Composites and methods for treating bone

• US 20060095138A1
• Filed: 06/09/2005
• Published: 05/04/2006
• Est. Priority Date: 06/09/2004
• 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
• Application Number:
  US11/148,973
• Publication Number:
  US 20060095138A1
• Time in Patent Office: Days
• US Class Current: 623/23.62
• CPC Class Codes: A61B 17/68 Internal fixation devices , including fasteners and spinal fixators, even if a part thereof projects from the skin bone staples A61B17/0642
• CPC Class Codes: A61B 17/686 Plugs, i.e. elements forming interface between bone hole and implant or fastener, e.g. screw
• CPC Class Codes: A61B 17/7095 the filler comprising unlinked macroscopic particles
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/3662 Femoral shafts
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30006 differing in density or specific weight
• CPC Class Codes: A61F 2002/30011 differing in porosity
• CPC Class Codes: A61F 2002/30023 differing in viscosity
• CPC Class Codes: A61F 2002/30069 elastomeric
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/3085 with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
• CPC Class Codes: A61F 2002/30957 using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/30971 : Laminates, i.e. layered products
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2250/0015 : differing in density or specific weight
• CPC Class Codes: A61F 2250/0018 : differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0023 : differing in porosity
• CPC Class Codes: A61F 2250/0034 : differing in viscosity
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00353 : Bone cement, e.g. polymethylmethacrylate or PMMA
• CPC Class Codes: A61L 2430/02 : for reconstruction of bones; weight-bearing implants
• 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

Abstract

A system and method for treating bone abnormalities including vertebral compression fractures and the like. In one vertebroplasty method, a fill material is injected under high pressures into cancellous bone wherein the fill material includes a flowable bone cement component and an elastomeric polymer component that is carried therein. The elastomer component can further carry microscale or mesoscale reticulated elements. Under suitable injection pressures, the elastomeric component ultimately migrates within the flowable material to alter the apparent viscosity across the plume of fill material to accomplish multiple functions. For example, the differential in apparent viscosity across the fill material creates a broad load-distributing layer within cancellous bone for applying retraction forces to cortical bone endplates. The differential in apparent viscosity also transitions into a flow impermeable layer at the interface of cancellous bone and the flowable material to prevent extravasion of the flowable bone cement component.

Claims

1-31. -31. (canceled)

32. A method of treating mammalian bone, comprising introducing a flowable media under pressure into cancellous bone, the media including a volume of elastomeric elements wherein the elastomeric elements cause differential apparent viscosity within regions of the flowable media.

33. The method of claim 32 wherein the elastomeric elements cause surface regions of the flowable media to have substantially higher apparent viscosity than interior regions thereof.

34. The method of claim 32 wherein the elastomeric elements cause surface regions of the flowable media to be substantially less permeable to flows therethrough.

35. The method of claim 32 wherein introducing the flowable media applies expansion forces to the bone substantially without extravasation.

36. The method of claim 32 wherein introducing the flowable media expands the cancellous bone.

37. The method of claim 32 wherein introducing the flowable media includes introducing a hardenable cement.

38. The method of claim 37 including permitting the cement to harden thereby providing support to the cortical bone about the cancellous bone.

39. The method of claim 32 wherein introducing the flowable media reduces a fracture.

40. The method of claim 32 wherein introducing the flowable media moves cortical bone.

41. The method of claim 32 wherein introducing the flowable media increases height of a fractured vertebra.

42. The method of claim 32 further including the step of applying energy to the elastomeric elements to heat the flowable media.

43. The method of claim 42 wherein applying energy is carried out by at least one of a radiofrequency energy source and a light energy source.

44. A method of treating mammalian bone, comprising flowing a volume of flowable composite media into cancellous bone and transforming the surface regions of the flowable composite media to a substantially flow impermeable form while introducing additional flowable media into the interior of volume.

45. The method of claim 44 wherein transforming the surface regions to a substantially flow impermeable form includes causing the aggregation of elastomeric elements in said surface regions.

46. The method of claim 44 wherein transforming the surface regions to a substantially flow impermeable form includes causing the expansion of shape memory polymer elements.

47. The method of claim 44 wherein transforming the surface regions to a substantially flow impermeable form includes delivering energy to said surface regions from a remote energy source.

48. The method of claim 44 wherein flowing the volume of composite media expands cancellous bone.

49. The method of claim 44 wherein flowing the volume of composite media moves cortical bone.

50. A method of treating mammalian bone, comprising:

introducing a volume of elastomeric elements into the interior of a bone; and

introducing a flowable media within the volume of elastomeric elements, wherein the elastomeric elements aggregate in outward regions of a plume of the flowable media to cause said outward regions to be substantially flow-impermeable.