CN215273059U - Embolism object - Google Patents

Abstract

The utility model relates to an embolus, including the first helical component of tubulose that has the inner chamber, nest in the second helical component of first helical component lateral surface and at least part are arranged in fixed part in the first helical component inner chamber, wherein, first helical component includes radio opaque material, second helical component includes bioabsorbable material, fixed part's both ends connect respectively in the both ends of second helical component for it is fixed first helical component with second helical component. The double-layer structure embolus is provided with the fixing component, so that the embolus not only has the performance of degrading and relieving the occupying effect, but also has better structural stability in the aneurysm.

Description

Embolism object

Technical Field

The utility model relates to the technical field of medical equipment, concretely relates to endovascular embolism thing.

Background

Intracranial aneurysm refers to abnormal protrusion of intracranial arterial blood vessel wall, forming neoplastic lesion. Researches show that in recent years, the incidence rate of intracranial aneurysm tends to increase, and the disease is high in fatality and disability rate, so that the problem that improvement of the cure rate of intracranial aneurysm needs to be solved urgently is solved.

With the development of imaging and materials science, compared with surgical operations, the spring ring is utilized to embolize intracranial aneurysms, and people pay more and more attention and attention to the intracranial aneurysms due to the advantages of small trauma, small risk, few complications and the like. At present, most of spring rings for interventional therapy are made of metal materials, and after the spring rings are filled into a aneurysm cavity, the blood flow direction can be effectively changed, and the pressure on the aneurysm wall is reduced; simultaneously, the method can induce thrombosis and promote endothelialization at the tumor neck, thereby realizing the treatment of intracranial aneurysm.

However, for large or giant aneurysms, conventional metal coil embolic aneurysms still have certain limitations: the coils, which are permanently located within the tumor lumen, may create a space-occupying effect, causing compression of peripheral nerves and tissue, etc. The spring ring is prepared from a bioabsorbable material and implanted into the aneurysm, and the volume of the aneurysm gradually shrinks under the extrusion of surrounding tissues along with the degradation and absorption of the spring ring, so that the occupying effect is reduced; moreover, the bioactive material can accelerate fibroblasts at the tumor neck, achieve the effect of promoting the regeneration of vascular smooth muscle, and is widely concerned.

Currently, coils comprising degradable/absorbable materials are still in the conceptual stage and there are no mature products on the market. According to research, the coil made of absorbable bioactive materials generally has good X-ray permeability, so that the developing effect is poor in the actual pushing operation process, and the operation difficulty of a doctor is increased. In addition, few reports have proposed the addition of radiopaque elements to degradable coils, which are relatively complex structures and have relatively high difficulty in joining and securing the elements.

Therefore, a new embolus is needed to solve at least the above problems.

SUMMERY OF THE UTILITY MODEL

The utility model provides an embolus, this embolus can be degraded and absorbed by the organism gradually under the visual prerequisite that satisfies clinical need and its support nature and stability in the aneurysm, at least partial embolus to convert into the harmless micromolecule material of organism to play the effect that reduces the occupy-place effect.

In order to achieve the above object, the present invention provides an embolus, comprising a tubular first spiral member having an inner cavity, a second spiral member nested on an outer side surface of the first spiral member, and a fixing member at least partially disposed in the inner cavity of the first spiral member, wherein the first spiral member comprises a radiopaque material, the second spiral member comprises a bioabsorbable material, and both ends of the fixing member are respectively connected to both ends of the second spiral member for fixing the first spiral member and the second spiral member.

Optionally, the first helical member comprises a radiopaque material and the second helical member comprises a bioabsorbable material.

Optionally, the first helical member is a metal member made of one of platinum, iridium, gold, silver, tantalum, and tungsten, or an alloy thereof.

Optionally, the first spiral member is a composite material member in which a matrix is doped with a developing substance, wherein the developing substance is an iodine contrast agent or barium sulfate, and the matrix is one of polylactic acid, polyglycolic acid, a lactic acid-glycolic acid copolymer, polydioxanone, polycaprolactone, polyurethane, chitosan, and hyaluronic acid.

Optionally, the second helical member is one of polylactic acid, polyglycolic acid, a lactic acid-glycolic acid copolymer, polydioxanone, polycaprolactone, polyurethane, chitosan, hyaluronic acid, magnesium alloy, iron, and iron alloy.

Optionally, the fixing member is a polymer filament, wherein the polymer filament is one of polypropylene, nylon, polyester, polylactic acid, polyglycolic acid, a lactic-glycolic acid copolymer, and polycaprolactone.

Optionally, the polymer wire is physically wound or knotted to both ends of the second spiral member to fix the first spiral member and the second spiral member.

Optionally, both ends of the polymer filament are connected to both ends of the first and second helical members, respectively, by knotting.

Optionally, the polymer wire is knotted separately for at least one spiral on the first spiral component of the inner turn and at least one spiral on the second spiral component of the outer turn.

Optionally, the polymer filament winds together at least one turn of the helix on the first helical member and at least one turn of the helix on the second helical member to be knotted to maintain the first helical member and the second helical member coaxial or axially parallel.

Optionally, the first helical member comprises a first helical unit and a second helical unit, the first helical unit and the second helical unit being coaxial or axially parallel.

Optionally, the fixing member is a polymer wire which passes through the inner cavities of the first spiral unit and the second spiral unit, wherein the portion of the polymer wire which passes out of the first spiral unit and the second spiral unit is connected to the second spiral member for fixing the first spiral unit, the second spiral unit and the second spiral member.

Optionally, the fixing member is a curing adhesive, and the curing adhesive is disposed between the first spiral member and the second spiral member, and at least a portion of the curing adhesive is disposed in the inner cavity of the first spiral member to fix the first spiral member and the second spiral member.

Optionally, the fixing component includes a first curing adhesive and a second curing adhesive, and the first curing adhesive and the second curing adhesive are respectively disposed at two ends of the second spiral component.

Optionally, the fixing component further includes a third curing glue, and the third curing glue is disposed at any position between the first curing glue and the second curing glue.

Optionally, the first helical member and the second helical member are coaxial or axially parallel, and/or the axial length of the first helical member is no greater than the axial length of the second helical member.

Optionally, at least one end of the second spiral member is terminated by forming a ball cap in a hot melting or dispensing manner, wherein an end of the first spiral member is also covered by the ball cap.

Optionally, at least a portion of the fixing member near the end of the second helical member is also wrapped around the ball cap.

Optionally, the plug further comprises a shape-fixing member at least partially disposed in the inner cavity of the first spiral member, and one end of the shape-fixing member is covered on the ball cap.

Optionally, the shaping component comprises at least one shaping wire, wherein each shaping wire has a circular, elliptical or polygonal cross section.

Optionally, the material of the shaping component is one of cobalt-chromium alloy, nickel-titanium alloy and platinum-tungsten alloy.

Optionally, the shaping member has at least one secondary shaping structure of a spiral shape, a wave shape, a tetrahedron, a pentahedron, and a hexahedron.

Optionally, the tubular second helical member has an outer diameter dimension in the range of 0.005-0.05 inches and a length dimension in the range of 0.5-200 centimeters, wherein the wire wound around the second helical member has a cross-section that is circular or a portion thereof, and the wire has a diameter or radius of curvature that is 2 times the diameter of the wire in the range of 0.0005-0.005 inches.

Optionally, the first tubular helical member has an outer diameter in the range of 0.002-0.02 inches and a length in the range of 10% -100% of the length of the second tubular helical member, wherein the wire wound around the first helical member has a cross-section that is a circle or a portion of a circle, and the wire has a diameter or radius of curvature 2 times the size in the range of 0.0003-0.003 inches.

In order to achieve the above object, the present invention further provides an embolus, which comprises a tubular first spiral member having an inner cavity, a second spiral member wound on the outer side of the first spiral member, a fixing member at least partially disposed in the inner cavity of the first spiral member, and a fixing member at least partially disposed in the inner cavity of the first spiral member, wherein: the first helical member comprises a radiopaque material and the second helical member comprises a bioabsorbable material; the fixing parts are respectively connected to two ends of the second spiral part in a physical winding or knotting mode; one end of the shaping component is fixed at one end of the first spiral component and one end of the second spiral component; and at least one end of the second spiral component forms a spherical cap in a hot melting or dispensing mode for end sealing, and at least parts of the first spiral component and the shaping component are covered on the spherical cap.

To sum up, the utility model provides an embolus has following advantage:

first, the embolus adopts a double-layer structure of a bioabsorbable material and a metal nontransmissive material, so that the embolus can be partially degraded and absorbed within a certain time while the characteristics of better developing property, better supporting property and the like of the traditional metal spring ring are kept, and the problems of space occupation effect and the like which can cause compression of surrounding tissues and nerves to large-scale aneurysms can be effectively relieved.

Secondly, the double-layer spiral structure of the embolus is reasonably connected and fixed among different components, the basic coaxial or axial parallel of the double-layer structure is kept, and the operability of a doctor in the process of using the embolus is effectively improved.

Drawings

FIG. 1 is a partial cross-sectional view of an embolic material according to a first embodiment of the present invention;

FIG. 2 is a cross-sectional view of the plug shown in FIG. 1;

FIG. 3 is a cross-sectional view of an embolic material according to a second embodiment of the present invention;

FIG. 4 is a cross-sectional view of an embolic material according to a third embodiment of the present invention;

FIG. 5 is a cross-sectional view of an embolic material according to a fourth embodiment of the present invention;

fig. 6 is a cross-sectional view of a plug according to a fifth embodiment of the present invention.

[ reference numerals are described below ]:

10-an embolus; 100-a first helical member; 102-a first spiral unit; 104-a second spiral unit; 106-a third spiral element; 110-lumen; 120-a second helical member; 130-a shaping component; 132-a distal end of the styling member; 134-the proximal end of the styling member; 140-a distal end; 150-a ball cap; 160-a proximal end; 170-a fixing member; 171. 173, 175-polymer wire exits portions of the first and second spiral units; 172-first curing glue; 174-second curing glue; 176-third curing glue; 177-a distal end of the fixation member; 179-proximal end of the fixation member.

Detailed Description

To make the objects, advantages and features of the present invention clearer, the present invention will be described in further detail with reference to the accompanying drawings. It should be noted that the drawings are in simplified form and are not to precise scale, and are provided for convenience and clarity in order to facilitate the description of the embodiments of the present 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 meaning of the above terms in the present invention can be understood according to specific situations by those skilled in the art. The same or similar reference numbers in the drawings identify the same or similar elements.

Further, in the following description, for convenience of description, "distal" and "proximal" are used; "proximal" is the end proximal to the medical instrument operator; "distal end" is the end that is distal to the operator of the medical device. Furthermore, in the following description, numerous specific details are set forth in order to provide a more thorough understanding of the present invention. It will be apparent, however, to one skilled in the art, that the present invention may be practiced without one or more of these specific details. In other instances, well-known features have not been described in order to avoid obscuring the present invention.

The core idea of the utility model is to provide an embolus, including the first helical component of the tubulose that has the inner chamber, nest in the second helical component of first helical component lateral surface and at least part arrange in the fixed part in the first helical component inner chamber, wherein, first helical component includes radio opaque material, the second helical component includes bioabsorbable material, the both ends of fixed part connect respectively in the both ends of second helical component for fix first helical component with the second helical component.

In order to achieve the above object, the present invention further provides an embolus, which comprises a tubular first spiral member having an inner cavity, a second spiral member wound on the outer side of the first spiral member, a fixing member at least partially disposed in the inner cavity of the first spiral member, and a fixing member at least partially disposed in the inner cavity of the first spiral member, wherein: the first helical member comprises a radiopaque material and the second helical member comprises a bioabsorbable material; the fixing parts are respectively connected to two ends of the second spiral part in a physical winding or knotting mode; one end of the shaping component is fixed at one end of the first spiral component and one end of the second spiral component; and at least one end of the second spiral component forms a spherical cap in a hot melting or dispensing mode for end sealing, and at least parts of the first spiral component and the shaping component are covered on the spherical cap.

It is understood that the embolus of the present application may be a coil for use in the treatment of intracranial vascular diseases, such as intracranial aneurysms. In addition, the vascular implant can also be applied to the treatment of diseases such as non-intracranial vascular aneurysm and the like.

After the embolus is implanted into a focus for a period of time, the biological material in the double-layer structure can be gradually degraded and absorbed by an organism and converted into small molecular substances harmless to the organism, so that the effect of reducing the space occupying effect is achieved. In addition, the fixing part is arranged in the double-layer spiral structure, and reasonable connection and fixation are designed among different parts, so that the fixing part and the double-layer structure are basically coaxial or axially parallel, and the operability of a doctor in the process of using the embolus is effectively improved.

The embolus and the preparation method thereof provided by the invention are further described below with reference to the drawings and a plurality of examples.

Fig. 1 is a partial cross-sectional view of an embolic material 10 according to a first embodiment of the present invention. Fig. 2 is a cross-sectional view of the plug 10 shown in fig. 1. With the plug 10 in its linear primary shape as shown, the plug 10 is an elongated device of greater length extending from its proximal end 160 to its distal end 140. The proximal end 160 of the embolus 10 is configured to be connected to a pushing device (not shown) of the embolus 10. The tampon 10 includes a tubular first helical member 100 having a lumen 110, a second helical member 120 nested on an outer side of the first helical member 100, and a fixation member 170 disposed at least partially within the lumen 110 of the first helical member 100. Wherein the first helical member 100, the second helical member 120 and the sizing member 170 are substantially coaxial or axially parallel. Both ends of the fixing member 170 are connected to both ends of the second screw member 120, respectively, to fix the first screw member 100 and the second screw member 120.

Wherein the first helical member 100 comprises a radiopaque material. In some embodiments, the first spiral member 100 is a metal member made of one of platinum, iridium, gold, silver, tantalum, and tungsten, or an alloy thereof, and a metal wire made of the above material is spirally wound on a core column of a predetermined diameter to form the first spiral member 100. The pitch of the coils of the first helical member 100 may be uniform, may be gradual along the length of the coils, or may have different pitches in different sections of the coils.

In some embodiments, the first helical member 100 is a composite member with a matrix doped with a developing substance, wherein the developing substance may be iodine contrast agent or barium sulfate, and the matrix may be one or more of polylactic acid, polyglycolic acid, lactic acid-glycolic acid copolymer, polydioxanone, polycaprolactone, polyurethane, chitosan, and hyaluronic acid. The first helical member 100 is formed by helically winding a filament-like composite material member around a core rod of a predetermined diameter.

In some embodiments, the second helical member 120 comprises a bioabsorbable material, which may be one or more of polylactic acid, polyglycolic acid, lactic acid-glycolic acid copolymer, polydioxanone, polycaprolactone, polyurethane, chitosan, hyaluronic acid, magnesium alloy, iron, and iron alloy. In some embodiments, the second helical member 120 may be modified, for example, by loading some active substance, such as a growth factor or a drug molecule, into or on the surface of the second helical member 120. The second screw part 120 is spirally wound on a core column of a predetermined diameter by a polymer or metal wire made of the above material. It will be appreciated that the pitch of the coils of the second helical member 120 may be uniform, may be tapered along the length of the coils, or may have different pitches at different sections of the coils.

The volume of the second helical member 120, which is made of a bioabsorbable material, is in the range of 30-90% of the total volume of the entire tampon 10. The embolus 10 with the double-layer structure of the bioabsorbable material and the metal nontransmissive material is adopted, so that the characteristics of better developing property, better supporting property and the like of the traditional metal spring ring are kept, meanwhile, the bioabsorbable material part can be partially degraded and absorbed within a certain time, and the problems of space occupying effect and the like which can cause compression of surrounding tissues and nerves to large-scale aneurysms can be effectively relieved.

In some embodiments, the first helical member 100 has an outer diameter dimension in the range of 0.002 to 0.02 inches, and the wire wound around the first helical member 100 has a cross-section that is circular or a portion thereof, the wire having a diameter or radius of curvature that is 2 times the diameter or radius of curvature in the range of 0.0003 to 0.003 inches. The outer diameter of the second helical member 120 is in the range of 0.005-0.05 inches in size, and the wire wound around the second helical member 120 has a cross section of a circle or a portion of a circle having a size in the range of 0.0005-0.005 inches in diameter or 2 times the radius of curvature. With continued reference to fig. 1 and 2, the second helical member 120 wraps around the outside of the first helical member 100, and the axial length of the first helical member 100 is no greater than the axial length of the second helical member 120. The second helical member 120 has a length dimension in the range of 0.5-200 cm, and the first helical member 100 has a length slightly shorter than the length of the second helical member 120 and is 10-100% of the length of the tubular structure around which the second helical member 120 is wound.

As shown in fig. 2, the fixing member 170 may be a polymer wire made of one or more of polypropylene, polyester, nylon, polylactic acid, polyglycolic acid, lactic acid-glycolic acid copolymer, and polycaprolactone. The polymer wire is attached to both ends of the first and second spiral members 100 and 120, respectively, by physical winding or knotting, to fix the first and second spiral members 100 and 120.

In some embodiments, the fixation element 170 is knotted to the first and second helical elements 100, 120 in a manner that the fixation element 170 simultaneously knots at least one turn of the helix on the first helical element 100 and at least one turn of the helix on the second helical element 120 to maintain the first and second helical elements 100, 120 substantially coaxial or axially parallel. It is to be understood that the coupling position of the fixing member 170 with the first screw member 100 and/or the second screw member 120 is not limited to that shown in fig. 2, and the fixing member 170 may be knotted at any position on the circumference of the screw member. In other embodiments, the fixing member 170 is knotted to the first and second spiral members 100 and 120 in such a manner that the fixing member 170 is knotted to at least one spiral of the first spiral member 100 of the inner turn and then at least one spiral of the second spiral member 120 of the outer turn.

In some embodiments, the knotting of the fixing member 170 with the first and second screw members 100 and 120 may also be: at both ends of the first and second screw members 100 and 120, the fixing member 170 knots only at least one turn of the screw on the first screw member 100 or at least one turn of the screw on the second screw member 120, respectively.

With continued reference to fig. 2, a non-invasive distal tip is formed by heat staking or spot gluing at the distal ends 140 of the first and second helical members 100, 120, securely joining the distal end 177 of the fixation member 170 and at least portions of the distal ends 140 of the first and second helical members 100, 120 to one another. The atraumatic distal tip may be a ball cap 150 as shown in fig. 2, or may be a conical or elliptical closed end, with at least a portion of the distal ends 140 of the first and second helical members 100, 120 being encased in the ball cap 150. Wherein the atraumatic distal tip may be formed from a polymeric material, such as polyester, acrylic adhesive, or other polymeric materials suitable for hot melt or spot gluing. In some embodiments, at least a portion of the securing member 170 knotted over the second helical member 120 is also encased in the ball cap 150. In other embodiments, the proximal ends 160 of the first and second helical members 100, 120 may also be formed into atraumatic distal tips by heat staking or adhesive dispensing, which securely bonds the proximal end 179 of the fixation member 170 and at least a portion of the proximal end 160 of the first and/or second helical members 100, 120 to one another.

Fig. 3 is a cross-sectional view of an embolic material 10 according to a second embodiment of the present invention. The tampon 10 includes a tubular first helical member 100 having a lumen 110, a second helical member 120 nested on an outer side of the first helical member 100, and a fixation member 170 disposed at least partially within the lumen 110 of the first helical member 100. Therein, the first helical member 100 comprises a first helical element 102 and a second helical element 104 which are substantially coaxial or axially parallel. In some embodiments, the fixing member 170 is a polymer wire that passes through the inner cavities of the first spiral unit 102 and the second spiral unit 104, respectively, wherein portions 171, 173, and 175 of the polymer wire that pass out of the first spiral unit 102 and the second spiral unit 104 are connected to corresponding positions of the second spiral member 120, respectively, for fixing the first and second spiral units 102, 104 and the second spiral member 120. It is understood that the first screw member 100 may have 3, 4, 5 or more screw units.

Fig. 4 is a cross-sectional view of an embolus 10 of a third embodiment of the present invention. The tampon 10 includes a tubular first helical member 100 having a lumen 110, a second helical member 120 nested on an outer side of the first helical member 100, and a fixation member 170 disposed at least partially within the lumen 110 of the first helical member 100. The fixing member 170 includes a first curing adhesive 172 and a second curing adhesive 174, which are disposed between the first spiral member 100 and the second spiral member 120, and at least partially disposed in the inner cavity 110 of the first spiral member for fixing the first spiral member 100 and the second spiral member. In the illustrated embodiment, the first curing adhesive 172 and the second curing adhesive 174 are respectively disposed at both ends of the second screw member 120, and cover at least a portion of both ends of the first screw member 100 to fix the first screw member 100 to the second screw member 120. It is understood that the first curing glue 172 and the second curing glue 174 are formed by dispensing on the outside of the second spiral component 120, and the first curing glue 172 may be formed by dispensing around the second spiral component 120 or by dispensing at least one point on the outside of the second spiral component 120.

In some embodiments, the fixing member further includes a third curing glue, which may be disposed at any position between the first curing glue 172 and the second curing glue 174, and respectively coupled to the first spiral member 100 and the second spiral member 120, for fixing the first spiral member 100 to the second spiral member 120.

Fig. 5 is a cross-sectional view of an embolic material 10 according to a fourth embodiment of the present invention. Similar to the embodiment shown in fig. 3, the first helical member 100 includes a first helical element 102, a second helical element 104, and a third helical element 106 that are substantially coaxial or axially parallel. At this time, the fixing member 170 may include a first curing adhesive 172, a second curing adhesive 174, and a third curing adhesive 176, where the first curing adhesive 172 and the second curing adhesive 174 are respectively disposed between two ends of the second spiral member 120 and the first spiral unit 102 and the second spiral unit 104, so as to fix the first spiral unit 102 and the second spiral unit 104 to the second spiral member 120. Meanwhile, the third curing glue 176 is disposed between the second spiral member 120 and the third spiral unit 106 for fixing the third spiral unit 106 to the second spiral member 120. In other embodiments, the number of spiral units and curing glue is not limited thereto.

Fig. 6 is a cross-sectional view of a plug 10 according to a fifth embodiment of the present invention. The embolus 10 comprises a tubular first spiral member 100 with a cavity 110, a second spiral member 120 nested on the outer side of the first spiral member 100, a shaping member 130 at least partially arranged in the cavity 110 of the first spiral member 100, and a fixing member 170 at least partially arranged in the cavity 110 of the first spiral member 100. The first screw member 100, the second screw member 120, and the fixing member 170 are substantially the same in structure and use as those of the embodiment shown in fig. 2, and a description thereof will not be repeated. In some embodiments, the sizing component 130 and the first helical component 100 are substantially coaxial or axially parallel.

As shown in fig. 6, the distal end 132 of the shaping member 130 is fixed to the distal ends 140 of the first and second helical members 100, 120, and the proximal end 134 of the shaping member 130 is a free end and is disposed within the proximal lumen 110 of the first helical member 100. In one embodiment of the present application, the distal end 132 of the shaping member 130 is configured as an inverted J-shaped hook, which is connected to at least one coil, such as the last coil, of the distal end 140 of the first screw member 100, and then the distal ends 140 of the first and second screw members 100 and 120 are formed into an atraumatic distal tip by heat-fusing or spot-gluing, so that the distal end 132 of the shaping member 130 and the distal ends 140 of the first and second screw members 100 and 120 are firmly combined with each other, i.e., at least a portion of the inverted J-shaped hook and the distal ends 140 of the first and second screw members 100 and 120 are wrapped around the atraumatic distal tip. The atraumatic distal tip may be a ball cap 150 as shown in fig. 2, or may be a conical or elliptical closed end. Wherein the atraumatic distal tip may be formed from a polymeric material, such as polyester, acrylic adhesive, or other polymeric materials suitable for hot melt or spot gluing. In other embodiments, the distal end 132 of the shaping member 130 can be connected to the distal ends 140 of the first and second helical members 100, 120 by other means, such as, for example, a straight, inverted J, or other shaped shaping member 130 with the distal end 132 directly wrapped by the cap 150; or the distal end 132 of the shaping member 130 is connected to at least one coil of the second spiral member 120 and then wrapped and fixed by the ball cap 150; or the fixing member 130 is connected to at least one end of the first and second spiral members 100 and 120 by physically winding or knotting the wire.

In some embodiments, the proximal end 134 of the sizing member 130 is connected to the proximal end 160 of the first helical member 100 and the distal end 132 is a free end. The proximal and distal ends 134, 132 may also be connected to the proximal and distal ends 160, 140, respectively, of the first helical member 100.

In some embodiments, the sizing component 130 comprises at least one sizing wire, wherein each sizing wire has a cross-section that is circular, elliptical, or polygonal and has a diameter that is no more than 90% of the inner diameter of the first helical component 100, wherein the inner diameter of the first helical component ranges from 0.001 to 0.01 inches. The material forming the shaping component 130 is a memory alloy, and may be one or more of cobalt-chromium alloy, nickel-titanium alloy and platinum-tungsten alloy. The use of the above-mentioned material for the shaping member 130 not only enhances the visibility of the double-layer helical structure in the blood vessel and aneurysm, but also allows the memory alloy to be pre-shaped in a three-dimensional manner for improving the stability of the embolus 10, which may provide better support in the aneurysm. In some embodiments, the shaping member 130 may be pre-shaped to have at least one secondary structure of a spiral shape, a wave shape, a tetrahedron, a pentahedron, and a hexahedron.

To achieve the above object, the present invention also provides a method for preparing an embolus 10, referring to fig. 6, which mainly comprises the following steps:

s1, pre-shaping the wound first spiral component 100 and the shaping component 130 on a mold according to a preset shape, wherein the preset shape may be at least one of spiral (helicoid), wave, tetrahedron, pentahedron and hexahedron, and the preset shapes of the first spiral component 100 and the shaping component 130 are corresponding to each other.

S2, the preset shaping member 130 is set in the cavity 110 of the preset first spiral member 100, that is, the filamentous shaping member 130 is inserted into the cavity 110 of the first spiral member 100, and at least one end of the shaping member 130 is fixed to at least one end of the first spiral member 100.

S3, the fixing member 170 is disposed in the lumen 110 of the first helical member 100.

S4, the wound second spiral member 120 is sleeved outside the wound first spiral member 100.

S5, the fixing members 170 disposed in the inner cavity 110 of the first spiral member 100 are respectively connected to the two ends of the first spiral member 100 and the second spiral member 120 by physically winding or knotting, and a spherical cap 150 is formed at least one end of the second spiral member 120 by hot melting or dispensing, wherein at least a portion of the first spiral member 100 and the shaping member 130 is wrapped around the spherical cap 150.

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, if such modifications and variations of the present invention fall within the scope of the claims and their equivalents, the present invention is also intended to include such modifications and variations.

Claims (24)

1. An embolus comprising a tubular first helical member having a lumen, a second helical member nested on the outside of the first helical member, and a fixation member disposed at least partially within the lumen of the first helical member, wherein the first helical member comprises a radiopaque material and the second helical member comprises a bioabsorbable material, and wherein the fixation member is attached at each end to the second helical member for fixation of the first and second helical members.

2. The embolus of claim 1, wherein the first helical member is a metal member made of one of platinum, iridium, gold, silver, tantalum, and tungsten.

3. The embolus of claim 1, wherein the first helical member is a composite member having a matrix doped with a contrast material, wherein the contrast material is an iodine contrast agent or barium sulfate, and the matrix is any one of polylactic acid, polyglycolic acid, lactic acid-glycolic acid copolymer, polydioxanone, polycaprolactone, polyurethane, chitosan, and hyaluronic acid.

4. The embolic material of claim 1, wherein said second helical member is any one of polylactic acid, polyglycolic acid, lactic acid-glycolic acid copolymer, polydioxanone, polycaprolactone, polyurethane, chitosan, hyaluronic acid, magnesium alloy, iron, and iron alloy.

5. The embolus of claim 1, wherein the fixation component is a polymer wire, wherein the polymer wire is any one of polypropylene, nylon, polyester, polylactic acid, polyglycolic acid, lactic-glycolic acid copolymer, polycaprolactone.

6. The embolic material of claim 5, wherein said polymer wire is physically wrapped or knotted at both ends of said second helical member to secure said first helical member and said second helical member, respectively.

7. The embolic material of claim 6, wherein the ends of said polymer wire are attached to the ends of said first helical member and said second helical member, respectively, by knotting.

8. The embolus of claim 7, wherein the polymer wire separately knots at least one helix on the first helical member of an inner turn and at least one helix on the second helical member of an outer turn.

9. The embolus of claim 7, wherein the polymer wire wraps at least one turn of the helix on the first helical member and at least one turn of the helix on the second helical member together to tie off to maintain the first helical member and the second helical member coaxial or axially parallel.

10. The embolic device of claim 1, wherein said first helical member comprises a first helical element and a second helical element, said first helical element and said second helical element being coaxial or axially parallel.

11. The embolic material of claim 10, wherein said anchoring member is a polymer wire that passes through the lumens of said first helical element and said second helical element, respectively, wherein the portion of said polymer wire that exits said first helical element and said second helical element is attached to said second helical member for anchoring said first and second helical elements and said second helical member.

12. The embolic material of claim 1, wherein the securing member is a curable adhesive disposed between the first helical member and the second helical member and at least partially disposed within the lumen of the first helical member for securing the first helical member and the second helical member.

13. The plug of claim 12, wherein the fixing member includes a first curing glue and a second curing glue, and the first curing glue and the second curing glue are respectively disposed at two ends of the second spiral member.

14. The plug of claim 13, wherein the securing member further comprises a third curable glue disposed anywhere between the first and second curable glues.

15. The embolic device of claim 1, wherein said first helical member and said second helical member are coaxial or axially parallel, and/or wherein said first helical member has an axial length that is no greater than an axial length of said second helical member.

16. The tampon of claim 1 wherein at least one end of the second helical member is terminated by forming a ball cap by heat-melting or dispensing, wherein the end of the first helical member is also covered by the ball cap.

17. The tampon of claim 16 wherein at least a portion of the securing member proximate to the end of the second helical member is also coated on the ball cap.

18. The embolic device of claim 16, further comprising a shaping member disposed at least partially within the lumen of the first helical member, wherein one end of the shaping member is coated on the ball cap.

19. The embolus of claim 18, wherein the sizing component comprises at least one sizing wire, wherein each of the sizing wires has a cross-section that is circular, elliptical, or polygonal.

20. The embolus of claim 18, wherein the material of the shaped component is any one of cobalt-chromium alloy, nickel-titanium alloy and platinum-tungsten alloy.

21. The embolic device of claim 18, wherein said shaping member has at least one secondary shaping structure of a spiral, a wave, a tetrahedron, a pentahedron, and a hexahedron.

22. The embolic device of claim 1, wherein said tubular second helical member has an outer diameter dimension in the range of 0.005 to 0.05 inches and a length dimension in the range of 0.5 to 200 centimeters, wherein the wire wound around said second helical member has a cross-section that is a circle or a portion of a circle, and wherein the wire has a diameter or radius of curvature that is 2 times the dimension in the range of 0.0005 to 0.005 inches.

23. The embolic device of claim 22, wherein said tubular first helical member has an outer diameter dimension in the range of 0.002 to 0.02 inches and a length of 10 to 100 percent of the length of said tubular second helical member, wherein the wire wound around said first helical member has a cross-section that is a circle or a portion of a circle having a diameter or radius of curvature in the range of 0.0003 to 0.003 inches.

24. An embolus comprising a tubular first helical member having a lumen, a second helical member wound around the outside of the first helical member, a shaping member disposed at least partially within the lumen of the first helical member, and a fixation member disposed at least partially within the lumen of the first helical member, wherein:

the first helical member comprises a radiopaque material and the second helical member comprises a bioabsorbable material;

the fixing parts are respectively connected to two ends of the second spiral part in a physical winding or knotting mode;

one end of the shaping component is fixed at one end of the first spiral component and one end of the second spiral component; and

at least one end of the second spiral component forms a ball cap in a hot melting or dispensing mode for end sealing, and at least parts of the first spiral component and the shaping component are covered on the ball cap.

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