WO1999018894B1 - Enhanced visibility materials for implantation in hard tissue - Google Patents

Enhanced visibility materials for implantation in hard tissue

Info

Publication number
WO1999018894B1
WO1999018894B1 PCT/US1998/021576 US9821576W WO9918894B1 WO 1999018894 B1 WO1999018894 B1 WO 1999018894B1 US 9821576 W US9821576 W US 9821576W WO 9918894 B1 WO9918894 B1 WO 9918894B1
Authority
WO
WIPO (PCT)
Prior art keywords
composition
particles
enhanced visibility
particle size
radiopaque
Prior art date
Application number
PCT/US1998/021576
Other languages
French (fr)
Other versions
WO1999018894A1 (en
Inventor
Howard Preissman
Original Assignee
Parallax Medical Inc
Howard Preissman
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=25490179&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO1999018894(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Parallax Medical Inc, Howard Preissman filed Critical Parallax Medical Inc
Priority to AU10819/99A priority Critical patent/AU1081999A/en
Publication of WO1999018894A1 publication Critical patent/WO1999018894A1/en
Publication of WO1999018894B1 publication Critical patent/WO1999018894B1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7094—Solid vertebral fillers; devices for inserting such fillers
    • A61B17/7095—Solid vertebral fillers; devices for inserting such fillers the filler comprising unlinked macroscopic particles
    • 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
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/001—Use of materials characterised by their function or physical properties
    • 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
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30965—Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4601—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/3008—Properties of materials and coating materials radio-opaque, e.g. radio-opaque markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00179—Ceramics or ceramic-like structures
    • A61F2310/00293—Ceramics or ceramic-like structures containing a phosphorus-containing compound, e.g. apatite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00329—Glasses, e.g. bioglass
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00353—Bone cement, e.g. polymethylmethacrylate or PMMA

Abstract

An enhanced visibility composition for implantation from a remote source, so that the composition can be readily observed under fluoroscopy or other imaging techniques. The compositions include a biocompatible matrix, such as a hard tissue implant material for example, and radiopaque particles mixed in the matrix. The radiopaque particles have a particle size between about 120 ν and 2200 ν, more preferably about 350 ν and 2200 ν, even more preferably between about 450 ν and 1600 ν, and most preferably between about 570 ν and 1150 ν. Preferably the hard tissue implant and the radiopaque particles are formed or prepared in a slurry. Optionally, the enhanced visibility composition may further include additional radiopaque particles or constrast particles mixed in with the composition, which have a particle size between about 120 ν and 350 ν, preferably between about 120 ν and 250 ν.

Claims

AMENDED CLAIMS[received by the International Bureau on 23 April 1999 (23.04.99); original claims 1, 8, 27 and 33 amended; new claims 42-55 added; remaining claims unchanged (5 pages)]
1. An enhanced visibility composition for implantation into hard tissue comprising: a hard tissue implant material in powder form; and radiopaque particles mixed in said hard tissue implant material, said radiopaque particles having a particle size between about 350μ and 2200μ.
2. The enhanced visibility composition of claim 1, wherein said hard tissue implant and said radiopaque particles are formed in a slurry.
3. The enhanced visibility composition of claim 1, wherein said hard tissue implant material comprises polymethyl methacrylate.
4. The enhanced visibility composition of claim 1, wherein said hard tissue implant material comprises hydroxyapatite.
5. The enhanced visibility composition of claim 1, wherein said hard tissue implant material comprises calcium phosphates.
6. The enhanced visibility composition of claim 1, wherein said hard tissue implant material comprises calcium sulfates.
7. The enhanced visibility composition of claim 1, wherein said hard tissue implant material comprises at least one of the materials selected from the group consisting of demineralized bone particles and mineralized bone particles.
8. The enhanced visibility composition of claim 1, wherein said hard tissue implant material comprises at least one of the materials selected from the group consisting of polygly colic acid compounds and polylactic acid compounds.
9. The enhanced visibility composition of claim 1, wherein said hard tissue implant material comprises at least one of the materials selected from the group consisting of collagen and collagen derivatives.
10. The enhanced visibility composition of claim 1, wherein said hard tissue implant material comprises at least one of the materials selected from the group consisting of chitin and chitosan.
1 4
AMENDED SHEET (ARTICLE I9)
11. The enhanced visibility composition of claim 1 , wherein said hard tissue implant material comprises at least one of the materials selected from the group consisting of bioglasses including oxides of silicon, sodium, calcium and phosphorous and combinations thereof.
12. The enhanced visibility composition of claim 1, wherein said radiopaque particles have a particle size between about 450μ and 2200μ.
13. The enhanced visibility composition of claim 1, wherein said radiopaque particles have a particle size between about 570μ and 2200μ.
14. The enhanced visibility composition of claim 1, wherein said radiopaque particles have a particle size between about 350μ and 1600μ.
15. The enhanced visibility composition of claim 9, wherein said radiopaque particles have a particle size between about 350μ and 1150μ.
16. The enhanced visibility composition of claim 15, wherein said radiopaque particles have a particle size between about 450μ and 1150μ.
17. The enhanced visibility composition of claim 1, wherein said radiopaque particles have a particle size between about 570μ and 1150μ.
18. The enhanced visibility composition of claim 14, wherein said radiopaque particles have a particle size between about 45 Oμ and 1600μ.
19. The enhanced visibility composition of claim 1, further comprising: additional radiopaque particles mixed in said hard tissue implant material, said additional radiopaque particles having a particle size between about 120μ and 350μ.
20. The enhanced visibility composition of claim 1, wherein said additional radiopaque particles have a particle size between about 120μ and 25 Oμ.
21. The enhanced visibility composition of claim 1, wherein said radiopaque particles comprise barium sulfate.
22. The enhanced visibility composition of claim 1, wherein said radiopaque particles comprise tungsten.
23. The enhanced visibility composition of claim 1, wherein said radiopaque particles comprise tantalum.
1 5
24. The enhanced visibility composition of claim 19, wherein said additional radiopaque particles comprise barium sulfate.
25. The enhanced visibility composition of claim 19, wherein said additional radiopaque particles comprise tungsten.
26. The enhanced visibility composition of claim 19, wherein said additional radiopaque particles comprise tantalum.
27. A percutaneous vertebroplasty implant comprising a slurry of biocompatible implant material and radiopaque markers having a particle size of between about 120μ and 2200μ.
28. The composition of claim 27, wherein said biocompatible implant material comprises polymethyl methacrylate.
29. The composition of claim 27 wherein said markers have a particle size between about 350μ and 2000μ.
30. The composition of claim 29 wherein said markers have a particle size between about 450μ and 1600μ.
31. The composition of claim 30, further comprising contrast particles, wherein said contrast particles have a particle size between about 120μ and 350μ.
32. The composition of claim 31 wherein said markers have a particle size between about 570μ and 1150μ.
33. An injectable composition comprising: a biocompatible matrix; and discrete radiopaque particles mixed within said biocompatible matrix, said radiopaque particles having a particle size between about 120μ and 2200μ.
34. The injectable composition of claim 33, wherein said biocompatible matrix and said radiopaque particles form a slurry.
35. The injectable composition of claim 33, wherein the mixture of said biocompatible matrix and said radiopaque particles forms a hard tissue implant material.
36. The injectable composition of claim 33, wherein said radiopaque particles have a particle size υetween about 35 μ and 2200μ.
37. The injectable composition of claim 36, further comprising:
1 6 contrast particles having a particle size between about 120μ and 350μ.
38. The injectable composition of claim 36, wherein said radiopaque particles having a particle size between about 450μ and 1600μ.
39. The injectable composition of claim 38, wherein said radiopaque particles having a particle size between about 570μ and 1150μ.
40. An enhanced visibility composition comprising: a flowable matrix; and radiopaque particles in said flowable matrix, said radiopaque particles being of a size and concentration so as to be individually visible under medical fluoroscopy.
41. The enhanced visibility composition of claim 40, wherein said radiopaque particles have a size between about 120μ and 2200μ.
42. A kit for making an enhanced visibility composition for implantation into hard tissue comprising: a hard tissue implant material in powder form; and radiopaque particles, said radiopaque particles having a particle size between about
350μ and 2200μ.
43. The kit of claim 42, further comprising a biocompatible liquid combinable with said hard tissue implant powder and said radiopaque particles.
44. The kit of claim 43, wherein said composition forms a slurry.
45. The kit of claim 43, wherein said composition is injectable.
46. The kit of claim 43, wherein said composition forms a slurry which is injectable for percutaneous vertebroplasty.
47. A percutaneous vertebroplasty implant comprising a slurry of polymethyl methacrylate and radiopaque markers having a particle size of between about 120μ and 2200μ.
48. An implantable composition, comprising a settable slurry of polymethyl methacrylate, radiopaque markers having a particle size of between about 350μ and 2200μ, and contrast particles having a particle size of between about 120μ and 350u.
49. A tissue implant comprising a matrix and tracer particles, wherein said implant
1 7 is made by delivery to a site and viewing at least some of said tracer particles individually during advancement of said matrix and tracer particles into the site.
50. Use of tracer particles in a flowable matrix to treat osteoporosis.
51. Use of tracer particles in a flowable matrix to treat bone defects.
52. Use of tracer particles in a flowable matrix to treat metastatic disease.
53. An implant in the following stages: providing a settable composition comprising a matrix and tracer particles having a size between about 120μ and 2200μ; and flowing said composition to a site where it sets.
54. An implant composition for enhancing the visibility thereof during placement in an organism in the following stages: flowing the composition into a predetermined implant site; and visualizing individual radiopaque particles in the flowable composition using a medical imaging apparatus.
55. The implant of claim 54 wherein said composition is settable upon placement in said predetermined implant site.
1 8
PCT/US1998/021576 1997-10-14 1998-10-13 Enhanced visibility materials for implantation in hard tissue WO1999018894A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU10819/99A AU1081999A (en) 1997-10-14 1998-10-13 Enhanced visibility materials for implantation in hard tissue

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/950,256 1997-10-14
US08/950,256 US6309420B1 (en) 1997-10-14 1997-10-14 Enhanced visibility materials for implantation in hard tissue

Publications (2)

Publication Number Publication Date
WO1999018894A1 WO1999018894A1 (en) 1999-04-22
WO1999018894B1 true WO1999018894B1 (en) 1999-06-24

Family

ID=25490179

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1998/021576 WO1999018894A1 (en) 1997-10-14 1998-10-13 Enhanced visibility materials for implantation in hard tissue

Country Status (3)

Country Link
US (3) US6309420B1 (en)
AU (1) AU1081999A (en)
WO (1) WO1999018894A1 (en)

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US6309420B1 (en) 2001-10-30
US7510579B2 (en) 2009-03-31
US20010012968A1 (en) 2001-08-09
US6231615B1 (en) 2001-05-15

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