Connecting structure and connecting method of implant and conveying system and implant system

Abstract

The invention relates to a connecting structure and a connecting method of an implant and a conveying system and an implant system. The connecting structure comprises a near-end part of the implant and a connecting part of the conveying system, the conductive wire of the conveying system penetrates through a pushing rod of the conveying system, the conductive wire is provided with a head end part extending out of the far end of the pushing rod, the head end part of the conductive wire is provided with a disengagement point, and at least part, at the far end of the disengagement point, of the head end part of the conductive wire is arranged in the near end part of the implant; the fixing wire is arranged in the near-end part of the implant and fixedly connected with the near-end part of the implant, and the fixing wire is combined with the head end part of the conductive wire to form a connecting hook; and the fixing part is connected with the near end part of the implant and the head end part of the conductive wire. Through the configuration, the connection strength between the implant and the delivery system is improved, normal release can be guaranteed when release is needed in the operation, and advanced unexpected release cannot occur in the delivery process and the repeated adjustment process in the operation.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a connection structure of an implant and a delivery system, a connection method and an implant system. BACKGROUND

[0002] With the rapid development of economy, people's material living standards are improving, but factors such as unhealthy living habits and the accelerating process of population aging have led to cardiovascular and cerebrovascular diseases becoming a common disease that seriously threatens people's life and health, and has shown a trend of younger onset. According to statistics from the World Health Organization, the number of people dying from cardiovascular and cerebrovascular diseases worldwide each year is as high as 150 million, ranking first among all causes of death.

[0003] Intracranial aneurysm is a common hemorrhagic cerebrovascular disease, which often occurs on the intracranial arterial wall and is the most common cause of subarachnoid hemorrhage, with an incidence rate only second to cerebral thrombosis and hypertensive cerebral hemorrhage. At present, intracranial aneurysm is usually treated by craniotomy clipping and endovascular embolization. As the name implies, craniotomy clipping requires craniotomy, which has great surgical risk, is highly traumatic and has many side effects, and patients have to endure great pain. Endovascular intervention has small incision and low surgical risk, and has few side effects. It reduces the impact of blood flow on the aneurysm vessel wall by placing a spring coil or aneurysm flow disrupter in the intracranial aneurysm, or placing a covered stent or dense mesh stent in the parent artery, thereby reducing the risk of rupture. However, in the parent artery, the patient needs to take double-antibiotic drugs for life after the stent is placed, which greatly increases the psychological burden and economic pressure of the patient. Spring coil or aneurysm flow disrupter embolization can promote thrombosis in the aneurysm and promote the healing of the aneurysm. Since it is placed inside the aneurysm, there is no foreign matter in the parent artery, so the patient does not need to take double-antibiotic drugs after surgery, which is an ideal treatment method.

[0004] At present, the release methods of spring coil and aneurysm flow disrupter products on the market are roughly divided into electrolytic release, thermal melting release, mechanical release and hydrolysis release (pressure release). Electrolytic release generally uses the positive and negative electrodes of a release device to enter the human body through metal rods or metal needles and then be electrified. The metal wire connecting the implant and the positive electrode rod is electrolyzed into metal ions in the blood, and then the metal wire breaks, achieving the release effect. Thermal melting release is to melt the connection section of the push rod and the implant by a heating coil to achieve the effect of releasing the implant, that is, to generate heat by electricity, and when the heat reaches a certain amount, the thermal fuse is melted to release the implant. Mechanical release is to achieve the release effect by operating a special mechanical structure. Water release (pressure release) is composed of a high-pressure syringe, an implant delivery tube and an implant, and is to release the implant by injecting a solvent into the delivery tube.

[0005] Regardless of the release method used, it is essential to ensure that before releasing the implant, the surgeon will typically adjust the placement and angle of the device within the aneurysm. After adjustment, the release action is performed, separating the implant from the push rod. This leaves the implant within the aneurysm while the push rod is withdrawn from the body. This necessitates ensuring a sufficiently strong connection between the implant and the push rod before release to prevent premature or unexpected release during the procedure, and that the implant and push rod can be successfully released after the release action.

[0006] However, the following problems still exist in the existing related technologies: (1) Thermal melting release: Smoke will be generated during thermal melting, which may cause local damage to the human body; (2) The stability of mechanical release is relatively insufficient; (3) Water release: There is a problem of unstable release, and the injection of solvent can easily increase the pressure of blood vessels. If the amount of solvent injected is insufficient, it cannot reach the position that can cause the implant to be released; (4) The existing intratumoral disturbance device generally has a large resistance. Under normal circumstances, it needs to be released after reaching the lesion site. Moreover, it often needs to be adjusted and released repeatedly during the operation. The currently commonly used electric release connection method has low connection area strength, which can easily lead to premature and unexpected release and breakage during the operation.

[0007] It should be noted that the information disclosed in the background section of this application is intended only to enhance the understanding of the general background of this application, and should not be construed as an admission or in any way implying that the information constitutes prior art known to those skilled in the art. Summary of the Invention

[0008] The purpose of this application is to provide a connection structure, connection method and implant system for an implant and a delivery system, which aims to increase the connection strength between the implant and the delivery system, ensure normal release when release is required during the operation, and ensure that premature and unexpected release does not occur during the delivery process and repeated adjustments during the operation.

[0009] To achieve the above objectives, this application provides a connection structure between an implant and a delivery system, comprising:

[0010] The proximal portion of the implant;

[0011] The conductive wire of the delivery system passes through the push rod of the delivery system and has a head end portion extending beyond the distal end of the push rod. The head end portion of the conductive wire is provided with a release point, and at least a portion of the head end portion of the conductive wire distal to the release point is disposed within the proximal portion of the implant.

[0012] A fixing wire, wherein the fixing wire is disposed within the proximal portion of the implant and is fixedly connected to the proximal portion of the implant, and the fixing wire is coupled to the tip portion of the conductive wire to form a connecting hook; and

[0013] A fixation part connects the proximal portion of the implant and the tip portion of the conductive wire.

[0014] Optionally, the proximal portion of the implant includes a proximal filament bundle and an outer structural member; the proximal filament bundle is formed by a plurality of braided filaments; the outer structural member covers the outside of the proximal filament bundle; the fixing wire is at least partially disposed in the proximal filament bundle and is fixedly connected to the fixing portion.

[0015] Optionally, the outer structural member is a developable structure, and / or the outer structural member is a ring structure.

[0016] Optionally, an adhesive is provided at the junction of the fixing wire and the head end of the conductive wire, and / or the fixing part is connected to the proximal part of the implant and the head end of the conductive wire by at least one of the following methods: bonding, welding, hot-melt connection, and mechanical structure fixing connection.

[0017] Optionally, the fixation part uses an adhesive to connect the proximal portion of the implant and the tip portion of the conductive wire, and a portion of the connecting hook is disposed in the proximal wire bundle, while another portion is disposed in the fixation part and wrapped with the adhesive; or, all of the connecting hooks are disposed in the fixation part and wrapped with the adhesive.

[0018] Optionally, the connection structure further includes: an inner structural member disposed within the proximal portion of the implant; and the fixation wire fixed to the inner structural member.

[0019] Optionally, the fixing wire is fixed to the inner structural member by at least one of winding, welding, hot melting and bonding.

[0020] Optionally, the inner layer structure is a ring structure, and / or the inner layer structure is a radiopaque structure.

[0021] Optionally, the inner structural member is configured to prevent the connecting hook from moving toward the distal end of the implant under unintended conditions, thereby preventing the release point from entering the proximal portion of the implant.

[0022] Optionally, the inner layer structure is an annular structure, the outer diameter of the connecting hook is D1, the inner diameter of the inner layer structure is d1, the diameter of the fixing wire is d2, D1>d1>2d2, and / or, the inner diameter of the outer layer structure is D2, the outer diameter of the inner layer structure is d3, D2>d3.

[0023] To achieve the above objectives, this application also provides a method for connecting an implant to a delivery system, comprising:

[0024] A fixation wire is placed inside the proximal portion of the implant and fixedly connected to the proximal portion of the implant.

[0025] The conductive wire of the conveying system is passed through the push rod of the conveying system, and the head end of the conductive wire extends beyond the far end of the push rod, and a release point is provided on the head end of the conductive wire.

[0026] The tip portion of the conductive wire is disposed at least partially distal to the release point within the proximal portion of the implant.

[0027] The fixing wire and the head end of the conductive wire are combined to form a connecting hook; and

[0028] The proximal portion of the implant and the tip portion of the conductive wire are connected by a fixation part.

[0029] Optionally, the proximal portion of the implant includes a proximal filament bundle and an outer structural member; the proximal filament bundle is formed by the convergence of several braided filaments; the connection method further includes:

[0030] The outer structural member is wrapped around the outside of the proximal filament bundle, and the fixing wire is at least partially disposed in the proximal filament bundle and fixedly connected to the fixing part.

[0031] Optionally, the connection method further includes: applying an adhesive at the point where the fixing wire and the conductive wire meet.

[0032] Optionally, the connection method further includes:

[0033] An inner structural member is placed within the proximal portion of the implant, and the fixation wire is secured to the inner structural member.

[0034] Optionally, the connection method further includes:

[0035] The inner structural component is configured as a ring structure, and the outer diameter of the connecting hook is larger than the inner diameter of the inner structural component.

[0036] A portion of the fixing wire is inserted into the inner layer structure, thereby combining with the head end of the conductive wire to form the connecting hook, and the other portion of the fixing wire is disposed on the outside of the inner layer structure and fixedly connected to the fixing part.

[0037] To achieve the above objectives, this application also provides an implant system, which includes an implant, a delivery system, and a connection structure between the implant and the delivery system as described in any one of the claims.

[0038] Compared with the prior art, the connection structure, connection method, and implant system of the implant and delivery system provided in this application have at least the following advantages:

[0039] 1. By folding back the head end of the conductive wire extending beyond the distal end of the push rod and forming a connecting hook with the fixing wire, the friction between the conductive wire and the proximal part of the implant is increased. On the other hand, the proximal part of the implant can wrap the double-strand conductive wire, improving the bonding force between the conductive wire and the implant. Furthermore, the fixing wire is located at the distal end of the conductive wire, which can be used to prevent the conductive wire from coming out, further reducing the risk of the conductive wire slipping out of the implant during implant delivery.

[0040] Therefore, this application can greatly improve the connection strength of the connection area between the implant and the delivery system. Especially for products with increased resistance, it can ensure normal release when release is required during the operation, and can also ensure that premature and unexpected release will not occur during delivery and repeated adjustments during the operation.

[0041] 2. In further improvements, adhesive is added at the junction of the fixed wire and the conductive wire. The adhesive can increase the strength of the connecting hook and at the same time play an insulating role, preventing the insulation layer on the conductive wire from falling off and forming a circuit with the fixed wire, causing leakage, and increasing the reliability and safety of the structure.

[0042] 3. Further improvements include fixing the fixing wire to the inner structural component, which can indirectly increase the friction between the tip of the conductive wire and the proximal part of the implant, reducing the risk of the connecting hook coming out of the proximal part of the implant, thereby further increasing the connection strength of the connection area.

[0043] 4. Further improvements are underway. The inner structural components can also prevent the connecting hook from being pushed to the distal end of the implant under unexpected conditions, thereby avoiding the risk of the release point entering the proximal part of the implant and causing it to become unreleasable. Attached Figure Description

[0044] The accompanying drawings, which form part of this specification, are used to provide a further understanding of the embodiments of this application and to illustrate the implementation of this application, together with the textual description, to explain the principles of this application. Obviously, the drawings described below are merely some embodiments of this application.

[0045] Figure 1 This is a schematic diagram of the implant system in some embodiments of this application;

[0046] Figure 2 This is a schematic diagram of the connection between the implant and the push rod at the connection structure in some embodiments of this application;

[0047] Figure 3 This is a schematic diagram of the connection between the implant and the push rod in the comparative embodiment;

[0048] Figure 4 This is a schematic diagram showing the relevant dimensions of the connection structure in some embodiments of this application.

[0049] [Explanation of reference numerals in the attached figures]:

[0050] 1-Implant; 11-Proximal portion; 2-Delivery system; 21-Push rod; 211-Outer spring coil; 212-Inner spring coil; 213-Adhesive area; 22-Conductive wire; 23-Head end portion; 24-Release point; 3-Fixing wire; 4-Connecting hook; 5-Proximal wire bundle; 6-Outer structural component; 7-Fixing part; 8-Inner structural component; 10-Connecting structure; D1-Outer diameter of connecting hook; d1-Inner diameter of inner structural component; D2-Inner diameter of outer structural component; d2-Wire diameter of fixing wire; d3-Outer diameter of inner structural component. Detailed Implementation

[0051] To make the objectives, advantages, and features of this application clearer, the following detailed description is provided in conjunction with the accompanying drawings. It should be noted that the drawings are all in a very simplified form and use non-precise proportions, and are only used to facilitate and clarify the illustration of the embodiments of this application.

[0052] As used herein, the singular forms “a,” “an,” and “the” include plural objects unless otherwise expressly indicated. As used herein and in the appended claims, the term “or” is generally used to include “and / or” unless otherwise expressly indicated. The term “a plurality” is generally used to include two or more unless otherwise expressly indicated. The term “several” is used to include one or more unless otherwise expressly indicated.

[0053] Furthermore, in the following description, for ease of description, the terms "distal" and "proximal" are used; "proximal" is the end closer to the medical device operator; "distal" is the end farther from the medical device operator. Additionally, numerous specific details are provided in the following description to offer a more thorough understanding of this application. However, it will be apparent to those skilled in the art that this application can be practiced without one or more of these details. In other instances, certain technical features well-known in the art have not been described to avoid confusion with this application.

[0054] It should also be noted that the implants mentioned in this specification can be of various types, such as various sealing stents, intratumoral flow disruptors, or other implants. For convenience, a schematic diagram of a flow disruptor mesh is used in the accompanying drawings.

[0055] It should be understood that intratumoral disruptive devices generally have high resistance and normally need to be released only after reaching the lesion site. Therefore, it is necessary to ensure that the device can be released normally when needed during the operation, while also preventing premature or unexpected release during delivery and repeated adjustments during the operation. To ensure that premature or unexpected release does not occur during delivery, the connection strength between the implant and the push rod must be sufficiently high, that is, greater than the resistance during the device's push and retraction processes.

[0056] Therefore, the core of this application lies in improving the connection strength of the connection area between the implant and the delivery system. To this end, a connection structure, connection method and implant system for the implant and the delivery system are provided.

[0057] The connection structure, connection method, and implant system provided in this application are particularly suitable for high-resistance products such as intratumoral flow disturbance devices. The following description is in conjunction with the accompanying drawings.

[0058] Figure 1 This is a schematic diagram of the structure of an implant system according to some embodiments. Figure 2 This is a schematic diagram of the connection between the implant 1 and the delivery system 2 according to some embodiments at the connection structure 10.

[0059] like Figure 1 and Figure 2 As shown, the implant system includes an implant 1, a delivery system 2, and a connecting structure 10; the implant 1 includes a proximal portion 11; the delivery system 2 includes a push rod 21 and a conductive wire 22; wherein the proximal portion of the implant 1 and the push rod 21 of the delivery system 2 are connected at the connecting structure 10. The connecting structure 10 may include: the proximal portion 11 of the implant 1; the conductive wire 22 of the delivery system 2; a fixing wire 3; and a fixing part 7.

[0060] The conductive wire 22 passes through the push rod 21 and has a tip portion 23 extending beyond the distal end of the push rod 21. The conductive wire 22 is long enough to extend from the proximal end of the push rod 21 through its distal end to the proximal end of the implant 1. A release point 24 is provided on the tip portion 23 of the conductive wire 22, and at least a portion of the tip portion 23 of the conductive wire 22 distal to the release point 24 is disposed within the proximal portion 11 of the implant 1. Specifically, at least a portion of the tip portion 23 of the conductive wire 22 distal to the release point 24 is fixedly connected to the proximal portion 11 of the implant 1. This fixed connection can be achieved through bonding, welding, knotting with auxiliary materials, heat fusion, or mechanical structural fixing, and can employ one or a combination of these methods. More preferably, the head portion 23 of the conductive wire 22 is bonded and fixed to the proximal portion 11 of the implant 1 at the distal end of the release point 24 (at least partially). This fixation method is simpler and more convenient.

[0061] The fixing wire 3 is primarily made of materials with high mechanical strength, including but not limited to common stainless steel wire, nickel-titanium wire, and other metal wires, and can also be a high-strength polymer wire. The fixing wire 3 is disposed within the proximal portion 11 of the implant 1 and is fixedly connected to the proximal portion 11 of the implant 1. This connection can be achieved through one or more combinations of methods such as bonding, welding, heat fusion, and mechanical fixation, and can be a direct or indirect connection. Furthermore, the fixing wire 3 combines with the tip portion 23 of the conductive wire 22 to form a connecting hook 4. Preferably, an adhesive is applied at the junction of the fixing wire 3 and the tip portion 23 of the conductive wire 22. The type of adhesive is not limited; for example, UV adhesive may be used.

[0062] Furthermore, the fixing part 7 connects the proximal portion 11 of the implant 1 and the tip portion 23 of the conductive wire 22. Optionally, the fixing part 7 connects the proximal portion 11 of the implant 1 and the tip portion 23 of the conductive wire 22 using at least one of the following methods: adhesive bonding, welding, heat fusion connection, and mechanical structure fixing connection. Additionally, the fixing part 7 can simultaneously connect the proximal portion 11 of the implant 1, the tip portion 23 of the conductive wire 22, and the fixing wire 3. It should be noted that the mechanical structure fixing described herein refers to various common fixing methods understood by those skilled in the art, such as threaded connections and snap-fit ​​connections, which are fixing methods achieved through the cooperation between structural features.

[0063] This application, by folding back the head end portion 23 of the conductive wire 22 and forming a connecting hook 4 with the fixing wire 3 which has high mechanical strength, greatly increases the friction between the conductive wire 22 and the proximal portion 11 of the implant 1. On the other hand, it allows the proximal portion 11 of the implant 1 to change from wrapping only a single strand of conductive wire 22 to wrapping a double strand of conductive wire 22 (because the head end portion 23 of the conductive wire 22 is folded back to form a double strand), thereby greatly improving the bonding force between the conductive wire 22 and the implant 1.

[0064] Specifically, the implant 1 is preferably made of braided filaments, which can converge at the proximal portion 11 of the implant 1 to form a wire bundle. The wire bundle can accommodate the tip portion 23 of the conductive wire 22 and the fixing wire 3. After forming the connecting hook 4, the friction between the conductive wire 22 and the braided filaments of the implant 1 can be increased. In particular, when the fixing part 7 uses adhesive to bond and fix the tip portion 23 of the conductive wire 22 and the proximal portion 11 of the implant 1, the adhesive can wrap the double-strand conductive wire 22, resulting in a stronger bond. In some embodiments, in addition to bonding and fixing the tip portion 23 of the conductive wire 22 and the proximal portion 11 of the implant 1, the fixing part 7 also further bonds and fixes the two ends of the fixing wire 3. This means that in addition to forming the connecting hook 4 at the distal end, the fixing wire 3 and the tip portion 23 of the conductive wire 22 are further fixed at the proximal end by the fixing part 7, increasing the overall connection strength of the connection structure.

[0065] For ease of understanding, Figure 3 A comparative embodiment is provided in which the tip 23 of the conductive wire 22 is not bent and there is no fixing wire 3. In this case, the tip 23 is directly inserted into the wire bundle of the proximal portion 11. In this case, the friction between the conductive wire 22 and the braided wire is very small. For products with high resistance, the adhesive force provided by the glue at the proximal end of the implant 1 to bind the conductive wire 22 is far from sufficient. When the product is repeatedly pushed and pulled before or during the operation, the tip 23 of the conductive wire 22 is very easy to come out, causing premature and unexpected disengagement. Therefore, the "hook" connection method can greatly increase the connection strength between the implant 1 and the push rod 21.

[0066] After setting the fixing wire 3, it is equivalent to adding a component with a "buckle" function at the far end of the conductive wire 22 to prevent the conductive wire 22 from coming out, which can further increase the risk that the conductive wire 22 will slip out of the implant 1 during the pushing and pulling of the push rod 21.

[0067] In addition, if adhesive is applied at the junction of the fixing wire 3 and the head 23 of the conductive wire 22, the strength of the connecting hook 4 can be increased, and it also serves as insulation to prevent the insulation layer on the conductive wire 22 from falling off and forming a circuit with the fixing wire 3, causing leakage. In this case, the fixing wire 3 should be understood as a metal wire, so the reliability and safety of the structure are better.

[0068] As described above, the connection structure 10 can greatly improve the connection strength of the connection area between the implant 1 and the delivery system 2. Therefore, under the expected use conditions, the implant 1 and the push rod 21 will not easily separate from each other. However, when needed, the connection structure 10 can be electrolytically disconnected at the release point 24, so that the implant 1 and the push rod 21 can separate, thereby ensuring that it can be released normally when it is needed during the operation, and ensuring that there will be no premature or unexpected release during the delivery process and repeated adjustments during the operation.

[0069] The release point 24 is directly formed by the exposed metal wire of the conductive wire 22 at a preset position; that is, the release point 24 is formed without any insulating material on the conductive wire 22 at the preset position. Generally, after the positive and negative electrodes of the release device enter the human bloodstream through the conductive wire 22 and are energized, the exposed metal wire (release point 24) is electrolyzed into metal ions in the blood, and then the metal wire breaks, achieving the release effect. Those skilled in the art should know the implementation method of electro-release, and it will not be described in detail here.

[0070] In an embodiment where the implant 1 is made of braided filaments, the proximal portion 11 may include a proximal filament bundle 5 and an outer structural member 6. Several braided filaments converge at the proximal end of the implant 1 to form the proximal filament bundle 5, which is essentially a hollow wire bundle structure. The outer structural member 6 covers the outside of the proximal filament bundle 5 and can be used to bind the proximal filament bundle 5, preventing the braided filaments from unraveling. Additionally, the head end portion 23 of the conductive wire 22 and the fixing wire 3 can be connected via a fixing part 7.

[0071] Optionally, a fixing part 7 is provided at the proximal end of the outer structural member 6. The fixing part 7 is preferably connected to the proximal part 11 of the implant 1 and the tip part 23 of the conductive wire 22 by an adhesive.

[0072] In some embodiments, the conductive wire 22 is fixedly connected to the outer structural member 6 by bonding the head end portion 23 of the conductive wire 22 to the proximal portion 11 of the implant 1 through the fixing part 7. Furthermore, the fixing wire 3 is disposed within the hollow cavity of the proximal wire bundle 5. Specifically, a portion of the fixing wire 3 is disposed within the hollow cavity of the proximal wire bundle 5, and the proximal wire bundle 5 tightly wraps at least a portion of the fixing wire 3; another portion of the fixing wire 3 is disposed within the fixing part 7 and fixed with adhesive; or, all of the fixing wire 3 is disposed within the hollow cavity of the proximal wire bundle 5. This allows for the connection between the woven implant 1 (such as a turbulence-disrupting mesh) and the delivery system 2, and the assembly method is simple and easy to mass-produce.

[0073] The dimensions of the connecting structure 10 should also be configured to accommodate a catheter, which is a medical device used in conjunction with the implant system during surgery to deliver, withdraw, and release the implant, such as microcatheters, guiding catheters, intermediate catheters, access catheters, delivery sheaths, etc., of various sizes. For convenience, the term "catheter" is used throughout the specification. For example, the catheter may be 0.017 inches, 0.021 inches, 0.027 inches, or 0.033 inches or other sizes.

[0074] In practice, the outer diameter of the outer structural component 6 is the maximum size of the connecting structure 10. Therefore, the dimensions of other structures in the connecting structure 10 are all smaller than the outer diameter of the outer structural component 6. This makes the overall size of the connecting structure 10 smaller, which will not affect the pushing resistance of the product itself and can be transported in the conduit.

[0075] The outer structural component 6 can be any structure capable of covering the proximal filament bundle 5 without increasing the pushing resistance of the product. For example, the outer structural component 6 can optionally be a sleeve, a wound spring, or a block structure. In other words, the outer structural component 6 can be a circumferentially continuous annular structure or a circumferentially discontinuous open-loop structure, wherein the open-loop structure can overlap at the lateral opening after covering the proximal filament bundle 5.

[0076] The outer structural component 6 is preferably a radiopaque structure, specifically made of a radiopaque material. In this embodiment, the outer structural component 6 is a radiopaque ring (such as a platinum-iridium ring), which can serve as a marker at the proximal end of the implant 1. The outer structural component 6 is preferably a ring structure, such as a circumferentially continuous cannula or a wound spring; such a structure is simple and easy to assemble and use. The material of the outer structural component 6 can be any metal or polymer material suitable for long-term implantation; the specific material is not limited.

[0077] Return to reference Figure 2Preferably, the fixing part 7 is a structure formed after applying adhesive to the proximal end of the outer structural member 6. It serves both as an adhesive and a means of insulation between the conductive wire 22 and the outer structural member 6 when the outer structural member 6 is made of metal. The radial height of the fixing part 7 will not exceed the outer diameter of the outer structural member 6, and the release point 24 will not enter the fixing part 7, ensuring that the product can be released normally. The fixing part 7 can simultaneously connect the outer structural member 6, the end of the proximal wire bundle 5, the head end of the conductive wire 22, and the two ends of the fixing wire 3.

[0078] Continue to refer to Figure 2 In some embodiments, the push rod 21 may be provided with an outer spring coil 211, an inner spring coil 212, and a conductive wire 22 sequentially from the outside to the inside, but the specific structure of the push rod 21 is not limited to this. Optionally, an adhesive may also be applied to the distal end of the push rod 21 to form an adhesive area 213, which can bond and fix the conductive wire 22 and the push rod 21.

[0079] Furthermore, this application does not limit the specific assembly process of the connecting structure 10. For example, after combining the fixing wire 3 with the head end portion 23 of the conductive wire 22 to form a connecting hook 4, the connecting hook 4 is inserted into the proximal wire bundle 5. Then, the braided wire head end, the fixing wire head end, and the conductive wire head end are assembled and fixed together with the outer structure member 6 through the fixing part 7. In other ways, after forming the connecting hook 4, it is not necessary to insert the connecting hook 4 into the proximal wire bundle 5; it is sufficient to apply glue to the proximal end of the outer structure member 5 to wrap the conductive wire 22. In fact, various measures can be used to fix the fixing wire 3, the head end portion 23 of the conductive wire 22, and the outer structure member 6 together, and it is not limited to the situation described here.

[0080] Therefore, after assembly, the connecting hook 4 can be partially disposed in the proximal filament bundle 5, and the other part disposed in the fixing part 7 and preferably wrapped with adhesive; or, the connecting hook 4 can be entirely disposed in the fixing part 7 and preferably wrapped with adhesive. In short, the connecting hook 4 should not be exposed.

[0081] To further increase the connection strength in the connection area, in some embodiments, the connection structure 10 may further include an inner layer structure 8 disposed within the proximal portion 11 of the implant 1. For example, in this embodiment, the inner layer structure 8 is disposed within the hollow cavity of the proximal filament bundle 5. This allows the fixing wire 3 to be further fixed to the inner layer structure 8, indirectly increasing the friction between the conductive wire 22 and the proximal portion 11 (such as braided wire), reducing the risk of the connecting hook 4 dislodging from the proximal end of the implant 1.

[0082] The fixing wire 3 can be fixed to the inner structural component 8 by various means, such as by winding, welding, hot melting, or adhesive bonding. One or more fixing methods can be used in combination.

[0083] Specifically, in this embodiment, the fixing wire 3 is wound around the inner layer structure 8. Specifically, a portion of the fixing wire 3 is inserted into the hollow cavity of the inner layer structure 8, thereby combining with the tip portion 23 to form a connecting hook 4. Simultaneously, another portion of the fixing wire 3 is positioned on the outside of the inner layer structure 8. The inner layer structure 8 and the proximal wire bundle 5 clamp a portion of the fixing wire 3, allowing the tip of the fixing wire 3 to extend to the fixing part 7 and be fixedly connected to it. This fixing method is beneficial for preventing the connecting hook 4 from moving towards the distal end of the implant 1 under unforeseen conditions, thereby preventing the release point 24 from entering the proximal portion 11 of the implant 1, and most importantly, preventing the release point 24 from entering the fixing part 7 (such as the adhesive area). Here, the unforeseen conditions mainly include the separation of the conductive wire 22 and the fixing part 7, which could potentially push the connecting hook 4 to the distal end of the implant 1.

[0084] The inner structural member 8 can be any structure capable of inserting the proximal filament bundle 5, such as a sleeve, a wound spring, a block structure, a solid column or other structure, and the specific shape is not limited.

[0085] The inner layer structure 8 is preferably a radiopaque structure. Specifically, in this embodiment, the inner layer structure 8 is a radiopaque ring (such as a platinum-iridium ring), which can serve as an identifier for the connecting hook 4. The inner layer structure 8 is preferably a ring structure, such as a circumferentially continuous sleeve or a wound spring, which is simple and easy to assemble and use. Similar to the outer layer structure 5, the material of the inner layer structure 8 can be various metal or polymer materials suitable for long-term implantation, but is not limited to specific materials.

[0086] Figure 2 and Figure 4 In the specific embodiment described, the inner layer structure 8 is a ring structure, which facilitates the fixing wire 3 to be wound and fixed on the inner layer structure 8, and also facilitates the inner layer structure 8 to prevent the connecting hook 4 from moving toward the distal end of the implant 1 under the unexpected conditions.

[0087] It should be noted that, in addition to being wound around the inner structural component 8 as shown in the attached figure, the fixing wire 3 can also be fixed to the inner structural component 8 by welding, adhesive bonding, hot melting or other connection methods, thereby forming an integral component.

[0088] Alternatively, instead of setting the inner structural component 8, the head end of the fixing wire 3 can be directly fixed to the fixing part 7 by welding, gluing, hot melting, or other methods.

[0089] Continue to refer to Figure 4 In some embodiments, the outer diameter of the connecting hook 4 is D1, the inner diameter of the inner structural member 8 is d1, and the diameter of the fixing wire 3 is d2. Further, D1>d1>2d2.

[0090] In other words, the inner diameter d1 of the inner structural component 8 needs to be smaller than the maximum outer diameter D1 of the connecting hook 4. This is because during use, in addition to the pulling force (or retraction force) of the proximal push rod 21, the product will also be pushed to the distal end. If D1 is less than or equal to d1, then once the conductive wire 22 and the adhesive at the proximal end of the implant 1 separate, the connecting hook 4 may be pushed to the distal end of the implant 1. At this time, the release point 24 on the conductive wire 22 may enter the proximal side of the outer structural component 6, such as the adhesive area, thereby causing the risk that the product cannot be released.

[0091] On the other hand, if d1≤2d2, the double-strand fixing wire 3 will not be able to penetrate into the interior of the inner structural component 8, thus making it impossible to complete the subsequent assembly.

[0092] Furthermore, the inner diameter of the outer structural member 6 is D2, and the outer diameter of the inner structural member 8 is d3, where D2 > d3. This configuration allows the inner structural member 8 to be directly inserted into the proximal wire bundle 5 without increasing the product's outer diameter. If D2 ≤ d3, even if the inner structural member 8 is forcibly inserted into the proximal wire bundle 5, the outer diameter of the proximal portion 11 will become larger, potentially even deforming the outer structural member 6 (causing it to protrude abnormally), thus significantly increasing the product's pushing resistance.

[0093] The beneficial effects of the connection structure 10 provided in the embodiments of this application will be explained below through comparative experiments.

[0094] Tensile strength testing was conducted using a universal testing machine. During the test, the specimens (including control and target specimens) were placed in microcatheters of different inner diameters, and then the universal testing machine was used to push and pull the specimens until they fractured. The specific testing procedure is as follows:

[0095] 1. Turn on the universal testing machine and enter the testing interface;

[0096] 2. Adjust the distance between the upper and lower clamps;

[0097] 3. Set the test speed, for example, 200mm / min. Too high a speed will cause a large impact and affect the test results.

[0098] 4. Place the implant in the upper clamp and the push rod in the lower clamp;

[0099] 5. Confirm that there is no tension between the push rod and the implant;

[0100] 6. First clamp the upper fixture, then zero the load and displacement, and finally clamp the lower fixture to start the test;

[0101] 7. After the specimen breaks, record the maximum force value, which is the tensile strength.

[0102] In this comparative test, the comparison sample used Figure 3 The connection method, the target sample adopts Figure 2 and Figure 4 The connection method and the final measurement results are shown in Table 1 and Table 2.

[0103] As can be seen from Table 1, when implants are pushed into microcatheters with different inner diameters, the maximum connection strength of the comparative samples is 1.66 N and the minimum connection strength is 0.99 N when the connection is made up of the conventional connection method. The average strength of the connection area is 1.27 N.

[0104] Table 1 Measurement results of the comparative samples

[0105]

[0106] As can be seen from Table 2, when implants are pushed into microcatheters with different inner diameters, according to the connection method of this application, the maximum connection strength of the target sample can reach 4.96N, the minimum connection strength is 4.11N, and the average strength of the final connection area is 4.63N.

[0107] Table 2 Measurement results of the target sample

[0108]

[0109] It is evident that the connection strength achieved by the connection structure 10 provided in this application is significantly improved, and the connection force in the release region is increased by 3.6 times.

[0110] Because the connection strength must be greater than the product's pushing resistance to prevent premature and unexpected dislodgement during surgery, researchers often have to sacrifice some of the implant's and push rod's performance due to limitations in the strength of the connection area during implant and push rod design. Therefore, in this application, increasing the connection strength in the connection area can further release the upper limit of the implant and push rod's performance, reduce the requirements for pushing resistance, and simplify the design of the implant and push rod.

[0111] Furthermore, based on the same inventive concept, embodiments of this application also provide a method for connecting an implant to a delivery system, comprising the following steps:

[0112] The fixing wire 3 is placed in the proximal portion 11 of the implant 1 and fixedly connected to the proximal portion 11 of the implant 1.

[0113] The conductive wire 22 of the conveying system 2 is passed through the push rod 21 of the conveying system 2, and the head end portion 23 of the conductive wire 22 extends beyond the far end of the push rod 21. At the same time, a release point 24 is provided on the head end portion 23 of the conductive wire 22.

[0114] At least a portion of the tip portion 23 of the conductive wire 22 is disposed in the proximal portion 11 of the implant 1 at the distal end of the release point 24.

[0115] The fixing wire 3 is combined with the head end part 23 to form the connecting hook 4;

[0116] And the proximal portion 11 of the implant 1 and the tip portion 23 of the conductive wire 22 are connected by the fixation part 7.

[0117] Furthermore, the connection method also includes:

[0118] The outer structural member 6 is wrapped around the outside of the proximal filament bundle 5, and the fixing wire 3 is at least partially disposed in the proximal filament bundle 5 and fixedly connected to the fixing part 7.

[0119] Furthermore, the connection method further includes: applying an adhesive at the junction of the fixing wire 3 and the head end portion 23 of the conductive wire 22.

[0120] Furthermore, the connection method also includes:

[0121] The inner layer structure 8 is placed inside the proximal portion 11 of the implant 1, and the fixation wire 3 is fixed to the inner layer structure 8.

[0122] Furthermore, the connection method further includes: setting the inner layer structure 8 as a ring structure, and making the outer diameter of the connecting hook 4 larger than the inner diameter of the inner layer structure 8; and inserting a portion of the fixing wire 3 into the inner layer structure 8, thereby combining with the head end portion 23 of the conductive wire 22 to form the connecting hook 4, and setting the other portion of the fixing wire 3 on the outside of the inner layer structure 8 and fixing it to the fixing part 7.

[0123] It should be noted that the connection method between the implant and the delivery system provided in this application can realize the connection structure 10 described in any of the embodiments above. This connection method and the connection structure provided in this application belong to the same inventive concept. Therefore, the connection method between the implant and the delivery system provided in this application has at least all the beneficial effects of the connection structure between the implant and the delivery system provided in this application. For details, please refer to the relevant descriptions of the beneficial effects of the connection structure between the implant and the delivery system provided in this application above. Therefore, the beneficial effects of the connection method between the implant and the delivery system provided in this application will not be described in detail here.

[0124] Finally, it should be noted that the various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. Similar or identical parts between embodiments can be referred to interchangeably. For the systems disclosed in the embodiments, since they correspond to the methods disclosed in the embodiments, the descriptions are relatively simple, and relevant parts can be referred to the method section.

[0125] It should also be noted that although preferred embodiments have been disclosed above, these embodiments are not intended to limit this application. Any person skilled in the art can make many possible variations and modifications to the technical solutions of this application, or modify them into equivalent embodiments, without departing from the scope of the technical solutions of this application. Therefore, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of this application, without departing from the content of the technical solutions of this application, shall still fall within the scope of protection of the technical solutions of this application.

Claims

1. A connection structure of an implant and a delivery system, characterized by, The implant includes: a proximal portion of the implant; a conductive wire of the delivery system, the conductive wire passing through a push rod of the delivery system, and the conductive wire having a head portion extending out of a distal end of the push rod, the head portion of the conductive wire being provided with a release point, at least a part of the head portion of the conductive wire distal to the release point being disposed in the proximal portion of the implant; a fixing wire disposed in the proximal portion of the implant and fixedly connected with the proximal portion of the implant, and the fixing wire and the head portion of the conductive wire combining to form a connecting hook; and a fixing portion connecting the proximal portion of the implant and the head portion of the conductive wire. The proximal portion of the implant includes a proximal bundle and an outer structural member; the proximal bundle is formed by a plurality of braided wires; the outer structural member is wrapped outside the proximal bundle; the fixing wire is at least partially disposed in the proximal bundle and fixedly connected with the fixing portion.

2. The connection of an implant to a delivery system according to claim 1, characterized in that The outer structural member is a visible structure, and / or the outer structural member is an annular structure.

3. The connection of an implant to a delivery system according to claim 2, characterized in that The position where the fixing wire and the head portion of the conductive wire combine is provided with an adhesive, and / or the fixing portion connects the proximal portion of the implant and the head portion of the conductive wire by at least one of bonding, welding, hot melt connection, and mechanical structural fixed connection.

4. The connection of an implant to a delivery system according to claim 1, characterized in that The fixing portion connects the proximal portion of the implant and the head portion of the conductive wire by the adhesive, and a part of the connecting hook is disposed in the proximal bundle, another part is disposed in the fixing portion and wrapped by the adhesive, or the connecting hook is entirely disposed in the fixing portion and wrapped by the adhesive.

5. The connection of an implant to a delivery system according to claim 1, characterized in that Further including:

6. The connection of an implant to a delivery system according to claim 2, characterized in that an inner structural member disposed in the proximal portion of the implant; the fixing wire is fixed on the inner structural member. The fixing wire is fixed on the inner structural member by at least one of winding, welding, hot melting, and bonding.

7. The connection of an implant to a delivery system according to claim 6, characterized in that The inner structural member is an annular structure, and / or the inner structural member is a visible structure.

8. The connection of an implant to a delivery system according to claim 6, characterized in that The inner structural member is further configured to prevent the connecting hook from moving towards a distal end of the implant under an unexpected condition, thereby preventing the release point from entering the proximal portion of the implant.

9. The connection of an implant and a delivery system according to claim 6, characterized in that The inner structural member is an annular structure, an outer diameter of the connecting hook is D1, an inner diameter of the inner structural member is d1, a wire diameter of the fixing wire is d2, D1>d1>2d2, and / or an inner diameter of the outer structural member is D2, an outer diameter of the inner structural member is d3, D2>d3.

10. The connection of an implant and a delivery system according to claim 6, characterized in that The implant includes:

11. A method of connecting an implant to a delivery system, characterized by, a proximal portion of the implant; a conductive wire of the delivery system, the conductive wire passing through a push rod of the delivery system, and the conductive wire having a head portion extending out of a distal end of the push rod, the head portion of the conductive wire being provided with a release point, at least a part of the head portion of the conductive wire distal to the release point being disposed in the proximal portion of the implant; a fixing wire disposed in the proximal portion of the implant and fixedly connected with the proximal portion of the implant, and the fixing wire and the head portion of the conductive wire combining to form a connecting hook; and a fixing portion connecting the proximal portion of the implant and the head portion of the conductive wire. ​ ​ The proximal end portion of the implant and the head end portion of the conductive wire are connected by a fixing portion.

12. The method of connecting an implant and delivery system of claim 11, wherein, The proximal end portion of the implant comprises a proximal end bundle and an outer structural member; the proximal end bundle is formed by a plurality of braided wires; the connecting method further comprises: The outer structural member is wrapped outside the proximal end bundle, and the fixing wire is at least partially arranged in the proximal end bundle and fixedly connected with the fixing portion.

13. The method of connecting an implant and delivery system of claim 11, wherein, The connecting method further comprises: arranging an adhesive at the position where the fixing wire is combined with the head end portion of the conductive wire.

14. The method of connecting an implant and delivery system of claim 11, wherein, The connecting method further comprises: An inner structural member is arranged in the proximal end portion of the implant, and the fixing wire is fixed on the inner structural member.

15. The method of connecting an implant and delivery system of claim 14, wherein, The connecting method further comprises: The inner structural member is arranged in a ring shape, and the outer diameter of the connecting hook is greater than the inner diameter of the inner structural member; A part of the fixing wire is inserted into the inner structural member, thereby combining with the head end portion of the conductive wire to form the connecting hook, and another part of the fixing wire is arranged outside the inner structural member and fixedly connected with the fixing portion.

16. An implant system, characterized by The implant, the delivery system, and the connecting structure of the implant and the delivery system as claimed in any one of claims 1-10.

Images