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WO2008150781A1 - Raccord pour écoulement de fluide permettant une séparation latérale sous forte pression - Google Patents

Raccord pour écoulement de fluide permettant une séparation latérale sous forte pression Download PDF

Info

Publication number
WO2008150781A1
WO2008150781A1 PCT/US2008/064942 US2008064942W WO2008150781A1 WO 2008150781 A1 WO2008150781 A1 WO 2008150781A1 US 2008064942 W US2008064942 W US 2008064942W WO 2008150781 A1 WO2008150781 A1 WO 2008150781A1
Authority
WO
WIPO (PCT)
Prior art keywords
connector
fluid flow
tube
connector tube
connectors
Prior art date
Application number
PCT/US2008/064942
Other languages
English (en)
Inventor
William J. Schnell
David S. Utterberg
Original Assignee
Dsu Medical Corporation
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 Dsu Medical Corporation filed Critical Dsu Medical Corporation
Publication of WO2008150781A1 publication Critical patent/WO2008150781A1/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
    • A61M39/10—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
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1077—Adapters, e.g. couplings adapting a connector to one or several other connectors
    • 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
    • A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking

Definitions

  • Extracorporeal blood sets are used for conveying blood from a patient to an extracorporeal blood treatment device, such as a dialyzer.
  • These blood sets conventionally contain various components for obtaining access to an intermediate portion of the blood set, such as an injection site access port, a Y connector access port, or the like.
  • an access port may be carried on a flow- through chamber positioned in the set between the ends thereof.
  • Such a chamber may be a pressure chamber having rigid walls for pressure measurement, and may carry a fluid flow connector access site, for example a needleless access site of a known type, such as a needleless access site of the type disclosed in U.S. Patent No. 7,025,744.
  • This access site may be connected with a syringe, or a tube set having a luer or luer lock connector, for the administration of parenteral solution or other medicament, or for venting air, or for administration of blood, or the like.
  • a needleless access site or the like may be carried on a rigid chamber in the dialysis set.
  • a syringe containing heparin or the like may be carried during the procedure in the needleless access site. If the syringe is somehow accidentally, laterally struck, a great deal of torque is exerted on the needleless access site, with the syringe
  • a fluid flow connector which may be a needleless access site, is provided in which a sharp, lateral blow to a second connector or the like which is laterally connected to the fluid flow connector is not likely to cause breakage. Rather, the fluid flow connector is designed so that the second connector will pop out of connection with the fluid flow connector when it is struck with a severe, lateral blow, which might otherwise cause breakage.
  • the fluid flow connector which is provided can be of a proportion allowing swabbing with an antiseptic such as isopropyl alcohol prior to use, particularly when comprising a tubular access site and connector which contains an internal, perforated sealing diaphragm which may be opened by a male luer or other tubular connector member. This may be accomplished in part by typically enlarging the inner diameter of the fluid flow connector, above and beyond typical connectors that conform to ANSI specifications.
  • a first fluid flow connector comprises: a connector body which carries a first connector tube having a lumen for receiving a second connector tube of a second connector when said connectors are joined.
  • the first connector tube may have a lumen and a lumen wall, for example of angled cone shape, in at least a major outer portion thereof, to the longitudinal axis of the first connector.
  • the first connector tube carries a plurality of circumferentially spaced, outwardly extending lugs, to engage inwardly extending threads or lugs of the second connector tube when connected.
  • the first fluid flow connector may be made of a plastic which has a dimensions (especially thickness) and a flexural modulus that is low enough to allow deformation, permitting a connected, engaging second connector to pop loose from connection with the fluid flow connector when laterally struck, rather than breaking the first fluid flow connector.
  • the lugs of the first connector tube may comprise interrupted screw threads that occupy a spiral section, or they may comprise lugs that occupy essentially a single, longitudinal position along the length of the first connector tube.
  • the lugs in question are diametrically opposed and extend in an arc about the connector tube ranging from essentially 40 to about 180°. In some embodiments, only a pair of said lugs are present, the lugs being substantially diametrically opposed to each other.
  • the first fluid flow connector described above may be connected to the second connector, with the connector tubes being together in telescoping relation but radially spaced from each other at least at an outer portion of the lumen wall, or essentially completely radially spaced from each other, to avoid substantial frictional retention between the connector tubes.
  • the connectors would tend to fall apart, a 360 degree gap between the connector tubes being present, in some embodiments, on the order of at least 0.1 mm..
  • the conical lumen wall shape is at an angle of greater than three degrees to the lumen axis, thus providing lateral movability or rotatability to the engaging first and second connector tubes.
  • the second connector tube may define an outer wall of lesser angle to the longitudinal axis of the first connector than the angle of the first lumen wall major outer portion described above.
  • a zone of contact between the first connector tube and the second connector tube may be present as a relatively short zone along the length of the respective tubes, and remaining portions of the tubes are laterally (radially) spaced.
  • the above embodiments allow a measure of lateral movement between the first and second connector tubes, to facilitate the popping loose of the second connector if forcefully and laterally struck.
  • the second connector tube can effectively open the diaphragm by opening the perforation, to open flow through the connected system. Then, when the second connector tube is withdrawn again out of engagement with the perforated diaphragm, the elastomeric diaphragm reseals again to block fluid flow.
  • the second connector tube can be completely, laterally spaced from the inner wall that defines the lumen, while positioned in the lumen so that the second connector tube is typically only in contact with the fluid flow connector by its engagement with the diaphragm, when in connected, flow permitting position.
  • the second connector threads or lugs may be carried by a skirt that surrounds the lugs of the first connector.
  • the skirt has an inner diameter less than the maximum diameter of the diametrically opposed lugs, to be in frictional engagement with radially outer surfaces of the lugs of the first connector, for frictional retention of said connectors together.
  • a syringe which carries a second connector may be brought into connection with the first fluid flow connector, and advanced so that the second
  • CH1 11234498.2 connector tube of the second connector penetrates and opens the diaphragm, or the second connector can be in a retracted position, but is still frictionally retained with the first fluid flow connector, with the second connector tube being spaced from the diaphragm, so that the diaphragm is closed, and flow through the system is prevented.
  • the syringe may be held on an extracorporeal blood flow set by an attached fluid flow connector during a procedure, with flow being closed between the syringe and the set. Then, as desired, the syringe can be advanced, and flow is opened for administration of medicament or the like, or the taking of a blood sample. Then the syringe may retract again, while remaining in retained condition.
  • the first fluid flow connector may be made of plastic having a flexural modulus that is low enough to allow deformation permitting a connected, engaging second connector to pop loose from connection with the fluid flow connector when laterally struck.
  • this flexural modulus may be no more than about 370,000 psi, for example from about 250,000 to 350,000 psi, as determined by ASTM D 790.
  • this popping away, rather than breaking of the fluid flow connector is facilitated by the low flexural modulus as indicated for the plastic, as well as by a space defined between the first and second connector tubes permitting some lateral motion, with or without pivoting, between the first and second connector tubes when laterally struck.
  • CH 1 11234498.2 tube from cylindrical to a substantially oval cross section may take place upon the lateral striking, to facilitate spontaneous disconnection rather than breakage.
  • the first connector tube may have an inner diameter of at least 5.5 mm along its entire length, less than a conventional ANSI connector. This inner diameter may vary, since, typically, the first connector tube defines at least a portion of lumen wall of angled cone shape.
  • the first connector tube may have a length of 3.5 - 6 mm, which is less than a conventional ANSI connector, and which facilitates spontaneous disconnection upon lateral striking.
  • the wall thickness of the first connector tube may be from essentially 0.6 to 1.1 mm, which is typically less than conventional-ANSI tubular connection sites, to further facilitate the above-described, spontaneous disconnection on lateral striking.
  • the fluid flow connector of this invention may be carried on a generally rigid pressure sensing chamber, and the connector and chamber may comprise an integrally molded, single piece. If desired, a portion of the chamber may be comolded with the fluid flow connector of this invention and then attached to another chamber component. Thus, the fluid flow connector may be carried on the substantially rigid pressure sensing chamber.
  • a medical connector which comprises: a connector body which carries a first connector tube having a lumen for receiving a second connector tube of a second connector when the connectors are joined; the
  • CH 1 11234498.2 medical connector having a perforated diaphragm carried by the connector body and sealingly occluding flow through the first connector tube.
  • a locking member is provided for locking connection with a second connector having a second connector tube that enters into the lumen.
  • the first connector tube may be made of a material and dimensions to permit deformation thereof when the first connector tube is forcefully and laterally struck, causing disconnection of the first and second connector tubes rather than breakage of the connector body or first connector tube.
  • Fig. 1 is an elevational view of two connectors, prior to connection with each other, in accordance with this invention.
  • Fig. 2 is a sectional view taken along line 2-2 of Fig. 1.
  • Fig. 3 is an enlarged, longitudinal sectional view of a portion of the female connector of Figs. 1-2 that defines a conical lumen.
  • Fig. 4 is a perspective view of the component of Fig. 3.
  • Fig. 5 is a plan view of the component of Fig. 3, showing a section of the second connector skirt in connected relation.
  • Fig. 6 is an elevational view of the component of Fig. 3.
  • Fig. 7 is a longitudinal sectional view of the component of Fig. 3.
  • Fig. 8 is an elevational view of the respective connectors of Figs. 1-2, shown in connected form.
  • Fig. 9 is a sectional view taken along line 9-9 of Fig. 8.
  • FIG. 10 is an enlarged view of a portion of Fig. 9, showing a fully forward, different, connected position.
  • Fig. 11 is a longitudinal, sectional view showing the connected system of Fig. 10, in which the male connector has been laterally struck and is in the process of popping out of connection from the female connector.
  • Figs. 1-11 disclose a first embodiment of a fluid flow connector 10, which is shown to be a female connector, having a connector body comprising a forward component 12 and a rearward component 14. Between the two connector components there is a peripherally secured, elastomeric diaphragm 16, which defines a perforation 18, such as a slit which provides sealing against fluid flow at a substantially predetermined range of pressures.
  • Sleeve 17 of forward component 12 sealingly engages annular enlargement 19 of rearward component 14 by a conventional sealing process.
  • Connector body component 12 carries a first connector tube 20, which has a lumen 21 , defined by conical wall 22, wall 22 being of cone shape that, in some embodiments, defines an angle to the longitudinal axis 24 of connector 10 that is greater than about 3 degrees, such as 5° to 10°.
  • First connector tube 20 has an end portion that carries a plurality of circumferentially spaced, outwardly extending lugs 26, for engaging inwardly extending threads 28 (or lugs) of a skirt 30 of a second connector 32.
  • CH 1 11234498.2 connector 32 may comprise a conventional syringe 33 having a conventional male luer lock connector on its end.
  • the male luer second connector tube 34 of second connector 32 may have a conventional taper that is less than the taper of conical wall 22, with respect to axis 24.
  • the lesser angle of the male luer second connector tube 34 compared with the lumen angle of conical wall 22, causes the respective connector tubes 20, 34 to be spaced from each other, as at space 36 (Fig. 10) at least at an outer portion of first connector tube 20, or tubes 20, 34 are entirely radially spaced, optionally.
  • the respective connector tubes 20, 32 may be frictionally joined together at an inner junction area 36, if desired.
  • Threads or lugs 26 of first fluid flow connector 10 are helically arranged like an interrupted screw thread, and are substantially diametrically opposed to each other. It can also be seen from Fig. 5 that the radially outer edge 39 of lugs or threads 26 defines an arc , so that ends 40 of arc 39 (Fig. 5) merge with the outer surface of first connector tube 20, while central portions of lug outer surface 38 are radially outwardly spaced from the outer surface of first connector tube 20.
  • Second connector threads 28 are carried by skirt 30 that surrounds lugs 26 of first connector tube 20.
  • skirt 30 has an inner surface 43 between threads 28 that is in frictional engagement with radially outer surfaces of lugs 26, so that the position of the respective connectors 10, 32 may be maintained by frictional retention between lugs 26 and inner surface 43 of skirt 30, as in Figs. 5 and 9.
  • the radially outermost outer surface 42 of lugs 26 are slightly radially larger in diameter than the inner diameter 43 of skirt 30, typically by about 0.1 to 0.7 mm. to make this happen .
  • first and second connectors may be frictionally retained in a retracted position while fluid flow is blocked through the connectors.
  • the inner diameter of skirt 30 may, for example, be about 8.0 mm, with the maximum diameter of lugs 26 being about 8.3 mm.
  • the plastic material of particularly forward component 12 of first connector 10 may have a flexural modulus that is low enough to allow deformation at the dimensions used, permitting a connected, engaging second connector to pop loose from first connector 10 when laterally struck rather than breaking connector 10, so that first connector tube 20 can be briefly pushed into an oval shape or the like.
  • a particular plastic that may be used is a poly(styrene- methylmethacrylate) such as Zylar 530 having a flexural modulus of about 285,000 psi.
  • first connector tube 20 may have an inner diameter of at least 5.5mm along its entire length so that its inner diameter is larger than the outer diameter of second connector male luer tube 34 along their lengths in their most advanced engaging position where skirt 30 abuts upper surface 45 (Fig. 10) of forward component 12 of connector 10.
  • Fluid flow connector 10 may, for example, be carried on a substantially rigid, pressure sensing chamber wall 44 (Fig. 11) for an extracorporeal blood line or the like, with the pressure sensing chamber and connector 10 comprising an integrally molded, single piece, if desired.
  • First connector tube 20 also has a length of about 4.1 mm, which is less than the length of the corresponding tapered bore component of a conventional luer lock connector. This facilitates the "pop-off' characteristic of the connector of this invention, as illustrated in Fig. 11.
  • first connector tube 20 has a wall thickness of about 0.8 mm which is thinner than typical luer lock connectors in accordance with ANSI specifications.
  • first connector tube 20 has more flexibility because of the thinner wall than a corresponding component of a conventional female luer lock connector of ANSI specification, and also because of the material of relatively low flexural modulus from which first connector tube 20 is made.
  • the entire connector 10 may be made of such material of limited flexural modulus as described above, or rearward connector body component 14 may be made of a different material, with forward connector body component 12, and first connector tube 20 which comprises a part thereof, being made of the plastic material described above.
  • Fig. 11 the results of lateral striking of syringe 33 is shown, with connector 10 being attached to a stationary element, for example wall 44 of substantially rigid pressure sensing chamber for an extracorporeal blood line, or the like.
  • second connector tube (male luer) 34 can easily tip to an extent, as shown.
  • the thinner wall of first connector tube 20, and the plastic material from which it is made, under lateral pressure 41 by an inadvertent striking, syringe 33 can tip and even separate without breaking first connector tube 20 or second connector 32.
  • Syringe 33 can be tilted even further by pressure-distortion of the lumen 21 of first connector tube 20 into an oval shape, which can serve to facilitate disengagement of threads 28 from lugs 26, further facilitating the resultant pop-off, and separation of the connection between connectors 10 and 32.
  • CH 1 11234498.2 diaphragm 16 spontaneously closes back through its original configuration, providing sealing of the system from first, female connector 10 at predetermined pressures, which typically include the operating pressures of the system.
  • first connector tube 20 when compared with conventional luer connectors of ANSI specification, the lumen within first connector tube 20 may be wider than a conventional ANSI female luer connector, which facilitates sterilization using an antiseptic-soaked pad or the like.
  • second connector tube 34 may have sufficient exposure to permit swabbing with an antiseptic-soaked cotton swab, so that the system may be manually resterilized, and then reconnected in the event of an accidental separation.

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  • 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

La présente invention concerne un raccord pour écoulement de fluide qui comprend un corps de raccord lequel supporte un premier tube de raccord comportant une lumière servant à recevoir un second tube de raccord lorsque les raccords sont accouplés. Le premier tube de raccord est pourvu d'une lumière et d'une paroi de lumière. Le premier tube de raccord présente spécifiquement une partie terminale qui supporte une pluralité de pattes s'étendant vers l'extérieur, espacées circonférentiellement qui se mettent en prise avec le second tube de raccord lorsqu'ils sont accouplés. Le raccord pour écoulement de fluide est réalisé dans un plastique ayant un module d'élasticité en flexion qui est suffisamment faible pour assurer la déformation, ce qui permet à un second raccord couplé, en prise, de se dégager et de se désaccoupler du raccord pour écoulement de fluide lorsqu'il est frappé latéralement, plutôt que de briser le raccord pour écoulement de fluide.
PCT/US2008/064942 2007-06-05 2008-06-05 Raccord pour écoulement de fluide permettant une séparation latérale sous forte pression WO2008150781A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US11/810,427 US20080303267A1 (en) 2007-06-05 2007-06-05 Fluid flow connector permitting forceful lateral separation
US11/810,427 2007-06-05

Publications (1)

Publication Number Publication Date
WO2008150781A1 true WO2008150781A1 (fr) 2008-12-11

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Application Number Title Priority Date Filing Date
PCT/US2008/064942 WO2008150781A1 (fr) 2007-06-05 2008-06-05 Raccord pour écoulement de fluide permettant une séparation latérale sous forte pression

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US (1) US20080303267A1 (fr)
WO (1) WO2008150781A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011119021A1 (fr) 2010-03-23 2011-09-29 N.V. Nutricia Robinet d'arrêt trois voies pour applications d'alimentation par sonde entérale
EP2404637A1 (fr) * 2010-07-06 2012-01-11 Fresenius Medical Care Deutschland GmbH Raccord d'hémofiltration jetable

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US8777931B2 (en) 2011-08-19 2014-07-15 Alcon Research, Ltd. Retractable luer lock fittings
US20130322957A1 (en) * 2012-05-31 2013-12-05 James R. Conrad Hollow Rigid Cam Lock
AU2016237164A1 (en) * 2015-03-26 2017-10-12 Terumo Kabushiki Kaisha Syringe cap, syringe assembly, and prefilled syringe
DK3290073T3 (da) * 2016-08-29 2021-02-15 Hoffmann La Roche Forbindelsesanordning
US11541180B1 (en) 2017-12-21 2023-01-03 Patrick Vitello Closure assembly having a snap-fit construction
US11278681B1 (en) 2018-02-20 2022-03-22 Robert Banik Tamper evident adaptor closure
US11413406B1 (en) 2018-03-05 2022-08-16 Jonathan J. Vitello Tamper evident assembly
US11857751B1 (en) 2018-07-02 2024-01-02 International Medical Industries Inc. Assembly for a medical connector
US11779520B1 (en) 2018-07-02 2023-10-10 Patrick Vitello Closure for a medical dispenser including a one-piece tip cap
US11793987B1 (en) 2018-07-02 2023-10-24 Patrick Vitello Flex tec closure assembly for a medical dispenser
US11690994B1 (en) 2018-07-13 2023-07-04 Robert Banik Modular medical connector
US11426328B1 (en) 2018-08-31 2022-08-30 Alexander Ollmann Closure for a medical container
US11471610B1 (en) 2018-10-18 2022-10-18 Robert Banik Asymmetrical closure for a medical device
USD948713S1 (en) 2019-09-03 2022-04-12 International Medical Industries, Inc. Asymmetrical self righting tip cap
US11911339B1 (en) 2019-08-15 2024-02-27 Peter Lehel Universal additive port cap
US11697527B1 (en) 2019-09-11 2023-07-11 Logan Hendren Tamper evident closure assembly
US11357588B1 (en) 2019-11-25 2022-06-14 Patrick Vitello Needle packaging and disposal assembly
US11904149B1 (en) 2020-02-18 2024-02-20 Jonathan Vitello Oral tamper evident closure with retained indicator
US11523970B1 (en) 2020-08-28 2022-12-13 Jonathan Vitello Tamper evident shield
US12070591B1 (en) 2020-12-14 2024-08-27 Patrick Vitello Snap action tamper evident closure assembly
US11872187B1 (en) 2020-12-28 2024-01-16 Jonathan Vitello Tamper evident seal for a vial cover
US12172803B1 (en) 2021-10-04 2024-12-24 Patrick Vitello Tamper evident integrated closure

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US20040068238A1 (en) * 2002-10-04 2004-04-08 Utterberg David S. Injection site for male luer or other tubular connector
WO2007056363A2 (fr) * 2005-11-09 2007-05-18 Dsu Medical Corporation Capsule de pression a diaphragme pour des fluides medicaux

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011119021A1 (fr) 2010-03-23 2011-09-29 N.V. Nutricia Robinet d'arrêt trois voies pour applications d'alimentation par sonde entérale
CN102834140A (zh) * 2010-03-23 2012-12-19 N.V.努特里西阿公司 用于肠内管饲应用的三向关闭旋塞
EP2404637A1 (fr) * 2010-07-06 2012-01-11 Fresenius Medical Care Deutschland GmbH Raccord d'hémofiltration jetable
WO2012004123A1 (fr) * 2010-07-06 2012-01-12 Fresenius Medical Care Deutschland Gmbh Raccord jetable pour une hémofiltration
EP2962722A1 (fr) * 2010-07-06 2016-01-06 Fresenius Medical Care Deutschland GmbH Raccord d'hémofiltration jetable
US9352139B2 (en) 2010-07-06 2016-05-31 Fresenius Medical Care Deutschland Gmbh Disposable connector for hemofiltration
US10279158B2 (en) 2010-07-06 2019-05-07 Fresenius Medical Care Deutschland Gmbh Disposable connector for hemofiltration
EP4470596A3 (fr) * 2010-07-06 2025-03-12 Fresenius Medical Care Deutschland GmbH Raccord jetable pour hémofiltration

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