Systems and methods for treating fractured or diseased bone using expandable bodies

• US 6,899,719 B2
• Filed: 01/04/2001
• Issued: 05/31/2005
• Est. Priority Date: 01/26/1994
• Status: Expired due to Fees

• Current Assignee: Orthophoenix, LLC (Marathon Patent Group, Inc.)
• Original Assignee: Kyphon Incorporated
• Inventors: Scholten, Arie, Reiley, Mark A, Scribner, Robert M, Talmadge, Karen D
• Primary Examiner(s): Woo, Julian W.
• Application Number:
  US09/754,451
• Publication Number:
  US 20010049531A1
• Time in Patent Office: 1,608 Days
• Field of Search: 623/17.12, 606/92, 606/93, 606/94, 606/192, 606/193, 606/194, 600/207, 604/96.01
• US Class Current: 606/192
• CPC Class Codes: A61B 10/025 for taking bone, bone marrow or cartilage samples
• CPC Class Codes: A61B 10/0283 with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe A61B10/025, A61B10/0266 take precedence
• 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 17/7061 for stabilising vertebrae or discs by improving the condition of their tissues, e.g. using implanted medication or fluid exchange intraosseous injection devices A61B17/3472
• 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 17/7098 wherein the implant is permeable or has openings, e.g. fenestrated screw hollow surgical screws A61B17/864
• CPC Class Codes: A61B 17/7258 with laterally expanding parts, e.g. for gripping the bone
• CPC Class Codes: A61B 17/7291 for small bones, e.g. in the foot, ankle, hand or wrist
• 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 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61B 17/8811 characterised by the introducer tip, i.e. the part inserted into or onto the bone
• CPC Class Codes: A61B 17/8816 characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
• 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 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 2/44 : 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
• 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 29/00 : Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Systems and methods treat fractured or diseased bone by deploying more than a single therapeutic tool into the bone. In one arrangement, the systems and methods deploy an expandable body in association with a bone cement nozzle into the bone, such that both occupy the bone interior at the same time. In another arrangement, the systems and methods deploy multiple expandable bodies, which occupy the bone interior volume simultaneously. Expansion of the bodies form cavity or cavities in cancellous bone in the interior bone volume.

Claims

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

a first tool sized and configured to be introduced into the vertebral body through a percutaneous access path and including an expandable region sized and configured to form a void in the cancellous bone, and

a second tool sized and configured to be introduced into the vertebral body through a percutaneous access path and including a platform region sized and configured to be disposed relative to the expandable region of the first tool to define an expansion barrier that directs expansion of the expandable region away from the platform region to direct expansion of the expandable region in a desired direction.

2. A system as in claim 1

wherein the expandable region of the first tools is sized and configured to compact cancellous bone.

3. A system as in claim 1

wherein expansion of the expandable region of the first tool exerts force upon cortical bone.

4. A system as in claim 1

wherein expansion of the expandable region of the first tool exerts force upon cortical bone to move fractured cortical bone.

5. A system as in claim 1

wherein the expandable region of the first tool and the platform region of the second tool comprise parts of a single device.

6. A system as in claim 1

wherein the expandable region of the first tool and the platform region of the second tool comprise separate structures.

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

providing a system as defined in claim 1,

introducing the first and second tools into the certebral body, and

forming a void in the cancellous bone by expanding the expandable region of the first tool with the platform region of the second tool disposed to serve as an expandable barrier that directs expansion of the expandable region away from the platform region.

8. A method as in claim 7

wherein expanding the expandable region compacts cancellous bone.

9. A method as in claim 7

wherein expanding the expandable region exerts force upon cortical bone.

10. A method as in claim 7

wherein expanding the expandable region exerts force upon cortical bone to move fractured cortical bone.

22. A system as in claim 1 or 11 or 21

wherein the platform region comprises an expandable body.

23. A system as in claim 22

wherein the expandable body is inflatable.

24. A system as in claim 22

wherein the expandable body is a balloon.

25. A system as in claim 22

wherein the expandable body has a predetermined shape and size when expanded.

26. A system as in claim 1 or 11 or 21

wherein at least one of the first and second tools includes an elongated shaft sized and configured to pass through a percutaneous access path.

27. A system as in claim 26

wherein the elongated shaft comprises a catheter.

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

a first tool sized and configured to be introduced into the vertebral body through a percutaneous access path and including a void forming region that enlarges to form a void in the cancellous bone, and

a second tool sized and configured to be introduced into the vertebral body through a percutaneous access path and including a platform region sized and configured to be disposed relative to the void forming region of the first tool to define a barrier that directs enlargement of the void forming region away from the platform region to in a desired direction to form the void.

12. A system as in claim 11

wherein the void forming region of the first tool is sized and configured to compact cancellous bone.

13. A system as in claim 11

wherein enlargement of the void forming region of the first tool exerts force upon cortical bone.

14. A system as in claim 11

wherein enlargement of the void forming region of the first tool exerts force upon cortical bone to move fractured cortical bone.

15. A system as in claim 11

wherein the void forming region of the first tool and the platform region of the second tool comprise parts of a single device.

16. A system as in claim 11

wherein the void forming region of the first tool and the platform region of the second tool comprise separate structures.

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

providing a system as defined in claim 11,

introducing the first and second tools into the vertebral body, and

forming a void in the cancellous bone by enlarging the void forming region of the first tool with the platform region of the second tool disposed to serve as a barrier that directs enlargement of the void forming region away from the platform region.

18. A method as in claim 17

wherein enlarging the void forming region compacts cancellous bone.

19. A method as in claim 17

wherein enlarging the void forming region exerts force upon cortical bone.

20. A method as in claim 17

wherein enlarging the void forming region exerts force upon cortical bone to move fractured cortical bone.

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

a first tool sized and configured to be introduced into the vertebral body through a percutaneous access path and including a compacting region that enlarges to form a void in the cancellous bone and compact the cancellous bone, and

a second tool sized and configured to be introduced into the vertebral body through a percutaneous access path and including a platform region sized and configured to be disposed relative to the compacting region of the first tool to define a barrier that directs enlargement of the compacting region away from the platform region in a desired direction to form the void and compact the cancellous bone.

28. A system as in claim 21

wherein enlargement of the compacting region of the first tool exerts force upon cortical bone.

29. A system as in claim 21

wherein enlargement of the compacting region of the first tool exerts force upon cortical bone to move fractured cortical bone.

30. A system as in claim 21

wherein the compacting region of the first tool and the platform region of the second tool comprise parts of a single device.

31. A system as in claim 21

wherein the compacting region of the first tool and the platform region of the second tool comprise separate structures.

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

providing a system as defined in claim 21,

introducing the first and second tools into the vertebral body, and

forming a void in the cancellous bone and compacting the cancellous bone by enlarging the compacting region of the first tool with the platform region of the second tool disposed to serve as a barrier that directs enlargement of the compacting region a way from the platform region.

33. A method as in claim 32

wherein enlarging the compacting region exerts force upon cortical bone.

34. A method as in claim 32

wherein enlarging the compacting region exerts force upon cortical bone to move fractured cortical bone.