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WO2014085913A1 - Procédé et système de fabrication de prothèses cosmétiques - Google Patents

Procédé et système de fabrication de prothèses cosmétiques Download PDF

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Publication number
WO2014085913A1
WO2014085913A1 PCT/CA2013/001012 CA2013001012W WO2014085913A1 WO 2014085913 A1 WO2014085913 A1 WO 2014085913A1 CA 2013001012 W CA2013001012 W CA 2013001012W WO 2014085913 A1 WO2014085913 A1 WO 2014085913A1
Authority
WO
WIPO (PCT)
Prior art keywords
limb
remaining sound
mold
anatomical
tridimensional
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CA2013/001012
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English (en)
Inventor
Jean-Pierre Gibeault
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Individual
Original Assignee
Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of WO2014085913A1 publication Critical patent/WO2014085913A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/5044—Designing or manufacturing processes
    • A61F2/5046—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, finite-element analysis or CAD-CAM techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2002/5001—Cosmetic coverings

Definitions

  • the prosthetist will gather or collect several types of anatomical and aesthetical information about the amputee, about the amputated limb the prosthesis will replace, and also about the remaining sound limb since the amputated limb is no longer available to provide complete anatomical and aesthetical data.
  • This information will concern personal data on the individual amputee. For example, it may include the gender, age (or age group), lifestyle, activity level and expectations in term of the final look and functionality of the prosthesis.
  • the amputee information will also include size and weight of the amputee, the side and extent of the amputation, the range of motions of the amputated limb, etc.
  • the level of information collected is much more comprehensive since this information will be used in the fabrication and customization of the cosmetic prosthesis.
  • the anatomical and aesthetical information generally includes the basic skin color, changes in colors/pigmentations, and the location(s), dimension(s) and color(s) of color transitions, freckles (if any), nails (if any), veins (if any), wrinkles (if any), knuckles (if any), hairs (if any), deformities and scars (if any).
  • the more detailed the collected information the more realistic the prosthesis will be in appearance.
  • the 3D positive mold is used to produce the final 3D negative mold that will be used to produce the final prosthesis.
  • the 3D positive mold is used to produce a first 3D negative mold which will be used to produce a second 3D positive mold made from very fine and malleable material (e.g. plasticine).
  • the second 3D positive mold can be further modified to add, remove and/or correct aesthetical and/or anatomical details. This second 3D positive mold is then used to produce the final 3D negative mold that will be used to produce the final prosthesis.
  • a manufacturing process in accordance with the principles of the present invention generally increases the manufacturing speed while generally reducing the manufacturing costs of fully customized prostheses. In addition, it greatly simplifies the accurate capture and collection of the necessary information to fabricate and dispense a fully customized cosmetic prosthesis.
  • Figure 1 is a flowchart of an embodiment of a method for manufacturing a cosmetic prosthesis in accordance with the principles of the present invention.
  • Figure 2 is a flowchart of another embodiment of a method for manufacturing a cosmetic prosthesis in accordance with the principles of the present invention.
  • FIG. 1 the main steps of an embodiment of the method 10 to manufacture a custom cosmetic prosthesis are illustrated in a flow chart.
  • the method 10 generally starts at 100 with an initial consultation between the patient (or amputee) and a certified prosthetist or other prosthetic or medical professional.
  • the certified prosthetist will generally obtain three groups of information concerning the individual patient, the remaining sound limb and, the amputated limb.
  • the aesthetic information or data generally includes two types: color information (step 130) and anatomical information (step 140) of the amputated limb.
  • the color information that is gathered and documented typically includes the basic skin color and also changes in pigmentation (location(s), color(s) and dimension(s)), colors transition from one area of the anatomy to the next (location(s), color(s) and dimension(s)), and freckles (location(s), color(s) and dimension(s)).
  • location(s), color(s) and dimension(s) typically includes the basic skin color and also changes in pigmentation (location(s), color(s) and dimension(s)), colors transition from one area of the anatomy to the next (location(s), color(s) and dimension(s)), and freckles (location(s), color(s) and dimension(s)).
  • location(s), color(s) and dimension(s) Depending on the actual skin complexion of the limb under consideration of the patient, more or less color information could be collected.
  • the anatomical information typically includes the locations, colors and dimensions of nails (if any), veins, wrinkles, knuckles (if any), hairs (if any), deformities (if any), wounds (if any), scars (if any), and amputation (if any).
  • the cosmetic prosthesis intends to resemble as closely as possible the amputated limb, the more aesthetic information that is collected and documented, the more realistic the final cosmetic prosthesis will be. Since the level of detail of the final prosthesis will have an impact on cost, determining the expectations of the patient with respect to the aesthetic aspects of the final prosthesis during the initial consultation (step 1 10) will allow the certified prosthetist to decide how much aesthetic data to collect. There is generally no need to collect data about aesthetic aspects the limb under consideration if these aspects will not be replicated in the final prosthesis.
  • the remaining sound limb In order to fully capture all the anatomical shape information about the remaining sound limb, several scans of the remaining sound limb may be performed in which the position of the remaining sound limb would be changed. For instance, if the remaining sound limb is a hand, then the remaining sound hand would be scanned opened, closed, partially closed, with the fingers close to each other, with the fingers spread out, etc. By scanning the hand in various positions, more detailed anatomical infonnation can be captured. [0050] Even though the final prosthesis may not be able to function or move as the remaining sound limb, the capturing of its detailed anatomical information will assist in designing a prosthesis which will be more realistic in appearance.
  • the prosthesis Since the prosthesis must fit the anatomy of the amputee, it is generally preferable to extract precise dimensions of the remaining sound limb as these dimensions will be used later on in the manufacturing steps of the cosmetic prosthesis.
  • the 3D limb data and the extracted dimensions are used to generate a 3D computer model of the remaining sound limb using 3D modeling computer software (e.g. SolidworksTM, RhinoTM, etc.) (step 180).
  • 3D modeling computer software e.g. SolidworksTM, RhinoTM, etc.
  • a more realistic prosthesis will generally reduce unwanted external attention; it will also allow the amputee to personalize the prosthesis. In other words, a more realistic prosthesis has positive psychological personal and social benefits for the amputee.
  • the 3D computer model data is sent to an automated manufacturing machine such as a computer numerical controlled (“CNC") machine, a 3D printer, etc. to produce a high-definition (“HD”) 3D positive mold of the mirror of the remaining sound limb (step 200).
  • This HD 3D positive will preferably be made from ceramic or plaster materials as it will form the basis of a HD 3D negative mold of the mirror of the remaining sound limb.
  • a second high-definition 3D positive mold is produced (step 220).
  • the second HD 3D positive mold is made from very fine and malleable material.
  • the second HD 3D positive mold is made from material such as plasticine or alginate.
  • the second HD 3D positive mold can be slightly modified to add any anatomical details that could have been missed from the initial electronic capture, to remove any erroneous and/or unwanted anatomical details, and/or to correct any anatomical details for aesthetic and/or physiological purposes.
  • a second HD 3D negative mold is produced, this time with a more rigid material such as Plaster of Paris (step 240).
  • the preparation of the colored basic material could be done automatically in a computer-controlled mixing apparatus in which the recipes for preparing the various colors (e.g. quantity of base color, quantity and type of each pigment(s) to be added, etc.) are stored.
  • recipes for preparing the various colors e.g. quantity of base color, quantity and type of each pigment(s) to be added, etc.
  • two molding processes can be used to produce the main body of the prosthesis with the colored silicone material.
  • the second HD 3D positive mold is sequentially filled with liquid colored silicone and then emptied. At each iteration, a thin layer of colored silicone remains in the mold, adding to any previously deposed layers. Once the layers reach a predetermined thickness, the molding process is stopped. Notably, some color elements of the final cosmetic prosthesis could be added during the production of these layers.
  • the second HD 3D positive mold is partially filled with liquid colored silicone and then rotated for a predetermined length of time. As the mold is rotated, thin layers of silicone will adhere to the interior surface of the mold and then on any previous layers. This second molding process is generally known as "roto-molding". Again, some color elements of the final cosmetic prosthesis could be added during the production of these layers.
  • the molded prosthesis is cured to solidify the silicone.
  • the resulting molded prosthesis is typically a single-colored prosthesis having the shape of the mirror image of the remaining sound limb.
  • the molded prosthesis could comprise more than one (e.g. 2 or 3) basic colors.
  • the prosthesis does not contain all of the color elements (captured in step 130) and anatomical elements (captured in step 140).
  • the patient and the certified prosthetist will validate that the prosthesis properly resembles the amputated limb, at least with respect to its anatomical shape. Should the prosthesis fail to match the appearance of the amputated limb, there would be no need to proceed with the final customization steps.
  • colors are then applied to the prosthesis to match the color element data previously collected (step 260).
  • the color matching could be performed by a coloring technician using known techniques, in the present embodiment, the colors are applied using a computer-controlled 3D coloring process.
  • the main color elements could be applied using a computer-controlled 3D printer (i.e. a printer capable of printing on a 3D surface) while the finer color elements could be added afterwards by a coloring technician using known techniques.
  • a computer-controlled 3D printer i.e. a printer capable of printing on a 3D surface
  • the finer color elements could be added afterwards by a coloring technician using known techniques.
  • anatomical details are added to the prosthesis (step 270). These anatomical details typically include hairs and nails though they could also include other elements depending on the amputated limb the prosthesis replaces.
  • FIG. 2 another embodiment of a process 20 in accordance with the present invention is shown.
  • the embodiment of Fig. 2 is broadly similar to the embodiment of Fig. 1. The main difference is the absence of steps 210, 220 and 230 in the process 20.
  • steps 210 to 230 could be avoided altogether.
  • the certified prosthetist may decide to employ either process 10 or process 20.
  • the resulting prosthesis is more realistic as it substantially matches the amputated limb both anatomically and aesthetically.
  • the processes in accordance with the principles of the present invention generally reduce the processing time to manufacture fully customized prosthesis while reducing the manufacturing costs.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Manufacturing & Machinery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)

Abstract

L'invention concerne un procédé de fabrication d'une prothèse prothétique personnalisée, qui correspond sensiblement, à la fois anatomiquement et esthétiquement, au membre amputé. Le procédé comprend de manière générale la capture et la collecte d'informations anatomiques et esthétiques associées au membre amputé, la capture d'informations anatomiques associées au membre sain restant, la production d'un modèle informatisé du membre amputé à l'aide de la capture électronique d'informations anatomiques, la production de moules positif et négatif sur la base du modèle informatisé, le moulage de la prothèse prothétique et la personnalisation de la prothèse prothétique.
PCT/CA2013/001012 2012-12-07 2013-12-06 Procédé et système de fabrication de prothèses cosmétiques Ceased WO2014085913A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201261734494P 2012-12-07 2012-12-07
US61/734,494 2012-12-07

Publications (1)

Publication Number Publication Date
WO2014085913A1 true WO2014085913A1 (fr) 2014-06-12

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PCT/CA2013/001012 Ceased WO2014085913A1 (fr) 2012-12-07 2013-12-06 Procédé et système de fabrication de prothèses cosmétiques

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016119777A1 (fr) * 2015-01-27 2016-08-04 Otto Bock Healthcare Gmbh Procédé de production d'un article à coloration stable doté d'une surface silicone et article coloré obtenu d'après ledit procédé
US20170069131A1 (en) * 2015-09-09 2017-03-09 Siemens Healthcare Gmbh Data driven framework for optimizing artificial organ printing and scaffold selection for regenerative medicine
WO2018047112A1 (fr) * 2016-09-08 2018-03-15 Sabic Global Technologies B.V. Plâtre personnalisé et procédés de fabrication associés
CN114224577A (zh) * 2022-02-24 2022-03-25 深圳市心流科技有限公司 智能假肢的训练方法、装置、电子设备、智能假肢及介质

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0097001A1 (fr) * 1982-06-03 1983-12-28 Cemax Medical Products, Inc. Procédé de formation des prothèses implantables pour la chirurgie reconstructive
US5432703A (en) * 1990-10-31 1995-07-11 Clynch Technologies, Inc. Laser digitizer system for producing orthotic and prosthetic devices
WO1998030176A1 (fr) * 1997-01-08 1998-07-16 Clynch Technologies, Inc. Procede de production de dispositifs medicaux personnalises
EP0947899A2 (fr) * 1998-04-03 1999-10-06 A-Pear Biometric Replications Inc. Procédés pour fabriquer des surfaces prothétiques
GB2357725A (en) * 1999-12-02 2001-07-04 Blatchford & Sons Ltd Silicone cosmesis
US20040260402A1 (en) * 2003-06-20 2004-12-23 Baldini Steven E. Method of manufacturing a socket portion of a prosthetic limb
WO2012123693A1 (fr) * 2011-03-15 2012-09-20 Fripp Design & Research Limited Procédé et système de production de prothèses

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0097001A1 (fr) * 1982-06-03 1983-12-28 Cemax Medical Products, Inc. Procédé de formation des prothèses implantables pour la chirurgie reconstructive
US5432703A (en) * 1990-10-31 1995-07-11 Clynch Technologies, Inc. Laser digitizer system for producing orthotic and prosthetic devices
WO1998030176A1 (fr) * 1997-01-08 1998-07-16 Clynch Technologies, Inc. Procede de production de dispositifs medicaux personnalises
EP0947899A2 (fr) * 1998-04-03 1999-10-06 A-Pear Biometric Replications Inc. Procédés pour fabriquer des surfaces prothétiques
GB2357725A (en) * 1999-12-02 2001-07-04 Blatchford & Sons Ltd Silicone cosmesis
US20040260402A1 (en) * 2003-06-20 2004-12-23 Baldini Steven E. Method of manufacturing a socket portion of a prosthetic limb
WO2012123693A1 (fr) * 2011-03-15 2012-09-20 Fripp Design & Research Limited Procédé et système de production de prothèses

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016119777A1 (fr) * 2015-01-27 2016-08-04 Otto Bock Healthcare Gmbh Procédé de production d'un article à coloration stable doté d'une surface silicone et article coloré obtenu d'après ledit procédé
RU2707750C2 (ru) * 2015-01-27 2019-11-29 Отто Бок Хелткэр Гмбх Способ получения прочно окрашенного изделия с силиконовой поверхностью и окрашенное изделие, полученное этим способом
US10920022B2 (en) 2015-01-27 2021-02-16 Ottobock Se & Co. Kgaa Method for producing a permanently colored object having a silicone surface and colored object produced according to the method
US20170069131A1 (en) * 2015-09-09 2017-03-09 Siemens Healthcare Gmbh Data driven framework for optimizing artificial organ printing and scaffold selection for regenerative medicine
US9824491B2 (en) * 2015-09-09 2017-11-21 Siemens Healthcare Gmbh Data driven framework for optimizing artificial organ printing and scaffold selection for regenerative medicine
US10710354B2 (en) 2015-09-09 2020-07-14 Siemens Healthcare Gmbh Data driven framework for optimizing artificial organ printing and scaffold selection for regenerative medicine
WO2018047112A1 (fr) * 2016-09-08 2018-03-15 Sabic Global Technologies B.V. Plâtre personnalisé et procédés de fabrication associés
CN114224577A (zh) * 2022-02-24 2022-03-25 深圳市心流科技有限公司 智能假肢的训练方法、装置、电子设备、智能假肢及介质

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