Method for producing custom fitted medical devices

• US 6,463,351 B1
• Filed: 10/14/1999
• Issued: 10/08/2002
• Est. Priority Date: 01/08/1997
• Status: Expired due to Term

• Current Assignee: Clynch Technologies Incorporated
• Original Assignee: Clynch Technologies Incorporated
• Inventors: Clynch, George S.
• Primary Examiner(s): Picard, Leo P.
• Assistant Examiner(s): Garland, Steven R.
• Application Number:
  US09/341,413
• Time in Patent Office: 1,090 Days
• Field of Search: 700/163, 700/97, 700/98, 700/117, 700/118, 700/182, 700/183, 700/197, 623/27, 623/33, 623/901, 264/40.1, 702/153
• US Class Current: 700/163
• CPC Class Codes: A61F 2/5046 for designing or making customized prostheses, e.g. using templates, finite-element analysis or CAD-CAM techniques
• CPC Class Codes: A61F 2/80 Sockets, e.g. of suction type
• CPC Class Codes: A61F 2002/505 using CAD-CAM techniques or NC-techniques
• CPC Class Codes: A61F 2002/5053 using a positive or a negative model, e.g. casting model or mould
• CPC Class Codes: G05B 19/4099 Surface or curve machining, making 3D objects, e.g. desktop manufacturing
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

A method for producing a medical device, such as a prosthetic or orthotic structure which makes the procedure more widely available at less cost. The method involves making a model of the body part for which a medical structure is to be manufactured using conformable fabric impregnated with a settable resin. The model may be prepared by a physician or a prosthetist who has no direct access to an expensive digitizing scanner. The model is removed from the patient'"'"'s body part and shipped to a scanning facility where a digitizing scanner is used to produce a digitized image of the model. The digitized image is shrunk to compensate for the thickness of the model and the digitized data file is preferably sent back to the physician or prosthetist who manipulates the digitized image using a customized software program to produce a modified data file. The modified data file is sent to the scanning facility where the modified data file is converted into control code for a machine which produces a mold used in the manufacture of the medical device. The mold may be manufactured at the scanning facility or the modified data file may be uploaded to the manufacturing facility which may manufacture the mold as well as the medical device. The method is also adapted for use in producing many other medical or anthropometric devices which requires a precision fit to the human body.

Claims

1. A method for producing a structure for use in a prosthetic, orthotic or other medical device having a surface for engagement with a portion of the human body, including the steps of defining the body portion and presenting an outer surface thereof for laser digitizing, inspecting the body portion and identifying critical areas on the outer surface with small non-reflective markings, scanning the body portion with a laser digitizer to produce a plurality of closely spaced longitudinal lines read by the laser digitizer, storing contour coordinates representing a digital image as data including void-points produced by the non-reflective markings, displaying the digital image graphically and identifying basic modification areas for inner surfaces of said structure by way of the location of the void-points, identifying selected vertices within the basic modification areas, producing modified data by moving the selected vertices for some of the basic modification areas in a positive direction relative to non-selected surrounding vertices to produce build-ups and moving selected vertices of other basic modification areas in a negative direction relative to non-selected surrounding vertices to produce areas of reduction, using said modified data to produce control code for controlling a machine for producing a mold having a surface contoured in the likeness of the body surface, but including areas of build-up and areas of reduction, and producing the structure from the mold whereby the areas of build-up provide areas of relief in the surface of the structure and the areas of reduction provide higher pressure areas in the surface of the structure, the method further comprising:

covering the surface of the body portion with a comfortable reflective material that can be activated to harden and make a model of the body portion;

inspecting the body portion and identifying critical areas with non-reflective markings on the material;

activating the material to harden and produce the model of the body portion;

removing the model from the body portion and scanning the model to produce a digitized image of the model;

shrinking the digitized image to accurately represent the body portion by compensating for the thickness of the model; and

manipulating the compensated digitized image to provide areas of build-up and relief in the medical device, whereby the manipulated, compensated digitized image is used to produce code for controlling a machine for producing a mold or an anthropometric device having a surface contoured in the likeness of the body portion, but including the areas of build-up and relief.

2. The method as claimed in claim 1 wherein the material that can be activated to harden and make a model of the body portion is a knitted fabric impregnated with a curable plastics resin.

3. The method as claimed in claim 2 wherein the curable plastics resin is activated by the application of water to the material.

4. The method as claimed in claim 1 wherein the model is shipped to a facility for scanning where the model is scanned and the compensated digitized image is produced.

5. The method as claimed in claim 4 wherein the model is produced by a physician having access to a computerized system for manipulating the compensated digitized image and the compensated digitized image data is provided by the scanning facility to the physician who manipulates the compensated image to produce the modified data.

6. The method as claimed in claim 4 wherein the facility for scanning the model is a facility that serves a plurality of physicians and/or prosthetists.

7. The method as claimed in claim 6 wherein the compensated digitized image is electronically downloaded to the physicians'"'"' computerized system.

8. The method as claimed in claim 7 wherein the compensated digitized image is electronically downloaded using a telecommunications service.

9. The method as claimed in claim 8 wherein the telecommunications service is the Internet.

10. The method as claimed in claim 1 wherein the scanner includes an imaging device having a position detector with an apertured mask in a converging lens system and the digitized image is a three dimensional reconstruction of multiple range images.

11. The method as claimed in claim 1 wherein the machine for producing a mold is operated by a medical device manufacturing facility that is remote from a scanning facility.

12. The method as claimed in claim 11 wherein the manufacturing facility serves a plurality of scanning facilities.

13. The method as claimed in claim 11 wherein the code for controlling a machine for producing a mold or an anthropometric device having a surface contoured in the likeness of the body portion is electronically uploaded from the scanning facility to the manufacturing facility.

14. The method as claimed in claim 13 wherein the code for controlling a machine is uploaded using a telecommunications service.

15. The method as claimed in claim 1 wherein the machine for producing a mold having a surface contoured in the likeness of the body portion is located in a scan facility and the mold is shipped to the manufacturing facility which manufactures the medical device using the mold and related specifications.

16. The method as claimed in claim 1 wherein the medical device is an artificial limb.

17. The method as claimed in claim 1 wherein the medical device is a support or brace for weak or ineffective joints or muscles.

18. The method as claimed in claim 1 wherein the medical device is a device for positioning a patient for radiotherapy or laser surgery.

19. The method as claimed in claim 1 wherein the medical device is used for protecting a part of the human body.

20. An anthropometric device produced using the method of claim 1.