Enhanced visibility materials for implantation in hard tissue

• US 6,231,615 B1
• Filed: 10/18/1999
• Issued: 05/15/2001
• Est. Priority Date: 10/14/1997
• Status: Expired due to Term

• Current Assignee: NeuroTherm, Inc. (Abbott Laboratories)
• Original Assignee: Parallax Medical, Inc. (Abbott Laboratories)
• Inventors: Preissman, Howard
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): Koh, Choon P.
• Application Number:
  US09/420,093
• Time in Patent Office: 575 Days
• Field of Search: 623/23.62, 623/902, 623/17.11, 623/23.73, 606/76, 523/117, 523/116, 600/4
• US Class Current: 623/23.73
• 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 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 about 350μ and 2200μ, even more preferably between about 450μ and 1600μ, and most preferably between about 570μ0 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 method of delivering enhanced visibility hard tissue implant material, the implant material including particles for contrast having a size up to about 350μ

and tracer elements having a size between about 570μ and

about 2200μ

, said method comprising;

flowing an amount of the implant material into a desired implantation site;

viewing, via a medical imaging device, the tracer elements to discern the instantaneous placement of the implant material; and

continuing delivery of the implant material if appropriate initial placement has been achieved.

2. The method set forth in claim 1, wherein the implant material is flowed into a site for effecting vertebroplasty.

3. The method as set forth in claim 1, wherein said viewing the tracer elements comprises viewing the flow of the tracer elements.

4. The method as set forth in claim 1, further comprising accessing an implantation site from a remote location with a delivery tool prior to said flowing.

5. The method of claim 1, wherein said flowing is performed percutaneously.

6. The method of claim 5, wherein the implant material is flowed into a site for effecting vertebroplasty.

7. The method of any of claim 1-6 wherein the hard tissue implant material comprises 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.