Apparatus and methods for bone, tissue and duct dilatation

• US 8,394,056 B2
• Filed: 08/18/2011
• Issued: 03/12/2013
• Est. Priority Date: 09/30/2002
• Status: Active Grant

• Current Assignee: Nordson Corporation
• Original Assignee: Vention Medical Advanced Components, Inc. (Nordson Corporation)
• Inventors: Saab, Mark A., Barbere, Michael D.
• Primary Examiner(s): SHUMATE, VICTORIA PEARL
• Application Number:
  US13/199,083
• Publication Number:
  US 20120053611A1
• Time in Patent Office: 572 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. An assembly with proximal and distal ends for bone, tissue and/or duct dilatation of a living being comprising in combination:

(a) an inflatable and deflatable balloon element having a balloon interior;

(b) a conduit defining a channel for accessing the balloon interior from a location outside a living body when the balloon is positioned inside the living body;

(c) a balloon tensioning and/or balloon wrapping device 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 cannula, the device comprising a rod having proximal and distal ends and extending through the channel to or into the balloon element at the distal end of the rod in combination with a spring adjacent the proximal end of the rod, whereby compression of the spring applies an axial force to the rod tending to move it in a distal direction so as to apply axial tensioning to the balloon element; and

,

(d) a rotatable cap at the proximal end of the assembly whereby rotating the cap in a first direction compresses the spring and rotating the cap in a second direction decompresses the spring.

2. An assembly according to claim 1 wherein active and/or passive forces can be applied to the rod for tensioning and/or wrapping the balloon element.

3. An assembly according to claim 1 wherein the distal end of the balloon element is sealed, and the rod extends to the sealed distal end of the balloon element.

4. An assembly according to claim 3 wherein the cap can be rotated manually or automatically to compress the spring and push the rod against the sealed distal end of the balloon element causing tension and axial elongation of the balloon element.

5. An assembly according to claim 1 wherein the rod is not attached to the balloon element.

6. An assembly according to claim 1 wherein the rod is attached to or otherwise engages the balloon element.

7. An assembly according to claim 1 further wherein compression of the spring also applies rotational force to rotate the rod from its free-standing position causing the balloon element at least in part to wrap around the rod.

8. An assembly according to claim 1 wherein the spring has been at least partly compressed and said rod has been moved in a distal direction causing axial tensioning and elongation of the balloon element.

9. An assembly according to claim 1 wherein the spring has been at least partly compressed and said rod has been rotated causing wrapping and rotational tensioning of the balloon element.

10. An assembly according to claim 1 wherein the spring has been at least partly compressed and said rod has been moved in a distal direction and rotated causing both axial and rotational tensioning of the balloon element.

11. An assembly according to claim 1 further comprising a disc element between the distal end of the spring and the proximal end of the rod.

12. An assembly according to claim 1 wherein the proximal end of the assembly comprises a hollow tube portion housing the spring.

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

14. An assembly according to claim 1 wherein said rod is adjustable in length.

15. An assembly according to claim 1 further comprising at least a cannula element wherein at least one end of the balloon element extends into or completely through said cannula element when the balloon element is positioned in a cavity to be dilated.

16. An assembly according to claim 1 wherein said rod is spring loaded to apply axial tensioning to the balloon element and is also adapted for rotational tensioning of the balloon element.

17. A dilatation apparatus able to fit through a narrow opening, said dilatation apparatus comprising an inflatable balloon element at a distal apparatus end in fluid communication with a hollow tube, and a rod element spring loaded at a proximal apparatus end 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.

18. A dilatation apparatus according to claim 17 wherein said balloon element is stretched and/or folded, pleated or wrapped to a diameter of about 4-5 mm or less.

19. A dilatation apparatus according to claim 17 wherein the distal end of the balloon element is sealed.

20. A dilatation apparatus according to claim 19 wherein the rod element is attached to or otherwise engages the balloon element.

21. A dilatation apparatus according to claim 20 further wherein the balloon element is at least in part wrapped around the rod element.

22. A dilatation apparatus according to claim 20 wherein said rod element is applying rotational tensioning to the balloon element.

23. A dilatation apparatus according to claim 17 further comprising a hydraulic or pneumatic spring actuation system.

24. A dilatation apparatus according to claim 17 wherein said rod element is adjustable in length.

25. A dilatation apparatus able to fit through a narrow opening, said dilatation apparatus comprising an inflatable balloon element at a distal apparatus end in fluid communication with a hollow tube, and a rod element spring loaded at a proximal apparatus end 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, and also wherein the distal end of the balloon element is sealed and the rod element is not attached to the balloon element.

26. A dilatation apparatus able to fit through a narrow opening, said dilatation apparatus comprising an inflatable balloon element at a distal apparatus end in fluid communication with a hollow tube, and a rod element spring loaded at a proximal apparatus end 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, and also wherein said rod element is spring loaded to automatically apply axial tensioning to the balloon element during a balloon deflation.

27. A dilatation apparatus able to fit through a narrow opening, said dilatation apparatus comprising an inflatable balloon element at a distal apparatus end in fluid communication with a hollow tube, and a rod element spring loaded at a proximal apparatus end running through the interior of the hollow tube and the inflatable balloon element, wherein said balloon element is inflated 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, and also wherein said rod element comprises concentric inner and outer tubular members.

28. A dilatation apparatus able to fit through a narrow opening, said dilatation apparatus comprising an inflatable balloon element at a distal apparatus end in fluid communication with a hollow tube, and a rod element spring loaded at a proximal apparatus end 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, and also 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.

29. A dilatation 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 spring inside the tubular shell, 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 the spring;

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.

30. A medical dilatation apparatus having proximal and distal ends and adapted to fit through a narrow opening into a body location, said dilatation apparatus comprising an inflatable balloon 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, and a spring element which, when compressed, applies axial and/or rotational forces 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 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.