Driving handle and delivery system for delivering implant

Abstract

The present invention provides a driving handle and a delivery system for delivering an implant, which can drive an outer tube for delivering an implant to perform variable speed movement, that is, the handle controls the movement of the outer tube at different speeds according to the actual needs of the operation, thereby improving the efficiency of the operation and reducing the difficulty of the operation. The driving handle of the present invention specifically includes a handheld sleeve, a fixed sleeve, a first and a second driving mechanism, and a transmission mechanism; at least a portion of the fixed sleeve can be movably inserted into the handheld sleeve; the first and the second driving mechanisms and the transmission mechanism can be movably arranged on the handheld sleeve; the first driving mechanism is connected to the fixed sleeve, and is configured to directly drive the fixed sleeve to move along the axis of the driving handle at a first speed when subjected to an external force; the second driving mechanism is configured to push the transmission mechanism when subjected to an external force, and the transmission mechanism drives the first driving mechanism and the fixed sleeve to synchronously move along the axis of the driving handle at a second speed, and the second speed is not equal to the first speed.

Description

Technical Field

[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 an implant. Background Art

[0002] With the development of social economy and the aging of population, the incidence of valvular heart disease has increased significantly. Studies have shown that the incidence of valvular heart disease in the elderly population 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 the elderly, patients with multiple organ diseases, patients with a history of open-chest surgery and patients with poor heart function, traditional surgical treatment has high risks and mortality rates, and some patients do not even have the opportunity to undergo surgery.

[0003] Transcatheter heart valve surgery has the advantages of no need for thoracotomy, less trauma, and quick patient recovery, and has attracted widespread attention from experts and scholars. The surgery requires the insertion of an interventional catheter through the femoral artery to deliver the valve to the aortic valve area for opening, thereby completing the implantation of the artificial valve and restoring the valve function. The implantation of the valve is generally carried out with the help of a delivery system, which is inseparable from the sheath that carries the valve and the handle that drives the movement of the sheath, and the handle plays a vital role in the operation.

[0004] According to clinical needs, when loading the valve before surgery, it is hoped that the handle can achieve rapid withdrawal and slow advancement of the sheath to improve loading efficiency and ensure the success rate of loading; during valve implantation, positioning needs to be as accurate as possible, requiring the valve to be released as slowly as possible during operation, that is, the slower the sheath is withdrawn, the better; in addition, for recyclable valves, if they need to be recovered and released again during implantation, the faster the valve is recovered, the higher the efficiency and the more beneficial it is to the operation, that is, the faster the sheath is advanced, the better. In general, different stages of the operation will have different requirements for the speed of the handle. However, when releasing and retrieving the valve, the traditional handle cannot adjust the speed of the sheath's advancement and retreat, making it difficult for the operator to control the implantation speed and position of the valve, resulting in large positioning errors and low surgical efficiency. Summary of the invention

[0005] The purpose 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 move quickly or slowly according to the actual needs of the operation, thereby achieving more precise positioning control and more efficient surgical operations during the implantation process and reducing the difficulty of the operation.

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

[0007] At least a portion of the fixed sleeve is movably inserted into the hand-held sleeve; the first drive mechanism, the second drive mechanism and the transmission mechanism are all movably arranged on the hand-held sleeve; wherein:

[0008] The first driving mechanism is connected to the fixed sleeve and is configured to directly drive the fixed sleeve to move along the axis of the driving 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 move synchronously along the axis of the driving handle at a second speed, and the second speed is not equal to the first speed.

[0010] Preferably, the fixed sleeve is configured to remain relatively stationary with the hand-held sleeve in a circumferential direction.

[0011] Preferably, the second drive mechanism, the transmission mechanism and the first drive mechanism are arranged in sequence from the proximal end to the distal end of the drive handle. Alternatively, the first drive mechanism, the transmission mechanism and the second drive mechanism are arranged in sequence from the proximal end to the distal end of the drive handle.

[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 driving mechanism includes a first control knob, the second driving mechanism includes a second control knob, and both the first control knob and the second control knob can be movably mounted on the handheld sleeve; wherein:

[0014] The first control knob is connected to the fixed sleeve by a thread, the second control knob is connected to the transmission mechanism or the hand-held sleeve by a thread, and the thread pitch on the second control knob is not equal to the thread pitch on the first control knob;

[0015] The first control knob is configured to drive the fixed sleeve to move in a first direction at the first speed when the first control knob is rotated in a counterclockwise direction, and to drive the fixed sleeve to move in a second direction at the first speed when the first control knob is rotated in a clockwise direction, wherein the first direction is opposite to the second direction;

[0016] The second control knob is configured to, when rotating in a clockwise direction, push the transmission mechanism to drive the first control knob and the fixed sleeve to move synchronously in a second direction at the second speed, and when rotating in a counterclockwise direction, push the transmission mechanism to drive the first control knob and the fixed sleeve to move synchronously in a first direction at the second speed. Optionally, the first direction is a proximal direction toward the driving handle, and the second direction is a distal direction toward the driving handle.

[0017] Preferably, when the second control knob is threadedly connected to the hand-held sleeve, the inner surface of the second control knob and the outer surface of the hand-held sleeve are respectively provided with internal threads and external threads that cooperate with each other, and the second control knob is configured to maintain at least axial relative stillness with the transmission mechanism.

[0018] Preferably, when the second control knob is threadedly connected to the hand-held sleeve, the transmission mechanism is provided with one of a convex portion and a concave portion, and the second control knob is provided with the other of the convex portion and the concave portion, and the convex portion matches the concave portion.

[0019] Preferably, when the second control knob is threadedly connected to the transmission mechanism, the inner surface of the second control knob and the outer surface of the transmission mechanism are respectively provided with inner threads and outer threads that match each other, and the second control knob is rotatably provided on the handheld sleeve.

[0020] Preferably, when the second control knob is threadedly connected to the transmission mechanism, the hand-held sleeve is provided with one of a convex portion and a concave portion, and the second control knob is provided with the other of the convex portion and the concave portion, and the convex portion matches the concave portion.

[0021] Preferably, a first limiting portion is provided on the transmission mechanism, and a second limiting portion is provided on the hand-held sleeve, and the first limiting portion is used to cooperate with the second limiting portion 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 along the axial direction of the handheld sleeve and being hollowed out.

[0023] Preferably, the number and positions of the protrusions match those of the guide grooves.

[0024] Preferably, the transmission mechanism comprises a ring sleeve, which is movably mounted on the hand-held sleeve and is respectively connected to the first control knob and the second control knob.

[0025] Preferably, an axially extending and hollowed guide groove is provided on the hand-held sleeve, and an external thread arranged along a part of the circumference is provided on the outer surface of the fixed sleeve, and the external thread on the fixed sleeve passes through the guide groove and extends out of the hand-held sleeve to cooperate with the internal thread on the inner surface of the first control knob; the number and position of the guide grooves match the external thread on the fixed sleeve.

[0026] Preferably, the fixing sleeve has multiple external threads which are symmetrically arranged.

[0027] Preferably, the hand-held sleeve comprises an axially arranged 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 all arranged on the connecting portion.

[0028] To achieve the above object, the present invention also provides a delivery system for delivering an implant, which comprises a driving handle for delivering an implant according to any of the above items, and the delivery system further comprises an outer tube and an inner tube assembly;

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

[0030] The outer tube is connected to the fixed sleeve of the driving 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 comprises an inner tube, a fixing head and a conical head connected in sequence; the proximal end of the inner tube is connected to the hand-held sleeve, and the section of the inner tube between the fixing head and 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 the proximal end of the fixing sleeve.

[0033] In the driving handle and delivery system for delivering implants provided by the present invention, implants such as heart valves need to be implanted with the aid of the delivery system. The driving handle of the present invention includes a hand-held sleeve, a fixed sleeve, a first driving mechanism, a second driving mechanism and a transmission mechanism, at least a portion of the fixed sleeve can be movably inserted into the hand-held sleeve, the first driving mechanism, the second driving mechanism and the transmission mechanism can all be movably arranged on the hand-held sleeve, and the first driving mechanism is connected to the fixed sleeve and is configured to directly drive the fixed sleeve to move along the axis of the driving handle at a first speed when subjected to an external force, and 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 move synchronously along the axis of the driving handle at a second speed, and the second speed is not equal to the first speed. Under this structure, the fixed sleeve is connected to the outer tube of the delivery system, so that the outer tube can be controlled to move back quickly and move forward slowly, and the outer tube can also be controlled to move forward quickly and move back slowly, 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 clinical needs, when the driving handle of the present invention is loaded with the heart valve before surgery, the first driving mechanism can realize the rapid retraction of the outer tube, so as to facilitate the rapid loading of the heart valve and improve the loading efficiency; after the loading of the heart valve is completed, the second driving mechanism can realize the slow advancement 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 outer tube to retreat at a slower speed, so as to control the release speed of the heart valve, realize the precise positioning of the heart valve, ensure the success rate of the operation, and reduce the difficulty of the operation; in addition, for the recyclable heart valve, if it needs to be recovered and released again during the implantation process, the first driving mechanism can be used to control the outer tube to advance at a faster speed, so as 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 driving mechanism includes a first control knob, the second driving mechanism includes a second control knob, and the first control knob is connected to the fixed sleeve by a thread, and the second control knob is connected to the transmission mechanism or the hand-held sleeve by a thread, so that when the first control knob rotates in one direction, the fixed sleeve can be driven to drive the outer tube to move forward quickly, and when the first control knob rotates in another direction, the fixed sleeve can be driven to drive the outer tube to retreat quickly. Similarly, when the second control knob rotates in one direction, the transmission mechanism can be driven to drive the first control knob, the fixed sleeve and the outer tube to retreat slowly, and when the second control knob rotates in another direction, the transmission mechanism can be driven to drive the first control knob, the fixed sleeve and the outer tube to move forward slowly. Here, by setting different transmission threads, the control of the moving speed is achieved, the structure is simple, and the operation is convenient. Moreover, the small pitch thread converts the angular displacement of the circumferential rotation into the linear displacement of the fixed sleeve with higher accuracy, which can achieve more accurate positioning control. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1 is a schematic diagram of a conveying system in one embodiment of the present invention;

[0037] Figure 2 is a partial schematic diagram of a delivery system in which an inner tube assembly is omitted in one embodiment of the present invention;

[0038] Figure 3 yes Figure 2 A partial enlarged view of the conveying system in area A is shown;

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

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

[0041] Figure 6 is a three-dimensional diagram of a hand-held sleeve in one embodiment of the present invention;

[0042] Figure 7 is a three-dimensional diagram of a fixed sleeve in one embodiment of the present invention;

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

[0044] In the figure:

[0045] Driving 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 driving mechanism 3; first control knob 31; transmission mechanism 4; annular sleeve 41; circumferential groove 42; second driving mechanism 5; second control knob 51; catheter assembly 20; outer tube 6; inner tube assembly 7; conical head 71; fixed head 72; inner tube 73; valve support 8. DETAILED DESCRIPTION

[0046] In order to make the purpose, advantages and features of the present invention clearer, the present invention is further described in detail below in conjunction with the accompanying drawings. It should be noted that the drawings are all in simplified form and not drawn to scale, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. As used in this specification and the appended claims, the singular forms "one", "an" and "the" include plural objects, unless the content clearly indicates otherwise. As used in this specification and the appended claims, the term "or" is usually used to include the meaning of "and / or", unless the content clearly indicates 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. Therefore, 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 specified, the meaning of "multiple" is two or more.

[0047] In the following description, for the convenience of description, "distal" and "proximal", "axial" and "circumferential" are used; "distal" is the side away from the operator of the delivery system; "proximal" is the side close to the operator of the delivery system; "axial" refers to the axial direction along the drive handle; "circumferential" refers to the axial direction 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 can be implemented without one or more of these details. 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 comprising a handheld sleeve, a fixed sleeve, a first driving mechanism, a second driving mechanism and a transmission mechanism; at least a portion of the fixed sleeve is movably inserted into 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 driving mechanism is connected to the fixed sleeve and is configured to directly drive the fixed sleeve to move along the axis of the driving 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 then drives the first driving mechanism and the fixed sleeve to move along the axis of the driving handle at a second speed in synchronization with each other, 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 driving mechanism can quickly drive the fixed sleeve to move, and the second driving mechanism can drive the first driving mechanism and the fixed sleeve to move synchronously at a slow speed through the transmission mechanism. For example, the implant is a valve stent, which can be divided into the following operation stages:

[0052] First, loading the valve stent on the inner tube: before loading, the first driving mechanism can be used to drive the fixed sleeve to drive the outer tube to quickly withdraw (i.e., in the first direction), so as to quickly load the valve stent on the inner tube of the delivery system, thereby improving loading efficiency;

[0053] Second, the valve stent is pressed and gripped in the outer tube: after the valve stent is loaded in the inner tube, the second driving mechanism drives the fixed sleeve to drive the outer tube to move forward slowly (i.e., in the second direction), so that the valve stent is pressed and gripped in the outer tube, and the success rate of loading is ensured;

[0054] Third, releasing the valve stent: during the implantation process, the second driving mechanism drives the fixed sleeve to drive the outer tube to slowly withdraw (i.e., the first direction) to achieve the slow release of the valve stent, thereby accurately locating the implantation position of the valve stent and ensuring the accuracy of the positioning position;

[0055] Fourth, recovering the valve stent: After implantation, if the valve stent is found to be inaccurately positioned and needs to be released again, the valve stent can be recovered again. At this time, the first driving mechanism can drive the fixed sleeve to move forward quickly (i.e., 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 operations, the driving 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, implantation speed and implantation position of the valve stent, thereby reducing positioning errors and improving surgical efficiency.

[0057] However, in an alternative embodiment of the present invention, the first speed may also be smaller than the second speed. In this case, the first driving mechanism is used to slowly drive the fixed sleeve to move, while the second driving mechanism is used to quickly drive the fixed sleeve to move. However, the specific operating method is the same as the aforementioned embodiment.

[0058] The following description is given with reference to the accompanying drawings.

[0059] Please refer to Figures 1 to 8 , Figure 1 is a schematic diagram of a conveying system in one embodiment of the present invention, Figure 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, Figure 3 yes Figure 2 The conveying system shown is a partial enlarged view of area A. Figure 4 is an exploded view of a driving handle for delivering an implant in one embodiment of the present invention, Figure 5 is an assembly diagram of a driving handle for delivering an implant in one embodiment of the present invention, Figure 6 is a three-dimensional diagram of a hand-held sleeve in one embodiment of the present invention, Figure 7 is a three-dimensional diagram of a fixed sleeve in one embodiment of the present invention, Figure 8 It is a schematic diagram of a valve stent loaded between an inner tube and an outer tube in one embodiment of the present invention.

[0060] First, Figure 1 As shown, 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 arranged outside the inner tube assembly 7 and is coaxially arranged with the inner tube assembly 7, and the outer tube 6 can move axially 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 circumferentially. In addition, when the catheter assembly 20 is assembled with the driving handle 10, the outer tube 6 is connected to the movable part on the driving handle 10, so that the outer tube 6 is driven by the movable part to move axially relative to the inner tube assembly 7, so as to realize the advancement and retreat of the outer tube 6. Here, "advance" refers to the direction of movement toward the distal end of the driving handle 10; "retreat" is the direction opposite to "advance", that is, the direction of movement toward the proximal end of the driving handle 10. In addition, the implant is used to be fixed on the inner tube assembly 7, and the inner tube assembly 7 needs to be connected to the stationary part on the driving handle 10 to ensure that the inner tube assembly 7 is always fixed during operation.

[0061] Furthermore, in the process of the outer tube 6 advancing and retreating, in order to realize the fast or slow movement of the outer tube 6, as Figure 4 and Figure 5As shown, the driving handle 10 of the present embodiment specifically includes a hand-held sleeve 1, a fixed sleeve 2, a first driving mechanism 3, a transmission mechanism 4 and a second driving mechanism 5; at least a portion of the fixed sleeve 2 is movably inserted into the hand-held sleeve 1 (preferably the entire fixed sleeve 2 is arranged in the hand-held sleeve 1), and preferably the fixed sleeve 2 and the hand-held sleeve 1 remain relatively stationary in the circumferential direction, and the fixed sleeve 2 is connected to the outer tube 6 so as to drive the outer tube 6 to move axially along the driving handle 10 through the fixed sleeve 2.

[0062] In the embodiment of the present invention, from the proximal end to the distal end of the driving handle 10, the second driving mechanism 5, the transmission mechanism 4 and the first driving mechanism 3 are movably arranged on the hand-held sleeve 1 in sequence, and the transmission mechanism 4 is connected to the first driving mechanism 3 and the second driving mechanism 5 respectively. Moreover, 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 the axis of the driving handle 10 at a first speed V1 when subjected to an external force, and the second driving mechanism 5 is configured to push the transmission mechanism 4 when subjected to an external force, and then the transmission mechanism 4 drives the first driving mechanism 3 and the fixed sleeve 2 to move synchronously along the axis of the driving handle 10 at a second speed V2. Here, the first speed V1 is not equal to the second speed V2.

[0063] Next, for the convenience of description, the structure and operation method of the driving handle 10 are further explained by taking the first speed V1 as being greater than the second speed V2 as an illustration.

[0064] When the first speed V1 is greater than the second speed V2, the first driving mechanism 3 directly drives the fixed sleeve 2 to move quickly along the axial direction of the driving handle 10, and the second driving mechanism 5 drives the first driving mechanism 3 and the fixed sleeve 2 to move slowly along the axial direction of the driving handle 10 through the transmission mechanism 4, so that the forward and backward speeds of the fixed sleeve 2 are different, and the moving speed of the outer tube 6 connected to the fixed sleeve 2 can be adjusted according to the actual needs of the operation.

[0065] Preferably, the first driving mechanism 3 includes a first control knob 31 with an internal thread, and the second driving mechanism 5 includes a second control knob 51 with an internal thread. Both the first control knob 31 and the second control knob 51 can be movably mounted on the hand-held sleeve 1, and the pitch of the internal thread on the first control knob 31 is greater than the pitch of the internal thread on the second control knob 51, so that the first speed V1 is greater than the second speed V2, thereby ensuring that the first control knob 31 rotates one circle with a larger displacement and speed, achieving rapid movement, while the second control knob 51 rotates one circle with a smaller displacement and speed, which can achieve slow movement. With such a configuration, the driving handle has a simple structure, low cost, and convenient operation. Moreover, the threaded rotation of the control knob is converted into a linear displacement of the fixed sleeve 2 with high accuracy, which can achieve more accurate positioning control of the implant.

[0066] To this end, the fixing sleeve 2 is preferably connected to the first control knob 31 by a thread. Figure 7 As shown, a first external thread 22 is provided on the outer surface of the fixed sleeve 2, and the first external thread 22 is only provided along a portion of the circumference of the fixed sleeve 2, so that the first external thread 22 cooperates with the internal thread on the first control knob 31 to achieve the connection between the fixed sleeve 2 and the first control knob 31. In addition, the second control knob 51 is preferably connected to the transmission mechanism 4 by a thread, or connected to the hand-held sleeve 1 by a thread.

[0067] In this way, the driving handle 10 can be operated in the following manner, which can be combined with Figures 1 to 7 As shown:

[0068] First, rotate the first control knob 31 counterclockwise to directly drive the fixing sleeve 2 to quickly withdraw toward the proximal end of the driving handle 10 (first direction), thereby quickly loading the implant onto the inner tube assembly 7;

[0069] Second, rotating the second control knob 51 clockwise can push the transmission mechanism 4 to drive the first control knob 31 to move slowly toward the distal end of the driving handle 10 (in the second direction), and simultaneously drive the fixing sleeve 2 to move slowly forward, thereby pressing the implant into the outer tube 6 at a slower speed;

[0070] Third, rotating the second control knob 51 counterclockwise again can push the transmission mechanism 4 to drive the first control knob 31 to slowly withdraw toward the proximal end of the driving handle 10 (first direction), and simultaneously drive the fixing sleeve 2 to slowly withdraw, so as to slowly release the implant in the body;

[0071] Fourth, rotating the first control knob 31 clockwise again can directly drive the fixing sleeve 2 to quickly move forward toward the distal end of the driving handle 10 (the 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 the above-mentioned control knobs is not unique, as long as the control knobs can achieve the corresponding forward and backward movement of the fixed sleeve 2 by rotating in different directions.

[0073] Next reference Figure 7In the embodiment of the present invention, the fixed sleeve 2 specifically includes a hollow cylindrical body 21, and a first external thread 22 is provided on the outer surface of the cylindrical body 21, and the first external thread 22 is only provided along a part of the circumference of the cylindrical body 21, and is used to cooperate with the internal thread (not shown) on the first control knob 31. The number of the first external threads 22 can be 1, 2, or more than 2, and preferably 2 and symmetrically provided here to ensure the stability of motion transmission. The number of threads of the first external thread 22 is not specifically limited, and can be selectively provided according to the actual required movement stroke, and the first external thread 22 is preferably provided at the proximal end of the cylindrical body 21, so that the length of the fixed sleeve 2 can be shortened. Here, it cannot be narrowly understood that the first external thread 22 is provided on the proximal end face of the cylindrical body 21, but is broadly understood as being provided on the outer surface of the cylindrical body 21 at the proximal end.

[0074] In one embodiment, the second control knob 51 is threadedly connected to the hand-held sleeve 1 and maintains at least axial relative stillness with the transmission mechanism 4 (i.e., drives the transmission mechanism 4 to move axially), and the thread pitch on the second control knob 51 is smaller than the thread pitch on the first control knob 31 to ensure that the first speed V1 is greater than the second speed V2.

[0075] Specifically, Figure 6 As shown, a second external thread 13 is provided on the outer surface of the hand-held sleeve 1, and the second external thread 13 is provided along the entire circumference of the hand-held sleeve 1, and is used to cooperate with the internal thread (not indicated) on the inner surface of the second control knob 51. 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 produce relative displacement, so that the second control knob 51 only moves along the axial direction of the hand-held sleeve 1, and then drives the transmission mechanism 4 to move only along the axial direction. Preferably, the second external thread 13 is provided at the proximal end of the hand-held sleeve 1, which can effectively reduce the length of the hand-held sleeve 1. Moreover, it cannot be narrowly understood here that the second external thread 13 is provided on the proximal end face of the hand-held sleeve 1, but it can be broadly understood as being provided on the outer surface of the hand-held sleeve 1 at the proximal end.

[0076] Preferably, the hand-held sleeve 1 includes an axial hand-held portion 11 and a connecting portion 12, and the first control knob 31, the second control knob 51 and the transmission mechanism 4 are all arranged on the connecting portion 12. Preferably, the outer diameter of the connecting 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 rotate the first control knob 31 or the second control knob 51 for adjustment, which is more comfortable and convenient to operate.

[0077] Furthermore, the connecting portion 12 is also provided with a hollow guide groove 14 along the axial direction, so that the fixed sleeve 2 can only move axially along the guide groove 14, preventing the fixed sleeve 2 from moving circumferentially and affecting the positioning effect, and the first external thread 22 on the fixed sleeve 2 further passes through the guide groove 14 and extends out of the handheld sleeve 1 to cooperate with the internal thread on the first control knob 31. In this way, through the cooperation between the guide groove 14 and the first external thread 22 extending out of the handheld sleeve 1, the fixed sleeve 2 can be limited to move only in the axial direction (since the fixed sleeve 2 is limited in the rotation direction, it cannot rotate with the first control knob 31). Therefore, the number and position of the guide grooves 14 match the first external thread 22. Preferably, the number of guide grooves 14 is two and they are symmetrically arranged. In addition, the length of the guide groove 14 is not limited to Figure 6 As disclosed in , 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 can be rectangular, waist-shaped, elliptical, etc., which is not specifically limited.

[0078] When the second control knob 51 is connected to the hand-held sleeve 1 by threading, 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 pushes the transmission mechanism 4 to move synchronously along 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 the convex part and the concave part, and the second control knob 51 is provided with the other of the convex part and the concave part. The convex part cooperates with the concave part, so that the connection between the two can be simply and conveniently achieved.

[0079] like Figure 1 As shown, combined with Figure 2 and Figure 3 The transmission mechanism 4 of this embodiment preferably includes a ring sleeve 41, which can be movably sleeved on the connecting portion 12 of the hand-held sleeve 1, and is respectively connected to the first control knob 31 and the second control knob 51. Optionally, the ring sleeve 41 is engaged with the first control knob 31, for example, a circumferential groove 42 (recess) is provided on the side of the ring sleeve 41 facing the first control knob 31, and a hook (convex portion) is provided on the first control knob 31. The connection between the two can be simply achieved by matching the hook with the circumferential groove 42. In addition, when the first control knob 31 is rotated on the hand-held sleeve 1, since the first control knob 31 is threadedly connected to the fixed sleeve 2, the first control knob 31 rotates relative to the ring sleeve 41 (the ring sleeve 41 does not move), and drives the fixed sleeve 2 to move only in the axial direction (because the fixed sleeve 2 is limited in the rotation direction).

[0080] Further, the ring sleeve 41 is provided with a first limiting portion, and the hand-held sleeve 1 is provided with a second limiting portion, and the first limiting portion cooperates with the second limiting portion to limit the circumferential movement of the ring sleeve 41. Here, the first limiting portion is preferably a protrusion (not shown) provided on the inner side of the ring sleeve 41, which is used to cooperate with the guide groove 14 on the hand-held sleeve 1 to limit the circumferential movement of the ring sleeve 41, that is, the ring sleeve 41 can only move axially along the guide groove 14. Therefore, the guide groove 14 can provide a linear travel track for the fixed sleeve 2 so that the fixed sleeve 2 moves axially along the guide groove 14, and can also provide a linear travel track for the ring sleeve 41 so that the ring sleeve 41 also moves axially along the guide groove 14. Furthermore, the number and position of the protrusions on the ring sleeve 41 match the number and position of the guide groove 14, and therefore, the number of the protrusions is preferably multiple and symmetrically arranged.

[0081] Optionally, an internal thread (not shown) is provided on the inner surface of the second control knob 51, and matches with the second external thread 13 on the outer surface of the hand-held sleeve 1. In this case, preferably, the second control knob 51 is snap-fitted with the ring sleeve 41, and the structure is relatively simple. Figure 2 and Figure 3 As shown, a circumferential groove 42 (recess) is provided on the side of the ring sleeve 41 facing the second control knob 51, and a hook (convex portion) is provided on the second control knob 51. Through the cooperation between the hook and the circumferential groove 42, the connection between the two can be conveniently and quickly achieved.

[0082] In another embodiment, the second control knob 51 is connected to the ring sleeve 41 by a threaded connection. In this case, the second control knob 51 is rotatably arranged on the hand-held sleeve 1, and the thread pitch on the second control knob 51 is smaller than the thread pitch on the first control knob 31, so as to ensure that the first speed V1 is greater than the second speed V2. Preferably, the hand-held sleeve 1 is connected to the second control knob 51 in a snap-fit ​​manner, for example, the hand-held sleeve 1 is provided with a circumferential groove (recess) with the same structure as that on the ring sleeve 41, so that the second control knob 51 is also matched with the circumferential groove on the hand-held sleeve 1 through a hook, so that when the second control knob 51 is rotated, the ring sleeve 41 is driven by the threaded connection to move only in the axial direction and drive the first control knob 31 and the fixed sleeve 2 to move in the axial direction together. Here, the ring sleeve 41 can only move in the axial direction because it is limited in the rotation direction.

[0083] Further integration Figure 2 Specifically, the proximal end of the outer tube 6 is connected to the cylindrical body 21 on the fixed sleeve 2, but can 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 detachably connected to the connecting portion 12 on the hand-held sleeve 1.

[0084] like Figure 8 As shown, from the proximal end to the distal end, the inner tube assembly 7 specifically includes an inner tube 73, a fixing head 72 and a conical head 71 connected in sequence. Taking the implant as a valve stent 8 as an example, Figure 8 The valve support 8 is shown in an unreleased state. Figure 8 It can be clearly known that during transportation, the valve stent 8 is loaded on the periphery of the inner tube 73 between the conical head 71 and the fixed head 72, and is fixedly supported by the fixed head 72 (one end of the valve stent 8 is fixed on the fixed head 72), and the fixed head 72 is immovable (that is, all degrees of freedom are restricted), and the proximal end of the inner tube 73 is fixedly connected to the connecting portion 12 on the handheld sleeve 1 by means of threads or glue, so that the inner tube 73 is fixed as a whole relative to the driving handle 10, thereby ensuring that the valve stent 8 loaded on the fixed head 72 and the driving handle 10 remain relatively fixed. The distal end of the outer tube 6 is sleeved on the periphery of the valve stent 8 loaded on the inner tube 73, and preferably the distal end of the outer tube 6 contacts the proximal end face of the conical 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 drive, so that the outer tube 6 moves forward and backward relative to the inner tube assembly 7, and the loading, release and recovery of the valve stent 8 can be realized.

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

[0086] First, the valve stent 8 is loaded: the left hand holds the hand-held part 11, and the right hand rotates the first control knob 31 counterclockwise. The rotation of the first control knob 31 only causes the fixing sleeve 2 and the outer tube 6 to quickly retreat synchronously, so that the portion of the inner tube 73 between the fixing head 72 and the conical head 71 is exposed to the outside, thereby loading the valve stent 8 onto the inner tube 73;

[0087] The second step is to press and hold the valve stent 8: after loading the valve stent 8, the second control knob 51 is rotated clockwise. The rotation of the second control knob 51 causes the annulus 41, the first control knob 31, the fixing sleeve 2 and the outer tube 6 to move forward synchronously and slowly, so that the valve stent 8 can be pressed and held in the outer tube 6.

[0088] Then, the valve stent 8 is released: during the implantation process, the second control knob 51 is rotated counterclockwise, and the rotation of the second control knob 51 causes the annulus 41, the first control knob 31, the fixing sleeve 2 and the outer tube 6 to synchronously and slowly retreat, so that the outer tube 6 is retreated to slowly release the valve stent 8;

[0089] Further, for the recovery of the valve stent 8: if it is found that the valve stent 8 is not accurately positioned during the implantation process, the valve stent 8 can be put back into the outer tube 6. Therefore, the first control knob 31 can be rotated clockwise again. The rotation of the first control knob 31 only makes the fixed sleeve 2 and the outer tube 6 move forward synchronously and quickly, so as to realize the rapid advancement of the outer tube 6 to quickly recover the valve stent 8.

[0090] Therefore, at different stages of the operation, by adjusting the travel speed of the driving handle 10 according to the operation requirements, different surgical operation requirements can be conveniently met, thereby improving surgical efficiency, reducing surgical difficulty, and improving the positioning accuracy of the valve stent to achieve better treatment effects.

[0091] The above embodiment mainly describes the structure and operation mode of the driving handle when the first speed V1 is greater than the second speed V2. However, when the first speed V1 is less than the second speed V2, the structure and operation mode of the driving handle are also basically the same as those of the above embodiment. The difference is that the thread pitch on the first control knob 31 is less than the thread pitch on the second control knob 51, which also changes the corresponding operation mode, namely:

[0092] First, rotating the second control knob 51 counterclockwise can push the transmission mechanism 4 to drive the first control knob 31 to quickly withdraw toward the proximal end of the driving handle 10 (first direction), and simultaneously drive the fixing sleeve 2 to quickly withdraw, so as to quickly load the implant;

[0093] Second, rotating the first control knob 31 clockwise can directly drive the fixed sleeve 2 to move slowly toward the distal end of the driving handle 10 (second direction), so as to slowly load the implant into the outer tube;

[0094] Third, rotating the first control knob 31 counterclockwise can directly drive the fixed sleeve 2 to slowly withdraw toward the proximal end of the driving handle 10 (first direction) to slowly release the implant;

[0095] Fourth, rotating the second control knob 51 clockwise can push the transmission mechanism 4 to drive the first control knob 31 to quickly move forward toward the distal end of the driving handle 10, and simultaneously drive the fixing sleeve 2 to quickly move forward, thereby realizing rapid recovery of the implant.

[0096] Further, in an alternative embodiment of the present invention, the first drive mechanism 3, the transmission mechanism 4 and the second drive mechanism 5 can also be arranged in sequence from the proximal end to the distal end of the driving handle 10, and 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 above embodiment, and the same technical effects as those in the above embodiment can be achieved, but the positions of some structural features will be adjusted, for example, the second external thread 13 moves toward the distal end of the hand-held sleeve 1, and can be specifically set at a position close to the proximal end surface of the hand-held portion 11, and the guide groove 14 starts from the proximal end of the second external thread 13, etc. The detailed content will not be further described here. Based on the content disclosed in this application document, those skilled in the art should be able to know the adjustment of the specific structure, and thus modify it to obtain the driving handle. In this way, the first driving mechanism connected to the fixed sleeve 2 is set at the proximal end of the driving handle 10, and the length of the fixed sleeve 2 will be relatively lengthened.

[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 specifically limit the structure of the first drive mechanism and the second drive mechanism, as long as the two drive mechanisms can realize the fast and slow movement of the fixed sleeve 2. In addition, the embodiments of the present invention are described with the valve stent 8 (such as a heart valve stent) as the implant. It can be understood by those skilled in the art that the delivery system disclosed in the present invention can also be used to place other implants (such as a vascular stent) into the corresponding position of the body in addition to the valve stent.

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

[0099] The above description is only a description of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention. Any changes or modifications made by a person skilled in the art in the field of the present invention based on the above disclosure shall fall within the scope of protection of the claims.

Claims

1. A driving handle for delivering an implant, characterized in that: It comprises a hand-held sleeve, a fixed sleeve, a first driving mechanism, a second driving mechanism and a transmission mechanism; from the proximal end to the distal end of the driving handle, the second driving mechanism, the transmission mechanism and the first driving mechanism are arranged in sequence; At least a portion of the fixed sleeve is movably disposed in the hand-held sleeve, and the fixed sleeve is configured to remain relatively stationary with the hand-held sleeve in a circumferential direction; The first driving mechanism comprises a first control knob having an internal thread; the second driving mechanism comprises a second control knob having an internal thread; the pitch of the thread on the second control knob is not equal to the pitch of the thread on the first control knob; The transmission mechanism comprises a ring sleeve, which is respectively connected to the first control knob and the second control knob; the second control knob is configured to keep at least axially relatively stationary with the transmission mechanism; A first external thread is provided on the outer surface of the fixing sleeve, and the first external thread matches with the internal thread on the first control knob; The second control knob is connected to the transmission mechanism or the hand-held sleeve via a thread; The first control knob, the second control knob and the ring sleeve can be movably arranged on the hand-held sleeve; wherein: The first control knob is configured to directly drive the fixed sleeve to move along the axis of the driving handle at a first speed when subjected to an external force; The second control knob is configured to push the transmission mechanism when subjected to an external force, and the transmission mechanism further drives the first control knob and the fixed sleeve to move synchronously along the axis of the drive handle at a second speed, and the second speed is not equal to the first speed.

2. The driving handle for delivering an implant according to claim 1, characterized in that: The first control knob is configured to drive the fixed sleeve to move in a first direction at the first speed when the first control knob is rotated in a counterclockwise direction, and to drive the fixed sleeve to move in a second direction at the first speed when the first control knob is rotated in a clockwise direction, wherein the first direction is opposite to the second direction; The second control knob is configured to push the transmission mechanism to drive the first control knob and the fixed sleeve to move synchronously along the second direction at the second speed when the second control knob is rotated in the clockwise direction, and to push the transmission mechanism to drive the first control knob and the fixed sleeve to move synchronously along the first direction at the second speed when the second control knob is rotated in the counterclockwise direction.

3. The driving handle for delivering an implant according to claim 1, characterized in that: The transmission mechanism is provided with one of the convex part and the concave part, and the second control knob is provided with the other of the convex part and the concave part, and the convex part matches with the concave part.

4. The driving handle for delivering an implant according to claim 1, characterized in that: When the second control knob is threadedly connected to the transmission mechanism, the inner surface of the second control knob and the outer surface of the transmission mechanism are respectively provided with inner threads and outer threads that match each other, and the second control knob is rotatably arranged on the handheld sleeve.

5. The driving handle for delivering an implant according to claim 4, characterized in that: The hand-held sleeve is provided with one of a convex portion and a concave portion, and the second control knob is provided with the other of the convex portion and the concave portion, and the convex portion matches with the concave portion.

6. The driving handle for delivering an implant according to claim 1, characterized in that: The transmission mechanism is provided with a first limiting portion, and the hand-held sleeve is provided with a second limiting portion, and the first limiting portion is used to cooperate with the second limiting portion to limit the circumferential movement of the transmission mechanism.

7. The driving handle for delivering an implant according to claim 6, characterized in that: The first limiting portion is a protrusion, and the second limiting portion is a hollowed-out guide groove extending along the axial direction of the handheld sleeve.

8. The driving handle for delivering an implant according to claim 7, characterized in that: The number and positions of the protrusions match those of the guide grooves.

9. The driving handle for delivering an implant according to claim 1, characterized in that: The hand-held sleeve is provided with an axially extending and hollowed-out guide groove, and the outer surface of the fixed sleeve is provided with an external thread arranged along a portion of the circumference, and the external thread on the fixed sleeve passes through the guide groove and extends out of the hand-held sleeve to cooperate with the internal thread on the inner surface of the first control knob; the number and position of the guide grooves match the external thread on the fixed sleeve.

10. The driving handle for delivering an implant according to claim 9, characterized in that: The external threads on the fixing sleeve are multiple and symmetrically arranged.

11. The driving handle for delivering an implant according to claim 1, characterized in that: The hand-held sleeve comprises an axially arranged hand-held portion and a connecting portion, wherein 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 arranged on the connecting portion.

12. A delivery system for delivering an implant, characterized in that: comprising a driving handle for delivering an implant according to any one of claims 1 to 11, and the delivery system further comprising an outer tube and an inner tube assembly; The inner tube assembly is inserted into the outer tube and used to fix the implant, and is connected to the hand-held sleeve of the driving handle and remains relatively still with the hand-held sleeve; The outer tube is connected to the fixed sleeve of the driving handle, and the fixed sleeve is used to drive the outer tube to perform axial movement relative to the inner tube assembly.

13. The delivery system for delivering an implant according to claim 12, characterized in that: The inner tube assembly comprises an inner tube, a fixing head and a conical head which are connected in sequence; the proximal end of the inner tube is connected to the hand-held sleeve, and the section of the inner tube between the fixing head and the conical head is used to load the implant.

14. The delivery system for delivering an implant according to claim 12, characterized in that: The proximal end of the outer tube is connected to the distal end or the proximal end of the fixing sleeve.

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