Bone cement compositions comprising an indicator agent and related methods thereof

• US 7,754,005 B2
• Filed: 05/02/2006
• Issued: 07/13/2010
• Est. Priority Date: 05/02/2006
• Status: Active Grant

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: Kyphon SARL (Medtronic Plc)
• Inventors: Wenz, Robert
• Primary Examiner(s): KOSLOW, CAROL M
• Application Number:
  US11/416,093
• Publication Number:
  US 20070260325A1
• Time in Patent Office: 1,533 Days
• Field of Search: 623/23.62, 106/690, 106/691, 523/116, 523/117, 523/115, 523/114
• US Class Current: 106/690
• CPC Class Codes: A61L 24/001 Use of materials characterised by their function or physical properties
• CPC Class Codes: A61L 24/06 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043, A61L24/046 take precedence
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• 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
• CPC Class Codes: C08L 33/12 Homopolymers or copolymers of methyl methacrylate

Abstract

The invention relates to methods, compositions, kits and systems for determining one or more cement material properties. In one variation, a color change agent is introduced into bone cement to allow a physician to determine when a cement has the desired viscosity for insertion into a patient. In another variation, the composition comprises one or more curable bioactive agents and one or more color change agents. The curable bioactive agent(s) may be one or more bone cement(s). These Bone cements contain a color change agent that allows a physician to tell when the cement has reached the property viscosity for insertion of the bone cement into a patient at the bone site.

Claims

1. A method of preparing a bone cement comprising:

mixing together a powder and a liquid phase to generate a bone cement, wherein the bone cement further includes a thermosensitive color change agent; and

monitoring the color of the bone cement to determine when to place the bone cement inside a patient'"'"'s body.

2. The method according to claim 1, wherein the thermosensitive color change agent is added in an amount such that a color threshold is achieved when the bone cement viscosity reaches a predefined viscosity threshold level.

3. The method according to claim 1 further comprising:

mixing the color change agent with the powder and the liquid phase.

4. The method according to claim 1, wherein either or both of the powder and the liquid phase contain a color change agent.

5. The method of claim 1, wherein either or both of the powder or the liquid phase contain one or more members selected from the group consisting of gentamicin sulfate, erythromycin, tobramycin, vancomycin, cefazolin, oxacillin, cefotaxime, colistin, clindamycin, fusidic acid, barium sulfate, zirconium(IV) oxide, methotrexate, cisplatin, carbon, graphite, aramid, bone particle, polyethylene, titanium, ultra high weight polyethylene, polymethylmethacrylate fibers in a cement matrix, tricalcium phosphate, and hydroxycarbonate apatite.

6. A kit comprising:

a first material and a second material, wherein when at least the first material and the second material are mixed together a bone cement is generated and wherein the first material, second material, or combination thereof contains a thermosensitive color change agent added in an amount to provide indication on a material property of the bone cement during mixing or after mixing the first material and the second material; and

a color chart including at least one colored area, wherein the colored area contains a reference color for determining whether the bone cement has achieved the material property after mixing.

7. The kit according to claim 6, wherein the material property is a predefined viscosity state of the bone cement.

8. The kit according to claim 6, wherein the material property is a predefined temperature threshold.

9. The kit according to claim 6, wherein the first material is a powder and a second material is a liquid.

10. The kit according to claim 6, further comprising written instructions which instruct a user to monitor a change in color of the bone cement during mixing or after mixing the first material and the second material.

11. A kit for repairing bone comprising:

a first material and a second material;

a mixer for mixing at least the first material and the second material to form a bone cement;

a thermosensitive color change agent contained within the first material, the second material, or a combination thereof, wherein the thermosensitive color change agent is added in an amount to provide an indication on a material property of the bone cement during mixing or after mixing the first material and the second material in the mixer; and

written instructions which instruct a user to monitor a change in color of the bone cement during mixing or after mixing the first material and the second material.

12. The kit according to claim 11, wherein the material characteristic threshold is a predefined viscosity.