Systems and methods for forming a cavity in cancellous bone

• US 8,034,071 B2
• Filed: 09/27/2006
• Issued: 10/11/2011
• Est. Priority Date: 08/15/1997
• Status: Expired due to Fees

• Current Assignee: Orthophoenix, LLC (Marathon Patent Group, Inc.)
• Original Assignee: Kyphon SARL (Medtronic Plc)
• Inventors: Scribner, Robert M, Reo, Michael L
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US11/527,861
• Publication Number:
  US 20070021769A1
• Time in Patent Office: 1,840 Days
• Field of Search: 606 60- 68, 606 92- 94, 606/192, 606/195, 606/190, 604 9601-10105
• 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 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• 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 17/74 Devices for the head or neck or trochanter of the femur trochanteric devices connected to the proximal part of an endoprosthetic femoral shaft A61F2/30739; endoprosthetic internal fixation devices for the head or neck of the femur A61F2/3601
• 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 2010/0258 Marrow samples
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00544 pneumatically
• 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 2/44 : 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 2002/30133 : 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 2002/30581 : 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 2002/30909 : Nets
• 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 2230/0015 : 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 2250/0063 : 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

Abstract

A cavity creating device having a cavity creating axis is introduced through a percutaneous access path into a cancellous bone volume, e.g., within a vertebral body. The cavity creating device is manipulated to form a cavity in the cancellous bone volume. The manipulation includes deflecting the cavity creating device along the cavity creating axis relative to the axis of the access path. A material, such as bone cement, can be conveyed into the cavity.

Claims

1. A method for treating an interior body region having a bone wall, the method comprising:

accessing the interior body region with a therapeutic device along a first axis, the therapeutic device including

a catheter tube and

an expandable structure, having a collapsed geometry and an expanded geometry, and including an interior lumen extending through the expandable structure and sized to accommodate passage of an elongated member for directing the expandable structure;

directing the interior lumen along the first axis;

expanding the expandable structure from the collapsed geometry to the expanded geometry within the interior body region; and

moving at least a portion of the bone wall with a force applied by the expandable structure in its expanded geometry.

2. The method of claim 1 wherein the elongated member is bendable.

3. The method of claim 1 wherein the expandable structure comprises an inflatable chamber.

4. The method of claim 1 further comprising accessing the interior body region through a passage.

5. The method of claim 4 wherein the passage is naturally occurring.

6. The method of claim 1 further comprising collapsing the expandable structure from the expanded geometry to the collapsed geometry;

removing the expandable structure from the interior body region; and

introducing a fluid material into the interior body region.

7. The method of claim 1 further comprising collapsing the expandable structure from the expanded geometry to the collapsed geometry;

removing the expandable structure from the interior body region; and

introducing a therapeutic substance into the interior body region.

8. The method of claim 1 wherein the elongated member has a preformed shape memory.

9. The method of claim 1 further comprising passing the expandable structure through the catheter tube.

10. The method of claim 1 further comprising compressing tissue against the bone wall with the expanded structure in its expanded geometry.

11. The method of claim 10 wherein the tissue comprises cancellous bone.

12. The method of claim 10 wherein the tissue comprises reticulated bone.

13. The method of claim 10 wherein the tissue comprises spongy bone.

14. The method of claim 10 wherein the tissue comprises medullary bone.

15. The method of claim 10 wherein the tissue comprises trabecular bone.

16. The method of claim 10 wherein the step of compressing includes increasing the size of a passage between two portions of the bone wall.

17. The method of claim 1 wherein the step of directing the interior lumen includes directing the interior lumen along a second axis offset from the first axis.

18. The method of claim 1 further comprising removing the therapeutic device from the interior body region.

19. The method of claim 1 further comprising dilating tissue with the expandable structure in its expanded geometry.

20. The method of claim 19 wherein the tissue comprises cancellous bone.

21. The method of claim 1 wherein the elongated member is a guidewire.

22. A method for treating an interior body region enclosed, at least in part, by a bone wall, the method comprising:

inserting a catheter tube into the interior body region along a first axis;

inserting a bone manipulation device through the catheter tube, the bone manipulation device including an inflatable chamber and an interior lumen extending through the inflatable chamber;

directing the orientation of the inflatable chamber within the interior body region with an elongated member extended within the interior lumen of the inflatable chamber;

inflating the inflatable chamber; and

displacing at least a portion of the cortical bone wall with a force applied by the inflatable chamber.

23. The method of claim 22 wherein the step of directing includes positioning the interior lumen along a second axis, not aligned with the first axis.

24. The method of claim 22 wherein the elongated member has a preformed shape memory.

25. The method of claim 22 further comprising deflating the inflatable chamber;

removing the bone manipulation device from the interior body region; and

introducing a fluid material into the interior body region.

26. The method of claim 22 further comprising deflating the inflatable chamber;

removing the bone manipulation device from the interior body region; and

introducing a therapeutic substance into the interior body region.

27. The method of claim 22 further comprising monitoring the expandable body with medical images.

28. The method of claim 27 wherein the medical images are used to perform image guided surgery.

29. The method of claim 22 wherein the bone wall comprises cortical bone.

30. The method of claim 22 wherein the bone wall comprises cancellous bone.

31. A method for treating an interior body region having tissue bounded, at least in part, by a bone wall, the method comprising:

inserting an expandable body into the interior body region thereby creating a passage through the tissue, the expandable body comprising an expandable chamber and an internal tube passing through the expandable chamber;

directing the orientation of the internal tube with an elongated member extended within the internal tube;

expanding the expandable body within the interior body region; and

compressing the tissue against the bone wall with a force applied by the expandable body.

32. The method of claim 31 further comprising moving at least a portion of the bone wall with the force applied by the expandable body.

33. The method of claim 31 wherein the tissue is softer than the bone wall.

34. The method of claim 31 wherein the tissue is cancellous bone.

35. The method of claim 31 further comprising enlarging the passage in the interior body region.

36. The method of claim 32 wherein the step of moving further comprises moving a first portion of the bone wall with respect to a second portion of the bone wall to enlarge the passage.

37. The method of claim 31 wherein the step of expanding includes inflating the expandable chamber.

38. The method of claim 31 further comprising collapsing the expandable body;

removing the expandable body from the passage; and

introducing a fluid material into the interior body region.

39. The method of claim 31 further comprising collapsing the expandable body;

removing the expandable body from the passage; and

introducing a therapeutic substance into the interior body region.

40. The method of claim 31 further comprising inserting the expandable body through a guide tube into the interior body region.

41. The method of claim 31 further comprising fluoroscopically monitoring the expandable body.

42. The method of claim 31 further comprising removing tissue from the interior body region.

43. The method of claim 31 further comprising removing fat from the interior body region.

44. The method of claim 31 further comprising rinsing debris from the interior body region.

45. A method for treating an interior body region enclosed, at least in part, by a bone wall, the method comprising:

accessing the interior body region with a catheter tube;

extending a stiffening member through the catheter tube and into the interior body region;

inserting an expandable body into the interior body region, the expandable body including an interior tube defining an interior lumen sized to receive the stiffening member;

expanding the expandable body within the interior body region;

compressing the tissue against the bone wall with a force applied by the expandable body; and

introducing a therapeutic substance into the interior body region.

46. The method of claim 45 wherein the stiffening member is a guidewire.

47. The method of claim 45 further comprising moving the expandable body along the stiffening member.

48. The method of claim 45 further comprising monitoring the expandable body within the interior body region with medical images.

49. The method of claim 45 further comprising removing the expandable body from the interior body region.

50. The method of claim 45 wherein the step of expanding comprises displacing at least a portion of the bone wall.