Dynamic knee balancer

• US 7,442,196 B2
• Filed: 02/06/2004
• Issued: 10/28/2008
• Est. Priority Date: 02/06/2004
• Status: Active Grant

• Current Assignee: Synvasive Technology Incorporated (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Synvasive Technology Incorporated (Zimmer Biomet Holdings, Inc.)
• Inventors: Howard, Michael, Cordes, Kevin, Fisher, Michael G., Hedley, Anthony K., Katsuya, Toshinobu
• Primary Examiner(s): Robert; Eduardo C.
• Assistant Examiner(s): HOFFMAN, MARY C
• Application Number:
  US10/773,608
• Publication Number:
  US 20050177169A1
• Time in Patent Office: 1,726 Days
• Field of Search: 606 86- 88, 623 2014- 2036
• US Class Current: 606/88
• CPC Class Codes: A61B 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 17/155 Cutting femur
• CPC Class Codes: A61B 2017/0268 for the knee
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2/4657 Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2/4684 Trial or dummy prostheses
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30428 made by inserting a protrusion into a slot
• CPC Class Codes: A61F 2002/30507 using a threaded locking member, e.g. a locking screw or a set screw
• CPC Class Codes: A61F 2002/30538 for adjusting angular orientation
• CPC Class Codes: A61F 2002/30553 for adjusting a position by translation along an axis
• CPC Class Codes: A61F 2002/30566 Helical springs
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2250/0006 for adjusting angular orientation
• CPC Class Codes: A61F 2250/0008 for adjusting a position by translation along an axis or two perpendicular axes

Abstract

Dynamic knee balancing devices, systems and methods provide for enhanced total knee arthroplasty (“TKA”) procedures. Devices generally include a stationary femoral member for removably attaching to a distal femur and an adjustable femoral member coupled with the stationary member for adjusting ligament tension of the knee. The adjustable femoral member includes at least one positioning feature for providing positional and/or orientation information for facilitating the TKA procedure. Additionally, the adjustable femoral member is movably couplable with a tibial member engaged with the proximal tibia to allow movement of the knee through a range of motion without removing the device from the joint space. When the adjustable femoral member is adjusted, the positional feature(s) move relative to the distal femur to provide positional information.

Claims

1. A device for enhancing a surgical procedure on a knee, the device comprising:

a tibial member having a pair of complementary depressions, said tibial member being engageable with a surface of the proximal tibia;

at least one stationary femoral member for removably attaching to a distal femur; and

at least one adjustable femoral member having a first surface disposed to contact the tibial member when the knee is in extension and having a posterior condylar member including a medial femoral posterior condylar portion and a lateral femoral posterior condylar portion, said posterior condylar member being disposed at a substantially right angle relative to the first surface so that the medial and lateral femoral posterior condylar portions slidingly contact the complementary depressions in the tibial member when the knee is in flexion, said adjustable femoral member being movably engaged with the stationary femoral member to adjust tension in at least one ligament of the knee, the adjustable femoral member including an adjustment member that moves the adjustable femoral member in an anterior-posterior direction relative to the stationary femoral member for facilitating completion of the surgical procedure to enhance range of motion, stability or patella tracking of the knee;

wherein the adjustable femoral member is movably engageable with said tibial member engaged with a proximal tibia to allow the knee to be moved through a range of motion from a fixed position to an extended position without removing the femoral and tibial members.

2. A device as in claim 1, wherein the at least one stationary femoral member is engageable with a surface at the distal end of the distal femur.

3. A device as in claim 1, wherein the adjustable femoral member is separately adjustable on a medial side and a lateral side of the femoral member to adjust tension in the at least one ligament.

4. A device as in claim 3, wherein adjusting on one side relative to the other side causes the adjustable femoral member to rotate relative to the distal femur.

5. A device as in claim 4, wherein the adjustment member comprises:

at least one lateral adjustment member for adjusting a lateral portion of the adjustable member; and

at least one medial adjustment member for adjusting a medial portion of the adjustable member.

6. A device as in claim 5, wherein the lateral and medial adjustment members are selected from the group consisting of screws, pins, levers, rods, springs, spring-loaded mechanisms and shape memory materials.

7. A device as in claim 1, wherein the at least one adjustable femoral member further has at least one distal femoral portion for emulating a distal surface of the femur.

8. A device as in claim 7, wherein the distal femoral portion, the, medial femoral posterior condylar portion, and the lateral femoral posterior condylar portion all comprise one piece or extrusion.

9. A device as in claim 7, wherein the at least one stationary femoral member comprises:

at least one distal femoral plate for coupling the distal femoral portion of the adjustable femoral member to the distal femur; and

wherein the posterior condylar member extends from the distal femoral portion to contact at least part of a medial posterior femoral condyle and a lateral posterior femoral condyle of the distal femur.

10. A device as in claim 9, wherein the distal femoral plate, the medial femoral posterior condylar member, and the lateral femoral posterior condylar member all comprise one piece or extrusion.

11. A device as in claim 9, wherein the medial femoral posterior condylar portion of the adjustable femoral member is adjustable relative to the medial femoral posterior condylar member of the stationary femoral member, and wherein the lateral femoral posterior condylar portion of the adjustable femoral member is separately adjustable relative to the lateral femoral posterior condylar member of the stationary femoral member.

12. A device as in claim 1, wherein the adjustable femoral member is adjustable relative to the stationary femoral member to separately adjust tension in at least one of a medial collateral ligament and a lateral collateral ligament of the knee.

13. A device as in claim 1, wherein the at least one adjustable femoral member comprises at least one self-adjusting member.

14. A device as in claim 13, wherein the at least one self-adjusting member comprises at least one of a spring-loaded member and a shape memory member.

15. A device as in claim 13, wherein the at least one self-adjusting member adjusts relative to the stationary femoral member to adjust tension in at least one of a medial collateral ligament and a lateral collateral ligament of the knee.

16. A device as in claim 1, wherein the at least one adjustable femoral member comprises a plurality of pre-adjusted femoral members, each having a different asymmetry relative to the stationary member;

wherein one of the pre-adjusted members is selected for facilitating the surgical procedure to provide a desired range of motion when the surgical procedure is completed.

17. A device as in claim 1, wherein the adjustment member of the adjustable femoral member is selected from the group consisting of an aperture, a drill bit guide, a surface marker, a surface feature, a measurement device, an embedded marker, a fiducial, a transponder, a transceiver and a sensor.

18. A device as in claim 17, wherein the adjustment member facilitates at least one of placing a cutting guide on the distal femur for making bone cuts, making one or more bone cuts on the distal femur, and positioning a prosthetic femoral component on the distal femur.

19. A device as in claim 17, wherein the adjustment member comprises at least two apertures.

20. A device as in claim 19, wherein each of the at least two apertures is configured to guide a drill bit to form a hole in the distal femur for attaching a cutting guide to the femur.

21. A device as in claim 19, wherein each of the at least two apertures are configured to receive at least one of a marker, a fiducial, a transponder, a transceiver and a sensor.

22. A device as in claim 19, wherein the at least two apertures extend through the adjustable femoral member and through apertures in the stationary femoral member to provide access to the distal femur.

23. A device as in claim 22, wherein the at least two apertures are positioned slightly asymmetrically on the adjustable femoral member to provide for a built-in desired flexibility in the ligaments when the surgical procedure is completed.

24. A device as in claim 17, wherein at least one of the adjustable femoral member and the adjustment member is asymmetrically oriented relative to the stationary member to provide built-in enhanced range of motion when the surgical procedure is completed.

25. A device as in claim 24, further comprising multiple adjustable femoral members, each having a different asymmetry relative to the stationary member, wherein one of the multiple adjustable femoral members is selected for facilitating the surgical procedure to provide a desired range of motion when the surgical procedure is completed.

26. A device as in claim 1, wherein the tibial member comprises at least one shim, paddle, plate, bar, platform or rod.

27. A device as in claim 26, wherein the tibial member comprises a plurality of tibial shims having different thicknesses or heights, wherein any one of the plurality of shims may be selected for engaging with the surface of the proximal tibia to provide a desired amount of tension in the ligaments.

28. A device as in claim 27, wherein the tibial member further comprises a plate for removably attaching to the surface of the proximal tibia, disposed between the surface and the selected tibial shim.

29. A device, as in claim 1, wherein the femoral member and the tibial member are configured to be movably coupled via force provided by the at least one ligament of or adjacent the knee.

30. A device as in claim 1, wherein the femoral and tibial members, when engaged with the distal femur and proximal tibia respectively, are disposed primarily within a joint space between the distal femur and the proximal tibia.

31. A device as in claim 30, wherein a patella of the knee remains approximately in its anatomical position while the femoral and tibial members are engaged and the knee is moved through the range of motion.

32. A device as in claim 1, wherein the movable coupling of the femoral and tibial members allows for flexion and extension through the range of motion.

33. A device as in claim 32, wherein the range of motion comprises a range from approximately full extension of the knee to approximately full flexion of the knee.

34. A device as in claim 1, wherein the stationary femoral member comprises at least one material selected from the group consisting of plastics, composites, aluminum, stainless steel, composite, cobalt-chrome, titanium, and other metals.

35. A device as in claim 1, wherein the adjustable femoral member comprises at least one material selected from the group consisting of plastics, composites, aluminum, stainless steel, composite, cobalt-chrome, titanium, and other metals.

36. A device as in claim 1, further comprising at least one grasping member coupled with at least one of the stationary and adjustable femoral members for facilitating placement and/or removal of the device from the knee.

37. A device as in claim 1, wherein the adjustable femoral member is configured to be adjusted to identify at least one position on the distal femur for rotationally orienting a guiding device on the femur to make at least one bone cut for positioning of an implanted prosthetic femoral device, the position of the implanted device enhancing at least one of range of motion, stability and patella tracking of the knee.

38. A device as in claim 37, wherein the guiding devices is a cutting guide, a fiducial, a marker, a transponder or a transceiver and sensor.

39. A device as in claim 1, wherein the at least one stationary femoral member comprises:

at least one distal femoral plate for removably attaching to the distal femur; and

at least one stationary posterior condylar member extending substantially perpendicular from the distal femoral plate to contact at least part of a medial posterior femoral condyle or a lateral posterior femoral condyle of the distal femur.

40. A device as in claim 1, wherein the adjustable femoral member comprises a plate and the posterior condylar member extends substantially perpendicularly from the plate.