CN113288517A - Valve closing apparatus - Google Patents

Valve closing apparatus Download PDF

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Publication number
CN113288517A
CN113288517A CN202110573799.3A CN202110573799A CN113288517A CN 113288517 A CN113288517 A CN 113288517A CN 202110573799 A CN202110573799 A CN 202110573799A CN 113288517 A CN113288517 A CN 113288517A
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CN
China
Prior art keywords
arm
septum
hinged
arms
closing
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Pending
Application number
CN202110573799.3A
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Chinese (zh)
Inventor
谢晨光
周晓军
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Beijing Lingjian Medical Technology Co ltd
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Beijing Lingjian Medical Technology Co ltd
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Application filed by Beijing Lingjian Medical Technology Co ltd filed Critical Beijing Lingjian Medical Technology Co ltd
Priority to CN202110573799.3A priority Critical patent/CN113288517A/en
Publication of CN113288517A publication Critical patent/CN113288517A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246Devices for obstructing a leak through a native valve in a closed condition
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466Delivery devices therefor

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

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 U-shaped anchoring clamps at intervals, two clamp arms of each anchoring clamp are respectively a support arm and a capture arm, the capture arm is positioned on the near end side of the support arm, a traction structure is arranged on the capture arm, the connection part of the support arm and the capture arm is hinged at the far end of the septum, one side of the far end of the septum is provided with a U-shaped closing clamp, each closing clamp 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 support 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, smaller in size and lighter in weight.

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, smaller in size and lighter in weight.
The valve closing device comprises a septum, wherein the septum is provided with a septum channel extending from a proximal end to a distal end, the distal end of the septum is articulated at intervals with two U-shaped anchoring clips which can rotate away from or close to the proximal end of the septum, the two clamping arms of the anchoring clamp are respectively a supporting arm and a catching arm, the catching arm is positioned at the proximal end side of the supporting arm, the catching arm is provided with a traction structure, the joint of the supporting arm and the catching arm is hinged with the far end of the middle spacer, 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.
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 anchoring clamps are respectively hinged to two opposite sides of the connecting block, and the hinged shafts of the anchoring clamps and the connecting block are perpendicular to the axial direction of the connecting block through hole.
The valve closing device comprises a connecting block, two connecting rods and two anchoring clamps, wherein two opposite sides of the connecting block are respectively provided with two hinge support lugs which are oppositely arranged, 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 anchoring clamps are respectively hinged between the first pair of hinge support lugs and between the second pair of hinge support lugs through hinge shafts.
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.
The valve closing apparatus of the present invention, wherein the catching arm of the anchoring clip is provided with a barb, the barb is located between the catching arm and the supporting arm, and the barb is obliquely arranged toward the joint of the catching arm and the supporting arm.
The valve closing device comprises a support arm, a catching arm, a hinge neck, a hinge hole, hinge shafts and two closing clamp arms.
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 are integrally formed with the connecting block, and the traction structure is a traction hole arranged on the capturing 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 catching arm (the traction wire drives the catching arm to move 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 anchor clip in the closed position 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, and meanwhile, the anchoring clamp in the closed state rotates close to the near end of the septum), so that the closed instrument is in a pre-capture state, the closed instrument is positioned on the ventricular side, combining with the imaging, adjusting corresponding handles of the conveying system to enable the closed instrument to be in an ideal capture position, adjusting corresponding keys of the conveying system to enable the anchoring clamp to be completely opened, so that the closed instrument is in a capture state, and at the moment, one edge of a valve leaflet is positioned between the two clamping arms of one anchoring clamp, the other edge of the leaflet is located between the two arms of the other anchoring 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, smaller volume and lighter weight.
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 illustration of a preformed anchor clip according to the present invention;
FIG. 10 is a schematic view of the anchoring clip of the present invention after it has been formed;
FIG. 11 is a schematic structural diagram of a first embodiment of a splice block according to the present invention;
FIG. 12 is a schematic view of the articulation of a first embodiment of a splice block of the present invention with an anchoring clip;
FIG. 13 is a schematic view of the construction of the top cap of the present invention;
FIG. 14 is a schematic view of a closure clip arm of the U-shaped closure clip of the present invention;
FIG. 15 is a schematic view of the U-shaped closure clip of the present invention in operation;
FIG. 16 is a schematic view of the initial state of the U-shaped closure clip of the present invention;
FIG. 17 is a schematic illustration of a coupling of the septum of the present invention connected to the tip of a multi-lumen tube of a delivery system;
FIG. 18 is a schematic view of the tip of a multi-lumen tube in the delivery system;
FIG. 19 is a schematic view of a multi-lumen tube tip coupled with a coupling element;
fig. 20 is a schematic view of a multi-lumen tip and coupling decoupling;
FIG. 21 is a schematic view of the anchor clip of the present invention with rotational freedom relative to a first embodiment of the engagement block;
FIG. 22 is a schematic structural view of a second embodiment of a splice block of the present invention;
FIG. 23 is a schematic view of the position of two pairs of anchor clips according to an embodiment of the engagement block of the present invention;
FIG. 24 is a cross-sectional view of FIG. 23;
FIG. 25 is a schematic view of another embodiment of a septum of the present invention;
FIG. 26 is a schematic view of a valve closure device of the present invention capturing leaflets (with the anchor clips in an open position);
FIG. 27 is a schematic view of a valve closure device of the present invention capturing leaflets (with the anchor clips in a closed position);
FIG. 28 is a schematic view of a valve closed by the valve closure device of the present invention;
FIG. 29 is a cross-sectional view taken along line A-A of FIG. 28;
FIG. 30 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. 2-30, the valve closure device of the present invention comprises a septum 2, wherein the septum 2 is provided with a septum passage 32 extending from a proximal end 3 to a distal end, the distal end of the septum 2 is hinged with two U-shaped anchoring clips 1 at intervals, the anchoring clips 1 can rotate away from or close to the proximal end 3 of the septum, the two clip arms of the anchoring clips 1 are respectively a support arm 4 and a catching arm 9, the catching arm 9 is located at the proximal end side of the support arm 4, the catching arm 9 is provided with a traction structure, the traction structure is a traction hole 10 arranged on the catching arm 9, and the connection between the support arm 4 and the catching arm 9 is hinged with the distal end of the septum 2. The U-shaped closed clamp is arranged on one side of the far end of the middle partition 2 and comprises a top cap 6 and two closed clamping arms, the far ends of the two closed clamping arms are fixedly connected with the top cap 6, the near ends of the two closed clamping arms are hinged to the two supporting arms 4 respectively, a coupling structure is arranged on the near end side of the top cap 6, and the coupling structure and the middle partition passage 32 are arranged oppositely.
As shown in fig. 1, the valve closure device of the present invention, in which the septum 2 is cylindrical, the lumen of the septum 2 is the septum channel 32, that is, the septum channel 32 is arranged along the axial direction of the septum 2.
As shown in fig. 25, in addition to the above structure, the septum 2 may also adopt the following structure: the septum 2 is cylindrical, the cavity of the septum 2 is the septum channel 32, and the wall of the septum 2 is a grid structure.
As shown in fig. 1 and fig. 11 and 12, the valve closing device of the present invention, wherein a distal end of the septum 2 is fixedly connected with a joint block 34, a joint block through hole 15 is formed on the joint block 34, the joint block through hole 15 is coaxially arranged with the septum channel 32, two anchoring clips 1 are respectively hinged on two opposite sides of the joint block 34, and the hinge shafts 11 of the anchoring clips 1 and the joint block 34 are perpendicular to the axial direction of the joint block through hole 15.
As shown in fig. 11 and 12, the valve closing device of the present invention has two oppositely disposed hinge lugs on two opposite sides of the joint block 34, and the hinge lugs are integrally formed with the joint block 34. The two hinged lugs on one side of the joining block 34 are a first pair of hinged lugs, the two hinged lugs on the other side of the joining block 34 are a second pair of hinged lugs, and the two anchoring clamps 1 are respectively hinged between the first pair of hinged lugs and between the second pair of hinged lugs through hinged shafts 11. The first pair of hinged lugs and the second pair of hinged lugs are respectively provided with a mounting hole 14, the mounting holes 14 are perpendicular to the axial direction of the connecting block through hole 15, and the hinged shaft 11 penetrates through the mounting holes 14 of the first pair of hinged lugs/the second pair of hinged lugs.
As shown in fig. 22, and in conjunction with fig. 23 and 24, the valve closure device of the present invention, wherein a stop structure is disposed between the first and second pairs of hinge lugs, the stop structure being located on the proximal side of the hinge axis 11. Limit structure is with linking piece 34 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 linking piece 34 integrated into one piece's spacing inclined plane 30, can effectively restrict the degree of freedom of anchor clamp 1 (i.e. anchor clamp 1 when the near-end 3 of spacing body 2 rotates towards, just blockked by spacing inclined plane 30 when rotating to a certain extent, 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. 21, when the engaging block 34 is not provided with the limiting structure, the anchoring clip 1 has a large degree of freedom of rotation relative to the engaging block 34.
As shown in figure 1, the valve closure device of the present invention, wherein the catching arm 9 of the U-shaped anchoring clip 1 is provided with a barb 8, said barb 8 is located between the catching arm 9 and the supporting arm 4, said barb 8 is obliquely arranged towards the junction of the catching arm 9 and the supporting arm 4. The end of the catching arm 9 of the anchoring clip 1 is provided with a pulling hole 10 for the passing of the pulling wire 7, and the barb 8 is provided at the position of the catching arm 9 near the end. The U-shaped anchoring clip 1 can be in an open or closed state by manipulating the pulling wire 7, and since a closing force exists between the supporting arm 4 and the catching arm 9 of the anchoring clip 1, in an initial state, as shown in fig. 6, the anchoring clip 1 is in a closed state, and then the pulling wire 7 is pulled in a proximal direction, so that the catching arm 9 can move away from the supporting arm 4, that is, the anchoring clip 1 is opened; when the anchoring clip 1 needs to be closed, the traction wire 7 is only required to be released, and at the moment, the catching arm 9 moves towards the supporting arm 4 under the action of the self-closing force of the anchoring clip 1 until the anchoring clip 1 is closed.
As shown in fig. 9, and as shown in fig. 1, 10 and 12, the valve closing device of the present invention, wherein one end of the supporting arm 4 connected to the catching arm 9 is provided with a hinge neck 13, the hinge neck 13 is integrally formed with the supporting arm 4, the other end of the supporting arm 4 is provided with a hinge hole 12, the hinge neck 13 is fixedly connected with a hinge shaft 11, and the proximal ends of the two closing arm arms are respectively hinged to the hinge holes 12 of the two supporting arms 4. The support arm 4 is connected to the catch arm 9 by a spring section which provides a closing force for the anchoring clip 1. The elastic section is provided with an opening, one end of the hinged neck 13 is arranged on the supporting arm 4, and the other end of the hinged neck passes through the opening of the elastic section and then is fixedly connected with the hinged shaft 11. The supporting arms 4 can be pivoted relative to the joint blocks 34 by means of the articulated shafts 11, i.e. the anchoring clip 1 can be pivoted relative to the joint blocks 34 by means of the articulated shafts 11, and the closing clip arms can be pivoted relative to the supporting arms 4 and about the axis of the articulated holes 12.
As shown in fig. 14, and as shown in fig. 1 and 2, the valve closing device of the present invention, wherein the closing clip arm is a U-shaped closing spring 5, the distal end of the closing spring 5 is an open end, the closing spring 5 is sequentially provided with a fixing portion 18, an elastic portion 22, an intermediate portion 21, a Y portion 20 and a hinge portion 19 along a direction from the distal end to the proximal end, the fixing portion 18 of the closing spring 5 is fixedly connected to the top cap 6, the hinge portion 19 of the closing spring 5 is disposed through the hinge hole 12 of the support arm 4 and can rotate relative to the hinge hole 12, and two spring arms of the closing spring 5 are respectively located on opposite sides of the hinged support arm 4. The top cap 6 is provided with a closing spring fixing hole 16, the fixing part 18 of the closing spring 5 is inserted into the closing spring fixing hole 16 to be fixed with the top cap 6, the elastic part 22 of the closing spring 5 provides main closing force to enable the valve blades 31 to be involuted edge to edge, the Y part 20 of the closing spring 5 better conforms to the tissue structure of the involuted valve blades 31, and in addition, the Y part 20 of the closing spring 5 provides an effective force arm for opening the closing spring 5.
As shown in fig. 13, the valve closing device of the present invention, wherein the coupling structure is a screw hole 17, the distal end of the driving rod 29 is provided with a thread 33 matching with the screw hole 17, i.e. the distal end of the driving rod 29 is threaded into the screw hole 17 of the top cap 6, so as to achieve coupling.
As shown in fig. 30, when the valve closure device of the present invention is used, it is required to cooperate with a delivery system, the delivery system comprises a multi-lumen tip 36, a pull wire 7 and a driving rod 29, the multi-lumen tip 36 is connected to the proximal end 3 of the septum 2 (i.e. the proximal end 3 of the septum 2 is fixedly connected with a coupling element 35 having a tubular structure, the coupling element 35 is connected to the multi-lumen tip 36 by a mortise and tenon structure, as shown in fig. 19), the pull wire 7 is connected to the pull hole 10 of the capturing arm 9, the driving rod 29 passes through the multi-lumen tip 36 in sequence from the proximal end to the distal end, coupling member 35 and septum 2 are then coupled to the coupling structure on overcap 6 (i.e., distal threads 33 of drive rod 29 are threaded into threaded bore 17), with drive rod 29 positioned within lumen 26 of multi-lumen tip 36, lumen 23 of coupling member 35, and septum channel 32 of septum 2. The following description of the use of the closure device is given for mitral valve closure as an example: the drive rod 29 is first moved proximally to distally until the U-shaped closure clip is in the closed position (with the anchor clip 1 in the closed position rotated to the distal side of the septum 2) and the closure device is in the loaded position. Then establishing a channel (not shown) through a catheter, placing the closure device in a loading state (as shown in fig. 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 29 proximally by adjusting corresponding buttons of the delivery system (due to the coupling between the driving rod 29 and the top cap 6, the top cap 6 also moves proximally along with the driving rod 29 when the driving rod 29 moves proximally, so that the two closure arms of the U-shaped closure clip gradually open, and the anchoring clip 1 in the closed state rotates close to the proximal end 3 of the septum), so as to place the closure device in a pre-capture state (as shown in fig. 6), and at the time, the closure device is located on the ventricular side, adjusting corresponding handles of the delivery system to place the closure device in a desired capture position in combination with imaging, and adjusting corresponding buttons of the delivery system, pulling the pull wire 7 in the proximal direction (movement of the catching arm 9 away from the supporting arm 4) brings the anchoring clamps 1 fully open and the closure device into the catching position (as shown in fig. 7 and 26), in which one edge of the leaflet 31 is located between the two arms of one anchoring clamp 1 and the other edge of the leaflet 31 is located between the two arms of the other anchoring clamp 1. Then the corresponding key of the delivery system is adjusted, the traction wire 7 is released, the anchoring clip 1 is closed, the valve leaflet 31 is clamped by the anchoring clip 1 (as shown in fig. 27), the corresponding key of the delivery system is operated, the driving rod 29 is slowly moved towards the near end again, in the process, the top cap 6 pushes the anchoring clip 1 to gradually rotate towards the near end 3 of the septum 2 through the closing clip arms, simultaneously, under the closing force of the U-shaped closing clip, the two closing clip arms of the U-shaped closing clip are closed again, and at the moment, the two opposite edges of the valve leaflet 31 are clamped by the two closing clip arms of the U-shaped closing clip to realize closing (as shown in fig. 28 and 29). Then, the driving rod 29 is rotated to be decoupled with the top cap 6 by rotating a corresponding key of the delivery system, the driving rod 29 is pulled out, the multi-lumen tube head end 36 is rotated to disconnect the multi-lumen tube head end 36 from the septum 2 (namely, the multi-lumen tube head end 36 is decoupled from the coupling piece 35 on the septum 2, as shown in fig. 20, after the decoupling, the coupling piece 35 is continuously and fixedly connected to the septum 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, smaller volume and lighter weight.
It can be seen that the anchoring clip 1 of the present invention is used for capturing the valve leaflet 31, and after the anchoring clip 1 captures the valve leaflet 31, the two closing clip arms of the U-shaped closing clip can close the valve leaflet 31 edge to edge in the subsequent process.
As shown in fig. 1, when the driving rod 29 moves proximally, the driving rod 29 is coupled with the screw hole 17 of the top cap 6 by the thread 33 of the driving rod 29, so as to drive the top cap 6 to move proximally, and the hinge shaft 11 and the hinge part 19 of the closing spring 5 perform corresponding hinge movements, so that the closing appliance tends to close.
As shown in fig. 2, and in conjunction with fig. 5-8 and 17-20, the multi-lumen tip 36 of the delivery system is connected to the proximal end 3 of the septum 2 by a coupling element 35, i.e., the proximal end 3 of the septum 2 is fixedly connected to the distal end of the coupling element 35, and the multi-lumen tip 36 is coupled to the proximal end of the coupling element 35. The coupling element 35 is a tubular structure such that after the coupling element 35 is coupled to the multi-lumen tip 36, the drive rod 29 passes coaxially through the multi-lumen tip 36 and the coupling element 35 and into the septum channel 32 of the septum 2. It should be noted that, the coupling piece 35 is coupled with the multi-lumen tube head 36 through a mortise and tenon structure, the coupling piece tenon 24 is coupled with the multi-lumen tube head mortise 28, the coupling piece mortise 25 is coupled with the multi-lumen tube head end tenon 27, the driving rod 29 coaxially penetrates through the multi-lumen tube head 36 and the coupling piece 35, the driving rod 29 is withdrawn and the multi-lumen tube head 36 is rotated, so that the decoupling of the multi-lumen tube head and the coupling piece 35 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 the anchoring 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 the leaflets 31 clamped therebetween, the anchoring clip 1 can be shaped by heat treatment to achieve the above-mentioned function.
To improve tissue compliance, better fit against the leaflets 31, the septum 2 should be suitably resilient, especially radially enough to be resilient, while in the axial direction the septum 2 needs to provide enough rigidity to support the opening and closing device.
To achieve the above-described function of the septum 2, the septum 2 may be fabricated as a thin-walled structure, as shown in FIG. 1, or as a mesh structure, as shown in FIG. 25.
As shown in fig. 1, the structure of the present invention is an axisymmetric structure in which the septum 2, the engagement block through hole 15 and the screw hole 17 of the top cap 6 are coaxially arranged, and the anchor clip 1 and the closing 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. 16 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 the tissue structure of the valve leaflet 31 with the thickness close to 0, and the function can be obtained by a heat treatment pre-forming or mechanical dislocation installation method.
Fig. 15 is a schematic view of the closing springs 5 in operation, i.e. after clamping of the leaflets 31 (leaflets 31 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. 16).
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: the middle spacer comprises a middle spacer body, wherein a middle spacer body channel extending from a near end to a far end is arranged on the middle spacer body, two U-shaped anchoring clamps are hinged to the far end of the middle spacer body at intervals, the anchoring clamps can rotate far away from or close to the near end of the middle spacer body, two clamping arms of each anchoring clamp are a supporting arm and a capturing arm respectively, the capturing arms are located on the near end sides of the supporting arms, a traction structure is arranged on each capturing arm, the connecting parts of the supporting arms and the capturing arms are hinged to the far end of the middle spacer body, a U-shaped closing clamp is arranged on one side of the far end of the middle spacer body, each 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 caps, the near ends of the two closing clamping arms are hinged to the two supporting arms respectively, a coupling structure is arranged on the near end side of the top caps, and the coupling structure is arranged opposite to the middle spacer body channel.
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, a connecting block through hole is formed in the connecting block, the connecting block through hole and the middle separation part channel are arranged coaxially, the two anchoring clamps are hinged to two opposite sides of the connecting block respectively, and a hinged shaft of each of the anchoring clamps 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 anchoring clamp 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 anchoring clip is provided with a barb on the capturing arm, the barb is positioned between the capturing arm and the supporting arm, and the barb is obliquely arranged towards the joint of the capturing arm and the supporting arm.
8. The valve closure device of claim 7, wherein: the support arm with catch the arm and be connected one end and be equipped with articulated neck, the other end of support arm is equipped with the hinge hole, fixedly connected with articulated shaft on the articulated neck, two the near-end of closed arm lock articulates respectively on the hinge hole of two support arms.
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 are integrally formed with the connecting block, and the traction structure is a traction hole arranged on the capturing arm.
CN202110573799.3A 2021-05-25 2021-05-25 Valve closing apparatus Pending CN113288517A (en)

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