A handle for an implantation device

Abstract

A handle for an implant device is disclosed. The handle includes a housing, a middle tube connector seat for connecting a middle tube of a delivery sheath, movably disposed in the housing in a forward and backward direction, a dissociation knob for connecting an inner tube of the delivery sheath, rotatably connected to a rear end of the housing, a locking prompt member for prompting whether the implant is locked, one of the middle tube connector seat and the locking prompt member is provided with a first thread groove and a rebound groove, and the other is provided with a first connecting tooth, the rebound groove extends in the forward and backward direction and is communicated between a last thread groove and a second thread groove of the first thread groove, the first connecting tooth is located in the last thread groove when the middle tube connector seat moves to a last position, and can rebound into the second thread groove through the rebound groove and hit a groove wall of the second thread groove. The present application can prevent misoperation and avoid releasing the implant under the condition that the implant is not locked.

Description

[0001] This application is a divisional application of the invention patent application with application number 202211486695X filed on November 25, 2022. Technical Field

[0002] This invention belongs to the field of medical device technology, and particularly relates to a handle for an implantable device, especially a handle for a cardiac implantable device. Background Technology

[0003] Structural heart disease refers to anatomical abnormalities that cause changes in the internal tissues of the heart and the blood vessels that originate from it, resulting in vascular anatomy and pathophysiology. This includes congenital heart disease, valvular heart disease, cardiomyopathy, and great vessel diseases. For example, in the treatment of mitral regurgitation, many products on the market now offer edge-to-edge repair techniques.

[0004] Implantable devices for mitral regurgitation typically consist of two main parts: a handle and a delivery sheath. The delivery sheath's function is to deliver the implant via the cardiovascular system to the mitral valve in the left atrium. Through a series of logically linked movements, including the sequential motion of multiple sheath layers, the device controls the implant to clamp and close the mitral valve before releasing it. A typical implant includes an anterior clip and a posterior clip. The delivery sheath must perform a series of actions: opening, closing, and locking the anterior and posterior clips. The handle controls the delivery sheath to execute these actions in the correct logical sequence. The procedure is complex and requires a high level of operational logic; errors during surgery are prone to occur, posing a danger to the patient. For example, if the implant is released before the anterior and posterior clips are locked, it can lead to serious consequences such as the implant dislodging from the heart valve. Summary of the Invention

[0005] To address the aforementioned problems, the purpose of this invention is to provide a handle for an implantable device that can prevent accidental operation.

[0006] One aspect of the present invention provides a handle for an implantable device for manipulating a delivery sheath to clamp cardiac implantation tissue, the handle comprising: The outer casing has a front end and a rear end; A central tube connector for connecting to the central tube of the conveying sheath, the central tube connector being movably disposed within the housing in the back-and-forth direction; A disengagement knob for connecting to the inner tube of the delivery sheath, the disengagement knob being rotatably connected to the rear end of the housing; The handle also includes a locking indicator for indicating whether the implant is locked. The locking indicator is movably disposed in the housing in the front-back direction. The locking indicator cooperates with the central tube connector. One component of the central tube connector and the locking indicator has a first threaded groove and a spring-loaded groove, while the other component has a first connecting tooth. The first connecting tooth is inserted into the first threaded groove or the spring-loaded groove. The first threaded groove has a last threaded groove on the rearmost side and a second threaded groove adjacent to it. The spring-loaded groove extends in the front-back direction and communicates between the last threaded groove and the second threaded groove. When the central tube connector moves to the rearmost position, the first connecting tooth is located in the last threaded groove and can bounce back with the central tube connector through the spring-loaded groove to the second threaded groove and impact the groove wall of the second threaded groove.

[0007] Preferably, the handle further includes a linkage core, which is movably disposed in the release knob in the front-to-back direction, and the front end of the linkage core is threadedly connected to the rear end of the housing; wherein, one component of the release knob and the linkage core has a locking groove and the other component has a locking part that engages with the locking groove; The handle has a locked state and a released state. In the locked state, the locking part is inserted into the locking groove to prevent the release knob from rotating relative to the housing in a set direction. In the released state, the locking part disengages from the locking groove to allow the release knob to rotate relative to the housing in a set direction. During the switching process from the locked state to the released state, the middle tube connecting seat moves backward to connect with the linkage core and drives the linkage core to rotate, thereby causing the locking part to disengage from the locking groove.

[0008] More preferably, the handle further includes a locking element; the locking state includes a first locking state and a second locking state. In the first locking state, the locking element is located on the front side of the linkage core and in the path of the middle tube connecting seat moving backward; in the second locking state, the locking element leaves the path of the middle tube connecting seat moving backward.

[0009] More preferably, the locking element is a safety pin, the housing is provided with a pin hole, and the middle tube connecting seat has a blocking part that can abut against the safety pin; in the first locking state, the safety pin is inserted into the housing through the pin hole, the safety pin is located on the front side of the linkage core, and the blocking part is located on the front side of the safety pin or abuts against the front surface of the safety pin; in the second locking state, the safety pin is disengaged from the housing.

[0010] Furthermore, the handle also includes: An operating knob is rotatably mounted on the front end of the housing; A transmission component, which is driven to rotate by the operating knob, is rotatably disposed within the housing; The middle tube connecting seat and the transmission component are provided with a second threaded groove and a sliding groove, while the other component is provided with a second connecting tooth. The sliding groove and the second threaded groove are connected and extend backward or forward from one end of the second threaded groove. The second connecting tooth is inserted into the second threaded groove or the sliding groove. When the second connecting tooth is located in the sliding groove, the middle tube connecting seat can rotate with the transmission component. When the handle is in the first locked state, the second connecting tooth is located in the second threaded groove, and the middle tube connecting seat can drive the locking indicator to move backward; when the handle is in the second locked state, the second connecting tooth is located in the slide groove, the middle tube connecting seat can rotate with the transmission component, and the locking indicator can move forward; when the handle is in the disengaged state, the middle tube connecting seat can move back and forth until the second connecting groove is located at the end of the slide groove, after which the middle tube connecting seat automatically rebounds, the groove wall of the first threaded groove emits an impact sound, and the second connecting tooth impacts the groove wall of the second threaded groove, emitting an impact sound.

[0011] Furthermore, the locking indicator is fitted onto the central tube connecting seat, and the inner wall of the outer shell is provided with a limiting groove extending in the front-rear direction. The locking indicator has a first limiting tooth, which is slidably inserted into the limiting groove.

[0012] Furthermore, the inner wall of the outer casing is provided with a limiting groove extending in the front-rear direction, and the middle tube connecting seat has a second limiting tooth. When the first connecting tooth is in the sliding groove, the second limiting tooth disengages from the limiting groove. When the middle tube connecting seat is in the first threaded groove, the second limiting tooth is slidably inserted into the limiting groove.

[0013] Furthermore, the locking indicator is fitted onto the middle tube connector, and the transmission component is inserted into the middle tube connector. The middle tube connector has a first connecting tooth and a second connecting tooth. The inner sidewall of the locking indicator has a first threaded groove and a spring-loaded groove, and the outer sidewall of the transmission component has a second threaded groove and a sliding groove. The sliding groove extends linearly backward from the rear end of the second threaded groove. The first connecting tooth extends outward to insert into the first threaded groove, and the second connecting tooth extends inward to insert into the second threaded groove or the sliding groove. When the first connecting tooth is located at the rear end of the spring-loaded groove and the second connecting tooth is located at the rear end of the sliding groove, the middle tube connector automatically springs back.

[0014] Furthermore, the distance between the last threaded groove and the second threaded groove gradually increases, and the springback groove is located at the maximum distance between them.

[0015] Furthermore, the front part of the spring-loaded groove wall has a slope, so the width of the front part of the spring-loaded groove gradually increases from back to front. Even if the first connecting tooth does not spring back into place, the middle tube connecting seat can still rotate relative to the locking indicator to avoid jamming.

[0016] Furthermore, the rotation axis of the transmission component extends in the front-to-back direction, and the rotation axis of the operating knob intersects with the rotation axis of the transmission component.

[0017] Specifically, the front part of the transmission component has a first bevel gear, and the inner end of the operating knob is inserted into the housing and has a second bevel gear, with the first bevel gear and the second bevel gear meshing with each other.

[0018] Specifically, there are two operation knobs, which are located on opposite sides of the housing.

[0019] Preferably, the rear end of the middle tube connecting seat is provided with a cam connecting block, the linkage core is provided with a connecting groove, and the cam connecting block is inserted into the connecting groove during the switching process from the locked state to the disengaged state of the handle.

[0020] Preferably, the front end of the linkage core has an external thread, and the rear end of the outer shell has a matching internal thread, wherein the external thread and the internal thread are always engaged.

[0021] Preferably, the front part of the disengagement knob is detachably fitted onto the rear end of the housing.

[0022] Preferably, the locking groove is eccentrically located on the rear end of the release knob; the locking part is a rearward extension of the linkage core, and the extension is eccentrically located.

[0023] Preferably, a fixing seat is embedded in the rear part of the middle tube connecting seat to connect the middle tube of the conveying sheath through the fixing seat.

[0024] Preferably, the front end of the outer casing is provided with an outer tube connection component for connecting with the middle tube of the conveying sheath.

[0025] Another aspect of the present invention provides a method for operating the handle of the implantable device described above, for non-diagnostic and therapeutic purposes, the method comprising the following steps: S100, the central tube connector of the handle is moved to its final position to lock the front and rear clamping assemblies of the cardiac implant. The middle tube connecting seat and the linkage core are connected. The middle tube connecting seat drives the linkage core to rotate, so that the locking part disengages from the locking groove and the release knob is released. S200. Rotate the disengagement knob in the set direction to disconnect the inner tube from the cardiac implant, thereby allowing the inner tube to be removed.

[0026] Preferably, step S100 specifically includes the following steps: S101, Move the central tube connector rearward to abut against the locking member inside the housing to close the front clamp assembly of the cardiac implant to its minimum; S102. Remove the locking element and continue to move the middle tube connector backward to the middle position; at the middle position, the locking part is inserted into the locking groove, and the middle tube connector is rotated to release the release knob; S103. Continue to move the middle tube connector backward to its final position, stop operating the middle tube connector, the middle tube connector automatically springs forward, and collidees with the locking indicator of the middle tube connector to make a knocking sound. S104. Determine whether an impact sound has been emitted. If the result is yes, proceed to step S200; otherwise, do not proceed to step S200.

[0027] The present invention adopts the above solution, which has the following advantages compared with the prior art: The handle of the implantable device of the present invention, the middle tube connector can move back and forth. When the second connecting groove is located at the end of the sliding groove, the middle tube connector automatically rebounds under the tension of the middle tube, thereby emitting an impact sound to indicate to medical staff that the cardiac implant has been locked and that subsequent disengagement operations can begin to release the cardiac implant and withdraw the delivery sheath from the body. If no impact sound is heard, the lever knob should not be rotated to prevent accidental operation and effectively avoid accidentally releasing the implant without locking it, reducing the risks of surgeries such as mitral valve repair. Attached Figure Description

[0028] 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.

[0029] Figure 1 This is a perspective view of the handle of an implantable device according to an embodiment of the present invention, wherein the safety pin, outer tube, and outer tube connecting component are not shown.

[0030] Figure 2 for Figure 1An exploded view of the handle shown.

[0031] Figure 3 for Figure 2 The structural diagram of the outer shell.

[0032] Figure 4 for Figure 2 The structural diagram of the linkage core.

[0033] Figure 5 for Figure 2 The structural diagram of the middle tube connector.

[0034] Figure 6 for Figure 2 The structural diagram of the transmission components.

[0035] Figure 7a A front view of a locking indicator according to an embodiment of the present invention; Figure 7b and Figure 7c They are respectively Figure 7a Sectional views along the EE and FF axes.

[0036] Figure 8 This is a cross-sectional view of a handle according to an embodiment of the present invention, wherein the handle is in a first locked state.

[0037] Figure 9 This is a cross-sectional view of a handle according to an embodiment of the present invention, wherein the handle is in a first locked state and the blocking portion of the middle tube connecting seat abuts against the safety pin; Figure 10 This is a cross-sectional view of a handle according to an embodiment of the present invention, wherein the handle is switched to a second locked state; Figure 11 This is a cross-sectional view of a handle according to an embodiment of the present invention, wherein the handle is switched to a disengaged state; Figure 12 This is a cross-sectional view of the handle according to an embodiment of the present invention, wherein the handle is in a detached state and the middle tube connecting seat is in its final position. Figure 13 This is a cross-sectional view of the handle according to an embodiment of the present invention, wherein the handle is in a disengaged state and the middle tube connector has automatically returned to its original position.

[0038] Figure 14 This is a schematic diagram of the implantation of a cardiac implant with a handle to which the present invention can be applied.

[0039] Figure 15 This is a flowchart of an operation method according to an embodiment of the present invention.

[0040] Figure label: 100. Handle; 200. Delivery sheath; 300. Implant; 202. Middle tube; 203. Inner tube; 204. Guy wire; 301. Front clamp assembly; 302. Rear clamp assembly; 1. Outer shell; 10. Pin hole; 11. Internal thread; 12. Limiting groove; 2. Release knob; 20. Locking slot; 3. Linkage core; 30. Locking part; 31. External thread; 32. Connecting groove; 4. Middle tube connecting seat; 40. Cam connecting block; 41. Blocking part; 42. First connecting tooth; 43. Second connecting tooth; 44. Second limiting tooth; 45. Fixing seat; 5. Transmission component; 50. Second threaded groove; 51. Sliding groove; 52. First bevel gear; 6. Operation knob; 60. Second bevel gear; 7. Locking indicator; 70. First threaded groove; 70a. Last threaded groove; 70b. Second threaded groove; 71. Springback groove; 71a. Transition slope; 72. First limiting tooth; 8. Safety pin. Detailed Implementation

[0041] 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.

[0042] This embodiment relates to medical devices for interventional treatment of structural heart disease, particularly the handle of an implantable device used in mitral valve marginal-to-margin repair surgery. (See reference...) Figures 1 to 14 As shown, the handle 100 of this cardiac implantation device is used to manipulate the delivery sheath 200 to clamp the implant 300 with cardiac tissue and withdraw it after closing. Specifically, the cardiac implantation device mainly includes a delivery sheath 200 for carrying the implant 300 and a handle 100 for controlling the delivery sheath 200. The delivery sheath 200 includes an outer tube (not shown in the figure), a middle tube 202, and an inner tube 203 stacked from the inside out. Figure 15As shown, the implant 300 mainly includes a front clamping component 301 and a rear clamping component 302. The front clamping component 301 and the rear clamping component 302 can be opened and closed respectively. The front clamping component 301 and the rear clamping component 302 can also move relative to each other and lock together. The outer tube and the rear clamp assembly 302 are detachably connected, the middle tube 202 and the two clamping arms 3011 of the front clamp assembly 301 are detachably connected, and the inner tube 203 and the main base of the front clamp assembly 301 are detachably connected. The inner tube 203 and the front clamp assembly 301 are connected by threads and can be separated after rotating a certain number of times in a specific direction (such as counterclockwise). The middle tube 202 and the clamping arms 3011 of the front clamp assembly 301 are connected by a detachable elastic connecting buckle. When the inner tube 203 is withdrawn from the middle tube 202, the elastic connecting buckle resets inward, causing the middle tube 202 and the clamping arms 3011 to separate. Similarly, the outer tube and the rear clamp assembly 302 are also connected by a detachable elastic connecting buckle. When the middle tube 202 is withdrawn from the outer tube, the elastic connecting buckle resets inward, causing the outer tube and the rear clamp assembly 302 to separate. The delivery sheath 200 and the implant 300 are not the key points of this application. They can adopt structures known in the prior art. For example, the distal end of the delivery sheath 200 can be provided with a human cardiac implantation device delivery interface as disclosed in patent document CN113476182B, and the implant 300 can be connected through this interface. The implant 300 is a medical device with adjustable clamping method disclosed in patent document CN113768554A.

[0043] In this embodiment, combined with Figure 14As shown, the operation logic of the implant 300 generally includes the following actions: (1) After the delivery sheath 200 delivers the implant 300 to the placement area of ​​the heart, the middle tube 202 moves forward to open the front clamp assembly 301; (2) The middle tube 202 and the inner tube 203 move forward synchronously to move the front clamp assembly 301 forward; the release cable 204 opens the rear clamp assembly 302 (in the natural state, the rear clamp assembly 302 is in the unfolded state. When the delivery sheath 200 is delivered in the blood vessel, the cable 204 pulls back to retract the rear clamp assembly 302. When performing this action (2), the cable 204 is released forward, and the rear clamp assembly 302 opens automatically); (3) the outer tube (3) Move forward to bring the rear clamping assembly 302 closer to the front clamping assembly 301 until they merge; (4) Move the middle tube 202 backward a certain distance to close the front clamping assembly 301; (5) Move the middle tube 202 further backward to lock the front clamping assembly 301 and the rear clamping assembly 302 together, specifically locking the two clamping arms 3011 of the front clamping assembly 301 and the rear clamping assembly 302 together, with the two clamping arms 3011 clamped between the two elastic arms 3012 of the front clamping assembly 301; (6) Disconnect the inner tube 203, the middle tube 202, and the outer tube from the implant 300 in sequence, release the implant 300, and withdraw the delivery sheath 200 from the patient's body. In this embodiment, the handle 100 is interlocked with the control logic corresponding to the above-mentioned action sequence, and the next operation cannot be performed before the previous operation is completed, effectively preventing misoperation. The handle 100 that executes this operation logic is described in detail below.

[0044] Combination Figure 1 , Figure 2 and Figures 8 to 13 As shown, the handle 100 includes a housing 1, a release knob 2, a linkage core 3, a central tube connecting seat 4, a transmission component 5, an operating knob 6, and a locking indicator 7. The housing 1 has a front end and a rear end. The release knob 2 is rotatably connected to the rear end of the housing 1. The linkage core 3, the central tube connecting seat 4, the transmission component 5, and the locking indicator 7 are movably disposed within the housing 1. The operating knob 6 is rotatably connected to the front end of the housing 1. The front of the housing 1 also has an outer tube connecting component (not shown in the figure) for connecting to the outer tube of the delivery sheath. In this text, the directional terms "front" and "rear" are defined from the operator's (e.g., a doctor's) perspective, with the side farther from the operator being considered "front" and vice versa.

[0045] The middle tube connector 4 is used to connect with the middle tube 202 of the delivery sheath 200, and is movably disposed in the outer casing 1 in the front-to-back direction. The release knob 2 is used to connect with the inner tube 203 of the delivery sheath 200. The linkage core 3 is movably disposed in the release knob 2 in the front-to-back direction, and the front end of the linkage core 3 is threadedly connected to the rear end of the outer casing 1. One of the components, the release knob 2 and the linkage core 3, has a locking groove 20, while the other component has a locking part 30 that engages with the locking groove 20. The handle has a locked state and a released state. In the locked state, the locking part 30 is inserted into the locking groove 20 to prevent the release knob 2 from rotating relative to the outer casing 1 in a set direction; in the released state, the locking part 30 disengages from the locking groove 20 to allow the release knob 2 to rotate relative to the outer casing 1 in a set direction; during the switching process from the locked state to the released state, the middle tube connector 4 moves backward to connect with the linkage core 3 and drives the linkage core 3 to rotate, causing the locking part 30 to disengage from the locking groove 20.

[0046] The aforementioned locking states specifically include a first locking state and a second locking state. The handle also includes a locking element. In the first locking state, the locking element is located in front of the linkage core 3 and within the path of the rearward movement of the central tube connecting seat 4; in the second locking state, the locking element leaves the path of the central tube connecting seat 4. Specifically, the locking element is a safety pin 8, the housing 1 has a pin hole 10, and the central tube connecting seat 4 has a blocking portion 41 that can abut against the safety pin 8. In the first locking state, the safety pin 8 is inserted into the housing 1 through the pin hole 10, the safety pin 8 is located in front of the linkage core 3, and the blocking portion 41 is located in front of the safety pin 8 or abuts against the front surface of the safety pin 8; in the second locking state, the safety pin 8 disengages from the housing 1.

[0047] The following is a detailed description of each component.

[0048] Figure 3 Half of casing 1 is shown. (See reference...) Figure 3 As shown, the outer casing 1 is generally elongated cylindrical, and the inner wall of the rear end of the outer casing 1 is provided with multiple internal threads 11. A pin hole 10 is provided at the rear of the outer casing 1. A limiting groove 12 extending in the front-rear direction is provided on the inner wall of the middle part of the outer casing 1. An operating knob 6 is rotatably disposed at the front of the outer casing 1; specifically, the rotation axis of the operating knob 6 is perpendicular to the front-rear direction, and the inner end of the operating knob 6 is inserted into the outer casing 1 and has a second bevel gear 60. In this embodiment, there are two operating knobs 6, respectively disposed on opposite sides of the outer casing 1, for example, the left and right sides.

[0049] Figure 4 The linkage core 3 is shown, which can lock or release the disengagement knob 2 relative to the housing 1 to allow the disengagement knob 2 to rotate in a set disengagement direction (e.g., counterclockwise). (See reference...) Figure 4As shown, the rear part of the linkage core 3 forms a locking part 30, which is specifically an extension section extending rearward and is eccentrically positioned relative to the rotation axis of the release knob 2 (linkage core 3). In the locked state, the locking part 30 is inserted rearward into the locking groove 20, and the linkage core 3 and the release knob 2 cannot rotate relative to each other. The front end of the linkage core 3 has an external thread 31, which always engages with the internal thread 11 at the rear end of the housing 1. The linkage core 3 also has a connecting groove 32 that can mate with the middle tube connecting seat 4, which is eccentrically positioned relative to the rotation axis of the middle tube connecting seat 4 (linkage core 3).

[0050] Figure 5 The middle tube connector 4 is shown. (Refer to...) Figure 5 As shown, the rear end of the middle tube connecting seat 4 has a cam connecting block 40 eccentrically positioned relative to the rotation axis of the middle tube connecting seat 4. During the switching process from the self-locking state to the disengaged state of the handle 100, the cam connecting block 40 is inserted into the connecting groove 32. When the cam connecting block 40 is inserted into the connecting groove 32 of the linkage core 3, the middle tube connecting seat 4 can drive the linkage core 3 to rotate around its own axis, and under the action of the thread with the outer shell 1, the linkage core 3 rotates along... Figure 10 The locking part 30 moves forward in the direction indicated by the middle arrow a2, thereby disengaging the release knob 2 and releasing the release knob 2. This means the handle 100 is switched to the disengaged state, allowing the release knob 2 to rotate in the set direction, thus disconnecting the inner tube 203 from the cardiac implant. The rear of the inner tube connecting seat 4 also has a blocking part 41, which cooperates with the safety pin 8; specifically, the blocking part 41 is a stepped surface formed at the rear of the inner tube 202 connecting assembly and facing rearward. Figure 5 and Figures 8 to 13 As shown, the middle tube connector 4 also has a first connecting tooth 42 and a second connecting tooth 43. The first connecting tooth 42 extends radially outward from the outer surface of the front part of the middle tube connector 4, and the second connecting tooth 43 extends radially inward from the inner surface of the front part of the middle tube connector 4. The middle tube connector 4 also has a second limiting tooth 44, which extends radially outward from the outer surface of the middle tube connector 4. Figure 2 and Figure 5 As shown, a fixing seat 45 is embedded in the middle tube connecting seat 4 so as to connect the middle tube 202 of the conveying sheath 200 through the fixing seat 45.

[0051] Figure 6 Transmission component 5 is shown. (Refer to...) Figure 6As shown, a second threaded groove 50 and a sliding groove 51 are formed on the outer surface of the transmission component 5. The sliding groove 51 extends linearly rearward from the rear end of the second threaded groove 50 and communicates with the second threaded groove 50. The front part of the transmission component 5 has a first bevel gear 52, which meshes with a second bevel gear 60. As the operating knob 6 is rotated, the transmission component 5 rotates around its own axis. Further, the axis of rotation of the transmission component 5 extends in the front-rear direction, and the axis of rotation of the operating knob 6 intersects with the axis of rotation of the transmission component 5. In this embodiment, the axis of rotation of the operating knob 6 and the axis of rotation of the transmission component 5 are perpendicular to each other.

[0052] Figures 7a to 7c The structure of the locking indicator 7 is shown; the locking indicator 7 is used to indicate whether the implant is locked. Combined with... Figure 2 and Figures 7a to 7c As shown, the locking indicator 7 is specifically a threaded sleeve fitted onto the middle tube connecting seat 4. A first threaded groove 70 and a spring-loaded groove 71 are formed on the inner surface of the locking indicator 7. The first threaded groove 70 has a last threaded groove 70a located on the rearmost side and an adjacent second threaded groove 70b. The spring-loaded groove 71 extends in the front-rear direction and connects between the last threaded groove 70a and the second threaded groove 70b. The distance between the last threaded groove 70a and the second threaded groove 70b gradually increases from front to back, and the spring-loaded groove 71 is located at the maximum distance between them. Furthermore, the front part of the groove wall of the spring-loaded groove 71 has a slope 71a, so the width of the front part of the spring-loaded groove 71 gradually increases from back to front. Even if the first connecting tooth 42 of the middle tube connecting seat 4 does not spring back into place, the middle tube connecting seat 4 can still rotate relative to the locking indicator 7 under the action of the slope, avoiding jamming. Figure 7a , Figures 8 to 13 As shown, the locking indicator 7 also has a first limiting tooth 72, which specifically extends radially outward from the outer surface of the locking indicator 7.

[0053] Combination Figure 1 , Figure 2 , Figure 7b , Figure 7c and Figures 8 to 13As shown, the locking indicator 7 is movable in the housing 1 in the front-to-back direction. The locking indicator 7 cooperates with the middle tube connecting seat 4. The second connecting tooth 43 of the middle tube connecting seat 4 is inserted into the second threaded groove 50 or the spring-loaded groove 71 of the locking indicator 7. When the middle tube connecting seat 4 moves to its final position, the first connecting tooth 42 of the locking indicator 7 is located in the last threaded groove 70a and can spring back with the middle tube connecting seat 4 through the spring-loaded groove 71 to the second threaded groove 70b and impact the groove wall of the second threaded groove 70b. In some other embodiments, the first threaded groove and the spring-loaded groove can be provided on the middle tube connecting seat 4, and the locking indicator 7 is provided with the first connecting tooth. The transmission member 5 is driven to rotate by the operating knob 6 and is rotatably disposed in the housing 1. The second connecting tooth 43 of the middle tube connecting seat 4 is inserted into the second threaded groove 50 or the sliding groove 51. When the second connecting tooth 43 is located in the sliding groove 51, the middle tube connecting seat 4 can rotate with the transmission member 5. After the middle tube connecting seat 4 automatically springs forward, the second connecting tooth 43 also impacts the groove wall of the second threaded groove 50 of the transmission component 5, producing an impact sound. In some other embodiments, a second threaded groove and a sliding groove can also be provided on the middle tube connecting seat 4, while a second connecting tooth 43 can be provided on the transmission component 5.

[0054] In the first locked state, the second connecting tooth 43 of the handle 100 is located in the second threaded groove 50, and the middle tube connecting seat 4 can drive the locking indicator 7 to move backward. In the second locked state, the second connecting tooth 43 of the handle 100 is located in the slide groove 51, and the middle tube connecting seat 4 can rotate with the transmission component 5, and the locking indicator 7 can move forward. In the disengaged state, the middle tube connecting seat 4 can move back and forth until the second connecting groove 32 is located at the end of the slide groove 51. Then, the middle tube connecting seat 4 automatically rebounds under the tension of the middle tube 202, thus emitting a clicking sound to indicate to medical staff that the cardiac implant has been locked and that the subsequent disengagement operation can begin to release the cardiac implant and withdraw the delivery sheath 200 from the body.

[0055] It should also be noted that the locking indicator 7 is fitted onto the middle tube connecting seat 4, and the first limiting tooth 72 of the locking indicator 7 is slidably inserted into the limiting groove 12 of the outer shell 1; thus, when the middle tube connecting seat 4 rotates, the locking indicator 7 can move forward because the first limiting tooth 72 is limited by the limiting groove 12; when the middle tube connecting seat 4 moves backward, the locking indicator 7 can move backward accordingly. The middle tube connecting seat 4 has a second limiting tooth 44. When the first connecting tooth 42 is in the sliding groove 51, the second limiting tooth 44 disengages from the limiting groove 12; when the middle tube connecting seat 4 is in the first threaded groove 70, the second limiting tooth 44 is slidably inserted into the limiting groove 12; thus, the middle tube connecting seat 4 can slide back and forth along the limiting groove 12, and can also rotate with the operating knob 6 after disengaging from the limiting groove 12.

[0056] Furthermore, the transmission component 5 is inserted into the middle tube connector 4. The first connecting tooth 42 of the middle tube connector 4 extends outward to insert into the first threaded groove 70 of the locking indicator 7, and the second connecting tooth 43 of the middle tube connector 4 extends inward to insert into the second threaded groove 50 or the sliding groove 51 of the transmission component 5. When the first connecting tooth 42 is located at the rear end of the springback groove 71 and the second connecting tooth 43 is located at the rear end of the sliding groove 51, the middle tube connector 4 automatically springs back.

[0057] It should also be noted that the front of the release knob 2 is detachably fitted onto the rear end of the outer casing 1. After the release knob 2 is rotated a certain number of times in the set direction, the inner tube 203 and the cardiac implant are in contact and connected; at this time, pulling the release knob 2 backward will completely remove the inner tube 203 from the cardiac implant.

[0058] The operation method of the handle 100 of the implantable device in this embodiment is for non-diagnostic and non-therapeutic purposes and is applicable to the handle 100 described above. The operation method includes the following steps: S100, the central tube connector 4 of the handle 100 is moved to its last position to lock the anterior and posterior clamping components of the cardiac implant. Among them, the middle tube connecting seat 4 and the linkage core 3 are connected. The middle tube connecting seat 4 drives the linkage core 3 to rotate so that the locking part 30 is disengaged from the locking groove 20 and the release knob 2 is released. S200, rotate the disengagement knob 2 in the set direction to disconnect the inner tube 203 from the cardiac implant, thereby allowing the inner tube 203 to be removed.

[0059] Combination Figure 15 As shown, step S100 specifically includes the following steps: S101, Move the central tube connector 4 backward to abut against the locking member inside the housing 1 to close the front clamp assembly of the cardiac implant to its minimum; S102. Remove the locking part and continue to move the middle tube connecting seat 4 backward to the middle position; at the middle position, the locking part 30 is inserted into the locking groove 20, and the middle tube connecting seat 4 is rotated to release the release knob 2. S103. Continue to move the middle tube connector 4 backward to its last position, stop the operation on the middle tube connector 4, the middle tube connector 4 automatically springs forward, and the locking indicator 7 that cooperates with the middle tube connector 4 hits each other and makes a knocking sound. S104. Determine whether an impact sound has been emitted. If the result is yes, proceed to step S200; otherwise, do not proceed to step S200.

[0060] In step S103, after the middle tube connecting seat 4 automatically springs forward, it also impacts the groove wall of the second threaded groove 50 of the transmission component 5, producing an impact sound.

[0061] The operation of the handle 100 is roughly as follows: Rotating the operating knob 6 in the first direction moves the central tube connector 4 backward, causing the central tube 202 to move backward. Removing the safety pin 8 and continuing to rotate the operating knob 6 in the first direction causes the central tube connector to move the central tube 202 backward. Continuing to rotate the operating knob 6 will rotate the release knob 2 6 times. Continuing to rotate the operating knob 6 will stop the central tube connector from rotating and move backward, locking the cardiac implant before the central tube connector springs back. The cardiac implant is released after rotating the release knob 2 in the set direction (e.g., counterclockwise).

[0062] The following is about the combination Figures 8 to 13 The various states shown describe in detail the specific operation process of the handle 100 described above: (1) Figure 8 In the initial position, i.e., the first locked state, rotating the operating knob 6 in the first direction causes the middle tube connecting seat 4 to move backward due to the restriction of the second limiting tooth 44 by the limiting groove 12 and the interaction of the second connecting tooth 43 and the second threaded groove 50, thus moving the inner tube 203 backward until it reaches the safety pin 8 (i.e., the middle position of the middle tube connecting seat 4). Figure 9 As shown, due to the obstruction of safety pin 8, it cannot move further backward, and this operation will close the front clamp assembly to its minimum. Specifically, the second connecting tooth 43 is in the second threaded groove 50, and the second limiting tooth 44 is in the limiting groove 12, so the middle tube connecting seat 4 cannot rotate but can only move backward; at the same time, the first connecting tooth 42 is in the first threaded groove 70, so it drives the locking indicator 7 to move backward together.

[0063] (2) For example Figure 10 As shown, pull out the safety pin 8, and the handle 100 is in the second locked state. Continue to rotate the operating knob 6 in the first direction. At this time, the second limiting tooth 44 exits the limiting groove 12, and the second connecting tooth 43 enters the front end of the slide groove 51. Therefore, the middle tube connecting seat will not continue to move backward, but will rotate. At this time, the locking part 30 of the middle tube connecting seat 4 is inserted into the locking groove 20 of the linkage core 3. The middle tube connecting seat 4 rotates 6 times, which will drive the linkage core 3 to rotate. Due to the threaded engagement with the outer shell 1, the linkage core 3 will rotate along the... Figure 10 The middle arrow a2 moves forward and drives the disengagement knob 2 along the direction indicated by the middle arrow a2. Figure 10 Rotate 6 revolutions in the direction indicated by the middle arrow a1. Simultaneously, the rotation of the middle tube connector 4 will cause the locking indicator 7 to move along... Figure 10 Move forward to the end in the direction indicated by the middle arrow a3.

[0064] like Figure 11 As shown, after 6 rotations, the linkage core 3 will be pulled out from the release knob 2, and the locking indicator 7 will move forward to the end. At this time, the handle 100 switches to the release state.

[0065] (3) Continue to rotate the operating knob 6 in the first direction. As the locking indicator 7 moves forward to the bottom, and as the first connecting tooth 42 of the middle tube connecting seat 4 inserts into the first threaded groove 70 of the locking indicator 7, such as Figure 12 As shown, the middle tube connecting seat 4 will move backward to its final position until the first connecting tooth 42 enters the last threaded groove 70a. At this time, the middle tube connecting seat 4 will move forward due to the tension of the middle tube 202 to release the stress of the middle tube 202 (at this time, the clamping parts should be locked and the handle 100 will make a clicking sound, and the first connecting tooth 42 will slide directly into the second threaded groove 70b through the spring groove 71 at the end of the last threaded groove 70a. The clicking sound is the impact sound made by the first connecting tooth 42 returning forward to the second threaded groove 70b and hitting the groove wall, and the impact sound made by the first connecting tooth 43 returning forward to the second threaded groove 50 and hitting the groove wall). Figure 13 As shown in the diagram, rotating the dissociation knob 2 will dissociate the inner tube 203 from the cardiac implant.

[0066] 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 8 .

[0067] 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.

[0068] 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.

[0069] 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 an implantable device, used to manipulate a delivery sheath to clamp cardiac implantation tissue, characterized in that, The handle includes: The outer casing has a front end and a rear end; A central tube connector for connecting to the central tube of the conveying sheath, the central tube connector being movably disposed within the housing in the back-and-forth direction; A disengagement knob for connecting to the inner tube of the delivery sheath, the disengagement knob being rotatably connected to the rear end of the housing; The handle also includes a locking indicator for indicating whether the implant is locked. The locking indicator is movably disposed within the housing in a front-to-back direction. The locking indicator cooperates with the central tube connector. One component of the central tube connector and the locking indicator has a first threaded groove and a spring-loaded groove, while the other component has a first connecting tooth. The first connecting tooth is inserted into the first threaded groove or the spring-loaded groove. The first threaded groove has a last threaded groove on the rearmost side and an adjacent second threaded groove. The spring-loaded groove extends in a front-to-back direction and connects between the last threaded groove and the second threaded groove. When the central tube connector moves to its final position, the first connecting tooth is located in the last threaded groove and can spring back along with the central tube connector through the spring-loaded groove to the second threaded groove and strike the groove wall of the second threaded groove, producing an impact sound to indicate to medical personnel that the cardiac implant is locked and that subsequent disengagement operations can begin to release the cardiac implant and withdraw the delivery sheath from the body. If no impact sound is heard, the disengagement knob should not be rotated.

2. The handle of the implantable device according to claim 1, characterized in that, The handle also includes a linkage core, which is movably disposed in the release knob in the front-to-back direction, and the front end of the linkage core is threadedly connected to the rear end of the housing; wherein, one component of the release knob and the linkage core has a locking groove and the other component has a locking part that engages with the locking groove; The handle has a locked state and a released state. In the locked state, the locking part is inserted into the locking groove to prevent the release knob from rotating relative to the housing in a set direction. In the released state, the locking part disengages from the locking groove to allow the release knob to rotate relative to the housing in a set direction. During the switching process from the locked state to the released state, the middle tube connecting seat moves backward to connect with the linkage core and drives the linkage core to rotate, thereby causing the locking part to disengage from the locking groove.

3. The handle of the implantable device according to claim 2, characterized in that, The handle also includes a locking element; the locking state includes a first locking state and a second locking state. In the first locking state, the locking element is located in front of the linkage core and in the path of the middle tube connecting seat moving backward; in the second locking state, the locking element leaves the path of the middle tube connecting seat moving backward.

4. The handle of the implantable device according to claim 3, characterized in that, The locking element is a safety pin, the outer shell is provided with a pin hole, and the middle tube connecting seat has a blocking part that can abut against the safety pin; in the first locking state, the safety pin is inserted into the outer shell through the pin hole, the safety pin is located on the front side of the linkage core, and the blocking part is located on the front side of the safety pin or abuts against the front surface of the safety pin; In the second locked state, the safety pin disengages from the housing.

5. The handle of the implantable device according to claim 3, characterized in that, The handle also includes: An operating knob is rotatably mounted on the front end of the housing; A transmission component, which is driven to rotate by the operating knob, is rotatably disposed within the housing; The middle tube connecting seat and the transmission component are provided with a second threaded groove and a sliding groove, while the other component is provided with a second connecting tooth. The sliding groove and the second threaded groove are connected and extend backward or forward from one end of the second threaded groove. The second connecting tooth is inserted into the second threaded groove or the sliding groove. When the second connecting tooth is located in the sliding groove, the middle tube connecting seat can rotate with the transmission component. When the handle is in the first locked state, the second connecting tooth is located in the second threaded groove, and the middle tube connecting seat can drive the locking indicator to move backward; when the handle is in the second locked state, the second connecting tooth is located in the slide groove, the middle tube connecting seat can rotate with the transmission component, and the locking indicator can move forward; when the handle is in the disengaged state, the middle tube connecting seat can move back and forth until the second connecting tooth is located at the end of the slide groove, after which the middle tube connecting seat automatically rebounds, the first connecting tooth strikes the groove wall of the first threaded groove to make an impact sound, and the second connecting tooth strikes the groove wall of the second threaded groove to make an impact sound.

6. The handle of the implantable device according to claim 5, characterized in that, The locking indicator is fitted onto the central tube connector. The inner wall of the outer shell is provided with a limiting groove extending in the front-to-back direction. The locking indicator has a first limiting tooth, which is slidably inserted into the limiting groove.

7. The handle of the implantable device according to claim 5, characterized in that, The inner wall of the outer casing is provided with a limiting groove extending in the front-to-back direction. The middle tube connecting seat has a second limiting tooth. When the first connecting tooth is in the sliding groove, the second limiting tooth disengages from the limiting groove. When the middle tube connecting seat is in the first threaded groove, the second limiting tooth is slidably inserted into the limiting groove.

8. The handle of the implantable device according to claim 5, characterized in that, The locking indicator is fitted onto the middle tube connector, and the transmission component is inserted into the middle tube connector. The middle tube connector has a first connecting tooth and a second connecting tooth. The inner sidewall of the locking indicator has a first threaded groove and a spring-loaded groove, and the outer sidewall of the transmission component has a second threaded groove and a sliding groove. The sliding groove extends linearly from the rear end of the second threaded groove to the rear. The first connecting tooth extends outward to insert into the first threaded groove, and the second connecting tooth extends inward to insert into the second threaded groove or the sliding groove. When the first connecting tooth is located at the rear end of the spring-loaded groove and the second connecting tooth is located at the rear end of the sliding groove, the middle tube connector automatically springs back. The distance between the last threaded groove and the second threaded groove gradually increases, and the spring-loaded groove is located at the maximum distance between them. The front part of the groove wall of the spring-loaded groove has a slope, so the width of the front part of the spring-loaded groove gradually increases from back to front.

9. The handle of the implantable device according to claim 5, characterized in that, The rotation axis of the transmission component extends in the front-to-back direction, and the rotation axis of the operating knob intersects with the rotation axis of the transmission component.

10. The handle of the implantable device according to claim 9, characterized in that, The front part of the transmission component has a first bevel gear, and the inner end of the operating knob is inserted into the housing and has a second bevel gear. The first bevel gear and the second bevel gear mesh with each other. There are two operating knobs, which are located on opposite sides of the housing.

11. The handle of the implantable device according to claim 2, characterized in that, The rear end of the middle tube connector is provided with a cam connecting block. The handle includes a linkage core with a connecting groove. During the switching process from the locked state to the disengaged state, the cam connecting block is inserted into the connecting groove. The front end of the linkage core has an external thread, and the rear end of the housing has a matching internal thread. The external thread and the internal thread are always engaged.

12. The handle of the implantable device according to claim 2, characterized in that, The front part of the release knob is detachably fitted onto the rear end of the housing; the locking groove is eccentrically located on the rear end of the release knob; the locking part is a rearward extension of the linkage core, and the extension is eccentrically located.

13. The handle of the implantable device according to claim 1, characterized in that, A fixing seat is embedded in the rear part of the middle tube connector to connect the middle tube of the conveying sheath through the fixing seat; the front end of the outer shell is provided with an outer tube connecting component for connecting with the middle tube of the conveying sheath.

Images