Prosthesis and method of making

• US 20020016631A1
• Filed: 05/02/2001
• Published: 02/07/2002
• Est. Priority Date: 05/03/2000
• Status: Active Grant

• Current Assignee: Rocky Mountain Biosystems, Inc.
• Original Assignee: Rocky Mountain Biosystems, Inc.
• Inventors: Marchitto, Kevin S., Flock, Stephen T.
• Granted Patent: US 6,564,086 B2
• Time in Patent Office: Days
• US Class Current: 623/7
• CPC Class Codes: A61B 5/0064 Body surface scanning
• CPC Class Codes: A61B 5/1077 Measuring of profiles
• CPC Class Codes: A61B 5/4312 Breast evaluation or disorder diagnosis A61B5/0091 takes precedence
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• 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 2/52 Mammary prostheses brassieres A41C3/00
• 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: A61F 2310/00383 Gelatin
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing
• CPC Class Codes: G01B 11/2513 with several lines being projected in more than one direction, e.g. grids, patterns
• CPC Class Codes: G01B 11/2518 Projection by scanning of the object
• CPC Class Codes: G06T 17/00 Three dimensional [3D] modelling, e.g. data description of 3D objects

Abstract

The present invention provides a novel apparatus for measuring the shape of various parts of anatomy, and alternatively capturing and digitizing an image of the part for the purpose of creating prosthetic or orthotic devices. Also provided are methods of measuring anatomical profiles involving physical contact with the body parts, and methods of manufacturing internal or external prosthetic and orthotic articles which mimic natural body parts in texture and motion characteristics, and in some cases, appearance.

Claims

1. A method of imaging an object of an individual, comprising the steps of:

capturing perspective images in a fixed location relative to the individual using multiple cameras;

capturing images of a calibration target;

processing the data using a computer algorithm into a processed digital image.

2. A method of imaging a breast or chest of an individual, comprising the steps of:

positioning said individual with exposed breasts in front of a projection device such as a slide-projector, said device facing said individual, is level and at the same height as said individual'"'"'s chest and at a known distance from the individual;

projecting an image of a pattern onto the breast and/or chest;

imaging the projected pattern on the chest of the individual using an imaging device;

digitizing and storing said image; and

calculating spatial coordinates of the pattern off the digitized image and calculating the shape of the object on which the pattern was projected.

3. The method of claim 2, wherein said imaging device is a charge-coupled-device video camera.

4. The method of claim 2, wherein said digitizing is performed using a frame-grabber.

5. The method of claim 2, wherein said image is stored on a computer archival device such as a magnetic hard disk.

6. The method of claim 2, wherein said individual in an upright position or a supine position.

7. The method of claim 2, wherein said breast are imaged from several different directions, such as laterally, anterior-posterior and coronary.

8. The method of claim 2, wherein said projection devices and image capturing device rest on a movable track that rotates around the patient in order to attain a three dimensional perspective.

9. The method of claim 2, wherein an increasingly fine pattern is projected as one moves laterally or inferiorly further away from the nipple.

10. The method of claim 2, wherein morphing software is used to model the flow or motion characteristics of a prosthesis as the individual assumes one position or another.

11. A method of measuring a three-dimensional profile of an object of an individual, comprising the steps of:

positioning said individual upright and facing forwards with exposed breasts;

positioning a slide projector parallel to the floor of the examination room and at the height of the patient'"'"'s nipple;

projecting an image of a 64×

64 matrix of small dots onto said object;

capturing and digitizing said matrix of points;

determining the real position in space of a point so as to provide a three-dimensional profile of an object.

12. The method of claim 11, wherein volume of an anatomical component is measured by using the three-dimensional information to create a volume measurement either by comparison to an imaged external standard or an internal standard which has been saved in the devices memory.

14. The breast prosthesis of claim 13, wherein said shell is a single or multi-piece.

15. The breast prosthesis of claim 14, wherein said shell comprises of an elastomeric material.

16. The breast prosthesis of claim 15, wherein said elastomeric material is silastic.

17. The breast prosthesis of claim 13, further comprising viscous low-density or viscoelastic materials contained within the prosthesis.

18. The breast prosthesis of claim 13, wherein the walls of said prosthesis are thin.

19. The breast prosthesis of claim 13, wherein the walls of the breast prosthesis have a non-uniform thickness.

20. The breast prosthesis of claim 13, wherein the viscoelastic material has (1) a low density), (2) has low thermal conductivity, (3) has continuum-mechanical properties similar to human tissue, and (4) is in a pourable form.

21. The breast prosthesis of claim 20, wherein the viscoelastic material is selected from the group consisting of soybean oil, agar, gelatin, silicone, and biologically inert polymers.

22. The breast prosthesis of claim 20, wherein the viscoelastic material is silica-aerogel.

23. The breast prosthesis of claim 13, wherein the posterior aspect of the prosthesis is composed of a plastic material having a lattice-like structure.

24. The breast prosthesis of claim 13, further comprising an antifungicide and/or an antibacteriocide incorporated in the shell.

13. A breast prosthesis, comprising

an external shell, said shell molded to fit the shape of a breast;

and

a hollow cavity defined by the shell, said cavity filled with a viscoelastic material.