Enhanced visibility materials for implantation in hard tissue

• US 7,510,579 B2
• Filed: 04/05/2001
• Issued: 03/31/2009
• Est. Priority Date: 10/14/1997
• Status: Expired due to Fees

• Current Assignee: NeuroTherm, Inc. (Abbott Laboratories)
• Original Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Inventors: Preissman, Howard
• Primary Examiner(s): McDermott; Corrine
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US09/828,539
• Publication Number:
  US 20010012968A1
• Time in Patent Office: 2,917 Days
• Field of Search: 623/23.73, 623/17.12, 623/923, 623/902, 623/917, 623/919, 623/908, 623 2361- 2363, 623/23.51, 623/23.56, 623/23.58, 623/23.72, 600/431, 606/76, 606/77, 606/92, 606/94, 606/97, 523/117
• US Class Current: 623/23.72
• 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 is disclosed. 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 120μ and 2200μ, more preferably bout 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. An injectable hard tissue implant composition comprising:

a settably hardenable, flowable matrix comprising polymethylmethacrylate;

radiopaque tracer particles in said flowable matrix, said radiopaque tracer particles comprising at least particles having a size between about 350μ and

2200μ and

present in an amount so as to be individually visible during implantation; and

radiopaque contrast particles comprising at least particles having a particle size between about 120μ and

350μ

;

wherein said contrast particles enhance the visibility of said matrix, and

wherein said radiopaque tracer particles visibly indicate flow of said matrix during implantation.

2. The injectable composition of claim 1, wherein said radiopaque tracer particles comprise at least particles having a size between about 570μ

and 2200μ

.

3. The injectable composition of claim 1, wherein said radiopaque tracer particles comprise at least particles having a size between about 450μ

and 1600μ

.

4. The injectable composition of claim 1, wherein said radiopaque tracer particles comprise at least particles having a size between about 570μ

and 1150μ

.

5. The injectable composition of claim 1, wherein said radiopaque contrast particles comprise at least particles having a size between about 120μ

and 250μ

.

6. The injectable composition of claim 1, wherein the radiopaque tracer particles is selected from the group consisting of barium sulfate, tungsten, tantalum, zirconium, platinum, gold, silver, stainless steel, titanium, alloys thereof, combinations thereof, and equivalent materials used as radiographic agents in hard tissue implant materials that can be formed as particles.

7. The injectable composition of claim 1, wherein the radiopaque contrast particles is selected from the group consisting of barium sulfate, bismuth subcarbonate, bismuth sulfate, powdered tungsten, powdered tantalum, zirconium, combinations thereof, and equivalent materials for use as radiographic agents in hard tissue implant materials that can be formed as particles.

8. The injectable composition of claim 1, wherein the matrix and radiopaque tracer particles comprise a slurry.

9. The injectable composition of claim 8, wherein the slurry comprises an injectable composition for hard tissue implantation.

10. The injectable composition of claim 1, wherein the radiopaque tracer particles comprises about 1% of the total weight of the composition.

11. An injectable hard tissue implant composition comprising:

a settably hardenable, flowable matrix comprising at least polymethylmethacrylate;

radiopaque tracer particles,

wherein the size of the radiopaque tracer particles comprises at least particles having a size between about 350μ and

2200μ and

wherein the amount of radiopaque tracer particles present is such that radiopaque tracer particles are individually visible under fluoroscopy during implantation to visually indicate flow of the injectable composition during implantation; and

radiopaque contrast particles consisting of particles having a particle size between about 120μ and

350μ

wherein the contrast particles enhance the visibility of said matrix.

12. The injectable composition of claim 11, wherein the radiopaque tracer particles is selected from the group consisting of barium sulfate, tungsten, tantalum, zirconium, platinum, gold, silver, stainless steel, titanium, alloys thereof combinations thereof, and equivalent materials used as radiographic agents in hard tissue implant materials that can be formed as particles.

13. The injectable composition of claim 11, wherein the radiopaque contrast particles is selected from the group consisting of barium sulfate, bismuth subcarbonate, bismuth sulfate, powdered tungsten, powdered tantalum, zirconium, combinations thereof, and equivalent materials for use as radiographic agents in hard tissue implant materials that can be formed as particles.

14. The injectable composition of claim 11, wherein the amount of radiopaque tracer particles comprises about 1% of the total weight of the composition.

15. The injectable composition of claim 11, wherein the radiopaque tracer particles comprise at least particles sized between about 570μ

and 2200μ

.

16. The injectable composition of claim 11, wherein the radiopaque tracer particles comprise at least particles sized between about 450μ

and 1600μ

.

17. The injectable composition of claim 11, wherein the radiopaque tracer particles comprise at least particles sized between about 570μ

and 1150μ

.

18. The injectable composition of claim 11, wherein the amount of radiopaque tracer particles comprises about 10% of the total weight of the composition.

19. The injectable composition of claim 11 wherein the radiopaque tracer particles comprise barium sulfate.

20. An enhanced visibility composition for implantation into tissue comprising:

a hard tissue implant material including a settably hardenable, flowable matrix comprising polymethylmethacrylate;

radiopaque tracer particles in said flowable matrix, said radiopaque tracer particles comprising at least particles having a size between about 350μ and

2200μ and

present in an amount so as to be individually visible during implantation; and

radiopaque contrast particles comprising at least particles having a particle size between about 120μ and

350μ

;

wherein said contrast particles enhance the visibility of said matrix; and

wherein said radiopaque tracer particles visibly indicate flow of said matrix during implantation.

21. An injectable hard tissue implant composition comprising:

a settably hardenable, flowable matrix comprising polymethylmethacrylate;

radiopaque tracer particles in said flowable matrix, said radiopaque tracer particles comprising at least particles having a size between about 350μ and

2200μ and

present in an amount so as to be individually visible during implantation; and

radiopaque contrast particles comprising at least particles having a particle size between about 120μ and

350μ

;

wherein said contrast particles enhance the visibility of said matrix, and wherein said radiopaque tracer particles visibly indicate flow of said matrix during implantation, and wherein the radiopaque tracer particles comprise about 1% of the total weight of the composition, and wherein the radiopaque tracer particles comprises a mixture of barium sulphate and tungsten particles.