|Publication number||USRE32056 E|
|Application number||US 06/271,907|
|Publication date||24 Dec 1985|
|Filing date||9 Jun 1981|
|Priority date||19 Oct 1977|
|Publication number||06271907, 271907, US RE32056 E, US RE32056E, US-E-RE32056, USRE32056 E, USRE32056E|
|Inventors||Daniel B. Granzow, Garry L. Carter, David W. Ammann|
|Original Assignee||Baxter Travenol Laboratories, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (56), Non-Patent Citations (16), Referenced by (22), Classifications (57)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The need to form a sterile, sealed connection between a pair of conduits arises particularly in the field of blood and blood component handling, as well as in other areas where a sterile connection between containers is desired.
In the blood handling field, it may be desired to make use of only one half of a unit of blood in a bag or the like. When this happens, it is customary to discard the nonused portion of the blood unit within a day after the access to the bag was made, even when efforts are made to maintain sterility by using conventionally accepted aseptic methods of access to the blood bag. This is so because only one or two air-borne bacteria could multiply in the stored blood to create the danger of septicemia, if the bacteria were allowed to multiply over a period of more than a very few hours, and the blood was then administered to a patient.
Accordingly, to eliminate the need for disposing of the remainder of a unit of blood when only a partial unit is needed, or for the many other reasons why sealed, sterile access between various containers would be desired, a considerable amount of research has taken place in developing aseptic fluid transfer systems. For example, Berkman, et al. U.S. Pat. No. 4,022,256, discloses a sterile connection means in which a heat-fusable tube carries an inner layer of plastic material which is nonmeltable at the temperature used. An allegedly-sterile connection is made by the use of a heating die pressing the nonmeltable layer through the melting outer layers of the tube, to provide a sterile connection between the two tubes, with the melted layers of the tube forming a single, perforated layer.
The invention of the Berkman patent requires a special heating die to press the nonmelting layer of material through the meltable layers of the conduits. Also, in the embodiment shown in the Berkman patent, the meltable material presses against the heating die. Any adhesion of the meltable material to the heating die when the die is pulled apart after the pressing step could cause the connection to rip open, or at least be seriously weakened.
In accordance with this invention, the use of a heating and pressing die for obtaining a sterile connection between two conduits is eliminated. Instead, .Iadd.electromagnetic .Iaddend.radiant energy is used to selectively melt a portion of the conduit wall without providing any physical contact of a die or the like to the melting portion. Also, in this invention, mechanical connection means may be provided between the two conduits to protect the fused, sterile connection area from being mechanically ripped apart.
In accordance with this invention, a connection, and particularly a sterile connection, may be formed between sealed conduits. Each conduit carries a thermoplastic wall portion preferably having a melting temperature of at least essentially 200° C., and which is opaque to the particular radiant energy intended for use herein. Such melting temperature, which may be a range of temperatures, may be determined, for example, by differential thermal analysis.
To make the sterile connection, the opaque wall portions of the conduits are brought together into facing contact. The opaque wall portions are exposed to sufficient .Iadd.electromagnetic .Iaddend.radiant energy to cause them to fuse together, and to open an aperture through the fused wall portions. This provides sealed communication between the interiors of the conduits.
Preferably, the opaque thermoplastic wall portions are carried about their peripheries by a transparent, rigid housing which typically defines the end of a conduit. The remainder of the conduit may be flexible, if desired. The rigid housing is transparent, and is made of a material which is not materially softened under the specific .Iadd.electromagnetic .Iaddend.radiant energy conditions used in the process. Instead, the .Iadd.electromagnetic .Iaddend.radiant energy can pass through the transparent housing, which preferably surrounds and protects the opaque wall portions as they are placed together in facing contact, so that primarily it is the opaque facing wall portions that are heated to their melting point rather than the transparent housing, which supports and protects the opaque wall portions.
As the opaque wall portions melt, they preferably fuse together into a single sealed mass, and, due to the melting, a central aperture is formed in the melted, opaque, thermoplastic wall portion. Any bacteria residing upon the exterior surfaces of the opaque wall portions are entrapped in the melted mass and preferably killed by exposure to the melting temperature of the opaque wall portions, which melting temperature is preferably on the order of 220° to 250° C.
The .Iadd.electromagnetic .Iaddend.radiant energy can be provided to the system by means of visible, infrared, ultraviolet, or radio frequency energy as may be desired. The term "opaque" implies that the opaque wall portions are adapted to absorb a high percentage of the particular .Iadd.electromagnetic .Iaddend.radiant energy to which it is exposed. The term "transparent" implies that a lower percentage of the .Iadd.electromagnetic .Iaddend.radiant energy applied is absorbed. Focused, infrared radiant energy is particularly desirable for use.
Lasers may also be used as desired to provide the .Iadd.electromagnetic .Iaddend.radiant energy.
The opaque wall portions may be prestressed by uniaxial or biaxial orientation, or with radial stress patterns, to facilitate the formation of the central aperture as the opaque wall portions seal together. Also, unstressed wall portions may be used, with the central aperture formation taking place by cohesion.
Referring to the drawings, FIG. 1 is an elevational view of a pair of conduit ends, the other ends of which may be connected to a pair of blood bags or the like, each terminating in a pair of housings which carry an opaque, thermoplastic wall portion in accordance with this invention.
FIG. 2 is an enlarged view, taken partly in longitudinal section, of one of the conduit ends as shown in FIG. 1.
FIG. 3 is an elevational view showing the two conduit ends of FIG. 1 after they have been joined together to bring the opaque wall portions into facing contact, further showing schematically the step of exposing the opaque wall portions to sufficient .Iadd.electromagnetic .Iaddend.radiant energy to cause them to fuse together and open an aperture.
FIG. 4 is an enlarged view, taken in longitudinal section, of the structure of FIG. 3 prior to the step of exposure to .Iadd.electromagnetic .Iaddend.radiant energy as described above.
FIG. 5 is an enlarged, longitudinal sectional view of a portion of the structure of FIG. 3, taken after the step of exposure to .Iadd.electromagnetic .Iaddend.radiant energy.
Referring to the drawings, conduits 10,12, are shown to include flexible sections 14, 16, one end of each which may be connected to a conventional blood bag 17, 19 or other container.
Housings 18, 20 are shown being made of a transparent, high melting plastic material such as Lexan, a polycarbonate material sold by General Electric. Each housing defines a hollow interior chamber 21 in communication with the bore of tubes 14 or 16, plus a bayonet member 22 and a slot 24. Both bayonet 22 and slot 24 are positioned asymmetrically on the housing so that each bayonet 22 can fit into a corresponding slot 24 of an identical housing in a generally permanent, snap-fit relation. Each bayonet 22 may be retained in slot 24 by the hooking action of barbs 26.
Accordingly, upon connection of a pair of housings 18, 20, they are only disconnected again with a great deal of effort. Preferably, enlarged portions 28 of each bayonet 22 are proportioned to bear against the inner wall of the slot 24 of the mating housing, to make the disconnection of the housings yet more difficult by reducing the capability of bayonets 22 to flex rearwardly.
Each housing 18, 20 carries an opaque wall portion 30, which may be made out of a thermoplastic material having a melting temperature of preferably at least 200° C.
For example, polycarbonate materials such as Lexan may be used, or polysulfone material such as Union Carbide's Udel or Radel. Also, polyethersulfone materials may be used.
The thermoplastic opaque wall portion 30 generally contains a filler such as carbon black to render it opaque, although other desired fillers which are absorbent of the type of .Iadd.electromagnetic .Iaddend.radiant energy to be used may be provided as a substitute for carbon black, for example, iron oxide, manganese dioxide, or the like.
Opaque, thermoplastic wall portion 30 is shown to be a disc which is preferably thinner at its central portion 32 than at its peripheral portions. Disc 30 may be retained by ultrasonic sealing or the like about its periphery to its housing in a recess 34 thereof, and is shown to bulge slightly outwardly, to facilitate good, pressurized contact between facing pairs of opaque wall portions, as shown in FIG. 4. Annular groove 33 provides room for the plastic of wall portion to flow as the opaque disc is assembled into the transparent housing.
FIG. 4 also shows how bayonets 22 fit into the opposed slots 24 of the mating housings, to provide permanent connection between the respective housings, with the opaque wall portions 30 being pressed togehter, and surrounded in protective manner by the respective housings.
After housings 18, 20 have been connected, they are irradiated with .Iadd.electromagnetic .Iaddend.radiant energy of a type which is absorbed by the particular opaque wall portions used. Specifically, infrared radiations is one preferred form of .Iadd.electromagnetic .Iaddend.radiant energy. It may be provided, for example, by the use of two 150 Watt Sylvania lamps .Iadd.35 .Iaddend.with elliptical reflector type (model DJL). This provides focused, infrared light which can be focused at the centers of abutting wall portions 30 to rapidly heat them over a period of preferably ten to twenty seconds to essentially the melting point, resulting in the fusing of the respective wall portions 30 together, and the formation of aperture 36, by relief of stress or by simple cohesive forces, through wall portions 30.
Bacteria trapped on the wall portion are killed by heating of wall portion 30 to its melting temperature, and are further entrapped upon rehardening of the melted material of wall portions 30. This results in the formation of a connection between the sterile flow channels 21, while the continued maintenance of sterility in the channels is assured.
The fused wall portions 30 fuse together to form a hermetic seal about aperture 36, to prevent a break in the sterility of the flow path. At the same time, the seal line 38 between the respective membrane wall portions 30 is protected from mechanical rupture by the generally permanent connection between respective housings 18, 20.
Alternatively, if it is desired to utilize radio frequency eneregy or the like as the .Iadd.electromagnetic .Iaddend.radiant energy, opaque wall portions 30 may be made out of a plasticized polyvinylchloride, while the remainder of housings 18, 20 may be made of a plastic material which is relatively inert to R.F. energy, for example polypropylene, polyethylene, or a similar material which does not heat significantly when it is exposed to radio frequency or other high energy, high frequency radiant electrical fields.
Accordingly, by this invention a sterile connection can be made, for example, between a full and an empty blood bag by simply connecting a conduit from each of the bags which carries a respective housing 18, 20 in accordance with this invention. The connected housings can be briefly exposed, for example for about fifteen seconds to focused infrared radiation, to melt the opaque wall sections, fusing them together and forming an aperture through the sections. The sterile connection is thus achieved, through which a portion of the blood of the full blood bag can be passed to the empty bag for use. Thereafter, the bags may be disconnected in conventional manner by heat sealing one or both of the flexible conduits 14, 16 leading from the blood bag to the housings 18, .[.29.]. .Iadd.20 .Iaddend.in a HEMATRON® heat sealer, sold by the Fenwal Division of Baxter Travenol Laboratories, Inc. Then the blood bags may be conveyed to their desired site of use, or back to long-term storage.
The above has been offered for illustrative purposes only, and is not intended to limit the scope of the invention of this application, which is as defined in the claims below.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US998507 *||22 Jul 1909||18 Jul 1911||Hasty Mfg Company||Automatically-operable valve.|
|US1010626 *||20 Dec 1909||5 Dec 1911||Hasty Mfg Company||Automatically-operable valve.|
|US1151300 *||22 Jan 1915||24 Aug 1915||Angelo L Soresi||Instrument for the transfusion of blood.|
|US1292603 *||5 Jun 1916||28 Jan 1919||Westinghouse Electric & Mfg Co||Valve-sealing means.|
|US1313225 *||24 Oct 1918||12 Aug 1919||Coupling eoe|
|US1921809 *||6 Nov 1931||8 Aug 1933||Earl Crain||Gas pipe stop|
|US2507379 *||9 Feb 1946||9 May 1950||Willard L Morrison||Demountable cold box|
|US2553259 *||2 Sep 1947||15 May 1951||Nordisk Insulinlab||Process of joining plastic substances|
|US2622053 *||4 Dec 1945||16 Dec 1952||Henry W Clowe||Method of joining surfaces of heat-fusible materials|
|US2729221 *||12 Sep 1950||3 Jan 1956||George Gorham||Safety device for gas burning appliances|
|US2744432 *||27 Jul 1954||8 May 1956||Sherman Klove Company||Reversible ratchet wrench|
|US2782496 *||8 Apr 1954||26 Feb 1957||Gen Electric||Method for assembling refrigeration systems|
|US2839788 *||24 Apr 1953||24 Jun 1958||Dembiak Matthew||Method of making hollow plastic or rubber articles|
|US2903004 *||1 Nov 1955||8 Sep 1959||Carrier Corp||Coupling devices|
|US2910083 *||10 Jan 1958||27 Oct 1959||C W Fuelling Inc||Method and apparatus for terminating and extending fluid transmission mains|
|US2933333 *||26 Sep 1955||19 Apr 1960||Crane Co||Pipe coupling|
|US2958545 *||15 Sep 1958||1 Nov 1960||Weatherhead Co||Rupturable union device|
|US2998018 *||6 Jul 1959||29 Aug 1961||Lockheed Aircraft Corp||Electro thermal valve|
|US3023762 *||30 Aug 1960||6 Mar 1962||Charles W Fuelling Inc||Gas main terminal fixture|
|US3052253 *||11 May 1960||4 Sep 1962||Pirelli||Valve for liquid metal|
|US3084705 *||13 Mar 1961||9 Apr 1963||Canrad Prec Ind||Device for rupturing glass seals|
|US3214502 *||15 Jan 1962||26 Oct 1965||Kendall & Co||Method and apparatus for making adhesive tapes|
|US3244412 *||18 Oct 1962||5 Apr 1966||Northwestern Steel & Wire Comp||Apparatus for melting meltable materials|
|US3285627 *||10 Feb 1964||15 Nov 1966||Weatherhead Co||Pipe coupling|
|US3384526 *||2 Sep 1965||21 May 1968||Research Inc||Method and machine for joining plastics|
|US3391951 *||7 Dec 1966||9 Jul 1968||Weatherhead Co||Diaphragm sealed coupling|
|US3404051 *||9 Mar 1965||1 Oct 1968||Morey Paper Mill Supply Co||Method of splicing thermoplastic rope ends by flame treatment|
|US3410979 *||28 May 1964||12 Nov 1968||Burroughs Corp||Method and apparatus for drilling holes by means of a focused laser beam|
|US3466065 *||4 Apr 1968||9 Sep 1969||Weatherhead Co||Rupturable diaphragm coupling|
|US3493002 *||11 Dec 1967||3 Feb 1970||Chrysler Corp||Coupling apparatus|
|US3549451 *||6 Mar 1968||22 Dec 1970||Emanuel Kugler||Method of manufacturing satchel bottom bags|
|US3588440 *||26 Jun 1969||28 Jun 1971||Hughes Aircraft Co||Laser combination energy system|
|US3616024 *||14 Jul 1969||26 Oct 1971||Phillips Petroleum Co||Method and apparatus for welding heat sealable pipes|
|US3640790 *||23 Apr 1970||8 Feb 1972||Canadian Ind||Sealing plastic film|
|US3812659 *||2 Aug 1972||28 May 1974||Whirlpool Co||Canister vacuum cleaner latching means|
|US3865411 *||29 Mar 1973||11 Feb 1975||Union Carbide Corp||Sterile connector for conduits|
|US3902489 *||22 Jun 1973||2 Sep 1975||Avon Medicals||Couplings|
|US3909910 *||23 Aug 1974||7 Oct 1975||Union Carbide Corp||Method of joining the ends of two conduits together in a sterile manner|
|US3913348 *||22 Jul 1974||21 Oct 1975||Gen Electric||Refrigerant system connecting apparatus|
|US3941641 *||26 Feb 1974||2 Mar 1976||William C. Heller, Jr.||Bonding method and apparatus|
|US3968195 *||17 Jun 1974||6 Jul 1976||Marilyn Bishop||Method for making sterile connections|
|US3977385 *||12 Jun 1974||31 Aug 1976||National Research Development Corporation||Internal combustion engines with straight line reinforcing members between cylinder heads and main bearings|
|US3986508 *||6 Nov 1974||19 Oct 1976||Abcor, Inc.||Sterilizable, medical connector for blood processing|
|US4004586 *||12 Mar 1975||25 Jan 1977||Baxter Travenol Laboratories, Inc.||Method and apparatus for sealed, sterile connection|
|US4019512 *||4 Dec 1975||26 Apr 1977||Tenczar Francis J||Adhesively activated sterile connector|
|US4022205 *||5 Nov 1973||10 May 1977||Tenczar Francis J||Fluid connectors|
|US4022256 *||25 Sep 1975||10 May 1977||California Institute Of Technology||Aseptic fluid transfer system|
|US4030494 *||15 Nov 1976||21 Jun 1977||Francis Tenczar||Fluid connectors|
|US4139005 *||1 Sep 1977||13 Feb 1979||Dickey Gilbert C||Safety release pipe cap|
|US4177372 *||24 May 1977||4 Dec 1979||Hitachi, Ltd.||Method and apparatus for laser zone melting|
|DE2331687A1 *||22 Jun 1973||10 Jan 1974||Avon Medicals||Kupplung fuer geraete im bereich der medizin oder der forschung|
|DE2452858A1 *||5 Nov 1974||7 May 1975||Francis Tenczar||Sterile kupplung|
|DE2639584A1 *||2 Sep 1976||31 Mar 1977||California Inst Of Techn||Verfahren und vorrichtung zur keimfreien uebertragung von fluessigkeiten zwischen behaeltern|
|GB801162A *||Title not available|
|GB1027528A *||Title not available|
|GB1428391A *||Title not available|
|1||B. A. Myhre et al., "An Aseptic Fluid Transfer System for Blood and Blood Components", Transfusion, Sep.-Oct., 1978, pp. 546-553.|
|2||*||B. A. Myhre et al., An Aseptic Fluid Transfer System for Blood and Blood Components , Transfusion, Sep. Oct., 1978, pp. 546 553.|
|3||*||DHEW Publication No. (NIH) 76 1004, Frozen Red Cell Outdating , Mar. 14, 1975, Bethesda, Maryland, pp. 43 51.|
|4||DHEW Publication No. (NIH) 76-1004, "Frozen Red Cell Outdating", Mar. 14, 1975, Bethesda, Maryland, pp. 43-51.|
|5||*||F. J. Tenczar, Transfusion, Sep. Oct. 1976, pp. 477 482, entitled Sterile Connector .|
|6||F. J. Tenczar, Transfusion, Sep.-Oct. 1976, pp. 477-482, entitled "Sterile Connector".|
|7||R. E. Trotman, "Sterilization by Radio Frequency Induction Heating: A Method for the In Situ Sterilization of Vessels in Automatic Bacteriological Apparatus", Journal of Applied Bacteriology 32, pp. 2, 9, 7-300, (1960).|
|8||*||R. E. Trotman, Sterilization by Radio Frequency Induction Heating: A Method for the In Situ Sterilization of Vessels in Automatic Bacteriological Apparatus , Journal of Applied Bacteriology 32, pp. 2, 9, 7 300, (1960).|
|9||*||The International Dictionary of Physics, 1961, pp. 239 241.|
|10||The International Dictionary of Physics, 1961, pp. 239-241.|
|11||*||Van Nostrand s Scientific Encyclopedia, 1968, pp. 582, 583, 1458 and 1459.|
|12||Van Nostrand's Scientific Encyclopedia, 1968, pp. 582, 583, 1458 and 1459.|
|13||*||Webster s New Collegiate Dictionary, 1979, p. 583.|
|14||Webster's New Collegiate Dictionary, 1979, p. 583.|
|15||*||William W. Cooper et al., pp. 31 41 of DHEW Publication No. (NIH 76 1004, Mar. 14, 1975, entitled, A Two Stage Heat Sterilizable Connector For Use In Processing Frozen Blood .|
|16||William W. Cooper et al., pp. 31-41 of DHEW Publication No. (NIH 76-1004, Mar. 14, 1975, entitled, "A Two-Stage Heat Sterilizable Connector For Use In Processing Frozen Blood".|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US5641622 *||7 Jun 1994||24 Jun 1997||Baxter International Inc.||Continuous centrifugation process for the separation of biological components from heterogeneous cell populations|
|US5858016 *||14 Jul 1992||12 Jan 1999||Baxter International Inc.||Sterile/aseptic connector|
|US6174404 *||3 Mar 1995||16 Jan 2001||Supercom Ltd||Laminated plastic cards and process and apparatus for making them|
|US6221315||12 Apr 1999||24 Apr 2001||Baxter International Inc.||Apparatus for separation of biologic components from heterogeneous cell populations|
|US6596179||16 Feb 2001||22 Jul 2003||Baxter International Inc.||Apparatus for the separation of biologic components from heterogeneous cell populations|
|US7264771||20 Apr 1999||4 Sep 2007||Baxter International Inc.||Method and apparatus for manipulating pre-sterilized components in an active sterile field|
|US7419563||23 Jun 2005||2 Sep 2008||Boston Scientific Scimed, Inc.||Methods of making medical devices|
|US7655198||30 Dec 2005||2 Feb 2010||Baxter International Inc.||Method and apparatus for manipulating pre-sterilized components in an active sterile field|
|US7922211||8 Feb 2006||12 Apr 2011||Millipore Ab||Method and device for interconnecting, sealed against contamination, the ends of elongate elements such as tubes or pipes|
|US7938454||10 May 2011||Hyclone Laboratories, Inc.||Sterile connector systems|
|US8029023||8 Feb 2006||4 Oct 2011||Millipore Ab||Device and method for contamination-free and/or sterile sealing between at least two interconnectable connecting means|
|US8448992 *||16 Feb 2011||28 May 2013||Fenwal, Inc.||Sterile docking device, medical fluid flow system with sterile docking device and method of using same|
|US8702129||23 Apr 2008||22 Apr 2014||Hyclone Laboratories, Inc.||Sterile connector systems|
|US9199070||12 Dec 2012||1 Dec 2015||Fenwal, Inc.||Fluid flow conduits and apparatus and methods for making and joining fluid conduits|
|US20050161614 *||14 Dec 2004||28 Jul 2005||Bilstad Arnold C.||Apparatus for manipulating pre-sterilized components in an active sterile field|
|US20060110282 *||30 Dec 2005||25 May 2006||Bilstad Arnold C||Method and apparatus for manipulating pre-sterilized components in an active sterile field|
|US20060289112 *||23 Jun 2005||28 Dec 2006||Holman Thomas J||Methods of making medical devices|
|US20080217915 *||8 Feb 2006||11 Sep 2008||Nils Arthun||Method and Device for Interconnecting, Sealed Against Contamination, the Ends of Elongate Elements Such as Tubes or Pipes|
|US20080277878 *||8 Feb 2006||13 Nov 2008||Nils Arthun||Device and Method for Contamination-Free and/or Sterile Sealing Between At Least Two Interconnectable Connecting Means|
|US20100133807 *||23 Apr 2008||3 Jun 2010||Hyclone Laboratories, Inc.||Sterile connector systems|
|US20120204990 *||16 Feb 2011||16 Aug 2012||Fenwal, Inc.||Sterile Docking Device, Medical Fluid Flow System With Sterile Docking Device and Method Of Using Same|
|WO2000062820A2||12 Apr 2000||26 Oct 2000||Baxter Int||Method and apparatus for manipulating pre-sterilized components in an active sterile field|
|U.S. Classification||141/1, 156/304.6, 250/432.00R, 156/272.2, 600/573, 141/311.00R|
|International Classification||F16L37/26, B29C65/72, A61M39/14, F16L37/098, B29C65/00, F16L37/30, B29C35/08, B29C65/14, B29C65/58, F16L29/00|
|Cooperative Classification||B29C66/73921, B29L2031/7148, B29C66/857, B29L2031/712, B29K2105/16, B29C65/1467, B29L2031/753, B29C65/58, B29C2035/0822, B29C65/72, B29K2069/00, F16L37/26, F16L37/098, B29C65/1412, B29C65/1445, B29C65/7473, B29K2027/06, A61M2039/1027, B29L2031/7542, B29C66/71, B29K2071/00, F16L37/30, A61M39/143, B29C65/148, B29C66/1122, F16L29/005, B29C66/5223, F16L2201/44|
|European Classification||B29C66/71, B29C66/50, B29C65/14, B29C66/1122, B29C65/72, B29C66/5221, B29C65/14D10B, B29C65/14D6, A61M39/14B, F16L37/098, F16L37/30, F16L37/26, F16L29/00F|