Control handles, bending wires and implant delivery devices

Abstract

The present invention provides a control handle, a bending control wire and a delivery device for an implant, wherein the control handle comprises: a base and a rotating part; the base is used to be connected to a bending control tube of a catheter assembly, and the axial direction of the base is the same as the axial direction of the bending control tube; the rotating part is rotatably connected to the base along the radial direction of the base, and the rotation axis of the rotating part is not in the same plane as the axis of the base; the rotating part is used to be fixedly connected to the proximal end of the bending control wire, and is used to drive the bending control wire to be coiled thereon by rotation. With such a configuration, the rotation axis of the rotating part is configured to be not in the same plane as the axis of the base, so that when the rotating part rotates, the bending control wire is coiled thereon, thereby realizing bending control, thereby reducing the length of the control handle and making the structure more compact; further, by adjusting the size of the rotating part around which the bending control wire is coiled, the transmission ratio can be adjusted, thereby realizing the adjustment of the bending control rate, which meets the use requirements.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a control handle, a bending control wire and an implant delivery device. Background Art

[0002] The heart contains four chambers. The left atrium and left ventricle are located on the left side of the heart, and the right atrium and right ventricle are located on the right side of the heart. The ventricular inflow tract is formed between the atrium and the ventricle, the left ventricular outflow tract is formed between the left ventricle and the aorta, and the right ventricle and the pulmonary artery form the right ventricular outflow tract. There are valves with the function of "one-way valves" at the ventricular inflow tract and the ventricular outflow tract. The human heart has four valves. They are the aortic valve connecting the left ventricle and the aorta, the pulmonary valve connecting the right ventricle and the pulmonary artery, the mitral valve connecting the left atrium and the left ventricle, and the tricuspid valve connecting the right atrium and the right ventricle. They all act as one-way valves, so that blood can only flow from one direction to another and cannot flow back. When a problem occurs in a certain valve, the heart's hemodynamics changes and the heart function becomes abnormal, which is called valvular heart disease.

[0003] 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, and some patients do not even have the opportunity for surgery. Transcatheter valve replacement / repair has the advantages of no need for open-chest surgery, less trauma, and faster patient recovery, and has attracted widespread attention from experts and scholars.

[0004] Due to the complexity of the human body structure, the accuracy of interventional surgical positioning is particularly important. In order to accurately deliver the implant to the target location through blood vessels of different routes, a controllable bend delivery device is usually used.

[0005] The traditional bending control technology is to bury a bending control wire on the side of the bending control catheter, weld the distal end of the bending control wire to the wire pull ring at the distal end of the bending control catheter, and connect the proximal end of the bending control wire to the handle. If the bending control wire is fixed on the slider, the slider can be controlled to move linearly to pull the bending control wire to achieve the purpose of bending control. The bending control rate of the traditional bending control technology is uncontrollable, and the slider drives the bending control wire in a way that makes the handle larger in length, and the overall structure of the handle is not compact enough. Summary of the invention

[0006] The object of the present invention is to provide a control handle, a bending control wire and a delivery device for an implant, so as to solve the problems of uncontrollable bending control rate and non-compact structure of the existing delivery device.

[0007] In order to solve the above technical problems, the present invention provides a control handle for a delivery device of an implant, the control handle comprising: a base and a rotating part;

[0008] The base is used to connect with the bending control tube of the catheter assembly, and the axial direction of the base is the same as the axial direction of the bending control tube;

[0009] The rotating part is rotatably connected to the base, and the rotation axis of the rotating part is not in the same plane as the axis of the base; the rotating part is used to be fixedly connected to the proximal end of the bending control line, and is used to drive the bending control line to be coiled thereon by rotation.

[0010] Optionally, in the control handle, the rotating portion includes an operating section and a winding section which are sequentially connected along its own axial direction, and a radial outer dimension of the operating section is larger than a radial outer dimension of the winding section; the winding section is used for winding the control bending line.

[0011] Optionally, in the control handle, the coiled section includes at least two shaft sections with different outer diameters along the axial direction.

[0012] Optionally, in the control handle, the rotating portion includes a bending control line fixing piece, and the rotating portion is used to be fixedly connected to the proximal end of the bending control line through the bending control line fixing piece.

[0013] Optionally, in the control handle, the bending control wire fixing member includes a top screw having a first external thread; the rotating portion has an axially opened blind hole and a bending control wire passing hole opened radially, and the blind hole is connected to the bending control wire passing hole; the blind hole has a first internal thread adapted to the first external thread, the blind hole is used for allowing the proximal end of the bending control wire to pass through the bending control wire passing hole, and the top screw is used to screw into the blind hole and press and fix the bending control wire.

[0014] Optionally, in the control handle, the rotating part includes a self-locking section, and the control handle also includes a locking part, and the locking part is used to apply an impedance torque to the self-locking section to limit the rotation of the rotating part when the rotating torque is less than the impedance torque.

[0015] Optionally, in the control handle, the self-locking section includes a plurality of grooves arranged circumferentially around the rotation axis of the rotating part, the locking part includes a spring plunger, the spring plunger includes a fixing part, an elastic part and a limiting ball, the limiting ball is connected to the fixing part via the elastic part, and the fixing part is fixedly connected to the base; the limiting ball abuts against the groove under the elastic force of the elastic part to apply the impedance torque to the self-locking section.

[0016] Optionally, in the control handle, the rotating part includes a threaded segment, the threaded segment has a second external thread; the base has a second internal thread that matches the second external thread, the rotating part is threadedly connected to the base through the threaded segment, and the rotation of the rotating part relative to the base is converted into axial movement of the rotating part relative to the base through the second external thread and the second internal thread.

[0017] Optionally, in the control handle, the base includes a hollow catheter fixing section, which is arranged along the axial direction of the base and is used for the proximal insertion of the control bending tube; the catheter fixing section has an avoidance groove opened in the radial direction, and the avoidance groove is used for the passage of the control bending line.

[0018] Optionally, in the control handle, the control handle also includes a limit shell, and the avoidance groove extends to the distal end along the axial direction of the catheter fixing section; the distal end of the catheter fixing section has a third external thread, and the limit shell has a third internal thread adapted to the third external thread, and the limit shell is connected to the catheter fixing section by threads.

[0019] In order to solve the above technical problems, the present invention also provides a bending control wire, which is used in the control handle as described above, and the bending control wire includes: a first traction wire segment and a second traction wire segment; the distal end of the first traction wire segment is fixedly connected to the proximal end of the second traction wire segment, the first traction wire segment is softer than the second traction wire segment, the proximal end of the first traction wire segment is fixedly connected to the rotating part, and the first traction wire segment is used to be coiled on the rotating part.

[0020] Optionally, in the bending control wire, the first traction wire segment is a polymer material wire segment, and the second traction wire segment is a metal wire segment.

[0021] In order to solve the above-mentioned technical problems, the present invention also provides an implant delivery device, which includes the control handle and catheter assembly as described above; the catheter assembly includes the bending control wire and bending control tube as described above, and the distal end of the bending control wire penetrates into the bending control tube and is fixedly connected to the distal end of the bending control tube.

[0022] To summarize, in the control handle, the bending control wire and the implant delivery device provided by the present invention, the control handle comprises: a base and a rotating part; the base is used to be connected to the bending control tube of the catheter assembly, and the axial direction of the base is used to be the same as the axial direction of the bending control tube; the rotating part is rotatably connected to the base along the radial direction of the base, and the rotation axis of the rotating part is not in the same plane as the axis of the base; the rotating part is used to be fixedly connected to the proximal end of the bending control wire, and is used to drive the bending control wire to be coiled thereon by rotation.

[0023] With such a configuration, the rotation axis of the rotating part and the axis of the base are configured to be skewed, so that when the rotating part rotates, the bending control wire is coiled thereon, thereby achieving bending control, thereby reducing the length of the control handle and making the structure more compact; further, by adjusting the size of the rotating part around which the bending control wire is coiled, the transmission ratio can be adjusted, thereby achieving adjustment of the bending control rate to meet usage requirements. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0025] Figure 1 is an overall schematic diagram of a control handle according to an embodiment of the present invention;

[0026] Figure 2 yes Figure 1 A partial exploded view of the control handle;

[0027] Figure 3 is a schematic diagram of a control handle according to an embodiment of the present invention;

[0028] Figure 4 is a schematic diagram of a catheter fixing section according to an embodiment of the present invention;

[0029] Figure 5 is a schematic diagram of a preferred example of a rotating part of an embodiment of the present invention;

[0030] Figure 6 is a schematic diagram of another preferred example of the rotating part of the embodiment of the present invention;

[0031] Figure 7 is a schematic diagram of a self-locking section and a locking portion of an embodiment of the present invention;

[0032] Figure 8 is a schematic diagram of a bending control line according to an embodiment of the present invention;

[0033] Fig. 9 is a schematic diagram of a conveying device according to an embodiment of the present invention;

[0034] Fig.10 Schematic diagram of the distal end of a catheter assembly according to an embodiment of the present invention.

[0035] In the attached figure:

[0036] 1-control handle; 11-base; 110-base body; 111-catheter fixing section; 112-avoidance groove; 113-glue injection port; 114-third external thread; 115-protrusion; 116-limiting groove; 117-circlip; 118-emptying port; 12-rotating part; 121-operating section; 122-coiled section; 123-threaded section; 124-top screw; 125-bending line penetration hole; 126-transition section; 127-self-locking section; 128-groove; 129-limiting piece; 13-housing; 131-limiting shell; 14-spring plunger; 141-fixing piece; 142-limiting ball;

[0037] 2-catheter assembly; 21-bending control wire; 211-first traction wire segment; 212-second traction wire segment; 22-bending control tube; 221-balloon; 222-external catheter; 223-catheter seat; 2231-filling fluid infusion port; 2232-guide wire port; 23-balloon catheter; 231-conical head; 232-balloon support; 233-inner catheter; 24-wire outlet;

[0038] 3- Implant. DETAILED DESCRIPTION

[0039] 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 and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. In addition, the structure shown in the drawings is often a part of the actual structure. In particular, the emphasis of each drawing is different, and sometimes different scales are used.

[0040] As used in the present invention, the singular forms "a", "an" and "the" include plural objects, the term "or" is generally used in a sense including "and / or", the term "several" is generally used in a sense including "at least one", and the term "at least two" is generally used in a sense including "two or more". In addition, the terms "first", "second" and "third" are used for descriptive purposes only and cannot be understood as indicating or suggesting relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first", "second" and "third" may explicitly or implicitly include one or at least two of the features. The term "proximal end" is usually the end close to the operator, and the term "distal end" is usually the end close to the patient, that is, the end close to the lesion. "One end" and "the other end" as well as "proximal end" and "distal end" usually refer to two corresponding parts, which not only include the endpoints. The terms "installed", "connected" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral body; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the internal connection of the two elements or the interaction relationship between the two elements. In addition, as used in the present invention, an element is arranged on another element, which usually only means that there is a connection, coupling, matching or transmission relationship between the two elements, and the connection, coupling, matching or transmission between the two elements can be direct or indirect through an intermediate element, and it cannot be understood as indicating or implying the spatial position relationship between the two elements, that is, an element can be in any position such as inside, outside, above, below or on one side of another element, unless the content clearly indicates otherwise. For those skilled in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0041] The purpose of the present invention is to provide a control handle, a bending control wire and an implant delivery device to solve the problems of uncontrollable bending control rate and non-compact structure of existing delivery devices resulting in large size.

[0042] Please refer to Figure 1 , Figure 2 , Fig. 9 and Fig.10The embodiment of the invention provides a delivery device for delivering an implant 3, which may be an artificial heart valve prosthesis. The delivery device includes a control handle 1 and a catheter assembly 2, wherein the catheter assembly 2 includes a bending control wire 21 and a bending control tube 22. The distal end of the bending control wire 21 penetrates into the bending control tube 22 and is fixedly connected to the distal end of the bending control tube 22, for example, the distal end of the bending control wire 21 is welded and fixed to the bending control tube 22. The middle part of the bending control wire 21 may be arranged in the bending control tube 22, such as being buried in the tube wall of the bending control tube 22, and then passing through the tube wall of the bending control tube 22 from a wire outlet 24 near the proximal end of the bending control tube 22 to extend outward; the proximal end of the bending control tube 22 passes through the wire outlet 24 and is connected to the control handle 1. With such a configuration, the control handle 1 can drive the bending control tube 22 to bend by controlling the movement of the bending control wire 21 along the axial direction to achieve bending control. The present invention does not elaborate on the structure and principle of the bending control pipe 22, and those skilled in the art can understand it based on the existing technology.

[0043] Optionally, the catheter assembly 2 also includes a balloon catheter 23, which is inserted into the control bend tube 22. In an alternative exemplary embodiment, the balloon catheter 23 includes a conical head 231, a balloon support 232 and an inner catheter 233 connected in sequence from the distal end to the proximal end, and the control bend tube 22 includes a balloon 221, an outer catheter 222 and a catheter seat 223 connected in sequence from the distal end to the proximal end. The distal end of the balloon 221 is tightly connected to the distal end of the balloon support 232, and the balloon 221 is a retractable or foldable arrangement, which can expand when filled with a filling fluid (such as a contrast solution). The proximal end of the inner catheter 233 is tightly connected to the catheter seat 223, and the interior of the inner catheter 233 is used for the guide wire to be inserted. The proximal end of the catheter seat 223 is provided with a filling fluid infusion port 2231 and a guide wire port 2232. The guide wire port 2232 is preferably arranged along the axial direction of the inner catheter 233, while the filling fluid infusion port 2231 can be arranged at an angle with the axial direction of the inner catheter 233 to form a side branch. A gap is formed between the inner catheter 233 and the outer catheter 222, and the gap is communicated with the filling fluid infusion port 2231. The filling fluid is filled into or discharged from the balloon 221 through the gap between the inner catheter 233 and the outer catheter 222. When the balloon 221 is not filled with the filling fluid, the balloon 221 is in a contracted or folded state, and the implant 3 can be pressed and held outside the balloon 221 and moved with the balloon 221. After the implant 3 is pushed to the target position, the filling fluid is filled into the balloon 221 through the filling fluid infusion port 2231, and the balloon 221 is paced to expand the implant 3 to a predetermined size.

[0044] To solve the technical problem of the present invention, please refer to Figures 1 to 3An embodiment of the present invention provides a control handle 1, which includes: a base 11 and a rotating portion 12; the base 11 is used to connect with the control bending tube 22 of the catheter assembly 2, and the axial direction of the base 11 is the same as the axial direction of the control bending tube 22; it should be understood that since the control bending tube 22 is flexible and bendable, its axial direction will also change with the bending, and the axial direction of the control bending tube 22 here should be understood as the axial direction of a section of the control bending tube 22 connected to the base 11.

[0045] The rotating part 12 is rotatably connected to the base 11, and the rotation axis of the rotating part 12 is not in the same plane as the axis of the base 11. Preferably, the rotation axis of the rotating part 12 is perpendicular to the axis of the base 11. The rotating part 12 is used to be fixedly connected to the proximal end of the control bending wire 21, and is used to drive the control bending wire 21 to be wound thereon by rotation. In this configuration, through the setting of the rotating part 12, the moving direction of the control bending wire 21 is converted from along its own axial direction to the circumferential direction around the rotating part 12. When the rotating part 12 rotates, the control bending wire 21 is wound thereon, thereby realizing control bending, thereby reducing the length of the control handle 1 and making the structure more compact. Furthermore, by adjusting the size of the rotating part 12 around which the control bending wire 21 is wound, the transmission ratio can be adjusted, thereby realizing the adjustment of the control bending rate, which is more in line with the use requirements.

[0046] Preferably, the rotating part 12 includes an operating section 121 and a winding section 122 connected in sequence along its own axial direction, and the radial outer dimension of the operating section 121 is larger than the radial outer dimension of the winding section 122; the winding section 122 is used for the bending control line 21 to be wound. It should be noted that the radial outer dimension of the operating section 121 refers to the maximum outer dimension of the operating section 121 along the radial direction of the rotating part 12. In an alternative embodiment, the outer circumference of the operating section 121 is circular, and the radial outer dimension of the operating section 121 is its outer diameter. If the outer circumference of the operating section 121 is polygonal, the radial outer dimension of the operating section 121 is the diameter of its circumscribed circle. The radial outer dimensions of the other components described below are also the same. The operating section 121 is used for the operator to hold and rotate. The operator applies external force to the operating section 121 to form a rotational torque on the rotation axis of the rotating part 12, driving the entire rotating part 12 to rotate around its own rotation axis. Therefore, the operating section 121 should have a relatively large radial outer dimension to facilitate increasing the rotational torque. Figure 1 and Figure 2 In the illustrated example, the operating section 121 is a toothed disc with a plurality of pits, the arrangement of which is conducive to increasing friction and facilitating the operator to apply force. The outer periphery of the winding section 122 is preferably circular, facilitating the winding of the bending control wire 21.

[0047] Please refer to Figure 5 and Figure 6Optionally, the rotating part 12 includes a bending control wire fixing part, and the rotating part 12 is used to be fixedly connected with the proximal end of the bending control wire 21 through the bending control wire fixing part. In an alternative embodiment, the bending control wire fixing part includes a top screw 124 having a first external thread; the rotating part 12 has an axially opened blind hole and a bending control wire through hole 125 opened radially, and the blind hole is connected to the bending control wire through hole 125; the blind hole has a first internal thread adapted to the first external thread, and the blind hole is used for the proximal end of the bending control wire 21 to pass through the bending control wire through hole 125, and the top screw 124 is used to screw into the blind hole and press and fix the bending control wire 21. It can be understood that the above-mentioned top screw 124 is only an example of a bending control wire fixing part and not a limitation of the bending control wire fixing part. In other embodiments, those skilled in the art can also set a bending control wire fixing part with other structures, such as a fixing hook, a fixing ring, etc., which is not limited in this embodiment.

[0048] like Figure 1 and Figure 2 As shown, optionally, the control handle 1 further comprises a shell 13, the shell 13 is used to wrap and protect the base 11 and the coiled section 122, and the operating section 121 is exposed outside the shell 13. The shape of the shell 13 is set to facilitate holding.

[0049] Please refer to Figures 2 to 4 Optionally, the base 11 includes a hollow catheter fixing section 111, and the catheter fixing section 111 is arranged along the axial direction of the base 11, and is used to connect with the control bending tube 22; the catheter fixing section 111 has an avoidance groove 112 opened in the radial direction, and the avoidance groove 112 is used for the control bending line 21 to pass through. In an alternative exemplary embodiment, the catheter fixing section 111 and the control bending tube 22 are both round tubes, and the inner diameter of the catheter fixing section 111 is matched with the outer diameter of the control bending tube 22, and the proximal end of the control bending tube 22 can be inserted into the catheter fixing section 111, and then bonded with glue. Preferably, the catheter fixing section 111 also has a glue injection port 113 opened in the radial direction, and glue can enter the gap between the control bending tube 22 and the catheter fixing section 111 from the glue injection port 113 for bonding. Figure 2 As shown, after the proximal end of the bending control line 21 is inserted into the catheter fixing section 111 along with the bending control tube 22, it passes through the catheter fixing section 111 from the avoidance groove 112 and is then fixed on the coiling section 122. It can be understood that since the rotation axis of the rotating part 12 and the axis of the catheter fixing section 111 are not in the same plane, the section of the bending control line 21 passing through the avoidance groove 112 is at an angle to the axis of the catheter fixing section 111. For ease of assembly, the avoidance groove 112 can have a certain length along the axial direction of the catheter fixing section 111 to meet the avoidance of the bending control line 21.

[0050] Preferably, the avoidance groove 112 extends to the distal end along the axial direction of the catheter fixing section 111, so that the cross section of the distal end of the catheter fixing section 111 forms a C-shape and is not closed. Further, the distal end of the catheter fixing section 111 has a third external thread 114, and the housing 13 includes a limiting shell 131, the limiting shell 131 has a third internal thread adapted to the third external thread 114, and the limiting shell 131 is connected to the catheter fixing section 111 by threads. In the process of threaded connection between the limiting shell 131 and the catheter fixing section 111, since the cross section of the distal end of the catheter fixing section 111 forms a C-shape and is not closed, it will be deformed inwardly under the extrusion of the limiting shell 131, so that the inner wall of the catheter fixing section 111 and the outer wall of the control bending pipe 22 are tightly abutted together, further improving the connection reliability of the control bending pipe 22 and the catheter fixing section 111.

[0051] Please continue to refer to Figure 3 In an alternative embodiment, the base 11 includes a base body 110, and the base body 110 is connected to the catheter fixing section 111. Optionally, the base body 110 has a through hole that penetrates along its own axial direction, and the inner diameter of the through hole is adapted to the outer diameter of the catheter fixing section 111, and the catheter fixing section 111 is used to be inserted into the through hole. Preferably, the catheter fixing section 111 has a radial protrusion 115, and correspondingly, the through hole of the base body 110 has a recessed area that matches the protrusion 115; more preferably, the protrusion 115 and the recessed area both extend in the axial direction. After the catheter fixing section 111 is inserted into the through hole of the base body 110, the protrusion 115 is engaged with the recessed area, thereby limiting the circumferential rotation of the catheter fixing section 111 relative to the base body 110. Furthermore, the conduit fixing section 111 also has a limiting groove 116 arranged along the circumferential direction. After the conduit fixing section 111 is inserted into the through hole of the base body 110, the axial movement of the conduit fixing section 111 relative to the base body 110 can be limited by engaging the retaining ring 117 into the limiting groove 116. Therefore, after the conduit fixing section 111 and the base body 110 are assembled, the two are relatively fixed. Furthermore, the conduit fixing section 111 also has an exhaust port 118, which is communicated with the gap between the inner conduit 233 and the outer conduit 222, and is used to exhaust the air between the inner conduit 233 and the outer conduit 222.

[0052] Please refer to Figure 5 and Figure 6 , and combined with Figure 2Optionally, the rotating part 12 includes a threaded section 123, and the threaded section 123 has a second external thread; the base 11 has a second internal thread matched with the second external thread, and the rotating part 12 is threadedly connected to the base 11 through the threaded section 123, and the rotation of the rotating part 12 relative to the base 11 is converted into the movement of the rotating part 12 relative to the base 11 along the axial direction through the second external thread and the second internal thread. In an exemplary embodiment, in addition to being connected with the catheter fixing section 111, the base body 110 also serves as a rotating shaft seat of the rotating part 12. It can be understood that after the rotating part 12 is threadedly connected to the base body 110, when the rotating part 12 rotates relative to the base body 110, it will also move relative to the base body 110 along its own axial direction. When the rotating part 12 rotates, the winding section 122 is used for winding the control bending wire 21. Therefore, the pitch of the second external thread and the second internal thread can be adapted to the outer diameter of the control bending wire 21 (referring to the first traction wire section, see the following description for details), so that the control bending wire 21 can be better wound on the winding section 122 without causing problems such as overlapping.

[0053] Preferably, the rotating portion 12 also includes two limit members 129 arranged at intervals along the axial direction. The limit members 129 can be a structure such as a retaining spring that protrudes from the main part of the rotating portion 12. When the rotating portion 12 rotates and moves to a certain position along its own axial direction relative to the base body 110, the limit members 129 limit the rotating portion 12 from continuing to move along its own axial direction by abutting against the base body 110, thereby limiting the axial progress of the rotating portion 12 and further controlling the moving stroke of the bending control line 21.

[0054] Optionally, the rotating part 12 includes a self-locking section 127, and the control handle 1 further includes a locking part, which is used to apply an impedance torque to the self-locking section 127 to limit the rotation of the rotating part 12 when the rotation torque is less than the impedance torque. Figure 7In one exemplary embodiment, the self-locking section 127 includes a plurality of grooves 128 arranged circumferentially around the rotation axis of the rotating portion 12, and the locking portion includes a spring plunger 14, the spring plunger 14 includes a fixing member 141, an elastic member (not shown) and a limiting ball 142, the limiting ball 142 is connected to the fixing member 141 through the elastic member, and the fixing member 141 is fixedly connected to the base 11 (such as the base body 110); the limiting ball 142 abuts against the groove 128 under the elastic force of the elastic member to apply the impedance torque to the self-locking section 127. Optionally, in the spring plunger 14, the fixing member 141 is substantially cylindrical, with one end closed and the other end open, and the elastic member may be a spring, which is arranged inside the fixing member 141, with one end connected to the fixing member 141 and the other end connected to the limiting ball 142. The limiting ball 142 abuts against the groove 128 under the elastic force of the elastic member, thus forming an impedance torque relative to the rotation axis of the rotating part 12. When the rotating part 12 rotates, it is necessary to overcome the impedance torque and squeeze the limiting ball 142 toward the spring plunger 14 to achieve rotation. Once the rotation torque applied to the rotating part 12 is less than the impedance torque, the rotation of the rotating part 12 is limited by the spring plunger 14 to achieve self-locking. The arrangement of the self-locking section 127 and the locking part is conducive to improving the rotation accuracy of the rotating part 12 and the bending control accuracy. Preferably, the locking part includes more than two (such as three) spring plungers 14, and the more than two spring plungers 14 are arranged at an angle to each other. It should be understood that the cooperation between the groove 128 and the spring plunger 14 is only an example of the self-locking section 127 and the locking part rather than a limitation of the structure of the self-locking section 127 and the locking part. Those skilled in the art can reasonably improve and configure the self-locking section 127 and the locking part based on the prior art, for example, they can be set to a magnetic resistance type, and the present invention is not limited to this.

[0055] like Figure 5 As shown, in a preferred example, the coiled section 122 includes only one shaft section with a constant outer diameter, and the coiled section 122 is cylindrical. If the diameter of the coiled section 122 is D, when the rotating part 12 rotates one circle, the bending control line 21 moves along its own axial direction by a stroke L=π*D. Therefore, the bending control rate can be adjusted by adjusting the diameter D of the coiled section 122. Those skilled in the art can select a suitable diameter D for the coiled section 122 according to actual needs.

[0056] like Figure 6As shown, in another preferred example, the winding section 122 includes at least two shaft sections with different outer diameters along the axial direction. With such a configuration, when the rotating part 12 rotates one circle, the bending control line 21 moves differently along its own axial direction when it is wound on shaft sections with different outer diameters, which is more suitable for achieving different bending control rates during the same conveying process, and then achieving different movement rates of the bending control line 21 under the premise that the rotation rate of the rotating part 12 is the same, so that the bending control rates under different requirements can be achieved, which is more in line with the use requirements and achieves the purpose of fast bending control and precise positioning. In actual use, the rotation speed of the rotating part 12 can remain basically unchanged, and different bending control rates can be adjusted according to the configuration of shaft sections with different outer diameters.

[0057] Figure 6 In the illustrated example, the coiled section 122 includes two shaft sections with different outer diameters along the axial direction, and the two shaft sections are connected by a transition section 126. It should be noted that the transition section 126 is not necessarily provided, and the two shaft sections with different outer diameters can also be directly adjacent to each other.

[0058] In some application scenarios, a variable bending control rate is required during the entire delivery process of the implant. For example, during the delivery process of a heart valve prosthesis, the heart valve prosthesis needs to be slowly controlled before reaching the aortic arch, quickly controlled when passing the aortic arch, and slowly controlled after passing the aortic arch. Correspondingly, the coiled section 122 includes three axial sections along the axial direction, and the outer diameters of the three axial sections are 2.5 mm, 4.0 mm, and 2.5 mm, respectively. Adjacent axial sections are preferably connected by a transition section 126, and the axial lengths of the three axial sections can be configured according to actual needs. In use, the heart valve prosthesis is loaded with a crimping device before the operation, and the heart valve prosthesis is pressed and gripped to the middle of the balloon 221 with the crimping device to ensure that the two ends of the heart valve prosthesis are between the two balloon supports 232, and then the distal end of the catheter assembly 2 is pushed forward through the femoral artery to deliver the heart valve prosthesis to the distal end. When the heart valve prosthesis is about to reach the aortic arch, the operating section 121 is rotated to push and bend the prosthesis at the same time, and the prosthesis reaches the predetermined position after three bending control stages, namely, slow bending control, fast bending control and slow bending control. Then, a rated amount of diluted contrast fluid can be filled from the filling fluid infusion port 2231 through the balloon pressure pump to expand the heart valve prosthesis to a predetermined size.

[0059] The inventors have found that although the method of winding the bending control wire 21 on the rotating part 12 can reduce the overall size of the control handle 1, the existing delivery devices generally use metal wires such as stainless steel wires as the bending control wires, and the winding arrangement is prone to fatigue and breakage. Therefore, this embodiment also provides a bending control wire 21, which includes: a first traction wire segment 211 and a second traction wire segment 212; the distal end ( Figure 8 The left side of the drawing wire 210 is connected to the proximal end of the second traction wire segment 212 ( Figure 8The first traction wire segment 211 is fixedly connected to the rotating part 12, and the first traction wire segment 211 is softer than the second traction wire segment 212. The proximal end of the first traction wire segment 211 is fixedly connected to the rotating part 12, and the first traction wire segment 211 is used to be coiled on the rotating part 12. In this configuration, the relatively softer first traction wire segment 211 is used for coiling, and the relatively harder second traction wire segment 212 is connected to the control bending tube 22 for control bending. The soft and hard combination of the control bending wire 21 effectively avoids the problem of fatigue fracture that is easily caused when using stainless steel wire for coiling.

[0060] Optionally, the first traction wire segment 211 is a polymer wire segment, and its material is preferably polyethylene; the second traction wire segment 212 is a metal wire segment, and its material is preferably austenitic stainless steel or nickel-titanium alloy.

[0061] Optionally, the distal end of the first traction wire segment 211 and the proximal end of the second traction wire segment 212 are fixed together by gluing, welding or crimping.

[0062] In summary, in the control handle, the control bending wire and the implant delivery device provided by the present invention, the control handle includes: a base and a rotating part; the base is used to connect with the control bending tube of the catheter assembly, and the axial direction of the base is the same as the axial direction of the control bending tube; the rotating part is rotatably connected to the base along the radial direction of the base, and the rotation axis of the rotating part is not in the same plane as the axis of the base; the rotating part is used to be fixedly connected to the proximal end of the control bending wire, and is used to drive the control bending wire to be coiled thereon by rotation. In such a configuration, the rotation axis of the rotating part is configured to be not in the same plane as the axis of the base, so that when the rotating part rotates, the control bending wire is coiled thereon, thereby realizing control bending, thereby reducing the length of the control handle and making the structure more compact; further, by adjusting the size of the rotating part around which the control bending wire is coiled, the transmission ratio can be adjusted, thereby realizing the adjustment of the control bending rate, which meets the use requirements.

[0063] It should be noted that the above embodiments can be combined with each other. The above description is only a description of the preferred embodiments of the present invention, and does not limit the scope of the present invention. Any changes and modifications made by ordinary technicians in the field of the present invention based on the above disclosure are within the scope of protection of the claims.

Claims

1. A control handle for an implant delivery device, characterized in that: include: Base and rotating part; The base is used to connect with the bending control tube of the catheter assembly, and the axial direction of the base is the same as the axial direction of the bending control tube; The rotating part is rotatably connected to the base, and the rotation axis of the rotating part is not in the same plane as the axis of the base; and is used to drive the bending control wire to be coiled thereon by rotation; The rotating part includes an operating section and a winding section connected in sequence along its own axial direction, and also includes a bending control line fixing member; the radial outer dimension of the operating section is larger than the radial outer dimension of the winding section; the winding section is used for the bending control line to be wound; the rotating part is used to be fixedly connected to the proximal end of the bending control line through the bending control line fixing member; The bending control wire fixing member includes a top screw with a first external thread; the rotating portion has an axially opened blind hole and a bending control wire passing hole opened radially, and the blind hole is connected to the bending control wire passing hole; the blind hole has a first internal thread adapted to the first external thread, and the blind hole is used for allowing the proximal end of the bending control wire to pass through the bending control wire passing hole, and the top screw is used to screw into the blind hole and press and fix the bending control wire.

2. The control handle according to claim 1, characterized in that: The coiled section includes at least two shaft sections with different outer diameters along the axial direction.

3. The control handle according to claim 1, characterized in that: The rotating part includes a self-locking section, and the control handle also includes a locking part, which is used to apply an impedance torque to the self-locking section to limit the rotation of the rotating part when the rotating torque is smaller than the impedance torque.

4. The control handle according to claim 3, characterized in that: The self-locking section includes a plurality of grooves circumferentially arranged around the rotation axis of the rotating portion, the locking portion includes a spring plunger, the spring plunger includes a fixing member, an elastic member and a limiting ball, the limiting ball is connected to the fixing member through the elastic member, and the fixing member is fixedly connected to the base; the limiting ball abuts against the groove under the elastic force of the elastic member to apply the impedance torque to the self-locking section.

5. The control handle according to claim 1, characterized in that: The rotating part includes a threaded segment, which has a second external thread; the base has a second internal thread that matches the second external thread, and the rotating part is threadedly connected to the base through the threaded segment. The rotation of the rotating part relative to the base is converted into axial movement of the rotating part relative to the base through the second external thread and the second internal thread.

6. The control handle according to claim 1, characterized in that: The base includes a hollow catheter fixing section, which is arranged along the axial direction of the base and is used for the proximal end of the bending control tube to be inserted; the catheter fixing section has an avoidance groove opened in the radial direction, and the avoidance groove is used for the bending control line to pass through.

7. The control handle according to claim 6, characterized in that: The control handle also includes a limiting shell, and the avoidance groove extends to the distal end along the axial direction of the catheter fixing section; the distal end of the catheter fixing section has a third external thread, and the limiting shell has a third internal thread adapted to the third external thread, and the limiting shell is connected to the catheter fixing section by threads.

8. A bending control wire, used in a control handle according to any one of claims 1 to 7, characterized in that: include: A first traction wire segment and a second traction wire segment; the distal end of the first traction wire segment is fixedly connected to the proximal end of the second traction wire segment, the first traction wire segment is softer than the second traction wire segment, the proximal end of the first traction wire segment is fixedly connected to the rotating part, and the first traction wire segment is used to be coiled on the rotating part.

9. The bending control wire according to claim 8, characterized in that: The first traction wire segment is a polymer wire segment, and the second traction wire segment is a metal wire segment.

10. An implant delivery device, characterized in that: It comprises a control handle and a catheter assembly according to any one of claims 1 to 7; the catheter assembly comprises a bending control wire and a bending control tube according to any one of claims 8 to 9, the distal end of the bending control wire penetrates into the bending control tube and is fixedly connected to the distal end of the bending control tube.

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