Connects to reliable implant pushers and implant delivery systems

Abstract

The present invention discloses an implant pushing device and an implant delivery system with reliable connection. The implant delivery system includes an implant pushing device, an expansion device, a loading device, a hemostatic device and an outer sheath. The pushing device includes a pushing assembly and a handle assembly connected to the proximal end of the pushing assembly. The pushing assembly includes a pushing steel cable, an inner core movably installed in the pushing steel cable, and a clamping member provided at the distal end of the inner core and detachably connected to the implant; the handle assembly includes a handle, an axial drive control mechanism provided on the handle, and an elastic member connected to the axial drive control mechanism; the compression or resetting of the elastic member drives the axial movement of the axial drive control mechanism to drive the axial relative movement between the pushing steel cable and the inner core. The present invention has a reliable connection with the implant, prevents the implant from being released prematurely before reaching the designated position, and can be released by single-handed operation to release the implant.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices and relates to an implant pushing device and an implant delivery system with reliable connection. Background Art

[0002] In recent years, interventional therapy has been widely used in clinical applications. Interventional therapy refers to the use of catheter technology to place various materials, instruments, etc. into the heart, arteries, veins and other parts of the human body to treat cardiovascular diseases. For example, a vena cava filter (abbreviated as: VCF) is placed in the patient's superior and inferior vena cava through catheter intervention to capture detached thrombi and prevent the thrombi from moving up along the vena cava system to the heart and lungs, causing pulmonary embolism; or a left atrial appendage occluder is delivered to the left atrial appendage to prevent thrombi caused by atrial fibrillation from ascending to the brain, causing stroke or other systemic embolism. The implantation of such devices requires a delivery system to deliver the implant to various parts of the human body, and then separate the push device from the implant.

[0003] Existing implant pushers include a pusher and a handle. The distal end of the pusher can be detachably connected to the implant via a threaded connection or friction, and the proximal end of the pusher is connected to the handle, making it easier for the doctor to push the implant and control its release during surgery. This type of delivery system has certain limitations: for threaded delivery systems, the operating handle and pusher need to be rotated for release, but the operator must use both hands, which is inconvenient. For delivery systems connected by friction, the friction force is constantly changing in the curved blood vessel path of the human body, and the friction force may be too large or too small, causing the implant to become stuck or to be released prematurely, resulting in surgical failure. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to provide an implant pushing device and an implant delivery system with a reliable connection in response to the defects of the existing technology. The implant pushing device not only has a reliable connection with the implant, preventing the implant from being prematurely released before reaching the designated position, but also when the implant is released, the operator does not need to rotate the pushing device, but only needs to operate with one hand to release the connection with the implant and quickly release the implant.

[0005] The technical solution adopted by the present invention to solve its technical problem is:

[0006] A reliably connected implant pushing device comprises a pushing assembly and a handle assembly connected to the proximal end of the pushing assembly, wherein the pushing assembly comprises a hollow pushing cable, an inner core movably inserted into the pushing cable, and a clamping member disposed at the distal end of the inner core and detachably connected to the implant; the clamping member comprises at least two clamping arms, at least one of the clamping arms having a hook at its distal end; and the planes on which the at least two hooks are located do not overlap.

[0007] The handle assembly includes a handle, an axial drive control mechanism provided on the handle, and an elastic member connected to the axial drive control mechanism; compression or resetting of the elastic member drives the axial movement of the axial drive control mechanism to drive the axial relative movement between the push steel cable and the inner core.

[0008] Furthermore, the hook extends toward the center axis of the push cable or extends away from the center axis of the push cable, and the extension directions of the plurality of hooks are different.

[0009] Furthermore, the clamping member has a free state and a locked state. When the clamping member is in the free state, the clamping arm extends out of the distal end of the push steel cable, and all the distal ends of the clamping arms radiate radially in different directions; when the clamping member is in the locked state, all the clamping arms retract into the push steel cable and converge toward the central axis of the push steel cable, and at least one of the hooks is connected to or interlaced with the clamping arm to form an annular closed structure, or at least two of the hooks are connected to or interlaced to form an annular closed structure.

[0010] Furthermore, in the free state, the angle between at least one of the clamping arms and the central axis of the push steel cable ranges from 90° to 150° or from 200° to 270°, and the angles between the two clamping arms forming an annular closed structure and the central axis of the push steel cable are not equal.

[0011] Furthermore, a control groove is provided axially on the handle, and the axial drive control mechanism includes a sliding member connected to the push steel cable or the inner core, and a connecting member connected to the sliding member. The connecting member passes through the control groove to the outside of the handle, and the connecting member slides axially and drives the sliding member to move, so as to drive the axial relative movement between the push steel cable and the inner core.

[0012] Furthermore, the sliding member is connected to the pushing cable, and the elastic member is connected to the proximal end of the sliding member. Thus, when the elastic member is compressed, the clamping member is in a free state; when the elastic member is reset, the clamping member is in a locked state.

[0013] Furthermore, the sliding member is connected to the inner core, and the elastic member is connected to the distal end of the sliding member. Thus, when the elastic member is compressed, the clamping member is in a free state; when the elastic member is reset, the clamping member is in a locked state.

[0014] Furthermore, a guide member is axially provided in the handle, and the sliding member moves axially along the guide member.

[0015] Furthermore, a drive limiter is provided in the handle, and the drive limiter limits the radial movement of the elastic member.

[0016] Furthermore, a limiting piece is provided at the distal end of the pushing steel cable, and a limiting hole is provided along the axial direction of the pushing steel cable. When the clamping piece is in a free state, the hook piece and the distal end of the clamping arm both extend from the limiting hole. When the clamping piece is in a locked state, the hook piece is located outside the limiting hole, and the distal end of the clamping arm connected to the proximal end of the hook piece is closed together in the limiting hole.

[0017] Furthermore, the major axis dimension of the limiting hole is larger than the dimension of the outermost side of each clamping arm of the clamping member in a locked state on a plane perpendicular to the axial direction of the inner core, and smaller than the dimension of each hook of the clamping member in a locked state on a plane perpendicular to the axial direction of the inner core; the minor axis dimension of the limiting hole is approximately equal to the sum of the dimensions of the proximal ends of multiple clamping arms on a plane perpendicular to the axial direction of the inner core.

[0018] Furthermore, the implant pushing device further comprises an inner core fixing member, the inner core fixing member comprises a travel portion fixedly connected to the inner core, and an adjustment portion fixedly connected to the handle, the adjustment portion and the travel portion being movably connected.

[0019] An implant delivery system comprises the aforementioned implant pushing device and an outer sheath tube with a certain axial length. The implant pushing device is movably installed in the outer sheath tube and is detachably connected to the proximal end of the outer sheath tube.

[0020] Furthermore, the implant delivery system further comprises an expansion device, which is movably installed in the outer sheath, and the proximal end of the expansion device is detachably connected to the proximal end of the outer sheath.

[0021] Furthermore, the implant delivery system further comprises a loading device, which is detachably connected between the proximal end of the outer sheath and the distal end of the pushing device.

[0022] Furthermore, the implant delivery system further comprises a hemostatic device, which is detachably connected between the loading device and the distal end of the pushing device.

[0023] Furthermore, at least one of the outer sheath, the loading device and the hemostasis device is provided with an elastic sealing member, and the elastic sealing member is provided with at least one aperture along the axial direction of the pushing device.

[0024] Furthermore, a first slit is formed at the proximal end of the elastic seal, and a second slit is formed at the distal end of the elastic seal, the sum of the thicknesses of the first slit and the second slit is equal to the thickness of the elastic seal, the directions of the first slit and the second slit are different, and the projection of the first slit on the distal surface of the elastic seal intersects with the projection of the second slit on the distal surface of the elastic seal.

[0025] Furthermore, the projection of the first slit on the distal end surface of the elastic seal is perpendicular to the projection of the second slit on the distal end surface of the elastic seal.

[0026] Compared with the prior art, the present invention has at least the following beneficial effects:

[0027] The hooks of the implant pushing device are connected or overlapped to form a ring-shaped closed structure, which has a reliable connection and locking force with the implant, preventing the implant from being released prematurely before reaching the designated position; furthermore, the opening shape and locking force of the clamping member can be adjusted according to different implant types and the implant's requirements for the connection force of the pushing device, and has a wide range of applications.

[0028] When releasing the implant, the operator does not need to rotate the pushing device. He only needs to operate the axial drive control mechanism and the elastic part on the handle with one hand. The axial movement of the axial drive control mechanism is driven by the compression or resetting of the elastic part to drive the axial relative movement between the pushing steel cable and the inner core, so that the implant can be quickly released. The operation is convenient and simple. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] The present invention will be further described below with reference to the accompanying drawings and embodiments, in which:

[0030] Figure 1 1 is a schematic structural diagram of an implant delivery system according to one embodiment of the present invention, wherein the implant delivery system includes a pushing device, an expansion device, a loading device, a hemostatic device, and an outer sheath;

[0031] Figure 2 yes Figure 1 Schematic diagram of the outer sheath and dilation device assembled together;

[0032] Figure 3 yes Figure 1 Schematic diagram of the loading device, hemostasis device and pushing device assembled together;

[0033] Figure 4 yes Figure 1 Schematic diagram of the outer sheath, loading device, hemostasis device and pushing device assembled together;

[0034] Figure 5 yes Figure 1 A schematic structural diagram of a pushing device in FIG. 1 , wherein the pushing device includes a pushing assembly and a handle assembly, and the pushing assembly includes a pushing steel cable, an inner core, and a clamping member;

[0035] Figure 6 yes Figure 5 A cross-sectional view of the pushing device in FIG. 1 when the clamping member is in a locked state;

[0036] Figure 7 yes Figure 5 A cross-sectional view of the pushing device in FIG. 1 when the clamping member is in a free state;

[0037] Figure 8 yes Figure 5 An exploded view of the push component in ;

[0038] Figure 9a and Figure 9b yes Figure 8 Schematic diagram of different states of the clamping member in FIG, wherein: Figure 9a The clamp is in a free state. Figure 9b The clamping member is in a locked state;

[0039] Figure 10 It is a structural schematic diagram of another embodiment of the clamping member;

[0040] Figure 11 and Figure 12 It is a structural diagram of the angle between the clamping arms of the clamping member;

[0041] Figure 13 yes Figure 8 A schematic diagram of the structure of the limiting member in FIG.

[0042] Figure 14 yes Figure 5 Schematic diagram of the connection between the clamp and the implant;

[0043] Figure 15 yes Figure 5 a cross-sectional view of the handle assembly in FIG.

[0044] Figure 16 yes Figure 5 Exploded view of the handle assembly in;

[0045] Figure 17 yes Figure 1 Schematic diagram of the structure of the outer sheath;

[0046] Figure 18 yes Figure 17 A partial cross-sectional view of the sheath tube seat;

[0047] Figure 19 yes Figure 18 A schematic diagram of the structure of the elastic seal;

[0048] Figure 20 yes Figure 19 Cross-sectional view along BB;

[0049] Figure 21 yes Figure 19 Cross-sectional view along CC.

[0050] Figure 22 yes Figure 1 A schematic structural diagram of the expansion device in FIG.

[0051] Figure 23 yes Figure 1 A schematic structural diagram of the loading device in FIG.

[0052] Figure 24 yes Figure 1 Schematic diagram of the structure of the hemostatic device. DETAILED DESCRIPTION

[0053] In order to have a clearer understanding of the technical features, purposes and effects of the present invention, specific embodiments of the present invention are now described in detail with reference to the accompanying drawings.

[0054] Definition of orientation: In the field of interventional medicine, the end closer to the operator during surgery is usually called the "proximal end" and the end farther from the operator is called the "distal end".

[0055] See Figures 1 to 24 The implant delivery system 100 provided in this embodiment is used to deliver the implant 200 to a predetermined position in the patient's body and release it. The implant 200 includes but is not limited to a vascular filter, a vascular stent, a heart valve clamp, a heart defect occluder, a vascular plug or a lung volume reduction elastomer. The implant 200 is made of a material with shape memory function and can be stretched into a linear shape and loaded into a hollow tube body when used. The proximal end of the implant 200 is provided with a connecting portion, usually a curved retrieval hook or at least one through hole, for forming a detachable connection with the implant delivery system 100. In this embodiment, the implant 200 is an inferior vena cava filter, and the proximal end of the inferior vena cava filter is provided with a curved retrieval hook. The implant delivery system 100 delivers the inferior vena cava filter to the patient's inferior vena cava and releases it.

[0056] See also Figure 1 The implant delivery system 100 includes an implant pushing device 10, an expansion device 20, a loading device 30, a hemostatic device 40, and an outer sheath 50. Figure 2The distal end of the expansion device 20 passes through the distal end of the outer sheath 50 to form an expansion assembly. The distal end of the expansion assembly follows the track established by the guide wire (not shown) to reach the predetermined treatment site in the patient's body. The expansion device 20 is then withdrawn, leaving the outer sheath 50 in the body, thus establishing a passage from the outside to the inside. Figure 3 After establishing the passage from the outside to the inside of the body, the proximal end of the loading device 30 is first connected to the distal end of the hemostatic device 40. Then, the distal end of the implant pushing device 10 is passed through the hemostatic device 40 and the loading device 30 in sequence, and then detachably connected to the connecting portion of the proximal end of the implant 200. The pushing device 10 is then withdrawn proximally to store the implant 200 in the loading device 30. Figure 4 The distal end of the loading device 30 is connected to the proximal end of the outer sheath 50, and the pushing device 10 is operated to push the implant 200 toward the distal end until the implant 200 is pushed out of the distal end of the outer sheath 50. The implant 200 is released from the connection with the implant pushing device 10 and returns to the expanded state, completing the release and implantation of the implant 200.

[0057] See also Figure 5 The implant pushing device 10 includes a pushing assembly 1000 and a handle assembly 2000 connected to the proximal end of the pushing assembly 1000. Figures 6 to 8 The push assembly 1000 includes a hollow push cable 1100, an inner core 1200 movably inserted into the push cable 1100, and a clamp 1300 disposed at the distal end of the inner core 1200 and detachably connected to the implant 200. The clamp 1300 includes at least two clamp arms 1320, at least one of which is provided with a hook 1310 at its distal end. The hook 1310 extends toward or away from the central axis of the push cable 1100. The extension directions of the multiple hooks 1310 are different, and the planes on which at least two hooks 1310 are located do not overlap. Figure 9a and Figure 9b The clamping member 1300 has a free state and a locked state. When the clamping member 1300 is in the free state, the distal end of the clamping arm 1320 extends out of the distal end of the push cable 1100, and the distal ends of all the clamping arms 1320 radiate in different directions along the radial direction; when the clamping member 1300 is in the locked state, all the clamping arms 1320 retract into the push cable 1100 and converge toward the central axis of the push cable 1100, and at least one hook 1310 is connected to or interlaced with the clamping arm 1320 to form an annular closed structure, or at least two hooks 1310 are connected to or interlaced to form an annular closed structure. Figure 10When only one hook 1310 is provided at the distal end of one clamping arm 1320, the hook 1310 cooperates with the other clamping arms 1320 to form a ring-shaped closed structure. When hooks 1310 are provided at the distal ends of multiple clamping arms 1320, each hook 1310 can cooperate with the other clamping arms 1320 to form a ring-shaped closed structure, and each hook 1310 can also cooperate with the other hooks 1310 to form a ring-shaped closed structure.

[0058] In the present invention, "the hook 1310 extends toward the central axis of the push cable 1100" means that the distal end of the hook 1310 faces the central axis of the push cable 1100, and "the hook 1310 extends away from the central axis of the push cable 1100" means that the distal end of the hook 1310 faces away from the central axis of the push cable 1100. "Connecting" of the hooks 1310 means that the distal ends of at least two hooks 1310 contact and press against each other, or that the distal ends of the hooks 1310 contact and press against the distal ends of the clamping arms 1320, forming an annular closed structure. "Interlacing" of the hooks 1310 means that the hooks 1310 at least cross each other at their distal ends to form an annular closed structure, or that the distal ends of the hooks 1310 do not contact each other but their radial projections on the same plane overlap, or that multiple hooks 1310 at least partially contact each other at their distal ends to form an annular closed structure. Likewise, when one hook member 1310 is provided, the end of the hook member 1310 or the hook member 1310 and the clamping arm 1320 intersect to form a ring-shaped closed structure.

[0059] See again Figure 8 The push cable 1100 is made of a material with a certain degree of flexibility and support. Its cross-section can be a smooth structure such as circular or semicircular, preferably circular. Flexibility here means that the push cable 1100 can bend or twist to a certain degree. The push cable 1100 is typically made of a biocompatible metal material or polymer. Preferred metal materials include 316 stainless steel and 304 stainless steel, and polymer materials include nylon, polyethylene, and Pebax. In this embodiment, the push cable 1100 is a hollow tube with a smooth inner wall, twisted together from three strands of steel wire. To enhance the support of the push cable 1100, a steel wire (not shown) can be wrapped around the twisted strands. It is understood that in other embodiments, to enhance the smoothness and support of the push cable 1100, the push cable 1100 is covered with a coating or a metal reinforcement tube; the coating is made of a biocompatible polymer material, preferably PTFE, e-PTFE, or Pebax.

[0060] The inner core 1200 is of a certain length and is more flexible than the push cable 1100. The inner core 1200 is typically a single metal wire (such as a steel wire or a nickel-titanium wire). The inner core 1200 is movably mounted within the push cable 1100, meaning that the inner core 1200 and the push cable 1100 can move relative to each other along the axial direction and can also rotate relative to each other.

[0061] The clamping member 1300 is disposed at the distal end of the inner core 1200. In this embodiment, the clamping member 1300 includes two clamping arms 1320, each of which is provided with a hook 1310 at its distal end. Each hook 1310 extends toward the central axis of the push cable 1100. The two hooks 1310 extend in different directions, and the planes on which the two hooks 1310 are located do not overlap. Thus, the two hooks 1310 interlace to form an annular closed structure.

[0062] When the clamping arms 1320 are opened, sufficient space is left between the hooks 1310 for the connection portion of the implant 200 to enter. When the clamping arms 1320 are closed, the ends of the two hooks 1310 are close to each other and intertwined to form an annular closed structure, thereby connecting with the connection portion of the implant 200. It is understood that in other embodiments, multiple clamping arms 1320 can be provided to strengthen the firmness of the annular closed structure and improve the connection force. Each clamping arm 1320 is provided with a hook 1310 extending toward the central axis of the push cable 1100. That is, when the clamping arms 1320 are closed, the ends of all hooks 1310 are connected or intertwined at or near the central axis of the push cable 1100, together enclosing a annular closed structure. It is understandable that in other embodiments, multiple hooks 1310 can extend away from the central axis of the push cable 1100. In this structure, at least two clamping arms 1320 are cross-arranged at the proximal end or the middle so that the hooks 1310 can be connected or overlapped.

[0063] When the clamping member 1300 is in a free state, the clamping arm 1320 is selected from at least one of a straight rod structure, a broken line rod structure, and a curved rod structure. In this embodiment, the clamping arm 1320 is a hollow or solid straight rod structure.

[0064] When the clamping member 1300 is in a free state, the distal ends of the clamping arms 1320 are radially extended in different directions, that is, the proximal ends of the plurality of clamping arms 1320 are concentrated and the distal ends are spread out. Figure 11In the free state, the angle α between at least one clamping arm 1320 and the central axis of the push cable 1100 is preferably in the range of 90° to 150° or 200° to 270°, that is, 90°≤α≤150° or 200°≤α≤270°, preferably 100°≤α≤130° or 230°≤α≤260°. In order to form an annular closed structure, it is necessary to ensure that the two adjacent clamping arms 1320 do not overlap, that is, the angles α between the two clamping arms 1320 forming the annular closed structure and the central axis of the push cable 1100 are not equal. Therefore, when the clamping member 1300 is in the free state, there is always a certain opening angle between at least two clamping arms 1320, and they will not be completely closed, which is more conducive to the clamping arm 1320 being retracted into the push cable 1100 and reducing the contraction force. In this embodiment, the angles α between the two clamping arms 1320 and the central axis of the pushing cable 1100 are 120° and 240° respectively, that is, the two clamping arms 1320 are symmetrically arranged about the central axis of the pushing cable 1100.

[0065] The clamping member 1300 undergoes a shaping process so that the clamping arm 1320 is in an extended state when in a free state. To ensure that the clamping arm 1320 can be smoothly retracted after being compressed by the push cable 1100 and can be smoothly extended after being released from the restraint, the clamping arm 1320 of the clamping member 1300 should be made of an elastic material and shaped so that the clamping arm 1320 is in an extended state when in a free state. The elastic material in this context refers to a material that can bend or twist under external force and then return to its original shape. Preferably, it is a shape memory material such as nickel-titanium alloy, stainless steel, or cobalt-chromium alloy.

[0066] At least one clamping arm 1320 has a hook 1310 at its distal end. Hook 1310 is a short rod extending toward or away from the central axis. The short rod can be a straight rod, a broken-line rod composed of multiple straight rods, a straight rod with forks, or a curved rod. The shapes of the multiple hooks 1310 can be the same or different.

[0067] In this embodiment, the planes on which the ends of the two hooks 1310 lie do not overlap, and they interlace and overlap to form a closed annular structure. In other embodiments, the two hooks 1310 may alternatively have their ends contacting each other to form a connected annular structure. The interlaced, overlapping, or connected arrangement of the multiple hooks 1310 ensures a secure connection and locking force between the hooks 1310 of the push assembly 1000 and the implant, preventing premature release of the implant before reaching the designated location, thereby improving the connection security and device reliability. When unlocked, the push cable 1100 and the inner core 1200 are driven to move relative to each other axially, causing the hooks 1310 and their clamping arms 1320 to extend from the push cable 1100. The clamping arms 1320 are no longer constrained by the inner walls of the push cable 1100 and return to a free state, expanding outside the push cable 1100. The closed annular structure formed by the multiple hooks 1310 opens, releasing the connection between the implant 200 and the push device 10. In addition, when the two hooks 1310 are compressed by the push cable 1100, the two hooks 1310 that are not in the same plane can overlap each other, and the outer diameter of the clamping member 1300 after closing is smaller, making the overall size of the device smaller and having better passability in the blood vessel.

[0068] See also Figure 8 、 Figure 10 and Figure 11 , the clamping member 1300 and the inner core 1200 can be integrally formed, or they can be separately formed and then fixed together. The proximal end of the clamping member 1300 is provided with a clamping connection portion 1330 for being connected to the inner core 1200. The clamping connection portion 1330 and the clamping arm 1320 can be made of the same material or different materials. Preferably, in order to ensure the proximal support of the clamping member 1300, the clamping connection portion 1330 is a tubular or rod-shaped structure with supporting force, and is made of a material with a certain rigidity. The clamping connection portion 1330 is preferably made of 316 stainless steel, 304 stainless steel, nickel titanium alloy or cobalt chromium alloy. In this embodiment, the clamping connection portion 1330 and the clamping arm 1320 are both made of stainless steel, and the two are integrally formed.

[0069] See also Figure 9a 、 Figure 9b and Figure 13To further limit the relative rotation between the clamping member 1300 and the push cable 1100 and ensure that the clamping member 1300 always overlaps and closes in the same position, a limiter 1110 is provided at the distal end of the push cable 1100, and a limit hole 1111 is defined in the limiter 1110 along the axial direction of the push cable 1100. When the clamping member 1300 is in a free state, the hooks 1310 and the distal ends of the clamping arms 1320 both extend from the limit hole 1111. When the clamping member 1300 is in a locked state, the annular closed structure formed by the multiple hooks 1310 is located outside the limit hole 1111. That is, the hooks 1310 are located outside the limit hole 1111, and the distal ends of the clamping arms 1320, connected to the proximal ends of the hooks 1310, are closed together within the limit hole 1111. It can be understood that in other embodiments, when an annular closed structure is formed between the hook 1310 and the clamping arm 1320, the annular closed structure is located outside the limiting hole 1111, which means that the hook 1310 is located outside the limiting hole 1111, and the distal part of the clamping arm 1320 connected to or interlaced with the hook 1310 to form an annular closed structure is also located outside the limiting hole 1111, and the clamping arm 1320 connected to the proximal end of the hook 1310 is received in the limiting hole 1111 and is closed together with the proximal part of the other clamping arm 1320 in the limiting hole 1111.

[0070] The cross-section of the limiting hole 1111 is rectangular, elliptical, or oblate. The major axis of the limiting hole 1111 satisfies the following requirements: when all the clamping arms 1320 are closed together, at least two hooks 1310 are connected or interlaced to form a closed annular structure, or at least one hook 1310 is connected or interlaced with the clamping arm 1320 to form a closed annular structure. The limiting hole 1111 prevents the closed clamping arms 1320 from overlapping tightly and from radially deviating, thereby ensuring that the hooks 1310 connected to the clamping arms 1320 are tightly connected or interlaced to form a closed annular structure, thereby ensuring the connection is effective.

[0071] In this embodiment, the two clamping arms 1320 of the clamping member 1300 are both extended from the limiting hole 1111 on the limiting member 1110. The limiting hole 1111 has an oblate cross-section and can accommodate the two hooks 1310 and the clamping arms 1320 in the locked state. The long axis dimension of the limiting hole 1111 is larger than the dimension of the outermost side of each clamping arm 1320 of the clamping member 1300 in the locked state on a plane perpendicular to the axial direction of the inner core 1200, and smaller than the dimension of each hook 1310 of the clamping member 1300 in the locked state on a plane perpendicular to the axial direction of the inner core 1200, ensuring that the clamping arm 1320 can be smoothly retracted into the limiting hole 1111 in the locked state, and the hook 1310 will press against the distal end of the limiting member 1110 and will not enter the limiting hole 1111; the short axis dimension of the limiting hole 1111 is roughly equal to the sum of the dimensions of the proximal ends of multiple clamping arms 1320 in a plane perpendicular to the axial direction of the inner core 1200, ensuring that the proximal ends of the clamping arms 1320 can be closed together in the limiting hole 1111, and the clamping arms 1320 can be smoothly extended out of the limiting hole 1111.

[0072] In this embodiment, when the inner core 1200 is pushed to the distal end or the steel cable 1100 is withdrawn to the proximal end, the two clamping arms 1320 of the clamping member 1300 extend from the limiting hole 1111. The two clamping arms 1320 are radially restricted and spread out radially outward, and the clamping member 1300 is in an open free state; when the inner core 1200 is withdrawn proximally or the steel cable 1100 is pushed distally, the two clamping arms 1320 of the clamping member 1300 are accommodated in the limiting hole 1111, and the distal ends of the two clamping arms 1320 are radially restricted by the limiting member 1110 and squeezed by the limiting hole 1111 on the limiting member 1110, and gathered toward the central axis, forcing the hooks 1310 to overlap and intertwine, and the hooks 1310 and the clamping arms 1320 cooperate to form a closed loop, and the clamping member 1300 is in a closed state, locking the connection with the implant 200.

[0073] The limiting member 1110 is preferably made of a relatively hard biocompatible material (eg, stainless steel) to ensure that the clamping member 1300 can overlap and close after being pressed by the limiting member 1110 .

[0074] See also Figure 12 In other embodiments, the clamping arm 1320 may be arc-shaped, curving away from the central axis, while the hook member 1310 may be arc-shaped with its opening pointing toward the central axis. Furthermore, the angle β between the tangent line of the arc midpoint of at least one clamping arm 1320 and the clamping connection portion 1330 may range from 90° to 150°. This structure further reduces bending stress in the clamping member 1300 and improves its fatigue strength.

[0075] See also Figure 14The connection between the implant pushing device 10 and the implant 200 of this embodiment has a certain degree of flexibility for the following reasons: once the clamp 1300 is connected to the implant 200, the pushing assembly 1000 can deflect axially along the plane of the proximal connection portion of the implant 200, with a deflection angle C1 ranging from 0° to 180°. Furthermore, the pushing assembly 1000 can also deflect in a plane perpendicular to the plane of the proximal connection portion of the implant 200, with a deflection angle C2 ranging from 0° to 180°. Therefore, the implant pushing device 10 of this embodiment has greater adaptability in curved blood vessels.

[0076] See also Figure 15 To ensure optimal locking and maintain an optimal locking state, an inner core fixing member is preferably provided between the proximal end of the inner core 1200 and the handle 2100 to adjust the relative position of the inner core 1200 and the handle 2100. The inner core fixing member includes a travel portion 1230 fixedly connected to the inner core 1200 and an adjustment portion 2130 fixedly connected to the handle 2100. The adjustment portion 2130 is movably connected to the travel portion 1230. In this embodiment, a screw is connected to the proximal end of the inner core 1200, which serves as the travel portion 1230. A nut is provided in the handle 2100 to serve as the adjustment portion 2130, and the screw and nut are adapted to fit together. Therefore, when assembling the inner core 1200 in the handle 2100, the operator can adjust the relative position between the inner core 1200, the handle 2100 and the push cable 1100 by adjusting the position of the nut on the screw, so as to prevent the inner core 1200 from being excessively pulled or being too loose, thereby affecting the locking effect of the clamp 1300.

[0077] See also Figure 16 The handle assembly 2000 is disposed at the proximal end of the pushing device 1000 and is used to operate the connection or disconnection between the pushing device 1000 and the implant 200. The handle assembly 2000 includes a handle 2100, an axial drive control mechanism 2300 disposed on the handle 2100, and an elastic member 2500 disposed at the proximal end of the axial drive control mechanism 2300.

[0078] The handle 2100 includes a first shell 2110 and a second shell 2120 that are arranged opposite to each other. The two are fixedly connected together by snapping, bonding, etc., and a front end cover 2400 is provided at the distal ends of the two to limit the movement between the two.

[0079] A control groove 2200 is axially defined in the handle 2100. The length of the control groove 2200 is greater than or equal to the maximum relative motion distance between the push cable 1100 and the inner core 1200, thereby enabling the clamping member 1300 to transition between a free state and a locked state. The control groove 2200 can be formed directly in the first housing 2110 or the second housing 2120, or a groove can be formed in each of the first and second housings 2110, 2120, which then snap together to form the control groove 2200.

[0080] The axial drive control mechanism 2300 includes a sliding member 2330 connected to the push steel cable 1100 or the inner core 1200, and a connecting member 2320 connected to the sliding member 2330. The connecting member 2320 passes through the control groove 2200 to the outside of the handle 2100. The connecting member 2320 slides axially and drives the sliding member 2330 to move, thereby driving the axial relative movement between the push steel cable 1100 and the inner core 1200.

[0081] In this embodiment, the sliding member 2330 is connected to the proximal end of the pushing steel cable 1100 by means of screw connection, clamping, interference fit, pin connection, welding, riveting, etc. which are common in this field, and the proximal end of the inner core 1200 extends from the proximal end of the pushing steel cable 1100 and is fixed in the handle 2100 by an inner core fixing member.

[0082] A guide member is provided within the handle 2100 to restrict the sliding member 2330 to axial movement along the guide member, ensuring smooth sliding of the sliding member 2330. The guide member may be in the form of a groove in which the sliding member 2330 slidably fits, or in the form of a rod on which the sliding member 2330 is mounted and moves axially along the rod.

[0083] The connecting member 2320 is installed in the control groove 2200 and passes through the control groove 2200 to the outside of the handle 2100, which is convenient for the operator to operate.

[0084] See again Figure 6 and Figure 7The proximal or distal end of the slider 2330 is connected to an elastic member 2500. The compression or reset of the elastic member 2500 drives the axial movement of the axial drive control mechanism 2300, thereby driving the axial relative movement between the push cable 1100 and the inner core 1200. Specifically, when the slider 2330 is connected to the inner core 1200, the elastic member 2500 is connected to the distal end of the slider 2330; when the slider 2330 is connected to the push cable 1100, the elastic member 2500 is connected to the proximal end of the slider 2330. Thus, when the elastic member 2500 is compressed, the push cable 1100 moves proximally, and the clamping member 1300 extends from the push cable 1100, becoming free and capable of connecting to the implant 200. When the elastic member 2500 returns to its original position due to its own elasticity, the push cable 1100 moves distally, the clamping member 1300 retracts into the push cable 1100, and the hooks 1310 overlap to form a ring-shaped closed structure, locking the connection with the implant 200. Because the elastic member 2500 exerts its elastic force, the axial drive control mechanism 2300 is squeezed by the elastic member 2500, and the clamping member 1300 remains locked, preventing accidental disconnection between the push assembly 1000 and the implant 200. Only when the operator operates the axial drive control mechanism 2300 to overcome the elastic force of the elastic member 2500, the elastic member 2500 is compressed, the push cable 1100 is retracted, and the clamping member 1300 extends from the push cable 1100, releasing the connection with the implant 200, and the operation is simple.

[0085] In this embodiment, the elastic member 2500 is in the form of a spring. It is understandable that in other embodiments, the elastic member 2500 may also be in other forms such as an elastic rod.

[0086] A drive stopper 2170 is axially disposed within the handle 2100 to limit radial movement of the elastic member 2500. This drive stopper 2170 can be positioned proximally or distally of the guide member 2180. Specifically, in this embodiment, a strip-shaped groove is provided within the handle 2100 to serve as the drive stopper, and the elastic member 2500 is accommodated within the strip-shaped groove. It is understood that in other embodiments, the elastic member 2500 can also be mounted on a rod-shaped body, with the rod-shaped body serving as the drive stopper.

[0087] See also Figure 17The outer sheath 50 is hollow inside to allow the expansion device 20 or the push cable 1100 to pass through. The wall of the outer sheath 50 is a multi-layer structure, which includes a polytetrafluoroethylene layer, a stainless steel braided layer and a polyether block amide layer from the inside to the outside. The polytetrafluoroethylene layer is located in the innermost layer. Due to its extremely low friction coefficient, the push cable 1100 and the implant 200 have little resistance when passing through the outer sheath 50; the polytetrafluoroethylene layer is acid and alkali resistant, and blood, developing liquid, etc. will not damage the polytetrafluoroethylene layer; the stainless steel braided layer has high strength, so the outer sheath 50 is not easily damaged. The polyether block amide layer is located in the outermost layer. The polyether block amide layer has good mechanical elastic properties, chemical stability and thermal stability, which makes the outer sheath 50 have good bending properties and is not easy to damage. The outer sheath 50 also includes at least one side branch for connecting to an external device (not shown) to inject liquids such as drugs or contrast agents, and can also prevent air from entering the blood vessels during surgery. A sheath seat 52 is provided at the proximal end of the outer sheath 50 to connect with the expansion device 20 or the loading device 30. The sheath seat 52 is T-shaped or Y-shaped, and is T-shaped here.

[0088] See also Figure 18 An elastic seal 521 is provided in the sheath seat 52. The elastic seal 521 is made of an elastic material, and the elastic seal 521 is provided with at least one aperture along the axial direction of the pushing device 10 for the passage of the pushing cable 1100.

[0089] See also Figures 19 to 21The elastic seal 521 is cylindrical, with a first elongated slit 5211 formed at the proximal end of the elastic seal 521 and a second elongated slit 5212 formed at the distal end. The sum of the thicknesses of the first slit 5211 and the second slit 5212 equals the thickness of the elastic seal 521, where the thickness refers to the axial length of the sheath holder 52. In this embodiment, the thickness of the first slit 5211 and the second slit 5212 are the same, both equal to half the thickness of the elastic seal 521. That is, the first slit 5211 is located at the proximal half of the elastic seal 521, and the second slit 5212 is located at the distal half of the elastic seal 521. There is no overlap between the first slit 5211 and the second slit 5212 in the thickness direction. The first slit 5211 and the second slit 5212 are oriented in different directions. In this embodiment, the first slit 5211 extends in the horizontal direction, while the second slit 5212 extends in the longitudinal direction. The projections of the first slit 5211 and the second slit 5212 on the distal surface of the elastic seal 521 intersect. In this embodiment, the intersection is the center of the circle of the distal surface of the elastic seal 521. Preferably, the projections of the first slit 5211 and the second slit 5212 on the distal surface of the elastic seal 521 are perpendicular to each other, that is, they form a cross. Because the two slits on the proximal and distal surfaces of the elastic seal 521 intersect, the intersection is relatively fragile and easily penetrated. This intersection becomes the only channel for the insertion tube body such as the push wire cable 1100 or the expansion device 20 to pass through the elastic seal 521. Because the elastic seal 521 is made of an elastic material, when the insertion tube body is withdrawn, the pierced elastic seal 521 tends to close again, and after closing, there are basically no holes or gaps. Therefore, the elastic seal 521 of this embodiment can achieve a self-sealing effect. The elastic seal 521 of this embodiment is installed in the sheath tube seat 52. After the push cable 1100 is passed through and pulled out of the elastic seal 521 three times in a row, after testing, the sealing performance of the sheath tube seat 52 can still reach 1.5ATM (standard atmospheric pressure), which can effectively prevent blood leakage and ensure air tightness.

[0090] See also Figure 22 The expansion device 20 mainly includes an expansion tube 21 and an expansion tube seat 22. The proximal end of the expansion tube 21 is connected to the distal end of the expansion tube seat 22. The expansion tube 21 is made of polyethylene, and the outer diameter of the expansion tube 21 is slightly smaller than the inner diameter of the outer sheath 50. The expansion tube 21 also includes a pointed tip 23 at the distal end. The pointed tip 23 is tapered, and the outer diameter gradually increases from the distal end to the proximal end. Therefore, when the expansion assembly composed of the expansion device 20 and the outer sheath 50 is advanced along the guidewire and passes through a narrowed blood vessel, the pointed tip 23 can dilate the blood vessel, facilitating the smooth passage of the expansion assembly.

[0091] See also Figure 23After establishing the passage from the outside to the inside of the body, the distal end of the loading device 30 is connected to the proximal end of the outer sheath 50 by means of a threaded connection or the like. The hollow loading device 30 is used to accommodate and pass the compressed implant 200 .

[0092] See also Figure 24 The hemostatic device 40 is connected to the proximal end of the loading device 30. The hemostatic device 40 is hollow and communicates with the loading device 30. The push cable 1100 passes through the proximal end of the hemostatic device 40 and exits from the distal end of the hemostatic device 40 to connect with the implant 200. The hemostatic device 40 is provided with an elastic seal 41. The structure of the elastic seal 41 can be a common sealing ring or sealing gasket, or it can be the same as the structure of the elastic seal 521 in the sheath seat 52. It is understood that in other embodiments, the loading device 30 can also be provided with an elastic seal. In this case, the implant delivery system 100 may not require the hemostatic device 40. The structure of the elastic seal in the loading device 30 can be a sealing ring or sealing gasket, or it can be the same as the structure of the elastic seal 521 in the sheath seat 52.

[0093] It is understood that, in other embodiments, the implant delivery system 100 may not include the loading device 30 , and the proximal end of the outer sheath 50 may be directly connected to the distal end of the hemostatic device 40 .

[0094] It should be noted that the various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from the other embodiments. Similar or identical parts between the various embodiments can be referred to in conjunction with each other. For the device embodiments, since they are generally similar to the method embodiments, their description is relatively simple, and for relevant parts, reference can be made to the partial description of the method embodiments.

[0095] The above disclosure is merely a preferred embodiment of the present invention and certainly cannot be used to limit the scope of the present invention. Therefore, equivalent changes made according to the claims of the present invention are still within the scope of the present invention.

Claims

1. A reliably connected implant pushing device, comprising a pushing assembly and a handle assembly connected to the proximal end of the pushing assembly, characterized in that: The pushing assembly includes a hollow pushing steel cable, an inner core movably inserted into the pushing steel cable, and a clamping member disposed at the distal end of the inner core and detachably connected to the implant; the clamping member includes at least two clamping arms, at least one of which is provided with a hook at its distal end; and the planes on which the at least two hooks are located do not overlap. The handle assembly includes a handle, an axial drive control mechanism provided on the handle, and an elastic member connected to the axial drive control mechanism; compression or reset of the elastic member drives the axial movement of the axial drive control mechanism to drive the axial relative movement between the push cable and the inner core; The clamping member has a free state and a locked state. When the clamping member is in the free state, the distal end of the clamping arm extends out of the distal end of the push steel cable, and all the distal ends of the clamping arms radiate radially in different directions; when the clamping member is in the locked state, all the clamping arms retract into the push steel cable and converge towards the central axis of the push steel cable, and the ends of at least two of the hooks are staggered to form an annular closed structure, and the ends of the hooks do not touch but the radial projections on the same plane overlap.

2. The implant pushing device according to claim 1, characterized in that The hook extends toward the center axis of the push cable or extends away from the center axis of the push cable, and the extension directions of the plurality of hooks are different.

3. The implant pushing device according to claim 1, characterized in that In the free state, the angle between at least one of the clamping arms and the central axis of the push steel cable ranges from 90° to 150° or from 200° to 270°, and the angles between the two clamping arms forming an annular closed structure and the central axis of the push steel cable are not equal.

4. The implant pushing device according to claim 1, characterized in that A control groove is provided axially on the handle, and the axial drive control mechanism includes a sliding member connected to the push steel cable or the inner core, and a connecting member connected to the sliding member. The connecting member passes through the control groove to the outside of the handle, and the connecting member slides axially and drives the sliding member to move, so as to drive the axial relative movement between the push steel cable and the inner core.

5. The implant pushing device according to claim 4, characterized in that: The sliding member is connected to the pushing steel cable, and the elastic member is connected to the proximal end of the sliding member.

6. The implant pushing device according to claim 4, characterized in that: The sliding member is connected to the inner core, and the elastic member is connected to the distal end of the sliding member.

7. The implant pushing device according to claim 4, characterized in that A guide piece is axially provided in the handle, and the sliding piece moves axially along the guide piece.

8. The implant pushing device according to claim 1, characterized in that The handle is further provided with a drive limiting member, which limits the radial movement of the elastic member.

9. The implant pushing device according to claim 1, characterized in that: A limiting piece is provided at the distal end of the pushing steel cable, and a limiting hole is provided on the limiting piece along the axial direction of the pushing steel cable. When the clamping piece is in a free state, the hook piece and the distal end of the clamping arm both extend from the limiting hole. When the clamping piece is in a locked state, the hook piece is located outside the limiting hole, and the distal end of the clamping arm connected to the proximal end of the hook piece is closed together in the limiting hole.

10. The implant pushing device according to claim 9, characterized in that: The major axis dimension of the limiting hole is larger than the dimension of the outermost side of each clamping arm of the clamping member in a locked state on a plane perpendicular to the axial direction of the inner core, and smaller than the dimension of each hook of the clamping member in a locked state on a plane perpendicular to the axial direction of the inner core; the minor axis dimension of the limiting hole is roughly equal to the sum of the dimensions of the proximal ends of multiple clamping arms on a plane perpendicular to the axial direction of the inner core.

11. The implant pushing device according to claim 1, characterized in that: The implant pushing device further comprises an inner core fixing member, which comprises a travel portion fixedly connected to the inner core and an adjustment portion fixedly connected to the handle, wherein the adjustment portion is movably connected to the travel portion.

12. An implant delivery system, characterized in that: The implant pushing device comprises the implant pushing device according to any one of claims 1 to 11, further comprising an outer sheath having a certain axial length, wherein the implant pushing device is movably installed in the outer sheath and is detachably connected to the proximal end of the outer sheath.

13. The implant delivery system according to claim 12, wherein: The implant delivery system further comprises an expansion device, which is movably installed in the outer sheath tube, and the proximal end of the expansion device is detachably connected to the proximal end of the outer sheath tube.

14. The implant delivery system according to claim 13, wherein: The implant delivery system further comprises a loading device, which is detachably connected between the proximal end of the outer sheath and the distal end of the pushing device.

15. The implant delivery system according to claim 14, wherein: The implant delivery system further includes a hemostatic device detachably connected between the loading device and a distal end of the pushing device.

16. The implant delivery system according to claim 15, wherein: At least one of the outer sheath, the loading device and the hemostasis device is provided with an elastic sealing member, and the elastic sealing member is provided with at least one aperture along the axial direction of the pushing device.

17. The implant delivery system according to claim 16, wherein: A first slit is formed at the proximal end of the elastic seal, and a second slit is formed at the distal end of the elastic seal. The sum of the thicknesses of the first slit and the second slit is equal to the thickness of the elastic seal. The directions of the first slit and the second slit are different. The projection of the first slit on the distal surface of the elastic seal intersects with the projection of the second slit on the distal surface of the elastic seal.

18. The implant delivery system of claim 17, wherein: The projection of the first slit on the distal end surface of the elastic seal is perpendicular to the projection of the second slit on the distal end surface of the elastic seal.

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