CA2449055A1 - Method of manufacturing expansile filamentous embolization devices - Google Patents

Method of manufacturing expansile filamentous embolization devices Download PDF

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Publication number
CA2449055A1
CA2449055A1 CA002449055A CA2449055A CA2449055A1 CA 2449055 A1 CA2449055 A1 CA 2449055A1 CA 002449055 A CA002449055 A CA 002449055A CA 2449055 A CA2449055 A CA 2449055A CA 2449055 A1 CA2449055 A1 CA 2449055A1
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CA
Canada
Prior art keywords
carrier
polymer
embolizing
embolization device
hydrogel
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.)
Granted
Application number
CA002449055A
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French (fr)
Other versions
CA2449055C (en
Inventor
George R. Greene, Jr.
Gregory M. Cruise
Michael Constant
Brian J. Cox
Terrance Tran
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MicroVention Inc
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Individual
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Filing date
Publication date
Priority claimed from US09/867,340 external-priority patent/US6602261B2/en
Application filed by Individual filed Critical Individual
Priority to CA2689598A priority Critical patent/CA2689598A1/en
Publication of CA2449055A1 publication Critical patent/CA2449055A1/en
Application granted granted Critical
Publication of CA2449055C publication Critical patent/CA2449055C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C70/00—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts
    • B29C70/68—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts by incorporating or moulding on preformed parts, e.g. inserts or layers, e.g. foam blocks
    • B29C70/74—Moulding material on a relatively small portion of the preformed part, e.g. outsert moulding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A61B17/12118—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm for positioning in conjunction with a stent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A61B17/12145—Coils or wires having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A61B17/12154—Coils or wires having stretch limiting means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12163—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a string of elements connected to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12181—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
    • A61B17/1219—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices expandable in contact with liquids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/145—Hydrogels or hydrocolloids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/18—Materials at least partially X-ray or laser opaque
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526—Methods of manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/36—Materials or treatment for tissue regeneration for embolization or occlusion, e.g. vaso-occlusive compositions or devices
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor
    • B29L2031/7542—Catheters

Abstract

An embolization device (10)for occluding a body cavity includes one or more elongated, expansible, hydrophilic embolizing elements (12) non-releasably carried along the length of an elongated filamentous carrier (16) that is preferably made of a very thin, highly flexible filament or microcoil of nickel/titanium alloy. At least one expansile embolizing element is non- releasably attached to the carrier. A first embodiment includes a plurality of embolizing elements (12) fixed to the carrier (16) at spaced-apart intervals along its length. In second, third and fourth embodiments, an elongate, continuous, coaxial embolizing element is non-releasably fixed to the exteri or surface of the carrier, extending along a substantial portion of the length of the carrier proximally from a distal tip, and optionally includes a lumenal reservoir for delivery of therapeutic agents. Exemplary methods for making these devices include skewering and molding the embolizing elements. In any of the embodiments, the embolizing elements may be made of a hydrophilic, macroporous, polymeric, hydrogel foam material. In the second, third and fourth embodiments, the elongate embolizing element is preferably made of a porous, environmentally-sensitive, expansile hydrogel, which can optionally be made biodegradable and/orbioresorbable, having a rate of expansion that changes in response to a change in an environmental parameter, such as the p H or temperature of the environment.

Claims (46)

1. A method for making a body cavity occlusion device, the method compris-ing:
providing an elongated, flexible, filamentous carrier; and coaxially encapsulating at least a portion of the length of the carrier in an expansile, hydrophilic polymer.
2. The method of claim 1, wherein encapsulating the carrier comprises:
providing an elongated member of the polymer in a softened state; and skewering the member coaxially with the carrier.
3. The method of claim 2, wherein providing the elongated member com-prises inserting the member into a tubular holder such that the member is radially confined and axially restrained therein.
4. The method of claim 1, wherein encapsulating the carrier comprises:
providing a mold having an elongated cavity therein;
disposing the carrier coaxially within the cavity of the mold; and transferring the polymer into the cavity such that the polymer is thereby molded into a member coaxially encapsulating at least a portion of the length of the carrier.
5. The method of claim 1, wherein the carrier includes an axial lumen, and wherein encapsulating the carrier comprises substantially filling the lumen of the encapsulated portion of the carrier with the polymer.
6. The method of claim 1, wherein the carrier includes an axial lumen, and further comprising forming an axial reservoir in the lumen.
7. The method of claim 6, wherein forming the axial reservoir comprises:
inserting an elongated mandrel into the lumen of the carrier before the encapsulation thereof; and removing the mandrel from the lumen of the carrier after the encapsulation thereof.
8. A method for delivering a therapeutic agent to a patient, the method comprising:
making an embolization device in accordance with the method of claim 6;
disposing a therapeutic agent in the axial reservoir of the device; and embolizing a body cavity of the patient with the device.
9. The method of claim 1, further comprising dehydrating the polymer to shrink it.
10. The method of claim 9, wherein dehydrating the polymer comprises immersing the device in a hygroscopic medium.
11. The method of claim 9, wherein dehydrating the polymer comprises heating the device.
12. The method of claim 1, wherein the polymer has a rate of hydration in an aqueous medium that is a function of a physical parameter of the medium, and further comprising setting the rate of hydration of the polymer in response to the parameter.
13. The method of claim 12, wherein adjusting the rate of hydration com-prises treating the polymer with an acid.
14. The method of claim 12, further comprising immersing the device for a period of time in an aqueous medium having the physical parameter, wherein the period of time and the physical parameter of the medium are selected so as to soften the polymer and render it lubricious without substantially expanding it.
15. A device for occluding a body cavity, the device comprising:
an elongated, flexible, filamentous carrier; and a member of an expansile, hydrophilic polymer coaxially encapsulating at least a portion of the length of the carrier.
16. The device of claim 15, wherein the carrier includes an axial lumen, and wherein the polymer of the member substantially fills the lumen of the encapsulated portion of the carrier.
17. The device of claim 15, wherein the carrier includes an axial lumen having an axial reservoir therein.
18. The device of claim 15, wherein the carrier comprises a filamentous element selected from the group consisting of a flexible wire, helical coil, and tube.
19. The device of claim 15, wherein the coaxial member is cylindrical.
20. The device of claim 15, wherein the coaxial member comprises hydrogel.
21. The device of claim 15, wherein the coaxial member is at least one of biodegradable and bioresorbable.
22. The device of claim 15, wherein the coaxial member has a substantially greater lubricity when hydrated than when dry.
23. A device for occluding a cavity, the device comprising:
an elongated, filamentous carrier formed of a biocompatible material having an elastic memory and an external surface; and a coaxial member of an expansile hydrogel formed over the carrier such that the member covers a substantial portion of the external surface of the carrier;
wherein the device has at least one of a greater flexibility and a greater lubricity when the hydrogel is hydrated than when the hydrogel is dehydrated.
24. The device of claim 23, wherein an unsupported end of a portion of the device deflects downward under the weight of the portion and relative to an opposite, supported end of the portion about 0.75 in. (19.1 mm) when:
the hydrogel is in a dry state and a horizontal distance between the opposite ends of the portion is more than about 2.25 in. (57.2 mm);
the hydrogel is in a moderately hydrated state and the horizontal length is between about 1.5 in. (38.2 mm) and 2.25 in. (57.2 mm); and, the hydrogel is in a fully hydrated stated and the horizontal length is less than about 1.5 in (38.2 mm).
25. A device for occluding a body cavity, the device comprising:
an elongated, filamentous carrier with an external surface; and a coaxial member of a hydrophilic polymer covering a substantial portion of the external surface of the carrier;
wherein a physical property of the coaxial member in an aqueous environ-ment is a function of time in the environment and a physical parameter of the environment.
26. The device of claim 25, wherein the physical property is at least one of the flexibility and the lubricity of the member, and wherein the physical parameter of the environment is at least one of the temperature and the pH of the environment.
27. A vascular embolization device, comprising:
a flexible, filamentous carrier having a distal tip and an exterior surface;
and an elongate, continuous, coaxial embolizing element non-releasably fixed to the exterior surface of the carrier along a substantial portion of the length of the carrier proximally from the distal tip.
28. The embolization device of Claim 27, wherein the embolizing element is formed of a stretch-resistant, biocompatible polymer.
29. The embolization device of Claim 27, wherein the embolizing element is formed of an expansile, hydrophilic polymer.
30. The embolization device of Claim 27, wherein the carrier comprises a material that is visible under X-rays.
31. The embolization device of Claim 29, wherein the polymer is an environmentally-sensitive polymer that changes its physical character in response to a change in an environmental parameter selected from the group consisting of temperature and pH.
32. The embolization device of Claim 29, wherein the embolizing element is expansible by a volumetric expansion factor of between about 2X and about 100X.
33. The embolization device of Claim 27, wherein the embolizing element is radiopaque.
34. The embolization device of Claim 27, wherein the carrier is configured in the form of a multi-looped structure that may assume a three-dimensional shape when unconstrained
35. The embolization device of Claim 34, wherein the three-dimensional shape is selected from the group consisting of a sphere, a helix, and an ovoid.
36. A vascular embolization device, comprising:
an elongate, flexible, filamentous carrier; and an embolizing element non-releasably fixed to the carrier, the embolizing element being formed from an expansile polymer that expands in response to a change in an environmental parameter selected from the group consisting of tempera-tore and pH after a predetermined time interval.
37. The embolization device of Claim 36, wherein the polymer is a porous hydrogel.
38. The embolization device of Claim 36, wherein the embolizing element comprises an elongate, continuous, coaxial embolizing element non-releasably fixed to the exterior surface of the carrier along a substantial portion of the length of the carrier.
39. The embolization device of Claim 36, wherein the embolizing element comprises a plurality of expansile polymer fibers attached to the carrier.
40. The embolization device of Claim 36, wherein the embolizing element is radiopaque.
41. The embolization device of Claim 36, wherein the carrier is configured in the form of a multi-looped structure that may assume a three-dimensional shape when unconstrained
42. The embolization device of Claim 41, wherein the three-dimensional shape is selected from the group consisting of a sphere, a helix, and an ovoid.
43. A vascular embolization device, comprising:
an elongate, flexible, filamentous carrier of predetermined length; and a plurality of expansile fibers fixed to the carrier at spaced intervals along the length of the carrier, the fibers being formed from an expansile polymer hydrogel.
44. The embolization device of Claim 43, wherein the polymer hydrogel is of a type that expands in response to a change in an environmental parameter selected from the group consisting of temperature and pH after a predetermined time interval.
45. The embolization device of Claim 43, wherein the carrier is configured in the form of a multi-looped structure that may assume a three-dimensional shape when unconstrained
46. The embolization device of Claim 45, wherein the three-dimensional shape is selected from the group consisting of a sphere, a helix, and an ovoid.
CA002449055A 2001-05-29 2002-05-29 Method of manufacturing expansile filamentous embolization devices Expired - Fee Related CA2449055C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2689598A CA2689598A1 (en) 2001-05-29 2002-05-29 Method of manufacturing expansile filamentous embolization devices

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US09/867,340 2001-05-29
US09/867,340 US6602261B2 (en) 1999-10-04 2001-05-29 Filamentous embolic device with expansile elements
US10/157,621 2002-05-29
US10/157,621 US7014645B2 (en) 1999-10-04 2002-05-29 Method of manufacturing expansile filamentous embolization devices
PCT/US2002/016873 WO2002096302A1 (en) 2001-05-29 2002-05-29 Method of manufacturing expansile filamentous embolization devices

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2689598A Division CA2689598A1 (en) 2001-05-29 2002-05-29 Method of manufacturing expansile filamentous embolization devices

Publications (2)

Publication Number Publication Date
CA2449055A1 true CA2449055A1 (en) 2002-12-05
CA2449055C CA2449055C (en) 2010-03-02

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CA002449055A Expired - Fee Related CA2449055C (en) 2001-05-29 2002-05-29 Method of manufacturing expansile filamentous embolization devices
CA2689598A Abandoned CA2689598A1 (en) 2001-05-29 2002-05-29 Method of manufacturing expansile filamentous embolization devices

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CA2689598A Abandoned CA2689598A1 (en) 2001-05-29 2002-05-29 Method of manufacturing expansile filamentous embolization devices

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US (4) US7014645B2 (en)
EP (2) EP2319430B1 (en)
JP (1) JP4383746B2 (en)
AT (1) ATE516759T1 (en)
AU (3) AU2002344223B2 (en)
CA (2) CA2449055C (en)
ES (1) ES2441341T3 (en)
WO (1) WO2002096302A1 (en)

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US7491214B2 (en) 2009-02-17
US20060149299A1 (en) 2006-07-06
ATE516759T1 (en) 2011-08-15
CA2689598A1 (en) 2002-12-05
US7842054B2 (en) 2010-11-30
AU2002344223B2 (en) 2006-07-06
US7014645B2 (en) 2006-03-21
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CA2449055C (en) 2010-03-02
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US20040059370A1 (en) 2004-03-25
US20090232869A1 (en) 2009-09-17
AU2002344223C1 (en) 2002-12-09
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EP2319430A3 (en) 2011-09-28
JP4383746B2 (en) 2009-12-16

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