Expandable preformed structures for deployment in interior body regions

• US 6,607,544 B1
• Filed: 10/19/1999
• Issued: 08/19/2003
• Est. Priority Date: 01/26/1994
• Status: Expired due to Term

• Current Assignee: Orthophoenix, LLC (Marathon Patent Group, Inc.)
• Original Assignee: Kyphon Incorporated
• Inventors: Boucher, Ryan P, Reiley, Mark A, Scribner, Robert M, Talmadge, Karen D
• Primary Examiner(s): REIP, DAVID OWEN
• Application Number:
  US09/420,529
• Time in Patent Office: 1,400 Days
• Field of Search: 606/60, 606/61-75, 606/86-89, 606/190, 606/191, 606/192, 606/194, 606/53, 604/96.01
• US Class Current: 606/192
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• 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 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• 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 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 2210/02 Bones
• CPC Class Codes: A61M 2210/1003 Spinal column
• CPC Class Codes: A61M 25/002 Packages specially adapted therefor combined with means for introducing catheters, e.g. dispensers, A61M25/0113; catheter kit packages for surgical articles A61B50/30
• 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 25/1011 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

An expandable structure made from an elastomer material is preformed to a desired geometry by exposure to heat and pressure. The structure undergoes controlled expansion and further distention in cancellous bone, with controlled deformation and without failure.

Claims

1. A device for compacting cancellous bone comprising

a wall made from a flexible material, the wall peripherally defining an interior space and including an expandable region preformed with a normally expanded shape outside bone, the expandable region having proximal and distal ends, the expandable region further having a first expanded section having an interior cross-sectional area adjacent the proximal end, a second expanded section having an interior cross-sectional area adjacent the distal end, and a third section having an interior cross-sectional area located between the first and second expanded sections, the interior cross-sectional area of the third section being less than the interior cross-sectional area of either the first or second expanded sections, and the first expanded section, the second expanded section, and the third expanded section further having, respectively, a first average wall thickness, a second average wall thickness, and a third average wall thickness, and the third average wall thickness being greater than either the first average wall thickness or the second average wall thickness,

the expandable region, when expanded beyond its normally expanded shape to reach a given inflation volume, presenting a maximum diameter less than a sphere expanded to an equal inflation volume.

2. A device according to claim 1

wherein the expandable region includes a further expanded shape, outside bone, having a diameter greater than the normally expanded shape.

3. A device according to claim 2

wherein the expandable region has a further expanded shape inside bone that substantially corresponds to the further expanded shape outside bone.

4. A device according to claim 1

wherein the expandable region is essentially cylindrical.

5. A device according to claim 1

wherein the expandable region expands in a non-spherical manner.

6. A device according to claim 1

wherein the expandable region expands in an essentially cylindrical manner.

7. A method for manipulating bone comprising the steps of

deploying into bone an expandable structure having a wall material peripherally defining an interior space, the structure having a proximal and a distal end, the structure further having a first expandable region located near the distal end and a second expandable region located proximally of the first expandable region, the first and second expandable regions separated by a third region of the structure, the third region having a reduced cross-sectional area as compared to the cross-sectional areas of the first and second regions, and the first expandable region, the second expandable region, and the third expandable region further having, respectively, a first average wall thickness, a second average wall thickness, and a third average wall thickness, and the third average wall thickness being greater than either the first average wall thickness or the second average wall thickness, and

expanding the device in bone to manipulate bone.

8. A method according to claim 7

wherein the wall material of the first expandable region substantially surrounds a first maximum cross-sectional area of the interior space, the wall material of the second expandable region substantially surrounds a second maximum cross-sectional area of the interior space, and the wall material of the third region substantially surrounds a minimum cross-sectional area of the interior space, the first and second maximum cross-sectional areas each being larger than the minimum cross-sectional area.

9. A method according to claim 7

wherein the wall material comprises polyurethane.

10. A method for compacting cancellous bone comprising the steps of

deploying into bone a device having a wall made from a flexible material, the wall peripherally defining an interior space and including an expandable region, the expandable region having proximal and distal ends, the expandable region further having a first expanded section adjacent the distal end, a second expanded section located proximally of the first expanded section, and a third section located between the first and second expanded sections, wherein the average outer diameter of the third section is less than the average outer diameter of either of the first or second expanded sections, and the first expandable region, the second expandable region, and the third expandable region further having, respectively, a first average wall thickness, a second average wall thickness, and a third average wall thickness, and the third average wall thickness being greater than either the first average wall thickness or the second average wall thickness, and expanding the device inside bone to compact cancellous bone.

11. A method according to claim 10

wherein the expandable region expands in response to introduction of a flowable material into the interior space.