Disposable knee mold

• US 6,942,475 B2
• Filed: 03/13/2003
• Issued: 09/13/2005
• Est. Priority Date: 03/13/2002
• Status: Active Grant

• Current Assignee: Ortho Development Corporation (Japan Medical Dynamic Marketing, Inc.)
• Original Assignee: Ortho Development Corporation (Japan Medical Dynamic Marketing, Inc.)
• Inventors: Ensign, Michael D., Mariani, E. Marc, Bourne, Michael H., Lowe, Matthew M.
• Primary Examiner(s): Davis, Robert B.
• Application Number:
  US10/389,247
• Publication Number:
  US 20040036189A1
• Time in Patent Office: 915 Days
• Field of Search: 425/2, 425/DIG.44, 249/55, 249/61, 623/901, 623/20.21, 264/DIG.30, 606/102
• US Class Current: 425/2
• 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 2/38 for elbows or knees
• CPC Class Codes: A61F 2002/30133 kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/30616 Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/30672 temporary
• CPC Class Codes: A61F 2002/30957 using a positive or a negative model, e.g. moulds
• CPC Class Codes: B29C 2043/3652 Elastic moulds or mould parts, e.g. cores or inserts
• CPC Class Codes: B29C 33/405 Elastomers, e.g. rubber B29C33/50 takes precedence
• CPC Class Codes: B29C 39/10 incorporating preformed parts or layers, e.g. casting around inserts or for coating articles coating a surface by casting in general B05D1/30, B29C39/126 takes precedence
• CPC Class Codes: B29C 43/36 Moulds for making articles of definite length, i.e. discrete articles
• CPC Class Codes: B29K 2995/0056 Biocompatible, e.g. biopolymers or bioelastomers
• CPC Class Codes: B29L 2031/7532 Artificial members, protheses
• CPC Class Codes: Y10S 264/30 Use of anatomy in making a mold or using said mold
• CPC Class Codes: Y10S 425/044 Rubber mold
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

An orthopedic implant device and method is disclosed. Specifically, a knee mold system is disclosed, including elastic tibial and femoral molds, each of which may be configured and dimensioned as a unitary mold for in situ placement during a surgical procedure. Each mold may be manufactured from an elastic material that may be disposable. The tibial mold may further comprise a sidewall forming a cavity, markings for relative depth measurement, and depth rings for use as a guide for scoring, cutting, and/or trimming and tearing away an excess portion of the tibial mold. The femoral mold may further comprise a sidewall defining a cavity, two legs extending from a body of the femoral mold for forming the artificial condyles, and an eyelet for aiding in placement and removal of the femoral mold. The resulting prosthetic tibial and femoral components may form an articulation surface that mimics, at least in part, the natural articulation surface of the knee.

Claims

1. An elastic mold for forming a prosthetic component of a prosthetic joint on a patient'"'"'s bone, said elastic mold comprising:

a main body portion comprising a sidewall, an inner surface and an outer surface, the inner surface and the outer surface defining a thickness of the sidewall therebetween; and

a cavity defined by the sidewall, said sidewall extending around a perimeter of the main body portion, the cavity being formed within the main body portion of the elastic mold, wherein said cavity may be characterized by an open face and configured for receiving an amount of biocompatible material thereinto, said biocompatible material configured for being used as the prosthetic component;

wherein said elastic mold may be configured and dimensioned for being located, in situ, on a portion of the patient'"'"'s bone; and

wherein said elastic mold may be characterized by the absence of a substantially enclosed casing.

2. The elastic mold of claim 1, wherein said elastic mold comprises a tibial mold having an inner base surface comprising at least one protrusion and at least one depression configured for forming a corresponding and opposing at least one depression and at least one protrusion in the prosthetic component such that a natural tibial plateau may be simulated.

3. The elastic mold of claim 1, wherein said elastic mold comprises a tibial mold having a plurality of markings formed on the outer surface of the main body portion such that a surgeon may use the plurality of markings of the tibial mold as a guide.

4. The elastic mold of claim 3, wherein said plurality of markings comprise a series of symbols representing a predetermined size and thickness of the prosthetic component, and may be used for visually determining a thickness of bone cement for fitting between a gap in the patient'"'"'s tibial bone and femoral bone.

5. The elastic mold of claim 1, wherein said elastic mold comprises a tibial mold having a plurality of depth rings for scoring, cutting, trimming, and peeling off an excess portion of the tibial mold, said plurality of depth rings comprising a series of indentations in the outer surface of the main body portion configured for running an instrument in said plurality of depth rings such that the series of indentations acts as a guide.

6. The elastic mold of claim 1, wherein said elastic mold comprises a tibial mold having an external shape defined by the outer surface of the main body portion, wherein said external shape may be substantially kidney shaped and corresponds to a cross sectional shape of the natural tibial bone.

7. The elastic mold of claim 1, wherein said elastic mold comprises a tibial mold that may be configured and dimensioned for forming a resulting prosthetic tibial component having an articulating surface for articulation with a corresponding surface of a prosthetic femoral component.

8. The elastic mold of claim 1, wherein said elastic mold comprises a femoral mold having an eyelet shaped as a loop with a rounded top, and a first end and a second end connected to the main body portion, the eyelet being configured for aiding a surgeon in wrapping the femoral mold around a distal portion of a femur and for further aiding in the separation of the femoral mold from a resulting prosthetic femoral component.

9. The elastic mold of claim 1, wherein said elastic mold comprises a femoral mold, and wherein said sidewall extends around a perimeter of the main body portion, and said sidewall may be configured to provide a barrier such that an amount of biocompatible material, configured for use as the prosthetic component, may be poured into the cavity and retained within said cavity by said sidewall.

10. The elastic mold of claim 1, wherein said elastic mold comprises a femoral mold having a protruding arched surface located on a portion of said inner surface configured and dimensioned for forming a corresponding depression in a prosthetic femoral component.

11. The elastic mold of claim 1, wherein said elastic mold comprises a femoral mold having a main body portion, a medial leg and a lateral leg, each leg having a substantially arcuate inner surface designed to form a prosthetic femoral condyle to simulate the biomechanics of the natural femoral condyle such that the prosthetic femoral condyle may articulate with a tibial surface.

12. The elastic mold of claim 11, wherein said femoral mold has a gap formed between the medial leg and the lateral leg, wherein the medial leg joins the lateral leg at a junction, said junction defining a crotch portion of the main body portion.

13. The elastic mold of claim 1, wherein said elastic mold comprises a femoral mold, said femoral mold being manufactured from an elastic material that may be substantially filled with an amount of biocompatible material such that the femoral mold may be wrapped around a portion of the patient'"'"'s femur to bring the biocompatible material into contact with a surface of a portion of the femur, wherein said elastic material permits the femoral mold to stretch, allowing a single femoral mold to accommodate various sizes of bone and also aids in removing the femoral mold from the femur.

14. The elastic mold of claim 1, wherein said elastic mold comprises a femoral mold configured and dimensioned to form a resulting prosthetic femoral component having an articulating surface for articulation with a corresponding surface of a prosthetic tibial component.

15. The elastic mold of claim 14, wherein the resulting prosthetic femoral component comprises a plurality of protruding surfaces dimensioned to simulate the natural femoral condyles.

16. The elastic mold of claim 1, wherein the mold may be manufactured from an elastic material that may be designed for being used once and then disposed of such that a surgeon may alter and adjust the mold to accommodate an anatomy of the patient.

17. The elastic mold of claim 1, wherein the mold may be a femoral mold having a first engagement side and a second engagement side, each engagement side configured for engaging a portion of the patient'"'"'s femur, and a separation distance formed between the first engagement side and the second engagement side, wherein the separation distance between the first engagement side and the second engagement side may be dimensioned to be less than a width of a distal end of the patient'"'"'s femur such that a secure fit may be formed between the patient'"'"'s femur and the mold, due, at least in part, to the elasticity of the mold.

18. An elastic mold for forming a prosthetic component on a patient'"'"'s femur, said elastic mold comprising:

a main body portion having a first engagement side and a second engagement side, each engagement side configured for engaging a portion of the patient'"'"'s femur, the main body portion further having a sidewall, an inner surface and an outer surface, the inner surface and the outer surface defining a thickness of the elastic mold therebetween;

a cavity defined by the sidewall and the inner surface and formed within the main body portion, the cavity having an open face, the elastic mold being further characterized by the absence of a substantially enclosed casing; and

a separation distance formed between the first engagement side and the second engagement side, wherein the separation distance between the first engagement side and the second engagement side may be dimensioned to be less than a width of a distal end of the femur such that a secure fit may be formed between the femur and the mold, due, at least in part, to the elasticity of the mold.

19. The elastic mold of claim 18, wherein said elastic mold comprises a femoral mold having an eyelet for aiding a surgeon in wrapping the femoral mold around a distal portion of the femur and for further aiding in the separation of the femoral mold from the femur and a resulting prosthetic femoral component located on said femur.

20. The elastic mold of claim 18, wherein said elastic mold comprises a femoral mold, and wherein said sidewall extends around a perimeter of the main body portion, and said sidewall may be configured to provide a barrier such that an amount of biocompatible material, configured for use as the prosthetic component, may be poured into the cavity and retained within said cavity by said sidewall.

21. The elastic mold of claim 18, wherein said elastic mold comprises a femoral mold having a protruding arched surface located on a portion of said inner surface for forming a corresponding depression in a prosthetic femoral component.

22. The elastic mold of claim 18, wherein said elastic mold comprises a femoral mold having a medial leg and a lateral leg, each leg having a substantially arcuate inner surface configured to form a prosthetic femoral condyle that may be dimensioned to simulate the biomechanics of the natural femoral condyles.

23. The elastic mold of claim 22, wherein said femoral mold further comprises a gap formed between and separating the medial leg and the lateral leg, wherein the medial leg joins the lateral leg at a junction, said junction defining a crotch portion of the main body portion.

24. The elastic mold of claim 18, wherein said elastic mold comprises a femoral mold that may be manufactured from an elastic material and being substantially filled with an amount of biocompatible material such that the femoral mold may be wrapped around a portion of the patient'"'"'s femur to bring the biocompatible material into engagement with a surface of a portion of the femur, wherein said elastic material permits the femoral mold to stretch, allowing a single femoral mold to accommodate various sizes of distal femurs and for peeling the femoral mold away from the femur after said mold may be scored.

25. The elastic mold of claim 18, wherein said elastic mold comprises a femoral mold that forms a resulting prosthetic femoral component having an articulating surface for articulation with a corresponding surface of a prosthetic tibial component.

26. The elastic mold of claim 25, wherein the resulting prosthetic femoral component comprises a plurality of protruding surfaces such that the natural femoral condyles may be simulated by said protruding surfaces.

27. The elastic mold of claim 18, wherein the mold may be manufactured from an elastic material that may be designed for being used once and then disposed of such that a surgeon may alter and adjust the mold to accommodate an anatomy of the patient.

28. An elastic mold for forming a prosthetic component on a patient'"'"'s femur, said elastic mold comprising:

a main body portion having an inner surface and an outer surface, said inner surface and said outer surface defining a thickness of the elastic mold therebetween;

a cavity defined at least partially by the inner surface and formed within the main body portion, said cavity being characterized by an open face; and

a means for attaching the elastic mold, in situ, to the patient'"'"'s femur such that the elastic mold may form the prosthetic component on said femur, wherein the prosthetic component simulates, at least in part, the biomechanics of a natural knee joint;

wherein the elastic mold may be characterized by the absence of a substantially enclosed casing.

29. The elastic mold of claim 28, wherein said elastic mold comprises a femoral mold having an eyelet for aiding a surgeon in stretching and wrapping the femoral mold around a distal portion of the femur, and for further aiding in the separation of the femoral mold from a resulting prosthetic femoral component.

30. The elastic mold of claim 28, wherein said elastic mold comprises a femoral mold, and wherein said means for attaching the elastic mold comprises a circumferential elastic gripping means for circumferentially gripping a proximal portion of the femur.

31. The elastic mold of claim 28, wherein said elastic mold comprises a femoral mold, and wherein said means for attaching the elastic mold comprises a sidewall that extends around a perimeter of the main body portion, said sidewall configured to provide a barrier such that an amount of biocompatible material, configured for use as the prosthetic component, may be poured into the cavity and retained within said cavity by said sidewall.

32. The elastic mold of claim 28, wherein said elastic mold comprises a femoral mold having a protruding arched surface located on a portion of said inner surface for forming a corresponding depression in a prosthetic femoral component.

33. The elastic mold of claim 28, wherein said elastic mold comprises a femoral mold having a medial leg and a lateral leg, each leg having a substantially arcuate inner surface configured to form a prosthetic femoral condyle that may be dimensioned to simulate the biomechanics of the natural femoral condyle.

34. The elastic mold of claim 33, wherein said femoral mold further comprises a gap formed between and separating the medial leg and the lateral leg, wherein the medial leg joins the lateral leg at a junction, said junction defining a crotch portion of the main body portion.

35. The elastic mold of claim 28, wherein said elastic mold comprises a femoral mold that may be manufactured from an elastic material and being substantially filled with an amount of biocompatible material such that the femoral mold may be wrapped around a portion of the patient'"'"'s femur to bring the biocompatible material into engagement with a surface of a portion of the femur, wherein said elastic material permits the femoral mold to stretch, allowing a single femoral mold to accommodate various sizes of distal femurs and to aid a surgeon in peeling the femoral mold away from the femur and resulting prosthetic femoral component.

36. The elastic mold of claim 28, wherein said elastic mold comprises a femoral mold configured to form a resulting prosthetic femoral component having an articulating surface for articulation with a corresponding surface of a prosthetic tibial component.

37. The elastic mold of claim 36, wherein the resulting prosthetic femoral component comprises a plurality of protruding surfaces configured and dimensioned to simulate the biomechanics of the natural femoral condyles.

38. The elastic mold of claim 28, wherein the mold may be manufactured from an elastic material that may be designed for being used once and then disposed of such that a surgeon may alter and adjust the mold to accommodate an anatomy of the patient.

39. The elastic mold of claim 28, wherein the mold may have a first engagement side and a second engagement side, each engagement side configured for engaging a portion of the patient'"'"'s femur, and a separation distance formed, between the first engagement side and the second engagement side, wherein the separation distance between the first engagement side and the second engagement side may be dimensioned to be less than a width of a distal end of the patient'"'"'s femur such that a secure fit may be formed between the patient'"'"'s femur and the mold, due, at least in part, to the elasticity of the mold.

40. An elastic mold for forming a prosthetic component on a patient'"'"'s bone, said elastic mold comprising:

a main body portion comprising an inner surface and an outer surface, said inner surface and said outer surface defining a thickness of the elastic mold therebetween;

a cavity defined by a sidewall and the inner surface, the cavity comprising an open face and being formed within the main body portion of the elastic mold, said inner surface having a protruding arched surface located on a portion of said inner surface;

wherein said protruding arched surface forms a depression in an articulating surface of the resulting prosthetic component for articulating with another component between two bones.

41. The elastic mold of claim 40, wherein said elastic mold comprises a femoral mold having an eyelet for aiding a surgeon in stretching and wrapping the femoral mold around a distal portion of a femur, and for further aiding the surgeon in separating the femoral mold from a resulting prosthetic femoral component and femur after use.

42. The elastic mold of claim 40, wherein said elastic mold comprises a femoral mold, and wherein the sidewall forming the cavity extends around a perimeter of the main body portion, and said sidewall being configured to provide a barrier such that an amount of biocompatible material, configured for use as the prosthetic component, may be poured into the cavity and retained within said cavity by said sidewall.

43. The elastic mold of claim 40, wherein said elastic mold comprises a femoral mold, wherein the main body portion has a medial leg and a lateral leg, each leg having a substantially arcuate inner surface configured to form a prosthetic femoral condyle that may be dimensioned to simulate the biomechanics of the natural femoral condyle.

44. The elastic mold of claim 43, wherein said femoral mold further comprises a gap formed between and separating the medial leg and the lateral leg, wherein the medial leg joins the lateral leg at a junction, said junction defining a crotch portion of the main body portion.

45. The elastic mold of claim 40, wherein said elastic mold comprises a femoral mold that may be manufactured from an elastic material and substantially filled with an amount of biocompatible material such that the femoral mold may be wrapped around a portion of a patient'"'"'s femur to bring the biocompatible material into contact with a surface of a portion of the femur, wherein said elastic material permits the femoral mold to stretch, allowing a single femoral mold to accommodate various sizes of distal femurs and for peeling the femoral mold away from the femur and a resulting component.

46. The elastic mold of claim 40, wherein said elastic mold comprises a femoral mold configured for forming a resulting prosthetic femoral component having an articulating surface for articulation with a corresponding surface of a prosthetic tibial component.

47. The elastic mold of claim 46, wherein the femoral mold comprises a rounded contour formed in the inner surface of the main body portion such that the resulting prosthetic femoral component comprises a plurality of protruding surfaces configured and dimensioned to simulate the natural femoral condyles.

48. The elastic mold of claim 40, wherein the mold may be manufactured from an elastic material that may be designed for being used once and then disposed of such that a surgeon may alter and adjust the mold to accommodate an anatomy of the patient.

49. The elastic mold of claim 40, wherein the mold may have a first engagement side and a second engagement side, each engagement side configured for engaging a portion of the patient'"'"'s femur, and a separation distance formed between the first engagement side and the second engagement side, wherein the separation distance between the first engagement side and the second engagement side may be dimensioned to be less than a width of a distal end of the patient'"'"'s femur such that a secure fit may be formed between the patient'"'"'s femur and the mold, due, at least in part, to the elasticity of the mold.

50. An elastic mold for forming a prosthetic component on a patient'"'"'s bone, said elastic mold comprising:

a main body portion comprising a sidewall and having an inner surface and an outer surface, said inner surface and said outer surface defining a thickness of the elastic mold therebetween, said main body portion further comprising an arcuate surface;

a cavity defined by the sidewall and formed within the main body portion of the elastic mold;

a first leg and a second leg each having a substantially arcuate inner surface configured to form a prosthetic femoral condyle, the prosthetic femoral condyle configured and dimensioned to simulate the biomechanics of a natural femoral condyle; and

a gap formed between and separating the first leg and the second leg wherein the first leg joins the second leg at a junction, said junction defining a crotch portion of the main body portion.

51. The elastic mold of claim 50, wherein said elastic mold comprises a femoral mold having an eyelet for aiding a surgeon in stretching and wrapping the femoral mold around a distal portion of a femur, and for further aiding the surgeon in separating the femoral mold from a resulting prosthetic femoral component and femur.

52. The elastic mold of claim 50, wherein said elastic mold comprises a femoral mold, and wherein said sidewall extends around a perimeter of the main body portion, and said sidewall may be configured to provide a barrier such that an amount of biocompatible material, configured for use as the prosthetic component, may be poured into the cavity and retained within said cavity by said sidewall.

53. The elastic mold of claim 50, wherein said elastic mold comprises a femoral mold having a protruding arched surface located on a portion of said inner surface of said main body portion for forming a corresponding depression in a prosthetic femoral component.

54. The elastic mold of claim 50, wherein said elastic mold comprises a femoral mold, and wherein said first leg may be located on a medial side of a distal end of a femur and said second leg may be located on a lateral side of the distal end of the femur.

55. The elastic mold of claim 50, wherein said elastic mold comprises a femoral mold, said femoral mold being manufactured from an elastic material and substantially filled with an amount of biocompatible material such that the femoral mold may be wrapped around a portion of a patient'"'"'s femur to thereby bring the biocompatible material into engagement with a surface of the portion of the femur, wherein said elastic material permits the femoral mold to stretch, allowing a single femoral mold to accommodate various sizes of distal femurs and for peeling the femoral mold away from the femur.

56. The elastic mold of claim 50, wherein said elastic mold comprises a femoral mold, wherein said femoral mold forms a resulting prosthetic femoral component having an articulating surface for articulation with a corresponding surface of a prosthetic tibial component.

57. The elastic mold of claim 56, wherein the resulting prosthetic femoral component comprises a plurality of protruding surfaces simulating the natural femoral condyles.

58. The elastic mold of claim 50, wherein the mold may be manufactured from an elastic material that may be designed for being used once and then disposed of such that a surgeon may alter and adjust the mold to accommodate an anatomy of the patient.

59. The elastic mold of claim 50, wherein the mold may have a first engagement side and a second engagement side, each engagement side configured for engaging a portion of the patient'"'"'s femur, and a separation distance formed between the first engagement side and the second engagement side, wherein the separation distance between the first engagement side and the second engagement side may be dimensioned to be less than a width of a distal end of the patient'"'"'s femur such that a secure fit may be formed between the patient'"'"'s femur and the mold, due, at least in part, to the elasticity of the mold.

60. A device for forming a temporary prosthetic component on a patient'"'"'s tibia, the device comprising:

a mold comprised of an elastic material, the elastic material comprising an elastic memory such that the mold may also comprise an elastic memory, the mold including;

a main body portion having a cavity formed therein, said cavity being defined, at least partially, by an inner surface;

a depth reference feature for aiding a surgeon in making a depth measurement such that the prosthetic component may be increased or decreased to fit a portion of a gap between the patient'"'"'s tibia and femur; and

a means for attaching the mold, in situ, directly to the patient'"'"'s tibia such that the mold may attach to said tibia to form the prosthetic component on said tibia to thereby simulate, at least in part, a natural surface of a tibial plateau.

61. The device for forming a temporary prosthetic component of claim 60, wherein said mold comprises a tibial mold having an inner base surface with at least one protrusion and at least one depression configured for forming a corresponding set of at least one depression and at least one protrusion in the prosthetic component such that the inner base surface creates a the prosthetic implant that simulates, at least in part, the natural surface of the tibial plateau.

62. The device for forming a temporary prosthetic component of claim 60, wherein said mold comprises a tibial mold, and said depth reference feature further comprises a plurality of markings formed on the outer surface of the main body portion such that a surgeon may use the plurality of markings of the tibial mold as a guide for visually determining a thickness of a biocompatible material needed to create the prosthetic component, which may be fitted in the gap formed between the patient'"'"'s tibia and femur.

63. The device for forming a temporary prosthetic component of claim 62, wherein said plurality of markings comprise a series of symbols representing a predetermined size and thickness corresponding to the prosthetic component.

64. The device for forming a temporary prosthetic component of claim 60, wherein said mold comprises a tibial mold, and said at least one groove comprises a plurality of grooves that make up a plurality of depth rings that extend at least partially around an outer surface of the main body portion for scoring, cutting and peeling off an excess portion of the tibial molds and for running an instrument in said plurality of depth rings, which act as a guide.

65. The device for forming a temporary prosthetic component of claim 60, wherein said mold comprises a tibial mold having an external shape defined by an outer surface of the main body portion, wherein said external shape may be substantially kidney shaped and corresponds to a cross sectional shape of the natural tibial bone.

66. The device for forming a temporary prosthetic component of claim 61, wherein the inner base surface with the at least one protrusion comprises two protrusions located laterally of the at least one depression, and the at least one depression may be formed in a central location of the inner base surface such that the prosthetic component may be formed with an articulating surface that articulates with a corresponding surface of a prosthetic femoral component.

67. The device for forming a temporary prosthetic component of claim 60, wherein the mold may be designed for being used once and then disposed of such that a surgeon may alter and adjust the mold, due to the elastic material, to accommodate an anatomy of the patient.

68. The device for forming a temporary prosthetic component of claim 60, wherein the depth reference feature has at least one groove formed in the main body portion.

69. The device for forming a temporary prosthetic component of claim 60, wherein the depth reference feature has at least one protrusion formed in the main body portion.

70. The device for forming a temporary prosthetic component of claim 60, wherein the mold may be characterized by the absence of a substantially enclosed casing.

71. The device for forming a temporary prosthetic component of claim 60, wherein the means for attaching may be a circumferential elastic contacting means for circumferentially contacting a proximal portion of the tibia.

72. A device for forming a temporary prosthetic component on a bone of a patient'"'"'s knee joint, said device comprising:

a mold comprised of an elastic material and substantially filled with a biocompatible material such that the mold may be stretched around a portion of the bone, in situ, and configured to wrap around the portion of the bone to thereby bring the biocompatible material into contact with a surface of said portion of the bone, said mold further comprising;

a main body portion comprising a sidewall, an inner surface and an outer surface, the inner surface and the outer surface defining a thickness of the mold therebetween; and

a cavity defined by the sidewall and the inner surface, wherein the cavity may be configured and dimensioned for receiving an amount of biocompatible material therein;

wherein said mold may be manufactured as a single, unitary piece of elastic material that may stretch and fit over a variety of bone sizes, and said mold being removable from the bone and prosthetic component, due, at least in part, to the elasticity of the material from which the mold may be manufactured, by scoring, cutting, and peeling the mold.

73. The device for forming a temporary prosthetic component of claim 72, wherein said mold comprises a tibial mold that comprises an inner base surface with at least one protrusion and at least one depression thereon, wherein said base surface may be configured for forming a corresponding set of at least one depression and at least one protrusion in the prosthetic component such that a natural tibial plateau may be simulated, at least in part.

74. The device for forming a temporary prosthetic component of claim 72, wherein said mold comprises a tibial mold having a plurality of markings formed on the outer surface of the main body portion such that a surgeon may use the plurality of markings as a guide for visually determining a thickness of bone cement to be fitted in a gap between the patient'"'"'s tibial bone and femoral bone.

75. The device for forming a temporary prosthetic component of claim 74, wherein said plurality of markings comprise a series of symbols representing a predetermined size and thickness of the prosthetic component.

76. The device for forming a temporary prosthetic component of claim 72, wherein said mold comprises a tibial mold having a plurality of depth rings for scoring, cutting and peeling off an excess portion of the tibial mold, said plurality of depth rings comprising a series of indentations in the outer surface of the main body portion configured for running an instrument in said plurality of depth rings such that the series of indentations acts as a guide.

77. The device for forming a temporary prosthetic component of claim 72, wherein said mold comprises a tibial mold having an external shape defined by the outer surf ace of the main body portion, wherein said external shape may be substantially kidney shaped and corresponds to a cross sectional shape of a natural tibial bone.

78. The device for forming a temporary prosthetic component of claim 72, wherein said mold comprises a tibial mold that may be configured to form a resulting prosthetic tibial component having an articulating surface to articulate with a corresponding surface of a prosthetic femoral component.

79. The device for forming a temporary prosthetic component of claim 72, wherein said mold comprises a femoral mold having an eyelet for aiding a surgeon in wrapping the femoral mold around a distal portion of a femur and for further aiding the surgeon in separating the femoral mold from a resulting prosthetic femoral component and femur.

80. The device for forming a temporary prosthetic component of claim 72, wherein said mold comprises a femoral mold, and wherein said sidewall extends around a perimeter of the main body portion, and said sidewall may be configured to provide a barrier such that the amount of the biocompatible material, configured for use as the prosthetic component, may be poured into the cavity and retained within said cavity by said sidewall.

81. The device for forming a temporary prosthetic component of claim 72, wherein said mold comprises a femoral mold having a protruding arched surface located on a portion of said inner surface for forming a corresponding depression in a prosthetic femoral component.

82. The device for forming a temporary prosthetic component of claim 72, wherein said mold comprises a femoral mold having a medial leg and a lateral leg, each leg having a substantially arcuate inner surface configured to form a prosthetic femoral condyle that may be dimensioned to simulate the biomechanics of a natural femoral condyle.

83. The device for forming a temporary prosthetic component of claim 72, wherein said mold comprises a femoral mold having a gap formed between and separating a medial leg and a lateral leg, wherein the medial leg joins the lateral leg at a junction, said junction defining a crotch portion of the main body portion.

84. The device for forming a temporary prosthetic component of claim 72, wherein said mold comprises a femoral mold that may be configured to form a resulting prosthetic femoral component having an articulating surface to articulate with a corresponding surface of a prosthetic tibial component.

85. The device for forming a temporary prosthetic component of claim 84, wherein the resulting prosthetic femoral component comprises a plurality of protruding surfaces that simulate natural femoral condyles.

86. The device for forming a temporary prosthetic component of claim 72, wherein the mold may be manufactured from an elastic material that may be designed for being used once and then disposed of such that a surgeon may alter and adjust the mold to accommodate an anatomy of the patient.

87. The device for forming a temporary prosthetic component of claim 72, wherein the mold may be a femoral mold having a first engagement side and a second engagement side, each engagement side configured for engaging a portion of the patient'"'"'s femur, and a separation distance formed between the first engagement side and the second engagement side, wherein the separation distance between the first engagement side and the second engagement side may be dimensioned to be less than a width of a distal end of the patient'"'"'s femur such that a secure fit may be formed between the patient'"'"'s femur and the mold, due, at least in part, to the elasticity of the mold.

88. An elastic mold for forming a prosthetic component on a patient'"'"'s femur, said elastic mold comprising:

a main body portion comprising a sidewall, an inner surface and an outer surface, said inner surface and said outer surface defining a thickness of the elastic mold therebetween; and

a cavity defined by the sidewall and the inner surface, and formed within the main body portion of the elastic mold;

wherein said elastic mold may be manufactured in a unitary piece such that the unitary elastic mold forms one complete prosthetic component to attach to the patient'"'"'s femur, and wherein said elastic mold may be configured and dimensioned to be located, in situ, on the patient'"'"'s femur.

89. The elastic mold of claim 88, wherein said elastic mold comprises a femoral mold having an eyelet for aiding a surgeon in stretching and wrapping the femoral mold around a distal portion of the femur, and for further aiding the surgeon in separating the femoral mold from the resulting prosthetic femoral implant and femur.

90. The elastic mold of claim 88, wherein said elastic mold comprises a femoral mold, and wherein said sidewall extends around a perimeter of the main body portion, and said sidewall may be configured to provide a barrier such that an amount of biocompatible material, configured for use as the prosthetic component, may be poured into the cavity and retained within said cavity by said sidewall.

91. The elastic mold of claim 88, wherein said elastic mold comprises a femoral mold having a protruding arched surface located on a portion of said inner surface for forming a corresponding depression in the femoral implant.

92. The elastic mold of claim 88, wherein said elastic mold comprises a femoral mold, and said main body portion comprises a first leg that may be located on a medial side of a distal end of the femur and a second leg that may be located on a lateral side of the distal end of the femur.

93. The elastic mold of claim 88, wherein said elastic mold comprises a femoral mold that may be manufactured from an elastic material and substantially filled with an amount of biocompatible material such that the femoral mold may be wrapped around a distal portion of the patient'"'"'s femur to bring the biocompatible material into engagement with a surface of the distal portion of the femur, wherein said elastic material permits the femoral mold to stretch, allowing a single femoral mold to accommodate various sizes of distal femurs and for peeling the femoral mold away from the femur and the prosthetic component.

94. The elastic mold of claim 88, wherein said elastic mold comprises a femoral mold that may be configured to form the resulting prosthetic component having an articulating surface to articulate with a corresponding surface of a prosthetic tibial component.

95. The elastic mold of claim 88, wherein the resulting prosthetic component has a plurality of protruding surfaces simulating natural femoral condyles.

96. The elastic mold of claim 88, wherein the mold may be manufactured from an elastic material that may be designed for being used once and then disposed of such that a surgeon may alter and adjust the mold to accommodate an anatomy of the patient.

97. The elastic mold of claim 88, wherein the mold may have a first engagement side and a second engagement side, each engagement side configured for engaging a portion of the patient'"'"'s femur, and a separation distance formed between the first engagement side and the second engagement side, wherein the separation distance between the first engagement side and the second engagement side may be dimensioned to be less than a width of a distal end of the patient'"'"'s femur such that a secure fit may be formed between the patient'"'"'s femur and the mold, due, at least in part, to the elasticity of the mold.

98. An elastic mold system for forming a prosthetic component in a patient'"'"'s knee joint, said elastic mold system comprising:

an elastic femoral mold configured for attachment to a distal end of the patient'"'"'s femoral bone, and further configured for forming a first portion of the prosthetic component with an exterior contour dimensioned to simulate natural femoral condyles of the femur;

a first cavity defined by a first sidewall of the femoral mold, wherein the cavity comprises an open face, and wherein the femoral mold may be further characterized by an absence of a substantially, enclosed casing; and

an elastic tibial mold configured for attachment to a proximal end of the patient'"'"'s tibial bone for forming a second portion of the prosthetic component, said second portion having an exterior contour that simulates, at least partially, a natural tibial plateau;

wherein said elastic tibial mold comprises a second cavity defined by a second sidewall, and a depth reference feature located on the second sidewall for making a depth determination and for scoring and cutting away a portion of the elastic tibial mold.

99. The elastic mold system of claim 98, wherein said tibial mold further comprises an inner base surface with at least one protrusion and at least one depression thereon configured for forming a corresponding set of at least one depression and at least one protrusion in the second portion of the prosthetic component such that the natural tibial plateau may be simulated, at least in part.

100. The elastic mold system of claim 98, wherein said tibial mold comprises a main body portion and an outer surface, and said depth reference feature comprises a plurality of markings formed on the outer surface such that a surgeon may use the plurality of markings of the tibial mold as a guide for visually determining a thickness of bone cement to be fitted in a gap between a patient'"'"'s tibial bone and femoral bone.

101. The elastic mold system of claim 100, wherein said plurality of markings comprise a series of symbols representing a predetermined size and thickness of the second portion of the prosthetic component.

102. The elastic mold system of claim 98, wherein said tibial mold comprises a plurality of depth rings for scoring, cutting and peeling off an excess portion of the tibial mold, said plurality of depth rings comprising a series of indentations in the outer surface of the main body portion configured for running an instrument therein such that the series of indentations acts as a guide.

103. The elastic mold system of claim 98, wherein said tibial mold comprises a main body portion and an outer surface defining an external shape of the tibial mold, wherein said external shape may be substantially kidney shaped and corresponds to a cross sectional shape of a natural tibial bone.

104. The elastic mold system of claim 98, wherein said tibial mold may be configured to form a resulting prosthetic tibial component having an articulating surface to articulate with a corresponding surface of a prosthetic femoral component.

105. The elastic mold system of claim 98, wherein said femoral mold comprises an eyelet for aiding a surgeon in wrapping the femoral mold around a distal portion of a femur and for further aiding the surgeon in separating the femoral mold from a resulting prosthetic femoral component.

106. The elastic mold system of claim 105, wherein said eyelet may be formed on an end of the femoral mold.

107. The elastic mold system of claim 98, wherein said femoral mold comprises a main body portion, an outer surface, wherein said first sidewall extends around a perimeter of the main body portion, said first sidewall configured to provide a barrier such that an amount of biocompatible material, configured for use as the prosthetic component, may be poured into the first cavity and retained within said first cavity by said first sidewall.

108. The elastic mold system of claim 98, wherein said femoral mold comprises an inner surface and an outer surface, said femoral mold further comprises a protruding arched surface located on a portion of said inner surface for forming a corresponding depression in the first portion of the prosthetic component.

109. The elastic mold system of claim 98, wherein said femoral mold comprises a main body portion, a medial leg and a lateral leg, each leg having a substantially arcuate inner surface configured to form a prosthetic femoral condyle that may be dimensioned to simulate the biomechanics of the natural femoral condyle.

110. The elastic mold system of claim 98, wherein said femoral mold further comprises a main body portion and a gap formed between and separating the medial leg and the lateral leg, wherein the medial leg joins the lateral leg at a junction, said junction defining a crotch portion of the main body portion.

111. The elastic mold system of claim 98, wherein said femoral mold may be manufactured from an elastic material and substantially filled with an amount of biocompatible material such that the femoral mold may be wrapped around a portion of a patient'"'"'s femur to bring the biocompatible material into engagement with a surface of a portion of the femur, wherein said elastic material permits the femoral mold to stretch, allowing a single femoral mold to accommodate various sizes of femoral bone and for peeling the femoral mold away from the femur.

112. The elastic mold system of claim 98, wherein the femoral mold and the tibial mold are both manufactured from an elastic material that may be designed for being used once and then disposed of such that a surgeon may alter and adjust the mold to accommodate an anatomy of the patient.

113. An elastic femoral mold for forming a component of a prosthetic knee joint on a patient'"'"'s femur, said elastic mold comprising:

a main body portion comprising a sidewall and an inner base surface that together define a cavity formed within the main body portion, said cavity having an open face such that at least a portion of the sidewall of the elastic mold may be attached to the patient'"'"'s femur for forming the component of the prosthetic knee joint on said patient'"'"'s femur;

an outer surface defining an outer shape of the elastic mold;

wherein said sidewall extends around a perimeter of the cavity opposite the outer surface, said sidewall providing a barrier such that an amount of biocompatible material, configured for use as the component of the prosthetic knee joint, may be poured into the cavity and retained by the barrier within said cavity.

114. The elastic femoral mold of claim 113, wherein the mold may have a first engagement side and a second engagement side, each engagement side configured for engaging a portion of the patient'"'"'s femur, and a separation distance formed between the first engagement side and the second engagement side, wherein the separation distance between the first engagement side and the second engagement side may be dimensioned to be less than a width of a distal end of the patient'"'"'s femur such that a secure fit may be formed between the patient'"'"'s femur and the mold, due, at least in part, to the elasticity of the mold.

115. An apparatus used in molding a temporary prosthetic component, in situ, directly on a patient'"'"'s bone, said apparatus comprising:

a main body portion comprised of an elastic material and formed into a single, unitary mold, said elastic material permitting the mold to contact a portion of the patient'"'"'s bone;

an inner base surface comprising a contour that produces a first surface on the prosthetic component that simulates a natural surface of the bone; and

a means for attaching the mold, in situ, directly to the patient'"'"'s bone to maintain the mold temporarily on said bone while a biocompatible material at least partially cures and forms the temporary prosthetic component.

116. The apparatus of claim 115, wherein said inner base surface comprises at least one depression located substantially in a central position, and at least one protrusion located laterally of said at least one depression.

117. The apparatus of claim 115, wherein said inner base surface comprises at least one protrusion located substantially in a central position, and at least one depression located laterally of said at least one protrusion.

118. The apparatus of claim 115, wherein the means for attaching comprises a sidewall defining a cavity, said cavity configured for receiving an amount of the biocompatible material therein.

119. The apparatus of claim 115, wherein the elastic material of the mold permits the mold to be easily removed from the patient'"'"'s bone through scoring, cutting, tearing, ripping, splitting, peeling and otherwise pulling the mold apart and removing said mold from said bone.

120. The apparatus of claim 115, wherein the means for attaching the mold provides a friction fit between the mold and the bone.

121. The apparatus of claim 120, wherein the friction fit may be a compression fit.

122. An elastic mold system for forming a prosthetic knee joint, said elastic mold system comprising:

a first mold being formed as a one piece mold and having an inner surface and an outer surface, and a cavity defined by a sidewall, wherein said cavity may be characterized by an open face and configured and dimensioned for receiving an amount of biocompatible material therein, wherein said biocompatible material may be configured for being used as the prosthetic component;

a second mold being formed as a one piece mold and having an inner surface and an outer surface, and a cavity defined by a sidewall, the cavity being configured and dimensioned to receive an amount of biocompatible material therein;

wherein the first mold and the second mold may both be configured and dimensioned for being located, in situ, on a portion of the patient'"'"'s femur and tibia, respectively, to thereby form component parts of the prosthetic knee joint; and

wherein the first mold and the second mold may be characterized by the absence of a substantially enclosed casing such that the first mold and the second mold may be attached to the patient'"'"'s femur and tibia, respectively.

123. The elastic mold system of claim 122, wherein the first mold comprises a femoral mold that may be manufactured from an elastic material, and wherein the first mold further comprises a first leg and a second leg separated by a gap such that the first and second legs form prosthetic femoral condyles of the prosthetic knee joint.

124. The elastic mold system of claim 122, wherein the second mold comprises a tibial mold that may be manufactured from an elastic material, and wherein the second mold further comprises a base portion formed within the inner surface and having at least one protrusion and at least one depression formed on the base portion such that a prosthetic tibial plateau may be formed in the prosthetic knee joint.

125. An elastic mold system for forming a prosthetic knee joint, said elastic mold system comprising:

an elastic femoral mold configured for attachment to a distal end of the patient'"'"'s femoral bone configured for forming a first portion of the prosthetic knee joint, said first portion comprising an exterior contour dimensioned to simulate natural femoral condyles, said elastic femoral mold having a first sidewall and an inner surface that together define a first cavity, said first cavity having an open face such that the femoral mold may be further characterized by an absence of a substantially enclosed casing;

wherein said femoral mold comprises an eyelet formed on an end of the femoral mold for aiding a surgeon in wrapping the femoral mold around a distal portion of the femur and for further aiding the surgeon in separating the femoral mold from the resulting first portion of the prosthetic knee joint and the femur;

wherein said femoral mold comprises a main body portion, and wherein said first sidewall extends around a perimeter of the first cavity and may be configured to provide a barrier such that an amount of biocompatible material, configured for use as the prosthetic knee joint, may be poured into the first cavity and retained within said first cavity by said first sidewall;

wherein said femoral mold comprises an inner surface and an outer surface, and a protruding arched surface located on a portion of said inner surface for forming a corresponding depression in the first portion of the prosthetic knee joint;

wherein said femoral mold comprises a medial leg and a lateral leg, each leg having a substantially arcuate inner surface configured to form a prosthetic femoral condyle that may be dimensioned to simulate the biomechanics of the natural femoral condyle, said femoral mold further having a gap formed between and separating the medial leg and the lateral leg wherein the medial leg joins the lateral leg at a junction, said junction defining a crotch portion of the main body portion of the femoral mold;

wherein said femoral mold may be manufactured from an elastic material and substantially filled with the amount of biocompatible material such that the femoral mold may be wrapped around the distal portion of the patient'"'"'s femur to bring the biocompatible material into contact with a surface of the distal portion of the femur, wherein said elastic material permits the femoral mold to stretch, allowing a single femoral mold to accommodate various sizes of distal femurs, and for peeling the femoral mold away from the first portion of the prosthetic knee joint and the femur; and

an elastic tibial mold configured for attachment to a proximal end of a patient'"'"'s tibial bone for forming a second portion of the prosthetic knee joint, said second portion having an exterior contour simulating a natural tibial plateau, said elastic tibial mold having a second cavity defined by a second sidewall and an inner surface, and a depth reference feature located on the second sidewall for making a depth determination and for scoring and cutting away a portion of the elastic tibial mold;

wherein said tibial mold comprises an inner base surface with at least one protrusion and at least one depression thereon configured for forming a corresponding set of at least one depression and at least one protrusion in the second portion of the prosthetic knee joint such that the natural tibial plateau may be further simulated;

wherein said tibial mold comprises a main body portion, and said depth reference feature comprises a plurality of markings formed on an outer surface of the main body portion of the tibial mold such that a surgeon may use the plurality of markings of the tibial mold as a guide for visually determining a thickness of biocompatible material to be fitted in a gap between the patient'"'"'s tibial bone and femoral bone;

wherein said plurality of markings comprise a series of symbols representing a predetermined size and thickness of the resulting second portion of the prosthetic knee joint;

wherein said tibial mold comprises a plurality of depth rings for scoring, cutting and peeling off an excess portion of the tibial mold, said plurality of depth rings comprising a series of indentations in the outer surface of the main body portion of the tibial mold configured for running an instrument in said plurality of depth rings such that the series of indentations acts as a guide;

wherein said tibial mold comprises an external shape defined by the outer surface of the main body portion of the tibial mold, wherein said external shape may be substantially kidney shaped and corresponds to a cross sectional shape of the natural tibial bone; and

wherein said femoral mold and said tibial mold are both manufactured from an elastic material that may be designed for being used once and then disposed of such that the surgeon may alter and adjust the mold to accommodate an anatomy of the patient.