Fluid sampling device for closed collection systems

• US 5,496,301 A
• Filed: 08/09/1993
• Issued: 03/05/1996
• Est. Priority Date: 09/25/1992
• Status: Expired due to Fees

• Current Assignee: Gambro, Inc. (DaVita Incorporated)
• Original Assignee: COBE Laboratories Incorporated (Terumo Corporation)
• Inventors: White, Robert L., Green, Todd C., Hlavinka, Dennis J.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): ZUTTARELLI, ANTHONY
• Application Number:
  US08/104,343
• Time in Patent Office: 939 Days
• Field of Search: 604/403, 604/408, 604/409, 604/410, 604/411, 604/412, 604/414, 604/905, 128/760, 128/762, 128/767, 128/770, 128/912, 128/DIG. 24
• US Class Current: 604/409
• CPC Class Codes: B29C 57/10 Closing
• CPC Class Codes: B29C 65/04 Dielectric heating, e.g. high-frequency welding , i.e. radio frequency welding of plastic materials having dielectric properties, e.g. PVC
• CPC Class Codes: B29C 65/743 using the same tool for both joining and severing, said tool being monobloc or formed by several parts mounted together and forming a monobloc B29C65/2046 takes precedence
• CPC Class Codes: B29C 66/1122 Single lap to lap joints, i.e. overlap joints B29C66/45, B29C66/472, B29C66/52272 take precedence
• CPC Class Codes: B29C 66/4312 for making flat seams in tubular or hollow articles, e.g. transversal seams
• CPC Class Codes: B29C 66/71 characterised by the composition of the plastics material of the parts to be joined welding bar compositions B29C65/125
• CPC Class Codes: B29C 66/73921 characterised by the materials of both parts being thermoplastics
• CPC Class Codes: B29C 66/8122 characterised by the composition of the material constituting the pressing elements, e.g. constituting the welding jaws or clamps
• CPC Class Codes: B29C 66/81263 Dielectric properties
• CPC Class Codes: B29C 66/81422 being convex
• CPC Class Codes: B29C 66/8187 characterised by the electrical insulating constructional aspects
• CPC Class Codes: B29C 66/81871 of the welding jaws
• CPC Class Codes: B29C 66/8322 Joining or pressing tools reciprocating along one axis
• CPC Class Codes: B29C 66/857 Medical tube welding machines
• CPC Class Codes: B29C 66/8614 Tongs, pincers or scissors
• CPC Class Codes: B29K 2023/06 PE, i.e. polyethylene
• CPC Class Codes: B29K 2023/12 PP, i.e. polypropylene
• CPC Class Codes: B29L 2023/007 Medical tubes other than catheters catheters B29L2031/7542
• CPC Class Codes: B29L 2031/753 Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008
• CPC Class Codes: Y10S 128/24 Medical-surgical bags
• CPC Class Codes: Y10S 604/905 : Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

A method and device for sampling biological fluids during collection without opening the functionally closed collection system, thereby compromising the sterility of the collected fluid. A sample bag connected to a fluid line or collection reservoir is filled coincident with fluid collection, then hermetically sealed and physically separated from the collection system using a radio frequency tubing sealer. A vacuum tube collection device is attached to the sample bag to minimize exposure to the fluid during sample handling and processing.

Claims

1. A functionally closed system for maintaining sterile conditions while collecting and sampling biological fluids comprising:

a tubular line for withdrawing biological fluids during a collection procedure;

a sample receptacle connected to said tubular line, said receptacle comprising a sample reservoir and an entry tube connected to said reservoir and to said tubular line for enabling said fluid to flow into said reservoir;

a radio frequency heating apparatus with jaws sized to surround and heat said entry tube to close said tube; and

a thermal insulating sleeve means located around said entry tube, said sleeve means having a low dielectric loss coefficient for insulating said entry tube from said jaws when said jaws are used to close said entry tube after filling said reservoir;

whereby when said sample reservoir is filled with fluid and removed from the closed system to enable laboratory analysis of said fluid the sterility of said closed system is not compromised and danger of spillage from said entry tube or said sample reservoir is averted.

2. The system of claim 1 wherein the system comprises a plurality of sample receptacles.

3. The system of claim 1 wherein said entry tube of said sample receptacle is removably connected to a fluid collection bag, said bag directly connected to said tubular line whereby said sample receptacle is filled together with said bag.

4. The system of claim 3 wherein said sample receptacle is removably connected to said bag by a perforated border positioned between said sample receptacle and said bag so that said receptacle is easily removed after said entry tube is sealed.

5. The system of claim 1 wherein said receptacle is formed of a flexible thermoplastic material, said thermoplastic material having a relatively high dielectric loss coefficient.

6. The system of claim 5 wherein the flexible thermoplastic material is polyvinyl chloride.

7. The system of claim 1 further including withdrawal means attached to said reservoir for enabling the withdrawal of fluids therein for laboratory analysis.

8. The system of claim 7 wherein said withdrawal means comprises an outlet tube connected to a needle, said needle encapsulated within a resealable elastomeric sheath, said sheath surrounded by a plastic shield thereby guarding said needle from accidental damage or exposure.

9. The system of claim 8 wherein said withdrawal means further includes an evacuated tube closed by a septum for insertion onto said needle for withdrawing fluid from said reservoir into said evacuated tube.

10. A device for collecting samples of biological fluids comprising:

a flexible sample receptacle with an entry tube through which biological fluids can enter for collection in said sample receptacle, said entry tube and sample receptacle comprised of a thermoplastic material with a relatively high dielectric loss coefficient, said entry tube having an outer sleeve comprised of a material with a relatively low dielectric loss coefficient, whereby said entry tube can be sealed by application of heat thereto, enabling transport of said sample receptacle without danger of spillage of biological fluid.

11. The device of claim 10 wherein said sample receptacle is formed in a unitary construction as an appendage to a larger fluid collection bag, said entry tube communicating with said bag such that said fluids enter said receptacle as they build up in said bag.

12. The device of claim 11 wherein said receptacle is removably connected to said bag by a perforated border positioned between said sample receptacle and said bag so that said receptacle is easily removed after said entry tube is sealed.

13. The device of claim 10 further including withdrawal means attached to said sample receptacle for enabling the withdrawal of fluids therein into tubes for laboratory analysis.

14. The device of claim 13 wherein said withdrawal means comprises an outlet tube connected to a needle, said needle encapsulated within a resealable elastomeric sheath, said sheath surrounded by a plastic shield, thereby guarding said needle from accidental damage or exposure.

15. The device of claim 14 wherein said withdrawal means further includes an evacuated tube closed by a septum for insertion onto said needle for withdrawing fluid from said reservoir into said evacuated tube.

16. A device for collecting samples of biological fluids comprising:

a flexible sample receptacle with an entry tube through which biological fluids can enter for collection in said sample receptacle, said entry tube having located around it a thermal insulating sleeve means wherein said sleeve means has a low dielectric coefficient for insulating the entry tube; and

a withdrawal means attached to said sample receptacle for withdrawing fluids therein into a sample tube for laboratory analysis, wherein said withdrawal means comprises a first end securely connected to said sample receptacle and a second free end, wherein said sample tube is inserted into the second end of said withdrawal means to withdraw fluids from said receptacle into said sample tube.

17. The device of claim 16 wherein said withdrawal means further comprises an outlet tube connected to a needle, said needle encapsulated within a resealable elastomeric sheath, said sheath surrounded by a plastic shield, thereby guarding said needle from accidental damage or exposure.

18. The device of claim 17 wherein said sample tube further comprises a septum for insertion onto said needle for withdrawing fluid from said receptacle into said sample tube.