Custom replacement device for resurfacing a femur and method of making the same

• US 6,905,514 B2
• Filed: 11/12/2003
• Issued: 06/14/2005
• Est. Priority Date: 03/17/2000
• Status: Expired due to Term

• Current Assignee: Kinamed Inc (VME Acquisition Corp)
• Original Assignee: Kinamed Inc (VME Acquisition Corp)
• Inventors: Carignan, Roger, Pratt, Clyde R.
• Primary Examiner(s): STEWART, ALVIN J
• Application Number:
  US10/712,436
• Publication Number:
  US 20040098133A1
• Time in Patent Office: 580 Days
• Field of Search: 623/901, 623/911, 623/20.35, 623/20.3, 623/20.31, 606/102, 264/299, 264/212, 264/298, 700/197, 700198-207
• US Class Current: 623/20.35
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/1764 for the knee
• 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 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/30942 for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
• CPC Class Codes: A61F 2/3859 Femoral components
• CPC Class Codes: A61F 2/3877 Patellae or trochleae
• CPC Class Codes: A61F 2/461 of knees
• CPC Class Codes: A61F 2/4657 Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2002/30125 elliptical or oval
• CPC Class Codes: A61F 2002/30594 slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots
• CPC Class Codes: A61F 2002/30685 Means for reducing or preventing the generation of wear particulates
• CPC Class Codes: A61F 2002/30892 parallel
• CPC Class Codes: A61F 2002/30948 using computerized tomography, i.e. CT scans
• CPC Class Codes: A61F 2002/30952 using CAD-CAM techniques or NC-techniques
• CPC Class Codes: A61F 2002/30957 using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/4658 for measuring dimensions, e.g. length
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2310/00017 Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00203 : containing alumina or aluminium oxide
• CPC Class Codes: A61F 2310/00239 : containing zirconia or zirconium oxide ZrO2
• CPC Class Codes: A61F 2310/00407 : Coating made of titanium or of Ti-based alloys
• CPC Class Codes: A61F 2310/00796 : Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
• CPC Class Codes: Y10S 623/901 : Method of manufacturing prosthetic device
• CPC Class Codes: Y10T 29/49764 : with testing or indicating

Abstract

A replacement device for resurfacing a joint surface of a femur and a method of making and installing such a 5 device is provided. The custom replacement device is designed to substantially fit the trochlear groove surface, of an individual femur. Thereby creating a “customized” replacement device for that individual femur and maintaining the original kinematics of the joint. The replacement device may be defined by four boundary points, and a first and a second surface. The first of four points is 3 to 5 mm from the point of attachment of the anterior cruciate ligament to the femur. The second point is near the bottom edge of the end of the natural articulatar cartilage. The third point is at the top ridge of the right condyle and the fourth point at the top ridge of the left condyle of the femur. The top surface is designed so as to maintain centrally directed tracking of the patella perpendicular to the plane established by the distal end of the femoral condyles and aligned with the center of the femoral head.

Claims

1. A method of making a replacement device, comprising the steps of:

forming a model of a distal end of a patient'"'"'s femur;

forming a first mold from the model, wherein the first mold has a bottom side that substantially matches the trochlear groove of the patient'"'"'s femur, wherein the first mold has a top side opposite of the bottom side;

coupling a peg on a predetermined location on the bottom side of the first mold;

shaping the top side of the mold to substantially track the trochlear groove of the patient'"'"'s femur;

forming a second mold from the first mold; and

pouring viscous material into the second mold to make a replacement device.

2. A method according to claim 1, further comprising the steps of:

streamlining the edges of the replacement device.

3. A method according to claim 1, further comprising the steps of:

shaping the replacement device to have an oval shape defined by first, second, third, and fourth boundary conditions, wherein;

the first boundary condition being approximately 3 mm to 5 mm from the attachment of an anterior cruciate ligament to the femur;

the second boundary condition being approximately at least near the superior edge of an end of a natural cartilage of the femur;

the third boundary condition being approximately at the top ridge of a right condyle of the femur; and

the fourth boundary condition being approximately at the top ridge of a left condyle of the femur.

4. A method according claim 1, further comprising the steps of:

shaping the top surface of the replacement device to have a substantially similar thickness between the top and bottom surfaces, wherein the thickness is approximately between 2 mm and 6 mm.

5. A method according to claim 1, further including the steps of:

taking a predetermined number of sliced images along the distal end of a patient'"'"'s femur

transposing each of the predetermined number of sliced images into a plate;

cutting the sliced images from each of the plates;

assembling each of the plates to define outer edges of the distal end of the femur; and

applying filler over the outer edges to form the model of the distal end of the femur.

6. A method of forming a replacement device and a marking template device from a single mold, comprising the steps of:

forming a model of patient'"'"'s distal end of a femur,

forming a first mold from die model, wherein the first mold has a back side that matches the trochlear groove of the femur, wherein the first mold has a face side

opposite of the back side;

shaping the face side of the first mold to substantially track the trochlear groove of the femur;

forming a second mold from the first mold; and

pouring a first viscous material into the second mold to make a replacement device.

7. A method according to claim 6, further including the stops of:

coupling a peg to the back side of the first mold at a predetermined location;

removing the peg from the back side of the first mold;

forming a third mold from the first mold without the peg on the back side; and

pouring a second viscous material into the third mold to make a marking template.

8. A method according to claim 6, further including the steps of:

forming an opening through the first mold along the predetermined location.

9. A method according to claim 6, wherein the first viscous material and second viscous material is the same material.

10. A method according claim 6, wherein the step for forming the model of patients distal end of the femur further includes the steps of:

compiling in a computer a CT image data of the patient'"'"'s distal end of the femur;

creating a surface of the patients distal end of the femur; and

driving a computer assisted machine system to machine the model of patient'"'"'s distal end of the femur.