Patient Specific High Tibia Osteotomy

• US 20100152782A1
• Filed: 02/26/2010
• Published: 06/17/2010
• Est. Priority Date: 02/27/2006
• Status: Active Grant

• Current Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Metzger, Robert, Stone, Kevin T.
• Granted Patent: US 8,241,293 B2
• Time in Patent Office: Days
• US Class Current: 606/280
• CPC Class Codes: A61B 17/142 with reciprocating saw blades, e.g. with cutting edges at the distal end of the saw blades
• CPC Class Codes: A61B 17/151 for corrective osteotomy
• CPC Class Codes: A61B 17/152 for removing a wedge-shaped piece of bone
• CPC Class Codes: A61B 17/157 Cutting tibia
• CPC Class Codes: A61B 17/1764 for the knee
• CPC Class Codes: A61B 17/683 comprising bone transfixation elements, e.g. bolt with a distal cooperating element such as a nut
• CPC Class Codes: A61B 17/8061 specially adapted for particular bones A61B17/70 and A61B17/74 take precedence
• CPC Class Codes: A61B 17/809 with bone-penetrating elements, e.g. blades or prongs bone staples A61B17/0642; intramedullary nails with a plate at an end A61B17/7233
• CPC Class Codes: A61B 17/8095 Wedge osteotomy devices
• CPC Class Codes: A61B 2034/108 Computer aided selection or customisation of medical implants or cutting guides
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61F 2002/30617 Visible markings for adjusting, locating or measuring
• CPC Class Codes: A61F 2002/4662 for measuring penetration depth
• CPC Class Codes: A61F 2002/4668 for measuring angles
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: A61F 5/00 Orthopaedic methods or devices for non-surgical treatment of bones or joints surgical instruments or methods for treatment of bones or joints, devices specially adapted therefor A61B17/56; Nursing devices; Anti-rape devicesbandages, dressings or absorbent pads A61F13/00

Abstract

A surgical kit includes a patient-specific alignment guide having a three-dimensional engagement surface custom-made by computer imaging to conform to a corresponding portion of a patient'"'"'s tibial bone. The patient-specific alignment guide defines an elongated planar slot for guiding a blade. The planar slot is oriented at a selected angle and at a selected position relative to an anatomic axis of the patient when the engagement surface engages the corresponding portion of the tibial bone. The selected angle and selected position are determined during a pre-operative planning stage.

Claims

1. A surgical kit comprising:

a patient-specific alignment guide including a three-dimensional engagement surface custom-made by computer imaging to conform to a corresponding portion of a patient'"'"'s tibial bone, the patient-specific alignment guide defining a first elongated planar slot for guiding a blade, the first planar slot oriented at a selected angle and at a selected position relative to an anatomic axis of the patient when the engagement surface engages the corresponding portion of the tibial bone, the selected angle and selected position determined during a pre-operative planning stage.

2. The surgical kit of claim 1, wherein the alignment guide defines a plurality of openings receiving bone fasteners for supporting the alignment guide on the tibial bone at a patient specific position and orientation.

3. The surgical kit of claim 1, wherein the alignment guide defines a plurality of guide apertures, the guide apertures oriented and positioned at locations selected during a pre-operative planning stage for attaching a patient-specific implant.

4. The surgical kit of claim 3, further comprising a patient-specific implantable fixation plate having a patient-specific surface engageable with the tibia.

5. The surgical kit of claim 1, further comprising a patient-specific implantable wedge, the implantable wedge including first and second planar surfaces defining a wedge angle therebetween, the wedge angle selected during pre-operative planning for correcting the patient'"'"'s anatomy.

6. The surgical kit of claim 5, wherein the implantable wedge includes a patient-specific curved surface opposite to the wedge angle, the curved surface continuing a contour of the tibial bone between each side of an open-wedge osteotomy.

7. The surgical kit of claim 5, further comprising a patient-specific implantable fixation plate connected with the implantable wedge.

8. The surgical kit of claim 7, wherein the fixation plate and the implantable wedge comprise a single monolithic implant.

9. The surgical kit of claim 7, wherein the fixation plate and the implantable wedge are removably coupled to one another.

10. The surgical kit of claim 7, wherein the fixation plate and the implantable wedge are removably coupled to one another with a dovetail connection.

11. The surgical kit of claim 1, further comprising a blade.

12. The surgical kit of claim 11, wherein the blade is customized for the patient.

13. The surgical kit of claim 1, further comprising a second elongated planar slot for guiding a blade, the second planar slot at an angle with the first planar slot for closed osteotomy.

14. The surgical kit of claim 1, wherein the patient-specific alignment guide includes a central guiding aperture through the planar slot.

15. The surgical kit of claim 14, further comprising a patient-specific implantable wedge, the implantable wedge including an elongated curved central portion and pairs planar surfaces extending radially from the central portion and defining a wedge angle therebetween, the wedge angle selected during pre-operative planning for correcting the patient'"'"'s anatomy.

16. The surgical kit of claim 1, further comprising an implantable wedge including a plurality of separate components.

17. A surgical kit comprising:

a patient-specific implantable wedge for an open-wedge osteotomy, the implantable wedge including first and second planar surfaces forming a patient-specific wedge angle, the implantable wedge including a patient-specific outer surface opposite to the straight edge;

a patient-specific fixation plate, the fixation plate having a patient-specific engagement surface for engaging the tibia and a surface engageable with the implantable wedge; and

a patient-specific alignment guide including a three-dimensional engagement surface custom-made by computer imaging to conform to a corresponding portion of a patient'"'"'s tibial bone, the patient-specific alignment guide defining an elongated planar slot for guiding a blade, the planar slot oriented at a selected angle and at a selected position relative to an anatomic axis of the patient when the engagement surface engages the corresponding portion of the tibial bone, the selected angle and selected position determined during a pre-operative planning stage

18. The surgical kit of claim 17, wherein the patient-specific alignment guide defines apertures at patient-specific orientations and positions for guiding bone fasteners for the fixation plate.

19. The surgical kit of claim 17, wherein the implantable wedge and the fixation plate comprise a single monolithically formed component.

20. The surgical kit of claim 17, wherein the implantable wedge and the fixation plate are removably connected.

21. The surgical kit of claim 17, wherein the implantable wedge and the fixation plate are removably connected with a dovetail connection.

22. The surgical kit of claim 17, further comprising a blade with depth control.

23. The surgical kit of claim 17, wherein the implantable wedge includes a plurality of separate components.

24. A surgical method comprising:

attaching a patient-specific alignment guide to a corresponding surface of a tibia of a patient for whom the alignment guide is customized during a pre-operative planning stage;

making a partial bone cut in the tibia through a planar slot of the alignment guide, the planar slot oriented at a patient-specific angle relative to an anatomic axis of the patient, the angle customized during the pre-operative planning stage;

opening the bone cut to form an opening wedge; and

inserting a patient-specific implantable wedge into the opening wedge.

25. The surgical method of claim 24, further comprising removably attaching a patient-specific fixation plate to the implantable wedge.

26. The surgical method of claim 24, wherein inserting a patient-specific implantable wedge into the opening wedge includes attaching a patient-specific fixation plate monolithically formed with the implantable wedge.

27. The surgical method of claim 24, further comprising drilling bone apertures for bone fasteners through patient-specific apertures of the alignment guide.

28. The surgical method of claim 24, wherein the planar slot defines a depth or length dimension of the cut.

29. The surgical method of claim 24, further comprising drilling a hole in the tibia through a central aperture intersecting the planar slot of the patient-specific alignment guide before making a bone cut through the planar slot.

30. A surgical method comprising:

attaching a patient-specific alignment guide to a corresponding surface of a tibia of a patient for whom the alignment guide is customized during a pre-operative planning stage;

making a first partial planar cut in the tibia through a first planar slot of the alignment guide, the first planar slot oriented at a first patient-specific angle relative to an anatomic axis of the patient, the first angle customized during a pre-operative planning stage;

making a second partial planar cut in the tibia through a second planar slot of the alignment guide, the second planar slot oriented at a second patient-specific angle relative to an anatomic axis of the patient, the second angle customized during a pre-operative planning stage, the first and second planar cuts meeting at an angle to define a bone wedge having a third patient-specific angle;

removing the bone wedge to form a wedge opening; and

closing the wedge opening.

31. The surgical method of claim 30, further comprising attaching a patient-specific fixation plate to the tibia, the patient-specific fixation plate having a three-dimensional patient-specific engagement surface attachable over the tibia to secure the tibia after closing the wedge opening.