Delivery device and delivery system for an implant

Abstract

This invention provides an implant delivery device and system. The implant delivery device includes a stent support unit and a wire control unit. The stent support unit extends axially along the delivery device and serves as a delivery carrier for the wire-controlled stent. The wire control unit is located at the proximal end of the stent support unit. The wire control unit is used to drive the wire-controlled stent mounted on the stent support unit to expand or contract via a pull wire. A portion of the distal end of the wire control unit is flexible; or the axial length of the wire control unit along the delivery device is not greater than a preset value. This configuration reduces the length of the inflexible distal section of the delivery device, decreases the bending radius, and thus reduces the risk of vascular injury.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an implant delivery device and delivery system. Background Technology

[0002] Interventional valve implantation is a novel minimally invasive valve replacement technique developed internationally in recent years. There are two main mechanisms for valve implantation: self-expanding and bulb-expanding. Each has its advantages and disadvantages. Bulb-expanding valve prostheses can provide stable support and stability during deployment, but due to the nature of their stent material, they cannot be retrieved after deployment. Self-expanding valve prostheses have the advantage of error correction and can be retrieved and re-deployed within the body during implantation. However, due to the nature of the self-expanding stent, its shape is not conducive to anchoring during deployment.

[0003] Currently, a wire control technology based on self-expanding valve prostheses has emerged. The purpose of wire control is to add wire control to the self-expanding valve prosthesis to achieve a release mechanism similar to a ball expansion, thereby improving the stability during the implantation process and thus increasing the success rate of the surgery.

[0004] However, in existing wire-controlled technologies, a relatively long travel segment is often required at the far end of the delivery device to drive the retrieval and release of the pull cable. This travel segment increases the length of the inflexible section at the far end of the delivery device, making it difficult for the delivery device to pass through the small aortic arch or easily puncturing blood vessels when passing through the aortic arch, causing vascular complications. Summary of the Invention

[0005] The purpose of this invention is to provide an implant delivery device and delivery system to solve the problem of large bending radius in existing delivery devices.

[0006] To solve the above-mentioned technical problems, the present invention provides an implant delivery device, which includes: a stent support unit and a wire control unit;

[0007] The bracket support unit extends along the axial direction of the conveying device and is used as a conveying carrier for the wire-controlled bracket to be loaded.

[0008] The wired control unit is disposed at the proximal end of the support unit; the wired control unit is used to drive the wired support unit mounted on the support unit to expand or contract via a pull wire;

[0009] Wherein, a portion of the distal end of the wire control unit is bendable; or, the axial length of the wire control unit along the conveying device is not greater than a preset value.

[0010] Optionally, the drive unit includes a travel section and a bendable section;

[0011] The travel segment extends along the axial direction of the conveying device;

[0012] The distal end of the flexible section is connected to the proximal end of the support unit, and the proximal end of the flexible section is connected to the travel section.

[0013] Optionally, the bendable section includes a metal-cut tube, a spring tube, or a flexible polymer material tube.

[0014] Optionally, the bendable section includes a flexible structural tube and a wire distribution component;

[0015] The flexible structural tube extends along the axial direction of the conveying device;

[0016] The pull wire distribution component is connected to the flexible structural tube, and the pull wire distribution component has a plurality of circumferentially distributed pull wire holes for the pull wire to pass through.

[0017] Optionally, the wire distribution member is coaxially connected to the flexible structural tube; and / or the wire distribution member is disposed at the proximal end of the flexible structural tube.

[0018] Optionally, the flexible section further includes a protective layer covering the outer and / or inner periphery of the flexible structural tube.

[0019] Optionally, the flexible section includes a multi-lumen tube;

[0020] The multi-cavity tube includes multiple circumferentially distributed pull holes, which are axially continuous and used for the pull wire to pass through.

[0021] Optionally, the stroke section includes a base and a drive component. The base extends along the axial direction of the conveying device, and the drive component is movably sleeved on the base along the axial direction of the conveying device. The drive component is used to connect with the pull wire and to drive the wire-controlled bracket loaded on the bracket support unit to expand or contract via the pull wire.

[0022] Optionally, the drive member has a first limiting structure for limiting the circumferential position of the pull wire around the conveying device.

[0023] Optionally, the conveying device includes a line deployment component connected to the support unit, the line deployment component being used to change the extension direction of the pull wire from extending axially along the conveying device to extending radially along the conveying device.

[0024] Optionally, the conveying device includes two or more line deployment components, which are spaced apart along the axial direction of the conveying device.

[0025] Optionally, the wire control unit includes a drive component, the axial length of which is not greater than a preset value along the conveying device; the drive component is rotatably arranged in the circumferential direction; the drive component is used for winding the pull wire, and is used to drive the pull wire to expand or contract the wire control bracket mounted on the bracket support unit by rotation.

[0026] Optionally, the driving component includes a wire fixing component and a wire disengagement component;

[0027] The wire fixing component is used to connect to the fixed end of the pull wire;

[0028] The wire disconnection component is used to connect to the disconnection end of the pull wire; when the wire disconnection component meets the preset conditions, the wire disconnection component disconnects from the disconnection end of the pull wire.

[0029] Optionally, the preset conditions include mechanical movement of the wire disconnection component, energization, or waiting for a predetermined time.

[0030] To address the aforementioned technical problems, the present invention also provides an implant delivery system, comprising: a wire-controlled valve prosthesis and an implant delivery device as described above; the wire-controlled valve prosthesis includes a wire-controlled stent and at least one set of pull wires; the wire-controlled stent is detachably mounted on the stent support unit, and a portion of the pull wires is arranged circumferentially around the wire-controlled stent and is used to drive the wire-controlled stent to expand or contract under the drive of the wire-controlled unit.

[0031] In summary, in the implant delivery device and delivery system provided by the present invention, the implant delivery device includes: a stent support unit and a wire control unit; the stent support unit extends axially along the delivery device and serves as a delivery carrier for the wire control stent; the wire control unit is located at the proximal end of the stent support unit; the wire control unit is used to drive the wire control stent loaded on the stent support unit to expand or contract via a pull wire; wherein, a portion of the distal end of the wire control unit is bendable; or the axial length of the wire control unit along the delivery device is not greater than a preset value.

[0032] This configuration reduces the length of the inflexible section at the distal end of the delivery device and decreases the bending radius, thereby reducing the risk of damaging blood vessels. Attached Figure Description

[0033] Those skilled in the art will understand that the accompanying drawings are provided to better understand the invention and do not constitute any limitation on the scope of the invention. Wherein:

[0034] Figure 1aThis is a schematic diagram of a conveying device and a wired control bracket assembled together, wherein the wired control bracket is in an expanded state;

[0035] Figure 1b yes Figure 1a A schematic diagram of the wired control bracket in its retracted state;

[0036] Figure 2 This is a schematic diagram illustrating an application scenario for a conveying device;

[0037] Figure 3 This is a schematic diagram of the application scenario of the conveying device according to Embodiment 1 of the present invention;

[0038] Figure 4a This is a schematic diagram of the conveying device and the wire control bracket after assembly according to Embodiment 1 of the present invention, wherein the wire control bracket is in an expanded state;

[0039] Figure 4b yes Figure 4a A schematic diagram of the wired control bracket in its retracted state;

[0040] Figure 5 This is a partial schematic diagram of a first preferred example of the bendable segment of Embodiment 1 of the present invention;

[0041] Figure 6 This is a partial schematic diagram of a second preferred example of the bendable segment of Embodiment 1 of the present invention;

[0042] Figure 7a This is a partial schematic diagram of a third preferred example of the bendable segment of Embodiment 1 of the present invention;

[0043] Figure 7b yes Figure 7a A schematic diagram of the cross-section of the bendable section;

[0044] Figure 8 This is a schematic diagram of the wire control unit of the conveying device according to Embodiment 1 of the present invention;

[0045] Figures 9a-9c This is a schematic diagram of several preferred examples of the wire fixing component according to Embodiment 1 of the present invention;

[0046] Figures 10a-10d This is a schematic diagram of several preferred examples of the first and second through holes in Embodiment 1 of the present invention;

[0047] Figure 11a and Figure 11b This is a schematic diagram of several preferred examples of the wire-controlled valve prosthesis according to Embodiment 1 of the present invention;

[0048] Figures 12a-12c This is a schematic diagram of several preferred examples of the pin-shaped component according to Embodiment 1 of the present invention;

[0049] Figure 13a and Figure 13b This is a schematic diagram of several preferred examples of the line deployment component according to Embodiment 1 of the present invention;

[0050] Figure 14 This is a schematic diagram of the application scenario of the conveying device according to Embodiment 2 of the present invention;

[0051] Figure 15a This is a schematic diagram of the conveying device and the wire control bracket after assembly according to Embodiment 2 of the present invention, wherein the wire control bracket is in an expanded state;

[0052] Figure 15b yes Figure 15a A schematic diagram of the wired control bracket in its retracted state;

[0053] Figure 15c yes Figure 15a Enlarged view of part A;

[0054] Figure 15d yes Figure 15b Enlarged view of part B.

[0055] In the attached image:

[0056] 01-Conical head; 02-Support unit; 03-Wire control unit; 04-Conveying pipe assembly; 05-Operating component; 08-Wire control bracket; 09-Pull wire; 091-Fixing wire; 092-Disconnecting wire; 092a-Fixing end; 092b-Disconnecting end;

[0057] 10-Support unit; 11-Line deployment component; 111-Conversion component; 111a-Second through hole; 111b-Second groove; 111c-Channel; 112-Second fixing ring; 113-Third through hole; 20-Line control unit; 21-Stroke section; 210-Base; 211-Drive component; 211a-First through hole; 211b-First groove; 212-Drive tube; 213a-First fixing ring; 214-Line release component; 214a-Pin-shaped component; 214b-Traction component; 22-Flexible section; 221-Flexible structure tube; 222-Pull wire distribution component; 223-Pull wire hole; 224-Protective layer; 225-Multi-cavity tube; 225a-Center hole. Detailed Implementation

[0058] To make the objectives, advantages, and features of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to facilitate and clarify the explanation of the embodiments of this invention. Furthermore, the structures shown in the drawings are often part of the actual structures. In particular, different figures may emphasize different aspects and may sometimes use different scales.

[0059] As used herein, the singular forms “a,” “an,” and “the” include plural objects; the term “or” is generally used to mean “and / or”; the term “a number” is generally used to mean “at least one”; and the term “at least two” is generally used to mean “two or more”. Furthermore, the terms “first,” “second,” and “third” are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as “first,” “second,” or “third” may explicitly or implicitly include one or at least two of that feature; “one end” and “the other end,” and “proximal end” and “distal end” generally refer to two corresponding parts, which include not only endpoints. The terms “proximal end” and “distal end” are defined herein with respect to a delivery device having an end for insertion into the human body and a control end extending outside the body. The term "proximal" refers to the position of the element closer to the control end of the delivery device protruding from the body, and the term "distal" refers to the position of the element closer to the end of the delivery device that is inserted into the human body and therefore further away from the control end of the delivery device. Optionally, in manual or hand-operated applications, the terms "proximal" and "distal" are defined herein in relation to the operator, such as a surgeon or clinician. The term "proximal" refers to the position of the element closer to the operator, and the term "distal" refers to the position of the element closer to the delivery device and therefore further away from the operator. Furthermore, as used in this invention, "mounted," "connected," "attached," and "set" of one element on another should be interpreted broadly, generally indicating only a connection, coupling, engagement, or transmission relationship between the two elements, which can be direct or indirect through an intermediate element, and should not be construed as indicating or implying a spatial positional relationship between the two elements, i.e., one element can be located inside, outside, above, below, or to one side of the other element, unless otherwise expressly stated. Those skilled in the art will understand the specific meaning of the above terms in this invention according to the specific circumstances. Furthermore, directional terms such as above, below, up, down, upward, downward, left, right, etc., are used relative to exemplary embodiments as they are shown in the figures, with upward or up direction pointing towards the top of the corresponding figure, and downward or down direction pointing towards the bottom of the corresponding figure.

[0060] The purpose of this invention is to provide an implant delivery device to solve the problem of large bending radii in existing delivery devices. The following description refers to the accompanying drawings.

[0061] Figure 1a and Figure 1b This diagram shows a conveying device assembled with a wired control bracket 08. Figure 2 An application scenario of the conveying device is illustrated. For example... Figure 1a and Figure 1b As shown, the conveying device starts from the remote end ( Figure 1a and Figure 1b The middle is the left end) to the proximal end ( Figure 1a and Figure 1b The conveying device (right end, center) includes a conical head 01, a support unit 02, and a wired control unit 03 connected in sequence. The conveying device also includes a conveying pipe assembly 04 and an operating component 05 (such as a handle) located near the proximal end. A wired support 08 is mounted on the support unit 02 via several pull wires 09. One end of each pull wire 09 is connected to the wired control unit 03 and moves with it. When the wired control unit 03 is driven, for example by… Figure 1a The position is along the axial direction of the conveying device ( Figure 1a and Figure 1b (Move horizontally) to Figure 1b At the desired position, the pull wire 09 is pulled towards the proximal end to tighten, thereby driving the wire control bracket 08 to change from an expanded state to a contracted state, as shown below. Figure 1b As shown. It should be noted that since the delivery device is mainly used for intervention in the human body, it needs to bend along the curves of the blood vessels; therefore, its axis is also curved and not straight. The extension of each component along the axial direction of the delivery device in this article refers to the direction in which each component extends along the flexible axis of the delivery device.

[0062] Generally, the axial length of the support unit 02 is matched with the axial length of the wire-controlled bracket 08. Once the specifications of the wire-controlled bracket 08 are determined, the axial length of the support unit 02 is also essentially fixed. The drive of the wire-controlled unit 03 requires a certain stroke, and this stroke is set along the axial direction of the conveying device, giving the wire-controlled unit 03 a certain axial length and making it unable to bend (because when bent, the operation on the wire-controlled unit 03 from the proximal end cannot be effectively transmitted to the distal end). With the wire-controlled unit 03 located at the proximal end of the support unit 02, the combination of the two forms a relatively long, inflexible section. Please refer to [reference needed]. Figure 2 When such a delivery device passes through some blood vessel areas with small curvature (such as the aortic arch), the length of the inflexible section may exceed the internal capacity of the aortic arch, making it impossible to pass through. If too much force is applied, it may damage the blood vessel and cause harm.

[0063] Based on the above research, embodiments of the present invention provide an implant delivery device to solve the problem of large bending radii in existing delivery devices. The implant delivery device of the present invention will be specifically described below with reference to several embodiments.

[0064] Example 1

[0065] Please refer to Figures 3 to 13bThis embodiment provides an implant delivery device, comprising: a stent support unit 10 and a wire control unit 20; the stent support unit 10 extends axially along the delivery device and serves as a delivery carrier for a wire-controlled stent 08; the wire control unit 20 is disposed at the proximal end of the stent support unit 10; the wire control unit 20 is used to drive the wire-controlled stent 08 mounted on the stent support unit 10 to expand or contract via a pull wire 09; wherein a portion of the distal end of the wire control unit 20 is bendable. Figure 3 As shown, because a portion of the distal end of the wire control unit 20 is flexible, the stent support unit 10 and the proximal end of the wire control unit 20 are separated by the flexible portion, thereby reducing the length of the inflexible section at the distal end of the delivery device, reducing the bending radius, and thus reducing the risk of damaging blood vessels.

[0066] Please refer to Figure 4a and Figure 4b Optionally, the wire control unit 20 includes a stroke section 21 and a flexible section 22; the stroke section 21 extends axially along the conveying device; the distal end of the flexible section 22 is connected to the proximal end of the support unit 10, and the proximal end of the flexible section 22 is connected to the stroke section 21. The stroke section 21 can be an inflexible, rigid section, which is connected to the proximal end of the support unit 10 through the flexible section 22, allowing bending to occur between the stroke section 21 and the support unit 10, thereby reducing the overall bending radius.

[0067] Please refer to Figures 5 to 7b Optionally, the flexible segment 22 may comprise a metal-cut tube, a spring tube, or a flexible polymer material tube. For example... Figure 5 As shown, in the first preferred example, the bendable section 22 includes a flexible structural tube 221 and a drawwire distribution member 222; the flexible structural tube 221 extends axially along the conveying device; the drawwire distribution member 222 is connected to the flexible structural tube 221, and the drawwire distribution member 222 has a plurality of circumferentially distributed drawwire holes 223 for the drawwire 09 to pass through. The flexible structural tube 221 has a certain structural strength, and at the same time, it also has a certain flexibility and can be bent. In some embodiments, the flexible structural tube 221 may be a spring tube. In the second preferred example, such as... Figure 6As shown, the flexible structure tube 221 can be a metal tube formed by cutting metal material, such as a sodium hypochlorite tube. Optionally, the flexible structure tube 221 has an internal cavity extending along the axial direction of the conveying device, which can be used for the insertion of guide wires. Preferably, the draw wire distributor 222 is coaxially connected to the flexible structure tube 221, and the draw wire holes 223 of the draw wire distributor 222 are evenly distributed circumferentially around the axis of the conveying device. Preferably, the draw wire holes 223 extend along the axial direction of the conveying device. Different draw wires 09 can be inserted into different draw wire holes 223, such that multiple draw wires 09 are defined and separated from each other by different draw wire holes 223. In some embodiments, the diameter of the circumference of the center of the multiple draw wire holes 223 is larger than the outer diameter of the flexible structure tube 221, such a configuration allows the draw wires 09 to be located outside the flexible structure tube 221 after passing through the draw wire holes 223.

[0068] The axial position of the drawstring distributor 222 along the flexible structural tube 221 is not particularly limited. Preferably, the drawstring distributor 222 is disposed at the proximal end of the flexible structural tube 221, and the drawstring 09, as it extends from the travel section 21 to the distal end, can first pass through the drawstring hole 223 of the drawstring distributor 222 and be arranged in a circumferential distribution. In other embodiments, the flexible section 22 may include two or more drawstring distributors 222, which are arranged at intervals along the axial direction of the conveying device. Those skilled in the art can make reasonable improvements to the number and axial position of the drawstring distributors 222 according to actual conditions, and the present invention is not limited thereto.

[0069] Preferably, the flexible section 22 further includes a protective layer 224, which covers the outer periphery of the flexible structural tube 221. The protective layer 224 can be made of a flexible medical polymer material, such as PEBAX, PP, or PA. The protective layer 224 can prevent the pull wire 09 from directly contacting the flexible structural tube 221, thereby preventing the pull wire 09 from being stuck, clamped, or hooked by the flexible structural tube 221. It also isolates the cavity of the flexible structural tube 221 from the outside, preventing the cavity of the flexible structural tube 221 from being contaminated by blood or other bodily fluids.

[0070] In other embodiments, the diameter of the circumference of the center of the plurality of draw wire holes 223 may also be smaller than the inner diameter of the flexible structure tube 221. That is, the diameter of the flexible structure tube 221 is set to be larger, and the draw wire 09 is located inside the flexible structure tube 221 after passing through the draw wire hole 223. Correspondingly, the protective layer 224 may be disposed on the inner circumference of the flexible structure tube 221, or simultaneously disposed on the inner and outer circumferences of the flexible structure tube 221. Optionally, an inner tube may also be additionally attached inside the flexible structure tube 221 for the guide wire, etc., to pass through, as can be understood by those skilled in the art based on the prior art.

[0071] Please refer to Figure 7a and Figure 7b In a third preferred example, the flexible section 22 comprises a flexible polymer material tube, preferably a multi-lumen tube 225. The multi-lumen tube 225 may include a central hole 225a and multiple circumferentially arranged drawwire holes 223. The central hole 225a may be used for guidewire insertion, and different drawwires 09 may be inserted into different drawwire holes 223. Optionally, the multi-lumen tube 225 may be made of a flexible medical polymer material, such as PEBAX, PP, or PA. The multi-lumen tube 225 separates the different drawwires 09, preventing them from intertwining or tangling even when the multi-lumen tube 225 is bent, effectively improving the reliability of the delivery device.

[0072] Please refer to Figure 8 Optionally, the travel segment 21 includes a base 210 and a drive member 211. The base 210 extends axially along the conveying device, and the drive member 211 is movably sleeved outside the base 210 along the axial direction of the conveying device. The drive member 211 is used to connect with the pull wire 09 and to drive the wire-controlled bracket 08 mounted on the bracket support unit 10 to expand or contract via the pull wire 09. In one example, the base 210 may be an inner catheter, the lumen of which allows a guidewire to be inserted.

[0073] Optionally, the driving component 211 has a first limiting structure, which limits the circumferential position of the pull wires around the conveying device. Optionally, the conveying device further includes a driving tube 212, with the proximal end of the driving component 211 connected to the driving tube 212. The driving tube 212 extends proximally and connects to a handle. The operator can pull or push the driving tube 212 proximally or distally using the handle at the proximal end, thereby driving the driving component 211 to move axially along the conveying device. The driving component 211 can be located near the distal end of the conveying device. The driving component 211 can collect and converge multiple pull wires 09, thus all pull wires 09 are located at the distal end of the entire conveying device. The driving component 211 is controlled via the driving tube 212. The wiring path of the pull wires 09 is short, and each pull wire 09 can be simultaneously retracted and extended, resulting in high release accuracy of the wire control bracket 08. Furthermore, the first limiting structure limits the circumferential position of each pull wire 09, preventing them from intersecting and tangling.

[0074] Preferably, the first limiting structure includes a plurality of first through holes 211a extending along the axial direction of the driving member 211 (e.g., ...). Figure 9a and Figure 9b (as shown), or, the first limiting structure includes a plurality of first grooves 211b formed along the axial direction of the driving member 211 on the outer periphery of the driving member 211 (as shown). Figure 9c(As shown); the first through hole 211a or the first groove 211b is used for the pull wire 09 to pass through. Figure 9a and Figure 9b In the illustrated example, the drive component 211 is a multi-cavity tube, each of its first through holes 211a accommodating one or more pull wires. Thus, the first through holes 211a restrict the circumferential position of the pull wires 09. This embodiment does not limit the cross-sectional shape or number of the first through holes 211a and the first grooves 211b. Figures 10a to 10d Several preferred cross-sectional shapes of the first through-hole 211a are illustrated exemplary. It should be understood that... Figures 10a to 10d This is merely an example of the cross-sectional shape and number of the first through hole 211a, and not a limitation on the cross-sectional shape and number of the first through hole 211a. Figure 9c In the illustrated example, the drive member 211 is a gear-like structure with a plurality of first grooves 211b on its outer periphery. Each first groove 211b can accommodate one or more pull wires 09 through which they pass and can also limit the circumferential position of the pull wires 09.

[0075] Please refer to Figure 11a and Figure 11b The illustration shows an implant, specifically a wire-controlled valve prosthesis, comprising: a wire-controlled stent 08 and at least one set of pull wires 09. The wire-controlled stent 08 is preferably a self-expanding stent, which is radially expandable or contractible. A portion of the pull wires 09 is arranged circumferentially around the wire-controlled stent 08 and is used to drive the wire-controlled stent 08 to expand or contract under the drive of the wire-controlled unit 20. In some embodiments, the pull wires 09 may be divided into a fixing wire 091 and a detachable wire 092 according to their functions. The fixing wire 091 can be understood as a pull wire with fixed ends 092a at both ends, both of which are fixedly connected to the drive member 211 of the delivery device, thereby forming a loop. If there are two or more fixed wires 091, the subsequent fixed wire 091 passes through the loop of the previous fixed wire 091, forming a sequential pin-connected relationship. The disconnect wire 092 has a fixed end 092a and a disconnect end 092b. The fixed end 092a is used to fix it to the drive component 211, and the disconnect end 092b is detachably connected to the drive component 211. Then, the disconnect wire 092 passes through the loop of the last fixed wire 091 and pins it to the last fixed wire 091. With this configuration, after the disconnect end 092b of the disconnect wire 092 is disconnected from the drive component 211, the disconnect wire 092 is equivalent to releasing the pin connection to the last fixed wire 091. Several fixed wires 091 are also sequentially released from their pin connections, so that the entire group of pull wires 09 is disconnected from the wire control bracket 08, thus completing the wire removal.

[0076] exist Figure 11a In the example shown, line 092 is disconnected to form a single coil loop. For example... Figure 11bAs shown, in some other embodiments, the disconnect line 092 forms a double coil loop. In other embodiments, all pull lines 09 are used for disconnection without distinguishing between fixed lines and disconnect lines, or all pull lines 09 can be considered as disconnect lines 092. In these embodiments, each pull line 09 has a fixed end 092a and a disconnect end 092b. The fixed end 092a of the pull line 09 is fixedly connected to the drive member 211, and the disconnect end 092b of the pull line 09 is detachably connected to the drive member 211. With this configuration, after the drive member 211 is disconnected from the disconnect end 092b of the pull line 09, the disconnect end 092b of the pull line 09 is released, causing the pull line 09 to disengage from the wire control bracket 08, thus completing the wire removal.

[0077] To achieve wire removal, preferably, the driving component 211 includes a wire fixing component and a wire disengagement component 214; the wire fixing component is used to connect with the fixing end 091a of the pull wire 09; the wire disengagement component 214 is used to connect with the disengagement end 091b of the pull wire 09; when the wire disengagement component 214 meets a preset condition, the wire disengagement component 214 disengages from the disengagement end 091b of the pull wire 09. The preset condition can vary depending on the structure of the wire disengagement component 214. For example, in some embodiments, the wire disengagement component 214 is a mechanical disengagement structure, so the preset condition can be mechanical movement of the wire disengagement component 214, such as mechanical movement, expansion, or unlocking; in other embodiments, the wire disengagement component 214 is an electrolytic disengagement structure, so the preset condition can be energization; in still other embodiments, the wire disengagement component 214 is a dissolving structure, so the preset condition can be waiting for a certain period of time, etc. Those skilled in the art can set specific preset conditions according to different structures of the wire disengagement component 214.

[0078] Please refer to Figures 12a-12c In one example, the wire release component 214 is a mechanical release structure, comprising a pin 214a having an opening; the preset condition includes: the wire release component 214 moving relative to the release end 092b of the pull wire 09, so that the release end 092b of the pull wire 09 disengages from the opening. This embodiment does not limit the specific form of the pin 214a. Figures 12a-12c Spiral, L-shaped, and hook-shaped pins 214a are shown respectively. Their common feature is that they are open but not closed. As the pin 214a moves towards the proximal end relative to the release end 092b, it can be deformed by force, causing the release end 092b of the draw wire 09 to slip off the pin 214a. In an alternative example, the pin 214a is spiral-shaped, with the number of turns between 1 and 3. The pin 214a can be made of metallic or non-metallic materials. Understandably, the force causing the pin 214a to deform should be less than the tensile strength of the draw wire 09.

[0079] Preferably, the conveying device further includes a traction member 214b, one end of which is connected to the pin-shaped member 214a, and the other end of which extends proximally. The traction member 214b can be a traction wire or similar component, which, after extending proximally, can be connected to a handle. The operator can pull the traction member 214b using the handle at the proximal end, thereby moving the pin-shaped member 214a towards the proximal end. It should be noted that if the traction member 214b is a component such as a traction wire that can only be pulled but cannot transmit thrust, the pin-shaped member 214a can be configured to disengage from the pull wire when moving towards the proximal end. Of course, in some other embodiments, if a conduit is used as the traction member 214b, since it can transmit thrust, the direction of movement of the pin-shaped member 214a after disengaging from the pull wire is not restricted. To reduce the size of the conveying device, it is preferable to use a tension-bearing component such as a traction wire as the traction member 214b.

[0080] Furthermore, the wire release component 214 is located near the wire fixing component. When the wire release component 214 fails to meet a preset condition, it moves synchronously with the wire fixing component along the axial direction of the conveying device. When the preset condition is not met, all the pull wires 09 function essentially the same, all serving to drive and control the retraction or expansion of the wire control bracket 08. Therefore, the wire release component 214 and the wire fixing component should be configured to move synchronously along the axial direction of the conveying device so that each pull wire 09 is retracted and extended synchronously.

[0081] Optionally, the wire fixing component is used to connect with the fixing end 092a of the pull wire. Figure 9a In the illustrated example, two different first through holes 211a are used for the same pull wire 09 to pass through and wind sequentially. The drive member 211 and the two different first through holes 211a thereon are configured together as the wire fixing component. Preferably, the same pull wire 09 passes through two adjacent first through holes 211a sequentially, thus completing the connection between the pull wire 09 and the drive member 211. It can be understood that in Figure 9a In the example shown, the pull wire 09 is preferably formed as follows: Figure 11b The double coil ring shown has two wires at its fixed end 092a, which allows the fixed end 092a of the pull wire 09 to pass through the two first through holes 211a respectively.

[0082] exist Figure 9b and Figure 9c In the illustrated example, the wire fixing component includes a first fixing ring 213a, which is used for the fixing end 092a of the pull wire 09 to be wound around, so that the pull wire 09 is connected to the wire fixing component. It should be noted that the winding here can be done by two wires wrapping around, or by a single wire forming a loop (such as by knotting or welding).

[0083] In some embodiments, the wire fixing component includes a first fixing ring 213a additionally attached relative to the drive member 211. Figure 9b In the illustrated example, the radial inner dimension of the first retaining ring 213a is smaller than the radial outer dimension of the driving member 211, and the first retaining ring 213a is used to abut against the driving member 211. It should be noted that the radial inner dimension of the first retaining ring 213a refers to the minimum radial inner dimension of the first retaining ring 213a. Optionally, if the inner circumference of the first retaining ring 213a is circular, then the radial inner dimension of the first retaining ring 213a is its inner diameter. If the inner circumference of the first retaining ring 213a is polygonal, then the radial inner dimension of the first retaining ring 213a is the diameter of its inscribed circle. The same applies to the radial inner dimensions of other components described below. The radial outer dimension of the driving member 211 refers to the maximum radial outer dimension of the driving member 211. Optionally, if the outer circumference of the driving member 211 is circular, then the radial outer dimension of the driving member 211 is its outer diameter. If the outer circumference of the driving member 211 is polygonal, then the radial outer dimension of the driving member 211 is the diameter of its circumscribed circle. The same applies to the radial outer dimensions of the other components described below.

[0084] In an optional embodiment, the first retaining ring 213a is located at the proximal end of the drive member 211. The fixed end 092a of the pull wire is wound around the first retaining ring 213a, extends distally through the first through hole 211a, and then surrounds the wire control bracket 08. When the drive member 211 is pulled proximally, the first retaining ring 213a is driven by the drive member 211 and moves proximally along with it, causing the pull wire 09 to be pulled proximally. When the drive member 211 is pushed distally, the self-expansion of the wire control bracket 08 drives the pull wire 09 to move distally, causing the first retaining ring 213a to move distally and continue to abut against the drive member 211. It should be understood that this embodiment is not limited to placing the first fixing ring 213a at the proximal end of the driving member 211. In other embodiments, the relationship between the first fixing ring 213a and the driving member 211 can also be reversed, that is, the first fixing ring 213a is placed at the distal end of the driving member 211. In this case, when the driving member 211 is pushed toward the distal end, the pull wire 09 is tightened to drive the wire control bracket 08 to retract; while when the driving member 211 is pulled toward the proximal end, the pull wire 09 is loosened and the wire control bracket 08 expands.

[0085] exist Figure 9cIn the illustrated example, the first fixing ring 213a is fixedly sleeved on the outer periphery of the driving member 211. Correspondingly, the first limiting structure of the driving member 211 includes a plurality of first grooves 211b formed along the axial direction of the driving member 211 on its outer periphery. The first fixing ring 213a and the driving member 211 can be connected by welding, bonding, mechanical limiting, etc. The inner periphery of the first fixing ring 213a and the first grooves 211b form a closed hole, which allows the fixing end 092a of the pull wire 09 to be wound around, the principle of which is similar to... Figure 9b The examples shown are similar and will not be repeated here.

[0086] Please refer to Figure 5 and in conjunction with references Figure 4a Preferably, the conveying device includes a wire deployment component 11, which is connected to the support unit 10. The wire deployment component 11 is used to change the extension direction of the pull wire 09 from extending axially along the conveying device to extending radially along the conveying device. The wire deployment component 11 is mainly used to change the extension direction of the pull wire 09. Preferably, the axial position of the wire deployment component 11 along the conveying device is adapted to the loading position of the wire control bracket 08. More preferably, the distal end of the wire deployment component 11 is adapted to the position where the pull wire 09 surrounds the wire control bracket 08, so as to minimize the angle between the pull wire and the wire control bracket 08 radially relative to the wire control bracket 08. Preferably, this part of the pull wire 09 is parallel to the radial direction of the wire control bracket 08.

[0087] Optionally, the wire deployment component 11 includes a conversion member 111, which has a second limiting structure for restricting the circumferential position of the pull wires 09 around the bracket support unit 10. The second limiting structure restricts the circumferential position of each pull wire 09, preventing them from intersecting and tangling.

[0088] Preferably, the second limiting structure includes a plurality of second through holes 111a extending along the axial direction of the conversion member 111; or, the second limiting structure includes a plurality of second grooves 111b extending along the axial direction of the conversion member 111 on the outer periphery of the conversion member 111; the second through holes 111a or the second grooves 111b are used for the pull wire 09 to pass through. The structure and setting principle of the second through holes 111a and the second grooves 111b are similar to those of the first through holes 211a and the first grooves 211b on the driving member 211. In this embodiment, the cross-sectional shape of the second through holes 111a and the second grooves 111b is not limited. The second through hole 111a can be, for example, a... Figures 10a to 10d As shown.

[0089] Preferably, the wire deployment component 11 further includes a transition structure, which is used to gradually change the extension direction of the pull wire 09. It should be noted that gradually changing the extension direction of the pull wire 09 here means that the pull wire 09 has a certain turning radius at the transition structure, rather than a sharp angle. Optionally, the gradual change can be a smooth, arc-shaped change, or a multi-fold change formed by multiple folds. The transition structure can effectively reduce wear on the pull wire.

[0090] Please refer to Figure 13a In an alternative example, the transition structure includes a second retaining ring 112; the second retaining ring 112 is fixed relative to the transition member 111, and the second retaining ring 112 is used for the pull wire 09 to change its extension direction by winding around it. Figure 13a In the illustrated example, the outer periphery of the conversion member 111 has a second groove 111b opened axially. The second fixing ring 112 is connected to the conversion member 111 by welding, bonding, mechanical limiting, or other means. The inner periphery of the second fixing ring 112 and the second groove 111b form a closed hole, which allows the fixed end 092a of the pull wire 09 to be wound around and change its extension direction. This not only restricts the circumferential position of the pull wire 09, but also serves as a transition structure, allowing the pull wire 09 to smoothly change its extension direction. Of course, in other embodiments, the conversion member 111 with a second through hole 111a can also be used in conjunction with the second fixing ring 112 to change the extension direction of the pull wire 09. The present invention is not limited to this.

[0091] Please refer to Figure 13b In another alternative example, the conversion element 111 has a channel 111c opening along the axial direction of the delivery tube assembly, and the second limiting structure includes a plurality of third through holes 113 opening radially along the conversion element 111 and communicating with the channel 111c; the transition structure includes the third through holes 113; the channel 111c and the third through holes 113 are used for the pull wire 09 to pass through and change its extension direction. The channel 111c can be in various forms such as a through hole, a blind hole, or an annular groove, and the pull wire 09 can change its extension direction by passing through the channel 111c and then through the third through holes 113. Figure 13b In the illustrated example, the channel 111c is annular and opens proximally along the axial direction of the conversion member 111, with the sidewall of the third through hole 113 serving as a transition structure. Preferably, the junction between the sidewall of the third through hole 113 and the channel 111c is an arc surface to create a smooth transition. With this configuration, an additional second retaining ring 112 is no longer required on the outer periphery of the conversion member 111, reducing the radial outer dimension of the wire deployment component 11, decreasing the contact height between the wire deployment component 11 and the wire control bracket 08, and reducing interference when gripping the wire control bracket 08.

[0092] Optional, please refer to Figure 4a and Figure 4b The conveying device includes two or more wire deployment components 11, which are spaced apart along the axial direction of the conveying device. Preferably, at least one wire deployment component 11 is provided at the proximal and distal ends of the support unit 10, so that the pull wire 09 can apply force evenly to the wire-controlled support 08 at the proximal and distal ends, making the extension and retraction of the wire-controlled support 08 more uniform.

[0093] The specific structure of other components of the delivery device can be understood and configured by those skilled in the art based on existing technology, and will not be described in detail in this invention. Furthermore, this embodiment also provides an implant delivery system, comprising: a wire-controlled valve prosthesis and the implant delivery device as described above; the wire-controlled stent 08 of the wire-controlled valve prosthesis is detachably mounted on the stent support unit 10, a portion of the pull wire 09 is arranged circumferentially around the wire-controlled stent 08, and is used to drive the wire-controlled stent 08 to expand or contract under the drive of the wire-controlled unit 20.

[0094] This embodiment reduces the length of the inflexible section at the distal end of the delivery device by configuring a portion of the remote control unit to be flexible, thereby reducing the bending radius and lowering the risk of damaging blood vessels.

[0095]

Example 2

[0096] Please refer to Figures 14 to 15d The implant delivery device and delivery system of Embodiment 2 of the present invention are basically the same as those of Embodiment 1. The same parts will not be described again. The following only describes the differences.

[0097] In this second embodiment, the structure of the wire control unit 20 differs from that in the first embodiment. Specifically, in this second embodiment, the axial length of the wire control unit 20 along the delivery device is no greater than a preset value. This preset value can be set relatively small so that the length of the combination of the stent support unit 10 and the wire control unit 20 is controlled within a small range, thereby enabling the delivery device to pass through some vascular regions with small bending radii (such as the aortic arch).

[0098] Please refer to Figure 15c and Figure 15dOptionally, the wire control unit 20 includes a drive member 211, which is rotatably arranged circumferentially. The drive member 211 is used for winding the pull wire 09 and for driving the wire control bracket 08 mounted on the bracket support unit 10 to expand or contract by rotating the pull wire 09. In embodiment two, the drive member 211 is configured to be rotatable, and the pull wire 09 is wound around it by rotation to tighten the pull wire 09. Of course, when rotating in the opposite direction, the pull wire 09 is unwound from the drive member 211, and the self-expansion of the wire control bracket 08 drives the pull wire 09 to move toward the distal end.

[0099] Since the drive component 211 does not need to move axially along the delivery device, its axial length can be greatly reduced. This reduces the length of the inflexible section at the distal end of the delivery device, decreases the bending radius, and thus reduces the risk of blood vessel damage.

[0100] Optionally, the proximal end of the drive unit 211 is connected to the drive tube 212, which extends to the proximal end and is connected to the handle. The operator can operate the drive tube 212 to rotate through the handle at the proximal end, thereby driving the drive unit 211 to rotate circumferentially.

[0101] Optionally, in this second embodiment, the driving component 211 may also include a wire fixing component and a wire disengagement component 214. For specific setting principles and structures, please refer to the first embodiment, which will not be elaborated here.

[0102] In summary, in the implant delivery device and delivery system provided by the present invention, the implant delivery device includes: a stent support unit and a wire control unit; the stent support unit extends axially along the delivery device and serves as a delivery carrier for the wire-controlled stent; the wire control unit is located at the proximal end of the stent support unit; the wire control unit is used to drive the wire-controlled stent mounted on the stent support unit to expand or contract via a pull wire; wherein, a portion of the distal end of the wire control unit is flexible; or the axial length of the wire control unit along the delivery device is not greater than a preset value. This configuration reduces the length of the inflexible section at the distal end of the delivery device, decreases the bending radius, and thereby reduces the risk of vascular injury.

[0103] It should be noted that the above embodiments can be combined with each other. The above description is only a description of preferred embodiments of the present invention and is not intended to limit the scope of the present invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure shall fall within the protection scope of the claims.

Claims

1. An implant delivery device, characterized by, include: Support bracket unit and wired control unit; The bracket support unit extends along the axial direction of the conveying device and is used as a conveying carrier for the wire-controlled bracket to be loaded. The wired control unit is disposed at the proximal end of the support unit; the wired control unit is used to drive the wired support unit mounted on the support unit to expand or contract via a pull wire; The distal end of the wire control unit is flexible; the wire control unit includes a stroke section and a flexible section; the stroke section extends along the axial direction of the conveying device; the distal end of the flexible section is connected to the proximal end of the support unit, and the proximal end of the flexible section is connected to the stroke section.

2. The implant delivery device of claim 1, wherein, The bendable section includes a metal cut tube, a spring tube, or a flexible polymer material tube.

3. The implant delivery device of claim 1, wherein, The bendable section includes a flexible structural tube and a wire distribution component; The flexible structural tube extends along the axial direction of the conveying device; The pull wire distribution component is connected to the flexible structural tube, and the pull wire distribution component has a plurality of circumferentially distributed pull wire holes for the pull wire to pass through.

4. The implant delivery device of claim 3, wherein, The pull wire distribution component is coaxially connected to the flexible structural tube; and / or the pull wire distribution component is disposed at the proximal end of the flexible structural tube.

5. The implant delivery device of claim 3, wherein, The flexible section also includes a protective layer that covers the outer and / or inner periphery of the flexible structural tube.

6. The implant delivery device of claim 1, wherein, The flexible section includes a multi-lumen tube; The multi-cavity tube includes multiple circumferentially distributed pull holes, which are axially continuous and used for the pull wire to pass through.

7. The delivery device of an implant according to claim 1, characterized in that The travel segment includes a base and a drive component. The base extends along the axial direction of the conveying device, and the drive component is movably sleeved on the base along the axial direction of the conveying device. The drive component is used to connect with the pull wire and to drive the wire-controlled bracket loaded on the bracket support unit to expand or contract via the pull wire.

8. The implant delivery device of claim 7, wherein, The drive component has a first limiting structure, which limits the circumferential position of the pull wire around the conveying device.

9. The delivery device of an implant according to claim 1, characterized in that The conveying device includes a wire deployment component connected to the support unit. The wire deployment component is used to change the extension direction of the pull wire from extending axially along the conveying device to extending radially along the conveying device.

10. The implant delivery device of claim 9, wherein, The conveying device includes two or more line deployment components, which are spaced apart along the axial direction of the conveying device.

11. The delivery device of an implant according to claim 1, characterized in that The wire control unit includes a drive component, the length of which along the axial direction of the conveying device is not greater than a preset value; the drive component is rotatably arranged in the circumferential direction; the drive component is used for winding the pull wire, and is used to drive the pull wire to expand or contract the wire control bracket mounted on the bracket support unit by rotation.

12. The delivery device of an implant according to claim 7 or 11, characterized in that The driving component includes a wire fixing component and a wire disengagement component; The wire fixing component is used to connect to the fixed end of the pull wire; The wire disconnection component is used to connect to the disconnection end of the pull wire; when the wire disconnection component meets the preset conditions, the wire disconnection component disconnects from the disconnection end of the pull wire.

13. The implant delivery device of claim 12, wherein, The preset conditions include mechanical movement of the wire disconnection component, power supply, or waiting for a predetermined time.

14. An implant delivery system characterized in that, include: A wire-controlled valve prosthesis and a delivery device for the implant according to any one of claims 1 to 13; the wire-controlled valve prosthesis includes a wire-controlled stent and at least one set of pull wires; the wire-controlled stent is detachably mounted on the stent support unit, and a portion of the pull wires is arranged circumferentially around the wire-controlled stent and is used to drive the wire-controlled stent to expand or contract under the drive of the wire-controlled unit.

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