Photodynamic bone stabilization systems and methods for reinforcing bone

• US 8,512,338 B2
• Filed: 04/07/2010
• Issued: 08/20/2013
• Est. Priority Date: 04/07/2009
• Status: Active Grant

• Current Assignee: Illuminoss Medical, Inc.
• Original Assignee: Illuminoss Medical, Inc.
• Inventors: Rabiner, Robert A., Colleran, Dennis P., O'Leary, Anthony W., Chang, Narissa Y., Kornbluth, Douglas A., Dye, Justin G., Morin, Joshua M.
• Primary Examiner(s): Robert, Eduardo C
• Assistant Examiner(s): HARVEY, JULIANNA NANCY
• Application Number:
  US12/755,784
• Publication Number:
  US 20100262069A1
• Time in Patent Office: 1,231 Days
• Field of Search: 606 92- 95, 606 62- 63, 606/262
• US Class Current: 606/63
• 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 17/7275 with expanding cylindrical parts
• CPC Class Codes: A61B 17/8836 for heating, cooling or curing of bone cement or fluid fillers
• CPC Class Codes: A61B 2017/00411 actuated by application of energy from an energy source outside the body
• CPC Class Codes: A61B 2018/1807 using light other than laser radiation
• CPC Class Codes: A61N 2005/063 comprising light transmitting means, e.g. optical fibres
• CPC Class Codes: A61N 5/0601 Apparatus for use inside the body
• CPC Class Codes: A61N 5/062 Photodynamic therapy, i.e. excitation of an agent

Abstract

Photodynamic bone stabilization systems are disclosed herein. In an embodiment, a photodynamic bone stabilization system includes a catheter having an elongated shaft with a proximal end adapter, a distal end releasably engaging an expandable portion, and a longitudinal axis therebetween; a light-conducting fiber configured to transmit light energy to the expandable portion; a light-sensitive liquid monomer comprising an initiator, wherein the initiator is activated when the light-conducting fiber transmits the light energy to initiate polymerization of the light-sensitive liquid monomer; and a cooling medium configured to control polymerization temperature, wherein the catheter comprises an inner void sufficiently designed to pass the light-sensitive liquid monomer into the expandable portion, and wherein the catheter comprises an inner lumen sufficiently designed to pass the light-conducting fiber into the expandable portion and configured to circulate the cooling medium.

Claims

1. A photodynamic bone stabilization system comprising:

a catheter having an elongated shaft with a proximal end adapter, a distal end releasably engaging an expandable portion, and a longitudinal axis therebetween, the catheter comprising;

an inner lumen extending longitudinally within the catheter from the proximal end into the expandable portion at the distal end, and wherein a septum lumen divides the inner lumen into a cooling medium intake lumen and a cooling medium return lumen; and

an inner void;

a light-conducting fiber configured to transmit light energy to the expandable portion, wherein the light-conducting fiber is sized to pass within a longitudinal length of the septum lumen;

a light-sensitive liquid monomer comprising an initiator, wherein the initiator is activated when the light-conducting fiber transmits the light energy to initiate polymerization of the light-sensitive liquid monomer;

a cooling medium configured to control polymerization temperature, wherein the cooling medium enters the inner lumen through the cooling medium intake lumen and exits the inner lumen through the cooling medium return lumen; and

a pressurizing medium configured to control polymerization shrinkage,

wherein the inner lumen comprises at least two separate areas configured to expand when the pressurizing medium is delivered to the inner lumen to cause internal diameter pressure against the light-sensitive liquid monomer contained within the expandable portion during polymerization.

2. The system of claim 1 wherein the proximal end adapter comprises:

a first adapter for infusion of the light-sensitive liquid;

a second adapter for infusion of the cooling medium; and

a third adapter for introduction of the light-conducting fiber.

3. The system of claim 1 wherein the expandable portion is fabricated from a thin-walled, non-compliant PET nylon aramet.

4. The system of claim 1 wherein the cooling medium is one of saline or water.

5. The system of claim 1 wherein the light-conducting fiber is an optical fiber configured to transmit light with a wavelength between about 420 nanometers and about 500 nanometers.

6. The system of claim 1 wherein at least a portion of the inner lumen is expandable when pressurized with air or other fluids, the expandable portions configured to prevent effects of polymerization shrinkage during curing of the light-sensitive liquid.

7. The system of claim 1 wherein the expandable portion includes stiffening members for selectively stiffening the expandable portion.

8. The system of claim 7 wherein the stiffening members are positioned radially around an outside surface of the expandable portion.

9. The system of claim 7 wherein the stiffening members are positioned radially around an inner surface of the expandable portion.

10. The system of claim 7 wherein the stiffening members are fabricated from metallic memory-type metal piece(s).

11. A photodynamic bone stabilization system comprising:

a light-conducting fiber configured to transmit light energy;

a light-sensitive liquid monomer comprising an initiator, wherein the initiator is activated when the light-conducting fiber transmits the light energy;

a pressurizing medium configured to control polymerization shrinkage; and

a catheter having an elongated shaft with a proximal end adapter, a distal end releasably engaging an expandable portion, and a longitudinal axis therebetween,

wherein the catheter comprises an inner void and an inner lumen,

wherein the inner void is sufficiently designed to pass the light-sensitive liquid monomer into the expandable portion, and wherein entry of the light-sensitive liquid monomer into the expandable portion moves the expandable portion from a deflated state to an inflated state,

wherein the inner lumen is sufficiently designed to pass the light-conducting fiber into the expandable portion, and

wherein the inner lumen comprises at least two separate areas configured to expand when the pressurizing medium is delivered to the inner lumen so as to cause internal diameter pressure against the light-sensitive liquid monomer contained within the expandable portion during polymerization.

12. The system of claim 11 further comprising:

a cooling medium configured to control polymerization temperature of the expandable portion.

13. A method comprising:

providing a system comprising;

a catheter having an elongated shaft with a proximal end adapter, a distal end releasably engaging an expandable portion, and a longitudinal axis therebetween, the catheter comprising;

an inner lumen extending longitudinally within the catheter into the expandable portion, wherein a septum lumen divides the inner lumen into a cooling medium intake lumen and a cooling medium return lumen; and

an inner void having a first section formed along the longitudinal axis of the catheter between an outer surface of the inner lumen and an inner surface of the elongated shaft of the catheter and a second section formed between an outer surface of the inner lumen and an inner surface of the expandable portion;

a light-conducting fiber configured to transmit light energy to the expandable portion, wherein the light-conducting fiber is sized to pass within a longitudinal length of the septum lumen;

a light-sensitive liquid monomer comprising an initiator, wherein the initiator is activated when the light-conducting fiber transmits the light energy, to initiate polymerization of the light-sensitive liquid monomer, and wherein the light-sensitive liquid monomer is delivered through the first section and the second section of the inner void into the expandable portion to move the expandable portion from a deflated state to an inflated state;

a cooling medium configured to control polymerization temperature, wherein the cooling medium enters the inner lumen through the cooling medium intake lumen and exits the inner lumen through the cooling medium return lumen; and

a pressurizing medium configured to control polymerization shrinkage, wherein the inner lumen comprises at least two separate areas configured to expand when the pressurizing medium is delivered to the inner lumen to cause internal diameter pressure against the light-sensitive liquid monomer contained within the expandable portion during polymerization,

inserting the expandable portion of the system into an intramedullary canal spanning a fracture site comprising a plurality of fractured pieces;

infusing the light-sensitive liquid monomer into the inner void of the catheter so that the light-sensitive liquid monomer expands the expandable portion until the fractured pieces are substantially restored to their natural positions;

inserting the light-conducting fiber into the septum lumen of the catheter so that the light-conducting fiber resides in the expandable portion;

activating the light-conducting fiber to transmit light energy to the expandable portion to initiate in situ polymerization of the light-sensitive liquid monomer within the expandable portion;

delivering the pressurizing medium to the inner lumen of the catheter;

infusing the cooling medium into the cooling medium intake lumen of the catheter to control polymerization temperature; and

completing the in situ polymerization of the light-sensitive liquid monomer to harden the expandable portion at the fracture site.

14. The method of claim 13 further comprising removing the light-conducting fiber from the catheter.

15. The method of claim 13 further comprising releasing the expandable portion from the catheter.

16. The method of claim 13 wherein the hardened expandable portion stabilizes the fracture site.

17. The method of claim 13 wherein the hardened expandable portion maintains the positions of the plurality of fractured pieces of bone while the bone heals.

18. The method of claim 13 wherein the hardened expandable portion immobilizes joints above and below the fracture site.