Clipping instrument and handle therefor, method of operation

Abstract

The application discloses a clamping instrument and a handle thereof, and an operation method. The handle of the clamping instrument comprises a shell, a rotating part with a torque limiting seat, a torque limiting disc, an elastic part for pressing the torque limiting disc on the torque limiting seat, and a first opening and closing knob for driving the torque limiting disc to rotate. The torque limiting seat and the torque limiting disc have a first matching surface and a second matching surface. The first matching surface is provided with a groove and a stopper. The stopper has a vertical surface, and the groove is arranged close to the vertical surface. The second matching surface is provided with a protrusion. The handle has an opening working state for opening the clamping arm and a closing working state for closing the clamping arm. In the opening working state, the protrusion is inserted into the groove and is in contact with the vertical surface. In the closing working state, the protrusion is inserted into the groove and has a tendency to be separated from the vertical surface, and is separated from the groove and the vertical surface when the force applied to the first opening and closing knob is greater than a set value. The application has the function of limiting the operation torque, is convenient to operate, and improves the safety.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, and particularly relates to a clamping device and its handle, as well as a method for operating the handle, especially a clamping device for cardiac interventional therapy. Background Technology

[0002] Cardiac interventional therapy is a novel technique for diagnosing and treating cardiovascular diseases. It eliminates the need for open-chest surgery. Guided by imaging methods, a catheter is inserted through a superficial blood vessel and, using certain instruments, delivered to the lesion site. Specific cardiac catheterization techniques are then employed to diagnose and treat heart disease. For example, document CN110403670A discloses a clamping device for holding human tissue (such as heart valve annulus). This device utilizes an actuating rod that rotates circumferentially relative to a positioning base and a movable base, changing the distance between the positioning and movable bases coaxially mounted on the actuating rod, thereby controlling the rotation of the clamping arm relative to the movable base. However, circumferential rotation of the actuating rod requires a certain amount of torque to close the tissue at a safe and effective angle. Excessive torque can exceed the structural strength limit, leading to device damage. Currently, most methods rely on the surgeon's feel, cannot provide accurate torque, are difficult to operate, and are prone to errors. Summary of the Invention

[0003] To address the aforementioned problems, one objective of this invention is to provide a clamping device and its handle, which has the function of limiting operating torque, making operation convenient and improving safety.

[0004] Another object of the present invention is to provide an operating method for a handle having the above-described clamping device, which can limit the operating torque.

[0005] According to one aspect of the present invention, a handle of a clamping device includes: A housing having a centerline extending along the length direction of the clamping device; A rotating element for transmitting a driving force to open or close the clamping arm of the clamping device, the rotating element being rotatably disposed within the housing about the center line, the rotating element including a torque limiting seat; A torque limiting disc is provided that is rotatable about and movable along the center line; An elastic element that presses the torque limiting disc against the torque limiting seat; A first opening and closing knob is used to drive the torque limiting disk to rotate. The first opening and closing knob is connected to the torque limiting disk and can be rotatably set relative to the housing. In this design, one component of the torque limiting seat and the torque limiting disc has a first mating surface, while the other component has a second mating surface. The first and second mating surfaces are arranged opposite to each other. The first mating surface is provided with a groove and a stop block. The stop block has a vertical surface, and the groove is located close to the vertical surface. The second mating surface has a protrusion extending toward the first mating surface. The protrusion and / or the groove has an inclined surface or a curved surface. The handle has an open working state for opening the clamping arm and a closed working state for closing the clamping arm. In the open working state, the protrusion is inserted into the groove and contacts the vertical surface. In the closed working state, the protrusion is inserted into the groove and tends to disengage from the vertical surface. When the force applied to the first opening / closing knob is greater than a set value, it disengages from the groove and the vertical surface.

[0006] In a preferred embodiment, the rotating member further includes a rotating seat, the rotating seat and the torque limiting seat being detachably connected; The handle also includes: The second opening and closing knob is used to drive the rotating base to rotate, and the second opening and closing knob is connected to the rotating base; The second opening and closing knob is rotatably connected to the housing about the center line, and the first opening and closing knob is rotatably connected to the second opening and closing knob about the center line relative to the second opening and closing knob; The handle also has an unlimited torque working state corresponding to the second opening and closing knob. Rotating the second opening and closing knob switches the handle to the unlimited torque working state, and rotating the first opening and closing knob switches the handle to the closed working state or the open working state.

[0007] More preferably, the rotating component further includes an adapter for connecting to the clamping arm, the adapter being connected to the rotating base.

[0008] More preferably, the housing has a front end and a rear end opposite thereto, the second opening and closing knob is rotatably connected to the rear end of the housing, and the first opening and closing knob is rotatably connected to the second opening and closing knob.

[0009] Furthermore, the front part of the rotating component is located inside the housing, the second opening and closing knob is sleeved on the rear part of the rotating component, and the first opening and closing knob is sleeved on the torque limiting disc.

[0010] In a preferred embodiment, a limiting nut is provided inside the housing, the rotating seat has external threads, the limiting nut is fitted onto the rotating seat and threadedly connected, the handle also includes a limiting member, the limiting member is fixedly connected to or integrally formed with the housing; the rotating seat has an extreme position, in which the limiting nut abuts against the limiting member.

[0011] More preferably, there are two limiting members, which are spaced apart from each other, and the limiting nut is located between the two limiting members.

[0012] Preferably, the torque limiting seat is connected to the front end of a connector, the connector including a main body extending along the center line and a flange located at the rear end of the main body, the torque limiting disc being sleeved on the main body of the connector, and the elastic element being disposed between the torque limiting disc and the flange to press the torque limiting disc tightly onto the torque limiting seat.

[0013] More preferably, the front end of the connector is movably connected to the torque limiting seat along the center line; the handle further includes a fastener for locking the torque limiting seat and the connector, the fastener being detachably connected to the torque limiting seat and the connector.

[0014] Furthermore, the rear end of the torque limiting seat is provided with a first screw hole extending along the center line and a second screw hole communicating with the first screw hole. The front end of the connector is inserted into the screw hole and threaded, the fastener is inserted into the second screw hole and threaded, and the end of the fastener abuts against the connector.

[0015] Preferably, the stop block also has an inclined surface opposite to the vertical surface; a plurality of the stop blocks are provided on the first mating surface, the plurality of stop blocks are distributed at intervals around the center line, the vertical surface of any stop block is opposite to the inclined surface of another adjacent stop block, a plurality of the protrusions are provided on the second mating surface, the plurality of protrusions are distributed at intervals along the center line, and there is one protrusion between two adjacent stop blocks.

[0016] Preferably, the first mating surface is perpendicular to the center line, and the angle between the inclined surface and the first mating surface is less than 45 degrees; the angle between the vertical surface and the first mating surface is between 80 degrees and 100 degrees, more preferably 90 degrees.

[0017] Preferably, the groove is conical in shape.

[0018] Preferably, the outer surface of the end of the stop block that is inserted into the groove is part of a sphere.

[0019] According to another invention of the present invention, a clamping device includes a handle, a clamping arm assembly, and an outer sheath assembly connected between the clamping arm assembly and the handle, wherein the handle is the handle of the clamping device as described above.

[0020] Preferably, the outer sheath assembly includes an outer sheath and an inner tube inserted into the outer sheath, the rear end of the outer sheath being connected to the housing, and the rear end of the inner tube being connected to the rotating member.

[0021] Preferably, the clamping arm assembly includes a pair of clamping arms, a movable seat, a fixed seat, a connecting rod, and a screw. The movable seat has a threaded hole, the front end of the screw is inserted into the threaded hole and threadedly connected, the fixed seat is sleeved on the screw and can rotate relative to the screw about the center line, the rear end of the clamping arm is rotatably connected to the movable seat, the front end of the connecting rod is rotatably connected to the clamping arm and the connection point is offset from the rear end of the clamping arm, and the rear end of the connecting rod is rotatably connected to the fixed seat.

[0022] According to another aspect of the present invention, a method of operating the handle of a clamping device as described above, for non-diagnostic and therapeutic purposes, includes the following steps: S1. Rotate the first opening and closing knob in the first direction to make the torque limiting disc drive the torque limiting seat to rotate in the first direction, so that the clamping arm opens. S2. Rotate the first opening / closing knob in the second direction to cause the torque limiting disc to drive the torque limiting seat to rotate in the second direction, thereby closing the clamping arm; the second direction is opposite to the first direction. In step S2, when the operating force applied to the first opening and closing knob is greater than the set value, the protrusion disengages from the groove, and the torque limiting seat stops rotating with the torque limiting disc.

[0023] Preferably, the handle further includes a second opening / closing knob connected to the rotating component; the operation method further includes the following steps: S3. Determine if the operating torque is sufficient. If it is sufficient, stop applying torque in the second direction. If it is insufficient, proceed with the following steps. S4. Rotate the second opening / closing knob in the second direction to drive the rotating component to rotate, so that the clamping arm continues to close.

[0024] Preferably, a limiting nut is provided inside the housing, the rotating component has external threads, the limiting nut is fitted onto the rotating component and threadedly connected, and the handle also includes a limiting component, which is fixedly connected to or integrally formed with the housing; In step S2, when the limiting nut abuts against the limiting member, rotation of the first opening / closing knob stops, and the angle of the clamping arm is at its minimum; or In step S3, when the limiting nut abuts against the limiting member, the rotation of the second opening and closing knob stops, and the angle of the clamping arm is at its minimum.

[0025] Preferably, a limiting nut is provided inside the housing, the rotating component has external threads, the limiting nut is fitted onto the rotating component and threadedly connected, and the handle also includes a limiting component, which is fixedly connected to or integrally formed with the housing; In step S1, when the limiting nut abuts against the limiting member, the first opening and closing knob stops rotating, and the opening angle of the clamping arm is at its maximum.

[0026] The present invention adopts the above solution, which has the following advantages compared with the prior art: The clamping device and its handle of the present invention, when the clamping arm is closed, if the operating torque applied to the first opening and closing knob is greater than the set value, the torque limiting disc and the torque limiting seat will slip, that is, the protrusion will disengage from the inclined surface, and the torque limiting seat will not rotate with the torque limiting disc. The excessive torque will not act on the rotating part and the parts connected to it, avoiding exceeding the structural strength of the device, thereby preventing damage to the device and providing extremely high safety. It can automatically limit the operating torque, without relying on the operator's feel, making the operation more convenient. It not only ensures the structural safety of the device, but also ensures that the tissue is clamped at the expected angle to achieve a good therapeutic effect. Attached Figure Description

[0027] To more clearly illustrate the technical solution of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0028] Figure 1 This is a perspective view of a clamping device according to an embodiment of the present invention.

[0029] Figure 2 for Figure 1 A partial schematic diagram of the clamping device is shown, in which a portion of the housing and a portion of the rotating seat are not shown.

[0030] Figure 3 for Figure 1 An exploded view of the clamping device is shown, in which a portion of the housing is not shown.

[0031] Figure 4 for Figure 3 A magnified view of a portion of point A in the middle.

[0032] Figure 5 for Figure 1A partial schematic diagram of the clamping device is shown, in which a portion of the housing, the first opening knob, and the second opening knob are not shown.

[0033] Figure 6 This is a perspective view of the outer sheath assembly and clamping arm.

[0034] Figure 7 for Figure 6 A magnified view of a section at point B in the middle.

[0035] Figure 8 This is a partial view of the outer sheath assembly and a cross-sectional view of the clamping arm along the center line.

[0036] Figure 9 This is a schematic diagram showing the connection between the second opening / closing knob and the rotating base.

[0037] Figure 10 This is a schematic diagram showing the interaction between the first opening / closing knob and the torque limiting disc.

[0038] Figure 11 This is a schematic diagram of the torque limiting seat, torque limiting disc, and connecting parts after assembly.

[0039] Figure 12 for Figure 11 An exploded view of the assembly shown.

[0040] Figure 13 for Figure 11 The front view of the assembly shown.

[0041] Figure 14 for Figure 13 A magnified view of a section at point C.

[0042] Figure 15 for Figure 13 A sectional view along the DD direction.

[0043] Figure 16 This is an exploded view of the torque limiting seat and the torque limiting disc.

[0044] Figure 17 This is a flowchart illustrating the operation of a clamping device according to an embodiment of the present invention.

[0045] in, 1. Handle; 10. Housing; 101. Limiting component; 11. First opening / closing knob; 12. Second opening / closing knob; 13. Rotating component; 13a. Rotating seat; 13b. Torque limiting seat; 13c. Adapter; 130. First mating surface; 131. Groove; 132. Stop; 132a. Inclined surface; 132b. Vertical surface; 133. First screw hole; 134. Second screw hole; 135. External thread; 14. Torque limiting disc; 141. Second mating surface; 142. Protrusion; 15. Elastic component; 16. Adjusting screw; 161. Flange; 17. Locking screw; 18. Limiting nut; 191. Key; 192. Keyway; 2. Sheath assembly; 21. Outer sheath; 22. Inner tube; 3. Clamping arm assembly; 30. Clamping arm; 31. Movable seat; 32. Fixed seat; 33. Connecting rod; 34. Screw. Detailed Implementation

[0046] The preferred embodiments of the present invention will now be described in detail with reference to the accompanying drawings, so that the advantages and features of the present invention can be more readily understood by those skilled in the art. It should be noted that the description of these embodiments is for the purpose of aiding understanding the present invention, but does not constitute a limitation thereof.

[0047] This embodiment provides a handle for a clamping device and a clamping device having such a handle. This clamping device can be used in minimally invasive catheter-based interventional treatment of tricuspid regurgitation, specifically for clamping human tissue (e.g., heart valve annulus) to the desired extent and suturing. Figures 1 to 16 A clamping device employing this type of handle is shown.

[0048] Reference Figures 1 to 16 As shown, the clamping device mainly includes a handle 1, a sheath assembly 2, and a clamping arm assembly 3. The clamping arm assembly 3 mainly includes a clamping arm 30, which clamps human tissue. The sheath assembly 2 connects the clamping arm assembly 3 to the handle 1. The handle 1 is used to grip and operate the clamping arm assembly 3, such as opening and closing the clamping arm 30. The sheath assembly 2 has an outer sheath 21 and an inner tube 22 that penetrates the outer sheath 21. Specifically, the inner tube 22 connects the clamping arm assembly 3 and the handle 1 to drive the clamping arm 30 to open and close.

[0049] The handle 1 of this clamping device mainly includes a housing 10, a first opening / closing knob 11, a second opening / closing knob 12, a rotating component 13, and a torque limiting disc 14. The housing 10 has a centerline c extending along the length of the clamping device. The housing 10 is a hollow cylindrical shape with a front end and a rear end opposite to it, the rear end being open. In this document, the direction of extension of the centerline c is defined as the front-rear direction, and the side of the component closer to / farthest from the operator from the clamping arm 30 is defined as "front," and vice versa. Specifically, in this embodiment, the housing 10 is formed by two half-shells connected by snap-fit. The second opening / closing knob 12 is a hollow cylinder with open front and rear ends. The front end of the second opening / closing knob 12 is rotatably connected to the rear end of the housing 10. Specifically, the rear end of the housing 10 is fitted over the outer side of the front end of the second opening / closing knob 12, and a limiting mechanism is provided between them to restrict their relative movement along the center line c (also known as the axial direction). Only the second opening / closing knob 12 is allowed to rotate relative to the housing 10 around the center line c, without any displacement in the front-to-back direction. The first opening / closing knob 11 is also a hollow cylinder. At least the front end of the first opening / closing knob 11 is open, and its front end is rotatably connected to the rear end of the second opening / closing knob 12. Specifically, in this embodiment, the rear end of the second opening / closing knob 12 is fitted over the outer side of the front end of the first opening / closing knob 11, and a limiting mechanism is provided between them to restrict their relative movement along the center line c. Only the first opening / closing knob 11 is allowed to rotate relative to the second opening / closing knob 12 around the center line c, without any displacement in the front-to-back direction.

[0050] The rotating component 13 transmits torque from the first opening / closing knob 11 or the second opening / closing knob 12 to the clamping arm 30 as a driving force for opening or closing the clamping arm 30. The rotating component 13 is rotatably disposed within the housing 10 about the center line c and can be driven to rotate by the first opening / closing knob 11 or the second opening / closing knob 12. The rotating component 13 specifically includes a rotating base 13a, a torque limiting base 13b, and an adapter 13c; the rear end of the inner tube 22 is connected to the rotating base 13a via the adapter 13c, and the rotating base 13a and the torque limiting base 13b are fixedly connected, integrally disposed, or detachably connected. The adapter 13c is fixedly connected to the rear end of the inner tube 22, and the adapter 13c is keyed to the front end of the rotating seat 13a. Specifically, the adapter 13c is provided with multiple keys 191, and the rotating seat 13a is provided with a corresponding keyway. The adapter 13c is inserted into the front end of the rotating seat 13a and keyed, so that the rotating seat 13a can drive the adapter 13c and the inner tube 22 to rotate in a first direction (e.g., counterclockwise) and a second direction (e.g., clockwise). The torque limiting seat 13b is embedded in the rear end of the rotating seat 13a and can drive the rotating seat 13a to rotate.

[0051] The first opening / closing knob 11 is connected to the torque limiting disk 14 (e.g., a key connection) to drive the torque limiting disk 14 to rotate; the second opening / closing knob 12 is connected to the rotating base 13a (e.g., a key connection) to drive the rotating base 13a to rotate. Specifically, as... Figure 9 As shown, the rear end of the rotating base 13a is located inside the front end of the second opening and closing knob 12. The rotating base 13a has multiple keys 191 extending along the center line c. The front end of the second opening and closing knob 12 has a corresponding keyway. Rotating the second opening and closing knob 12 causes the rotating base 13a to rotate accordingly. Figure 10 As shown, the torque limiting disk 14 is located inside the first opening and closing knob 11. The rear end of the torque limiting disk 14 is provided with multiple keys 191. The first opening and closing knob 11 has multiple keyways 192 extending along the center line c. The keys 191 can be movably inserted into the keyways 192 along the center line c. When the first opening and closing knob 11 is rotated, the torque limiting disk 14 rotates with the first opening and closing knob 11 and can also move slightly backward or forward along the center line c at the same time.

[0052] The torque limiting disc 14 is rotatable about and movable along the center line c, and is pressed against the torque limiting seat 13b by an elastic member 15. Figure 2 As shown, the torque limiting disc 14 is connected to the torque limiting seat 13b via a connector. Specifically, the connector is an adjusting screw 16, which includes a main body extending along the centerline c and a flange 161 (screw head) located at the rear end of the main body. The front end of the adjusting screw 16 is connected to the torque limiting seat 13b. The torque limiting disc 14 is sleeved on the main body of the adjusting screw 16. An elastic element 15, specifically a compression spring, is disposed between the torque limiting disc 14 and the flange 161 of the adjusting screw 16. The elastic element 15 has an initial deformation, applying a preset clamping force to the torque limiting disc 14, pressing it firmly against the torque limiting seat 13b.

[0053] The torque limiting seat 13b has a first mating surface 130 (i.e., the rear surface), on which a plurality of grooves 131 and a plurality of stops 132 are provided, three of which are shown in the figure. The plurality of grooves 131 and the plurality of stops 132 are spaced apart around the center line c. Each stop 132 has an inclined surface 132a and a vertical surface 132b. The vertical surface 132b of any stop 132 is spaced apart from and opposite to the inclined surface 132a of the adjacent stop 132; in other words, the groove 131 is provided between two adjacent stops 132 and adjacent to the vertical surface 132b of one of the stops 132. The first mating surface 130 is perpendicular to the center line c. The angle between the inclined surface 132a and the first mating surface 130 is less than 45 degrees, and the angle between the vertical surface 132b and the first mating surface 130 is between 80 degrees and 100 degrees, preferably 90 degrees. Furthermore, the facade 132b is disposed around one side of the groove 131, and the length of the surrounding surface is less than half the circumference of the groove 131; the inclined surface 132a of the other stop 132 is located on the other side of the groove 131. In some other embodiments, the stop may be disposed in the groove, and the facade forms part of the groove wall.

[0054] The torque limiting disc 14 has a second mating surface 141 (i.e., a front surface), with the first mating surface 130 and the second mating surface 141 disposed opposite to each other. The second mating surface 141 has a plurality of protrusions 142 extending forward toward the first mating surface 130, the number and position of which correspond to the grooves 131. The protrusions 142 can be inserted into the grooves 131, and at least one of the protrusions 142 and the grooves 131 has a slope or curved surface to allow the protrusions 142 to slide out of the grooves 131 when the torque is too high. Specifically, the grooves 131 are conical grooves, and the front ends of the protrusions 142 are hemispherical.

[0055] The handle 1 has an open working state for opening the clamping arm 30 and a closed working state for closing the clamping arm 30. In the open working state, each protrusion 142 is inserted into the corresponding groove 131 and contacts the surface 132b. In the closed working state, the protrusion 142 is inserted into the groove 131 and tends to disengage from the surface 132b, and when the force applied to the first opening / closing knob 11 is greater than a set value, the protrusion 142 disengages from the groove 131 and the surface 132b. Specifically, when it is necessary to open the clamping arm 30, the first opening / closing knob 11 is rotated counterclockwise, which drives the torque limiting disc 14 to rotate counterclockwise. The protrusion 142 is inserted into the groove 131 and contacts the surface 132b of the stop block 132, thereby driving the torque limiting seat 13b to rotate, which in turn drives the inner tube 22 to rotate counterclockwise, thus opening the clamping arm 30. When it is necessary to close the clamping arm 30, the first opening and closing knob 11 is rotated clockwise. When the operating force applied to the first opening and closing knob 11 is less than the set value, the front end of the protrusion 142 is still inserted in the groove 131 and will not press against the vertical surface 132b and has a tendency to detach from the vertical surface 132b. At this time, the torque limiting seat 13b can close the clamping arm 30 by rotating clockwise with the torque limiting seat 13b. However, when the operating force applied to the first opening and closing knob 11 is too large... When the operating torque exceeds the set value, the component of the operating torque along the center line c at the inclined groove wall of the groove 131 (slippage force) is greater than the elastic force of the elastic element 15. The torque limiting disc 14 overcomes the clamping force of the elastic element 15 and moves slightly backward. The protrusion 142 disengages from the groove 131, and the protrusion 142 even slides on the inclined surface 132a. That is, the torque limiting disc 14 and the torque limiting seat 13b slip, and the torque limiting seat 13b does not rotate with the torque limiting disc 14.

[0056] The handle 1 also has a corresponding unlimited torque working state for the second opening / closing knob 12. Rotating the second opening / closing knob 12 switches the handle 1 to the unlimited torque working state, while rotating the first opening / closing knob 11 switches the handle 1 to the closed or open working state. In the unlimited torque working state, rotating the second opening / closing knob 12 clockwise provides a larger torque to the clamping arm 30, closing it without being limited by the torque setting value. In this unlimited torque working state, unidirectional unlimited torque is possible; specifically, the torque required to close the clamping arm 30 is not limited.

[0057] The handle 1 also includes a fastener for locking the torque limiting seat 13b and the adjusting screw 16, specifically a locking screw 17. The locking screw 17 is detachably connected to the torque limiting seat 13b and the adjusting screw 16. Specifically, the rear end of the torque limiting seat 13b has a first screw hole 133 extending along the center line c and a second screw hole 134 communicating with the first screw hole 133. The front end of the adjusting screw 16 is inserted into the first screw hole 133 and threaded, the locking screw 17 is inserted into the second screw hole 134 and threaded, and the end of the locking screw 17 abuts against the adjusting screw 16 to lock the adjusting screw 16. By adjusting the length of the adjusting screw 16 inserted into the first screw hole 133, the clamping force of the elastic element 15 can be adjusted, that is, the slippage force between the torque limiting seat 13b and the torque limiting disc 14 can be adjusted. The elastic element 15 is compressed by the adjusting screw 16 and the torque limiting disc 14, pressing the torque limiting disc 14 against the torque limiting seat 13b with a certain pressure. Rotating the adjusting screw 16 can adjust the pressure value of the elastic element 15, and different pressure values ​​ultimately reflect different torque values. After adjusting and confirming a specific torque value, the adjusting screw 16 is fixed to the torque limiting seat 13b with the locking screw 17.

[0058] The handle 1 also has an angle limiting function. Specifically, a limiting nut 18 is provided inside the housing 10, and the front part of the rotating seat 13a has an external thread 135. The limiting nut 18 is fitted onto the rotating seat 13a and threadedly connected. The handle 1 also includes a limiting member 101, which is fixedly connected to or integrally formed with the housing 10. The rotating member 13 has an extreme position, in which the limiting nut 18 abuts against the limiting member 101. Specifically, there are two limiting members 101, which are spaced apart. The limiting nut 18 is located between the two limiting members 101. The rotating member 13 has an open extreme position and a closed extreme position. The limiting nut 18 is restricted from rotation by the housing 10 and can move axially along the center line c, but the axial travel of the limiting nut 18 is fixed by the two limiting members 101 on the housing 10. The number of rotations of the rotating seat 13a is related to the distance the limit nut 18 moves. Through calculation, the number of rotations of the rotating seat 13a can be designed, that is, the number of rotations of the inner tube 22 is set, which also sets the angle of the clamping arm 30, and the clamping arm 30 will not fall off due to excessive rotations.

[0059] The rear end of the outer sheath tube 21 is fixedly connected to the housing 10, and the rear end of the inner tube 22 is connected to the rotating seat 13a via an adapter 13c.

[0060] The clamping arm assembly 3 is disposed on the front end of the inner tube 22. Specifically, the clamping arm assembly 3 includes a pair of clamping arms 30, a movable seat 31, a fixed seat 32, a connecting rod 33, and a screw 34. The movable seat 31 is provided with a threaded hole, and the front end of the screw 34 is inserted into the threaded hole and threadedly connected; the fixed seat 32 is sleeved on the screw 34 and can rotate relative to the screw 34 about the center line c; the rear end of the clamping arm 30 is rotatably connected to the movable seat 31, the front end of the connecting rod 33 is rotatably connected to the clamping arm 30 and the connection point is offset from the rear end of the clamping arm 30, and the rear end of the connecting rod 33 is rotatably connected to the fixed seat 32, forming a crank-slider mechanism. As the inner tube 22 rotates, the movable seat 31 moves along the center line c on the screw 34 under the action of the thread, and the clamping arms 30 are relatively opened or closed through the first connecting rod 33.

[0061] This embodiment also provides a method for operating the handle 1 of the above-mentioned clamping device for non-diagnostic and therapeutic purposes. (Refer to...) Figure 17 As shown, the operation method also includes the following steps: S101. Rotate the first opening and closing knob 11 in the first direction to make the torque limiting disk 14 drive the torque limiting seat 13b to rotate in the first direction, so that the clamping arm 30 opens. S102. Rotate the first opening and closing knob 11 in the second direction to make the torque limiting disk 14 drive the torque limiting seat 13b to rotate in the second direction, so that the clamping arm 30 is closed; the second direction is opposite to the first direction. S103. Determine if the operating torque is sufficient. If not, proceed to step S104 below. If sufficient, stop applying torque in the second direction. S104. Rotate the second opening and closing knob 12 in the second direction to drive the rotating seat 13a to rotate, so that the clamping arm 30 continues to close until it is judged by experience to be in the correct clamping position, and then stop closing.

[0062] In step S102, when the operating force applied to the first opening and closing knob 11 is greater than the set value, the protrusion 142 disengages from the groove 131, the torque limiting disk 14 and the torque limiting seat 13b slip, the torque limiting seat 13b stops rotating with the torque limiting disk 14, and the clamping arm 30 stops closing.

[0063] Furthermore, in step S101, when the limiting nut 18 abuts against the limiting member 101 on the rear side, the first opening and closing knob stops rotating, and the opening angle of the clamping arm 30 is at its maximum.

[0064] In step S102, when the limiting nut 18 abuts against the front limiting member 101, the first opening and closing knob 11 stops rotating, and the clamping arm 30 closes to the set closing angle.

[0065] Alternatively, in step S103, when the limiting nut 18 abuts against the front limiting member 101, the second opening and closing knob 12 stops rotating, and the clamping arm 30 closes to the set closing angle.

[0066] In this embodiment, the operator first rotates the first opening and closing knob 11 counterclockwise. The torque limiting disc 14 drives the torque limiting seat 13b, the rotating seat 13a, the adapter 13c, and the inner tube 22 to rotate counterclockwise, opening the clamping arm 30. After the human tissue is clamped between the clamping arms 30, the operator operates the handle 1 in a way that limits the torque, that is, rotates the first opening and closing knob 11 clockwise. The torque limiting disc 14 drives the torque limiting seat 13b, the rotating seat 13a, the adapter 13c, and the inner tube 22 to rotate clockwise, closing the clamping arm 30. When the operating torque is greater than the set value, the torque limiting disc 14 and the torque limiting seat 13b slip, and the torque limiting seat 13b will not rotate with the torque limiting disc 14, thus avoiding excessive torque applied to the inner tube 22 and limiting the operating torque. In some other embodiments, steps S102 and S103 can be skipped, and step S104 can be executed directly. This allows for the selection of an unrestricted torque operating state, where the operator controls the torque by feel. Specifically, rotating the second opening / closing knob 12 clockwise causes the rotating seat 13a to directly rotate the adapter 13c and inner tube 22 clockwise, without being limited by the slippage between the torque limiting seat 13b and the torque limiting disc 14. This provides a larger torque, unrestricted by the torque setting value. Doctors can flexibly choose which operating method to use.

[0067] This embodiment has the following advantages: 1. Torque can be limited. Conventional clamping devices rely on the operator's feel to maintain torque within a suitable range. This method cannot provide accurate torque, cannot guarantee treatment effectiveness, and is prone to exceeding structural strength limits, leading to device damage. In this embodiment, however, the operating torque when closing the clamping arm 30 can be automatically limited, eliminating the need for manual control. This makes operation convenient, improves safety, and ensures that human tissue is closed at a safe and effective angle, achieving good treatment results.

[0068] 2. The maximum opening and closing angles of the clamping arm 30 can be limited. In conventional clamping devices, when the opening and closing knob is operated to open the clamping arm 30, there is no angle limiting device. If the opening angle is too large, the clamping arm 30 may easily fall off and cannot be restored, posing a significant safety risk. For example, the movable seat 31 may fall off the screw 34, causing a major safety accident. Alternatively, the opening angle of the clamping arm 30 can be limited by counting the number of turns of the opening and closing knob, such as mentally counting to 10 turns to stop, to ensure that the clamp does not fall off. This method requires skilled operators, is cumbersome, and is unreliable. In contrast, this application automatically limits the opening angle and closing of the clamping arm 30 by limiting the travel of the limiting nut. It eliminates the need to count turns, simplifies operation, reduces the risk of errors, and improves safety.

[0069] 3. The torque limiting function and the angle limiting function are independent and do not interfere with each other. In this embodiment, angle limitation and torque limitation are combined, each performing its function without interfering with the other. Angle limitation can be applied regardless of whether the working state is open, closed (torque limitation), or unlimited torque.

[0070] 4. The torque can be flexibly limited or not limited. In special circumstances where greater torque is required, the torque limit function can be bypassed, and greater torque can be applied directly, giving the operator more options.

[0071] As indicated in this specification and claims, the terms "comprising" and "including" only indicate the inclusion of expressly identified steps and elements, and these steps and elements do not constitute an exclusive list; the method or apparatus may also include other steps or elements. The term "and / or" as used herein includes any combination of one or more of the associated listed items.

[0072] It should be noted that, unless otherwise specified, when a feature is referred to as "fixed" or "connected" to another feature, it can be directly fixed or connected to the other feature, or indirectly fixed or connected to the other feature. Furthermore, the descriptions of "upper," "lower," "left," and "right" used in this invention are only relative to the relative positional relationships of the various components of the invention in the accompanying drawings, which can be referred to in the drawings. Figure 1 .

[0073] It can be further understood that in this disclosure, "multiple" refers to two or more, and other quantifiers are similar. "And / or" describes the relationship between related objects, indicating that there can be three relationships. For example, A and / or B can mean: A exists alone, A and B exist simultaneously, or B exists alone.

[0074] It is further understood that the terms "first," "second," etc., are used to describe various types of information, but this information should not be limited to these terms. These terms are only used to distinguish information of the same type from one another, and do not indicate a specific order or degree of importance. In fact, the expressions "first," "second," etc., are completely interchangeable. For example, without departing from the scope of this disclosure, first information can also be referred to as second information, and similarly, second information can also be referred to as first information.

[0075] The above embodiments are merely illustrative of the technical concept and features of the present invention, and are preferred embodiments. Their purpose is to enable those skilled in the art to understand the content of the present invention and implement it accordingly, and they should not be construed as limiting the scope of protection of the present invention. All equivalent transformations or modifications made according to the principles of the present invention should be covered within the scope of protection of the present invention.

Claims

1. A handle for a heart valve annulus clamping device, characterized in that, include: A housing having a centerline extending along the length direction of the clamping device; A rotating element for transmitting a driving force to open or close the clamping arm of the clamping device, the rotating element being rotatably disposed within the housing about the center line, the rotating element including a torque limiting seat; A torque limiting disc is provided that is rotatable about and movable along the center line; An elastic element that presses the torque limiting disc against the torque limiting seat; A first opening and closing knob is used to drive the torque limiting disk to rotate. The first opening and closing knob is connected to the torque limiting disk and can be rotatably set relative to the housing. In this configuration, one component of the torque limiting seat and the torque limiting disc has a first mating surface, while the other component has a second mating surface. The first and second mating surfaces are arranged opposite to each other. The first mating surface is provided with a groove and a stop block. The stop block has a vertical surface, and the groove is located close to the vertical surface. The second mating surface has a protrusion extending toward the first mating surface. The protrusion and / or the groove has an inclined surface or a curved surface. The stop block also has an inclined surface opposite to the vertical surface. Multiple stop blocks are provided on the first mating surface, and the multiple stop blocks are spaced apart around the center line. The vertical surface of any stop block is opposite to the inclined surface of an adjacent stop block. Multiple protrusions are provided on the second mating surface. The protrusions are spaced apart along the center line, with one protrusion between two adjacent stops; the first mating surface is perpendicular to the center line, the angle between the inclined surface and the first mating surface is less than 45 degrees, and the angle between the vertical surface and the first mating surface is between 80 and 100 degrees; the handle has an open working state for opening the clamping arm and a closed working state for closing the clamping arm. In the open working state, the protrusion is inserted into the groove and contacts the vertical surface; in the closed working state, the protrusion is inserted into the groove and tends to disengage from the vertical surface, and disengages from the groove and the vertical surface when the force applied to the first opening / closing knob is greater than a set value. The torque limiting seat is connected to the front end of a connector, the connector including a main body extending along the center line and a flange located at the rear end of the main body, the torque limiting disc being sleeved on the main body of the connector, the elastic element being disposed between the torque limiting disc and the flange to press the torque limiting disc onto the torque limiting seat; the front end of the connector is movably connected to the torque limiting seat along the center line; the handle also includes a fastener for locking the torque limiting seat and the connector, the fastener being detachably connected to the torque limiting seat and the connector.

2. The handle of the cardiac valve annulus clamping device according to claim 1, characterized in that, The rotating component also includes a rotating seat, which is detachably connected to the torque limiting seat; The handle also includes: The second opening and closing knob is used to drive the rotating base to rotate, and the second opening and closing knob is connected to the rotating base; The second opening and closing knob is rotatably connected to the housing about the center line, and the first opening and closing knob is rotatably connected to the second opening and closing knob about the center line relative to the second opening and closing knob; The handle also has an unlimited torque working state corresponding to the second opening and closing knob. Rotating the second opening and closing knob switches the handle to the unlimited torque working state, and rotating the first opening and closing knob switches the handle to the closed working state or the open working state.

3. The handle of the cardiac valve annulus clamping device according to claim 2, characterized in that, The rotating component also includes an adapter for connecting to the clamping arm, the adapter being connected to the rotating base.

4. The handle of the cardiac valve annulus clamping device according to claim 2, characterized in that, The housing has a front end and a rear end opposite to it, and the second opening and closing knob is rotatably connected to the rear end of the housing, and the first opening and closing knob is rotatably connected to the second opening and closing knob.

5. The handle of the cardiac valve annulus clamping device according to claim 4, characterized in that, The front part of the rotating component is located inside the housing, the second opening and closing knob is sleeved on the rear part of the rotating component, and the first opening and closing knob is sleeved on the torque limiting disc.

6. The handle of the cardiac valve annulus clamping device according to claim 2, characterized in that, A limiting nut is provided inside the housing, the rotating seat has an external thread, the limiting nut is fitted onto the rotating seat and threadedly connected, the handle also includes a limiting member, the limiting member is fixedly connected to or integrally formed with the housing; the rotating seat has an extreme position, in which the limiting nut abuts against the limiting member.

7. The handle of the cardiac valve annulus clamping device according to claim 6, characterized in that, The number of limiting members is two, and the two limiting members are arranged at an interval, with the limiting nut located between the two limiting members.

8. The handle of the cardiac valve annulus clamping device according to claim 1, characterized in that, The rear end of the torque limiting seat is provided with a first screw hole extending along the center line and a second screw hole communicating with the first screw hole. The front end of the connector is inserted into the screw hole and threaded, the fastener is inserted into the second screw hole and threaded, and the end of the fastener abuts against the connector.

9. The handle of the cardiac valve annulus clamping device according to claim 1, characterized in that, The groove is generally conical, and / or the outer surface of the end of the stop that is inserted into the groove is part of a spherical surface.

10. A heart valve annulus clamping device, comprising a handle, a clamping arm assembly, and an outer sheath assembly connected between the clamping arm assembly and the handle, characterized in that, The handle is the handle of the clamping device as described in any one of claims 1 to 9.

11. The cardiac valve annulus clamping device according to claim 10, characterized in that, The outer sheath assembly includes an outer sheath and an inner tube inserted inside the outer sheath. The rear end of the outer sheath is connected to the housing, and the rear end of the inner tube is connected to the rotating component.

12. The cardiac valve annulus clamping device according to claim 11, characterized in that, The clamping arm assembly includes a pair of clamping arms, a movable seat, a fixed seat, a connecting rod, and a screw. The movable seat has a threaded hole, and the front end of the screw is inserted into the threaded hole and threadedly connected. The fixed seat is sleeved on the screw and can rotate relative to the screw around the center line. The rear end of the clamping arm is rotatably connected to the movable seat. The front end of the connecting rod is rotatably connected to the clamping arm, and the connection point is offset from the rear end of the clamping arm. The rear end of the connecting rod is rotatably connected to the fixed seat.

13. A method for operating the handle of the cardiac valve annulus clamping device as described in claim 1, characterized in that, Includes the following steps: S1. Rotate the first opening and closing knob in the first direction to make the torque limiting disc drive the torque limiting seat to rotate in the first direction, so that the clamping arm opens. S2. Rotate the first opening / closing knob in the second direction to cause the torque limiting disc to drive the torque limiting seat to rotate in the second direction, thereby closing the clamping arm; the second direction is opposite to the first direction. In step S2, when the operating force applied to the first opening and closing knob is greater than the set value, the protrusion disengages from the groove, and the torque limiting seat stops rotating with the torque limiting disc.

14. The operating method according to claim 13, characterized in that, The handle further includes a second opening / closing knob connected to the rotating component; the operation method further includes the following steps: S3. Determine if the operating torque is sufficient. If it is sufficient, stop applying torque in the second direction. If it is insufficient, proceed with the following steps. S4. Rotate the second opening / closing knob in the second direction to drive the rotating component to rotate, so that the clamping arm continues to close.

15. The operating method according to claim 14, characterized in that, A limiting nut is provided inside the housing, the rotating component has external threads, the limiting nut is fitted onto the rotating component and threadedly connected, and the handle also includes a limiting component, which is fixedly connected to or integrally formed with the housing; In step S2, when the limiting nut abuts against the limiting member, rotation of the first opening / closing knob stops, and the angle of the clamping arm is at its minimum; or In step S3, when the limiting nut abuts against the limiting member, the rotation of the second opening and closing knob stops, and the angle of the clamping arm is at its minimum.

16. The operating method according to claim 13, characterized in that, A limiting nut is provided inside the housing, the rotating component has external threads, the limiting nut is fitted onto the rotating component and threadedly connected, and the handle also includes a limiting component, which is fixedly connected to or integrally formed with the housing; In step S1, when the limiting nut abuts against the limiting member, the first opening and closing knob stops rotating, and the opening angle of the clamping arm is at its maximum.

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