DK2765944T3 - Lille fleksibelt kateter med flydende kerne til laserablation i kropslumener - Google Patents

Lille fleksibelt kateter med flydende kerne til laserablation i kropslumener Download PDF

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Publication number
DK2765944T3
DK2765944T3 DK12840010.8T DK12840010T DK2765944T3 DK 2765944 T3 DK2765944 T3 DK 2765944T3 DK 12840010 T DK12840010 T DK 12840010T DK 2765944 T3 DK2765944 T3 DK 2765944T3
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Prior art keywords
catheter
layer
ablation catheter
laser
item
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DK12840010.8T
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English (en)
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James B Laudenslager
Dean S Irwin
Cesar M Diaz
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Ra Medical Systems Inc
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    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials
    • A61L29/041—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/24—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/24—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter
    • A61B18/245—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter for removing obstructions in blood vessels or calculi
    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08—Materials for coatings
    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08—Materials for coatings
    • A61L29/085—Macromolecular materials
    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B2018/2015—Miscellaneous features
    • A61B2018/2025—Miscellaneous features with a pilot laser
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B2018/206—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the laser light passing along a liquid-filled conduit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image
    • 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
    • A61M25/0009—Making of catheters or other medical or surgical tubes

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Physics & Mathematics (AREA)
  • Surgery (AREA)
  • Otolaryngology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Electromagnetism (AREA)
  • Optics & Photonics (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Vascular Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Laser Surgery Devices (AREA)
  • Medicinal Chemistry (AREA)
  • Polymers & Plastics (AREA)
  • Organic Chemistry (AREA)
  • Optical Fibers, Optical Fiber Cores, And Optical Fiber Bundles (AREA)

Claims (14)

1. Laserkatetersystem (8) til ablation af blokeringer i kropslumener, som bruger kortvarende laserpulseringer med høj energi og stor kraft, omfattende: en kortvarende ultraviolet pulserende laserkilde med høj energi og stor kraft (10); og et knækkeresistent, vridbart lavprofil-ablationskateter (22) med en flydende kerne, som kan forbindes virkningsmæssigt med laserkilden, omfattende: et elongeret flerlaget kateterrør (38), som indbefatter en tynd indre lumenfilm af UV-transparent, amorf fluorpolymer med et lavt IR-brydningsindeks og med et brydningsindeks på mindre end eller lig med ca. 1,33, hvilken er belagt på en indre overflade af et rørformet basislag; et optisk indgangsvindue (82) eller vinduesaggregat beregnet til ultraviolet lys forseglet til en distal ende af kateterrøret, hvor det optiske udgangsvindue er fastgjort til kateterrørets distale ende med et tilspidset metalhus (96) anbragt ved en distal ende af kateterrøret; et optisk indgangsvindue (80) beregnet til ultraviolet lys, forseglet til en proksimal ende af kateterrøret for at skabe et væsketæt kernevæskevolumen; og en biokompatibel UV-transparent væske (40), som er anbragt inden i og fuldstændigt udfylder kernevæskevolumet dannet mellem en indre overflade af det tynde indre luminale lag, det optiske udgangsvindue og det optiske indgangsvindue.
2. System ifølge krav 1, hvor et forhold mellem arealet af det optiske udgangsvindue og arealet af en ydre diameter af en distal ende af kateterrøret er større end omkring 40%.
3. System ifølge krav 1, hvor kernevæsken omfatter en væske valgt fra gruppen bestående af vand, fysiologisk saltvand og Ringers væske.
4. System ifølge krav 1, hvor laserkilden omfatter en kortpulserende XeCI-excimer laser med en udgangslaserenergi med en bølgelængde på ca. 308 nm, især hvor pulsbredden af laserkilden er mindre end ca. 50 nanosekunder.
5. System ifølge krav 1, hvor det tynde indre luminale lag består af en enkelt eller flere belægninger af en amorf fluorpolymer valgt fra gruppen bestående af PFPE-olie, Teflon AF 2400®, AF 1601®, Cytop® og Hyflon AD® opløst i et opløsningsmiddel såsom en Fluorinert.
6. System ifølge krav 1, hvor ablationskatetret med den flydende kerne er konfigureret til at levere fuld ablationsenergi til typiske blokeringer i arterier indbefattende forkalket plaque med energitætheder, der i det væsentlige er lig med eller større end omkring 14 mJ/mm2 og en gentagelseshastighed på op til omkring 100 Hz.
7. System ifølge krav, hvor det tilspidsede metalhus omfatter en røntgenfast markør konfigureret til at blive visualiseret under fluoroskopisk billeddannelse.
8. System ifølge krav 1, hvor ablationskatetret med den flydende kerne omfatter en ydre diameter, der er tilstrækkelig til at passere gennem humane arterier, og som ligger i intervallet fra omkring 1 mm til omkring 2,5 mm.
9. System ifølge krav 1, hvor det flerlagede kateterrør omfatter en total vægtykkelse på mindre end eller lig med omkring 0,254 mm (0,010 tommer), fortrinsvist hvor det flerlagede kateterrør omfatter en samlet vægtykkelse på mindre end eller lig med omkring 0,2032 mm (0,008 tommer).
10. System ifølge krav 1, der yderligere omfatter en rød diodelaserstråle, som er optisk koblet til ablationskatetret med den flydende kerne og konfigureret til at under en operation at blive udsendt fra en distal ende deraf ved anvendelse af systemet.
11. Laserkatetersystem ifølge krav 1, hvor det flerlagede kateterrør yderligere omfatter: et rørformet basislag der inkluderer fluoreret eller overvejende fluoreret materiale, et flettet lag anbragt udover en udvendig overflade af det rørformede basislag, et overjakkelag belagt på det flettede lag og det rørformede basislag for at indkapsle det flettede lag, og hvor den biokompatible U.V. transparente væske er anbragt inden i og fuldstændigt udfylder kernevæskevolumenet som findes mellem en indre overflade af det tynde indre luminale lag, en proksimal overflade af det optiske udgangsvindue og en distal overflade af det optiske indgangsvindue.
12. System ifølge krav 11, hvor ablationskatetret omfatter et excentrisk ledetrådslumen anbragt langs en ydre overflade af kateteret, som har en distal åbning anbragt mindst omkring 5 mm proksimalt fra en distal ende af ablationskatetret, og som har en langsgående længde på mindst omkring 10 cm.
13. Laserkatetersystem ifølge krav 1, omfattende et pakningsaggregat til et ablationskateter med flydende kerne, omfattende: en tyndvægget hermetisk lukket indkapsling indbefattende et indre volumen og omfattende et materiale egnet til gammasterilisering; det nævnte ablationskateter med flydende kerne anbragt inden i det indvendige volumen af den hermetisk lukkede indkapsling; og en væske anbragt inden i det indre volumen, der er konfigureret til at opretholde et damptryk i det indre volumen, der er tilstrækkeligt til at forhindre tab af væske fra en flydende kerne fra et ablationskateter med flydende kerne som følge af diffusion af væskekernen ind i det indre volumen.
14. Laserkatetersystem ifølge krav 13, hvor den tyndvæggede hermetisk forseglede indkapsling omfatter et tyndt metalliseret plastmateriale, og/eller hvor den tyndvæggede hermetisk lukkede indkapsling omfatter PTCFE.
DK12840010.8T 2011-10-14 2012-10-12 Lille fleksibelt kateter med flydende kerne til laserablation i kropslumener DK2765944T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161547435P 2011-10-14 2011-10-14
PCT/US2012/060065 WO2013056125A2 (en) 2011-10-14 2012-10-12 Small flexible liquid core catheter for laser ablation in body lumens and methods for use

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DK2765944T3 true DK2765944T3 (da) 2018-12-03

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US (5) US9700655B2 (da)
EP (1) EP2765944B1 (da)
CN (1) CN103997981B (da)
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WO (1) WO2013056125A2 (da)

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