Implants and Implant Delivery Systems

Abstract

This invention relates to an implant and an implant delivery system. The implant delivery system further includes a delivery device. The delivery device includes a connecting tube, a locking rod, and at least one connecting wire. The connecting tube has a cavity and at least one through-hole. The locking rod passes through the cavity. The connecting wire has at least one locking part, which is detachably connected to the locking rod. The connecting wire passes through the through-hole, exits from the connecting tube, passes through a through-hole on the implant, and then enters the connecting tube through the same or another through-hole. When the at least one locking part is connected to the locking rod, the connecting wire connects the implant and the locking rod. The flexible connection between the implant and the delivery system via the connecting wire provides better conformability and prevents positional deviations after implant release.

Description

Technical Field

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

[0002] Existing implants (such as filters, valves, stents, and occluders) are generally connected to the delivery device via a threaded connection. This involves welding a threaded connector to the proximal end of the implant, which then connects to a steel cable in the delivery device. After the implant is delivered to the target location and the sheath covering it is removed, the doctor operates a proximal handle to rotate the steel cable, thus separating it from the implant. This connection structure results in a rigid connection between the implant and the cable. When the delivery device passes through a curved blood vessel, the connection point between the implant and the cable is difficult to bend, increasing the difficulty of navigating such a vessel. Furthermore, rigid connections such as threaded or snap-fit ​​connections limit the compliance of the delivery device and implant within the blood vessel, easily leading to positional deviations after implant release. For implants that are ejected directly without being connected to the delivery device, significant forward bounce occurs during release, also resulting in positional deviations after deployment. Summary of the Invention

[0003] Therefore, it is necessary to provide an implant delivery system that enables the implant and delivery device to pass through blood vessels with greater compliance, avoiding positional deviations after the implant is released.

[0004] The present invention provides an implant, comprising: a main body and a hollow connector; the connector is disposed at the proximal end of the stent for detachable connection with an external delivery device; the connector is provided with at least two through holes, both of which communicate with a cavity within the connector.

[0005] In one embodiment, one of the through holes is disposed on the proximal end face of the connector, and the remaining through holes are disposed on the circumferential surface of the connector.

[0006] In one embodiment, the implant is a filter.

[0007] The present invention also provides an implant delivery system, the implant delivery system comprising a delivery device and the aforementioned implant. The delivery device includes a connecting tube, a locking rod, and at least one connecting wire;

[0008] The connecting pipe has a cavity inside and at least one wire through hole on it.

[0009] The locking rod passes through the cavity and can move axially along the cavity under the action of external force;

[0010] The connecting line is provided with at least one locking part, which is detachably connected to the locking rod. The connecting line passes through the wire hole from the connecting tube and through the through hole on the implant to connect the implant and the connecting line. The connecting line then enters the connecting tube through the same wire hole or another wire hole. When the at least one locking part is connected to the locking rod, the connecting line connects the implant and the locking rod.

[0011] In one embodiment, the locking part is a ring structure or a semi-ring structure formed by folding a connecting line in half.

[0012] In one embodiment, the implant delivery system further includes a suffocating element fixedly connected to the locking rod and moving axially along the connecting tube with the locking rod; the suffocating element is interference-fitted with the inner wall of the connecting tube to prevent liquid from flowing out of the connecting tube.

[0013] In one embodiment, the sealing element is made of one or more materials selected from rubber, silicone, and elastic polymers.

[0014] In one embodiment, the sealing member is provided with a wire passage, the connecting wire passes through the wire passage and is interference-fitted with the wire passage, and the connecting wire can move relative to the sealing member along the wire passage under the action of external force.

[0015] In one embodiment, the end of the connecting line away from the locking part is fixedly connected to the sealing member.

[0016] In one embodiment, a limiting member is provided on the connecting line, the maximum outer diameter of the limiting member being greater than the diameter of one or more through holes through which the connecting line passes, and the maximum outer diameter of the limiting member being smaller than the diameter of the through hole.

[0017] In the implant delivery system of the present invention, the implant is detachably connected to the locking rod via a connecting wire, allowing the implant to be connected to the delivery device via the flexible connecting wire during delivery. The connection between the implant and the delivery device can be bent arbitrarily to adapt to different blood vessels in the human body. After the implant reaches the release position, it conforms to the shape of the blood vessel to avoid deviation in position after release. Attached Figure Description

[0018] Figure 1 This is a perspective view of the filter in the implant delivery system of the present invention.

[0019] Figure 2 This is a perspective view of the implant delivery system of Embodiment 1 of the present invention.

[0020] Figure 3 for Figure 2 Enlarged view of point A in the middle.

[0021] Figure 4 This is a schematic diagram of the implantation device of Embodiment 1 of the present invention when the locking part is connected to the locking rod.

[0022] Figure 5 This is a schematic diagram of the implantation device of Embodiment 1 of the present invention when the locking part and the locking rod are detached.

[0023] Figure 6 This is a schematic diagram of the implantation device of Embodiment 1 of the present invention when the connecting wire is detached from the filter.

[0024] Figure 7 This is a schematic diagram of another connecting wire winding method for the implant delivery system of Embodiment 1 of the present invention.

[0025] Figure 8 This is a schematic diagram of the implant delivery system of Embodiment 2 of the present invention.

[0026] Figure 9 This is a schematic diagram of the conveying device according to Embodiment 2 of the present invention.

[0027] Figure 10 This is a schematic diagram of the implant delivery system of Embodiment 3 of the present invention. Detailed Implementation

[0028] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0029] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0030] To more clearly describe the structure of the implant delivery device, the terms "distal" and "proximal" are used here, which are conventional terms in the field of interventional medical devices. Specifically, "distal" refers to the end furthest from the operator during the procedure, and "proximal" refers to the end closest to the operator during the procedure.

[0031] The delivery system of the present invention includes a delivery device and an implant, wherein the delivery device can implant the implant into a designated location in the human body. The implant may be a luminal stent, a heart valve, a filter, or other medical device that needs to be contained within the delivery device before entering the body and released upon reaching the designated location. To further illustrate the implant delivery device and delivery system of the present invention, an embodiment of the present invention uses a filter as an example; please refer to [link to relevant documentation]. Figure 1 The filter 1 of the present invention includes a main body 11 and a hollow connector 12. The connector 12 is disposed at the proximal end of the main body 11 and is used for detachable connection with an external conveying device. The connector 12 has at least two through holes 121, both of which communicate with a cavity 122 within the connector. In some embodiments, one of the through holes 121 on the connector 12 is disposed on the proximal end face of the connector 12, and the remaining through holes 121 are disposed on the circumferential surface of the connector 12. For ease of description and distinction, the through hole 121 disposed at the proximal end of the connector 12 is called a proximal through hole 121a, and the through holes 121 disposed on the circumferential surface of the connector 12 are called circumferential through holes 121b.

[0032] The scaffold is made of a flexible material that is woven or laser-cut, such as biocompatible materials like stainless steel, nickel-titanium alloy, or cobalt-chromium alloy.

[0033] Example 1

[0034] like Figure 2 and Figure 3 As shown, the implant delivery system 2 of this embodiment includes a filter 1 and a delivery device 22, as follows: Figure 4 As shown, the conveying device 2 includes a connecting pipe 21, a locking rod 22, and at least one connecting wire 23. For ease of observation, Figures 4 to 7 The connecting pipe in the middle has been partially sectionally viewed.

[0035] The connecting pipe 21 has a cavity 211 inside, and at least one wire passage hole 212 is provided on the connecting pipe 21, which communicates with the cavity 211.

[0036] The locking rod 22 is inserted into the cavity 211 and can move axially along the cavity 211 under the action of external force.

[0037] The connecting line 23 is provided with at least one locking part 231, which is detachably connected to the locking rod 22. The connecting line 23 passes through the wire hole 212 from the connecting tube 21 and through the through hole 121 on the implant, and then enters the connecting tube 21 through the same wire hole 212 or another wire hole 212. When the at least one locking part 231 is connected to the locking rod 22, the connecting line 23 connects the filter 1 and the locking rod 22.

[0038] The locking lever 22 and the connecting line 23 are both connected to the handle (not shown in the figure) at the proximal end of the implant delivery system. The doctor can move the locking lever 22 and the connecting line 23 relative to the connecting tube 21 proximally by operating the handle.

[0039] In the implant delivery system of this application, because the locking part 231 of the connecting line 23 is connected to the locking rod 22, the connecting line 23 cannot detach from the connecting tube 21, thereby connecting the filter 1 and the delivery device 2 together. Furthermore, because the connecting line 23 is flexible, the connection between the filter and the delivery device 2 can be bent arbitrarily to adapt to different blood vessel curves within the human body. Especially for the filter 1, which needs to be delivered by the delivery device 2 to a position level with the inferior vena cava and renal vein for release, the connecting line 23 allows the filter 1 to conform to the shape of the blood vessel upon reaching the release position, preventing post-release deviation.

[0040] Specifically, the locking part 231 is a ring structure or a semi-ring structure formed by folding a connecting line 23 in half. In this embodiment, the locking part 231 is a semi-ring structure formed by folding a connecting line 23 in half. Figure 4 As shown, when the locking part 231 passes through the threading hole from the outside of the connecting tube 21 into the inside and is fitted onto the locking rod 22, as long as the locking rod 22 and the connecting tube 21 do not move relative to each other, the locking part 231 will be difficult to disengage from the locking rod 22, that is, the locking part 231 and the locking rod 22 are in a connected state. Figure 5 As shown, when the doctor operates the handle to move the locking lever 22 proximally relative to the connecting tube 21 until the locking part 231 disengages from the locking lever 22, the locking lever 22 and the locking part 231 are in a separated state. After the locking lever 22 is separated from the connecting line 23, as... Figure 6 As shown, at this time, the doctor can remove the connecting wire 23 from the filter 1 by pulling the handle, thus completely releasing the filter 1.

[0041] In this embodiment, to ensure that the filter 1 experiences uniform force during the conveying and releasing processes, combined with Figure 3 and Figure 4 The filter 1 has four evenly distributed circumferential through holes 121a on its circumferential surface, and the connecting pipe 21 has four wire passage holes 212. The conveying device 2 includes two connecting wires 23. One connecting wire 23 passes through the filter 1 through two oppositely arranged circumferential through holes 121a and connects to the locking rod 22. The other connecting wire 23 passes through the filter 1 through two other oppositely arranged circumferential through holes 121a and connects to the locking rod 22. Therefore, the two connecting wires 23 are wrapped around the filter 1 in a cross shape, so that the filter 1 is subjected to uniform force. When the filter 1 is pulled into the sheath of the conveying system by the connecting wires 23, it can avoid tilting due to uneven force, thereby reducing the difficulty of sheathing. In this embodiment, the connecting pipe 21 is provided with four wire passage holes 212 for the connecting wires 23 to pass through, so that different parts of the connecting wires 23 will not interfere with or entangle with each other. In other embodiments, the same connecting wire 23 may also pass through the same wire hole 212 and into the connecting tube 21.

[0042] In other embodiments, the connecting wire 23 may enter the filter 1 through the proximal through-hole 121b and exit through one of the peripheral through-holes 121a on the filter 1. Accordingly, in this embodiment, the number of peripheral through-holes 121a is the same as the number of connecting wires 23. In other embodiments, the conveying device 2 may include fewer or more connecting wires 23, such as one, three, or more.

[0043] Furthermore, a distal through-hole 213 is provided at the distal end of the connecting pipe 21, and the distal through-hole 213 communicates with the cavity 211 of the connecting pipe 21. In the actual connection of the filter 1 and the conveying device 2, the locking part 231 is usually inserted into the connecting pipe 21 through the threading hole first, and then the locking rod 22 is passed through the locking part 231 to achieve the connection. The distal through-hole 213 facilitates observation of the position of the locking part 231, and if necessary, an external tool such as a wire can be inserted into the connecting pipe 21 through the distal through-hole 213 to adjust the position of the locking part 231.

[0044] like Figure 7As shown, in another method of winding the connecting wire 23 in the implant delivery system of this embodiment, the distal through hole 213 can also serve as the hole through which the connecting wire 23 passes. That is, the connecting wire 23 exits from the distal through hole 213, passes through the through hole on the filter 1, and then enters the connecting tube 21 through the wire passage hole 212. It should be noted that different winding methods of the connecting wire 23 in the connecting tube 21 can be freely combined with different winding methods of the connecting wire 23 in the filter 1, as long as the connecting wire 23 exits from the connecting tube 21, passes through the filter 1, enters the connecting tube 21, and connects with the locking rod 22.

[0045] Example 2

[0046] The main difference between the implant delivery system of Example 2 and Example 1 is that the delivery device 3 of this example includes only one connecting line 33, which is provided with two locking parts 331. The locking part 331 is a semi-ring structure formed by folding the connecting line 33 in half.

[0047] like Figure 8 and Figure 9 As shown (for ease of observation, Figures 8 to 9 (Partial cross-section of the connecting tube is shown). The connecting wire 33 is folded in half and passes through the distal through-hole 313 of the connecting tube 31, and then through the proximal through-hole 121b into the cavity 122 of the filter 1. Two parts of the connecting wire 33 pass through the two peripheral through-holes 121a, forming two semi-ring locking parts 331. The two locking parts 331 are re-entered into the connecting tube 31 through the two wire holes 312 of the connecting tube 31 and connected to the locking rod 32. In this embodiment, the implant delivery system uses only one connecting wire 33. Compared with using two or more connecting wires 33, using only one connecting wire 33 eliminates the need to pull multiple connecting wires 33 simultaneously when pulling the connecting wire 33 away from the filter 1. This not only facilitates the doctor's operation but also reduces the risk of tangling caused by an excessive number of connecting wires 33.

[0048] Example 3

[0049] The main difference between the implant delivery device in Example 3 and Example 1 is that, as Figure 10 As shown (for ease of observation, Figure 10 (Partial cross-sectional view of the connecting pipe is shown). The conveying device 4 also includes a sealing member 44, which is fixedly connected to the locking rod 42 and moves axially along the connecting pipe 41 with the locking rod 42. The sealing member 44 is interference-fitted with the inner wall of the connecting pipe 41 to prevent liquid from flowing out of the connecting pipe 41.

[0050] The sealing element 44 is made of one or more materials selected from rubber, silicone, and elastic polymers. It is biocompatible and has a certain sealing performance, preventing blood from flowing directly through the lumen 411 of the connecting tube 41. It should be noted that although the sealing element 44 is press-fitted with the connecting tube 41, it possesses a certain degree of deformability and can still move along the connecting tube 41 under external force. Furthermore, pulling the locking rod 42 and the sealing element 44 provides some resistance, thus preventing accidental activation.

[0051] Because the proximal end of the delivery device 4 extends outside the body, facilitating operation by the doctor, blood from the body flows through the through-hole 412 into the lumen 411 of the connecting tube, and then out of the body. By setting the sealing element 44, blood can be effectively prevented from flowing out of the body along the lumen 411 of the connecting tube, avoiding unnecessary blood loss during the operation.

[0052] In this embodiment, the end of the connecting line 43 away from the locking part 431 is fixedly connected to the sealing member 44. Therefore, when the locking rod 42 is moved proximally, as the locking rod 42 moves, the locking part 431 on the connecting line 43 disengages from the locking rod 42, and then the connecting line 43 is pulled away from the filter 1 by the sealing member 44, thereby completing the release of the filter 1. In this embodiment, the delivery device 4 combines the action of first pulling the locking rod 42 to unlock and then pulling the connecting line 43 to loosen into one action, simplifying the doctor's operation and shortening the operation time.

[0053] In this embodiment, as Figure 10 As shown, in this embodiment, a limiting member 432 is provided on the connecting line 43. The maximum outer diameter of the limiting member 432 is larger than the diameter of one or more through holes 121 through which the connecting line 43 passes, and the maximum outer diameter of the limiting member 432 is smaller than the diameter of the through hole 412. That is, at least one through hole 121 can prevent the connecting line 43 from continuing to advance through the through hole 121. Therefore, by controlling the length of the connecting line 43 portion between the locking part 431 and the limiting member 432, and controlling the length of the connecting line 43 portion between the limiting member 432 and the blocking member 44, it can be achieved that when the connecting line 43 portion between the locking part 431 and the limiting member 432 is in a taut state, the connecting line 43 portion between the blocking member 44 and the limiting member 432 is still in a slack state. Thus, when it is necessary to move the locking rod 42 to the proximal end, a jamming situation will not occur. Understandably, if the connecting line 43 is taut, the locking lever 42 may not be able to move to the proximal end, affecting the release of the filter 1.

[0054] In other embodiments, the sealing member is provided with a threading channel (not shown in the figure), through which the connecting wire passes and is interference-fitted with the threading channel. The connecting wire can move relative to the sealing member along the threading channel under external force. This structure with a threading channel avoids limitations.

[0055] Even if the guide rod is stuck, the threading channel still has the risk of leakage. It is necessary to precisely control the inner diameter of the threading channel 5 so that the connecting wire can move within the threading channel while minimizing the amount of leakage.

[0056] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0057] The embodiments described above are merely examples of several implementations of the present invention, and their descriptions are relatively specific and detailed.

[0058] However, this should not be construed as a limitation on the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the inventive concept, and these all fall within the scope of protection of this invention. Therefore, the scope of protection of this invention patent should be determined by the appended claims.

Claims

1. An implant delivery system, characterized in that, The device includes a delivery device and an implant. The implant includes a main body and a hollow connector. The connector is located at the proximal end of the main body and is used for detachable connection with an external delivery device. The connector has at least two through holes, both of which communicate with a cavity inside the connector. The delivery device includes a connecting tube, a locking rod, and at least one connecting wire. The connecting pipe has a cavity inside and at least one wire through hole on it. The locking rod passes through the cavity and can move axially along the cavity under the action of external force; The connecting line is provided with at least one locking part, which is detachably connected to the locking rod. The connecting line passes through the wire hole from the connecting tube and through the through hole on the implant to connect the implant and the connecting line. The connecting line then enters the connecting tube through the same wire hole or another wire hole. When the at least one locking part is connected to the locking rod, the connecting line connects the implant and the locking rod. The locking part is a ring-shaped structure or a semi-ring structure formed by folding a connecting line in half; The implant delivery system also includes a sealing element, which is fixedly connected to the locking rod and moves axially along the connecting tube with the locking rod; the sealing element is interference-fitted with the inner wall of the connecting tube to prevent liquid from flowing out of the connecting tube.

2. The implant delivery system according to claim 1, characterized in that, The sealing element is made of an elastic polymer material.

3. The implant delivery system according to claim 1, characterized in that, The sealing component is provided with a wire passage, the connecting wire passes through the wire passage and is interference-fitted with the wire passage, and the connecting wire can move relative to the sealing component along the wire passage under the action of external force.

4. The implant delivery system according to claim 1, characterized in that, The end of the connecting line away from the locking part is fixedly connected to the sealing member.

5. The implant delivery system according to claim 4, characterized in that, A limiting member is provided on the connecting line. The maximum outer diameter of the limiting member is greater than the diameter of one or more through holes through which the connecting line passes, and the maximum outer diameter of the limiting member is smaller than the diameter of the through hole.

6. The implant delivery system according to claim 2, characterized in that, The sealing element is made of one or more materials selected from rubber and silicone.

7. The implant delivery system according to claim 1, characterized in that, One of the through holes is located on the proximal end face of the connector, and the remaining through holes are located on the circumferential surface of the connector.

8. The implant delivery system according to claim 1, characterized in that, The implant is a filter.

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