A delivery device and conveying system

Abstract

This utility model discloses a delivery device and delivery system, comprising: a delivery tube with a through-cavity, including a delivery tube body and a distal limiting seat; and a core wire, including a core wire body, a limiting element, and a connecting element. The core wire body is disposed in the cavity, and the connecting element extends from the distal end of the delivery tube and can be detachably connected to the implant. In the delivery state, the limiting seat and the limiting element are connected, restricting the core wire from proximal displacement relative to the delivery tube. In the implantation state, the delivery tube displaces proximal relative to the core wire, and the limiting element separates from the limiting seat. This patent utilizes a delivery catheter and a limited core wire to reduce the impact of the delivery device on the implant, enabling more precise intraoperative observation, improving surgical success rate, and reducing surgical risks.

Description

Technical Field

[0001] This invention relates to the field of interventional therapy, and more particularly to a delivery system. Background Technology

[0002] Medical devices play a vital role in disease diagnosis and treatment. For example, in interventional medicine, operators, guided by medical imaging equipment (such as angiography machines, fluoroscopy machines, computed tomography (CT) scanners, magnetic resonance imaging (MRI) machines, and ultrasound), utilize delivery systems to deliver interventional substances to target locations and manipulate them to diagnose or treat diseases. The delivery system plays a crucial role in manipulating interventional substances; therefore, continuously improving the performance of delivery systems in manipulating interventional substances, especially given the complex environment within the body, is of great significance to interventional medicine.

[0003] For example, occluders are commonly used implants in interventional therapy for the prevention or treatment of various cardiovascular and cerebrovascular diseases, such as congenital heart diseases like atrial septal defects and ventricular septal defects, or left atrial appendage occlusion to prevent stroke. The occluder is delivered to the implantation site, and the surgeon examines its installation status using medical imaging. The delivery system traverses a tortuous vascular path, resulting in one or more local bends in its main body, accumulating potential energy at the distal end. This can affect the implant, causing the surgeon to observe an inaccurate implant morphology, reducing the success rate of the implantation procedure, and even leading to open-chest surgery due to implantation failure. Therefore, improving the implant delivery device to achieve more effective implantation procedures is a technical problem that those skilled in the art are eager to solve. Summary of the Invention

[0004] The purpose of this invention is to provide a delivery device and delivery system, which includes a delivery catheter and a confined core wire. By reducing the impact of the delivery device on the implant, more accurate intraoperative observation can be achieved, thereby improving the success rate of the surgery and reducing surgical risks.

[0005] The technical solution provided by this utility model is as follows.

[0006] A delivery device for delivering and retrieving implants, comprising:

[0007] The delivery tube has a through-cavity inside, including the delivery tube body and the distal limiting seat;

[0008] The core wire includes a core wire body, a limiting element, and a connecting element. The core wire body is arranged in the inner cavity, and the connecting element extends from the distal end of the delivery tube and can be detachably connected to the implant.

[0009] In the delivery state, the limiting seat and the limiting element are connected to restrict the core wire from moving proximally relative to the delivery tube;

[0010] In the implanted state, the limiting element is separated from the limiting seat, and the distal portion of the core wire body extends beyond the distal end of the delivery tube.

[0011] This technical solution involves a connecting element on the core wire that extends to the distal end of the delivery tube and connects to the implant's connection structure. During implant delivery, the limiting seat of the delivery tube cooperates with the limiting element of the core wire to fix the delivery tube and core wire relatively, jointly delivering the implant to the target location. When the implant is placed at or near the lesion, the limiting seat of the delivery tube moves away from the limiting element of the core wire, allowing only the smaller core wire to act on the implant. This reduces the force exerted by the delivery device on the implant, facilitating more accurate observation of the implantation effect by the surgeon and allowing for the retrieval and repositioning of implants with substandard results, improving surgical effectiveness and reducing surgical risk. Once the surgeon confirms successful implantation, the connecting element of the core wire is separated from the implant, and the core wire and delivery tube are withdrawn from the body in the delivered state, further reducing the surgical risk during device withdrawal.

[0012] More preferably, the core wire body includes at least a flexible distal segment with a stiffness lower than that of the delivery tube body.

[0013] The enhanced flexibility of the distal end of the core wire further reduces the force exerted by the delivery device on the implant when only the core wire is connected to the implant, effectively improving the success rate of the surgery.

[0014] More preferably, the limiting seat includes a connected distal receiving space and a proximal channel, and a limiting surface facing the distal end is provided at the connection point, with the distal end of the proximal channel located at the center of the limiting surface;

[0015] The proximal channel has a circular cross-section and a first radial dimension;

[0016] The limiting element includes a proximal end face and has a second radial dimension that is larger than the first radial dimension.

[0017] The center of the limiting surface facing distally is the distal end of the proximal channel of the limiting seat, from which the core wire body extends proximally along the inner lumen of the delivery catheter body. The first radial dimension of the proximal channel is smaller than the second radial dimension of the proximal surface of the limiting element. By restricting the limiting element, the limiting surface ensures that the core wire does not shift proximally relative to the delivery tube during implant delivery, thus maintaining a smooth and stable delivery process. On the other hand, the proximal channel provides good support for the core wire, thereby enhancing delivery efficiency.

[0018] More preferably, the limiting element further includes a distal surface and a guide surface, wherein the guide surface is a circumferential surface between the proximal surface and the distal surface;

[0019] The distal end face has a third radial dimension, which is larger than the second radial dimension.

[0020] In this technical solution, the limiting element is equipped with a guide surface. The circumferential cross-sectional dimension of the guide surface decreases from the distal end to the proximal end, which facilitates the core wire to pull the limiting element into the limiting seat, making the operation convenient and reducing surgical risks.

[0021] More preferably, the core wire further includes a support element disposed between the limiting element and the connecting element.

[0022] By placing a support element between the limiting element and the connecting element, a certain buffer space can be provided between the limiting seat and the implant during delivery. The possible slight movement of the core wire will not affect the implant, and the delivery efficiency will be improved to a certain extent. When the core wire and the implant need to be separated, the supporting force of the support element on the connecting element makes it easier for the force applied by the bundle to the proximal end of the core wire to be transmitted to the distal end, thus improving the separation efficiency.

[0023] Specifically, the support element includes a rod, the axial length of which is not less than the axial length of the connecting element.

[0024] This technical solution, with a rod of a certain length, can ensure buffer space and better support force, further enhancing the technical effect of the support element.

[0025] Specifically, the support element includes at least one steering device that can swing in a radial direction, with the maximum swing amplitude forming an angle of 10-50° with the central axis of the limiting element.

[0026] In this technical solution, the steering device is located at the distal end of the core wire, providing a deflectable angle with a defined orientation. On the one hand, it takes into account the support force requirements of the support element, and on the other hand, it provides additional flexibility to the distal end of the core wire, further reducing the force exerted by the core wire on the implant. On the other hand, it enhances the navigation performance of the distal end of the delivery device, which helps the surgeon to select a better implantation position for the implant, thereby improving the success rate and efficiency of the surgery.

[0027] More preferably, the limiting seat further includes at least two grooves distributed axially on the inner wall of the limiting seat;

[0028] The limiting element also includes at least two additional guide elements that axially conform to the guide surface along the trend of the guide surface and are adapted to the groove.

[0029] This technical solution further limits the relative rotation between the limiting element and the limiting seat, that is, it limits the relative rotation between the delivery tube and the core wire in the delivery state. On the one hand, it improves delivery efficiency; on the other hand, when the core wire needs to be separated from the implant, the delivery tube and the core wire can return to the delivery state, improving separation efficiency.

[0030] More preferably, the delivery tube body includes a spring surrounding the inner cavity; and / or

[0031] The core wire body includes a spring.

[0032] A delivery system includes a delivery conduit and any of the delivery devices described above.

[0033] The technical advantages of this utility model are as follows:

[0034] A novel delivery catheter with a through-lumen is designed, with the core wire inserted within the catheter's lumen. The distal end of the core wire is restrained, and its connecting element extends beyond the distal end of the catheter, detachably connecting to the implant. During delivery, the core wire does not shift proximally relative to the delivery catheter, facilitating a smooth delivery process. When the implant is placed at the lesion site, the delivery tube's restraining seat moves away from the core wire's restraining element, allowing only the smaller core wire to act on the implant. This reduces the force exerted by the delivery device on the implant, enabling the surgeon to observe more accurate implantation results and allowing for the retrieval and repositioning of implants with substandard results, improving surgical effectiveness and reducing surgical risk. Once the surgeon confirms successful implantation, the core wire's connecting element is separated from the implant, and the core wire and delivery tube are withdrawn from the body in the delivered state, further reducing the surgical risk during device removal. Attached Figure Description

[0035] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments:

[0036] Figure 1 This is a schematic diagram of the delivery system and implant structure according to a specific embodiment of the present invention;

[0037] Figure 2 This is a schematic diagram of the delivery device in the delivery state according to a specific embodiment of the present invention;

[0038] Figure 3 This is a cross-sectional structural diagram of the delivery device in the delivery state according to a specific embodiment of the present invention.

[0039] Figure 4 This is a schematic diagram of the delivery device of a specific embodiment of the present invention in the implantation state;

[0040] Figure 5This is a schematic diagram of the delivery system and implant in the implantation state according to a specific embodiment of the present invention;

[0041] Figure 6 This is a schematic diagram of the structure of the limiting seat and limiting element in the delivery state according to a specific embodiment of the present invention;

[0042] Figure 7 This is a schematic diagram of the steering device according to a specific embodiment of the present invention;

[0043] Figure 8 This is a cross-sectional structural schematic diagram of a limiting element according to a specific embodiment of the present invention;

[0044] Figure 9 This is a schematic diagram of the steering device during deflection according to a specific embodiment of the present invention;

[0045] Explanation of icon numbers:

[0046] 10-Left atrial appendage occluder; 11-Occlusion assembly; 12-Catching assembly; 121-First catch-up element; 122-Second catch-up element; 123-Third catch-up element; 20-Delivery system; 21-Delivery conduit; 22-Delivery tube; 23-Core wire; 221-Limiting seat; 222-Delivery tube body; 223-Delivery tube body inner cavity; 231-Limiting element; 232-Supporting element; 233-Connecting element; 234-Core wire body; 2211-Accommodation space; 2212-Channel; 2213-Limiting surface; 2311-Proximal surface; 2312-Distal surface; 2313-Guide surface; 2314-Additional guide element; 2321-First steering device; 2322-Second steering device; 2323-Shaft; 23211-Swing arm; 23212-Block. Detailed Implementation

[0047] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0048] To keep the drawings concise, each drawing only schematically represents the parts relevant to the application; these do not represent the actual structure of the product. Furthermore, for ease of understanding, in some drawings, components with the same structure or function are shown only schematically, or only one is labeled. In this document, "one" can mean not only "only one" but also "more than one."

[0049] It should also be further understood that the term “and / or” as used in this application specification and the appended claims means any combination of one or more of the associated listed items and all possible combinations, and includes such combinations.

[0050] In this document, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0051] In the embodiments shown in the accompanying drawings, the directional indications (such as up, down, left, right, front, and back) are relative rather than absolute when describing the structure and movement of the various components, and are not intended to limit the direction of the product during actual use.

[0052] In the embodiments of this application, "proximal" and "distal" are used to describe the position or orientation of the associated (or described) object (hereinafter referred to as the associated object) relative to the operator from the perspective of the operator (e.g., a doctor or surgeon). For example, "proximal" refers to the end closer to the operator during normal operation of the medical device; "distal" refers to the end further away from the operator during normal operation of the medical device, or the end that first enters the patient's body. For example, the "proximal" of A refers to the end of A closer to the operator; the "distal" of A refers to the end of A further away from the operator. Alternatively, the "proximal" of A refers to the end of A further away from the patient (or the affected area, or the occluder implantation site); the "distal" of A refers to the end of A closer to the patient (or the affected area, or the occluder implantation site).

[0053] The delivery device and conveying system provided in this application, such as Figures 1-3 As shown, the implant 10 and the delivery system 20 constitute an interventional treatment system. The delivery catheter 21 is used to establish a passage in a blood vessel, and the delivery device is connected to the implant 10 to deliver the implant 10 along the delivery catheter 21 to the lesion site.

[0054] At this time, the delivery device is in the delivery state. The delivery tube 22 has a limiting seat 221, a delivery tube body 222 and an inner cavity 223 that penetrates the delivery tube body. The body 234 of the core wire 23 passes through the inside of the delivery tube 22. The limiting element 231 is located in the limiting seat 221. The connecting element 233 is at the farthest end of the core wire 23, extends out of the far end of the limiting seat 221, and is detachably connected to the implant 10.

[0055] During the procedure, the delivery device delivers the implant 10 in the delivery state. The limiting seat 221 of the delivery tube 22 cooperates with the limiting element 231 of the core wire 23 to prevent the core wire 23 from displacing proximally relative to the delivery tube 22. The delivery tube and the core wire are relatively fixed, working together to deliver the implant to the target position. At this time, the delivery device is similar to a solid structure, which is beneficial for transmitting the pushing force and torque applied by the surgeon to the delivery device, thus improving delivery efficiency.

[0056] The delivery device also has an implantable state, such as Figure 4 As shown, the implant 10 is placed at or near the lesion site (not shown in the figure). The surgeon can pull the delivery tube 22 proximally, moving it a suitable distance. At this time, the limiting element 231 moves away from the limiting seat 221, and the distal portion of the core wire body 234 extends beyond the distal end of the delivery tube 22. Understandably, pushing the core wire 23 distally also achieves the same effect. The surgeon can choose the appropriate operating method and the distance by which the distal portion of the core wire 23 extends beyond the distal end of the delivery tube 22, depending on the surgical environment and type.

[0057] At this point, the limiting seat 221 of the delivery tube 22 separates from the limiting element 231 of the core wire 23. Only the smaller core wire 23 may exert an effect on the implant 10, thus minimizing the force exerted by the delivery device on the implant 10. This facilitates the surgeon's observation of a more accurate implantation effect and allows for the retrieval and repositioning of implants with substandard implantation results, improving surgical effectiveness and reducing surgical risks. Once the surgeon confirms successful implantation, the connecting element 233 of the core wire 23 is separated from the implant 10, and the core wire 23 and delivery tube 22 are withdrawn from the body in a delivered state, further reducing the surgical risks during the withdrawal of the delivery device.

[0058] like Figure 5 As shown, when the delivery device is implanted and neither the implant 10 nor the delivery system 20 is constrained by external forces, the core wire 23 can be bent by the weight of the implant 10. Therefore, the core wire 23 exerts a small force on the implant 10 when there is no external force.

[0059] In some embodiments, a more flexible distal portion of the core wire body 234 can be provided to further reduce the force exerted by the core wire 23 on the implant 10 in the implanted state. The proximal portion of the core wire body 234 can be more rigid than the distal portion to facilitate the transmission of pushing force for delivery of the implant 10. In a preferred embodiment, the distal portion of the core wire body 234 employs a spring structure, which can account for 20% or more of the overall length of the core wire body 234. Understandably, the core wire body 234 can also use the same material and structure from proximal to distal.

[0060] like Figure 3 , Figure 5 and Figure 8 As shown, the delivery tube 22 can be a microcatheter, made of materials such as block polyetheramide resin, PTFE, PU, ​​and nylon. The delivery tube body 222 has better rigidity than the core wire body 234, so as to play a more important delivery role in the delivery state. In a preferred embodiment, the inner cavity 223 of the delivery tube body can be formed by a spring. The delivery tube body 222 can be composed of only springs, taking into account both delivery performance and flexibility. Alternatively, the aforementioned polymer materials can be stacked on the outside of the springs to form a reinforced delivery tube 22.

[0061] In some embodiments, such as Figure 3 The implant 10 is a left atrial appendage occluder, having an occlusion component 11 and a convergence component 12. In a preferred embodiment, the occlusion component 11 can be configured as two independent parts, and the convergence component 12 includes a first convergence element 121 that converges the distal portion of the occlusion component 11, a second convergence element 122 that connects the two portions of the occlusion component 11, and a third convergence element 123 that converges the proximal portion of the occlusion component 11; at the proximal end of the third convergence element 123, a connection position can be provided for fitting and connecting with the connecting element 231 of the core wire 23, and it is detachable.

[0062] More specifically, such as Figure 6 and Figure 9 As shown, the limiting seat 221 located at the distal end of the delivery tube 22 has a distal receiving space 2211 and a proximal channel 2212 inside, which are interconnected and together with the inner cavity 223 of the delivery tube body form the inner cavity through which the delivery tube 22 passes. In a preferred embodiment, a limiting surface 2213 is provided at the connection position between the distal receiving space 2211 and the proximal channel 2212. The distal end of the proximal channel 2212 starts from the limiting surface. The cross-section of the proximal channel 2212 is approximately circular and has a first radial dimension. The contour dimension of the limiting element 231 of the core wire 23 can be accommodated within the distal receiving space 2211. The proximal surface 2311 has a second radial dimension, which is larger than the first radial dimension of the proximal channel 2212. The core wire body 234 is connected to the proximal surface 2311. Therefore, in the delivery state, the core wire body 234 extends proximally from the distal end of the proximal channel 2212, and the core wire body 234 does not move proximally relative to the delivery tube 22. The delivery tube 22 and the core wire 23 jointly deliver the implant 10, which is beneficial to improving delivery efficiency.

[0063] The limiting element 231 also has a distal surface 2312 with a third radial dimension that is larger than the second radial dimension, so as to form an inclined guide surface 2313, making the axial cross section of the limiting element 231 approximately frustum-shaped, which is conducive to the entry of the limiting element 231 into the limiting seat 221, thereby improving the efficiency of forming a delivery state during surgery, increasing the success rate of surgery, and reducing surgical risks.

[0064] In other embodiments, at least two additional guide elements 2314 may be provided axially on the surface of the guide surface 2313. In a preferred embodiment, there are two additional guide elements 2314, symmetrically distributed with respect to the central axis of the limiting element 231. Each additional guide element 2314 may be wedge-shaped, with its side facing the guide surface 2313 in close contact with the surface of the guide surface 2313. Correspondingly, at least two grooves are provided on the wall of the distal receiving space 2211 of the limiting seat 221 to accommodate the two additional guide elements 2314. At this time, when the limiting element 231 enters the limiting seat 221, the additional guide elements 2314 enter the grooves, restricting the relative rotation of the limiting element 231 with respect to the limiting seat 221. That is, in the delivery state, the relative rotation between the core wire 23 and the delivery tube 22 is also restricted, which is more conducive to the stability of the delivery process. When the implantation effect is satisfactory and the delivery device needs to remove the implant 10, it is also beneficial to transmit the torque applied by the surgeon and improve the removal efficiency.

[0065] More specifically, a support element 232 can also be provided between the limiting element 231 and the connecting element 233. In a preferred embodiment, the support element 232 is a solid rod, with its proximal end connected to approximately the center position of the distal end face 2312 of the limiting element 231, and its axial length is not shorter than that of the connecting element 233, ranging from 2 to 6 mm. With this configuration, during delivery, the support element 232 helps to transmit pushing force or torque, and even slight axial displacement between the core wire 23 and the delivery tube 22 does not affect delivery efficiency. During the separation of the delivery device from the implant 10, the support element 232 also facilitates timely transmission of pulling force or torque, improving separation efficiency.

[0066] In some embodiments, such as Figures 7-9As shown, the support element 232 may have one or more steering devices, preferably 1-3. In a preferred embodiment, the support element 232 has a first steering device 2321, a second steering device 2322, and a shaft 2323. The structures of the two steering devices can be similar. Taking the first steering device 2321 as an example, it includes two swing arms 23211 and a block 23212. The swing arms 23211 can be symmetrically distributed on both sides of the block 23212. The shaft 2323 connects the ends of the two swing arms 23211. The shaft dimension of the second steering device 2322 can be larger than that of the shaft 2323, and it can have a through hole in the middle, the size of which is just enough for the shaft 2323 to pass through and rotate. In this way, the swing arms of the first steering device 2321 and the second steering device 2322 are perpendicularly distributed and can swing relative to each other in one direction. When the second steering device 2322 is fixed, the maximum swing amplitude of the first steering device 2321 is 10-50° on one side of the radial direction relative to the axis of the second steering device 2322. The steering mechanism provides greater flexibility to the distal end of the core wire 23, limiting the deflection angle of the orientation. On the one hand, it takes into account the support force requirements of the support element, and on the other hand, it provides additional flexibility to the distal end of the core wire, further reducing the force of the core wire on the implant. On the other hand, it enhances the navigation performance of the distal end of the delivery device, which helps the surgeon to select a better implantation position for the implant, thereby improving the success rate and efficiency of the surgery.

[0067] The delivery device can be adjusted according to the target organ, delivery method, and type of implant 10, and all adjusted solutions are within the protection scope of this patent. Structures on the implant 10 and the delivery device that can function as connections, position adjustments, or separations can all be used as connection structures in this patent.

[0068] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of this patent.

Claims

1. A delivery device for delivering and retrieving implants, characterized in that, include: The delivery tube has a through-cavity inside, including the delivery tube body and the distal limiting seat; The core wire includes a core wire body, a limiting element, and a connecting element. The core wire body is arranged in the inner cavity, and the connecting element extends from the distal end of the delivery tube and can be detachably connected to the implant. In the delivery state, the limiting element is housed in the limiting seat to restrict the core wire from moving proximally relative to the delivery tube; In the implanted state, the limiting element is separated from the limiting seat, and the distal portion of the core wire body extends beyond the distal end of the delivery tube.

2. The delivery device according to claim 1, characterized in that: The core wire body includes at least a flexible distal segment with a stiffness lower than that of the delivery tube body.

3. A delivery device according to claim 2, characterized in that: The limiting seat includes a connected distal receiving space and a proximal channel, and a limiting surface facing the distal end is provided at the connection point, with the distal end of the proximal channel located at the center of the limiting surface. The proximal channel has a circular cross-section and a first radial dimension; The limiting element includes a proximal end face and has a second radial dimension that is larger than the first radial dimension.

4. A delivery device according to claim 3, characterized in that: The limiting element further includes a distal surface and a guide surface, wherein the guide surface is a circumferential surface between the proximal surface and the distal surface; The distal end face has a third radial dimension, which is larger than the second radial dimension.

5. A delivery device according to claim 4, characterized in that: The core wire also includes a support element disposed between the limiting element and the connecting element.

6. A delivery device according to claim 5, characterized in that: The support element includes a rod, the axial length of which is not less than the axial length of the connecting element.

7. A delivery device according to claim 5, characterized in that: The support element includes at least one steering device that can swing in a radial direction, with the maximum swing amplitude having an angle of 10-50° between it and the central axis of the limiting element.

8. A delivery device according to claim 4, characterized in that: The limiting seat also includes at least two grooves distributed axially on the inner wall of the limiting seat; The limiting element also includes at least two additional guide elements that axially conform to the guide surface along the trend of the guide surface and are adapted to the groove.

9. A delivery device according to claim 2, characterized in that: The delivery tube body includes a spring surrounding the inner cavity; and / or The core wire body includes a spring.

10. A conveying system, characterized in that: It includes a delivery conduit and a delivery device as described in any one of claims 1-9.

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