Inflatable device for use in surgical protocol relating to fixation of bone

• US 20040153115A1
• Filed: 12/29/2003
• Published: 08/05/2004
• Est. Priority Date: 01/26/1994
• Status: Abandoned Application

• Current Assignee: Orthophoenix, LLC (Marathon Patent Group, Inc.)
• Original Assignee: Kyphon Incorporated (Medtronic Plc)
• Inventors: Scholten, Arie, Reiley, Mark A., Talmadge, Karen
• Application Number:
  US10/747,558
• Publication Number:
  US 20040153115A1
• Time in Patent Office: Days
• US Class Current: 606/192
• CPC Class Codes: A61B 10/025 for taking bone, bone marrow or cartilage samples
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61B 17/7258 with laterally expanding parts, e.g. for gripping the bone
• CPC Class Codes: A61B 17/7275 with expanding cylindrical parts
• CPC Class Codes: A61B 17/742 having one or more longitudinal elements oriented along or parallel to the axis of the neck
• CPC Class Codes: A61B 17/744 the longitudinal elements coupled to an intramedullary nail
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 17/8866 for gripping or pushing bones, e.g. approximators joint distractors A61B17/025
• CPC Class Codes: A61B 2010/0258 Marrow samples
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00544 pneumatically
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2050/0065 Peelable cover
• CPC Class Codes: A61B 2050/3015 transparent
• CPC Class Codes: A61B 50/33 Trays
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61B 90/94 coded with symbols, e.g. text
• CPC Class Codes: A61F 2/28 : Bones joints A61F2/30
• CPC Class Codes: A61F 2/2846 : Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects nets or sleeves applied to surface of endoprostheses A61F2/30907; bone plates A61B17/80; bone regeneration in dental surgery A61C8/0006
• CPC Class Codes: A61F 2/3601 : for replacing only the epiphyseal or metaphyseal parts of the femur, e.g. endoprosthetic femoral heads or necks directly fixed to the natural femur by internal fixation devices non-prosthetic internal fixation devices for the femoral head or neck A61B17/74
• CPC Class Codes: A61F 2/389 : Tibial components A61F2/3868 takes precedence
• CPC Class Codes: A61F 2/44 : for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/441 : made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/4601 : for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4611 : of spinal prostheses
• 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 2002/2825 : Femur
• CPC Class Codes: A61F 2002/2828 : Femoral head
• CPC Class Codes: A61F 2002/2832 : Femoral neck
• 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 2002/2853 : Humerus
• CPC Class Codes: A61F 2002/2871 : Radius
• CPC Class Codes: A61F 2002/2892 : Tibia
• CPC Class Codes: A61F 2002/30113 : circular
• CPC Class Codes: A61F 2002/30115 : circular-O-shaped
• CPC Class Codes: A61F 2002/30125 : elliptical or oval
• CPC Class Codes: A61F 2002/30131 : horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30133 : kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/302 : toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30225 : Flat cylinders, i.e. discs
• CPC Class Codes: A61F 2002/30228 : Cylinders of elliptical or oval basis
• CPC Class Codes: A61F 2002/30242 : spherical
• CPC Class Codes: A61F 2002/30245 : Partial spheres
• CPC Class Codes: A61F 2002/30253 : ellipsoidal or ovoid
• CPC Class Codes: A61F 2002/30285 : rugby-ball-shaped
• CPC Class Codes: A61F 2002/30288 : bottle-shaped
• CPC Class Codes: A61F 2002/30308 : banana-shaped
• CPC Class Codes: A61F 2002/30313 : pear-shaped
• CPC Class Codes: A61F 2002/30448 : using adhesives
• CPC Class Codes: A61F 2002/30462 : retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/30535 : Special structural features of bone or joint prostheses not otherwise provided for
• CPC Class Codes: A61F 2002/30581 : having a pocket filled with fluid, e.g. liquid
• CPC Class Codes: A61F 2002/30586 : having two or more inflatable pockets or chambers
• CPC Class Codes: A61F 2002/30599 : stackable
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30686 : Devices for removing particulate debris from prosthetic joints
• CPC Class Codes: A61F 2002/30909 : Nets
• CPC Class Codes: A61F 2002/3611 : Heads or epiphyseal parts of femur
• CPC Class Codes: A61F 2002/3625 : Necks
• CPC Class Codes: A61F 2002/4062 : Proximal or metaphyseal parts of shafts
• CPC Class Codes: A61F 2002/4217 : Calcaneum or calcaneus or heel bone
• CPC Class Codes: A61F 2002/4627 : with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2002/4685 : by means of vacuum
• CPC Class Codes: A61F 2220/005 : using adhesives
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0008 : elliptical or oval
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0015 : Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2230/0063 : Three-dimensional shapes
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61F 2230/0076 : ellipsoidal or ovoid
• CPC Class Codes: A61F 2250/0058 : Additional features; Implant or prostheses properties not otherwise provided for
• CPC Class Codes: A61F 2250/0063 : Nested prosthetic parts
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00353 : Bone cement, e.g. polymethylmethacrylate or PMMA
• CPC Class Codes: A61F 2310/0097 : Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61M 2025/105 : having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1072 : having balloons with two or more compartments
• CPC Class Codes: A61M 2210/02 : Bones
• CPC Class Codes: A61M 2210/1003 : Spinal column
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: Y10S 606/91 : Polymer

Abstract

Systems for treating a bone, e.g. a vertebral body, having an interior volume occupied, at least in part, by cancellous bone provide a first tool, a second tool, and a third tool. The first tool establishes a percutaneous access path to bone. The second tool is sized and configured to be introduced through the percutaneous access path to form a void that occupies less than the interior volume. The third tool places within the void through the percutaneous access path a volume of filling material. Related methods for treating a bone, e.g. a vertebral body, having an interior volume occupied, at least in part, by cancellous bone provide establishing a percutaneous access path to bone. A tool is introduced through the percutaneous access path and manipulated to form a void that occupies less than the interior volume. A volume of filling material is then placed within the void through the percutaneous access path.

Claims

1. A system for treating a bone having an interior volume occupied, at least in part, by cancellous bone comprising

a first tool to establish a percutaneous access path to bone,

a second tool sized and configured to be introduced through the percutaneous access path to form a void that occupies less than the interior volume, and

a third tool to place within the void through the percutaneous access path a volume of filling material.

2. A system according to claim 1

wherein the second tool is sized and configured to form a void that occupies less than about 90% of the interior volume.

3. A system according to claim 1

wherein the second tool is sized and configured to form a void that occupies about 10% to about 90% of the interior volume.

4. A system according to claim 1

wherein the second tool is sized and configured to form a void that occupies about 40% to about 90% of the interior volume.

5. A system according to claim 1

wherein the second tool is sized and configured to form a void that occupies about 70% to about 90% of the interior volume.

61. A system according to claim 1 or 6 or 13 or 20 or 31 or 36 or 43 or 50

wherein the first tool comprises a cannula.

62. A system according to claim 1 or 6 or 13 or 20 or 31 or 36 or 43 or 50

wherein the second tool is carried by an elongate member sized and configured to pass through the percutaneous access path.

63. A system according to claim 62

wherein the elongate member comprises a catheter.

64. A system according to claim 1 or 6 or 13 or 20 or 31 or 36 or 43 or 50

wherein the second tool is sized and configured to compact cancellous bone.

65. A system according to claim 64

wherein the second tool is sized and configured to compact cancellous bone and form a shell about the void.

66. A system according to claim 1 or 6 or 13 or 20 or 31 or 36 or 43 or 50

wherein the second tool is sized and configured to lift fractured cortical bone.

67. A system according to claim 1 or 6 or 13 or 20 or 31 or 36 or 43 or 50

wherein the second tool is sized and configured to reduce a cortical bone fracture.

68. A system according to claim 1 or 6 or 13 or 20 or 31 or 36 or 43 or 50

wherein the second tool is sized and configured to move fractured cortical bone towards a natural anatomic position.

69. A system according to claim 1 or 6 or 13 or 20 or 31 or 36 or 43 or 50

wherein the second tool comprises an expandable body.

70. A system according to claim 69

wherein the expandable body is inflatable.

71. A system according to claim 69

wherein the expandable body comprises a balloon.

72. A system according to claim 69

wherein the expandable body, when expanded, assumes a non-spherical shape.

73. A system according to claim 69

wherein the expandable body is sized and configured to be removed from bone after formation of the void.

74. A system according to claim 1 or 6 or 13 or 20 or 31 or 36 or 43 or 50

wherein the filler material imparts compressive strength

6. A system for treating a bone having an interior volume with a maximum anterior-to-posterior dimension occupied, at least in part, by cancellous bone comprising

a first tool to establish a percutaneous access path to bone,

a second tool sized and configured to be introduced through the percutaneous access path to form a void having a dimension, measured in an anterior-to-posterior direction, that is less than the maximum anterior-to-posterior dimension of the interior volume, and

a third tool to place within the void through the percutaneous access path a volume of filling material.

7. A system according to claim 6

wherein the second tool is sized and configured to form a void having a dimension, measured in an anterior-to-posterior direction, that is at least about 5 mm less than the maximum anterior-to-posterior dimension of the interior volume.

8. A system according to claim 6

wherein the second tool is sized and configured to form a void having a dimension, measured in an anterior-to-posterior direction, that is about 5 mm to about 7 mm less than the maximum anterior-to-posterior dimension of the interior volume.

9. A system according to claim 6

wherein the second tool is sized and configured to form a void that occupies less than about 90% of the interior volume.

10. A system according to claim 6

wherein the second tool is sized and configured to form a void that occupies about 10% to about 90% of the interior volume.

11. A system according to claim 6

wherein the second tool is sized and configured to form a void that occupies about 40% to about 90% of the interior volume.

12. A system according to claim 6

wherein the second tool is sized and configured to form a void that occupies about 70% to about 90% of the interior volume.

13. A system for treating a bone having an interior volume with a maximum side-to-side dimension occupied, at least in part, by cancellous bone comprising

a first tool to establish a percutaneous access path to bone,

a second tool sized and configured to be introduced through the percutaneous access path to form a void having a dimension, measured in a side-to-side direction, that is less than the maximum side-to-side dimension of the interior volume, and

a third tool to place within the void through the percutaneous access path a volume of filling material.

14. A system according to claim 13

wherein the second tool is sized and configured to form a void having a dimension, measured in a side-to-side direction, that is at least about 5 mm less than the maximum side-to-side dimension of the interior volume.

15. A system according to claim 13

wherein the second tool is sized and configured to form a void having a dimension, measured in a side-to-side direction, that is about 5 mm to about 7 mm less than the maximum side-to-side dimension of the interior volume.

16. A system according to claim 13

wherein the second tool is sized and configured to form a void that occupies less than about 90% of the interior volume.

17. A system according to claim 13

wherein the second tool is sized and configured to form a void that occupies about 10% to about 90% of the interior volume.

18. A system according to claim 13

wherein the second tool is sized and configured to form a void that occupies about 40% to about 90% of the interior volume.

19. A system according to claim 13

wherein the second tool is sized and configured to form a void that occupies about 70% to about 90% of the interior volume.

20. A system for treating a bone having an interior volume with a maximum anterior-to-posterior dimension and a maximum side-to-side dimension occupied, at least in part, by cancellous bone comprising

a first tool to establish a percutaneous access path to bone,

a second tool sized and configured to be introduced through the percutaneous access path to form a void having a dimension, measured in an anterior-to-posterior direction, that is less than the maximum anterior-to-posterior dimension of the interior volume and a dimension, measured in a side-to-side direction, that is less than the maximum side-to-side dimension of the interior volume, and

a third tool to place within the void through the percutaneous access path a volume of filling material.

21. A system according to claim 20

wherein the second tool is sized and configured to form a void that occupies less than about 90% of the interior volume.

22. A system according to claim 20

wherein the second tool is sized and configured to form a void that occupies about 10% to about 90% of the interior volume.

23. A system according to claim 20

wherein the second tool is sized and configured to form a void that occupies about 40% to about 90% of the interior volume.

24. A system according to claim 20

wherein the second tool is sized and configured to form a void that occupies about 70% to about 90% of the interior volume.

25. A system according to claim 20

wherein the second tool is sized and configured to form a void having a dimension, measured in an anterior-to-posterior direction, that is at least about 5 mm less than the maximum anterior-to-posterior dimension of the interior volume.

26. A system according to claim 20

wherein the second tool is sized and configured to form a void having a dimension, measured in an anterior-to-posterior direction, that is about 5 mm to about 7 mm less than the maximum anterior-to-posterior dimension of the interior volume.

27. A system according to claim 25 or 26

wherein the second tool is sized and configured to form a void having a dimension, measured in a side-to-side direction, that is at least about 5 mm less than the maximum side-to-side dimension of the interior volume.

28. A system according to claim 25 or 26

wherein the second tool is sized and configured to form a void having a dimension, measured in a side-to-side direction, that is about 5 mm to about 7 mm less than the maximum side-to-side dimension of the interior volume.

29. A system according to claim 20

wherein the second tool is sized and configured to form a void having a dimension, measured in a side-to-side direction, that is at least about 5 mm less than the maximum side-to-side dimension of the interior volume.

30. A system according to claim 20

wherein the second tool is sized and configured to form a void having a dimension, measured in a side-to-side direction, that is about 5 mm to about 7 mm less than the maximum side-to-side dimension of the interior volume.

31. A system for treating a vertebral body having an interior volume occupied, at least in part, by cancellous bone comprising

a first tool to establish a percutaneous access path to the vertebral body,

a second tool sized and configured to be introduced through the percutaneous access path to form a void that occupies less than the interior volume, and

a third tool to place within the void through the percutaneous access path a volume of filling material.

32. A system according to claim 31

wherein the second tool is sized and configured to form a void that occupies less than about 90% of the interior volume.

33. A system according to claim 31

wherein the second tool is sized and configured to form a void that occupies about 10% to about 90% of the interior volume.

34. A system according to claim 31

wherein the second tool is sized and configured to form a void that occupies about 40% to about 90% of the interior volume.

35. A system according to claim 31

wherein the second tool is sized and configured to form a void that occupies about 70% to about 90% of the interior volume.

36. A system for treating a vertebral body having an interior volume with a maximum anterior-to-posterior dimension occupied, at least in part, by cancellous bone comprising

a first tool to establish a percutaneous access path to the vertebral body,

a second tool sized and configured to be introduced through the percutaneous access path to form a void having a dimension, measured in an anterior-to-posterior direction, that is less than the maximum anterior-to-posterior dimension of the interior volume, and

a third tool to place within the void through the percutaneous access path a volume of filling material.

37. A system according to claim 36

wherein the second tool is sized and configured to form a void having a dimension, measured in an anterior-to-posterior direction, that is at least about 5 mm less than the maximum anterior-to-posterior dimension of the interior volume.

38. A system according to claim 36

wherein the second tool is sized and configured to form a void having a dimension, measured in an anterior-to-posterior direction, that is about 5 mm to about 7 mm less than the maximum anterior-to-posterior dimension of the interior volume.

39. A system according to claim 36

wherein the second tool is sized and configured to form a void that occupies less than about 90% of the interior volume.

40. A system according to claim 36

wherein the second tool is sized and configured to form a void that occupies about 10% to about 90% of the interior volume.

41. A system according to claim 36

wherein the second tool is sized and configured to form a void that occupies about 40% to about 90% of the interior volume.

42. A system according to claim 36

wherein the second tool is sized and configured to form a void that occupies about 70% to about 90% of the interior volume.

43. A system for treating a vertebral body having an interior volume with a maximum side-to-side dimension occupied, at least in part, by cancellous bone comprising

a first tool to establish a percutaneous access path to the vertebral body,

a second tool sized and configured to be introduced through the percutaneous access path to form a void having a dimension, measured in a side-to-side direction, that is less than the maximum side-to-side dimension of the interior volume, and

a third tool to place within the void through the percutaneous access path a volume of filling material.

44. A system according to claim 43

wherein the second tool is sized and configured to form a void having a dimension, measured in a side-to-side direction, that is at least about 5 mm less than the maximum side-to-side dimension of the interior volume.

45. A system according to claim 43

wherein the second tool is sized and configured to form a void having a dimension, measured in a side-to-side direction, that is about 5 mm to about 7 mm less than the maximum side-to-side dimension of the interior volume.

46. A system according to claim 43

wherein the second tool is sized and configured to form a void that occupies less than about 90% of the interior volume.

47. A system according to claim 43

wherein the second tool is sized and configured to form a void that occupies about 10% to about 90% of the interior volume.

48. A system according to claim 43

wherein the second tool is sized and configured to form a void that occupies about 40% to about 90% of the interior volume.

49. A system according to claim 43

wherein the second tool is sized and configured to form a void that occupies about 70% to about 90% of the interior volume.

50. A system for treating a vertebral body having an interior volume with a maximum anterior-to-posterior dimension and a maximum side-to-side dimension occupied, at least in part, by cancellous bone comprising

a first tool to establish a percutaneous access path to the vertebral body,

a second tool sized and configured to be introduced through the percutaneous access path to form a void having a dimension, measured in an anterior-to-posterior direction, that is less than the maximum anterior-to-posterior dimension of the interior volume and a dimension, measured in a side-to-side direction, that is less than the maximum side-to-side dimension of the interior volume, and

a third tool to place within the void through the percutaneous access path a volume of filling material.

51. A system according to claim 50

wherein the second tool is sized and configured to form a void that occupies less than about 90% of the interior volume.

52. A system according to claim 50

wherein the second tool is sized and configured to form a void that occupies about 10% to about 90% of the interior volume.

53. A system according to claim 50

wherein the second tool is sized and configured to form a void that occupies about 40% to about 90% of the interior volume.

54. A system according to claim 50

wherein the second tool is sized and configured to form a void that occupies about 70% to about 90% of the interior volume.

55. A system according to claim 50

wherein the second tool is sized and configured to form a void having a dimension, measured in an anterior-to-posterior direction, that is at least about 5 mm less than the maximum anterior-to-posterior dimension of the interior volume.

56. A system according to claim 50

wherein the second tool is sized and configured to form a void having a dimension, measured in an anterior-to-posterior direction, that is about 5 mm to about 7 mm less than the maximum anterior-to-posterior dimension of the interior volume.

57. A system according to claim 55 or 56

wherein the second tool is sized and configured to form a void having a dimension, measured in a side-to-side direction, that is at least about 5 mm less than the maximum side-to-side dimension of the interior volume.

58. A system according to claim 55 or 56

wherein the second tool is sized and configured to form a void having a dimension, measured in a side-to-side direction, that is about 5 mm to about 7 mm less than the maximum side-to-side dimension of the interior volume.

59. A system according to claim 50

wherein the second tool is sized and configured to form a void having a dimension, measured in a side-to-side direction, that is at least about 5 mm less than the maximum side-to-side dimension of the interior volume.

60. A system according to claim 50

wherein the second tool is sized and configured to form a void having a dimension, measured in a side-to-side direction, that is about 5 mm to about 7 mm less than the maximum side-to-side dimension of the interior volume.