Control device, conveying system and interventional therapy system

Abstract

The invention 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] The present application relates to the field of medical device technology, and in particular to a control device, a delivery system and an interventional treatment system. Background Art

[0002] Structural heart disease in a broad sense refers to any abnormality of the heart structure and any disease related to the heart and large blood vessel structure, except for primary coronary artery disease and electrocardiographic disease (such as coronary heart disease, arrhythmia, etc.). Among them, valvular heart disease is a common type of disease, such as blood reflux caused by valvular disease between the atrium and ventricle. Taking mitral regurgitation as an example, moderate to severe mitral regurgitation can lead to increased left atrial blood flow and increased blood pressure, which may cause pulmonary hypertension, pulmonary edema, atrial fibrillation, heart failure, and even death.

[0003] With the development of interventional cardiology, transcatheter cardiac interventional treatment techniques with the main characteristics of minimal trauma, less pain and rapid recovery are increasingly being used in clinical practice. The interventional treatment technology for mitral regurgitation is derived from surgical techniques. Interventional treatment of mitral regurgitation is suitable for patients with moderate to severe mitral regurgitation who cannot tolerate traditional surgical operations. The main types include annular repair, leaflet repair and chord repair. The corresponding procedures include annuloplasty, edge-to-edge repair and chord repair, among which edge-to-edge repair is a relatively mainstream method. Due to the diversity of the anatomical structures of the annulus, leaflets and their adjacent areas, there is a need for continuous improvement in device design, such as the convenience of operator manipulation and feedback response, which need to be improved. Summary of the invention

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

[0005] The technical solution provided by the present invention is as follows:

[0006] A control device, applicable to an interventional treatment system, comprising:

[0007] A control assembly, comprising a control handle and a driving element, wherein the control handle is used to drive the driving element to rotate and move axially;

[0008] The feedback component includes a paddle and a rotating member, wherein the rotating member is arranged on the driving element and has at least two tooth blocks. When the driving element rotates, the paddle is suitable for being engaged with one of the tooth blocks to provide force feedback.

[0009] In some embodiments, there are multiple tooth blocks on the rotating member, and a slot is formed between two adjacent tooth blocks, suitable for the paddle to be clamped.

[0010] In some embodiments, the tooth block is formed with guide surfaces on both sides of the circumference of the rotating member, suitable for guiding the paddle to enter and exit the slot.

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

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

[0013] A fixing block, used for fixing the plectrum;

[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 butt against the tooth block on the rotating member.

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

[0016] The control handle is connected to the proximal end of the sleeve to drive the sleeve and the driving rod to rotate and move axially toward the proximal end.

[0017] In some embodiments, the driving rod includes a first segment at a distal end and a second segment at a proximal end; a radial dimension of the first segment is greater than a 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 is connected to the first internal space, the second section is passed through the first internal space and the second internal space, the first section is partially passed 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, thereby limiting the relative rotation between the drive rod and the sleeve.

[0019] In some embodiments, the control assembly also includes a first elastic member, which is mounted on the second section in the first space, and the proximal end of the first elastic member is axially limited at the proximal end of the first space, and the distal end of the first elastic member is axially limited at the distal end of the first space or the proximal end of the first section.

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

[0021] A housing and a connecting assembly, wherein the connecting assembly comprises a limiting track and a limiting element, wherein the limiting track extends along the axial direction of the driving rod, and the limiting element matches the limiting track and can slide axially relative to the limiting track;

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

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

[0024] In some embodiments, the connection assembly further includes a connection piece, which is used to connect the two limiting elements and is sleeved on the distal end of the sleeve;

[0025] The connecting assembly further comprises two limiting rings, which are rotatably sleeved on 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 comprises:

[0027] The locking assembly comprises a locking member, wherein the locking member is provided with an opening suitable for the sleeve to pass through, and the locking member has a locking side corresponding to the peripheral side of the opening;

[0028] The locking member can be selectively in a first position and a second position. In the first position, the locking side is against the sleeve to limit the axial movement of the sleeve; in the second position, the locking side is away from the sleeve, suitable for the control handle to drive the sleeve and the drive rod to move toward the proximal end.

[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 two ends of the second elastic member are respectively in contact with the outer wall of the locking member and the inner wall of the housing;

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

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

[0032] The present application also discloses a delivery system, comprising:

[0033] An implantation catheter, a delivery rod, and a manipulation 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 driving rod, and the distal end extends along the internal channel of the implant catheter until it passes through the distal end of the implant catheter. The control device is arranged at the proximal end of the implant catheter, and is used to drive the radial rotation and axial displacement of the delivery rod;

[0035] Also included is a delivery catheter for providing an implantation channel.

[0036] The present application further discloses an interventional treatment system, characterized in that it comprises:

[0037] Implants and delivery systems as provided in the above embodiments;

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

[0039] The technical effects of this application are:

[0040] 1. In the present application, by providing a paddle and a rotating member, and utilizing the cooperation between the paddle and the teeth on the rotating member, force feedback can be provided during the operator's manipulation, so that the operator can feel the resistance during the rotation, thereby achieving the purpose of prompting the operator to rotate to the right position or the angle of rotation, making it easier for the operator to perform the manipulation operation.

[0041] 2. In this application, the paddle uses a metal spring sheet with good resilience. When it cooperates with the tooth block, it can provide not only force feedback but also sound feedback. In addition, the tooth block also forms guide surfaces on both sides of the circumference of the rotating part. Whether the operator rotates the control handle clockwise or counterclockwise, the paddle can be easily separated from the original card slot under the guidance of the guide surface, which can provide force feedback without affecting the normal rotation of the control handle, and has good performance. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] The present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments:

[0043] Figure 1 is a schematic diagram of an application scenario of transcatheter interventional therapy provided in an embodiment of the present application;

[0044] Figure 2 is a schematic structural diagram of an interventional treatment system provided in one embodiment of the present application;

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

[0046] Figure 4 It is a schematic structural diagram of a clutch assembly detachable implant provided in one embodiment of the present application;

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

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

[0049] Figure 7 is a structural schematic diagram of a control device provided in an embodiment of the present application;

[0050] Figure 8 is a schematic structural diagram of a driving assembly provided in one embodiment of the present application;

[0051] Fig. 9 is a schematic structural diagram of an implantation catheter, a clutch assembly, and a valve clamping device provided in another embodiment of the present application;

[0052] Fig.10 is a schematic diagram of the far end of a drive assembly provided in one embodiment of the present application;

[0053] Fig.11 is a side view of a drive assembly provided in one embodiment of the present application;

[0054] Fig.12 is a schematic structural diagram of a driving component and a connecting component provided in an embodiment of the present application;

[0055] Fig.13 is a schematic structural diagram of a drive component and a feedback component provided in an embodiment of the present application;

[0056] Fig.14 is a structural schematic diagram of a feedback component provided in an embodiment of the present application;

[0057] Fig.15 It is a structural schematic diagram of a control device provided in another embodiment of the present application. DETAILED DESCRIPTION

[0058] In the following description, specific details such as specific system structures, technologies, etc. are provided for the purpose of illustration rather than limitation, so as to provide a thorough understanding of the embodiments of the present application. However, it should be clear to those skilled in the art that the present application may also be implemented in other embodiments without these specific details. In other cases, detailed descriptions of well-known systems, devices, circuits, and methods are omitted to prevent unnecessary details from obstructing the description of the present application.

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

[0060] In order to simplify the drawings, only the parts related to the present application are schematically shown in each figure, and they do not represent the actual structure of the product. In addition, in order to simplify the drawings and facilitate understanding, in some figures, only one of the parts with the same structure or function is schematically drawn or marked. In this article, "one" not only means "only one", but also means "more than one".

[0061] It should be further understood that the term “and / or” used in the specification and appended claims refers to any combination and all possible combinations of one or more of the associated listed items, and includes these combinations.

[0062] In this document, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two parts. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0063] In the embodiments shown in the drawings, the indications of directions (such as up, down, left, right, front and back) used to explain the structure and movement of various components of the present application are not absolute but relative. 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, the indications of these directions also change accordingly.

[0064] In the embodiments of the present application, "proximal end" refers to the end of the associated object close to the operator; "distal end" refers to the end of the associated object away from the operator. "Proximal end" and "distal end" refer to the position or direction of the associated object (e.g., a component of a medical device) relative to the operator from the perspective of the operator (e.g., a doctor) who uses the device (e.g., a medical device) where the associated object is located. For example, "proximal end" refers to the end close to the doctor during the doctor's normal operation of the medical device, while "distal end" refers to the end away from the doctor during the doctor's normal operation of the medical device, that is, the end that first enters the patient's body.

[0065] In addition, in the description of the present application, the terms "first", "second", etc. are only used to distinguish the description and cannot be understood as indicating or implying relative importance.

[0066] Transcatheter interventional therapy can introduce implants such as materials, medical devices, or drugs into the body through a catheter to perform minimally invasive diagnosis and / or treatment of diseases. Transcatheter interventional therapy can achieve better treatment effects through smaller wounds and is more conducive to postoperative recovery, so it is increasingly used in clinical practice. For example, transcatheter interventional therapy can be used for intravascular specimen collection or angiography and other diagnoses; for example, it can be used for drug infusion, embolization, vascular dilatation and shaping, intravascular stent placement, vascular filter placement, intravascular foreign body or thrombus removal, or intravascular plaque grinding and other treatments; for example, it can be used to implant medical devices into organs such as the heart to treat heart diseases.

[0067] For example, for heart disease treatment, please refer to Figure 1 , which is a schematic diagram of an application scenario of transcatheter interventional treatment provided in an embodiment of the present application. Figure 1 The structure of the heart is shown, as Figure 1 As shown, the heart is a hollow muscular organ with four chambers, namely the left atrium (LA) 11, the right atrium (RA) 21, the left ventricle (LV) 12, and the right ventricle (RV) 22. There is an atrioventricular valve (hereinafter referred to as the valve) between the atrium and the ventricle. When the ventricle relaxes, the valve opens and blood flows from the atrium to the ventricle; when the ventricle contracts, the valve closes to prevent blood from flowing back from the ventricle to the atrium. 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, which are perpendicular to the ventricular cavity and connected to the left ventricular wall through chordae tendineae 14 and papillary muscles 15; the tricuspid valve 23 has three leaflets, which are perpendicular to the ventricular cavity and connected to the right ventricular wall through chordae tendineae 24 and papillary muscles 25. The large blood vessels connected to the heart mainly include the aorta 31, the pulmonary artery 32, the superior vena cava 41 and the inferior vena cava 42. The heart and the large blood vessels work together to achieve blood circulation.

[0068] For example, transcatheter interventional therapy can be applied to structural heart diseases, such as diseases caused by abnormal cardiac structure or abnormal large blood vessel structure. For example, valve diseases or defect diseases. For example, valve diseases include blood regurgitation caused by valve lesions between the atria and ventricles (such as mitral regurgitation or tricuspid regurgitation), aortic stenosis, aortic regurgitation, pulmonary stenosis, or pulmonary regurgitation. Defect diseases include, for example, ventricular septal defect (VSD), atrial septal defect (ASD), or patent ductus arteriosus. For valvular diseases such as mitral regurgitation or tricuspid regurgitation, transcatheter interventional therapy technology can be used to deliver implanted medical devices such as valve clamping devices to the lesion site to perform edge-to-edge repair of the mitral valve or tricuspid valve. For defect diseases such as ventricular septal defect (VSD), atrial septal defect (ASD), or patent ductus arteriosus, transcatheter interventional treatment can be used. Medical devices such as occluders are implanted and delivered to the lesion site via catheter to block defects in the left or right ventricles, or between the left and right atria, or to block the passage between the aorta and the pulmonary artery.

[0069] Due to the complexity of the biological body's internal environment, such as the diversity of the anatomical structures of the valve ring, valve leaflets and their adjacent areas, the operator's operation requirements are high when manipulating the implant, and there may be problems such as insufficient control stability and cumbersome operation, thereby affecting the effect of interventional treatment. The embodiment of the present application provides a control device that improves the operator's convenience and feedback response during operation, making it easier for the operator to perform control operations. At the same time, the implant can remain stable during the implantation process, promoting the smooth progress of the operation.

[0070] The following is a description with reference to the accompanying drawings:

[0071] Please refer to Figure 2 , which is a schematic diagram of the structure of an interventional treatment system provided in an embodiment of the present application. Figure 2 As shown, the interventional treatment 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 is used to provide a delivery channel for the implant 100, and the control mechanism 220 is used to control the distal movement of the catheter 210; the control mechanism 220 can also be used to control the implant 100, for example, to control the connection and detachment of the implant 100 and the distal end of the catheter 210, and for example, to control 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 to change its state, which is conducive to the control of the implantation process of the implant 100, so that the implant 100 can be more accurately implanted in the lesion position.

[0072] The catheter 210 may adopt a multi-layer catheter structure, which includes, for example, at least two layers of catheters, wherein the outer layer of the catheter provides an operation channel for other catheters, and the other catheters are used to deliver the implant 100. The control mechanism 220 includes, for example, a plurality of control devices for controlling the distal end movement of the catheter 210. For example, Figure 2 As shown, the delivery system 200 includes, for example, a three-layer catheter structure and a control device corresponding to the three-layer catheter. For example, the catheter 210 includes a delivery catheter 211, a control catheter 212, and an implantation catheter 213; the control mechanism 220 includes a control device 221, a control device 222, and a control device 223, which are 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, and the loader 224 includes a base 2241 and a loading catheter 2242. When in use, the loading catheter 2242 penetrates the proximal end of the control device 221, becomes 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 through the control device 221. To complete the implantation operation, the distal ends of the delivery catheter 211 and the control catheter 212 should have navigation settings, so that the operator can adjust the distal curvature according to the needs of the procedure, control the direction of the distal end of the catheter 210, and make 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 detaching the implant 100. The proximal end of the implant 100 is provided with a connecting seat 110 for cooperating with the clutch assembly 215 to achieve the connection and detachment of the implant 100. The delivery system 200 also includes a delivery rod 214, which is inserted into the implant 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 is stably connected to the implant 100. During the implantation process, the delivery rod 214 can manipulate the implant 100 by rotation. When removing the implant 100, the delivery rod 214 removes the external force from the clutch assembly 215, thereby achieving rapid separation of the implant 100 from the clutch assembly 215.

[0073] The above description of the delivery system is only an example. The present application does not limit the shape and number of the catheters of the delivery system, nor does it limit the shape and number of the 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 by this application, see Figure 6 to Figure 7A manipulation device 300 is suitable for an interventional treatment system 1, comprising a housing 310 and a manipulation assembly 320. A channel 311 for a delivery rod 214 is provided in the housing 310, and the channel 311 is used to accommodate the proximal end of the delivery rod 214. The manipulation assembly 320 is used to drive the delivery rod 214 so that the delivery rod 214 moves (including rotation or axial displacement). The delivery rod 214 is inserted into the implant catheter 213, and when delivering the implant 100, the distal end of the delivery rod 214 applies an external force to the embracing piece 2152 of the clutch assembly 215, so that at least two embracing pieces 2152 are enclosed. When the implant 100 is removed, the distal end of the delivery rod 214 withdraws from the embracing piece 2152 of the clutch assembly 215.

[0075] See also Figure 3 , Figure 4 , Figure 7 and Figure 5 Taking the implant 100 as a valve clamping device as an example, the valve clamping device 400 includes a main body 410, a clamping element 420 (also referred to as a clamping arm) and a capture device 430 (also referred to as a capture arm). The capture device 430 is located between the clamping element 420 and the main body 410. Both the clamping element 420 and the capture device 430 can perform opening and closing movements 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 can also include an inverted state. The proximal end of the main body 410 can be detachably connected to the distal end of the implant catheter 213 through the clutch assembly 215. The distal end of the delivery rod 214 extends from the distal end of the implant catheter 213 and is inserted into the engaging member 2151 of the clutch assembly 215, so that the engaging member 2152 of the clutch assembly 215 is engaged together, thereby clamping the valve clamping device 400 to the distal end of the implant catheter 213. When the distal end of the delivery rod 214 is withdrawn from the engaging member 2151, the engaging member 2152 is opened, and the valve clamping device 400 is detached from the distal end of the implant catheter 213. A transmission assembly 440 may be provided in the main body 410, and the distal end of the delivery rod 214 is inserted into the proximal end of the transmission assembly 440, and torque is applied to the transmission assembly 440. The transmission assembly 440 is provided as a segmented structure to transmit axial motion, and the axial motion transmitted by the transmission assembly 440 drives the opening and closing motion of the clamping element 420, so that the state of the valve clamping device 400 is changed.

[0076] Specifically, see Fig. 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 cooperation between the main body 410 and the proximal section, the transmission assembly 440 can move axially relative to the main body 410, and the distal section of the transmission assembly 440 transmits the axial displacement to the clamping element 420, so that the clamping element 420 generates an opening and closing movement. Among them, the distal cross-section of the delivery rod 214 adopts a non-circular setting, and the internal contour of the proximal section of the transmission assembly 440 matches the distal end of the delivery rod 214, so as to realize the synchronous rotation of the delivery rod 214 and the transmission assembly 440.

[0077] Further, see Figure 8 The manipulation assembly 320 includes a manipulation handle 322 and a driving element. The manipulation handle 322 of the manipulation assembly 320 extends out of the housing 310 to receive a driving force. The distal end of the driving element of the manipulation assembly 320 has a component that can be inserted into the channel 311 and connected to the proximal end of the delivery rod 214. The manipulation handle 322 is used to drive the rotation and axial movement of the driving element. In this way, the manipulation assembly 320 can drive the delivery rod 214 to rotate and move axially through the driving element, thereby controlling the state of the valve clamping device 400, and controlling the connection and detachment of the valve clamping device 400 with the distal end of the implantation catheter 213.

[0078] Figure 8 Fig. 9 In one example embodiment, see Figure 7 and Fig.13 , the control device 300 may include a feedback component 380, which is used to provide feedback when the operator rotates the control handle 322, so that the operator can perform the control operation more easily. Specifically, the feedback component 380 includes a paddle 381 and a rotating member 382, ​​and the rotating member 382 is arranged on the driving element and can rotate with the driving element. At least two tooth blocks 3821 are also provided on the rotating member 382, ​​and the at least two tooth blocks 3821 are arranged around the driving element, and a preset angle is formed between the at least two tooth blocks 3821. In this way, when the operator rotates the driving element to a specific angle, the paddle 381 can be engaged with the corresponding tooth block 3821 to provide force feedback, so that the operator can feel the blockage when rotating, so as to prompt the operator that the rotation has reached the right position or the angle that has been rotated.

[0079] Preferably, the paddle 381 is made of metal springs, which have good resilience and can provide sound feedback when matched with the tooth block 3821, thus being highly practical.

[0080] Further, see Fig.14The number of tooth blocks 3821 on the rotating member 382 is multiple, and a slot 3822 can be formed between two adjacent tooth blocks 3821 for the paddle 381 to be clamped. In actual production, the number and spacing of the tooth blocks 3821 can be flexibly set according to actual needs, so that the operator can receive force (and sound) feedback in time when rotating the control handle 322.

[0081] Furthermore, the tooth block 3821 preferably adopts triangular teeth or trapezoidal teeth. At this time, the tooth block 3821 can form guide surfaces on both sides of the circumference of the rotating member 382. Regardless of whether the operator rotates the control handle 322 clockwise or counterclockwise, the paddle 381 can be easily disengaged from the originally stuck 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 further includes a fixing block 383 disposed in the housing 310 for fixing the paddle 381. The paddle 381 has an inclined portion 3811 and a straight portion 3812 connected to each other, the inclined portion 3811 is fixedly connected to the fixing block 383, and the straight portion 3812 is used to dock with the tooth block 3821 on the rotating member 382.

[0083] Specifically, see Figure 8 and Fig. 9 The driving element may further include a sleeve 321 and a driving rod 323. The 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 toward the proximal end. At this time, the rotating member 382 is preferably arranged on the sleeve 321.

[0084] The sleeve 321 has a first internal space S1, and the control handle 322 is connected to the proximal end of the sleeve 321 and has a second internal space S2, and the second internal space S2 is connected to the first internal space S1. The driving rod 323 includes a first section 3232 at the distal end and a second section 3231 at the proximal end, and the radial dimension of the first section 3232 is greater than the radial dimension of the second section 3231. The second section 3231 is arranged in the first internal space S1 and the second internal space S2, and can rotate relative to the first internal space S1 and the second internal space S2; the first section 3232 is partially arranged in the first internal space S1, extends from the distal end of the sleeve 321 out of the sleeve 321 and extends into the channel 311 to connect the proximal end of the delivery rod 214. The first section 3232 can limit the relative rotation between the driving rod 323 and the sleeve 321, so that the control handle 322 drives the sleeve 321 and the driving rod 323 to rotate synchronously.

[0085] The present application does not limit the specific shape of the outer contour of the first section 3232 or the inner contour of the distal end of the sleeve 321, which can be a regular shape or an irregular shape, for example, it can be an ellipse, a rectangle, a triangle, or other polygons; for example, it can be a racetrack shape, including two parallel sides and symmetrical arc sides connecting the two sides. In some embodiments of the present application, see Fig.10 The outer contour of the first section 3232 or the inner contour of the distal end of the sleeve 321 includes an arc-shaped edge, such as an elliptical or racetrack shape, which can reduce the friction of the axial movement between the first section 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 manipulation assembly 320, the manipulation handle 322 is connected to the proximal end of the sleeve 321. When the operator rotates the manipulation handle 322, the manipulation handle 322 can drive the sleeve 321 to rotate together; that is, the manipulation handle 322 receives torque and transmits the torque to the sleeve 321. Since the relative rotation between the sleeve 321 and the driving rod 323 is limited by the first section 3232, the sleeve 321 can drive the driving rod 323 to rotate; that is, the sleeve 321 can further transmit the torque to the driving rod 323, and the driving rod 323 further transmits the torque to the delivery rod 214.

[0087] A floating adjustment mechanism for axial displacement is provided for the driving rod 323. Fig.13 The control assembly 320 may further include a first elastic member 325, which is sleeved on the second section 3231 of the driving rod 323 in the first space S1, and the second section 3231 of the driving rod 323 has no obvious contact with the first elastic member 325, and can freely move axially and rotate relative to the first elastic member 325. The proximal end of the first elastic member 325 is axially limited at the proximal end of the first space S1, and the distal end is axially limited at the distal end of the first space S1 or the proximal end of the first section 3232.

[0088] In the preset state, the first elastic member 325 is in a compressed state, and elastic force is applied to both ends. At this time, the proximal end of the first section 3232 is subjected to force, so that the driving rod 323 tends to be fed to the distal end, and the distal end of the delivery rod 214 tends to be fed to the distal end, so as to avoid the distal end of the delivery rod 214 from retracting to the proximal end during the implantation process, so as to maintain the effective connection between the implantation catheter 213 and the valve clamping device 400, and the effective control of the valve clamping device 400 by the delivery rod 214. The driving rod 323 feeds to the distal end, and the first section 3232 also feeds to the distal end, and the first elastic member 325 extends accordingly, and can reach the internal limit at the distal end of the first space S1 at the far end.

[0089] When delivering the implant, due to the complex biological environment, the distal end of the delivery rod 214 may also be blocked during the delivery process because it cannot continue to extend, causing the main body of the delivery rod 214 to retract. When the resistance is greater than the elastic force applied by the first elastic member 325 to the first section 3232, the delivery rod 214 and the driving rod 323 are synchronously displaced toward the proximal end. In this way, the main body of the delivery rod 214 is immediately free from the influence of the distal resistance, so that the torque can be transmitted without external force, and the synchronization of the torque transmission can be maintained more easily. It can be understood that when the first elastic member 325 is compressed, it will apply a greater elastic force to the first section 3232 to resist the retraction of the delivery rod 214, so that when the resistance at the distal end of the delivery rod 214 is released, the trend of feeding toward the distal end is immediately restored.

[0090] During this process, the length of the first section 3232 of the driving rod 323 extending out of the sleeve 321 floats within a micro range, which is equivalent to setting a floating length for the delivery rod 214, and has more flexible applicability. In this way, on the one hand, spontaneous floating adjustment can be performed according to the implantation environment to enhance the safety and effectiveness of the implantation process; on the other hand, when facing different implants, a suitable floating length can be set to reduce the difficulty of operation, which is conducive to the promotion and application of transcatheter intervention technology.

[0091] Specifically, the control assembly 320 further includes a stopper 327, which is sleeved outside the second section 3231 of the driving rod 323 in the first space S1, and the driving rod 323 has no obvious contact with the stopper 327, and can freely move axially relative to the stopper 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 stopper 327.

[0092] Optionally, a mounting handle 324 is further connected to the proximal end of the second section 3231 of the driving rod 323, and the mounting handle 324 is located in the second space S2, and the mounting handle 324 and the control handle 322 do not constrain each other. The provision of the mounting handle 324 is more conducive to assembling the driving rod 323 in 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 Fig.11 and Fig.12, the control device 300 may further include a connecting assembly 360 for connecting the control assembly 320 and the housing 310. The connecting assembly 360 may specifically include a limiting track 361 and a limiting element 362, wherein the limiting element 362 matches the limiting track 361 and can slide axially relative to the limiting track 361. The limiting track 361 may extend axially along the driving rod 323 (or the housing 310). The limiting track 361 may be provided on the sleeve 321, in which case the limiting element 362 is provided on the housing 310; conversely, the limiting element 362 may also be provided on the sleeve 321, in which case the limiting track 361 is provided on the housing 310.

[0094] Preferably, the number of the limiting elements 362 is two, which are symmetrically arranged on both sides of the distal end of the sleeve 321. At this time, the number of the limiting rails 361 is also two, which are symmetrically arranged on the housing 310. The limiting rails 361 and the limiting elements 362 cooperate with each other, which can not only realize the sliding cooperation between the sleeve 321 and the housing 310, but also limit the radial shaking of the sleeve 321, so that it can move axially more smoothly, thereby driving the driving rod 323 and the delivery rod 214 to move axially stably. At the same time, there is no radial limit between the sleeve 321 and the limiting element 362, and the sleeve 321 can rotate relative to the limiting element 362.

[0095] Specifically, the connection assembly 360 further includes a connection piece 363, which is used to connect the two limiting elements 362 and is sleeved on the distal end of the sleeve 321, and is axially limited with the distal end of the sleeve 321, and is not radially limited. The number of the connection pieces 363 can be two, and the two limiting elements 362 are respectively connected to different connection pieces 363, and the two connection pieces 363 and the two limiting elements 362 are jointly sleeved on the distal end of the sleeve 321, and the sleeve 321 is not radially limited. Alternatively, preferably, the two limiting elements 362 are connected to the same connection piece 363, and the connection piece 363 and the two limiting elements 362 are jointly sleeved on the distal end of the sleeve 321, and the sleeve 321 is not radially limited. Furthermore, the connection assembly 360 further includes a limit ring 364, the number of which is two, which are rotatably connected to the distal end of the sleeve 321, and the connection member 363 is axially limited between the two. In a preferred embodiment, the distal end of the sleeve 321 is provided with two grooves 3213, and the two limit rings 364 are respectively embedded in the two grooves 3213, and the connection member 363 is arranged between the two grooves 3213. In this way, a stable connection and a stable axial displacement direction between the sleeve 321 and the housing 310 are achieved, and when a torque is applied to the control handle 322, the sleeve 321 can rotate to transmit the torque, and when an axial force is applied to the control handle 322, the sleeve 321 can stably displace axially relative to the housing.

[0096] Preferably, see Figure 7The manipulation device 300 may further include a locking assembly 330, which has a locked state and an unlocked state, and is used to lock or unlock the axial movement of the manipulation assembly 320 relative to the housing 310. Specifically, when the locking assembly 330 is in the locked state, the manipulation handle 322 is rotated to drive the delivery rod 214 to rotate, thereby driving the state change of the valve clamping device 400. When the locking assembly 330 is in the unlocked state, the manipulation handle 322 can be pulled toward the proximal end, so that the manipulation handle 322 drives the sleeve 321 and the driving rod 323, and then drives the delivery rod 214 to move toward the proximal end, so that the valve clamping device 400 can be quickly detached from the implantation catheter 213.

[0097] In an exemplary embodiment, the locking assembly 330 may include a locking member 331, wherein the locking member 331 is provided with an opening suitable for the sleeve 321 to pass through, and the locking member 331 has a locking side 3311 around the corresponding opening. During use, the locking member 331 can be selectively in a first position and a second position, in which the locking side 3311 is against the sleeve 321 to limit the axial movement of the sleeve 321; in the second position, the locking side 3311 is away from the sleeve 321, suitable for the manipulation handle 322 to drive the sleeve 321 and the driving rod 323 to move toward the proximal end.

[0098] Specifically, see Figure 7 , Fig.10 and Fig.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 the proximal end. The base 3211 at the proximal end of the sleeve 321 is clamped to the proximal end of the housing 310, and can move axially toward 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, and the outer contour of the first limiting structure 3212 is substantially the same as the outer contour of the base 3211. At this time, a limiting slot 3213 is formed between the first limiting structure 3212 and the base 3211, and the locking assembly 330 can be arranged in the limiting slot 3213, and is substantially perpendicular to the sleeve 321.

[0099] Furthermore, the locking assembly 330 further 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 are respectively in contact with the outer wall of the locking member 331 and the inner wall of the housing 310. The opening on the locking member 331 is an elliptical hole that is generally similar to a runway, and its long diameter is consistent with the distribution direction of the locking assembly 330, which is approximately 1.5-2.5 times the outer diameter of the base 3211 or the first limiting structure 3212, and the 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 proximal to distal orientation, the locking member 331 can be divided into a locking side 3311 on the left half and an unlocking side 3312 on the right half along the extension direction of the short diameter, and the locking side 3311 is provided with a second limiting structure along the shape of the inner wall.

[0100] In this embodiment, the locking state of the locking assembly 330 is a preset state. In the locked state, the second elastic member 333 is in a compressed state and has an outward elastic force. The locking member 331 is located in the first position, and its locking side 3311 is close to 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 to further compress the second elastic member 333, and the locking member 331 is located in the second position, and its locking side 3311 is away from the sleeve 321, and the unlocking side 3312 is close to the sleeve 321. The first limiting structure 3212 on the sleeve 321 can pass through the locking member 331 and pull the control handle 322 toward the proximal end, so as to drive the sleeve 321 and the driving rod 323 to move toward the proximal end.

[0101] In actual production, see Figure 7 and Figure 5 , the capture device 430 on the valve clamping device 400 is connected to a control element 450, and the operator can change the state of the capture device 430 by pulling the control element 450. For example, after the valve clamping device 400 is sent into the left ventricle, the operator can adjust the position of the valve clamping device 400 through the image and determine whether the position and opening state of the valve clamping device 400 are suitable for capturing the valve leaflets. When the valve clamping device 400 is suitable for capturing the valve leaflets, the capture device 430 can be controlled to open by pulling the control element 450, and move to the clamping element 420 on the same side, so as to capture the valve leaflets between the capture device 430 and the clamping element 420. Specifically, the control element 450 passes through the auxiliary channel 2133 of the multi-lumen tube 2131 in the implant catheter 213 and is connected to the manipulation device 300 disposed at the proximal end of the implant catheter 213.

[0102] Specifically, see Figure 6 and Fig.15The manipulation device 300 may also include a capture device control handle 370, which is disposed at the distal end of the housing 310, and the housing 310 has a channel 312 for the control element 450, and the control element 450 can be withdrawn from the channel 312. The capture device control handle 370 is connected to the control element 450, so that the operator can control the capture device 430 to open through the capture device control handle 370. In practical applications, the number of the capture devices 430 is preferably two, and the number of the capture device control handles 370 in the manipulation device 300 is also two, which are located on opposite sides of the distal end of the housing 310. By pushing the two capture device control handles 370 toward the distal end respectively, the two capture devices 430 can be controlled to open respectively, so that the leaflets can be captured respectively. After the leaflet capture is completed, the clamping element 420 moves to a closed state to make the leaflets apposed.

[0103] The present application also provides a delivery system 200 for delivering an implant 100, comprising an implantation catheter 213, a delivery catheter 211, a delivery rod 214 and a control device 300 provided by any of the above items, wherein the control device 300 is disposed 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 also Figure 2 The present application also provides an interventional treatment system 1, comprising an implant and a delivery system 200 provided in any of the above embodiments. Figure 3 A connecting seat is provided at the proximal end of the implant 100, and 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 are engaged in parallel and connected to the connecting seat.

[0105] Taking the implant 100 as a valve clamping device as an example, during the implantation process, the delivery catheter 211 is equipped with a dilator and enters the right atrium along the guidewire through the femoral vein, and the distal end of the delivery catheter 211 passes through the atrial septum and enters the left atrium. Then the dilator is withdrawn, and the control catheter 212 is equipped with the implantation catheter 213213 and the valve clamping device 400, and enters the left atrium along the inner cavity of the delivery catheter 211. The valve clamping device 400 is connected to the distal end of the implantation catheter 213213; during the process of delivering the valve clamping device 400, the valve clamping device 400 is in a closed state. At this time, the valve clamping device 400 enters the patient's body with the minimum radial size, which can effectively reduce the damage of the valve clamping device 400 to the patient and alleviate the patient's discomfort.

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

[0107] After the valve clamping device 400 is delivered into the left ventricle, if the valve clamping device 400 is suitable for capturing the valve leaflets, the capture device 430 can be controlled to open by the capture device control handle 370 to achieve the capture of the valve leaflets. After the valve leaflet capture is completed, the driving handle 322 is rotated to drive the delivery rod 214 through the driving assembly to control the clamping element 420 to close to the main body 410. Since the capture device 430 is located between the clamping element 420 and the main body 410, the clamping element 420 can drive the capture device 430 to close, so that the valve clamping device 400 is restored to the closed state. Then, the push rod 332 of the locking assembly 330 is pressed to release the lock on the driving assembly; the driving handle is pulled toward the proximal end to drive the delivery rod 214 to leave the matching piece 2151 of the clutch device 215; so that the valve clamping device 400 is separated 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 the proximal end can be further increased. In this way, when the leaflet capture fails, the driving handle can be rotated to control the valve clamping device 400 to an inverted state through the delivery rod 214. In the inverted state, the angle between the clamping elements 420 facing the proximal end can be an obtuse angle, which is conducive to the valve clamping device 400 to retreat from the ventricle side to the atrial side and not to entangle the tendons connecting the leaflets. In this way, it is convenient for the operator to control and reduce the damage to the patient's body tissue caused by the valve clamping device 400. Afterwards, the position and state of the valve clamping device 400 can be readjusted, and the above leaflet capture and clamping steps are repeated until the leaflet is clamped.

[0109] In the above embodiments, the description of each embodiment has its own emphasis. For parts that are not described or recorded in detail in a certain embodiment, reference can be made 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 only preferred implementations of the present application. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present application, and these improvements and modifications should also be regarded as the protection scope of the present application.

Claims

1. A control device, applicable to an interventional treatment system, characterized in that: include: A control assembly, comprising a control handle and a driving element, wherein the control handle is used to drive the driving element to rotate and move axially; The feedback component includes a paddle and a rotating member, wherein the rotating member is arranged on the driving element and has at least two tooth blocks. When the driving element rotates, the paddle is suitable for being engaged with one of the tooth blocks to provide force feedback.

2. The control device according to claim 1, characterized in that , There are multiple tooth blocks on the rotating member, and a slot is formed between two adjacent tooth blocks, suitable for the paddle to be clamped.

3. The control device according to claim 2, characterized in that: The tooth block is formed with guide surfaces on both sides of the rotating member in the circumferential direction, which are suitable for guiding the paddle to enter and exit the slot.

4. The control device according to claim 1, characterized in that: The plectrum is made of metal springs.

5. The control device according to claim 1, characterized in that: Also includes: A fixing block, used for fixing the plectrum; 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 butt against the tooth block on the rotating member.

6. The control device according to any one of claims 1 to 5, characterized in that: The driving element comprises a sleeve and a driving rod, and the rotating member is arranged on the sleeve; The control handle is connected to the proximal end of the sleeve to drive the sleeve and the driving rod to rotate and move axially toward the proximal end.

7. The control device according to claim 6, characterized in that: The driving rod comprises a first section at a distal end and a second section at a proximal end; the radial dimension of the first section is greater than the radial dimension of the second section; The sleeve has a first internal space, the control handle has a second internal space, the second internal space is connected to the first internal space, the second section is passed through the first internal space and the second internal space, the first section is partially passed 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, thereby limiting the relative rotation between the drive rod and the sleeve.

8. The control device according to claim 7, characterized in that: The control assembly also includes a first elastic member, which is sleeved on the second section in the first space, and the proximal end of the first elastic member is axially limited at the proximal end of the first space, and the distal end of the first elastic member is axially limited at the distal end of the first space or the proximal end of the first section.

9. The control device according to claim 6, characterized in that: Also includes: A housing and a connecting assembly, wherein the connecting assembly comprises a limiting track and a limiting element, wherein the limiting track extends along the axial direction of the driving rod, and the limiting element matches the limiting track and can slide axially relative to the limiting track; The distal end of the sleeve is axially limited by the limiting element, the limiting track is provided on the inner wall of the shell, 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 the limiting elements is two, which are symmetrically arranged on both sides of the distal end of the sleeve, and the number of the limiting rails is two, which are symmetrically arranged on the shell.

11. The control device according to claim 10, characterized in that: The connecting assembly further comprises a connecting piece, which is used to connect the two limiting elements and is sleeved on the distal end of the sleeve; The connecting assembly further comprises two limiting rings, which are rotatably sleeved on the distal end of the sleeve, and the connecting member is axially limited between the two limiting rings.

12. The control device according to claim 6, characterized in that: Also includes: The locking assembly comprises a locking member, wherein the locking member is provided with an opening suitable for the sleeve to pass through, and the locking member has a locking side corresponding to the peripheral side of the opening; The locking member can be selectively in a first position and a second position. In the first position, the locking side is against the sleeve to limit the axial movement of the sleeve; in the second position, the locking side is away from the sleeve, suitable for the control handle to drive the sleeve and the drive rod to move toward the proximal end.

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

14. A conveying system, characterized in that: include: An implantation catheter, a delivery rod, and a manipulation device as described in any one of claims 1 to 13; The proximal end of the delivery rod is connected to the distal end of the driving rod, and the distal end extends along the internal channel of the implant catheter until it passes through the distal end of the implant catheter. The control device is arranged at the proximal end of the implant catheter, and is used to drive the radial rotation and axial displacement of the delivery rod; Also included is a delivery catheter for providing an implantation channel.

15. An interventional treatment system, characterized in that: include: An implant and a delivery system as claimed in claim 14; The manipulation device drives the delivery rod to control the state of the implant, and the connection and separation of the implant from the delivery system.

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