Osteotomy system

• US 20050075641A1
• Filed: 10/04/2004
• Published: 04/07/2005
• Est. Priority Date: 10/03/2003
• Status: Active Grant

• Current Assignee: Linvatec Corporation (Jefferies Financial Group, Inc.)
• Original Assignee: Linvatec Corporation (Jefferies Financial Group, Inc.)
• Inventors: Singhatat, Wamis, Amery, Drew, Lombardo, Giuseppe
• Granted Patent: US 8,388,690 B2
• Time in Patent Office: Days
• US Class Current: 606/86.R
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 17/15 Guides therefor arrangements for guiding straight saw blades in general B23D51/025
• CPC Class Codes: A61B 17/152 for removing a wedge-shaped piece of bone
• CPC Class Codes: A61B 17/1728 for holes for bone plates or plate screws
• CPC Class Codes: A61B 17/1764 for the knee
• CPC Class Codes: A61B 17/8095 Wedge osteotomy devices

Abstract

An osteotomy system includes a wedge implant and an osteotomy guide.

Claims

1. A wedge-shaped spacer for insertion into an osteotomy formed in a bone, the osteotomy partially dividing the bone into two bone portions connected by a bony hinge, the osteotomy having a proximal opening at a cortical surface of the bone and a distal vertex adjacent to the bony hinge, the wedge-shaped spacer comprising a body having a first surface, a second surface, and an insertion axis, the first and second surfaces being angled relative to one another in a first plane containing the insertion axis by a first angle, the first and second surfaces being angled relative to one another in a second plane perpendicular to the insertion axis by a second angle.

2. The spacer of claim 1 further comprising a proximal sidewall and a distal sidewall, the first and second surfaces being spaced further apart at a position adjacent to the proximal sidewall than at a position adjacent to the distal sidewall, the spacer including an opening from the first surface to the second surface and extending to the proximal sidewall forming a gap in the proximal sidewall such that the gap permits bone growth between the two bone portions at the proximal opening.

3. The spacer of claim 2 wherein the spacer is generally U-shaped.

4. The spacer of claim 2 further comprising lips extending transversely from the first and second surfaces adjacent to the proximal sidewall on opposing sides of the opening.

5. The spacer of claim 2 further comprising at least one fixation plate extending transversely from the first and second surfaces adjacent to the proximal sidewall, the fixation plate including at least one transverse hole configured to receive a bone screw.

6. The spacer of claim 5 wherein the fixation plate is formed from a relatively more malleable material than the spacer body.

7. The spacer of claim 5 wherein the fixation plate and spacer body are a unitary construction.

8. The spacer of claim 1 wherein the first and second angles are sized to produce a predetermined varus-valgus angular correction and a predetermined posterior slope angular correction.

9. The spacer of claim 1 wherein spacer comprises a bioresorbable material.

10. The spacer of claim 1 wherein the first and second surfaces comprise planar surfaces converging toward the distal end.

11. A wedge-shaped spacer for insertion into an osteotomy formed in a bone, the osteotomy partially dividing the bone into two bone portions connected by a bony hinge, the osteotomy having a proximal opening at a cortical surface of the bone and a distal vertex adjacent the bony hinge, the wedge-shaped spacer comprising a body having first and second surfaces and proximal and distal ends, the first and second surfaces being angled relative to one another, the first and second surfaces converging from the proximal end toward the distal end, the body comprising an opening extending through a portion of the body from near the distal end to near the proximal end and lying between the first and second surfaces over a portion of the length of the opening, the spacer further comprising a threaded fastener inserted into the opening and engaging the spacer such that the fastener may be mounted on the bone and threaded into the spacer to translate the spacer toward the distal vertex.

12. A wedge-shaped spacer for insertion into an osteotomy formed in a bone, the osteotomy partially dividing the bone into two bone portions connected by a bony hinge, the osteotomy having a proximal opening at a cortical surface of the bone and a distal vertex adjacent the bony hinge, the wedge-shaped spacer comprising a body having first and second surfaces and proximal and distal sidewalls, the first and second surfaces being angled relative to one another, the first and second surfaces converging from the proximal sidewall toward the distal sidewall, the spacer including an opening from the first surface to the second surface and extending to the proximal sidewall to form a gap in the proximal sidewall such that the gap permits bone growth between the two bone portions at the proximal opening.

13. The spacer of claim 12 further comprising a plurality of openings formed between the first surface and the second surfaces to permit bone growth through the body of the spacer.

14. The spacer of claim 12 further comprising at least one elongated opening that extends from the first surface to the second surface and along a path generally parallel to the outer profile of the spacer to permit bone growth through the body of the spacer.

15. The spacer of claim 12 wherein the opening is filled with a bone growth promoting substance.

16. A wedge-shaped spacer for insertion into an osteotomy formed in a bone, the osteotomy partially dividing the bone into two bone portions connected by a bony hinge, the osteotomy having a proximal opening at a cortical surface of the bone and a distal vertex adjacent the bony hinge, the wedge-shaped spacer comprising a body having a first surface, a second surface, a proximal end, and a distal end, the first and second surfaces being angled relative to one another, the first and second surfaces converging from the proximal end toward the distal end, the spacer body comprising a plurality of zones comprising one or more bioresorbable materials, the zones having different rates of bioresorption.

17. The spacer of claim 16 wherein the rate of bioresorption of the zones is higher for zones nearer the distal end and lower for zones nearer the proximal end of the spacer.

18. The spacer of claim 16 wherein the spacer body comprises a porous structure in which the pores are filled with one or more resorbable materials.

19. The spacer of claim 18 wherein the body comprises a porous resorbable polymer and the pores in different zones are filled with different resorbable ceramics.

20. The spacer of claim 19 wherein the resorbable polymer comprises PLLA polymer and the spacer body comprises at least three zones arranged proximally to distally, the ceramics filling the pores comprising hydroxy apatite, beta tricalcium phosphate, and calcium sulfate proximally to distally.

21. A wedge-shaped spacer for insertion into an osteotomy formed in a bone, the osteotomy partially dividing the bone into two bone portions connected by a bony hinge, the osteotomy having a proximal opening at a cortical surface of the bone and a distal vertex adjacent the bony hinge, the wedge-shaped spacer comprising a body having a first surface, a second surface, a proximal end, and a distal end, the first and second surfaces being angled relative to one another, the first and second surfaces converging from the proximal end toward the distal end, at least one fixation plate extending from the proximal end transversely to the first and second surfaces, the fixation plate including at least one transverse hole configured to receive a bone screw, the fixation plate being formed from a relatively more malleable material than the spacer body.

22. The spacer of claim 21 wherein the fixation plate and spacer body are a unitary structure.

23. The spacer of claim 21 wherein the spacer body is formed from a first resorbable polymer and the fixation plate is formed from a second resorbable polymer.

24. The spacer of claim 23 wherein the spacer body comprises a homogenous PLLA polymer and the fixation plate comprises a PLLA polymer in which the polymer chains have been oriented by drawing in one or more directions to align the chains and improve malleability.

25. In combination:

a wedge-shaped spacer for insertion into an osteotomy formed in a bone, the osteotomy partially dividing the bone into two bone portions connected by a bony hinge, the osteotomy having a proximal opening at a cortical surface of the bone and a distal vertex adjacent the bony hinge, the wedge-shaped spacer comprising a body having first and second surfaces and proximal and distal ends, the first and second surfaces being angled relative to one another, the first and second surfaces converging from the proximal end toward the distal end, the body comprising a portal extending through a portion of the body from near the proximal end to the distal end and lying generally between the first and second surfaces; and

an inserter, the inserter comprising;

an inserter shaft having a proximal end and a distal end, the inserter shaft including an axial bore extending from the proximal end to the distal end, the distal end of the inserter shaft being engageable with the proximal end of the spacer in force transmitting relationship; and

a plunger, the plunger engaging the axial bore of the inserter shaft and operable to expel material from the distal end of the inserter shaft into the portal in the spacer.

26. An inserter for inserting a wedge-shaped spacer into an osteotomy formed in a bone, the osteotomy partially dividing the bone into two bone portions connected by a bony hinge, the osteotomy having a proximal opening at a cortical surface of the bone and a distal vertex adjacent the bony hinge, the wedge-shaped spacer having a proximal fixation plate that abuts the bone adjacent to the proximal opening of the osteotomy, the fixation plate including at least one through hole for receiving a fixation screw directed into the bone, the inserter comprising:

a shaft having a proximal end and a distal end, the distal end being engageable with the spacer in force transmitting relationship;

a drill sleeve guide including a body mountable on the shaft, an elongated tab extending outwardly away from the drill sleeve guide body generally parallel to the fixation plate, the tab including an elongated through hole having a vertically oriented long axis, the vertical dimension of the elongated through hole being greater than the vertical dimension of the fixation plate through hole; and

a drill sleeve having a proximal end, a distal end, and a longitudinal through bore, the longitudinal through bore being sized to guide a drill, the drill sleeve being extendable through the elongated through hole of the drill sleeve guide, the distal end of the drill sleeve engaging the fixation plate through hole, the drill sleeve being pivotable between a first angular position in which it abuts the top of the elongated through hole of the drill sleeve guide and the drill sleeve bore is normal to the fixation plate and a second angular position in which it abuts the bottom of the elongated through hole of the drill sleeve guide and the drill sleeve is directed at an angle away from the spacer body such that the drill sleeve can be angled to remain normal to the fixation plate if the fixation plate is bent toward the drill sleeve guide.

27. An osteotomy guide for guiding the creation of an osteotomy in a bone in which the osteotomy partially divides the bone into two bone portions connected by a bony hinge, the osteotomy having a proximal opening at a cortical surface of the bone and a distal vertex adjacent to the bony hinge, the osteotomy guide comprising:

a first clamping arm;

a second clamping arm opposing the first clamping arm and mounted to the first clamping arm for relative translation, the arms being translatable between a first position in which they are spaced from opposite sides of the bone and a second position in which they abut opposite sides of the bone in clamping arrangement;

a cutter guide mounted to one of the first and second arms such that the cutter guide can guide a cutter to form the osteotomy in the bone at a predetermined orientation relative to the first and second clamping arms.

28. The osteotomy guide of claim 27 further comprising a drive screw mounted between the first and second clamping arms such that rotating the screw translates the arms between the first and second positions.

29. The osteotomy guide of claim 27 further comprising:

a drill guide mounted to one of the first and second arms, the drill guide including a guide bore; and

a drill, the drill being received in the guide bore such that the drill guide can guide the drill to form a hole in the bone at the vertex of the osteotomy.

30. The osteotomy guide of claim 29 wherein the drill includes at least one index mark able to be referenced to the drill guide to indicate the relative position of the drill in the bone.

31. The osteotomy guide of claim 27 wherein each of the clamping arms includes a cannulated prong mounted on the arm such that each prong can receive a fixation pin.

32. The osteotomy guide of claim 31 wherein the prong on each arm is coaxially aligned with the prong on the opposite arm to create a rotation axis for the guide on the bone.

33. The osteotomy guide of claim 31 wherein the prong on each arm is adjustable along a portion of the length of each arm and can be locked in a desired position along the length of each arm.

34. The osteotomy guide of claim 27 wherein each of the clamping arms includes a cannula for receiving a fixation pin, each cannula generally facing the opposite clamping arm, each cannula forming an angle with the clamping arm, the angle of the cannula relative to the arm being adjustable.

35. The osteotomy guide of claim 34 wherein each cannula is also adjustable along a portion of the length of each arm and can be locked in a desired position along the length of each arm such that each cannula may be independently adjusted on each arm and angled to face the opposite cannula.

36. The osteotomy guide of claim 34 further comprising a plurality of flexible fixation pins, one of the plurality of fixation pins being insertable through each cannula such that the guide can be pinned to the bone and subsequently rotated and the cannulae will angle so that they remain parallel and the fixation pins will bend.

37. The osteotomy guide of claim 27 wherein one of the first and second clamping arms comprises a plurality of modular attachments.

38. An osteotomy guide for guiding the creation of an osteotomy in a bone in which the osteotomy partially divides the bone into two bone portions connected by a bony hinge, the osteotomy having a proximal opening at a cortical surface of the bone and a distal vertex adjacent the bony hinge, the osteotomy guide comprising:

a base having means for mounting it on the bone;

a cutter guide mounted to the base such that the cutter guide can guide a cutter to form the osteotomy in the bone at a predetermined orientation relative to the base;

a drill guide mounted to the base, the drill guide including a guide bore; and

a drill, the drill being received in the guide bore such that the drill guide can guide the drill to form a hole in the bone at the vertex of the osteotomy.

39. The osteotomy guide of claim 38 further comprising an alignment rod, the alignment rod comprising:

a support, the support including means for releasably mounting it in predetermined fixed relationship to the base;

a boom mounted at a predetermined fixed angle to the support.

40. A method of correcting the angular alignment of a bone, the method comprising:

creating an osteotomy in a bone in which the osteotomy partially divides the bone into two bone portions connected by a bony hinge, the osteotomy having a proximal opening at a cortical surface of the bone and a distal vertex adjacent the bony hinge;

determining a required first angular correction in a first plane;

determining a required second angular correction in a second plane;

providing a wedge-shaped spacer comprising a body having first and second surfaces and an insertion axis, the first and second surfaces being angled relative to one another in a third plane containing the insertion axis by a third angle, the first and second surfaces being angled relative to one another in a fourth plane perpendicular to the insertion axis by a fourth angle; and

inserting the spacer into the osteotomy to simultaneously correct the bone alignment in the first and second planes.

41. The method of claim 40 further comprising:

inserting a fixation screw through a fixation plate to secure the wedge-shaped spacer in the osteotomy.

42. A method of correcting the angular alignment of a bone, the method comprising:

creating an osteotomy in a bone in which the osteotomy partially divides the bone into two bone portions connected by a bony hinge, the osteotomy having a proximal opening at a cortical surface of the bone and a distal vertex adjacent the bony hinge;

determining at least one required angular correction for the bone;

providing a wedge-shaped spacer comprising a body having first and second surfaces, and an insertion axis, the first and second surfaces being angled relative to one another in a first plane containing the insertion axis by a first angle different from the value of the predetermined angular correction, the first and second surfaces being angled relative to one another in a second plane perpendicular to the insertion axis by a second angle different from the value of the predetermined angular correction; and

inserting the spacer into the osteotomy obliquely such that bone alignment is corrected by the predetermined angular correction as a result of the combined effects of the first and second spacer angles.

43. A method of correcting the angular alignment of a bone, the method comprising:

mounting a guide base on the bone;

guiding a drill relative to the guide base to create a bone hole at a desired vertex for the angular correction;

guiding a cutter relative to the guide base to create an osteotomy in the bone extending from a cortical surface of the bone to the bone hole; and

opening the osteotomy to correct the angular alignment of the bone.

44. The method of claim 43 wherein the drill is left in the drill hole during cutting of the osteotomy to act as a shield to limit the depth of cut.

45. The method of claim 43 wherein the step of mounting the guide base on the bone further comprises the steps of:

pinning the guide base on the bone at a first angle relative to the bone in a first plane using fixation pins;

pivoting the guide base about the fixation pins to set the guide base at a second angle relative to the bone in a second plane; and

pinning the guide base to fix the second angle.

46. The method of claim 45 wherein the step of pinning the guide base to fix the second angle comprises inserting the drill into the bone.

47. A method of correcting the angular alignment of a bone, the method comprising:

creating an osteotomy in a bone in which the osteotomy partially divides the bone into two bone portions connected by a bony hinge, the osteotomy having a proximal opening at a cortical surface of the bone and a distal vertex adjacent the bony hinge;

engaging a wedge-shaped implant with an insertion tool;

inserting the implant into the osteotomy with the insertion tool; and

using the insertion tool as a syringe to inject bone growth promoting substances through the implant and into the vertex of the osteotomy.

48. A method of correcting the angular alignment of a bone, the method comprising:

creating an osteotomy in a bone in which the osteotomy partially divides the bone into two bone portions connected by a bony hinge, the osteotomy having a proximal opening at a cortical surface of the bone and a distal vertex adjacent the bony hinge;

inserting a wedge-shaped spacer into the osteotomy, the spacer comprising a body having first and second surfaces and proximal and distal sidewalls, the first and second surfaces being angled relative to one another, the first and second surfaces converging from the proximal sidewall toward the distal sidewall, the spacer including an opening from the first surface to the second surface and extending to the proximal sidewall forming a gap in the proximal sidewall such that the gap permits bone growth between the two bone portions at the proximal opening of the osteotomy; and

permitting bone to grow through the gap in the proximal side wall.

49. A method of correcting the angular alignment of a bone, the method comprising:

creating an osteotomy in a bone in which the osteotomy partially divides the bone into two bone portions connected by a bony hinge, the osteotomy having a proximal opening in a medial cortical surface of the bone and a distal vertex adjacent the bony hinge near a lateral cortical surface;

inserting a wedge implant into the osteotomy through the opening in the medial cortical surface; and

inserting a fastener through the lateral cortical surface and into engagement with the implant.

50. The method of claim 49 wherein the fastener abuts the lateral cortical surface and threads into the implant, the method further comprising:

rotating the fastener to draw the implant into the osteotomy.