BONE TREATMENT SYSTEMS AND METHODS

• US 20080188858A1
• Filed: 02/01/2008
• Published: 08/07/2008
• Est. Priority Date: 02/05/2007
• Status: Abandoned Application

• Current Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Original Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Inventors: Shadduck, John H., Truckai, Csaba, Luzzi, Robert
• Application Number:
  US12/024,969
• Publication Number:
  US 20080188858A1
• Time in Patent Office: Days
• US Class Current: 606/94
• 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 17/8836 for heating, cooling or curing of bone cement or fluid fillers
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00088 using thermistors
• CPC Class Codes: A61B 2017/00101 using an array of thermosensors
• 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 24/06 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 27/46 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

Bone cement formulations are provided that have an extended working time for use in vertebroplasty procedures and other osteoplasty procedures. In one embodiment, a settable bone cement includes a polymerizable composition with a powder component comprising an X-Ray contrast medium and a liquid component, wherein the setting time of the cement is at least about 25 minutes, at least about 30 minutes, at least about 35 minutes, and at least about 40 minutes.

Claims

1. A settable bone cement, comprising:

a polymerizable composition comprising;

a powder component comprising an X-Ray contrast medium and;

a liquid component;

wherein the cement has a setting time of about 25 minutes or more.

2. A bone cement according to claim 1, wherein the powder component further comprises polymethyl methacrylate (PMMA) that is about 64% to 75% by weight based on overall weight of the powder component.

3. A bone cement according to claim 1, wherein the amount of X-ray contrast medium is about 27% to 32% by weight based on overall weight of the powder component.

4. A bone cement according to claim 1, wherein the X-ray contrast medium is selected from the group consisting of barium sulfate (BaSO₄) and zirconium dioxide (ZrO₂).

5. A bone cement according to claim 1, further including benzoyl peroxide (BPO) that is about 0.4% to 0.8% by weight based on overall weight of the powder component.

6. A bone cement according to claim 1, wherein the liquid component comprises methyl methacrylate (MMA) that is greater than about 99% by weight based on overall weight of the liquid component.

7. A bone cement according to claim 1, wherein the liquid component comprises N,N-dimethyl-p-toluidine (DMPT) that is less than about 1% by weight based on overall weight of the liquid component.

8. A bone cement according to claim 1, wherein the liquid component includes hydroquinone that ranges between about 30 and 120 ppm of the liquid component.

9. A bone cement according to claim 1, wherein the liquid weight/powder weight ratio is equal to or greater than about 0.4.

10. A bone cement according to claim 1, wherein the PMMA comprises particles having a mean diameter ranging from about 25 microns to 200 microns.

11. A bone cement according to claim 1, wherein the PMMA comprises particles having a mean diameter ranging from about 50 microns to 100 microns.

12. A bone cement according to claim 1, further comprising a filler selected from at least one of chromophores, ferromagnetic materials, a fluid that thermally responds to microwaves, a bone ingrowth accelerator, a bioactive agent, and a thermally insulating solid.

13. A settable bone cement comprising:

a powder component comprising polymethyl methacrylate (PMMA) and;

a liquid component;

wherein the bone cement provides a setting time of at least 25 minutes.

14. A settable bone cement as in claim 13, wherein the bone cement provides a setting time of at least 30 minutes.

15. A settable bone cement as in claim 13, wherein the bone cement provides a setting time of at least 35 minutes.

16. A settable bone cement as in claim 13, wherein the bone cement provides a setting time of at least 40 minutes.

17. A bone cement comprising:

a powder component comprising;

about 64 to 75 wt. % PMMA;

about 27 to 32 wt. % of an X-ray contrast medium; and

about 0.4 to 0.8 wt. % benzoyl peroxide (BPO);

wherein the amount of each is on the basis of the total weight of the powder component; and

a liquid component comprising;

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

less than about 1 wt. % N,N-dimethyl-p-toluidine (DMPT), about 30 to 120 ppm hydroquinone;

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

18. The bone cement according to claim 17, wherein the ratio of the weight of the liquid component to the weight of the powder component is equal to or greater than about 0.4.

19. A bone cement according to claim 17, further comprising a filler selected from at least one of chromophores, ferromagnetic materials, a fluid that thermally responds to microwaves, a bone ingrowth accelerator, a bioactive agent, and a thermally insulating solid.

20. A method for injecting a bone cement to treat an abnormality in a bone, comprising:

providing a bone cement having a setting time of about 25 minutes or more;

injecting said bone cement into a vertebra of a patient using a bone cement injector system; and

applying energy to the bone cement from an energy emitter in the injector system to thereby increase the viscosity of the bone cement and accelerate said setting time.

21. The method as in claim 20, wherein the bone cement comprises:

a powder component comprising;

about 64 to 75 wt. % PMMA;

about 27 to 32 wt. % of an X-ray contrast medium; and

about 0.4 to 0.8 wt. % benzoyl peroxide (BPO);

wherein the amount of each is on the basis of the total weight of the powder component; and

a liquid component comprising;

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

less than about 1 wt. % N,N-dimethyl-p-toluidine (DMPT), about 30 to 120 ppm hydroquinone;

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

22. The method of claim 20, wherein the energy emitter comprises a thermal energy emitter configured to deliver thermal energy to the bone cement.

23. The method of claim 22, wherein the thermal energy emitter comprises at least one of a resistive heating element, an Rf emitter, a light energy emitter, an inductive heating emitter, an ultrasound emitter, and a microwave emitter.

24. The method of claim 20, wherein the X-ray contrast medium is selected from the group consisting of barium sulfate (BaSO₄) and zirconium dioxide (ZrO₂).

25. The method of claim 20, wherein the liquid weight/powder weight ratio is equal to or greater than about 0.4.

26. The method of claim 20, further comprising providing a bone cement having a setting time of at least 30 minutes.

27. The method of claim 20, further comprising providing a bone cement having a setting time of at least 35 minutes.

28. The method of claim 20, further comprising providing a bone cement having a setting time of at least 40 minutes.

29. A method for anchoring an implant member in a bone with a bone cement, comprising:

positioning an implant member in a bone of a patient;

injecting a bone cement within the region of the bone-implant interface with an injector system, wherein said bone cement has a setting time of about 25 minutes or more; and

applying energy to the bone cement from the injector system to thereby increase the viscosity of the bone cement and accelerate said setting time.

30. The method as in claim 29, wherein the bone cement comprises:

a powder component comprising;

about 64 to 75 wt. % PMMA;

about 27 to 32 wt. % of an X-ray contrast medium; and

about 0.4 to 0.8 wt. % benzoyl peroxide (BPO);

wherein the amount of each is on the basis of the total weight of the powder component; and

a liquid component comprising;

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

less than about 1 wt. % N,N-dimethyl-p-toluidine (DMPT), about 30 to 120 ppm hydroquinone;

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

31. The method as in claim 29, wherein the implant member comprises at least one of anchors, screws, plates, supports, ports, rods and a prosthesis.

32. A bone cement kit comprising:

a bone cement, comprising a powder component, comprising polymethyl methacrylate (PMMA), and a liquid component, wherein the bone cement provides a setting time of about 25 minutes or more; and

a bone cement injector system configured to apply energy to the bone cement to thereby increase the viscosity of the bone cement and accelerate said setting time of said bone cement.

33. A bone cement kit according to claim 32, wherein the bone cement injector system includes a positive temperature coefficient of resistance (PTCR) material operatively coupled to a voltage source.

34. A bone cement kit according to claim 32, wherein the bone cement injector system is operatively coupled to at least one energy source comprising an electromagnetic energy source, a radiofrequency source, a resistive heating source, a coherent light source, a non-coherent light source, a microwave source, a magnetic source, and an ultrasound source.