Conveyor device

Abstract

The present invention discloses a delivery device for loading, delivering, and releasing an implant. The delivery device includes: a handle, an inner core tube, a sheath tube, and a guiding head. Among them, the proximal end of the inner core tube is connected to an inner core tube moving part within the handle, and the guiding head disposed at the distal end of the inner core tube is fixedly connected to the distal end of the sheath tube. Herein, the proximal end refers to the end close to the handle, and the distal end refers to the end far from the handle. In the present invention, the distal end of the sheath tube is fixedly connected to the guiding head, such that the delivery device can only load the implant through the proximal end of the sheath tube. When releasing the implant, the sheath tube should move distally, that is, the sheath tube continues to advance towards the target position of the implant instead of retracting towards the handle direction, thereby effectively avoiding problems such as unstable implant release or even errors caused by the sheath tube retracting through a three-dimensional curved passage, and improving the release quality of the implant.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a delivery device. Background Art

[0002] For transcatheter mitral valve replacement (TMVR) surgery, the accurate and reliable positioning of the valve stent is the key to the success of the surgery. The mitral valve structure is more complex than the aortic valve, the annulus shape is irregular, and multiple chordae tendineae in the ventricular cavity seriously interfere with the implantation and positioning of the interventional valve, and the intracavitary pressure generated by ventricular contraction is very high. If the positioning device is not reasonably designed, it will directly lead to a series of fatal complications.

[0003] The sheath of the mitral valve delivery device needs to bear a large radial force of the stent, so a relatively hard material must be used to avoid being damaged. The material of the sheath is hard and the length is relatively long (50 - 70 mm), resulting in a large turning radius during wire guiding and release processes, which is much larger than the spatial configuration of the anatomical structure. In addition, during the implantation of the mitral valve stent, after the instrument is positioned by controlling the bending of the delivery guide catheter, the delivery track cannot change during the entire release process, otherwise it will affect the accuracy of the valve release position. To sum up, the sheath of the delivery device is very hard and long, and the delivery catheter needs to control the bending and maintain the shape unchanged, and the delivery catheter will also show a relatively high hardness after the bending is achieved. In this way, it is difficult for the hard sheath (straight tube) to retreat on this curved track (the bending radius provided by the anatomical space configuration). If forced to retreat, it will affect the bending control of the delivery catheter and is not conducive to the stability of valve release. At the same time, it is easy to cause the catheter to move in the body during release, driving the mitral valve prosthesis that has started to be released, resulting in a reduction in the quality of the valve prosthesis release.

[0004] In addition, in order to adapt to the shape of the annulus and better fit the anatomical structure, generally, the radius dimension of the inflow tract of the stent is larger than that of the outflow tract of the stent. The inflow tract is anchored above the native annulus - the atrial part, and the outflow tract is anchored below the native annulus - the ventricular part. Such a design is more conducive to the anchoring of the valve stent. Using the traditional valve delivery method, that is, the sheath is retracted and the stent is self - expanded for release, the outflow tract of the stent is released first, and the inflow tract is released later. However, in actual operation, it is very difficult to accurately position the inflow tract on the annulus, and there is often a position deviation, and it is impossible to adjust after the deviation is found.

[0005] Therefore, there is an urgent need for a delivery device that can avoid the sheath passing through a three - dimensional curved path during stent release, and at the same time can ensure the coaxiality between the valve stent and the annulus during release and the stability of the release process, that is, replace the valve with high quality. Summary of the Invention

[0006] The object of the present invention is to provide a delivery device to avoid the space three-dimensional curved path of the sheath tube during the release of the implant, and ensure the coaxiality during the release of the implant structure and the stability during the release process.

[0007] To achieve the above object, the present invention provides a delivery device for loading, delivering and releasing an implant, and the delivery device includes:

[0008] A handle, an inner core tube, a sheath tube and a guiding head, wherein the proximal end of the inner core tube is connected to the inner core tube moving part in the handle, and the guiding head arranged at the distal end of the inner core tube is fixedly connected to the distal end of the sheath tube.

[0009] Optionally, the delivery device further includes:

[0010] An inner tube, which is arranged between the inner core tube and the sheath tube, and its proximal end is fixedly connected to the inner tube fixing part in the handle;

[0011] A fixing head, which is fixedly connected to the inner tube and configured to fix the implant.

[0012] Optionally, the guiding head is a conical head, and the distal end of the sheath tube is smoothly and fixedly connected to the proximal end of the guiding head.

[0013] Optionally, the delivery device further includes a transition component, and the transition component is a tubular structure sleeved outside the inner tube. The maximum outer diameter size of the transition component is smaller than the inner diameter size of the sheath tube, so as to ensure that the transition component is just sleeved inside the sheath tube and there is no gap between the two.

[0014] Optionally, the proximal end of the sheath tube is smoothly and detachably connected to the transition component by a static friction connection method.

[0015] Optionally, the transition component includes a transition part and a catheter part that are communicated with each other. The transition part is a hollow protruding structure. The distal end of the transition part is smoothly and detachably connected to the proximal end of the sheath tube. The proximal end of the transition part is smoothly and fixedly connected to the distal end of the catheter part. The proximal end of the catheter part is connected to the catheter moving part in the handle.

[0016] Optionally, the delivery device further includes a bending control tube, and the bending control tube is sleeved outside the catheter part. The distal end of the bending control tube abuts against the transition part. The proximal end of the bending control tube is connected to the bending control tube moving part in the handle. The bending control tube includes a bending control structure for adjusting the axial bending angle of the bending control tube.

[0017] Optionally, the transition component includes a transition part, and the transition part is a hollow protruding structure. The distal end of the transition part is smoothly and detachably connected to the proximal end of the sheath tube.

[0018] Optionally, the delivery device further includes a bending control tube sleeved outside the inner tube. The distal end of the bending control tube is fixedly connected to the proximal end of the transition part, and the proximal end of the bending control tube is connected to a bending control tube movable part in the handle. The bending control tube includes a bending control structure for adjusting the axial bending angle of the bending control tube.

[0019] Optionally, the protruding structure includes: a semi-conical structure, a hemispherical structure or a frustum-shaped structure.

[0020] Optionally, along the distal end to the proximal end of the transition part, the outer diameter of at least one section of the transition part gradually decreases.

[0021] Optionally, a plurality of grooves are provided on the fixing head.

[0022] In the delivery device provided by the present invention, the distal end of the sheath tube is fixedly connected to the guiding head, so that the delivery device can only load the implant through the proximal end of the sheath tube. At the same time, when releasing the implant, the sheath tube should move distally, that is, the sheath tube continues to advance towards the target position of the implant, rather than retracting towards the handle direction, so as to effectively avoid problems such as unstable or even incorrect release of the implant caused by the retraction of the sheath tube through the three-dimensional curved passage; at the same time, combined with the implant structure of "the radius size of the inflow channel is larger than the radius size of the outflow channel", the inflow channel of the implant is released first, and the outflow channel of the implant is released later. After the inflow channel of the implant is released, referring to the target position, if it is found that the positioning is inaccurate, it can be adjusted in time to make the release more accurate, further improving the release quality of the implant. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 is a schematic structural diagram of the delivery device of the implant in Embodiment 1 of the present invention;

[0024] Figures 2-4 is a schematic diagram of the loading and release of the delivery device of the implant in Embodiment 1 of the present invention;

[0025] Figure 5 is a schematic structural diagram of the delivery device of the implant in Embodiment 2 of the present invention;

[0026] Wherein, 1, 1'-delivery device of the implant, 11-inner core tube, 12-guiding head, 13-sheath tube, 14-inner tube, 15-fixing head, 151-step, 16-transition member, 161-transition part, 162-catheter part, 17-bending control tube, 18-handle, 2-implant, 21-hanging ear, 22-outflow channel, 23-inflow channel. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0027] The specific embodiments of the present invention will be described in more detail below in conjunction with the schematic diagrams. The advantages and features of the present invention will become clearer according to the following description and claims. It should be noted that the attached drawings are all in very simplified forms and use non-precise scales, only for conveniently and clearly assisting in explaining the purpose of the embodiments of the present invention.

[0028] As mentioned in the background art above, when the delivery device of the implant in the prior art releases the implant, the sheath tube needs to be retracted. The hard sheath tube (straight tube) is difficult to retract on a curved track. If forced to retract, it will affect the bending control of the bending control tube and is not conducive to the stability of valve release. At the same time, during release, it is easy to cause the catheter to move in the body, driving the implant that has started to be released, resulting in a reduction in the quality of implant release. In addition, when using the release method of sheath tube retraction and implant self-expansion, the outflow tract of the implant is released first, and the inflow tract is released later. However, in actual operation, it is very difficult to accurately position the inflow tract at the target position, and there is often a position deviation. It is difficult to adjust after the deviation is found.

[0029] Based on this, as Figure 1 shown in FIG. 4 or 5, the present invention proposes a delivery device 1 for an implant, which is used for loading, transporting and releasing the implant. The delivery device 1 is composed of a catheter assembly and a handle 18. Specifically, the catheter assembly includes: an inner core tube 11, a guiding head 12, a sheath tube 13, an inner tube 14, a fixing head 15, a transition member 16 and a bending control tube 17.

[0030] In addition, for the convenience of description, as Figure 1 shown in FIG. 6, in the present invention, it is defined that: the direction towards the catheter assembly is the distal end, and the direction towards the handle 18 is the proximal end; that is to say, the end far from the handle 18 is the distal end, and the end close to the handle 18 is the proximal end.

[0031] As Figures 1-2 shown in FIG. 7, the proximal end of the inner core tube 11 is connected to the inner core tube movable part in the handle 18, so that the handle 18 can drive the axial movement of the inner core tube 11, and the distal end of the inner core tube 11 is fixedly connected to the guiding head 12; the distal end of the sheath tube 13 is smoothly and fixedly connected to the proximal end of the guiding head 12, and the sheath tube 13 is sleeved outside the inner core tube 11;

[0032] The fixing head 15 is fixed on the inner tube 14. The inner tube 14 is sleeved between the inner core tube 11 and the sheath tube 13. The proximal end of the inner tube 14 is fixedly connected to the inner tube fixing part in the handle 18, so that the six degrees of freedom of the inner tube 14 (i.e., the translational degrees of freedom along the three rectangular coordinate axes of x, y, and z and the rotational degrees of freedom around these three coordinate axes) are restricted by the handle 18;

[0033] The transition member 16 is a tubular structure sleeved outside the inner tube 14. The maximum outer diameter of the transition member 16 is slightly smaller than the inner diameter of the sheath tube 13 to ensure that the transition member 16 is exactly sleeved inside the sheath tube 13 without forming a gap therebetween. The proximal end of the sheath tube 13 is smoothly and detachably connected to the transition member 16; the bending control tube 17 is mainly used to adjust the axial bending angle of the catheter assembly.

[0034] Among them, the structure of the transition member 16 includes at least two cases. According to the different structures of the transition member 16, the present invention is divided into two embodiments.

[0035] Embodiment 1

[0036] As Figure 1 shown, the delivery device 1 in this embodiment is composed of a catheter assembly and a handle 18. Specifically, the catheter assembly includes: an inner core tube 11, a guiding head 12, a sheath tube 13, an inner tube 14, a fixing head 15, a transition member 16, and a bending control tube 17.

[0037] Among them, the proximal end of the inner core tube 11 is connected to the inner core tube moving part in the handle 18, so that the handle 18 can drive the axial movement of the inner core tube 11; in addition, the distal end of the inner core tube 11 is fixedly connected to the guiding head 12, and the distal end of the sheath tube 13 is smoothly and fixedly connected to the proximal end of the guiding head 12 at A, and the sheath tube 13 is sleeved outside the inner core tube 11. In this way, after the inner core tube 11 is driven, it can drive the guiding head 12 and the sheath tube 13 to move axially together.

[0038] Optionally, the guiding head 12 adopts a streamlined design, and the material of the guiding head 12 is preferably a polymer material; the sheath tube 13 is used to press and hold the implant 2, and the loading and release of the implant 2 are realized by driving the overall forward and backward movement of the guiding head 12 and the sheath tube 13 through the inner core tube 11. The sheath tube 13 can be made of a metal material, a composite material of polymer and metal, etc.; the inner core tube 11 can be made of a polymer material, a composite material of polymer and metal, or a metal material, etc.

[0039] Optionally, as Figure 1 shown, the guiding head 12 is a conical head, and the distal end of the sheath tube 13 is smoothly and fixedly connected to the proximal end (the end with a larger diameter) of the guiding head 12. Such a structural design can reduce the resistance suffered by the sheath tube 13 when moving from the proximal end to the distal end and enhance the stability of the implantation process. Of course, the guiding head 12 can also be other structures such as a frustum structure or a hemispherical structure, etc., and at least one section of the outer diameter of the guiding head 12 gradually shrinks from the proximal end to the distal end of the guiding head 12.

[0040] In addition, in the present invention, there is no special limitation on the handle 18, and any one of a manual handle, an electric handle, or a hybrid electric and manual drive handle can be adopted.

[0041] As Figure 1 shown, the proximal end of the sheath tube 13 is smoothly and detachably connected to the transition member 16 at B. The transition member 16 is a tubular structure sleeved outside the inner tube 14. In this embodiment, the transition member 16 includes two parts, a transition part 161 and a catheter part 162 that are interconnected. These two parts can be separately manufactured and then combined, or integrally manufactured. The transition member 16 can be made of a polymer material, a composite material of polymer and metal, or a metal material, etc.

[0042] Among them, the distal end of the transition part 161 is smoothly and detachably connected (such as a static friction connection) to the proximal end of the sheath tube 13 at B. The proximal end of the transition part 161 is smoothly and fixedly connected to the distal end of the catheter part 162; along the distal end to the proximal end of the transition part 161, the outer diameter of at least one section in the transition part 161 gradually decreases. For example, the transition part 161 can be a hollow protruding structure in the shape of a semi-conical shape, a hemispherical shape, a frustum of a cone shape, etc. The maximum outer diameter dimension is slightly smaller than the inner diameter dimension of the sheath tube 13. The sheath tube 13 can accommodate and wrap a part of the transition part 161, so as to form a smooth transition zone at the connection between the proximal end of the sheath tube 13 and the subsequent bending control tube 17; the catheter part 162 is a tubular structure sleeved outside the inner tube 14, and its proximal end is connected to the catheter moving part inside the handle 18, so that the handle 18 can drive the axial movement of the catheter part 162. In this way, after the catheter part 162 is driven, it can drive the transition part 161 to move axially together.

[0043] The delivery device further includes a bending control tube 17. The bending control tube 17 is sleeved outside the catheter part 162. The inner diameter dimension of the bending control tube 17 is larger than the outer diameter dimension of the catheter part 162, that is, the catheter part 162 can perform axial movement inside the bending control tube 17; the distal end of the bending control tube 17 abuts against the transition part 161, that is, as Figure 1 shown, the proximal end of the entire transition member 16 is not fixedly connected to the bending control tube 17 at C; the proximal end of the bending control tube 17 is connected to the bending control tube moving part in the handle 18, so that the handle 18 can drive the axial movement of the bending control tube 17.

[0044] Among them, the bending control tube 17 includes a bending control structure, and the axial bending angle of the bending control tube 17 is adjusted through the bending control structure, so as to adjust the axial bending angle of the entire catheter assembly.

[0045] The bendable control tube 17 can be a controllable bendable reinforced polymer tube, a metal-reinforced layer tube, a metal multi-module connection tube, etc. Specifically, the reinforced polymer tube refers to a polymer tube embedded with one, two or more metal wires. By pulling the metal wires, bending control can be achieved, and by pulling different metal wires, bending control in different directions can be realized; the metal-reinforced layer tube is obtained by braiding or cutting a metal tube. Braiding refers to having a helical braided structure or a cross-braided structure, and cutting refers to having a cut groove formed by laser cutting. One, two or more metal wires are embedded in the braided or cut metal tube. By pulling the metal wires, bending control can be achieved, and by pulling different metal wires, bending control in different directions can be realized; the metal multi-module connection tube refers to a tube formed by a series of solid or hollow modules. This actively bendable design can more easily pass through complex bending paths and reach the target position.

[0046] As Figure 1 shown, the fixing head 15 is fixed on the inner tube 14 and is configured to fix the implant 2; the inner tube 14 is sleeved between the inner core tube 11 and the sheath tube 13. The proximal end of the inner tube 14 is fixedly connected to the inner tube fixing member in the handle 18. By the handle 18, the six degrees of freedom of the entire inner tube 14 are restricted (i.e., three translational motions: translational motions along the x, y, and z axes, and three rotational motions: rotations about the x, y, and z axes) to fixedly support the implant 2. Among them, the inner tube 14 can be made of a polymer material, a composite material of polymer and metal, a metal material, etc.

[0047] Optionally, the fixing head 15 is provided with a plurality of grooves (not shown in the figure) for fixing the implant 2; the fixing head 15 is made of a metal material or a polymer material. Preferably, as Figures 3-5 shown, a step 151 is connected to the proximal end of the fixing head 15. The step 151 is made of a metal material or a polymer material, and the step 151 is also fixed on the inner tube 14 to better support the implant 2 and prevent the implant 2 from kinking during loading and retrieval.

[0048] Among them, as Figure 1 shown, the inner diameters of the inner core tube 11, the inner tube 14, the catheter part 162, the bendable control tube 17, and the sheath tube 13 increase in sequence. Preferably, the inner core tube 11, the inner tube 14, the catheter part 162, the bendable control tube 17, and the sheath tube 13 are concentrically arranged.

[0049] In addition, the embodiment of the present invention also provides an implantation method for an implant for the above-mentioned delivery device 1. Refer to Figures 2-4 , the implantation method includes the steps:

[0050] S1. Provide the delivery device 1 for the implant and the implant 2 to be loaded;

[0051] S2. Drive the inner core tube 11 through the handle 18 to drive the sheath tube 13 to move distally, expose the fixing head 15, and fix one end of the implant 2 on the fixing head 15; then drive the inner core tube 11 through the handle 18 to drive the sheath tube 13 to move proximally, compress and hold the implant 2, and load the implant 2 into the sheath tube 13;

[0052] S3. Drive the entire catheter assembly through an external force to drive the sheath tube 13 and the fixing head 15 to move distally synchronously;

[0053] S4. After the implant 2 is delivered to the target position, drive the inner core tube 11 through the handle 18 to drive the sheath tube 13 to move distally and release the implant 2.

[0054] The implantation process of the implant 2 can be divided into: loading, delivery, and release. The handle 18 drives the bearing to drive the front and back movement of the movable part of the inner core tube (the inner core tube 11 is driven by the movable part of the inner core tube) through electric drive or manual drive, so that the inner core tube 11 drives the sheath tube 13 and the guiding head 12 to make an axial movement relative to the inner tube 14, and operations such as loading and releasing the implant 2 are realized. The specific implantation process is as follows.

[0055] First, perform step S1 to provide the delivery device 1 and the implant 2 to be loaded. Among them, the implant 2 in this embodiment can specifically be a mitral valve stent, as Figure 4 shown, including a lugs 21, an outflow tract 22, and an inflow tract 23 connected in sequence, and the radius dimension of the inflow tract 23 is larger than the radius dimension of the outflow tract 22. It can be understood that the implant 2 uses a mitral valve stent as an example to explain the invention, but the mitral valve stent is not a limitation on the implant 2. Although this embodiment shows the geometric shape of a common mitral valve stent, the present invention is not limited to any specific valve stent geometric shape.

[0056] Next, perform step S2 to load the implant 2: Manipulate the handle 18 to make the inner core tube 11 drive the whole of the guiding head 12 and the sheath tube 13 to move distally until the groove on the fixing head 15 is exposed, as Figure 4 shown; then, hook the two lugs 21 of the implant 2 into the groove, stabilize the stent with the aid of an auxiliary loading tool, manipulate the handle 18, and drive the inner core tube 11 to move proximally. The outflow tract 22 of the implant 2 is first compressed and held as Figure 3 shown; as the sheath tube 13 continues to move, the inflow tract 23 of the implant 2 is compressed and held until the sheath tube 13 completely wraps the implant 2, and the distal end face of the implant 2 abuts against the end face of the guiding head 12, and the implant 2 is loaded completely, as Figure 2 shown.

[0057] Then, perform step S3 to deliver the implant 2: Use an external force to insert the catheter assembly in the delivery device 1 into the puncture port along the guide wire and into the human body; then follow the vascular access of the femoral vein, pass the entire catheter assembly through the atrial septum, and synchronously deliver the sheath 13 and the fixing head 15 distally to the target position (i.e., the lesion position).

[0058] Finally, perform step S4 to release the implant 2: When the sheath 13 reaches the designated target position and adjusts the angle (adjusted by the bending control tube 17, and after adjustment, the bending control tube 17 remains stationary), after being coaxial with the root of the valve annulus, press the forward button of the driving handle 18 to move the guiding head 12 and the sheath 13 distally, and start to release the implant 2 until the implant 2 is completely released to the designated position and detaches from the catheter assembly, as Figures 2-4 shown.

[0059] Specifically, during the distal movement of the sheath 13, the inflow tract 23 of the implant 2 is first released. As the sheath 13 continues to move, the outflow tract 22 of the implant 2 is slowly released until the proximal end of the sheath 13 moves to the fixing head 15, exposing the groove on the fixing head 15, and the implant 2 is completely released.

[0060] In addition, after the implantation of the implant 2 is completed, it is also necessary to withdraw the catheter assembly of the implant delivery device 1: Drive the transition part 161 distally through the catheter part 162 of the transition part 16, so that the relative positions of the transition part 161 of the transition part 16 and the sheath 13 are as Figure 1 shown, that is, the two are smoothly detachably connected together; then control the handle 18 to withdraw the catheter assembly from the human body.

[0061] In the delivery device 1 of the implant provided in the embodiments of the present invention, the sheath 13 is fixedly connected to the guiding head 12, and at the same time, an inner core tube 11 is connected. During loading, the inner core tube 11 drives the sheath 13 and the guiding head 12 to move distally. After the fixing head 15 is exposed, the lug 21 of the implant 2 is hung on the fixing head 15, and then the inner core tube 11 is controlled to drive the sheath 13 and the guiding head 12 to move proximally to compress and hold the implant 2 until the loading of the implant 2 is completed; during release, the inner core tube 11 drives the sheath 13 and the guiding head 12 to move distally. The inflow channel 23 of the implant is released first, and the outflow channel 22 is released later; in this way, when the implant 2 is released, the sheath 13 does not need to be retracted, so there is no need to pass through a three-dimensional curved path, thereby effectively avoiding problems such as unstable or even incorrect release of the implant 2 caused by the sheath 13 retracting through the three-dimensional curved path. In actual operation, in combination with the structure of the implant 2 where "the radius dimension of the inflow channel is larger than the radius dimension of the outflow channel", after the outflow channel 22 is released, it will interfere with the valve leaf on the implant 2. If it is found that the positioning is inaccurate at this time, it is very difficult to adjust the position. However, according to the present invention, by adopting the method of releasing the sheath 13 distally, the inflow channel 23 is released first, and the outflow channel 22 is released later. After the inflow channel 23 is released, referring to the target position, if it is found that the positioning is inaccurate during the release process, it can be adjusted in time. The delivery device provided by the present invention can accurately release the implant 2 at the lesion position and ensure the release quality of the implant 2.

[0062] In addition, the implant delivery device of the embodiments of the present invention further includes a transition member 16, which can avoid serious interference between a part of the structure of the implant 2 and the sheath 13 when the implant delivery device is retracted, resulting in damage to the structure of the implant 2.

[0063] Embodiment Two

[0064] In Embodiment One, the transition member 16 includes two parts, a transition part 161 and a catheter part 162 that are interconnected, and the structure is relatively complex, and the implantation operation process of the implant 2 is also relatively complex. Based on this, as Figure 5 shown, in this embodiment, the transition member 16 is modified, and a delivery device 1' of the implant with another structure is proposed.

[0065] As Figure 5 shown, in this embodiment, the transition member 16 does not have a catheter part 162, only a transition part 161. In this case, the proximal end of the transition part 161 is directly and smoothly fixedly connected to the distal end of the bending control tube 17, and the axial movement of the transition part 161 is controlled by the axial movement of the bending control tube 17. The structures of the other parts of the implant delivery device 1' in this embodiment and the implantation method of the implant by this delivery device 1' are the same as those in Embodiment One, and will not be elaborated here.

[0066] After the implantation of the implant 2 is completed, it is necessary to withdraw the catheter assembly in the delivery device 1' of the implant: First, unlock the bending control structure of the bending control tube 17, and drive the bending control tube 17 through the handle 18 to drive the transition part 161 to move distally, so that the relative positions of the transition part 161 and the sheath 13 are as Figure 5 shown, that is, the two are smoothly connected together; then control the handle 18 to withdraw the catheter assembly from the human body.

[0067] In summary, in the loading device of the implant provided in the embodiment of the present invention, the distal end of the sheath is fixedly connected to the guiding head, so that the delivery device can only load the implant through the proximal end of the sheath. When releasing the implant, the sheath should move distally, that is, the sheath continues to advance towards the target position of the implant, rather than retracting towards the handle direction, thereby effectively avoiding problems such as unstable or even incorrect implant release caused by the sheath retracting through the three-dimensional curved path; at the same time, combined with the implant structure of "the radius size of the inflow channel is greater than the radius size of the outflow channel", the inflow channel of the implant is released first, and the outflow channel of the implant is released later. After the inflow channel of the implant is released, referring to the target position, if it is found that the positioning is inaccurate, it can be adjusted in time to make the release more accurate, further improving the release quality of the implant; in addition, a transition component is provided at the proximal end of the sheath, which can avoid serious interference between some structures of the implant and the sheath when the delivery device retracts, resulting in damage to the structure of the implant.

[0068] The above is only the preferred embodiment of the present invention and does not impose any limitation on the present invention. Any person skilled in the art, without departing from the technical solution of the present invention, makes any form of equivalent replacement or modification and other changes to the technical solution and technical content disclosed in the present invention, which are still within the content of the technical solution of the present invention and still belong to the protection scope of the present invention.

Claims

1. A delivery device for loading, delivering, and releasing an implant, characterized in that, The delivery device includes: a handle, an inner core tube, a sheath tube, and a guiding head. Among them, the proximal end of the inner core tube is connected to the inner core tube moving part within the handle, and the guiding head disposed at the distal end of the inner core tube is fixedly connected to the distal end of the sheath tube; The delivery device further includes: an inner tube, which is disposed between the inner core tube and the sheath tube, and its proximal end is fixedly connected to the inner tube fixing part in the handle; a fixing head, which is fixedly connected to the inner tube and configured to fix the implant; the delivery device further includes a transition member, the transition member is a tubular structure sleeved outside the inner tube, the transition member includes a transition portion, the transition portion is a hollow protruding structure, and the distal end of the transition portion is smoothly and detachably connected to the proximal end of the sheath tube; The delivery device further includes a bending control tube, the bending control tube is sleeved outside the inner tube, and the distal end of the bending control tube is fixedly connected to the proximal end of the transition portion; When the implant is released, the bending control tube remains stationary; after the implantation is completed, the bending control tube is first unlocked, and then drives the transition portion to move distally, so that the transition portion and the sheath tube are smoothly connected together to achieve withdrawal.

2. The delivery device according to claim 1, characterized in that, The guiding head is a conical head, and the distal end of the sheath tube is smoothly and fixedly connected to the proximal end of the guiding head.

3. The delivery device according to claim 1, characterized in that, The maximum outer diameter dimension of the transition member is smaller than the inner diameter dimension of the sheath tube to ensure that the transition member is exactly sleeved within the sheath tube and there is no gap between the two.

4. The delivery device according to claim 3, characterized in that, The proximal end of the sheath tube is smoothly and detachably connected to the transition member by a static friction connection method.

5. The delivery device according to claim 1, characterized in that, The distal end of the bending control tube is fixedly connected to the proximal end of the transition portion, the proximal end of the bending control tube is connected to the bending control tube moving part in the handle, and the bending control tube includes a bending control structure for adjusting the axial bending angle of the bending control tube.

6. The delivery device according to claim 1, characterized in that, The protruding structure includes: a semi-conical structure, a hemispherical structure, or a frustum-shaped structure.

7. The delivery device according to claim 1, characterized in that, Along the distal end to the proximal end of the transition portion, the outer diameter of at least one section of the transition portion gradually decreases.

8. The delivery device according to claim 1, characterized in that, The fixing head is provided with a plurality of grooves.

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