Apparatus and methods for bone, tissue and duct dilatation

• US 8,177,744 B2
• Filed: 02/06/2009
• Issued: 05/15/2012
• 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): Campbell, Victoria P
• Application Number:
  US12/322,747
• Publication Number:
  US 20090177200A1
• Time in Patent Office: 1,194 Days
• Field of Search: 604/96.01, 604/103.07, 604/103.08, 604/103.13, 604/103.14, 606/192
• US Class Current: 604/103.08
• 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:

(a) using an assembly for inserting an inflatable balloon element 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, the assembly comprising proximal and distal ends and the balloon element having a balloon interior;

(b) positioning the balloon element in an uninflated state at the body location;

(c) inflating the balloon element with a working fluid supplied through a fluid inlet/outlet to a working pressure and/or volume and for a time period sufficient to dilate the interior region, cavity or passage;

(d) deflating the balloon element by withdrawing the working fluid through the fluid inlet/outlet;

during and/or subsequent to said deflating step, stretching and/or folding, pleating or wrapping the balloon element to reduce its profile using a spring element capable of temporarily applying at least axial force to the balloon by means of a rod causing the balloon to elongate, or to wrap about the rod, or both, said spring element being housed in a spring housing section located at the proximal end of the assembly; and

,

(e) 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.

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 and a working pressure of about 200-400 psi during the inflating step.

3. A method according to claim 1 wherein said balloon element is stretched and/or folded, pleated or wrapped to a diameter of about 4-5 mm or less for the steps of inserting and/or withdrawing the balloon element.

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

5. 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 with withdrawal of the working fluid.

6. A method according to claim 1 wherein the balloon element is mounted on the distal end of a hollow tube, and the proximal end of the balloon element is bonded to or integrally connected with an end of the tube to create a passage through the tube to the interior of the balloon element.

7. A method according to claim 6 wherein the distal end of the balloon element is sealed.

8. A method according to claim 7 further wherein said rod passes through the tube and the interior of the balloon element to the sealed end of the balloon element.

9. A method according to claim 8 wherein the rod is not attached to the balloon element.

10. A method according to claim 8 wherein the rod is attached to or otherwise engages the balloon element.

11. A method according to claim 10 wherein the force applied to said rod during and/or subsequent to the deflating step causes the balloon element at least in part to wrap around the rod.

12. A method according to claim 11 wherein said rod is spring-loaded to apply rotational tensioning to the balloon element.

13. A method according to claim 10 wherein said rod is spring-loaded to automatically apply 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 8 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.

15. A method according to claim 8 wherein said rod is pre-curved and fabricated from a material having memory properties.

16. A method according to claim 1 wherein the balloon tensioning and/or wrapping device is hydraulically or pneumatically actuated.

17. 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.

18. 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 canula element positioned in one of the narrow diameter openings or passageways.

19. A method according to claim 1 wherein said balloon element comprises a multi-lumen balloon.

20. 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.

21. A method according to claim 20 wherein said guidewire is pre-curved.

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

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

24. A method according to claim 1 wherein a cannula element threadably engages external threads along a portion of the assembly such that the cannula annularly surrounds a portion of the balloon element, the method further comprising the step of adjusting the portion of the balloon contained inside the cannula element by axially moving the cannula element along the external threads in either the proximal or the distal direction.

25. A method for treating a living being for dilatation of a section of a body to relieve a compression fracture or blockage condition comprising the sequential steps of:

(a) providing a dilatation apparatus having proximal and distal ends and able to fit through a narrow opening, said dilatation apparatus comprising an inflatable balloon element having a balloon interior in fluid communication with a hollow tube, a rod element running through the interiors of the hollow tube and the inflatable balloon element, and a spring element capable of temporarily applying at least axial force to the balloon by means of the rod element, said spring element being housed in a spring housing section located at the proximal end of the apparatus, wherein said balloon element is initially 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;

(b) inserting at least the balloon portion of the dilatation apparatus into the body section to be treated to position the balloon element at a location requiring dilatation;

(c) inflating the balloon element through the hollow tube with a working fluid to a working pressure and/or volume and for a time period sufficient to dilate the body section;

(d) 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 using the spring element to apply the at least axial force to the balloon to reduce its profile; and

,

(e) withdrawing the dilatation apparatus including the previously-inflated balloon element from the treated location.

26. A method according to claim 25 wherein said balloon element is inflated to a working diameter of about 12 mm to about 25 mm and a working pressure of about 200-400 psi during the inflating step.

27. A method according to claim 25 wherein said balloon element is stretched and/or folded, pleated or wrapped to a diameter of about 4-5 mm or less for the steps of inserting and/or withdrawing the balloon element.

28. 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 with withdrawal of the working fluid.

29. A method according to claim 25 wherein the distal end of the balloon element is sealed, said method further comprising the step of applying axial force manually or automatically to said sealed end of the balloon element through said rod element during and/or subsequent to the deflating step causing tension and axial elongation of the balloon element.

30. A method according to claim 29 wherein the rod element is not attached to the balloon element.

31. A method according to claim 29 wherein the rod element is attached to or otherwise engages the balloon element.

32. A method according to claim 31 wherein the force applied to said rod element during and/or subsequent to the deflating step causes the balloon element at least in part to wrap around the rod element.

33. A method according to claim 32 wherein said rod element is spring-loaded to apply rotational tensioning to the balloon element.

34. A method according to claim 32 wherein said rod element is spring-loaded to automatically apply 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.

35. A method according to claim 25 wherein the balloon tensioning and/or wrapping device is hydraulically or pneumatically actuated.

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

37. A method according to claim 25 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, said method further comprising the step of rotating said tubular members relative to one another during and/or subsequent to the deflating step to cause the balloon element to wrap at least in part around one of said tubular members.

38. A method according to claim 25 wherein a cannula element threadably engages external threads along a portion of the dilatation apparatus such that the cannula annularly surrounds a portion of the balloon element, the method further comprising the step of adjusting the portion of the balloon contained inside the cannula element by axially moving the cannula element along the external threads in either the proximal or the distal direction.

39. 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 spring element;

a cap element with 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;

at the distal end of the region housing the spring element, a disc element or circular fitting is sized to slide inside the region housing the spring element so as to compress the spring element by displacement in the proximal direction or to decompress the spring element by displacement in the distal direction;

associated with the disc element is an axially moveable rod element which runs axially through the interior of the catheter from the distal side of the disc element to a sealed tip portion of the balloon and thus can act like a piston to alternately compress and allow decompression of the spring element;

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

(c) turning the cap element and at least partially advancing it in a distal direction and at least partially compressing the spring element;

(d) introducing fluid through the inlet/outlet conduit of the second arm, and through the interiors of the proximal and middle sleeve portions, thereby inflating the balloon, and in turn displacing the disc element in a proximal direction and further compressing the spring element; and

,

(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, thereby decompressing the spring element, displacing the disc element in a distal direction, and causing the rod element to also move in a distal direction thereby stretching and tensioning the balloon in preparation for withdrawing it from the body.