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 control the movement of an outer tube at different speeds according to the needs of actual surgery. The driving handle of the present invention specifically includes a handheld sleeve, a fixing member, a first driving mechanism, a second driving mechanism, and a gear switching mechanism; the fixing member can be movably inserted into the handheld sleeve; the first driving mechanism, the second driving mechanism, and the gear switching mechanism are all arranged on the handheld sleeve; the driving handle has a first working mode and a second working mode, and the gear switching mechanism is used to limit the driving handle to be in one of the first and second working modes; when the driving handle is in the first working mode, the first driving mechanism cooperates with the fixing member to drive the fixing member to move along the axis of the handheld sleeve at a first speed; when the driving handle is in the second working mode, the second driving mechanism cooperates with the fixing member to drive the fixing member to move along the axis of the handheld sleeve at a second speed, and the second speed is less than 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. However, 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. Some patients do not even have the opportunity for surgery. Transcatheter heart valve surgery has the advantages of no need for open-chest surgery, less trauma, and faster patient recovery, and has received widespread attention from experts and scholars.

[0003] Transcatheter heart valve 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 operated with the help of a delivery system, and the delivery system is inseparable from the sheath tube that loads the valve and the handle that drives the movement of the sheath tube, and the handle plays a vital role in the operation. According to clinical needs, when loading the valve before surgery, it is generally hoped that the handle can achieve rapid withdrawal and slow advancement of the sheath tube to improve loading efficiency and loading success rate; and in the process of valve implantation, in order to ensure accurate positioning, the valve release speed during operation is required to be as slow as possible, that is, the sheath tube is withdrawn as slowly as possible; and then after accurate positioning, in order to avoid excessive blood pressure reduction, the valve needs to be released quickly, that is, the sheath tube is required to be withdrawn quickly. For recyclable valves, if they need to be recovered and released again during the implantation process, the faster the valve is recovered, the more beneficial it is to the operation, that is, the faster the sheath tube advances, the better. In general, there will be different requirements for the fast and slow operation of the handle at different stages of the operation.

[0004] However, the existing handles have problems of low efficiency and precision in achieving control of valve speed and position. Therefore, it is necessary to develop a driving handle that can achieve high-efficiency and high-precision control of valve speed and position. 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 purpose or other related purposes, the present invention provides a driving handle for delivering an implant, comprising a hand-held sleeve, a fixing member, a first driving mechanism, a second driving mechanism and a gear switching mechanism; at least a portion of the fixing member is movably disposed in the hand-held sleeve, and the first driving mechanism, the second driving mechanism and the gear switching mechanism are all disposed on the hand-held sleeve;

[0007] The driving handle has a first working mode and a second working mode, and the gear switching mechanism is used to limit the driving handle to be in one of the first working mode and the second working mode; when the driving handle is in the first working mode, the first driving mechanism is configured to cooperate with the fixing member to drive the fixing member to move along the axis of the hand-held sleeve at a first speed; when the driving handle is in the second working mode, the second driving mechanism is configured to cooperate with the fixing member to drive the fixing member to move along the axis of the hand-held sleeve at a second speed, and the second speed is less than the first speed.

[0008] Optionally, the driving handle further comprises a gear locking mechanism disposed on the handheld sleeve;

[0009] When the driving handle is in the first working mode, the gear locking mechanism is configured to lock the second driving mechanism with the hand-held sleeve; when the driving handle is in the second working mode, the gear locking mechanism is also configured to lock the first driving mechanism with the hand-held sleeve.

[0010] Optionally, when the driving handle is in the first working mode, the gear switching mechanism is also configured to lock the second driving mechanism with the hand-held sleeve; when the driving handle is in the second working mode, the gear switching mechanism is also configured to lock the first driving mechanism with the hand-held sleeve.

[0011] Optionally, the gear switching mechanism is movably arranged on the handheld sleeve;

[0012] The gear switching mechanism has a first position and a second position; when the gear switching mechanism moves to the first position, the driving handle is limited to the first working mode, and the gear switching mechanism also locks the second driving mechanism with the hand-held sleeve;

[0013] When the gear switching mechanism moves to the second position, the driving handle is also limited to the second working mode, and the gear switching mechanism also locks the first driving mechanism and the hand-held sleeve.

[0014] Optionally, the gear switching mechanism includes a switching switch, which is movably disposed on the hand-held sleeve and located between the first driving mechanism and the second driving mechanism, and the switching switch and the hand-held sleeve remain relatively stationary in the circumferential direction;

[0015] When the switch moves to the first position toward the second drive mechanism, the switch cooperates with the second drive mechanism to lock the second drive mechanism with the hand-held sleeve and limit the drive handle to the first working mode;

[0016] When the switch moves to the second position in the direction of the first driving mechanism, the switch cooperates with the first driving mechanism to lock the first driving mechanism and the hand-held sleeve, and limits the driving handle to the second working mode.

[0017] Optionally, the first driving mechanism includes a first knob sleeved on the hand-held sleeve, and the second driving mechanism includes a second knob sleeved on the hand-held sleeve, and the first knob and the second knob are both relatively stationary with respect to the hand-held sleeve in the axial direction; wherein:

[0018] A first limiting portion is provided on a side of the first knob facing the second knob, and a third limiting portion is provided on the switching switch; the first limiting portion is used to cooperate with the third limiting portion to limit the movement of the first knob in the circumferential direction of the handheld sleeve;

[0019] A second limiting portion is provided on a side of the second knob facing the first knob, and a fourth limiting portion is also provided on the switching switch, and the second limiting portion is used to cooperate with the fourth limiting portion to limit the movement of the first knob in the circumferential direction of the handheld sleeve.

[0020] Optionally, the first limiting portion is a first limiting groove extending axially, the first limiting groove is not connected to the interior of the first knob, and the third limiting portion is a first limiting protrusion;

[0021] The second limiting portion is a second limiting groove extending axially, the second limiting groove is not connected to the interior of the second knob, and the fourth limiting portion is a second limiting protrusion.

[0022] Optionally, the switch is a sleeve structure and is movably sleeved between the first knob and the second knob, and the switch is coaxial with the handheld sleeve;

[0023] The first knob has a first cylindrical section and a third cylindrical section, the diameter of the third cylindrical section is smaller than that of the first cylindrical section, and the third cylindrical section is used for sleeve-mounting the switch;

[0024] The second knob comprises a second cylindrical section and a fourth cylindrical section, the diameter of the fourth cylindrical section is smaller than the diameter of the second cylindrical section, and the fourth cylindrical section is used for sleeve-mounting the switch;

[0025] Wherein: the distance that the switching switch moves from the second position to the first position is less than the length of the third cylindrical segment, and the distance that the switching switch moves from the first position to the second position is less than the length of the fourth cylindrical segment.

[0026] Optionally, a fifth limiting portion is provided on the switching switch, and a sixth limiting portion is provided on the hand-held sleeve; the sixth limiting portion is used to cooperate with the fifth limiting portion to limit the movement of the switching switch in the circumferential direction of the hand-held sleeve.

[0027] Optionally, the fifth limiting portion is a protrusion, and the protrusions are multiple and symmetrically arranged, and the sixth limiting portion is a hollow limiting groove, and all protrusions are used to insert into corresponding limiting grooves so that the switching switch moves along the limiting grooves.

[0028] Optionally, the driving handle also includes a first connecting member and a second connecting member arranged on the hand-held sleeve, and the first connecting member and the second connecting member remain at least axially relatively stationary with the hand-held sleeve; wherein: the first connecting member is used to limit the axial movement of the first driving mechanism in the hand-held sleeve; the second connecting member is used to limit the axial movement of the second driving mechanism in the hand-held sleeve.

[0029] Optionally, the first connecting member includes a first connecting ring sleeved on the hand-held sleeve, and the second connecting member includes a second connecting ring sleeved on the hand-held sleeve; the first connecting ring, the first driving mechanism, the gear switching mechanism, the second driving mechanism and the second connecting ring are arranged in sequence and remain coaxial with the hand-held sleeve.

[0030] Optionally, the first driving mechanism includes a first knob sleeved on the handheld sleeve, and the second driving mechanism includes a second knob sleeved on the handheld sleeve, and the first knob and the second knob both remain relatively stationary axially with the handheld sleeve;

[0031] The fixing member is coaxially arranged with the hand-held sleeve and has a first external thread and a second external thread axially spaced apart; the first knob has a first internal thread, and the first external thread is used to cooperate with the first internal thread; the second knob has a second internal thread, and the second external thread is used to cooperate with the second internal thread; the pitch of the first external thread is M times the pitch of the second external thread, and M is an integer greater than or equal to 2.

[0032] Optionally, the hand-held sleeve is provided with an avoidance structure for avoiding the first external thread and the second external thread, the avoidance structure is a hollow limiting groove, the first external thread passes through the limiting groove and cooperates with the first internal thread; the second external thread passes through the limiting groove and cooperates with the second internal thread, and the fixing piece is used to make axial movement along the limiting groove.

[0033] Optionally, the first knob has a first groove for avoiding the first external thread, and the second knob has a second groove for avoiding the second external thread;

[0034] The driving handle also has an initial mode; when the driving handle is in the initial mode, the first external thread is accommodated in the first groove, and the second external thread is accommodated in the second groove; and, in the initial mode, the gear switching mechanism is used to be driven by external force to limit the driving handle to the first working mode or the second working mode.

[0035] Optionally, a plurality of scale lines are axially arranged on the fixing member, and the distance between any adjacent scale lines is equal to the pitch of the first external thread. At the same time, an alignment mark is arranged on the hand-held sleeve, and the alignment mark is used to coincide with any scale line to limit the driving handle to the initial mode.

[0036] Optionally, the alignment mark is an edge line of an end surface of the handheld sleeve.

[0037] Optionally, the fixing member is a circular rod, and the first external thread and the second external thread are both arranged on the rod along a portion of the circumference of a circle.

[0038] Optionally, there are multiple first external threads and multiple second external threads, all of the first external threads and all of the second external threads are symmetrically arranged on their respective circumferences, and all of the first external threads and all of the second external threads overlap in the axial direction.

[0039] Optionally, the hand-held sleeve includes an axially connected hand-held section and a connecting section, and the diameter of the connecting section is smaller than the diameter of the hand-held section; the first driving mechanism, the second driving mechanism, and the gear switching mechanism are all arranged on the connecting section.

[0040] Optionally, the driving handle is a manual driving handle.

[0041] To achieve the above-mentioned object, the present invention also provides a delivery system for delivering an implant, comprising the driving handle for delivering an implant, and the delivery system further comprises an outer tube and an inner tube assembly;

[0042] 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;

[0043] The outer tube is connected to the fixing member of the driving handle, and the fixing member is used to drive the outer tube to perform axial movement relative to the inner tube assembly.

[0044] Optionally, the inner tube assembly passes through one end of the fixing member and comes out from the other end to be connected to the hand-held sleeve.

[0045] In summary, the driving handle and delivery system for delivering an implant provided by the present invention have the following advantages:

[0046] First, the driving handle of the present invention includes a hand-held sleeve, a fixing part, a first driving mechanism, a second driving mechanism and a gear switching mechanism. In actual use, the working mode of the driving handle needs to be switched to the first working mode through the gear switching mechanism. In this mode, the first driving mechanism can move relative to the hand-held sleeve, and the first driving mechanism cooperates with the fixing part, so that the first driving mechanism can drive the fixing part to move along the axis of the hand-held sleeve at a first speed. Conversely, the working mode of the driving handle is also switched to the second working mode through the gear switching mechanism. In this mode, the second driving mechanism can move relative to the hand-held sleeve, and the second driving mechanism cooperates with the fixing part, so that the second driving mechanism drives the fixing part to move along the axis of the hand-held sleeve at a second speed. Furthermore, in actual operation, as long as the fixing part is connected to the outer tube of the conveying system, the driving handle can control the outer tube to move quickly and slowly, so that different surgical operation requirements can be met at different stages of the operation. Moreover, during the operation, the gear switching mechanism is used to switch the different working modes of the driving handle, which helps the doctor to make faster and more accurate adjustments to the driving handle according to the current surgical operation needs, thereby reducing the doctor's burden during the operation and improving surgical efficiency.

[0047] Second, the driving handle of the present invention is also provided with a gear locking mechanism. When the driving handle is in the first working mode, the gear locking mechanism is configured to lock the second driving mechanism with the hand-held sleeve; and when the driving handle is in the second working mode, the gear locking mechanism is also configured to lock the first driving mechanism with the hand-held sleeve. Therefore, the interlocking of slow movement and fast movement can be achieved through the gear locking mechanism, thereby improving the accuracy of the driving handle operation, and at the same time, it can also reduce the difficulty of the doctor's operation and further improve the efficiency of the operation.

[0048] Third, the driving handle of the present invention is preferably a manual driving handle, and all structures are coaxially arranged, which not only has high reliability but also has a small radial dimension, making the handle small in size, light in weight, and easy to carry and operate. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] Figure 1a is an isometric schematic diagram of a conveying system in one embodiment of the present invention;

[0050] Figure 1b is an axonometric cross-sectional view of a conveying system in one embodiment of the present invention;

[0051] Figure 1c yes Figure 1b A partial enlarged view of the conveying system;

[0052] Figure 1d yes Figure 1a Exploded view of the drive handle on the conveyor system;

[0053] Figure 2 It is a schematic diagram of the structure of a hand-held sleeve on a driving handle in one embodiment of the present invention;

[0054] Figure 3a is an end view of a switch on a driving handle in one embodiment of the present invention;

[0055] Figure 3b This is an isometric cross-sectional view of a switch on a driving handle in one embodiment of the present invention.

[0056] Figure 4a is a front view of a first knob on a driving handle in one embodiment of the present invention;

[0057] Figure 4b is an end view of a first knob on a driving handle in one embodiment of the present invention;

[0058] Figure 5a is a front view of a second knob on a driving handle in one embodiment of the present invention;

[0059] Figure 5b is an end view of a second knob on a driving handle in one embodiment of the present invention;

[0060] Figure 6 is a schematic diagram of the structure of a fixing member on a driving handle in one embodiment of the present invention;

[0061] Figure 7 is a partial cross-sectional view of a conveying system in one embodiment of the present invention;

[0062] 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.

[0063] In the figure:

[0064] A driving handle 100;

[0065] Hand-held sleeve 1; hand-held section 11; connecting section 12; first connecting groove 121; limiting groove -122; proximal connecting portion 123;

[0066] First connecting ring 2; third circumferential protrusion 21; first circumferential protrusion 22;

[0067] The first knob 3; the first circumferential groove 31; the first cylindrical section 32; the first limiting groove 33; the third cylindrical section 34; the first groove 35; the first internal thread 36; the first limiting surface 37;

[0068] Switch 4; first limit protrusion 41; second limit protrusion 43; third limit protrusion 42;

[0069] The second knob 5; the second circumferential groove 51; the second cylindrical section 52; the second limiting groove 53; the fourth cylindrical section 54; the second groove 55; the second internal thread 56; the second limiting surface 57;

[0070] A second connecting ring 6; a second circumferential protrusion 61; a proximal end portion 62;

[0071] Fixing member 7; rod body 71; first external thread 72; second external thread 73;

[0072] Catheter assembly 200;

[0073] Outer tube 8;

[0074] Inner tube assembly 9; conical head 91; fixed head 92; inner tube 93;

[0075] Valve stent 10. DETAILED DESCRIPTION

[0076] 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.

[0077] 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 handheld sleeve; "circumferential" refers to the axial direction around the corresponding 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.

[0078] The core idea of ​​the present invention is to provide a driving handle for delivering an implant, which is preferably a manual driving handle. The manual driving handle will not have faults such as motor abnormalities, transmission abnormalities, etc. that are prone to occur in electric driving handles, so it has high reliability and simple structure.

[0079] The driving handle provided by the present invention specifically comprises a hand-held sleeve, a fixing member, a first driving mechanism, a second driving mechanism and a gear switching mechanism; at least a part of the fixing member is movably arranged in the hand-held sleeve; the first driving mechanism, the second driving mechanism and the gear switching mechanism are all arranged on the hand-held sleeve;

[0080] Wherein: the driving handle has a first working mode and a second working mode, and the gear switching mechanism is used to limit the driving handle to be in one of the first working mode and the second working mode;

[0081] When the driving handle is in the first working mode, the first driving mechanism is configured to cooperate with the fixing member to drive the fixing member to move along the axis of the hand-held sleeve at a first speed; when the driving handle is in the second working mode, the second driving mechanism is configured to cooperate with the fixing member to drive the fixing member to move along the axis of the hand-held sleeve at a second speed, and the second speed is less than the first speed.

[0082] The working principle of the driving handle is as follows:

[0083] a) Rapid movement: The working mode of the driving handle needs to be switched to the first working mode (i.e., the rapid working mode) through the gear switching mechanism. In this mode, the first driving mechanism can move relative to the hand-held sleeve, and the first driving mechanism cooperates with the fixing member, so that the first driving mechanism can drive the fixing member to move rapidly along the axis of the hand-held sleeve;

[0084] b) Slow movement: The working mode of the driving handle is also switched to the second working mode (i.e., slow working mode) through the gear switching mechanism. In this mode, the second driving mechanism can move relative to the hand-held sleeve, and the second driving mechanism cooperates with the fixing part, so that the second driving mechanism drives the fixing part to move slowly along the axis of the hand-held sleeve.

[0085] Obviously, during the operation, using the gear switching mechanism to switch the different working modes of the drive handle is beneficial for the doctor to make faster and more accurate adjustments to the drive handle according to the current surgical operation needs, thereby reducing the doctor's burden during the operation and improving surgical efficiency.

[0086] Furthermore, the driving handle further comprises a gear locking mechanism disposed on the hand-held sleeve. When the driving handle is in the first working mode, the gear locking mechanism is configured to lock the second driving mechanism with the hand-held sleeve; and when the driving handle is in the second working mode, the gear locking mechanism is further configured to lock the first driving mechanism with the hand-held sleeve. Therefore, the interlocking of slow motion and fast motion can be achieved through the gear locking mechanism, thereby improving the accuracy of the driving handle operation, and also reducing the difficulty of the doctor's operation, further improving the surgical efficiency. Specifically, when the driving handle is in the first working mode, the second driving mechanism maintains a locking relationship with the hand-held sleeve through the gear locking mechanism, so that the second driving mechanism remains stationary relative to the hand-held sleeve (neither movable nor rotatable); on the contrary, when the driving handle is in the second working mode, the first driving mechanism maintains a locking relationship with the hand-held sleeve through the gear locking mechanism, so that the first driving mechanism remains stationary relative to the hand-held sleeve. Therefore, with the help of the interlocking of slow movement and fast movement, human error can be effectively avoided, thereby reducing the difficulty of operation for doctors and improving the accuracy of surgical operations.

[0087] Furthermore, when the driving handle is in the first working mode, the gear switching mechanism is further configured to lock the second driving mechanism with the hand-held sleeve; when the driving handle is in the second working mode, the gear switching mechanism is further configured to lock the first driving mechanism with the hand-held sleeve. In this way, the locking and switching of the gears can be achieved through one structure, which is more convenient to operate and the structure of the driving handle is also simpler.

[0088] Furthermore, the gear switching mechanism is movably arranged on the hand-held sleeve. Specifically, the gear switching mechanism has a first position and a second position; when the gear switching mechanism moves to the first position, the driving handle is limited to the first working mode, and the gear switching mechanism also locks the second driving mechanism with the hand-held sleeve; when the gear switching mechanism moves to the second position, the driving handle is also limited to the second working mode, and the gear switching mechanism also locks the first driving mechanism with the hand-held sleeve. In actual use, as long as the gear switching mechanism is manually driven to move to the above-mentioned position, it can be conveniently and quickly switched to the corresponding working mode, and when the gear switching mechanism moves to these positions, the corresponding driving mechanism can be locked with the hand-held sleeve through its own structure, so that the structure is simpler and the operation is more convenient.

[0089] The preferred structure and working mode of the driving handle and the conveying system including the driving handle are further described below with reference to the accompanying drawings.

[0090] First, please refer to Figure 1a and Figure 1b , Figure 1a is an isometric schematic diagram of a conveying system in one embodiment of the present invention, Figure 1b FIG. 1 is an axonometric cross-sectional view of a conveying system in one embodiment of the present invention. Figure 1a and Figure 1b As shown, a delivery system for delivering an implant comprises a driving handle 100 and a catheter assembly 200. The catheter assembly 200 comprises an outer tube 8 and an inner tube assembly 9; the inner tube assembly 9 is used to be inserted into the outer tube 8 and arranged coaxially with the outer tube 8; the outer tube 8 is used to be connected to the driving handle 100, so that the driving handle 100 drives the outer tube 8 to move relative to the inner tube assembly 9. Preferably, the outer tube 8 only moves axially but not circumferentially, so as to ensure the positioning accuracy of the implant when it is released in the body.

[0091] The driving handle 100 includes a hand-held sleeve 1, a first knob 3, a switch 4, a second knob 5 and a fixing member 7. The first knob 3, the switch 4 and the second knob 5 are all arranged on the hand-held sleeve 1, and the fixing member 7 can be movably inserted into the hand-held sleeve 1 and is used to cooperate with the first knob 3 and the second knob 5 through threads, so that the first knob 3 drives the fixing member 7 to move quickly, and the second knob 5 drives the fixing member 7 to move slowly. It should be understood that the first knob 3 constitutes the first driving mechanism of the present invention; the second knob 5 constitutes the second driving mechanism of the present invention; and the switch 4 constitutes the gear switching mechanism of the present invention, and preferably the switch 4 also constitutes the gear locking mechanism of the present invention.

[0092] In the embodiment of the present invention, the second knob 5, the switch 4 and the first knob 3 are arranged in sequence from the proximal end to the distal end of the driving handle, but in other embodiments, the first knob 3, the switch 4 and the second knob 5 may also be arranged in sequence from the proximal end to the distal end. Figure 1a The illustrated arrangement further illustrates the preferred structure of the driving handle 100 .

[0093] like Figure 1a and Figure 1bAs shown, the first knob 3 and the second knob 5 can be rotatably mounted on the hand-held sleeve 1 and preferably remain coaxial with the hand-held sleeve 1, and the two knobs remain relatively stationary axially with the hand-held sleeve 1, that is, they can only rotate but not move axially. In addition, the switching switch 4 is arranged between the first knob 3 and the second knob 5, and can move back and forth between the two. In the embodiment of the present invention, the switching switch 4 is constructed as a sleeve structure and is directly mounted on the hand-held sleeve 1 or on two knobs, and the switching switch 4 can only move but not rotate circumferentially. Preferably, the switching switch 4 remains coaxial with the hand-held sleeve 1. Of course, the switching switch 4 is not limited to the sleeve form, and can also be a slider structure. The present invention does not impose specific restrictions on the structure of the switching switch 4.

[0094] The fixing member 7 can be partially inserted into the hand-held sleeve 1, or can be completely set in the hand-held sleeve 1. If the whole setting can reduce the length of the driving handle, it is beneficial to reduce the volume and weight of the driving handle. The fixing member 7 can be a round rod, such as a screw rod, etc. Figure 6 Alternatively, the fixing member 7 may be a long strip-shaped member, such as a rack, etc. The present invention does not impose any particular restrictions on the specific structure of the fixing member 7, as long as it can cooperate with the two knobs to drive the outer tube 8 to move axially. Figure 6 As shown in the figure, the fixing member 7 is configured as a circular rod, which is preferably coaxially arranged with the hand-held sleeve 1, and the rod body 71 of the rod is provided with two kinds of threads, namely a first external thread 72 and a second external thread 73, the first external thread 72 and the second external thread 73 are axially spaced, and the pitch P1 of the first external thread 72 is greater than the pitch P2 of the second external thread 73. Figure 4b As shown, the first knob 3 has a first inner hole, the first inner hole has a first inner thread 36, and the first inner thread 36 is used to match with the first outer thread 72; Figure 5b As shown, the second knob 5 has a second inner hole, and the second inner hole has a second inner thread 56 . The second inner thread 56 is used to match with the second outer thread 73 .

[0095] In specific use, when the driving handle 100 needs to work in the fast working mode, the driving handle 100 is first locked in this mode by the switching switch 4. At this time, the fixing member 7 cooperates with the first internal thread 36 on the first knob 3 through the first external thread 72, and then the fixing member 7 can be driven to move quickly along the axis of the hand-held sleeve 1 by rotating the first knob 3.

[0096] On the contrary, when the driving handle 100 needs to work in the slow working mode, the driving handle 100 is also locked in this mode by switching the switch 4, and the fixing member 7 is matched with the second internal thread 56 on the second knob 5 through the second external thread 73, so that the fixing member 7 can be driven to move slowly along the axis of the handheld sleeve 1 by simply rotating the second knob 5.

[0097] In the embodiment of the present invention, the fixing member 7 preferably remains relatively stationary with the hand-held sleeve 1 in the circumferential direction, that is, the fixing member 7 can only move axially but not rotate circumferentially, so that the outer tube 8 can only be driven to move axially relative to the inner tube assembly 9. Obviously, the thread pitch of the first knob 3 is relatively large, which can achieve rapid movement, thereby improving surgical efficiency, while the thread pitch of the second knob 5 is relatively small, which can achieve slow movement, thereby achieving more accurate positioning control, making it easier for the operator to operate accurately and reducing the difficulty of surgery.

[0098] In addition, the switch 4 can realize the interlocking of slow motion and fast motion in addition to the switching of the working mode. Figure 1a As shown, the switch 4 can be manually turned to the first position (i.e., the position shown in b), so that the driving handle 100 can be limited to the fast working mode, and when the switch 4 is in the first position, it can also directly lock the second knob 5 with the hand-held sleeve 1; conversely, if the switch 4 is manually turned to the second position (i.e., the position shown in a), the driving handle 100 can be switched to the slow working mode, and at this time, the switch 4 can also directly lock the first knob 3 with the hand-held sleeve 1. For example, when the switch 4 moves to the first position in the direction of the second knob 5, the switch 4 can cooperate with the second knob 5 to lock the second knob 5, thereby preventing the second knob 5 from rotating; and when the switch 4 moves to the second position in the direction of the first knob 3, the switch 4 can cooperate with the first knob 3 to lock the first knob 3, thereby preventing the first knob 3 from rotating; such operation is very convenient and the structure is also simple.

[0099] Optionally, a first limiting portion is provided on the side of the first knob 3 facing the second knob 5, and a third limiting portion is provided on the switch 4. When the switch 4 is located at the second position, the third limiting portion cooperates with the first limiting portion to limit the rotation of the first knob 3 in the circumferential direction of the handheld sleeve 1. Figure 3a~Figure 3b As shown, combined with Figure 1c~Figure 1dAs shown in Fig. 4, the first limiting portion may be a first limiting groove 33 extending axially on the first knob 3, and the third limiting portion may be a first limiting protrusion 41 extending axially on the switch 4. By inserting the first limiting protrusion 41 into the first limiting groove 33, the first knob 3 and the hand-held sleeve 1 can be conveniently and quickly locked. When the switch 4 is located at the first position, the first limiting protrusion 41 also needs to be able to completely disengage from the first limiting groove 33 to ensure that the first knob 3 can rotate smoothly during rapid movement.

[0100] Optionally, a second limit portion is provided on the side of the second knob 5 facing the first knob 3, and a fourth limit portion is also provided on the switch 4. When the switch 4 is located at the first position, the fourth limit portion cooperates with the second limit portion to limit the movement of the second knob 5 in the circumferential direction of the handheld sleeve 1. Figure 3a~Figure 3b , and as shown in Figure 5, combined with Figure 1c and Figure 1d The second limiting portion may be a second limiting groove 53 extending axially on the second knob 5, and the fourth limiting portion may be a second limiting protrusion 43 extending axially on the switch 4. By inserting the second limiting protrusion 43 into the second limiting groove 53, the second knob 5 and the hand-held sleeve 1 can be conveniently and quickly locked. Similarly, when the switch 4 is in the second position, the second limiting protrusion 43 also needs to be able to completely disengage from the second limiting groove 53 to ensure that the second knob 5 can rotate smoothly during slow motion.

[0101] It should also be known that, in actual use, only when the first limiting groove 33 and the second limiting groove 53 are aligned in the axial direction, the switch 4 can be toggled to switch between the fast working mode and the slow working mode. Moreover, for any knob, the number of limiting grooves it has is not limited to one, but can be multiple, and the multiple limiting grooves are arranged at intervals around the axis of the hand-held sleeve 1. Of course, when switching the working mode, all the limiting grooves on the two knobs need to be aligned one by one. Correspondingly, when there are multiple limiting grooves on each knob, there are also multiple limiting protrusions on the switch 4, and the limiting protrusions and limiting grooves cooperate one by one to achieve matching locking.

[0102] As mentioned above, the switch 4 cannot rotate relative to the hand-held sleeve 1, so it can limit the rotation of the corresponding knob in the first position or the second position. To this end, the switch 4 is preferably provided with a fifth limiter, and the hand-held sleeve 1 is provided with a sixth limiter, which is used to cooperate with the fifth limiter to limit the movement of the switch 4 in the circumferential direction of the hand-held sleeve 1. Figure 3aAs shown, the switch 4 has a third inner hole, and the third inner hole has a third limiting protrusion 42 serving as a fifth limiting portion, and the third limiting protrusion 42 extends inwardly along the radial direction of the third inner hole. Figure 2 As shown, the hand-held sleeve 1 is provided with a radially hollowed limit groove 122. The third limit protrusion 42 is inserted into the limit groove 122 to limit the circumferential rotation of the switch 4. Preferably, the third limit protrusion 42 is multiple and preferably symmetrically distributed. More preferably, the third limit protrusion 42 is two, which has a good anti-rotation effect and a simple structure. Of course, the width of the limit groove 122 is greater than the width of the third limit protrusion 42, ensuring that the switch 4 can move back and forth along the limit groove 122.

[0103] Furthermore, in order to ensure that the external threads on the fixing member 7 can be matched with the internal threads on the knob, the hand-held sleeve 1 is also provided with a position-avoiding structure for avoiding the external threads. Preferably, the position-limiting groove 122 constitutes the position-avoiding structure, so that all the external threads on the fixing member 7 can pass through the position-limiting groove 122 and match with the internal threads on the knob, and the position-limiting groove 122 is also used to limit the fixing member 7 to move axially only along the groove. Figure 2 As shown, the limiting groove 122 is opened from the distal end to the proximal end of the hand-held sleeve 1, but the length is less than the length of the hand-held sleeve 1, and the limiting groove 122 is hollowed out in the radial direction, that is, the other side of the hand-held sleeve 1 can be seen through the limiting groove 122. The cross-section of the limiting groove 122 can be rectangular, waist-shaped, elliptical, etc., and the present invention has no special restrictions on this. Moreover, the present invention does not specifically limit the opening method of the limiting groove 122, and it can be opened at one time. Figure 2 The limiting groove 122 shown can also be divided into multiple limiting grooves 122 in the axial direction, such as a limiting groove 122 is set for each of the second external thread 73, the first external thread 72 and the switch 4. In short, it is sufficient to ensure that the external thread on the fixing member 7 can pass through the corresponding limiting groove and cooperate with the knob, and it is also necessary to ensure that the switch 4 can move in the corresponding limiting groove and switch normally. In addition, the length of the limiting groove also needs to ensure the effective travel of the fixing member when moving quickly and slowly.

[0104] like Figure 6 As shown, the first external thread 72 and the second external thread 73 are both arranged along a part of the circumference of the shaft 71, that is, the first external thread 72 and the second external thread 73 are not full-circumference threads. The second external thread 73 is not limited to being arranged at the proximal end of the shaft 71, but the arrangement shown in the figure is convenient for shortening the length of the rod, thereby shortening the length of the handle.

[0105] In the embodiment of the present invention, a plurality of first external threads 72 may be arranged on the shaft 71, and all the first external threads 72 are spaced along the same circumference. Of course, the number of the first external threads 72 must correspond to the limiting groove 122. For example, a radially hollowed limiting groove 122 can accommodate two symmetrical first external threads 72 at the same time. Then, N limiting grooves 122 can accommodate 2N first external threads 72, where N is an integer greater than or equal to 1. Preferably, all the first external threads 72 are symmetrical about the axis of the shaft 71, that is, symmetrically arranged on the shaft 71. Similarly, a plurality of second external threads 73 may also be arranged on the shaft 71, and all the second external threads 73 are also spaced along the same circumference, and the number of the second external threads 73 must correspond to the limiting groove 122. Preferably, all the second external threads 73 are also symmetrical about the axis of the shaft 71. However, if the shaft 71 is a rack, external threads may be arranged on both opposite surfaces of the rack body, and only one limiting groove 122 may be arranged at this time. The present invention can make the transmission smoother and the transmission accuracy higher by setting a plurality of first external threads 72 or a plurality of second external threads 73. In addition, the total pitch of each first external thread 72 in the axial direction needs to be greater than the effective stroke of fast motion, and the total pitch of each second external thread 73 in the axial direction also needs to be greater than the effective stroke of slow motion. In addition, from the axial point of view, the first external thread 72 and the second external thread 73 may overlap or not overlap (i.e., circumferentially staggered), preferably the two overlap to simplify the structure and simplify the operation. Here, "axial overlap" refers to the overlap of the orthographic projections of the first external thread 72 and the second external thread 73 in the same plane in the axial direction. The overlap of the orthographic projections cannot be narrowly understood as the shape and size of the first external thread 72 and the second external thread 73 being the same, but should be broadly understood as the overlap of the positions of the two, for example, the midpoint of the first external thread 72 in the circumferential direction overlaps with the midpoint of the second external thread 73 in the circumferential direction, and this overlap has nothing to do with the shape and size of the thread.

[0106] In actual use, to ensure that the switch 4 can switch normally, it is preferred to meet the following conditions:

[0107] a) Conversion from fast motion to slow motion: the first limiting groove 33 on the first knob 3 and the second limiting groove 53 on the second knob 5 are aligned to ensure that after the second limiting protrusion 43 is separated from the second limiting groove 53, the first limiting protrusion 41 can be smoothly inserted into the first limiting groove 33, and at the same time, the first knob 3 and the second knob 5 are released from the threaded engagement with the fixing member 7;

[0108] b) Conversion from slow motion to fast motion: the first limiting groove 33 on the first knob 3 and the second limiting groove 53 on the second knob 5 are aligned to ensure that after the first limiting protrusion 41 is disengaged from the first limiting groove 33, the second limiting protrusion 43 can be smoothly inserted into the second limiting groove 53, and at the same time, the first knob 3 and the second knob 5 are released from the threaded engagement with the fixing member 7.

[0109] like Figure 4b As shown, the first knob 3 also has a first groove 35, which is arranged in the first inner hole of the first knob 3 and extends axially. Obviously, the first groove 35 divides the first internal thread 36 into several parts in the circumferential direction. Therefore, when switching from fast motion to slow motion, if the first external thread 72 just enters the first groove 35, the matching relationship between the first external thread 72 and the first internal thread 36 can be released. Therefore, when moving slowly, the first knob 3 can also just avoid the first external thread 72 on the fixing member 7. Obviously, the number of the first grooves 35 should be consistent with the number of the first external threads 72. Of course, the distribution mode of the first external threads 72 also determines the distribution mode of the first grooves 35.

[0110] Similarly Figure 5b As shown, the second knob 5 also has a second groove 55, which is arranged in the second inner hole of the second knob 5 and extends axially. Obviously, the second groove 55 divides the second inner thread 56 into several parts in the circumferential direction. Therefore, when switching from slow motion to fast motion, if the second outer thread 73 just enters the second groove 55, the matching relationship between the second outer thread 73 and the second inner thread 56 can be released. Therefore, when moving quickly, the second knob 5 just avoids the second outer thread 73 on the fixing member 7. Moreover, the number of the second grooves 55 is consistent with the number of the second outer threads 73. It should be understood that based on the fact that the first outer thread 72 and the second outer thread 73 can be axially overlapped or not axially overlapped, the first groove 35 and the second groove 55 are also the same. Therefore, when switching the working mode, if the second outer thread 73 enters the second groove 55 and the first outer thread 72 also enters the first groove 35, in this case, the switch 4 can be operated.

[0111] Furthermore, the driving handle 100 also includes a first connecting member and a second connecting member, and the first connecting member and the second connecting member are both configured to remain relatively stationary axially with the hand-held sleeve 1 at least, that is, they cannot move axially. Among them, the first connecting member is used to limit the axial movement of the first knob 3 in the hand-held sleeve 1, and the second connecting member is used to limit the axial movement of the second knob 5 in the hand-held sleeve 1. However, in other embodiments, the hand-held sleeve 1 itself may be provided with a corresponding structure to limit the axial freedom of the two knobs. The present invention does not make specific limitations on this. Here, the provision of the first connecting member and the second connecting member facilitates the simplification of the structure of the hand-held sleeve 1 and reduces the difficulty of processing.

[0112] Furthermore, if Figure 1a~Figure 1b ,and Figure 1dAs shown, the first connecting member includes a first connecting ring 2 sleeved on the hand-held sleeve 1, and the second connecting member includes a second connecting ring 6 sleeved on the hand-held sleeve 1. In one embodiment, from the distal end to the proximal end, the first connecting ring 2, the first knob 3, the switching switch 4, the second knob 5 and the second connecting ring 6 are arranged in sequence, and preferably these components are coaxially arranged with the hand-held sleeve 1. In other embodiments, from the distal end to the proximal end, the second connecting ring 6, the second knob 5, the switching switch 4, the first knob 3 and the first connecting ring 2 are arranged in sequence.

[0113] like Figure 1c and Figure 4a As shown, the first connecting ring 2 has a first circumferential protrusion 22 (i.e., a first connecting structure), and the first knob 3 has a first circumferential groove 31 (i.e., a third connecting structure). The first circumferential protrusion 22 is inserted into the first circumferential groove 31, thereby limiting the axial movement of the first knob 3 in the handheld sleeve 1, but the first knob 3 can still rotate circumferentially.

[0114] like Figure 1c and Figure 5a As shown, the second connecting ring 6 has a second circumferential protrusion 61 (i.e., the second connecting structure), and the second knob 5 has a second circumferential groove 51 (i.e., the fourth connecting structure). The second circumferential protrusion 61 is inserted into the second circumferential groove 51 to limit the axial movement of the second knob 5 in the hand-held sleeve 1, but the second knob 5 can still rotate circumferentially. Of course, in other embodiments, the first circumferential protrusion 22 on the first connecting ring 2 can also be replaced by a circumferential groove, and the first circumferential groove 31 on the first knob 3 can be replaced by a circumferential protrusion. Similarly, the second circumferential protrusion 61 on the second connecting ring 6 can also be replaced by a circumferential groove, and the second circumferential groove 51 on the second knob 5 can be replaced by a circumferential protrusion. Therefore, one of the first connecting structure and the third connecting structure is a circumferential protrusion, and the other is a circumferential groove; similarly, one of the second connecting structure and the fourth connecting structure is a circumferential protrusion, and the other is a circumferential groove.

[0115] In the embodiment of the present invention, the first connecting ring 2 and the second connecting ring 6 both remain axially relatively stationary with the hand-held sleeve 1, and the first connecting ring 2 and the second connecting ring 6 also preferably remain circumferentially relatively stationary with the hand-held sleeve 1. However, the present invention has no special limitation on the method of achieving circumferential fixation, which may be an interference connection, a keyway connection, a screw connection or glue bonding, etc.

[0116] Continue reading Figure 1c and Figure 2The first connecting ring 2 also has a third circumferential protrusion 21, which is inserted into the first connecting groove 121 of the hand-held sleeve 1. Here, the third circumferential protrusion 21 and the first connecting groove 121 can be fixed by interference connection, glue bonding, etc. The second connecting ring 6 also has a proximal portion 62, which is sleeved on the proximal connecting portion 123 of the hand-held sleeve 1 and can be glued to the proximal connecting portion 123.

[0117] Further, such as Figure 1b and Figure 2 As shown, the hand-held sleeve 1 specifically includes a hand-held section 11 and a connecting section 12, and the hand-held section 11 is located at the distal end of the driving handle 100, so that the operator can hold the hand-held section 11 to operate the handle. In order to facilitate operation, the surface of the hand-held section 11 can be made of frosted material or provided with ribs, waves, etc. to increase friction and optimize the operating feel. In this regard, the present invention has no special restrictions. The connecting section 12 is located at the proximal end of the driving handle 100, and the outer diameter of the connecting section 12 is smaller than the outer diameter of the hand-held section 11, wherein the first connecting ring 2, the first knob 3, the switching switch 4, the second knob 5 and the second connecting ring 6 are all arranged on the connecting section 12. The limiting groove 122 extends from the hand-held section 11 to the connecting section 12.

[0118] Further, such as Figure 4a As shown, the first knob 3 may include a first cylindrical section 32 in the middle and third cylindrical sections 34 on both sides, wherein the outer diameter of the third cylindrical section 34 is smaller than the outer diameter of the first cylindrical section 32. The first cylindrical section 32 is used for manual quick circumferential adjustment, while the third cylindrical section 34 on the left is used to connect with the first connecting ring 2, and the third cylindrical section 34 on the right is used to sleeve the switch 4. Therefore, a first circumferential groove 31 is formed on the third cylindrical section 34 on the left, and a first limiting surface 37 is formed on the third cylindrical section 34 on the right and the first cylindrical section 32, which can limit the moving distance of the switch 4, that is, when the switch 4 abuts against the first limiting surface 37, it is limited to the second position. The first limiting groove 33 is specifically provided on the first cylindrical section 32, and extends axially from the proximal end to the distal end of the first cylindrical section 32, and the first limiting groove 33 is preferably not connected to the inner hole of the first knob 3, so as to prevent foreign matter from entering the handle. In addition, the third cylindrical section 34 on the right side is preferably always matched with the switch 4 to prevent foreign matter from entering the handle. Therefore, the distance when the switch 4 moves from the second position to the first position should be less than the length of the third cylindrical section 34 on the right side.

[0119] like Figure 5aAs shown, the second knob 5 may also include a second cylindrical section 52 in the middle and fourth cylindrical sections 54 on both sides, wherein the outer diameter of the fourth cylindrical section 54 is smaller than the outer diameter of the second cylindrical section 52. The second cylindrical section 52 is used for manual slow circumferential adjustment, while the fourth cylindrical section 54 on the right is used to connect with the second connecting ring 6, and the fourth cylindrical section 54 on the left is used to sleeve the switch 4. Therefore, a second circumferential groove 51 is formed on the fourth cylindrical section 54 on the right, and a second limiting surface 57 is formed between the fourth cylindrical section 54 on the right and the second cylindrical section 52, which can limit the moving distance of the switch 4, that is, when the switch 4 abuts against the second limiting surface 57, it is limited to the first position. The second limiting groove 53 is specifically provided on the second cylindrical section 52, extending from the distal end of the second cylindrical section 52 to the proximal end, and the second limiting groove 53 is preferably not connected to the interior of the second knob 5, so as to prevent foreign matter from entering the handle. In addition, the second cylindrical section 52 is preferably always matched with the switch 4 to prevent foreign matter from entering the handle. Therefore, the distance when the switch 4 moves from the first position to the second position is less than the length of the second cylindrical section 52.

[0120] Furthermore, the pitch P1 of the first external thread 72 and the pitch P2 of the second external thread 73 preferably have the following relationship: P1=M*P2, where M is an integer greater than or equal to 2. The appropriate M value can be selected according to the multiple difference between the fast speed and the slow speed required by the operation, that is, the displacement generated by rotating the first knob 3 one circle is the displacement generated by rotating the second knob 3 M circles.

[0121] Furthermore, the fixing member 7, such as the shaft 71, is provided with a plurality of scale lines axially spaced apart, and the distance between adjacent scale lines is equal to the pitch P1 of the first external thread 72, that is, the fixing member 7 can be moved by one scale mark by rotating the first knob 3 one circle, so that it is convenient for the operator to determine the delivery stroke according to the scale lines, making the operation more accurate and convenient. More preferably, an alignment mark is provided on the hand-held sleeve 1, and the alignment mark is used to coincide with any scale line to limit the driving handle to the initial mode. The switching switch 4 can be operated only when the driving handle is in the initial mode, that is, when any scale line coincides with the alignment mark on the hand-held sleeve 1, it indicates that the driving handle is in the initial mode: the grooves on the two knobs just avoid the external thread on the fixing member, and the limit grooves on the two knobs are also axially aligned.

[0122] Optionally, the alignment mark is an edge line of the distal end surface of the hand-held section 11 .

[0123] Therefore, in the embodiment of the present invention, the conditions for the switch 4 to switch normally include:

[0124] First, P1=M*P2;

[0125] Second, the distance between any adjacent scale lines is P1;

[0126] Third, ensure that any scale line can coincide with the alignment mark.

[0127] In more detail, when any scale line on the fixing member 7 just coincides with the edge line on the hand-held section 11, the first limit groove 33 on the first knob 3 is just aligned with the second limit groove 53 on the second knob 5, and the grooves on the two knobs each avoid the external thread on the fixing member 7. At this time, it is possible to switch to slow movement. Just push the switch 4 toward the first knob 3, so that the switch 4 is separated from the second knob 5, and cooperates with the first knob 3 so that the switch 4 limits the circumferential movement of the first knob 3. At this time, the second knob 5 can be rotated, and the second knob 5 drives the fixing member 7 to move axially at a slow speed. Then, when any scale line on the fixing member 7 coincides with the edge line on the hand-held section 11, it can ensure that the second limit groove 53 on the second knob 5 is aligned with the first limit groove 33 on the first knob 3, and at the same time, the grooves on the two knobs also avoid the external thread on the fixing member 7. At this time, it can be switched to fast motion, and the switch 4 can be switched to the second knob 5 side by just toggling the switch 4 to separate from the first knob 3 and cooperate with the second knob 5. Similarly, after switching to fast motion, when any scale line on the fixing member 7 coincides with the edge line on the hand-held section 11, it can be switched to slow motion.

[0128] Further, if Figure 8 As shown, from the proximal end to the distal end, the inner tube assembly 9 specifically includes an inner tube 93, a fixing head 92 and a conical head 91 connected in sequence. Taking the implant as a valve stent 10 as an example, Figure 8 The valve support 10 is shown in an unreleased state. Figure 8 It can be clearly known that during transportation, the valve stent 10 is loaded on the periphery of the inner tube 93 between the conical head 91 and the fixed head 92, and is fixedly supported by the fixed head 92 (one end of the valve stent 10 is fixed on the fixed head 92), and the fixed head 92 is immovable (that is, all degrees of freedom are restricted), and the proximal end of the inner tube 93 is fixedly connected to the hand-held sleeve 1 by means of threads or glue, so that the inner tube 93 is fixed relative to the hand-held sleeve 1 as a whole, thereby ensuring that the valve stent 10 loaded on the fixed head 92 remains relatively fixed to the hand-held sleeve 1. The distal end of the outer tube 8 is sleeved on the periphery of the valve stent 10 loaded on the inner tube 93, and preferably the distal end of the outer tube 8 contacts the proximal end surface of the conical head 91 at the distal end of the inner tube 93.

[0129] In actual use, such as Figure 1bAs shown, the outer tube 8 can be connected to the distal end of the fixing member 7, and is preferably arranged coaxially with the fixing member 7. In addition, the inner tube assembly 9 can be connected to the proximal end of the hand-held sleeve 1 after passing through the outer tube 8 and the fixing member 7 in sequence, wherein the proximal end of the inner tube assembly 9 can extend out of the hand-held sleeve 1 or not. Then, the fixing member 7 can drive the outer tube 8 to move forward and backward by manual drive, so that the outer tube 8 moves forward and backward relative to the inner tube assembly 9, so as to realize the loading, release and recovery of the valve stent 10.

[0130] More specifically, the loading process of the valve stent 10 is as follows:

[0131] First, the driving handle 100 is set in the initial mode: that is, any scale line on the fixing member 7 just coincides with the edge line on the hand-held sleeve 1, preferably, the conical head 91 is in contact with the distal end of the outer tube 8;

[0132] Then, the valve stent 10 is loaded: the left hand holds the handheld section 11, and the switch 4 is turned to the second knob 5, and then the right hand rotates the first knob 3 counterclockwise. The rotation of the first knob 3 causes the fixing member 7 to drive the outer tube 8 to quickly withdraw toward the proximal end to expose the fixing head 92, and any scale line coincides with the edge line on the handheld section 11, and then the valve stent 10 is loaded onto the tube section of the inner tube 93 between the fixing head 92 and the conical head 91;

[0133] Then, turn the switch 4 to the first knob 3, and then rotate the second knob 5 clockwise. The rotation of the second knob 5 causes the fixing member 7 to drive the outer tube 8 to move slowly toward the distal end, so that the distal end of the outer tube 8 is sleeved on the periphery of the valve support 10 loaded on the inner tube 93.

[0134] After the valve stent 10 is loaded, the valve stent 10 can be further implanted into the body through the catheter assembly 200. The process of implanting the valve stent 10 includes the following operating requirements:

[0135] First, before positioning, in order to slowly release the bracket, the outer tube 8 needs to be withdrawn at a slower speed. At this time, the driving handle 100 can be operated as follows: first, the driving handle 100 is also set to the initial mode, that is, any scale line on the fixing member 7 just coincides with the edge line on the hand-held section 11, and then, the switch 4 is turned to the first knob 3, and then the second knob 5 is rotated counterclockwise to make the fixing member 7 drive the outer tube 8 to withdraw slowly; it should be known that a slow release speed is conducive to improving the accuracy of the release position;

[0136] Secondly, after positioning, in order to improve the efficiency of release and save operation time, the following operations are required: set the driving handle 100 to the initial mode, then turn the switch 4 to the second knob 5, and then rotate the first knob 3 counterclockwise to make the fixing member 7 drive the outer tube 8 to withdraw quickly; however, in the final stage of the valve stent release, in order to check the position of the valve stent and to avoid the instantaneous impact caused by too fast release speed, the valve stent needs to be released slowly again.

[0137] Then, during the recovery process of the valve stent 10, the switch 4 can be turned to the second knob 5, and then the first knob 3 can be rotated clockwise, so that the fixing member 7 drives the outer tube 8 to move rapidly toward the distal end, thereby realizing rapid recovery of the valve stent 10.

[0138] Therefore, at different stages of the operation, by adjusting the travel speed of the driving handle 100 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.

[0139] The above embodiment mainly describes the preferred structure of the driving handle when the second knob 5, the switching switch 4 and the first knob 3 are arranged in sequence from the proximal end to the distal end, but it should be known that the positions of the second knob 5 and the first knob 3 can also be interchanged. After the interchange, the structure and operation mode of the driving handle are also basically the same as the above embodiment. The detailed content is not 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. It should be known that the pitch of the large thread is M times the pitch of the small thread, and the distance between any adjacent scale lines on the fixing member 7 is the pitch of the large thread. At the same time, when the driving handle is in the initial mode, it is also necessary to meet the following conditions: when any scale line coincides with the edge line of the distal end of the hand-held sleeve, the switching switch can smoothly cooperate with the corresponding knob, and both knobs are released from the threaded cooperation relationship with the fixing member. Under these conditions, it can be ensured that the switching switch 4 can switch between slow motion and fast motion.

[0140] 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 fixing member. In addition, the embodiment of the present invention is described with the valve stent 10 (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 be used to place other implants (such as vascular stents) into corresponding positions of the body in addition to the valve stent. And the parts in the driving handle of the present invention are all coaxially assembled, and the radial dimension is small, so that the handle is small in size, light in weight, and easy to carry and operate.

[0141] 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.

[0142] 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: The invention comprises a hand-held sleeve, a fixing member, a first driving mechanism, a second driving mechanism and a gear switching mechanism; at least a part of the fixing member is movably arranged in the hand-held sleeve, and the first driving mechanism, the second driving mechanism and the gear switching mechanism are all arranged on the hand-held sleeve; The first driving mechanism comprises a first knob sleeved on the hand-held sleeve, and the second driving mechanism comprises a second knob sleeved on the hand-held sleeve, and the first knob and the second knob both remain relatively stationary axially with the hand-held sleeve; The fixing member is coaxially arranged with the hand-held sleeve and has a first external thread and a second external thread spaced axially apart; the first knob has a first internal thread, the first external thread is used to cooperate with the first internal thread; the second knob has a second internal thread, the second external thread is used to cooperate with the second internal thread; the pitch of the first external thread is M times the pitch of the second external thread, and M is an integer greater than or equal to 2; The first knob has a first groove to avoid the first external thread, and the second knob has a second groove to avoid the second external thread; The driving handle has an initial mode, a first working mode, and a second working mode, and the gear switching mechanism is used to limit the driving handle to be in one of the first working mode and the second working mode; when the driving handle is in the first working mode, the gear switching mechanism locks the second knob with the hand-held sleeve, and the first driving mechanism is configured to cooperate with the fixing member to drive the fixing member to move along the axis of the hand-held sleeve at a first speed; When the driving handle is in the second working mode, the gear switching mechanism locks the first knob with the hand-held sleeve, and the second driving mechanism is configured to cooperate with the fixing member to drive the fixing member to move along the axis of the hand-held sleeve at a second speed, and the second speed is less than the first speed; When the driving handle is in the initial mode, the first external thread is accommodated in the first groove, and the second external thread is accommodated in the second groove; and in the initial mode, the gear switching mechanism is used to be driven by an external force to limit the driving handle to the first working mode or the second working mode; The fixing member is axially provided with a plurality of scale lines, and the distance between any adjacent scale lines is equal to the pitch of the first external thread. The hand-held sleeve is provided with an alignment mark, and the alignment mark is used to coincide with any scale line to limit the driving handle to the initial mode.

2. The driving handle for delivering an implant according to claim 1, characterized in that: The gear switching mechanism is movably arranged on the handheld sleeve; The gear switching mechanism has a first position and a second position; when the gear switching mechanism moves to the first position, the driving handle is limited to the first working mode, and the gear switching mechanism also locks the second knob with the hand-held sleeve; When the gear switching mechanism moves to the second position, the driving handle is also limited to the second working mode, and the gear switching mechanism also locks the first knob and the hand-held sleeve.

3. The driving handle for delivering an implant according to claim 2, characterized in that: The gear switching mechanism includes a switching switch, which is movably arranged on the hand-held sleeve and located between the first knob and the second knob, and the switching switch and the hand-held sleeve remain relatively stationary in the circumferential direction; When the switch moves toward the second knob to the first position, the switch cooperates with the second knob to lock the second knob with the hand-held sleeve, and limits the driving handle to the first working mode; When the switch moves toward the first knob to the second position, the switch cooperates with the first knob to lock the first knob and the hand-held sleeve, and limits the driving handle to the second working mode.

4. The driving handle for delivering an implant according to claim 3, characterized in that: A first limiting portion is provided on a side of the first knob facing the second knob, and a third limiting portion is provided on the switching switch, and the first limiting portion is used to cooperate with the third limiting portion to limit the movement of the first knob in the circumferential direction of the handheld sleeve; A second limiting portion is provided on a side of the second knob facing the first knob, and a fourth limiting portion is also provided on the switching switch, and the second limiting portion is used to cooperate with the fourth limiting portion to limit the movement of the first knob in the circumferential direction of the handheld sleeve.

5. The driving handle for delivering an implant according to claim 4, characterized in that: The first limiting portion is a first limiting groove extending axially, the first limiting groove is not connected to the interior of the first knob, and the third limiting portion is a first limiting protrusion; The second limiting portion is a second limiting groove extending axially, the second limiting groove is not connected to the interior of the second knob, and the fourth limiting portion is a second limiting protrusion.

6. The driving handle for delivering an implant according to claim 4, characterized in that: The switch is a sleeve structure and is movably sleeved between the first knob and the second knob, and the switch is coaxial with the hand-held sleeve; The first knob has a first cylindrical section and a third cylindrical section, the diameter of the third cylindrical section is smaller than that of the first cylindrical section, and the third cylindrical section is used for sleeve-mounting the switch; The second knob comprises a second cylindrical section and a fourth cylindrical section, the diameter of the fourth cylindrical section is smaller than the diameter of the second cylindrical section, and the fourth cylindrical section is used for sleeve-mounting the switch; Wherein: the distance that the switching switch moves from the second position to the first position is less than the length of the third cylindrical segment, and the distance that the switching switch moves from the first position to the second position is less than the length of the fourth cylindrical segment.

7. The driving handle for delivering an implant according to any one of claims 3 to 6, characterized in that: The switching switch is provided with a fifth limiting portion, and the hand-held sleeve is provided with a sixth limiting portion; the sixth limiting portion is used to cooperate with the fifth limiting portion to limit the movement of the switching switch in the circumferential direction of the hand-held sleeve.

8. The driving handle for delivering an implant according to claim 7, characterized in that: The fifth limiting portion is a protrusion, and the protrusions are multiple and symmetrically arranged. The sixth limiting portion is a hollow limiting groove, and all the protrusions are used to insert into the corresponding limiting grooves so that the switching switch moves along the limiting grooves.

9. The driving handle for delivering an implant according to any one of claims 1 to 6, characterized in that: It also includes a first connecting member and a second connecting member disposed on the handheld sleeve, wherein the first connecting member and the second connecting member at least remain relatively stationary axially with the handheld sleeve; wherein: The first connecting member is used to limit the axial movement of the first knob on the hand-held sleeve; the second connecting member is used to limit the axial movement of the second knob on the hand-held sleeve.

10. The driving handle for delivering an implant according to claim 9, characterized in that: The first connecting member includes a first connecting ring sleeved on the hand-held sleeve, and the second connecting member includes a second connecting ring sleeved on the hand-held sleeve; the first connecting ring, the first knob, the gear switching mechanism, the second knob and the second connecting ring are arranged in sequence and remain coaxial with the hand-held sleeve.

11. The driving handle for delivering an implant according to claim 1, characterized in that: The hand-held sleeve is provided with an avoidance structure for avoiding the first external thread and the second external thread. The avoidance structure is a hollow limiting groove. The first external thread passes through the limiting groove and cooperates with the first internal thread; the second external thread passes through the limiting groove and cooperates with the second internal thread, and the fixing piece is used to make axial movement along the limiting groove.

12. The driving handle for delivering an implant according to claim 1 or 11, characterized in that: The fixing member is a circular rod, and the first external thread and the second external thread are both arranged on the rod along a portion of the circumference.

13. The driving handle for delivering an implant according to claim 12, characterized in that: There are multiple first external threads and multiple second external threads, all of the first external threads and all of the second external threads are symmetrically arranged on their respective circumferences, and all of the first external threads and all of the second external threads overlap in the axial direction.

14. The driving handle for delivering an implant according to any one of claims 1 to 6, characterized in that: The hand-held sleeve comprises an axially connected hand-held section and a connecting section, wherein the diameter of the connecting section is smaller than the diameter of the hand-held section; the first driving mechanism, the second driving mechanism and the gear switching mechanism are all arranged on the connecting section.

15. The driving handle for delivering an implant according to any one of claims 1 to 6, characterized in that: The driving handle is a manual driving handle.

16. 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 15, 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 fixing member of the driving handle, and the fixing member is used to drive the outer tube to perform axial movement relative to the inner tube assembly.

17. The delivery system for delivering an implant according to claim 16, characterized in that: The inner tube assembly passes through one end of the fixing member and comes out from the other end to be connected with the hand-held sleeve.

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