CA2567331A1 - Metallic coils enlaced with biological or biodegradable or synthetic polymers or fibers for embolization of a body cavity - Google Patents

Metallic coils enlaced with biological or biodegradable or synthetic polymers or fibers for embolization of a body cavity Download PDF

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Publication number
CA2567331A1
CA2567331A1 CA002567331A CA2567331A CA2567331A1 CA 2567331 A1 CA2567331 A1 CA 2567331A1 CA 002567331 A CA002567331 A CA 002567331A CA 2567331 A CA2567331 A CA 2567331A CA 2567331 A1 CA2567331 A1 CA 2567331A1
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comprised
coil
fibers
metal wire
coating
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CA002567331A
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French (fr)
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CA2567331C (en
Inventor
William R. Patterson
Earl H. Slee
Tom Wilder
Thomas Mccarthy
Brian Strauss
Hermann Monstadt
Hans Henkes
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Covidien LP
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    • 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
    • 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
    • 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
    • A61B17/12131—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
    • A61B17/1215—Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
    • 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
    • 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
    • A61L31/08—Materials for coatings
    • A61L31/10—Macromolecular materials
    • 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
    • A61L31/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L31/125—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • A61L31/128—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127
    • 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
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • 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
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606—Coatings
    • 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

Abstract

Vaso-occlusive coils comprising fibers. The vaso-occlusive coil (12) can be a helical coil or a double helix made of biocompatible metal wire whereas the fibers (14, 16, 18, 28) are enlaced between at least a winding of the coil (12) and are made of polymeric materials like copolymers of glycolic/lactic acid. The fibers (14, 16, 18, 28) or the coil (12) can be coated with a bioactive material. The device (10) can comprise a stretch-resistant member and can be radio-opaque.

Claims (217)

1. A vaso-occlusive device for occluding blood flow in a patient comprising a) a coil sized for insertion to a point of use in a vascular network of the patient, where the coil is comprised of a first surface area; and b) a plurality of enlaced fibers where the enlaced fibers are comprised of a second surface area where the second surface area is at least 0.1 times the surface area of the first surface area.
2. The device of claim 1, wherein the coil is a helical coil.
3. The device of claim 1, wherein the fibers are enlaced through the coil.
4. The device of claim 1, wherein the coil is comprised of metal wire.
5. The device of claim 4, wherein the metal wire is a biocompatible metal wire.
6. The device of claim 4, wherein the metal wire is at least 5 mm in length.
7. The device of claim 4, wherein the metal wire is radio-opaque.
8. The device of claim 4, wherein the metal wire is comprised of a metal chosen from platinum, palladium, rhodium, rhenium, iridium, gold, silver, tungsten and tantalum or an alloy of these metals.
9. The device of claim 8, wherein the metal wire is comprised of a platinum iridium alloy.
10. The device of claim 8, wherein the metal wire is comprised of a platinum tungsten alloy.
11. The device of claim 4, wherein the metal wire is comprised of a super-elastic metal.
12. The device of claim 11, wherein the super-elastic metal is nitinol.
13. The device of claim 4, wherein the metal wire has a diameter of about 0.025 mm to about 0.09 mm.
14. The device of claim 4, wherein the metal wire has a diameter of about 0.04 mm to about 0.06 mm.
15. The device of claim 1, wherein the coil is comprised of a primary helix which is itself wound into a secondary shape.
16. The device of claim 15, wherein the secondary shape is a complicated three dimensional structure.
17. The device of claim 15, wherein the secondary shape is another helix.
18. The device of claim 17, wherein the secondary shape is a double helix.
19. The device of claim 15, wherein the primary helix has a diameter of about 0.1 millimeters to about 0.8 millimeters.
20. The device of claim 15, wherein the primary helix has a diameter of about 0.28 millimeters.
21. The device of claim 15, wherein the primary helix has a diameter of about 0.24 millimeters.
22. The device of claim 15, wherein the primary helix has about 2 to about 50 windings per millimeter.
23. The device of claim 15, wherein the primary helix is comprised of a pitch that provides for free space between adjacent coils.
24. The device of claim 23, wherein up to about 60% of the length of secondary shape is comprised of the free space.
25. The device of claim 23, wherein about 0% to about 25% of the length of secondary shape is comprised of the free space.
26. The device of claim 25, wherein the free space is small enough to permit the adjacent coils to grip the fibers.
27. The device of claim 1, wherein a majority of fibers each enlace a single winding of the helical coil.
28. The device of claim 1, wherein a majority of fibers each enlace two or more windings of the helical coil.
29. The device of claim 1, wherein the fibers are comprised of a bioactive material.
30. The device of claim 1, wherein the fibers are comprised of a non-bioactive material.
31. The device of claim 1, wherein the fibers are comprised of a copolymer of glycolic acid and lactic acid.
32. The device of claim 1, further comprising a bioactive coating.
33. The device of claim 32, wherein the bioactive coating is a lubricious hydrophilic coating.
34. The device of claim 32, wherein the bioactive coating is a hydrophobic coating.
35. The device of claim 32, wherein the bioactive coating is applied to the fiber.
36. The device of claim 32, wherein the bioactive coating is a copolymer.
37. The device of claim 36, wherein the copolymer is comprised of lactic acid and glycolic acid.
38. The device of claim 1, wherein the fibers are comprised of non-biodegradable polymer.
39. The device of claim 38, wherein the non-biodegradable polymer is chosen from a polyethylene, a polyacrylic, a polypropylene, a polyvinylchloride, a polyamide, a polyurethane, a polyvinylpyrrolidone, a polyvinyl alcohol, a polyvinylacetate, a cellulose acetate, a polystyrene, a polytetrafluoroethylene, a polyester, silk or cotton.
40. The device of claim 38, wherein the non-biodegradable polymer is nylon.
41. The device of claim 38, wherein the non-biodegradable polymer is polyethylene terephthalate.
42. The device of claim 1, wherein the fibers are comprised of biodegradable polymer.
43. The device of claim 42, wherein the biodegradable polymer is chosen from polyglycolic acid, polycaprolactone, polyhydroxybutyrate valerate, polyorthoester, polylactic acid, poly (p-dioxanone), poly (valetolactone), poly (tartronic acid), poly (.beta.-malonic acid), poly (propylene fumarate), a tyrosine based polycarbonate, and a copolymer of polyethylene oxide and polybutylene terephthalate.
44. The device of claim 31, wherein the ratio of glycolic acid to lactic acid is 99:1.
45. The device of claim 31, wherein the ratio of glycolic acid to lactic acid is 1:99.
46. The device of claim 31, wherein the ratio of glycolic acid to lactic acid is 95:5.
47. The device of claim 31, wherein the ratio of glycolic acid to lactic acid is 5:95.
48 The device of claim 31, wherein the ratio of glycolic acid to lactic acid is 50:50.
49. The device of claim 31, wherein the ratio of glycolic acid to lactic acid is 90:10.
50. The device of claim 32, wherein the coating material is chosen from a growth factor, a gene, an oligonucleotide, a peptide, a marine biopolymer, a mono-saccahride, a di-saccahride, a poly-saccahride, collagen and combinations of any of the aforementioned.
51. The device of claim 32, wherein the coating is applied to the coil.
52. The device of claim 35, wherein the coating is applied to the fiber as a single layer.
53. The device of claim 43, wherein the bioactive coating is applied to the coil as a single layer.
54. The device of claim 32, wherein the bioactive coating is dispersed throughout the fiber.
55. The device of claim 32, wherein the coating promotes cell attachment and is thrombogenic.
56 The device of claim 55, wherein the coating material is chosen from collagen, fibrinogen, vitronectin, vascular endothelial growth factor, a peptide comprising the sequence arginine-glycine-aspartic acid (RGD).
57. A method of treating an aneurysm in a patient comprising introducing a vaso-occlusive device into the patient thereby treating the aneurysm, wherein the vaso-occlusive device comprises a) a coil sized for insertion to a point of use in a vascular network of the patient, where the coil is comprised of a first surface area; and b) a plurality of enlaced fibers where the enlaced fibers are comprised of a second surface area where the second surface area is at least 0.1 times the surface area of the first surface area.
58. The method of claim 57, wherein the coil has a complicated 3 dimensional structure.
59. The method of claim 57, wherein the coil is a helix.
60. The method of claim 57, wherein the vaso-occlusive device is introduced using a catheter.
61. The method of claim 57, wherein the vaso-occlusive device is introduced through an entry site in the vasculature.
62. The method of claim 61, wherein the entry site is in the femoral artery.
63. A method of making a vaso-occlusive device comprising the steps of a) obtaining a helically coiled wire core having a fiber gripping spacing between adjacent windings when not under tension;

b) extending the wire core into an extended condition;

c) enlacing between adjacent windings of said core a plurality of fibers, thereby increasing the surface area of the coil by at least a factor of 0.1;
and d) relaxing the coil thereby causing the adjacent windings of the coil to grip the enlaced fibers.
64. The method of claim 63, wherein the fibers are comprised of a copolymer of polyglycolic acid and lactic acid.
65. The method of claim 63, wherein the enlacing is around a single winding.
66. The method of claim 63, wherein the enlacing is through a single winding.
67. The method of claim 63, wherein the enlacing is through multiple windings.
68. The method of claim 63, wherein the enlacing forms an "S" configuration.
69. A vaso-occlusive device for occluding blood flow in a patient comprising a) a coil sized for insertion to a point of use in a vascular network of the patient; and b) a plurality of enlaced fibers where the enlaced fibers are comprised of a copolymer of lactic acid and glycolic acid.
70. The device of claim 69, wherein the coil is a helical coil.
71. The device of claim 69, wherein the fibers are enlaced through the coil.
72. The device of claim 69, wherein the coil is comprised of metal wire.
73. The device of claim 72, wherein the metal wire is a biocompatible metal wire.
74. The device of claim 72, wherein the metal wire is at least 5 mm in length.
75. The device of claim 72, wherein the metal wire is radio-opaque.
76. The device of claim 72 wherein the metal wire is comprised of a metal chosen from platinum, palladium, rhodium, rhenium, iridium, gold, silver, tungsten and tantalum or an alloy of these metals.
77. The device of claim 76, wherein the metal wire is comprised of a platinum iridium alloy.
78. The device of claim 76, wherein the metal wire is comprised of a platinum tungsten alloy.
79. The device of claim 72, wherein the metal wire is comprised of a super-elastic metal.
80. The device of claim 79, wherein the super-elastic metal is nitinol.
81. The device of claim 72, wherein the metal wire has a diameter of about 0.025 mm to about 0.09 mm.
82. The device of claim 72, wherein the metal wire has a diameter of about 0.04 mm to about 0.06 mm.
83. The device of claim 69, wherein the coil is comprised of a primary helix which is itself wound into a secondary shape.
84. The device of claim 83, wherein the secondary shape is a complicated three dimensional structure.
85. The device of claim 83, wherein the secondary shape is another helix.
86. The device of claim 85, wherein the secondary shape is a double helix.
87. The device of claim 83, wherein the primary helix has a diameter of about 0.1 millimeters to about 0.8 millimeters.
88. The device of claim 83, wherein the primary helix has a diameter of about 0.28 millimeters.
89. The device of claim 83, wherein the primary helix has a.diameter of about 0.24 millimeters.
90. The device of claim 83, wherein the primary helix has about 2 to about 50 windings per millimeter.
91. The device of claim 83, wherein the primary helix is comprised of a pitch that provides for free space between adjacent coils.
92. The device of claim 91, wherein up to about 60% of the length of secondary shape is comprised of the free space.
93. The device of claim 91 wherein about 0% to about 25% of the length of secondary shape is comprised of the free space.
94. The device of claim 93, wherein the free space is small enough to permit the adjacent coils to grip the fibers.
95. The device of claim 69, wherein a majority of fibers each enlace a single winding of the helical coil.
96. The device of claim 69, wherein a majority of fibers each enlace two or more windings of the helical coil.
97. The device of claim 69, wherein the fibers are comprised of a bioactive material.
98. The device of claim 69, wherein the fibers are comprised of a non-bioactive material.
99. The device of claim 69, wherein the fibers are comprised of a copolymer of glycolic acid and lactic acid.
100. The device of claim 69, further comprising a bioactive coating.
101. The device of claim 100, wherein the bioactive coating is a lubricious hydrophilic coating.
102. The device of claim 100, wherein the bioactive coating is a hydrophobic coating.
103 The device of claim 100, wherein the bioactive coating is a copolymer.
104. The device of claim 103, wherein the copolymer is comprised of lactic acid and glycolic acid.
105. The device of claim 69, wherein the fibers are comprised of non-biodegradable polymer.
106. The device of claim 105, wherein the non-biodegradable polymer is chosen from a polyethylene, a polyacrylic, a polypropylene, a polyvinylchloride, a polyamide, a polyurethane, a polyvinylpyrrolidone, a polyvinyl alcohol, a polyvinylacetate, a cellulose acetate, a polystyrene, a polytetrafluoroethylene, a polyester, silk or cotton.
107. The device of claim 105, wherein the non-biodegradable polymer is nylon.
108. The device of claim 105, wherein the non-biodegradable polymer is polyethylene terephthalate.
109. The device of claim 69, wherein the fibers are comprised of biodegradable polymer.
110. The device of claim 109, wherein the biodegradable polymer is chosen from polyglycolic acid, polycaprolactone, polyhydroxybutyrate valerate, polyorthoester, polylactic acid, poly (p-dioxanone), poly (valetolactone), poly (tartronic acid), poly (.beta.-malonic acid), poly (propylene fumarate), a tyrosine based polycarbonate, and a copolymer of polyethylene oxide and polybutylene terephthalate.
111. The device of claim 99, wherein the ratio of glycolic acid to lactic acid is 99:1.
112. The device of claim 99, wherein the ratio of glycolic acid to lactic acid is 1:99.
113. The device of claim 99, wherein the ratio of glycolic acid to lactic acid is 95:5.
114. The device of claim 99, wherein the ratio of glycolic acid to lactic acid is 5:95.
115. The device of claim 99, wherein the ratio of glycolic acid to lactic acid is 50:50.
116. The device of claim 99, wherein the ratio of glycolic acid to lactic acid is 90:10.
117. The device of claim 100, wherein the coating is chosen from a growth factor, a gene, an oligonucleotide, a peptide, a marine biopolymer, a mono-saccahride, a di-saccahride, a poly-saccahride, collagen and combinations of any of the aforementioned.
118. The device of claim 100, wherein the coating is applied to the coil.
119. The device of claim 100, wherein the coating is applied to the fibers as a single layer.
120. The device of claim 118, wherein the bioactive coating is applied to the coil as a single layer.
121. The device of claim 100, wherein the bioactive coating is dispersed throughout the fiber.
122. The device of claim 100, wherein the coating promotes cell attachment and is thrombogenic.
123. The device of claim 122, wherein the coating material is chosen from collagen, fibrinogen, vitronectin, vascular endothelial growth factor, a peptide comprising the sequence arginine-glycine-aspartic acid (RGD).
124. The device of claim 100, wherein the bioactive coating is applied to the fiber.
125. A method of treating an aneurysm in a patient comprising introducing a vaso-occlusive device into the patient thereby treating the aneurysm, wherein the vaso-occlusive device comprises a) a coil sized for insertion to a point of use in a vascular network of the patient, where the coil is comprised of a first surface area; and b) a plurality of enlaced fibers where the enlaced fibers are comprised of a copolymer of lactic acid and glycolic acid.
126. The method of claim 125, wherein the coil has a complicated 3 dimensional structure.
127. The method of claim 125, wherein the coil is a helix.
128. The method of claim 125, wherein the vaso-occlusive device is introduced using a catheter.
129. The method of claim 125, wherein the vaso-occlusive device is introduced through an entry site in the vasculature.
130. The method of claim 129, wherein the entry site is in the femoral artery.
131. A method of making a vaso-occlusive device comprising the steps of a) obtaining a helically coiled wire core having a fiber gripping spacing between adjacent windings when not under tension;

b) extending the wire core into an extended condition;

c) enlacing between adjacent windings of said core a plurality of fibers comprised of a copolymer comprised of lactic acid and glycolic acid; and d) relaxing the coil thereby causing the adjacent windings of the coil to grip the enlaced fibers.
132. The method of claim 131, wherein the enlacing is around a single winding.
133. The method of claim 131, wherein the enlacing is through a single winding.
134. The method of claim 131, wherein the enlacing is through multiple windings.
135. The method of claim 131, wherein the enlacing forms an "S" configuration.
136. A vaso-occlusive device for occluding blood flow in a patient comprising a) a coil, comprising a lumen and a first and a second end, and sized for insertion to a point of use in a vascular network of the patient;

b) a stretch resistant member fixedly attached to at least one end of the coil; and c) a plurality of enlaced fibers where each of the enlaced fibers is enlaced around the stretch resistant member at least two times.
137. The device of 136, wherein the stretch resistant member axially traverses the lumen of the coil.
138. The device of 136, wherein the stretch resistant member is fixedly attached to both the first and second ends of the coil.
139. The device of 136, wherein the plurality of fibers are not tied in a knot.
140. The device of claim 136, wherein the stretch resistant member is comprised of a metal wire.
141. The device of claim 140, wherein the metal wire is radio-opaque.
142. The device of claim 140, wherein the metal wire is comprised of a metal chosen from platinum, palladium, rhodium, rhenium, iridium, gold, silver, tungsten and tantalum or an alloy of these metals.
143. The device of claim 140, wherein the metal wire is comprised of a platinum iridium alloy.
144. The device of claim 140, wherein the metal wire is comprised of a platinum tungsten alloy.
145. The device of claim 140, wherein the metal wire is comprised of a super-elastic metal.
146. The device of claim 145, wherein the super-elastic metal is nitinol.
147. The device of claim 136, wherein the stretch resistant member is comprised of a polymer.
148. The device of claim 147, wherein the polymer is non-biodegradable.
149. The device of claim 147, wherein the polymer is biodegradable.
150. The device of claim 136, wherein the stretch resistant member is further comprised of a bioactive coating.
151. The device of claim 150, wherein the coating is chosen from a growth factor, a gene, an oligonucleotide, a peptide, a marine biopolymer, a mono-saccahride, a di-saccahride, a poly-saccahride, collagen and combinations of any of the aforementioned.
152. The device of claim 150, wherein the coating is a polymer.
153. The device of claim 136, wherein the coil is a helical coil.
154. The device of claim 136, wherein the fibers are enlaced through the coil.
155. The device of claim 136, wherein the coil is comprised of metal wire.
156. The device of claim 155, wherein the metal wire is a biocompatible metal wire.
157. The device of claim 155, wherein the metal wire is at least 5 mm in length.
158. The device of claim 155, wherein the metal wire is radio-opaque.
159. The device of claim 155, wherein the metal wire is comprised of a metal chosen from platinum, palladium, rhodium, rhenium, iridium, gold, silver, tungsten and tantalum or an alloy of these metals.
160. The device of claim 155, wherein the metal wire is comprised of a platinum iridium alloy.
161. The device of claim 155, wherein the metal wire is comprised of a platinum tungsten alloy.
162. The device of claim 155, wherein the metal wire is comprised of a super-elastic metal.
163. The device of claim 162, wherein the super-elastic metal is nitinol.
164. The device of claim 155, wherein the metal wire has a diameter of about 0.025 mm to about 0.09 mm.
165. The device of claim 155, wherein the metal wire has a diameter of about 0.04 mm to about 0.06 mm.
166. The device of claim 136, wherein the coil is comprised of a primary helix which is itself wound into a secondary shape.
167. The device of claim 166, wherein the secondary shape is a complicated three dimensional structure.
168. The device of claim 166, wherein the secondary shape is another helix.
169. The device of claim 166, wherein the secondary shape is a double helix.
170. The device of claim 166, wherein the primary helix has a diameter of about 0.1 millimeters to about 0.8 millimeters.
171. The device of claim 166, wherein the primary helix has a diameter of about 0.28 millimeters.
172. The device of claim 166, wherein the primary helix has a diameter of about 0.24 millimeters.
173. The device of claim 166, wherein the primary helix has about 2 to about 50 windings per millimeter.
174. The device of claim 166, wherein the primary helix is comprised of a pitch that provides for free space between adjacent coils.
175. The device of claim 174, wherein up to about 60% of the length of secondary shape is comprised of the free space.
176. The device of claim 174, wherein about 0% to about 25% of the length of secondary shape is comprised of the free space.
177. The device of claim 174, wherein the free space is small enough to permit the adjacent coils to grip the fibers.
178. The device of claim 136, wherein the fibers are comprised of a bioactive material.
179. The device of claim 136, wherein the fibers are comprised of a non-bioactive material.
180. The device of claim 136, wherein the fibers are comprised of a copolymer of glycolic acid and lactic acid.
181. The device of claim 136, further comprising a bioactive coating.
182. The device of claim 181, wherein the bioactive coating is a lubricious hydrophilic coating.
183. The device of claim 181, wherein the bioactive coating is a hydrophobic coating.
184. The device of claim 181, wherein the bioactive coating is applied to the fiber.
185. The device of claim 181, wherein the bioactive coating is a copolymer.
186. The device of claim 185, wherein the copolymer is comprised of lactic acid and glycolic acid.
187. The device of claim 136, wherein the fibers are comprised of non-biodegradable polymer.
188. The device of claim 187, wherein the non-biodegradable polymer is chosen from a polyethylene, a polyacrylic, a polypropylene, a polyvinylchloride, a polyamide, a polyurethane, a polyvinylpyrrolidone, a polyvinyl alcohol, a polyvinylacetate, a cellulose acetate, a polystyrene, a polytetrafluoroethylene, a polyester, silk or cotton.
189. The device of claim 187, wherein the non-biodegradable polymer is nylon.
190. The device of claim 187, wherein the non-biodegradable polymer is polyethylene terephthalate.
191. The device of claim 136, wherein the fibers are comprised of biodegradable polymer.
192. The device of claim 191, wherein the biodegradable polymer is chosen from polyglycolic acid, polycaprolactone, polyhydroxybutyrate valerate, polyorthoester, polylactic acid, poly (p-dioxanone), poly (valetolactone), poly (tartronic acid), poly (.beta.-malonic acid), poly (propylene fumarate), a tyrosine based polycarbonate, and a copolymer of polyethylene oxide and polybutylene terephthalate.
193. The device of claim 186, wherein the ratio of glycolic acid to lactic acid is 99:1.
194. The device of claim 186, wherein the ratio of glycolic acid to lactic acid is 1:99.
195. The device of claim 186, wherein the ratio of glycolic acid to lactic acid is 95:5.
196. The device of claim 186, wherein the ratio of glycolic acid to lactic acid is 5:95.
197. The device of claim 186, wherein the ratio of glycolic acid to lactic acid is 50:50.
198. The device of claim 186, wherein the ratio of glycolic acid to lactic acid is 90:10.
199. The device of claim 181, wherein the coating material is chosen from, a growth factor, a gene, an oligonucleotide, a peptide, a marine biopolymer, a mono-saccahride, a di-saccahride, a poly-saccahride, collagen and combinations of any of the aforementioned.
200. The device of claim 181, wherein the coating is applied to the coil and the stretch resistant member.
201. The device of claim 181, wherein the coating is applied to the fiber as a single layer.
202. The device of claim 200, wherein the bioactive coating is applied to the coil and the stretch resistant member as a single layer.
203. The device of claim 181, wherein the bioactive coating is dispersed throughout the fiber.
204. The device of claim 181, wherein the coating promotes cell attachment and is thrombogenic.
205. The device of claim 181, wherein the coating material is chosen from collagen, fibrinogen, vitronectin, vascular endothelial growth factor, a peptide comprising the sequence arginine-glycine-aspartic acid (RGD).
206. A method of treating an aneurysm in a patient comprising introducing a vaso-occlusive device into the patient thereby treating the aneurysm, wherein the vaso-occlusive device comprises a) a coil sized for insertion to a point of use in a vascular network of the patient, where the coil is comprised of a first surface area;

b) a stretch resistant member fixedly attached to at least one end of the coil; and c) a plurality of enlaced fibers where each of the enlaced fibers is enlaced around the stretch resistant member at least two times.
207. The method of claim 206, wherein the coil has a complicated 3 dimensional structure.
208. The method of claim 206, wherein the coil is a helix.
209. The method of claim 206, wherein the vaso-occlusive device is introduced using a catheter.
210. The method of claim 206, wherein the vaso-occlusive device is introduced through an entry site in the vasculature.
211. The method of claim 206, wherein the entry site is in the femoral artery.
212. A method of making a vaso-occlusive device comprising the steps of a) obtaining a helically coiled wire core comprising a lumen, a first and second end and a fiber gripping spacing between adjacent windings when not under tension;

b) extending the wire core into an extended condition;

c) inserting a stretch resistant member into the lumen of the helically coiled wire and fixedly attaching the stretch resistant member to at least one end of the helically coiled wire d) enlacing a plurality of fibers around the stretch resistant member at least two times; and e) relaxing the coil thereby causing the adjacent windings of the coil to grip the enlaced fibers.
213. The method of claim 212, wherein stretch resistant member is fixedly attached to the first and second end of the helically coiled wire.
214. The method of claim 212, wherein the enlacing is through multiple windings.
215. The method of claim 212, wherein the enlacing forms an "S" configuration.
216. The method of claim 63, wherein the enlacing is around multiple windings.
217. The method of claim 131, wherein the enlacing is around multiple windings.
CA2567331A 2004-05-21 2005-05-23 Metallic coils enlaced with biological or biodegradable or synthetic polymers or fibers for embolization of a body cavity Expired - Fee Related CA2567331C (en)

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WO2005113035A2 (en) 2005-12-01
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