Apparatus and methods for bone, tissue and duct dilatation

• US 20090177153A1
• Filed: 02/06/2009
• Published: 07/09/2009
• Est. Priority Date: 09/30/2002
• Status: Active Grant

• Current Assignee: Nordson Corporation
• Original Assignee: Advanced Polymers Incorporated
• Inventors: Saab, Mark A., Barbere, Michael D.
• Granted Patent: US 8,216,182 B2
• Time in Patent Office: Days
• US Class Current: 604/98.10
• 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 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00544 pneumatically
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• 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 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/4677 using a guide wire
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61M 2210/02 Bones
• CPC Class Codes: A61M 2210/1003 Spinal column
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Apparatus and methods are disclosed for medical treatment comprising bone, tissue or duct dilatation using inflatable dilatation elements together with apparatus and techniques for tensioning, stretching, folding, and/or wrapping the dilatation elements externally as well as in situ to facilitate insertion, positioning and withdrawal procedures.

Claims

1. An assembly adapted for bone, tissue and/or duct dilatation of a living being comprising in combination:

a hollow tube;

an inflatable and deflatable balloon element having proximal and distal ends in fluid communication with the hollow tube; and

, balloon tensioning and/or balloon wrapping device(s) for stretching the balloon element and/or folding, pleating or wrapping the balloon element to facilitate insertion and/or removal of the balloon element through a narrow diameter duct, access channel or canula.

5. An assembly according to claim 1 wherein said balloon tensioning and/or balloon wrapping device(s) is/are selected from the group consisting of active and passive tensioning and wrapping devices.

8. An assembly according to claim 1 wherein the distal end of the balloon element is sealed, and the assembly further comprises a rod element running through the passage of the tube and the interior of the balloon element to the sealed distal end of the balloon element.

9. An assembly according to claim 8 wherein axial force can be applied manually or automatically to push the rod element against the sealed distal end of the balloon element causing tension and axial elongation of the balloon element.

10. An assembly according to claim 9 wherein the rod element is not attached to the balloon element.

11. An assembly according to claim 9 wherein the rod element is attached to or otherwise engages the balloon element.

12. An assembly according to claim 11 further wherein rotational force can be applied manually or automatically to rotate the rod element from its free-standing position causing the balloon element at least in part to wrap around the rod element.

13. An assembly according to claim 9 further wherein said rod element is spring loaded to apply axial tensioning and elongation to the balloon element.

14. An assembly according to claim 11 further wherein said rod element is spring loaded to apply rotational tensioning to the balloon element.

15. An assembly according to claim 11 further wherein said rod element is spring loaded to apply both automatic axial and rotational tensioning to the balloon element.

16. An assembly according to claim 9 wherein said rod element comprises a compressive or rotational spring element.

17. An assembly according to claim 1 wherein said hollow tube comprises a compressive spring element.

18. An assembly according to claim 1 wherein the balloon tensioning and/or wrapping device is hydraulically or pneumatically actuated.

19. An assembly according to claim 8 wherein said rod element is adjustable in length.

22. An assembly according to claim 11 further comprising at least a canula element wherein at least one end of the balloon element extends into or completely through said canula element when the balloon element is positioned in a cavity to be dilated.

29. An assembly according to claim 11 wherein said rod element is spring loaded to apply automatic axial tensioning to the balloon element and is adapted for optional manual rotational tensioning of the balloon element.

31. An assembly according to claim 8 wherein said rod element comprises concentric inner and outer tubular members which are rotatable relative to one another and said balloon element is attached to or engages one of said tubular members whereby rotational forces can be applied to cause the balloon element at least in part to wrap around one of said tubular members.

2-4. -4. (canceled)

6. (canceled)

7. (canceled)

20. (canceled)

21. (canceled)

23-28. -28. (canceled)

30. (canceled)

32-34. -34. (canceled)

35. A method for treating a living being for bone, tissue and/or body duct dilatation comprising the sequential steps of:

inserting an inflatable balloon element in an uninflated state into an interior region, cavity or passage of a damaged, collapsed or deformed bone, tissue or duct through a first narrow diameter opening or passageway to position the balloon element at a body location requiring dilatation;

inflating the balloon element with a working fluid to a working pressure and for a time period sufficient to substantially completely dilate the interior region, cavity or passage to substantially restore its normal size, shape and/or alignment;

deflating the balloon element by withdrawing the working fluid;

during and/or subsequent to said deflating step, stretching and/or folding, pleating or wrapping the balloon element to reduce its profile; and

, withdrawing the previously-inflated balloon element through a narrow diameter opening or passageway, which may be the same as or different than said first narrow diameter opening or passageway.

36-61. -61. (canceled)

62. A method for treating a living being for bone or tissue dilatation comprising the sequential steps of:

providing a dilatation apparatus able to fit through a narrow opening, said dilatation apparatus comprising an inflatable balloon element in fluid communication with a hollow tube, and a rod element running through the interior of the hollow tube and the inflatable balloon element, wherein said balloon element is uninflated and is wrapped, folded, pleated or stretched at least in part about said rod element to reduce the profile of the balloon portion of the dilatation apparatus;

inserting the dilatation apparatus into an interior region, cavity or passage of a damaged, collapsed or deformed bone or tissue region through a first narrow diameter opening or passageway to position the balloon element at a body location requiring dilatation;

inflating the balloon element through the hollow tube with a working fluid to a working pressure and for a time period sufficient to substantially completely dilate the interior region, cavity or passage to substantially its normal size, shape and/or alignment; and

, filling the inflated balloon element in situ through the hollow tube with a cement material.

63-74. -74. (canceled)

75. A method for treating a living being for dilatation of a section of a body duct to relieve a collapse or blockage condition comprising the sequential steps of:

providing a dilatation apparatus able to fit through a narrow opening, said dilatation apparatus comprising an inflatable balloon element in fluid communication with a hollow tube, and a rod element running through the interior of the hollow tube and the inflatable balloon element, wherein said balloon element is uninflated and is wrapped, folded, pleated or stretched at least in part about said rod element to reduce the profile of the balloon portion of the dilatation apparatus;

inserting the dilatation apparatus into a body duct to be dilated to position the balloon element at a duct section requiring dilatation;

inflating the balloon element through the hollow tube with a working fluid to a working pressure and for a time period sufficient to substantially completely dilate the duct section to substantially its normal size;

deflating the balloon element by withdrawing the working fluid;

during and/or subsequent to said deflating step, stretching and/or folding, pleating or wrapping the balloon element to reduce its profile; and

, withdrawing the dilatation apparatus including the previously-inflated balloon element from the treated duct.

76-90. -90. (canceled)