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WO2016085464A1 - Ensemble de casque et procédé associé - Google Patents

Ensemble de casque et procédé associé Download PDF

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Publication number
WO2016085464A1
WO2016085464A1 PCT/US2014/067281 US2014067281W WO2016085464A1 WO 2016085464 A1 WO2016085464 A1 WO 2016085464A1 US 2014067281 W US2014067281 W US 2014067281W WO 2016085464 A1 WO2016085464 A1 WO 2016085464A1
Authority
WO
WIPO (PCT)
Prior art keywords
components
headgear device
junction
headgear
radio frequency
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/US2014/067281
Other languages
English (en)
Inventor
Amirtharajan KRISHNASAMY
Michael DIMEO
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.)
Accumed Innovative Technologies LLC
Original Assignee
Accumed Innovative Technologies LLC
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 Accumed Innovative Technologies LLC filed Critical Accumed Innovative Technologies LLC
Priority to PCT/US2014/067281 priority Critical patent/WO2016085464A1/fr
Publication of WO2016085464A1 publication Critical patent/WO2016085464A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/56—Devices for preventing snoring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0683—Holding devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production

Definitions

  • the present invention relates to medical headgear and, more particularly, to medical headgear fabrication methods.
  • the conventional/traditional laminated composite used for medical devices like headgear is typically a three layer or five layer material which consists of an open cell polyurethane foam, flame laminated with fabrics on either sides.
  • This laminated composite is converted as usable soft goods medical products such as headgears which holds respiratory masks for sleep apnea.
  • a hook-engageable fabric is laminated to a polyurethane foam on one side, and fabric on the other.
  • Silver-Tec® brand laminate is similar to a polyurethane laminate and contains silver to provide antimicrobial properties. Despite the perforations in these products, air permeation is limited.
  • an open, net-like fabric is provided, as in the Powerstretch-Rx® product available from Polartec and used on some Futuro® brand straps made by Biersdorf Inc. of Wilton, Conn., USA.
  • This fabric is a non-hook-engageable knit spacer fabric with top and bottom fabric layers and yarns knit between the layers to space them apart. It is said to have moisture-releasing properties.
  • Other brace straps like the Futuro® Infinity precision-fit braces, advertise enhanced breathability and anti-microbial support.
  • These laminates are foam laminates with a soft interior skin contact fabric laminated to a foam core, then laminated to an outer layer of hook-engageable loop material with holes on one side of the laminate that allow for some air and moisture transport.
  • headgear devices are traditionally made using a combination of manufacturing methods like die cutting, sewing, and welding. Indeed, the traditional process involves various stages of operation to produce one complete finished headgear. Accordingly, there is a continued need for quick, efficient, and inexpensive methods of manufacture for headgear and other medical devices.
  • the present disclosure is directed to methods for medical headgear fabrication.
  • a method for manufacturing a headgear device from at least two components comprising the steps of: aligning, at a first junction, at least two components of the headgear device; welding, using radio frequency welding, the at least two components of the headgear device together at the first junction; and repeating, if necessary, at a second junction.
  • the method includes the steps of providing a source material for the at least two components of the headgear device; and generating the at least two components of the headgear device from the source material.
  • the step of generating the at least two components of the headgear device from the source material comprises radio frequency welding.
  • the step of generating the at least two components of the headgear device from the source material comprises die cutting and/or computer numerical controlled (CNC) cutting.
  • CNC computer numerical controlled
  • components of the headgear device from the source material comprises compression molding.
  • a die is used to at least partially align the two components.
  • the method includes the steps of aligning, at a junction, at least two other components of the headgear device, and welding, using radio frequency welding, the at least two other components of the headgear device together at the third junction.
  • At least three of the at least two components are welded together at the first junction.
  • the source material is a soft, layered material, a foam layer, and/or an elastic.
  • each of the components of the headgear device comprises a unique component thickness
  • the junction of the at least two components of the headgear device comprises a first thickness, such that after welding the first thickness is approximately equal to or less than at least one of the unique component thicknesses.
  • this invention describes a headgear device comprising at least two individual components welded together at a first junction by radio frequency welding.
  • the at least two individual components of the headgear device are welded together at a second junction by radio frequency welding.
  • At least one of the at least two individual components comprise a soft, layered material, a foam layer, and/or an elastic.
  • a system for manufacturing a headgear device from at least two components comprising at least two components of the headgear device, a die configured to align at least two of the components of the headgear device at a first junction, and a radio frequency welder configured to weld the at least two of the components of the headgear device at the first junction.
  • a system for manufacturing a headgear device from at least two weldable components including the steps of: (i) aligning, using a die, all of the at least two weldable components of the headgear device; and (ii) simultaneously welding, using radio frequency welding, the at least two components of the headgear device together at a plurality of junctions.
  • the die can also seal together an edge of each of two or more of the at least two weldable components.
  • FIG. 1 is a graphical representation of headgear in accordance with an embodiment
  • FIG. 2 is a flow chart illustrating a method of radio frequency welding of medical device components in accordance with an embodiment.
  • FIG. 1 a medical headgear device 100.
  • headgear Although particular embodiments of headgear are described or otherwise envisioned herein, one of skill in the art will recognize that the inventive methods can be utilized for a wide variety of medical devices, including headgear and many other devices which require comfortable fit.
  • Medical headgear device 100 can comprise, for example, two or more parts that must be permanently combined in a manner that provides comfort to the user.
  • the medical headgear device in FIG. 1 is comprises of a forehead strap 110, a top portion 120 with a second strap 130, and a bottom portion 140 with a chin strap 150.
  • the forehead strap, top portion, and bottom portion must be permanently combined in a manner that provides comfort to the user.
  • Each of forehead strap 110, top portion 120, and bottom portion 140 can be composed of the same or different materials.
  • the components can be composed of soft, fabric that is comfortable to the skin.
  • the fabric may also exhibit stretch, elasticity, and/or wicking properties. Examples include, but are not limited to a nylon-LYCRA® blend, and microfiber knit fabric.
  • the primary benefit of the fabric is to provide minimal friction with the user's skin. It is preferable that the knit fabric is porous and allows airflow to reduce perspiration.
  • the skin-facing fabric may be treated with a chemical that promotes wicking, i.e., transportation of moisture, through to the next layer of the assembly.
  • One or more of forehead strap 110, top portion 120, and bottom portion 140 can be composed of foam or a foam layer to provide cushioning.
  • the foam or foam layer is preferably breathable, aiding in allowing moisture to move away from the skin toward the outside atmosphere by means of capillary attraction.
  • the foam may be fabricated of a cellular, stretch-elastomer foam, including but not limited to polyurethane foam.
  • the source material may also include one or more of an elastic, a film, non-woven fabric, a knitted fabric, a elastomer, a molded plastic, an extruded plastic, a woven fabric coated polymer or laminated with film, a synthetic or natural rubber, a spacer fabric, a molded hook, and a woven hook.
  • One or more of forehead strap 110, top portion 120, and bottom portion 140 can be composed of a rigid layer or rigid material to provide integrity to the structure without the need for an external support or structure (such as rigidizers or yokes that are typically applied to similar structures on the external surface).
  • the material may be any plastic, composite, metal, or ceramic material having enough strength to provide integrity to the structure, but also allows for some flexibility.
  • materials include, but are not limited to, thermoplastic and fiber reinforced thermoplastic materials.
  • thermoplastic materials include, but are not limited to, polyamides.
  • polyamides include, but are not limited to, nylon.
  • a flow chart illustrating a method 200 for fabricating a medical device in accordance with an embodiment of the invention is disclosed.
  • a laminated source material is provided for the headgear device.
  • the source material may be any material described or otherwise envisioned herein.
  • the components are cut out of the source material using any of a variety of methods.
  • the components are provided individually.
  • the unassembled components can be purchased from one or more suppliers.
  • the source materials are generated using radio frequency welding, die cutting, computer numerical controlled (CNC) cutting, laser cutting, ultrasonic cutting, and/or compression molding.
  • step 230 of the method two or more of the individual components of the device to be assembled are aligned for assembly.
  • forehead strap 110 and top portion 120 can be aligned at junction 160a for welding.
  • dies are used to direct the welding process, and forehead strap 110 and top portion 120 are properly aligned on a portion of a press in the die.
  • the die may also weld together the aligned edges of two or more of the components of the device, thereby further facilitating the welding process.
  • radio frequency welding is used to weld two components of the device, such as forehead strap 110 and top portion 120 (at junction 160a), together.
  • Radio frequency welding uses electromagnetic energy to permanently bond the components together, which may or may not be composed of the same material.
  • high frequency waves cause the molecules in the component materials to vibrate and gain energy, and the combination of heat and pressure causes the junction to weld in the shape of the die.
  • the radio frequency welding combines the two components of the device, such as forehead strap 110 and top portion 120, at a junction while simultaneously providing a superior level of comfort to the user.
  • step 250 of the method radio frequency welding is used to weld two other components of the device together.
  • the welding method can be used to weld forehead strap 110 and top portion 120 at junction 160b.
  • Step 250 can be repeated as necessary until all junctions of the device are welded or all junctions 160a, 160b, 170a and 170b, and 180a and 180b can be welded in one step after aligning the headgear components 110, 120, 130, 140 and 150 in position. Referring to the embodiment depicted in FIG. 1, junctions 160a, 160b, 170a and 170b, and 180a and 180b can all be welded.
  • the material of two components is compressed at a junction resulting in a thickness of the welded area that is less than the sum of thickness of the first component and second component.
  • multiple components can be assembled at one junction without increasing the total thickness of the overlapped area.
  • the geometry of the welded junction can be changed using radio frequency welding, and the junction can have customizable finished thicknesses.
  • either a stiff or a soft junction can be obtained, and because of the nature of the junction, it can be utilized as a hinge or a pivot without significantly weakening the weld.
  • the pattern on the junction can be customized to any required pattern. The welding seals the edge of the material to produce sealed edge components, while allowing the sealing of the desired area while leaving other areas open.
  • the materials can be softened, melted, and fused together, which can result in material failure under high shear forces.
  • Radio frequency welding is compatible with wide range of materials.
  • a fabric/foam/fabric laminated composite like breathe-O-Prene can be utilized for manufacturing headgear.
  • One or more of the components of the headgear can be made from materials including thermoplastic elastomers, molded thermoplastics, extruded thermoplastics, knitted fabrics, woven fabrics, spacer fabric, films, woven fabric coated polymer or laminated with film, non-woven fabrics, and compression molded (thermoformed or cold formed) material, among other materials.
  • One or more of these materials can be combined with each other to form a finished product. Two or more layers of any these materials, including with varying thickness, are compatible with radio frequency welding.
  • radio frequency welding can provide a number of other advantages to the finished product.
  • the wide range of material compatibility and flexibility of using radio frequency welding with preprocessed components enables the radio frequency welding to produce not only headgear, but a hybrid combination of the headgear, frame, and/or mask.
  • the radio frequency welding can be used to create a combination of devices.
  • molded plastic or elastomeric parts can be used as a rigidiser to increase the rigidity or support at desired location to achieve required form fit or functions.

Landscapes

  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Vascular Medicine (AREA)
  • Nursing (AREA)
  • Otolaryngology (AREA)
  • Emergency Medicine (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Lining Or Joining Of Plastics Or The Like (AREA)

Abstract

La présente invention concerne un procédé de fabrication d'un dispositif de casque pouvant être porté, confortable, à partir de composants individuels. Au moins deux des composants sont alignés au niveau d'une première jonction, et sont soudés ensemble au niveau de la première jonction à l'aide d'un soudage par radiofréquences. Des composants supplémentaires sont soudés au dispositif de casque partiellement assemblé, pour constituer un dispositif de casque final confortable. Le soudage par radiofréquences permet d'obtenir des jonctions qui ne frottent pas et ne deviennent pas inconfortables malgré une utilisation prolongée.
PCT/US2014/067281 2014-11-25 2014-11-25 Ensemble de casque et procédé associé Ceased WO2016085464A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2014/067281 WO2016085464A1 (fr) 2014-11-25 2014-11-25 Ensemble de casque et procédé associé

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2014/067281 WO2016085464A1 (fr) 2014-11-25 2014-11-25 Ensemble de casque et procédé associé

Publications (1)

Publication Number Publication Date
WO2016085464A1 true WO2016085464A1 (fr) 2016-06-02

Family

ID=52134390

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2014/067281 Ceased WO2016085464A1 (fr) 2014-11-25 2014-11-25 Ensemble de casque et procédé associé

Country Status (1)

Country Link
WO (1) WO2016085464A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018002169A1 (fr) * 2016-06-29 2018-01-04 Koninklijke Philips N.V. Procédé de génération d'une configuration pour un casque personnalisé

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005099801A1 (fr) * 2004-04-15 2005-10-27 Resmed Limited Conduit de machine a pression d'air positive
WO2008030831A2 (fr) * 2006-09-07 2008-03-13 Ric Investments, Llc Dispositif de harnais
US20110197341A1 (en) * 2008-12-10 2011-08-18 Resmed Limited Headgear for masks
US20120152255A1 (en) * 2009-05-29 2012-06-21 Resmed Limited Pap system
WO2014077708A1 (fr) * 2012-11-16 2014-05-22 Fisher & Paykel Healthcare Limited Joint d'étanchéité nasal pour interface respiratoire

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005099801A1 (fr) * 2004-04-15 2005-10-27 Resmed Limited Conduit de machine a pression d'air positive
WO2008030831A2 (fr) * 2006-09-07 2008-03-13 Ric Investments, Llc Dispositif de harnais
US20110197341A1 (en) * 2008-12-10 2011-08-18 Resmed Limited Headgear for masks
US20120152255A1 (en) * 2009-05-29 2012-06-21 Resmed Limited Pap system
WO2014077708A1 (fr) * 2012-11-16 2014-05-22 Fisher & Paykel Healthcare Limited Joint d'étanchéité nasal pour interface respiratoire

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018002169A1 (fr) * 2016-06-29 2018-01-04 Koninklijke Philips N.V. Procédé de génération d'une configuration pour un casque personnalisé
CN109414559A (zh) * 2016-06-29 2019-03-01 皇家飞利浦有限公司 生成针对定制的头戴式设备的构造的方法
US11544417B2 (en) 2016-06-29 2023-01-03 Koninklijke Philips N.V. Method of generating a configuration for a customized headgear

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