CN113288315A - Medical implant and manufacturing method thereof - Google Patents

Medical implant and manufacturing method thereof Download PDF

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Publication number
CN113288315A
CN113288315A CN202110686347.6A CN202110686347A CN113288315A CN 113288315 A CN113288315 A CN 113288315A CN 202110686347 A CN202110686347 A CN 202110686347A CN 113288315 A CN113288315 A CN 113288315A
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CN
China
Prior art keywords
unit
spring ring
spring
coil
medical implant
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202110686347.6A
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Chinese (zh)
Inventor
张广建
杨波
王洪杰
刘梦钦
郭澜涛
苗铮华
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shanghai Hongmai Medical Technology Co Ltd
Original Assignee
Shanghai Hongmai Medical Technology Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shanghai Hongmai Medical Technology Co Ltd filed Critical Shanghai Hongmai Medical Technology Co Ltd
Priority to CN202110686347.6A priority Critical patent/CN113288315A/en
Publication of CN113288315A publication Critical patent/CN113288315A/en
Priority to PCT/CN2022/098135 priority patent/WO2022267904A1/en
Priority to ARP220101619A priority patent/AR126190A1/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214Coils or wires
    • A61B17/12145Coils or wires having a pre-set deployed three-dimensional shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214Coils or wires
    • A61B17/1215Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526Methods of manufacturing

Abstract

The invention provides a medical implant and a manufacturing method thereof, wherein the medical implant comprises a spring ring, wherein the spring ring comprises a first spring ring unit and a second spring ring unit, and the first spring ring unit is connected with the second spring ring unit; the outer surface of the first spring ring unit is located on a first curved surface, and the concave side of the first curved surface is arranged towards the second spring ring unit. The medical implant is used for the blocking treatment of hemangioma, and the first spring ring unit can adapt to the shape of the hemangioma wall, thereby being beneficial to improving the compactness of the intratumoral plug and improving the treatment effect.

Description

Medical implant and manufacturing method thereof
Technical Field
The invention relates to the technical field of medical instruments, in particular to a medical implant and a manufacturing method thereof.
Background
Aneurysms are localized bulging or fusiform distensible lesions formed by lesions or lesions of the arterial wall, which have a serious impact on the health of the patient. With the development of imaging technology and intravascular biomaterials, intravascular interventional therapy has become the first choice for treating aneurysms because it has fewer risks and trauma than surgical treatment.
The coil is used for the first time to treat aneurysm, and during the process of coil embolization of aneurysm, the coil is expanded into a preset shape in aneurysm and achieves corresponding embolization effect. To fit and occlude the coil to different sized vascular structures, the coil may have different shapes and/or different cross-sectional diameters. In use, the coil is delivered in a small diameter elongate configuration and deployed into a blood vessel, and then the coil assumes a two-dimensional or 3D shape such as a spindle, bird's nest, or the like. The spring coil is structurally flexible and can be delivered through narrow or tortuous vasculature, but may require the simultaneous use of multiple coils when the occlusion of relatively large vasculature is desired. For the treatment of aneurysm, the instant embolization compactness is one of the important factors influencing the long-term stability of embolization structure, so that the greater the packing density of the coil in the aneurysm, the more beneficial is to improve the clinical effect of aneurysm treatment.
The existing spring rings comprise a three-dimensional spring ring and a two-dimensional spring ring, in most cases, the three-dimensional spring ring needs to be matched with the two-dimensional spring ring to form a complete spring ring system, wherein the three-dimensional spring ring is mainly used for forming a basket ring and forming a space frame in the aneurysm so as to be stably supported in the aneurysm and cover an open area, and then the two-dimensional spring ring is used for filling the remaining space in the aneurysm to finally form a compact embolism of the aneurysm. However, the coil systems of the prior art, which have three-dimensional structures with a planar end profile, do not fully conform to the shape of the aneurysm, resulting in incomplete embolization of the aneurysm.
Disclosure of Invention
The invention aims to provide a medical implant and a manufacturing method thereof, wherein the medical implant is used for hemangioma embolism, can well conform to the shape of hemangioma, and is beneficial to improving the compactness of filling and improving the treatment effect.
In order to achieve the above object, the present invention provides a medical implant comprising a coil including a first coil unit and a second coil unit, the first coil unit being connected with the second coil unit; the outer surface of the first spring ring unit is located on a first curved surface, and the concave side of the first curved surface is arranged towards the second spring ring unit.
Optionally, the first spring ring unit comprises at least two basic units with different shapes, and each basic unit is O-shaped, C-shaped or omega-shaped.
Alternatively, the first spring ring unit has opposite ends, one of the base units at one end is connected to the second spring ring unit, and one of the base units at the other end has an O-shape.
Optionally, the outer surface of the second spring coil unit is located on a second curved surface, and the concave side of the second curved surface is arranged towards the first spring coil unit.
Optionally, the second spring ring unit comprises at least two basic units with different shapes, and each basic unit is O-shaped, C-shaped or omega-shaped.
Alternatively, the second spring ring unit has opposite ends, one of the base units at one end is connected to the first spring ring unit, and one of the base units at the other end has an O-shape.
Optionally, the spring ring further comprises a third spring ring unit, and the first spring ring unit is connected with the second spring ring unit through the third spring ring unit.
Optionally, the third spring ring unit comprises at least three basic units, and at least three basic units are arranged in a three-dimensional structure.
Optionally, at least three of the basic units in the third spring ring units have the same or different shapes, and the basic units have a C shape, an O shape or an S shape.
Optionally, the medical implant further comprises an procoagulant structure disposed on the spring ring.
In order to achieve the above object, the present invention also provides a method for manufacturing a medical implant, for preparing the medical implant as described above, the method comprising:
providing a primary coil;
routing the primary coil according to a die so as to wind the spring ring on the die; and the number of the first and second groups,
and (5) shaping treatment.
Optionally, the primary coil is formed by helically winding a metal, alloy or polymer wire.
Optionally, the manufacturing method further comprises: and a coagulation promoting structure is arranged on the spring ring.
Compared with the prior art, the medical implant and the manufacturing method thereof have the following advantages:
the medical implant comprises a spring coil which comprises a first spring coil unit and a second spring coil unit, wherein the first spring coil unit is connected with the second spring coil unit, and the outer surface of the first spring ring unit is positioned on the first curved surface, the concave side of the first curved surface is arranged towards the second spring ring, when the medical implant is implanted into the tumor cavity of the hemangioma, the first spring ring unit is used for supporting on the tumor wall opposite to the neck opening of the hemangioma, the second spring ring unit is used for covering the neck opening of the hemangioma and supporting on the tumor wall at the opening, the first spring ring unit and the second spring ring unit form a space frame in the hemangioma, the outer surface of the first spring ring unit of the medical implant is located on the first curved surface, so that the first spring ring unit can conform to the shape of the tumor wall, the compactness of the packing is improved, and the treatment effect is improved.
Further, the outer surface of the second spring ring unit is located on a second curved surface, and the concave side of the second curved surface is arranged towards the first spring ring unit. Thus, the compactness of the spring coil packing can be further improved.
Still further, the spring ring further comprises a third spring ring unit, and the first spring ring unit is connected with the second spring ring unit through the third spring ring unit; the concave side of the first curved surface and the concave side of the second curved surface are both arranged facing the third spring ring unit, so when the medical implant is implanted into the hemangioma, the third spring ring unit is directly utilized to fill the residual space between the first spring ring unit and the second spring ring unit in the hemangioma cavity and promote thrombopoiesis, other embolism structures do not need to be additionally implanted, the operation is simplified, and the operation time is shortened. The first spring ring unit, the second spring ring unit and the third spring ring unit are utilized to construct a smooth three-dimensional curved surface structure, so that the medical implant can conform to the shape of hemangioma to the maximum extent, and a better embolization effect can be achieved.
Drawings
The drawings are included to provide a better understanding of the invention and are not to be construed as unduly limiting the invention. Wherein:
FIG. 1 is a schematic view of a medical implant according to an embodiment of the present invention;
FIG. 2 is a schematic view of a coil of a medical implant according to an embodiment of the present invention;
FIG. 3 is a schematic view of a coil of a medical implant according to an embodiment of the present invention, the coil being viewed in a different orientation from that of FIG. 2 in FIG. 3;
fig. 4 is a schematic structural view of a primary coil of a medical implant according to an embodiment of the present invention;
FIG. 5 is a schematic structural diagram of a mold for a medical implant according to an embodiment of the present invention;
FIG. 6 is a schematic view of a coil wound on a die in accordance with a first embodiment of the present invention;
FIG. 7 is a schematic view of a spring ring with an coagulation promoting structure according to a first embodiment of the present invention;
FIG. 8 is a schematic structural view of a medical implant according to a second embodiment of the present invention;
FIG. 9 is a schematic view of a coil of a medical implant according to a second embodiment of the present invention;
FIG. 10 is a structural schematic view of a coil of a medical implant according to a second embodiment of the present invention, the view orientation of FIG. 10 being different from that of FIG. 9;
fig. 11 is a structural diagram of a mold for a medical implant according to a second embodiment of the present invention.
[ reference numerals are described below ]:
100-coil, 110-first coil unit, 120-second coil unit, 130-third coil unit;
210-thrombogenic villi;
10-a primary coil;
20-mold, 21-body, 21 a-cylinder, 21 b-first hemisphere, 21 c-human hemisphere, 22-convex column.
Detailed Description
The embodiments of the present invention are described below with reference to specific embodiments, and other advantages and effects of the present invention will be easily understood by those skilled in the art from the disclosure of the present specification. The invention is capable of other and different embodiments and of being practiced or of being carried out in various ways, and its several details are capable of modification in various respects, all without departing from the spirit and scope of the present invention. It should be noted that the drawings provided in the present embodiment are only for illustrating the basic idea of the present invention, and the drawings only show the components related to the present invention rather than the number, shape and size of the components in actual implementation, and the form, quantity and proportion of the components in actual implementation may be changed arbitrarily, and the layout of the components may be more complicated.
Furthermore, each of the embodiments described below has one or more technical features, and thus, the use of the technical features of any one embodiment does not necessarily mean that all of the technical features of any one embodiment are implemented at the same time or that only some or all of the technical features of different embodiments are implemented separately. In other words, those skilled in the art can selectively implement some or all of the features of any embodiment or combinations of some or all of the features of multiple embodiments according to the disclosure of the present invention and according to design specifications or implementation requirements, thereby increasing the flexibility in implementing the invention.
As used in this specification, the singular forms "a", "an" and "the" include plural referents, and the plural forms "a plurality" includes more than two referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise, and the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either fixedly connected, detachably connected, or integrally connected. Either mechanically or electrically. Either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.
To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to the appended drawings. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention. The same or similar reference numbers in the drawings identify the same or similar elements.
Referring to fig. 1 to 3 and 8 to 11, a medical implant according to an embodiment of the present invention includes a coil unit 100, where the coil unit 100 includes a first coil unit 110 and a second coil unit 120, and the first coil unit 110 is connected to the second coil unit 120. The first coil unit 110 is a three-dimensional structure, and the outer surface of the first coil unit 110 is located on a first curved surface, the concave side of the first curved surface is disposed toward the second coil unit 120 (i.e. the curvature center of the first curved surface is located on the side of the first coil unit 110 close to the second coil unit 120. the medical implant can be used for the occlusion treatment of hemangioma, including but not limited to intracranial aneurysm and peripheral aneurysm. in use, the second coil unit 120 is supported on the wall of the neck opening of the hemangioma and covers the opening, the first coil unit 110 is supported on the wall of the aneurysm opposite to the opening, so that the first coil unit 110 and the second coil unit 120 form a basket, i.e. the first coil unit 110 and the second coil unit 120 form a spatial frame in the hemangioma. the outer surface of the first coil unit 110 is located on the side of the second coil unit 120 On the first curved surface, the first spring coil unit 110 can conform to the shape of the hemangioma, which is beneficial to improving the compactness of the hemangioma packing and improving the treatment effect. As will be appreciated by those skilled in the art, the coil is a three-dimensional structure that is used to fill the lumen of a hemangioma and promote embolization of the hemangioma. And, the outer surface of the first spring coil unit 110 is located on the first curved surface, including the case where the outer surface of the first spring coil 110 is strictly located on the first curved surface, and also including the case where the outer surface of the first spring coil 110 is substantially located on the first curved surface.
Preferably, the outer surface of the secondary spring coil unit 120 is located on a secondary curved surface, and the concave side of the secondary curved surface is arranged opposite to the concave side of the primary curved surface (i.e. the curvature center of the secondary curved surface is located on the side of the secondary spring coil unit 120 close to the primary spring coil unit 110), so that the secondary spring coil unit 120 adapts to the tumor wall around the opening of the hemangioma, and the compactness of the hemangioma packing is further improved.
Referring to fig. 2, 3, 9 and 10, the first spring ring unit 110 has at least two different shapes, and the basic unit of the first spring ring unit 110 has one of an O shape, a C shape and an Ω shape, that is, the basic unit of the first spring ring unit 110 may be a combination of at least two of an O-shaped basic unit, a C-shaped basic unit and an Ω -shaped basic unit, wherein the O-shaped basic unit and the Ω -shaped basic unit have good stability and are not easy to deform, so that the stability of the first spring ring unit 110 can be maintained.
The number of the basic units included in the first spring ring unit 110 is selected according to actual needs, for example, two, three, four or five, and the shape of each basic unit is also selected according to needs. Generally, one of the two basic units at both ends of the first spring ring unit 110 is connected to the second spring ring unit 120 (including a case where the basic unit is directly connected to the second spring ring unit 120 and a case where the basic unit is indirectly connected to the second spring ring unit 120 through a third spring ring unit 130 described later), and the other is preferably O-shaped. Specifically, when the first spring coil unit 110 includes three basic units connected in series, if the third basic unit is connected to the second spring coil unit 120, the first basic unit has an O-shape, so that when the first spring coil unit 110 is supported on the tumor wall opposite to the opening, the tumor wall is not scratched.
The second spring coil unit 120 may have a similar configuration to the first spring coil unit 110. That is, the secondary spring ring unit 120 includes at least two of the basic units, and at least some of the basic units are different in shape. The basic unit of the second spring ring unit 120 has an O-shape, a C-shape, or an Ω -shape. The number of the basic units included in the second spring ring unit 120 is selected according to actual needs, for example, two, three, four, or five. The shape of each of the basic cells is also selected as desired. Thus, the secondary coil unit 120 is combined with the primary coil unit 110 to form a frame structure and provide good support properties and to conform to the shape of the hemangioma.
And one of the two basic units at the two ends of the second spring coil unit 120 is connected with the first spring coil unit 110 (including the case that the basic unit is directly connected with the first spring coil unit 110 and also including the case that the basic unit is indirectly connected with the first spring coil unit 110 through the third spring coil unit 130), and the other basic unit is in an O-shape, so that when the second spring coil unit 120 is arranged at the opening of the hemangioma, the situation that the free end of the second spring coil unit 120 extends into the true lumen of the blood vessel to scratch the blood vessel wall is avoided.
It should be noted that the first spring ring unit 110 and the second spring ring unit 120 may be symmetrically or asymmetrically arranged, and the first curved surface and the second curved surface may be a part of a spherical surface or an aspheric surface, which is not limited in this embodiment of the present invention. It should also be noted that the O-shape described in the embodiments of the present invention includes, but is not limited to, a circular shape, and may also be an oval or irregular closed loop, and those skilled in the art should understand that "closed loop" refers to a closed loop structure without an opening viewed along the axial direction of the loop, rather than an end-to-end closed loop structure. Here, the C shape includes, but is not limited to, a circular arc, and may be an elliptical arc, a circular arc having a different curvature, or an open loop such as a "concave" shape including a partially straight line and a partially curved line. Omega-shape refers to an open loop with an opening arc less than the opening arc of a C-shape, which again includes, but is not limited to, a circular arc. Optionally, the arc length of the C-shape is greater than or equal to 50% of the circumference and less than 75% of the circumference, and the arc length of the q-shape is greater than or equal to 75% of the circumference and less than 100% of the circumference.
It will be understood by those skilled in the art that when the coil 100 includes only the first coil unit 110 and the second coil unit 120, the aneurysm cavity can be filled and thrombolysis can be promoted by implanting other embolic structures in the space between the first coil unit 110 and the second coil unit 120.
Preferably, the spring ring 100 further comprises a third spring ring unit 130, and the first spring ring unit 110 is connected with the second spring ring unit 120 through the third spring ring unit 130. That is, the first spring ring unit 110, the third spring ring unit 130, and the second spring ring unit 120 are connected in sequence. Also, the concave side of the first curved surface and the concave side of the second curved surface are both disposed facing the third spring ring unit 130. Thus, after the medical implant is implanted into the hemangioma, the third spring coil unit 130 is directly used for filling the space between the first spring coil unit 110 and the second spring coil unit 120 and promoting thrombopoiesis without additionally implanting other embolism structures, thereby simplifying the operation, shortening the operation time, and after the hemangioma is completely embolized, the blood flow can not enter the tumor cavity, reducing the blood flow pressure of the hemangioma and avoiding the rupture risk.
The third spring ring unit 130 comprises at least three basic units, and the shapes of the at least three basic units are the same or different. The basic units are C-shaped, O-shaped or S-shaped, and at least three basic units are arranged in a proper manner to construct the third spring coil unit 130 into a three-dimensional structure with good compliance, so that the space between the first spring coil unit 110 and the second spring coil unit 120 can be densely packed. The third spring coil unit 130 may have a single-layer structure or a multi-layer structure.
In this embodiment, the spring ring 100 is formed by winding and shaping a primary coil on a mold, which allows the spring ring 100 to be stretched into an elongated configuration with a small radial dimension during delivery, facilitating delivery. The primary coil may be a cylindrical spring structure formed by spirally winding a metal, alloy or polymer wire around an axial direction. The primary coil includes a first section, a second section, and a third section, wherein the first section is used to wind the first spring coil unit 110, and the axis of the first section is preferably located on a third curved surface, such that the outer surface of the first spring coil unit 110 is located on the first curved surface. The second segment is used to wind the third spring coil unit 130. And the third segment is used to wind the second spring coil 120, and the axis of the third segment is located on a fourth curved surface, so that the outer surface of the second spring coil unit 120 is located on the second curved surface. Preferably, the primary coil is of a unitary structure. Alternatively, the first segment, the second segment, and the third segment may be formed separately and wound into the corresponding spring ring units, respectively, and then connected to each other.
Furthermore, the medical implant includes an procoagulant structure disposed on the coil 100. In an exemplary embodiment, the procoagulant structure is a thrombogenic pile 210 wound around the coil 100, and the thrombogenic pile 210 may be a polymer fiber, and the specific material may be at least one of PET, PA, and PGLA, which may be Fully Drawn Yarn (FDY) or Draw Textured Yarn (DTY). The material of the thrombogenic pile 210 can also be natural fiber material. In practical arrangement, the thrombus promotion floss 210 can be wound on the primary coil (1-5 turns) and clamped and fixed by two adjacent spiral coils of the primary coil, and the length of the thrombus promotion floss 200 can be 1-20 mm. When the spring coil 100 is stretched into an elongated configuration, the distance between two adjacent thrombogenic hairs 210 is 5mm to 20 mm. In alternative embodiments, the procoagulant structure may also be a procoagulant coating, such as a hydrogel coating, applied to the outer surface of the coil 100.
Further, the embodiment of the invention also provides a manufacturing method of the medical implant, which is used for manufacturing the medical implant. The manufacturing method comprises the following steps: first, a primary coil 10 is provided (as shown in fig. 4). Next, the primary coil 10 is routed according to a mold 20 (as shown in fig. 5 and 6) to wind the spring coil 100 on the mold 20. Finally, the spring ring 100 is given a shaping treatment.
The method of manufacturing the medical implant and the medical implant obtained are described below with reference to examples.
< example one >
First, a wire having a diameter of 0.5mm to 2mm is spirally wound along a mandrel to form a cylindrical coil spring structure, and then the mandrel is withdrawn, to obtain a primary coil 10 (shown in fig. 4).
Next, a mold 20 is provided, wherein the mold 20 includes a main body 21 and a convex pillar 22. In this embodiment, the main body 21 includes a cylindrical body 21a and first and second hemispheres 21b and 21c provided at both ends of the cylindrical body 21a, respectively. The cross section of the convex columns 22 is circular, and the number of the convex columns 22 is ten, wherein three convex columns 22 are uniformly arranged around the axis of the first hemisphere 21b, four convex columns 22 are uniformly arranged around the axis of the cylinder 21a, and the remaining three convex columns 22 are uniformly arranged around the axis of the second hemisphere 21c (as shown in fig. 5).
The primary coil 10 is then routed along the mold 20 and wound to form the spring coil 100. During the winding process, the primary coil 10 is routed from one of the studs 22 on the first hemisphere 21b, then sequentially bypasses the remaining two studs 22 on the first hemisphere 21b, sequentially bypasses the four studs 22 on the cylinder 21a, and finally sequentially bypasses the three studs 22 on the second hemisphere 21c to form the spring ring 100 (as shown in fig. 6). Those skilled in the art will understand that the primary coil 10 forms the basic units while bypassing the convex pillars 22, and thus the shape of each basic unit is determined by the routing path of the primary coil 10. In this embodiment, when the primary coil 10 is routed on the first hemisphere 21b, an O-shaped basic unit, an Ω -shaped basic coil and a C-shaped basic coil are sequentially formed. When the primary coil 10 is routed on the cylinder 21a, the path of the primary coil 10 is controlled to form four basic units, and the shapes of the four basic units include at least two of an O shape, a C shape and an S shape. When the second hemisphere 21C is wired, a C-shaped basic unit, an Ω -shaped basic unit and an O-shaped basic unit are sequentially formed. The C-shaped base unit of the first spring coil unit 110 and the C-shaped base unit of the second spring coil unit 120 are connected to the third spring coil unit 130, respectively.
Thereafter, the mold 20 is placed into a heat treatment furnace along with the spring ring 100 for heat treatment to shape the spring ring 100. The temperature of the heat treatment is 500-700 ℃, and the time is 60-120 min.
The spring ring 100 is then removed from the mold 20, resulting in the spring ring 100 shown in fig. 2 and 3. In this embodiment, the first curved surface of the outer surface of the first spring ring unit 110 is a hemisphere surface, the second curved surface of the outer surface of the second spring ring unit 120 is a hemisphere surface, and the outer surface of the third spring ring unit 130 is located on a circumferential surface, i.e., the third spring ring unit 130 is integrally formed into a cylindrical three-dimensional structure. Since the first spring ring unit 110 and the second spring ring unit 120 each include an omega-shaped basic unit and an O-shaped basic unit, the stability of the two is good, so that the spring ring 100 has good support and is not easy to displace. The third spring coil unit 130 at least comprises a basic unit in a C shape or an S shape, the C shape or the S shape has better turning performance and compressibility, the compliance of the third spring coil unit 130 is effectively improved, and the formation of dense embolism in the tumor is facilitated.
Finally, the spring coil 100 is straightened to temporarily return to the elongated form of the initial coil 10 with a gap between any adjacent two coils of the initial coil 10, and the embolic fluff 210 is wrapped around the spring coil 100 (as shown in FIG. 7).
It should be understood by those skilled in the art that, in the present embodiment, when the coil ring 100 is wound, if the primary coil 10 completes one turn of routing on the cylindrical body 21a and then bypasses four of the protruding columns 22 on the cylindrical body 21a again, the third coil ring unit 130 with a double-layer structure can be obtained, and if the routing is repeated on the cylindrical body 21a multiple times, the number of layers of the third coil ring unit 130 can be obtained. In addition, if the first hemisphere 21b and/or the second hemisphere 21c of the mold 20 is replaced with a portion of an ellipsoid, the first curved surface on which the outer surface of the first spring unit 110 is located is a portion of an ellipsoid, and/or the second curved surface on which the outer surface of the second spring ring unit 120 is located is a portion of an ellipsoid. And if the cylinder 21a of the mold 20 is replaced with another shape, the shape of the curved surface where the outer surfaces of the third spring ring units 130 are located is changed accordingly, for example, when the cylinder is replaced with a circular truncated cone structure, the outer surfaces of the third spring ring units 130 are located on a conical surface.
< example two >
The difference between this embodiment and the first embodiment is that the number and arrangement of the convex pillars 22 on the mold 20 are different. Specifically, referring to fig. 11, the mold 20 includes sixteen convex pillars 22, wherein three convex pillars 22 are uniformly arranged around an axis of the first hemisphere 21b, three convex pillars 22 are uniformly arranged around an axis of the second hemisphere 21c, and the remaining ten convex pillars 22 are divided into a first convex pillar group and a second convex pillar group, each group including five convex pillars 22. The first set of studs is adjacent to the first hemisphere 21b, and five studs 22 of the set are arranged uniformly around the circumference of the cylinder 21 a. The second set of studs is adjacent to the second hemisphere 21c, and five studs 22 of the set are arranged uniformly around the circumference of the cylinder 21 a. In the circumferential direction of the cylinder 21a, the lugs 22 in the two lug groups are arranged in a staggered manner.
In the winding process, the primary coil 10 is routed from one of the studs 22 on the first hemisphere 21b, and sequentially bypasses the other two studs 22 on the first hemisphere 21 b. Then, the convex columns 22 in the second convex column group, the convex columns 22 in the first convex column group, the convex columns 22 in the second convex column group and the convex columns 22 … … in the first convex column group are wound in sequence until the wiring on the cylinder 21a is completed, and finally, the three convex columns 22 on the second hemisphere 21c are wound in sequence to form the spring ring 100.
After the mold 20 and the spring ring 100 on the mold 20 are heated and set, the spring ring 100 is removed, and the structure is shown in fig. 9 and 10. In this embodiment, the first spring ring unit 110 includes an O-shaped base unit, an Ω -shaped base unit, and an O-shaped base unit, which are connected in this order. The third spring ring unit 130 comprises nine S-shaped basic units (or ten C-shaped basic units, two adjacent C-shaped basic units are spliced to form the S-shaped basic unit), and the outer surface of the third spring ring unit 130 is located on a cylindrical surface. The second spring ring unit 120 is connected with an O-shaped basic unit, an omega-shaped basic unit and an O-shaped basic unit in sequence.
After the spring ring 100 is shaped, the spring ring 100 may be provided with the thrombogenic hairs 210.
To sum up, the medical implant provided by the embodiment of the invention comprises a spring ring, wherein the spring ring at least comprises a first spring ring unit and a second spring ring unit, the first spring ring unit is connected with the second spring ring unit, the outer surface of the first spring ring unit is positioned on a first curved surface, the outer surface of the second spring ring unit is positioned on a second curved surface, and the concave side of the second curved surface is opposite to the concave side of the first curved surface. When the medical implant is used for embolization treatment of hemangioma, the spring ring can conform to the shape of the hemangioma tumor wall, which is beneficial to improving the compactness of the packing and improving the treatment effect.
Although the present invention is disclosed above, it is not limited thereto. Various modifications and alterations of this invention may be made by those skilled in the art without departing from the spirit and scope of this invention. Thus, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.

Claims (13)

1. A medical implant, comprising a spring coil, wherein the spring coil comprises a first spring coil unit and a second spring coil unit, and the first spring coil unit is connected with the second spring coil unit; the outer surface of the first spring ring unit is located on a first curved surface, and the concave side of the first curved surface is arranged towards the second spring ring unit.
2. The medical implant of claim 1, wherein said primary spring coil unit comprises at least two differently shaped base units, each of said base units being O-shaped, C-shaped, or Ω -shaped.
3. The medical implant of claim 2, wherein said first coil unit has opposite ends, one of said base units at one end being connected to said second coil unit, and one of said base units at the other end being O-shaped.
4. The medical implant of claim 1, wherein the outer surface of the secondary coil unit is on a secondary curved surface, the concave side of the secondary curved surface being disposed toward the primary coil unit.
5. The medical implant of claim 4, wherein said secondary coil unit comprises at least two differently shaped base units, each of said base units being O-shaped, C-shaped, or omega-shaped.
6. The medical implant of claim 5, wherein said second coil unit has opposite ends, one of said base units at one end being connected to said first coil unit, and one of said base units at the other end being O-shaped.
7. The medical implant of claim 1 or 4, wherein the coil further comprises a tertiary coil unit, the primary coil unit being connected to the secondary coil unit by the tertiary coil unit.
8. The medical implant of claim 7, wherein said tertiary spring coil unit comprises at least three base units, at least three of said base units being arranged in a three-dimensional volumetric configuration.
9. The medical implant of claim 8, wherein at least three of the base units in the third spring coil unit are identical or non-identical in shape, and the base units are C-shaped, O-shaped, or S-shaped.
10. The medical implant of claim 1, further comprising an procoagulant structure disposed on the spring ring.
11. A method of manufacturing a medical implant for preparing a medical implant according to any of claims 1-9, the method comprising:
providing a primary coil;
routing the primary coil according to a die so as to wind the spring ring on the die; and the number of the first and second groups,
and (5) shaping treatment.
12. The method of manufacturing a medical implant according to claim 11, wherein the primary coil is formed by spirally winding a metal, alloy or polymer wire.
13. The method of manufacturing a medical implant according to claim 11 or 12, further comprising providing an procoagulant structure on the spring ring.
CN202110686347.6A 2021-06-21 2021-06-21 Medical implant and manufacturing method thereof Pending CN113288315A (en)

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ARP220101619A AR126190A1 (en) 2021-06-21 2022-06-21 MEDICAL IMPLANT AND METHOD FOR ITS MANUFACTURE

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CN116525121A (en) * 2023-07-05 2023-08-01 昆明同心医联科技有限公司 Method for establishing primary spring coil recommendation model of embolic aneurysm and application of primary spring coil recommendation model

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JP5227344B2 (en) * 2007-03-13 2013-07-03 タイコ ヘルスケア グループ リミテッド パートナーシップ Implant, mandrel, and implant formation method
WO2017086477A1 (en) * 2015-11-19 2017-05-26 株式会社カネカ In vivo indwelling member, and in vivo indwelling member placement device provided with said in vivo indwelling member
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CN113288315A (en) * 2021-06-21 2021-08-24 上海鸿脉医疗科技有限公司 Medical implant and manufacturing method thereof
CN217066489U (en) * 2021-06-21 2022-07-29 上海鸿脉医疗科技有限公司 Medical implant

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Publication number Priority date Publication date Assignee Title
WO2022267904A1 (en) * 2021-06-21 2022-12-29 上海鸿脉医疗科技有限公司 Medical implant and manufacturing method therefor
CN116525121A (en) * 2023-07-05 2023-08-01 昆明同心医联科技有限公司 Method for establishing primary spring coil recommendation model of embolic aneurysm and application of primary spring coil recommendation model
CN116525121B (en) * 2023-07-05 2023-09-26 昆明同心医联科技有限公司 Method for establishing primary spring coil recommendation model of embolic aneurysm and application of primary spring coil recommendation model

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