Apparatus and methods for bone, tissue and duct dilatation

• US 8,216,182 B2
• Filed: 02/06/2009
• Issued: 07/10/2012
• 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:
  US12/322,825
• Publication Number:
  US 20090177153A1
• Time in Patent Office: 1,250 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 comprising a rod having proximal and distal ends extending through the channel to the balloon at the distal end of the rod;

(d) a sealing gasket inside the proximal end of the channel having a centrally-located aperture to accommodate the rod, whereby under compression the sealing gasket forms a fluid-tight seal of the channel; and

,

(e) a rod control element connected to the proximal end of the rod whereby the rod can be moved in a proximal or distal direction and/or rotated from a location outside the conduit.

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 axial force can be applied manually or automatically to 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 rotational force can be applied manually or automatically 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 said rod is positioned sufficiently in a distal direction to cause axial tensioning and elongation of the balloon element.

9. An assembly according to claim 1 wherein said rod is rotated sufficiently to cause wrapping and rotational tensioning of the balloon element.

10. An assembly according to claim 1 wherein said rod is positioned sufficiently in a distal direction and is rotated sufficiently to cause both axial and rotational tensioning of the balloon element.

11. An assembly according to claim 1 wherein said rod control element comprises a knob at the proximal end of the rod.

12. An assembly according to claim 1 wherein the rod is hydraulically or pneumatically actuated.

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

14. 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.

15. An assembly according to claim 1 wherein said rod 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.

16. 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 apparatus;

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 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 and internal threads sized to mate with the external threads at the proximal end of the first branch, whereby the cap element engages the proximal end of the first branch;

the rod 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.

17. An assembly with proximal and distal ends for bone, tissue and/or duct dilatation of a living being comprising in combination:

(a) a tube having a fluid inlet at a tube proximal end, a fluid outlet at a tube distal end, and a tube lumen extending between the fluid inlet and the fluid outlet;

(b) an inflatable and deflatable balloon element having a balloon interior and balloon proximal and distal ends in fluid communication with the tube lumen; and

, (c) a balloon tensioning and/or balloon wrapping device for stretching the balloon element and/or folding, pleating or wrapping the balloon element before and/or after inflation to facilitate insertion and/or removal of the balloon element through a narrow diameter duct, access channel or cannula, said balloon tensioning and/or balloon wrapping device comprising at least a rod slidably extending through at least a part of said tube lumen and said balloon interior such that the rod can be externally manipulated by moving it in a distal direction to apply an axial stretching force to the balloon and/or it can be externally rotated to at least partly wrap the balloon element and apply rotational tensioning to the balloon element;

said assembly further comprising;

a threaded portion at the proximal end of the assembly;

a threaded cap element sized to mate with the threaded portion, wherein the cap element includes a centrally-located axial bore to accommodate the rod, and the rod includes a section that extends through the axial bore of the cap element; and

a sealing gasket in the interior of the threaded portion, said gasket having a centrally-located aperture in alignment with the axial bore of the cap element to accommodate the rod, whereby the cap element engages the threaded portion such that by turning the cap element the sealing gasket is compressed to form a fluid-tight seal at the proximal end of the assembly.

18. An assembly with proximal and distal ends for bone, tissue and/or duct dilatation of a living being comprising in combination:

an inflatable and deflatable medical balloon having a balloon interior;

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;

a rod having proximal and distal ends extending through the channel to the balloon; and

,

a knob element connected to the proximal end of the rod for manual manipulation of the rod;

further wherein the assembly comprises;

a threaded portion at its proximal end;

a threaded cap element sized to mate with the threaded portion, wherein the cap element includes a centrally-located axial bore to accommodate the rod, and the rod includes a section that extends through the axial bore of the cap element; and

a sealing gasket in the interior of the threaded portion, said gasket having a centrally-located aperture in alignment with the axial bore of the cap element to accommodate the rod, whereby the cap element engages the threaded portion such that by turning the cap element the sealing gasket is compressed to form a fluid-tight seal at the proximal end of the assembly.