Orthognathic implant and methods of use

• US 9,855,056 B2
• Filed: 01/29/2016
• Issued: 01/02/2018
• Est. Priority Date: 04/29/2010
• Status: Active Grant

• Current Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Original Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Inventors: Furrer, Andre, Zillig, Timo, Wilde, Frank
• Primary Examiner(s): BOLES, SAMEH RAAFAT
• Application Number:
  US15/010,553
• Publication Number:
  US 20160143677A1
• Time in Patent Office: 704 Days
• Field of Search: None
• CPC Class Codes: A61B 17/151 for corrective osteotomy
• CPC Class Codes: A61B 17/1728 for holes for bone plates or plate screws
• CPC Class Codes: A61B 17/176 for the jaw guiding dental drills A61C1/082
• CPC Class Codes: A61B 17/8061 specially adapted for particular bones A61B17/70 and A61B17/74 take precedence
• CPC Class Codes: A61B 17/8071 for the jaw
• CPC Class Codes: A61B 17/808 Instruments for holding or positioning bone plates, or for adjusting screw-to-plate locking mechanisms
• 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
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/568 produced with shape and dimensions specific for an individual patient
• CPC Class Codes: Y10T 29/4978 Assisting assembly or disassembly

Abstract

An implant for use in orthognathic surgery of a mandible may include a longitudinal plate member and a plurality of pre-configured guides coupled to the plate member. The longitudinal plate member is pre-bent to correspond to the post-operative shape of the mandible; and the guides are pre-configured to align the plate member with the mandible when the implant is positioned against the mandible after the mandible has been separated.

Claims

1. An implant configured to fix at least a first mandibular bone part relative to a second mandibular bone part that is separated from the first mandibular bone part by a bone gap, the implant comprising:

a plate member including a pre-operatively bent body having a shape corresponding to a post-operative shape of a mandible when aligned with the mandible, the plate member including a first surface configured to face at least one of the first and second mandibular bone parts, a second surface opposite the first surface, the plate member defining a plate fixation aperture that extends through the pre-operatively bent body from the first surface to the second surface along a central aperture axis, and is configured to receive a bone fixation element so as to secure the plate member to the mandible, the plate member further including an upper surface and a lower surface, the upper surface extends between the first and second surfaces, and the lower surface is opposite the upper surface and extends between the first and second surfaces; and

at least one guide including a guide body, the guide body including an alignment portion defining an inner bone contacting surface that is pre-shaped to correspond to the post-operative shape of the mandible, the guide body defining a guide fixation aperture, the at least one guide configured to be coupled to the plate member such that;

     1) the at least one guide abuts each of the second surface, the upper surface, and the lower surface,

     2) the guide fixation aperture is aligned with the plate fixation aperture, and

     3) the central aperture axis does not intersect the at least one guide, the at least one guide pre-operatively configured to align the plate member with the mandible when the implant is positioned against the mandible after the mandible has been separated so as to define the bone gap.

2. The implant of claim 1, wherein the guide body is configured to align the plate member with the mandible when the implant is positioned against the mandible after the mandible has been separated into at least the first and second mandibular bone parts.

3. The implant of claim 1, wherein the guide body is made from a biocompatible material.

4. The implant of claim 1, wherein the at least one guide includes three guides, each of the three guides having a respective guide body that is pre-shaped to correspond to the post-operative shape of the mandible so as to align the plate member with the mandible when the implant is positioned against the mandible after the mandible has been separated into at least the first and second mandibular bone parts.

5. The implant of claim 1, wherein the guide fixation aperture is configured to receive a fixation element to temporarily couple the at least one guide to the plate member.

6. The implant of claim 1, wherein the at least one guide includes a guide body, a pusher aperture that extends transversely through the guide body, and a pusher that is disposed within the pusher aperture, the pusher configured to abut a bottom of the mandible so as to align the plate member with the mandible when the implant is positioned against the mandible after the mandible has been separated into at least the first and second mandibular bone parts.

7. The implant of claim 6, wherein the pusher is adjustable along the transverse direction within the pusher aperture.

8. The implant of claim 7, wherein the at least one guide further includes a bore that extends laterally through the guide body and into the pusher aperture, the bore configured to receive a set screw to thereby lock the pusher to the guide body.

9. The implant of claim 6, wherein the at least one guide further includes a bone plate receiving channel that extends longitudinally through the guide body, the bone plate receiving channel configured to receive the bone plate when the at least one guide is coupled to the bone plate.

10. The implant of claim 6, wherein the pusher includes a transverse portion and a lateral portion that extends from a distal end of the transverse portion toward the mandible.

11. The implant of claim 6, wherein the pusher defines a bone contacting surface that is configured to abut the mandible when the implant is positioned against the mandible.

12. The implant of claim 1, wherein the at least one guide includes a guide body that has an inner surface configured to face the plate member when the at least one guide is coupled to the plate member, the guide body further including an outer surface opposite the inner surface, the at least one guide defining a first aperture that extends through the guide body between the inner surface and the outer surface along a first central axis, a second aperture that extends through the guide body between the inner surface and the outer surface along a second central axis, and a third aperture that extends through the guide body between the inner surface and the outer surface along a third central axis, the guide configured such that any straight line that intersects two of the first, second, and third central axes, does not intersect the remaining one of the first, second, and third central axes.

13. An implant configured to fix at least a first mandibular bone part relative to a second mandibular bone part that is separated from the first mandibular bone part by a bone gap, the implant comprising:

a plate member including a pre-operatively bent body having a shape corresponding to a post-operative shape of a mandible when aligned with the mandible, the plate member defining a first plate fixation aperture, a second plate fixation aperture, and a third plate fixation aperture that each extend through the pre-operatively bent body and that each are configured to receive a bone fixation element so as to secure the plate member to the mandible; and

a guide including a guide body having an inner surface, the inner surface defining a plurality of non-linear undulations, the inner surface configured to face the plate member when the guide is coupled to the plate member, the guide body further including an outer surface opposite the inner surface, the guide defining a first guide aperture that extends through the guide body between the inner surface and the outer surface along a first central axis, a second guide aperture that extends through the guide body between the inner surface and the outer surface along a second central axis, and a third guide aperture that extends through the guide body between the inner surface and the outer surface along a third central axis, the guide configured to be coupled to the plate member such that each of the first guide aperture, the second guide aperture, and the third guide aperture is aligned with a respective one of the first plate fixation aperture, the second plate fixation aperture, and third plate fixation aperture,

wherein the guide is configured such that any straight line that intersects two of the first, second, and third central axes, does not intersect the remaining one of the first, second, and third central axes.

14. The implant of claim 13, wherein the inner surface is curved.

15. The implant of claim 14, wherein the inner surface is pre-operatively curved to correspond to a post-operative shape of the mandible.

16. An implant configured to fix at least a first mandibular bone part relative to a second mandibular bone part that is separated from the first mandibular bone part by a bone gap, the implant comprising:

a plate member including a pre-operatively bent body having a shape corresponding to a post-operative shape of a mandible when aligned with the mandible, the plate member defining a first plate fixation aperture, a second plate fixation aperture, and a third plate fixation aperture that each extend through the pre-operatively bent body and that each are configured to receive a bone fixation element so as to secure the plate member to the mandible; and

a guide including a guide body having an inner surface configured to face the plate member when the guide is coupled to the plate member, the inner surface pre-operatively curved to correspond to a post-operative shape of the mandible, the guide body further including an outer surface opposite the inner surface, the guide defining a first guide aperture that extends through the guide body between the inner surface and the outer surface along a first central axis, a second guide aperture that extends through the guide body between the inner surface and the outer surface along a second central axis, and a third guide aperture that extends through the guide body between the inner surface and the outer surface along a third central axis, the guide configured to be coupled to the plate member such that each of the first guide aperture, the second guide aperture, and the third guide aperture is aligned with a respective one of the first plate fixation aperture, the second plate fixation aperture, and third plate fixation aperture,

wherein the guide is configured such that any straight line that intersects two of the first, second, and third central axes, does not intersect the remaining one of the first, second, and third central axes.

17. The implant of claim 16, wherein the inner surface is curved.

18. The implant of claim 16, wherein the inner surface defines a plurality of non-linear undulations.