Medical implant and medical device

By providing medical implants with thrombus-promoting coating at the opening of the aneurysm, the problems of aneurysm regeneration and embolizing coil fallout in the prior art are solved, and thrombosis and vascular remodeling of the aneurysm are achieved.

CN113456150BActive Publication Date: 2025-06-06SUZHOU SHUTONG MEDICAL TECH CO LTD
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Patent Information

Application Number
CN202110756451.8
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2021-07-05
Publication Date
2025-06-06
Estimated Expiration
2041-07-05

AI Technical Summary

Technical Problem

Prior Art In the treatment of intracranial aneurysms, there are limitations in filling an aneurysm with embolizing coils, which may regenerate and embolizing coils may fall off and thromboembolic events.

Method used

A medical implant is provided, including a closure part and a thrombus-promoting coating. The closure part is a curved structure, arranged at the opening of the aneurysm, and a thrombus-promoting coating is provided on the coating. The thrombus-promoting coating material includes a thrombus-promoting drug and a carrier for promoting the thrombosis of the aneurysm.

Benefits of technology

Through the thrombopromoting coating of the implant, the aneurysm can thrombosis, avoiding the risk of embolizing coils falling off, reducing the possibility of aneurysm regeneration, and changing the hemodynamics to facilitate vascular remodeling.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention provides a medical implant and a medical device, wherein the medical device comprises the medical implant, wherein the medical implant comprises a blocking portion and a thrombus-promoting coating; the blocking portion is a curved structure and is used to be arranged at the opening of a target object; the blocking portion comprises a support body and a coating attached to the support body, and the thrombus-promoting coating is formed on at least a part of the surface of the coating closest to the inner cavity of the target object. The target object is, for example, an aneurysm. When the medical implant is arranged at the neck opening of the aneurysm, the thrombus-promoting coating is arranged toward the aneurysm cavity, which can promote aneurysm thrombosis. It is not necessary to fill the aneurysm cavity with an embolic coil, thus avoiding the risk of thrombus caused by the embolic coil falling off, and will not cause the aneurysm to grow again.
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Description

Technical Field

[0001] The present invention relates to the technical field of medical instruments, and in particular to medical implants and medical devices. Background Art

[0002] The traditional treatment for intracranial aneurysms is open surgery, which involves craniotomy and is extremely invasive, with high technical requirements, high mortality, and long postoperative recovery time for patients. In recent years, vascular intervention has been applied to the treatment of intracranial aneurysms. By introducing embolic coils, the embolic coils are used to fill the aneurysm and promote aneurysm thrombosis. The emergence of this treatment method has revolutionized the treatment of intracranial aneurysms.

[0003] However, there are limitations to using embolic coils alone to fill aneurysms. For example, after the embolic coils are filled into the aneurysm lumen, they are squeezed and pushed by blood flow, causing the aneurysm to grow again, which requires additional medical treatment. For aneurysms with a wide neck opening, after the embolic coils are filled into the aneurysm lumen, they may fall out of the neck opening and fall into the surrounding blood vessels, causing thromboembolic events. Summary of the invention

[0004] The object of the present invention is to provide a medical implant and a medical device, which can treat aneurysms without using embolic coils to fill the aneurysms, and can also thrombose the aneurysms, thereby avoiding thromboembolic events caused by the embolic coils falling off and falling into the blood vessels.

[0005] To achieve the above-mentioned objectives, the present invention provides a medical implant, comprising a sealing portion and a thromboembolic coating; the sealing portion is a curved structure and is used to be arranged at the opening of a target object; the sealing portion comprises a support body and a coating attached to the support body, and the thromboembolic coating is arranged on at least a portion of the surface of the coating closest to the inner cavity of the target object.

[0006] Optionally, the material of the pro-thrombotic coating includes a pro-thrombotic drug and a carrier, wherein the pro-thrombotic drug includes at least one of protamine sulfate or prothrombin complex; and the carrier includes at least one of polyglycolide, polylactic acid, polyvinyl alcohol, polyethylene glycol, collagen, gelatin, and chitosan.

[0007] Optionally, an adhesive layer is formed on at least a portion of a surface of the coating film that is farthest from the inner cavity of the target object, and the adhesive layer is used to bond the sealing portion to the target object.

[0008] Optionally, the adhesive layer is formed by coating a bioadhesive material on the covering film.

[0009] Optionally, the material of the adhesive layer includes at least one of chitosan, carbomer, fatty acid compounds, phospholipid compounds, and polyethylene glycol.

[0010] Optionally, the support body is a self-expanding structure.

[0011] To achieve the above object, the present invention further provides a medical device, comprising:

[0012] The medical implant as described in any of the preceding items, wherein the medical implant has a through hole formed therein;

[0013] a connecting portion, disposed on the concave side of the blocking portion, and comprising a plurality of connecting ends, each of the connecting ends being connected to the blocking portion; and

[0014] A pushing assembly, comprising a first pushing rod and a second pushing rod; the first pushing rod is located at the convex side of the blocking portion, and the distal end of the first pushing rod is detachably connected to the blocking portion; the distal end of the second pushing rod passes through the through hole and is detachably connected to the connecting portion;

[0015] The medical device is configured such that when the second pushing rod moves in the direction from the proximal end to the distal end, the second pushing rod applies a pulling force to the blocking portion through the connecting portion, and causes the edge of the blocking portion to move toward a direction close to the second pushing rod, so that the blocking portion contracts radially.

[0016] Optionally, the multiple connection ends of the connection portion are evenly arranged along the circumference of the blocking portion.

[0017] Optionally, the first pushing rod comprises a first rod body and a first releasing portion, the proximal end of the first releasing portion is connected to the distal end of the first rod body, the distal end of the first releasing portion is connected to the blocking portion, and the first releasing portion is configured to be electrolytically dissolved through electrical conduction and release the connection with the blocking portion; and / or,

[0018] The second pushing rod includes a second rod body and a second releasing portion, wherein the proximal end of the second releasing portion is connected to the distal end of the second rod body, and the distal end of the second releasing portion is connected to the connecting portion, and the second releasing portion is configured to be electrolytically dissolved through electrical conduction and release the connection with the connecting portion.

[0019] Optionally, the first pushing rod further includes a first insulating layer disposed on an outer surface of the first rod body; and / or the second pushing rod further includes a second insulating layer disposed on an outer surface of the second rod body.

[0020] Compared with the prior art, the medical implant and medical device of the present invention have the following advantages:

[0021] The aforementioned medical device includes a medical implant, a connecting part and a pushing assembly, wherein the medical implant includes a sealing part and a embolism-promoting coating, the sealing part is a curved structure and is used to be arranged at the opening of the target object, the sealing part includes a support body and a coating attached to the support body, and the embolism-promoting coating is arranged on at least a part of the surface of the coating facing the inner cavity of the target object; the connecting part is arranged on the concave side of the sealing part and includes a plurality of connecting ends, each of which is connected to the sealing part; the pushing assembly includes a first pushing rod and a second pushing rod, the first pushing rod is located on the convex side of the sealing part, and the distal end of the first pushing rod is detachably connected to the sealing part, and the distal end of the second pushing rod passes through the sealing part and is connected to the connecting part; the medical device is configured so that when the second pushing rod moves in the direction from the proximal end to the distal end, the second pushing rod applies a pulling force to the sealing part through the connecting part, and causes the edge of the sealing part to move toward a direction close to the second pushing rod, so that the sealing part contracts radially. When the medical implant is used to treat an aneurysm, the pushing component delivers and positions the medical implant to the neck opening of the aneurysm, and the surface provided with the thrombogenic coating is arranged toward the aneurysm cavity to promote thrombosis of the aneurysm. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The accompanying drawings are used to better understand the present invention and do not constitute an improper limitation of the present invention.

[0023] Figure 1 is a schematic structural diagram of a medical device provided according to an embodiment of the present invention, showing a medical implant in an expanded state;

[0024] Figure 2 is a schematic structural diagram of a medical device provided according to an embodiment of the present invention, showing radial contraction of a medical implant;

[0025] Figure 3 yes Figure 1 A partial cross-sectional view of a medical implant of a medical device is shown, wherein the covering includes a first covering;

[0026] Figure 4 yes Figure 1 A partial cross-sectional view of a medical implant of the medical device shown, wherein the covering includes a second covering;

[0027] Figure 5 yes Figure 1 A partial cross-sectional view of a medical implant of a medical device is shown, wherein the covering film includes a first covering film and a second covering film;

[0028] Figures 6a to 6d It is a schematic diagram of the use process of a medical device provided according to an embodiment of the present invention.

[0029] [Description of reference numerals is as follows]:

[0030] 100 - blocking portion, 110 - supporting body, 120 - coating, 121 - first coating, 122 - second coating;

[0031] 200-thrombopromoting coating;

[0032] 300-adhesive layer;

[0033] 20-connecting part;

[0034] 30-push assembly, 31-first push rod, 32-second push rod;

[0035] 1- Microcatheter. DETAILED DESCRIPTION

[0036] The following is an explanation of the embodiments of the present invention by specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the illustrations provided in the present embodiment only illustrate the basic concept of the present invention in a schematic manner, and only the components related to the present invention are shown in the figure instead of being drawn according to the number, shape and size of the components in the actual implementation. The type, quantity and proportion of each component in the actual implementation can be a random change, and the component layout type may also be more complicated.

[0037] In addition, each embodiment of the following description has one or more technical features, but this does not mean that the user of the present invention must implement all the technical features in any embodiment at the same time, or can only implement part or all of the technical features in different embodiments separately. In other words, under the premise that implementation is possible, those skilled in the art can selectively implement part or all of the technical features in any embodiment according to the disclosure of the present invention and according to the design specifications or implementation requirements, or selectively implement a combination of part or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.

[0038] As used in this specification, the singular forms "a", "an", and "the" include plural objects, and the plural form "plurality" includes more than two objects, unless the content clearly indicates otherwise. As used in this specification, the term "or" is generally used to include the meaning of "and / or", unless the content clearly indicates otherwise, and the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium, and it can be a communication between the inner cavities of two components or an interaction relationship between two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances.

[0039] In this article, the terms "proximal" and "distal" refer to the relative orientation, relative position, and direction of components or actions relative to each other from the perspective of a doctor using the medical device. Although "proximal" and "distal" are not restrictive, "proximal" usually refers to the end of the medical device that is close to the doctor during normal operation, and "distal" usually refers to the end that first enters the patient's body.

[0040] In order to make the purpose, advantages and features of the present invention more clear, the present invention is further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are all in very simplified form and in non-precise proportions, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. The same or similar reference numerals in the drawings represent the same or similar components.

[0041] like Figures 1 to 5 As shown, one of the purposes of the embodiment of the present invention is to provide a medical implant, which includes a closure portion 100 and a thrombus-promoting coating 200. The closure portion 100 is a curved structure and is used to be arranged at the opening of the target object. The closure portion 100 includes a support body 110 and a coating 120 attached to the support body 110, and the thrombus-promoting coating 200 is arranged on at least a part of the surface of the coating 120 closest to the inner cavity of the target object. The target object described in this embodiment is, for example, an aneurysm. In this case, the medical implant is used to be arranged at the opening of the aneurysm, and the thrombus-promoting coating 200 is arranged toward the aneurysm cavity of the aneurysm. The thrombogenic coating 200 has a thrombogenic function, which can accelerate the formation and organization of thrombus in the aneurysm, thereby causing the aneurysm to be thrombosed. The thrombosis of the aneurysm can be achieved without filling the aneurysm cavity with embolic coils. There is no risk of embolic coils falling off into the blood vessels and causing intravascular embolism, nor will it cause the regrowth of the aneurysm. In addition, the occluding portion 100 can also change the hemodynamics and facilitate vascular remodeling.

[0042] The material of the thrombus-promoting coating 200 includes a thrombus-promoting drug and a carrier, wherein the thrombus-promoting drug includes at least one of protamine sulfate or prothrombin complex, and the prothrombin complex described here refers to a substance containing coagulation factors and having the function of promoting coagulation. The carrier includes at least one of polyglycolide, polylactic acid, polyvinyl alcohol, polyethylene glycol, collagen, gelatin, and chitosan. Further, the carrier is preferably biodegradable, so that when the carrier is degraded, the thrombus-promoting drug can diffuse into the aneurysm cavity and accelerate the thrombosis process of the aneurysm. It should be noted that when at least two thrombus-promoting drugs are mixed, the various thrombus-promoting materials can be simply mixed without chemical reaction. Similarly, when at least two of the carriers are mixed, at least two of the carriers can be simply mixed without chemical reaction. The thrombus-promoting material can be attached to the coating 120 by any suitable method such as spraying, dipping, electrostatic deposition, printing, and pipetting.

[0043] It should be noted that the support body 110 includes an inner surface and an outer surface, wherein the inner surface refers to the surface of the support body 110 closest to the aneurysm cavity when the medical implant is disposed at the opening of the aneurysm, and the outer surface refers to the surface of the support body 110 farthest from the aneurysm cavity. In some embodiments, the coating 120 includes a first coating 121, wherein the first coating 121 is attached to the outer surface of the support body 110, and the support body 110 is a mesh structure, and the thrombogenic coating 200 is disposed on the surface of the first coating 121 close to the support body 110 and corresponding to the mesh arrangement of the support body 110 (such as Figure 3 In other embodiments, the coating 120 includes a second coating 122, the second coating 122 is attached to the inner surface of the support 110, and the embolism-promoting coating 200 is disposed on the surface of the second coating 122 away from the support 110 (as shown in FIG. Figure 4 In some other embodiments, the coating 120 includes a first coating 121 and a second coating 122, wherein the first coating 121 is attached to the outer surface of the support 110, the second coating 122 is attached to the inner surface of the support 120, and the embolism-promoting coating 200 is disposed on the surface of the second coating 122 away from the support 110 (as shown in FIG. Figure 5 The coating 120 (including the first coating 121 and / or the coating 122) is attached to the support 110 by any suitable method such as heat pressing, sewing, etc.

[0044] Furthermore, the medical implant further comprises an adhesive layer 300, and the adhesive layer 300 is disposed on the surface of the coating 120 which is farthest from the inner cavity of the aneurysm. Figure 3 and Figure 5 As shown, the adhesive layer 300 is disposed on at least a portion of the surface of the first coating 121 away from the support body 110 (that is, the adhesive layer 300 is disposed on the surface of the first coating 121 away from the aneurysm cavity). Figure 4 As shown, when the coating 120 only includes the second coating 122, the adhesive layer 300 is arranged on the surface of the second coating 122 close to the support body 110 and is arranged corresponding to the pores of the support body 110. The adhesive layer 300 can be formed by coating the first coating 122 with a material having bioadhesive properties, and is used to make the blocking part 100 adhere to the aneurysm wall of the aneurysm, thereby improving the positioning stability of the medical implant at the opening of the aneurysm. The optional materials of the adhesive layer 300 include but are not limited to chitosan, carbomer, polyethylene glycol, fatty acid compounds, and phospholipid compounds, wherein the fatty acid compounds include but are not limited to lauric acid, laureic acid, linolenic acid, linoleic acid, stearic acid, arachidonic acid, etc., and the phospholipid compounds include but are not limited to cationic phospholipids phosphatidylcholine, phosphatidylethanolamine, phosphatidylserine, etc. The material of the adhesive layer 300 may be a single component, or may be a mixture of multiple materials having bioadhesive properties. When mixing, the multiple materials may be simply mixed without chemical reaction.

[0045] In the present embodiment, the support body 110 is a self-expanding structure. The so-called self-expanding structure means that the support body 110 is made of a highly elastic material, which deforms when subjected to an external force, and recovers its deformation under the action of its own elastic force after the external force is removed. The self-expanding structure can usually be made of a shape memory alloy material such as Nitinol alloy. In addition, the embodiment of the present invention does not limit the molding method of the support body 110, which can be woven or cut. The support body 110 can be a part of a spherical surface, so that the blocking portion 100 is formed as a part of a spherical surface, or the support body 110 can also be a part of an ellipsoidal surface, so that the blocking portion 100 is formed as a part of an ellipsoidal surface. When the blocking portion 100 is a part of an ellipsoidal surface, the contour of the projection of the blocking portion 100 on a plane parallel to its axis is an arcuate shape, and its straight line sides are parallel to the long axis of the ellipsoid (such as Figure 1As shown). When the medical implant is positioned at the opening of the aneurysm, the concave side of the occluding portion 100 faces the aneurysm cavity of the aneurysm, and the convex side of the occluding portion 100 faces the parent artery. It should be noted that the maximum radial dimension of the occluding portion 100 is determined according to the size of the opening of the aneurysm, and after the maximum radial dimension of the occluding portion 100 is determined, the axial dimension of the occluding portion 100 should be as small as possible, so that the occluding portion 100 extends into the parent artery as little as possible, reducing the adverse effect on the blood flow in the parent artery. It should also be noted that the axis of the occluding portion 100 refers to the line connecting the center of the occluding portion 100 and the center of the sphere (when the occluding portion 100 is a part of the sphere) or the center of the ellipsoid (when the occluding portion 100 is a part of the ellipsoid), then the direction perpendicular to the axis of the occluding portion 100 is the radial direction, and the direction around the axis of the occluding portion 100 is the circumferential direction.

[0046] Further, please refer back to Figures 1 to 3 An embodiment of the present invention further provides a medical device, comprising the medical implant, a connecting portion 20 and a pushing assembly 30 as described above, wherein the connecting portion 20 and the pushing assembly 30 are used to jointly apply a force to the medical implant so that the medical implant is radially compressed and can be delivered to the aneurysm opening for release.

[0047] Specifically, the medical implant is formed with a through hole (not shown in the figure) that penetrates the support body 110, the coating 120, and the embolization coating 200. It is understandable that when the medical implant includes the adhesive layer 300, the through hole may also penetrate the adhesive layer 300 (determined according to the setting position of the adhesive layer 300). The connecting portion 20 is arranged on the concave side of the blocking portion 100, and the connecting portion 20 includes a plurality of connecting ends (not marked in the figure), the number of the connecting ends is usually more than three, and each connecting end is connected to the blocking portion 100. The pushing assembly 30 includes a first pushing rod 31 and a second pushing rod 32. The first pushing rod 31 is located on the convex side of the blocking portion 100, and the distal end of the first pushing rod 31 is detachably connected to the blocking portion 100. The distal end of the second pushing rod 32 passes through the through hole and is detachably connected to the connecting portion 20. The medical device is configured such that when the second push rod 32 moves from the proximal end to the distal end, the second push rod 32 applies a pulling force to the blocking portion 100 through the connecting portion 20, and causes the edge of the blocking portion 100 to move toward the direction close to the second push rod 32, so that the blocking portion 100 contracts radially. Conversely, when the second push rod 32 moves from the distal end to the proximal end, the pulling force gradually decreases, and the blocking portion 100, under the action of its own expansion force, causes the edge of the blocking portion 100 to move in a direction away from the second push rod 32, so that the blocking portion 100 radially expands to an initial shape. That is, in actual use, the medical implant can be controlled to switch between a compressed state and an expanded state by manipulating the movement of the second push rod 32.

[0048] Preferably, the multiple connecting ends of the connecting portion 20 are evenly arranged along the circumference of the blocking portion 100, and the distal end of the second pushing rod 32 is detachably connected to the center of the connecting portion 20 as much as possible to balance the force on the blocking portion 100.

[0049] As mentioned above, the first push rod 31 is detachably connected to the blocking portion 100, and the second push rod 32 is detachably connected to the connection portion. This is because the main function of the two push rods is to transport the medical implant. When the positioning of the medical implant is completed, the two push rods will be withdrawn from the body. Optionally, the first push rod 31 includes a first rod body and a first release portion, the proximal end of the first release portion is connected to the distal end of the first rod body, the distal end of the first release portion is connected to the blocking portion 100, and the first release portion is configured to be electrolytically dissolved through electrical conduction and release the connection with the blocking portion 100. In other words, the first release portion constitutes a part of the electrolytic release mechanism, and the first push rod 31 can be released from the blocking portion 100 by electrolytic release.

[0050] Those skilled in the art know that the electrolytic release mechanism also includes an anode conductor and a cathode conductor. The embodiment of the present invention does not limit the specific arrangement of the anode conductor and the cathode conductor, as long as the anode conductor and the cathode conductor can be electrically connected to the first release part under the action of an external electrolytic release device after the positioning of the medical implant is completed. In other words, those skilled in the art can refer to any electrolytic release mechanism in the prior art to set the anode conductor and the cathode conductor. Since it does not involve the improvement of the present invention, it will not be described in detail here. In an optional implementation, the first rod body is configured to have conductivity and serves as the anode conductor or the cathode conductor.

[0051] Furthermore, the first push rod further includes a first insulating layer (not shown in the figure), which is arranged on the outer surface of the first rod body to achieve electrical isolation between the first rod body and other structures such as microcatheters. The first insulating layer can be formed by coating an insulating coating on the surface of the first rod body and curing it, or the first insulating layer is formed by an insulating tube, which is sleeved on the first rod body and connected to the first rod body by heat shrinking. The insulating tube can be a PEFE tube, a Pebax tube or a nylon tube, etc.

[0052] The second push rod 32 may have a configuration substantially the same as that of the first push rod 31. That is, the second push rod 32 includes a second rod body and a second release portion, the proximal end of the second release portion is connected to the distal end of the second rod body, the distal end of the second release portion is connected to the connecting portion 20, and the second release portion is configured to be electrolytically eroded by electrical conduction and to release the connection with the connecting portion 20. When the second rod body is configured to have electrical conductivity to serve as an anode conductor or a cathode conductor of an electrolytic release mechanism, the second push rod 32 further includes a second insulating layer, which is disposed on the outer surface of the second rod body.

[0053] Alternatively, the first releasing portion and the second releasing portion may also be mechanical releasing mechanisms, such as the cooperation between a retaining ring and a ball head, etc., which is also well known to those skilled in the art and will not be introduced here.

[0054] In addition, the first push rod 31 and the second push rod 32 are arranged in parallel to simplify the structure of the medical device. The distal end of the first push rod 31 is connected to the center of the blocking part 100 as much as possible. In addition, the first push rod 31 and the second push rod 32 can be solid structures or hollow tubes, which is not limited by the present invention.

[0055] Next, the method for forming the medical device is described in conjunction with a non-limiting embodiment.

[0056] First, a tubular mesh structure is formed by weaving a nitinol wire with a diameter of 0.1 mm, and then cut according to the design size to obtain a tubular mesh structure of appropriate length. The diameter of the tubular mesh structure can be determined according to the length of the neck opening of the aneurysm.

[0057] Then, all the wire heads at one end of the tubular mesh structure are pulled to shrink the end until the tubular mesh structure as a whole forms a part of a spherical surface (or an ellipsoidal surface) and serves as the support body.

[0058] Subsequently, all the wire ends are fixed to prevent the support from spreading out, and the support is subjected to a heat setting treatment.

[0059] Then, the film material is cut and attached to the inner and outer surfaces of the support body to form the first coating and the second coating. The film material can be any one of polyvinyl chloride film (PVC), polyethylene terephthalate film (PET), and polytetrafluoroethylene film (PTFE).

[0060] Next, a polyethylene glycol-ethanol solution with a weight percentage of 30% was prepared, and the polyethylene glycol-ethanol solution was coated on the first coating film by using a pipette gun to form the adhesive layer.

[0061] Next, a suspension of protamine sulfate-polylactic acid-glycolic acid copolymer with a weight percentage of 40% was prepared by nanoprecipitation method, and the suspension of protamine sulfate-polylactic acid-glycolic acid copolymer was coated on the second coating with a pipette, and the thrombopromoting coating was formed after drying.

[0062] Afterwards, the through hole is formed on the medical implant; and three connecting ropes are taken to jointly constitute the connecting part, the connecting part has six connecting ends, the six connecting ends are evenly arranged along the circumference of the blocking part and connected to the edge of the blocking part.

[0063] Next, a first push rod and a second push rod are manufactured according to the prior art, wherein the first rod body and the second rod body are both made of Nitinol alloy, and the first insulating layer and the second insulating layer are both formed by Pebax tubes sheathed on the corresponding rod bodies.

[0064] Finally, the distal end of the first pushing rod is connected to the blocking portion at the convex side of the blocking portion, and the distal end of the second pushing rod is passed through the through hole and connected to the centers of the three connecting ropes at the same time.

[0065] Next, the method of using the medical device described in the simulation experiment instructions is described.

[0066] First, a blood vessel model is provided. The blood vessel model is an intracranial lateral wall aneurysm. The length of the aneurysm is 4 mm, the width is 4 mm, the height is 4.5 mm, and the length of the neck opening is 3.5 mm.

[0067] Then, the distal end of a microcatheter 1 is introduced into the aneurysmal lesion area in the blood vessel model.

[0068] Afterwards, the second pushing rod 32 is moved in a direction from the proximal end to the distal end to radially shrink the medical implant to a minimum radial dimension.

[0069] Then, the distal end of the medical device (i.e., the medical implant) is introduced into the microcatheter 1, and the distal end of the medical implant is pushed to the aneurysm by pushing the first pushing rod 31 and the second pushing rod 32, and the medical implant is extended from the distal end of the microcatheter 1 and enters the aneurysm cavity (e.g., Figure 6a as shown).

[0070] Next, the second push rod 32 is moved from the distal end to the proximal end to radially expand the medical implant, and the posture of the medical implant is adjusted so that the medical implant can be stably positioned at the neck opening of the aneurysm (such as Figure 6b As shown), when the medical implant includes the adhesive layer, the occluding portion 100 can be bonded to the aneurysm wall through the adhesive layer.

[0071] Subsequently, the connection between the first push rod 31 and the blocking portion 100 is released, and the connection between the second push rod 32 and the connecting portion 20 is released, and the first push rod 31 and the second push rod 32 are retracted into the microcatheter 1 (as shown in FIG. Figure 6c as shown).

[0072] Finally, the microcatheter 1, the first push rod 31 and the second push rod 32 are withdrawn, and the medical implant and the connecting portion 20 are retained at the neck opening of the aneurysm (eg, Figure 6d as shown).

[0073] Although the present invention is disclosed as above, it is not limited thereto. Those skilled in the art may make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A medical device, It is characterized in that include: A medical implant, comprising a blocking portion and a embolization coating; the blocking portion is a curved structure and is used to be arranged at an opening of a target object; the blocking portion comprises a support body and a coating attached to the support body, and the embolization coating is arranged on at least a portion of a surface of the coating closest to an inner cavity of the target object; a through hole is formed on the medical implant; a connecting portion, disposed on the concave side of the blocking portion, and comprising a plurality of connecting ends, each of the connecting ends being connected to the blocking portion; and A pushing assembly, comprising a first pushing rod and a second pushing rod; the first pushing rod is located at the convex side of the blocking portion, and the distal end of the first pushing rod is detachably connected to the blocking portion; the distal end of the second pushing rod passes through the through hole and is detachably connected to the connecting portion; The medical device is configured such that when the second pushing rod moves in the direction from the proximal end to the distal end, the second pushing rod applies a pulling force to the blocking portion through the connecting portion, and causes the edge of the blocking portion to move toward a direction close to the second pushing rod, so that the blocking portion contracts radially.

2. The medical device according to claim 1, It is characterized in that The material of the pro-thrombotic coating includes a pro-thrombotic drug and a carrier, wherein the pro-thrombotic drug includes at least one of protamine sulfate or prothrombin complex; the carrier includes at least one of polyglycolide, polylactic acid, polyvinyl alcohol, polyethylene glycol, collagen, gelatin, and chitosan.

3. The medical device according to claim 1, It is characterized in that An adhesive layer is formed on at least a portion of the surface of the covering film that is farthest from the inner cavity of the target object, and the adhesive layer is used to bond the blocking portion to the target object.

4. The medical device according to claim 3, It is characterized in that The adhesive layer is formed by coating a material with bioadhesive properties on the covering film.

5. The medical device according to claim 4, It is characterized in that The material of the adhesive layer includes at least one of chitosan, carbomer, fatty acid compounds, phospholipid compounds, and polyethylene glycol.

6. The medical device according to claim 1, It is characterized in that The support body is a self-expanding structure.

7. The medical device according to claim 1, It is characterized in that The multiple connection ends of the connection part are evenly arranged along the circumference of the blocking part.

8. The medical device according to claim 7, It is characterized in that The first pushing rod comprises a first rod body and a first releasing portion, wherein the proximal end of the first releasing portion is connected to the distal end of the first rod body, the distal end of the first releasing portion is connected to the blocking portion, and the first releasing portion is configured to be electrolytically dissolved through electrical conduction and release the connection with the blocking portion; and / or, The second pushing rod includes a second rod body and a second releasing portion, wherein the proximal end of the second releasing portion is connected to the distal end of the second rod body, and the distal end of the second releasing portion is connected to the connecting portion, and the second releasing portion is configured to be electrolytically dissolved through electrical conduction and release the connection with the connecting portion.

9. The medical device according to claim 8, It is characterized in that The first pushing rod further includes a first insulating layer disposed on an outer surface of the first rod body; and / or the second pushing rod further includes a second insulating layer disposed on an outer surface of the second rod body.

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