EP0128904A1 - Fluidübertragungsglied und zusammenbau der eine strahlungsenergie absorbierende wand mit optimalen schmelzmerkmalen einschliesst - Google Patents

Fluidübertragungsglied und zusammenbau der eine strahlungsenergie absorbierende wand mit optimalen schmelzmerkmalen einschliesst

Info

Publication number
EP0128904A1
EP0128904A1 EP83903653A EP83903653A EP0128904A1 EP 0128904 A1 EP0128904 A1 EP 0128904A1 EP 83903653 A EP83903653 A EP 83903653A EP 83903653 A EP83903653 A EP 83903653A EP 0128904 A1 EP0128904 A1 EP 0128904A1
Authority
EP
European Patent Office
Prior art keywords
wall
radiant energy
density
meltable
expressed
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP83903653A
Other languages
English (en)
French (fr)
Inventor
Arnold C. Bilstad
Richard I. Brown
John T. Foley
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Baxter International Inc
Original Assignee
Baxter Travenol Laboratories Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Baxter Travenol Laboratories Inc filed Critical Baxter Travenol Laboratories Inc
Publication of EP0128904A1 publication Critical patent/EP0128904A1/de
Withdrawn legal-status Critical Current

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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/05Particular design of joint configurations
    • B29C66/10Particular design of joint configurations particular design of the joint cross-sections
    • B29C66/11Joint cross-sections comprising a single joint-segment, i.e. one of the parts to be joined comprising a single joint-segment in the joint cross-section
    • B29C66/116Single bevelled joints, i.e. one of the parts to be joined being bevelled in the joint area
    • B29C66/1162Single bevel to bevel joints, e.g. mitre joints
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M39/14Tube connectors; Tube couplings for connecting tubes having sealed ends
    • A61M39/143Tube connectors; Tube couplings for connecting tubes having sealed ends both tube ends being sealed by meltable membranes pierced after connection by use of heat, e.g. using radiant energy
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/14Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation
    • B29C65/1429Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation characterised by the way of heating the interface
    • B29C65/1435Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation characterised by the way of heating the interface at least passing through one of the parts to be joined, i.e. transmission welding
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/14Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation
    • B29C65/1477Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation making use of an absorber or impact modifier
    • B29C65/148Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation making use of an absorber or impact modifier placed at the interface
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C65/00Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/56Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using mechanical means or mechanical connections, e.g. form-fits
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    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C65/72Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by combined operations or combined techniques, e.g. welding and stitching
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    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
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    • B29C65/74Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by welding and severing, or by joining and severing, the severing being performed in the area to be joined, next to the area to be joined, in the joint area or next to the joint area
    • B29C65/747Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by welding and severing, or by joining and severing, the severing being performed in the area to be joined, next to the area to be joined, in the joint area or next to the joint area using other than mechanical means
    • B29C65/7473Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by welding and severing, or by joining and severing, the severing being performed in the area to be joined, next to the area to be joined, in the joint area or next to the joint area using other than mechanical means using radiation, e.g. laser, for simultaneously welding and severing
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C66/00General aspects of processes or apparatus for joining preformed parts
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    • B29C66/1312Single flange to flange joints, the parts to be joined being rigid
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/50General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
    • B29C66/51Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
    • B29C66/52Joining tubular articles, bars or profiled elements
    • B29C66/522Joining tubular articles
    • B29C66/5221Joining tubular articles for forming coaxial connections, i.e. the tubular articles to be joined forming a zero angle relative to each other
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/50General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
    • B29C66/51Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
    • B29C66/52Joining tubular articles, bars or profiled elements
    • B29C66/522Joining tubular articles
    • B29C66/5223Joining tubular articles for forming corner connections or elbows, e.g. for making V-shaped pieces
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/50General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
    • B29C66/51Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
    • B29C66/52Joining tubular articles, bars or profiled elements
    • B29C66/522Joining tubular articles
    • B29C66/5229Joining tubular articles involving the use of a socket
    • B29C66/52298Joining tubular articles involving the use of a socket said socket being composed by several elements
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/50General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
    • B29C66/51Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
    • B29C66/53Joining single elements to tubular articles, hollow articles or bars
    • B29C66/534Joining single elements to open ends of tubular or hollow articles or to the ends of bars
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/50General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
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    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/70General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/73General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset
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    • B29C66/7377General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the state of the material of the parts to be joined amorphous, semi-crystalline or crystalline
    • B29C66/73773General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the state of the material of the parts to be joined amorphous, semi-crystalline or crystalline the to-be-joined area of at least one of the parts to be joined being semi-crystalline
    • B29C66/73774General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the state of the material of the parts to be joined amorphous, semi-crystalline or crystalline the to-be-joined area of at least one of the parts to be joined being semi-crystalline the to-be-joined areas of both parts to be joined being semi-crystalline
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    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/70General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
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    • B29C66/739General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of the parts to be joined being a thermoplastic or a thermoset
    • B29C66/7392General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of at least one of the parts being a thermoplastic
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/14Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation
    • B29C65/16Laser beams
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/70General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/71General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the composition of the plastics material of the parts to be joined
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00Other particular articles
    • B29L2031/712Containers; Packaging elements or accessories, Packages
    • B29L2031/7148Blood bags, medical bags

Definitions

  • This invention generally relates to fluid transfer devices.
  • this invention relates to fluid transfer devices which include meltable portions.
  • Granzow et al U.S. Patent 4,157,723 concerns a fluid transfer device which uses a meltable, radiant energy absorbing wall to normally seal a conduit from communication with the atmosphere. The wall is melted in response to exposure to radiant energy to open a fluid path through the device. By coupling two of these devices together and then applying radiant energy to melt the walls, a sterile, hermetically sealed fluid pathway can be formed between the assembled devices.
  • This general type of fluid transfer device lends itself to use in systems in which fluids are transferred in a sterile, or aseptic, manner; for example, in blood component collection and processing systems; in chemical compounding and parenteral solution formation systems; and in fluid systems associated with peritoneal dialysis.
  • the performance characteristics of a meltable, radiant energy absorbing wall can be best optimized by maximizing the density, or opacity, of the meltable wall to the applied radiant energy.
  • the meltable wall conventionally includes a relatively large percentage by weight of a carbon filler to maximize its opacity to these types of radiant energy.
  • the performance characteristics of a meltable, radiant energy absorbing wall are not optimized at these maximum opacity levels.
  • a fluid transfer member comprising means which defines a meltable wall made of a radiant energy absorbing material.
  • the wall normally seals the member from communication with the atmosphere. In response to the application of radiant energy, the wall melts, and an opening is formed in the wall.
  • the meltable wall has density, or opacity, to the applied radiant energy which lies within a specially defined range of density values. Density values falling within this defined range do not maximize the opacity of the meltable wall to the applied radiant energy. Nevertheless, within this range, the desirable melt characteristics of the wall are significantly better than in a wall having an opacity which falls above or below the range. More particularly, the invention provides a meltable wall which has a density, or opacity, to the applied radiant energy (hereafter referred to simply as the "D-value") which lies within the range of about 3 ⁇ D-value ⁇ about 12. The D-value is dimensionless and is directly indicative of the degree of opacity of the wall. The D-value is determined by the formula:
  • D-value ⁇ L.
  • represents the radiant energy absorbance of the wall.
  • is itself determined by the formula and is expressed in units per centimeter:
  • I o represents the intensity of the applied radiant energy as it enters the meltable wall, expressed in watts per square centimeter, or any derivative thereof;
  • I represents the intensity of the applied radiant energy as it exits the meltable wall, expressed in the same terms as I o ;
  • the D-value of the meltable wall lies within the range of about 4 ⁇ D-value ⁇ about 6.
  • the D-value of the meltable wall lies within the range of about 5.5 ⁇ D-value ⁇ about 6.0.
  • the meltable wall is interposed between two fluid conduits to normally block communication therebetween.
  • an opening is formed the meltable wall in response to the application of radiant energy, thereby opening flow communication between the conduits.
  • Fig. 1 is a perspective view of a fluid transfer system which employs a pair of fluid transfer members, each of which embodies the features of the invention
  • Fig. 2 is an enlarged side view, with a portion broken away and in section, of the fluid transfer members shown in Fig. 1 in an uncoupled relationship
  • Fig. 3 is an enlarged side view, with portions broken away and in section, of the fluid transfer members shown in Fig. 1 in a coupled relationship as radiant energy is being applied
  • Fig. 4 is an enlarged side view, similar to
  • Fig. 5 is a graph which plots the absorbance ( ⁇ ) of a meltable radiant energy absorbing wall against the charcoal content of the wall;
  • Fig. 6 is a graph which plots the diameter of the hole formed in the wall against the associated D-value
  • Fig. 7 is a graph which plots the temperature distribution across the wall against the associated absorbance ( ⁇ );
  • Fig. 8 is a graph which plots the melt efficiency of the wall against the associated D-value
  • Fig. 9 is a graph which plots the temperature uniformity across the wall against the associated D-value.
  • a member 10 which is attachable to a conduit 12 is shown in Figs. 1 through 4. As can best be seen in Fig. 2, the member 10 comprises means which defines a meltable wall 14. When the member 10 is attached to the conduit 12, the meltable wall 14 normally seals the conduit 12 from communication with the atmosphere.
  • the meltable wall 14 is made of a radiant energy absorbing material. By applying radiant energy, the wall 14 is melted, and an opening is formed in the wall 14. Fluid communication is thereby opened with the associated conduit 12.
  • radiant energy broadly refers to energy which is in the form of electromagnetic waves, such as radio waves, infrared waves, visible light, ultraviolet waves, x-rays, and the like. Because the transfer of radiant energy requires no intervening medium, the transfer can be faster and more efficient than in conductive or convective heat transfer, both of which require an intervening medium.
  • the member 10 may be variously constructed.
  • the member 10 includes body means 18 which is attachable to the end portion 20 of the conduit 12.
  • the meltable wall 14 is sealingly disposed on the body means 18 (see, in particular, Fig. 2).
  • the wall 14 melts, and an opening is formed in the body means 18.
  • the body means 18 includes a housing 22 which defines a hollow interior 24 which communicates with the interior of the attached conduit 12.
  • the meltable wall 14 normally seals or closes the housing interior 24 from communication with the atmosphere.
  • the housing 22 further includes a tubular conduit portion 26 which communicates with the interior 24 and which serves to interconnect the housing 22 with the conduit end portion 20. While the housing 22 may be variously attached to the end 20 of the conduit 12, in the illustrated embodiment, a hermetic, friction-fit between the end 20 and conduit portion 26 is envisioned.
  • the conduit 12 to which the member 20 is attached can itself be integrally connected with a container 30, such as a plastic bag.
  • the container 30 can contain a fluid and be used to dispense fluids, or it can be empty and be used to receive fluids.
  • a manually operated inline valve member 32 (shown in phantom lines in Fig. 1) is preferably provided to normally prevent fluid communication between the container 30 and the housing interior 24. While the valve member 32 may be variously constructed, in the illustrated embodiment, it takes the form of a manually frangible valve member, such as that disclosed in Carter et al, U.S. Patent 4,294,247.
  • valve member 32 may form an integral part of the member housing 22, such as disclosed in Ammann et al U.S. Patent 4,340,097.
  • the material from which the meltable wall 14 is constructed is preferably selected to melt only at temperatures which result in the destruction of bacterial contaminants on the surface of the material (i.e., over 200oC).
  • the wall 14 can be opened only in conjunction with an active sterilization step which serves to sterilize the regions adjacent to the fluid path as the fluid path is formed.
  • the housing 22 is made of a material which absorbs the applied radiant energy in lesser amounts than the wall 14. Most preferably, the housing 22 is relatively nonabsorbant of the particular type of radiant energy applied. By virtue of this construction, as radiant energy is applied to melt the wall 14, the housing 22 itself is not heated to any great extent. Rather, the housing 22 serves to pass the radiant energy directly to the wall 14. The transfer of radiant energy is fast and efficient.
  • the particular material selected for the member 10 depends largely upon the type of radiant energy which is to be applied. Conventionally, radiant energy which includes infrared and/or visible light is used.
  • the member 10 is conventionally made of a material fabricated from poly(4-methyl-1-pentene), which is sold under the trademark TPX by Mitsui Chemical Company. This material has a crystalline melting point of approximately 235°C and is further discussed in Boggs et al, U.S. Patent 4,325,417.
  • the meltable wall 14 conventionally contains large amounts by weight of a carbon filler so as to absorb radiant energy in the infrared and visible light band.
  • the housing 22 is conventionally free of the filler and is thus relatively transparent to (i.e., generally nonabsorbant of) this band of radiant energy.
  • the member 10 as heretofore described can serve by itself to seal the end portion 20 of the conduit 12 from communication with the atmosphere until time of use.
  • the application of radiant energy opens the wall 14 at the time fluid flow through the conduit 12 is desired.
  • a pair of the members 10 may also be used to form a fluid transfer assembly 40 to form a connection between two fluid containers 30 and 31. More particularly, in the transfer assembly
  • the member 10 includes coupling means 34 for bringing the meltable wall 14 of one member 10 into facing contact with a corresponding meltable wall 14 of a second member.
  • the second member is preferably constructed identically to the member 10 heretofore described. Because of this, the second member is also designated by the numeral 10 in Figs. 1 through 4. Other structural elements common to the first and second members 10 are likewise identified with the same reference numerals heretofore assigned.
  • the coupling means 34 may be variously constructed.
  • the coupling means 34 takes the form of mating bayonet-type coupling mechanisms 36 which interlock the members 10 together with their radiant energy absorbing walls 14 in facing contact (see, in particular, Fig. 3).
  • the radiant energy absorbing walls 14 When exposed to a source 38 of radiant energy spaced from the assembly 40, the radiant energy absorbing walls 14 jointly melt and fuse together, as can be seen in Fig. 4. A fusion bond between the walls 14 is thereby formed.
  • the walls form an opening 16 which establishes through the members 10 a fluid path which is at once sterile and hermetically sealed about its periphery to communication with the atmosphere.
  • Certain characteristics are desirable for each of the members 10 to optimize the performance of the assembly 40. These desirable characteristics include: (1) The opening 16 which is formed should be large enough to allow unimpeded fluid flow through and between the members 10. In this respect, it is believed that the diameter of the formed hole should approximate the interior diameter of the associated conduit 12. For example, in the case of conventional blood flow tubing, the desired minimum hole diameter is about .10 inch;
  • the fusion bond which is formed between the walls 14 during the melting process should be strong enough to protect against an accidental separation of the members 10. The fusion bond will thus protect the system 40 against an inadvertant breach in sterility.
  • the performance characteristics of the members 10 could be optimized only by maximizing the opacity of the meltable walls 14 to the particular type of radiant energy applied.
  • a source of radiant energy which has been used is a incandescent quartz lamp which has a tungsten filament operating at about 3150oK. This lamp emits radiant energy which lies in a continuous band encompassing mostly infrared and visible energy, although some ultraviolet radiation is included.
  • the TPX material of the wall 14 conventionally contains about one percent (1%) activated charcoal by weight to maximize, to the fullest possible extent, the wall's density to the radiation band emitted by the tungsten lamp.
  • the wall 14 in order to optimize the melt characteristics of the radiant energy absorbing wall 14, the wall 14 must have a density, or opacity, to the applied radiant energy which lies only within a specifically defined range. More particularly, it has been discovered that the melt characteristics of the radiant energy absorbing wall 14 are optimized only when the radiant energy density of the wall (referred to as the "D-value") lies within the range of between about 3 ⁇ D-value ⁇ about 12.
  • the D-value is a dimensionless quantity and is a function of the thickness of the wall and the ability of the wall to absorb the applied radiant energy per unit of thickness.
  • D-value is determined by the formula:
  • represents the radiant energy absorbance of the wall per unit of thickness and is itself determined by the following formula:
  • I o represents the intensity of the applied radiant energy as it enters the wall 14 and is expressed in terms of watts per square centimeter or any other derivative thereof, such as amps, volts, lamberts, lumens, etc.
  • I represents the intensity of the applied radiant energy as it exits the wall 14 and is expressed in the same term selected for I o .
  • the numerator of the formula by which ⁇ is determined is the natural log (In) of the ratio between I and I o and is itself negatively signed, because the ratio is a fraction. A negative sign is therefore provided before “In” in the above formula to convert ⁇ to a positive number.
  • L represents the thickness of the area to be melted measured along the path of radiant energy. L is expressed in centimeters.
  • L represents the thickness of only the single wall 14. However, in the case of an assembly 40 of two walls 14, as shown in Fig. 3, L represents the combined thickness of both walls 14, i.e., generally twice the thickness of the single wall 14.
  • the range of D-values is between about 4 and about 6.
  • melt efficiencies are maximized to the greatest extent possible.
  • the range of D-values is between about 5.5 and about 6.0. Within this narrowest sub-range, it has been discovered that both hole size and melt efficiency are maximized to the greatest extent possible.
  • the blends were used in the meltable walls 14 for members 10 constructed as shown in Figs. 1 through 4.
  • a model Number 325H-PC Hughes helium neon laser was used as the source of radiant energy. The laser emits radiant energy having a wavelength of 6328 Angstroms.
  • a 10 mm lens was used to broaden the beam. The diverging beam was aligned to impinge upon a silicon sensor photo detector which was located about 3.5 inches from the 10 mm lens. The photo detector was used in the closed loop current mode, and the current was measured on a Model 3465A Hewlett Packard Digital Multimeter. Each wall to be measured was placed in the beam at a distance of about 2.25 inches from the lens. The intensity of the radiant energy was determined both before and after each wall was inserted in the beam path. Mean and standard deviations were determined. The ratio of the detected entering and exiting intensities, i.e., I o and I, respectively, was calculated .
  • Table 1 summarizes absorbance ( ⁇ ) obtained.
  • is expressed in units per centimeter of wall thickness.
  • Figure 5 is a graphic display of Table 1.
  • the absorbance ( ⁇ ) progressively increases as the percent of activated charcoal by weight in the wall increases.
  • the slope of the curve is believed to be universally applicable to virtually any type of base material which is laden with activated charcoal and which has, before the addition of the activated charcoal, an inherent absorbance value of zero (i.e., it is virtually nonabsorbant of radiant energy).
  • the origin of the curve in Fig. 5 will change, however, if the initial or inherent absorbance of the particular base material is greater than zero. For example, if the inherent absorbance of the base material is 50 per centimeter, the applicable curve will shift and appear as shown in phantom lines in Fig. 5.
  • the slope of the curve itself may change if a material other than activated charcoal is used to render the base material absorbant to the applied radiant energy.
  • the slope of the curve represents the inherent absorbance of the material which is used to render the base material radiant energy absorbant.
  • the assemblies 40 were exposed to the radiant energy for various amounts of time, ranging from about 5 to about 20 seconds.
  • Table 2 summarizes the hole formation data obtained. Except where noted, the statistical evaluation is based upon a sample size of five (5).
  • Figure 6 is a graphic display of the results summarized in Table 2.
  • the diameter of holes formed in assembled walls having D-values of about 3 to about 12 is substantially equal to or better than the holes formed in the assembled walls having higher D-values.
  • the V2 blend which has an D-value of only 5.8, has a significantly higher tensile strength than the conventional blend V6, having a much higher D-value of 16.0.
  • thermal properties such as heat conduction and capacity, remain constant with time, temperature, and charcoal content
  • the model was reduced to a boundary value problem and was solved using an integral transform technique that removes the space variable.
  • the absorbed radiant energy enters the solution by way of the heat generation function.
  • the temperature distribution solution is solved for time periods after the above-identified transient function has decayed, using the material properties of TPX (Mitsui Grade RT18) as found in
  • Figure 7 plots the temperature distribution across the meltable wall for several absorbance values ( ⁇ ), based upon the foregoing solution and using only a single source of radiant energy.
  • the "incident face” is the side of the meltable wall facing the radiant energy source.
  • the conventional formulation (V6) has an absorbance of about 250 per centimeter, placing its temperature distribution somewhat between E and F in Figure 7.
  • EXAMPLE 5 Theoretical Melt Efficiency
  • the energy required bring the far side of the wall (i.e., the side opposite to the incident face) up to a given temperature can be calculated as a function of D-value. This relationship is directly indicative of the melt efficiency of the wall 14. This plot is shown on Figure 8, and has been normalized to the energy requirements at infinite absorbance.
  • Fig. 8 clearly shows that maximum melt efficiencies occur at D-values of between about 3 and about 6. At D-values below about 3, melt efficiencies significantly deteriorate. It is significant to recall that, as shown in Fig. 6, hole formation is also optimized within the same range of D-values at which optimal melt efficiency is achieved (i.e., between about 3 and about 6).
  • EXAMPLE 6 Theoretical Temperature Uniformity
  • Fig. 9 clearly shows that, as the D-values are successively reduced from about 12 toward 3, the distribution of heat across the wall becomes increasingly more uniform. Thus, the formation of localized "hot spots" is avoided.
  • the model indicates that the principal effect of lowering the D-value is to reduce the range of temperature existent within the wall during the melting phase (see, in particular, Figs. 7 and 9).
  • the model also indicates that the energy requirements are optimized in D-values falling within the range of about 3 to 6 (see, in particular, Fig. 8).
  • Example 3 the tensile pull tests (Example 3) confirm that increased fusion strengths occur at lower D-values. This is because, at lower D-values, the heat penetrates deeper into the wall as a result of the more uniform temperature distribution indicated by the model, and the melt zone does become, in fact, more uniform. Furthermore, as Example 7 confirms, "hot spots” and attendant “splattering” and “bubbling” are in fact eliminated at lower D-values. This confirms that more uniform distributions of temperatures do in fact occur at lower D-values, as again indicated by the model.
  • Example 8 The following Example 8 is provided to illustrate how the invention can be used in selecting a meltable radiant energy absorbing wall having optimal melt characteristics.
  • EXAMPLE 8 (Hypothetical)
  • thermoplastic blend containing about .5% by weight of activated charcoal.
  • absorbance
  • this blend has an absorbance ( ⁇ ) of about 150 per centimeter. If one wants to use this blend as a meltable radiant energy absorbing wall having optimized melt characteristics (i.e., a D-value of about 6.0), the thickness of the meltable wall should be about .04 cm;
EP83903653A 1982-12-16 1983-10-06 Fluidübertragungsglied und zusammenbau der eine strahlungsenergie absorbierende wand mit optimalen schmelzmerkmalen einschliesst Withdrawn EP0128904A1 (de)

Applications Claiming Priority (2)

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US450165 1982-12-16

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SE451089B (sv) * 1985-12-20 1987-08-31 Steridose Systems Ab Kontaminationsfri koppling
DE69012736T2 (de) * 1989-05-05 1995-01-19 Baxter Int Verfahren und vorrichtung für sterile verbindungen zwischen leitungen für flüssigkeiten.
CA2167188A1 (en) * 1993-08-06 1995-02-16 Dan L. Fanselow Chlorine-free multilayered film medical device assemblies
US7938454B2 (en) 2007-04-24 2011-05-10 Hyclone Laboratories, Inc. Sterile connector systems
WO2008131442A2 (en) * 2007-04-24 2008-10-30 Hyclone Laboratories, Inc. Sterile connector systems
WO2022251698A1 (en) * 2021-05-27 2022-12-01 Entegris, Inc. Aseptic coupling assembly and method of aseptic coupling
WO2023132965A1 (en) * 2022-01-06 2023-07-13 Entegris, Inc. Aseptic coupling assembly and method of aseptic coupling

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US4157723A (en) * 1977-10-19 1979-06-12 Baxter Travenol Laboratories, Inc. Method of forming a connection between two sealed conduits using radiant energy
US4265280A (en) * 1979-01-23 1981-05-05 Baxter Travenol Laboratories, Inc. Connector member for sealed conduits
US4325417A (en) * 1979-04-06 1982-04-20 Baxter Travenol Laboratories, Inc. Connector member for sealed conduits utilizing crystalline plastic barrier membrane
ES274987Y (es) * 1981-01-19 1985-04-01 Baxter Travenol Laboratories, Inc. Dispositivo conector esteril perfeccionado.
US4356394A (en) * 1981-01-30 1982-10-26 Baxter Travenol Laboratories, Inc. Apparatus for applying radiant beam

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WO1984002321A1 (en) 1984-06-21
ES8407187A1 (es) 1984-09-01
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CA1219298A (en) 1987-03-17
ZA837743B (en) 1984-06-27

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