WO2022052506A1 - Mitral valve clamping device, clamp body of mitral valve clamping device, and mitral valve repair device - Google Patents
Mitral valve clamping device, clamp body of mitral valve clamping device, and mitral valve repair device Download PDFInfo
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- WO2022052506A1 WO2022052506A1 PCT/CN2021/094985 CN2021094985W WO2022052506A1 WO 2022052506 A1 WO2022052506 A1 WO 2022052506A1 CN 2021094985 W CN2021094985 W CN 2021094985W WO 2022052506 A1 WO2022052506 A1 WO 2022052506A1
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- clamp arm
- mitral valve
- inner clamp
- clip
- clamping device
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart 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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2466—Delivery devices therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
Definitions
- the present disclosure relates to the field of medical equipment, and more particularly to a clamp body of a mitral valve clamping device, a mitral valve clamping device, and a mitral valve repair device.
- Valves have membrane-like structures that can be opened and closed in organs of humans or some animals. For example, there are four valves in the human's heart, including an aortic valve, a pulmonary valve, a mitral valve, and a tricuspid valve. Taking the human's mitral valve as an example, the mitral valve is located between the left atrium and the left ventricle. When the left ventricle contracts, the mitral valve, acting as a check valve, tightly closes an atrioventricular opening to prevent blood from flowing back from the left ventricle to the left atrium.
- the mitral valve may be difficult for the mitral valve to close the left ventricle when it contracts, causing the left atrium to receive a large amount of reflux blood. This may lead to a sharp rise in pressures of the left atrium and the pulmonary vein, an increase in the load of the left ventricular diastolic volume, and further lead to a series of pathological changes such as left ventricular enlargement and pulmonary hypertension. Eventually, it may result in clinical manifestations such as heart failure, arrhythmia, etc., which may be life-threatening in severe cases.
- a mitral valve repair device can be used to repair the diseased mitral valve, for example, clamp opposite sides of the mitral valve, so that one large hole formed by the valves changes to two small holes, and thus a regurgitation area is reduced, thereby effectively preventing mitral regurgitation.
- a clamp body is one of the main components of the mitral valve clamping device for clamping the mitral valve.
- the mitral valve clamping device can also be applied to the repair of the heart's tricuspid valve and other valves, achieving the same effect of reducing the regurgitation area by clamping both valve leaflets.
- the clamp body may include a supporting part, a first inner clamp arm, a first outer clamp arm, a second inner clamp arm and a second outer clamp arm.
- a first side of the supporting part may be connected to the first inner clamp arm and the first outer clamp arm in sequence via a bendable connection, and a second side of the supporting part may be connected to the second inner clamp arm and the second outer clamp arm in sequence via a bendable connection.
- a length of the first inner clamp arm may be larger than a length of the second inner clamp arm.
- a length of the first outer clamp arm may be larger than a length of the second outer clamp arm.
- One of the embodiments of the present disclosure provides a mitral valve clamping device including the clamp body described in any of the technical solutions.
- the control handle may be configured to deliver the mitral valve clamping device to the mitral valve via a left atrial appendage and a left atrium, and control an opening or closing of the first inner clamp arm and the first clip of the mitral valve clamping device, and control an opening or closing of the second inner clamp arm and the second clip.
- FIG. 1 is a structural schematic diagram illustrating a clamp body of a mitral valve clamping device from a perspective view according to some embodiments of the present disclosure
- FIG. 2 is a schematic diagram illustrating a front view of a clamp body of a mitral valve clamping device according to some embodiments of the present disclosure
- FIG. 3 is a structural schematic diagram illustrating a clamp body of a mitral valve clamping device without bending according to some embodiments of the present disclosure
- FIG. 4 is a schematic diagram illustrating a side view of a clamp body of a mitral valve clamping device shown in FIG. 3;
- FIG. 5 is a schematic diagram illustrating an S rod bendable structure of a clamp body of a mitral valve clamping device according to some embodiments of the present disclosure
- FIG. 6 is a schematic diagram illustrating a thin waist bendable structure of a clamp body of a mitral valve clamping device according to some embodiments of the present disclosure
- FIG. 7 is a schematic diagram illustrating a connection of a clamp body, a first connection member, and a second connection member of a mitral valve clamping device according to some embodiments of the present disclosure
- FIG. 8 is a schematic diagram illustrating a connection of a clamp body and a clamp clip of a mitral valve clamping device according to some embodiments of the present disclosure
- FIG. 9 is a structural schematic diagram illustrating an integrally formed structure of a barded clip and a clamp body of a mitral valve clamping device according to some embodiments of the present disclosure.
- FIG. 10 is a structural schematic diagram illustrating an elastic bracket of a mitral valve clamping device from a perspective view according to some embodiments of the present disclosure
- FIG. 11 is a schematic diagram illustrating a connection of a clamp body, a first connection member, a second connection member, and an elastic bracket of a mitral valve clamping device according to some embodiments of the present disclosure
- FIG. 12 is a structural schematic diagram illustrating a mitral valve repair device according to some embodiments of the present disclosure.
- FIG. 13 is a partial sectional diagram illustrating an inner clamp arm control mechanism according to some embodiments of the present disclosure
- FIG. 14 is a structural schematic diagram illustrating a sleeve according to some embodiments of the present disclosure.
- FIG. 15 is a structural schematic diagram illustrating a sliding part and a protective cover according to some embodiments of the present disclosure
- FIG. 16 is a structural schematic diagram illustrating an inner clamp arm control mechanism according to another embodiment of the present disclosure.
- FIG. 17 is a schematic diagram illustrating an internal structure of the inner clamp arm control mechanism according to another embodiment of the present disclosure.
- FIG. 18 is a structural schematic diagram illustrating a thread engagement mechanism according to another embodiment of the present disclosure.
- FIG. 19 is a partial sectional diagram illustrating a clip control mechanism according to some embodiments of the present disclosure.
- FIG. 20 is a schematic diagram illustrating a housing according to some embodiments of the present disclosure.
- FIG. 21 is a structural schematic diagram illustrating a second control part according to some embodiments of the present disclosure.
- FIG. 22 is a structural schematic diagram illustrating the second control part and a locking mechanism at a first perspective according to some embodiments of the present disclosure
- FIG. 23 is a structural schematic diagram illustrating the second control part and the locking mechanism at a second perspective according to some embodiments of the present disclosure
- FIG. 24 is a structural schematic diagram illustrating a flexible pipe from a front view according to some embodiments of the present disclosure.
- FIG. 25 is a structural schematic diagram illustrating different parts of the flexible pipe according to some embodiments of the present disclosure.
- FIG. 26 is a structural schematic diagram illustrating different parts of a flexible pipe control mechanism according to some embodiments of the present disclosure.
- Embodiments of the present disclosure relate to a clamp body of a mitral valve clamping device, a mitral valve clamping device, and a mitral valve repair device.
- a first inner clamp arm and a second inner clamp arm of the clamp body of the mitral valve clamping device may be opened or closed relative to each other.
- the clamp of the mitral valve clamping device may be configured to clamp a mitral valve or other valves (such as a tricuspid valve) with a clamp clip.
- a length of the first inner clamp arm of the clamp body may be larger than a length of the second inner clamp arm of the clamp body, and a length of the first outer clamp arm of the clamp body may be larger than a length of the second outer clamp arm of the clamp body.
- the relatively long first inner clamp arm and the relatively long first outer clamp arm may be configured to clamp an anterior leaflet of the mitral valve
- the relatively short second inner clamp arm and the relatively short second outer clamp arm may be configured to clamp a posterior leaflet of the mitral valve, which may facilitate the dynamic balance of the mitral valve after being clamped, and ensure the stable operation of the repaired mitral valve, thereby improving the effect of mitral valve repair.
- the mitral valve repair device may include a control handle and a mitral valve clamping device, and the control handle may be configured to deliver and control the mitral valve clamping device.
- the mitral valve clamping device may reach a predetermined position through a plurality of routes.
- the mitral valve clamping device may be delivered to the mitral valve via a femoral vein, an inferior vena cava, a right atrium, and a left atrium to repair the mitral valve.
- the mitral valve clamping device may be delivered to the mitral valve via a left atrial appendage and a left atrium to repair the mitral valve.
- FIG. 1 is a structural schematic diagram illustrating a clamp body of a mitral valve clamping device from a perspective view according to some embodiments of the present disclosure.
- FIG. 2 is a schematic diagram illustrating a front view of a clamp body of a mitral valve clamping device according to some embodiments of the present disclosure.
- FIG. 3 is a structural schematic diagram illustrating a clamp body of a mitral valve clamping device without bending according to some embodiments of the present disclosure.
- FIG. 4 is a schematic diagram illustrating a side view of a clamp body of a mitral valve clamping device shown in FIG. 3.
- a clamp body of a mitral valve clamping device disclosed in the present disclosure will be described in detail with reference to FIGs. 1-4. It should be noted that the following examples are merely intended to explain the present disclosure, and not intended to limit the scope of the present disclosure.
- a clamp body 100 of a mitral valve clamping device may include a supporting part 110, a first inner clamp arm 120, a first outer clamp arm 140, a second inner clamp arm 130, and a second outer clamp arm 150.
- a first side of the supporting part 110 may be connected to the first inner clamp arm 120 and the first outer clamp arm 140 in sequence via a bendable connection, and a second side of the supporting part 110 may be connected to the second inner clamp arm 130 and the second outer clamp arm 150 in sequence via a bendable connection.
- a length of the first inner clamp arm 120 may be larger than a length of the second inner clamp arm 130.
- a length of the first outer clamp arm 140 may be larger than a length of the second outer clamp arm 150.
- the supporting part 110 may be connected to the first inner clamp arm 120 via a bendable connection, and the supporting part 110 may be connected to the second inner clamp arm 130 via a bendable connection.
- the bendable connection used to connect the supporting part 110 and the first inner clamp arm 120 may refer to that a first connection part connecting the first inner clamp arm 120 and the supporting part 110 may be bendable.
- the bendable connection used to connect the supporting part 110 and the second inner clamp arm 130 may refer to that a second connection part connecting the second inner clamp arm 130 and the supporting part 110 may be bendable.
- the first inner clamp arm 120 may be bent in a direction from the first inner clamp arm 120 to the supporting part 110, and the second inner clamp arm 130 may be bent in a direction from the second inner clamp arm 130 to the supporting part 110, such that the first inner clamp arm 120 and the second inner clamp arm 130 may be closed relative to each other.
- the first inner clamp arm 120 may be bent in a direction from the supporting part 110 to the first inner clamp arm 120, and the second inner clamp arm 130 may be bent in a direction from the supporting part 110 to the second inner clamp arm 130, such that the first inner clamp arm 120 and the second inner clamp arm 130 may be opened relative to each other.
- the first inner clamp arm 120 may be connected to the first outer clamp arm 140 via a bendable connection
- the second inner clamp arm 130 may be connected to the second outer clamp arm 150 via a bendable connection
- the bendable connection used to connect the first inner clamp arm 120 and the first outer clamp arm 140 or the bendable connection used to connect the second inner clamp arm 130 and the second outer clamp arm 150 may refer to that a third connection part connecting the first inner clamp arm 120 and the first outer clamp arm 140 and/or a fourth connection part connecting the second inner clamp arm 130 and the second outer clamp arm 150 may be bendable, and an angle between the first inner clamp arm 120 and the first outer clamp arm 140 may be changed and/or an angle between the second inner clamp arm 130 and the second outer clamp arm 150 may be changed.
- a count of inner clamp arm (s) and outer clamp arm (s) may be increased as needed.
- the inner clamp arms may also include a third inner clamp arm and a fourth inner clamp arm.
- the outer clamp arms may also include a third outer clamp arm, and a fourth outer clamp arm.
- the supporting part 110, the third inner clamp arm, and the third outer clamp arm may be connected in sequence via a bendable connection.
- the supporting part 110, the fourth inner clamp arm, and the fourth outer clamp arm may be connected in sequence via a bendable connection.
- the lengths of the first inner clamp arm 120, the second inner clamp arm 130, the first outer clamp arm 140, and the second outer clamp arm 150 may be illustrated in combination with the clamp body 100 when the clamp body 100 is not bent.
- the length of the first inner clamp arm 120 may refer to a distance between a first end of the first inner clamp arm 120 close to the supporting part 110 and a second end of the first inner clamp arm 120 away from the supporting part 110.
- the length of the second inner clamp arm 130 may refer to a distance between a first end of the second inner clamp arm 130 close to the supporting part 110 and a second end of the second inner clamp arm 130 away from the supporting part 110.
- the length of the first inner clamp arm 120 may be 1.1 to 2.5 times the length of the second inner clamp arm 130. In some embodiments, the length of the first inner clamp arm 120 may be 1.2 to 2.2 times the length of the second inner clamp arm 130. In some embodiments, the length of the first inner clamp arm 120 may be 1.5 to 1.8 times the length of the second inner clamp arm 130. Specifically, the length of the first inner clamp arm 120 may be 1.2 times (or 1.5 times, 2 times, 2.2 times, etc. ) the length of the second inner clamp arm 130.
- the length of the first outer clamp arm 140 may refer to a distance between a first end of the first outer clamp arm 140 close to the first inner clamp arm 120 and a second end of the first outer clamp arm 140 away from the first inner clamp arm 120.
- the length of the second outer clamp arm 150 may refer to a distance between a first end of the second outer clamp arm 150 close to the second inner clamp arm 130 and a second end of the second outer clamp arm 150 away from the second inner clamp arm 130.
- the length of the first outer clamp arm 140 may be 1.1 to 2.5 times the length of the second outer clamp arm 150.
- the length of the first outer clamp arm 140 may be 1.2 to 2.2 times the length of the second outer clamp arm 150.
- the length of the first outer clamp arm 140 may be 1.5 to 1.8 times the length of the second outer clamp arm 150. Specifically, the length of the first outer clamp arm 140 may be 1.2 times (or 1.5 times, 2 times, 2.2 times, etc. ) the length of the second outer clamp arm 150. Further, those skilled in the art may specifically design the lengths of the first inner clamp arm 120, the second inner clamp arm 130, the first outer clamp arm 140, and/or the second outer clamp arm 150 according to structural characteristics and size characteristics of the valve to be clamped.
- a shape of a cross-sectional of the supporting part 110 may include a circle, or an elliptical, and a cross-sectional area of the middle portion of the supporting part 110 may be larger than a cross-sectional area of the two ends thereof.
- the beneficial effects include but are not limited to: the supporting part 110 may not cause damage to the tissues, and may effectively form a support for the tissue clamped by the tissue clamping device.
- the shape of the supporting part 110 may include a pear-like shape, a cylinder, or the like.
- the supporting part 110 of the clamp body 100 has different shapes according to a specific condition of the tissues (such as a shape of a mating edge of the mitral valve) to be clamped, so that the shape of the supporting part 110 may fit the shape of the tissues (such as a shape of a mating edge of the mitral valve) better to improve a clamping performance of the clamping device.
- the supporting part 110 may include a grid structure.
- the grid structure may include a rhombus grid structure, a circular grid structure, a rectangular grid structure, a square grid structure, a triangular grid structure, a regular polygon grid structure, or the like, or any combination thereof.
- the supporting part 110 of the grid structure may effectively fill a space between the first inner clamp arm 120 and the second inner clamp arm 130, which may prevent a formation of thrombus after the mitral valve clamping device clamps a valve (e.g., a mitral valve, a tricuspid valve) .
- a valve e.g., a mitral valve, a tricuspid valve
- the clamp body 100 may be in an integrally formed structure. Specifically, in a manufacturing process of the clamp body 100, the clamp body 100 may be produced by cutting a metal tube, for example, using a laser. In some alternative embodiments, the clamp body 100 may be produced by weaving a metal wire. In some embodiments, the clamp body 100 may be in an integrally formed structure, for example, the clamp body 100 may be produced by cutting and performing a heating operation on a shape-memory alloy tube.
- the shape-memory alloy tube may include a nickel-titanium alloy tube or a cobalt-chromium alloy tube, or the like.
- the length of the first inner clamp arm 120 may be larger than, equal to, or smaller than the length of the first outer clamp arm 140, and the length of the second inner clamp arm 130 may be larger than, equal to, or smaller than the length of the second outer clamp arm 150.
- a ratio of the length of the first inner clamp arm 120 to the length of the first outer clamp arm 140 may be equal to a ratio of the length of the second inner clamp arm 130 to the length of the second outer clamp arm 150.
- the ratio of the length of the first inner clamp arm 120 to the length of the first outer clamp arm 140 is 0.9
- a ratio of the length of the second inner clamp arm 130 to the length of the second outer clamp arm 150 may be 0.9. According to such configuration mentioned above, the structure of the clamp body 100 may be more reasonable, and the stress of the valve may be more uniform after the valve (such as a mitral valve, a tricuspid valve) is clamped.
- the first side of the supporting part 110 may be connected to the first inner clamp arm 120 via a first bendable structure 160.
- the second side of the supporting part 110 may be connected to the second inner clamp arm 130 via the first bendable structure 160.
- the first bendable structure 160 may include an S rod bendable structure 1110 or a thin waist bendable structure 1120.
- the first inner clamp arm 120 may be connected to the first outer clamp arm 140 via a second bendable structure 170.
- the second inner clamp arm 130 may be connected to the second outer clamp arm 150 via the second bendable structure 170.
- the second bendable structure 170 may include an S rod bendable structure 1110 or a thin waist bendable structure 1120. Due to structural characteristics and/or material characteristics, the first bendable structure 160 and the second bendable structure 170 may be bent.
- a structure of the first bendable structure 160 may be the same as or different from that of the second bendable structure 170.
- the second bendable structure 170 may include the S rod bendable structure 1110, or the thin waist bendable structure 1120.
- the S rod bendable structure 1110 and the thin waist bendable structure 1120 may be processed by a heating operation.
- the S rod bendable structure 1110 and the thin waist bendable structure 1120 may be deformed during/after the heating operation.
- a bending part of the S rod bendable structure 1110 and the thin waist bendable structure 1120 may share a stress uniformly, which may improve a bending performance of the S rod bendable structure 1110 and the thin waist bendable structure 1120, thereby extending a service life of the clamp body 100.
- FIG. 5 is a schematic diagram illustrating an S rod bendable structure of a clamp body of a mitral valve clamping device according to some embodiments of the present disclosure.
- the S rod bendable structure 1110 refers to a bendable road structure which presents a shape of "S" .
- the S rod bendable structure 1110 may at least include three straight rods 1111 and two curved rods 1112. The three straight rods 1111 may be parallel to each other, and the three straight rods 1111 may be arranged in sequence.
- FIG. 6 is a schematic diagram illustrating a thin waist bendable structure of a clamp body of a mitral valve clamping device according to some embodiments of the present disclosure. As shown in FIG.
- the thin waist bendable structure 1120 refers to a bendable rod-like structure with a middle portion and at least two ends, and a width of the middle portion is smaller than a width of each of at least two ends of the thin waist bendable structure 1120. That is, the thin waist bendable structure 1120 may present a shape of thin waist, thereby improving the bending performance of the thin waist bendable structure 1120.
- the beneficial effects of the clamp body of the mitral valve clamping device disclosed in the embodiment of the present disclosure may include but are not limited to: (1) the design that the length of the first inner clamp arm is larger than the length of the second inner clamp and the length of the first outer clamp arm is larger than the second outer clamp arm, can facilitate the dynamic balance of a valve (e.g., a tricuspid valve, a tricuspid valve) after the valve is clamped, and ensure the stable operation of the repaired valve, thereby improving the effect of valve repair; (2) an integrally formed structure of the clamp body can improve the stability, the reliability of the clamp body and reduce the difficulty in manufacturing the clamp body; (3) one or more bendable structures may be disposed between components of the clamp body (e.g., a bendable structure disposed between the inner clamp arm and a supporting part, a bendable structure disposed between the inner clamp arm and an outer clamp arm) , which can improve the bending performance of the inner clamp arm of the clamp body and improve clamping efficiency of the clamp body; and (4) the bendable structure
- FIG. 7 is a schematic diagram illustrating a connection of a clamp body, a first connection member, and a second connection member of a mitral valve clamping device according to some embodiments of the present disclosure.
- FIG. 8 is a schematic diagram illustrating a connection of a clamp body and a clamp clip of a mitral valve clamping device according to some embodiments of the present disclosure.
- the mitral valve clamping device may further include a first connection member 800, a second connection member 900, and a clamp clip 200.
- the clamp body 100 may be connected to the first connection member 800 and the second connection member 900, and between the first connection member 800 and the second connection member 900.
- a relative movement of the first connection member 800 and the second connection member 900 may drive the first inner clamp arm 120 and the second inner clamp arm 130 to be opened or closed relative to each other.
- the clamp clip 200 may include a first clip 210 disposed on the first inner clamp arm 120 and a second clip 220 disposed on the second inner clamp arm 130.
- the first clip 210 and the second clip 220 may be able to be opened or closed relative to the first inner clamp arm 120 and the second inner clamp arm 130, respectively, such that a mitral valve may be clamped between the first clip 210 and the first inner clamp arm 120, and between the second clip 220 and the second inner clamp arm 130.
- an opening angle between the first inner clamp arm 120 and the second inner clamp arm 130 may be various, such as 40°, 90°, 120°, 180°, 270°, 350°, 360°, etc.
- a first end of the supporting part 110 e.g., an upper end as shown in FIG. 7 may be connected to the first connection member 800, for example, via a fixed connection mode.
- a first end of the first outer clamp arm 140 e.g., a lower end shown in FIG. 7 and a first end of the second outer clamp arm 150 (e.g., a lower end as shown in FIG. 7) may be respectively connected to the second connection member 900, for example, via a fixed connection mode.
- the second connection member 900 may move relative to the supporting part 110 when the second connection member 900 moves relative to the first connection member 800.
- a movement of the first outer clamp arm 140 and the second outer clamp arm 150 may be configured to drive the first inner clamp arm 120 and the second inner clamp arm 130 to be opened relative to each other, respectively.
- a first end of the first outer clamp arm 140 and a first end of the second outer clamp arm 150 may be connected to the second connection member 900 via a bendable connection, which may cause the first inner clamp arm 120 and the second inner clamp arm 130 to be opened relatively to form a relatively large angle.
- first inner clamp arm 120 and the second inner clamp arm 130 may be opened or closed relative to each other.
- Descriptions regarding how to further control the first clip 210 and the second clip 220 to be opened or closed relative to the first inner clamp arm 120 and the second inner clamp arm 130 may be found in descriptions of the control mechanism of the clamp clip 200 below.
- first inner clamp arm 120 and the first clip 210 may be configured to clamp an anterior leaflet of the mitral valve
- second inner clamp arm 130 and the second clip 220 may be configured to clamp a posterior leaflet of the mitral valve.
- the anterior leaflet of the mitral valve is located on the relatively anterior side, has a relatively large area, and is referred to as a large valve, and is a demarcation mark between the inflow and outflow tracts of the left ventricle.
- the posterior leaflet of the mitral valve is located on the relatively posterior side, has a relatively small area, and is referred to as a small valve.
- the anterior leaflet may be clamped using the first clip 210 and the relatively long first inner clamp arm 120, and the posterior leaflet may be clamped using the second clip 220 and the relatively short second inner clamp arm 130, which may facilitate the dynamic balance of the mitral valve after being clamped.
- a leaflet of the tricuspid valve with a relatively large area may be clamped using the first inner clamp arm 120 and the first clip 210, and a leaflet of the tricuspid valve with a relatively small area (or a relatively short length) may be clamped using the second inner clamp arm 130 and the second clip 220, which may facilitate the dynamic balance of the tricuspid valve after being clamped.
- the length of the first clip 210 may be larger than the length of the second clip 220.
- the length of the first clip 210 may refer to a distance between a first end of the first clip 210 close to the first inner clamp arm 120 and a second end of the first clip 210 away from the first inner clamp arm 120 when the first clip 210 is opened.
- the length of the second clip 220 may refer to a distance between a first end of the second clip 220 close to the second inner clamp arm 130 and a second end of the second clip 220 away from the second inner clamp arm 130 when the second clip 220 is opened.
- the first clip 210 and the first inner clamp arm 120 may be more conveniently matched to clamp a leaflet with a relatively large area (such as an anterior leaflet of a mitral valve)
- the second clip 220 and the second inner clamp arm 130 may be more conveniently matched to clamp a leaflet with a relatively small area (such as a posterior leaflet of a mitral valve) , which may further facilitate the dynamic balance of the valve after being clamped.
- a ratio of the length of the first clip 210 to the length of the first inner clamp arm 120 may be equal to a ratio of the length of the second clip 220 to the length of the second inner clamp arm 130.
- the ratio of the length of the first clip 210 to the length of the first inner clamp arm 120 is 0.6
- the ratio of the length of the second clip 220 to the length of the second inner clamp arm 130 may be 0.6. According to such configuration mentioned above, the structure of the mitral valve clamping device may be more reasonable, and the force of the clamped valve leaflet may be more uniform.
- the clamp clip 200 may include a barbed clip.
- the barbed clip may include a fixing part 230, a clipping part 240, and a barb 250.
- a first end of the clipping part 240 may be connected to a first end of the fixing part 230 via a bending part.
- the barb 250 may be disposed on a second end of the clipping part 240.
- the barb 250 may be disposed on one side of the clipping part 240 of the clamp clip 200 (e.g., the first clip 210 or the second clip 220) , which may face an inner clamp arm (e.g., the first inner clamp arm 120 or the second inner clamp arm 130) .
- the fixing part 230 may be configured to fix the clamp clip 200 (e.g., the first clip 210 or the second clip 220) on the inner clamp arm (e.g., the first inner clamp arm 120 or the second inner clamp arm 130) .
- the clipping part 240 may be configured to clamp the tissues together with the inner clamp arm (e.g., the first inner clamp arm 120 or the second inner clamp arm 130) .
- a first end of the fixing part 230 may be connected to a first end of the clipping part 240 via a bending part, so that the clamp clip 200 (e.g., the first clip 210 or the second clip 220) may be opened or closed relative to an inner clamp arm (e.g., the first inner clamp arm 120 or the second inner clamp arm 130) .
- the bending part may have an S rod bendable structure 1110 or a thin waist bendable structure 1120.
- the two bendable structures of the clamp clip 200 may be similar to the two bendable structures of the clamp body 100. More descriptions may be found in the relevant descriptions of FIG . 5 and FIG. 6.
- the barb 250 may effectively prevent the valve sliding from a space between the clamp clip 200 to the inner clamp arm, thereby effectively improving the clamping stability of the mitral valve clamping device.
- the clamp clip 200 may also be other types of the clamp clip 200.
- a side of the clamp clip 200 facing an inner clamp arm (e.g., the first inner clamp arm 120 or the second inner clamp arm 130) may include barbs and/or protrusions, or the like.
- FIG. 9 is a structural schematic diagram illustrating an integrally formed structure of a barded clip and a clamp body of a mitral valve clamping device according to some embodiments of the present disclosure.
- the first clip 210 may be integrally formed by cutting
- the second clip 220 may be integrally formed by cutting.
- the fixing part 230, the clipping part 240, and the barb 250 of the barbed clip may be integrally formed with the clamp body 100.
- an inner clamp arm e.g., the first inner clamp arm 120 and the second inner clamp arm 130
- an inner clamp arm e.g., the first inner clamp arm 120 and the second inner clamp arm 130
- the clamp body 100 may be cut to form shapes of the clipping part 240 and the barb 250 of the barbed clip, and a first end of the cut clipping part 240 may be connected to the inner clamp arm (in this case, an end of the fixing part 230 of the barbed clip may be connected to the inner clamp arm) .
- the barb 250 may be bent through a heating operation.
- the fixing part 230 and the clipping part 240 of the barbed clip may be integrally formed with the clamp body 100.
- the integral formation of the clamp clip 200 and the inner clamp arm may improve the reliability of a connection between the clamp clip 200 and the inner clamp arm, improve clamping stability of the mitral valve clamping device, simplify an assembly of the mitral valve clamping device, and improve the production efficiency of the mitral valve clamping device.
- the mitral valve clamping device may include an elastic bracket 1000.
- FIG. 10 is a structural schematic diagram illustrating an elastic bracket of a mitral valve clamping device from a perspective view according to some embodiments of the present disclosure.
- FIG. 11 is a schematic diagram illustrating a connection of a clamp body, a first connection member, a second connection member, and an elastic bracket of a mitral valve clamping device according to some embodiments of the present disclosure.
- the elastic bracket 1000 may include a first supporting rod 1010, a second supporting rod 1020, a first mounting part 1030, and a second mounting part 1040. A first end of the first supporting rod 1010 and a first end of the second supporting rod 1020 may be connected to the first mounting part 1030.
- a second end of the first supporting rod 1010 and the second supporting rod 1020 may be connected to the second mounting part 1040.
- the elastic bracket 1000 may be in an integrally formed structure. That is, the first supporting rod 1010, the second supporting rod 1020, the first mounting part 1030, and the second mounting part 1040 may be in an integrally formed structure, thereby improving the stability, the reliability of connections between components of the elastic bracket 1000 and reducing the difficulty in manufacturing.
- the first mounting part 1030 and the second mounting part 1040 of the elastic bracket 1000 may be fixedly connected to the second connection member 900. That is, both ends of the first supporting rod 1010 and the second supporting rod 1020 may be fixed to the second connection member 900.
- the first supporting rod 1010 of the elastic bracket 1000 may bear against a connection of the first inner clamp arm 120 and the first outer clamp arm 140.
- the second supporting rod 1020 of the elastic bracket 1000 may bear against a connection of the second inner clamp arm 130 and the second outer clamp arm 150.
- FIG. 11 the first mounting part 1030 and the second mounting part 1040 of the elastic bracket 1000 may be fixedly connected to the second connection member 900. That is, both ends of the first supporting rod 1010 and the second supporting rod 1020 may be fixed to the second connection member 900.
- the first supporting rod 1010 of the elastic bracket 1000 may bear against a connection of the first inner clamp arm 120 and the first outer clamp arm 140.
- the second supporting rod 1020 of the elastic bracket 1000 may bear against a connection of the second inner clamp arm
- the first supporting rod 1010 may internally bear against between the first inner clamp arm 120 and the first outer clamp arm 140
- the second supporting rod 1020 may internally bear against between the second interior clamp arm 130 and the second outer clamp arm 150.
- the first supporting rod 1010 or the second supporting rod 1020 may be fixedly connected to a connection of the inner clamp arm and the outer clamp arm, for example, via a bonding connection, a laser welding connection, a winding wire connection, or the like, or any combination thereof.
- a length of the first supporting rod 1010 may be larger than a length of the second supporting rod 1020, so that the first supporting rod 1010 may suitably bear against between the first inner clamp arm 120 and the first outer clamp arm 140, and the second supporting rod 1020 may suitably bear against between the second inner clamp arm 130 and the second outer clamp arm 150.
- the first supporting rod 1010 may bear outside the first outer clamp arm 140 and the second supporting rod 1020 may bear outside the second outer clamp arm 150.
- a middle portion of the first supporting rod 1010 may be fixedly connected to the outside of the first outer clamp arm 140 (e.g., via a bonding connection, a laser welding connection, a winding wire connection, etc. )
- the second supporting rod 1020 may be fixedly connected to the outside of the second outer clamp arm 150.
- the elastic bracket 1000 may increase an area of the mitral valve clamping device for clamping valves, and the elastic bracket 1000 may have a better supporting effect on the tissues, thereby improving a clamping performance of the mitral valve clamping device.
- the elastic bracket 1000 may have a good tightening effect, so the elastic force of the elastic bracket 1000 may improve the clamping force of the first inner clamp arm 120 and the second inner clamp arm 130 on the tissues when the first inner clamp arm 120 and the second inner clamp arm 130 are closed.
- the elastic force provided by the elastic bracket 1000 may be adjusted according to different clamping requirements for different tissues or different patients (e.g., a width of the first supporting rod 1010 and/or the second supporting rod 1020 may be adjusted) .
- the mitral valve clamping device with the elastic bracket 1000 may be used for different tissues or different patients.
- the beneficial effects of the mitral valve clamping device disclosed in the embodiment of the present disclosure may include but are not limited to: (1) the clamp body with the length of the first inner clamp arm being larger than the second inner clamp arm and the length of the first outer clamp arm being larger than the second outer clamp arm can facilitate the dynamic balance of the mitral valve after being clamped, and ensure that the stable operation of the repaired mitral valve, thereby improving the effect of mitral valve repair; (2) the clamp body of the mitral valve clamping device and the barbed clip may be in an integrally formed structure, thereby improving the stability, the reliability of the mitral valve clamping device, and reducing the difficultly in manufacturing of the mitral valve clamping device; (3) one or more barbed clips may be disposed on the mitral valve clamping device, which can prevent the tissues from sliding from a space between the clamp clip and the inner clamp arm, thereby improving the clamping stability of the mitral valve clamping device; and (4) an elastic bracket may be disposed on the mitral valve clamping device, which can improve the clamping performance of the mitral valve clamp
- FIG. 12 is a structural schematic diagram illustrating a mitral valve repair device according to some embodiments of the present disclosure.
- the mitral valve repair device may include a control handle and the mitral valve clamping device described in any of the technical solutions.
- the control handle may be configured to deliver the mitral valve clamping device to the mitral valve, and control an opening or closing of the first inner clamp arm 120 and the first clip 210 of the mitral valve clamping device, and control an opening or closing of the second inner clamp arm 130 and the second clip 220.
- the mitral valve repair device may include a delivery pipe 600.
- the first connection member 800 of the mitral valve clamping device may be connected to the control handle 300 via the delivery pipe 600.
- the control handle 300 may include a flexible pipe control mechanism 620, and the flexible pipe control mechanism 620 may be configured to control the bending of the flexible pipe 610.
- the delivery pipe 600 may be detachably connected to the mitral valve clamping device via a delivery connection member 700.
- the control handle 300 may include no flexible pipe control mechanism 620.
- FIG. 13 is a partial sectional diagram illustrating an inner clamp arm control mechanism according to some embodiments of the present disclosure.
- FIG. 14 is a structural schematic diagram illustrating a sleeve according to some embodiments of the present disclosure.
- FIG. 15 is a structural schematic diagram illustrating a sliding part and a protective cover according to some embodiments of the present disclosure.
- FIG. 16 is a structural schematic diagram illustrating an inner clamp arm control mechanism according to another embodiment of the present disclosure.
- FIG. 17 is a schematic diagram illustrating an internal structure of the inner clamp arm control mechanism according to another embodiment of the present disclosure.
- FIG. 18 is a structural schematic diagram illustrating a thread engagement mechanism according to another embodiment of the present disclosure. As shown in FIGs.
- the control handle 300 may include an inner clamp arm control mechanism 400 and a clip control mechanism 500.
- the inner clamp arm control mechanism 400 may be configured to control a movement of the first inner clamp arm 120 and the second inner clamp arm 130 of the mitral valve clamping device.
- the clip control mechanism 500 may be configured to control a movement of a clamp clip 200 (e.g., a first clip 210 and a second clip 220) of the mitral valve clamping device.
- the inner clamp arm control mechanism 400 may include a sleeve 410, a first control part 420, and a sliding part 430.
- the sliding part 430 may be disposed in the sleeve 410.
- the first control part 420 may rotate to drive the sliding part 430 to move in the sleeve 410 and along a length direction of the sleeve 410, so as to control an opening or closing of the first inner clamp arm 120 and the second inner clamp arm 130.
- one end of the control handle 300 close to the mitral valve clamping device is defined as a front end, and the other end of the control handle 300 is defined as a rear end
- the inner clamp arm may be controlled to be opened (for example, the first inner clamp arm 120 and the second inner clamp arm 130 may be opened relative to each other)
- the inner clamp arm may be controlled to be closed (for example, the first inner clamp arm 120 and the second inner clamp arm 130 may be closed relative to each other) .
- the sleeve 410 may include one or more interlayers.
- the sliding part 430 may be disposed in the interlayers of the sleeve 410.
- the first control part 420 may drive the sliding part 430 to move in the sleeve 410 and along the length direction of the sleeve 410.
- the sleeve 410 may have a hollow cylindrical shape, which may be formed by connecting two semi-cylindrical housings.
- the sliding part 430 may have a cylindrical shape and may be clamped between the two semi-cylindrical housings of the sleeve 410.
- an external thread may be disposed on an outer circumferential surface of the sleeve 410.
- An internal thread may be disposed on an inner circumferential surface of the first control part 420.
- the sleeve 410 and the first control part 420 may be connected by the threads.
- the sleeve 410 may be equipped with one or more first sliding grooves 412 along the length direction thereof.
- the sliding part 430 may be connected to the first control part 420 by passing through the first sliding groove (s) 412.
- the sliding part 430 may include one or more protruding connection block (s) 429.
- the inner circumferential surface of the first control part 420 may include one or more connection grooves 421.
- connection block (s) 429 may protrude from the first sliding groove (s) 412 and be clamped with the connection groove (s) 421, respectively, so that the first control part 420 may rotate to drive the sliding part 430 to move along the first sliding groove (s) 412.
- the sleeve 410 may include two first sliding grooves 412, which may be respectively disposed on two sides of the sleeve 410.
- the sliding part 430 may include two protruding connection blocks 429 corresponding to the two first sliding grooves 412, respectively, thereby ensuring the stability of the movement of the sliding part 430 driven by the first control part 420.
- a count of the first sliding grooves 412 may be other numbers, such as one, three, five, etc.
- the first control part 420 may have a circular outer contour, and a rubber layer may be disposed on a surface of the outer contour.
- a rubber layer may increase the friction of the first control part 420 and the palm or fingers, so that the operator may precisely control the first control part 420.
- a layer made of hard materials such as plastic, metal, etc., may be disposed on the surface of the outer contour of the first control part 420 without the rubber layer, and anti-slip patterns may be added on the layer to increase the friction.
- the inner clamp arm control mechanism 400 may include a driving rod 440, a fixing block 460, and a protective cover 470.
- the sliding part 430 may control an opening or closing of the inner clamp arm (e.g., the first inner clamp arm 120 and the second inner clamp arm 130) by the driving rod 440, and a rear end of the driving rod 440 may be fixedly connected to the fixing block 460, and a front end of the driving rod 440 may be detachably connected to the second connection member 900 (such as a thread connection, a snapping connection, etc. ) .
- the fixing block 460 may be cylindrical, and a cross-sectional diameter thereof may be larger than that of the driving rod 440.
- the driving rod 440 may be inserted into and fixedly connected to the fixing block 460 in a manner such as a bonding connection, a welding connection, an interference connection, etc.
- the protective cover 470 may be detachably connected to the sliding part 430 by a thread. When connected to the sliding part 430, the protective cover 470 may restrict the relative movement of the fixing block 460 and the sliding part 430.
- the driving rod 440 may be made of a memory alloy (such as a nickel-titanium alloy) , so that the driving rod 440 may have relatively good tensile and compressive properties and relatively good bending performance.
- the inner clamp arm control mechanism 400 may also effectively control an opening or closing of the inner clamp arm (e.g., the first inner clamp arm 120 and the second inner clamp arm 130) by the driving rod 440.
- the driving rod 440 may need to be separated from the mitral valve clamping device, and part or whole of the driving rod 440 may be drawn out from the control handle 300.
- the protective cover 470 may be detachably connected to the sliding part 430 by the thread.
- the operator may rotate the protective cover 470 to separate the protective cover 470 from the sliding part 430, rotate the fixing block 460 (i.e., rotate the driving rod 440) to separate the driving rod 440 from the second connection member 900 of the mitral valve clamping device, and pull the fixing block 460 to draw out the driving rod 440 from the control handle 300.
- the first control part 420 may include a thread engagement mechanism 450.
- the thread engagement mechanism 450 may include manipulation buttons 451, a first elastic member 453, and a pair of engagement members 455.
- the engagement member 455 may be symmetrically disposed (e.g., central symmetrically) and configured to be engaged with the external thread of the sleeve 410 by an elastic force of the first elastic member 453.
- the manipulation buttons 451 may be disposed on outer sides of the engagement members 455, and configured to control the engagement member 455 to be separated from the external thread of the sleeve 410 by overcoming the elastic force of the first elastic member 453.
- the operator may press the two manipulation buttons 451 that drive the pair of engagement members 455 to relatively move and thereby compress the first elastic member 453, such that the tooth structure inside the engagement members 455 is separated from the external thread of the sleeve 410. Therefore, the first control part 420 and the sleeve 410 may slide relatively in the length direction of the sleeve 410. At this time, the operator may directly drag the first control part 420 to slide on the sleeve 410, thereby achieving the quick opening and closing of the inner clamp arm (e.g., the first inner clamp arm 120 and the second inner clamp arm 130) .
- the inner clamp arm e.g., the first inner clamp arm 120 and the second inner clamp arm 130
- the mitral valve repair device or the control handle thereof may be operated more flexibly during surgery (such as mitral valve repair surgery) and suitable for different surgical conditions.
- the engagement member 455 may be again engaged with the external thread of the sleeve 410 under the elastic force of the first elastic member 453, and the operator may rotate the first control part 420 as needed to adjust the opening or closing angles of the inner clamp arm or perform the next operation.
- two opposing manipulation buttons 451 it may be convenient for the operator to quickly control the inner clamp arm to be opened or closed, and effective to prevent the operator from misoperation due to accidental touch.
- FIG. 19 is a partial sectional diagram illustrating clip control mechanism according to some embodiments of the present disclosure.
- FIG. 20 is a schematic diagram illustrating a housing according to some embodiments of the present disclosure.
- FIG. 21 is a structural schematic diagram illustrating a second control part according to some embodiments of the present disclosure.
- FIG. 22 is a structural schematic diagram illustrating the second control part and a locking mechanism at a first perspective according to some embodiments of the present disclosure.
- FIG. 23 is a structural schematic diagram illustrating the second control part and the locking mechanism at a second perspective according to some embodiments of the present disclosure.
- a clip control mechanism 500 may include a housing 510 and a second control part 520.
- the housing 510 may be equipped with one or more second sliding grooves 511.
- the second control part 520 may be configured to pass through the second sliding groove (s) 511 and move along the second sliding groove (s) 511 to control the clamp clip (e.g., the first clip 210 and the second clip 220) to be opened or closed relative to the inner clamp arm (e.g., the first inner clamp arm 120 and the second inner clamp arm 130) .
- the second control part 520 may include an L-shaped duct 521 and an end cover 523. One end of the duct 521 may pass through the second sliding groove (s) 511 and be detachably connected to the end cover 523. During operation, the second control part 520 may slide in the second sliding groove (s) 511 by pushing and pulling the duct 521 at the end cover 523. By disposing the L-shaped duct 521, it may be more convenient for the operator to control. In the embodiment, the second control part 520 may be drivingly connected to the clamp clip (e.g., the first clip 210 and the second clip 220) by a traction cable.
- the clamp clip e.g., the first clip 210 and the second clip 220
- the traction cable may pass through a through hole at a movable end of the clamp clip (e.g., the first clip 210 and the second clip 220) , and both ends of the traction cable may be fixed at the end cover 523.
- the end cover 523 and the duct 521 may be separated to release the fixing of the two ends of the traction cable and the traction cable may be drawn out, so that the control handle 300 may be separated from the clamp clip.
- releasing the fixing of the two ends of the traction cable may include: releasing the snapping connection between the two ends of the traction cable and the end cover, untying the knot formed at both ends of the traction cable, cutting the traction cable, or the like.
- the traction cable may be incompletely removed from the control handle 300, and just detached from the clamp clip.
- the second sliding groove (s) 511 may be of an elongated shape.
- the clamp clip may be in a closed state.
- the second sliding groove (s) 511 may have an L-shaped contour. Specifically, a passage may be opened at the rear end of the second sliding groove (s) 511 and along a direction that forms an angle (e.g., 90°) with the second sliding groove (s) 511.
- the second control part 520 When the end cover 523 of the second control part 520 (or the portion of the duct 521 protruding from the second sliding groove) moves to the rear end of the second sliding groove (s) 511, the second control part 520 may be pushed and pulled laterally so that the part of the duct 521 protruding from the second sliding groove is clamped into the passage. In this way, the clamp clip may be kept in a closed state, thereby preventing misoperation during the surgery.
- both sides of the housing 510 may be equipped with the second sliding groove (s) 511, respectively.
- the second control part 520 may include a first sub-control part for controlling the first clip 210 and a second sub-control part for controlling the second clip 220.
- the first sub-control part and the second sub-control part may respectively correspond to separate traction cables.
- the second control part 520 may be operated successively or simultaneously according to actual needs, so as to accurately control the clamp clip 200 according to needs of experiments or surgery. For example, during the mitral valve repair process, the first clip 210 may be controlled to clamp one side of the mitral valve, and then the second clip 220 may be controlled to clamp the other side of the mitral valve. As another example, the second control part 520 may simultaneously control the first clip 210 and the second clip 220 to clamp the mitral valve.
- one end of the housing 510 may be connected (or integrally formed) with the sleeve 410, and the central axes of the housing 510 and the sleeve 410 may coincide, making the control handle 300 more compact and easier for manipulation.
- the housing 510 may be disposed at one end of the sleeve 410 close to the mitral valve clamping device, and when the first control part 420 bear against the rear end of the housing 510, the inner clamp arm (e.g., the first inner clamp arm 120 and the second inner clamp arm 130) may be in a maximum opening state.
- the housing 510 may be disposed at one end of the sleeve 410 away from the mitral valve clamping device.
- the clip control mechanism 500 may include a locking mechanism 530.
- the locking mechanism 530 may include a second elastic member 531, one or more locking buttons 533, and one or more locking blocks 535.
- the second control part 520 may further include one or more tooth-shaped connection parts 537.
- the locking button (s) 533 may be configured to control the locking block (s) 535 to overcome an elastic force of the second elastic member 531, so as to release the restriction of the locking block (s) 535 on the tooth-shaped connection part (s) 537.
- the locking mechanism 530 may include a pair of oppositely disposed locking blocks 535, and the first sub-control part and the second sub-control part may include tooth-shaped connection parts 537 corresponding to the locking blocks 535, respectively.
- the tooth-shaped connection parts 537 may be connected to or integrally formed with the duct 521 of the first sub-control part or the second sub-control part, respectively.
- the pair of oppositely disposed locking blocks 535 may be configured to restrict the movement of the first sub-control part and the second sub-control part under the elastic force of the second elastic member 531, respectively.
- one of the pair of locking blocks 535 corresponding to the first sub-control part may be snapped into one of the tooth-shaped connection parts 537 corresponding to the first sub-control part under the elastic force of the second elastic member 531.
- the other one of the pair of locking blocks 535 corresponding to the second sub-control part may be snapped into the other one of the tooth-shaped connection parts 537 corresponding to the second sub-control part under the elastic force of the second elastic member 531.
- the second elastic member 531 may be two springs.
- the first sub-control part when one of the locking buttons 533 corresponding to the first sub-control part is pressed, it may drive the corresponding locking block 535 to overcome the elastic force of the second elastic member 531 so as to disengage from the corresponding tooth-shaped connection part 537.
- the operator may push or pull the first sub-control part (such as the duct 521 of the first sub-control part) to slide in the second sliding groove (s) 511 to control the first clip 210 to be opened or closed.
- the locking block 535 When the operator releases the one of the locking buttons 533 corresponding to the first sub-control part, under the elastic force of the second elastic member 531, the locking block 535 may be re-snapped into the corresponding tooth-shaped connection part 537 to restrict the movement of the tooth-shaped connection part 537 (i.e., the movement of the duct 521) .
- the operation on the second sub-control part may be similar to that on the first sub-control part, which will not be repeated herein.
- FIG. 24 is a structural schematic diagram illustrating a flexible pipe from a front view according to some embodiments of the present disclosure.
- FIG. 25 is a structural schematic diagram illustrating different parts of the flexible pipe according to some embodiments of the present disclosure.
- the flexible pipe 610 may be connected to the front end (i.e., an end close to the mitral valve clamping device) of the delivery pipe 600.
- the flexible pipe 610 may be connected to (such as laser welding) or integrally formed with the body of the delivery pipe 600.
- the front end of the flexible pipe 610 may be connected to a first connection member 800 through the delivery connection member 700. Through holes may be disposed on the delivery connection member 700.
- a driving rod 440 and a traction cable controlling the clamp chip to be opened or closed may pass through the through holes, respectively.
- the flexible pipe 610 may include an inner core 612 and an outer pipe 614.
- the outer pipe 614 may be sleeved outside the inner core 612.
- one or more through holes may be disposed inside the inner core 612 to allow the driving rod 440 and the traction cable controlling the clamp clip to be opened or closed to pass through.
- the flexible pipe 610 may be disposed with a plurality of notches 616 along a length direction of the flexible pipe 610.
- the outer pipe 614 of the flexible pipe 610 may be equipped with the plurality of notches 616.
- the flexible pipe 610 may be easily bent, and bent in a particular direction.
- the plurality of notches 616 may be disposed on one side of the flexible pipe 610, so that the flexible pipe may be bent toward an opening direction of the notch 616.
- the plurality of notches 616 may be spaced on different sides of the flexible pipe 610, so that the flexible pipe 610 may be bent toward a plurality of directions.
- the outer pipe 614 of the flexible pipe 610 may be made of stainless steel (such as a pipe 316) or an elastic metal (such as nickel- titanium alloy) .
- the inner core 612 of the flexible pipe 610 may be made of an elastic material (such as nylon, silicone, heat shrinkable polyether block polyamide (Pebax) , polytetrafluoroethylene (PTFE) , etc. ) .
- the flexible pipe 610 may have elasticity. If there is no external force, the flexible pipe 610 may maintain a cylindrical shape.
- a polymer material layer (such as heat shrinkable polyether block polyamide (Pebax) ) may be disposed on an outer surface of the flexible pipe 610, which can effectively prevent the flexible pipe 610 from contacting blood.
- the plurality of notches 616 may be disposed on one side of the flexible pipe 610, and a side of the inner core 612 facing the opening direction of the notched 616 may be equipped with a groove, and a traction rope 625 may be disposed in the groove.
- the front end of the traction rope 625 may be fixedly connected (such as a welding connection, a bonding connection, etc. ) to the inner core 612 and/or outer pipe 614.
- the flexible pipe control mechanism 620 may control a bending of the flexible pipe 610 by pulling the traction rope 625.
- FIG. 26 is a structural schematic diagram illustrating different parts of a flexible pipe control mechanism according to some embodiments of the present disclosure.
- the flexible pipe control mechanism 620 may include a screw 621, a rotating part 622, and a traction part 623.
- the screw 621 and the traction part 623 may be threadedly connected.
- the rotating part 622 may drive the screw 621 to rotate, thereby driving the traction part 623 to move.
- the traction part 623 may control the flexible pipe 610 to bend when moving.
- the traction part 623 may include the traction rope 625 and a threaded traction block 627.
- One end (such as a rear end) of the traction rope 625 may be connected to the threaded traction block 627, and the other end (such as a front end) of the traction rope 625 may be fixedly connected to the front end of the flexible pipe 610.
- An internal thread may be disposed in the screw 621, and the threaded traction block 627 may be movably disposed in the screw 621 and cooperate with the internal thread of the screw 621.
- the screw 621 may drive the threaded traction block 627 to move, along the length direction, in the screw 621, so as to realize the traction or loosening of the traction rope 625, thereby controlling the bending of the flexible pipe 610.
- the traction of the flexible pipe 610 by the traction rope 625 may cause the plurality of notches 616 on the flexible pipe 610 to be closed relative to each other, so that the flexible pipe 610 may bend.
- the threaded traction block 627 stops moving, the flexible pipe 610 may maintain a bending state.
- the threaded traction block 627 loosens the traction rope 625, the flexible pipe 610 may reduce a bending degree under its own elastic force until returning to a natural state (such as maintaining a cylindrical shape) .
- the mitral valve repair device disclosed in the embodiments of the present disclosure may include but are not limited to: (1) a mitral valve is repaired by the mitral valve repair device using the clamp body with characteristics that the length of the first inner clamp arm is larger than the length of the second inner clamp and the length of the first outer clamp arm is larger than the second outer clamp arm, which can facilitate the dynamic balance of the valve (such as a mitral valve, a tricuspid valve) after being clamped, and ensure the stable operation of the repaired valve, thereby improving the effect of valve repair; (2) quick and accurate controlling of the inner clamp arm and/or the clamp clip of the mitral valve clamping device, with a higher accuracy of the mitral valve repair device in repairing the mitral valve; (3) quick controlling of the inner clamp arm of the clamping device, which may shorten the operation time; (4) the operation of mitral valve repair may be more convenient, and the efficiency and the success rate of mitral valve repair may be improved; and (5) effectively preventing misoperation during the mitral valve repair. It should be noted that different embodiment
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Abstract
A mitral valve clamping device, comprising a clamp body(100) of the mitral valve clamping device, and a mitral valve repair device. The clamp body(100) may include a supporting part(110), a first inner clamp arm(120), a first outer clamp arm(140), a second inner clamp arm(130) and a second outer clamp arm(150). A first side of the supporting part(110) may be connected to the first inner clamp arm(120) and the first outer clamp arm(140) in sequence via a bendable connection, and a second side of the supporting part(110) may be connected to the second inner clamp arm(130) and the second outer clamp arm(150) in sequence via a bendable connection. A length of the first inner clamp arm(120) may be larger than a length of the second inner clamp arm(130). A length of the first outer clamp arm(140) may be larger than a length of the second outer clamp arm(150).
Description
CROSS-REFERENCE TO RELATED APPLICATION
This application claims priority of Chinese Patent Application No. 202010950172.0, filed on September 10, 2020, the contents of which are entirely incorporated herein by reference.
The present disclosure relates to the field of medical equipment, and more particularly to a clamp body of a mitral valve clamping device, a mitral valve clamping device, and a mitral valve repair device.
Valves have membrane-like structures that can be opened and closed in organs of humans or some animals. For example, there are four valves in the human's heart, including an aortic valve, a pulmonary valve, a mitral valve, and a tricuspid valve. Taking the human's mitral valve as an example, the mitral valve is located between the left atrium and the left ventricle. When the left ventricle contracts, the mitral valve, acting as a check valve, tightly closes an atrioventricular opening to prevent blood from flowing back from the left ventricle to the left atrium. However, if the mitral valve is diseased, it may be difficult for the mitral valve to close the left ventricle when it contracts, causing the left atrium to receive a large amount of reflux blood. This may lead to a sharp rise in pressures of the left atrium and the pulmonary vein, an increase in the load of the left ventricular diastolic volume, and further lead to a series of pathological changes such as left ventricular enlargement and pulmonary hypertension. Eventually, it may result in clinical manifestations such as heart failure, arrhythmia, etc., which may be life-threatening in severe cases.
A mitral valve repair device can be used to repair the diseased mitral valve, for example, clamp opposite sides of the mitral valve, so that one large hole formed by the valves changes to two small holes, and thus a regurgitation area is reduced, thereby effectively preventing mitral regurgitation. A clamp body is one of the main components of the mitral valve clamping device for clamping the mitral valve. Similarly, the mitral valve clamping device can also be applied to the repair of the heart's tricuspid valve and other valves, achieving the same effect of reducing the regurgitation area by clamping both valve leaflets.
SUMMARY
One of the embodiments of the present disclosure provides a clamp body of a mitral valve clamping device. The clamp body may include a supporting part, a first inner clamp arm, a first outer clamp arm, a second inner clamp arm and a second outer clamp arm. A first side of the supporting part may be connected to the first inner clamp arm and the first outer clamp arm in sequence via a bendable connection, and a second side of the supporting part may be connected to the second inner clamp arm and the second outer clamp arm in sequence via a bendable connection. A length of the first inner clamp arm may be larger than a length of the second inner clamp arm. A length of the first outer clamp arm may be larger than a length of the second outer clamp arm.
One of the embodiments of the present disclosure provides a mitral valve clamping device including the clamp body described in any of the technical solutions.
One of the embodiments of the present disclosure provides a mitral valve repair device including a control handle and the mitral valve clamping device described in any of the technical solutions. The control handle may be configured to deliver the mitral valve clamping device to the mitral valve via a left atrial appendage and a left atrium, and control an opening or closing of the first inner clamp arm and the first clip of the mitral valve clamping device, and control an opening or closing of the second inner clamp arm and the second clip.
The present disclosure is further illustrated in terms of exemplary embodiments. These exemplary embodiments are described in detail with reference to the drawings. It should be noted that the drawings are not to scale. These embodiments are non-limiting exemplary embodiments, in which like reference numerals represent similar structures throughout the several views of the drawings, and wherein:
FIG. 1 is a structural schematic diagram illustrating a clamp body of a mitral valve clamping device from a perspective view according to some embodiments of the present disclosure;
FIG. 2 is a schematic diagram illustrating a front view of a clamp body of a mitral valve clamping device according to some embodiments of the present disclosure;
FIG. 3 is a structural schematic diagram illustrating a clamp body of a mitral valve clamping device without bending according to some embodiments of the present disclosure;
FIG. 4 is a schematic diagram illustrating a side view of a clamp body of a mitral valve clamping device shown in FIG. 3;
FIG. 5 is a schematic diagram illustrating an S rod bendable structure of a clamp body of a mitral valve clamping device according to some embodiments of the present disclosure;
FIG. 6 is a schematic diagram illustrating a thin waist bendable structure of a clamp body of a mitral valve clamping device according to some embodiments of the present disclosure;
FIG. 7 is a schematic diagram illustrating a connection of a clamp body, a first connection member, and a second connection member of a mitral valve clamping device according to some embodiments of the present disclosure;
FIG. 8 is a schematic diagram illustrating a connection of a clamp body and a clamp clip of a mitral valve clamping device according to some embodiments of the present disclosure;
FIG. 9 is a structural schematic diagram illustrating an integrally formed structure of a barded clip and a clamp body of a mitral valve clamping device according to some embodiments of the present disclosure;
FIG. 10 is a structural schematic diagram illustrating an elastic bracket of a mitral valve clamping device from a perspective view according to some embodiments of the present disclosure;
FIG. 11 is a schematic diagram illustrating a connection of a clamp body, a first connection member, a second connection member, and an elastic bracket of a mitral valve clamping device according to some embodiments of the present disclosure;
FIG. 12 is a structural schematic diagram illustrating a mitral valve repair device according to some embodiments of the present disclosure;
FIG. 13 is a partial sectional diagram illustrating an inner clamp arm control mechanism according to some embodiments of the present disclosure;
FIG. 14 is a structural schematic diagram illustrating a sleeve according to some embodiments of the present disclosure;
FIG. 15 is a structural schematic diagram illustrating a sliding part and a protective cover according to some embodiments of the present disclosure;
FIG. 16 is a structural schematic diagram illustrating an inner clamp arm control mechanism according to another embodiment of the present disclosure;
FIG. 17 is a schematic diagram illustrating an internal structure of the inner clamp arm control mechanism according to another embodiment of the present disclosure;
FIG. 18 is a structural schematic diagram illustrating a thread engagement mechanism according to another embodiment of the present disclosure;
FIG. 19 is a partial sectional diagram illustrating a clip control mechanism according to some embodiments of the present disclosure;
FIG. 20 is a schematic diagram illustrating a housing according to some embodiments of the present disclosure;
FIG. 21 is a structural schematic diagram illustrating a second control part according to some embodiments of the present disclosure;
FIG. 22 is a structural schematic diagram illustrating the second control part and a locking mechanism at a first perspective according to some embodiments of the present disclosure;
FIG. 23 is a structural schematic diagram illustrating the second control part and the locking mechanism at a second perspective according to some embodiments of the present disclosure;
FIG. 24 is a structural schematic diagram illustrating a flexible pipe from a front view according to some embodiments of the present disclosure;
FIG. 25 is a structural schematic diagram illustrating different parts of the flexible pipe according to some embodiments of the present disclosure;
FIG. 26 is a structural schematic diagram illustrating different parts of a flexible pipe control mechanism according to some embodiments of the present disclosure.
Reference numerals and corresponding structures are described as follows: 100, clamp body; 110, supporting part; 120, first inner clamp arm; 130, second inner clamp arm; 140, first outer clamp arm; 150, second outer clamp arm; 160, first bendable structure; 170, second bendable structure; 200, clamp clip; 210, first clip; 220, second clip; 230, fixing part; 240, clipping part; 250, barb; 300, control handle; 400, inner clamp arm control mechanism; 410, sleeve; 412, first sliding groove; 420, first control part; 421, connection groove; 429, connection block; 430, sliding part; 440, driving rod; 450, thread engagement mechanism; 451, manipulation button; 453, first elastic member; 455, engagement member; 460, fixing block; 470, protective cover 500, clip control mechanism; 510, housing; 511, second sliding groove 520, second control part; 521, duct; 523, end cover; 530, locking mechanism; 531, second elastic member; 533, locking button; 535, locking block; 537, tooth-shaped connecting part; 600, delivery pipe; 610, flexible pipe; 612, inner core; 614, outer pipe; 616, notch; 620, flexible pipe control mechanism 621, screw; 622, rotating part; 623, traction part; 625, traction rope; 627, threaded traction block; 700, delivery connection member; 800, first connection member; 900, second connection member; 1000, elastic bracket; 1010, first supporting rod; 1020, second supporting rod; 1030, first mounting part; 1040, second mounting part; 1110, S rod bendable structure; 1111, straight rod; 1112, curved rod; 1120, thin waist bendable structure.
To make the purpose, technical solutions, and advantages of the embodiments of the present disclosure clearer, the technical solutions in the embodiments of the present disclosure will be described clearly in conjunction with the drawings in the embodiments of the present disclosure. It should be understood that the drawings are only for illustration, and are not intended to limit the protection scope of the present disclosure.
On the contrary, the present disclosure covers any alternatives, modifications, equivalent methods and solutions defined by the claims in the spirit and scope. Further, in order to enable those skilled in the art to have a better understanding of the present disclosure, some specific details are described in detail in the detailed description below. Those skilled in the art can fully understand the present disclosure without the description of these details.
Embodiments of the present disclosure relate to a clamp body of a mitral valve clamping device, a mitral valve clamping device, and a mitral valve repair device. A first inner clamp arm and a second inner clamp arm of the clamp body of the mitral valve clamping device may be opened or closed relative to each other. The clamp of the mitral valve clamping device may be configured to clamp a mitral valve or other valves (such as a tricuspid valve) with a clamp clip. In some embodiments, a length of the first inner clamp arm of the clamp body may be larger than a length of the second inner clamp arm of the clamp body, and a length of the first outer clamp arm of the clamp body may be larger than a length of the second outer clamp arm of the clamp body. In some embodiments, taking clamping of the mitral valve as an example, during the process of clamping the mitral valve, the relatively long first inner clamp arm and the relatively long first outer clamp arm may be configured to clamp an anterior leaflet of the mitral valve, and the relatively short second inner clamp arm and the relatively short second outer clamp arm may be configured to clamp a posterior leaflet of the mitral valve, which may facilitate the dynamic balance of the mitral valve after being clamped, and ensure the stable operation of the repaired mitral valve, thereby improving the effect of mitral valve repair. In addition, the mitral valve repair device may include a control handle and a mitral valve clamping device, and the control handle may be configured to deliver and control the mitral valve clamping device. In some embodiments, the mitral valve clamping device may reach a predetermined position through a plurality of routes. For example, the mitral valve clamping device may be delivered to the mitral valve via a femoral vein, an inferior vena cava, a right atrium, and a left atrium to repair the mitral valve. As another example, the mitral valve clamping device may be delivered to the mitral valve via a left atrial appendage and a left atrium to repair the mitral valve.
FIG. 1 is a structural schematic diagram illustrating a clamp body of a mitral valve clamping device from a perspective view according to some embodiments of the present disclosure. FIG. 2 is a schematic diagram illustrating a front view of a clamp body of a mitral valve clamping device according to some embodiments of the present disclosure. FIG. 3 is a structural schematic diagram illustrating a clamp body of a mitral valve clamping device without bending according to some embodiments of the present disclosure. FIG. 4 is a schematic diagram illustrating a side view of a clamp body of a mitral valve clamping device shown in FIG. 3. A clamp body of a mitral valve clamping device disclosed in the present disclosure will be described in detail with reference to FIGs. 1-4. It should be noted that the following examples are merely intended to explain the present disclosure, and not intended to limit the scope of the present disclosure.
As shown in FIGs. 1-4, a clamp body 100 of a mitral valve clamping device may include a supporting part 110, a first inner clamp arm 120, a first outer clamp arm 140, a second inner clamp arm 130, and a second outer clamp arm 150. A first side of the supporting part 110 may be connected to the first inner clamp arm 120 and the first outer clamp arm 140 in sequence via a bendable connection, and a second side of the supporting part 110 may be connected to the second inner clamp arm 130 and the second outer clamp arm 150 in sequence via a bendable connection. A length of the first inner clamp arm 120 may be larger than a length of the second inner clamp arm 130. A length of the first outer clamp arm 140 may be larger than a length of the second outer clamp arm 150.
In the embodiment, the supporting part 110 may be connected to the first inner clamp arm 120 via a bendable connection, and the supporting part 110 may be connected to the second inner clamp arm 130 via a bendable connection. The bendable connection used to connect the supporting part 110 and the first inner clamp arm 120 may refer to that a first connection part connecting the first inner clamp arm 120 and the supporting part 110 may be bendable. The bendable connection used to connect the supporting part 110 and the second inner clamp arm 130 may refer to that a second connection part connecting the second inner clamp arm 130 and the supporting part 110 may be bendable. The first inner clamp arm 120 may be bent in a direction from the first inner clamp arm 120 to the supporting part 110, and the second inner clamp arm 130 may be bent in a direction from the second inner clamp arm 130 to the supporting part 110, such that the first inner clamp arm 120 and the second inner clamp arm 130 may be closed relative to each other. The first inner clamp arm 120 may be bent in a direction from the supporting part 110 to the first inner clamp arm 120, and the second inner clamp arm 130 may be bent in a direction from the supporting part 110 to the second inner clamp arm 130, such that the first inner clamp arm 120 and the second inner clamp arm 130 may be opened relative to each other. The first inner clamp arm 120 may be connected to the first outer clamp arm 140 via a bendable connection, and the second inner clamp arm 130 may be connected to the second outer clamp arm 150 via a bendable connection. The bendable connection used to connect the first inner clamp arm 120 and the first outer clamp arm 140 or the bendable connection used to connect the second inner clamp arm 130 and the second outer clamp arm 150 may refer to that a third connection part connecting the first inner clamp arm 120 and the first outer clamp arm 140 and/or a fourth connection part connecting the second inner clamp arm 130 and the second outer clamp arm 150 may be bendable, and an angle between the first inner clamp arm 120 and the first outer clamp arm 140 may be changed and/or an angle between the second inner clamp arm 130 and the second outer clamp arm 150 may be changed. In some embodiments, a count of inner clamp arm (s) and outer clamp arm (s) may be increased as needed. For example, the inner clamp arms may also include a third inner clamp arm and a fourth inner clamp arm. The outer clamp arms may also include a third outer clamp arm, and a fourth outer clamp arm. The supporting part 110, the third inner clamp arm, and the third outer clamp arm may be connected in sequence via a bendable connection. The supporting part 110, the fourth inner clamp arm, and the fourth outer clamp arm may be connected in sequence via a bendable connection.
In the embodiment, the lengths of the first inner clamp arm 120, the second inner clamp arm 130, the first outer clamp arm 140, and the second outer clamp arm 150 may be illustrated in combination with the clamp body 100 when the clamp body 100 is not bent. Specifically, as shown in FIG. 3, the length of the first inner clamp arm 120 may refer to a distance between a first end of the first inner clamp arm 120 close to the supporting part 110 and a second end of the first inner clamp arm 120 away from the supporting part 110. The length of the second inner clamp arm 130 may refer to a distance between a first end of the second inner clamp arm 130 close to the supporting part 110 and a second end of the second inner clamp arm 130 away from the supporting part 110. In some embodiments, the length of the first inner clamp arm 120 may be 1.1 to 2.5 times the length of the second inner clamp arm 130. In some embodiments, the length of the first inner clamp arm 120 may be 1.2 to 2.2 times the length of the second inner clamp arm 130. In some embodiments, the length of the first inner clamp arm 120 may be 1.5 to 1.8 times the length of the second inner clamp arm 130. Specifically, the length of the first inner clamp arm 120 may be 1.2 times (or 1.5 times, 2 times, 2.2 times, etc. ) the length of the second inner clamp arm 130. The length of the first outer clamp arm 140 may refer to a distance between a first end of the first outer clamp arm 140 close to the first inner clamp arm 120 and a second end of the first outer clamp arm 140 away from the first inner clamp arm 120. The length of the second outer clamp arm 150 may refer to a distance between a first end of the second outer clamp arm 150 close to the second inner clamp arm 130 and a second end of the second outer clamp arm 150 away from the second inner clamp arm 130. In some embodiments, the length of the first outer clamp arm 140 may be 1.1 to 2.5 times the length of the second outer clamp arm 150. In some embodiments, the length of the first outer clamp arm 140 may be 1.2 to 2.2 times the length of the second outer clamp arm 150. In some embodiments, the length of the first outer clamp arm 140 may be 1.5 to 1.8 times the length of the second outer clamp arm 150. Specifically, the length of the first outer clamp arm 140 may be 1.2 times (or 1.5 times, 2 times, 2.2 times, etc. ) the length of the second outer clamp arm 150. Further, those skilled in the art may specifically design the lengths of the first inner clamp arm 120, the second inner clamp arm 130, the first outer clamp arm 140, and/or the second outer clamp arm 150 according to structural characteristics and size characteristics of the valve to be clamped.
As shown in FIG. 3 and FIG. 4, a shape of a cross-sectional of the supporting part 110 may include a circle, or an elliptical, and a cross-sectional area of the middle portion of the supporting part 110 may be larger than a cross-sectional area of the two ends thereof. Through such a design, the beneficial effects include but are not limited to: the supporting part 110 may not cause damage to the tissues, and may effectively form a support for the tissue clamped by the tissue clamping device. In some embodiments, the shape of the supporting part 110 may include a pear-like shape, a cylinder, or the like. Those skilled in the art may determine that the supporting part 110 of the clamp body 100 has different shapes according to a specific condition of the tissues (such as a shape of a mating edge of the mitral valve) to be clamped, so that the shape of the supporting part 110 may fit the shape of the tissues (such as a shape of a mating edge of the mitral valve) better to improve a clamping performance of the clamping device.
As shown in FIG. 3, in some embodiments, the supporting part 110 may include a grid structure. The grid structure may include a rhombus grid structure, a circular grid structure, a rectangular grid structure, a square grid structure, a triangular grid structure, a regular polygon grid structure, or the like, or any combination thereof. The supporting part 110 of the grid structure may effectively fill a space between the first inner clamp arm 120 and the second inner clamp arm 130, which may prevent a formation of thrombus after the mitral valve clamping device clamps a valve (e.g., a mitral valve, a tricuspid valve) .
In some embodiments, the clamp body 100 may be in an integrally formed structure. Specifically, in a manufacturing process of the clamp body 100, the clamp body 100 may be produced by cutting a metal tube, for example, using a laser. In some alternative embodiments, the clamp body 100 may be produced by weaving a metal wire. In some embodiments, the clamp body 100 may be in an integrally formed structure, for example, the clamp body 100 may be produced by cutting and performing a heating operation on a shape-memory alloy tube. The shape-memory alloy tube may include a nickel-titanium alloy tube or a cobalt-chromium alloy tube, or the like.
The length of the first inner clamp arm 120 may be larger than, equal to, or smaller than the length of the first outer clamp arm 140, and the length of the second inner clamp arm 130 may be larger than, equal to, or smaller than the length of the second outer clamp arm 150. In some embodiments, a ratio of the length of the first inner clamp arm 120 to the length of the first outer clamp arm 140 may be equal to a ratio of the length of the second inner clamp arm 130 to the length of the second outer clamp arm 150. For example, if the ratio of the length of the first inner clamp arm 120 to the length of the first outer clamp arm 140 is 0.9, a ratio of the length of the second inner clamp arm 130 to the length of the second outer clamp arm 150 may be 0.9. According to such configuration mentioned above, the structure of the clamp body 100 may be more reasonable, and the stress of the valve may be more uniform after the valve (such as a mitral valve, a tricuspid valve) is clamped.
In some embodiments, the first side of the supporting part 110 may be connected to the first inner clamp arm 120 via a first bendable structure 160. The second side of the supporting part 110 may be connected to the second inner clamp arm 130 via the first bendable structure 160. The first bendable structure 160 may include an S rod bendable structure 1110 or a thin waist bendable structure 1120. The first inner clamp arm 120 may be connected to the first outer clamp arm 140 via a second bendable structure 170. The second inner clamp arm 130 may be connected to the second outer clamp arm 150 via the second bendable structure 170. The second bendable structure 170 may include an S rod bendable structure 1110 or a thin waist bendable structure 1120. Due to structural characteristics and/or material characteristics, the first bendable structure 160 and the second bendable structure 170 may be bent. A structure of the first bendable structure 160 may be the same as or different from that of the second bendable structure 170. For example, if the first bendable structure 160 includes the S rod bendable structure 1110, the second bendable structure 170 may include the S rod bendable structure 1110, or the thin waist bendable structure 1120. The S rod bendable structure 1110 and the thin waist bendable structure 1120 may be processed by a heating operation. The S rod bendable structure 1110 and the thin waist bendable structure 1120 may be deformed during/after the heating operation. A bending part of the S rod bendable structure 1110 and the thin waist bendable structure 1120 may share a stress uniformly, which may improve a bending performance of the S rod bendable structure 1110 and the thin waist bendable structure 1120, thereby extending a service life of the clamp body 100.
Specifically, FIG. 5 is a schematic diagram illustrating an S rod bendable structure of a clamp body of a mitral valve clamping device according to some embodiments of the present disclosure. As shown in FIG. 5, the S rod bendable structure 1110 refers to a bendable road structure which presents a shape of "S" . In some embodiments, the S rod bendable structure 1110 may at least include three straight rods 1111 and two curved rods 1112. The three straight rods 1111 may be parallel to each other, and the three straight rods 1111 may be arranged in sequence. Two ends of each two adjacent straight rods of the three straight rods 1111 may be connected, and the two ends of each two adjacent straight rods of the three straight rods 1111 may be located at a same side of the S rod bendable structure 1110. The two ends of each two adjacent straight rods of the three straight rods 1111 may be connected via one of the two curved rods 1112. FIG. 6 is a schematic diagram illustrating a thin waist bendable structure of a clamp body of a mitral valve clamping device according to some embodiments of the present disclosure. As shown in FIG. 6, the thin waist bendable structure 1120 refers to a bendable rod-like structure with a middle portion and at least two ends, and a width of the middle portion is smaller than a width of each of at least two ends of the thin waist bendable structure 1120. That is, the thin waist bendable structure 1120 may present a shape of thin waist, thereby improving the bending performance of the thin waist bendable structure 1120.
The beneficial effects of the clamp body of the mitral valve clamping device disclosed in the embodiment of the present disclosure may include but are not limited to: (1) the design that the length of the first inner clamp arm is larger than the length of the second inner clamp and the length of the first outer clamp arm is larger than the second outer clamp arm, can facilitate the dynamic balance of a valve (e.g., a tricuspid valve, a tricuspid valve) after the valve is clamped, and ensure the stable operation of the repaired valve, thereby improving the effect of valve repair; (2) an integrally formed structure of the clamp body can improve the stability, the reliability of the clamp body and reduce the difficulty in manufacturing the clamp body; (3) one or more bendable structures may be disposed between components of the clamp body (e.g., a bendable structure disposed between the inner clamp arm and a supporting part, a bendable structure disposed between the inner clamp arm and an outer clamp arm) , which can improve the bending performance of the inner clamp arm of the clamp body and improve clamping efficiency of the clamp body; and (4) the bendable structure (s) can improve deformation performance when the components of the clamp body are processed by a heating operation. It should be noted that different embodiments may have different beneficial effects. In different embodiments, the possible beneficial effects may include any combination of one or more of the above, or any other possible beneficial effects that may be obtained.
In another aspect, one of the embodiments of the present disclosure provides a mitral valve clamping device. The mitral valve clamping device may include a clamp body 100 described in any of the technical solutions. FIG. 7 is a schematic diagram illustrating a connection of a clamp body, a first connection member, and a second connection member of a mitral valve clamping device according to some embodiments of the present disclosure. FIG. 8 is a schematic diagram illustrating a connection of a clamp body and a clamp clip of a mitral valve clamping device according to some embodiments of the present disclosure. As shown in FIG. 7 and FIG. 8, the mitral valve clamping device may further include a first connection member 800, a second connection member 900, and a clamp clip 200. The clamp body 100 may be connected to the first connection member 800 and the second connection member 900, and between the first connection member 800 and the second connection member 900. A relative movement of the first connection member 800 and the second connection member 900 may drive the first inner clamp arm 120 and the second inner clamp arm 130 to be opened or closed relative to each other. The clamp clip 200 may include a first clip 210 disposed on the first inner clamp arm 120 and a second clip 220 disposed on the second inner clamp arm 130. The first clip 210 and the second clip 220 may be able to be opened or closed relative to the first inner clamp arm 120 and the second inner clamp arm 130, respectively, such that a mitral valve may be clamped between the first clip 210 and the first inner clamp arm 120, and between the second clip 220 and the second inner clamp arm 130.
In the embodiment, an opening angle between the first inner clamp arm 120 and the second inner clamp arm 130 may be various, such as 40°, 90°, 120°, 180°, 270°, 350°, 360°, etc. As shown in FIG. 7, a first end of the supporting part 110 (e.g., an upper end as shown in FIG. 7) may be connected to the first connection member 800, for example, via a fixed connection mode. A first end of the first outer clamp arm 140 (e.g., a lower end shown in FIG. 7) and a first end of the second outer clamp arm 150 (e.g., a lower end as shown in FIG. 7) may be respectively connected to the second connection member 900, for example, via a fixed connection mode. According to such configuration mentioned above, the second connection member 900 may move relative to the supporting part 110 when the second connection member 900 moves relative to the first connection member 800. When the second connection member 900 moves away from the supporting part 110, a movement of the first outer clamp arm 140 and the second outer clamp arm 150 may be configured to drive the first inner clamp arm 120 and the second inner clamp arm 130 to be opened relative to each other, respectively. In some embodiments, a first end of the first outer clamp arm 140 and a first end of the second outer clamp arm 150 may be connected to the second connection member 900 via a bendable connection, which may cause the first inner clamp arm 120 and the second inner clamp arm 130 to be opened relatively to form a relatively large angle. Further, descriptions regarding how to further control the first inner clamp arm 120 and the second inner clamp arm 130 to be opened or closed relative to each other may be found in relevant descriptions of the inner clamp arm control mechanism below. Descriptions regarding how to further control the first clip 210 and the second clip 220 to be opened or closed relative to the first inner clamp arm 120 and the second inner clamp arm 130 may be found in descriptions of the control mechanism of the clamp clip 200 below.
In some embodiments, the first inner clamp arm 120 and the first clip 210 may be configured to clamp an anterior leaflet of the mitral valve, and the second inner clamp arm 130 and the second clip 220 may be configured to clamp a posterior leaflet of the mitral valve. The anterior leaflet of the mitral valve is located on the relatively anterior side, has a relatively large area, and is referred to as a large valve, and is a demarcation mark between the inflow and outflow tracts of the left ventricle. The posterior leaflet of the mitral valve is located on the relatively posterior side, has a relatively small area, and is referred to as a small valve. Because the area of the anterior leaflet is relatively large, and the area of the posterior leaflet is relatively small, the anterior leaflet may be clamped using the first clip 210 and the relatively long first inner clamp arm 120, and the posterior leaflet may be clamped using the second clip 220 and the relatively short second inner clamp arm 130, which may facilitate the dynamic balance of the mitral valve after being clamped. In other embodiments, if the mitral valve clamping device is used to clamp a tricuspid valve, a leaflet of the tricuspid valve with a relatively large area (or a relatively long length) may be clamped using the first inner clamp arm 120 and the first clip 210, and a leaflet of the tricuspid valve with a relatively small area (or a relatively short length) may be clamped using the second inner clamp arm 130 and the second clip 220, which may facilitate the dynamic balance of the tricuspid valve after being clamped.
In some embodiments, the length of the first clip 210 may be larger than the length of the second clip 220. The length of the first clip 210 may refer to a distance between a first end of the first clip 210 close to the first inner clamp arm 120 and a second end of the first clip 210 away from the first inner clamp arm 120 when the first clip 210 is opened. The length of the second clip 220 may refer to a distance between a first end of the second clip 220 close to the second inner clamp arm 130 and a second end of the second clip 220 away from the second inner clamp arm 130 when the second clip 220 is opened. According to such configuration mentioned above, the first clip 210 and the first inner clamp arm 120 may be more conveniently matched to clamp a leaflet with a relatively large area (such as an anterior leaflet of a mitral valve) , and the second clip 220 and the second inner clamp arm 130 may be more conveniently matched to clamp a leaflet with a relatively small area (such as a posterior leaflet of a mitral valve) , which may further facilitate the dynamic balance of the valve after being clamped.
In some embodiments, in order to make the stress of the leaflets of the valve (such as a mitral valve, a tricuspid valve) more uniform and the valve easy to be clamped, a ratio of the length of the first clip 210 to the length of the first inner clamp arm 120 may be equal to a ratio of the length of the second clip 220 to the length of the second inner clamp arm 130. For example, if the ratio of the length of the first clip 210 to the length of the first inner clamp arm 120 is 0.6, the ratio of the length of the second clip 220 to the length of the second inner clamp arm 130 may be 0.6. According to such configuration mentioned above, the structure of the mitral valve clamping device may be more reasonable, and the force of the clamped valve leaflet may be more uniform.
In some embodiments, as shown in FIG. 8, the clamp clip 200 may include a barbed clip. The barbed clip may include a fixing part 230, a clipping part 240, and a barb 250. A first end of the clipping part 240 may be connected to a first end of the fixing part 230 via a bending part. The barb 250 may be disposed on a second end of the clipping part 240. The barb 250 may be disposed on one side of the clipping part 240 of the clamp clip 200 (e.g., the first clip 210 or the second clip 220) , which may face an inner clamp arm (e.g., the first inner clamp arm 120 or the second inner clamp arm 130) . The fixing part 230 may be configured to fix the clamp clip 200 (e.g., the first clip 210 or the second clip 220) on the inner clamp arm (e.g., the first inner clamp arm 120 or the second inner clamp arm 130) . The clipping part 240 may be configured to clamp the tissues together with the inner clamp arm (e.g., the first inner clamp arm 120 or the second inner clamp arm 130) . A first end of the fixing part 230 may be connected to a first end of the clipping part 240 via a bending part, so that the clamp clip 200 (e.g., the first clip 210 or the second clip 220) may be opened or closed relative to an inner clamp arm (e.g., the first inner clamp arm 120 or the second inner clamp arm 130) . The bending part may have an S rod bendable structure 1110 or a thin waist bendable structure 1120. The two bendable structures of the clamp clip 200 may be similar to the two bendable structures of the clamp body 100. More descriptions may be found in the relevant descriptions of FIG . 5 and FIG. 6. The barb 250 may effectively prevent the valve sliding from a space between the clamp clip 200 to the inner clamp arm, thereby effectively improving the clamping stability of the mitral valve clamping device. In some alternative embodiments, the clamp clip 200 may also be other types of the clamp clip 200. For example, a side of the clamp clip 200 facing an inner clamp arm (e.g., the first inner clamp arm 120 or the second inner clamp arm 130) may include barbs and/or protrusions, or the like.
FIG. 9 is a structural schematic diagram illustrating an integrally formed structure of a barded clip and a clamp body of a mitral valve clamping device according to some embodiments of the present disclosure. As shown in FIG. 9, the first clip 210 may be integrally formed by cutting, and the second clip 220 may be integrally formed by cutting. Specifically, the fixing part 230, the clipping part 240, and the barb 250 of the barbed clip may be integrally formed with the clamp body 100. Specifically, when the clamp body 100 is cut, an inner clamp arm (e.g., the first inner clamp arm 120 and the second inner clamp arm 130) of the clamp body 100 may be cut to form shapes of the clipping part 240 and the barb 250 of the barbed clip, and a first end of the cut clipping part 240 may be connected to the inner clamp arm (in this case, an end of the fixing part 230 of the barbed clip may be connected to the inner clamp arm) . In some embodiments, after the clipping part 240 and the barb 250 are formed integrally by cutting, the barb 250 may be bent through a heating operation. In some alternative embodiments, the fixing part 230 and the clipping part 240 of the barbed clip may be integrally formed with the clamp body 100. The integral formation of the clamp clip 200 and the inner clamp arm may improve the reliability of a connection between the clamp clip 200 and the inner clamp arm, improve clamping stability of the mitral valve clamping device, simplify an assembly of the mitral valve clamping device, and improve the production efficiency of the mitral valve clamping device.
In some embodiments, the mitral valve clamping device may include an elastic bracket 1000. FIG. 10 is a structural schematic diagram illustrating an elastic bracket of a mitral valve clamping device from a perspective view according to some embodiments of the present disclosure. FIG. 11 is a schematic diagram illustrating a connection of a clamp body, a first connection member, a second connection member, and an elastic bracket of a mitral valve clamping device according to some embodiments of the present disclosure. As shown in FIG. 10, the elastic bracket 1000 may include a first supporting rod 1010, a second supporting rod 1020, a first mounting part 1030, and a second mounting part 1040. A first end of the first supporting rod 1010 and a first end of the second supporting rod 1020 may be connected to the first mounting part 1030. A second end of the first supporting rod 1010 and the second supporting rod 1020 may be connected to the second mounting part 1040. In the embodiment, the elastic bracket 1000 may be in an integrally formed structure. That is, the first supporting rod 1010, the second supporting rod 1020, the first mounting part 1030, and the second mounting part 1040 may be in an integrally formed structure, thereby improving the stability, the reliability of connections between components of the elastic bracket 1000 and reducing the difficulty in manufacturing.
In some embodiments, as shown in FIG. 11, the first mounting part 1030 and the second mounting part 1040 of the elastic bracket 1000 may be fixedly connected to the second connection member 900. That is, both ends of the first supporting rod 1010 and the second supporting rod 1020 may be fixed to the second connection member 900. The first supporting rod 1010 of the elastic bracket 1000 may bear against a connection of the first inner clamp arm 120 and the first outer clamp arm 140. The second supporting rod 1020 of the elastic bracket 1000 may bear against a connection of the second inner clamp arm 130 and the second outer clamp arm 150. For example, as shown in FIG. 11, the first supporting rod 1010 may internally bear against between the first inner clamp arm 120 and the first outer clamp arm 140, and the second supporting rod 1020 may internally bear against between the second interior clamp arm 130 and the second outer clamp arm 150. In some embodiments, when the first supporting rod 1010 or the second supporting rod 1020 bears against between an inner clamp arm and an outer clamp arm, the first supporting rod 1010 or the second supporting rod 1020 may be fixedly connected to a connection of the inner clamp arm and the outer clamp arm, for example, via a bonding connection, a laser welding connection, a winding wire connection, or the like, or any combination thereof. A length of the first supporting rod 1010 may be larger than a length of the second supporting rod 1020, so that the first supporting rod 1010 may suitably bear against between the first inner clamp arm 120 and the first outer clamp arm 140, and the second supporting rod 1020 may suitably bear against between the second inner clamp arm 130 and the second outer clamp arm 150.
In some alternative embodiments, the first supporting rod 1010 may bear outside the first outer clamp arm 140 and the second supporting rod 1020 may bear outside the second outer clamp arm 150. For example, a middle portion of the first supporting rod 1010 may be fixedly connected to the outside of the first outer clamp arm 140 (e.g., via a bonding connection, a laser welding connection, a winding wire connection, etc. ) , and the second supporting rod 1020 may be fixedly connected to the outside of the second outer clamp arm 150.
In the embodiment, the elastic bracket 1000 may increase an area of the mitral valve clamping device for clamping valves, and the elastic bracket 1000 may have a better supporting effect on the tissues, thereby improving a clamping performance of the mitral valve clamping device. At the same time, the elastic bracket 1000 may have a good tightening effect, so the elastic force of the elastic bracket 1000 may improve the clamping force of the first inner clamp arm 120 and the second inner clamp arm 130 on the tissues when the first inner clamp arm 120 and the second inner clamp arm 130 are closed. Further, the elastic force provided by the elastic bracket 1000 may be adjusted according to different clamping requirements for different tissues or different patients (e.g., a width of the first supporting rod 1010 and/or the second supporting rod 1020 may be adjusted) . The mitral valve clamping device with the elastic bracket 1000 may be used for different tissues or different patients.
The beneficial effects of the mitral valve clamping device disclosed in the embodiment of the present disclosure may include but are not limited to: (1) the clamp body with the length of the first inner clamp arm being larger than the second inner clamp arm and the length of the first outer clamp arm being larger than the second outer clamp arm can facilitate the dynamic balance of the mitral valve after being clamped, and ensure that the stable operation of the repaired mitral valve, thereby improving the effect of mitral valve repair; (2) the clamp body of the mitral valve clamping device and the barbed clip may be in an integrally formed structure, thereby improving the stability, the reliability of the mitral valve clamping device, and reducing the difficultly in manufacturing of the mitral valve clamping device; (3) one or more barbed clips may be disposed on the mitral valve clamping device, which can prevent the tissues from sliding from a space between the clamp clip and the inner clamp arm, thereby improving the clamping stability of the mitral valve clamping device; and (4) an elastic bracket may be disposed on the mitral valve clamping device, which can improve the clamping performance of the mitral valve clamping device on the tissues, protect the tissues, and improve the clamping stability of the mitral valve clamping device. It should be noted that different embodiments may have different beneficial effects. In different embodiments, the beneficial effects may include any of the beneficial effects mentioned above or any other beneficial effects that may be realized.
In yet another aspect, one of the embodiments of the present disclosure provides a mitral valve repair device. FIG. 12 is a structural schematic diagram illustrating a mitral valve repair device according to some embodiments of the present disclosure. As shown in FIG. 12, the mitral valve repair device may include a control handle and the mitral valve clamping device described in any of the technical solutions. The control handle may be configured to deliver the mitral valve clamping device to the mitral valve, and control an opening or closing of the first inner clamp arm 120 and the first clip 210 of the mitral valve clamping device, and control an opening or closing of the second inner clamp arm 130 and the second clip 220.
In some embodiments, the mitral valve repair device may include a delivery pipe 600. The first connection member 800 of the mitral valve clamping device may be connected to the control handle 300 via the delivery pipe 600. In some embodiments, if the delivery pipe 600 includes a flexible pipe 610, the control handle 300 may include a flexible pipe control mechanism 620, and the flexible pipe control mechanism 620 may be configured to control the bending of the flexible pipe 610. In some embodiments, the delivery pipe 600 may be detachably connected to the mitral valve clamping device via a delivery connection member 700. In some embodiments, if the delivery pipe 600 does not include the flexible pipe 610 (for example, the delivery pipe 600 is in an inflexible structure) , the control handle 300 may include no flexible pipe control mechanism 620.
FIG. 13 is a partial sectional diagram illustrating an inner clamp arm control mechanism according to some embodiments of the present disclosure. FIG. 14 is a structural schematic diagram illustrating a sleeve according to some embodiments of the present disclosure. FIG. 15 is a structural schematic diagram illustrating a sliding part and a protective cover according to some embodiments of the present disclosure. FIG. 16 is a structural schematic diagram illustrating an inner clamp arm control mechanism according to another embodiment of the present disclosure. FIG. 17 is a schematic diagram illustrating an internal structure of the inner clamp arm control mechanism according to another embodiment of the present disclosure. FIG. 18 is a structural schematic diagram illustrating a thread engagement mechanism according to another embodiment of the present disclosure. As shown in FIGs. 13-18, in some embodiments, the control handle 300 may include an inner clamp arm control mechanism 400 and a clip control mechanism 500. The inner clamp arm control mechanism 400 may be configured to control a movement of the first inner clamp arm 120 and the second inner clamp arm 130 of the mitral valve clamping device. The clip control mechanism 500 may be configured to control a movement of a clamp clip 200 (e.g., a first clip 210 and a second clip 220) of the mitral valve clamping device.
In some embodiments, as shown in FIGs. 13-18, the inner clamp arm control mechanism 400 may include a sleeve 410, a first control part 420, and a sliding part 430. The sliding part 430 may be disposed in the sleeve 410. The first control part 420 may rotate to drive the sliding part 430 to move in the sleeve 410 and along a length direction of the sleeve 410, so as to control an opening or closing of the first inner clamp arm 120 and the second inner clamp arm 130. If one end of the control handle 300 close to the mitral valve clamping device is defined as a front end, and the other end of the control handle 300 is defined as a rear end, when the sliding part 430 moves toward the front end in the sleeve 410, the inner clamp arm may be controlled to be opened (for example, the first inner clamp arm 120 and the second inner clamp arm 130 may be opened relative to each other) . When the sliding part 430 moves toward the rear end, the inner clamp arm may be controlled to be closed (for example, the first inner clamp arm 120 and the second inner clamp arm 130 may be closed relative to each other) .
In some embodiments, the sleeve 410 may include one or more interlayers. The sliding part 430 may be disposed in the interlayers of the sleeve 410. The first control part 420 may drive the sliding part 430 to move in the sleeve 410 and along the length direction of the sleeve 410. For example, the sleeve 410 may have a hollow cylindrical shape, which may be formed by connecting two semi-cylindrical housings. The sliding part 430 may have a cylindrical shape and may be clamped between the two semi-cylindrical housings of the sleeve 410.
In some embodiments, referring to FIGs. 13-14, an external thread may be disposed on an outer circumferential surface of the sleeve 410. An internal thread may be disposed on an inner circumferential surface of the first control part 420. The sleeve 410 and the first control part 420 may be connected by the threads. The sleeve 410 may be equipped with one or more first sliding grooves 412 along the length direction thereof. The sliding part 430 may be connected to the first control part 420 by passing through the first sliding groove (s) 412. Specifically, the sliding part 430 may include one or more protruding connection block (s) 429. The inner circumferential surface of the first control part 420 may include one or more connection grooves 421. The connection block (s) 429 may protrude from the first sliding groove (s) 412 and be clamped with the connection groove (s) 421, respectively, so that the first control part 420 may rotate to drive the sliding part 430 to move along the first sliding groove (s) 412. In the embodiment of the present disclosure, the sleeve 410 may include two first sliding grooves 412, which may be respectively disposed on two sides of the sleeve 410. The sliding part 430 may include two protruding connection blocks 429 corresponding to the two first sliding grooves 412, respectively, thereby ensuring the stability of the movement of the sliding part 430 driven by the first control part 420. In some alternative embodiments, a count of the first sliding grooves 412 may be other numbers, such as one, three, five, etc.
In some embodiments, the first control part 420 may have a circular outer contour, and a rubber layer may be disposed on a surface of the outer contour. When an operator controls the inner clamp arm (e.g., the first inner clamp arm 120 and the second inner clamp arm 130) by rotating the first control part 420, the rubber layer may increase the friction of the first control part 420 and the palm or fingers, so that the operator may precisely control the first control part 420. In other embodiments, a layer made of hard materials such as plastic, metal, etc., may be disposed on the surface of the outer contour of the first control part 420 without the rubber layer, and anti-slip patterns may be added on the layer to increase the friction.
In some embodiments, as shown in FIGs. 13-15, the inner clamp arm control mechanism 400 may include a driving rod 440, a fixing block 460, and a protective cover 470. The sliding part 430 may control an opening or closing of the inner clamp arm (e.g., the first inner clamp arm 120 and the second inner clamp arm 130) by the driving rod 440, and a rear end of the driving rod 440 may be fixedly connected to the fixing block 460, and a front end of the driving rod 440 may be detachably connected to the second connection member 900 (such as a thread connection, a snapping connection, etc. ) . Specifically, the fixing block 460 may be cylindrical, and a cross-sectional diameter thereof may be larger than that of the driving rod 440. The driving rod 440 may be inserted into and fixedly connected to the fixing block 460 in a manner such as a bonding connection, a welding connection, an interference connection, etc. The protective cover 470 may be detachably connected to the sliding part 430 by a thread. When connected to the sliding part 430, the protective cover 470 may restrict the relative movement of the fixing block 460 and the sliding part 430. In some embodiments, the driving rod 440 may be made of a memory alloy (such as a nickel-titanium alloy) , so that the driving rod 440 may have relatively good tensile and compressive properties and relatively good bending performance. Thus, although the delivery pipe 600 is bent, the inner clamp arm control mechanism 400 may also effectively control an opening or closing of the inner clamp arm (e.g., the first inner clamp arm 120 and the second inner clamp arm 130) by the driving rod 440.
In some embodiments, after the clamping of the mitral valve clamping device is completed, the driving rod 440 may need to be separated from the mitral valve clamping device, and part or whole of the driving rod 440 may be drawn out from the control handle 300. As shown in FIGs. 11-13, the protective cover 470 may be detachably connected to the sliding part 430 by the thread. When the driving rod 440 needs to be separated from the mitral valve clamping device, the operator may rotate the protective cover 470 to separate the protective cover 470 from the sliding part 430, rotate the fixing block 460 (i.e., rotate the driving rod 440) to separate the driving rod 440 from the second connection member 900 of the mitral valve clamping device, and pull the fixing block 460 to draw out the driving rod 440 from the control handle 300.
In some embodiments, as shown in FIGs. 16-18, the first control part 420 may include a thread engagement mechanism 450. The thread engagement mechanism 450 may include manipulation buttons 451, a first elastic member 453, and a pair of engagement members 455. The engagement member 455 may be symmetrically disposed (e.g., central symmetrically) and configured to be engaged with the external thread of the sleeve 410 by an elastic force of the first elastic member 453. The manipulation buttons 451 may be disposed on outer sides of the engagement members 455, and configured to control the engagement member 455 to be separated from the external thread of the sleeve 410 by overcoming the elastic force of the first elastic member 453.
In the actual operation, the operator may press the two manipulation buttons 451 that drive the pair of engagement members 455 to relatively move and thereby compress the first elastic member 453, such that the tooth structure inside the engagement members 455 is separated from the external thread of the sleeve 410. Therefore, the first control part 420 and the sleeve 410 may slide relatively in the length direction of the sleeve 410. At this time, the operator may directly drag the first control part 420 to slide on the sleeve 410, thereby achieving the quick opening and closing of the inner clamp arm (e.g., the first inner clamp arm 120 and the second inner clamp arm 130) . By controlling the quick opening and closing of the inner clamp arm, the mitral valve repair device or the control handle thereof may be operated more flexibly during surgery (such as mitral valve repair surgery) and suitable for different surgical conditions. When the operator releases the manipulation buttons, the engagement member 455 may be again engaged with the external thread of the sleeve 410 under the elastic force of the first elastic member 453, and the operator may rotate the first control part 420 as needed to adjust the opening or closing angles of the inner clamp arm or perform the next operation. By disposing two opposing manipulation buttons 451, it may be convenient for the operator to quickly control the inner clamp arm to be opened or closed, and effective to prevent the operator from misoperation due to accidental touch.
FIG. 19 is a partial sectional diagram illustrating clip control mechanism according to some embodiments of the present disclosure. FIG. 20 is a schematic diagram illustrating a housing according to some embodiments of the present disclosure. FIG. 21 is a structural schematic diagram illustrating a second control part according to some embodiments of the present disclosure. FIG. 22 is a structural schematic diagram illustrating the second control part and a locking mechanism at a first perspective according to some embodiments of the present disclosure. FIG. 23 is a structural schematic diagram illustrating the second control part and the locking mechanism at a second perspective according to some embodiments of the present disclosure. In some embodiments, as shown in FIGs. 19-23, a clip control mechanism 500 may include a housing 510 and a second control part 520. The housing 510 may be equipped with one or more second sliding grooves 511. The second control part 520 may be configured to pass through the second sliding groove (s) 511 and move along the second sliding groove (s) 511 to control the clamp clip (e.g., the first clip 210 and the second clip 220) to be opened or closed relative to the inner clamp arm (e.g., the first inner clamp arm 120 and the second inner clamp arm 130) .
In some embodiments, as shown in FIG. 21, the second control part 520 may include an L-shaped duct 521 and an end cover 523. One end of the duct 521 may pass through the second sliding groove (s) 511 and be detachably connected to the end cover 523. During operation, the second control part 520 may slide in the second sliding groove (s) 511 by pushing and pulling the duct 521 at the end cover 523. By disposing the L-shaped duct 521, it may be more convenient for the operator to control. In the embodiment, the second control part 520 may be drivingly connected to the clamp clip (e.g., the first clip 210 and the second clip 220) by a traction cable. In some specific embodiments, the traction cable may pass through a through hole at a movable end of the clamp clip (e.g., the first clip 210 and the second clip 220) , and both ends of the traction cable may be fixed at the end cover 523. When it is necessary to separate the mitral valve clamping device from the control handle 300, the end cover 523 and the duct 521 may be separated to release the fixing of the two ends of the traction cable and the traction cable may be drawn out, so that the control handle 300 may be separated from the clamp clip. In some embodiments, releasing the fixing of the two ends of the traction cable may include: releasing the snapping connection between the two ends of the traction cable and the end cover, untying the knot formed at both ends of the traction cable, cutting the traction cable, or the like. In some embodiments, the traction cable may be incompletely removed from the control handle 300, and just detached from the clamp clip.
In some embodiments, as shown in FIG. 20, the second sliding groove (s) 511 may be of an elongated shape. When the end cover 523 of the second control part 520 (or a portion of the duct 521 protruding from the second sliding groove) moves to the rear end (e.g., an end away from the mitral valve clamping device) of the second sliding groove (s) 511, the clamp clip may be in a closed state. In some alternative embodiments, the second sliding groove (s) 511 may have an L-shaped contour. Specifically, a passage may be opened at the rear end of the second sliding groove (s) 511 and along a direction that forms an angle (e.g., 90°) with the second sliding groove (s) 511. When the end cover 523 of the second control part 520 (or the portion of the duct 521 protruding from the second sliding groove) moves to the rear end of the second sliding groove (s) 511, the second control part 520 may be pushed and pulled laterally so that the part of the duct 521 protruding from the second sliding groove is clamped into the passage. In this way, the clamp clip may be kept in a closed state, thereby preventing misoperation during the surgery.
In this embodiment, both sides of the housing 510 may be equipped with the second sliding groove (s) 511, respectively. The second control part 520 may include a first sub-control part for controlling the first clip 210 and a second sub-control part for controlling the second clip 220. The first sub-control part and the second sub-control part may respectively correspond to separate traction cables. In some embodiments, the second control part 520 may be operated successively or simultaneously according to actual needs, so as to accurately control the clamp clip 200 according to needs of experiments or surgery. For example, during the mitral valve repair process, the first clip 210 may be controlled to clamp one side of the mitral valve, and then the second clip 220 may be controlled to clamp the other side of the mitral valve. As another example, the second control part 520 may simultaneously control the first clip 210 and the second clip 220 to clamp the mitral valve.
In some embodiments, one end of the housing 510 may be connected (or integrally formed) with the sleeve 410, and the central axes of the housing 510 and the sleeve 410 may coincide, making the control handle 300 more compact and easier for manipulation. For example, the housing 510 may be disposed at one end of the sleeve 410 close to the mitral valve clamping device, and when the first control part 420 bear against the rear end of the housing 510, the inner clamp arm (e.g., the first inner clamp arm 120 and the second inner clamp arm 130) may be in a maximum opening state. In some alternative embodiments, the housing 510 may be disposed at one end of the sleeve 410 away from the mitral valve clamping device.
In some embodiments, as shown in FIGs. 19-23, the clip control mechanism 500 may include a locking mechanism 530. The locking mechanism 530 may include a second elastic member 531, one or more locking buttons 533, and one or more locking blocks 535. The second control part 520 may further include one or more tooth-shaped connection parts 537. The locking button (s) 533 may be configured to control the locking block (s) 535 to overcome an elastic force of the second elastic member 531, so as to release the restriction of the locking block (s) 535 on the tooth-shaped connection part (s) 537.
As shown in FIGs. 19-23, in the embodiment, the locking mechanism 530 may include a pair of oppositely disposed locking blocks 535, and the first sub-control part and the second sub-control part may include tooth-shaped connection parts 537 corresponding to the locking blocks 535, respectively. Specifically, the tooth-shaped connection parts 537 may be connected to or integrally formed with the duct 521 of the first sub-control part or the second sub-control part, respectively. The pair of oppositely disposed locking blocks 535 may be configured to restrict the movement of the first sub-control part and the second sub-control part under the elastic force of the second elastic member 531, respectively. For example, one of the pair of locking blocks 535 corresponding to the first sub-control part may be snapped into one of the tooth-shaped connection parts 537 corresponding to the first sub-control part under the elastic force of the second elastic member 531. The other one of the pair of locking blocks 535 corresponding to the second sub-control part may be snapped into the other one of the tooth-shaped connection parts 537 corresponding to the second sub-control part under the elastic force of the second elastic member 531. In this embodiment, the second elastic member 531 may be two springs. There may be two locking buttons 533, which may be connected to the two locking blocks 535, respectively. The locking buttons 533 may be exposed from the housing 510. Taking the operation of the first sub-control part as an example, when one of the locking buttons 533 corresponding to the first sub-control part is pressed, it may drive the corresponding locking block 535 to overcome the elastic force of the second elastic member 531 so as to disengage from the corresponding tooth-shaped connection part 537. The operator may push or pull the first sub-control part (such as the duct 521 of the first sub-control part) to slide in the second sliding groove (s) 511 to control the first clip 210 to be opened or closed. When the operator releases the one of the locking buttons 533 corresponding to the first sub-control part, under the elastic force of the second elastic member 531, the locking block 535 may be re-snapped into the corresponding tooth-shaped connection part 537 to restrict the movement of the tooth-shaped connection part 537 (i.e., the movement of the duct 521) . The operation on the second sub-control part may be similar to that on the first sub-control part, which will not be repeated herein.
FIG. 24 is a structural schematic diagram illustrating a flexible pipe from a front view according to some embodiments of the present disclosure. FIG. 25 is a structural schematic diagram illustrating different parts of the flexible pipe according to some embodiments of the present disclosure. As shown in FIG. 24 and FIG. 25, the flexible pipe 610 may be connected to the front end (i.e., an end close to the mitral valve clamping device) of the delivery pipe 600. For example, the flexible pipe 610 may be connected to (such as laser welding) or integrally formed with the body of the delivery pipe 600. The front end of the flexible pipe 610 may be connected to a first connection member 800 through the delivery connection member 700. Through holes may be disposed on the delivery connection member 700. A driving rod 440 and a traction cable controlling the clamp chip to be opened or closed may pass through the through holes, respectively. In some embodiments, the flexible pipe 610 may include an inner core 612 and an outer pipe 614. The outer pipe 614 may be sleeved outside the inner core 612. In some embodiments, one or more through holes may be disposed inside the inner core 612 to allow the driving rod 440 and the traction cable controlling the clamp clip to be opened or closed to pass through.
In the embodiment shown in FIG. 24 and FIG. 25, the flexible pipe 610 may be disposed with a plurality of notches 616 along a length direction of the flexible pipe 610. Specifically, the outer pipe 614 of the flexible pipe 610 may be equipped with the plurality of notches 616. Using the plurality of notches 616, the flexible pipe 610 may be easily bent, and bent in a particular direction. In the embodiment, the plurality of notches 616 may be disposed on one side of the flexible pipe 610, so that the flexible pipe may be bent toward an opening direction of the notch 616. In other embodiments, the plurality of notches 616 may be spaced on different sides of the flexible pipe 610, so that the flexible pipe 610 may be bent toward a plurality of directions. In some embodiments, the outer pipe 614 of the flexible pipe 610 may be made of stainless steel (such as a pipe 316) or an elastic metal (such as nickel- titanium alloy) . The inner core 612 of the flexible pipe 610 may be made of an elastic material (such as nylon, silicone, heat shrinkable polyether block polyamide (Pebax) , polytetrafluoroethylene (PTFE) , etc. ) . In some embodiments, the flexible pipe 610 may have elasticity. If there is no external force, the flexible pipe 610 may maintain a cylindrical shape. Further, a polymer material layer (such as heat shrinkable polyether block polyamide (Pebax) ) may be disposed on an outer surface of the flexible pipe 610, which can effectively prevent the flexible pipe 610 from contacting blood. In some embodiments, the plurality of notches 616 may be disposed on one side of the flexible pipe 610, and a side of the inner core 612 facing the opening direction of the notched 616 may be equipped with a groove, and a traction rope 625 may be disposed in the groove. Specifically, the front end of the traction rope 625 may be fixedly connected (such as a welding connection, a bonding connection, etc. ) to the inner core 612 and/or outer pipe 614. The flexible pipe control mechanism 620 may control a bending of the flexible pipe 610 by pulling the traction rope 625.
FIG. 26 is a structural schematic diagram illustrating different parts of a flexible pipe control mechanism according to some embodiments of the present disclosure. In some embodiments, as shown in FIG. 26, the flexible pipe control mechanism 620 may include a screw 621, a rotating part 622, and a traction part 623. The screw 621 and the traction part 623 may be threadedly connected. The rotating part 622 may drive the screw 621 to rotate, thereby driving the traction part 623 to move. The traction part 623 may control the flexible pipe 610 to bend when moving. In some embodiments, the traction part 623 may include the traction rope 625 and a threaded traction block 627. One end (such as a rear end) of the traction rope 625 may be connected to the threaded traction block 627, and the other end (such as a front end) of the traction rope 625 may be fixedly connected to the front end of the flexible pipe 610. An internal thread may be disposed in the screw 621, and the threaded traction block 627 may be movably disposed in the screw 621 and cooperate with the internal thread of the screw 621. When the rotating part 622 drives the screw 621 to rotate, the screw 621 may drive the threaded traction block 627 to move, along the length direction, in the screw 621, so as to realize the traction or loosening of the traction rope 625, thereby controlling the bending of the flexible pipe 610. Specifically, the traction of the flexible pipe 610 by the traction rope 625 may cause the plurality of notches 616 on the flexible pipe 610 to be closed relative to each other, so that the flexible pipe 610 may bend. When the threaded traction block 627 stops moving, the flexible pipe 610 may maintain a bending state. When the threaded traction block 627 loosens the traction rope 625, the flexible pipe 610 may reduce a bending degree under its own elastic force until returning to a natural state (such as maintaining a cylindrical shape) .
The beneficial effects that the mitral valve repair device disclosed in the embodiments of the present disclosure may include but are not limited to: (1) a mitral valve is repaired by the mitral valve repair device using the clamp body with characteristics that the length of the first inner clamp arm is larger than the length of the second inner clamp and the length of the first outer clamp arm is larger than the second outer clamp arm, which can facilitate the dynamic balance of the valve (such as a mitral valve, a tricuspid valve) after being clamped, and ensure the stable operation of the repaired valve, thereby improving the effect of valve repair; (2) quick and accurate controlling of the inner clamp arm and/or the clamp clip of the mitral valve clamping device, with a higher accuracy of the mitral valve repair device in repairing the mitral valve; (3) quick controlling of the inner clamp arm of the clamping device, which may shorten the operation time; (4) the operation of mitral valve repair may be more convenient, and the efficiency and the success rate of mitral valve repair may be improved; and (5) effectively preventing misoperation during the mitral valve repair. It should be noted that different embodiments may have different beneficial effects. In different embodiments, the beneficial effects may include any of the beneficial effects mentioned above or any other beneficial effects that may be realized.
The above are only preferred embodiments of the present disclosure, but are not intended to limit the present disclosure. Any change, replacement and improvement made within the spirit and principle of the present disclosure shall be covered by the protection scope of the present disclosure.
Claims (20)
- A clamp body of a mitral valve clamping device, comprising a supporting part, a first inner clamp arm, a first outer clamp arm, a second inner clamp arm and a second outer clamp arm, whereina first side of the supporting part is connected to the first inner clamp arm and the first outer clamp arm in sequence via a bendable connection, and a second side of the supporting part is connected to the second inner clamp arm and the second outer clamp arm in sequence via a bendable connection;a length of the first inner clamp arm is larger than a length of the second inner clamp arm; anda length of the first outer clamp arm is larger than a length of the second outer clamp arm.
- The clamp body of claim 1, wherein the clamp body is in an integrally formed structure.
- The clamp body of claim 1, wherein a ratio of the length of the first inner clamp arm to the length of the first outer clamp arm is equal to a ratio of the length of the second inner clamp arm to the length of the second outer clamp arm.
- The clamp body of claim 3, wherein the length of the first inner clamp arm is 1.1 to 2.5 times the length of the second inner clamp arm.
- The clamp body of claim 1, whereinthe first side of the supporting part is connected to the first inner clamp arm via a first bendable structure;the second side of the supporting part is connected to the second inner clamp arm via the first bendable structure;the first inner clamp arm is connected to the first outer clamp arm via a second bendable structure; andthe second inner clamp arm is connected to the second outer clamp arm via the second bendable structure.
- The clamp body of claim 5, whereinthe first bendable structure includes a first S rod bendable structure or a first thin waist bendable structure; andthe second bendable structure includes a second S rod bendable structure or a second thin waist bendable structure.
- A mitral valve clamping device, comprising the clamp body of any one of claims 1-6.
- The mitral valve clamping device of claim 7, further comprising a first connection member, a second connection member, and a clamp clip, whereinthe clamp body is connected to the first connection member and the second connection member and between the first connection member and the second connection member, and a relative movement of the first connection member and the second connection member is configured to drive the first inner clamp arm and the second inner clamp to be opened or closed relative to each other; andthe clamp clip includes a first clip disposed on the first inner clamp arm and a second clip disposed on the second inner clamp arm, and the first clip and the second clip are able to be opened or closed relative to the first inner clamp arm and the second inner clamp arm, respectively, such that a mitral valve is clamped between the first clip and the first inner clamp arm, and clamped between the second clip and the second inner clamp arm.
- The mitral valve clamping device of claim 8, wherein the first inner clamp arm and the first clip are configured to clamp a valve leaflet with a relatively large area, and the second inner clamp arm and the second clip are configured to clamp a valve leaflet with a relatively small area.
- The mitral valve clamping device of claim 8, wherein the first inner clamp arm and the first clip are configured to clamp a valve leaflet with a relatively long length, and the second inner clamp arm and the second clip are configured to clamp a valve leaflet with a relatively short length.
- The mitral valve clamping device of claim 8, wherein the first inner clamp arm and the first clip are configured to clamp an anterior leaflet of the mitral valve, and the second inner clamp arm and the second clip are configured to clamp a posterior leaflet of the mitral valve.
- The mitral valve clamping device of claim 8, wherein a length of the first clip is larger than a length of the second clip.
- The mitral valve clamping device of claim 12, wherein a ratio of the length of the first clip to the length of the first inner clamp arm is equal to a ratio of the length of the second clip to the length of the second inner clamp arm.
- The mitral valve clamping device of claim 8, wherein the clamp clip includes a barbed clip, and the barbed clip includes a fixing part, a clipping part, and a barb, whereina first end of the fixing part is connected to a first end of the clipping part via a bending part; andthe barb is disposed on a second end of the clipping part.
- The mitral valve clamping device of claim 8, wherein the first clip and the first inner clamp arm are integrally formed by cutting, and the second clip and the second inner clamp arm are integrally formed by cutting.
- The mitral valve clamping device of claim 8, further including an elastic bracket, and the elastic bracket including a first supporting rod, a second supporting rod, a first mounting part and a second mounting part, whereina first end of the first supporting rod and a first end of the second supporting rod are connected to the first mounting part;a second end of the first supporting rod and a second end of the second supporting rod are connected to the second mounting part;the first supporting rod, the second supporting rod, the first mounting part, and the second mounting part are in an integrally formed structure;a length of the first supporting rod is larger than a length of the second supporting rod;the first mounting part and the second mounting part of the elastic bracket are fixedly connected to the second connection member;the first supporting rod of the elastic bracket bears against a connection of the first inner clamp arm and the first outer clamp arm; andthe second supporting rod of the elastic bracket bears against a connection of the second inner clamp arm and the second outer clamp arm.
- A mitral valve repair device, comprising a control handle and a mitral valve clamping device according to any one of claims 8-16, whereinthe control handle is configured to deliver the mitral valve clamping device to the mitral valve via a left atrial appendage and a left atrium, and control an openging or closing of the first inner clamp arm and the first clip of the mitral valve clamping device, and control an opening or closing of the second inner clamp arm and the second clip.
- The mitral valve repair device of claim 17, whereinthe control handle includes an inner clamp arm control mechanism configured to control a movement of the first inner clamp arm and the second inner clamp arm of the mitral valve clamping device;the inner clamp arm control mechanism includes a sleeve, a first control part, and a sliding part, the sliding part being disposed in the sleeve;the first control part is configured to rotate to drive the sliding part to move in the sleeve along a length direction of the sleeve and control an opening or closing of the first inner clamp arm and the second inner clamp arm;a chip control mechanism configured to control a movement of a clamp clip of the mitral valve clamping device;the chip control mechanism includes a housing and a second control part, the housing being equipped with a second sliding groove; andthe second control part is configured to pass through the second sliding groove and move along the second sliding groove, to control the first clip to be opened or closed relative to the first inner clamp arm, and control the second clip to be opened or closed relative to the second inner clamp arm.
- The mitral valve repair device of claim 17, further comprising a delivery pipe, wherein the first connection member of the mitral valve clamping device is connected to the control handle via the delivery pipe.
- The mitral valve repair device of claim 19, wherein the delivery pipe includes a flexible pipe, and the control handle further includes a flexible pipe control mechanism configured to control a bending of the flexible pipe.
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CN202010950172.0 | 2020-09-10 | ||
CN202010950172.0A CN111920549A (en) | 2020-09-10 | 2020-09-10 | Clip body of mitral valve clamping device, mitral valve clamping device and repair equipment |
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WO2022052506A1 true WO2022052506A1 (en) | 2022-03-17 |
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PCT/CN2021/094985 WO2022052506A1 (en) | 2020-09-10 | 2021-05-20 | Mitral valve clamping device, clamp body of mitral valve clamping device, and mitral valve repair device |
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