KNEE ALIGNER FOR SURGERY

• US 20100179605A1
• Filed: 01/11/2010
• Published: 07/15/2010
• Est. Priority Date: 03/11/2004
• Status: Active Grant

• Current Assignee: Ermi LLC
• Original Assignee: Thomas P. Branch
• Inventors: Sattler, Alexander JR., Westin, Fredrik, Branch, Thomas P.
• Granted Patent: US 7,985,227 B2
• Time in Patent Office: Days
• US Class Current: 606/86.R
• CPC Class Codes: A61B 17/154 for preparing bone for knee prosthesis
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/565 for surgical correction of axial deviation, e.g. hallux valgus or genu valgus
• CPC Class Codes: A61F 2002/4658 for measuring dimensions, e.g. length
• CPC Class Codes: A61F 2002/4666 for measuring force, pressure or mechanical tension

Abstract

Generally described the invention relates to methods and apparatuses for aligning the lower extremities of a patient with a mechanical axis. More specifically, the present invention provides an exoskeleton or external framework that positions a patient'"'"'s leg into a desired mechanical axis in preparation for surgery or other medical treatment.

Claims

1-8. -8. (canceled)

9. A method for preparing a patient'"'"'s leg having a femur with a femoral head, a thigh portion, a knee portion, a tibia, and an ankle portion, for treatment thereon, said method comprising the steps of:

providing a first reference point proximate said femoral head;

providing a second reference point proximate the center of said ankle portion; and

providing a visual indication of a reference axis passing from said first reference point to said second reference point such that said visual indication is within substantially the same plane as the mechanical axis of said leg, said mechanical axis having a portion extending from the center of said femoral head to the center of said ankle

10. The method of claim 9, wherein said step of providing a first reference point comprises the steps of:

taking an X-ray of said patient showing at least the location of a skeletal reference and said femoral head;

identifying said skeletal reference on said patient; and

positioning said first reference point proximate said femoral head of said patient responsive to said distance obtained from said X-ray.

11. The method of claim 9, further comprising the steps of:

urging said leg into a desired alignment with said reference axis;

providing an external frame configured to secure said leg in said desired alignment; and

securing said leg relative to said external frame proximate said alignment.

12. The method of claim 9, further comprising the steps of:

providing a cutting guide mounting assembly attached relative to said external frame and configured to position a cutting tool proximate to said knee joint;

removing at least a portion of the distal end of said femur with a cutting tool guided by said cutting guide mounting assembly; and

removing at least a portion of the proximal end of said tibia with a cutting tool guided by said cutting guide mounting assembly.

13. The method of claim 12, further comprising the steps of:

providing an upper pivoting assembly including a thigh support portion configured to support said leg proximate said thigh and having an inflatable bladder positioned intermediate said leg and said thigh support portion;

positioning said leg in with said knee in a bent condition such that said thigh support is positioned proximate said thigh portion of said leg; and

selectively inflating said bladder such that said thigh is urged away from said upper pivoting assembly tending to cause distraction at the knee.

14. The method of claim 9, further comprising the steps of:

distracting said knee portion of said leg by applying a force to said foot portion in a direction away from said torso of said patient in a direction substantially parallel to the longitudinal axis of said leg;

providing a wedged shaped measuring tool configured to contact bearing surfaces of said femur and said tibia at said knee portion and provide indicia of a clearance between said bearing surfaces.

15. The method of claim 14, further comprising the steps of:

providing a prosthesis assembly having a first member configured to be secured to said femur of said leg, and a second member configured to be secured to said tibia of said leg, each of said first and second members having a bearing portion configured to provide movement at said knee portion; and

providing a dissolvable spacer between said bearing surfaces, said spacer having a thickness substantially the same as said measured clearance.

16. The method of claim 15, further comprising the step of releasing an antibiotic from said spacer when said spacer dissolves.

17. The method of claim 9, further comprising the steps of:

providing a cutting guide mounting assembly attached relative to said external frame and configured to position a cutting tool proximate to said knee joint; and

removing at least a portion of the distal end of said femur with a cutting tool guided by said cutting guide mounting assembly.

18. The method of claim 17, further comprising the step of removing at least a portion of the proximal end of said tibia with a cutting tool guided by said cutting guide mounting assembly.

19. A method for aligning a leg of a patient with a mechanical axis to facilitate medical treatment thereon, said leg having a femoral head, a thigh portion, and a foot portion, which itself includes an ankle portion, said method comprising the steps of:

A) providing a device comprising;

1) a base member including a spine portion and a head portion, said spine portion being substantially elongate and having a longitudinal axis, said head portion attached proximate one longitudinal end of said spine portion;

2) a pelvic location assembly attached relative to said base member proximate said head portion, said pelvic location assembly including a femoral head location member;

3) a carriage moveably attached relative to said spine portion and configured to be moved along a carriage path having a portion being substantially parallel to said longitudinal axis of said spine portion;

4) a boot assembly pivotably attached relative to said carriage;

5) a mechanical axis indicator; and

6) a leg manipulation assembly attached relative to said spine portion between said pelvic location assembly and said boot assembly, said leg manipulating assembly having a first lateral force assembly and a second lateral force assembly, said force assemblies being proximate said thigh portion and spaced apart to accept said leg therebetween, said first lateral force assembly being adjustable and selectably securable along an axis substantially perpendicular to said longitudinal axis of said spine portion;

B) positioning said leg adjacent said base member such that said leg is generally parallel to said longitudinal axis of said spine portion;

C) securing said foot portion of said patient'"'"'s leg to said boot assembly;

D) selectively securing said carriage relative to said spine portion so as to discourage said relative movement between said boot assembly and said spine portion;

E) manipulating said femoral head location assembly to establish a first reference point positioned at a known location relative to the center of said femoral head;

F) manipulating said boot assembly to establish a second reference point at a known location relative to the center of said ankle portion of said foot portion;

G) obtaining from said mechanical axis indicator a visual indication of a portion of a reference axis passing from said first reference point to said second reference point, such that said reference axis is within substantially the same plane as said mechanical axis;

H) adjusting said first lateral force assembly to urge said leg into a desired alignment with said mechanical axis indicator; and

I) selectively securing said first lateral force assembly to discourage said leg from moving away from said desired alignment.

20. The method of claim 19, wherein said leg also includes a knee, wherein said first lateral force assembly further includes a first post member and a first inflatable bladder, and wherein step “

H”

further comprises;

selectively inflating said first inflatable bladder such that said first inflatable bladder tends to provide a bias against said leg proximate said knee, thus urging said knee away from said first post and into said desired alignment with said mechanical axis indicator.

21. The method of claim 20, wherein said leg also includes a knee, wherein said second lateral force assembly further includes a second post member and a second inflatable bladder, and wherein step “

H”

further comprises;

selectively inflating said first and said second bladders such that said inflating of said first and second bladders tends to provide a bias between said leg proximate said thigh portion and at least one of said first and said second bladders, thus urging said knee into a desired alignment with said mechanical axis indicator.

22. The method of claim 21, wherein, during step “

H”

, selectively inflating said first and said second inflatable bladders discourages movement of said leg relative to said first and said second post members.

23. The method of claim 19, wherein said first and said second lateral force assemblies, provided during step “

A”

, include a corresponding first and a second post member, said first and said second post members moveably attached relative to said base member such that said first and said second lateral force assemblies are adjustable and selectively securable in an axis substantially perpendicular to the longitudinal axis of said spine portion, said second post member spaced apart from said first post member, and wherein;

during step “

B”

, said positioning of said patient'"'"'s leg comprises accepting said leg between said first and said second post members; and

during step “

H”

, said adjusting of said first lateral force assembly comprises selectively contacting said leg with said first or said second post member to urge a knee of said leg into alignment with said mechanical axis indicator.

24. The method of claim 23, wherein step “

A”

further comprises providing a cutting guide mounting assembly attached relative to said first post member and configured to position a cutting guide proximate a knee portion of said leg, said cutting guide mounting assembly further adjustable in at least two orthogonal axes, and further comprising a step “

J”

of using said cutting guide mounting assembly to guide a cutting tool to remove bone from said leg.

25. The method of claim 24, wherein said cutting guide includes a slot configured to provide a path for a bone cutting tool to follow, and wherein in step “

J”

, said bone cutting tool follows said slot while removing bone from said leg.

26. The method of claim 23, further comprising:

J) positioning said cutting guide assembly to facilitate leg bone removal in an axis perpendicular to said mechanical axis.

27. The method of claim 19, wherein said leg also includes a knee, wherein said carriage in step “

A(3)”

is a first carriage, and wherein;

step “

A”

further comprises providing said leg manipulation assembly with;

1) an upper pivoting assembly having a first end and a second end and including a thigh support portion, said upper pivoting assembly including said first and said second lateral force assemblies spaced apart to accept said leg therebetween, said first end being pivotably attached relative to said spine portion proximate said head portion and said first and second lateral force assemblies being positioned proximate said second end such that they can pivot together relative to said spine portion while still retaining said leg therebetween; and

2) a second carriage slidably mounted along the longitudinal axis of said spine portion; and

3) a lower pivoting member having a first end and a second end, said first end of said lower pivoting member being pivotably attached to said second end of said upper pivoting assembly proximate said patient'"'"'s knee portion, said second end of said lower pivoting member being pivotably attached to said carriage;

and wherein said method further comprises;

J) pivoting said upper pivoting assembly about its said first end so as to move said lower pivoting member and said carriage from a first, “

straight-leg”

configuration, in which said first and second lateral force assemblies retain said leg therebetween while said leg of said patient is substantially straight, to a second, “

bent-leg”

, configuration, in which said first and second lateral force assemblies retain said leg therebetween while said leg of said patient is bent and while said thigh support portion provides support proximate said thigh portion of said leg.

28. The method of claim 27, further comprising a step prior to step J, namely a step of adjusting a length of said upper pivoting assembly between its said first and second ends to allow adjustability to accommodate the length of a patient'"'"'s leg such that the position of said first and said second lateral force assemblies can be adjusted together relative to the leg of said patient.

29. The method of claim 27, wherein said thigh support portion is configured to allow free movement of a calf portion of said leg when said leg is in said bent condition, and such that said method includes free movement of said calf portion.

30. The method of claim 27, wherein said device provided in step “

A”

further comprises an inflatable bladder positioned intermediate said thigh portion and said upper pivoting assembly to encourage distraction of said knee joint when said knee is in a bent condition and said bladder is selectively inflated, and further comprising the step of distracting said knee joint when said knee is in a bent condition by inflating said bladder.

31. The method of claim 19, further comprising, subsequent to step “

I”

, the step of moving said leg manipulation assembly from a first, “

straight-leg”

configuration, to a second, “

bent-leg”

, configuration while still tending to retain said leg in said desired alignment with said mechanical axis.

32. A method for treating a patient'"'"'s leg having a femur, a tibia, and a knee portion intermediate the two, said method comprising the steps of:

providing a prosthesis assembly having a first member configured to be secured to said femur of said leg, and a second member configured to be secured to said tibia of said leg, each of said first and second members having a bearing portion configured to provide movement to said knee portion; and

providing a dissolvable spacer between bearing surfaces of said femur, said spacer having a thickness substantially the same as a measured clearance between said bearing surfaces.

33. An apparatus configured to measure the clearance between the mating surfaces of the femur and a tibia at the knee joint, said apparatus being elongate with a substantially wedge shaped tip portion, said tip portion including indicia associated with a width at a distance spaced apart from the end of said tip.