EP1668957A1 - Procedes de fabrication d'un moule femelle pour prothese auditive - Google Patents

Procedes de fabrication d'un moule femelle pour prothese auditive

Info

Publication number
EP1668957A1
EP1668957A1 EP03752583A EP03752583A EP1668957A1 EP 1668957 A1 EP1668957 A1 EP 1668957A1 EP 03752583 A EP03752583 A EP 03752583A EP 03752583 A EP03752583 A EP 03752583A EP 1668957 A1 EP1668957 A1 EP 1668957A1
Authority
EP
European Patent Office
Prior art keywords
mold
hearing aid
data
outside
auditory canal
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.)
Withdrawn
Application number
EP03752583A
Other languages
German (de)
English (en)
Inventor
Randal Alan Stevens
Remir M. Vassserman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
In'Tech Industries Inc
Interton USA
In Tech Ind Inc
Original Assignee
In'Tech Industries Inc
Interton USA
In Tech Ind Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by In'Tech Industries Inc, Interton USA, In Tech Ind Inc filed Critical In'Tech Industries Inc
Publication of EP1668957A1 publication Critical patent/EP1668957A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
    • H04R25/00—Deaf-aid sets, i.e. electro-acoustic or electro-mechanical hearing aids; Electric tinnitus maskers providing an auditory perception
    • H04R25/65—Housing parts, e.g. shells, tips or moulds, or their manufacture
    • H04R25/658—Manufacture of housing parts
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y80/00—Products made by additive manufacturing
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
    • H04R2225/00—Details of deaf aids covered by H04R25/00, not provided for in any of its subgroups
    • H04R2225/77—Design aspects, e.g. CAD, of hearing aid tips, moulds or housings
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
    • H04R25/00—Deaf-aid sets, i.e. electro-acoustic or electro-mechanical hearing aids; Electric tinnitus maskers providing an auditory perception
    • H04R25/65—Housing parts, e.g. shells, tips or moulds, or their manufacture
    • H04R25/652—Ear tips; Ear moulds

Definitions

  • the present invention relates to methods to make a negative hearing aid mold and more particularly to methods to use rapid prototyping such as stereo lithography, fused deposition modeling, and laser sintering to make a negative hearing aid mold.
  • BACKGROUND OF THE INVENTION Hearing aids have been made utilizing various techniques including using vacuum forming to create a negative mold for the hearing aid and the creation of the hard solid hearing aid bodies directly from stereo lithography techniques.
  • Many hearing aids are designed for insertion in the auditory canal which includes the portion of the ear defined by parts of the pinna and the external ear canal.
  • the external ear canal includes the cartilaginous portion and the bony portion.
  • Vacuum forming has the distinct draw back that auditory canal shapes and dimensions are not faithfully reproduced.
  • the vacuum forming techniques do not have the ability to faithfully reproduce the topology of the auditory canal due to surface undulations and curves that exceed the limits of this technology. This situation creates a potentially uncomfortable or irritating hearing aid because of misfit and audio feedback. These discomforts arise directly from the nonconforming aspects of the resulting hearing aid.
  • the nonconforming aspects of the resulting hearing aid are a direct result of a low fidelity mold.
  • a misfit hearing aid is uncomfortable due to the tender nature of the pinna and external auditory canal.
  • a nonconforming hearing aid creates an auditory feedback pathway from the canal tip region, through the space between the hearing aid body and microphone input. Audio feedback directly interferes with the functioning of the hearing aid and is uncomfortable.
  • a shell hearing aid body is directly created using rapid prototyping such as stereo lithography. Directly creating the shell hearing aid body does not utilize a negative mold and thus cannot be used to create soft solid hearing aids.
  • a negative hearing aid mold is created from the outside mold data using rapid prototyping such as stereo lithography, fused deposition modeling, Digital light processing, such as Perfactory TM DLP technology, and laser sintering, with the negative hearing aid mold having an inside surface representing the outside dimensions of the auditory canal from the outside mold data, with the negative hearing aid mold suitable for receipt of a soft solid during the formation of a soft solid hearing aid.
  • the methods provide that the soft solid is silicone or any other suitable materials available to create the soft solid.
  • the methods provide that the auditory canal dimension measurement data representing internal dimensions of an auditory canal includes measuring the outside dimensions of an impression of an auditory canal to generate the outside auditory canal dimension data.
  • the methods provide measuring the outside dimensions of the impression of an auditory canal by measuring the outside dimensions of the impression of an auditory canal with a laser to generate laser measured auditory canal data and then generating point cloud/STL data from the laser measured auditory canal data.
  • the methods process the outside auditory canal dimension data to generate the outside mold data in the form of point cloud/STL data.
  • the methods further include generating stereo lithography data from the point cloud/STL data.
  • the methods analyze the impression to generate auditory canal point cloud/STL data using a laser to measure a plurality of surface positions on the impression to generate the auditory canal point cloud/STL data.
  • the methods create a negative hearing aid mold from the outside mold data using stereo lithographic techniques.
  • the negative hearing aid mold is suitable for use as an outside mold for the construction of a hearing aid.
  • a soft solid negative hearing aid mold is created from the outside mold data using stereo lithographic techniques, with the soft solid negative hearing aid mold suitable for use as an outside mold for the construction of a soft solid hearing aid.
  • the methods create a negative hearing aid mold from the outside mold data using rapid prototyping such as stereo lithography, fused deposition modeling, Digital light processing, and laser sintering with the addition of making an hearing aid mold from the outside mold data using rapid prototyping such as stereo lithography, fused deposition modeling, Digital light processing, and laser sintering.
  • the methods create a negative hearing aid mold from the outside mold data using rapid prototyping such as stereo lithography, fused deposition modeling, digital light processing, and laser sintering with the addition of making an epoxy based hearing aid mold from the outside mold data using rapid prototyping such as stereo lithography, fused deposition modeling, Digital light processing, and laser sintering with SLA Epoxy Resin Si, medical grade acrylonitrile butadiene styrene (ABS), or with powdered nylon.
  • the methods further include mounting the negative hearing aid mold on a faceplate and placing a soft solid in the negative hearing aid mold.
  • the methods place a soft solid in the form of silicone in the negative hearing aid mold.
  • the methods include installing hearing aid transducers and electronics in the negative hearing aid mold.
  • the methods process, with a computer processor, the auditory canal dimension measurement data representing dimensions of an auditory canal to generate outside auditory canal dimension data that represents outside dimensions of the auditory canal.
  • the methods process, with a computer processor, the outside auditory canal dimension data to generate outside mold data.
  • the methods further comprising measuring auditory canal dimension measurement data representing dimensions of an auditory canal directly from the auditory canal to generate outside auditory canal dimension data that represents outside dimensions of the auditory canal.
  • the methods provide creating a negative hearing aid mold from the outside mold data using rapid prototyping further comprises creating the negative hearing aid mold from the outside mold data using rapid prototyping such as stereo lithography. In other aspects of the invention, the methods provide creating a negative hearing aid mold from the outside mold data using rapid prototyping further comprises creating the negative hearing aid mold from the outside mold data using fused deposition modeling. hi other aspects of the invention, the methods provide creating a negative hearing aid mold from the outside mold data using rapid prototyping further comprises creating the negative hearing aid mold from the outside mold data using laser sintering.
  • the methods provide for making a negative hearing aid mold comprising the steps of processing laser measured auditory canal dimension measurement data representing dimensions of an auditory canal to generate outside auditory canal dimension data that represents outside dimensions of the auditory canal, with the laser measured auditory canal dimension measurement data obtained with a laser measurement system; processing the outside auditory canal dimension data to generate outside mold data; and creating a negative hearing aid mold from the outside mold data using rapid prototyping, with the negative hearing aid mold having an inside surface, with the inside surface representing the outside dimensions of the auditory canal from the outside mold data, with the negative hearing aid mold suitable for receipt of a soft solid.
  • Figure 1 shows a negative hearing aid mold created following the preferred methods according to the teachings of the present invention.
  • Figure 2 diagrammatically shows preferred methods according to the teachings of the present invention.
  • Figure 3 shows an impression taken from the auditory canal.
  • Figure 4 shows a schematic diagram of a laser measuring system measuring the impression following the preferred methods according to the teachings of the present invention.
  • Figure 5 shows point cloud/STL data representing the impression following the preferred methods according to the teachings of the present invention.
  • Figure 6 shows the point cloud/STL data representing the impression after being processed into outside auditory canal data for use in making a stereo lithography, fused deposition modeling, and laser sintering based negative hearing aid mold following the preferred methods according to the teachings of the present invention.
  • Figure 7 shows the negative hearing aid mold being created in a stereo lithography machine following the preferred methods according to the teachings of the present invention.
  • Figure 8 shows the negative hearing aid mold created following the preferred methods according to the teachings of the present invention being filled with a soft solid and hearing aid electronics to create a soft solid hearing aid.
  • FIG. 1 shows a negative hearing aid mold 10 created following the preferred methods according to the teachings of the present invention.
  • the negative hearing aid mold 10 is used as a mold to create a soft solid hearing aid 16; the hearing aid 16 is shown being created in Figure 8.
  • An inside surface 15 of the negative hearing aid mold 10 conforms to an outside surface 24 of an impression 22 taken of an auditory canal 21. The impression
  • the negative hearing aid mold 10 according to the teachings I of the present invention provides a negative impression of the auditory canal 21, so that when the negative hearing aid mold 10 is filled with a soft solid 12 from a soft solid applicator 19, the soft solid hearing aid 16 may be produced that fits well in the auditory canal 21.
  • a bowl end 17 of the negative hearing aid mold 10 is mounted on a faceplate 18.
  • a helix area 47 of the negative hearing aid mold 10 maybe used to insert the soft solid 12 from a soft solid applicator 19 to create the body of the hearing aid 16.
  • the hearing aid mold 10 is designed to create the hearing aid 16 that fits in the auditory canal 21 but other types of negative hearing aid molds 10 may be created with the preferred methods of the present invention and are within the spirit and scope of the invention. Undercuts and undulations in the topology of the auditory canal 21 make it difficult for prior art methods to produce a mold that conforms.
  • a nonconforming mold may create a hearing aid 16 that is uncomfortable or impossible to wear.
  • the hearing aid 16 that can be constructed with the negative hearing aid mold
  • FIG. 10 shows a diagram 20 diagrammatically illustrating the preferred methods of the present invention. As diagrammatically shown by box 29 and Figure 3, the impression 22 of the auditory canal 21 is taken. The impression 22 provides a model of the auditory canal 21 and is obtained with conventional means.
  • impression 22 of the auditory canal 21 is made available to a topology characterization device, such as a laser topology system 26.
  • a topology characterization device such as a laser topology system 26.
  • dimensions are taken from the outside surface 24 of the impression 22.
  • a laser topology system 26 is utilized to measure the outside dimensions of the impression 22 with a laser beam 33.
  • other technologies can be used to measure the outside dimensions of the impression such as white light and digital imagining.
  • the impression 22 is mounted in the laser topology system 26 in a way that permits reliable and consistent measurement.
  • the impression 22 is mounted on a three-pronged mount 44 in an orientation that facilitates an analysis methodology, conventionally known as a path plan.
  • the canal faces the laser and the tragus portion of the impression faces a consistent way from impression to impression.
  • Other laser topology systems require that the impression 22 be positioned perpendicular to the mount 44. Other scanners do not require such orientations.
  • the laser topology system 26 captures complex geometry through laser line scanning and translating of X, Y, Z data. Conformance utilizing prior methods is thus hit or miss.
  • the present invention therefore avoids the hit and miss techniques of the prior art by producing a high fidelity negative hearing aid mold 10.
  • the laser topology system 26 outputs the three-dimensional measurement of the outside dimensions of the impression 22 as point cloud/STL data 28.
  • the point cloud data may be converted to a file type used for stereo lithography data also known as STL data.
  • the laser topology system 26 analyzes the impression 22 to generate point cloud/STL data 28 from the auditory canal 21 using the laser beam 33 to measure surface positions on the outside surface 24 of the impression 22 to generate the auditory canal point cloud/STL data 28.
  • auditory canal dimension measurement data representing dimensions of the auditory canal 21 are processed by the laser topology system 26 to generate outside auditory canal dimension data, such as the point cloud/STL data 28, that represents outside dimensions of the auditory canal 21.
  • the outside dimension data represents the boundary of the auditory canal 21 such that, when the negative hearing aid mold 10 is used to create the hearing aid 16, the inside surface 15 of the negative hearing aid mold 10 conforms to the outside dimension of the auditory canal 21 as represented by the impression 22. Thus, the resultant hearing aid 16 will conform well to the auditory canal 21.
  • Figure 4 shows a schematic diagram of the laser topology system 26 measuring the impression 22 with the laser beam 33. To obtain the outside dimensions 28 of the impression 22, which represent the dimensions of the auditory canal 21, the laser topology system 26 scans the impression with the laser beam 33 and detects reflected laser signals and converts this data into measurements of the outside 24 of the impression 22. Laser based measurement of the impression 22 has the advantage of providing a rapid and accurate measurement of the impression 22.
  • the laser topology system 26 which can be utilized with the methods of the present invention is available from either Laser Design, Inc. or ThreeShape of Copenhagen, Denmark. Those skilled in the art will recognize that other methods, both automated and manual, of obtaining the dimensions of the auditory canal 21 may be used such as mechanical measurement or other laser based methods such as efforts of workers in the art to directly measure the auditory canal 21 without the need for the impression 22, without deviating from the spirit and scope of the invention. According to the preferred teachings of the present invention, the laser topology system 26 is computer processor based. Figure 5 shows the point cloud/STL data 28 representing the impression 22. The point cloud/STL data 28 is diagrammatically shown being provided to a computer processor 31 in Figure 2.
  • the point cloud/STL data 28 is the result of processing the laser measurements of the impression 22.
  • the point cloud/STL data 28 is provided in three-dimensional format representing the spatial measurements of the impression 22 by the laser topology system 26.
  • Arrow 25 indicates that the point cloud/STL data 28 is provided for further processing as diagrammatically shown by box 32.
  • the provision of the point cloud/STL data 28 could either be through a local connection or a remote connection such as the internet. Other communication methods may be used without deviating from the spirit and scope of the present invention.
  • the point cloud/STL data 28 is converted to stereo lithography data such as auditory canal shell data 38 by the computer processor 31.
  • the computer processor 31 receives the point cloud/STL data 28 from the laser topology system 26.
  • the computer processor 31 outputs the stereo lithography data such as auditory canal shell data 38.
  • the computer processor 31 processes the outside auditory canal dimension data, such as the point cloud/STL data 28, to generate outside mold data, such as the auditory canal shell data 38.
  • Figure 6 shows a graphical representation of the point cloud/STL data 28, representing the impression 22, after being processed into auditory canal shell data 38 for use in making a stereo lithography based negative hearing aid mold 10 and follow techniques used in the either the shell design software called Shell Designer from 3 Shape of Copenhagen, Denmark or the software called E-Shell from RainDrop Geomagic of North Carolina, USA.
  • the computer processor 31 utilizes detailing software from RainDrop Geomagic or 3 Shape and establishes well known customer features and parameters such as shell thickness, hole dimension, engraving, and surface editing.
  • Other data conversion techniques and customization methods that produce an auditory canal shell design from measurement of the impression 22 are within the spirit and scope of the present invention.
  • the provision of the auditory canal shell data 38 could either be through a local connection or a remote connection such as the Internet. Other communication methods may be used without deviating from the spirit and scope of the invention.
  • the negative hearing aid mold 10 is created from the auditory canal shell data 38.
  • Figure 7 shows a partially formed negative hearing aid mold 11 being created in a stereo lithography machine 36.
  • Other production technologies could be used such as fused deposition modeling and laser sintering.
  • the article In fused deposition modeling the article is created out of medical grade ABS acrylonitrile butadiene styrene. In laser sintering the article is made out of powdered nylon.
  • the partially formed negative hearing aid mold 11 is made using standard stereo lithography techniques. According to the preferred teachings of the present invention, the stereo lithography machine 36 is, and, utilizes an epoxy, from 3D Systems of Valencia, California known as part description: SLA Epoxy Resin Si-10. Other stereo lithographic construction materials can be used without deviating from the spirit and scope of the invention, such as any other rapid prototype material suitable for stereo lithography.
  • the resulting negative hearing aid mold 10 functions as a form for the construction of a hearing aid 16.
  • the stereo lithography machine 36 creates the negative hearing aid mold 10 from the outside mold data, such as the auditory canal shell data 38, using rapid prototyping such as stereo lithography, fused deposition modeling, Digital light processing, and laser sintering, with the negative hearing aid mold 10 having the inside surface 15 rapid prototyping is also known as concept modeling or rapid manufacturing systems.
  • the inside surface 15 represents the outside dimensions of the auditory canal 21 from the outside mold data, such as the auditory canal shell data 38.
  • the negative hearing aid mold 10 is suitable for receipt of a soft solid 12 from a soft solid applicator 19.
  • the 3D Systems makes use of Light Year software and Build Station software to create a multi part-multi slice database as is conventionally used in the stereo lithography art.
  • More than one negative hearing aid mold 10 may be created at a time. For example, up to 120 or more negative hearing aid molds 10 may be made in a run. As diagrammatically illustrated by box 35, the negative hearing aid mold 10 is further processed to create the hearing aid 16.
  • Figure 8 shows the negative hearing aid mold 10 being filled with the soft solid 12 and hearing aid electronics and transducers 14 to create the soft solid hearing aid 16.
  • the negative hearing aid mold 10 is designed to receive the soft solid 12 and hearing aid electronics and transducers 14.
  • the soft solid 12 is made from silicone, as the principal material used to ultimately form the body of the hearing aid 16. Silicones are materials that exhibit physiological inertness and thermal stability.
  • the hearing aid electronics and transducers 14 are those well known in the art but other electronic and transducer combinations may be used that are compatible with the applied soft solid 12.
  • the negative hearing aid mold 10 is filled with the soft solid 12 after being placed on faceplate 18, as diagrammatically illustrated by arrow 27, and after having the hearing aid electronics and transducers 14 installed, preferably by being attached to the faceplate 18 before the negative hearing aid mold 10 is placed on the faceplate 18.

Landscapes

  • Engineering & Computer Science (AREA)
  • Manufacturing & Machinery (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Neurosurgery (AREA)
  • Otolaryngology (AREA)
  • Physics & Mathematics (AREA)
  • Acoustics & Sound (AREA)
  • Signal Processing (AREA)
  • Length Measuring Devices By Optical Means (AREA)

Abstract

L'invention porte sur un moule femelle (10) pour prothèse auditive obtenu par un premier traitement de données de mesure des dimensions du canal auditif (21), ces données représentant les dimensions internes d'un canal auditif (21) pour générer des données relatives aux dimensions externes du canal auditif qui représentent les dimensions externes du canal auditif (21). On fait une empreinte (22) du canal auditif (21) d'un utilisateur. On traite les données relatives aux dimensions externes du canal auditif afin de générer les données du moule externe. On utilise un laser (26) pour relever les dimensions de l'empreinte (22). On crée un moule femelle (10) pour prothèse auditive à partir des données du moule externe à l'aide d'un prototypage rapide tel qu'une machine de lithographie stéréo (36). Le moule femelle (10) comporte une surface interne représentant les dimensions externes du canal auditif (21) à partir des données du moule externe. Le moule femelle (10) pour prothèse auditive est approprié pour accueillir un solide mou tel que le silicone. Le moule femelle (10) est utilisé pour fabriquer une prothèse auditive solide molle (16).
EP03752583A 2003-09-25 2003-09-25 Procedes de fabrication d'un moule femelle pour prothese auditive Withdrawn EP1668957A1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2003/030045 WO2005041617A1 (fr) 2003-09-25 2003-09-25 Procedes de fabrication d'un moule femelle pour prothese auditive

Publications (1)

Publication Number Publication Date
EP1668957A1 true EP1668957A1 (fr) 2006-06-14

Family

ID=34519478

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03752583A Withdrawn EP1668957A1 (fr) 2003-09-25 2003-09-25 Procedes de fabrication d'un moule femelle pour prothese auditive

Country Status (4)

Country Link
EP (1) EP1668957A1 (fr)
AU (1) AU2003270870A1 (fr)
CA (1) CA2539685A1 (fr)
WO (1) WO2005041617A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102006046269A1 (de) * 2006-09-28 2008-04-03 Egger Otoplastik + Labortechnik Gmbh Otoplastik mit Verbindungseinrichtung

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5487012A (en) 1990-12-21 1996-01-23 Topholm & Westermann Aps Method of preparing an otoplasty or adaptive earpiece individually matched to the shape of an auditory canal
US6584207B1 (en) * 1999-02-02 2003-06-24 Beltone Electronics Corporation Molded hearing aid housing
AU7265900A (en) 2000-09-25 2002-04-02 Phonak Ag Method for producing otoplastics
US7050876B1 (en) * 2000-10-06 2006-05-23 Phonak Ltd. Manufacturing methods and systems for rapid production of hearing-aid shells
EP1246506A1 (fr) 2001-03-26 2002-10-02 Widex A/S Système CAD-CAM pour préparer une prothèse auditive

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2005041617A1 *

Also Published As

Publication number Publication date
AU2003270870A1 (en) 2005-05-11
WO2005041617A1 (fr) 2005-05-06
CA2539685A1 (fr) 2005-05-06

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