Bone treatment systems and methods

• US 9,445,854 B2
• Filed: 02/27/2009
• Issued: 09/20/2016
• 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): PEPITONE, MICHAEL F
• Application Number:
  US12/395,527
• Publication Number:
  US 20100016467A1
• Time in Patent Office: 2,762 Days
• Field of Search: 523/116
• US Class Current: 1/1
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• 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 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61L 24/0084 containing fillers of phosphorus-containing inorganic compounds, e.g. apatite
• CPC Class Codes: A61L 24/02 containing inorganic materials
• CPC Class Codes: A61L 24/043 Mixtures of macromolecular materials
• 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 system, comprising:

a pre-mixture comprising;

a first monomer-carrying component; and

a second polymer-carrying component, separate from the first monomer-carrying component, the second polymer-carrying component comprising a plurality of bead populations that have different mean particle sizes and an initiator in different amounts, the second polymer-carrying component comprising;

a first polymer bead population having a first mean particle size and including the initiator at a first weight percent of the first polymer bead population, wherein the initiator is integrated throughout the volume of each of the first polymer beads;

a second polymer bead population having a second mean particle size smaller than the first mean particle size and including the initiator at a second weight percent of the second polymer bead population that is higher than the first weight percent, wherein the initiator is integrated throughout the volume of each of the second polymer; and

a third polymer bead population having a third mean particle size smaller than the second mean particle size and including an initiator at a third weight percent of the third polymer bead population that is lower than the first weight percent,

wherein upon forming a mixture of the first monomer-carrying component and the second polymer-carrying component, different dissolution rates and the different initiator amounts of the plurality of bead populations control an availability of the initiator in the mixture that is sufficiently low and slow-varying over time, such that the temperature of the mixture remains below 75°

C. and, after an initial exposure period post-mixing, a time-viscosity curve slope remains less than or equal to about 200 Pa·

s/minute until the mixture reaches a viscosity of about 2500 Pa·

s.

2. The bone cement system of claim 1, wherein post-mixing the mixture is characterized as having a time-viscosity curve slope of less than or equal to about 200 Pa·

s/minute for at least 5 minutes after reaching a viscosity of about 500 Pa·

s.

3. The bone cement system of claim 1, wherein after the initial exposure period post-mixing, the time-viscosity curve slope remains less than or equal to about 200 Pa·

s/minute until the mixture reaches a viscosity of about 3000 Pa·

s.

4. The bone cement system of claim 1, wherein after the initial exposure period post-mixing, the mixture has a viscosity of greater than or equal to about 2000 Pa·

s at about 18 minutes post-mixing and substantially before the set time of the cement.

5. The bone cement system of claim 1, wherein after the initial exposure period post-mixing, the mixture is characterized by a change of viscosity of less than or equal to about 30%/minute for at least three minutes after reaching about 1000 Pa·

s.

6. The bone cement system of claim 5, wherein after the initial exposure period post-mixing, the mixture is characterized by a change of viscosity of less than or equal to about 30%/minute for at least about five minutes after reaching about 1000 Pa·

s.

7. The bone cement system of claim 6, wherein after the initial exposure period post-mixing, the mixture is characterized by a change of viscosity of less than or equal to about 30%/minute for at least about five minutes after reaching about 4000 Pa·

s.

21. The bone cement system of claim 1, wherein after the initial exposure period post-mixing, the viscosity of the mixture increases substantially linearly until the mixture reaches the viscosity of about 2000 Pa·

s.

22. The bone cement system of claim 1, wherein a total amount of the initiator in the second polymer-carrying component is between about 0.30% and about 0.80% of the second polymer-carrying component by weight.

23. The bone cement system of claim 22, wherein the availability of the initiator remains between about 0.004 g/ml/min and about 0.04 g/ml/min for at least 6 minutes after the initial exposure period.

24. The bone cement system of claim 1, wherein the temperature remains below about 50°

C.

25. The bone cement system of claim 1, wherein the first monomer-carrying component comprises methylmethacrylate (MMA) in an amount between about 98.0% and about 99.9% by weight and further comprises N,N-dimethyl-p-toluidine (DPMT) in an amount between about 0.15% and about 0.95% by weight.

26. The bone cement system of claim 1, wherein a total amount of polymer chains in the plurality of bead populations is between about 64% and about 75% of the second polymer-carrying component by weight, and wherein the second polymer-carrying component further comprises an X-ray contrast medium comprising barium sulfate in an amount between about 25% and about 35% of the second polymer-carrying component by weight.

27. The bone cement system of claim 1, wherein a total amount of polymer chains in the plurality of bead populations is between about 45% and about 55% of the second polymer-carrying component by weight, and wherein the second polymer-carrying component further comprises an X-ray contrast medium comprising zirconium oxide in an amount between about 45% and about 55% of the second polymer-carrying component by weight.

28. The bone cement system of claim 1, wherein a first amount of the first polymer bead population is between about 40% and about 50% of a total weight of the plurality of bead populations, wherein a second amount of the second polymer bead population is between about 30% and about 40% of the total weight of the plurality of bead populations, and wherein a third amount of the third polymer bead population is a remainder of the total weight of the plurality of bead populations.

8. A bone cement system, comprising:

a pre-mixture comprising;

a first monomer-carrying component; and

a second polymer-carrying component, separate from the first monomer-carrying component, the second polymer-carrying component comprising a plurality of bead populations that have different mean particle sizes and an initiator in different amounts, the second polymer-carrying component comprising;

a first polymer bead population having a first mean particle size and including the initiator at a first weight percent of the first polymer bead population, wherein the initiator is integrated throughout the volume of each of the first polymer beads;

a second polymer bead population having a second mean particle size smaller than the first mean particle size and including the initiator at a second weight percent of the second polymer bead population that is higher than the first weight percent, wherein the initiator is integrated throughout the volume of each of the second polymer; and

a third polymer bead population having a third mean particle size smaller than the second mean particle size and including an initiator at a third weight percent of the third polymer bead population that is lower than the first weight percent,

wherein upon forming a mixture of the first monomer-carrying component and the second polymer-carrying component, different dissolution rates and the different initiator amounts of the plurality of bead populations control an availability of the initiator in the mixture that is sufficiently low and slow-varying over time, such that the temperature of the mixture remains below 75°

C. and a time-viscosity curve slope remains less than or equal to about 200 Pa·

s/minute immediately before the mixture reaches a viscosity of about 2000 Pa·

s.

9. The bone cement system of claim 8, wherein the time-viscosity curve slope is less than or equal to about 100 Pa·

s/minute before the mixture reaches a viscosity of about 1500 Pa·

s.

10. The bone cement system of claim 8, wherein the time-viscosity curve slope is less than or equal to about 200 Pa·

s/minute immediately before the mixture reaches a viscosity of about 1000 Pa·

s.

11. A bone cement system, comprising:

a pre-mixture comprising;

a first monomer-carrying component; and

a second polymer-carrying component, separate from the first monomer-carrying component, the second polymer-carrying component comprising a plurality of bead populations that have different mean particle sizes and an initiator in different amounts, the second polymer-carrying component comprising;

a first polymer bead population having a first mean particle size and including the initiator at a first weight percent of the first polymer bead population, wherein the initiator is integrated throughout the volume of each of the first polymer beads;

a second polymer bead population having a second mean particle size smaller than the first mean particle size and including the initiator at a second weight percent of the second polymer bead population that is higher than the first weight percent, wherein the initiator is integrated throughout the volume of each of the second polymer; and

a third polymer bead population having a third mean particle size smaller than the second mean particle size and including an initiator at a third weight percent of the third polymer bead population that is lower than the first weight percent,

wherein upon forming a mixture of the first monomer-carrying component and the second polymer-carrying component, different dissolution rates and the different initiator amounts of the plurality of bead populations control an availability of the initiator in the mixture that is sufficiently low and slow-varying over time, such that the temperature of the mixture remains below 75°

C. and, after an initial exposure period post-mixing, a time-viscosity curve slope remains less than or equal to about 200 Pa·

s/minute at about 25 minutes.

12. The bone cement system of claim 11, wherein after the initial exposure period post-mixing, the time-viscosity curve slope remains less than about 200 Pa·

s/minute for at least about 5 minutes after reaching a viscosity of about 500 Pa·

s.

13. The bone cement system of claim 11, wherein after the initial exposure period post-mixing, the mixture has a viscosity less than about 200 Pa·

s at about 15 minutes post-mixing.

14. The bone cement system of claim 11, wherein after the initial exposure period post-mixing, the time-viscosity curve slope remains less than about 200 Pa·

s/minute for at least about 25 minutes.

15. The bone cement system of claim 11, wherein after the initial exposure period post-mixing, the time-viscosity curve slope remains less than about 100 Pa·

s/minute for at least about 20 minutes.

16. The bone cement system of claim 11, wherein after the initial exposure period post-mixing, the time-viscosity curve has a rate of change of less than about 40% over an interval of at least about 20 minutes.

17. The bone cement system of claim 11, wherein the mixture is characterized by a post-mixing interval in which viscosity is between about 500 Pa·

s and about 5000 Pa·

s, and in which the change of viscosity of less than about 30%/minute within the interval.

18. The bone cement system of claim 11, wherein after the initial exposure period post-mixing, the mixture is characterized by a change of viscosity of less than or equal to about 30%/minute for at least about three minutes after reaching about 1500 Pa·

s.

19. The bone cement system of claim 11, wherein after the initial exposure period post-mixing, the mixture is characterized by a change of viscosity of less than or equal to about 30%/minute for at least about five minutes after reaching about 1000 Pa·

s.

20. The bone cement system of claim 11, wherein after the initial exposure period post-mixing, the mixture is characterized by a rate of change of viscosity of less than or equal to about 50%/minute after reaching a viscosity of about 3000 Pa·

s.