Methods for repairing craniomaxillofacial bones using customized bone plate

• US 9,005,254 B2
• Filed: 01/24/2014
• Issued: 04/14/2015
• Est. Priority Date: 12/26/2007
• Status: Active Grant

• Current Assignee: Illuminoss Medical, Inc.
• Original Assignee: Illuminoss Medical, Inc.
• Inventors: Rabiner, Robert A., Crisco, Joseph John III
• Primary Examiner(s): Bates, David
• Assistant Examiner(s): HANNA, SAMUEL SALEEB
• Application Number:
  US14/163,027
• Publication Number:
  US 20140135847A1
• Time in Patent Office: 445 Days
• US Class Current: 606/285
• CPC Class Codes: A61B 17/8061 specially adapted for particular bones A61B17/70 and A61B17/74 take precedence
• CPC Class Codes: A61B 17/8085 with pliable or malleable elements or having a mesh-like structure, e.g. small strips A61B17/8071, A61B17/8076 take precedence

Abstract

Bone plates and methods of using the bone plates for adjoining bone fragments are disclosed herein. A device for adjoining at least two bone fragments includes a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, wherein the delivery catheter has an inner void for passage of at least one filling material and an inner lumen for passage of a light source; a conformable bone plate releasably engaging the distal end of the delivery catheter, wherein the conformable bone plate has a first surface, a second surface, a proximal end, and a distal end and at least one aperture extending from the first surface to the second surface for receiving a fastener; and an adapter releasably engaging the proximal end of the delivery catheter for receiving the light source and a delivery system housing the at least one filling material.

Claims

1. A method for adjoining at least two craniomaxillofacial bone fragments comprising:

positioning a conformable bone pad in a deflated state over an exterior surface of the at least two craniomaxillofacial bone fragments, the conformable bone pad having an opening engaged to a delivery catheter, the delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis extending therebetween,

wherein the conformable bone pad has at least one through aperture extending from a first bone contacting surface of the conformable bone pad to a second outer surface of the conformable bone pad for receiving a fastener to affix the bone pad to the at least two bone fragments, the conformable bone pad further includes a proximal side surface, an opposing distal side surface, a right side surface and an opposing left side surface extending between the first bone contacting surface and the second outer surface of the conformable bone pad defining an inner space within the conformable bone pad in communication with the elongated shaft of the delivery catheter,

wherein the opening of the conformable bone pad extends through at least one of the proximal and distal side surface of the conformable bone pad;

attaching a delivery system having at least one filling material to the delivery catheter, wherein the elongated shaft of the delivery catheter has an inner void for passage of the at least one filling material through the opening extending through at least one of the proximal and distal side surface of the conformable bone pad to the inner space within the conformable bone pad;

inserting a light fiber into the delivery catheter, wherein the elongated shaft of the delivery catheter has an inner lumen for passage of the light fiber into the conformable bone pad;

infusing the at least one filling material through the elongated shaft of the delivery catheter and into the inner space within the conformable bone pad to expand the conformable bone pad from the deflated state to an inflated state;

activating the light source to harden the at least one filling material in the expanded conformable bone pad;

releasing the hardened conformable bone pad from the delivery catheter; and

affixing the conformable bone pad to the exterior surfaces of the at least two craniomaxillofacial bone fragments to adjoin the bone fragments, by inserting at least one fastener through the at least one aperture of the conformable bone pad and into at least one of the at least two craniomaxillofacial bone fragments,

wherein the conformable bone pad includes a major longitudinal axis running from the proximal side surface to the distal side surface and a minor longitudinal axis running from the first bone contacting surface to the second outer surface and intersecting the major longitudinal axis at an intersection,

wherein the at least one aperture includes at least one centered through aperture extending from the second outer surface to the first bone contacting surface through a center of the conformable bone pad and through the intersection of the minor longitudinal axis and the major longitudinal axis of the conformable bone pad, and

wherein the at least one aperture includes one or more peripheral through apertures extending from the second outer surface to the first bone contacting surface at a periphery of the conformable bone pad.

2. The method of claim 1 further comprising contouring the comfortable to engage against the at least two craniomaxillofacial bone fragments.

3. The method of claim 1 wherein the at least two bone fragments are bones of the face.

4. The method of claim 1 further comprising removing the light fiber from the delivery catheter after the at least one filling material has been hardened.

5. The method of claim 1 wherein the conformable bone pad is constructed from a polymer material.

6. A method for repairing craniomaxillofacial bone fractures comprising:

placing a conformable bone pad spanning at least two craniomaxillofacial bone fragments, the conformable bone pad being releasably engaged to a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis extending therebetween, wherein the conformable bone pad comprises;

a first bone contacting surface and an opposing second outer surface, a left side surface and an opposing right side surface extending between the first bone contacting surface and the second outer surface, and a proximal side surface and an opposing distal side surface extending between the first bone contacting surface and the second outer surface defining an inner space within the conformable bone pad in communication with an inner void of the delivery catheter for passage of at least one filling material into the inner space of the conformable bone pad for expanding the expandable conformable bone pad;

a major longitudinal axis running from the proximal side surface to the distal side surface;

a minor longitudinal axis running from the first bone contacting surface to the second outer surface and intersecting the major longitudinal axis at an intersection;

an opening extending through at least one of the proximal and distal side surfaces of the conformable bone pad to pass the at least one filling material from the delivery catheter into the inner space of the conformable bone pad; and

at least one through aperture extending from the second outer surface to the first bone contacting surface for receiving a fastener therethrough to affix the bone pad to at least two craniomaxillofacial bone fragments;

engaging the at least two craniomaxillofacial bone fragments with the conformable bone pad by positioning the conformable bone pad in a deflated state over an exterior surface of the at least two craniomaxillofacial bone fragments;

expanding the conformable bone pad from the deflated state to an inflated state by infusing the at least one filling material into the inner space within the conformable bone pad through the inner void of the delivery catheter;

hardening the at least one filling material in the inner space of the expanded conformable bone pad by transmitting light from a light source through the delivery catheter;

releasing the hardened conformable bone pad from the delivery catheter; and

affixing the conformable bone pad to the exterior surfaces of the at least two craniomaxillofacial bone fragments with at least one fastener inserted through the at least one through aperture and into at least one of the at least two craniomaxillofacial bone fragments,

wherein the at least one aperture includes at least one centered through aperture extending from the second outer surface to the first bone contacting surface through a center of the conformable bone pad and through the intersection of the minor longitudinal axis and the major longitudinal axis of the conformable bone pad, and

wherein the at least one aperture includes one or more peripheral through apertures extending from the second outer surface to the first bone contacting surface at a periphery of the conformable bone pad.

7. The method of claim 6 further comprising passing a light fiber into the inner space of the conformable bone pad through an inner lumen of the delivery catheter.

8. The method of claim 7 wherein the optical fiber is passed into the inner space of the conformable bone pad through the opening of the conformable bone pad along the major longitudinal axis of the conformable bone pad.

9. The method of claim 6 further comprising transmitting light from the light source through a light fiber into the inner space for hardening the at least one filling material in the inner space of the conformable bone pad.

10. The method of claim 9 further comprising removing the light fiber from the delivery catheter after at least one filling material has been hardened.

11. The method of claim 6 further comprising contouring the conformable bone pad to engage against the at least two craniomaxillofacial bone fragments.

12. The method of claim 6 wherein the conformable bone pad is constructed from a polymer material.

13. The method of claim 6 wherein the at least one filling material is a light curable glue.