Bone treatment systems and methods

• US 9,821,085 B2
• Filed: 11/12/2015
• Issued: 11/21/2017
• Est. Priority Date: 02/28/2008
• 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:
  US14/939,804
• Publication Number:
  US 20160058906A1
• Time in Patent Office: 740 Days
• Field of Search: 523116, 523211, 525265
• 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 configured to provide a controlled viscosity, comprising:

a liquid component comprising a monomer; and

a non-liquid component comprising first polymer beads having a first average cross-sectional dimension and comprising a radical initiator at a first amount, and second polymer beads having a second average cross-sectional dimension greater than the first average cross-sectional dimension and comprising the radical initiator at a second amount lower than the first amount.

2. The bone cement composition of claim 1, wherein the initiator is dispersed throughout each of the first polymer beads and the second polymer beads.

3. The bone cement composition of claim 1, wherein the first average cross-sectional dimension is less than 100 microns, and the second average cross-sectional dimension is greater than 100 microns.

4. The bone cement composition of claim 1, wherein the first polymer beads and the second polymer beads comprise polymethyl methacrylate polymer (PMMA).

5. The bone cement composition of claim 4, wherein the non-liquid component comprises less than 75 wt % PMMA on the basis of a total weight of the non-liquid component.

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

7. The bone cement composition of claim 6, wherein the non-liquid component has a mean BPO concentration between 0.3 wt. % and 0.6 wt. % on the basis of the a total weight of the non-liquid component.

8. The bone cement composition of claim 6, wherein the first polymer beads have greater than 0.5 wt. % of BPO on the basis of a total weight of the non-liquid component.

9. The bone cement composition of claim 1, wherein the non-liquid component further comprises third polymer beads having a third average cross-sectional dimension smaller than each of the first and second average cross-sectional dimensions, and wherein the third polymer beads comprise the initiator at a third amount lower than each of the first amount and the second amount.

10. A bone cement composition, comprising:

a liquid component comprising a monomer; and

a non-liquid component comprising a plurality of polymer bead populations having different dissolution rates and different amounts of an initiator, wherein one of the polymer bead populations has a lower dissolution rate and a higher amount of the initiator compared to another one of the polymer bead populations, such that upon forming a mixture with the liquid component, an initiator availability in the mixture increases relatively rapidly during a first time interval and thereafter stays relatively constant during a second time interval compared to the first time interval.

11. The bone cement composition of claim 10, wherein the second time interval is longer than the first time interval and exceeds 2 minutes.

12. The bone cement composition of claim 10, wherein the liquid component further comprises an activator at a sufficient concentration, and wherein the initiator availability is such that, post-mixing, the mixture has a setting time greater than 25 minutes.

13. The bone cement composition of claim 12, wherein during the second time interval, the initiator availability is between 0.004 g/ml/min and 0.04 g/ml/min.

14. The bone cement composition of claim 12, wherein the liquid component comprises an activator at a concentration less than about 1% based on an overall weight of the liquid component.

15. The bone cement kit package of claim 12, wherein the initiator comprises benzoyl peroxide (BPO) and the activator comprises N,N-dimethyl-p-toluidine (DMPT).

16. The bone cement composition of claim 12, wherein the liquid component comprises:

greater than 99 wt. % methyl methacrylate (MMA);

less than 1 wt. % N, N-dimethyl-p-toluidine (DMPT); and

30 to 120 ppm hydroquinone (HQ),

wherein the amount of each component is on the basis of a total amount of the liquid component.

17. A method of providing a bone cement mixture having a controlled viscosity, the method comprising:

mixing a liquid component comprising a monomer and a non-liquid component comprising at plurality of polymer bead populations having different dissolution rates and different amounts of an initiator, wherein mixing dissolves one of the polymer bead populations having a higher amount of an initiator at a faster rate compared to a dissolution rate another one of the polymer bead populations having a lower amount of the initiator, such that an initiator availability in the mixture initially increases relatively rapidly during a first time interval, followed by a second time interval during which the initiator availability stays substantially constant relative to the first time interval.

18. The method of claim 17, wherein the liquid component further comprises an activator at a sufficient concentration, and wherein the initiator availability is such that, post-mixing, the mixture has a setting time greater than 25 minutes.

19. The method of claim 17, wherein during the second interval, 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 1500 Pa·

s.

20. The method of claim 17, wherein during the second interval, a time-viscosity curve slope remains less than or equal to about 200 Pa·

s at about 15 minutes post-mixing.