DEVICES AND METHODS FOR BONE ALIGNMENT, STABILIZATION AND DISTRACTION

• US 20150080900A1
• Filed: 11/24/2014
• Published: 03/19/2015
• 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 9,125,706 B2
• Time in Patent Office: Days
• US Class Current: 606/93
• 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 method of maintaining distraction of a 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 a light-sensitive liquid through the open end into an open inner cavity of the expandable body that adjustably changes the changeable dimension of the distraction thickness of the expandable body, wherein the amount of light-sensitive liquid is substantially equivalent to the amount of the first fluid, the expandable body has an insertion depth with a fixed dimension, a width with a fixed dimension, and a distraction thickness with a changeable dimension;

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.

2. The method of claim 1, further comprising distracting the distal radius bone so that a radial length of the distal radius bone is returned to a normal range of about 12 mm.

3. The method of claim 1, further comprising distracting the distal radius bone so that a palmar tilt of the distal radius bone is returned to a normal range of about 11°

.

4. The method of claim 1, further comprising changing the changeable dimension of the distraction thickness of the expandable body by adding or removing the light sensitive liquid, without changing the dimension of the insertion depth and the dimension of the width of the expandable body.

5. The method of claim 1, wherein the insertion depth is a length between the sealable open end and the closed end of the expandable body.

6. A bone implant system comprising:

a light-sensitive liquid;

a light-conducting fiber for delivering a light energy 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 distraction thickness with a changeable dimension, and

wherein entry of the light-sensitive liquid through the open end into an open the inner cavity of the expandable body adjustably changes the changeable dimension of the distraction thickness of the expandable body.

7. The system of claim 6, wherein entry of the light-sensitive liquid through the open end into an open the inner cavity of the expandable body adjustably changes the changeable dimension of the distraction thickness of the expandable body, without changing the dimension of the insertion depth and the dimension of the width of the expandable body.

8. The system of claim 6, wherein the light-sensitive liquid is a liquid monomer that polymerizes at a wavelength between about 400 nanometers and about 470 nanometers, such that the light energy has a wavelength between about 400 nanometers and about 470 nanometers.

9. The system of claim 6, wherein the expandable body is infused with a light-sensitive liquid, and has a final cured photodynamic expandable body with a distraction of about 2 mm to about 12 mm to bone fragments.

10. The system of claim 6, wherein the insertion depth is a length between the sealable open end and the closed end of the expandable body.

11. The system of claim 6, wherein a portion of an external surface of the expandable body invaginates to form at least one textured element.

12. The system of claim 6, wherein the expandable body is one of an acorn shape, a triangular shape or a trapezoidal shape.

13. The system of claim 6, wherein the expandable body includes at least one rib that is one of a concave rib, a convex rib, such that the at least one rib has a width of about 2 mm to 4 mm, and the width of two or more ribs is one of a same rib width or a varying rib width.

14. The system of claim 6, wherein the expandable body has at least one textured element having one of a convex shape, a concave shape, or an outer textured element partially or completely circumferential around a width of the expandable body.

15. A bone implant system comprising:

a light-sensitive liquid;

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

a delivery catheter having 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 engaged to a distal end of the delivery catheter and defining an inner cavity for receiving the light-sensitive liquid, the expandable body having a closed end, a sealable open end and two or more fixation fibers embedded therein to fix dimensions of an insertion depth and a width of the expandable member,

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

wherein a distraction thickness of the expandable is changeable by the entry of the light-sensitive liquid into the inner cavity of the expandable body, without changing the dimension of the insertion depth and the dimension of the width of the expandable body,

wherein, when the light-sensitive liquid is cured inside the inner cavity of the expandable body, the expandable body is removable from the delivery catheter to form a rigid photodynamic bone implant to provide distraction and support to the bone.

16. The system of claim 15, wherein the insertion depth is a length between the sealable end and the closed end of the expandable body.

17. The system of claim 15, wherein the photodynamic bone implant has a compressive modulus approximate to that of a cancellous bone.

18. The system of claim 15, wherein the light-sensitive liquid is a liquid monomer that polymerizes at a wavelength between about 400 nanometers and about 470 nanometers.

19. The system of claim 15, wherein at least a portion of an external surface of the expandable body includes at least one textured element.

20. The system of claim 15, wherein the expandable body is manufactured from a non-compliant conformable material.