CA2319447A1 - Embolization device - Google Patents

Embolization device Download PDF

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Publication number
CA2319447A1
CA2319447A1 CA002319447A CA2319447A CA2319447A1 CA 2319447 A1 CA2319447 A1 CA 2319447A1 CA 002319447 A CA002319447 A CA 002319447A CA 2319447 A CA2319447 A CA 2319447A CA 2319447 A1 CA2319447 A1 CA 2319447A1
Authority
CA
Canada
Prior art keywords
embolization device
collagenous biomaterial
thrombogenic
component
submucosa
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
CA002319447A
Other languages
French (fr)
Other versions
CA2319447C (en
Inventor
Christopher J. Moran
Mark W. Bleyer
Thomas G. Kozma
Umesh H. Patel
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cook Biotech Inc
Washington University in St Louis WUSTL
Cook Research Inc
Original Assignee
Washington University
Cook Biotech, Inc.
Med Institute, Inc.
Christopher J. Moran
Mark W. Bleyer
Thomas G. Kozma
Umesh H. Patel
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Washington University, Cook Biotech, Inc., Med Institute, Inc., Christopher J. Moran, Mark W. Bleyer, Thomas G. Kozma, Umesh H. Patel filed Critical Washington University
Publication of CA2319447A1 publication Critical patent/CA2319447A1/en
Application granted granted Critical
Publication of CA2319447C publication Critical patent/CA2319447C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/37—Digestive system
    • A61K35/38—Stomach; Intestine; Goblet cells; Oral mucosa; Saliva
    • 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
    • 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
    • A61B17/12163—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
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • 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
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure 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
    • A61B17/12181—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
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • A61L27/3629—Intestinal tissue, e.g. small intestinal submucosa
    • 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
    • A61L31/005—Ingredients of undetermined constitution or reaction products thereof
    • 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
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • 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

A medical device (40) including a collagenous biomaterial (10) for causing embolus and treating an aneurysm. The collagenous biomaterial (10) includes a small intestine submucosa (12) that is configured into various components (16) for causing a vascular occlusion or packing aneurysm lumen.

Claims (30)

1. An embolization device, comprising:
a collagenous biomaterial (12);
a radiopaque marker (18) disposed on the collagenous biomaterial (12);
and the collagenous biomaterial (12) having a thrombogenic component.
2. The embolization device of claim 1, wherein the collagenous biomaterial comprises a biocompatible submucosa (10).
3. The embolization device of claim 2, wherein the collagenous biomaterial further comprises a submucosa (10) having an endotoxin level less than 12 endotoxin units per gram.
4. The embolization device of claim 2, wherein a pharmacologic agent is (14) disposed on the collagenous biomaterial.
5. The embolization device of claim 4, wherein the pharmacologic agent further comprises at least one of a growth factor, protein, proteoglycan, glycoprotein, glycosaminoglycan, physiological compatible mineral, antibiotic, chemotherapeutic agent, pharmaceutical, enzyme, genetic material, and hormone.
6. The embolization device of claim 2, wherein the collagenous biomaterial further comprises a lyophilized component.
7. The embolization device of claim 2, wherein the thrombogenic component further comprises at least one of a brush-like, braided, branched, coil, cubic, cylindrical, helical, injectable, layered, randomized, sheet-like, spherical, and tubular component (16).
8. The embolization device of claim 1, wherein the collagenous biomaterial further comprises at least a tunics submucosa and a lamina muscularis mucosa of an intestine.
9. The embolization device of claim 1, wherein the thrombogenic component further comprises a backbone and the collagenous biomaterial further comprises submucosa.
10. The embolization device of claim 1, wherein the thrombogenic component comprises at least one thrombogenic fibril.
11. The embolization device of claim 1, wherein a collagenous biomaterial further comprises submucosa and the thrombogenic component further comprises a coil.
12. The embolization device of claim 11, wherein the thrombogenic component further comprises the coil having at least one thrombogenic fibril.
13. The embolization device of claim 1, wherein a pharmacologic agent is disposed on the collagenous biomaterial.
14. The embotization device of claim 13, wherein the pharmacologic agent is taxol, or a taxol derivative.
15. The embolization device claim 1, wherein the collagenous biomaterial further comprises at least one of a urinary bladder, pericardium, basement membrane, amniotic membrane, tissue mucosa, gastric submucosa, and stomach submucosa tissues.
16. The embolization device of claim 15, wherein the collagenous biomaterial further comprises a biocompatible tissue.
17. The embolization device of claim 15, wherein a pharmacologic agent is disposed on the collagenous biomaterial.
18. The embolization device of claim 17, the pharmacologic agent (14) further comprises at least one of a growth factor, protein, proteoglycan, glycoprotein, glycosaminoglycan, physiological compatible mineral, antibiotic, chemotherapeutic agent, enzyme, pharmaceutical, taxol, taxol derivative, genetic material, and hormone.
19. The embolization device of claim 15, wherein the collagenous biomaterial further comprises a lyophilized component.
20. The embolization device of claim 15, wherein the collagenous biomaterial further comprises at least one of a brush-like, braided, branched, coil, cubic, cylindrical, helical, injectable, layered, randomized, sheet-like, spherical, and tubular component (16).
21. The embolization device of claim 15, wherein the thrombogenic component further comprises a central backbone and the collagenous biomaterial further comprises submucosa.
22. The embolization device of claim 15 wherein the thrombogenic component comprises at least one thrombogenic fibril.
23. The embolization device claim 15 wherein the thrombogenic component comprises a coil.
24. The embolization device claim 23, wherein the coil further comprises at least one thrombogenic fibril.
25. The medical device, comprising:
a means for filling a blood vessel or an aneurysm; and a radiopaque marker disposed on the means.
26. The medical device of claim 25, wherein the means for filling includes a collagenous biomaterial, the collagenous biomaterial comprising at least one of a submucosa, pericardium, basement membrane, amniotic membrane, mucosa, liver, gastric submucosa, stomach submucosa, and urinary bladder submucosa.
27. The medical device, comprising:
a submucosal component;
a radiopaque marker;
wherein the submucosal component further comprises a coil.
28. The medical device of claim 27, wherein: the coil further comprises at least one thrombogenic fibril.
29. The medical device of claim 27, wherein the submucosal component further comprises at least a first spiral adjacent to a second spiral, each spiral having a radius, the first spiral being of a different radius than the second spiral.
30. The medical device of claim 29, wherein the submucosal component further comprises a central backbone connecting the at least first and second spirals.
CA2319447A 1998-12-01 1999-11-24 Embolization device Expired - Fee Related CA2319447C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US11043498P 1998-12-01 1998-12-01
US60/110,434 1998-12-01
PCT/US1999/028070 WO2000032112A1 (en) 1998-12-01 1999-11-24 Embolization device

Publications (2)

Publication Number Publication Date
CA2319447A1 true CA2319447A1 (en) 2000-06-08
CA2319447C CA2319447C (en) 2010-01-26

Family

ID=22332990

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2319447A Expired - Fee Related CA2319447C (en) 1998-12-01 1999-11-24 Embolization device

Country Status (8)

Country Link
US (2) US7857825B2 (en)
EP (1) EP1051116B8 (en)
AT (1) ATE410119T1 (en)
AU (1) AU1832700A (en)
CA (1) CA2319447C (en)
DE (1) DE69939685D1 (en)
DK (1) DK1051116T3 (en)
WO (1) WO2000032112A1 (en)

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US8439942B2 (en) 2013-05-14
US20110077679A1 (en) 2011-03-31

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