WO2020103760A1

WO2020103760A1 - Driving handle and delivery system used for delivering implant

Info

Publication number: WO2020103760A1
Application number: PCT/CN2019/118486
Authority: WO
Inventors: 刘祥; 刘世红; 程小明; 赵婧; 陈国明; 李�雨
Original assignee: 上海微创心通医疗科技有限公司
Priority date: 2018-11-23
Filing date: 2019-11-14
Publication date: 2020-05-28
Also published as: CN111214310A

Abstract

A driving handle (10) and delivery system used for delivering an implant, which may drive an outer tube (6) used for delivering the implant to perform variable speed movement, which is to say that the handle (10) controls the outer tube (6) to move at different speeds according actual surgical needs, thereby improving the efficiency of surgery and reducing the difficulty of surgery. The driving handle (10) specifically comprises a hand-held sleeve (1), a fixed sleeve (2), a first and second driving mechanism (3, 5) and a transmission mechanism (4); at least a part of the fixed sleeve (2) movably penetrates the hand-held sleeve (1); the first and second driving mechanisms (3, 5) and the transmission mechanism (4) may all be movably disposed on the hand-held sleeve (1); the first driving mechanism (3) is connected to the fixed sleeve (2), and is configured to directly drive the fixed sleeve (2) to move along an axis of the driving handle (10) at a first speed (V1) when receiving an external force; the second driving mechanism (5) is configured to push the transmission mechanism (4) when receiving an external force, the transmission mechanism (4) driving the first driving mechanism (3) and the fixed sleeve (2) to move synchronously at a second speed (V2) along the axis of the drive handle (10), wherein the second speed (V2) is not equal to the first speed (V1).

Description

Drive handle and delivery system for delivery of implants

[0001] The present invention relates to the technical field of medical devices, and in particular, to a driving handle and a delivery system for delivering implants.

Background technique

[0002] With the development of the social economy and the aging of the population, the incidence of valvular heart disease has increased significantly. Studies have shown that the incidence of valvular heart disease in the elderly over 75 years old is as high as 13.3%. At present, traditional surgical treatment is still the first choice for patients with severe valvular disease, but for elderly patients with multiple organ diseases, a history of thoracotomy and poor cardiac function, traditional surgery is a high risk and death The rate is high, and some patients do not even have the opportunity for surgery.

[0003] Transcatheter heart valve surgery has the advantages of no need for thoracotomy, less trauma, and faster recovery of patients, and has received extensive attention from experts and scholars. This operation requires delivery of an interventional catheter through the femoral artery to deliver the valve to the aortic valve area to open, thereby completing the implantation of the artificial valve and restoring valve function. The implantation of the valve is generally performed by means of a delivery system, and the delivery system is inseparable from the sheath carrying the valve and the handle that drives the movement of the sheath, and the handle plays a vital role in the surgical procedure.

Summary of the invention

technical problem

[0004] According to clinical needs, during the preoperative valve loading, it is hoped that the handle can achieve rapid withdrawal and slow advancement of the sheath to improve the loading efficiency and ensure the success rate of loading; and in the process of valve implantation, The positioning needs to be as precise as possible. The slower the valve release speed during operation, the slower the sheath withdrawal rate. In addition, for the recyclable valve, if it needs to be recovered and re-released during the implantation process The faster the valve is recovered, the higher the efficiency, and the more beneficial it is to surgery, that is, the faster the sheath advances, the better. In general, different stages of the operation will have different requirements for the speed of the handle. However, the traditional handle cannot adjust the speed of advancement and retreat of the sheath when releasing and recovering the valve, making it difficult for the surgeon to control the implantation speed and position of the valve, resulting in a large positioning error and low surgical efficiency. Solution to the problem

Technical solution

[0005] The objective of the present invention is to provide a driving handle and a delivery system for delivering an implant, wherein the driving handle can control the sheath used to deliver the implant to be fast or slow according to the needs of actual surgery Exercise to achieve more precise positioning control and more efficient surgical operation during the implantation process, and reduce the difficulty of surgery.

[0006] To achieve the above object, the present invention provides a drive handle for delivering an implant, which includes a hand-held sleeve, a fixed sleeve, a first drive mechanism, a second drive mechanism, and a transmission mechanism;

[0007] At least a portion of the fixed sleeve is movably inserted in the handheld sleeve; the first drive mechanism, the second drive mechanism, and the transmission mechanism are all movably disposed in the On the handheld sleeve; where:

[0008] The first drive mechanism is connected to the fixed sleeve, and is configured to directly drive the fixed sleeve to move along the axis of the drive handle at a first speed when subjected to an external force;

[0009] The second driving mechanism is configured to push the transmission mechanism when subjected to an external force, and the transmission mechanism further drives the first driving mechanism and the fixed sleeve to synchronously move along the driving handle at a second speed , The second speed is not equal to the first speed.

[0010] Preferably, the fixed sleeve is configured to remain relatively stationary circumferentially with the handheld sleeve.

[0011] Preferably, the second driving mechanism, the transmission mechanism and the first driving mechanism are arranged in order from the proximal end to the distal end of the driving handle. Or, from the proximal end to the distal end of the driving handle, the first driving mechanism, the transmission mechanism, and the second driving mechanism are sequentially arranged.

[0012] Preferably, the first speed is greater than the second speed, or the first speed is less than the second speed.

[0013] Preferably, the first drive mechanism includes a first control knob, the second drive mechanism includes a second control knob, the first control knob and the second control knob can be movably nested in On the handheld sleeve; wherein:

[0014] The first control knob and the fixed sleeve are connected by a thread, the second control knob and the transmission mechanism or the handheld sleeve are connected by a thread, and the thread pitch on the second control knob The pitch of the thread on the first control knob is not equal; [0015] When the first control knob is configured to rotate counterclockwise, the fixed sleeve is driven to move at the first speed in the first direction, and the first control knob rotates clockwise , Driving the fixed sleeve to move at the first speed in a second direction, the first direction being opposite to the second direction

[0016] when the second control knob is configured to rotate clockwise, pushing the transmission mechanism to drive the first control knob and the fixed sleeve to move in the second direction at the second speed simultaneously, When the second control knob rotates in the counterclockwise direction, the transmission mechanism is driven to drive the first control knob and the fixed sleeve to move at the second speed in the first direction simultaneously. Optionally, the first direction is toward the proximal end of the drive handle, and the second direction is toward the distal end of the drive handle.

[0017] Preferably, when the second control knob and the hand-held sleeve are connected by threads, the inner surface of the second control knob and the outer surface of the hand-held sleeve are respectively provided with mutually matching internal threads And an external thread, and the second control knob is configured to be at least relatively axially stationary with the transmission mechanism.

[0018] Preferably, when the second control knob and the hand-held sleeve are connected by threads, the transmission mechanism is provided with one of a convex portion and a concave portion, and the second control knob is provided with a convex portion and a concave portion In the other one, the convex portion and the concave portion cooperate.

[0019] Preferably, when the second control knob and the transmission mechanism are connected by threads, the inner surface of the second control knob and the outer surface of the transmission mechanism are provided with mutually matching internal threads and external And the second control knob is rotatably provided on the handheld sleeve.

[0020] Preferably, when the second control knob and the transmission mechanism are connected by a screw, the handheld sleeve is provided with one of a convex portion and a concave portion, the second control knob is provided with a convex portion and a concave portion In the other one, the convex portion and the concave portion cooperate.

[0021] Preferably, a first limiting portion is provided on the transmission mechanism, a second limiting portion is provided on the handheld sleeve, and the first limiting portion is used to communicate with the second limiting portion Cooperate to limit the circumferential movement of the transmission mechanism.

[0022] Preferably, the first limiting portion is a protrusion, and the second limiting portion is a guide groove extending and hollowed in the axial direction of the handheld sleeve.

[0023] Preferably, the number and position of the protrusions match the guide groove.

[0024] Preferably, the transmission mechanism includes a ring sleeve, which is movably sleeved on the handheld sleeve, and respectively The first control knob and the second control knob are connected.

[0025] Preferably, the handheld sleeve is provided with an axially extending and hollow guide groove, and the outer surface of the fixed sleeve is provided with an external thread provided along a part of the circumference, and the fixed sleeve The external thread on the barrel extends through the guide groove. The hand-held sleeve cooperates with the internal thread on the internal surface of the first control knob; The external threads on the barrel match.

[0026] Preferably, the external threads on the fixed sleeve are two and are arranged symmetrically.

[0027] Preferably, the hand-held sleeve includes an axially provided hand-held portion and a connecting portion, the diameter of the connecting portion is smaller than the diameter of the hand-held portion; and the first control knob, the second control knob And the transmission mechanism are both provided on the connecting portion.

[0028] In order to achieve the above object, the present invention also provides a delivery system for delivering an implant, which includes the drive handle for delivering the implant according to any one of the foregoing, and the delivery system further Including outer tube and inner tube components;

[0029] The inner tube assembly is penetrated in the outer tube and used to fix the implant, and is connected to the hand-held sleeve of the driving handle, and is kept relatively still with the hand-held sleeve ;

[0030] The outer tube is connected to the fixed sleeve of the drive handle, and the fixed sleeve is used to drive the outer tube to perform axial movement relative to the inner tube assembly.

[0031] Preferably, the inner tube assembly includes a sequentially connected inner tube, a fixed head and a tapered head; the proximal end of the inner tube is connected to the handheld sleeve, the inner tube is at the fixed head The section between the conical head is used to load the implant.

[0032] Preferably, the proximal end of the outer tube is connected to the distal end or proximal end of the fixed sleeve.

[0033] In the drive handle and the delivery system for delivering implants provided by the present invention, implants such as heart valves need to be implanted by means of the delivery system. Wherein, the driving handle of the present invention includes a hand-held sleeve, a fixed sleeve, a first drive mechanism, a second drive mechanism and a transmission mechanism, at least a part of the fixed sleeve is movably penetrated in the hand-held sleeve, The first drive mechanism, the second drive mechanism, and the transmission mechanism are all movably disposed on the hand-held sleeve, and the first drive mechanism is connected to the fixed sleeve and is configured In order to directly drive the fixed sleeve to move along the axis of the driving handle at the first speed when receiving an external force, and at the same time, the second driving mechanism is configured to push the transmission mechanism when the external force is applied, and the transmission mechanism further drives the The first drive mechanism and the fixed The sleeve moves synchronously along the axis of the drive handle at a second speed which is not equal to the first speed. In this configuration, the fixed sleeve is connected to the outer tube of the delivery system to control the outer The fast retreat and slow advance of the tube can also control the fast advance and slow retreat of the outer tube, so that different surgical operation requirements can be met at different stages of the operation.

[0034] Specifically, the first speed is greater than the second speed as an illustration. Furthermore, in order to adapt to the clinical needs, when the drive handle of the present invention is loaded with a heart valve before surgery, the first drive mechanism can achieve rapid outer tube Withdrawing to facilitate the rapid loading of the heart valve and improve the loading efficiency; after the heart valve is loaded, the second drive mechanism can be used to achieve the slow advance of the outer tube to ensure the success rate of loading; and then in the process of heart valve implantation, The second driving mechanism is used to control the withdrawal of the outer tube at a slower speed, so as to control the release rate of the heart valve, realize the accurate positioning of the heart valve, ensure the success rate of the operation, and reduce the difficulty of the operation; For the valve, if it needs to be recovered and re-released during the implantation process, the first drive mechanism can be used to control the outer tube to advance at a faster speed to realize the rapid recovery of the heart valve, improve the recovery efficiency, and shorten the operation time.

[0035] In a preferred embodiment, the first drive mechanism includes a first control knob, the second drive mechanism includes a second control knob, and the first control knob and the fixed sleeve are connected by a thread, The second control knob is connected with the transmission mechanism or the hand-held sleeve through a thread, so that when the first control knob is rotated in one direction, the fixed sleeve can be driven to drive the outer tube to quickly advance, and the first control knob is directed to the other When rotating in the direction, the fixed sleeve can be driven to drive the outer tube to quickly retreat. Similarly, when the second control knob is rotated in one direction, the transmission mechanism can be driven to drive the first control knob, the fixed sleeve and the outer tube to slowly retreat, and When the second control knob rotates in the other direction, the transmission mechanism is driven to drive the first control knob, the fixed sleeve, and the outer tube to advance slowly. Here, by setting different transmission threads, the movement speed is controlled, the structure is simple, and the operation is convenient. Moreover, the thread with a small pitch converts the angular displacement of the circumferential rotation into the linear displacement of the fixed sleeve with higher precision, enabling more precise positioning control.

Beneficial effects of invention

Brief description of the drawings

BRIEF DESCRIPTION

[0036] FIG. 1 is a schematic diagram of a delivery system in an embodiment of the invention;

[0037] FIG. 2 is a partial schematic view of a delivery system in which an inner tube assembly is omitted in an embodiment of the present invention; [0038] FIG. 3 is a partial enlarged view of the delivery system shown in FIG. 2 in the area A;

[0039] FIG. 4 is an exploded view of a driving handle for delivering an implant in an embodiment of the present invention;

[0040] FIG. 5 is an assembly diagram of a driving handle for delivering an implant in an embodiment of the present invention;

[0041] FIG. 6 is a perspective view of a handheld sleeve in an embodiment of the present invention;

[0042] FIG. 7 is a perspective view of a fixing sleeve in an embodiment of the present invention;

[0043] FIG. 8 is a schematic diagram of a valve stent loaded between an inner tube and an outer tube in an embodiment of the present invention.

[0044] In the figure:

[0045] drive handle 10; hand-held sleeve 1; hand-held portion 11; connecting portion 12; second external thread 13; guide groove 14; fixed sleeve 2; cylindrical body 21; first external thread 22; first drive Mechanism 3; first control knob 31; transmission mechanism 4; ring sleeve 41; circumferential groove 42; second drive mechanism 5; second control knob 51; catheter assembly 20; outer tube 6; inner tube assembly 7; tapered Head 71; fixed head 72; inner tube 73; valve holder 8 Example of invention

Embodiments of the invention

[0046] In order to make the objectives, advantages and features of the present invention clearer, the present invention will be described in further detail below with reference to the accompanying drawings. It should be noted that the drawings are in a simplified form and not drawn to scale, and are only used to conveniently and clearly assist the purpose of explaining the embodiments of the present invention. As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural objects unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used to include "and / or" unless the content clearly dictates otherwise. The terms "first" and "second" are used only for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, unless otherwise stated, "multiple" means two or more

[0047] In the following description, for ease of description, "distal" and "proximal", "axial" and "circumferential" are used; "distal" is the side away from the operator of the delivery system; "near "End" is the side close to the operator of the conveyor system; "Axial" refers to the direction of the axis along the drive handle; "Circumferential" refers to the direction of the axis around the corresponding mechanical component. In addition, in the following description, a large number of specific details are given in order to provide a more thorough understanding of the present invention. However, it is obvious to those skilled in the art that the present invention may One or more of these details are required to be implemented. In other examples, in order to avoid confusion with the present invention, some technical features known in the art are not described.

[0048] The core idea of the present invention is to provide a driving handle for delivering an implant, the driving handle including a hand-held sleeve, a fixing sleeve, a first driving mechanism, a second driving mechanism, and a transmission mechanism; the fixing At least a part of the sleeve is movably penetrated in the handheld sleeve; the first driving mechanism, the second driving mechanism and the transmission mechanism are all movably arranged on the handheld sleeve; wherein :

[0049] The first drive mechanism is connected to the fixed sleeve and is configured to directly drive the fixed sleeve to move along the axis of the drive handle at a first speed when subjected to an external force;

[0050] The second driving mechanism is configured to push the transmission mechanism when subjected to an external force, and the transmission mechanism further drives the driving handle at a second speed in synchronization with the first driving mechanism and the fixed sleeve The axis moves, and the second speed is not equal to the first speed.

[0051] In one embodiment, the first speed is greater than the second speed, at this time, the first drive mechanism can quickly drive the fixed sleeve movement, and the second drive mechanism can be driven by a transmission mechanism The first driving mechanism and the fixed sleeve simultaneously perform slow motion. Taking the implant as a valve stent, it can be divided into the following operation stages:

[0052] First, loading the valve stent on the inner tube: Before loading, the fixing sleeve can be driven by the first driving mechanism to drive the outer tube to quickly withdraw (ie, the first direction), so as to quickly load the valve stent on the delivery system On the inner tube, improve the loading efficiency;

[0053] Second, press the valve holder into the outer tube: After loading the valve holder into the inner tube, the second drive mechanism drives the fixed sleeve to drive the outer tube to advance slowly (ie, the second direction), so that the valve Hold the stent in the outer tube and ensure the success rate of loading;

[0054] Third, the valve stent is released: During the implantation process, the second driving mechanism drives the fixed sleeve to drive the outer tube to slowly withdraw (ie, the first direction) to achieve the slow release of the valve stent, thereby accurately positioning The implantation position of the valve stent to ensure the accuracy of the positioning position;

[0055] Fourth, the recovery of the valve stent: After implantation, if it is found that the positioning is not correct and the valve stent needs to be released again, the valve stent can be recovered again. At this time, the fixed sleeve can be driven by the first driving mechanism to quickly advance (ie The second direction), to quickly recover the valve stent into the outer tube, thereby improving the recovery efficiency and shortening the operation time. [0056] Obviously, through the above operation, the drive handle can control the movement of the outer tube at different speeds according to the needs of the operation, so that the doctor can better control the loading speed of the valve stent, the implantation speed and the implantation position, thereby reducing Positioning error improves surgical efficiency.

[0057] However, in an alternative embodiment of the present invention, the first speed may also be less than the second speed, in this case, the first driving mechanism is used to slowly drive the fixed sleeve movement, and The second driving mechanism is used to quickly drive the fixed sleeve to move, but the specific operation method is the same as the foregoing embodiment.

[0058] The following description will be made with reference to the drawings.

[0059] Please refer to FIGS. 1 to 8, FIG. 1 is a schematic diagram of a delivery system in an embodiment of the present invention, FIG. 2 is a partial schematic diagram of a delivery system in which an inner tube assembly is omitted in an embodiment of the present invention, and FIG. 3 is 2 is a partially enlarged view of the delivery system shown in FIG. 2 in the area A, FIG. 4 is an exploded view of a driving handle for delivering an implant in an embodiment of the present invention, and FIG. 5 is an embodiment of the present invention is used for Fig. 6 is a perspective view of a hand-held sleeve in an embodiment of the invention, Fig. 7 is a perspective view of a fixed sleeve in an embodiment of the invention, and Fig. 8 is an implementation of the invention In the example, the valve stent is loaded between the inner tube and the outer tube.

[0060] First, as shown in FIG. 1, an embodiment of the present invention provides a delivery system for delivering an implant, which includes a driving handle 10 and a catheter assembly 20. The catheter assembly 20 includes an outer tube 6 and an inner tube assembly 7; the outer tube 6 is disposed outside the inner tube assembly 7 and is coaxially arranged with the inner tube assembly 7, and the outer tube 6 can be axially moved relative to the inner tube assembly 7, here In order to ensure the accuracy of positioning, the outer tube 6 is preferably not allowed to move in the circumferential direction. In addition, when the catheter assembly 20 is assembled with the driving handle 10, the outer tube 6 is connected to the movable component on the driving handle 10, so that the movable component drives the outer tube 6 to move axially relative to the inner tube assembly 7 to realize the outer tube 6 Advance and retreat. Here, "advance" refers to the direction of movement toward the distal end of the drive handle 10; "backward" refers to the direction opposite to "advance", that is, toward the proximal end of the drive handle 10. In addition, the implant is used to fix the inner tube assembly 7, and the inner tube assembly 7 needs to be connected to the stationary component on the drive handle 10 to ensure that the inner tube assembly 7 is always fixed during operation.

[0061] Furthermore, in the process of advancing and retreating the outer tube 6, in order to achieve fast or slow movement of the outer tube 6, as shown in FIGS. 4 and 5, the driving handle 10 of this embodiment specifically includes a handheld sleeve 1, The fixed sleeve 2, the first drive mechanism 3, the transmission mechanism 4 and the second drive mechanism 5; at least a portion of the fixed sleeve 2 can be movably penetrated in the handheld sleeve 1 (preferably the entire fixed sleeve 2 is provided in the handheld Inside sleeve 1), and preferably fixed sleeve 2 It is relatively stationary in the circumferential direction with the handheld sleeve 1, and the fixed sleeve 2 is connected to the outer tube 6 to drive the outer tube 6 to move in the axial direction of the drive handle 10 through the fixed sleeve 2.

[0062] In the embodiment of the present invention, from the proximal end of the driving handle 10 to the distal direction, the second driving mechanism 5, the transmission mechanism 4 and the first driving mechanism 3 are sequentially movably arranged on the hand-held sleeve 1, and the transmission The mechanism 4 is connected to the first drive mechanism 3 and the second drive mechanism 5, respectively. Moreover, the first drive mechanism 3 is connected to the fixed sleeve 2 and is configured to directly drive the fixed sleeve 2 to move along the axis of the drive handle 10 at a first speed when subjected to an external force, while the second drive mechanism 5 is configured to receive When the external force acts, the transmission mechanism 4 is pushed, and then the transmission mechanism 4 drives the first driving mechanism 3 and the fixed sleeve 2 to move along the axis of the driving handle 10 at the second speed V2 simultaneously. Here, the first speed VI and the second speed V2 are not equal.

[0063] Next, for convenience of description, the first speed VI is greater than the second speed V2 as an example, and the structure and operation mode of the driving handle 10 will be further described.

[0064] When the first speed VI is greater than the second speed V2, the first drive mechanism 3 directly drives the fixed sleeve 2 to make rapid movement along the axial direction of the drive handle 10, and the second drive mechanism 5 drives the first through the transmission mechanism 4 The driving mechanism 3 and the fixed sleeve 2 move slowly along the axial direction of the drive handle 10, so that the speed at which the fixed sleeve 2 advances and retreats is not the same, that is, the moving speed of the outer tube 6 connected to the fixed sleeve 2 It can be adjusted according to the needs of actual surgery.

[0065] Preferably, the first drive mechanism 3 includes a first control knob 31 having an internal thread, and the second drive mechanism 5 includes a second control knob 51 having an internal thread. Both the first control knob 31 and the second control knob 51 can be movably sleeved on the handheld sleeve 1, and the internal thread pitch on the first control knob 31 is greater than the internal thread pitch on the second control knob 51, so that the first The first speed VI is greater than the second speed V2, so as to ensure that the first control knob 31 has a large displacement and speed for one rotation, and realizes a fast movement, while the second control knob 51 has a small displacement and speed for one rotation, which can be achieved Slow motion, so configured, the structure of the driving handle is simple, the cost is low, and the operation is also convenient. Moreover, the rotation of the screw thread of the control knob is converted into a linear displacement of the fixed sleeve 2 with high precision, which can achieve more accurate positioning control of the implant.

[0066] For this reason, the fixed sleeve 2 is preferably connected to the first control knob 31 by threads. As shown in FIG. 7, a first external thread 22 is provided on the outer surface of the fixed sleeve 2, and the first external thread 22 It is only provided along a part of the circumference of the fixed sleeve 2, so that the first external thread 22 and the internal thread on the first control knob 31 cooperate to realize the connection between the fixed sleeve 2 and the first control knob 31. In addition, the second control knob 51 preferably passes through the transmission mechanism 4 Threaded connection, or threaded connection with the handheld sleeve 1.

[0067] In this way, the driving handle 10 can be operated in the following manner, as shown in FIGS. 1 to 7:

[0068] First, turn the first control knob 31 counterclockwise to directly drive the fixed sleeve 2 to the proximal end of the drive handle 10 to quickly withdraw (first direction), thereby quickly loading the implant into the inner tube assembly 7 On

[0069] Second, turn the second control knob 51 clockwise to drive the transmission mechanism 4 to drive the first control knob 31 to slowly advance toward the distal end of the drive handle 10 (second direction), and simultaneously drive the fixed sleeve 2 Advance slowly so that the implant is held in the outer tube 6 at a slower speed;

[0070] Third, turn the second control knob 51 counterclockwise again to drive the transmission mechanism 4 to drive the first control knob 31 toward the proximal end of the drive handle 10 to slowly retreat (first direction), and synchronously drive the fixed The sleeve 2 is slowly withdrawn to release the implant slowly in the body;

[0071] Fourth, turn the first control knob 31 clockwise again to directly drive the fixing sleeve 2 to the distal end of the driving handle 10 (second direction), thereby quickly recovering the implant.

[0072] Here, it should be noted that the movement direction of the fixed sleeve 2 corresponding to the rotation direction of each control knob is not unique, as long as each control knob can rotate the different directions to achieve the corresponding Just move forward and backward.

[0073] Next, referring to FIG. 7, in the embodiment of the present invention, the fixed sleeve 2 specifically includes a hollow cylindrical body 21, the outer surface of the cylindrical body 21 is provided with a first external thread 22, and the first external thread 22 only It is arranged along a part of the circumference of the cylindrical body 21 and is used to cooperate with the internal thread (not marked) on the first control knob 31. The number of the first external threads 22 may be one, two, or more than two. Here, two are preferably arranged symmetrically to ensure the stability of the motion transmission. The number of threads of the first external thread 22 is not specifically limited, and can be selectively set according to the actual travel required to move, and the first external thread 22 is preferably provided at the proximal end of the cylindrical body 21, which can shorten the fixing sleeve 2 length. Here, it cannot be understood in a narrow sense that the first external thread 22 is provided on the proximal end surface of the cylindrical body 21, but broadly understood as provided on the outer surface of the cylindrical body 21 located at the proximal end.

[0074] In one embodiment, the second control knob 51 and the hand-held sleeve 1 are connected by a thread, and at least axially relatively stationary with the transmission mechanism 4 (that is, the transmission mechanism 4 is driven to move axially), and the second control The thread pitch on the knob 51 is smaller than the thread pitch on the first control knob 31 to ensure that the first speed VI is greater than the second speed V2. [0075] Specifically, as shown in FIG. 6, a second external thread 13 is provided on the outer surface of the handheld sleeve 1, the second external thread 13 is provided along the entire circumference of the handheld sleeve 1, and is used to communicate with the second The internal threads (not shown) on the inner surface of the knob 51 are matched. Then, when the second control knob 51 rotates on the hand-held sleeve 1, since the hand-held sleeve 1 cannot rotate together with the second control knob 51, the threads of the two are relatively displaced, so that the second control knob 51 is only held along The axial movement of the sleeve 1 drives the transmission mechanism 4 to move only in the axial direction. Preferably, the second external thread 13 is disposed at the proximal end of the handheld sleeve 1, which can effectively reduce the length of the handheld sleeve 1. Moreover, it should not be understood in a narrow sense here that the second external thread 13 is provided on the proximal end surface of the handheld sleeve 1, but broadly understood as provided on the outer surface of the proximal end of the handheld sleeve 1.

[0076] Preferably, the hand-held sleeve 1 includes an axial hand-held portion 11 and a connection portion 12, and the first control knob 31, the second control knob 51 and the transmission mechanism 4 are all provided on the connection portion 12, preferably, connected The outer diameter of the portion 12 is smaller than the outer diameter of the hand-held portion 11, thereby forming a T-shaped hand-held sleeve 1. Therefore, in actual operation, the doctor can hold the hand-held portion 11 with one hand to ensure that the hand-held sleeve 1 is fixed, and the other hand can turn the first control knob 31 or the second control knob 51 to adjust, so The operation is more comfortable and convenient.

[0077] Further, the connecting portion 12 is also provided with a hollow guide groove 14 in the axial direction, so that the fixed sleeve 2 only moves axially along the guide groove 14 to prevent the circumferential movement of the fixed sleeve 2 from affecting Positioning effect, and the first external thread 22 on the fixed sleeve 2 further extends through the guide groove 14 and the handheld sleeve 1 cooperates with the internal thread on the first control knob 31. In this way, through the guide groove 14 The cooperation with the first external thread 22 extending out of the hand-held sleeve 1 can restrict the fixed sleeve 2 to move only in the axial direction (because the fixed sleeve 2 has a limit in the rotation direction, it cannot be connected with the first control knob 31— Rotation). Therefore, the number and position of the guide grooves 14 are matched with the first external threads 22. Preferably, the number of the guide grooves 14 is two and is symmetrically arranged. In addition, the length of the guide groove 14 is not limited to that disclosed in FIG. 6, one end starts from the proximal end surface of the hand-held portion 11, and the other end ends at the distal end of the second external thread 13. In addition, the shape of the guide groove 14 may be a rectangle, a waist, an ellipse, etc., which is not specifically limited.

[0078] When the second control knob 51 and the handheld sleeve 1 are connected by threads, the transmission mechanism 4 and the second control knob 51 preferably remain relatively stationary (including axial and circumferential directions), so that the second control knob 51 is pushed The transmission mechanism 4 moves synchronously in the axial direction. Optionally, the transmission mechanism 4 and the second control knob 51 are connected in a snap-fit manner. Specifically, the transmission mechanism 4 is provided with one of a convex portion and a concave portion, and the second control knob 51 is provided with a convex portion and a concave portion On the other hand, the convex part and the concave part cooperate, so that the connection between the two can be realized simply and conveniently Pick up.

[0079] As shown in FIG. 1, combined with FIG. 2 and FIG. 3, the transmission mechanism 4 of this embodiment preferably includes a ring sleeve 41, which is movably sleeved on the connection portion 12 of the hand-held sleeve 1, and respectively The first control knob 31 and the second control knob 51 are connected. Optionally, the ring sleeve 41 is engaged with the first control knob 31, for example, the side of the ring sleeve 41 facing the first control knob 31 is provided with a circumferential groove 42 (recess), and at the same time, the first control knob 31 is provided There is a hook (convex part), and the connection between the two can be achieved simply by the cooperation of the hook and the circumferential groove 42. Moreover, when the first control knob 31 is turned on the hand-held sleeve 1, the first control knob 31 is screwed with the fixed sleeve 2, so that the first control knob 31 makes a rotational movement relative to the ring sleeve 41 (the ring sleeve 41 does not Move), and drive the fixed sleeve 2 to move only in the axial direction (because the fixed sleeve 2 has a limit in the direction of rotation).

[0080] Further, the ring sleeve 41 is provided with a first limit portion, and the hand sleeve 1 is provided with a second limit portion. The first limit portion cooperates with the second limit portion to limit the ring sleeve 41 Circumferential movement. Here, the first limiting portion is preferably a protrusion (not shown) provided on the inside of the ring sleeve 41 for cooperating with the guide groove 14 on the handheld sleeve 1 to limit the circumferential movement of the ring sleeve 41, that is, the ring The sleeve 41 can only move axially along the guide groove 14. Therefore, the guide groove 14 can not only provide a linear stroke track for the fixed sleeve 2, so that the fixed sleeve 2 makes an axial movement along the guide groove 14, but also can provide a linear stroke track for the ring sleeve 41, so that the ring sleeve 41 It also moves axially along the guide groove 14. Furthermore, the number and position of the protrusions on the ring sleeve 41 and the number and position of the guide grooves 14 match. Therefore, the number of the protrusions is preferably plural and symmetrically arranged.

[0081] Optionally, the inner surface of the second control knob 51 is provided with an internal thread (not shown), and is connected with the handheld sleeve

1. The second external thread 13 on the outer surface cooperates. In this case, it is preferable that the second control knob 51 is snap-fitted with the ring sleeve 41, and the structure is relatively simple. As shown in FIGS. 2 and 3, the side of the ring sleeve 41 facing the second control knob 51 is provided with a circumferential groove 42 (concave portion), and the second control knob 51 is provided with a hook (convex portion), Through the cooperation of the hook and the circumferential groove 42, the connection between the two can also be achieved conveniently and quickly.

[0082] In another embodiment, the second control knob 51 and the ring sleeve 41 are connected by a thread, at this time, the second control knob 51 is rotatably provided on the hand-held sleeve 1, and the second control knob 51 The thread pitch is smaller than the thread pitch on the first control knob 31 to ensure that the first speed VI is greater than the second speed V2. Preferably, the handheld sleeve 1 and the second control knob 51 are connected in a snap-fit manner. For example, the handheld sleeve 1 is provided with a circumferential groove (recess) having the same structure as the ring sleeve 41, so that the second control knob 51 It also cooperates with the circumferential groove on the hand-held sleeve 1 through the snap hook. Therefore, when the second control knob 51 is turned, the driving ring sleeve 41 is connected through the thread It only moves in the axial direction and drives the first control knob 31 and the fixed sleeve 2 to make an axial movement. Here, since the ring sleeve 41 has a limit in the rotation direction, it can only move in the axial direction.

[0083] With further reference to FIG. 2, the proximal end of the outer tube 6 is specifically connected to the cylindrical body 21 on the fixed sleeve 2, but may be connected to any end of the cylindrical body 21. In addition, the inner tube assembly 7 needs to be connected to the hand-held sleeve 1 and remains stationary relative to the hand-held sleeve 1. Specifically, the inner tube 73 on the inner tube assembly 7 passes through the fixed sleeve 2 and is connected to the hand-held sleeve 1 The connection section 12 is detachably connected.

As shown in FIG. 8, from the proximal end to the distal end, the inner tube assembly 7 specifically includes an inner tube 73, a fixed head 72, and a tapered head 71 that are connected in sequence. Taking the implant as the valve support 8 as an example, FIG. 8 shows that the valve support 8 is in an unreleased state. It can be clearly seen from FIG. 8 that the valve support 8 is loaded between the tapered head 71 and the fixed head 72 during delivery The periphery of the inner tube 73 is fixedly supported by the fixing head 72 (the end of the valve holder 8 is fixed to the fixing head 72), and the fixing head 72 is not movable (that is, all degrees of freedom are restricted), and the inner tube 73 The proximal end of the valve is fixedly connected to the connecting section 12 on the handheld sleeve 1 by means of threads or glue, etc., so that the entire inner tube 73 is fixed relative to the driving handle 10, thereby ensuring the valve holder 8 and the driving handle loaded on the fixing head 72 10 Keep it relatively fixed. The distal end of the outer tube 6 is sheathed on the periphery of the valve holder 8 loaded on the inner tube 73. Preferably, the distal end of the outer tube 6 contacts the proximal end surface of the tapered head 71 at the distal end of the inner tube 73. Then, the outer tube 6 can be driven to move forward and backward by manual driving, so that the outer tube 6 moves forward and backward relative to the inner tube assembly 7, and operations such as loading, releasing and recycling of the valve stent 8 can be realized.

[0085] More specifically, the process of loading, releasing and recovering the valve stent 8 is:

[0086] First, the loading of the valve holder 8: the hand portion 11 can be held with the left hand, and the first control knob 31 can be rotated counterclockwise with the right hand. In order to expose the portion of the inner tube 73 between the fixed head 72 and the tapered head 71 to load the valve support 8 onto the inner tube 73;

[0087] Secondly, the compression of the valve holder 8: After loading the valve holder 8, the second control knob 51 is rotated clockwise. The rotation of the second control knob 51 causes the ring sleeve 41, the first control knob 31, and the fixed sleeve 2 and the outer tube 6 move forward simultaneously and slowly, the valve holder 8 can be pressed and held in the outer tube 6;

[0088] Furthermore, the release of the valve holder 8: During the implantation process, the second control knob 51 is rotated counterclockwise, and the rotation of the second control knob 51 causes the ring sleeve 41, the first control knob 31, the fixing sleeve 2 and the outer The tube 6 slowly retreats synchronously to achieve the slow withdrawal of the outer tube 6 to slowly release the valve support 8; [0089] Further recovery of the valve stent 8: If the valve stent 8 is found to be inaccurately positioned during implantation, the valve stent 8 can be re-entered into the outer tube 6, so the first control knob 31 can be rotated clockwise again, the first The rotation of the control knob 31 only causes the fixed sleeve 2 and the outer tube 6 to advance synchronously and rapidly, and realizes the rapid advancement of the outer tube 6 to quickly recover the valve holder 8.

[0090] Therefore, at different stages of the operation, according to the operating requirements, by adjusting the travel speed of the driving handle 10, it is convenient to meet different surgical operation requirements, thereby improving the surgical efficiency, reducing the difficulty of the surgery, and improving the positioning accuracy of the valve stent Good treatment effect.

[0091] The above embodiment mainly illustrates the structure and operation mode of the driving handle when the first speed VI is greater than the second speed V2, but when the first speed VI is less than the second speed V2, the structure and operating mode of the driving handle are also The foregoing embodiments are basically the same, except that the thread pitch on the first control knob 31 is smaller than the thread pitch on the second control knob 51, which also changes the corresponding operation mode, namely:

[0092] First, turn the second control knob 51 counterclockwise to drive the transmission mechanism 4 to drive the first control knob 31 to quickly withdraw to the proximal end of the drive handle 10 (first direction), and synchronously drive the fixed sleeve 2 Quickly withdraw to quickly load the implant;

[0093] Second, turn the first control knob 31 clockwise to directly drive the fixed sleeve 2 to the distal end of the driving handle 10 at a slow speed (second direction) to load the implant in the outer tube at a slow speed Medium

[0094] Third, turn the first control knob 31 counterclockwise to directly drive the fixed sleeve 2 to the proximal end of the drive handle 10 to slowly withdraw (first direction) to release the implant at a slow speed;

[0095] Fourth, turn the second control knob 51 clockwise to drive the transmission mechanism 4 to drive the first control knob 31 to quickly advance toward the distal end of the drive handle 10, and synchronously drive the fixed sleeve 2 to quickly advance to achieve implantation Rapid recovery of the body.

[0096] Further, in an alternative embodiment of the present invention, from the proximal end of the driving handle 10 to the distal direction, the first driving mechanism 3, the transmission mechanism 4 and the second driving mechanism 5 may also be sequentially arranged, while The first drive mechanism 3 is also connected to the fixed sleeve 2. In this case, the structure and principle of the driving handle are basically the same as those described in the previous embodiment, and the same technical effect as the previous embodiment can be achieved, but the position of some structural features will be adjusted, such as the second external thread 13 moves toward the distal end of the hand-held sleeve 1, which can be specifically positioned near the proximal end surface of the hand-held portion 11, and the guide groove 14 starts at the proximal end of the second external thread 13, etc. Further description, the basis of the content disclosed by the person skilled in the art in this application document Above, it should be able to know the adjustment of the specific structure, so as to be modified to obtain the driving handle. In this way, the first driving mechanism connected to the fixing sleeve 2 is disposed at the proximal end of the driving handle 10, and relatively speaking, the length of the fixing sleeve 2 is increased.

[0097] Finally, the preferred embodiments of the present invention are as described above, but are not limited to the scope disclosed in the above embodiments. For example, the present invention does not particularly limit the structure of the first driving mechanism and the second driving mechanism, as long as the two The driving mechanism can realize fast and slow movement of the fixed sleeve 2. In addition, the embodiments of the present invention are described using the valve stent 8 (such as a heart valve stent) as an implant. Those skilled in the art can understand that the delivery system disclosed in the present invention can be used to place other implants (such as vascular stents) into corresponding positions of the body in addition to the valve stent.

[0098] The embodiments in this specification are described in a progressive manner. Each embodiment focuses on the differences from other embodiments, and the same or similar parts between the embodiments may refer to each other.

[0099] The above description is only a description of preferred embodiments of the present invention, and does not limit the scope of the present invention. Any changes or modifications made by those of ordinary skill in the art according to the above disclosure shall fall within the scope of protection of the claims. .

Claims

[Claim 1] A drive handle for delivering an implant, characterized in that it comprises a hand-held sleeve, a fixed sleeve, a first drive mechanism, a second drive mechanism and a transmission mechanism; at least of the fixed sleeve A part is movably inserted in the handheld sleeve; the first drive mechanism, the second drive mechanism and the transmission mechanism can be movably arranged on the handheld sleeve; wherein:

The first drive mechanism is connected to the fixed sleeve and is configured to directly drive the fixed sleeve to move along the axis of the drive handle at a first speed when subjected to an external force; the second drive mechanism is configured In order to push the transmission mechanism when receiving an external force, the transmission mechanism further drives the first driving mechanism and the fixed sleeve to move along the axis of the driving handle at a second speed synchronously. The first speed is not equal.

[Claim 2] The driving handle for delivering an implant according to claim 1, wherein the fixing sleeve is configured to remain relatively stationary circumferentially with the handheld sleeve.

[Claim 3] The driving handle for delivering an implant according to claim 1 or 2, wherein the second driving mechanism, the second driving mechanism, and the second driving mechanism are sequentially arranged from the proximal end to the distal end of the driving handle. The transmission mechanism and the first driving mechanism; or, from the proximal end to the distal end of the driving handle, the first driving mechanism, the transmission mechanism, and the second driving mechanism are sequentially arranged

[Claim 4] The driving handle for delivering an implant according to claim 1 or 2, wherein the first driving mechanism includes a first control knob, and the second driving mechanism includes a second control The knob, the first control knob and the second control knob can be movably sleeved on the handheld sleeve; wherein:

The first control knob and the fixed sleeve are connected by a thread, the second control knob and the transmission mechanism or the handheld sleeve are connected by a thread, and the thread pitch on the second control knob is The thread pitch on the first control knob is not equal;

When the first control knob is configured to rotate in the counterclockwise direction, the fixed sleeve is driven to move at the first speed in the first direction, and when the first control knob is rotated in the clockwise direction, the The fixed sleeve moves at the first speed in the second direction, the first One direction is opposite to the second direction;

When the second control knob is configured to rotate clockwise, the transmission mechanism is driven to drive the first control knob and the fixed sleeve to move synchronously in the second direction at the second speed, and the When the second control knob rotates in the counterclockwise direction, the transmission mechanism is driven to drive the first control knob and the fixed sleeve to move synchronously in the first direction at the second speed.

[Claim 5] The driving handle for delivering an implant according to claim 4, wherein when the second control knob and the hand-held sleeve are connected by a thread, the second control knob The inner surface of the and the outer surface of the handheld sleeve are provided with mutually matching internal and external threads, respectively, and the second control knob is configured to maintain at least axial relative static with the transmission mechanism.

[Claim 6] The driving handle for delivering an implant according to claim 5, wherein the transmission mechanism is provided with one of a convex portion and a concave portion, and the second control knob is provided with a convex portion With the other of the concave portions, the convex portion cooperates with the concave portion.

[Claim 7] The driving handle for delivering an implant according to claim 4, wherein when the second control knob and the transmission mechanism are connected by a thread, the The inner surface and the outer surface of the transmission mechanism are provided with mutually matching internal threads and external threads, respectively, and the second control knob is rotatably provided on the handheld sleeve.

[Claim 8] The driving handle for delivering an implant according to claim 7, wherein the hand sleeve is provided with one of a convex portion and a concave portion, and the second control knob is provided with a convex The other of the part and the concave part, the convex part cooperates with the concave part.

[Claim 9] The driving handle for delivering an implant according to claim 4, wherein the transmission mechanism is provided with a first limit portion, and the hand sleeve is provided with a second limit A position portion, where the first limit portion is used to cooperate with the second limit portion to limit the circumferential movement of the transmission mechanism.

[Claim 10] The driving handle for delivering an implant according to claim 9, wherein the first limiting portion is a protrusion, and the second limiting portion is along the hand grip A guide groove extending axially and hollowed out of the barrel.

[Claim 11] The driving handle for delivering an implant according to claim 10, wherein the number and position of the protrusions match the guide groove.

[Claim 12] The driving handle for delivering an implant according to claim 4, wherein the transmission mechanism includes a ring sleeve, which is movably sleeved on the hand-held sleeve, and respectively The first control knob and the second control knob are connected.

[Claim 13] The driving handle for delivering an implant according to claim 4, wherein the handheld sleeve is provided with an axially extending and hollow guide groove, and the fixing sleeve An external thread provided along a part of the circumference is provided on the outer surface of, and the external thread on the fixed sleeve extends through the guide groove on the inner surfaces of the handheld sleeve and the first control knob The internal threads of the are matched; the number and position of the guide grooves are matched with the external threads on the fixed sleeve.

[Claim 14] The driving handle for delivering an implant according to claim 13, characterized in that there are two external threads on the fixing sleeve which are symmetrically arranged.

[Claim 15] The driving handle for delivering an implant according to claim 4, wherein the hand-held sleeve includes a hand-held portion and a connecting portion provided axially, and the diameter of the connecting portion is smaller than The diameter of the hand-held portion; and the first control knob, the second control knob, and the transmission mechanism are all provided on the connection portion.

[Claim 16] A delivery system for delivering an implant, characterized in that it includes the drive handle for delivering the implant according to any one of claims 1 to 15, and the delivery system Also includes outer tube and inner tube components;

The inner tube assembly is penetrated in the outer tube and used for fixing the implant, and is connected with the hand-held sleeve of the driving handle, and is kept relatively still with the hand-held sleeve; The outer tube is connected to the fixed sleeve of the drive handle, and the fixed sleeve is used to drive the outer tube to perform axial movement relative to the inner tube assembly.

[Claim 17] The delivery system for delivering an implant according to claim 16, wherein the inner tube assembly includes an inner tube, a fixed head and a tapered head connected in sequence; the inner tube The proximal end of is connected to the handheld sleeve, and the section of the inner tube between the fixed head and the tapered head is used to load the implant. [Claim 18] The delivery system for delivering an implant according to claim 16, wherein the proximal end of the outer tube is connected to the distal end or proximal end of the fixation sleeve.