Delivery devices for medical implants

Abstract

The present invention provides a medical implant delivery device. The device is a split-type device comprising a separate handle and a catheter assembly, connected by a drive shaft. This separate handle and catheter assembly reduces the weight of a conventional catheter assembly, allowing the operator to position and adjust the medical implant simply by moving the catheter assembly. The catheter assembly is lightweight and compact, improving operational precision and accuracy. Furthermore, it prevents vibration and / or movement of the handle from affecting the catheter assembly, further enhancing stability and improving surgical quality.

Description

Technical Field

[0001] The present invention belongs to the field of medical surgical equipment, and in particular relates to a conveying device for medical implants. Background Art

[0002] The transapical approach is a commonly used pathway for cardiac surgery. Since the surface incision is very close to the target valve, about 10 cm or less, and the surface wound, cardiac puncture point and valve annulus center are well coaxial, the delivery device usually adopts an overall rigid straight tube design, making the operator's adjustment of angle and depth more sensitive and intuitive.

[0003] Valve replacement surgeries such as TAVI (transcatheter aortic valve implantation) and TMVR (transcatheter mitral valve replacement) all utilize a transapical approach, and these procedures place high demands on the accuracy of the prosthesis release. Real-time position maintenance and fine-tuning are required before, during, after, and after the prosthesis is released. Because existing delivery devices are large and heavy, they are cumbersome and unstable when held in the hand. Therefore, a commonly used method for instrument positioning and stabilization during surgery is to add a delivery system bracket system, with one end fixed to the operating table and the other end clamping the delivery device handle, thereby meeting the delivery device positioning and stabilization requirements during surgery.

[0004] However, the bracket system needs to provide stable support and meet the requirements of multiple degrees of freedom. Therefore, the bracket is usually heavy and bulky, which will prolong the operation time to a certain extent. The specific reasons are as follows:

[0005] 1. There are many steps involved in the operation, including assembling the bracket, adjusting the bracket, fixing the bracket, etc.

[0006] 2. During the operation, the complexity of the bracket operation may also affect the operation time;

[0007] 3. The bracket is generally large, affecting the convenience of other operations;

[0008] In view of the above shortcomings, a delivery device is needed that can adjust the release position in real time according to needs, so as to accurately release the prosthesis to the target position, shorten the time of adjusting the position of the delivery device as much as possible, and thus shorten the operation time, so as to achieve high-quality valve replacement. Summary of the Invention

[0009] The object of the present invention is to provide a medical implant delivery device that facilitates the positioning and position adjustment of the medical implant, improves the precision and accuracy of medical implant surgery, and improves the stability of the delivery device.

[0010] The present invention provides a medical implant delivery device, which is of a split type and comprises a handle and a catheter assembly separated from each other, wherein the handle and the catheter assembly are connected via a transmission shaft.

[0011] Furthermore, the transmission shaft is detachably connected to the catheter assembly.

[0012] Furthermore, the catheter assembly includes an inner tube assembly and an outer tube assembly sleeved outside the inner tube assembly, and the handle drives the transmission shaft to rotate so that the outer tube assembly generates axial movement relative to the inner tube assembly.

[0013] Furthermore, the catheter assembly also includes a transmission assembly, which includes a screw and a screw nut, the screw and the screw nut are meshed, and the screw nut is fixedly connected to the outer tube assembly. When the transmission shaft and the catheter assembly are in a connected state, the transmission shaft is fixedly connected to the screw, and the rotation of the transmission shaft drives the screw to rotate, thereby driving the screw nut and the outer tube assembly to move axially.

[0014] Furthermore, the catheter assembly further includes a housing, and the transmission assembly further includes a first bearing, wherein the outer ring of the first bearing is embedded and fixed at the proximal end of the housing, and the inner ring of the first bearing is sleeved and fixed at the proximal end of the screw rod.

[0015] Furthermore, the inner tube assembly includes, from the distal end to the proximal end, a tapered head, a distal inner tube, a fixed head, and a proximal inner tube that are connected in sequence.

[0016] Furthermore, the outer tube assembly includes: a sheath tube and a first outer tube connected to the proximal end of the sheath tube, and the proximal end of the first outer tube is fixedly connected to the screw nut.

[0017] Furthermore, the inner wall of the first outer tube is provided with a circumferential limiting structure, and the outer wall of the proximal inner tube matches the circumferential limiting structure to limit the circumferential rotation of the proximal inner tube.

[0018] Furthermore, the catheter assembly further includes a first stabilizing tube, the proximal end of the first stabilizing tube is fixedly connected to the distal end of the shell, and the first outer tube is sleeved in the first stabilizing tube.

[0019] Furthermore, the inner tube assembly further comprises an intermediate inner tube and a Luer connector, wherein the Luer connector has a protruding end, and the fixing head, the intermediate inner tube, the Luer connector, and the proximal inner tube are sequentially connected from the distal end to the proximal end.

[0020] Furthermore, the transmission assembly also includes a second bearing, the screw rod is axially provided with a through hole, the proximal inner tube passes through the through hole, the proximal inner tube and the through hole are gap-fitted, and the two ends of the proximal inner tube are respectively sleeved and fixed with the second bearing, the outer ring of the second bearing is fixed to the inner wall of the end of the screw rod, and the inner ring of the first bearing is sleeved and fixed on the proximal outer wall of the screw rod.

[0021] Furthermore, the inner tube assembly comprises, from the distal end to the proximal end, a tapered head, a distal inner tube, a fixed head, an intermediate inner tube, and a Luer connector connected in sequence, wherein the Luer connector has a protruding end.

[0022] Furthermore, the outer tube assembly includes: a sheath tube and a second outer tube connected to the proximal end of the sheath tube, the proximal end of the second outer tube is fixedly connected to the screw nut; the second outer tube is axially provided with a first strip opening, and the protruding end of the Luer connector protrudes from the first strip opening.

[0023] Furthermore, the catheter assembly also includes a second stabilizing tube, the proximal end of the second stabilizing tube is fixedly connected to the distal end of the shell, the second outer tube is sleeved in the second stabilizing tube, the second stabilizing tube has a second strip opening along the axial direction, the second strip opening is arranged corresponding to the first strip opening, and the protruding end extends from the second strip opening.

[0024] Furthermore, the catheter assembly further includes a circumferential limit block, which is fixedly connected to the screw nut and cooperates with the housing to form a circumferential limit and axially movable structure.

[0025] Furthermore, the transmission shaft includes a transmission flexible shaft.

[0026] Furthermore, the transmission flexible shaft has a 2-4 layer spiral structure, the spiral outer diameter of the spiral structure is greater than or equal to 0.1 mm, and the material of the transmission flexible shaft is metal material.

[0027] Furthermore, the transmission shaft also includes a connecting portion and a transmission flexible shaft outer tube, the transmission flexible shaft is sleeved in the transmission flexible shaft outer tube, and the transmission flexible shaft is connected to the transmission assembly through the connecting portion.

[0028] Furthermore, the transmission shaft is fixedly connected to the catheter assembly.

[0029] Compared with the prior art, the technical solution of the present invention has the following beneficial effects:

[0030] The medical implant delivery device is a split-body device, comprising a separate handle and catheter assembly. Compared to conventional integrated designs, the operator can position and adjust the medical implant by moving the lightweight and compact catheter assembly. Compared to the integral movement of conventional delivery systems, the lightweight and compact catheter assembly makes operation more convenient and flexible, facilitating intraoperative positioning and fine-tuning. It also provides high stability during operation, improving precision and accuracy, and enabling high-quality implant placement. Furthermore, it prevents vibration and / or movement of the handle from affecting the catheter assembly, further enhancing stability and improving surgical quality.

[0031] Furthermore, the transmission shaft and the catheter assembly are detachably connected, which improves the convenience in the process of loading, transporting and releasing the medical implant, and the detachable connection also improves the simplicity of packaging and transportation.

[0032] Furthermore, the transmission shaft is a flexible transmission shaft, which can be wound, saving packaging space and reducing the space occupied during surgery.

[0033] Furthermore, the screw rod is provided with a through hole along the axial direction, and the proximal inner tube passes through the through hole, which cleverly utilizes the inner cavity space of the screw rod, reduces the volume of the catheter assembly, and makes the catheter assembly more compact and more convenient to hold, move and position. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 Schematic diagram of the structure of the medical implant delivery device of this embodiment;

[0035] Figure 2 is a cross-sectional schematic diagram of the first catheter assembly of this embodiment;

[0036] Figure 3 is a partially enlarged schematic diagram of the proximal end of the catheter assembly of this embodiment;

[0037] Figure 4 Schematic diagram of the structure of the first inner tube assembly (excluding the Luer connector) of this embodiment;

[0038] Figure 5 is a schematic structural diagram of a first catheter assembly of this embodiment;

[0039] Figure 6 for Figure 5 Schematic cross-sectional view of ;

[0040] Figure 7 for Figure 6 A schematic cross-sectional view of the circumferential limiting structure;

[0041] Figure 8Schematic diagram of the structure of the second inner tube assembly (including the proximal inner tube and the Luer connector) of this embodiment;

[0042] Figure 9 for Figure 8 Schematic cross-sectional view of ;

[0043] Figure 10 This is a front view of the outer tube assembly of this embodiment;

[0044] Figure 11 for Figure 10 Schematic cross-sectional view of ;

[0045] Figure 12 Schematic diagram of the structure of the third inner tube assembly (excluding the proximal inner tube) of this embodiment;

[0046] Figure 13 is a cross-sectional schematic diagram of a third catheter assembly of this embodiment;

[0047] Figure 14 is a schematic diagram of the appearance of a second catheter assembly of this embodiment;

[0048] Figure 15 for Figure 14 Schematic cross-sectional view of ;

[0049] Figure 16 This is a front view of the transmission assembly of this embodiment;

[0050] Figure 17 is a cross-sectional schematic diagram of the transmission assembly of this embodiment;

[0051] Figure 18 Schematic diagram of the assembly of the housing and the stabilizing tube of this embodiment;

[0052] Figure 19 This is a schematic diagram of the assembly of the catheter assembly and the drive shaft of this embodiment;

[0053] Figure 20 for Figure 19 A half-cutaway perspective diagram of the connection between the middle guide tube assembly and the transmission shaft;

[0054] Figure 21 for Figure 19 A half-section schematic diagram of the connection between the center tube assembly and the drive shaft;

[0055] Figure 22 Schematic diagram of the handle of this embodiment;

[0056] Figure 23 This is a half-cutaway perspective diagram of the assembly of the handle and the transmission shaft of this embodiment. The reference numerals are as follows:

[0057] 1-catheter assembly; 2-drive shaft; 3-handle; 11-outer tube assembly; 12-inner tube assembly; 13-housing; 14-drive assembly; 111-sheath; 112-second outer tube; 113-screw nut; 114-circumferential limit block; 115-first outer tube; 121-conical head; 122-distal inner tube; 123-fixing head; 124-intermediate inner tube; 125-Luer connector; 126-proximal inner tube; 13-housing; 133-housing bushing; 141-inner tube fixing nut; 142-second bearing; 143-screw fixing seat; 144-screw; 145-flexible shaft fixing seat; 146-first bearing; 15-second stabilizing tube; 21-drive flexible shaft; 22-connecting part; 23-drive flexible shaft outer tube; 241-first fixing component; 242-second fixing component. DETAILED DESCRIPTION

[0058] Embodiments of the present invention provide a delivery device for a medical implant. The present invention is further described below in conjunction with the accompanying drawings and specific embodiments. The advantages and features of the present invention will become more apparent from the following description. It should be noted that the drawings are highly simplified and not to exact scale, and are intended solely to facilitate and clearly illustrate the embodiments of the present invention.

[0059] Figure 1 FIG. 1 is a schematic structural diagram of the medical implant delivery device of this embodiment; FIG. Figure 1 As shown, an embodiment of the present invention provides a delivery device for a medical implant. The delivery device is of a split type and includes: a separate handle 3 and a catheter assembly 1, the handle 3 and the catheter assembly 1 being connected by a drive shaft 2. The delivery device is of a split type, with the handle 3 and the catheter assembly 1 being separate. Specifically, the handle 3 and the catheter assembly 1 are not housed in the same enclosure; they are independent of each other, each having its own enclosure and internal components. The connection between the drive shaft 2 and the catheter assembly 1 can be detachable or fixed, depending on actual needs. Specifically, the catheter assembly 1 includes an inner tube assembly and an outer tube assembly that is sleeved over the inner tube assembly. The handle 3 drives the drive shaft 2 to rotate, causing the outer tube assembly to move axially relative to the inner tube assembly. The direction toward the catheter assembly 1 is defined as the distal end, and the direction toward the handle 3 is defined as the proximal end. The outer tube assembly and the inner tube assembly are coaxial. Herein, the axial direction is the direction parallel to the axis of the outer tube assembly (or inner tube assembly), and the circumferential direction is the circumferential direction in a plane perpendicular to the axial direction.

[0060] Catheter assembly 1 is used to load, transport, and release medical implants. Drive shaft 2 transmits motion signals from handle 3 to catheter assembly 1 during the loading, release, and retrieval phases. Handle 3 provides power during these phases, manipulating catheter assembly 1 via drive shaft 2.

[0061] In this embodiment, the medical implant delivery device is a split-type device, comprising a separate handle 3 and catheter assembly 1. The operator can position and adjust the medical implant by moving only the catheter assembly 1. Compared to conventional delivery systems that require integral movement, the catheter assembly's lightweight and compact size allows for more convenient and flexible movement, facilitating intraoperative positioning and fine-tuning. This improves stability, precision, and accuracy during the procedure, enabling high-quality implant placement. Furthermore, the device prevents vibration and / or movement of the handle from affecting the catheter assembly, further enhancing stability and improving surgical quality.

[0062] The drive shaft 2 is detachably connected to the catheter assembly 1, allowing the drive shaft 2 to be detached or connected to the catheter assembly 1 as needed. Specifically, when loading a medical implant in vitro, the two are connected; after loading the medical implant and before releasing the medical implant to the lesion site, the two are separated, and the catheter assembly 1 is used alone, which is more conducive to positioning and fine-tuning the position, improving accuracy and stability; when releasing or retrieving the medical implant, the two are connected, and the release or retrieval of the medical implant can be achieved by operating the handle 3. Moreover, the detachable connection between the drive shaft 2 and the catheter assembly 1 improves the ease of packaging and transportation. In addition, the drive shaft 2 and the handle 3 do not come into direct contact with human tissue and are reusable, saving resources.

[0063] Figure 2 FIG is a cross-sectional view of the first catheter assembly of this embodiment; FIG. Figure 1 and Figure 2 As shown, the catheter assembly 1 includes an outer tube assembly 11, an inner tube assembly 12, a housing 13, and a transmission assembly 14. The outer tube assembly 11 is sleeved over the inner tube assembly 12, and the transmission assembly 14 is disposed within the housing 13. In this embodiment, the inner tube assembly 12 and the housing 13 are relatively stationary, while the outer tube assembly 11 is driven by the handle 3 to move axially relative to the inner tube assembly 12.

[0064] Figure 3 FIG is a partially enlarged schematic diagram of the proximal end of the catheter assembly of this embodiment; Figures 1 to 3As shown, the transmission assembly 14 includes a screw rod 144, a screw rod nut 113 and a first bearing 146. The outer ring of the first bearing 146 is embedded and fixed at the proximal end of the housing 13, and the inner ring of the first bearing 146 is sleeved and fixed at the proximal end of the screw rod 144. The screw rod 144 and the screw rod nut 113 are engaged, and the screw rod nut 113 is fixedly connected to the outer tube assembly 11. When the transmission shaft and the catheter assembly are in a connected state, the transmission shaft 2 is fixedly connected to the screw rod 144. The rotation of the transmission shaft 2 drives the screw rod 144 to rotate, thereby driving the screw rod nut 113 and the outer tube assembly 11 to move axially.

[0065] Figure 4 Schematic diagram of the structure of the first inner tube assembly (excluding the Luer connector) of this embodiment; Figure 5 is a schematic structural diagram of a first catheter assembly of this embodiment; Figure 6 for Figure 5 Schematic cross-sectional view of ; Figure 7 for Figure 6 A schematic cross-sectional view of the circumferential limiting structure; Figures 4 to 7 As shown, the inner tube assembly 12 comprises, from distal to proximal, a tapered head 121, a distal inner tube 122, a fixed head 123, and a proximal inner tube 126, connected in sequence. The outer tube assembly comprises a sheath tube and a first outer tube 115 connected to the proximal end of the sheath tube. The proximal end of the first outer tube 115 is fixedly connected to the screw nut. The inner wall of the first outer tube 115 is provided with a circumferential limit structure 116. The outer wall of the proximal inner tube 126 mates with the circumferential limit structure 116 to restrict circumferential rotation of the proximal inner tube 126. The catheter assembly 1 also includes a first stabilizing tube 16. The proximal end of the first stabilizing tube 16 is fixedly connected to the distal end of the housing 13. The first outer tube 115 is sleeved within the first stabilizing tube 16. The inner tube assembly of this embodiment can be a solid tube and can be integrally formed or manufactured separately and then connected by welding or gluing. This makes processing and manufacturing more convenient. The outer tube can be configured with an exhaust system according to actual needs.

[0066] Figure 8 Schematic diagram of the structure of the second inner tube assembly (including the proximal inner tube and the Luer connector) of this embodiment; Figure 9 for Figure 8 Schematic cross-sectional view of ; Figure 10 This is a front view of the outer tube assembly of this embodiment; Figure 11 for Figure 10 Schematic cross-sectional view of ;

[0067] like Figure 8 and Figure 9As shown, the inner tube assembly further includes an intermediate inner tube 124 and a Luer connector 125. The Luer connector 125 has an extended end. From the distal end to the proximal end, the tapered head 121, the distal inner tube 122, the fixed head 123, the intermediate inner tube 124, the Luer connector 125, and the proximal inner tube 126 are fixedly connected in sequence. Figures 9 to 11 As shown, the outer tube assembly includes: a sheath tube 111, a second outer tube 112 fixedly connected to the proximal end of the sheath tube 111, the proximal end of the second outer tube 112 fixedly connected to the screw nut 113, and the second outer tube 112 is provided with a first strip opening along the axial direction, wherein the sheath tube 111 is used to cover the medical implant arranged on the distal inner tube 122.

[0068] Combine Figure 3 、 Figure 4 and Figure 9 As shown, in Figure 4 and Figure 9 The two illustrated inner tube assembly structures both include a proximal inner tube 126, which can be placed within a screw 144. The screw 144 allows for axial positioning of the proximal inner tube 126, thereby limiting the axial positioning of the inner tube assembly. This embodiment cleverly utilizes the lumen space of the screw 144, reducing the size of the catheter assembly 1 and making it more compact and easier to hold, move, and position.

[0069] like Figure 3 As shown, the transmission assembly 14 includes, in addition to a screw rod 144, a screw nut 113, and a first bearing 146, a second bearing 142. A through hole is axially provided inside the screw rod 144, and the proximal inner tube 126 passes through the through hole. The proximal inner tube 126 is clearance-matched with the through hole so that during the rotation of the screw rod 144, the inner wall of the screw rod 144 and the outer wall of the proximal inner tube 126 do not interfere with each other; the two ends of the proximal inner tube 126 are respectively sleeved and fixed with a second bearing 142, and an inner tube fixing nut 141 is provided on the side of the second bearing 142 away from the screw rod 144, and the inner tube fixing nut 141 is threadedly connected and fixed to the proximal inner tube 126 to limit the axial movement of the second bearing 142. The inner ring of the second bearing 142 is fixed to the proximal inner tube 126, while the outer ring of the second bearing 142 is fixed to the inner walls of the screw 144 at both ends. The inner ring of the first bearing 146 is sleeved and fixed to the proximal outer wall of the screw 144. The second bearing 142 is, for example, a deep groove ball bearing, and the first bearing 146 is, for example, an angular contact bearing. The screw nut 113 is fixedly connected to the outer tube assembly. Specifically, the screw nut 113 is fixedly connected to the proximal end of the outer tube A. The distal end of the housing 13 is fixedly connected to the proximal end of the stabilizing tube B.

[0070] In this embodiment, the outer ring of the first bearing 146 is fixed on the housing 13, the inner ring of the first bearing 146 is fixed on the proximal outer wall of the screw rod 144, the outer ring of the second bearing 142 is respectively fixed on the proximal inner wall and the distal inner wall of the screw rod 144, and the inner ring of the second bearing 142 is fixed on the proximal inner tube 126. In this way, the proximal inner tube 126 is restricted from axial movement, and the screw rod 144 is fixed in the axial direction. The screw rod 144 can rotate circumferentially and drive the screw nut 113 to move axially, so that the entire outer tube assembly 11 moves axially.

[0071] Figure 12 Schematic diagram of the structure of the third inner tube assembly (excluding the proximal inner tube) of this embodiment; Figure 13 FIG. 1 is a schematic diagram of the appearance of the third catheter assembly of this embodiment; FIG. Figure 4 and Figure 9 The structures of the two inner tube assemblies shown in FIG. 1 and FIG. 2 both include a proximal inner tube 126. It should be noted that the inner tube assembly of the embodiment of the present invention may also not include the proximal inner tube 126. Figure 12 and Figure 13 As shown, the inner tube assembly 12 comprises, from distal to proximal end, a tapered head 121, a distal inner tube 122, a fixed head 123, an intermediate inner tube 124, and a Luer connector 125, which are sequentially connected. The Luer connector 125 has an extended end. The extended end of the Luer connector 125 can be fixed to the housing 13 or the second stabilizing tube 15, thereby securing the inner tube assembly 12. Specifically, the extended end of the Luer connector 125 is fixed to the proximal end of the second strip-shaped opening on the second stabilizing tube 15 by welding or adhesive bonding. Alternatively, the extended end of the Luer connector 125 is fixed to the housing 13 by welding or snap-fitting, a method that can be selected by those skilled in the art based on practical needs.

[0072] Figure 9 and Figure 12 The inner tube assembly shown includes a Luer connector 125, and an outer tube assembly matching the Luer connector 125 can be configured. Figure 10 and Figure 11 The introduction of the outer tube assembly, for example, the second outer tube 112 in the outer tube assembly is provided with a first strip opening along the axial direction, and the protruding end of the Luer connector protrudes from the first strip opening, will not be repeated here.

[0073] Figure 14 is a schematic diagram of the appearance of a second catheter assembly of this embodiment; Figure 15 for Figure 14 Schematic cross-section of Figure 13 and Figure 15As shown, both the second and third catheter assemblies include a second stabilizing tube 15, the proximal end of which is fixedly connected to the distal end of the housing 13. The second outer tube 112 is sleeved within the second stabilizing tube 15. The second stabilizing tube 15 has a second strip-shaped opening axially disposed corresponding to the first strip-shaped opening, and the protruding end of the Luer connector 125 extends from the second strip-shaped opening. The second stabilizing tube 15 supports the second outer tube 112 and prevents the operator from directly contacting the outer tube assembly. The housing 13 and the second stabilizing tube 15 support the entire medical implant delivery device, not only facilitating the delivery device's advancement but also improving the stability of the release of the medical implant (e.g., a valve).

[0074] Figure 16 This is a front view of the transmission assembly of this embodiment; Figure 17 FIG is a cross-sectional view of the transmission assembly of this embodiment; FIG. Figure 1 、 Figure 3 、 Figures 15 to 17 As shown, the function of the transmission assembly is to transmit motion, that is, to receive the motion of the transmission shaft 2 and convert the circumferential motion of the transmission shaft 2 into the axial motion of the outer tube assembly 11. This embodiment cleverly utilizes the inner cavity space of the screw rod 144, reducing the volume of the catheter assembly 1, making the catheter assembly 1 more compact and more convenient to hold, move and position. Specifically, the middle of the screw rod 144 is threaded, and the two ends (proximal and distal ends) of the screw rod 144 are unthreaded for mounting bearings. The unthreaded portions at both ends of the screw rod 144 can be an integral structure with the threaded portion in the middle of the screw rod, or a split structure. In the case of a split structure, the unthreaded portions at both ends (proximal and distal ends) of the screw rod 144 are, for example, screw rod fixing seats 143, which are fixedly connected to the screw rod 144. The outer ring of the second bearing 142 is fixed to the inner wall of the screw rod fixing seat 143. The proximal screw rod fixing seat 143 is connected and fixed to the flexible shaft fixing seat 145, for example, by welding or bonding. The other end of the flexible shaft holder 145 is connected to the drive shaft 2, receiving the movement of the drive shaft 2 and converting it into self-rotational motion for the screw rod 144. The flexible shaft holder 145 and the screw rod holder 143 can be manufactured separately or as a single piece. The flexible shaft holder 145 and the screw rod holder 143 can also be manufactured with the threaded section of the screw rod 144 to form an integral structure. The inner ring of the first bearing 146 is fixedly mounted on the proximal outer wall of the screw rod 144 (i.e., the outer wall of the flexible shaft holder 145).

[0075] Specifically, the catheter assembly 1 also includes a circumferential limit block 114, which is fixedly connected to the nut 113. The circumferential limit block 114 cooperates with the housing 13 to form a circumferentially limited but axially movable structure. In the catheter assembly 1, from the distal end to the proximal end, the sheath 111, the second outer tube 112, the screw nut 113, and the circumferential limit block 114 are fixedly connected in sequence. The screw nut 113 engages with the screw 144, so that the entire outer tube assembly 11 can be driven axially by the screw 144. The circumferential limit block 114 limits the rotational freedom of the outer tube assembly 11 itself by matching the shape with the inner surface of the housing 13, so that the outer tube assembly 11 and the housing 13 remain circumferentially locked and axially movable. The circumferential limit block 114 and the screw nut 113 can be fixedly connected by welding or bonding, can be integrally formed, or can be separately connected.

[0076] Figure 18 This is a schematic diagram of the assembly of the housing and the stabilizing tube of this embodiment; Figures 2 to 7 As shown, the outer ring of the first bearing 146 is fixed to the housing 13, the inner ring of the first bearing 146 is fixed to the proximal outer wall of the screw 144, the outer ring of the second bearing 142 is fixed to the proximal and distal inner walls of the screw 144, and the inner ring of the second bearing 142 is fixed to the proximal inner tube 126. This restricts axial movement of the proximal inner tube 126. The distal end of the proximal inner tube 126 is fixedly connected to the proximal end of the Luer connector 125. The extended end of the Luer connector 125 extends through the first strip-shaped opening of the second outer tube 112 and the second strip-shaped opening of the second stabilizing tube 15, locking the proximal inner tube 126 and the intermediate inner tube 124 from circumferential rotation. This restricts both axial and circumferential movement of the proximal inner tube 126, thereby limiting the six degrees of freedom of the inner tube assembly 12, thereby securing a medical implant (e.g., a valve stent).

[0077] Furthermore, the housing 13 includes a housing bushing 133, which is fixed within the housing 13 and sleeved by the second outer tube 112. The housing bushing 133 is preferably made of a low-friction material. This helps stabilize the second outer tube 112 during axial movement while reducing frictional resistance. This ensures close contact between the second outer tube 112 and the housing bushing 133, further limiting radial movement of the second outer tube 112, while also preventing wear of the second outer tube 112.

[0078] Figure 19 This is a schematic diagram of the assembly of the catheter assembly and the drive shaft of this embodiment; Figure 20 for Figure 19 A half-cutaway perspective diagram of the connection between the middle guide tube assembly and the transmission shaft; Figure 21 for Figure 19A half-section schematic diagram of the connection between the middle guide tube assembly and the transmission shaft; Figure 1 、 Figures 19 to 21 As shown, the transmission shaft 2 plays the role of transmitting the driving force of the handle 3, and transmits the motion signal emitted by the handle 3 to the catheter assembly 1. The transmission shaft 2 includes a transmission soft shaft, which can be wound, saving packaging space and reducing the space occupied during surgery. The transmission shaft 2 also includes a connecting portion 22 and a transmission soft shaft outer tube 23. The transmission soft shaft 21 is a shaft with very low rigidity, elasticity, and free bending transmission. It is used to connect two shafts with different axes and not in the same direction or with relative motion to transmit rotational motion and torque, and can flexibly transmit rotational motion and torque. In this embodiment, the length of the transmission soft shaft 21 can be set according to actual needs, and circumferential motion can be transmitted regardless of the length; more preferably, it can rotate in both forward and reverse directions; it can be a solid material or a hollow tubular cavity. Exemplarily, the transmission flexible shaft 21 has the following characteristics: 2 to 4 layers of spiral structure, more preferably a double-layer spiral structure, the spiral directions are opposite, there is no pitch, and the single spiral material is filamentous or rope-shaped; the material is metal material, such as stainless steel, nickel-titanium alloy, etc.; the spiral outer diameter size range: greater than or equal to 0.1mm; more preferably, greater than or equal to 4mm, to match the size of the transmission component 14, so as to minimize the energy loss during the transmission process.

[0079] The connecting portion 22 is used to connect the transmission flexible shaft 21 to the flexible shaft fixing seat 145 of the transmission assembly 14, and is more preferably a detachable connection. The transmission flexible shaft 21 is disposed in the transmission flexible shaft outer tube 23, which is used to protect the transmission flexible shaft 21 and facilitate the operator's grip.

[0080] Please continue to refer to Figure 1 、 Figures 19 to 21 The transmission shaft 2 is detachably connected to the catheter assembly 1. For example, the connecting portion 22 and the flexible shaft fixing seat 145 can be connected by a snap-fitting manner. In this case, one end of the connecting portion 22 is connected to the transmission flexible shaft 21, and the other end of the connecting portion 22 is connected to the flexible shaft fixing seat 145. The connection between the connecting portion 22 and the transmission flexible shaft 21 can be any one of snap-fitting, bonding, or welding, or a combination of two or more. In order to facilitate processing and assembly, for example, a snap-fitting form is adopted. In this case, the distal end of the transmission flexible shaft 21 has a section with a non-circular surface structure, and the connecting portion 22 has an inner surface with a corresponding shape. The two form a snap-fitting and are fixed. The connection between the connecting portion 22 and the flexible shaft fixing seat 145 is preferably a detachable connection, and more preferably a snap-fitting connection. In this case, the distal end of the connecting portion 22 has an inner surface that matches the outer surface shape of the flexible shaft fixing seat 145. The two form a snap-fitting. When connection is required, the flexible shaft fixing seat 145 is snapped into the distal end of the connecting portion 22.

[0081] To further limit the axial displacement of the drive shaft 2 relative to the catheter assembly 1 and enhance the robustness of the device, the drive shaft 2 also includes a fixing portion comprising a first fixing member 241 connected to the drive shaft outer tube 23 and a second fixing member 242 connected to the housing 132. The second fixing member 242 is connected to the housing 132 via threads, a slot, or other means. The second fixing member 242, the first fixing member 241, and the drive shaft outer tube 23 are sequentially connected and sleeved onto the surface of the drive shaft 21.

[0082] Figure 22 Schematic diagram of the handle of this embodiment; Figure 23 This is a half-cut perspective diagram of the assembly of the handle and the transmission shaft of this embodiment. Figure 1 、 Figures 20 to 23 As shown, the handle 3 of the embodiment of the present invention can be any one of a manual handle, an electric handle, and an electric and manual hybrid drive handle. Taking the electric handle as an example, Figure 12 As shown, a drive mechanism is provided within handle 3, which is connected to drive shaft 2 to drive the circumferential motion of drive shaft 2. Drive shaft 2 transmits rotational torque to transmission assembly 14 in catheter assembly 1, ultimately driving the entire outer tube assembly 11 to move axially to achieve loading and release of medical implants. In an embodiment of the present invention, handle 3 generates a circumferential driving force manually or electrically. Drive shaft 2 transmits the circumferential rotation angle within a certain length of flexible transmission shaft in a 1:1 ratio, and transmits the rotational torque in a 1:1 ratio to catheter assembly 1. Catheter assembly 1 is able to convert circumferential rotation into axial motion, thereby achieving the separation of driving force from moving parts. Handle 3 and drive shaft 2 can be fixedly connected or detachably connected.

[0083] This embodiment discloses a delivery device for medical implants, which can solve the problem of inflexible delivery and positioning methods for medical implants (such as interventional valves), achieve effective positioning of medical implants (such as interventional valves) in the body, improve the accuracy of the operation, and at the same time shorten the operation time and improve the quality of the operation. The handle drives the bearing to rotate the flexible shaft movable part by electric drive or manual drive, and then drives the screw to drive the outer tube and sheath tube to move axially relative to the inner tube assembly, thereby achieving operations such as loading and releasing of medical implants (such as valve stents). The specific process is as follows. The transmission shaft 2 and the handle 3 are in a connected state in the following stages.

[0084] Valve loading process: Connect the drive shaft 2 to the catheter assembly 1, specifically by connecting the connecting portion 22 to the flexible shaft fixing seat 145. Actuating the handle 3 causes the drive shaft 2 to drive the screw 144, thereby moving the second outer tube 112 and sheath 111 proximally until the groove that exposes the fixing head 123 is exposed. Next, the two lugs of a medical implant (e.g., a self-expanding stent-valve) are positioned within the grooves. The stent is stabilized with the aid of an auxiliary loading tool. The second outer tube 112 is driven distally, and the valve stent is gripped until the sheath 111 completely encloses the valve stent. Valve stent loading is complete. The drive shaft 2 is then removed from the catheter assembly 1, leaving the catheter assembly 1 in a detached state.

[0085] Valve delivery process: The distal end of the separated catheter assembly 1 is extended along the guidewire into the puncture port and into the human body. The distal end of the catheter assembly 1 is delivered to the lesion site along the transapical pathway and adjusted to the appropriate angle.

[0086] Valve release process: Connect the drive shaft 2 to the catheter assembly 1, and after reconfirming the angle of the sheath 111, drive the handle 3 to make the drive shaft 2 drive the screw 144, thereby moving the second outer tube 112 and the sheath 111 toward the proximal end, and begin to release the valve stent until the valve stent is completely released to the designated position and detached from the delivery system. Specifically, as the sheath 111 moves toward the proximal end, the valve stent is slowly released until the distal end of the sheath 111 moves to the fixing head 123, exposing the groove of the fixing head 123, and the valve stent is completely released.

[0087] During the withdrawal of the delivery system: the drive shaft 2 and the catheter assembly 1 are still connected, closing the gap between the sheath 111 and the tapered head 121. The handle 3 is then controlled to withdraw the catheter assembly 1, leaving the purse string at the entrance of the apical passage, and allowing the catheter assembly 1 to exit the human body.

[0088] While the embodiments of the present invention describe the valve delivery and release process, those skilled in the art will appreciate that the release and recovery device disclosed herein is not limited to the delivery of heart valves but can also be used for the delivery of other valves. The present invention is not limited to a single method for delivering heart valves.

[0089] In summary, the medical implant delivery device is a split-type device, comprising a separate handle and catheter assembly. This reduces the weight of a conventional catheter assembly, allowing the operator to position and adjust the medical implant simply by moving the catheter assembly. Compared to the integral movement of conventional delivery systems, the catheter assembly's light weight and compact size allow for more convenient and flexible movement, facilitating positioning and fine-tuning during surgery. This improves stability and precision during the procedure, enabling high-quality implant placement. Furthermore, the device prevents vibration and / or movement of the handle from affecting the catheter assembly, further enhancing stability and surgical quality.

[0090] The transmission shaft and the catheter assembly are detachably connected, which improves the convenience in the process of loading, transporting and releasing the medical implant, and the detachable connection also improves the simplicity of packaging and transportation.

[0091] The drive shaft is a flexible, coilable drive shaft, saving packaging space and reducing the space occupied during surgery. The lead screw is axially provided with a through hole, through which the proximal inner tube passes. This cleverly utilizes the inner lumen of the lead screw, reducing the size of the catheter assembly and making it more compact, making it easier to hold, move, and position.

[0092] Compared to rigid straight tube delivery devices (with or without a bracket), this embodiment offers both sensitive and effective adjustment of the delivery device's positioning capabilities. The delivery device provided in this embodiment can precisely deliver medical implants (e.g., artificial valves) to the lesion site, ensuring delivery quality and shortening surgical procedures.

[0093] The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. Reference can be made to the common and similar parts between the various embodiments. The methods disclosed in the embodiments are described briefly because they correspond to the devices disclosed in the embodiments. For relevant details, refer to the method description.

[0094] 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 shall fall within the scope of protection of the claims.

Claims

1. A delivery device for a medical implant, characterized in that: The delivery device is of a split type, comprising: a handle and a catheter assembly that are separated from each other, the handle and the catheter assembly being connected via a transmission shaft; the transmission shaft being detachably connected to the catheter assembly; the catheter assembly comprising an inner tube assembly and an outer tube assembly sleeved outside the inner tube assembly, the handle driving the transmission shaft to rotate so that the outer tube assembly produces axial movement relative to the inner tube assembly; The catheter assembly further includes a transmission assembly, the transmission assembly including a screw and a screw nut, the screw and the screw nut are engaged, the screw nut is fixedly connected to the outer tube assembly, and when the transmission shaft and the catheter assembly are in a connected state, the transmission shaft is fixedly connected to the screw, and the rotation of the transmission shaft drives the screw to rotate, thereby driving the screw nut and the outer tube assembly to move axially; The catheter assembly further includes a housing, and the transmission assembly further includes a first bearing, wherein the outer ring of the first bearing is embedded and fixed at the proximal end of the housing, and the inner ring of the first bearing is sleeved and fixed at the proximal end of the screw rod.

2. The medical implant delivery device according to claim 1, wherein The inner tube assembly comprises, from the distal end to the proximal end, a tapered head, a distal inner tube, a fixed head, and a proximal inner tube, which are connected in sequence.

3. The medical implant delivery device according to claim 2, wherein: The outer tube assembly includes: a sheath tube and a first outer tube connected to the proximal end of the sheath tube, and the proximal end of the first outer tube is fixedly connected to the screw nut.

4. The medical implant delivery device according to claim 3, wherein: The inner wall of the first outer tube is provided with a circumferential limiting structure, and the outer wall of the proximal inner tube matches the circumferential limiting structure to limit the circumferential rotation of the proximal inner tube.

5. The medical implant delivery device according to claim 4, wherein: The catheter assembly further includes a first stabilizing tube, the proximal end of the first stabilizing tube is fixedly connected to the distal end of the shell, and the first outer tube is sleeved in the first stabilizing tube.

6. The medical implant delivery device according to claim 2, wherein: The inner tube assembly further includes an intermediate inner tube and a Luer connector, wherein the Luer connector has a protruding end, and the fixing head, the intermediate inner tube, the Luer connector, and the proximal inner tube are connected in sequence from the distal end to the proximal end.

7. The medical implant delivery device according to claim 2 or 6, characterized in that: The transmission assembly also includes a second bearing, the screw rod is provided with a through hole along the axial direction, the proximal inner tube passes through the through hole, the proximal inner tube and the through hole are loosely matched, the two ends of the proximal inner tube are respectively sleeved and fixed with the second bearing, the outer ring of the second bearing is fixed to the inner wall of the end of the screw rod, and the inner ring of the first bearing is sleeved and fixed on the proximal outer wall of the screw rod.

8. The medical implant delivery device according to claim 1, wherein: The inner tube assembly comprises, from the distal end to the proximal end, a tapered head, a distal inner tube, a fixed head, an intermediate inner tube, and a Luer connector that are connected in sequence, wherein the Luer connector has a protruding end.

9. The medical implant delivery device according to claim 6 or 8, characterized in that: The outer tube assembly includes: a sheath tube and a second outer tube connected to the proximal end of the sheath tube, the proximal end of the second outer tube is fixedly connected to the screw nut; the second outer tube is axially provided with a first strip opening, and the protruding end of the Luer connector protrudes from the first strip opening.

10. The medical implant delivery device according to claim 9, wherein: The catheter assembly also includes a second stabilizing tube, the proximal end of the second stabilizing tube is fixedly connected to the distal end of the shell, the second outer tube is sleeved in the second stabilizing tube, the second stabilizing tube has a second strip opening along the axial direction, the second strip opening is arranged corresponding to the first strip opening, and the protruding end extends from the second strip opening.

11. The medical implant delivery device according to any one of claims 1 to 6, characterized in that: The catheter assembly further comprises a circumferential limit block, which is fixedly connected to the screw nut and cooperates with the housing to form a circumferentially limited and axially movable structure.

12. The medical implant delivery device according to any one of claims 1 to 6, characterized in that: The transmission shaft includes a transmission flexible shaft.

13. The medical implant delivery device according to claim 12, wherein: The transmission flexible shaft has a 2-4 layer spiral structure, the spiral outer diameter of the spiral structure is greater than or equal to 0.1 mm, and the material of the transmission flexible shaft is metal material.

14. The medical implant delivery device according to claim 12, wherein: The transmission shaft further comprises a connecting portion and a transmission flexible shaft outer tube, the transmission flexible shaft is sleeved in the transmission flexible shaft outer tube, and the transmission flexible shaft is connected to the transmission assembly via the connecting portion.

15. The medical implant delivery device according to claim 1, wherein: The transmission shaft is fixedly connected to the catheter assembly.

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