Sterile/aseptic connector
AssigneeBaxter International Inc.
InventorsDavid Bacehowski, David Cerny, Dean Glash, Richard Afflerbaugh, Joseph West, Jr.
Life of this patent
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Abstract
An aseptic/sterile fluid connection between two containers is formed by radio frequency sealing together portions of transfer regions of two containers. Each transfer region has a layer of a relatively high melt temperature material such as a rubber or elastomer positioned between two outer container walls made of a flexible thermoplastic, for example polyvinyl chloride. The transfer regions are placed in registry, and the radio frequency welding fuses together portions of adjacent container outer walls and forms a fluid opening therethrough.
Claims22
A flexible sterile container comprising:
- at least two RF-responsive outer walls defining a cavity therebetween made of a thermoplastic material that will melt at a first temperature;
- and
- an RF-insulative liner disposed between two RF-responsive outer walls, the liner made of a bio-compatible, low dielectric material with a melting temperature above the first temperature wherein the liner is made of an elastomer.
A method of forming a sterile connection comprising the steps of:
- providing two flexible containers having outer walls made of an RF-responsive thermoplastic;
- providing an RF-insulative liner of a bicompatible, low dielectric material with a melting point above that of the outer walls within a transfer region of each container;
- positioning the containers such that the transfer regions are, at least in part, in registry and the outer walls of the containers are adjacent;
- clamping the transfer regions between dies of a radio frequency welding source;
- generating a radio frequency welding signal so as to fuse together the outer walls of the containers that are adjacent to each other;
- and
- forming an opening through the fused thermoplastic walls.
A connection system for forming a sterile fluid connection between two sterile containers, comprising:
- two containers having outer walls made of a thermoplastic that will melt at sterilizing temperatures and that is particularly susceptible to radio frequency welding;
- a liner disposed within each container and made of a biocompatible, low dielectric material with a melting point above that of the walls of the containers;
- a radio frequency source;
- and
- two welding dies associated with the radio frequency source capable of applying pressure while delivering radio frequency energy to effectively seal together portions of the outer walls of the containers when placed between the dies.
A method of forming a sterile connection comprising the steps of:
- providing two flexible containers having outer walls made of a thermoplastic;
- providing a liner of a biocompatible, low dielectric material with a melting point above that of the outer walls within a transfer region of each container wherein the bicompatible, low dielectric material is a rubber;
- positioning the containers such that the transfer regions are, at least in part, in registry and outer walls of the containers are adjacent;
- clamping the transfer regions between dies of a radio frequency welding source;
- generating a radio frequency welding signal so as to fuse together the outer walls of the containers that are adjacent to each other;
- and
- forming an opening through the fused thermoplastic walls.
A connection system for forming a sterile fluid connection between two sterile containers, comprising:
- two containers having outer walls made of a thermoplastic that will melt at sterilizing temperatures and that is particularly susceptible to radio frequency welding;
- a liner disposed within each container and made of a biocompatible, low dielectric material with a melting point above that of the walls of the containers;
- a radio frequency source;
- and
- two welding dies associated with the radio frequency source capable of applying pressure while delivering radio frequency energy to effectively seal together portions of the outer walls of the containers when placed between the dies wherein each die includes a crown with a convex surface at an axial end thereof.
A connection system for forming a sterile fluid connection between two sterile containers, comprising:
- two containers having outer walls made of a thermoplastic that will melt at sterilizing temperatures and that is particularly susceptible to radio frequency welding;
- a liner disposed within each container and made of a biocompatible, low dielectric material with a melting point above that of the walls of the containers;
- a radio frequency source;
- and
- two welding dies associated with the radio frequency source capable of applying pressure while delivering radio frequency energy to effectively seal together portions of the outer walls of the containers when placed between the dies wherein a die has a substantially cylindrical base and a smaller substantially cylindrical crown.
Two blood bags coupled together in fluid communication by means of a sterile connection, the blood bags comprising outer walls made of a thermoplastic material that will melt at sterilizing temperatures, each blood bag having a transfer region where a liner is disposed within the blood bag, the liner being made of a biocompatible, low-dielectric material with a melting temperature greater than that of the outer walls, the blood bags being connected at their transfer regions, the connection comprising portions of adjacent outer walls which are fused together and which include an opening therethrough wherein the liners are made of an elastomer.
A sterile connection comprising a plurality of layers arranged as follows:
- a first thermoplastic layer;
- a first liner of a low dielectric material;
- second and third thermoplastic layers fused together at portions thereof and including an opening therethrough;
- a second liner of a low dielectric material;
- and
- a fourth thermoplastic layer, the thermoplastic layers having a melting temperature that is lower than the melting temperature of the low dielectric material wherein the dielectric material is an elastomer.
A sterile connection comprising a plurality of layers arranged as follows:
- a first thermoplastic layer;
- a first liner of a low dielectric material;
- second and third thermoplastic layers fused together at portions thereof and including an opening therethrough;
- a second liner of a low dielectric material;
- and
- a fourth thermoplastic layer, the thermoplastic layers having a melting temperature that is lower than the melting temperature of the low dielectric material wherein the low dielectric material comprises silicone rubber.
Dependencies are inferred from the claim text.