US4004586A — Method and apparatus for sealed, sterile connecti…

Claim 1

Independent Claim 217 words

The method of transferring sterile contents from a first, sealed, sterile container, having a first, flexible, sealed, fluid transfer tube, to a second, sealed, sterile container having a second, flexible, sealed, fluid transfer tube, said first and second tubes communicating at one end with their respective sealed, sterile containers, said first and second tubes having a free end, and being each sealed with a diaphragm across their bores, said diaphragms being spaced from the free ends of said first and second tubes, said method comprising: inserting one end of a double-ended, hollow spike into each of the bores of said first and second tubes at the free end thereof, said spike being proportioned to tightly and sealingly fit into each bore of the first and second tubes; sterilizing said spike and that portion of said first and second tubes extending from each said diaphragm to the free ends of said tubes; and thereafter axially collapsing said first and second tubes adjacent the free ends thereof to pass the ends of said spike through said diaphragms to open a flow channel between said first and second containers; transferring said sterile contents through said fluid transfer tubes from said first to said second container; and resealing said second fluid transfer tube while sterility is retained in said second tube.

Claim 2

Independent Claim 217 words

The method of transferring sterile contents from a first, sealed, sterile container, having a first, flexible, sealed, fluid transfer tube, to a second, sealed, sterile container having a second, flexible, sealed, fluid transfer tube, said first and second tubes communicating at one end with their respective sealed, sterile containers, said first and second tubes having a free end, and being each sealed with a diaphragm across their bores, said diaphragms being spaced from the free ends of said first and second tubes, said method comprising: inserting one end of a double-ended, hollow spike into each of the bores of said first and second tubes at the free end thereof, said spike being proportioned to tightly and sealingly fit into each bore of the first and second tubes; sterilizing said spike and that portion of said first and second tubes extending from each said diaphragm to the free ends of said tubes; and thereafter axially collapsing said first and second tubes adjacent the free ends thereof to pass the ends of said spike through said diaphragms to open a flow channel between said first and second containers; transferring said sterile contents through said fluid transfer tubes from said first to said second container; and resealing said second fluid transfer tube while sterility is retained in said second tube.

Claim 3

Dependent Claim 25 words

The method of claim 1 in which the fluid transfer tubes are mechanically prevented from axial collapse to rupture said diaphragms, until after said sterilizing.

Claim 4

Dependent Claim 19 words

The method of claim 1 in which said first fluid transfer tube is resealed while sterility is retained therein.

Claim 5

Dependent Claim 180 words

A sealed sterile connection means between a first, sealed, sterile container having a sealed, flexible, sterile fluid transfer tube communicating at one end thereof with said first container and having a free end, and a second, sealed, sterile container having a second, sealed, flexible sterile fluid transfer tube communicating at one end thereof with said second container, and having a free end, said first and second fluid transfer tubes being each sealed with a diaphragm across their respective bores, said diaphragms being spaced from the free ends of said tubes, the improvement comprising: A double-ended, hollow spike, one end of said spike being inserted into each of the bores of said first and second tubes at the free ends thereof but spaced from said diaphragms to maintain the diaphragms intact, said spike being proportioned to tightly and sealingly fit into each bore of said first and second tubes, said first and second tubes being each sufficiently flexible adjacent their free ends to permit manual axial collapse thereof, to permit said diaphragms to be penetrated by the ends of said spike.

Claim 6

Dependent Claim 180 words

A sealed sterile connection means between a first, sealed, sterile container having a sealed, flexible, sterile fluid transfer tube communicating at one end thereof with said first container and having a free end, and a second, sealed, sterile container having a second, sealed, flexible sterile fluid transfer tube communicating at one end thereof with said second container, and having a free end, said first and second fluid transfer tubes being each sealed with a diaphragm across their respective bores, said diaphragms being spaced from the free ends of said tubes, the improvement comprising: A double-ended, hollow spike, one end of said spike being inserted into each of the bores of said first and second tubes at the free ends thereof but spaced from said diaphragms to maintain the diaphragms intact, said spike being proportioned to tightly and sealingly fit into each bore of said first and second tubes, said first and second tubes being each sufficiently flexible adjacent their free ends to permit manual axial collapse thereof, to permit said diaphragms to be penetrated by the ends of said spike.

Claim 7

Dependent Claim 180 words

A sealed sterile connection means between a first, sealed, sterile container having a sealed, flexible, sterile fluid transfer tube communicating at one end thereof with said first container and having a free end, and a second, sealed, sterile container having a second, flexible, sterile fluid transfer tube communicating at one end thereof with said second container and having a free end, said first and second fluid transfer tubes being each sealed with a diaphragm across their respective bores, said diaphragms being spaced from the free ends of said tubes, the improvement comprising: a double-ended, hollow spike, one end of said spike being inserted into each of the bores of said first and second tubes at the free ends thereof, but spaced from said diaphragms to maintain the diaphragms intact, said spike being proportioned to tightly and sealingly fit into each bore of said first and second tubes, said first and second tubes being each sufficiently flexible adjacent their free ends to permit manual axial collapse thereof, to permit said diaphragms to be penetrated by the ends of said spike, and

Claim 8

Dependent Claim 180 words

A sealed sterile connection means between a first, sealed, sterile container having a sealed, flexible, sterile fluid transfer tube communicating at one end thereof with said first container and having a free end, and a second, sealed, sterile container having a second, flexible, sterile fluid transfer tube communicating at one end thereof with said second container and having a free end, said first and second fluid transfer tubes being each sealed with a diaphragm across their respective bores, said diaphragms being spaced from the free ends of said tubes, the improvement comprising: a double-ended, hollow spike, one end of said spike being inserted into each of the bores of said first and second tubes at the free ends thereof, but spaced from said diaphragms to maintain the diaphragms intact, said spike being proportioned to tightly and sealingly fit into each bore of said first and second tubes, said first and second tubes being each sufficiently flexible adjacent their free ends to permit manual axial collapse thereof, to permit said diaphragms to be penetrated by the ends of said spike, and

Claim 9

Dependent Claim 86 words

removable clip members surrounding each said fluid transfer tube adjacent each free end, to prevent said axial collapse, and consequent rupturing of the diaphragms of said tubes, by said hollow spike prior to removal of said clip member in which the free end of said sealed, flexible tube is provided with a first external flange adjacent its free end and a second external flange positioned on said tube adjacent said diaphragm, said clip member being positioned in an abutting relationship between said first and second flanges.

Claim 10

Dependent Claim 86 words

removable clip members surrounding each said fluid transfer tube adjacent each free end, to prevent said axial collapse, and consequent rupturing of the diaphragms of said tubes, by said hollow spike prior to removal of said clip member in which the free end of said sealed, flexible tube is provided with a first external flange adjacent its free end and a second external flange positioned on said tube adjacent said diaphragm, said clip member being positioned in an abutting relationship between said first and second flanges.

Claim 11

Dependent Claim 63 words

The connection means of claim 5 in which the free end of each said flexible, sealed tube comprises a tubular connector member having a first external flange about its free end and a second external flange positioned on said tube near said diaphragms, and said clip members are positioned between said first and second flanges to facilitate the prevention of said axial collapse.

Claim 12

Dependent Claim 32 words

The connection means of claim 6 in which a portion of each said tube adjacent said clip member is of reduced thickness to facilitate axial collapse when said clip member is removed.

Claim 13

Dependent Claim 100 words

The connection means of claim 7 in which said clip member defines a rigid, malleable structure of hollow cylindrical shape, said structure defining an axial, open slot along the entire length thereof to facilitate the installation and removal of said clip member; a transverse, intermediately located cutaway portion, to define a strip portion connecting the respective ends of said clip member; a tab portion being located adjacent one end thereof, whereby the end of said clip member which carries the tab portion may be bent about said strip portion away from said connector member to permit the axial collapse thereof.

Claim 14

Dependent Claim 50 words

The connection means of claim 8 in which said connector member defines a partial flange having a longitudinal opening defined therethrough, said partial flange being located intermediate said first and second flanges on the exterior of said tube, said strip member of the clip member being positioned in said opening.

Claim 15

Dependent Claim 16 words

The device of claim 9 in which said first and second containers are plastic blood bags.

Claim 16

Dependent Claim 19 words

The device of claim 9 in which said connector member includes said diaphragm, and is made of silicone rubber.

Claim 17

Dependent Claim 25 words

The sealed sterile connection means of claim 5 in which the free ends of said first and second fluid transfer tubes are of identical shape.

Claim 18

Dependent Claim 88 words

A sealed, sterile container having a sealed, flexible, sterile fluid transfer tube communicating at one end thereof with said container and having a free end; the improvement comprising: a diaphragm positioned across the bore of said tube, said diaphragm being spaced from the free end thereof, said tube being sufficiently flexible to permit manual axial collapse thereof adjacent said free end, and a removable clip member surrounding said fluid transfer tube adjacent the free end thereof, to prevent said axial collapse prior to removal of said clip member.

Claim 19

Dependent Claim 88 words

A sealed, sterile container having a sealed, flexible, sterile fluid transfer tube communicating at one end thereof with said container and having a free end; the improvement comprising: a diaphragm positioned across the bore of said tube, said diaphragm being spaced from the free end thereof, said tube being sufficiently flexible to permit manual axial collapse thereof adjacent said free end, and a removable clip member surrounding said fluid transfer tube adjacent the free end thereof, to prevent said axial collapse prior to removal of said clip member.

Claim 20

Dependent Claim 96 words

The sealed sterile container of claim 13 including a double-pointed hollow spike, one point of said spike being inserted in the bore of said fluid transfer tube at the free end thereof, but spaced from said diaphragm, said spike being proportioned to tightly and sealingly fit into the bore of said free end, whereby, upon connection of the other point of said spike into the bore of another sealed, flexible, fluid transfer tube, and subsequent sterilization, a sterile path may be provided by axially collapsing said fluid transfer tube so that the spike ruptures the diaphragm.

Claim 21

Dependent Claim 11 words

The sterile container of claim 13 which is a blood bag.

Claim 22

Dependent Claim 24 words

The sterile container of claim 13 which is a bag for physiological solution and which carries a plurality of flexible, sealed fluid transfer tubes.

Claim 23

Dependent Claim 30 words

The sealed, sterile container of claim 13 in which said free tube end comprises a tubular connector member which includes said diaphragm, said connector member being made of silicone rubber.

Claim 24

Dependent Claim 31 words

The sealed, sterile container of claim 17 in which a portion of said tubular connector member is of reduced thickness to facilitate the axial collapse, when said clip member is removed.

Claim 25

Dependent Claim 101 words

The sealed, sterile container of claim 18 in which said clip member defines a rigid, malleable structure of hollow cylindrical shape, said structure defining an axial, open slot along the entire length thereof to facilitate the installation and removal of said clip member; a transverse, intermediately located cutaway portion, to define a strip portion connecting the respective ends of said clip member; a tab portion being located adjacent one end thereof, whereby the end of said clip member which carries the tab portion may be bent about said strip portion away from said connector member, to pemit the axial collapse thereof.

Claim 26

Dependent Claim 52 words

The sealed, sterile container of claim 19 in which said connector member defines a partial flange having a longitudinal opening defined therethrough, said partial flange being located intermediate said first and second flanges on the exterior of said connector member, said strip member of the clip member being positioned in said opening.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	1980-01-25	1980-07-26	1981-01-25	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	1984-01-25	1984-07-26	1985-01-25	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	1988-01-25	1988-07-26	1989-01-25	$7700.00	Window Closed / Lapsed

Method and apparatus for sealed, sterile connection

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