom plate of the expansion member is slidably connected to the bottom 111 of the clamping arm 11, and the side portion 112 of the clamping arm extends vertically in the same direction as the side plate of the expansion member, so that when the expansion assembly 22 is retracted and retracted, the side portion 112 and the side plate are arranged in a consistent orientation, so that no abnormal part appears when the device is integrally compressed, and more preferably, the side portion 112 is flush with the side plate, thereby not affecting the retraction of the device into the delivery catheter, and after the device is released in vivo, the side portion 112 and the side plate can clamp tissues together.

Referring to fig. 2, 3, 6 to 10, and 13, the clamp arm 11 includes, in a first direction H1: a connection section 11e having a connection end 11b, a suspended section 11c having a suspended end 11a, and an intermediate section 11d connected between the connection section 11e and the suspended section 11 c; the suspended segment 11c includes a suspended bottom 11c1 and a suspended side 11c2 vertically connected to the suspended bottom 11c1, the connecting segment 11e includes a connecting bottom 11e1 and a connecting side 11e2 vertically connected to the connecting bottom 11e1, and the intermediate segment 11d includes only an intermediate bottom 11d1. The bottom plates 2212b, 222b of the expansion elements are slidably connected to the middle bottom 11d1, and the side plates 2212a, 2222a of the expansion elements are arranged between the suspended side 11c2 and the connecting side 11e 2. The sliding grooves 1131 and 1132 are disposed on the middle bottom portion 11d1 and extend along the second direction H2, and the thickness of the middle bottom portion 11d1 is smaller than the thickness of the connecting bottom portion 11e1 and the thickness of the suspended bottom portion 11c1, respectively. The middle section 11d is not provided with a side part, but forms a gap relative to the suspended side part 11c2 and the connecting side part 11e2, and after the expansion assembly is retracted, the side plates 2212a and 2222a of the expansion assembly are accommodated in the gap, so that the space occupied by the expansion assembly is saved, and the volume of the tissue clamping device 00 is not increased.

Of course, the thickness of the middle bottom 11d1 of the middle section 11d may not be adjusted, and the same thickness as the thicknesses of the suspended bottom 11c1 and the connecting bottom 11e1 may be maintained, so as to improve the connection strength and help the support and clamping of the clamping arm 11 and the expansion assembly 22 to the valve leaflet more stable. One of ordinary skill in the art can employ suitable means as desired. It will be appreciated that in the case where the thickness of the intermediate bottom 11d1 of the intermediate section 11d is not reduced, it is preferable to provide the bottom plate of the expansion element on the inner side of the intermediate bottom 11d1, so that the overall thickness of the device is not increased, but the connection strength is also improved.

The stress direction of the expanding element after expanding and clamping the valve leaflet together with the clamping arm 11 is mainly distributed in the direction from inside to outside (i.e. in the direction substantially perpendicular to the expanding direction of the elastic element 21), but not in the expanding direction of the expanding element, i.e. the second direction H2, the expanding element provides a stable supporting force or clamping force by means of the rigid bottom plate and side plate connected with the clamping arm 11; once the expansion piece is unfolded, the bottom plate and the side plate side plates cannot be folded and deformed in the direction away from the valve leaves due to the acting force of the valve leaves, so that the stable clamping width can be kept, and the effective clamping width of the valve leaves can be practically increased.

Referring to fig. 1-3, the tissue clamping device 00 further comprises: the supporting mechanism 4 comprises an installation end and a free end which are axially oppositely arranged; the clamping mechanism 1 is arranged at the outer side of the supporting mechanism 4, and a clamping arm 11 of the clamping mechanism 1 is rotatably connected with the mounting end; and a driving mechanism 3, wherein the driving mechanism 3 is connected with the clamping arm 11 of the clamping mechanism 1 to drive the clamping arm 11 to open or close. The tissue clamping device 00 may further include an elastic mesh-shaped adjusting mechanism (not shown), at least a portion of the supporting mechanism 4 is disposed in the adjusting mechanism in a penetrating manner, for example, one end of the adjusting mechanism is sleeved outside the mounting end of the supporting mechanism and is fixedly connected with the supporting mechanism, and the other end of the adjusting mechanism is freely suspended. The tissue gripping device 00 further comprises a gripping mechanism 5 disposed between the support mechanism 4 and the gripping arm 11, the gripping mechanism 5 cooperating with the gripping arm 11 to capture the leaflet. After the two clamping arms 11 clamp the valve leaflet, the interval between the valve leaflet can be adapted by the deformation of the adjusting mechanism, so that the traction degree of the clamping arms 11 on the valve leaflet can be adjusted.

Referring to fig. 14 and 15, in comparison with the first embodiment, a tissue clamping device 00 according to a second embodiment of the present application differs in that the expansion assembly 22 comprises a third expansion unit 223 and a fourth expansion unit 224, and the clamping mechanism 1 comprises a first clamping arm 1101 and a second clamping arm 1102 which are relatively expandable and closable; the third expansion unit 223 is provided on the first clamping arm 1101. One end of the first elastic member 21a on the first clamping arm 1101 is fixedly connected to the side portion of the first clamping arm 1101, and the other end is connected to the side plate of the third expansion unit 223; one end of the second elastic member 21b on the second clamping arm 1102 is fixedly connected to the side portion of the second clamping arm 1102, and the other end is connected to the side plate of the fourth expansion unit 224. The third expansion unit 223 and the fourth expansion unit 224 may be disposed on the same side or opposite sides of the tissue clamping device 00 along the second direction H2, and the clamping width of the two clamping arms 1101 and 1102 on the valve leaflet may be widened, so that the clamping range is increased.

Referring to fig. 16, in addition to the first embodiment, the expansion unit of the tissue clamping device 00 according to the third embodiment of the present application further includes at least one adjusting wire 23, wherein the adjusting wire 23 is detachably connected to the expansion member 22a, and the adjusting wire 23 is configured to control the elastic member 21 to elastically compress or elastically return in the second direction H2 through the expansion member 22 a. The expansion piece 22a can be retracted into the embedded clamping arm 11 after being unfolded by controlling the adjusting wire 23, if the implantation is not proper in the operation process, the tissue clamping device 00 can be retracted into the conveying catheter again, and the tissue clamping device is released or withdrawn out of the body again after being adjusted, so that the use safety of the product is improved.

Specifically, the adjustment wire 23 is threaded into and out of the side plate 22a1 of the expansion member 22a and the side portion 112 of the clamp arm 11. When the adjusting wire 23 is in a released state, the expansion piece 22a is expanded under the action of the elastic piece 21, and at this time, the clamping width of the valve leaflet can be increased; when the adjusting wire 23 is in a tensioned state, the side plate 22a1 of the expansion member 22a is retracted inward against the urging force of the elastic member 21 by the adjusting wire 23 until the side plate of the expansion member 22 is re-inserted into the clamp arm 11. The threading holes provided on the side portions 112 of the clamp arm 11 and the side plates 22a1 of the expansion pieces 22a need to be smooth and burr-free to ensure smoothness of the winding and unwinding of the adjustment wire 23.

For example, a side portion 112 of a clamping arm 11 is correspondingly provided with an adjusting wire 23, the adjusting wire 23 is folded in two to form a U shape, the U-shaped portion is positioned at the inner side of the side portion 112 of the clamping arm 11, along the extending direction H1 of the clamping arm 11 from top to bottom, two ends of the adjusting wire 23 sequentially penetrate out of the side portion 112 of the clamping arm 11, into the side plate 22a1 of the expansion member 22a inwards, out of the side plate 22a1 of the expansion member 22a inwards, into the side portion 112 of the clamping arm 11 inwards, and then extend to the conveying conduit along the supporting mechanism 4 and are connected to the control handle. When the tissue clamping device 00 is implanted, the adjustment wire 23 should be withdrawn first when the tissue clamping device 00 needs to be separated from the delivery system.

The adjusting wire 23 can be made of nickel titanium wire, stainless steel wire or high-strength suture, and the nickel titanium multi-strand wire is used as the adjusting wire 23 in the embodiment. To further reduce the resistance of the adjustment wire 23 during operation, a lubricating layer, such as a Polytetrafluoroethylene (PTFE) coating, may be provided on its outer surface.

Referring to fig. 17-21, in contrast to the first embodiment, the expansion assembly of the tissue clamping device 00 according to the fourth embodiment of the present application comprises at least one expansion unit 220, and one or more expansion units 220 may be provided on each clamping arm 11, e.g. the expansion assembly 22 comprises two expansion units 220.

The connector of either expansion unit 220 comprises two first pins 2201a and two second pins 2201b, the expander comprises two links 2202a and one expander body 2202b; the expanding body 2202b is provided with two guide grooves 2202c extending along the first direction H1, and the clamping arm 11 is provided with at least one sliding groove 1101 extending along the first direction H1; one end of a connecting rod 2202a is relatively slidably connected with the expanding body 2202b along the first direction H1 through a first pin 2201a arranged in one guide groove 2202c, and the other end of the connecting rod 2202a is relatively slidably connected with the clamping arm 11 along the first direction H1 through a second pin 2201b arranged in the sliding groove 1101; one end of the other connecting rod 2202a is relatively slidably connected with the expansion body 2202b along the first direction H1 through another first pin 2201a arranged in the other guide groove 2202c, and the other end of the connecting rod 2202a is relatively slidably connected with the clamping arm 11 along the first direction H1 through another second pin 2201b arranged in the sliding groove 1101; the expansion body 2202b is connected to one end of the elastic member 21. Of course, the clamping arm 11 may also be provided with a notch for accommodating the expansion body 2202b, so that the volume of the clamping arm 11 is not increased when the expansion unit 220 is retracted.

The two expansion bodies 2202b of the two expansion units 220 are separated from the opposite sides of the clamping arm 11; one end of the elastic member 21 is connected to the expansion body 2202b of one expansion unit 220, and the other end of the elastic member 21 is connected to the expansion body 2202b of the other expansion unit 220, and the two opposite expansion units 220 can widen the holding arm 11 together.

In this embodiment, the two connecting rods 2202a cooperate with the guide groove 2202c and the sliding groove 1101, and drive the expansion body 2202b to expand or retract under the driving of the elastic member 21, so that the structure is equivalent to a three-connecting-rod structure, and the clamping width or clamping range of the valve leaflet 01 can be stably increased, and stable supporting force or clamping force can be provided as well. At the same time, the configuration of chute 1101 and channel 2202c is fully utilized, and the size of the expansion assembly can be reduced, reducing the overall weight of the tissue clamping device.

The application also provides a tissue clamping system comprising any of the tissue clamping devices 00 described above, and a delivery device. The clamping mechanism 1 is detachably connected to the far end of the conveying device, the conveying device comprises a pushing shaft with a certain axial length and a mandrel movably penetrating through the pushing shaft, the pushing shaft is detachably connected with the supporting mechanism 4, the mandrel is detachably connected with the driving mechanism 3, and the clamping mechanism is used for driving the two clamping arms to be relatively unfolded and closed.

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

In the description of the present specification, a description referring to the terms "one embodiment," "certain embodiments," "examples," "specific examples," or "some examples," etc., means that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the present application. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiments or examples. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

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

Claims (19)

1. A tissue clamping device, which is characterized by comprising a clamping mechanism and an expanding mechanism;

the clamping mechanism comprises at least two clamping arms which can be relatively unfolded and closed, the clamping arms comprise connecting ends movably connected with other clamping arms and suspension ends, and the clamping arms extend along a first direction from the connecting ends to the suspension ends;

the expansion mechanism comprises an elastic piece and at least one expansion assembly connected with the elastic piece, the elastic piece is configured to be elastically compressed or elastically restored along a second direction, one part of the expansion assembly is movably connected with the clamping arm, the other part of the expansion assembly is arranged in the direction, opposite to the clamping arm, of the expansion assembly to retract or expand along the second direction under the elastic driving of the elastic piece, and the included angle between the first direction and the second direction is larger than 0 degree and smaller than 180 degrees.

2. The tissue clamping device of claim 1 wherein the clamping arm has a clamping face and the second direction is parallel to the clamping face.

3. The tissue clamping device of claim 1, wherein the first direction is at an angle ranging from [45 °,135 ° ] to the second direction.

4. The tissue gripping device of claim 3, wherein the first direction is perpendicular to the second direction.

5. The tissue clamping device of claim 4, wherein the other portion of the expansion assembly includes a location parallel to the first direction.

6. The tissue clamping device of claim 1, wherein the resilient member comprises at least one spring extending in the second direction.

7. The tissue clamping device of any one of claims 1-6, wherein the expansion assembly comprises at least one expansion unit comprising a connector and an expander; the connecting piece is in sliding connection with the clamping arm, and the expansion piece is respectively connected with the elastic piece and the connecting piece, so that the expansion piece is driven to slide and retract or expand relative to the clamping arm through elastic compression or elastic recovery of the elastic piece.

8. The tissue clamping device of claim 7 wherein the connector comprises a pin and the extender comprises a base plate and a side plate attached at one end of the base plate in upstanding relation to the base plate; the clamping arm is provided with at least one sliding groove extending along the second direction, the bottom plate is in sliding connection with the clamping arm through the pin arranged in the sliding groove, and the side plate is connected with one end of the elastic piece.

9. The tissue clamping device of claim 8, wherein a thickness of a portion of the clamping arm overlying the base plate is less than a thickness of other portions of the clamping arm.

10. The tissue clamping device of claim 8, wherein the clamping arm comprises a bottom portion and a side portion that is vertically connected to the bottom portion; the bottom plate is in sliding connection with the bottom, and the side part and the side plate vertically extend along the same direction.

11. The tissue clamping device of claim 10 wherein the tissue clamping device comprises a tissue clamping device,

the clamp arm includes, in the first direction: a connection section having the connection end, a suspension section having the suspension end, and an intermediate section connected between the connection section and the suspension section;

the connecting section comprises a connecting bottom and a connecting side part vertically connected with the connecting bottom, and the middle section comprises a middle bottom;

the bottom plate is in sliding connection with the middle bottom, and the side plates are arranged between the suspended side parts and the connecting side parts.

12. The tissue clamping device of claim 8, wherein the expansion assembly comprises two expansion units, two of the side plates of the two expansion units being separate from opposite sides of the clamping arm; one end of the elastic piece is connected with the side plate of one expansion unit, and the other end of the elastic piece is connected with the side plate of the other expansion unit; the two side plates retract or expand back to back along the second direction relative to the clamping arms under the elastic drive of the elastic piece.

13. The tissue clamping device of claim 12, wherein the base plate of one of the expansion units is offset relative to the base plate of the other expansion unit on either the inner or outer side of the clamping arm; the clamping arm is provided with a first sliding groove and a second sliding groove which extend along the second direction and are staggered relatively, and the length of the first sliding groove and the length of the second sliding groove are at least greater than half of the length of the clamping arm along the second direction.

14. The tissue clamping device of claim 7, wherein the expansion unit further comprises at least one adjustment wire detachably connected to the expansion member, the adjustment wire configured to control the elastic member to elastically compress or elastically return in the second direction via the expansion member.

15. The tissue clamping device of claim 7 wherein the tissue clamping device comprises a tissue clamping device,

the connecting piece comprises two first pins and two second pins, and the expanding piece comprises two connecting rods and an expanding body; the expanding body is provided with two guide grooves extending along the first direction, and the clamping arm is provided with at least one sliding groove extending along the first direction;

one end of the connecting rod is in sliding connection with the expanding body along the first direction through one first pin arranged in one guide groove, and the other end of the connecting rod is in sliding connection with the clamping arm along the first direction through one second pin arranged in the guide groove;

one end of the other connecting rod is in sliding connection with the expansion body along the first direction through the other first pin arranged in the other guide groove, and the other end of the connecting rod is in sliding connection with the clamping arm along the first direction through the other second pin arranged in the guide groove;

the expansion body is connected with one end of the elastic piece.

16. The tissue clamping device of claim 15, wherein the expansion assembly comprises two expansion units, two of the expansion bodies of the two expansion units being separated on opposite sides of the clamping arm; one end of the elastic piece is connected with the expansion body of one expansion unit, and the other end of the elastic piece is connected with the expansion body of the other expansion unit.

17. The tissue clamping device of claim 1, wherein the tissue clamping device further comprises:

the support mechanism comprises an installation end and a free end which are axially and oppositely arranged; the clamping mechanism is arranged on the outer side of the supporting mechanism, and a clamping arm of the clamping mechanism is connected with the mounting end;

and the driving mechanism is connected with the clamping arms of the clamping mechanism so as to drive the clamping arms to be unfolded or closed.

18. The tissue clamping device of claim 17, further comprising an elastic mesh adjustment mechanism, at least a portion of the support mechanism being disposed through the adjustment mechanism.

19. A tissue clamping system comprising a tissue clamping device as claimed in any one of claims 1 to 18, and a delivery device, the clamping mechanism being detachably connected to a distal end of the delivery device.

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