Patient specific high tibia osteotomy

• US 8,241,293 B2
• Filed: 02/26/2010
• Issued: 08/14/2012
• 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: Stone, Kevin T., Metzger, Robert
• Primary Examiner(s): Stewart, Alvin J
• Application Number:
  US12/714,023
• Publication Number:
  US 20100152782A1
• Time in Patent Office: 900 Days
• Field of Search: 623/20.32, 623/20.14, 623/18.11, 623/16.11, 606/53, 606/247, 606/248, 606/300, 606/79, 606/87, 606/88, 606/86.R, 606/84, 606/99, 606/60, 606/286
• US Class Current: 606/87
• 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 as a negative surface to a corresponding surface 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 surface of the tibial bone, the selected angle and selected position determined during a pre-operative planning stage;

a patient-specific implantable wedge, the implantable wedge including first and second planar surfaces defining a wedge angle therebetween, the wedge angle custom-selected during pre-operative planning for correcting the patient'"'"'s anatomy; and

a patient-specific implantable fixation plate connected with the implantable wedge and having a custom-made surface mating as a negative surface with a corresponding surface of the patient'"'"'s tibia.

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 1, 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.

5. The surgical kit of claim 1, wherein the fixation plate and the implantable wedge comprise a single monolithic implant.

6. The surgical kit of claim 1, wherein the fixation plate and the implantable wedge are removably coupled to one another.

7. The surgical kit of claim 1, wherein the fixation plate and the implantable wedge are removably coupled to one another with a dovetail connection.

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

9. The surgical kit of claim 8, wherein the blade is customized for the patient and has a length corresponding to a preoperatively determined patient-specific cutting depth.

10. 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.

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

12. A surgical kit comprising:

a patient-specific alignment guide including a three-dimensional engagement surface custom-made by computer imaging to conform as a negative surface to a corresponding surface 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 surface of the tibial bone, the selected angle and selected position determined during a pre-operative planning stage, the patient-specific alignment guide including a central guiding aperture through the planar slot for drilling a guiding hole in the bone; and

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, and wherein the central portion is configured to conform to a shape of the guiding hole drilled through the central guiding aperture of the patient-specific alignment guide.

13. 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 mating as a negative to a corresponding surface of the patient'"'"'s 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 as a negative surface to a corresponding surface 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 surface of the tibial bone, the selected angle and selected position determined during a pre-operative planning stage.

14. The surgical kit of claim 13, wherein the patient-specific alignment guide defines apertures at patient-specific orientations and positions for guiding bone fasteners for the fixation plate.

15. The surgical kit of claim 13, wherein the implantable wedge and the fixation plate comprise a single monolithically formed component.

16. The surgical kit of claim 13, wherein the implantable wedge and the fixation plate are removably connected.

17. The surgical kit of claim 13, wherein the implantable wedge and the fixation plate are removably connected with a dovetail connection.

18. The surgical kit of claim 13, further comprising a blade with depth control.

19. The surgical kit of claim 13, wherein the implantable wedge includes a plurality of separate components.

20. A surgical kit comprising:

a patient-specific alignment guide including a three-dimensional engagement surface custom-made by computer imaging to conform as a negative surface to a corresponding surface 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 preoperatively selected angle and position relative to an anatomic axis of the patient, and

a patient-specific implantable fixation plate having a patient-specific surface mating as a negative surface to a corresponding surface of the patient'"'"'s tibial bone, and wherein the alignment guide defines a plurality of guide apertures oriented and positioned at locations preoperatively selected for attaching the patient-specific fixation plate to the patient'"'"'s tibial bone.