Systems and methods for treating conditions and diseases of the spine

• US 9,179,959 B2
• Filed: 12/22/2011
• Issued: 11/10/2015
• 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.
• Primary Examiner(s): Beccia, Christopher
• Assistant Examiner(s): Jones, Diana S
• Application Number:
  US13/335,110
• Publication Number:
  US 20120165941A1
• Time in Patent Office: 1,419 Days
• Field of Search: 623/17.12, 606/99, 606246-249
• 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 one inner lumen incorporated within the elongated shaft;

two or more inflatable balloons including at least a first inner inflatable balloon positioned inside and completely surrounded by a first outer inflatable balloon, the balloons located at the distal end; and

an adapter for passage of at least one of an inflation fluid or a medical instrument, the adapter located at the proximal end; and

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

an outer diameter sized to pass through the inner lumen of the elongated shaft of the balloon catheter and into one of the two or more inflatable balloons to cure the inflation fluid in at least one inflatable balloon of the two or more inflatable balloons;

a nonlinear light-emitting portion of a given length, the 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 inflatable balloon from inside the first outer inflatable balloon, and

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.

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 the first inner inflatable balloon and the first outer inflatable balloon are concentric relative to one another.

5. 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.

6. The device of claim 5 wherein the curved conformation of the nonlinear light-emitting portion forms a candy cane shape.

7. The device of claim 5 wherein the curved conformation of the nonlinear light-emitting portion forms a U shape.

8. The device of claim 5 wherein the curved conformation of the nonlinear light-emitting portion forms a coiled shape having multiple loops.

9. The device of claim 5 wherein the curved conformation of the nonlinear light-emitting portion forms a convoluted shape.

10. The device of claim 5 wherein the nonlinear light-emitting portion includes cuts in the cladding material forming a helical design along a length of the optical fiber.

11. The device of claim 1 wherein the two inflatable balloons have a diameter size ranging from about 0.5 mm to about 50 mm.

12. The device of claim 1 wherein the optical fiber includes a bend radius of approximately 6 times a diameter of the optical fiber, a temperature stability of up to approximately 90°

C., an acceptance angle of approximately 80° and

a refractive index core of approximately 1.48 or greater.

13. The device of claim 1 wherein each cut in the cladding material causes an internal reflectance from the core to be directed outwards at an angle, wherein each angle changes along the length of the nonlinear light-emitting portion relative to an amount of light dispersed.

14. The device of claim 1 wherein each cut in the cladding material causes an internal reflectance from the core to be directed outwards at an angle, wherein cuts located approximate a distal end and a proximal end of the balloon include a shallower angle than cuts positioned at a middle of the balloon.

15. The device of claim 1 wherein the optical fiber curves around at least one inflatable balloon of the two or more inflatable balloons by one of:

(a) curving around an outer wall or an inner wall of the at least one inflatable balloon of the two or more inflatable balloons;

(b) curving around an outer wall of the first inner inflatable balloon in a separate optical fiber conduit; and

(c) curving inside an inner wall of the first inner inflatable balloon in a separate optical fiber conduit.

16. The device of claim 1 wherein optical fiber uniformly disperses light radially from one of (a) an outside of the first inner inflatable balloon towards an inside of the first inner inflatable balloon to cure the light-sensitive fluid contained therein or (b) an inside the first inner inflatable balloon toward an outside of the first inner inflatable balloon to cure the light-sensitive fluid contained therein.

17. A system 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 one inner lumen incorporated within the elongated shaft;

two or more inflatable balloons including at least a first inner inflatable balloon positioned inside and completely surrounded by a first outer inflatable balloon, the balloons located at the distal end; and

a multipurpose adapter for passage of at least one of an inflation fluid or a medical instrument, the multipurpose adapter located at the proximal end;

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

an outer diameter sized to pass through the inner lumen of the elongated shaft of the balloon catheter and into one of the two or more inflatable balloons to cure the inflation fluid in at least one inflatable balloon of the two or more inflatable balloons;

a nonlinear light-emitting portion of a given length, the 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;

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 forming at least one loop around the first inner inflatable balloon from inside the first outer inflatable balloon,

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;

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;

a light-sensitive fluid; and

a light source.

18. The system of claim 17 wherein the first inner inflatable balloon and the first outer inflatable balloon are concentric relative to one another.

19. The system of claim 17 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.

20. The system of claim 17 wherein the curved conformation of the nonlinear light-emitting portion forms a convoluted shape.

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

22. The system of claim 17 wherein the nonlinear light-emitting portion includes cuts in the cladding material forming a helical design along a length of the optical fiber.

23. A device comprising:

a catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, at least one inner lumen incorporated within the elongated shaft;

two expandable members located at the distal end of the catheter and being in communication with the at least one inner lumen, the two expandable members comprising an outer expandable balloon and an inner expandable balloon;

an adapter located at the proximal end of the catheter for passage of at least one of an inflation fluid or a medical instrument into the expandable member through the catheter; and

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

an outer diameter sized to pass through the at least one inner lumen of the catheter and into one of the two expandable members to cure the inflation fluid in at least one expandable member of the two expandable members;

a nonlinear light-emitting portion having a length, the 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 inflatable balloon from inside the first outer inflatable balloon, and

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.

24. The device of claim 23 wherein the optical fiber further comprises:

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

a stretched condition in which the nonlinear light-emitting portion of the optical fiber has a linear shape 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.