WO2018089643A1 - Valve de raccord sans aiguille - Google Patents

Valve de raccord sans aiguille Download PDF

Info

Publication number
WO2018089643A1
WO2018089643A1 PCT/US2017/060874 US2017060874W WO2018089643A1 WO 2018089643 A1 WO2018089643 A1 WO 2018089643A1 US 2017060874 W US2017060874 W US 2017060874W WO 2018089643 A1 WO2018089643 A1 WO 2018089643A1
Authority
WO
WIPO (PCT)
Prior art keywords
valve
septum
connector
inlet
core
Prior art date
Application number
PCT/US2017/060874
Other languages
English (en)
Inventor
Justin A. LANCE
Stephen BOWER
John E. Ashley
Original Assignee
Puracath Medical, 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 Puracath Medical, Inc. filed Critical Puracath Medical, Inc.
Publication of WO2018089643A1 publication Critical patent/WO2018089643A1/fr

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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1072—Tube connectors; Tube couplings with a septum present in the connector
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection thereof
    • A61M2039/263—Valves closing automatically on disconnecting the line and opening on reconnection thereof where the fluid space within the valve is decreasing upon disconnection
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection thereof
    • A61M2039/267—Valves closing automatically on disconnecting the line and opening on reconnection thereof having a sealing sleeve around a tubular or solid stem portion of the connector
    • A61M2039/268—Valves closing automatically on disconnecting the line and opening on reconnection thereof having a sealing sleeve around a tubular or solid stem portion of the connector wherein the stem portion is moved for opening and closing the valve, e.g. by translation, rotation

Definitions

  • This application relates to needleless connector valves.
  • Figure l a is a top perspective view of the current invention.
  • Figure l b is a bottom perspective view of the device in Figure l a.
  • Figure 2a is a side view of another embodiment of the current invention in a closed
  • Figure 2b is a cross section view of the device in Figure 2a taken through line A-A
  • Figure 3a is a side view of the embodiment of Figure 2a but in an open configuration.
  • Figure 3b is a cross section view of the device in Figure 2a taken through line B-B
  • Figure 4a is a top view of the device of the current invention in a closed configuration.
  • Figure 4b is a side view of the embodiment of Figure 4a.
  • Figure 4c is a cross section view of the device in Figure 4b taken through line C-C.
  • Figures l a and lb show needleless connector 10 which is comprised of an inlet port 12 on the top side 1 1 , an outlet port 14 on the bottom side 13, and a body 16 between the top side 1 1 and the bottom side 13.
  • the inlet port 12 is formed by a standard female threaded luer connector 20 that is configured to connect to a male threaded luer connector such as is found on a syringe or an infusion tubing set (not shown).
  • the outlet port 14 is formed by a standard male threaded luer connector 22 that is configured to connect to a female luer connector such as is found on the typical vascular catheter hub (not shown).
  • the needleless connector 10 is therefore configured to be connected to the hub of a vascular catheter to provide quick and easy access without the need for a needle for blunt infusion devices such as a syringe or infusion tubing set.
  • the standard female threaded luer connector 20 comprises one or more male threads 26 that can be continuous or partial (as is shown).
  • the standard male threaded luer connector 22 comprises female threads 24.
  • the needleless connector 10 can also comprise a base section 30 with base ribs 32 near the bottom side 13 to facilitate connecting and disconnecting the needleless connector 10 to the hub of a vascular catheter.
  • the needleless connector also comprises a neck section 28 near the top side 1 1 that is generally of a smaller diameter than the diameter of the body 16.
  • the needleless connector's body 16, base 30, and neck 28 are made from an ultraviolet light transmissive moldable polymer material (e.g., a cyclic olefin copolymer such as Topas® Advance Polymers, GmbH, Frankfurt Germany, or polymethylpentene such as TPX ⁇ Mitsui Chemicals America, Rye Brook, NY) that allows ultraviolet light with a wavelength from about 250nm-300nm in length to penetrate through the material. Light of this wavelength is disruptive to microbial cell walls and DNA and has been shown to effectively kill bacteria, fungus, and viruses.
  • Current needleless connectors are made from standard moldable polymers which due to their crystalline structure do not allow the short 250nm-300nm wavelength light to propagate through.
  • FIG. 1 Figures 2a and 2b are now described to explain the function of the needleless connector 10.
  • the inlet port 12 is sealed with a septum 18 which blocks the ingress of fluids or any contaminates into the needleless connector 10 when the top side 1 1 of the device is in the closed disconnected state.
  • the septum 18 is made of a compliant material such as silicone, rubber, or an aliphatic polyether-based thermoplastic polyurethanes such as Tecoflex® (Lubrizol Advanced Materials, Inc. Cleveland, OH).
  • Tecoflex® Librizol Advanced Materials, Inc. Cleveland, OH
  • the septum 18 can be supported by a core 19 of a stiffer polymer material or a metal so that the overall shape of the septum in the neck 28 is maintained.
  • the core 19 can be attached to the septum 18 by adhesives, thermal welding, or alternately by over-molding the septum onto the core.
  • the core can have raised ribs 34 on the top surface that create fluid pathways as will be described herein.
  • the septum 18 can continue past the neck 10 and past the core 19 into the body 16 section of the needleless connector 10 where it is attached to a chamber body 38 that is positioned inside the body 16.
  • the septum 18 can be attached to the chamber body 38 by adhesive, thermal welding, or alternately by over-molding the septum 18 to the chamber body 38.
  • the septum 18 can be over-molded to the core 19 and the chamber body 38 in sequential molding operations where the septum 18 is partially formed in the first operation and completely formed in the second.
  • the septum 18 can be over-molded onto the core 19 and the chamber body 38 in one operation where it is completely formed.
  • the chamber body 38 is attached to a chamber base 40 by use of adhesives, solvents, thermal welding, ultrasonic welding, or molding.
  • the septum 18, core 19, chamber body 38 and chamber base 40 together form an inner chamber 36 that is sealed from the rest of the needleless connector 10.
  • the inner chamber 36 can contain a spring 44 and a piston 42 which are configured to press against the chamber base 40 and the core 19 to maintain the septum 18 in place in the neck 28 of the needleless connector 10 in the closed disconnected state shown in Figures 2a and 2b.
  • Figures 3a and 3b show the needless connector 10 in an open connected state where fluid can flow through the inlet port 12 into the body 16 and around the inner chamber 36 to the outlet port 14.
  • a male thread luer syringe tip or a male threaded luer infusion line connector is threaded over the female threaded luer connector 20 on neck 28 of the needleless connector 10.
  • the syringe tip (not shown) or infusion line tip enters into the inlet port 12 and pushes the septum 18 and core 19 down through the neck 28 to the position shown in Fig 3b.
  • the raised ribs 34 on the top of the core 19 provide a stop on the face of the syringe or infusion line tip around which the fluid can flow from the syringe or infusion line tip around the core 19 and septum 18 and into the fluid channels 48.
  • the spring 44 pushes on the piston 42 which forces the core 19 and attached septum 18 back up through the neck 28 to reseal the needleless connector 10.
  • a unique feature of the invention is that as the septum 18 unfolds it decreases the fluid volume inside the connector 10 in near equal proportion to the increase in fluid volume that occurs as the septum 18 and core 19 re-enter the neck 29. This can be important because as the syringe or infusion line tip is withdrawn from the inlet port 12 and the septum 18 and core 19 reenter the neck, if the septum 18 did not unfold, the change in fluid volume would pull fluid into the outlet port 14. This is undesirable as the fluid entering the outlet port would draw fluid all the way along the attached catheter resulting in blood being pulled into the tip of the catheter.
  • the inner chamber 36 is sealed and has an internal low pressure or vacuum when the septum 18 and core 19 are in the sealed position (as shown in Fig 2b) which allows it to fold into the chamber during insertion of the syringe or infusion line tip.
  • the septum 18 would bulge out during insertion of the syringe or infusion line tip and the fluid volume inside the needleless connector 10 would decrease rather than decreasing during retraction. Then retraction of the syringe or infusion line tip would cause fluid to be drawn into the outlet port 14.
  • the low or vacuum pressure in the inner chamber 36 and the folding septum 18 can be important features in the present invention.
  • Figure 4a is a top view of the device showing the cross-sectional line B-B that sections the view in Figure 2a and the cross-sectional line C-C that sections the view in Figure 4c.
  • Line C-C is rotated about the center of the needleless connector 10 by 45 degrees relative to line B-B.
  • chamber body flanges 52 is shown that extends from the chamber body 38.
  • chamber base flanges 54 extending from the chamber base 40 and base supports 56 that extend from the base 30.
  • the chamber body flanges 52, chamber base flanges 54 and base supports 56 position the inner chamber 36 relative to the body 16 and the base 30 such that the inner chamber 36 is stationary and the fluid pathways 50 are formed between the inner chamber 36 and the body 16 and base 30.

Landscapes

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

Abstract

Des modes de réalisation de valves de raccord sans aiguille sont prévus. La valve comprend une entrée et une sortie, et un corps entre l'entrée et la sortie. La valve comprend un segment de noyau étanche supportant un septum configuré pour sceller l'entrée. L'insertion d'un raccord dans l'entrée amène le segment de noyau à s'enfoncer et le septum à se replier sur lui-même, ce qui permet un écoulement de fluide autour du segment de noyau. Le retrait du raccord amène le segment de noyau à se rétracter et le septum à se déplier.
PCT/US2017/060874 2016-11-10 2017-11-09 Valve de raccord sans aiguille WO2018089643A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662420217P 2016-11-10 2016-11-10
US62/420,217 2016-11-10

Publications (1)

Publication Number Publication Date
WO2018089643A1 true WO2018089643A1 (fr) 2018-05-17

Family

ID=62109967

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2017/060874 WO2018089643A1 (fr) 2016-11-10 2017-11-09 Valve de raccord sans aiguille

Country Status (1)

Country Link
WO (1) WO2018089643A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020198042A1 (fr) * 2019-03-22 2020-10-01 Puracath Medical, Inc. Valve de raccord sans aiguille pour désinfection par uv
WO2021089754A1 (fr) * 2019-11-08 2021-05-14 B. Braun Melsungen Ag Élément d'accouplement de contre-broche, élément d'accouplement de broche et système d'accouplement pour un système de transfert de fluide fermé
US11071853B2 (en) 2017-06-21 2021-07-27 Uv Light Care, Inc. System and method for sterilization using ultraviolet radiation

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5439451A (en) * 1994-03-22 1995-08-08 B. Braun Medical, Inc. Capless medical backcheck valve
US5555908A (en) * 1995-06-23 1996-09-17 Becton, Dickinson And Company Valved PRN adapter for medical access devices
US20030017073A1 (en) * 2001-06-15 2003-01-23 Uv-Solutions, Llc Method and apparatus for sterilizing or disinfecting catheter components
US20040195538A1 (en) * 2003-04-03 2004-10-07 Raines Kenneth C Injection port valve
US20060163515A1 (en) * 2003-06-17 2006-07-27 Ruschke Ricky R Fluid handling device and method of making same
US20110028915A1 (en) * 2009-06-22 2011-02-03 Np Medical Inc. Medical Valve with Improved Back-Pressure Sealing
US20120310179A1 (en) * 2009-11-16 2012-12-06 Medegen, Inc. Needleless Access Connectors and Valve Elements Therefor

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5439451A (en) * 1994-03-22 1995-08-08 B. Braun Medical, Inc. Capless medical backcheck valve
US5555908A (en) * 1995-06-23 1996-09-17 Becton, Dickinson And Company Valved PRN adapter for medical access devices
US20030017073A1 (en) * 2001-06-15 2003-01-23 Uv-Solutions, Llc Method and apparatus for sterilizing or disinfecting catheter components
US20040195538A1 (en) * 2003-04-03 2004-10-07 Raines Kenneth C Injection port valve
US20060163515A1 (en) * 2003-06-17 2006-07-27 Ruschke Ricky R Fluid handling device and method of making same
US20110028915A1 (en) * 2009-06-22 2011-02-03 Np Medical Inc. Medical Valve with Improved Back-Pressure Sealing
US20120310179A1 (en) * 2009-11-16 2012-12-06 Medegen, Inc. Needleless Access Connectors and Valve Elements Therefor

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11071853B2 (en) 2017-06-21 2021-07-27 Uv Light Care, Inc. System and method for sterilization using ultraviolet radiation
WO2020198042A1 (fr) * 2019-03-22 2020-10-01 Puracath Medical, Inc. Valve de raccord sans aiguille pour désinfection par uv
CN113853233A (zh) * 2019-03-22 2021-12-28 普拉卡斯医疗公司 用于紫外线消毒的无针连接器阀
WO2021089754A1 (fr) * 2019-11-08 2021-05-14 B. Braun Melsungen Ag Élément d'accouplement de contre-broche, élément d'accouplement de broche et système d'accouplement pour un système de transfert de fluide fermé

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