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WO2022087060A1 - Systèmes de cathéter d'aspiration améliorés et leurs procédés de fabrication - Google Patents

Systèmes de cathéter d'aspiration améliorés et leurs procédés de fabrication Download PDF

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Publication number
WO2022087060A1
WO2022087060A1 PCT/US2021/055738 US2021055738W WO2022087060A1 WO 2022087060 A1 WO2022087060 A1 WO 2022087060A1 US 2021055738 W US2021055738 W US 2021055738W WO 2022087060 A1 WO2022087060 A1 WO 2022087060A1
Authority
WO
WIPO (PCT)
Prior art keywords
products
ptfe
improved
coil
braid
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/US2021/055738
Other languages
English (en)
Inventor
Russel CORVESE
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.)
Infinity Neuro LLC
Original Assignee
Infinity Neuro 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 Infinity Neuro LLC filed Critical Infinity Neuro LLC
Publication of WO2022087060A1 publication Critical patent/WO2022087060A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • 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
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/84—Drainage tubes; Aspiration tips
    • 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
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0693—Brain, cerebrum
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids

Definitions

  • the present disclosures relate to catheters, particularly those used for aspiration and effective for the delivery and staging of life-essential neurovascular therapies.
  • Catheter systems and micro-catheters are known and subject to constant evolution to deliver therapies and remove undesired obstruction and thrombi.
  • improved catheter systems leverage PTFE tubes and liners with gaps and spaces for flexure to enable navigation through tortuous and highly constrained neurovascular spaces without tissue insult and injury, unlike prior art attempts.
  • methods for manufacture include wrapping and counter wrapping of films, including PTFE.
  • the teachings of the instant disclosure provide improved catheter systems, comprising, in combination, at least a PTFE tube constructed of films of PTFE wrapped and counter-wrapped without extrusion, a coil wound over the at least a PTFE tube, a braid on top of the coil, marker bands located at a distal end, and ChronopreneTM jacket covering the assembly.
  • Processes for making catheters for aspiration and small tortuous vessels comprise, in combination, providing a liner of WPTFE, coil winding over the WPTFE liner, laying down a braid on top of the coil, including a marker band on a distal tip, and, application of a cover jacket.
  • Fig la shows an exemplary coil subassembly being a wrapped PTFE liner with incorporated NITINOL wire
  • Fig. lb showing a cross-sectional view
  • Fig. 1c showing detail of the subject coil assembly, according to the instant teachings.
  • Fig 2 shows an exemplary braid subassembly, being a wire braid pattern and construction, according to the instant teachings.
  • Fig 3 illustrates, for example, an exemplary catheter subassembly being a coating according to the instant teachings, with detail shown on and an end and cross sectional view.
  • Fig 4 shows a cartooned schematic of an exemplary catheter packaged assembly
  • Fig 5 shows the balance of the elements of a kit, according to the instant teachings
  • Fig 6 is a table showing wrapped v. extruded PTFE in terms of bend stiffness.
  • Fig 7 shows the unexpectedly flexible resulting catheter as part of a system with the instant disclosure.
  • the present inventor has discovered that unexpected properties emerge when PTFE is wrapped, as opposed to extruded, for use within catheters. As further described herein, more robust properties can be achieved without the sacrifice of flexibility, and the ability to be navigated into the neurovasculature is decidedly enhanced this way.
  • FIG. 1 shows an illustrative but not limiting embodiment of a coil subassembly being a wrapped PTFE liner , which then has a coil wind over, and (see Fig. 2) braid placed on top of coil, then (Fig. 3) marker band 3 attached distally while a ChronopreneTM type of over-jacket is attached.
  • Fig 4 shows an exemplary, but not limiting, embodiment of the catheter packaged assembly having of each said previously recited features incorporated therein. Namely, each piece of catheter sub assembly shown in Fig. 1, Fig. 2, and Fig 3 has been disposed within the shown catheter packaged assembly. Artisans understand this further comprises; a 6Fr hub combined with 6Fr strain relief, between at least about 122 cm and 144 cm as working length.
  • Figures 4 and 5 illustrate exemplary, but not limiting embodiments described above and claimed below, of subject catheter packaged assembly kit; this version is shown with 6 Fr hub and strain relief proximal end while distal end terminates marker band appliance, as expanded detail is shown for example below proximal end of the figure.
  • Distal end has the same at least about.0710 Min. ID (inner diameter) and approximately .0865 OD (outer diameter)
  • kits to include (even though not shown) packaging with product cards, catheter pouches, catheter vials, and IFU (Instructions for Use, etc.) along with pre-packaged introducers and indicators.
  • Figure 5 shows a detailed view of exemplary, but not limiting, dimensions of catheter hand to tip (distal end) and catheter hand to end of WPTFE ranging, again merely for example, from 0.0710 mm to 0.0865 mm maximum outer diameter (OD).
  • OD maximum outer diameter
  • a three-point bend stiffness (gF) test shows that instead of extruding PTFE (as is generally known and done in the prior art) unexpectedly better results came from film wrapping and counter wrapping. This in entirely unexpected based upon data that has been reviewed from known catheter systems
  • a liner of cross-linked polyolefin provides ostensive benefits and improvements over the prior art (namely, for example, Sophia® and Hospital PLUSTM brands of catheters from TERUMO/Microvention and/or Titan® brands of catheters).
  • the present invention uses WPTFE shrink tubes and creates a temperature stable (matt- free) ultra-thin aspiration catheter.
  • a computer system or machines of the invention include one or more processors (e.g., a central processing unit (CPU) a graphics processing unit (GPU) or both), a main memory and a static memory, which communicate with each other via a bus.
  • a processor may be provided by one or more processors including, for example, one or more of a single core or multi-core processor (e.g., AMD Phenom II X2, Intel Core Duo, AMD Phenom II X4, Intel Core i5, Intel Core I & Extreme Edition 980X, or Intel Xeon E7-2820).
  • a single core or multi-core processor e.g., AMD Phenom II X2, Intel Core Duo, AMD Phenom II X4, Intel Core i5, Intel Core I & Extreme Edition 980X, or Intel Xeon E7-2820.
  • An VO mechanism may include a video display unit (e.g., a liquid crystal display (LCD) or a cathode ray tube (CRT)), an alphanumeric input device (e.g., a keyboard), a cursor control device (e.g., a mouse), a disk drive unit, a signal generation device (e.g., a speaker), an accelerometer, a microphone, a cellular radio frequency antenna, and a network interface device (e.g., a network interface card (NIC), Wi-Fi card, cellular modem, data jack, Ethernet port, modem jack, HDMI port, mini-HDMI port, USB port), touchscreen (e.g., CRT, LCD, LED, AMOLED, Super AMOLED), pointing device, trackpad, light (e.g., LED), light/image projection device, or a combination thereof.
  • a video display unit e.g., a liquid crystal display (LCD) or a cathode ray tube (CRT)
  • Memory refers to a non-transitory memory which is provided by one or more tangible devices which preferably include one or more machine-readable medium on which is stored one or more sets of instructions (e.g., software) embodying any one or more of the methodologies or functions described herein.
  • the software may also reside, completely or at least partially, within the main memory, processor, or both during execution thereof by a computer within system, the main memory and the processor also constituting machine-readable media.
  • the software may further be transmitted or received over a network via the network interface device.
  • machine-readable medium can in an exemplary embodiment be a single medium
  • the term “machine-readable medium” should be taken to include a single medium or multiple media (e.g., a centralized or distributed database, and/or associated caches and servers) that store the one or more sets of instructions.
  • the term “machine-readable medium” shall also be taken to include any medium that is capable of storing, encoding or carrying a set of instructions for execution by the machine and that cause the machine to perform any one or more of the methodologies of the present invention.
  • Memory may be, for example, one or more of a hard disk drive, solid state drive (SSD), an optical disc, flash memory, zip disk, tape drive, “cloud” storage location, or a combination thereof.
  • a device of the invention includes a tangible, non-transitory computer readable medium for memory.
  • Exemplary devices for use as memory include semiconductor memory devices, (e.g., EPROM, EEPROM, solid state drive (SSD), and flash memory devices e.g., SD, micro SD, SDXC, SDIO, SDHC cards); magnetic disks, (e.g., internal hard disks or removable disks); and optical disks (e.g., CD and DVD disks).

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne des systèmes de cathéters améliorés comprenant du PTFE ou du WPTFE enveloppé (non fritté) qui présentent une flexibilité inattendue avec des espaces et des rainures, et comprennent des revêtements spécialisés permettent une navigation améliorée dans le système neurovasculaire à travers des espaces neurovasculaires sinueux et extrêmement restreints, sans insulte ni lésion tissulaire, contrairement aux tentatives de l'état de la technique.
PCT/US2021/055738 2020-10-23 2021-10-20 Systèmes de cathéter d'aspiration améliorés et leurs procédés de fabrication Ceased WO2022087060A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202063104576P 2020-10-23 2020-10-23
US63/104,576 2020-10-23
US202063116249P 2020-11-20 2020-11-20
US63/116,249 2020-11-20

Publications (1)

Publication Number Publication Date
WO2022087060A1 true WO2022087060A1 (fr) 2022-04-28

Family

ID=81289404

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2021/055738 Ceased WO2022087060A1 (fr) 2020-10-23 2021-10-20 Systèmes de cathéter d'aspiration améliorés et leurs procédés de fabrication

Country Status (1)

Country Link
WO (1) WO2022087060A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1991013648A1 (fr) * 1990-03-15 1991-09-19 W.L. Gore & Associates, Inc. Revetement interieur de catheter et son procede de fabrication
US20080021533A1 (en) * 1993-08-18 2008-01-24 Goffena Donald G M Thin-Wall Polytetrafluoroethylene Tube
US20090198219A1 (en) * 2003-01-17 2009-08-06 Campbell Carey V Catheter Assembly
US8911400B2 (en) * 2007-02-09 2014-12-16 Steve Ferry System for intraluminal travel within living vasculature
US20190366036A1 (en) * 2018-06-01 2019-12-05 Covidien Lp Flexible tip catheter

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1991013648A1 (fr) * 1990-03-15 1991-09-19 W.L. Gore & Associates, Inc. Revetement interieur de catheter et son procede de fabrication
US20080021533A1 (en) * 1993-08-18 2008-01-24 Goffena Donald G M Thin-Wall Polytetrafluoroethylene Tube
US20090198219A1 (en) * 2003-01-17 2009-08-06 Campbell Carey V Catheter Assembly
US8911400B2 (en) * 2007-02-09 2014-12-16 Steve Ferry System for intraluminal travel within living vasculature
US20190366036A1 (en) * 2018-06-01 2019-12-05 Covidien Lp Flexible tip catheter

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
ANONYMOUS: "Chronoprene® Thermoplastic Elastomer Medical Tubing", DUKE EXTRUSION, 8 August 2020 (2020-08-08), XP055923849, Retrieved from the Internet <URL:www.dukeextrusion.com/materials/chronoprene-medical-extrusion> *

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