CN113288515A - Valve closing apparatus - Google Patents

Abstract

The invention discloses a valve closing apparatus, which comprises a septum, wherein a septum channel is arranged on the septum, the far end of the septum is hinged with two supporting arms at intervals, the near end side of each supporting arm is provided with a U-shaped anchoring clamp, the two clamping arms of the anchoring clamp are respectively a fixed arm and a movable arm, the fixed arm is fixedly arranged at the near end side of each supporting arm, the movable arm is provided with a traction structure, the joint of the fixed arm and the movable arm is arranged close to the septum, one far end side of the septum is provided with a U-shaped closing clamp, the closing clamp comprises a top cap and two closing clamping arms, the far ends of the two closing clamping arms are fixedly connected with the top cap, the near ends of the two closing clamping arms are respectively hinged on the two supporting arms, the near end side of the top cap is provided with a coupling structure, and the coupling structure is arranged opposite to the septum channel. The valve closing device is simpler in structure, more reliable in performance, simpler and more convenient to operate and smaller in size.

Description

Valve closing apparatus

Technical Field

The invention relates to the technical field of surgical instruments, in particular to an instrument for closing a valve.

Background

Valve regurgitation is a common valve disease, the classic treatment method is to suture the middle edges of valve leaflets in an edge-to-edge manner through cardiac surgery to reduce the degree of regurgitation, and with the development of interventional and minimally invasive techniques, more and more closure instruments reach the valve leaflets through a delivery system to close the valve leaflets, and the channels between the valve leaflets are changed from single holes to double holes or even multiple holes, so that the occurrence of regurgitation is reduced.

Disclosure of Invention

The invention aims to provide a valve closing instrument which is simpler in structure, more reliable in performance, simpler and more convenient to operate and smaller in size.

The invention relates to a valve closing apparatus, which comprises a septum, wherein a septum passage extending from a near end to a far end is arranged on the septum, the far end of the septum is hinged with two supporting arms at intervals, the supporting arms can rotate far away from or close to the near end of the septum, the near end side of the supporting arms is provided with a U-shaped anchoring clamp, two clamping arms of the anchoring clamp are respectively a fixed arm and a movable arm, the fixed arm is fixedly arranged at the near end side of the supporting arms, the movable arm is provided with a traction structure, the joint of the fixed arm and the movable arm is arranged close to the septum, one side of the far end of the septum is provided with a U-shaped closing clamp, the closing clamp comprises a top cap and two closing clamping arms, the far ends of the two closing clamping arms are fixedly connected with the top cap, the near ends of the two closing clamping arms are respectively hinged on the two supporting arms, and the, the coupling structure is disposed opposite the septum passage.

The valve closing device is characterized in that the middle separator is cylindrical, and the cylindrical cavity of the middle separator is the middle separator channel.

The valve closing apparatus of the invention is characterized in that the septum is cylindrical, the barrel cavity of the septum is the septum channel, and the barrel wall of the septum is of a grid structure.

According to the valve closing device, the far end of the middle partition is fixedly connected with the connecting block, the connecting block is provided with the connecting block through hole, the connecting block through hole and the middle partition channel are coaxially arranged, the two supporting arms are hinged to two opposite sides of the connecting block respectively, and the hinged shafts of the supporting arms and the connecting block are perpendicular to the axial direction of the connecting block through hole.

According to the valve closing device, two hinge support lugs which are oppositely arranged are arranged on two opposite sides of the connecting block, the two hinge support lugs on one side of the connecting block are a first pair of hinge support lugs, the two hinge support lugs on the other side of the connecting block are a second pair of hinge support lugs, and the two support arms are hinged between the first pair of hinge support lugs and between the second pair of hinge support lugs through hinge shafts respectively.

According to the valve closing device, the limiting structures are arranged between the first pair of hinged support lugs and between the second pair of hinged support lugs, and the limiting structures are located on one side of the proximal end of the hinged shaft.

According to the valve closing instrument, the fixing arm of the anchoring clamp is fixed on the supporting arm in a welding, bonding, riveting, pressing and holding or sewing mode, the movable arm of the anchoring clamp is provided with the barb, the barb is located between the movable arm and the fixing arm, and the barb is obliquely arranged towards the joint of the movable arm and the fixing arm.

According to the valve closing device, one end of each supporting arm is provided with a hinge neck, the other end of each supporting arm is provided with a hinge hole, the hinge neck is fixedly connected with a hinge shaft, and the near ends of the two closing clamping arms are hinged to the hinge holes of the two supporting arms respectively.

The valve closing device comprises a closing clamping arm, a top cap, a supporting arm, a fixing part, an elastic part, a middle part, a Y part and a hinging part, wherein the closing clamping arm is a U-shaped closing spring, the far end of the closing spring is an opening end, the closing spring is sequentially provided with the fixing part, the elastic part, the middle part, the Y part and the hinging part along the direction from the far end to the near end, the fixing part of the closing spring is fixedly connected with the top cap, the hinging part of the closing spring penetrates through a hinging hole of the supporting arm and can rotate relative to the hinging hole, and two spring arms of the closing spring are respectively positioned on two opposite sides of the hinged supporting arm.

The valve closing device comprises a coupling structure, a connecting block and a traction structure, wherein the coupling structure is a screw hole, the limiting structure is a limiting point structure, a limiting line structure or a limiting surface structure which is integrally formed with the connecting block, and the traction structure is a traction hole arranged on the movable arm.

When the valve closing device is used, the valve closing device is matched with a conveying system, the conveying system comprises a multi-cavity tube head end, a traction wire and a driving rod, the multi-cavity tube head end is connected with the proximal end of the middle spacer, the traction wire is connected to a traction structure of the movable arm (the traction wire drives the movable arm so as to open or close the anchoring clamp), and the driving rod penetrates through the multi-cavity tube head end and the middle spacer in sequence from the proximal end to the distal end and then is coupled with a coupling structure on the top cap. The following description of the use of the closure device is given for mitral valve closure as an example: the drive rod is first moved distally from the proximal end until the U-shaped closure clip is in the closed position (with the support arm rotated to the distal side of the septum and the anchor clip in the closed position following the support arm also rotated to the distal side of the septum), at which time the closure device is in the stowed position. Then establishing a passage through a catheter, placing the closed instrument in a sheath tube in a loading state to reach the left atrium, adjusting the posture of the closed instrument under the assistance of an image (such as transesophageal ultrasound), enabling the driving rod to move towards the near end by adjusting corresponding keys of a conveying system (due to the coupling between the driving rod and the top cap, when the driving rod moves towards the near end, the top cap also moves towards the near end along with the driving rod, so that two closed clamping arms of the U-shaped closed clamp are gradually opened, meanwhile, the supporting arm rotates close to the near end of the septum, in the process, the anchoring clamp in the closed state rotates along with the supporting arm at the same time), so that the closed instrument is in a pre-capturing state, at the moment, the closed instrument is positioned on the heart chamber side, adjusting corresponding handles of the conveying system to enable the closed instrument to be in an ideal capturing position by combining with the imaging, adjusting corresponding keys of the conveying system to enable the anchoring clamp to be completely opened, and enabling the closed instrument to be in a capturing state, one edge of the leaflet is then located between the two arms of one anchor clip and the other edge of the leaflet is located between the two arms of the other anchor clip. And then adjusting a corresponding key of the conveying system to close the anchoring clamp, clamping the valve leaflet by the anchoring clamp, operating the corresponding key of the conveying system, and slowly moving the driving rod to the near end again until two closing clamp arms of the U-shaped closing clamp are closed again, wherein at the moment, two opposite edges of the valve leaflet are closed by the U-shaped closing clamp. And then, decoupling the driving rod and the top cap by rotating a corresponding key of the conveying system, withdrawing the driving rod, disconnecting the head end of the multi-cavity pipe from the septum, withdrawing the conveying system and finishing the operation. Therefore, the invention has the advantages of simpler structure, more reliable performance, simpler and more convenient operation and smaller volume.

The invention will be further explained with reference to the drawings.

Drawings

FIG. 1 is a schematic view of the overall construction of the valve closure device of the present invention;

FIG. 2 is a front view of the valve closure device of the present invention in a closed position;

FIG. 3 is a bottom view of the valve closure device of the present invention in a closed position;

FIG. 4 is a top view of the valve closure device of the present invention in a closed position;

FIG. 5 is a left side view of the valve closure device of the present invention in a closed position;

FIG. 6 is a front view of the valve closure device of the present invention in a pre-capture state (with the anchor clip closed);

FIG. 7 is a front view of the valve closure device of the present invention in a capture configuration (with the anchor clip open);

FIG. 8 is a front view of the valve closure device of the present invention in a loaded state;

FIG. 9 is a schematic view of a support arm according to the present invention;

FIG. 10 is a schematic structural diagram of a first embodiment of a splice block of the present invention;

FIG. 11 is a schematic view of the articulation of a first embodiment of an engagement block with a support arm according to the present invention;

FIG. 12 is a schematic view of the construction of the top cap of the present invention;

FIG. 13 is a schematic view of a closure clip arm of the U-shaped closure clip of the present invention;

FIG. 14 is a schematic view of the U-shaped closure clip of the present invention in operation;

FIG. 15 is a schematic view of the initial state of the U-shaped closure clip of the present invention;

FIG. 16 is a schematic view of a coupling of the septum of the present invention connected to the tip of a multi-lumen tube of a delivery system;

FIG. 17 is a schematic view of the tip of a multi-lumen tube in the delivery system;

FIG. 18 is a schematic view of a multi-lumen tube tip coupled with a coupling element;

FIG. 19 is a schematic view of a multi-lumen tube tip being decoupled from a coupling;

FIG. 20 is a schematic view of the rotational freedom of the support arm relative to the first embodiment of the engagement block of the present invention;

FIG. 21 is a schematic structural view of a second embodiment of a splice block of the present invention;

FIG. 22 is a schematic diagram illustrating the positioning of two pairs of support arms according to an embodiment of the engagement block of the present invention;

FIG. 23 is a cross-sectional view of FIG. 22;

FIG. 24 is a schematic view of another embodiment of a septum of the present invention;

FIG. 25 is a schematic view of a valve closure device of the present invention capturing leaflets (with the anchor clips in an open position);

FIG. 26 is a schematic view of a valve closure device of the present invention capturing leaflets (with the anchor clips in a closed position);

FIG. 27 is a schematic view of a valve closed by the valve closure device of the present invention;

FIG. 28 is a cross-sectional view taken along line A-A of FIG. 27;

FIG. 29 is a view of the connection of the valve closure device of the present invention to a delivery system.

Detailed Description

In the description of the present invention, for the convenience of understanding the technical solution of the present invention, the proximal and distal ends mentioned in the present invention are explained as follows: the proximal and distal ends are relative to the operator's distance, specifically, distal is defined as the distance to the operator and proximal is defined as the distance to the operator.

It should be noted that the terms "center", "upper", "lower", "front", "rear", "left", "right", "head end", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of describing the present invention and simplifying the description, but do not indicate or imply that the device or element referred to must have a specific orientation, be constructed in a specific orientation, and be operated, and thus should not be construed as limiting the present invention.

In the description of the present invention, it is to be noted that, unless otherwise explicitly specified or limited, the terms "connected" and "connected" are to be interpreted broadly, e.g., as being fixed or detachable or integrally connected; can be mechanically or electrically connected; may be directly connected or indirectly connected through an intermediate. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

As shown in fig. 1 and in conjunction with fig. 2-29, the valve closing device of the present invention comprises aseptum 2, wherein theseptum 2 is provided with aseptum passage 40 extending from aproximal end 3 to a distal end, the distal end of theseptum 2 is hinged with two supportingarms 4 at intervals, the supportingarms 4 can rotate away from or close to theproximal end 3 of the septum, the proximal side of the supportingarms 4 is provided with aU-shaped anchoring clip 1, the two clip arms of the U-shapedanchoring clip 1 are afixed arm 10 and amovable arm 9, respectively, and thefixed arm 10 and themovable arm 9 are connected through an elastic element, and the elastic element provides a closing force for theanchoring clip 1. Thefixed arm 10 is fixed and is located the near-end side ofsupport arm 4, be equipped with on thedigging arm 9 and pull the structure, pull the structure for locating thehole 12 that pulls on thedigging arm 9, the junction offixed arm 10 and diggingarm 9 is close to the distal end ofseptum 2 and arranges. The U-shaped closed clamp is arranged on one side of the far end of themiddle partition 2 and comprises atop cap 6 and two closed clamping arms, the far ends of the two closed clamping arms are fixedly connected with thetop cap 6, the near ends of the two closed clamping arms are hinged to the two supportingarms 4 respectively, a coupling structure is arranged on the near end side of thetop cap 6, and the coupling structure and themiddle partition passage 40 are arranged oppositely.

As shown in fig. 1, the valve closure device of the present invention, wherein theseptum 2 has a cylindrical shape, the cylindrical cavity of theseptum 2 is theseptum passage 40, that is, theseptum passage 40 is arranged along the axial direction of theseptum 2.

As shown in fig. 24, in addition to the above structure, theseptum 2 may also adopt the following structure: theseptum 2 is cylindrical, the barrel cavity of theseptum 2 is theseptum channel 40, and the barrel wall of theseptum 2 is of a grid structure.

As shown in fig. 1 and fig. 10 and 11, the valve closing device of the present invention, wherein the distal end of theseptum 2 is fixedly connected with ajoint block 50, thejoint block 50 is provided with a joint block throughhole 17, the joint block throughhole 17 is coaxially arranged with theseptum channel 40, twosupport arms 4 are respectively hinged on two opposite sides of thejoint block 50, and thehinge axes 13 of thesupport arms 4 and thejoint block 50 are perpendicular to the axial direction of the joint block throughhole 17.

As shown in fig. 10 and 11, the valve closing device of the present invention has two oppositely disposed hinge lugs on two opposite sides of thejoint block 50, and the hinge lugs are integrally formed with thejoint block 50. The two hinged lugs on one side of the joiningblock 50 are a first pair of hinged lugs, the two hinged lugs on the other side of the joiningblock 50 are a second pair of hinged lugs, and the two supportingarms 4 are hinged between the first pair of hinged lugs and between the second pair of hinged lugs through hingedshafts 13 respectively. The first pair of hinged lugs and the second pair of hinged lugs are respectively provided with a mountinghole 16, the mountingholes 16 are perpendicular to the axial direction of the connecting block throughhole 17, and the hingedshaft 13 penetrates through the mountingholes 16 of the first pair of hinged lugs/the second pair of hinged lugs.

As shown in fig. 21, and in conjunction with fig. 22 and 23, the valve closure device of the present invention, wherein a stop is disposed between the first and second pairs of hinge eyes, the stop being located on the proximal side of thehinge axis 13. Limit structure is with linkingpiece 50 integrated into one piece's spacing point structure (like spacing arch), spacing line structure (like spacing bulge loop) or spacing face structure, in this embodiment, limit structure is with linkingpiece 50 integrated into one piece's spacinginclined plane 32, can effectively restrict the degree of freedom of support arm 4 (support arm 4 is when the near-end 3 ofspacing body 2 rotates towards, when changeing to certain extent just blockked by spacinginclined plane 32, make it can not continue to rotate towards spacing body near-end 3), thereby the stability of closed apparatus has been guaranteed, further the closed effect has been promoted, thereby the security of product has been promoted. As shown in fig. 20, when theengagement block 50 is not provided with the limit structure, thesupport arm 4 has a large degree of freedom in rotation with respect to theengagement block 50.

As shown in fig. 1, the valve closing device of the present invention, wherein the fixingarm 10 of theU-shaped anchoring clip 1 is provided with a fixinghole 11, and the fixingarm 10 is fixed and sutured on the supportingarm 4 by a suture thread penetrating through the fixinghole 11, of course, besides being fixed by suturing, the fixingarm 10 can also be fixed on the supportingarm 4 by welding, bonding, riveting or pressing. Be equipped withbarb 8 on Utype anchoring clamp 1's thedigging arm 9,barb 8 is located between diggingarm 9 and the fixedarm 10,barb 8 is arranged towards the junction slope of diggingarm 9 and fixedarm 10. The end part of themovable arm 9 of theanchoring clip 1 is provided with adrawing hole 12 for thedrawing wire 7 to pass through, and thebarb 8 is arranged at the position of themovable arm 9 close to the end part. TheU-shaped anchoring clip 1 can be brought into an open or closed state by manipulating thepull wire 7, and in an initial state, as shown in fig. 6, theanchoring clip 1 is brought into a closed state due to the closing force between thestationary arm 10 and themoveable arm 9 of theanchoring clip 1, after which thepull wire 7 is pulled in a proximal direction to move themoveable arm 9 away from thestationary arm 10, i.e. to open theanchoring clip 1; when it is desired to close theanchoring clip 1, it is only necessary to release thetraction wire 7, at which point themobile arm 9 moves towards the fixedarm 10 under the action of the closing force of theanchoring clip 1 itself until theanchoring clip 1 is closed.

As shown in fig. 9, and as shown in fig. 1 and 11, the valve closing device of the present invention, wherein one end of the supportingarm 4 is provided with ahinge neck 15, thehinge neck 15 is integrally formed with the supportingarm 4, the other end of the supportingarm 4 is provided with ahinge hole 14, ahinge shaft 13 is fixedly connected to thehinge neck 15, and the proximal ends of the two closing arm arms are respectively hinged to the hinge holes 14 of the two supportingarms 4. Thesupport arm 4 can be pivoted relative to thejoint block 50 by means of thehinge axis 13, and the closing arm can be pivoted relative to thesupport arm 4 and about the axis of the hinge bore 14.

As shown in fig. 13, and as shown in fig. 1 and 2, the valve closing device of the present invention, wherein the closing clip arm is aU-shaped closing spring 5, the distal end of theclosing spring 5 is an open end, theclosing spring 5 is sequentially provided with a fixingportion 20, anelastic portion 24, anintermediate portion 23, aY portion 22 and ahinge portion 21 along a direction from the distal end to the proximal end, the fixingportion 20 of theclosing spring 5 is fixedly connected to thetop cap 6, thehinge portion 21 of theclosing spring 5 is disposed through thehinge hole 14 of thesupport arm 4 and can rotate relative to thehinge hole 14, and two spring arms of theclosing spring 5 are respectively located on opposite sides of the hingedsupport arm 4. Thetop cap 6 is provided with a closingspring fixing hole 18, the fixingpart 20 of theclosing spring 5 is inserted into the closingspring fixing hole 18 to be fixed with thetop cap 6, theelastic part 24 of theclosing spring 5 provides main closing force to enable thevalve leaflets 33 to be involuted edge to edge, theY part 22 of theclosing spring 5 better conforms to the tissue structure of theinvoluted valve leaflets 33, and in addition, theY part 22 of theclosing spring 5 provides an effective force arm for opening theclosing spring 5.

As shown in fig. 12, the valve closing device of the present invention, wherein the coupling structure is ascrew hole 19, the distal end of the drivingrod 31 is provided with athread 42 matching with thescrew hole 19, i.e. the distal end of the drivingrod 31 is threaded into thescrew hole 19 of thetop cap 6, so as to achieve coupling.

As shown in fig. 29, when the valve closure device of the present invention is used, it is required to cooperate with a delivery system, the delivery system comprises amulti-lumen tip 62, apull wire 7 and a drivingrod 31, themulti-lumen tip 62 is connected to theproximal end 3 of the septum 2 (i.e. theproximal end 3 of theseptum 2 is fixedly connected with acoupling element 61 in a tubular structure, thecoupling element 61 is connected to themulti-lumen tip 62 by a mortise and tenon structure, as shown in fig. 18), thepull wire 7 is connected to thepull hole 12 of themovable arm 9, the drivingrod 31 sequentially passes through themulti-lumen tip 62 from the proximal end to the distal end,coupling member 61 andseptum 2 are then coupled to the coupling structure on overcap 6 (i.e.,distal threads 42 ofdrive rod 31 are threaded into threaded bore 19) withdrive rod 31 positioned withinlumen 28 ofmulti-lumen tip 62,lumen 25 ofcoupling member 61, andseptum channel 40 ofseptum 2. The following description of the use of the closure device is given for mitral valve closure as an example: thedrive rod 31 is first moved from the proximal end to the distal end until the U-shaped closure clip is in the closed position (with thesupport arm 4 rotated to the distal side of theseptum 2 and theanchoring clip 1 in the closed position following thesupport arm 4 also rotated to the distal side of the septum 2), at which point the closure device is in the stowed position. Then establishing a channel (not shown in the figure) through a catheter, placing the closure device in a loading state (shown in figure 8) in a sheath tube to reach the left atrium, adjusting the posture of the closure device under the assistance of an image (such as transesophageal ultrasound), moving the driving rod 31 to the proximal end by adjusting corresponding keys of the delivery system (due to the coupling between the driving rod 31 and the top cap 6, the top cap 6 also moves to the proximal end along with the driving rod 31 when the driving rod 31 moves to the proximal end, so that the two closure arms of the U-shaped closure clip gradually open, and the supporting arm 4 rotates close to the proximal end 3 of the septum, during which the anchoring clip 1 in the closure state simultaneously rotates along with the supporting arm 4), so that the closure device is in a pre-capture state (shown in figure 6), and at the time the closure device is located on the ventricular side, and adjusting corresponding handles of the delivery system to make the closure device in an ideal capture position in combination with imaging, the corresponding push button of the delivery system is adjusted to pull the pull wire 7 in the proximal direction (movement of the moveable arm 9 away from the stationary arm 10) to fully open the anchoring clamps 1 and to place the closure device in the capturing position (see fig. 7 and 25), in which one edge of the leaflet 33 is located between the two arms of one anchoring clamp 1 and the other edge of the leaflet 33 is located between the two arms of the other anchoring clamp 1. Then the corresponding key of the delivery system is adjusted, thetraction wire 7 is released, theanchoring clip 1 is closed, thevalve leaflet 33 is clipped by the anchoring clip 1 (as shown in fig. 26), the corresponding key of the delivery system is operated, the drivingrod 31 is slowly moved towards the near end again, in the process, thetop cap 6 pushes the supportingarm 4 to gradually rotate towards thenear end 3 of theseptum 2 through the closing clamping arm, simultaneously, under the action of the self closing force of the U-shaped closing clip, the two closing clamping arms of the U-shaped closing clip are closed again, and at the moment, the two opposite edges of thevalve leaflet 33 are clipped by the two closing clamping arms of the U-shaped closing clip to realize closing (as shown in fig. 27 and 28. Then, the drivingrod 31 is rotated to be decoupled with thetop cap 6 by rotating the corresponding key of the delivery system, the drivingrod 31 is extracted, the multi-lumentube head end 62 is rotated to disconnect the multi-lumen tube head end 62 from the septum 2 (namely, the multi-lumentube head end 62 is decoupled from thecoupling piece 61 on theseptum 2, as shown in fig. 19, after the decoupling, thecoupling piece 61 is continuously and fixedly connected to theseptum 2 and is left in the human body), and the delivery system is withdrawn to finish the operation. Therefore, the invention has the advantages of simpler structure, more reliable performance, simpler and more convenient operation and smaller volume.

It can be seen that theanchoring clip 1 of the present invention is used for capturing thevalve leaflet 33, and after theanchoring clip 1 captures thevalve leaflet 33, the two closing clip arms of the U-shaped closing clip can close thevalve leaflet 33 edge to edge in the subsequent process.

As shown in fig. 1, when drivingrod 31 moves proximally, drivingcap 6 is moved proximally due to the coupling betweenthreads 42 of drivingrod 31 and threadedhole 19 ofcap 6, and hingeshaft 13 andhinge portion 21 ofclosing spring 5 perform corresponding hinge movements, the closing device tends to close.

As shown in fig. 2, and in conjunction with fig. 5-8, 16-19, themulti-lumen tip 62 of the delivery system is connected to theproximal end 3 of theseptum 2 by acoupling element 61, i.e., theproximal end 3 of theseptum 2 is fixedly connected to the distal end of thecoupling element 61, and themulti-lumen tip 62 is coupled to the proximal end of thecoupling element 61. Couplingelement 61 is a tubular structure such that, after couplingelement 61 is coupled tomulti-lumen tube tip 62,drive rod 31 passes coaxially throughmulti-lumen tube tip 62 andcoupling element 61 intoseptum channel 40 ofseptum 2. It should be noted that thecoupling piece 61 is coupled with themulti-lumen tube head 62 through a mortise and tenon structure, thecoupling piece tenon 26 is coupled with the multi-lumentube head mortise 30, the coupling piece mortise 27 is coupled with the multi-lumen tubehead end tenon 29, the drivingrod 31 coaxially penetrates through themulti-lumen tube head 62 and thecoupling piece 61, the drivingrod 31 is withdrawn and themulti-lumen tube head 62 is rotated, so that the decoupling of the multi-lumen tube head and thecoupling piece 61 is realized.

The components of the present invention may be made from conventional medical implant materials (e.g., stainless steel, titanium alloy, nitinol) by conventional machining methods (e.g., laser cutting, wire cutting, electrical discharge machining, and turning). In which theanchoring clip 1 has a suitable closing force in an initial state, which can be referred to in fig. 6, ensuring a sufficient clipping force of theleaflets 33 clamped therebetween, theanchoring clip 1 can be shaped by heat treatment to achieve the above-mentioned function.

To improve tissue compliance, better fit against theleaflets 33, theseptum 2 should be suitably resilient, in particular radially enough to be resilient, while in the axial direction theseptum 2 needs to provide enough rigidity to support the opening and closing of the device.

To achieve the above-described function of theseptum 2, theseptum 2 may be fabricated as a thin-walled structure, as shown in FIG. 1, or as a mesh structure, as shown in FIG. 24.

As shown in fig. 1, the structure of the present invention is an axisymmetric structure in which theseptum 2, the engagement block throughhole 17 and thescrew hole 19 of thetop cap 6 are coaxially arranged, and theanchor clip 1, thesupport arm 4 and theclosing spring 5 are symmetrically arranged along the axis, respectively. Of course, the symmetrical arrangement is for better understanding of the invention, and is in no way limiting, and it is feasible to use an asymmetrical distribution to meet the practical clinical requirements.

Fig. 15 is a schematic view of the initial state of the closing springs 5, and it can be seen that the closing springs 5 in the initial state are already closed, that is, the closing springs 5 can still provide clamping force when clamping theleaflet 33 tissue structure with the thickness close to 0, and the function can be obtained by a heat treatment pre-forming or mechanical dislocation installation method.

Fig. 14 is a schematic view of theclosing spring 5 in operation, i.e. after clamping of the leaflets 33 (leaflets 33 not shown), it being clear that there is a large clamping force between the closing springs 5 (relative to the initial state of the closing springs 5 shown in fig. 15).

It should be emphasized that this embodiment only illustrates the application process of the present invention by taking the mitral valve as an example, but the present invention is by no means limited to the application of the present invention, and the present invention can be applied to the closure of other valves such as the tricuspid valve, the aortic valve, the pulmonary valve, and the like.

The above-mentioned embodiments are merely illustrative of the preferred embodiments of the present invention, and do not limit the scope of the present invention, and various modifications and improvements of the technical solution of the present invention by those skilled in the art should fall within the protection scope defined by the claims of the present invention without departing from the spirit of the present invention.

Claims (10)

1. A valve closure device, characterized by: comprises a septum, a septum channel extending from a near end to a far end is arranged on the septum, the far end of the septum is hinged with two supporting arms at intervals, the supporting arm can rotate far away from or close to the near end of the septum, the near end side of the supporting arm is provided with a U-shaped anchoring clip, the two clamping arms of the anchoring clamp are respectively a fixed arm and a movable arm, the fixed arm is fixedly arranged at the proximal end side of the supporting arm, the movable arm is provided with a traction structure, the joint of the fixed arm and the movable arm is arranged close to the middle partition, one side of the far end of the middle spacer is provided with a U-shaped closing clamp which comprises a top cap and two closing clamp arms, the far ends of the two closing clamp arms are fixedly connected with the top cap, the near ends of the two closing clamp arms are respectively hinged on the two supporting arms, the proximal end side of the top cap is provided with a coupling structure, and the coupling structure is arranged opposite to the septum passage.

2. The valve closure device of claim 1, wherein: the septum is cylindrical, and a barrel cavity of the septum is the septum channel.

3. The valve closure device of claim 1, wherein: the septum is cylindrical, the barrel cavity of the septum is the septum channel, and the barrel wall of the septum is of a grid structure.

4. The valve closure device of claim 2 or 3, wherein: the far end of the middle separation part is fixedly connected with a connecting block, the connecting block is provided with a connecting block through hole, the connecting block through hole and the middle separation part channel are coaxially arranged, the two supporting arms are respectively hinged to two opposite sides of the connecting block, and a hinged shaft of the supporting arms and the connecting block is perpendicular to the axis direction of the connecting block through hole.

5. The valve closure device of claim 4, wherein: the relative both sides of linking up the piece all are equipped with two mutual disposition's articulated journal stirrup, link up two articulated journal stirrups of piece one side and be first pair of articulated journal stirrup, link up two articulated journal stirrups of piece opposite side and be second pair of articulated journal stirrup, two the support arm articulates between first pair of articulated journal stirrup and second pair of articulated journal stirrup through the articulated shaft respectively.

6. The valve closure device of claim 5, wherein: and limiting structures are arranged between the first pair of hinged lugs and between the second pair of hinged lugs and are positioned on one side of the near end of the hinged shaft.

7. The valve closure device of claim 6, wherein: the fixed arm that the anchoring pressed from both sides is fixed on the support arm through welding, bonding, riveting, the mode of pressing and holding or sewing up, be equipped with the barb on the digging arm that the anchoring pressed from both sides, the barb is located between digging arm and the fixed arm, the barb is arranged towards the junction slope of digging arm and fixed arm.

8. The valve closure device of claim 7, wherein: one end of each support arm is provided with a hinge neck, the other end of each support arm is provided with a hinge hole, each hinge neck is fixedly connected with a hinge shaft, and the near ends of the two closed clamp arms are hinged to the hinge holes of the two support arms respectively.

9. The valve closure device of claim 8, wherein: the closed clamping arm is a U-shaped closed spring, the far end of the closed spring is an open end, the closed spring is sequentially provided with a fixed portion, an elastic portion, a middle portion, a Y portion and a hinged portion along the direction from the far end to the near end, the fixed portion of the closed spring is fixedly connected with the top cap, the hinged portion of the closed spring penetrates through the hinged hole of the supporting arm and can rotate relative to the hinged hole, and two spring arms of the closed spring are respectively located on two opposite sides of the supporting arm which is hinged to the two spring arms.

10. The valve closure device of claim 9, wherein: the coupling structure is a screw hole, the limiting structure is a limiting point structure, a limiting line structure or a limiting surface structure which is integrally formed with the connecting block, and the traction structure is a traction hole arranged on the movable arm.

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