PHOTODYNAMIC BONE STABILIZATION AND DRUG DELIVERY SYSTEMS

• US 20110313356A1
• Filed: 04/18/2011
• Published: 12/22/2011
• Est. Priority Date: 06/21/2010
• Status: Active Grant

• Current Assignee: Illuminoss Medical, Inc.
• Original Assignee: Illuminoss Medical, Inc.
• Inventors: Rabiner, Robert A., Rader, Richard Scott
• Granted Patent: US 8,684,965 B2
• Time in Patent Office: Days
• US Class Current: 604/103.02
• 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 17/7098 wherein the implant is permeable or has openings, e.g. fenestrated screw hollow surgical screws A61B17/864
• 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 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2017/00411 actuated by application of energy from an energy source outside the body
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2205/0244 Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61N 2005/0612 using probes penetrating tissue; interstitial probes
• CPC Class Codes: A61N 2005/063 comprising light transmitting means, e.g. optical fibres
• CPC Class Codes: A61N 5/062 Photodynamic therapy, i.e. excitation of an agent

Abstract

Photodynamic bone stabilization and drug delivery systems are disclosed herein. In an embodiment, a photodynamic bone stabilization and drug delivery system of the present disclosure includes an insertion catheter having an inner void for passing at least one light-sensitive liquid, and an inner lumen; an expandable portion releasably engaging a distal end of the insertion catheter, wherein the expandable portion comprises an inner expandable portion in communication with the inner lumen of the insertion catheter and sufficiently designed to maintain a light-sensitive liquid therein; and an outer expandable portion, surrounding the inner expandable portion, sufficiently designed to house and release at least one additive from the outer expandable portion in an outward direction from the inner expandable portion; and a light-conducting fiber sized to pass through the inner lumen of the insertion catheter and into the inner expandable portion for delivering light energy to the light-sensitive liquid.

Claims

1. A photodynamic bone stabilization and drug delivery system for repairing a fractured bone comprising:

an insertion catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, the insertion catheter having an inner void for passing at least one light-sensitive liquid, and an inner lumen;

an expandable portion releasably engaging the distal end of the insertion catheter, wherein the expandable portion comprises;

an inner expandable portion fabricated from a non-permeable material, wherein the inner expandable portion is in communication with the inner lumen of the insertion catheter and wherein the inner expandable portion is sufficiently designed to maintain a light-sensitive liquid within the inner expandable portion; and

an outer expandable portion, surrounding the inner expandable portion, sufficiently designed to house and release at least one additive from the outer expandable portion in an outward direction from the inner expandable portion; and

a light-conducting fiber, wherein the light-conducting fiber is sized to pass through the inner lumen of the insertion catheter and into the inner expandable portion for delivering light energy to the light-sensitive liquid.

2. The system of claim 1, wherein the light-conducting fiber emits light radially in a uniform manner along a length of the light-conducting fiber.

3. The system of claim 1, wherein the outer expandable portion includes one or more porous sections designed to release the at least one additive.

4. The system of claim 1, wherein the outer expandable portion is fabricated from a porous polymer.

5. The system of claim 1 further comprising a tube in fluid communication with the outer expandable portion and a port disposed at a distal end of the tube.

6. The system of claim 1 wherein at least one of the outer expandable portion or the inner expandable portion includes a surface that is textured.

7. A photodynamic bone stabilization and drug delivery system for repairing a fractured bone comprising:

an insertion catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, the insertion catheter having an inner void for passing at least one light-sensitive liquid, and an inner lumen;

an expandable portion releasably engaging the distal end of the insertion catheter, wherein the expandable portion is movable from a deflated state to an inflated state when a light-sensitive liquid is delivered to the expandable portion;

one ore more surface layers disposed along an outer surface of the expandable portion, wherein the one or more surface layers are sufficiently designed to release at least one additive; and

a light-conducting fiber, wherein the light-conducting fiber is sized to pass through the inner lumen of the insertion catheter and into the expandable portion for delivering light energy to the light-sensitive liquid.

8. The system of claim 7, wherein the light-conducting fiber emits light radially in a uniform manner along a length of the light-conducting fiber.

9. The system of claim 7, wherein the one or more surface layers include a plurality of pores filled with the at least one additive.

10. The system of claim 9, wherein the pores are moveable between a substantially closed position for preventing release of the at least one additive when the expandable portion is in the deflated state to a substantially open position to release the at least one additive when the expandable portion is in the inflated state.

11. A method for repairing a fractured bone comprising:

delivering to an inner cavity of the fractured bone an expandable portion releasably engaging a distal end of an insertion catheter, wherein the expandable portion comprises;

an inner expandable portion fabricated from a non-permeable material, wherein the inner expandable portion is in communication with an inner lumen of the insertion catheter and wherein the inner expandable portion is sufficiently designed to maintain a light-sensitive liquid within the inner expandable portion; and

an outer expandable portion, surrounding the inner expandable portion, sufficiently designed to house and release at least one first additive from the outer expandable portion in an outward direction from the inner expandable portion; and

infusing a light-sensitive liquid through an inner void of the insertion catheter into the inner expandable portion to move the expandable portion from an initial deflated state to a final inflated state;

inserting a light-conducting fiber into the inner lumen of the insertion catheter;

activating the light-conducting fiber so as to cure the light sensitive liquid within the inner expandable portion;

delivering at least one first additive locally to the fractured bone by releasing the at least one additive from the outer expandable portion; and

releasing the expandable portion from the insertion catheter.

12. The method of claim 11, wherein the expandable portion comprises one or more surface layers having a plurality of pores filled with the at least one first additive and disposed on an outer surface of the expandable portion.

13. The method of claim 11, wherein the expandable portion comprises a first inner void for receiving the light sensitive liquid and a second inner void for receiving the at least one first additive.

15. The method of claim 11 further comprising a step of refilling the outer expandable portion with at least one first additive.

16. The method of claim 15, wherein the at least one first additive is refilled from a pump located outside the inner cavity of the fractured bone through a port in fluid communication with the outer expandable portion.

17. The method of claim 11 further comprising a step of adding at least one second additive to the outer expandable portion to release the, so that the at least one second additive is released within the medullary cavity.

14. The method of claim 14, wherein at least a section of an outer wall of the second inner void is porous to enable the release of the at least one first additive from the second inner void.

18. A system for local delivery of at least one additive to a medullary cavity of a bone comprising:

an insertion catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, the insertion catheter having one or more inner lumens;

an expandable portion releasably engaging the distal end of the insertion catheter, wherein the expandable portion comprises;

an inner expandable portion fabricated from a non-permeable material, wherein the inner expandable portion is in communication with an inner lumen of the insertion catheter and wherein the inner expandable portion is sufficiently designed to maintain a first fluid within the inner expandable portion; and

an outer expandable portion, surrounding the inner expandable portion, sufficiently designed to house and release at least one additive from the outer expandable portion in an outward direction from the inner expandable portion;

a tube fluidly connected to the outer expandable portion at a first end and fluidly connected to a port at a second end, such that, following the implantation of the expandable portion in a medullary cavity, the outer expandable portion can be filled with the at least one additive through the port from outside the medullary cavity.

19. The system of claim 18 further comprising an external pump positioned outside the medullary cavity and connectable to the port to supply the at least one additive to the outer expandable portion from the medullary cavity.

20. The system of claim 18, wherein the tube is removably attached to the outer expandable portion, such that the tube can be detached from the outer expandable portion without disruption of the medullary cavity.

21. A method for site specific delivery of at least one additive to a medullary cavity of a fractured bone comprising:

implanting the expandable portion of the system of claim 18 into a medullary cavity of a fractured bone;

connecting the port to a pump positioned outside the medullary cavity, so as to fill the outer expandable portion with at least one additive stored in an external reservoir;

delivering at least one additive locally to the fractured bone by releasing the at least one additive from the outer expandable portion.

22. The method of claim 21 further comprising changing the composition or concentration of the at least one additive during a healing process per specifications of a physician.