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

• US 6,663,647 B2
• Filed: 07/22/2002
• Issued: 12/16/2003
• Est. Priority Date: 01/26/1994
• Status: Expired due to Term

• Current Assignee: Orthophoenix, LLC (Marathon Patent Group, Inc.)
• Original Assignee: Kyphon Incorporated (Medtronic Plc)
• Inventors: Talmadge, Karen, Reiley, Mark A., Scholten, Arie
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US10/200,674
• Publication Number:
  US 20020183778A1
• Time in Patent Office: 512 Days
• Field of Search: 606/61, 606/192, 604/96.01, 600/207, 623/17.11, 623/17.12, 623/17.16
• 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

A balloon for use in compressing cancellous bone and marrow (also known as medullary bone or trabecular bone) against the inner cortex of bones whether the bones are fractured or not. The balloon comprises an inflatable, non-expandable balloon body for insertion into said bone. The body has a shape and size to compress at least a portion of the cancellous bone to form a cavity in the cancellous bone and to restore the original position of the outer cortical bone, if fractured or collapsed. The balloon is prevented from applying excessive pressure to the outer cortical bone. The wall or walls of the balloon are such that proper inflation the balloon body is achieved to provide for optimum compression of all the bone marrow. The balloon is able to be folded so that it can be inserted quickly into a bone. The balloon can be made to have a suction catheter. The main purpose of the balloon is the forming or enlarging of a cavity or passage in a bone, especially in, but not limited to, vertebral bodies.

Claims

1. A device for insertion into a vertebral body to apply a force capable of compacting cancellous bone and moving fractured cortical bone, the device including a catheter extending along an axis and having a distal end sized and configured for insertion through a cannula into the vertebral body, the catheter carrying near its distal end an inflatable body having a wall sized and configured for passage within the cannula into the vertebral body when the inflatable body is in a collapsed condition, the wall being further sized and configured to apply the force in response to expansion of the inflatable body within the vertebral body, the wall including, when inflated, opposed side surfaces and opposed superior and inferior surfaces extending along an elongated longitudinal axis that is substantially aligned with the axis of the catheter, the inflatable body, when inflated within the vertebral body, having a height measured between the superior and inferior surfaces of approximately 0.5 cm to 3.5 cm, an anterior to posterior dimension measured along the elongated axis of approximately 0.5 cm to 3.5 cm, and a side to side dimension measured between the opposed side surfaces of approximately 0.5 cm to 5.0 cm.

2. A device according to claim 1

wherein the side to side dimension is approximately 0.5 cm to 5.0 cm.

3. A device according to claim 1

wherein the inflatable body comprises a balloon.

4. A device according to claim 1

wherein the cannula is a percutaneous cannula.

5. A device according to claim 1

wherein the wall includes changes in wall thickness which restrain the opposed side surfaces from expanding beyond a substantially flat condition.

6. A device according to claim 1

wherein the wall includes an internal restraint which restrains the opposed side surfaces from expanding beyond a substantially flat condition.

7. A device according to claim 6

wherein the internal restraint includes mesh material.

8. A device according to claim 6

wherein the internal restraint includes string material.

9. A device according to claim 6

wherein the internal restraint includes woven material.

10. A device according to claim 6

wherein the internal restraint includes a seam.

11. A device according to claim 6

wherein the internal restraint includes an essentially non-elastic material.

12. A device according to claim 1

wherein the wall includes an external restraint which restrains the opposed side surfaces from expanding beyond a substantially flat condition.

13. A device according to claim 12

wherein the external restraint includes mesh material.

14. A device according to claim 12

wherein the external restraint includes string material.

15. A device according to claim 12

wherein the external restraint includes woven material.

16. A device according to claim 12

wherein the external restraint includes a seam.

17. A device according to claim 12

wherein the external restraint includes an essentially non-elastic material.

18. A device for insertion into a vertebral body to apply a force capable of compacting cancellous bone and moving fractured cortical bone, the device including a catheter extending along an axis and having a distal end sized and configured for insertion through a cannula into the vertebral body, the catheter carrying near its distal end an inflatable body having a wall sized and configured for passage within the cannula into the vertebral body when the inflatable body is in a collapsed condition, the wall being further sized and configured to apply the force in response to expansion of the inflatable body within the vertebral body, the wall including, when inflated, opposed superior and inferior surfaces extending along an elongated longitudinal axis that is substantially aligned with the axis of the catheter, the inflatable body, when inflated within the vertebral body, having a height measured between the superior and inferior surfaces of approximately 0.5 cm to 3.5 cm.

19. A device according to claim 18

wherein the inflatable body comprises a balloon.

20. A device according to claim 18

wherein the cannula is a percutaneous cannula.

21. A device according to claim 18

wherein the wall includes changes in wall thickness which restrain the opposed surfaces from expanding beyond a substantially flat condition.

22. A device according to claim 18

wherein the wall includes an internal restraint which restrains the opposed surfaces from expanding beyond a substantially flat condition.

23. A device according to claim 22

wherein the internal restraint includes mesh material.

24. A device according to claim 22

wherein the internal restraint includes string material.

25. A device according to claim 22

wherein the internal restraint includes woven material.

26. A device according to claim 22

wherein the internal restraint includes a seam.

27. A device according to claim 22

wherein the internal restraint includes an essentially non-elastic material.

28. A device according to claim 18

wherein the wall includes an external restraint which restrains the opposed surfaces from expanding beyond a substantially flat condition.

29. A device according to claim 28

wherein the external restraint includes mesh material.

30. A device according to claim 28

wherein the external restraint includes string material.

31. A device according to claim 28

wherein the external restraint includes woven material.

32. A device according to claim 28

wherein the external restraint includes a seam.

33. A device according to claim 28

wherein the external restraint includes an essentially non-elastic material.

34. A device according to claim 18

wherein the inflatable body has a side to side dimension of approximately 0.5 cm to 5.0 cm.

35. A device according to claim 34

wherein the side to side dimension is approximately 0.5 cm to 3.5 cm.

36. A device according to claim 18

wherein the inflatable body has an anterior to posterior dimension of approximately 0.5 cm to 3.5 cm.

37. A device for insertion into a vertebral body to apply a force capable of compacting cancellous bone and moving fractured cortical bone, the device including a catheter extending along an axis and having a distal end sized and configured for insertion through a cannula into the vertebral body, the catheter carrying near its distal end an inflatable body having a wall sized and configured for passage within the cannula into the vertebral body when the inflatable body is in a collapsed condition, the wall being further sized and configured to apply the force in response to expansion of the inflatable body within the vertebral body, the wall including, when inflated, opposed side surfaces extending along an elongated longitudinal axis that is substantially aligned with the axis of the catheter, the inflatable body, when inflated within the vertebral body, having an anterior to posterior dimension measured along the elongated axis of approximately 0.5 cm to 3.5 cm.

38. A device according to claim 37

wherein the inflatable body comprises a balloon.

39. A device according to claim 37

wherein the cannula is a percutaneous cannula.

40. A device according to claim 37

wherein the wall includes changes in wall thickness which restrain the opposed side surfaces from expanding beyond a substantially flat condition.

41. A device according to claim 37

wherein the wall includes an internal restraint which restrains the opposed side surfaces from expanding beyond a substantially flat condition.

42. A device according to claim 41

wherein the internal restraint includes mesh material.

43. A device according to claim 41

wherein the internal restraint includes string material.

44. A device according to claim 41

wherein the internal restraint includes woven material.

45. A device according to claim 41

wherein the internal restraint includes a seam.

46. A device according to claim 41

wherein the internal restraint includes an essentially non-elastic material.

47. A device according to claim 37

wherein the wall includes an external restraint which restrains the opposed side surfaces from expanding beyond a substantially flat condition.

48. A device according to claim 47

wherein the external restraint includes mesh material.

49. A device according to claim 47

wherein the external restraint includes string material.

50. A device according to claim 47

wherein the external restraint includes woven material.

51. A device according to claim 47

wherein the external restraint includes a seam.

52. A device according to claim 47

wherein the external restraint includes an essentially non-elastic material.

53. A device according to claim 37

wherein the inflatable body has a side to side dimension of approximately 0.5 cm to 5.0 cm.

54. A device according to claim 53

wherein the side to side dimension is approximately 0.5 cm to 3.5 cm.

55. A device according to claim 37

wherein the inflatable body has a height of approximately 0.5 cm to 3.5 cm.

56. A device for insertion into a vertebral body to apply a force capable of compacting cancellous bone and moving fractured cortical bone, the device including a catheter extending along an axis and having a distal end sized and configured for insertion through a cannula into the vertebral body, the catheter carrying near its distal end an inflatable body having a wall sized and configured for passage within the cannula into the vertebral body when the inflatable body is in a collapsed condition, the wall being further sized and configured to apply the force in response to expansion of the inflatable body within the vertebral body, the wall including, when inflated, opposed side surfaces extending along an elongated longitudinal axis that is substantially aligned with the axis of the catheter, the inflatable body, when inflated within the vertebral body, having a side to side dimension measured between the opposed side surfaces of approximately 0.5 cm to 5.0 cm.

57. A device according to claim 56

wherein the side to side dimension is approximately 0.5 cm to 3.5 cm.

58. A device according to claim 56

wherein the inflatable body comprises a balloon.

59. A device according to claim 56

wherein the cannula is a percutaneous cannula.

60. A device according to claim 56

wherein the wall includes changes in wall thickness which restrain the opposed side surfaces from expanding beyond a substantially flat condition.

61. A device according to claim 56

wherein the wall includes an internal restraint which restrains the opposed side surfaces from expanding beyond a substantially flat condition.

62. A device according to claim 61

wherein the internal restraint includes mesh material.

63. A device according to claim 61

wherein the internal restraint includes string material.

64. A device according to claim 61

wherein the internal restraint includes woven material.

65. A device according to claim 61

wherein the internal restraint includes a seam.

66. A device according to claim 61

wherein the internal restraint includes an essentially non-elastic material.

67. A device according to claim 56

wherein the wall includes an external restraint which restrains the opposed side surfaces from expanding beyond a substantially flat condition.

68. A device according to claim 67

wherein the external restraint includes mesh material.

69. A device according to claim 67

wherein the external restraint includes string material.

70. A device according to claim 67

wherein the external restraint includes woven material.

71. A device according to claim 67

wherein the external restraint includes a seam.

72. A device according to claim 67

wherein the external restraint includes an essentially non-elastic material.