US2923294A - Parenteral tubing set and method of making same - Google Patents

Parenteral tubing set and method of making same Download PDF

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Publication number
US2923294A
US2923294A US544726A US54472655A US2923294A US 2923294 A US2923294 A US 2923294A US 544726 A US544726 A US 544726A US 54472655 A US54472655 A US 54472655A US 2923294 A US2923294 A US 2923294A
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United States
Prior art keywords
tubing
protector
parenteral
closed
pressure
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Expired - Lifetime
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US544726A
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English (en)
Inventor
Robert C Reimann
Joseph A Olenicki
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Baxter International Inc
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Baxter Laboratories Inc
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Publication date
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Priority to US544726A priority Critical patent/US2923294A/en
Priority to BE554437D priority patent/BE554437A/fr
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Expired - Lifetime legal-status Critical Current

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    • 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
    • A61M39/08—Tubes; Storage means specially adapted therefor
    • 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

Definitions

  • This invention relates to a parenteral tubing setand a method for preparing the same and, more particularly, to a set provided with means adapted to indicate the absence of leaks therein.
  • the parenteral tubing sets to which our invention is applicable have essentially two uses.
  • One use involves the conveying of fluids suitable for injection into the human body from an outside source.
  • the seconduse involves the removal of parenteral fluids from the body for collection or other disposal.
  • An obvious example of the second use is the collection of blood.
  • the apparatus employed for these uses includes essentially a length of flexible tubing, the ends of which are provided with fittings, such as needles, suitable for introduction into the body and to the source or collection container, as the case may be.
  • the end fittings are plastic adapters constructed to be inserted into the hubs subjecting the assembled set to a temperature of about 250 F. Contamination subsequent to sterilization was attempted to be avoided by provisionof protector sleeves over the end fittings thereby insulating the interior of the tubing and fittings as well as the ensleeved exterior of the fittings from contact with unsterile objects and media.
  • a common method of testing currently employed is to provide one of the aforementioned protector sleeves with an unsealed end, plugging the opening formed thereby with cotton to minimize the entry of bacteria.
  • a valve and gage-equipped air pressure line is attached to the open end of the protector sleeve and the interiorof the set is pressurized with air from about 6 psi. to 15 psi.
  • the open-ended protector also serves another purpose in that it permits air exit and entry during heat sterilization.
  • Heat sterilization is ordinarily achieved in an autoclave wherein the steam temperature reaches about 250 F.
  • the pressure .insideatheset is :greater than that in the autoclave, which pressure, if unrelieved, it was 2,923,294 Pate ted Fens, 1960 believed would rupture the sch-hence the apparent .need for a vented protector.
  • our invention involves the provision of a closed-ended protector in place of the normally provided vent-type protector, the closed-endedprotector being of such character as to collapse to equalize the internal and external pressures, and at the same time to provide va visual indication of the reduced pressure conditionwithinthe set and thereby its integrity.
  • FIG. l is an elevational view depicting a conventional parenteral administration apparatus such as would utilize the tubing set of our invention
  • Fig. 2 is an enlarged, cross-sectional view of one end of the tubing set shown in Fig. 1 but before the protector has been removed
  • Fig. 3 is an enlarged, crosssectional view similar to Fig. 2 butshowing our invention as applied to a modified form of parenteral tubing set.
  • thenurneral l0 designates a parenteral solution container mounted in a mouth downward condition by means of suspending bail 11 from a suitable stand (not shown). Liquid from container 10 is permitted to flow through parenteral tubing set generally designated 12 into a human recipient (also not shown).
  • Parenteral tubing set 12 as depicted in Fig. 1 is seen to be composed of two interconnected conduit elements, a drip meter set generally designated 13 and a small bore tubing set, generally designated 14.
  • Set 14 as shown has particular application in pediatric parenteral therapy as where the needle 15 is inserted into an infants scalp vein.
  • set 13 is seen to include a conventional drip meter 16 inserted through a stopper (not shown) of container 10 so vasto establish an outlet conduit for the parenteral fluid contained in container 10.
  • the outlet portionof drip meter 16 is a length of flexible tubing 17 terminatingiin :aLuer adapter 18 inserted into tubing 17.
  • ,Set14 also includes a length of flexible tubing, desig nated 19k, itheends of which are also provided with Luer adapters, one of which, designated numeral 20 is'reverselyrnounted to accommodate engagement with adapter 18 of set "13.
  • the adapter provided at the opposite or discharge end of set 14 isdesignatedll and has needle 15 .removablymounted thereon.
  • the manner of coaxially attaching adapters 2t and 21 totubing 19:0f; set 14 will be explainedby ICfr6l1CeftO .Fig-.2.
  • FIG. 2 a specific-:embodiment of our invention is shown in enlarged cross-sectional view. 'As indicated above, the flexible tubing 19- of set 14is connected toadapter means designated 21. In the embodiment shown-in Fig. 2, this connection is'achieved through the use of an intermediate sleeve 22 heat sealed to tubing '19 according to the teaching of Patent'No. 2,702,036. Sleeve 22 is ensleeved over .plastic adapter 21 which is end as at 23so as to fit .into aiconventional hypodermic needle 15.
  • a similar end connection and protector can be provided at the other end of tubing 19 (not shown in Fig. 2) or the other end may be provided with various types of puncturing devices known to the art.
  • Such other puncturingdevices may take the form of the hypodermic needle shown in Fig. 3 wherein like numerals are used to denote like parts except for the addition of a prime.
  • tubing 19' is connected to needle 15 by ensleeving tubing 19' over the hub of needle 15' and securing the connection so achieved by collar 26'.
  • rigid protector 27' Also mounted over the hub portion of hypodermic needle 15' of is rigid protector 27'.
  • Such a protector is generally required to prevent inadvertent puncture of a softer protector prior to actual use of the set.
  • Ensleeved over rigid protector 27 is resilient protector 24, substantially similar to that shown in Fig. 2.
  • a length of flexible tubing 19 is secured into a larger diameter sleeve 22 by means of a four-way heat seal.
  • Adapter 21 is then inserted into sleeve 22 and protector 23, which has been previously provided with heat seal 25, is ensleeved over adapter 21.
  • tubing 19 When the other end of tubing 19 has been provided with a similar structure (as for example the reversely mounted Luer adapter shown in Fig. l) or otherwise closed against entrance of air, the assembly is introduced into an autoclave where the set is subjected to a temperature in the range of 230-250 F. for a sufficient time to bring the set and its contained air to that temperature.
  • a temperature in the range of 230-250 F.
  • the pressure external to the set is less than the internal pressure so that a portion of the air within the set tends to expand. The same phenomenon apparently takes place during the cooling portion of the sterilization cycle.
  • protector 24 Upon removal of the set from the autoclave, the walls of protector are found to be collapsed as at 28 or 28'. The drawing together of the opposite wall portionsproduces a distinctive shading or opaqueness when the set is held up to lightthereby providing a ready means for checking its integrity.
  • protector 24 By constructing protector 24 of a translucent or transparent plastic material, the above mentioned opacity is readily achieved.
  • protector 24 collapse in preference to those of tubing 19 because of the difference in dimensions, i.e., bore and wall thickness.
  • Tubing 19 is so sized as to be substantially not collapsible by p and extending over the length of the needle portion therethe application of atmospheric pressure when the internal 1 pressure is less than atmospheric.
  • An example of a set produced in accordance with the teaching of our invention includes an 18 length of flexible tubing 19 con structed of polyvinyl chloride having aninternal diameter of .054" and a wall thickness of .018".
  • Protector 24 has an unsupported length of approximately an overall length of 2%, an internal diameter of 0.180 and a wall thickness of .022".
  • tubing 19 When the dimensions of tubing 19 are increased to .140" internal diameter and .035" wall thickness the phenomenon described above is not achieved.
  • a parenteral tubing set comprising a length of flexible tubing, puncture means affixed to at least one end thereof, said tubing being closed at a point spaced from said puncture means, resilient protector tubing means removably mounted on said puncture means and closing the same, the said protector tubing means being so arranged and constructed as to cause a portion of said protector tubing means to collapse after the said set has been subjected to heat sterilization, whereby a visual indication of the integrity of the set is achieved.
  • a parenteral tubing set comprising a length of flexible tubing, puncture means affixed to at least one end thereof, the other end of said tubing being closed against rapid entrance of air whenever the pressure within the set is less than that external to the set, resilient protector tubing means removably mounted on said puncture means closing the same against rapid entrance of air whenever the pressure within the set is less than that external to the set, the said protector tubing means being of such a wall thickness and diameter in comparison to the wall thickness and diameter of said resilient tubing so as to cause a portion of said protector tubing means to preferentially collapse after the said set has been subjected to heat sterilization.
  • a parenteral tubing set comprising a length of flexible tubing, puncture means affixed to at least one end thereof, the other end of said tubing being provided with removable closure means closing the same, a resilient, translucent thermoplastic tube removably mounted on said puncture means, said protector tube being closed at its unmounted end by a single heat seal, the closed end of said protector tube being spaced from the unattached end of said puncture means, said protector tube being so dimensioned as contrasted to said flexible tubing as to cause opposite wall portions of said protector tube to draw together to produce an observable shading after the said set has been subjected to heat sterilization.
  • a method of producing a heat-sterilized, non-leaking-parenteral tubing set comprising: closing one end of a length of flexible tubing with a removable closure, inserting into the other end of said flexible tubing :1
  • non-collapsible tubular element removably ensleeving said tubular element with a flexible, resilient, translucent closed'ended protector, said protector being so dimensioned with respect to said flexible tubing as to preferentially collapse when the pressure inside the set is less than that external to the set, heat sterilizing the set so achieved, cooling the said set, whereby a portion of said protector is collapsed to provide an' indication of the non-leaking character of said set, and thereafter visually examining said protector.
  • a method of detecting air leaks in parenteral tubing equipment comprising the steps of releasably closing both ends of a length of flexible tubing, one of said ends being equipped with a closure member constructed of a flexible, resilient, translucent material, said closure member being so constructed and arranged with respect to said tubing as to preferentially collapse when the pressure inside of the closed set is less than that external to the set to provide a perceptible shading in said closure member, heat sterilizing the set, cooling the set and thereafter visually examining the said closure member to ascertain the presence of a shaded portion.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • Vascular Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
US544726A 1955-11-03 1955-11-03 Parenteral tubing set and method of making same Expired - Lifetime US2923294A (en)

Priority Applications (2)

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US544726A US2923294A (en) 1955-11-03 1955-11-03 Parenteral tubing set and method of making same
BE554437D BE554437A (enrdf_load_stackoverflow) 1955-11-03 1957-01-23

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3035351A (en) * 1960-04-27 1962-05-22 Arnold J Hirsch Methods of root canal and periodontal therapy
US3738361A (en) * 1971-09-20 1973-06-12 M Price Control device for parenteral liquid feed apparatus
FR2320113A1 (fr) * 1975-08-07 1977-03-04 Baxter Laboratories Inc Appareil d'injection de solution intraveineuse comportant un element de diametre interne retreci
FR2395758A2 (fr) * 1975-08-07 1979-01-26 Baxter Travenol Lab Appareil d'injection de solution intraveineuse comportant un element de diametre interne retreci
USD260432S (en) 1978-11-13 1981-08-25 Gabor Kadar Combined stand and container for storing liquids
EP0197383A3 (de) * 1985-04-10 1987-11-11 Pfrimmer-Viggo GmbH + Co. KG Verfahren und Gerät zum kontaminationssicheren Mischen von Flüssigkeiten
US4834706A (en) * 1987-11-24 1989-05-30 Sherwood Medical Company Medical apparatus with a tearable tamper evident indicator means

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2642866A (en) * 1951-02-03 1953-06-23 Arthur F Smith Blood container and method of making the same
US2722932A (en) * 1954-05-12 1955-11-08 Bishop & Co Platinum Works J Disposable blood donor set
US2725055A (en) * 1954-07-07 1955-11-29 Baxter Laboratories Inc Recipient needle mounting

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2642866A (en) * 1951-02-03 1953-06-23 Arthur F Smith Blood container and method of making the same
US2722932A (en) * 1954-05-12 1955-11-08 Bishop & Co Platinum Works J Disposable blood donor set
US2725055A (en) * 1954-07-07 1955-11-29 Baxter Laboratories Inc Recipient needle mounting

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3035351A (en) * 1960-04-27 1962-05-22 Arnold J Hirsch Methods of root canal and periodontal therapy
US3738361A (en) * 1971-09-20 1973-06-12 M Price Control device for parenteral liquid feed apparatus
FR2320113A1 (fr) * 1975-08-07 1977-03-04 Baxter Laboratories Inc Appareil d'injection de solution intraveineuse comportant un element de diametre interne retreci
FR2395758A2 (fr) * 1975-08-07 1979-01-26 Baxter Travenol Lab Appareil d'injection de solution intraveineuse comportant un element de diametre interne retreci
USD260432S (en) 1978-11-13 1981-08-25 Gabor Kadar Combined stand and container for storing liquids
EP0197383A3 (de) * 1985-04-10 1987-11-11 Pfrimmer-Viggo GmbH + Co. KG Verfahren und Gerät zum kontaminationssicheren Mischen von Flüssigkeiten
US4834706A (en) * 1987-11-24 1989-05-30 Sherwood Medical Company Medical apparatus with a tearable tamper evident indicator means

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Publication number Publication date
BE554437A (enrdf_load_stackoverflow) 1960-01-29

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