Method and apparatus for augumenting bone defects

• US 9,289,299 B2
• Filed: 03/15/2013
• Issued: 03/22/2016
• Est. Priority Date: 02/18/2010
• Status: Active Grant

• Current Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Metzger, Robert, May, Brian M., Williamson, Daniel E.
• Primary Examiner(s): STEWART, ALVIN J
• Application Number:
  US13/834,914
• Publication Number:
  US 20130211536A1
• Time in Patent Office: 1,103 Days
• Field of Search: 623/22.46, 623/14.12, 623 2371- 2376, 623/20.16, 623/23.28, 606/248, 606/249, 606/284, 606/285
• US Class Current: 1/1
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30734 Modular inserts, sleeves or augments, e.g. placed on proximal part of stem for fixation purposes or wedges for bridging a bone defect
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/3607 including proximal or total replacement of the femur
• CPC Class Codes: A61F 2/3662 Femoral shafts
• CPC Class Codes: A61F 2/3672 Intermediate parts of shafts
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/3021 frustoconical
• CPC Class Codes: A61F 2002/30217 hollow cones, e.g. tubular-like cones
• CPC Class Codes: A61F 2002/30332 Conically- or frustoconically-shaped protrusion and recess
• CPC Class Codes: A61F 2002/30339 Double cones, i.e. connecting element having two conical connections, one at each of its opposite ends
• CPC Class Codes: A61F 2002/30406 Threads machined on spherical, e.g. hemispherical, surfaces
• CPC Class Codes: A61F 2002/30487 Circumferential cooperating grooves and beads on cooperating lateral surfaces of a mainly longitudinal connection
• CPC Class Codes: A61F 2002/30578 having apertures, e.g. for receiving fixation screws
• CPC Class Codes: A61F 2002/30738 Sleeves
• CPC Class Codes: A61F 2002/3092 having an open-celled or open-pored structure
• CPC Class Codes: A61F 2002/3096 trimmed or cut to a customised size
• CPC Class Codes: A61F 2310/00341 Coral, e.g. aragonite, porite
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges

Abstract

A bone augment for repairing a bone defect and associated method. The bone augment includes a porous body and a reinforcement member. The porous body defines a plurality of pores and is configured to be intraoperatively shaped to correspond to the bone defect. The reinforcement member is mounted on an exterior surface of the porous body and is configured to be intraoperatively shaped to correspond to the bone defect.

Claims

1. A bone augment for repairing a bone defect present in a single bone comprising:

a bone-engaging body defining a plurality of pores, the body configured to be intraoperatively shaped to correspond to the bone defect present in the single bone; and

a polymeric reinforcement member having an inner surface and an outer surface, the inner surface having a first part and a second part, wherein the first part of the inner surface of the polymeric reinforcement member is mounted on an exterior surface of the bone-engaging body, the second part of the inner surface of the reinforcement member is configured to be in contact with an outer bone surface proximate to the bone defect, and the reinforcement member is configured to be intraoperatively deformed to correspond to the bone defect present in the single bone and the outer bone surface proximate to the bone defect;

wherein;

the first part of the inner surface of the polymeric reinforcement member is molded to the exterior surface such that portions of the reinforcement member are mechanically interlocked with the pores; and

the body includes a density that approximates a density of cancellous bone and the polymeric reinforcement member includes a density that approximates a density of cortical bone.

2. The bone augment of claim 1, the second part further comprising a projection extending from the polymeric reinforcement member, the projection including an aperture configured to receive a fastener to secure the bone augment to bone proximate to the bone defect.

3. The bone augment of claim 1, wherein the body includes at least one of a ceramic and Pro Osteon®

and the polymeric reinforcement member includes polyether ether ketone.

4. The bone augment of claim 1, wherein the bone augment is configured to repair an uncontained bone defect with the body replacing cancellous bone and the polymeric reinforcement member replacing cortical bone.

5. The bone augment of claim 1, the second part further comprising first and second projections extending from opposite sides the polymeric reinforcement member, each of the first and second projections including an aperture configured to receive a corresponding fastener to secure the bone augment to the single bone proximate to the bone defect present in the single bone.

6. The bone augment of claim 5, wherein each of the first and second projections is deformable to match the morphology proximate to the bone defect.

7. The bone augment of claim 5, wherein each of the first and second projections can be machined during manufacturing to match a specific patient'"'"'s morphology.

8. The bone augment of claim 5, wherein each of the first and second projections can be pressed into a mold of a corresponding implant site of a specific patient.

9. The bone augment of claim 1, wherein the reinforcement member is mounted on the body by injection or compression molding.

10. A bone augment for repairing a bone defect comprising:

a bone-engaging body defining a plurality of pores, the body configured to be intraoperatively shaped to correspond to the bone defect entirely defined at an upper extremity of a tibia; and

a polymeric reinforcement member having an inner surface and an outer surface, the inner surface having a first part and a second part, wherein the first part of the inner surface of the polymeric reinforcement member is mounted on an exterior surface of the bone-engaging body and the second part of the inner surface of the polymeric reinforcement member having first and second extensions corresponding to opposite sides of the defect entirely defined at the upper extremity of the tibia, and the reinforcement member configured to be intraoperatively deformed to correspond to the bone defect entirely defined at the upper extremity of the tibia with the first and second extensions configured to be deformed to correspond to an outer bone surface proximate to the bone defect;

wherein;

the first part of the inner surface of the polymeric reinforcement member is molded to the exterior surface such that portions of the reinforcement member are mechanically interlocked with the pores; and

the body includes a density that approximates a density of cancellous bone and the polymeric reinforcement member includes a density that approximates a density of cortical bone.

11. The bone augment of claim 10, wherein each of the first and second projections is deformable to match a patient'"'"'s morphology proximate to the bone defect.

12. The bone augment of claim 10, wherein each of the first and second projections can be machined during manufacturing to match a specific patient'"'"'s morphology.

13. The bone augment of claim 10, wherein each of the first and second extensions include an aperture configured to receive a corresponding fastener to secure the bone augment to a single bone proximate to the bone defect entirely defined at the upper extremity of the tibia.

14. The bone augment of claim 10, wherein the body includes at least one of a ceramic and Pro Ostean®

and the polymeric reinforcement member includes polyether ether ketone.

15. The bone augment of claim 10, wherein the bone augment is configured to repair the bone defect when the bone defect is an uncontained bone defect with the body replacing cancellous bone and the polymeric reinforcement member replacing cortical bone.

16. A method for repairing a bone defect comprising:

molding an inner surface of a polymeric reinforcement member to an exterior surface of a porous body at a first part of the inner surface of the polymeric reinforcement member such that portions of the reinforcement member are mechanically interlocked with pores of the porous body;

inserting the porous body into a bone defect entirely defined by a single bone, the porous body shaped to correspond to the bone defect entirely defined by the single bone;

deforming first and second extensions of a second part of the inner surface of the polymeric reinforcement member of the bone augment to match the inner surface at the second part of the polymeric reinforcement member with an outer surface of the single bone on opposite sides of the bone defect; and

fastening the first and second extensions of the second part of the inner surface of the polymeric reinforcement member to the single bone on opposite sides of the bone defect entirely defined by the single bone;

wherein the body includes a density that approximates density of cancellous bone and the polymeric reinforcement member includes a density that approximates density of cortical bone.

17. The method of claim 16, further comprising bending the first and second extensions to match a patient morphology of the single bone around the bone defect entirely defined by the single bone.

18. The method of claim 16, wherein the bone augment is configured for a bone defect entirely defined at an upper extremity of a tibia.

19. The method of claim 16, further comprising inserting the porous body into an uncontained bone defect entirely defined by the single bone such that the porous body replaces cancellous bone and the polymeric reinforcement member replaces cortical bone.