SI3054908T1 - Nosilni sistem za predmet, ki se nosi na telesu, in proizvodni postopek - Google Patents

Nosilni sistem za predmet, ki se nosi na telesu, in proizvodni postopek Download PDF

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Publication number
SI3054908T1
SI3054908T1 SI201430746T SI201430746T SI3054908T1 SI 3054908 T1 SI3054908 T1 SI 3054908T1 SI 201430746 T SI201430746 T SI 201430746T SI 201430746 T SI201430746 T SI 201430746T SI 3054908 T1 SI3054908 T1 SI 3054908T1
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adhesive
carrier
layer
carrier layer
mounting plate
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SI201430746T
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English (en)
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Norman Goldberg
Michael Herbertz
Oliver Kube
Ralf Nittenwilm
Helmut Walter
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F. Hoffmann-La Roche Ag
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Publication of SI3054908T1 publication Critical patent/SI3054908T1/sl

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/6833—Adhesive patches
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive plasters or dressings
    • A61F13/0203—Adhesive plasters or dressings having a fluid handling member
    • A61F13/0206—Adhesive plasters or dressings having a fluid handling member the fluid handling member being absorbent fibrous layer, e.g. woven or nonwoven absorbent pad, island dressings
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive plasters or dressings
    • A61F13/0203—Adhesive plasters or dressings having a fluid handling member
    • A61F13/0213—Adhesive plasters or dressings having a fluid handling member the fluid handling member being a layer of hydrocoloid, gel forming material
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive plasters or dressings
    • A61F13/0203—Adhesive plasters or dressings having a fluid handling member
    • A61F13/0223—Adhesive plasters or dressings having a fluid handling member characterized by parametric properties of the fluid handling layer, e.g. absorbency, wicking capacity, liquid distribution
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive plasters or dressings
    • A61F13/0203—Adhesive plasters or dressings having a fluid handling member
    • A61F13/0226—Adhesive plasters or dressings having a fluid handling member characterised by the support layer
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive plasters or dressings
    • A61F13/0246—Adhesive plasters or dressings characterised by the skin adhering layer
    • A61F13/0256—Adhesive plasters or dressings characterised by the skin adhering layer characterized by the parametric properties of the adhesive
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive plasters or dressings
    • A61F13/0259—Adhesive plasters or dressings characterised by the release liner covering the skin adhering layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/046—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/06—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/48—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using adhesives, i.e. using supplementary joining material; solvent bonding
    • B29C65/4805—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using adhesives, i.e. using supplementary joining material; solvent bonding characterised by the type of adhesives
    • B29C65/481—Non-reactive adhesives, e.g. physically hardening adhesives
    • B29C65/4825—Pressure sensitive adhesives
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/48—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using adhesives, i.e. using supplementary joining material; solvent bonding
    • B29C65/4805—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using adhesives, i.e. using supplementary joining material; solvent bonding characterised by the type of adhesives
    • B29C65/483—Reactive adhesives, e.g. chemically curing adhesives
    • B29C65/4845—Radiation curing adhesives, e.g. UV light curing adhesives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0443—Modular apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/12—Manufacturing methods specially adapted for producing sensors for in-vivo measurements
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00365—Plasters use
    • A61F2013/00412—Plasters use for use with needles, tubes or catheters
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M2025/0266—Holding devices, e.g. on the body using pads, patches, tapes or the like
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor

Claims (15)

  1. NOSILNI SISTEM ZA PREDMET, KI SE NOSI NA TELESU, IN PROIZVODNI POSTOPEK Patentni zahtevki
    1. Nosilni sistem za predmet (12), ki se nosi na telesu, zlasti medicinski instrument z gibkim nosilnim obližem (18), ki ima ploščat nosilni sloj (30) in na svoji spodnji strani lepilni sloj (32) iz sprijemnega lepila (34), ki se sprime s pritiskom na kožo (14) enega dela (16) telesa, in z montažno ploščo (20), ki je nameščena na zgornji strani nosilnega sloja (30), ki je obrnjena proč od kože, pri čemer je zgornja stran nosilnega sloja (30) plosko povezana s k njej obrnjeno spodnjo vstavljalno ploskvijo montažne plošče (20), označen s tem, da je vstavljalno območje (36) montažne plošče (20) preko strukturne lepilne zveze (38) iz strukturnega lepila (40) čvrsto povezano z zgornjo stranjo nosilnega sloja (30) in da ima lepilni sloj (32) nanos sprijemnega lepila od 80 do 120 g/m2.
  2. 2. Nosilni sistem po zahtevku 1, označen s tem, da ima nosilni obliž (18) pred nalepljenjem odstranljivo folijo (22), ki na strani lepila prekriva lepilni sloj (32), in se prednostno odstrani s pomočjo štrlečega jezička (24).
  3. 3. Nosilni sistem po zahtevku 1 ali 2, označen s tem, da je nosilni sloj (30) iz folijskega materiala ali tekstilnega materiala ali pene ali kombinacije le-teh.
  4. 4. Nosilni sistem po enem od zahtevkov od 1 do 3, označen s tem, da je nosilni sloj (30) iz prednostno mikro naluknjane termoplastične folije.
  5. 5. Nosilni sistem po enem od zahtevkov od 1 do 4, označen s tem, da je ima nosilni sloj (30) največji prožnostni modul manjši od 10 N/mm2, prednostno manjši od 5 N/mm2.
  6. 6. Nosilni sistem po enem od zahtevkov od 1 do 5, označen s tem, da ima lepilni sloj (32) nanos sprijemnega lepila od 100 do 110 g/m2.
  7. 7. Nosilni sistem po enem od zahtevkov od 1 do 6, označen s tem, da je lepilni sloj (32) tvorjen iz sprijemnega lepila (34) na osnovi akrilata, silikona, kavčuka, termoplastičnega elastomera, hidrogela, poliuretana, polisiloksana, vinilacetata ali zmesi le-teh.
  8. 8. Nosilni sistem po enem od zahtevkov od 1 do 7, označen s tem, da imata nosilni sloj (30) in/ali lepilni sloj (32) nosilnega obliža (18) vrednost MVTR večjo od 400 g/m2 prepustnosti vodne pare v 24 h.
  9. 9. Nosilni sistem po enem od zahtevkov od 1 do 8, označen s tem, da strukturna lepilna zveza (38) obsega strukturno lepilo (40) na osnovi cianoakrilatnega, epoksidnega ali poliuretanskega lepila.
  10. 10. Nosilni sistem po enem od zahtevkov od 1 do 9, označen s tem, da imata sprijemano lepilo (34) in strukturno lepilo (40) biokompatibilno sestavo, ki je dovoljena za medicinsko uporabo.
  11. 11. Nosilni sistem po enem od zahtevkov od 1 do 10, označen s tem, da je montažna plošča (20) tvorjena s formatnim delom iz umetne snovi, prednostno iz polikarbonata.
  12. 12. Postopek za izdelavo nosilnega sistema za predmet (12), ki se nosi na telesu, po enem od predhodnih zahtevkov z naslednjimi koraki: - zagotavljanje nosilnega obliža (18) prednostno kot izsekanega dela, ki sestoji iz nosilnega sloja (30), lepilnega sloja (32) in po izbiri odstranljive folije (22), pri čemer ima lepilni sloj (32) nanos sprijemnega lepila od 80 do 120 g/m2, - nanos strukturnega lepila (40) kot lepilnega niza na vstavitveno območje (36) montažne plošče (20), - kontaktiranje vstavitvenega območja (36) z zgornjo stranjo nosilnega obliža (18), ki je obrnjena proč od kože, da se tvori strukturna lepilna zveza (38), pri čemer je zgornja stran nosilnega sloja (30) plosko povezana s k njej obrnjeno spodnjo vstavljalno ploskvijo montažne plošče (20).
  13. 13. Postopek po zahtevku 12, označen s tem, da se nosilni obliž (18) pri strditvi strukturnega lepila (40) pritisne proti montažni plošči (20).
  14. 14. Postopek po zahtevku 12 ali 13, označen s tem, da se strukturno lepilo (40) pospešeni strdi prednostno z obsevanjem.
  15. 15. Nosilni sistem (10) po enem od zahtevkov od 1 do 11 za uporabo za vsaj eno aplikacijo iz naslednje skupine - senzorsko nadziranje oz. zajemanje telesnega parametra, - dajanje učinkovin, zlasti insulina na ali skozi kožo (14), - zagotavljanje dostopa v telo ali izstopa iz telesa, - nošenje telesnega nakita.
SI201430746T 2013-10-10 2014-10-09 Nosilni sistem za predmet, ki se nosi na telesu, in proizvodni postopek SI3054908T1 (sl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP13188144 2013-10-10
PCT/EP2014/071671 WO2015052288A1 (de) 2013-10-10 2014-10-09 Trägersystem für ein körpergetragenes objekt und herstellungsverfahren
EP14781596.3A EP3054908B1 (de) 2013-10-10 2014-10-09 Trägersystem für ein körpergetragenes objekt und herstellungsverfahren

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SI3054908T1 true SI3054908T1 (sl) 2018-07-31

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US (1) US10542936B2 (sl)
EP (1) EP3054908B1 (sl)
CN (1) CN105592830B (sl)
CA (1) CA2926370C (sl)
DK (1) DK3054908T3 (sl)
ES (1) ES2675006T3 (sl)
PL (1) PL3054908T3 (sl)
RU (1) RU2668200C2 (sl)
SI (1) SI3054908T1 (sl)
WO (1) WO2015052288A1 (sl)

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CA2926370A1 (en) 2015-04-16
CN105592830A (zh) 2016-05-18
DK3054908T3 (en) 2018-06-14
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EP3054908A1 (de) 2016-08-17
ES2675006T3 (es) 2018-07-05
RU2668200C2 (ru) 2018-09-26
RU2016117906A3 (sl) 2018-05-07
CA2926370C (en) 2018-06-26
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WO2015052288A1 (de) 2015-04-16
CN105592830B (zh) 2020-04-10

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