Control device, conveying system and interventional therapy system

Abstract

The utility model relates to the technical field of medical instruments, and discloses a control device, a conveying system and an interventional therapy system.The control device is suitable for the interventional therapy system and comprises a control assembly and a feedback assembly; the control assembly comprises a control handle and a driving rod, and the control handle is used for driving the driving rod to rotate and axially move; the feedback assembly comprises a shifting piece and a rotating piece, the rotating piece is arranged on the driving rod, at least two tooth blocks are arranged on the rotating piece, and when the driving rod rotates, the shifting piece is suitable for being clamped to a certain tooth block so as to provide force feedback. Therefore, when an operator rotates the driving rod to a specific angle, the shifting piece can be matched with the corresponding tooth block, so that the operator can feel retardation during rotation, the operator is prompted to rotate in place or rotate by an angle, and the operator can operate more easily.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more particularly to a control device, delivery system, and interventional treatment system. Background Technology

[0002] Structural heart disease, broadly defined, refers to any abnormality in the structure of the heart and any disease related to the structure of the heart and great vessels, excluding primary coronary artery disease and electrocardiographic diseases (such as coronary artery disease and arrhythmias). Valvular heart disease is a common type of lesion, such as blood regurgitation caused by valvular lesions located between the atria and ventricles. Taking mitral regurgitation as an example, moderate to severe mitral regurgitation can lead to increased blood flow to the left atrium, elevated blood pressure, and may cause pulmonary hypertension, pulmonary edema, atrial fibrillation, heart failure, and even death.

[0003] With the development of interventional cardiology, transcatheter cardiac interventional techniques, characterized by minimal invasiveness, less pain, and rapid recovery, are increasingly being used in clinical practice. Interventional treatment for mitral regurgitation originates from surgical techniques. Interventional treatment for mitral regurgitation is suitable for patients with moderate to severe mitral regurgitation who cannot tolerate traditional surgery. The main types include annular repair, leaflet repair, and chordae tendineae repair, with corresponding surgical procedures including annulusoplasty, edge-to-edge repair, and chordae tendineae repair, among which edge-to-edge repair is the relatively mainstream approach. Due to the diversity of the anatomical structures of the valve annulus, leaflets, and adjacent areas, continuous improvement is needed in instrument design, such as enhancing the ease of operator manipulation and feedback response. Utility Model Content

[0004] The purpose of this application is to provide a control device, a delivery system, and an interventional treatment system, wherein the control device can provide feedback during operation by the operator, making it easier for the operator to perform the operation.

[0005] The technical solution provided by this utility model is as follows:

[0006] A control device for an interventional therapy system, comprising:

[0007] A control assembly includes a control handle and a drive element, the control handle being used to drive the rotation and axial movement of the drive element;

[0008] The feedback component includes a paddle and a rotating component, the rotating component being disposed on the drive element and having at least two toothed blocks. When the drive element rotates, the paddle is adapted to engage with one of the toothed blocks to provide force feedback.

[0009] In some embodiments, the number of toothed blocks on the rotating member is multiple, and a groove is formed between two adjacent toothed blocks to accommodate the paddle.

[0010] In some embodiments, the toothed blocks have guide surfaces on both sides of the rotating member in the circumferential direction, which are adapted to guide the paddle into and out of the slot.

[0011] In some embodiments, the paddle is made of a metal spring.

[0012] In some embodiments, the control device further includes:

[0013] A fixing block is used to fix the lever;

[0014] The paddle includes an inclined portion and a straight portion. The inclined portion is fixedly connected to the fixed block, and the straight portion is used to engage with the toothed block on the rotating component.

[0015] In some embodiments, the driving element includes a sleeve and a driving rod, with the rotating member disposed in the sleeve;

[0016] The control handle is connected to the proximal end of the sleeve, driving the rotation of the sleeve and the drive rod, as well as their axial upward movement towards the proximal end.

[0017] In some embodiments, the drive rod includes a first segment at a distal end and a second segment at a proximal end; the radial dimension of the first segment is greater than the radial dimension of the second segment;

[0018] The sleeve has a first internal space, the control handle has a second internal space, the second internal space and the first internal space are connected, the second section passes through the first internal space and the second internal space, the first section partially passes through the first internal space, and the distal end of the first section extends out of the sleeve from the distal end of the sleeve, restricting the relative rotation between the drive rod and the sleeve.

[0019] In some embodiments, the control component further includes a first elastic member sleeved within the second segment in the first internal space, wherein the proximal end of the first elastic member is axially limited at the proximal end of the first internal space, and the distal end of the first elastic member is axially limited at the distal end of the first internal space or the proximal end of the first segment.

[0020] In some embodiments, the control device further includes:

[0021] The housing and connecting assembly include a limiting rail and a limiting element, the limiting rail extending axially along the drive rod, and the limiting element matching the limiting rail and slidable axially relative to the limiting rail;

[0022] The distal end of the sleeve is axially limited by the limiting element, the inner wall of the housing is provided with the limiting track, and the distal end of the sleeve can rotate relative to the limiting element.

[0023] In some embodiments, the number of limiting elements is two, symmetrically arranged on both sides of the distal end of the sleeve, and the number of limiting tracks is two, symmetrically arranged on the housing.

[0024] In some embodiments, the connecting assembly further includes a connector for connecting the two limiting elements and fitting them onto the distal end of the sleeve;

[0025] The connecting assembly further includes two limiting rings, which are rotatably fitted onto the distal end of the sleeve, and the connecting member is axially limited between the two limiting rings.

[0026] In some embodiments, the control device further includes:

[0027] A locking assembly includes a locking member, the locking member having an opening adapted for the sleeve to pass through, and the locking member having a locking side corresponding to the periphery of the opening;

[0028] The locking member can be selectively positioned in a first position and a second position. In the first position, the locking side is abutted against the sleeve to restrict axial movement of the sleeve. In the second position, the locking side is away from the sleeve, suitable for the operating handle to move the sleeve and the drive rod proximally.

[0029] In some embodiments, the control device further includes a housing, and the locking assembly further includes a push rod and a second elastic member; the push rod and the locking member are connected to each other, and the two ends of the second elastic member abut against the outer wall of the locking member and the inner wall of the housing, respectively;

[0030] The sleeve includes a base, the proximal end of the base is connected to the control handle, the sleeve is also provided with a first limiting structure, a limiting groove is formed between the first limiting structure and the base, and a second limiting structure is provided on the locking side;

[0031] In the first position, the second elastic element is compressed and has an outward elastic force. The locking side of the locking element is against the sleeve, and the second limiting structure is located in the limiting groove to restrict the axial movement of the sleeve. In the second position, the push rod is pressed inward to further compress the second elastic element, and the locking side is away from the sleeve, allowing the first limiting structure to pass through the locking element.

[0032] This application also discloses a conveying system, including:

[0033] Implantation catheter, delivery rod, and control device as provided in any of the above embodiments;

[0034] The proximal end of the delivery rod is connected to the distal end of the drive rod, and the distal end extends along the internal channel of the implantation catheter until it exits the distal end of the implantation catheter. The control device is located at the proximal end of the implantation catheter and is used to drive the radial rotation and axial displacement of the delivery rod.

[0035] It also includes a delivery catheter to provide an implantation pathway.

[0036] This application discloses another interventional therapy system, characterized in that it includes:

[0037] Implant and delivery system as described above;

[0038] The control device drives the delivery rod to control the state of the implant, as well as the connection and disconnection of the implant from the delivery system.

[0039] The technical advantages of this application are as follows:

[0040] 1. In this application, by setting up a paddle and a rotating component, and utilizing the cooperation between the teeth on the paddle and the rotating component, force feedback can be provided during the operator's operation, so that the operator can feel the resistance when rotating, thereby indicating to the operator that the rotation has reached the correct position or the angle of rotation, making it easier for the operator to perform the operation.

[0041] 2. In this application, the paddle uses a metal spring with good resilience. When engaged with the toothed block, it provides not only force feedback but also audible feedback. Furthermore, the toothed block has guide surfaces on both sides of the rotating part's circumferential direction. Whether the operator rotates the control handle clockwise or counterclockwise, the paddle can easily disengage from its original slot under the guidance of these guide surfaces, providing force feedback without affecting the normal rotation of the control handle, resulting in good usability. Attached Figure Description

[0042] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments:

[0043] Figure 1 This is a schematic diagram of a transcatheter interventional therapy application scenario provided in one embodiment of this application;

[0044] Figure 2 This is a schematic diagram of the structure of an interventional therapy system provided in one embodiment of this application;

[0045] Figure 3 This is a schematic diagram of the structure of the clutch assembly connected to the implant provided in one embodiment of the present application;

[0046] Figure 4 This is a schematic diagram of the structure of the clutch assembly for removing the implant provided in one embodiment of this application;

[0047] Figure 5 This is a schematic diagram of the implantation catheter, clutch assembly, and valve clamping device provided in one embodiment of this application;

[0048] Figure 6 This is a partial schematic diagram of an interventional treatment system provided in one embodiment of this application;

[0049] Figure 7 This is a schematic diagram of the structure of a control device provided in one embodiment of this application;

[0050] Figure 8 This is a schematic diagram of the structure of a driving component provided in one embodiment of this application;

[0051] Figure 9 This is a schematic diagram of the implantable catheter, clutch assembly, and valve clamping device provided in another embodiment of this application;

[0052] Figure 10 This is a remote schematic diagram of a driving component provided in one embodiment of this application;

[0053] Figure 11 This is a side view of a driving component provided in one embodiment of this application;

[0054] Figure 12 This is a schematic diagram of the structure of a driving component and a connecting component provided in one embodiment of the present application;

[0055] Figure 13 This is a schematic diagram of the structure of a driving component and a feedback component provided in one embodiment of this application;

[0056] Figure 14 This is a schematic diagram of the structure of a feedback component provided in one embodiment of this application;

[0057] Figure 15 This is a schematic diagram of a control device provided in another embodiment of this application. Detailed Implementation

[0058] In the following description, specific details such as particular system architectures and techniques are set forth for illustrative purposes and not for limitation, in order to provide a thorough understanding of the embodiments of this application. However, those skilled in the art will understand that this application can also be implemented in other embodiments without these specific details. In other instances, detailed descriptions of well-known systems, apparatuses, circuits, and methods have been omitted so as not to obscure the description of this application with unnecessary detail.

[0059] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the specific implementation methods of this application will be described below with reference to the accompanying drawings. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings and other implementation methods can be obtained based on these drawings without creative effort.

[0060] To keep the drawings concise, each drawing only schematically shows the parts relevant to this application, and they do not represent the actual structure of the product. Furthermore, for ease of understanding, in some drawings, only one of the components with the same structure or function is schematically shown, or only one is labeled. In this document, "one" not only means "only one," but can also mean "more than one."

[0061] It should also be further understood that the term “and / or” as used in this application specification and the appended claims means any combination of one or more of the associated listed items and all possible combinations, and includes such combinations.

[0062] In this document, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0063] In the embodiments shown in the accompanying drawings, the directional indications (such as up, down, left, right, front, and back) used to explain the structure and movement of the various components of this application are relative rather than absolute. These descriptions are appropriate when these components are in the positions shown in the drawings. If the descriptions of the positions of these components change, these directional indications also change accordingly.

[0064] In the embodiments of this application, "proximal end" refers to the end of the associated object closer to the surgeon; "distal end" refers to the end of the associated object farther from the surgeon. "Proximal end" and "distal end" are the position or orientation of the associated object (e.g., a component of a medical device) relative to the surgeon from the perspective of the surgeon (e.g., a doctor) using the device (e.g., a medical device). For example, "proximal end" refers to the end closer to the doctor during normal operation of the medical device, while "distal end" refers to the end farther from the doctor during normal operation of the medical device, that is, the end that first enters the patient's body.

[0065] Furthermore, in the description of this application, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0066] Transcatheter interventional therapy (TCA) involves introducing implants such as materials, medical devices, or drugs into the body via catheters for minimally invasive diagnosis and / or treatment of diseases. TCA can achieve better therapeutic effects with smaller incisions and facilitates better postoperative recovery, thus its increasing clinical application is a growing trend. For example, TCA can be used for endovascular specimen retrieval or angiography; it can also be used for drug infusion, embolization, angioplasty, endovascular stent placement, vascular filter placement, removal of foreign bodies or thrombi from blood vessels, or rotational atherectomy of plaques; and it can be used to implant medical devices into organs such as the heart for the treatment of heart diseases.

[0067] For example, regarding the treatment of heart disease, please refer to... Figure 1 This is a schematic diagram of a transcatheter interventional therapy application scenario provided in an embodiment of this application. Figure 1 The structure of the heart is shown, such as Figure 1 As shown, the heart is a hollow muscular organ with four chambers: the left atrium (LA) 11, the right atrium (RA) 21, the left ventricle (LV) 12, and the right ventricle (RV) 22. Atrioventricular valves (hereinafter referred to as valves) connect the atria and ventricles. During ventricular diastole, the valves open, allowing blood to flow from the atria into the ventricles; during ventricular systole, the valves close, preventing blood from flowing back from the ventricles into the atria. The valve between the left atrium 11 and the left ventricle 12 is the mitral valve (MV) 13, and the valve between the right atrium 21 and the right ventricle 22 is the tricuspid valve (TV) 23. The mitral valve 13 has two leaflets that hang downwards into the ventricular cavity and is connected to the left ventricular wall via chordae tendineae 14 and papillary muscles 15. The tricuspid valve 23 has three leaflets that hang downwards into the ventricular cavity and is connected to the right ventricular wall via chordae tendineae 24 and papillary muscles 25. The major blood vessels connected to the heart mainly include the aorta 31, pulmonary artery 32, superior vena cava 41, and inferior vena cava 42. The heart and major blood vessels work together to achieve blood circulation.

[0068] For example, transcatheter interventional therapy can be applied to structural heart diseases, such as those caused by abnormalities in the structure of the heart or great vessels. These include valvular diseases and valve defects. Valvular diseases include regurgitation caused by lesions of valves located between the atria and ventricles (e.g., mitral or tricuspid regurgitation), aortic stenosis, aortic regurgitation, pulmonary stenosis, or pulmonary regurgitation. Valvular defects include ventricular septal defect (VSD), atrial septal defect (ASD), or patent ductus arteriosus. For valvular diseases such as mitral or tricuspid regurgitation, transcatheter interventional therapy can be used to deliver implantable medical devices such as valve clamping devices to the lesion site for edge-to-edge repair of the mitral or tricuspid valves. For defects such as ventricular septal defect (VSD), atrial septal defect (ASD), or patent ductus arteriosus, transcatheter interventional therapy can be used. This involves implanting medical devices such as occluders and delivering them to the lesion site via a catheter to close the defects in the left or right ventricles or the left or right atria, or to block the passage between the aorta and the pulmonary artery.

[0069] Due to the complexity of the internal environment of a living organism, such as the diversity of anatomical structures in the valve annulus, leaflets, and adjacent areas, the surgeon's skill in manipulating the implant is highly demanding. Problems such as insufficient maneuverability and cumbersome procedures may arise, thus affecting the effectiveness of interventional treatment. This application provides a control device that improves the convenience and feedback response for the surgeon, making it easier for them to operate the device. Simultaneously, the implant remains stable during implantation, facilitating a smooth surgical procedure.

[0070] The following description is in conjunction with the accompanying drawings:

[0071] Please refer to Figure 2 This is a schematic diagram of the structure of an interventional treatment system provided in an embodiment of this application. Figure 2 As shown, the interventional therapy system 1 includes a delivery system 200 and an implant 100. The delivery system 200 is used to deliver the implant 100; the implant 100 includes, for example, an implantable medical device. The delivery system 200 includes, for example, a catheter 210 and a control mechanism 220. The catheter 210 provides a delivery channel for the implant 100, and the control mechanism 220 controls the distal movement of the catheter 210; the control mechanism 220 can also be used to control the implant 100, for example, controlling the connection and disconnection of the implant 100 from the distal end of the catheter 210, and, for example, controlling the state of the implant 100. By controlling the state of the distal end of the implant 100 through the control mechanism 220, the implant 100 can adapt to the distal environment and change its state, which is beneficial for controlling the implantation process of the implant 100, allowing the implant 100 to be implanted more accurately at the lesion site.

[0072] The catheter 210 may employ a multi-layer catheter structure, such as including at least two layers of catheters, where the outer layer provides an operating channel for the other catheters used for delivery of the implant 100. The control mechanism 220 includes, for example, multiple control devices for controlling the distal movement of the catheter 210. For example, such as... Figure 2 As shown, the delivery system 200 includes, for example, a three-layer catheter structure and corresponding control devices for the three layers of catheters. For example, catheter 210 includes a delivery catheter 211, a control catheter 212, and an implantation catheter 213; the control mechanism 220 includes control devices 221, 222, and 223, respectively used to control the distal movement of the delivery catheter 211, the control catheter 212, and the implantation catheter 213. The control mechanism 220 may also include a loader 224, which includes a base 2241 and a loading catheter 2242. In use, the loading catheter 2242 passes through the proximal end of the control device 221, becoming a channel for the control catheter 212, the implantation catheter 213, and the implant 100 to enter the delivery catheter 211, and the implant 100 is loaded into the delivery catheter 211 via the control device 221. To complete the implantation procedure, the distal ends of the delivery catheter 211 and the control catheter 212 should have navigation settings so that the surgeon can adjust the distal curvature according to the surgical requirements and control the direction of the distal end of the catheter 210, making it easier for the implant 100 to reach a more ideal relative position with the repaired tissue. The distal end of the implantation catheter 213 is provided with a clutch assembly 215 for connecting or disconnecting the implant 100. The proximal end of the implant 100 is provided with a connector 110, which cooperates with the clutch assembly 215 to connect and disconnect the implant 100. The delivery system 200 also includes a delivery rod 214, which is inserted into the implantation catheter 213. When delivering the implant 100, the distal end of the delivery rod 214 applies external force to the clutch assembly 215, so that the clutch assembly 215 stably connects to the implant 100. During the implantation process, the delivery rod 214 can be rotated to control the implant 100. When removing the implant 100, the delivery rod 214 removes external force from the clutch assembly 215, so as to achieve rapid separation of the implant 100 from the clutch assembly 215.

[0073] The above description of the delivery system is merely an example. This application does not limit the shape and number of catheters in the delivery system, nor does it limit the shape and number of control devices included in the control mechanism; delivery systems with different structures can be set according to different implants.

[0074] According to a specific embodiment provided in this application, see [link to specific embodiment]. Figures 6 to 7A control device 300, suitable for an interventional therapy system 1, includes a housing 310 and a control assembly 320. The housing 310 has a channel 311 for receiving the proximal end of a delivery rod 214. The control assembly 320 drives the delivery rod 214, causing it to move (including rotation or axial displacement). The delivery rod 214 passes through an implantation catheter 213, and during implantation of the implant 100, the distal end of the delivery rod 214 applies an external force to the engaging member 2152 of a clutch assembly 215, causing at least two engaging members 2152 to close. During implantation removal, the distal end of the delivery rod 214 disengages from the engaging member 2152 of the clutch assembly 215.

[0075] See Figure 3 , Figure 4 , Figure 7 and Figure 5 Taking the implant 100 as an example of a valve clamping device, the valve clamping device 400 includes a main body 410, a clamping element 420 (also referred to as a clamping arm), and a grasping device 430 (also referred to as a grasping arm). The grasping device 430 is located between the clamping element 420 and the main body 410. Both the clamping element 420 and the grasping device 430 can open and close relative to the main body 410, and their opening and closing movements can be independent of each other. The valve clamping device 400 has a closed state and an open state; optionally, the open state may also include an inverted state. The proximal end of the main body 410 can be detachably connected to the distal end of the implantation catheter 213 via a clutch assembly 215. The distal end of the delivery rod 214 extends from the distal end of the implanted catheter 213 and inserts into the engaging member 2151 of the clutch assembly 215, causing the engaging member 2152 of the clutch assembly 215 to engage together, thereby clamping the valve clamping device 400 to the distal end of the implanted catheter 213. When the distal end of the delivery rod 214 is withdrawn from the engaging member 2151, the engaging member 2152 opens, and the valve clamping device 400 is detached from the distal end of the implanted catheter 213. A transmission assembly 440 may be provided within the main body 410. The distal end of the delivery rod 214 is inserted into the proximal end of the transmission assembly 440 and applies torque to the transmission assembly 440. The transmission assembly 440 is configured with a segmented structure to transmit axial movement. The axial movement transmitted by the transmission assembly 440 drives the opening and closing movement of the clamping element 420, thereby changing the state of the valve clamping device 400.

[0076] Specifically, see Figure 9The main body 410 is provided with an internal thread 411, and the proximal section of the transmission assembly 440 is provided with an external thread. When the delivery rod 214 rotates, it can drive the proximal section of the transmission assembly 440 to rotate together. Through the threaded engagement between the main body 410 and the proximal section, the transmission assembly 440 can move axially relative to the main body 410. The distal section of the transmission assembly 440 transmits the axial displacement to the clamping element 420, causing the clamping element 420 to perform opening and closing movements. The distal cross-section of the delivery rod 214 is non-circular, and the internal contour of the proximal section of the transmission assembly 440 matches the distal end of the delivery rod 214 to achieve synchronous rotation of the delivery rod 214 and the transmission assembly 440.

[0077] Further, see Figure 8 The control assembly 320 includes a control handle 322 and a drive element. The control handle 322 extends out of the housing 310 to receive driving force. The distal portion of the drive element has a component that can extend into a channel 311, connecting to the proximal end of the delivery rod 214. The control handle 322 is used to drive the rotation and axial movement of the drive element. Thus, the control assembly 320 can drive the delivery rod 214 to rotate and move axially via the drive element, thereby controlling the state of the valve clamping device 400 and controlling the connection and disconnection of the valve clamping device 400 from the distal end of the implanted catheter 213.

[0078] Figure 8 Figure 9 In one example embodiment, see Figure 7 and Figure 13 The control device 300 may include a feedback component 380 to provide feedback when the operator rotates the control handle 322, making it easier for the operator to perform the operation. Specifically, the feedback component 380 includes a paddle 381 and a rotating member 382. The rotating member 382 is disposed on the drive element and can rotate with the drive element. The rotating member 382 is also provided with at least two toothed blocks 3821, which are arranged around the drive element and form a preset angle between them. Thus, when the operator rotates the drive element to a specific angle, the paddle 381 can engage with the corresponding toothed block 3821 to provide force feedback, allowing the operator to feel resistance during rotation, thus indicating to the operator that the rotation has reached the desired position or the correct angle.

[0079] As a preferred option, the paddle 381 is preferably made of a metal spring, which has good resilience and can also provide sound feedback when it is used with the tooth block 3821, making it highly practical.

[0080] Further, see Figure 14The rotating component 382 has multiple toothed blocks 3821, and a groove 3822 can be formed between two adjacent toothed blocks 3821 for the paddle 381 to be engaged. In actual production, the number and spacing of the toothed blocks 3821 can be flexibly set according to actual needs, so that the operator can receive force (and sound) feedback in a timely manner when rotating the control handle 322.

[0081] Furthermore, the toothed block 3821 preferably adopts triangular teeth or trapezoidal teeth. In this case, the toothed block 3821 can form guide surfaces on both sides of the rotating part 382 in the circumferential direction. Whether the operator rotates the control handle 322 clockwise or counterclockwise, the paddle 381 can be easily disengaged from the original slot 3822 under the guidance of the guide surface, which can provide force feedback without affecting the normal rotation of the control handle 322.

[0082] Specifically, the feedback assembly 380 also includes a fixing block 383 disposed within the housing 310 for fixing the paddle 381. The paddle 381 has a connected inclined portion 3811 and a straight portion 3812. The inclined portion 3811 is fixedly connected to the fixing block 383, and the straight portion 3812 is used to engage with the toothed block 3821 on the rotating member 382.

[0083] Specifically, see Figure 8 and Figure 9 The driving element may further include a sleeve 321 and a driving rod 323. A control handle 322 is connected to the proximal end of the sleeve 321. The control handle 322 can drive the sleeve 321 and the driving rod 323 to rotate and move axially upward toward the proximal end. In this case, the rotating member 382 is preferably provided on the sleeve 321.

[0084] The sleeve 321 has a first internal space S1, a control handle 322 connected to the proximal end of the sleeve 321, and a second internal space S2 communicating with the first internal space S1. The drive rod 323 includes a first segment 3232 at its distal end and a second segment 3231 at its proximal end, with the radial dimension of the first segment 3232 being larger than that of the second segment 3231. The second segment 3231 passes through the first internal space S1 and the second internal space S2 and is rotatable relative to both. The first segment 3232 partially passes through the first internal space S1, extends from the distal end of the sleeve 321, and enters the channel 311 to connect to the proximal end of the delivery rod 214. The first segment 3232 restricts relative rotation between the drive rod 323 and the sleeve 321 so that the control handle 322 drives the sleeve 321 and the drive rod 323 to rotate synchronously.

[0085] This application does not limit the specific shape of the outer contour of the first segment 3232 or the inner contour of the distal end of the sleeve 321. It can be a regular or irregular shape, for example, it can be an ellipse, rectangle, triangle, or other polygon; or, for instance, it can be a racetrack shape, including two parallel sides and a symmetrical arcuate edge connecting the two sides. See also some embodiments of this application. Figure 10 The outer contour of the first segment 3232 or the inner contour of the distal end of the sleeve 321 includes an arc-shaped edge, such as an ellipse or a racetrack shape, which can reduce the frictional force of axial movement between the first segment 3232 and the sleeve 321, making the axial movement between the drive rod 323 and the sleeve 321 smoother, while also limiting the relative rotation between the drive rod 323 and the sleeve 321.

[0086] In the above-described control assembly 320, the control handle 322 is connected to the proximal end of the cannula 321. When the operator rotates the control handle 322, the control handle 322 can drive the cannula 321 to rotate together; that is, the control handle 322 receives torque and transmits torque to the cannula 321. Since the relative rotation between the cannula 321 and the drive rod 323 is restricted by the first section 3232, the cannula 321 can drive the drive rod 323 to rotate; that is, the cannula 321 can further transmit torque to the drive rod 323, and the drive rod 323 can then transmit torque to the delivery rod 214.

[0087] Specifically, a floating adjustment mechanism for axial displacement is provided for the drive rod 323. See details... Figure 13 The control component 320 may further include a first elastic element 325, which is sleeved within the second segment 3231 of the drive rod 323 within the first internal space S1. The second segment 3231 of the drive rod 323 has no obvious contact with the first elastic element 325 and can move and rotate freely axially relative to the first elastic element 325. The proximal end of the first elastic element 325 is axially limited at the proximal end of the first internal space S1, while the distal end is axially limited at the distal end of the first internal space S1 or at the proximal end of the first segment 3232.

[0088] In the preset state, the first elastic element 325 is in a compressed state, applying elastic force to both ends. At this time, the proximal end of the first segment 3232 is subjected to force, causing the drive rod 323 to tend to advance distally, which in turn causes the distal end of the delivery rod 214 to tend to advance distally. This prevents the distal end of the delivery rod 214 from retracting proximally during implantation, thereby maintaining the effective connection between the implantation catheter 213 and the valve clamping device 400, as well as the effective control of the valve clamping device 400 by the delivery rod 214. As the drive rod 323 advances distally, the first segment 3232 also advances distally, and the first elastic element 325 extends accordingly, reaching as far as the internal limit point at the distal end of the first internal space S1.

[0089] During implant delivery, due to the complex biological environment, the distal end of the delivery rod 214 may become obstructed during delivery, causing the main body of the delivery rod 214 to retract. When the resistance exceeds the elastic force exerted by the first elastic element 325 on the first segment 3232, the delivery rod 214, along with the drive rod 323, synchronously displaces proximally. This keeps the main body of the delivery rod 214 immediately free from the influence of distal resistance, allowing torque transmission without external force and making it easier to maintain the synchronicity of torque transmission. Understandably, while the first elastic element 325 is compressed, it applies a greater elastic force to the first segment 3232 to resist the retraction of the delivery rod 214. Thus, when the resistance at the distal end of the delivery rod 214 is relieved, the tendency to advance distally is immediately restored.

[0090] During this process, the length of the first section 3232 of the drive rod 323 extending out of the cannula 321 fluctuates within a small range, which is equivalent to setting a floating length for the delivery rod 214, providing greater flexibility. This allows for spontaneous floating adjustment based on the implantation environment, enhancing the safety and effectiveness of the implantation process. Furthermore, it enables the setting of appropriate floating lengths for different implants, reducing operational difficulty and facilitating the widespread application of transcatheter interventional techniques.

[0091] Specifically, the control assembly 320 also includes a limiting member 327, which is sleeved within the first internal space S1 outside the second section 3231 of the drive rod 323, and the drive rod 323 has no obvious contact with the limiting member 327, allowing it to move freely axially relative to the limiting member 327. The distal end of the second elastic member 325 abuts against the proximal end of the first section 3232, and the proximal end abuts against the proximal end of the limiting member 327.

[0092] Optionally, a mounting handle 324 is also connected to the proximal end of the second section 3231 of the drive rod 323. The mounting handle 324 is located within the second space S2, and the mounting handle 324 and the control handle 322 are not mutually constrained. The mounting handle 324 is more conducive to assembling the drive rod 323 into the sleeve 321, and can reduce the gap between the second section 3231 and the second space S2 to a certain extent, thereby improving the stability of the overall structure.

[0093] In one example embodiment, see Figure 11 and Figure 12The control device 300 may further include a connecting assembly 360 for connecting the control assembly 320 and the housing 310. Specifically, the connecting assembly 360 may include a limiting rail 361 and a limiting element 362. The limiting element 362 matches the limiting rail 361 and is axially slidable relative to the limiting rail 361. The limiting rail 361 may extend axially along the drive rod 323 (or the housing 310). The limiting rail 361 may be located on the sleeve 321, in which case the limiting element 362 is located on the housing 310; conversely, the limiting element 362 may also be located on the sleeve 321, in which case the limiting rail 361 is located on the housing 310.

[0094] Preferably, there are two limiting elements 362, symmetrically arranged on both sides of the distal end of the sleeve 321. At this time, there are also two limiting tracks 361, symmetrically arranged on the housing 310. The limiting tracks 361 and the limiting elements 362 work together to not only achieve a sliding fit between the sleeve 321 and the housing 310, but also to limit the radial wobble of the sleeve 321, allowing it to move more smoothly axially, thereby driving the drive rod 323 and the delivery rod 214 to move axially stably. Simultaneously, there is no radial limitation between the sleeve 321 and the limiting elements 362, allowing the sleeve 321 to rotate relative to the limiting elements 362.

[0095] Specifically, the connecting assembly 360 further includes a connector 363, which connects two limiting elements 362 and is fitted onto the distal end of the sleeve 321, providing axial limitation with the distal end of the sleeve 321 without radial limitation. There can be two connectors 363, with the two limiting elements 362 connected to different connectors 363. Both connectors 363 and the two limiting elements 362 are fitted together onto the distal end of the sleeve 321, without radial limitation on the sleeve 321. Alternatively, preferably, the two limiting elements 362 are connected to the same connector 363, which is fitted together onto the distal end of the sleeve 321 without radial limitation on the sleeve 321. Furthermore, the connecting assembly 360 also includes two limiting rings 364, which are rotatably connected to the distal end of the sleeve 321, axially limiting the connector 363 between them. In a preferred embodiment, the distal end of the sleeve 321 has two grooves 3213, and the two limiting rings 364 are respectively embedded in the two grooves 3213, with the connector 363 arranged between the two grooves 3213. This achieves a stable connection between the sleeve 321 and the housing 310, as well as a stable axial displacement direction, and allows the sleeve 321 to rotate to transmit torque when torque is applied to the control handle 322, and allows the sleeve 321 to stably displace relative to the housing when axial power is applied to the control handle 322.

[0096] Preferably, see Figure 7The control device 300 may further include a locking component 330, which has a locked state and an unlocked state, used to lock or unlock the axial movement of the control component 320 relative to the housing 310, respectively. Specifically, when the locking component 330 is in the locked state, rotating the control handle 322 can drive the delivery rod 214 to rotate, thereby driving the state change of the valve clamping device 400. When the locking component 330 is in the unlocked state, the control handle 322 can be pulled proximally, causing the control handle 322 to drive the cannula 321 and the drive rod 323, thereby driving the delivery rod 214 to move proximally, so that the valve clamping device 400 can be quickly detached from the implanted catheter 213.

[0097] In one example embodiment, the locking assembly 330 may include a locking member 331, which has an opening for the sleeve 321 to pass through, and a locking side 3311 corresponding to the periphery of the opening. During use, the locking member 331 can be selectively positioned in a first position and a second position. In the first position, the locking side 3311 is abutted against the sleeve 321 to restrict axial movement of the sleeve 321; in the second position, the locking side 3311 is away from the sleeve 321, suitable for the operating handle 322 to move the sleeve 321 and the drive rod 323 proximally.

[0098] Specifically, see Figure 7 , Figure 10 and Figure 11 The sleeve 321 also includes a base 3211, the outer contour of which is larger than other parts, and the base 3211 is connected to the control handle 322 at its proximal end. The base 3211 at the proximal end of the sleeve 321 is engaged with the proximal end of the housing 310 and can move axially towards the proximal end relative to the housing 310; a first limiting structure 3212 is provided at the proximal end of the sleeve 321 near the base 3211, the outer contour of the first limiting structure 3212 being approximately the same as the outer contour of the base 3211. At this time, a limiting groove 3213 is formed between the first limiting structure 3212 and the base 3211, and the locking assembly 330 can be arranged in the limiting groove 3213 and is approximately perpendicular to the sleeve 321.

[0099] Furthermore, the locking assembly 330 also includes a push rod 332 and a second elastic member 333, wherein the push rod 332 and the locking member 331 are connected to each other, and the two ends of the second elastic member 333 abut against the outer wall of the locking member 331 and the inner wall of the housing 310, respectively. The opening on the locking member 331 is an elliptical hole that is roughly similar to a racetrack. Its long diameter is consistent with the distribution direction of the locking assembly 330 and is approximately 1.5-2.5 times the outer diameter of the base 3211 or the first limiting structure 3212, and its short diameter is approximately 1.2-1.8 times the outer diameter of the base 3211 or the first limiting structure 3212. According to the orientation from the proximal end to the distal end, the locking member 331 can be divided into a left half locking side 3311 and a right half unlocking side 3312 along the extension direction of the short diameter. The locking side 3311 is provided with a second limiting structure along the inner wall shape.

[0100] In this embodiment, the locking state of the locking component 330 is a preset state. In the locked state, the second elastic member 333 is compressed and has an outward elastic force. The locking member 331 is located in the first position, with its locking side 3311 abutting against the sleeve 321. Under the restriction of the second limiting structure on the inner wall of the locking side 3311, the first limiting structure 3212 and the base 3211 on the sleeve 321 cannot pass through the locking member 331, so that the sleeve 321 is locked in the preset position and cannot move axially. In the unlocked state, the push rod 332 is pressed inward, further compressing the second elastic member 333. The locking member 331 is located in the second position, with its locking side 3311 away from the sleeve 321 and its unlocking side 3312 close to the sleeve 321. The first limiting structure 3212 on the sleeve 321 can pull the control handle 322 towards the proximal end through the locking member 331, which can drive the sleeve 321 and the drive rod 323 to move towards the proximal end.

[0101] In actual production, see Figure 7 and Figure 5 The valve clamping device 400 has a capture device 430 connected to a control element 450. The surgeon can change the state of the capture device 430 by manipulating the control element 450. For example, after the valve clamping device 400 is inserted into the left ventricle, the surgeon can adjust the position of the valve clamping device 400 via imaging and determine whether the position and opening state of the valve clamping device 400 are suitable for capturing the leaflet. When the valve clamping device 400 is suitable for capturing the leaflet, the capture device 430 can be opened by manipulating the control element 450, moving towards the clamping element 420 on the same side, capturing the leaflet between the capture device 430 and the clamping element 420. Specifically, the control element 450 extends through the auxiliary channel 2133 of the multi-lumen tube 2131 within the implanted catheter 213 and connects to the control device 300 located proximal to the implanted catheter 213.

[0102] Specifically, see Figure 6 and Figure 15The control device 300 may further include a capture device control handle 370 located at the distal end of the housing 310, and the housing 310 has a channel 312 for a control element 450, from which the control element 450 can be withdrawn. The capture device control handle 370 is connected to the control element 450, allowing the operator to control the capture device 430 to open via the capture device control handle 370. In practical applications, the number of capture devices 430 is preferably two, and the number of capture device control handles 370 in the control device 300 is also two, located on opposite sides at the distal end of the housing 310. Pushing the two capture device control handles 370 distally respectively allows the two capture devices 430 to open separately, enabling the petals to be captured individually. After the petals are captured, the clamping element 420 moves to a closed state, causing the petals to align.

[0103] This application also provides a delivery system 200 for delivering an implant 100, including an implantation catheter 213, a delivery catheter 211, a delivery rod 214, and a control device 300 provided by any of the above. The control device 300 is located at the proximal end of the implantation catheter 213 and is used to drive the radial rotation and axial displacement of the delivery rod 214. The delivery catheter 211 is used to provide an implantation channel.

[0104] See Figure 2 This application also provides an interventional treatment system 1, including an implant and the delivery system 200 provided in any of the above embodiments. Specifically, see... Figure 3 The implant 100 is provided with a connector at its proximal end. The delivery system 200 is used to deliver the implant 100. When delivering the implant 100, at least two engaging members 2152 of the clutch assembly 215 engage in parallel and connect with the connector.

[0105] Taking the implant 100 as a valve clipping device as an example, during implantation, the delivery catheter 211, carrying a dilator, enters the right atrium via the femoral vein along the guidewire. The distal end of the delivery catheter 211 passes through the interatrial septum into the left atrium. The dilator is then withdrawn, and the manipulator catheter 212, carrying the implantation catheters 213 and 213 and the valve clipping device 400, enters the left atrium along the lumen of the delivery catheter 211. The valve clipping device 400 is connected to the distal end of the implantation catheters 213 and 213; during delivery of the valve clipping device 400, the valve clipping device 400 is in a closed state. At this time, the valve clipping device 400 enters the patient's body with minimal radial dimension, effectively reducing harm to the patient and alleviating discomfort.

[0106] When the valve clamping device 400 is delivered to the target position, the drive handle 322 is rotated to drive the delivery rod 214 via the drive assembly. The delivery rod 214 is inserted into the body 410 of the valve clamping device 400, and the clamping element 420 is gradually opened by the delivery rod 214. For example, the valve clamping device 400 in the open state can be delivered into the left ventricle, or the valve clamping device 400 in the closed state can be delivered into the left ventricle, and then the clamping element 420 is controlled to open.

[0107] After the valve clamping device 400 is inserted into the left ventricle, if the valve clamping device 400 is suitable for capturing the leaflets, the capturing device 430 can be opened by controlling the capturing device control handle 370 to capture the leaflets. After the leaflets are captured, the drive handle 322 is rotated to drive the delivery rod 214 through the drive assembly, thereby controlling the clamping element 420 to close towards the body 410. Since the capturing device 430 is located between the clamping element 420 and the body 410, the clamping element 420 can drive the capturing device 430 to close, so that the valve clamping device 400 returns to the closed state. Then, the push rod 332 of the locking assembly 330 is pressed to release the lock on the drive assembly; the drive handle is pulled proximally to drive the delivery rod 214 away from the engagement member 2151 of the clutch device 215; so that the valve clamping device 400 is detached from the distal end of the implantation catheter 213213 and remains in the patient's body.

[0108] The angle between the clamping elements 420 facing proximal to the leaflet can be further increased. This allows the drive handle to be rotated to control the valve clamping device 400 to an inverted state via the delivery rod 214 in the event of leaflet capture failure. In the inverted state, the angle between the clamping elements 420 facing proximal to the leaflet can be an obtuse angle, which facilitates the valve clamping device 400's retraction from the ventricular side to the atrial side without entanglement with the chordae tendineae connecting the leaflets. This improves operator control and reduces damage to the patient's tissues caused by the valve clamping device 400. Afterward, the position and state of the valve clamping device 400 can be readjusted, and the leaflet capture and clamping steps can be repeated until leaflet occlusion and clamping are complete.

[0109] In the above embodiments, the descriptions of each embodiment have different focuses. For parts that are not described in detail or recorded in a certain embodiment, please refer to the relevant descriptions of other embodiments.

[0110] It should be noted that the above embodiments can be freely combined as needed. The above are merely preferred embodiments of this application. It should be pointed out that for those skilled in the art, several improvements and modifications can be made without departing from the principles of this application, and these improvements and modifications should also be considered within the scope of protection of this application.

Claims

1. A control device suitable for interventional therapy systems, characterized in that, include: A control assembly includes a control handle and a drive element, the control handle being used to drive the rotation and axial movement of the drive element; The feedback component includes a paddle and a rotating component, the rotating component being disposed on the drive element and having at least two toothed blocks. When the drive element rotates, the paddle is adapted to engage with one of the toothed blocks to provide force feedback.

2. The steering device according to claim 1, characterized in that , The rotating component has multiple toothed blocks, and a groove is formed between two adjacent toothed blocks to accommodate the paddle.

3. The control device according to claim 2, characterized in that, The toothed block has guide surfaces on both sides of the rotating component in the circumferential direction, which are suitable for guiding the paddle into and out of the slot.

4. The control device according to claim 1, characterized in that, The paddle is made of a metal spring.

5. The steering device according to claim 1, characterized by Also includes: A fixing block is used to fix the lever; The paddle includes an inclined portion and a straight portion. The inclined portion is fixedly connected to the fixed block, and the straight portion is used to engage with the toothed block on the rotating component.

6. The control device according to any one of claims 1-5, characterized in that, The driving element includes a sleeve and a driving rod, and the rotating component is disposed in the sleeve; The control handle is connected to the proximal end of the sleeve, driving the rotation of the sleeve and the drive rod, as well as their axial upward movement towards the proximal end.

7. The control device according to claim 6, characterized in that, The drive rod includes a first segment at a distal end and a second segment at a proximal end; the radial dimension of the first segment is greater than the radial dimension of the second segment; The sleeve has a first internal space, the control handle has a second internal space, the second internal space and the first internal space are connected, the second section passes through the first internal space and the second internal space, the first section partially passes through the first internal space, and the distal end of the first section extends out of the sleeve from the distal end of the sleeve, restricting the relative rotation between the drive rod and the sleeve.

8. The control device according to claim 7, characterized in that, The control component further includes a first elastic element, which is sleeved on the second segment within the first internal space, and the proximal end of the first elastic element is axially limited at the proximal end of the first internal space, and the distal end of the first elastic element is axially limited at the distal end of the first internal space or the proximal end of the first segment.

9. The steering device according to claim 6, characterized by Also includes: The housing and connecting assembly include a limiting rail and a limiting element, the limiting rail extending axially along the drive rod, and the limiting element matching the limiting rail and slidable axially relative to the limiting rail; The distal end of the sleeve is axially limited by the limiting element, the inner wall of the housing is provided with the limiting track, and the distal end of the sleeve can rotate relative to the limiting element.

10. The control device according to claim 9, characterized in that, The number of limiting elements is two, symmetrically arranged on both sides of the distal end of the sleeve, and the number of limiting tracks is two, symmetrically arranged on the housing.

11. The control device according to claim 10, characterized in that, The connecting assembly further includes a connector for connecting the two limiting elements and sleeved on the distal end of the sleeve; The connecting assembly further includes two limiting rings, which are rotatably fitted onto the distal end of the sleeve, and the connecting member is axially limited between the two limiting rings.

12. The steering device according to claim 6, characterized by Also includes: A locking assembly includes a locking member, the locking member having an opening adapted for the sleeve to pass through, and the locking member having a locking side corresponding to the periphery of the opening; The locking member can be selectively positioned in a first position and a second position. In the first position, the locking side is abutted against the sleeve to restrict axial movement of the sleeve. In the second position, the locking side is away from the sleeve, suitable for the operating handle to move the sleeve and the drive rod proximally.

13. The control device according to claim 12, characterized in that, The control device also includes a housing, and the locking assembly further includes a push rod and a second elastic element; the push rod and the locking element are connected to each other, and the two ends of the second elastic element abut against the outer wall of the locking element and the inner wall of the housing, respectively. The sleeve includes a base, the proximal end of the base is connected to the control handle, the sleeve is also provided with a first limiting structure, a limiting groove is formed between the first limiting structure and the base, and a second limiting structure is provided on the locking side; In the first position, the second elastic element is compressed and has an outward elastic force. The locking side of the locking element is against the sleeve, and the second limiting structure is located in the limiting groove to restrict the axial movement of the sleeve. In the second position, the push rod is pressed inward to further compress the second elastic element, and the locking side is away from the sleeve, allowing the first limiting structure to pass through the locking element.

14. A delivery system characterized by, include: Implantation catheter, delivery rod, and control device as described in any one of claims 1-13; The proximal end of the delivery rod is connected to the distal end of the drive rod, and the distal end extends along the internal channel of the implantation catheter until it exits the distal end of the implantation catheter. The control device is located at the proximal end of the implantation catheter and is used to drive the radial rotation and axial displacement of the delivery rod. It also includes a delivery catheter to provide an implantation pathway.

15. An interventional therapy system, characterized by comprising: include: The implant and the delivery system as described in claim 14; The control device drives the delivery rod to control the state of the implant, as well as the connection and disconnection of the implant from the delivery system.

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