Patient-specific osteotomy devices and methods

• US 9,456,833 B2
• Filed: 01/20/2014
• Issued: 10/04/2016
• Est. Priority Date: 02/26/2010
• Status: Active Grant

• Current Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Sports Medicine LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Maxson, William, Stone, Kevin T., Pierce, Andrew L., Metzger, Robert
• Primary Examiner(s): STEWART, ALVIN J
• Application Number:
  US14/159,071
• Publication Number:
  US 20140135775A1
• Time in Patent Office: 988 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: 1/1
• 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 17/1764 for the knee
• CPC Class Codes: A61B 17/58 for osteosynthesis, e.g. bone plates, screws , setting implements or the like A61B17/14, A61B17/16 take precedence
• CPC Class Codes: A61B 17/8095 Wedge osteotomy devices
• CPC Class Codes: A61B 2017/568 produced with shape and dimensions specific for an individual patient
• 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

Abstract

An osteotomy method includes attaching a patient-specific osteotomy guide to a corresponding surface of a tibia of a patient and making an osteotomy at a patient-specific orientation through a resection slot of the osteotomy guide. The osteotomy guide is removed and first and second faces of the osteotomy are opened to form an implant insertion angle. The first and second faces of the osteotomy are secured at the implant insertion angle and an osteotomy implant having a patient-specific wedge angle that is smaller than the implant insertion angle is implanted. The first and second faces of the osteotomy are brought to the patient-specific wedge angle and in contact with the osteotomy implant.

Claims

1. An osteotomy surgical system comprising:

a patient-specific osteotomy guide having a three-dimensional inner surface as a negative surface of a specific patient'"'"'s tibia that is configured to closely mate and conform to a corresponding portion of the specific patient'"'"'s tibia in only one position, wherein the patient-specific osteotomy guide includes a resection slot at a patient-specific position and orientation for guiding a cutting tool to perform an osteotomy according to a preoperative plan for the patient, and a drill support sized and shaped for guiding a drilling of a stress-relief hole at a sharp edge of the osteotomy; and

further comprising a patient-specific osteotomy implant forming a wedge angle equal to a patient-specific osteotomy angle and having patient-specific outer surface.

2. The osteotomy surgical system of claim 1, wherein the osteotomy implant is shaped to form an open channel for a stem implant.

3. The osteotomy surgical system of claim 2, wherein the osteotomy implant is U-shaped or horseshoe-shaped.

4. The osteotomy surgical system of claim 3, wherein the osteotomy guide includes a drill hole for guiding the osteotomy implant and intersecting the resection slot and wherein the osteotomy implant includes a protrusion configured to be received into a guiding hole drilled into the tibia through the drill hole.

5. The osteotomy surgical system of claim 1, further comprising a patient-specific fixation plate having a patient-specific inner surface for engaging the tibia and securing the fixation plate.

6. An osteotomy surgical system comprising:

a patient-specific osteotomy guide having a three-dimensional inner surface as a negative surface of a specific patient'"'"'s tibia that is configured to closely mate and conform to a corresponding portion of the specific patient'"'"'s tibia in only one position, wherein the patient-specific osteotomy guide includes a resection slot at a patient-specific position and orientation for guiding a cutting tool to perform an osteotomy according to a preoperative plan for the patient, and a drill support sized and shaped for guiding a drilling of a stress-relief hole at a sharp edge of the osteotomy; and

further comprising a patient-specific osteotomy spreader having first and second surfaces forming a patient-specific osteotomy angle.

7. The osteotomy surgical system of claim 6, further comprising an osteotome having gradation markings for opening the osteotomy to an insertion angle greater than the osteotomy angle.

8. The osteotomy surgical system of claim 7, further comprising an impactor assembly including an impactor plate, a handle, a shaft and a distal tip having threads configured for selective coupling to the osteotomy spreader and the osteotome.

9. The osteotomy surgical system of claim 8, wherein each of the osteotomy spreader and the osteotome includes a threaded tubular portion couplable to the distal tip of the impactor assembly.

10. An osteotomy surgical system comprising:

a patient-specific osteotomy guide having a three-dimensional inner surface as a negative surface of a specific patient'"'"'s tibia that is configured to closely mate and conform to a corresponding portion of the specific patient'"'"'s tibia in only one position, wherein the patient-specific osteotomy guide includes a resection slot at a patient-specific position and orientation for guiding a cutting tool to perform an osteotomy according to a preoperative plan for the patient, and a drill support sized and shaped for guiding a drilling of a stress-relief hole at a sharp edge of the osteotomy; and

further comprising an osteotomy securing device including first and second members configured for securing first and second faces of the osteotomy at an implant insertion angle for inserting the osteotomy implant and wherein the first and second members are slidably adjustable relative to one another.

11. The osteotomy surgical system of claim 10, wherein the first member of the osteotomy securing device includes a cylindrical bore slidably receiving a cylindrical shaft of the second member.

12. The osteotomy surgical system of claim 11, wherein the osteotomy securing device includes a locking member for securing a relative position between the first and second members.

13. The osteotomy surgical system of claim 12, wherein the osteotomy securing device includes first and second blocks for removably attaching the first and second members to the tibia at opposite sides of the osteotomy.

14. The osteotomy surgical system of claim 10, further comprising a posterior blade guard having a blade stop portion configured to be inserted against a posterior bone surface of the tibia for protecting soft tissue and a curved retractor portion for retracting soft tissue at an incision site for the osteotomy.

15. An osteotomy surgical system comprising:

a patient-specific osteotomy guide having a three-dimensional inner engagement surface as a negative surface of a specific patient'"'"'s tibia that is configured to closely mate and conform to a corresponding surface of the specific patient'"'"'s tibia in only one position, wherein the patient-specific osteotomy guide defines a resection slot at a patient-specific position and orientation for guiding a cutting tool to perform an osteotomy according to a pre-operative plan for the patient;

wherein the resection slot includes two resection slots at patient-specific positions and orientations for guiding the cutting tool to perform osteotomies according to the pre-operative plan for the patient for use with a closed wedge osteotomy.

16. The osteotomy surgical system of claim 15, further comprising a patient-specific fixation plate having a patient-specific inner surface for engaging the tibia and securing the fixation plate.

17. The osteotomy surgical system of claim 15, further comprising a posterior blade guard having a blade stop portion configured to be inserted against a posterior bone surface of the tibia for protecting soft tissue and a curved retractor portion for retracting soft tissue at an incision site for the osteotomy.

18. An osteotomy surgical system comprising:

a patient-specific osteotomy guide having a three-dimensional inner engagement surface as a negative surface of a specific patient'"'"'s tibia that is configured to closely mate and conform to a corresponding surface of the specific patient'"'"'s tibia in only one position, wherein the patient-specific osteotomy guide defines a resection slot at a patient-specific position and orientation for guiding a cutting tool to perform an osteotomy according to a pre-operative plan for the patient;

wherein the patient-specific osteotomy guide further includes ad/ill guide to guide a drill along at least a portion of the resection slot between opposing ends of the slot.

19. The osteotomy surgical system of claim 18, further comprising a patient-specific osteotomy implant forming a wedge angle equal to a patient-specific osteotomy angle and having an elongated protrusion configured to align relative to the drill guide.

20. The osteotomy surgical system of claim 18, further comprising a second drill guide on the patient-specific osteotomy guide including a curved rig configured to guide a drill to form a stress relief hole relative to the osteotomy.

21. An osteotomy surgical system comprising:

a patient-specific osteotomy implant having a three-dimensional patient-specific surface configured to closely mate and conform to a corresponding portion of a specific patient'"'"'s tibia in only one position,

wherein the patient-specific osteotomy implant is a patient-specific fixation plate having a three-dimensional surface as a negative surface of the specific patient'"'"'s tibia that is configured to mate with a corresponding surface of the specific patient'"'"'s tibia in only one position relative to an osteotomy formed in the specific patient'"'"'s tibia; and

further comprising another patient-specific osteotomy implant that forms a wedge angle equal to a patient-specific osteotomy angle and includes another three-dimensional patient-specific surface that is a patient-specific outer boundary surface designed during a pre-operative planning stage as a continuous and smooth surface that provides a continuous contour relative to the contour of the tibia.

22. The osteotomy surgical system of claim 21, further comprising a posterior blade guard having a blade stop portion configured to be inserted against a posterior bone surface of the tibia for protecting soft tissue and a curved retractor portion for retracting soft tissue at an incision site for the osteotomy.

23. An osteotomy surgical system comprising:

a patient-specific osteotomy implant having a three-dimensional patient-specific surface configured to closely mate and conform to a corresponding portion of a specific patients tibia in only one position,

wherein the patient-specific osteotomy implant is a patient-specific fixation plate having a three-dimensional surface as a negative surface of the specific patient'"'"'s tibia that is configured to mate with a corresponding surface of the specific patient'"'"'s tibia in only one position relative to an osteotomy formed in the specific patient'"'"'s tibia; and

further comprising a patient-specific osteotomy guide having a three-dimensional inner surface configured to closely mate and conform to a corresponding surface of the patient'"'"'s tibia in only one position and defining a resection slot at a patient-specific position and orientation for guiding a cutting tool to perform an osteotomy according to a pre-operative plan.

24. An osteotomy surgical system comprising:

a patient-specific osteotomy guide having a three-dimensional inner engagement surface as a negative surface of a specific patient'"'"'s tibia that is configured to closely mate and conform to a corresponding surface of the specific patient'"'"'s tibia in only one position, wherein the patient-specific osteotomy guide defines a resection slot at a patient-specific position and orientation for guiding a cutting tool to perform an osteotomy according to a pre-operative plan for the patient;

further comprising a patient-specific osteotomy spreader having first and second surfaces forming a patient-specific osteotomy angle.

25. The osteotomy surgical system of claim 24, further comprising an osteotome having gradation markings for opening the osteotomy to an insertion angle greater than the osteotomy angle.

26. The osteotomy surgical system of claim 25, further comprising an impactor assembly including an impactor plate, a handle, a shaft and a distal tip having threads configured for selective coupling to the osteotomy spreader and the osteotome.

27. The osteotomy surgical system of claim 26, wherein each of the osteotomy spreader and the osteotome includes a threaded tubular portion couplable to the distal tip of the impactor assembly.

28. An osteotomy surgical system comprising:

a patient-specific osteotomy implant having a three-dimensional patient-specific surface configured to closely mate and conform to a corresponding portion of a specific patient'"'"'s tibia in only one position,

wherein the patient-specific osteotomy implant is a patient-specific fixation plate having a three-dimensional surface as a negative surface of the specific patient'"'"'s tibia that is configured to mate with a corresponding surface of the specific patient'"'"'s tibia in only one position relative to an osteotomy formed in the specific patient'"'"'s tibia; and

further comprising a patient-specific osteotomy spreader having first and second surfaces forming a patient-specific osteotomy angle.

29. The osteotomy surgical system of claim 28, further comprising an osteotome having gradation markings for opening the osteotomy to an insertion angle greater than the osteotomy angle.

30. The osteotomy surgical system of claim 29, further comprising an impactor assembly including an impactor plate, a handle, a shaft and a distal tip having threads configured for selective coupling to the osteotomy spreader and the osteotome.

31. The osteotomy surgical system of claim 30, wherein each of the osteotomy spreader and the osteotome includes a threaded tubular portion couplable to the distal tip of the impactor assembly.