Fluid sampling device for closed collection systems

• US 5,685,875 A
• Filed: 06/07/1995
• Issued: 11/11/1997
• 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 Lee, Hlavinka, Dennis J., Green, Todd Curtis
• Primary Examiner(s): ZUTTARELLI, ANTHONY
• Application Number:
  US08/484,835
• Time in Patent Office: 888 Days
• Field of Search: 604/403, 604/407-410, 128/760, 128/762, 128/763, 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 device for collecting samples of fluids said device comprising:

a fluid collection bag having opposing ends,

an entry tube in fluid communication with said fluid collection bag;

a hanger for said fluid collection bag;

a sample receptacle in fluid communication with said fluid collection bag;

wherein;

said entry tube, hanger, and said sample receptacle are formed in a unitary construction with said fluid collection bag, the sample receptacle being formed on the opposite end of the bag from the entry tube.

2. The device of claim 1 wherein the unitary construction of the fluid collection bag, entry tube, hanger and sample receptacle comprises:

a first sheet of flexible plastic material; and

a second sheet of flexible plastic material sealed to the first sheet of plastic material in a pattern that forms the fluid collection bag, entry tube, hanger, sample receptacle and perforated border.

3. The device of claim 2 wherein the second sheet is sealed to the first sheet by heat welding.

4. The device of claim 1 wherein the sample receptacle is removably connected to said bag and hanger by a perforated border positioned between said sample receptacle and said fluid collection bag and hanger.

5. The device of claim 4 wherein the unitary construction of the fluid collection bag, entry tube, and hanger and sample receptacle comprises:

a first sheet of flexible plastic material; and

a second sheet of flexible plastic material sealed to the first sheet of plastic material in a pattern that forms the fluid collection bag, entry tube, hanger, sample receptacle and perforated border.

6. The device of claim 5 wherein the second sheet is sealed to the first sheet by heat welding.

7. The device of claim 4 further comprising:

an aperture between said fluid collection bag and said sample receptacle wherein fluid from the entry tube enters the sample receptacle through the aperture.

8. The device of claim 7 further comprising:

an insulating sleeve on the sample receptacle above the aperture wherein said sleeve defines a sealing location for sealing said sample receptacle for removal from said fluid collection bag and hanger at said perforated border.

9. A tubing set for the collection or administration of blood or blood components, comprising:

a device for collecting samples of fluids in a fluid collection, said device comprising;

a fluid collection bag having opposite ends;

an entry tube in fluid communication with said fluid collection bag;

a hanger for said fluid collection bag;

a sample receptacle in fluid communication with said fluid collection bag;

wherein;

said entry tube, hanger, and said sample receptacle are formed in a unitary construction with said fluid collection bag, the sample receptacle being formed on the opposite end of the bag from the entry tube.

10. The device of claim 9 wherein the unitary construction of the fluid collection bag, entry tube, hanger and sample receptacle comprises:

a first sheet of flexible plastic material; and

a second sheet of flexible plastic material sealed to the first sheet of plastic material in a pattern that forms the fluid collection bag, entry tube, hanger, sample receptacle and perforated border.

11. The tubing set of claim 10 wherein the second sheet is sealed to the first sheet by heat welding.

12. The tubing set of claim 9 wherein the sample receptacle is removably connected to said bag and hanger by a perforated border positioned between said sample receptacle and said fluid collection bag and hanger.

13. The tubing set of claim 12 wherein the unitary construction of the fluid collection bag, entry tube, hanger and sample receptacle comprises:

a first sheet of flexible plastic material; and

a second sheet of flexible plastic material sealed to the first sheet of plastic material in a pattern that forms the fluid collection bag, entry tube, hanger, sample receptacle and perforated border.

14. The device of claim 13 wherein the second sheet is sealed to the first sheet by heat welding.

15. A device for collecting samples of fluid said device comprising:

a fluid collection bag having opposite ends;

an entry tube in fluid communication with said fluid collection bag;

a hanger for said fluid collection bag;

a first sample receptacle in fluid communication with said fluid collection bag;

a second sample receptacle in fluid communication with said fluid collection bag;

a perforated border between said first sample receptacle and said bag and hanger and between said second sample receptacle and said bag and hanger, wherein

said entry tube, hanger, first sample receptacle, and second sample receptacle are formed in a unitary construction with said fluid collection bag;

the first and second sample receptacles being formed on the opposite end of the bag from the entry tube.

16. The device of claim 15 wherein the unitary construction of the fluid collection bag, entry tube, hanger and sample receptacle comprises:

a first sheet of flexible plastic material; and

a second sheet of flexible plastic material sealed to the first sheet of plastic material in a pattern that forms the fluid collection bag, entry tube, hanger, sample receptacle and perforated border.

17. The device of claim 16 wherein the second sheet is sealed to the first sheet by heat welding.