Custom prosthetic liner manufacturing system and method

Abstract

A system and method for manufacturing a custom prosthetic liner. The system may include a shape capture device for capturing the shape of a residual limb. The captured shape may be used to generate a 3-dimensional electronic liner model using a processor and specialized software. A 3-dimensional electronic model of the residual limb may also be produced. Preferably, an interface is provided that allows a user of the system to alter the shape and/or size of the 3-dimensional model(s) to allow the subsequently-produced liner to accommodate particular features of the residual limb. Data associated with at least the resulting 3-dimensional liner model is provided to a manufacturing facility equipped to produce a custom liner therefrom. The data may be remotely transmitted to the manufacturing facility. A positive likeness of the residual limb is created from the data associated with the 3-dimensional model(s), and is subsequently used as a mold core in the liner molding process.

1 . A system for producing a custom polymeric prosthetic liner, comprising: 
 a shape capture apparatus for capturing the 3-dimensional shape of an amputee's residual limb;    a processing device for generating a 3-dimensional electronic liner model using said 3-dimensional shape captured by said shape capture apparatus, said processing device optionally adapted to generate a 3-dimensional electronic residual limb model;    a means of providing data associated with said 3-dimensional electronic liner model, said 3-dimensional electronic residual limb model, or both, to a facility equipped to produce said custom liner;    an apparatus for creating at least one custom mold component from said data associated with said 3-dimensional electronic liner model, said 3-dimensional electronic residual limb model, or both;    a mold for receiving and containing an amount of polymeric material, said mold incorporating said at least one custom mold component; and    a molding machine for producing said custom prosthetic liner from said mold.    
     
     
         2 . The system of  claim 1 , wherein said shape capture apparatus employs a plurality of spaced-apart image detectors.  
     
     
         3 . The system of  claim 1 , wherein said processing device consists of a computer program in combination with a device selected from the group consisting of a laptop computer, a desktop computer, a pen computer, a pocket personal computer (pocket PC), and a personal data assistant (PDA).  
     
     
         4 . The system of  claim 1 , wherein said at least one custom mold component is produced from said data by a computer-controlled machining device.  
     
     
         5 . The system of  claim 1 , wherein said at least one custom mold component is created from a closed-cell foam material.  
     
     
         6 . The system of  claim 1 , wherein said at least one custom mold component is a mold core for use with a common mold cavity.  
     
     
         7 . The system of  claim 6 , wherein said mold cavity is selected based on its size.  
     
     
         8 . The system of  claim 1 , wherein said at least one custom mold component is a mold cavity for use with a custom or common mold core.  
     
     
         9 . The system of  claim 1 , wherein said polymeric material is a silicone, urethane, or thermoplastic elastomer material.  
     
     
         10 . The system of  claim 9 , wherein said polymeric material is a block copolymer material.  
     
     
         11 . The system of  claim 1 , further comprising means for applying a fabric covering to an outer surface of said custom prosthetic liner during the liner manufacturing process.  
     
     
         12 . The system of  claim 1 , further comprising the ability to modify the shape of either or both of said 3-dimensional electronic models to accommodate particular features of said residual limb in said custom prosthetic liner.  
     
     
         13 . The system of  claim 1 , further comprising the ability to select liner materials and material properties.  
     
     
         14 . The system of  claim 1 , further comprising the ability to specify accessories to be included in/on said custom prosthetic liner.  
     
     
         15 . The system of  claim 14 , wherein the number, location, and/or orientation of said accessories may be specified.  
     
     
         16 . The system of  claim 15 , wherein said accessories are selected from the group consisting of suspension components, reinforcement, bladders (including inflatable bladders), additives, and sensors.  
     
     
         17 . The system of  claim 1 , further comprising a means of communication with an automated system for configuring and purchasing a medical device.  
     
     
         18 . A method for producing a custom polymeric prosthetic liner, comprising: 
 using a shape capture apparatus to capture the 3-dimensional shape of an amputee's residual limb;    using a processing device to generate a 3-dimensional electronic liner model from the captured shape;    optionally, using said processing device to generate a 3-dimensional electronic residual limb model from the captured shape;    providing a means of furnishing data associated with said 3-dimensional electronic liner model, said 3-dimensional electronic residual limb model, or both, to a facility equipped to produce said custom liner;    creating at least one custom mold component from said data associated with said 3-dimensional electronic liner model, said 3-dimensional electronic residual limb model, or both;    providing a mold adapted to receive and contain an amount of polymeric material, said mold incorporating said at least one custom mold component; and    using a molding machine to produce said custom prosthetic liner from said mold.    
     
     
         19 . The method of  claim 18 , wherein said means for capturing the 3-dimensional shape of an amputee's residual limb is a multiple image detector shape capture device.  
     
     
         20 . The method of  claim 18 , wherein said processing device consists of a computer program in combination with a device selected from the group consisting of a laptop computer, a desktop computer, a pen computer, a pocket personal computer (pocket PC), and a personal data assistant (PDA).  
     
     
         21 . The method of  claim 18 , wherein said at least one custom mold component is produced from said data by a computer-controlled machining device.  
     
     
         22 . The method of  claim 18 , wherein said at least one custom mold component is created from a closed-cell foam material.  
     
     
         23 . The method of  claim 18 , wherein said at least one custom mold component is a mold core for use with a common mold cavity.  
     
     
         24 . The method of  claim 23 , wherein said mold cavity is selected based on its size.  
     
     
         25 . The method of  claim 18 , wherein said at least one custom mold component is a mold cavity for use with a custom or common mold core.  
     
     
         26 . The method of  claim 18 , wherein said polymeric material is a silicone, urethane, or thermoplastic elastomer material.  
     
     
         27 . The method of  claim 26 , wherein said polymeric material is a block copolymer material.  
     
     
         28 . The method of  claim 18 , further comprising applying a fabric covering to an outer surface of said custom prosthetic liner during the liner manufacturing process.  
     
     
         29 . The method of  claim 18 , further comprising providing the ability to manipulate the shape of either or both of said 3-dimensional electronic liner and residual limb models to accommodate particular features of said residual limb in said custom prosthetic liner.  
     
     
         30 . The method of  claim 18 , further comprising providing the ability to select liner materials and material properties.  
     
     
         31 . The method of  claim 18 , further comprising providing the ability to specify accessories to be included in/on said custom prosthetic liner.  
     
     
         32 . The method of  claim 31 , wherein the number, location, and orientation of said accessories may also be specified.  
     
     
         33 . The method of  claim 31 , wherein said accessories are selected from the group consisting of suspension components, reinforcement, bladders (including inflatable bladders), additives, and sensors.  
     
     
         34 . The method of  claim 18 , further comprising a providing a means of communication with an automated system for configuring and purchasing a medical device.  
     
     
         35 . A system for producing a custom polymeric prosthetic liner, comprising: 
 a shape capture apparatus for capturing the 3-dimensional shape of an amputee's residual limb;    a storage means in communication with said shape capture apparatus for temporarily storing data associated with said 3-dimensional shape of an amputee's residual limb;    a means of providing said data to a facility equipped to produce said custom prosthetic liner;    a means at said facility for associating prosthetic liner parameters with said data;    an apparatus for creating at least one custom mold component from said data associated with said 3-dimensional shape of an amputee's residual limb and said prosthetic liner parameters;    a mold for receiving and containing an amount of polymeric material, said mold incorporating said at least one custom mold component; and    a molding machine for forming said custom prosthetic liner from said mold.    
     
     
         36 . The system of  claim 35 , wherein said shape capture apparatus employs a plurality of spaced-apart image detectors.  
     
     
         37 . The system of  claim 35 , further comprising a processing device in communication with said shape capture apparatus, said processing device for generating a 3-dimensional electronic model of said residual limb from said 3-dimensional shape captured by said shape capture apparatus  
     
     
         38 . The system of  claim 37 , wherein said processing device consists of a computer program in combination with a device selected from the group consisting of a laptop computer, a desktop computer, a pen computer, a pocket personal computer (pocket PC), and a personal data assistant (PDA).  
     
     
         39 . The system of  claim 35 , further comprising a means for generating numerical data representative of said 3-dimensional model.  
     
     
         40 . The system of  claim 35 , wherein said at least one custom mold component is a mold core for use with a common mold cavity.  
     
     
         41 . The system of  claim 35 , wherein said at least one custom mold component is a custom mold cavity for use with a custom or common mold core.  
     
     
         42 . The system of  claim 35 , wherein said polymeric material is a silicone, urethane, or block copolymer material.  
     
     
         43 . The system of  claim 42 , wherein said mold allows a fabric covering to be applied to an outer surface of said silicone, urethane, or block copolymer material during the liner manufacturing process.  
     
     
         44 . The system of  claim 35 , further comprising the ability to manipulate said data associated with said 3-dimensional shape of an amputee's residual limb in order to accommodate particular features of said residual limb in said custom prosthetic liner.  
     
     
         45 . The system of  claim 35 , further comprising the ability to select liner materials and material properties.  
     
     
         46 . The system of  claim 35 , further comprising the ability to specify accessories to be included in/on said custom prosthetic liner.  
     
     
         47 . The system of  claim 35 , further comprising a means of communication with an automated system for configuring and purchasing a medical device.  
     
     
         48 . A method of producing a custom polymeric prosthetic liner, comprising: 
 using a shape capture apparatus to capture the 3-dimensional shape of an amputee's residual limb;    providing a storage means in communication with said shape capture apparatus for temporarily storing data associated with said 3-dimensional shape of an amputee's residual limb;    providing a means of furnishing said data to a facility equipped to produce said custom prosthetic liner;    providing a means at said facility for associating prosthetic liner parameters with said data;    creating at least one custom mold component from said data associated with said 3-dimensional shape of an amputee's residual limb and said prosthetic liner parameters;    providing a mold for receiving and containing an amount of polymeric material, said mold incorporating said at least one custom mold component; and    using a molding machine to produce said custom prosthetic liner from said mold.    
     
     
         49 . The method of  claim 48 , wherein said shape capture apparatus employs a plurality of spaced-apart image detectors.  
     
     
         50 . The method of  claim 48 , further comprising providing a processing device in communication with said shape capture apparatus, said processing device for generating a 3-dimensional electronic model of said residual limb from said 3-dimensional shape captured by said shape capture apparatus  
     
     
         51 . The method of  claim 50 , wherein said processing device consists of a computer program in combination with a device selected from the group consisting of a laptop computer, a desktop computer, a pen computer, a pocket personal computer (pocket PC), and a personal data assistant (PDA).  
     
     
         52 . The method of  claim 48 , further comprising providing means for generating numerical data representative of said 3-dimensional model.  
     
     
         53 . The method of  claim 48 , wherein said at least one custom mold component is a mold core for use with a common mold cavity.  
     
     
         54 . The method of  claim 48 , wherein said at least one custom mold component is a custom mold cavity for use with a custom or common mold core.  
     
     
         55 . The method of  claim 48 , wherein said polymeric material is a silicone, urethane, or block copolymer material.  
     
     
         56 . The method of  claim 55 , further comprising applying a fabric covering to an outer surface of said silicone, urethane, or block copolymer material during the liner manufacturing process.  
     
     
         57 . The method of  claim 48 , further comprising manipulating said data associated with said 3-dimensional shape of an amputee's residual limb in order to accommodate particular features of said residual limb in said custom prosthetic liner.  
     
     
         58 . The method of  claim 48 , further comprising selecting liner materials and material properties.  
     
     
         59 . The method of  claim 48 , further comprising specifying accessories to be included in/on said custom prosthetic liner.  
     
     
         60 . The method of  claim 48 , further comprising communicating with an automated system for configuring and purchasing a medical device.  
     
     
         61 . A system for producing a custom polymeric prosthetic liner, comprising: 
 a shape capture apparatus for capturing the 3-dimensional shape of an amputee's residual limb;    a processing device running a computer program for generating a 3-dimensional electronic residual limb model from said 3-dimensional shape captured by said shape capture apparatus, said processing device and computer program further adapted to generate a 3-dimensional electronic liner model from said residual limb model and input liner parameters;    an interface for allowing a user of said system to operate said computer program to modify said 3-dimensional electronic residual limb model, said 3-dimensional electronic liner model, or both, if so desired;    an interface for allowing a user of said system to specify liner parameters;    optionally, an interface for allowing a user of said system to communicate with a separate system and computer program that facilitates the automatic configuration and purchasing of a medical device;    a storage device for temporarily storing data associated with said 3-dimensional electronic residual limb model and said 3-dimensional electronic liner model;    a transmission device for allowing data associated with a finalized version of said 3-dimensional electronic liner model, said 3-dimensional electronic residual limb model, or both, to be remotely sent to a manufacturing facility equipped to produce said custom prosthetic liner;    a means at said manufacturing facility for receiving said data associated with said finalized version of said 3-dimensional electronic liner model, said 3-dimensional electronic residual limb model, or both, and for reading said data or converting said data into a readable form;    an apparatus for creating at least one custom mold component from said data associated with said 3-dimensional electronic liner model, said 3-dimensional electronic residual limb model, or both;    a mold for receiving and containing an amount of polymeric material, said mold incorporating said at least one custom mold component; and    a molding machine for forming said custom prosthetic liner from said mold.    
     
     
         62 . The system of  claim 61 , wherein said shape capture apparatus employs a plurality of spaced-apart image detectors.  
     
     
         63 . The system of  claim 61 , wherein said processing device consists of a device selected from the group consisting of a laptop computer, a desktop computer, a pen computer, a pocket personal computer (pocket PC), and a personal data assistant (PDA).  
     
     
         64 . The system of  claim 61 , wherein said polymeric material is a silicone, urethane, or block copolymer material.  
     
     
         65 . The system of  claim 64 , wherein said mold allows a fabric covering to be applied to an outer surface of said silicone, urethane, or block copolymer material during the liner manufacturing process.  
     
     
         66 . A system for producing a custom polymeric prosthetic liner, comprising: 
 a shape capture apparatus for capturing the 3-dimensional shape of an amputee's residual limb;    a processing device running a computer program for generating a 3-dimensional electronic residual limb model from said 3-dimensional shape captured by said shape capture apparatus, said processing device and computer program further adapted to generate a 3-dimensional electronic liner model from said residual limb model and input liner parameters;    an interface for allowing a user of said system to operate said computer program to modify said 3-dimensional electronic residual limb model, said 3-dimensional electronic liner model, or both, if so desired;    an interface for allowing a user of said system to specify liner parameters;    optionally, an interface for allowing a user of said system to communicate with a separate system and computer program that facilitates the automatic configuration and purchasing of a medical device;    a storage device for temporarily storing data associated with said 3-dimensional electronic residual limb model and said 3-dimensional electronic liner model;    a transmission device for allowing data associated with a finalized version of said 3-dimensional electronic liner model, said 3-dimensional electronic residual limb model, or both, to be remotely sent to a manufacturing facility equipped to produce said custom prosthetic liner;    a means at said manufacturing facility for receiving said data associated with said finalized version of said 3-dimensional electronic liner model, said 3-dimensional electronic residual limb model, or both, and for reading said data or converting said data into a readable form;    an apparatus for creating at least one custom mold component from said data associated with said 3-dimensional electronic liner model, said 3-dimensional electronic residual limb model, or both;    a mold for receiving and containing an amount of polymeric material, said mold incorporating said at least one custom mold component; and    a molding machine for forming said custom prosthetic liner from said mold.    
     
     
         67 . The system of  claim 66 , wherein said shape capture apparatus employs a plurality of spaced-apart image detectors.  
     
     
         68 . The system of  claim 66 , wherein said processing device consists of a device selected from the group consisting of a laptop computer, a desktop computer, a pen computer, a pocket personal computer (pocket PC), and a personal data assistant (PDA).  
     
     
         69 . The system of  claim 66 , wherein said at least one custom mold component is a mold core for use with a common mold cavity.  
     
     
         70 . The system of  claim 66 , wherein said at least one custom mold component is a mold cavity for use with a custom or common mold core.  
     
     
         71 . The system of  claim 66 , further comprising the ability to use said computer program to select liner materials and material properties.  
     
     
         72 . The system of  claim 66 , wherein said polymeric material is a silicone, urethane, or block copolymer material.  
     
     
         73 . The system of  claim 72 , wherein said mold allows a fabric covering to be applied to an outer surface of said silicone, urethane, or block copolymer material during the liner manufacturing process.  
     
     
         74 . A system for producing a custom polymeric prosthetic liner, comprising: 
 a shape capture apparatus for capturing a 3-dimensional shape of an amputee's residual limb;    a processing device running a computer program for generating a 3-dimensional electronic liner model from said 3-dimensional shape captured by said shape capture apparatus and liner parameters input by user of said system;    an optional interface for allowing a user of said system to operate said computer program to view and modify a 3-dimensional electronic residual limb model prior to generation of said 3-dimensional electronic liner model, data associated with said 3-dimensional residual limb model subsequently used in generating said 3-dimensional electronic liner model;    an interface for allowing a user of said system to operate said computer program to specify accessories to be included in/on said custom prosthetic liner;    optionally, an interface for allowing a user of said system to communicate with a separate system and computer program that facilitates the automatic configuration and purchasing of a medical device;    a means for temporarily storing data associated with a finalized 3-dimensional electronic liner model, said 3-dimensional residual limb model, or both;    a transmission device for allowing data associated with said finalized 3-dimensional electronic liner model, said 3-dimensional residual limb model, or both, to be remotely sent to a manufacturing facility equipped to produce said custom prosthetic liner;    a means at said manufacturing facility for receiving said data associated with said finalized 3-dimensional electronic liner model, said 3-dimensional residual limb model, or both, and for reading said data or converting said data into a readable form;    an apparatus for creating at least one custom mold component from said data;    a molding machine for forming said custom prosthetic liner from a mold incorporating said at least one custom mold component;    once said custom prosthetic liner is completed, a storage means for storing said data associated with said finalized version of said 3-dimensional electronic liner model, said 3-dimensional electronic residual limb model, or both, for future use; and    a storage system for storing said at least one custom mold component for future use, said storage system including a means for identifying a particular custom mold component with a particular amputee.    
     
     
         75 . The system of  claim 73 , wherein said liner is manufactured from a silicone, urethane, or block copolymer material.  
     
     
         76 . The system of  claim 75 , wherein said mold allows a fabric covering to be applied to an outer surface of said silicone, urethane, or block copolymer material during the liner manufacturing process.  
     
     
         77 . A system for producing a custom polymeric prosthetic liner, comprising: 
 shape data associated with an amputee's residual limb;    a processing device in conjunction with a computer program for generating a 3-dimensional electronic liner model from said data and liner parameters input by a user of said system;    optionally, an interface for allowing a user of said system to operate said computer program to view and modify a 3-dimensional electronic residual limb model if so desired, data associated with said 3-dimensional electronic residual limb model subsequently used in the generating said 3-dimensional electronic liner model;    a means of providing data associated with said 3-dimensional electronic liner, said 3-dimensional electronic residual limb model, or both, to a facility equipped to produce said custom liner;    an apparatus for creating at least one custom mold component from said data;    a mold for receiving and containing an amount of polymeric material, said mold incorporating said at least one custom mold component; and    a molding machine for producing said custom prosthetic liner from said mold.    
     
     
         78 . The system of  claim 77 , wherein said shape data is in the form of a cast of said residual limb.  
     
     
         79 . The system of  claim 77 , further comprising an electronic shape capture apparatus that is used to capture a 3-dimensional image of an interior of said cast.  
     
     
         80 . The system of  claim 77 , wherein said shape data is in the form of measurements of said residual limb.  
     
     
         81 . The system of  claim 77 , further comprising an interface for allowing a user of said system to input said measurements into said computer program.  
     
     
         82 . The system of  claim 77 , wherein said polymeric material is a silicone, urethane, or block copolymer material.  
     
     
         83 . The system of  claim 82 , wherein said mold allows a fabric covering to be applied to an outer surface of said silicone, urethane, or block copolymer material during the liner manufacturing process.  
     
     
         84 . A method of producing a custom polymeric prosthetic liner, comprising: 
 obtaining shape data associated with an amputee's residual limb;    providing a processing device in conjunction with a computer program for generating a 3-dimensional electronic liner model from said shape data and liner parameters input by a user of said system;    optionally, providing an interface for allowing a user of said system to operate said computer program to view and modify a 3-dimensional electronic residual limb model if so desired, data associated with said residual limb model subsequently used in generating said liner model;    providing data associated with said residual limb shape, said 3-dimensional electronic liner model, or both, to a manufacturing facility equipped to produce said custom liner;    creating at least one custom mold component from said data;    providing a mold for receiving and containing an amount of polymeric material, said mold incorporating said at least one custom mold component; and    using a molding machine to produce said custom prosthetic liner from said mold.    
     
     
         85 . The method of  claim 84 , wherein said shape data is in the form of a cast of said residual limb.  
     
     
         86 . The method of  claim 84 , further comprising using an electronic shape capture apparatus to capture a 3-dimensional image of an interior of said cast.  
     
     
         87 . The method of  claim 84 , wherein said shape data is in the form of measurements of said residual limb.  
     
     
         88 . The method of  claim 84 , further comprising providing an interface for allowing a user of said system to input said measurements into said computer program.  
     
     
         89 . The method of  claim 84 , wherein said polymeric material is a silicone, urethane, or block copolymer material.  
     
     
         90 . The method of  claim 89 , further comprising applying a fabric covering to an outer surface of said silicone, urethane, or block copolymer material during the liner manufacturing process.