Bone treatment systems and methods

• US 8,487,021 B2
• Filed: 02/27/2009
• Issued: 07/16/2013
• Est. Priority Date: 02/01/2008
• Status: Active Grant

• Current Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Original Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Inventors: Truckai, Csaba, Kohm, Andrew, Shadduck, John, Luzzi, Robert
• Primary Examiner(s): Yoon, Tae H
• Application Number:
  US12/395,532
• Publication Number:
  US 20090247664A1
• Time in Patent Office: 1,600 Days
• Field of Search: 523/116, 523/211, 525/265
• US Class Current: 523/211
• CPC Class Codes: A61B 17/7095 the filler comprising unlinked macroscopic particles
• CPC Class Codes: A61B 17/8822 characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
• CPC Class Codes: A61B 17/8833 Osteosynthesis tools specially adapted for handling bone cement or fluid fillers; Means for supplying bone cement or fluid fillers to introducing tools, e.g. cartridge handling means
• CPC Class Codes: A61B 17/8836 for heating, cooling or curing of bone cement or fluid fillers
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61K 31/78 of acrylic acid or derivatives thereof
• CPC Class Codes: A61L 24/001 Use of materials characterised by their function or physical properties
• CPC Class Codes: A61L 24/0084 containing fillers of phosphorus-containing inorganic compounds, e.g. apatite
• CPC Class Codes: A61L 24/0089 containing inorganic fillers not covered by groups A61L24/0078 or A61L24/0084
• CPC Class Codes: A61L 24/0094 containing macromolecular fillers
• 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 2400/06 Flowable or injectable implant compositions
• 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 27/46 with phosphorus-containing inorganic fillers
• 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 present disclosure relates to bone cement formulations that have an extended working time for use in vertebroplasty procedures and other osteoplasty procedures together with cement injectors that include energy delivery systems for on-demand control of cement viscosity and flow parameters. The bone cement formulations may include a liquid component having at least one monomer and a non-liquid component including polymer particles and benzoyl peroxide (BPO). The non-liquid component may be further configured to allow controlled exposure of the BPO to the liquid monomer so as to enable control of the viscosity of the bone cement composition.

Claims

1. A bone cement composition, comprising:

a liquid component and a non-liquid component that, upon mixing, provide a polymerizable bone cement composition, the liquid component comprising at least one monomer and the non-liquid component comprising at least a polymer and an initiator;

wherein the non-liquid component is configured to provide controlled differential exposure of the initiator to the liquid monomer so as to control the viscosity of the bone cement composition and further comprises;

a first volume of polymer particles having a mean diameter less than 100 μ

m and on the basis of the total weight of the first volume of polymer particles, greater than or equal to 1.1 wt. % of the initiator being contained within the first volume;

a second volume of polymer particles having a mean diameter greater than 100 μ

m and on the basis of the total weight of the second volume of polymer particles, greater than or equal to 0.9 wt. % of the initiator being contained within the second volume; and

a third volume of polymer particles having a mean diameter less than 100 μ

m and on the basis of the total weight of the third volume of polymer particles, wherein 0-1.1 wt. % of the initiator is contained within the third volume,

wherein the wt. % of the initiator is different in each of the first, second, and third volumes of polymer particles.

2. The bone cement composition of claim 1, wherein the non-liquid component is configured to provide at least two time intervals in which exposure of the initiator to the liquid monomer is substantially the same.

3. The bone cement composition of claim 1, wherein the non-liquid component is configured to provide first and second time intervals in which exposure of the initiator to the liquid monomer is substantially different.

4. The bone cement composition of claim 1, wherein the non-liquid component is configured to provide first, second and third time intervals in which exposure of the initiator to the liquid monomer is substantially different.

5. The bone cement composition of claim 1, wherein the non-liquid component is configured to provide an initial time interval in which exposure of the initiator to the liquid monomer is substantially higher than a subsequent time interval.

6. The bone cement composition of claim 1, wherein the initiator is distributed within the polymer component so as to selectively be exposed to the liquid monomer component over at least a first and a second selected time intervals.

7. The bone cement composition of claim 2, wherein a greater volume of initiator is exposed to the liquid monomer during a first time interval than a second time interval.

8. The method bone cement composition of claim 2, wherein a greater volume of initiator is exposed to the liquid monomer during a third time interval than a second time interval.

9. The bone cement composition of claim 2, wherein the first time interval comprises at least 1 minute.

10. The bone cement composition of claim 2, wherein the first time interval comprises less than 5 minutes.

11. The bone cement composition of claim 1, wherein the initiator is benzoyl peroxide (BPO).

12. The bone cement composition of claim 1, wherein the monomer comprises methyl methacrylate (MMA) and the polymer comprises polymethyl methacrylate (PMMA).

13. The bone cement composition of claim 1, wherein the non-liquid component comprises particles of benzoyl peroxide (BPO) integrated into the polymer particles.

14. The bone cement composition of claim 1, wherein the bone cement composition exhibits a viscosity of at least 500 Pa·

s within about 30-90 sec after the liquid and non-liquid components are substantially mixed with one another.

15. The bone cement composition of claim 1, wherein the initiator comprises benzoyl peroxide (BPO).

16. The bone cement composition of claim 15, wherein the total concentration of BPO contained within the first and second volumes of polymer particles ranges between about 0.5 to 5 wt. %, on the basis of the total weight of the polymer component.

17. The bone cement composition of claim 1, wherein the molecular weight of the first volume of polymer particles is within the range between about 300,000 to about 500,000.

18. The bone cement composition of claim 1, wherein the amount of the first volume of polymer particles is within the range between about 30 wt. % to about 40 wt. % on the basis of the total weight of the polymer particles.

19. The bone cement composition of claim 1, wherein the mean diameter of particles in the first volume of polymer particles is within the range between about 70 μ

m to about 90 μ

m.

20. The bone cement composition of claim 1, wherein the molecular weight of the second volume of polymer particles is within the range between about 150,000 to about 350,000.

21. The bone cement composition of claim 1, wherein the amount of the second volume of polymer particles is within the range between about 40 wt. % to about 50 wt. % on the basis of the total weight of the polymer particles.

22. The bone cement composition of claim 1, wherein the mean diameter of particles in the second volume of polymer particles is within the range between about 100 μ

m to about 120 μ

m.

23. The bone cement composition of claim 1, wherein the molecular weight of the third volume of polymer particles is within the range between about 250,000 to about 450,000.

24. The bone cement composition of claim 1, wherein the mean diameter of particles in the third volume of polymer particles is within the range between about 25 μ

m to about 45 μ

m.

25. The bone cement composition of claim 1, wherein the non-liquid component further comprises zirconium dioxide or barium sulfate.

26. The bone cement composition of claim 1, wherein the liquid component comprises:

about 98.0 wt. % to about 99.9 wt. % methylmethacrylate (MMA);

about 0.15 wt. % to about 0.95 wt. % N, N-dimethyl-p-toluidine (DMPT); and

about 30 ppm to about 150 ppm hydroquinone (HQ);

wherein the amounts of the liquid components are on the basis of the total weight of the liquid component.

27. The bone cement composition of claim 15, wherein the molecular weight of the first volume of polymer particles is within the range between about 300,000 to about 500,000.

28. The bone cement composition of claim 15, wherein the amount of the first volume of polymer particles is within the range between about 30 wt. % to about 40 wt. % on the basis of the total weight of the polymer particles.

29. The bone cement composition of claim 15, wherein the mean diameter of particles in the first volume of polymer particles is within the range between about 70 μ

m to about 90 μ

m.

30. The bone cement composition of claim 15, wherein the molecular weight of the second volume of polymer particles is within the range between about 150,000 to about 350,000.

31. The bone cement composition of claim 15, wherein the amount of the second volume of polymer particles is within the range between about 40 wt. % to about 50 wt. % on the basis of the total weight of the polymer particles.

32. The bone cement composition of claim 15, wherein the mean diameter of particles in the second volume of polymer particles is within the range between about 100 μ

m to about 120 μ

m.

33. The bone cement composition of claim 15, wherein the molecular weight of the third volume of polymer particles is within the range between about 250,000 to about 450,000.

34. The bone cement composition of claim 15, wherein the mean diameter of particles in the third volume of polymer particles is within the range between about 25 μ

m to about 45 μ

m.

35. The bone cement composition of claim 15, wherein the non-liquid component further comprises zirconium dioxide or barium sulfate.

36. The bone cement composition of claim 15, wherein the liquid component comprises:

about 98.0 wt. % to about 99.9 wt. % methylmethacrylate (MMA);

about 0.15 wt. % to about 0.95 wt. % N, N-dimethyl-p-toluidine (DMPT); and

about 30 ppm to about 150 ppm hydroquinone (HQ);

wherein the amounts of the liquid components are on the basis of the total weight of the liquid component.

37. The bone cement composition of claim 1, wherein:

the first volume of polymer particles has a mean diameter in the range of 70-90 μ

m;

the second volume of polymer particles has a mean diameter in the range of 100-120 μ

m; and

the third volume of polymer particles has a mean diameter in the range of 25-45 μ

m.

38. The bone cement composition of claim 1, wherein

1.1-1.3 wt. % of the initiator is contained within the first volume of polymer particles;

0.9-1.1 wt. % of the initiator is contained within the second volume of polymer particles; and

0-1.1 wt. % of the initiator is contained within the third volume of polymer particles.

39. The bone cement composition of claim 1, wherein:

the first volume of polymer particles possesses a molecular weight within the range between 300,000 to 500,000;

the second volume of polymer particles possesses a molecular weight within the range between 150,000 to 350,000; and

the third volume of polymer particles possesses a molecular weight within the range between 250,000 to 450,000.

40. The bone cement composition of claim 1, wherein:

the first volume of particles is 30-40% of the polymer particles on the basis of the total weight of the polymer particles;

the second volume of particles is 40-50% of the polymer particles on the basis of the total weight of the polymer particles; and

the third volume of particles is 10-30% of the polymer particles on the basis of the total weight of the polymer particles.