Enhanced visibility materials for implantation in hard tissue

• US 6,309,420 B1
• Filed: 10/14/1997
• Issued: 10/30/2001
• Est. Priority Date: 10/14/1997
• Status: Expired due to Term

• Current Assignee: NeuroTherm, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Parallax Medical, Inc. (Abbott Laboratories Incorporated)
• Inventors: Preissman, Howard
• Primary Examiner(s): Isabella, David J.
• Assistant Examiner(s): Koh, Choon P.
• Application Number:
  US08/950,256
• Time in Patent Office: 1,477 Days
• Field of Search: 623/1, 623/11, 623/12, 623/16, 623/18, 623/66, 623/17, 623/16.11, 623/23.62, 606/77, 606/92, 606/76, 606/94, 523/116, 523/117, 523/113, 600/3
• US Class Current: 623/16.11
• CPC Class Codes: A61B 17/7095 the filler comprising unlinked macroscopic particles
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00293 containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00329 Glasses, e.g. bioglass
• CPC Class Codes: A61F 2310/00353 Bone cement, e.g. polymethylmethacrylate or PMMA
• CPC Class Codes: A61L 24/001 Use of materials characterised by their function or physical properties
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials

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 composition 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 120μ and 2200μ, more preferably about 350μ and 2200μ, even more preferably between about 450μ and 1600μ, and most preferably between about 570μ and 1150μ. 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 contrast particles mixed in with the composition, which have a particle size between about 120μ and 350μ, preferably between about 120μ and 250μ.

Claims

1. A settable enhanced visibility composition comprising:

matrix material implantable in a flowable form; and

radiopaque particles mixed in said matrix material, said particles including a first set of said radiopaque particles having a size between about 570μ and

about 2200μ

to be clearly and discretely viewable during implantation and a second set of said radiopaque particles having a size up to about 350μ

to provide contrast.

2. The settable composition of claim 1, wherein said second set of said radiopaque particles have a size between about 120μ

and about 350μ

.

3. The settable composition of claim 2, wherein said matrix material and said radiopaque particles are in a slurry form.

4. The settable composition of claim 2, wherein said first set of radiopaque particles have a size between about 570μ

and about 1150μ

.

5. The settable composition of claim 2, wherein said second set of radiopaque particles have a size between about 120μ

and about 250μ

.

6. The settable composition of claim 2, wherein said matrix material comprises a hard tissue implant material selected from a group consisting of polymethyl methacrylate, hydroxyapatite, calcium sulfates, polyglycolic acid compounds and polylactic acid compounds, and oxides of silicon.

7. The settable composition of claim 2, wherein said matrix material comprises an implant material selected from a group consisting of polymethyl methacrylate, hydroxyapatite, calcium phosphates, calcium sulfates, demineralized and mineralized bone particles, polyglycolic acid compounds and polylactic acid compounds, collagen and collagen derivatives, chitin and chitosan, oxides of silicon, oxides of sodium, oxides of calcium and oxides of phosphorous;

and wherein at least some of said radiopaque particles comprise radiopaque material selected from a group consisting of barium sulfate, zirconium dioxide, tantalum, tungsten, platinum, gold, silver, stainless steel and titanium.

8. The settable composition of claim 2, wherein at least some of said radiopaque particles comprise radiopaque material selected from a group consisting of barium sulfate, zirconium dioxide, tantalum, tungsten, platinum, gold, silver, stainless steel and titanium.

9. A settable enhanced visibility composition comprising:

matrix material implantable in a flowable form; and

radiopaque material mixed in said matrix material, said radiopaque material including conventional contrast agent and radiopaque particles having a size between about 120μ and

about 2200μ

.

10. The settable composition of claim 9, wherein said matrix material and said radiopaque material are in a slurry form.

11. The settable composition of claim 9, wherein said radiopaque particles have a size between about 350μ

and about 2200μ

.

12. The settable composition of claim 11, wherein said radiopaque particles have a size between about 450μ

and about 1600μ

.

13. The settable composition of claim 12, wherein said radiopaque particles have a size between about 570μ

and about 1150μ

.

14. The settable composition of claim 9, wherein said matrix material comprises a hard tissue implant material selected from a group consisting of polymethyl methacrylate, hydroxyapatite, calcium sulfates, polyglycolic acid compounds and polylactic acid compounds, and oxides of silicon.

15. The settable composition of claim 9, wherein said matrix material comprises an implant material selected from a group consisting of polymethyl methacrylate, hydroxyapatite, calcium phosphates, calcium sulfates, demineralized and mineralized bone particles, polyglycolic acid compounds and polylactic acid compounds, collagen and collagen derivatives, chitin and chitosan, oxides of silicon, oxides of sodium, oxides of calcium and oxides of phosphorous;

and wherein at least some of said radiopaque particles comprise radiopaque material selected from a group consisting of barium sulfate, zirconium dioxide, tantalum, tungsten, platinum, gold, silver, stainless steel and titanium.

16. The settable composition of claim 9, wherein at least some of said radiopaque particles comprise radiopaque material selected from a group consisting of barium sulfate, zirconium dioxide, tantalum, tungsten, platinum, gold, silver, stainless steel and titanium.