Electrolytic removal mechanism and electrolytic removal device

By using the adsorption part to adsorb the electrolyte in the electrolyte mechanism to form a stable electrolyte environment, the problems of low electrolyte reliability and long liberation time are solved, and safe and reliable electrolyte operation is achieved, avoiding the risk of the implant extending out of the catheter too long.

CN110960280BActive Publication Date: 2025-08-01MICROPORT NEUROTECH SHANGHAI
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Patent Information

Application Number
CN201811170257.6
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2018-09-30
Publication Date
2025-08-01
Estimated Expiration
2038-09-30

AI Technical Summary

Technical Problem

The existing electrolytic spring coil has low liberation reliability and a long liberation time, and there are problems such as the protrusion of the micro-catheter from the liberation point extending too long and causing danger and "pipe-top" effect.

Method used

The electrolytic mechanism is adopted, including the implant, the liberation part, the anode conductive part, the cathode conductive part and the adsorption part. After adsorbing the electrolyte, the liberation part and the cathode conductive part are continuously electrically conductive, forming a stable electrolytic environment, and liberation is achieved by electrochemical reactions.

Benefits of technology

It improves the reliability of electrolytic operation, avoids long removal time and "tube ejection" problems, ensures that the implant is safe and effective electrolytic in the catheter, and reduces the difficulty of doctors in operation.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention provides an electrolytic detachment mechanism and an electrolytic detachment device. The electrolytic detachment mechanism is used in cooperation with an electrolytic detachment instrument to achieve the electrolytic detachment of an implant. It includes an implant, a detachment part, a conductive part, and an adsorption part. After adsorbing the electrolyte, the adsorption part can continuously keep the detachment part and the cathode conductive part in electrical conduction, thereby improving the reliability of the electrolytic detachment operation and overcoming the problems of long detachment time and the need for multiple detachments in existing electrolytic detachment devices. The electrolytic detachment device adopts the above-mentioned electrolytic detachment mechanism, so that the detachment part can perform electrolytic detachment inside the catheter, without having to push the detachment part out of the distal opening of the catheter, which can avoid the danger caused by the implant protruding too long from the distal opening of the catheter and avoid the occurrence of the "pushing pipe" problem, thereby effectively improving the safety and reliability of the electrolytic detachment device during the implantation process.
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Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to an electrolytic detachment mechanism and an electrolytic detachment device. Background Art

[0002] Intracranial hemangioma is a tumor-like protrusion of blood vessels caused by abnormal blood vessel changes. In particular, intracranial aneurysms, when the blood pressure in the blood vessels suddenly rises, the intracranial aneurysms rupture and bleed, which can cause disability or death of patients. Since Guglielmi et al. first reported the treatment of intracranial aneurysms with Guglielmi detachable coil in 1991, with the development of materials and treatment equipment, the embolization treatment with coils has become the main treatment method for intracranial aneurysms.

[0003] Please refer to Figure 1 , which is a schematic cross-sectional view of an existing electrolytic detachable coil. The electrolytic detachable coil includes a microcatheter 10, a pusher 20, a conductive wire 30, a coil 40, and a detachment point 31. The distal opening 12 of the microcatheter 10 is held near the aneurysm neck. The pusher 20 is inserted into the interior of the microcatheter 10. A conductive wire 30 is disposed inside the pusher 20. The proximal end of the conductive wire 30 is electrically connected to an external detacher (not shown). The distal end of the conductive wire 30 is connected to the coil 40 through the detachment point 31. An elastic member 21 is disposed at the distal end of the pusher 20. The elastic member 21 is used to make the distal end of the pusher 20 softer and easier to shuttle through the curved intracranial blood vessels. A first imaging region 11 is provided at the distal end of the microcatheter 10. A second imaging region 22 is provided on the elastic member 21. Doctors judge the traveling position of the pusher 20 in the microcatheter 10 by observing the relative positional relationship between the first imaging region 11 and the second imaging region 22, and then judge whether the coil 40 has entered the aneurysm cavity.

[0004] Such as Figure 1As shown, when releasing the spring coil 40, the first developing area 11 and the second developing area 22 often need to form an "inverted T" image, that is, the second developing area 22 extends toward the distal end of the microcatheter 10 and completely crosses the first developing area 11, so as to ensure that the release point 31 extends from the distal opening 12 of the microcatheter 10, so that the release point 31 can contact the blood and provide the release point 31 with a release environment suitable for electrolytic release. Only then can the electrolysis operation of energizing the release point 31 be performed, and then the spring coil 40 can be released. However, the inventors have found that due to the tolerances of the microcatheter 10 and the push rod 20, when the first developing area 11 and the second developing area 22 form an "inverted T" image, there are cases where the release point 31 fails to extend out of the distal opening 12 of the microcatheter 10. In this case, the doctor needs to repeat the operation multiple times to successfully release the spring coil 40. In addition, due to the instability of the electrolytic environment after contact with blood, the random electrolytic environment formed by the combined influence of factors such as blood and thrombus can lead to the problem of excessive release time. Furthermore, there are cases where the release point 31 extends too far beyond the distal opening 12 of the microcatheter 10. In this case, the release point 31 and the push rod 20 that extend beyond the distal opening 12 can easily damage the aneurysm, causing a risk of rupture. Furthermore, when the push rod 20 pushes the unreleased coil 40 out of the distal opening 12 of the microcatheter 10, the entire release area, including the proximal end of the coil 40, can sometimes cause the microcatheter 10 to escape from the aneurysm cavity. This phenomenon, known as the "tube-pushing" effect, can also pose a risk.

[0005] Therefore, it is necessary to develop a new type of electrolytic release mechanism and electrolytic release device to solve the problems that the existing electrolytic release coil requires multiple operations to release, and the electrolytic release point needs to extend the microcatheter before it can easily cause danger. Summary of the Invention

[0006] The object of the present invention is to provide an electrolytic release mechanism and an electrolytic release device to solve the problems of low release reliability and excessively long extended microcatheter that may cause danger in existing electrolytic release devices.

[0007] In order to solve the above technical problems, the present invention provides an electrolytic release mechanism for cooperating with an electrolytic release device to achieve electrolytic release of the implant, which is characterized by comprising:

[0008] implants;

[0009] a release portion, the distal end of which is connected to the implant, and the release portion is configured to release the connection between the implant and the release portion by electrolytic dissolution through electrical conduction;

[0010] The conductive part includes:

[0011] The anodic conductive part is coated with a first insulating part, and the distal end of the anodic conductive part is connected to the proximal end of the release part, and the proximal end is used for connecting to the positive electrode of the electrolytic release device; and

[0012] The cathodic conductive part, the proximal end of which is used for connecting to the negative electrode of the electrolytic release device and is used for realizing electrical insulation from the anodic conductive part through the first insulating part; and

[0013] The adsorption part is used for making the release part and the cathodic conductive part electrically conductive after adsorbing an electrolyte.

[0014] Optionally, the adsorption part is made of a hydrogel material.

[0015] Optionally, the adsorption part wraps the release part and is used for making the release part and the cathodic conductive part electrically conductive after adsorbing an electrolyte.

[0016] Optionally, the adsorption part is in a spiral structure or a hollow pipe fitting and is sleeved on the release part.

[0017] Optionally, the adsorption part is coated on the release part and is used for making the release part and the cathodic conductive part electrically conductive after adsorbing an electrolyte.

[0018] Optionally, the hydrogel material is selected from one or a combination of the following materials: cellulose and its derivative hydrogels; gelatin-modified hydrogels; chitosan and its derivative cross-linked hydrogels; hyaluronic acid and its modified cross-linked hydrogels; polyethylene glycol and its derivative cross-linked hydrogels; polyvinyl alcohol and its derivative cross-linked hydrogels; poly-N-methylpyrrolidone and its derivative cross-linked hydrogels; polyester-based hydrogels; polyacrylamide and its derivative cross-linked hydrogels; cross-linked swellable polymers derived from one or more olefinically unsaturated polymerizable carboxylic acid monomers; and 2-hydroxyethyl methacrylate and its derivative hydrogels.

[0019] To solve the above technical problems, the present invention further provides an electrolytic release device, including the above-mentioned electrolytic release mechanism, and further including:

[0020] A catheter; and

[0021] A push rod, which is connected to the proximal end of the electrolytic release mechanism;

[0022] Wherein: both the electrolytic release mechanism and the push rod are movably disposed in the catheter, and the push rod is used for cooperating with the catheter to push the electrolytic release mechanism to a target position.

[0023] Optionally, a flexible member is disposed at the distal end of the push rod, and the push rod is connected to the electrolytic release mechanism through the flexible member.

[0024] Optionally, both the push rod and the flexible member are hollow structures, and the conductive portion is disposed through the push rod and the flexible member; the cathode conductive portion is coated with a second insulating portion to be electrically insulated from the push rod and the flexible member, and the distal end of the cathode conductive portion is exposed outside the second insulating portion and is electrically connected to the release portion through the adsorption portion.

[0025] Optionally, both the push rod and the flexible member are hollow structures, the anode conductive portion is disposed through the push rod and the flexible member, and the push rod and the flexible member are jointly configured as the cathode conductive portion.

[0026] Optionally, the adsorption portion and the flexible member are arranged side by side along the axial direction, and the adsorption portion is located at the distal end of the flexible member.

[0027] Optionally, the proximal end of the adsorption portion is inside the flexible member, and the distal end of the adsorption portion extends out from the distal end of the flexible member.

[0028] Optionally, the entire adsorption portion is inside the flexible member.

[0029] Optionally, the flexible member has a first imaging portion, and the distal end of the catheter is provided with a second imaging portion, and both the first imaging portion and the second imaging portion are made of imaging materials.

[0030] The electrolytic release mechanism and the electrolytic release device provided by the present invention have achieved the following beneficial effects:

[0031] First, after the electrolytic release mechanism provided by the present invention adsorbs the electrolyte through the adsorption portion, the release portion and the cathode conductive portion are continuously kept electrically connected, so as to form an electrolytic release environment for the release portion to electrolytically corrode. Therefore, after the conductive portion is energized, the release portion connected to the anode conductive portion undergoes an electrochemical reaction with the cathode conductive portion, causing the release portion itself to be electrolytically corroded. In this way, the implant is disconnected from the release portion and leaves the entire electrolytic release mechanism; compared with the prior art, since the adsorption portion can continuously conduct the release portion and the cathode conductive portion after adsorbing the electrolyte, forming a stable electrolytic environment, the reliability of the electrolytic release operation can be improved, overcoming the problems of long release time and the need for multiple releases of the existing electrolytic release devices, and improving the reliability of safe release;

[0032] Second, in the electrolytic release device provided by the present invention, due to the use of the electrolytic release mechanism, the release portion can be electrolytically released within the catheter, without having to push the release portion out of the distal opening of the catheter. This ensures that the release portion can contact the electrolyte, forming a stable electrolyte microcirculation electrolytic release environment. This allows the implant to be safely and effectively electrolytically released at any position within the catheter. This prevents the implant from extending too far beyond the distal opening of the catheter, which could cause danger, and also avoids the "tube-pushing" problem, thereby effectively improving the safety of the electrolytic release device during implantation.

[0033] Third, during actual operation, the electrolysis release device provided by the present invention drips electrolytes such as physiological saline into the catheter, so that the adsorption portion can always adsorb electrolytes, ensuring that the release portion always has a stable electrolyte microcirculation environment that can be electrolyzed. This overcomes the problem of long release time and multiple releases required by existing electrolysis release devices, and improves the reliability of safe release. Furthermore, since release can be performed without forming an "inverted T" image, the electrolysis release process of the implant can be started while pushing the push rod toward the distal end, which can also reduce the difficulty of the doctor's operation. The implant can also be electrolyzed after the push rod pushes it into place. The combination of multiple methods is beneficial to different surgical situations and complex surgical environments. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Those skilled in the art should understand that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0035] Figure 1 It is a cross-sectional schematic diagram of an existing electrolytically detachable spring coil;

[0036] Figure 2 Schematic diagram of a push rod provided with a flexible member at the distal end thereof according to an embodiment of the present invention;

[0037] Figure 3 Schematic diagram of an electrolytic release mechanism provided by one embodiment of the present invention, wherein the adsorption portion is a spring made of a hydrogel material;

[0038] Figure 4 is a cross-sectional schematic diagram of an electrolytic release device provided by one embodiment of the present invention, wherein the adsorption portion is entirely located at the distal end of the flexible member and does not overlap with the flexible member;

[0039] Figure 5 1 is a cross-sectional schematic diagram of an electrolytic release device provided by one embodiment of the present invention, wherein the proximal end of the adsorption portion is inside the flexible member and the distal end extends out of the flexible member;

[0040] Figure 6 1 is a cross-sectional schematic diagram of an electrolytic release device provided by an embodiment of the present invention, wherein the adsorption portion is entirely disposed inside the flexible member;

[0041] Figure 7 It is a schematic diagram of the electrolytic detachment mechanism provided by an embodiment of the present invention, wherein the adsorption part is a coating made of hydrogel material;

[0042] Figure 8 It is a schematic diagram of the electrolytic detachment mechanism provided by an embodiment of the present invention, wherein the adsorption part is a pipe fitting made of hydrogel material;

[0043] Figure 9 is Figure 8 A schematic cross-sectional view of the provided pipe fitting along the a-a connection line.

[0044] Explanation of reference numerals:

[0045] 10 - microcatheter; 11 - first imaging region; 12 - distal opening; 20 - push rod; 21 - elastic member; 22 - second imaging region; 30 - conductive wire; 31 - detachment point; 40 - coil spring;

[0046] 101 - conductive part; 102 - adsorption part; 102' - coating; 102" - pipe fitting; 103 - detachment part; 104 - coil spring; 201 - push rod; 202 - flexible member; 203 - first imaging part; 301 - catheter; 302 - second imaging part; 303 - distal end of the catheter. Detailed implementation manners

[0047] To make the objectives, advantages and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the accompanying drawings are all in very simplified forms and are not drawn to scale, only for conveniently and clearly assisting in explaining the objectives of the embodiments of the present invention. In addition, the structures shown in the accompanying drawings are often part of the actual structures. In particular, the accompanying drawings need to show different emphases and sometimes use different scales.

[0048] As used in this specification and the appended claims, the singular forms "a", "an" and "the" include plural objects unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in the sense of including "and / or" unless the context clearly dictates otherwise. The term "proximal" generally refers to the end closer to the operator, and the term "distal" generally refers to the end closer to the patient's lesion site.

[0049] The core idea of the present invention is to provide an electrolytic detachment mechanism for cooperating with an electrolytic detachment device to achieve the electrolytic detachment of an implant, which includes an implant, a detachment part, a conductive part, and an adsorption part. Compared with the prior art, the adsorption part is used to keep the detachment part and the cathode conductive part continuously electrically connected after adsorbing the electrolyte, so that the reliability of the electrolytic detachment operation can be improved, and the problems of long detachment time and the need for multiple detachments of the existing electrolytic detachment device are overcome.

[0050] The present invention also provides an electrolytic detachment device including the above-mentioned electrolytic detachment mechanism, and the electrolytic detachment device further includes a catheter and a push rod. During actual operation, the detachment part can perform electrolytic detachment inside the catheter, and it is not necessary to push the detachment part out of the distal opening of the catheter to ensure that the detachment part can contact the electrolyte to form a microcirculation electrolytic detachment environment, so that the implant can be safely and effectively electrolytically detached at any position inside the catheter. In this way, the risk caused by the implant extending too long out of the distal opening of the catheter can be avoided, and the occurrence of the "pipe pushing" problem can be avoided, thereby effectively improving the safety and reliability of the electrolytic detachment device during the implantation process.

[0051] More specifically, during the process of implanting the implant in the body, by dripping normal saline or other electrolyte solutions suitable for injecting into the human body into the catheter, the adsorption part can always adsorb the electrolyte, ensuring that the detachment part always has an electrolytic detachment microcirculation environment, overcoming the problems of long detachment time and the need for multiple detachments of the existing electrolytic detachment device, and improving the reliability of detachment. Further, since the detachment of the implant can be achieved without forming a "reverse T" image, that is, the electrolytic detachment process can be carried out at any time point during the process of pushing the push rod towards the distal end of the catheter, the operation difficulty for doctors can also be reduced.

[0052] The following will be described in detail with reference to the accompanying drawings. Figure 2 FIG. is a schematic diagram of a flexible member provided at the distal end of a push rod according to an embodiment of the present invention. Figure 3 FIG. is a schematic diagram of an electrolytic detachment mechanism according to an embodiment of the present invention. Figures 4 to 6 FIG. is a cross-sectional schematic diagram of an electrolytic detachment device according to a preferred embodiment of the present invention. Figure 7 and Figure 8 FIG. is a schematic diagram of an electrolytic detachment mechanism according to a preferred embodiment of the present invention. Figure 9 is Figure 8 a schematic cross-sectional view of a pipe fitting provided along the a-a connection line.

[0053] First, please refer to Figure 3, this embodiment provides an electrolytic detachment mechanism, which can be used to achieve the embolization treatment of hemangiomas, especially intracranial aneurysms. It includes: an implant, a detachment part 103, a conductive part 101, and an adsorption part 102. Among them, the implant is used to be retained at a predetermined position. Specifically, the implant can be a coil 104, which is used to embolize the hemangioma. One end of the detachment part 103 is connected to the coil 104, and when the detachment part 103 is electrolytically corroded, the connection between the coil 104 and the detachment part 103 can be released. Among them, the material of the detachment part 103 is preferably a biocompatible active metal, such as: Mg (magnesium), Zn (zinc), Fe (iron), etc. Of course, the material of the detachment part 103 can also be selected from some biocompatible relatively active alloy materials, such as magnesium-zinc alloy, magnesium-iron alloy, stainless steel, etc. In addition, the conductive part 101 includes a separately arranged anode conductive part and a cathode conductive part, and the anode conductive part is coated with a first insulating part. And the distal end of the anode conductive part is connected to the other end of the detachment part 103, and the proximal end is used to be connected to the positive electrode of an external electrolytic detachment device. The proximal end of the cathode conductive part is used to be connected to the negative electrode of the external electrolytic detachment device. Here, the external electrolytic detachment device has a positive electrode and a negative electrode, which is used to provide electrolytic current to the electrolytic detachment mechanism. Its structure is prior art and will not be described in detail here. In addition, the first insulating part is used to electrically insulate the anode conductive part from the cathode conductive part. Particularly, the adsorption part 102 is used to make the detachment part 103 electrically conductive with the cathode conductive part after adsorbing the electrolyte, so as to facilitate the electrolytic corrosion of the detachment part 103. Here, the adsorption part 102 may not be directly connected to the cathode conductive part, the detachment part 103 or the anode conductive part, as long as after it expands or chemically adsorbs the electrolyte, the electrolyte solution can make the detachment part 103 electrically conductive with the cathode conductive part; for the convenience of setting, the adsorption part 102 can be connected to one of the cathode conductive part, the detachment part 103 or the anode conductive part, or the coil 104, and can also be connected to the following push rod 201 or flexible part 202, so that the adsorption part 102 has a relatively fixed position in the whole electrolytic detachment device, so as to absorb the electrolyte and take effect. Specifically, the anode conductive part can be a conductive wire, and its surface is coated with the first insulating part as an insulating layer, so that the conductive wire is electrically insulated from the cathode conductive part, and the detachment part 103 is an electrical conductor and is connected to the anode conductive part and is exposed to the outside. In this way, the detachment part 103 and the cathode conductive part can be electrically conducted through the adsorption part 102 after adsorbing the electrolyte. It should be noted that the implant in the present invention is not limited to the coil 104, and can also be an interventional implantable device such as a stent, an artificial valve, a occluder, etc.

[0054] Thus, after the electrolyte is adsorbed by the adsorption part 102, the electrical conduction release part 103 and the cathode conductive part are electrically connected, thereby forming an electrolytic release environment for the release part 103 to electrolytically corrode. It should be understood that the electrical conduction here does not mean that the release part 103 and the cathode conductive part are in direct contact or electrically connected through an electrical conductor, but rather that the electrolyte adsorbed by the adsorption part 102 conducts the release part 103 and the cathode conductive part, that is, the release part 103 and the cathode conductive part are actually conducted through the electrolyte. The electrolyte here can be, for example, an electrolyte solution with good biocompatibility such as blood or physiological saline. After the adsorption part 102 adsorbs a similar electrolyte, it can conduct electricity and connect the release part 103 and the cathode conductive part. Since the release part 103 is connected to the anode conductive part, after the conductive part 101 is energized, the release part 103 undergoes an electrochemical reaction with the cathode conductive part, causing the release part 103 as the anode to undergo electrolytic corrosion itself. In this way, after the coil 104 is disconnected from the release part 103 and leaves the entire electrolytic release mechanism, it can embolize a hemangioma cavity. Compared with the prior art, since the adsorption part 102 can continuously conduct the release part 103 and the cathode conductive part after adsorbing the electrolyte, the reliability of the electrolytic release operation can be improved, overcoming the problems of long release time and possible multiple releases of the existing electrolytic release coils due to the instability of the electrolytic environment, improving the reliability of safe release, and being able to solve the problem of low release reliability of the existing electrolytic release coils.

[0055] Furthermore, the adsorption part 102 can connect the release part and the cathode / anode conductive part by expanding or adsorbing the electrolyte so that the electrolyte solution connects them. For example, it can be made of a hydrogel material or other materials with chemical adsorption properties. The hydrogel material here refers to a water-absorbing and expandable polymer, which has good water retention. Specifically, the hydrogel material includes natural polymer hydrogels and organic synthetic polymer hydrogels. The hydrogel material specifically includes, but is not limited to, one or a combination of more than one of the following materials: cellulose and its derivative hydrogels; gelatin-modified hydrogels; chitosan and its derivative cross-linked hydrogels; hyaluronic acid and its modified cross-linked hydrogels; polyethylene glycol and its derivative cross-linked hydrogels; polyvinyl alcohol and its derivative cross-linked hydrogels; poly-N-methylpyrrolidone and its derivative cross-linked hydrogels; polyester hydrogels; polyacrylamide and its derivative cross-linked hydrogels; 2-hydroxyethyl methacrylate and its derivative hydrogels; cross-linked expandable polymers derived from one or more olefinically unsaturated polymerizable carboxylic acid monomers, etc.

[0056] Furthermore, the adsorption part 102 can be made into various structural forms by the hydrogel material. For example, it can be made into a helical structure, such as a spring (such as Figure 3As shown, it wraps the release part 103 and is used to adsorb the electrolyte and then be electrically connected to the cathode conductive part. Specifically, a micro spring with a helical structure can be made by winding hydrogel fibers or hydrogel silk threads, and the micro spring wraps the release part 103, that is, the spring is sleeved on the release part 103 as a whole. Preferably, a section of the micro spring that wraps the release part 103 is designed to be sparsely wound, on the one hand, providing space for the release part 103 to contact the electrolyte, and on the other hand, leaving space for the expansion of the micro spring. In this way, after the hydrogel fibers or hydrogel silk threads adsorb the electrolyte, they can expand and contact the release part 103 and the cathode conductive part respectively, so that the release part 103 and the cathode conductive part remain electrically conductive.

[0057] In some other embodiments, the adsorption part 102 can be made into a coating 102' (such as Figure 7 As shown) and coated on the release part 103. Specifically, the hydrogel material can be coated on the surface (preferably the outer surface) of the release part 103, and here the coating includes coating part or all of the surface of the release part 103. The coating 102' made of the hydrogel material can also expand and contact the cathode conductive part after adsorbing the electrolyte, so that the release part 103 and the cathode conductive part remain electrically conductive. In some other embodiments, the adsorption part 102 can be made into a pipe fitting 102" (such as Figure 8 As shown), and the pipe fitting 102" can be sleeved and wrapped around the release part 103. The cross-section of the pipe fitting 102" can be a regular circle (such as Figure 9 (A) shown), rectangle (such as Figure 9 (B) shown), gear shape (such as Figure 9 (C) shown) or triangle (such as Figure 9 (D) shown), etc., and can also be other polygons or irregular shapes. The pipe fitting 102" can also expand and contact the cathode conductive part after adsorbing the electrolyte, so that the release part 103 and the cathode conductive part remain electrically conductive.

[0058] Please refer to Figures 2 to 4, this embodiment also provides an electrolytic detachment device, which includes the above-mentioned electrolytic detachment mechanism, and the electrolytic detachment device further includes: a catheter 301 and a push rod 201. The electrolytic detachment mechanism and the push rod 201 are both movably inserted into the catheter 301. The push rod 201 is used to cooperate with the catheter 301 to push the electrolytic detachment mechanism to a target position in the patient's body, such as a hemangioma cavity. The electrolytic detachment device provided in this embodiment can perform electrolytic detachment inside the catheter 301 due to the adoption of the above-mentioned electrolytic detachment mechanism. It is not necessary to push the detachment part 103 out of the opening of the distal end 303 of the catheter to ensure that the detachment part 103 can contact the electrolyte to form a microcirculation electrolytic detachment environment, so that the spring coil 104 can perform safe and effective electrolytic detachment at any position inside the catheter 301. In this way, it can be avoided that the spring coil 104 extends too long out of the opening of the distal end 303 of the catheter, which may cause danger. Preferably, the spring coil 104 can be electrolytically dissociated inside the catheter 301 near the distal end 303 of the catheter, which can avoid the problem of "pushing the catheter" that the opening of the distal end 303 of the catheter is separated from the aneurysm cavity under the resistance of the aneurysm cavity wall when the spring coil 104 extends out of the opening of the distal end 303 of the catheter, thereby improving the safety of the electrolytic detachment device during the implantation process. Generally, when the electrolytic detachment device is used to treat intracranial aneurysms, multiple spring coils 104 often need to be embolized. After electrolytic dissociation is performed in the above manner, the dissociated spring coils can be pushed out of the opening of the distal end 303 of the catheter by the spring coils electrolytically dissociated later and enter the aneurysm cavity. This is because the spring coil 104 itself is elastic. When the first detached spring coil does not enter the aneurysm cavity at the distal end 303 of the catheter, the second spring coil sent in by the push rod 201 will push the first spring coil towards the distal end and enter the aneurysm cavity. Thus, the occurrence of the "pushing the catheter" problem can be further reduced, and the safety of the electrolytic detachment device during the implantation process can be further improved.

[0059] Preferably, a flexible member 202 is provided at the distal end of the push rod 201; the flexible member 202 is made of a flexible material or has a flexible structure, such as a spring structure, and is used to connect to the electrolytic detachment mechanism to push the electrolytic detachment mechanism. Here, the setting of the flexible member 202 is used to make the distal end of the push rod 201 softer and easier to shuttle through the intracranial curved blood vessels.

[0060] Such as Figure 4As shown in the figure, the specific structure of the electrolytic release device will be introduced in detail below. The push rod 201 and the flexible member 202 are both hollow structures. For example, the push rod 201 can be a stainless steel hollow tube, and the flexible member 202 can be a stainless steel spring. Preferably, the conductive part 101 of the electrolytic release mechanism is a double-strand conductive wire, that is, both the anode conductive part and the cathode conductive part are conductive wires. The double-strand conductive wires are both inserted into the push rod 201, and insulating layers are respectively coated on the surfaces of the double-strand conductive wires. That is, in addition to the first insulating part being coated on the anode conductive part of the above-mentioned electrolytic release mechanism, the second insulating part is coated on the cathode conductive part, so that the anode conductive part and the cathode conductive part are electrically insulated from each other. The distal end of the cathode conductive part is disposed close to the release part 103 and is exposed outside the second insulating part and can contact the adsorption part 102 after adsorbing the electrolyte. With such a configuration, the cathode conductive part can be electrically connected to the release part 103 through the adsorption part 102. Preferably, a third insulating part is further coated on the outside of the conductive part 101, that is, in addition to the first insulating part being coated on the anode conductive part and the second insulating part being coated on the cathode conductive part, an insulating layer is further coated on the outside of the double-strand conductive wire to further ensure electrical insulation between the conductive part 101 and the push rod 201. In some other embodiments, only the anode conductive part of the electrolytic release mechanism is inserted into the push rod 201 and the flexible member 202, and the push rod 201 and the flexible member 202 are jointly configured as the cathode conductive part. At this time, the distal end of the flexible member 202 is disposed close to the release part 103 and can contact the adsorption part 102 after adsorbing the electrolyte. With such a configuration, it can also make the push rod 201 and the flexible member 202 as the cathode conductive part be electrically connected to the release part 103 through the adsorption part 102. Since the anode conductive part is coated with the first insulating part, it can be ensured that it is electrically insulated from the push rod 201 and the flexible member 202. When an external electrolytic release device supplies current to the conductive part 101, the current is conducted from the positive electrode of the electrolytic release device through the anode conductive part to the release part 103, and is conducted to the flexible member 202 through the adsorption part 102 after absorbing the electrolyte, and then is conducted to the push rod 201 through the flexible member 202, and finally flows to the negative electrode of the electrolytic release device through the push rod 201, thus forming a current loop. Under the continuous conduction of the current, the release part 103 undergoes electrochemical corrosion and breaks, so that the spring coil 104 is dissociated.

[0061] Preferably, the adsorption part 102 and the flexible member 202 are arranged side by side along the axial direction of the flexible member 202, and the adsorption part 102 is located at the distal end of the flexible member 202, so that the adsorption part 102 and the flexible member 202 do not overlap in the axial direction of the flexible member 202. As Figure 4As shown, the adsorption part 102 is arranged starting from the distal end of the flexible part 202. The adsorption part 102 and the flexible part 202 are axially staggered from each other on the flexible part 202 and do not overlap. This solution is more suitable for the case where the conductive part 101 is a double-stranded conductive wire. The release part 103 and the part of the cathode conductive part exposed outside the second insulating part are both covered by the adsorption part 102. When the adsorption part 102 adsorbs the electrolyte, it expands and simultaneously contacts the release part 103 and the part of the cathode conductive part exposed outside the second insulating part. With such a configuration, electrical conduction between the release part 103 and the cathode conductive part can be achieved through the adsorption part 102.

[0062] In some other embodiments, as Figure 5 shown, a part of the adsorption part 102 is arranged inside the flexible part 202. Specifically, the proximal end of the adsorption part 102 is inside the flexible part 202, and the distal end of the adsorption part 102 extends out from the distal end of the flexible part 202, so that the adsorption part 102 partially overlaps with the flexible part 202 in the axial direction of the flexible part 202.

[0063] In other embodiments, as Figure 6 shown, the entire adsorption part 102 is arranged inside the flexible part 202, so that the adsorption part 102 completely overlaps with the flexible part 202 in the axial direction of the flexible part 202. It should be understood that the complete overlap here means that the flexible part 202 completely covers the adsorption part 102 along the axial direction, but the length of the flexible part 202 can be greater than or equal to the length of the adsorption part 102.

[0064] In the above embodiments, the situation where the adsorption part 102 and the flexible part 202 partially overlap or completely overlap in the axial direction of the flexible part 202 is more suitable for the case where the push rod 201 and the flexible part 202 are jointly configured as the cathode conductive part. At this time, the adsorption part 102 only covers the release part 103, and at least part of the adsorption part 102 overlaps with the flexible part 202. Therefore, when the adsorption part 102 adsorbs the electrolyte, it expands and can simultaneously contact the release part 103 and the flexible part 202 configured as the cathode conductive part to make the two conduct electricity. Specifically, the adsorption part 102 can be a micro spring made of hydrogel fiber, the flexible part 202 can be a stainless steel spring, a part or all of the micro spring is placed inside the stainless steel spring, and the release part 103 is covered inside the micro spring.

[0065] Specifically, in some alternative embodiments, the push rod 201 may also be a solid push rod, such as a stainless-steel solid push rod, and is configured as the cathode conductive part. The anode conductive part of the conductive part 101 may be a conductive wire coated with a first insulating part. The conductive part 101 may be arranged side by side with the solid push rod in the radial direction instead of passing through the solid push rod. Preferably, the conductive part 101 can be fixed to the solid push rod through some fixed points, such as by tying or cementing. A flexible part 202 may also be provided at the distal end of the solid push rod to increase the flexibility of the distal end and facilitate passing through tortuous blood vessels. At this time, the release part 103 may be arranged side by side with the flexible part 202 in the radial direction. The adsorption part 102 may be made of a solid hydrogel material or a material with chemical adsorption properties. The two ends of the adsorption part 102 are in contact with the release part 103 and the flexible part 202 respectively. With such a configuration, electrical conduction between the release part 103 and the cathode conductive part can also be achieved through the adsorption part 102. Of course, the release part 103 may also penetrate into the flexible part 202 as described in the above embodiments.

[0066] Please refer to Figure 4 , and in combination with Figure 2 , preferably, the flexible part 202 has a first imaging part 203, and the distal end 303 of the catheter 301 is provided with a second imaging part 302. Both the first imaging part 203 and the second imaging part 302 are made of imaging materials for displaying their own positions under X-rays. For example, the first imaging part 203 may be made of a material different from other parts of the flexible part 202 and easy to image, such as a metal like platinum. In this way, under X-ray fluoroscopy monitoring and through the monitor, the relative position and distance between the flexible part 202 and the distal end 303 of the catheter 301 can be determined, thereby helping the doctor judge the specific electrolytic detachment timing of the coil 104.

[0067] This embodiment also provides an operation method of an electrolytic detachment device, which uses the electrolytic detachment device as described above. The method includes:

[0068] Step 1: Push the catheter 301 to a predetermined position in the body (such as near a hemangioma), and continuously drip physiological saline at the proximal end of the catheter 301 to make the adsorption part 102 adsorb the physiological saline;

[0069] Step 2: Push the push rod 201 towards the distal end of the catheter 301 to a predetermined detachment position;

[0070] Step 3: Apply an electric current to the conductive part 101 to electrolytically corrode the release part 103;

[0071] Step 4: After the detachment part 103 is electrolytically corroded, the coil 104 is detached from the detachment part 103, and the coil 104 reaches the hemangioma, thereby embolizing the hemangioma cavity.

[0072] Specifically, in Step 1, when the push rod 201 is in use, the doctor continuously drips physiological saline into the catheter 301. The adsorption part 102 located on the detachment part 103 absorbs the physiological saline and expands, and keeps the detachment part 103 in continuous contact with the cathode conductive part. At this time, the detachment part 103 has a conductive environment for electrolytic detachment. Compared with the prior art, the detachment point needs to first extend out of the microcatheter to ensure sufficient contact with electrolytes such as blood before electrolytic detachment can start. The method provided in this embodiment enables the adsorption part 102 to adsorb electrolytes during the pushing process and can continuously adsorb electrolytes, so the conductive environment for electrolytic detachment can be ensured to be better than that of the prior art, thereby improving the reliability of electrolytic detachment and avoiding multiple electrolytic detachments.

[0073] In Step 2, the setting of the predetermined detachment position is different according to the conditions of different patients, and is generally judged and set by the doctor's experience.

[0074] Furthermore, in Step 3, an electric current is applied to the conductive part 101, so that the current is conducted from the positive electrode of the external electrolytic detachment device through the anode conductive part, the detachment part 103 and the physiological saline to the cathode conductive part, and then flows to the negative electrode of the electrolytic detachment device, thus forming a current loop; under the continuous conduction of the current, the detachment part 103 undergoes electrolytic corrosion, and the coil 104 is dissociated.

[0075] Preferably, in Step 2, while pushing the push rod 201 distally, the relative distance between the first imaging part 203 and the second imaging part 302 can be observed through X-ray. When the distance between the first imaging part 203 and the second imaging part 302 is not greater than a predetermined distance, the pushing of the push rod 201 is stopped. The predetermined distance here can be set according to the structure of the actual electrolytic detachment device and the needs of the operation. The doctor can observe the relative position and distance between the first imaging part 203 and the second imaging part 302 through X-ray, judge the pushing depth of the push rod 201, and compare and refer to it with the predetermined detachment position. Since the detachment part 103 does not need to extend out of the catheter 301 to ensure sufficient contact with the electrolyte and complete the electrolytic dissociation of the coil 104, it effectively ensures that when the coil 104 is electrolytically dissociated, it will not extend out of the catheter too long and cause danger, avoiding the occurrence of the "pipe pushing" problem, thereby improving the safety of pushing and overcoming the problem that a "reverse T" image needs to be formed in the prior art to ensure the detachment of the coil.

[0076] Preferably, in step two, while pushing the push rod 201 distally, power can be supplied to the conductive part 101; alternatively, power can also be supplied to the conductive part 101 when the distance between the first developing part 203 and the second developing part 302 is not greater than a predetermined distance and after stopping the pushing of the push rod 201. After the adsorption part 102 comes into contact with the continuously dripping physiological saline in the catheter 301 or after contacting the blood, it will expand and continuously adsorb electrolytes (physiological saline or blood). Therefore, it can ensure that the detachment part 103 always has an electrolytic detachment microcirculation environment, overcoming the problems of long detachment time and the need for multiple detachments of the existing electrolytic detachment coils, and improving the safety and reliability of detachment. Preferably, after the push rod 201 pushes the electrolytic detachment mechanism to a position close to the distal end 303 of the catheter, it can be stopped and then electrolytic detachment can be started. In this way, after the coil 104 is electrolytically separated, it is located at the opening of the distal end 303 of the catheter, facilitating the coil 104 to reach and embolize the predetermined position. Of course, in some cases where multiple coils 104 are required, electrolytic detachment can also be started in the catheter 301, and the subsequent coils 104 can push out the previous coils 104. Specifically, it can be selected according to the needs of the operation. Since detachment can be achieved without forming a "reverse T" image, that is, electrolytic detachment can be started inside the catheter 301, this method can also reduce the operation difficulty of the doctor, and the electrolytic detachment process can be started while pushing the push rod 201 distally. Of course, the electrolytic detachment process can also be started after the push rod 201 is pushed in place. The combination of multiple methods is beneficial for different surgical conditions and complex surgical environments.

[0077] In summary, after the adsorption part of the electrolytic detachment mechanism provided by the embodiment of the present invention adsorbs electrolytes, the detachment part and the cathode conductive part are continuously kept in electrical conduction, so as to form a stable electrolytic detachment environment for the electrolytic erosion of the detachment part. Therefore, after power is supplied to the conductive part, the detachment part connected to the anode conductive part undergoes an electrochemical reaction with the cathode conductive part, causing the detachment part itself to undergo electrolytic erosion. In this way, the implant is disconnected from the detachment part and leaves the entire electrolytic detachment mechanism for placement at a predetermined site. Compared with the prior art, since the adsorption part can continuously conduct electricity between the detachment part and the cathode conductive part after adsorbing electrolytes, the reliability of the electrolytic detachment operation can be improved, overcoming the problems of long detachment time and the need for multiple detachments of the existing electrolytic detachment devices, and improving the safety and reliability of detachment.

[0078] In addition, in the electrolytic detachment device provided by the embodiments of the present invention, due to the adoption of the above-mentioned electrolytic detachment mechanism, the detachment part can perform electrolytic detachment inside the catheter. Without pushing the detachment part out of the distal opening of the catheter, it can ensure that the detachment part can contact the electrolyte to form a stable microcirculation electrolytic detachment environment, enabling the implant to perform safe and effective electrolytic detachment at any position inside the catheter. In this way, it can avoid the danger caused by the implant protruding too long from the distal opening of the catheter, and at the same time avoid the occurrence of the "pipe pushing" problem, thereby effectively improving the safety of the electrolytic detachment device during the implantation process;

[0079] In addition, when the electrolytic detachment device provided by the embodiments of the present invention is actually operated, by injecting physiological saline into the catheter, the adsorption part can always adsorb the electrolyte, which can ensure that the detachment part always has a stable electrolytic detachment electrolyte microcirculation environment, overcoming the problems of long detachment time and the need for multiple detachments of the existing electrolytic detachment devices, and improving the reliability of safe detachment; Further, since detachment can be performed without forming a "reverse T" image, that is, the electrolytic detachment process of the implant can be started while pushing the push rod distally, the operation difficulty of the doctor can also be reduced. The combination of multiple methods is beneficial to different surgical situations and complex surgical environments.

[0080] The above description is only a description of the preferred embodiments of the present invention, and does not limit the scope of the present invention in any way. Any changes and modifications made by those of ordinary skill in the field of the present invention based on the above disclosure fall within the protection scope of the claims.

Claims

1. An electrolytic removal mechanism is used in cooperation with an electrolytic remover to achieve the electrolytic removal of implants, and is characterized in that, Comprising: An implant; A release portion, distally connected to the implant, and the release portion is configured to release the connection between the implant and the release portion through electrically conductive electrolytic erosion; A conductive portion, comprising: An anodic conductive portion, coated with a first insulating portion, and the distal end of the anodic conductive portion is connected to the proximal end of the release portion, and the proximal end is for connection to the positive electrode of the electrolytic release device; and A cathodic conductive portion, the proximal end of which is for connection to the negative electrode of the electrolytic release device and is for achieving electrical insulation from the anodic conductive portion through the first insulating portion; and An adsorption portion, for making the release portion and the cathodic conductive portion electrically conductive after adsorbing an electrolyte; the adsorption portion expands after adsorbing the electrolyte and simultaneously contacts the release portion and the cathodic conductive portion.

2. The electrolytic removal mechanism according to claim 1, wherein The adsorption portion is made of a hydrogel material.

3. The electrolytic removal mechanism according to claim 2, wherein The adsorption portion wraps the release portion and is for making the release portion and the cathodic conductive portion electrically conductive after adsorbing an electrolyte.

4. The electrolytic removal mechanism according to claim 3, characterized in that, The adsorption portion is a spiral structure or a hollow pipe fitting, sleeved on the release portion.

5. The electrolytic removal mechanism according to claim 2, characterized in that The adsorption portion is coated on the release portion and is for making the release portion and the cathodic conductive portion electrically conductive after adsorbing an electrolyte.

6. The electrolytic removal mechanism according to claim 2, wherein The hydrogel material is selected from one or a combination of the following materials: cellulose and its derivative hydrogels; gelatin-modified hydrogels; chitosan and its derivative cross-linked hydrogels; hyaluronic acid and its modified cross-linked hydrogels; polyethylene glycol and its derivative cross-linked hydrogels; polyvinyl alcohol and its derivative cross-linked hydrogels; poly-N-methylpyrrolidone and its derivative cross-linked hydrogels; polyester-based hydrogels; polyacrylamide and its derivative cross-linked hydrogels; cross-linked swellable polymers derived from one or more olefinically unsaturated polymerizable carboxylic acid monomers; and 2-hydroxyethyl methacrylate and its derivative hydrogels.

7. An electrolytic removal device, characterized in that, Comprising the electrolytic release mechanism according to any one of claims 1 to 6, and further comprising: A catheter; and A push rod, connected to the proximal end of the electrolytic release mechanism; Wherein: the electrolytic release mechanism and the push rod are both movably disposed within the catheter, and the push rod is for cooperating with the catheter to push the electrolytic release mechanism to a target position.

8. The electrolytic removal device according to claim 7, characterized in that A flexible member is provided at the distal end of the push rod, and the push rod is connected to the electrolytic release mechanism through the flexible member.

9. The electrolytic removal device according to claim 8, characterized in that, The push rod and the flexible member are both hollow structures, and the conductive portion is disposed through the push rod and the flexible member; the cathodic conductive portion is coated with a second insulating portion to be electrically insulated from the push rod and the flexible member, and the distal end of the cathodic conductive portion is exposed outside the second insulating portion and is electrically conductive with the release portion through the adsorption portion.

10. The electrolytic removal device according to claim 8, characterized in that, The push rod and the flexible member are both hollow structures, the anodic conductive portion is disposed through the push rod and the flexible member, and the push rod and the flexible member are jointly configured as the cathodic conductive portion.

11. The electrolytic removal device according to claim 9 or 10, characterized in that, The adsorption portion and the flexible member are arranged side by side along the axial direction, and the adsorption portion is located at the distal end of the flexible member.

12. The electrolytic removal device according to claim 9 or 10, characterized in that, The proximal end of the adsorption portion is within the flexible member, and the distal end of the adsorption portion extends out from the distal end of the flexible member.

13. The electrolytic removal device according to claim 9 or 10, characterized in that, The entire adsorption portion is inside the flexible member.

14. The electrolytic removal device according to claim 8, characterized in that, The flexible member has a first imaging portion, and a second imaging portion is provided at the distal end of the catheter. Both the first imaging portion and the second imaging portion are made of imaging material.

Citation Information

Patent Citations

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