Apparatus and methods for bone, tissue and duct dilatation

• US 8,454,646 B2
• Filed: 02/09/2009
• Issued: 06/04/2013
• 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.
• Primary Examiner(s): SHUMATE, VICTORIA PEARL
• Application Number:
  US12/322,883
• Publication Number:
  US 20090177235A1
• Time in Patent Office: 1,576 Days
• Field of Search: 604/96.01, 604/103.07, 604/103.08, 604/103.13, 604/103.14, 606/192
• US Class Current: 606/192
• 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. A method for treating a living being for bone, tissue and/or 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 of one or more narrow diameter openings or passageways to position the balloon element at a body location requiring dilatation;

inflating the balloon element with a working fluid to a working pressure and/or volume and for a time period sufficient to dilate the interior region, cavity or passage;

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 using a rod that is not attached to the balloon element to apply axial force, and/or using a rod that is not attached to the balloon element but is capable of engaging the balloon element to apply rotational force, manually or automatically to the balloon element; and

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

2. A method according to claim 1 wherein said balloon element is inflated to a working diameter of about 12 mm to about 25 mm during the inflating step.

3. A method according to claim 1 wherein said balloon element is inflated to a working pressure of about 200-400 psi over a relatively short balloon working length during the inflating step.

4. A method according to claim 1 wherein said balloon element is stretched and/or folded, pleated or wrapped to a diameter of less than about 4 mm for the steps of inserting and/or withdrawing the balloon element.

5. A method according to claim 1 wherein said balloon element is stretched and/or folded, pleated or wrapped using a rod actuated by active and/or passive tensioning and wrapping forces.

6. A method according to claim 1 wherein, following inflation to its working pressure and/or volume, the balloon element maintains a high degree of puncture and abrasion resistance.

7. A method according to claim 1 further comprising the step of applying a vacuum to the inflated balloon element during the deflating step to assist withdrawal of the working fluid.

8. A method according to claim 1 wherein the proximal end of the balloon element is bonded to or integrally formed with a tube to create a passage through the tube to the interior of the balloon element.

9. A method according to claim 1 wherein the rod is hydraulically or pneumatically actuated.

10. A method according to claim 1 further wherein said rod is adjustable in length, said method further comprising the step of adjusting the length of said rod such that said rod applies an axial tensioning to the balloon element during the deflating step.

11. A method according to claim 1 further comprising the step of coating the exterior of the balloon element with a coating to improve puncture and abrasion resistance.

12. A method according to claim 1 further wherein, upon inserting the balloon element into an interior region, cavity or passage, at least one end of the balloon element extends into or completely through a cannula element positioned in at least one of the narrow diameter openings or passageways.

13. A method according to claim 1 wherein said rod applies axial tensioning to the balloon element during the deflating step, said method further comprising the step of applying manual rotational tensioning to the balloon element during and/or subsequent to the deflating step.

14. A method according to claim 1 further comprising the steps of positioning a guidewire through the interior region, cavity or passage to be dilated, and using the guidewire to position the balloon element during the inserting step.

15. A method according to claim 14 wherein said guidewire is pre-curved.

16. A method according to claim 14 wherein the guidewire is pre-curved and made of a material having memory properties.

17. A method according to claim 1 wherein said rod is pre-curved and fabricated from a material having memory properties.

18. A method according to claim 1 wherein said balloon element is pre-curved.

19. A method according to claim 1 wherein said balloon element consists essentially of a non-elastomeric material.

20. A method according to claim 1 wherein the body part to be treated is a vertebral segment, said method further comprising the step of forming a passageway including at least one opening from outside the vertebral segment into an interior region of the vertebral segment.

21. A method according to claim 20 wherein said passageway comprises a V-shaped or U-shaped duct through the interior region of the vertebral segment.

22. A method according to claim 21 wherein the balloon element is positioned in the V-shaped or U-shaped duct.

23. A method according to claim 22 wherein the balloon element is fabricated to be pre-curved.

24. A method according to claim 20 further comprising the steps of positioning a cannula element in at least one of the openings into the interior region of the vertebral segment and inserting the balloon element through the cannula element such that a portion of the balloon element is inside the cannula element during the inflation step.

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

inserting an inflatable balloon element having a sealed distal end and mounted on the distal end of a hollow tube, the balloon element initially in an uninflated state, into an interior region, cavity or passage of a damaged, collapsed or deformed bone, tissue or duct through a first of one or more narrow diameter openings or passageways to position the balloon element at a body location requiring dilatation;

inflating the balloon element with a working fluid to a working pressure and/or volume and for a time period sufficient to dilate the interior region, cavity or passage;

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 using a rod that is not attached to the balloon element to apply axial force, and/or using a rod that is not attached to the balloon element but is capable of engaging the balloon element to apply rotational force, manually or automatically to the balloon element; and

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

26. A method according to claim 25 wherein said balloon is stretched and/or folded, pleated or wrapped to a diameter of less than about 4 mm for the steps of inserting and/or withdrawing the balloon.

27. A method according to claim 25 further comprising the steps of positioning a cannula element having a cannula interior with an interior diameter in at least one of the openings into the body region, cavity or passage and inserting the balloon element through the cannula interior.

28. A method according to claim 27 further comprising the step of stretching and/or folding, pleating or wrapping the previously-inflated balloon element to a diameter less than the interior diameter of the cannula element prior to the step of withdrawing the balloon element.

29. A method according to claim 25 wherein said balloon element is inflated to a working diameter of about 12 mm to about 25 mm during the inflating step.

30. A method according to claim 25 wherein said balloon element is inflated to a working pressure of about 200-400 psi over a relatively short balloon working length during the inflating step.

31. A method according to claim 25 wherein said balloon element is stretched and/or folded, pleated or wrapped using a rod actuated by active and/or passive tensioning and wrapping forces.

32. A method according to claim 25 wherein, following inflation to its working pressure and/or volume, the balloon element maintains a high degree of puncture and abrasion resistance.

33. A method according to claim 25 further comprising the step of applying a vacuum to the inflated balloon element during the deflating step to assist withdrawal of the working fluid.

34. A method according to claim 25 wherein the rod is hydraulically or pneumatically actuated.

35. A method according to claim 25 further wherein said rod is adjustable in length, said method further comprising the step of adjusting the length of said rod such that said rod applies an axial tensioning to the balloon element during the deflating step.

36. A method according to claim 25 further comprising the step of coating the exterior of the balloon element with a coating to improve puncture and abrasion resistance.

37. A method according to claim 25 further wherein, upon inserting the balloon element into an interior region, cavity or passage, at least one end of the balloon element extends into or completely through a cannula element positioned in at least one of the narrow diameter openings or passageways.

38. A method according to claim 25 wherein said rod applies axial tensioning to the balloon element during the deflating step, said method further comprising the step of applying manual rotational tensioning to the balloon element during and/or subsequent to the deflating step.

39. A method according to claim 25 further comprising the steps of positioning a guidewire through the interior region, cavity or passage to be dilated, and using the guidewire to position the balloon element during the inserting step.

40. A method according to claim 25 wherein said guidewire is pre-curved.

41. A method according to claim 25 wherein said rod is pre-curved and fabricated from a material having memory properties.

42. A method according to claim 25 wherein said balloon element is pre-curved.

43. A method according to claim 25 wherein said balloon element consists essentially of a non-elastomeric material.

44. A method for treating a living being for bone, tissue and/or 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 of one or more narrow diameter openings or passageways to position the balloon element at a body location requiring dilatation;

inflating the balloon element with a working fluid to a working pressure and/or volume and for a time period sufficient to dilate the interior region, cavity or passage;

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 one of said narrow diameter openings or passageways, which may be the same as or different than said first narrow diameter opening or passageway,

wherein the body location to be treated is a vertebral segment and the method further comprises the step of forming a passageway including at least one opening from outside the vertebral segment into an interior region of the vertebral segment,

and also wherein at least two openings are formed into the interior region, said method further comprising the steps of positioning a cannula element in each opening and inserting the balloon element through the cannula elements such that a proximal portion of the balloon element is inside a first of the cannula elements and a distal portion of balloon element is inside a second of the cannula elements during the inflation step.

45. A method according to claim 44 wherein said balloon element is long enough to extend from outside the first cannula element, through the interior region, to outside the second cannula element.

46. A method according to claim 45 further comprising the step of simultaneously pulling on each end of the balloon element after the inflating step to reduce the profile of the balloon element prior to the withdrawing step.

47. A method according to claim 44 wherein one end of the balloon element is sealed.

48. A method according to claim 44 further wherein a rod passes through at least a portion of the interior of the balloon element.

49. A method according to claim 48 further comprising the step of applying axial force manually or automatically to the balloon element through said rod during and/or subsequent to the deflating step causing tension and axial elongation of the balloon element.

50. A method according to claim 48 wherein the rod is attached to or otherwise engages the balloon element.

51. A method according to claim 48 further comprising the step of applying rotational force manually or automatically to said rod during and/or subsequent to the deflating step causing the balloon element at least in part to wrap around the rod.

52. A dilatation procedure for treating the body of a living being by dilating an internal body part or region using a balloon dilatation catheter apparatus, wherein the procedure comprises the following steps:

(a) providing a balloon dilatation catheter apparatus having the following configuration;

a proximal end catheter sleeve portion, a middle sleeve portion, and a balloon or inflation element at or near the distal end of the catheter;

the proximal end catheter sleeve portion comprises a branched or Y-shaped element, of which a first arm or branch comprises a tubular shell with external threads at its proximal end, and a second arm or branch comprises a fluid inlet/outlet conduit for introducing pressurized fluid into the catheter for inflating the balloon or for withdrawing fluid after a dilatation procedure;

the tubular shell of the first branch comprises a region adjacent to the threaded region for housing a sealing gasket or a similar compressible sealing element having a centrally located aperture;

a cap element, that includes a centrally-located axial bore to accommodate a rod element and internal threads sized to mate with the external threads at the proximal end of the first branch, engages the proximal end of the first branch;

the rod element also has a knob portion at its proximal end, and is slidably positioned inside the catheter and sized to extend axially the full length of the catheter, extending through the central bore of the cap, through the sealing gasket, which acts like a bushing for supporting and centering the rod, through the interiors of the proximal and middle catheter sleeves, and through the interior of the balloon to a sealed tip portion of the apparatus;

(b) inserting the catheter apparatus into the body and positioning the balloon in the region to be dilated;

(c) turning the cap element at least partially advancing it in a distal direction and at least partially compressing the sealing gasket forming a fluid-tight seal at the sealing gasket and around the rod;

(d) introducing fluid through the inlet/outlet conduit of the second arm, and through the interiors of the proximal and middle sleeve portions, inflating the balloon, and causing the rod to slide in a proximal direction;

(e) after completing the dilatation procedure, withdrawing the fluid from the balloon and from the interior of the catheter through the inlet/outlet conduit of the second arm and deflating the balloon, while manually applying axial force to the proximal end of the rod pushing it toward the distal end of the catheter thereby stretching and tensioning the balloon; and

,

(f) applying a rotational force to the knob of the rod, rotating the rod, and causing the balloon to wrap around the rod in preparation for withdrawing the balloon from the body.

53. A dilatation procedure according to claim 52 wherein said balloon is stretched and/or folded, pleated or wrapped to a diameter of less than about 4 mm for the steps of inserting and/or withdrawing the balloon.