US 2894510 A
Description (OCR text may contain errors)
VJuly 14, 1959 D. BELLAMY, JR
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. SEALING cLosuREs FOR FLUID CONTAINERS Filed Feb. 25, 1954 1 2 Sheets-Shale?. 2
llitC-n Patented July 14, 1959 Bice SEALING CLOSURES FOR FLUID CONTAINERS David Bellamy, Jr., Framingham, Mass., assignor to Fenwal Laboratories, Inc., Ashland, Mass., a corporation of Massachusetts Application February 25, 1954, Serial No. 412,549
13 Claims. (Cl. 12S-272) This invention relates generally to fluid handling and more particularly to improvements in closed Huid carrying elements or units such as containers, bags, tubes, and the like. The invention aims generally to provide sterile entrance or exit openings or ports for such fluid carryingv units. In certain embodiments herein shown and de-y scribed and applicable to uid containers and conductors adapted for carrying medical and the like fluids which are required to be kept sterile, it seeks to provide port closing means facilitating uniting the containers and conductors in a continuous closed sealed collecting or administering system, and with minimum chance for contamination of the fluids.
The invention apparatus comprises generally novel means for sterile sheathing of the exposed or projecting portions of the entrance-exit or inlet-outlet openings or ports of uid carrying units, which means are adapted for ready removal to expose the ports and without undesired manual contact with the same. It further comprises port closing means novelly adapted for rupture or removal independent of and following and without affecting the coupling or connecting of the fluid carrying units. The ex-v pressions inlet-outlet or outlet-inlet as herein used with reference to openings or ports are to be understood as meaning such opening or port which serves as an outlet or as an inlet or as either or both outlet and inlet.
The invention will be better understood from a c011- sideration of the following specification in conjunction with the accompanying drawing in which:
Fig. l is a front view of the port sheathing and closing means of the invention shown as applied to a medical fluids container;
Fig. 2 is a larger scale section, taken along the line 2--2 of Fig. l;
Fig. 3 is a like section taken along the line 3 3 of Fig. 1;
Fig. 4 is a perspective view of the apparatus of Figs. l and 2 with the sheathing means manipulated to expose the port;
Fig. 5 is a sectional View of the apparatus of Figs. 1 and 3 as manipulated in coupling a iiuid conductor to the container; and
Fig 6 is a front view of the port sheathing and closing means of the invention as applied to a liuid conductor.
Of primary concern in the handling and administration of medical fluids is the preservation of the uids in a sterile condition as by the handling and manipulation of the same in a substantially sterile, closed sealed system. In other Words, the fluid carrying units and more particularly the lluid container and conductor elements of a medical uid handling system are required to be manipulable in the various collecting, storing and infusing phases in a manner calculated to reduce to a minimum the likelihood of contamination. My present invention novelly serves and meets these objects and conditions, and eiects more particularly a sealing of fluid container or conductor openings or ports uniquely providing for without exposure of the medical uids to atmosphere or other contaminating influence and thus conformant to desired sterile, aseptic techniques.
Referring now more particularly to the drawing, a flexible container for medical uids is indicated generally at 10, Fig. l. This flexible container or parenteral pack 10 is typically of collapsible construction, and comprises more particularly a sleeve of tough, flexible, thin-walled plastic, flatted and fused at its ends, as at 12, 12, Fig. l, so as to deline a relatively thin, exible, light-weight bag adapted to be evacuated, and also to be rolled into a small package for storage prior to use. It will be understood that the novel sheathing'and sealing means of the invention is indifferent to the number, form, and arrangement of the openings or ports with which a container or conductor may be provided. The parenteral pack 10 selected merely for purposes of illustration is herein shown to have three inlet-outlet ports arranged-at one end of the bag, one constructed primarily as an inlet and the others primarly as outlets. The ports designated principally but not solely as outlets are fitted as alternative embodiments A, B of the invention apparatus and are seen to comprise short lengths of tubing 13, 14 passed between and fused to the bag walls at the band seal 12 delining the bag end closure. The tubing lengths 13, 14 project a short distance without the bag and may terminate inwardly somewhat beyond or substantially flush with the inner margin of the seal 12.` v
In accordance with the invention, means are provided incomplementary association or combination for sterile sheathing and sealing closure of the openings or ports of uid carrying units, such as the outlets 13, 14 of the container 10 above described.
The port sheathing and closing means of the invention as combined and embodied in the left-hand assembly A, Fig. l, comprise a pair of thin plastic strips 15, 15 juxtaposed about and having a length and width substantially to overlap at its sides and `outer end the tubing length 13. The strips 15, 15 may be identical and fashioned of the thin, flexible, light-weight plastic material employed in the manufacture of the bag 10. While the strips 15, 15 may as well be applied to a port defined by a tube of substantially greater length, so that they engage only the tube, sheathing its end at a point remote from the bag, they are conveniently and herein atted and fused together about the tube 13 and engage also the bag 10. It will readily be appreciated that the sheath-forming strips may be assembled with the tube after it is united with and so as to be applied to the exterior of the bag 10; variously, and preferably both tubing and strips are passed between and joined to the bag walls at and with the flatting and fusing of the end closing strip 12, as shown. The sheath elements 15, 15 are thus closed about the tube 13 in the the coupling of fluid carrying units thereatsubstantially l region of and also external to the bag 10 and more particularly along the line 17, Fig. 1. The line seal 17 is of general U-shape, having longitudinal portions extending from the bag and beyond the outer end of the tubing and there converging to a central point opposite the said tube end. The seal 17 may be formed by dielectric or other convenient means. The strips 15, 15 are thus assembled or ordered as a unitary tab or sealing sheath for the bag port, and more particularly drawn and held together to form a pocket enclosing the projecting portion of the tube 13.
In the embodiment employed in assembly A, Fig. 1, the tab or sheath forming strips 15, 15 are adapted further and novelly for pull-apart manipulation. More particularly, their terminal portions lying outwardly of the said pocket forming seal have random and generally disconnected disposition, Fig. 2. These terminal strip portions may be provided with suitable grip-forming means, herein illustrated asvintegral lateral thickening ribs 15a, 15a- The new and improved port sheathing and closing apparatus of the invention as embodied and combined in assembly A comprises further tube sealing tab means engaging and closing the port wholly within but adapted for tear-apart manipulation entirely from without the bag. My novel tear-tab is herein shown as a strip 19 of the bag material having a width slightly greater and a length substantially greater than the diameter of the tube 13, and detachably fused or sealed across and closing its inner end, and having a laterally projecting manipulating portion 19a, Figs. 1, 2 and 4.
In operation, and as prerequisite to the use as herein disclosed of my novel port sealing assemblies A and B, the bag is charged or lilled with the desired fluid by openingl and more particularly working the ball or bead out of the primarily inlet port or tube I, Fig. l.
rl`he manipulation of the port sheathing and closing elements of assembly A for coupling and establishing fluid passage between the bag 1t) and a tube, intravenous set, recipient set, or the like medical fluid handling and administering apparatus is simple and certain. The tab 1S, 15 is merely grasped by and between the fingers, as at the terminal grip forming portions a, 15a and pulled apart, Fig. 4, to break the seal 17 and expose, brielly, the tubing 13. The indicated or appropriate liuid conducting element is then connected to the bag in the customary manner. The desired secure and hermeticsealed coupling of the fluid storing and conducting units is thus eected with minimum exposure of the fluid contactingV parts and without manual engagement and contamination of the same. The described coupling is seen also to be made without venting the bag 10 and preliminary to the establishment of a iluid passage between it and the uid conducting unit, thereby preserving the stored uid in sterile condition and in a closed, sealed system. It will be appreciated still further that the described or assembly A embodiment of my novel port sheathing means is manipulated 'or entry or access to the sterile pocket or iield defined therewithin without the use of any cutting or other tools.
The further manipulation of port sheathing and closing assembly A for establishing a uid passage between the fluid conducting and storing units requires merely a simple tearing of the tab 19 free of the tube 13. This is accomplished from without the 'bag 10, and by grasping the exible bag walls 11, 11 in the region of the tab and clamping them about the projecting tab portion 19a, and then manipulating them to pull the tab away from and open the tube, permitting the desired fluid flow from the bag 10 to the coupled liuid conducting element. It will be appreciated that the described manipulation of the port closing means of assembly A is eected in sterile preserving manner and without disturbing the seal established and obtaining in the system.
Alternative embodiments of my novel port sheathing and closing means are combined in the right-hand assembly B, Fig. l. The sheath forming means is shown as the thin plastic strips 16, 16 assembled about and united to the tubing length 14 and to the bag margin or seal 12 similarly as the, pull-apart tab of the left-hand assembly A. More particularly the strips 16, 16 are positioned to project inwardly of the said seal 12 and only slightly outwardly of the tube 14, and iiatted and fused about the tube in the region of the seal and outwardly thereof over an area 18 of appreciable or suicient extent surrounding the projecting portion of the tube 14 and comprehending also the terminal portions thereof. Thus the assembled' Aand substantially unitary strips 16, 16 also vdefine an integral sheath providing a sterile pocket, zone, or iield for the opening or port with which they are associated and herein the tubing length 14. The sheath forming means of kassembly B will be seen further to lbe adapted for cut-apart manipulation,
or more particularly tobe separable as for exposure of l the tube 14 by severing of the strips 16, 16 inwardly of the area seal 18 by a suitable cutting tool.
Associated with the sheath forming means just described in the right-hand assembly B is an alternative form of my novel port closing means comprising a puncturable wall-forming diaphragm 2t) of the plastic material sealed across and closing the port in the region of the end closure 12.
In the manipulation of the port sheathing and closing elements or right-hand assembly B for coupling and establishing communication with a lluid conducting element, the tab is lirst cut apart, as already described. A conductor is then coupled to the bag, as by inserting a tube mounted coupler C in the just exposed projecting portion of the tube 14, Fig. 5. The parts having thus been united as a closed sealed system, continued insertion of the coupler C will be seen to puncture the diaphragm and permit the desired liuid flow. It will be appreciated that the port closing diaphragm 20 is spaced inwardly of the outer end of the tube 14 a distance suiiicient to insure adequate sealing engagement of the coupler stem with the tube wall prior to diaphragm puncture by the coupler tip, and that the parts are otherwise sized and proportioned for establishment of the desired sterile sealed connection.
It is to be understood that the novel port sheathing and closing means of my invention such as are herein given only representative illustration may be advantageously employed independent of one another, as wellV as in the combinations herein disclosed. It will be appreciated further that the sheath of assembly A may b e combined as well with the closure of assembly B, and thatV the sheath of assembly B may alternatively be associated with theV closure of assembly A, in the practice of my invention.
It will be observed also and as earlier mentioned that my novel opening or port sheathing and closing means may be applied to conductors and other fluid carrying units as Well as to containers such as herein shown and described. In Fig. 6 I show port sheathing means like that of assembly A, and port closing means like that of assembly B as applied to the end opening of a conductor tube 30. The port sheathing means comprises more particularly a pair of the thin plastic strips 51, 31 juxtaposed and joined about the tube and fused together along the line 32 and upwardly or rearwardly thereof along the marginal band 32a, forming a unitary sheath and defining a sterile iield about the tube end. The strips 31, 31 are seen to have the disconnected, grip forming `terminal portions 31a, 31a adapting them for pull-apart manipulation. Combined and co-operating with the port sheathing pull-apart tab 31, 31 of Fig. 6 is a port closing element shown more particularly to comprisea puncturable membrane or diaphragm 33 of the plastic material sealed across the tube in the region of its end opening. The manipulation of the tube sheathing and closing assembly of Fig. 6 for sterile lestablishment of iluid passage at the end opening will lbe seen Vto require merely the manual l manipulation of the portions 31a, 31a to pull apart the sheath 31, 31 and the insertion of a coupler like that shown in Fig. 5 to puncture the diaphragm 33.
From the foregoing it will be appreciated that I' have provided new and improved means adapting fluid lcarrying units for sterile inter-connection. More particularly the invention provides independent, complementary tab means for closing and more particularly for sterile sealing or sheathing the entrance-exit or inlet-outlet openings or ports of fluid carrying units such as containers and tubes, The apparatus of the invention has been shown further to `be manipulable for establishment of fluid connection between container and conductor in desired sterile, aseptic manner and more particularly without engagement or exposure of the fluid or iluid contacting parts. In one embodiment disclosed herein my novel apparatus will be seen also to be manipulable without the use of any tools.
It will be understood that my invention, either as to means or method, is not limited to the exemplary embodiments herein illustrated or described, and I set forth its scope in my following claims.
1. In combination, a uid carrying tube and a sealing sheath for an end thereof comprising iiexible sheet strips juxtaposed and detachably joined about the tube end and having separable tabs adapted to be pulled apart to expose the tube end.
2. Apparatus for sterile sealing the port of a plastic conduit for lluid and adapting it for sterile coupling compuising flexible plastic strip means supported and projecting from said conduit and arranged as a sheath over said port, said strip means having tabs manipulable to pull apart said sheath and expose said port.
3. Apparatus for sterile sealing the port tube of a plastic conduit for fluid and adapting it for sterile coupling comprising flexible plastic strips supported from said conduit and arranged as a sheath over said port, said strips having -tabs manipulable to pull apart said sheath and expose said port.
4. Apparatus for sterile sealing the port of a plastic conduit for uid and adapting it for sterile coupuling comprising ilexi'ble plastic strip means supported and projecting from said conduit and arranged as a sheath over said port, said strip means having tabs manipulable to pull apart said sheath and expose said port, and other plastic means sealing said port independently of said sheath.
5. In combination, a fluid container, a Huid conductor` means porting and projecting from said container, a pair of flexible sheet strips detachably fused about and forming a sealing sheath for said means, and separable terminal portions on said strips manually manipulable to pull apart said sheath.
6. A sheath for a tube forming the port of a uid container comprising iiexible sheet strips integrally joined to said container and about a projecting portion of the tubing, said strips being manually separable from each other in tear-apart fashion outwardly of the tube for sterile access to the tube port.
7. Means adapting the outlet-inlet tube of a fluid container for sterile sealed coupling to a iiuid conductor, comprising a sheath for the tube portion projecting Without the container and a sheet strip removably closing said tube in the region of said container.
8. Means adapting the outlet-inlet tube of a uid container for sterile sealed coupling to a uid conductor comprising a sheath for the outer tube portion and a tear 6 tab sealed over the inner tube end, said tab having a portion projecting within and manipulable from Without the container for tearing the same away from said tube.
9'. In combination, a iiexible collapsible container mounting a port tube, and means for sheathing the projecting portion of the tube, said means comprising a pair of similarly projecting sheet strips joined along a line enclosing and sealing said portion and disconnected, random disposed terminal portions on said strips, said portions manipulable to pull apart the sterile-sealed pocket defined within said line.
10. Means adapting a fluid container of the class ported by an inlet-outlet tube for sterile-sealed coupling to a iluid conductor comprising sheet strips integrally dependent from the container and separably joined about and sheathing the tube, and a sheet portion removably closing said tube inwardly and independent of said strips.
11. Apparatus for adapting an outlet iitted, exible walled container for aspetic coupling to a iluid administering unit comprising a ilexible sheet strip received in the container and having a portion detachably sealed across and closing the outlet and a freely projecting portion manipulable through the container wall to tear said sealed portion away from said outlet from without said container.
12. In combination, a fluid container formed of sealed flexible plastic wall material, the container having at a wall thereof a iiuid flow and coupling port tube with an externally projecting portion, means comprising flexible plastic strip members forming a sealing sheath for the end of said projecting tube portion and havingy separable marginal portions manually manipulable to pull apart the sheath, and said port tube having other sealing means in the region of the container.
13. In combination, a iluid carrying tube, a sealing sheath for an end thereof comprising flexible sheet strips juxtaposed and detachably joined about the tube end and having separable tabs adapted to be pulled apart to expose the tube end, and a puncturable Wall forming diaphragm sealed across and closing oif the tube end.
References Cited in the tile of this patent UNITED STATES PATENTS 2,257,823 Stokes Oct. 7, 1941 2,432,968 Lahey Dec. 16, 1947 2,470,943 Page May 24, 1949 2,648,463 Scherer Aug. 11, 1953 2,702,034 Walter Feb. 15, 1955 FOREIGN PATENTS 120,476 Australia Sept. 21, 1943