Disposable knee mold
First Claim
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.
1 Assignment
0 Petitions
Accused Products
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.
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Citations
156 Claims
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1. An elastic mold for forming a prosthetic component of a prosthetic joint on a patient'"'"'s bone, said elastic mold comprising:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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18. An elastic mold for forming a prosthetic component on a patient'"'"'s femur, said elastic mold comprising:
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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. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25, 26, 27)
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28. An elastic mold for forming a prosthetic component on a patient'"'"'s femur, said elastic mold comprising:
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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. - View Dependent Claims (29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39)
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40. An elastic mold for forming a prosthetic component on a patient'"'"'s bone, said elastic mold comprising:
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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 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. - View Dependent Claims (41, 42, 43, 44, 45, 46, 47, 48, 49)
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50. An elastic mold for forming a prosthetic component on a patient'"'"'s bone, said elastic mold comprising:
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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. - View Dependent Claims (51, 52, 53, 54, 55, 56, 57, 58, 59)
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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. - View Dependent Claims (61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71)
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72. A device for forming a temporary prosthetic component on a bone of a patient'"'"'s knee joint, said device comprising:
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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. - View Dependent Claims (73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87)
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88. An elastic mold for forming a prosthetic component on a patient'"'"'s femur, said elastic mold comprising:
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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. - View Dependent Claims (89, 90, 91, 92, 93, 94, 95, 96, 97)
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98. An elastic mold system for forming a prosthetic component in a patient'"'"'s knee joint, said elastic mold system comprising:
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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. - View Dependent Claims (99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112)
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113. A method of forming at least one component of a temporary prosthetic knee joint on a bone during an in situ surgical procedure, the method comprising the steps of:
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providing an elastic mold configured and dimensioned for being affixed to a portion of the bone, said elastic mold having a cavity defined by a sidewall;
placing an amount of biocompatible material within the cavity of the elastic mold for forming the at least one component of the prosthetic knee joint;
positioning the elastic mold on the portion of the bone; and
removing the elastic mold from said portion of said bone after the amount of biocompatible material has been at least partially cured thereby forming said at least one component. - View Dependent Claims (114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143)
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144. An elastic femoral mold for forming a component of a prosthetic knee joint on a patient'"'"'s femur, said elastic mold comprising:
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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. - View Dependent Claims (145)
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146. An apparatus used in molding a temporary prosthetic component, in situ, directly on a patient'"'"'s bone, said apparatus comprising:
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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. - View Dependent Claims (147, 148, 149, 150, 151, 152)
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153. An elastic mold system for forming a prosthetic knee joint, said elastic mold system comprising:
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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. - View Dependent Claims (154, 155)
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156. An elastic mold system for forming a prosthetic knee joint, said elastic mold system comprising:
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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.
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Specification