Devices and Methods for Bone Alignment, Stabilization and Distraction

• US 20130013008A1
• Filed: 09/14/2012
• Published: 01/10/2013
• Est. Priority Date: 08/19/2009
• Status: Active Grant

• Current Assignee: Illuminoss Medical, Inc.
• Original Assignee: Illuminoss Medical, Inc.
• Inventors: Rabiner, Robert A., O'Leary, Anthony W., Chang, Narissa Y., Weiss, Arnold-Peter C., Bainbridge, Lionel C.
• Granted Patent: US 8,915,966 B2
• Time in Patent Office: Days
• US Class Current: 606/86.R
• CPC Class Codes: A61B 17/56 Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
• 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 17/8095 Wedge osteotomy devices
• CPC Class Codes: A61B 17/8811 characterised by the introducer tip, i.e. the part inserted into or onto the bone
• 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 2017/00411 actuated by application of energy from an energy source outside the body
• CPC Class Codes: A61B 2017/883 Means for indicating hardening of bone cement
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/4696 optical
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• 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

An embodiment of a bone stabilization and distraction system of the present disclosure includes a light-sensitive liquid; a light source for providing light energy; a light-conducting fiber for delivering the light energy from the light source to cure the light-sensitive liquid; a delivery catheter having a proximal end in communication with the light-conducting fiber and the light-sensitive liquid, an inner lumen for passage of the light-conducting fiber, and an inner void for passage of the light-sensitive liquid; and an expandable body removably engaging a distal end of the delivery catheter, wherein the expandable body has a closed end, a sealable open end, an inner cavity for passage of the light-sensitive liquid, an external surface and an internal surface, and wherein the expandable body has an insertion depth with a fixed dimension, a width with a fixed dimension, and a thickness with a changeable dimension.

Claims

1. A bone implant comprising:

an expandable body having a closed end, a sealable open end, an inner cavity, an external surface and an internal surface,

wherein the expandable body has an insertion depth with a fixed dimension, a width with a fixed dimension, and a thickness with a changeable dimension, and

wherein entry of a fluid into the inner cavity of the expandable body changes the dimension of the device thickness.

2. The bone implant of claim 1 wherein entry of the fluid into the inner cavity of the expandable body changes the dimension of the device thickness without changing the dimension of the insertion depth and the dimension of the width.

3. The bone implant of claim 1 wherein the expandable body is manufactured from a non-compliant conformable material.

4. The bone implant of claim 1 wherein the expandable body is manufactured from polyethylene terephthalate (PET).

5. The bone implant of claim 1 wherein at least a portion of the external surface of the expandable body is substantially even and smooth.

6. The bone implant of claim 1 wherein at least a portion of the external surface of the expandable body includes at least one textured element.

7. The bone implant of claim 6 wherein the at least one textured element is selected from one of ribs, ridges or bumps.

8. The bone implant of claim 1 wherein the insertion depth of the expandable body ranges from about 10 mm to about 25 mm.

9. The bone implant of claim 1 wherein the width of the expandable body ranges from about 8 mm to about 25 mm.

10. The bone implant of claim 1 wherein a final thickness of the expandable body ranges from about 2 mm to about 25 mm.

11. A bone implant system comprising:

a light-sensitive liquid;

a light source for providing light energy;

a light-conducting fiber for delivering the light energy from the light source to cure the light-sensitive liquid;

a delivery catheter having a proximal end in communication with the light-conducting fiber and the light-sensitive liquid, an inner lumen for passage of the light-conducting fiber, and an inner void for passage of the light-sensitive liquid; and

an expandable body removably engaging a distal end of the delivery catheter,

wherein the expandable body has a closed end, a sealable open end, an inner cavity for passage of the light-sensitive liquid, an external surface and an internal surface,

wherein the expandable body has an insertion depth with a fixed dimension, a width with a fixed dimension, and a thickness with a changeable dimension, and

wherein entry of the light-sensitive liquid into the inner cavity of the expandable body changes the dimension of the device thickness.

12. The system of claim 11 wherein entry of the fluid into the inner cavity of the expandable body changes the dimension of the device thickness without changing the dimension of the insertion depth and the dimension of the width.

13. The system of claim 11 wherein the light-sensitive liquid is a liquid monomer that polymerizes at a wavelength between about 400 nanometers and about 470 nanometers.

14. The system of claim 11 wherein the light source provides light energy having a wavelength between about 400 nanometers and about 470 nanometers.

15. The system of claim 11 wherein the light-conducting fiber is an optical fiber.

16. The system of claim 11 wherein the expandable body is manufactured from a non-compliant conformable material.

17. The system of claim 11 wherein at least a portion of the external surface of the expandable body includes at least one textured element.

18. A method of maintaining distraction of a fractured distal radius bone comprising:

providing temporary distraction to a fractured distal radius bone to provide a distraction gap;

delivering an expandable body in an unexpanded state into the distraction gap;

infusing a first fluid into the expandable body to expand the expandable body so that a desired amount of distraction is achieved at the distraction gap;

removing the first fluid from the expandable body;

determining an amount of the first fluid removed from the expandable body;

infusing an amount of light-sensitive liquid into the expandable body to expand the expandable body, wherein the amount of light-sensitive liquid is substantially equivalent to the amount of the first fluid;

curing the light-sensitive liquid in the expandable body to form a rigid photodynamic device; and

maintaining a desired amount of distraction at the distraction gap.

19. The method of claim 18 wherein implanting the photodynamic device into the distraction gap distracts the distal radius bone so that a radial length of the distal radius bone is returned to a normal range of about 12 mm.

20. The method of claim 18 wherein implanting the photodynamic device into the distraction gap distracts the distal radius bone so that a palmar tilt of the distal radius bone is returned to a normal range of about 11°

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