Low viscosity bone cement

• US 4,341,691 A
• Filed: 02/20/1980
• Issued: 07/27/1982
• Est. Priority Date: 02/20/1980
• Status: Expired due to Term

• Current Assignee: Zimmer Incorporated (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Zimmer Incorporated (Zimmer Biomet Holdings, Inc.)
• Inventors: Anuta, David A.
• Primary Examiner(s): Lieberman, Allan
• Application Number:
  US06/122,896
• Time in Patent Office: 888 Days
• Field of Search: 260/42.17, 260/42.52, 260/42.53, 525/309, 128/92 C, 128/92 CA, 128/92 G, 128/92 R
• US Class Current: 523/116
• CPC Class Codes: A61L 24/001 Use of materials characterised by their function or physical properties
• CPC Class Codes: A61L 24/0089 containing inorganic fillers not covered by groups A61L24/0078 or A61L24/0084
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: C08F 265/00 Macromolecular compounds obtained by polymerising monomers on to polymers of unsaturated monocarboxylic acids or derivatives thereof as defined in group C08F20/00
• CPC Class Codes: C08L 33/12 Homopolymers or copolymers of methyl methacrylate
• CPC Class Codes: C09J 4/06 Organic non-macromolecular compounds having at least one polymerisable carbon-to-carbon unsaturated bond in combination with a macromolecular compound other than an unsaturated polymer of groups C09J159/00 - C09J187/00

Abstract

An acrylic cement-like substance which permits seating and securing of a prosthesis into living bone which comprises a mixture of a liquid monomer component and a polymer powder component such that upon mixing the two components, a cement which maintains a low viscosity for a longer period of time is formed. The low viscosity bone cement is intended for syringe or injector gun use only as it is to be used before the cement becomes doughy. This low viscosity bone cement has a viscosity of approximately 20 degrees C. (68 degrees F.), of less than 1500 poise, and preferably less than 1000 poise up to the sixth or seventh minute after the two components are mixed. The cement used in the lower viscosity state is more capable of penetrating the trabeculae of bones when used to secure a prosthesis, than when the cement is applied in the doughy state.

Claims

1. An acrylic bone cement composition comprising:

a liquid monomer component and a polymer powder component in the form of beads wherein the liquid component to powder component ratio is 1 to 2 (volume weight) there the liquid component is measured in milliliters and the powder component is measured in grams and wherein said liquid monomer component is comprised of methylmethacrylate monomer and said polymer powder component is comprised at least 80% by weight of polymethylmethacrylate polymer powder in which at least 85-95% by weight of the polymethylmethacrylate polymer powder beads are regular beads which fall through a #40 mesh (425 micron openings) screen and a #100 mesh screen (150 micron openings) and which have a maximum average size of about 25 microns and a minimum average size of about 13 microns, and about 5-15% by weight of polymethylmethacrylate polymer powder beads which fall through a #40 mesh (425 micron openings) screen, but not through a #100 mesh screen, (150 micron openings) and are subsequently milled to roughen and break up the surface of the bead, and whereby when the liquid monomer component is mixed with said polymer powder component, the resulting cement has a viscosity of less than 1500 poise at approximately 20 degrees C. (68 degrees F.) for at least six minutes after the components are initially mixed, and such that the resulting bone cement becomes completely hard in not more than ten to eleven minutes from the time the components were initially mixed.

2. An acrylic cement as described in claim 1, wherein the polymer powder is comprised of a mixture of 90% regular polymer beads and 10% of said polymer beads which have been milled.

3. An acrylic cement as described in claim 1, wherein the liquid monomer component is comprised of 96.2 % to 98.3% by volume of methyl methacrylate monomer, and 2.5% to 3.0% by volume of N,N-dimethyl-p-toluidine.

4. An acrylic cement as described in claim 3, wherein the liquid monomer component further includes 75±

10 ppm of hydroquinone.

5. An acrylic cement as described in claim 1, wherein the powder component is comprised of 80 to 100% by weight of the poly methyl methacrylate bead mixture and 0.5 to 1.0% by weight of benzoyl peroxide, a catalyst, and wherein the powder component allows for a maximum of 1% by weight moisture content.

6. An acrylic cement as described in claims 1 or 5, wherein the polymer powder component further includes 9.0 to 11.0% by weight of barium sulfate, U.S.P. to provide radiopacity to the cement.

7. An acrylic cement as described in claim 1, wherein the polymer powder component further includes a dispersion of 1.8 to 2.2% by weight of high modulus graphite fibers, wherein the cross-section of said fibers is substantially dog-bone shaped and has a major and minor diameter, wherein the major diameter is approximately 15 microns and the minor diameter is approximately 6 microns, and wherein said fibers have a length of approximately 0.79 to 7.14 millimeters.

8. An acrylic cement as described in claim 7, wherein the liquid monomer component is comprised of the proportions as stated in claim 3.

9. An acrylic cement as described in claim 7, wherein the powder component is comprised of 80 to 100% by weight of the poly methyl methacrylate bead mixture, 1.8 to 2.2% by weight of high modulus carbon fibers, and 0.5 to 1.0% by weight of benzoyl peroxide, a catalyst, and allows for a maximum of 1% by weight moisture content.

10. An acrylic cement as described in claims 7 or 9 wherein the polymer powder component further includes 9 to 11% by weight of barium sulfate, U.S.P. to provide radiopacity to the cement.

21. An acrylic cement as described in claims 1 or 11, wherein the viscosity of the resulting bone cement after mixing is less than 1000 poise at approximately 20 degrees C. (68 degrees F.) for at least six minutes after the components are initially mixed.

11. An acyrlic bone cement composition comprising:

a liquid monomer component and a polymer powder component in the form of beads wherein the liquid component to powder component ratio is 1 to 2 (volume/weight) where the liquid component is measured in milliliters and the powder component is measured in grams and wherein said liquid monomer component is comprised of methylmethacrylate monomer and said polymer powder component is comprised at least 80% by weight of poly methylmethacrylate polymer powder in which at least 85-95% by weight of the poly methylmethacrylate polymer powder beads are regular beads which fall through a #40 mesh (425 micron openings) screen and a #100 mesh screen (150 micron openings) and which have a maximum average size of about 25 microns and a minimum average size of about 13 microns, and about 5-15% by weight of poly methylmethacrylate polymer powder beads which are less than 13 to 17 microns in diameter, and whereby when the liquid monomer component is mixed with said polymer powder component, the resulting cement has a viscosity of less than 1500 poise at approximately 20 degrees C. (68 degrees F.) for at least six minutes after the components are initially mixed, and such that the resulting bone cement becomes completely hard in not more than ten to eleven minutes from the time the components were initially mixed.

12. An acrylic cement as described in claim 11, wherein the polymer powder is comprised of a mixture of 90% regular polymer beads and 10% of said polymer beads which are less than 13 to 17 microns in diameter.

13. An acrylic cement as described in claim 11, wherein the liquid monomer component is comprised of 96.2% to 98.3% by volume of methyl methacrylate monomer, and 2.5% to 3.0% by volume of N, N-dimethyl-p-toluidine.

14. An acrylic cement as described in claim 13, wherein the liquid monomer component further includes 75±

10 ppm of hydroquinone.

15. An acrylic cement as described in claim 11, wherein the powder component is comprised of 80 to 100% by weight of the poly methylmethacrylate bead mixture and 0.5 to 1.0% by weight of benzoyl peroxide, a catalyst, and wherein the powder component allows for a maximum of 1% by weight moisture content.

16. An acrylic cement as described in claims 11 or 15, wherein the polymer powder component further includes 9.0 to 11.0% by weight of barium sulfate, U.S.P. to provide radiopacity to the cement.

17. An acrylic cement as described in claim 11, wherein the polymer powder component further includes a dispersion of 1.8 to 2.2% by weight of high modulus graphite fibers, wherein the cross-section of said fibers is substantially dog-bone shaped and has a major and minor diameter, wherein the major diameter is approximately 15 microns and the minor diameter is approximately 6 microns, and wherein said fibers have a length of approximately 0.79 to 7.14 millimeters.

18. An acrylic cement as described in claim 17, wherein the liquid monomer component is comprised of the proportions as stated in claim 3.

19. An acrylic cement as described in claim 17, wherein the powder component is comprised of 80 to 100% by weight of the poly methylmethacrylate bead mixture, 1.8 to 2.2% by weight of high modulus carbon fibers, and 0.5 to 1.0% by weight of benzoyl peroxide, a catalyst, and allows for a maximum of 1% by weight moisture content.

20. An acrylic cement as described in claims 17 or 19, wherein the polymer powder component further includes 9 to 11% by weight of barium sulfate, U.S.P. to provide radiopacity to the cement.