SYSTEMS AND METHODS FOR TREATING CONDITIONS AND DISEASES OF THE SPINE

• US 20160022333A1
• Filed: 10/05/2015
• Published: 01/28/2016
• Est. Priority Date: 12/22/2010
• Status: Active Grant

• Current Assignee: Illuminoss Medical, Inc.
• Original Assignee: Illuminoss Medical, Inc.
• Inventors: Rabiner, Robert A., DiPoto, Gene P.
• Granted Patent: US 9,855,080 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61B 17/8802 Equipment for handling bone cement or other fluid fillers
• 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 17/8833 Osteosynthesis tools specially adapted for handling bone cement or fluid fillers; Means for supplying bone cement or fluid fillers to introducing tools, e.g. cartridge handling means
• CPC Class Codes: A61B 17/8836 for heating, cooling or curing of bone cement or fluid fillers
• CPC Class Codes: A61B 17/885 Tools for expanding or compacting bones or discs or cavities therein A61B17/8805, A61B17/7097 take precedence
• CPC Class Codes: A61B 17/8852 capable of being assembled or enlarged, or changing shape, inside the bone or disc
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2090/306 using optical fibres
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2002/30581 having a pocket filled with fluid, e.g. liquid
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30971 Laminates, i.e. layered products
• CPC Class Codes: A61F 2002/4495 having a fabric structure, e.g. made from wires or fibres

Abstract

Systems and methods for treating conditions and diseases of the spine are disclosed herein. A device includes a balloon catheter comprising at least one inner lumen incorporated within an elongated shaft; a distal end having an inner balloon positioned inside and completely surrounded by an outer balloon; and a proximal end having an adapter for passage of at least one of an inflation fluid or a medical instrument; and an optical fiber comprising an outer diameter sized to pass through the inner lumen of the elongated shaft; a nonlinear light-emitting portion of a given length, wherein a portion of a cladding material from the nonlinear light-emitting portion has been removed so that light energy may be emitted along the length of the nonlinear light-emitting portion; and a linear elongated portion for guiding light towards the nonlinear light-emitting portion.

Claims

1. A device comprising:

a balloon catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, the balloon catheter comprising;

at least a first inner balloon positioned inside an outer balloon, the balloons located at the distal end of the balloon catheter, the outer balloon having a flat top side and a flat bottom side;

an optical fiber having a core surrounded by a cladding material, the optical fiber comprising;

a nonlinear light-emitting portion including a plurality of spaced apart cuts in the cladding material along a length of the nonlinear light-emitting portion exposing the core so that light energy may be emitted from the core along the length of the nonlinear light-emitting portion; and

a linear elongated portion for guiding light towards the nonlinear light-emitting portion,

wherein the optical fiber has a curved conformation in which the nonlinear light-emitting portion of the optical fiber forms at least one loop around the first inner balloon from inside the outer balloon.

2. The device of claim 1 wherein the balloon catheter has an outside diameter ranging from about 3 mm to about 8 mm.

3. The device of claim 1 wherein the optical fiber has an outside diameter ranging from about 0.75 mm to about 2.0 mm.

4. The device of claim 1 wherein spaces between the cuts decrease toward a distal end of the optical fiber to harden the light-sensitive fluid in a substantially circumferential uniform light intensity when the optical fiber is in the curved conformation.

5. The device of claim 1 wherein the outer balloon has a toroidal shape.

6. The device of claim 1 further comprising a second inner balloon having an oval shape.

7. The device of claim 1 wherein the optical fiber further comprises:

a relaxed condition in which the nonlinear light-emitting portion of the optical fiber assumes the curved conformation;

a stretched condition in which the nonlinear light-emitting portion of the optical fiber has a linear conformation in which the nonlinear light-emitting portion of the optical fiber can be advanced through the inner lumen of the elongated shaft of the balloon catheter; and

a memory which returns the nonlinear light-emitting portion from the stretched condition to the relaxed condition.

8. The device of claim 7 wherein the curved conformation of the nonlinear light-emitting portion forms a candy cane shape.

9. The device of claim 7 wherein the curved conformation of the nonlinear light-emitting portion forms a U shape.

10. The device of claim 7 wherein the curved conformation of the nonlinear light-emitting portion forms a coiled shape having multiple loops.

11. The device of claim 7 wherein the curved conformation of the nonlinear light-emitting portion forms a convoluted shape.

12. The device of claim 7 wherein the nonlinear light-emitting portion includes cuts in the cladding material forming a helical design along a length of the optical fiber.

13. A system for treatment of an intervertebral disc comprising:

a balloon catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, the balloon catheter comprising;

a first inner balloon positioned inside an outer balloon, the balloons located at the distal end of the balloon catheter, the outer balloon having a flat top side and a flat bottom side; and

an optical fiber having a core surrounded by a cladding material, the optical fiber comprising;

a nonlinear light-emitting portion including a plurality of spaced apart cuts in the cladding material along a length of the nonlinear light-emitting portion exposing the core so that light energy may be emitted from the core along the length of the nonlinear light-emitting portion;

a linear elongated portion for guiding light towards the nonlinear light-emitting portion;

wherein, the optical fiber has a relaxed condition in which the nonlinear light-emitting portion of the optical fiber assumes a curved conformation, in which the nonlinear light-emitting portion of the optical fiber forms at least one loop around the first inner balloon, and has a stretched condition in which the nonlinear light-emitting portion of the optical fiber has a linear conformation in which the nonlinear light-emitting portion of the optical fiber can be advanced through the inner lumen of the elongated shaft of the balloon catheter;

a light-sensitive fluid; and

a light source.

14. The system of claim 13 wherein the first inner balloon and the outer balloon are concentric relative to one another.

15. The system of claim 13 wherein the curved conformation of the nonlinear light-emitting portion forms one of a candy cane shape, a U shape or a coiled shape having multiple loops.

16. The system of claim 13 wherein spaces between the cuts decrease toward a distal end of the optical fiber to harden the light-sensitive fluid in a substantially circumferential uniform light intensity when the optical fiber is in the curved conformation.

17. The system of claim 13 wherein the light-sensitive fluid has a viscosity ranging from about 650 cP to about 450 cP.

18. The system of claim 13 wherein the cuts in the cladding material form a helical design along a length of the optical fiber.

19. A method for repairing a vertebral compression fracture comprising:

gaining access to a collapsed vertebrae;

delivering to the collapsed vertebrae, in an unexpanded state, an expandable member having a first inner balloon positioned inside and completely surrounded by an outer balloon;

injecting an inflation fluid into the outer balloon to expand the outer balloon and to temporarily restore height of the collapsed vertebrae;

maintaining the expanded outer balloon while injecting a light-curable fluid into the inner balloon to expand the inner balloon within the expanded outer balloon;

positioning an optical fiber sufficiently designed to emit light energy along a length of the optical fiber inside the expandable member, wherein the optical fiber is connected to a light source;

activating the light source;

delivering light energy to the optical fiber from the light source; and

curing the light-curable fluid inside the inner balloon to harden the inner balloon within the expanded outer balloon.

20. The method of claim 19 further comprising removing the inflation fluid from the outer balloon after curing the light-curable fluid inside the inner balloon.