BODY FLUID SAMPLING DEVICE AND A METHOD THEREOF

• US 20120017999A1
• Filed: 12/02/2009
• Published: 01/26/2012
• Est. Priority Date: 12/05/2008
• Status: Active Application

• Current Assignee: Fluisense APS
• Original Assignee: Fluisense APS
• Inventors: Velschow, Sten
• Granted Patent: US 10,286,149 B2
• Time in Patent Office: Days
• US Class Current: 137/1
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/150015 Source of blood
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61M 5/178 Syringes
• CPC Class Codes: Y10T 137/0318 Processes
• CPC Class Codes: Y10T 137/8593 Systems
• CPC Class Codes: Y10T 137/85978 With pump

Abstract

According to an embodiment of the invention, a body fluid sampling device is disclosed. The device includes a channel for allowing passage of the fluid through the channel, a flow controller for maintaining flow of the fluid in the channel; a flow direction controller for changing the direction of the flow of the fluid towards a collection medium; and the flow controller for delivering a portion of the fluid as a sample onto the collection medium.

Claims

1. A fluid sampling device comprising:

a channel for allowing passage of the fluid through the channel;

a flow controller for maintaining flow of the fluid in the channel;

a flow direction controller for changing the direction of the flow of the fluid towards a collection medium; and

the flow controller for delivering a portion of the fluid as a sample onto the collection medium.

2. The device according to claim 1, wherein the channel is selected from a flexible tube, such as a catheter tube, and a passage within the housing of the device.

3. The device according to claim 1, wherein the channel includes an inflow channel, an outflow channel and a channel part positioned between the inflow channel and the outflow channel.

4. The device according to claim 3, wherein the inflow channel comprises a curvature/linear tube portion, the curvature/linear tube portion interacts with the flow controller, which maintains the flow of fluid in the channel.

5. The device according to claim 1, wherein the flow controller comprises a pump, such as a peristaltic pump.

6. The device according to claim 1, wherein the flow direction controller comprises the channel part controlled by an actuation means, the actuation means being adapted to position the channel part in at least two positions such that in a first position the channel part forms a closed loop of fluid flow in the channel and in a second position the channel part faces the collection medium and allows delivery of the portion of the fluid as the sample onto the collection medium.

7. The device according to claim 1, wherein the flow direction controller comprises the channel part controlled by an actuation means, the actuation means being adapted to position the channel part in at least two positions such that in a first position the channel part forms an open loop of fluid flow in the channel and in a second position the channel part faces the collection medium and allows delivery of the portion of the fluid as the sample onto the collection medium.

8. The device according to claim 1, wherein the flow direction controller comprises:

a cylindrical rotating member; and

a flexible conduit having an afferent part, a slit and an efferent part, with the efferent part passing tangentially through a groove in said rotating member and where the afferent and efferent parts are fixed to the housing at a distance from the rotating member to allow 45 degrees to 180 degrees rotation of the member, and

where the housing in one position of the member the efferent conduit is pressed against the housing creating a knick and closing the efferent flow while at the slit the conduit is bent so as to open the slit, and

where the member in another position straightens out the knick of the efferent conduit and bends the afferent conduit with the slit in the opposite direction causing the slit to close.

9. The device according to claim 1, wherein the flow controller compresses the curvature/linear tube portion of the inflow channel for maintaining the flow in the channel and for delivering the portion of fluid from the outflow end of the channel part onto the collection medium when the channel part is in the second position.

10. The device according to claim 3 wherein:

the inflow channel receives the fluid from a subject;

the channel part allows delivery of the portion of the fluid as the sample onto the collection medium when the channel part is in the second position; and

the outflow channel takes the fluid back to the subject, thereby forming the closed loop, or forms an open loop, when the channel part is in the first position.

11. The device according to claim 1, wherein:

the channel part comprises an inflow end and an outflow end, the inflow end receives the fluid from the inflow channel in both the first position and the second position; and

the outflow end allows delivery of the sample onto the collection medium when the channel part is in the second position and provides the fluid back to the subject through the outflow channel, thereby forming the closed loop, or forms an open loop when the channel part is in the first position.

12. The device according to claim 1, wherein the actuation means is selected from a manual mechanism and an automatic mechanism, the mechanisms being adapted to control the positioning of the channel part based on a predetermined parameter such as time difference between deliveries of two samples.

13. The device according to claim 1, wherein the collection medium is made up of an absorbent material and is selected from a group consisting of a roll, tape, string, disc and pockets for each sample on the collection medium.

14. The device according to claim 1, wherein the collection medium comprises an unused collection medium and a used collection medium comprising the collection medium containing the sample.

15. The device according to claim 14 wherein:

the unused collection medium is rolled around an unused bobbin and the used collection medium is rolled around a used bobbin; and

the used bobbin is connected to a drive means, which rotates the used bobbin such that the collection medium unrolls from the unused bobbin and the used collection medium rolls around the used bobbin.

16. The device according to claim 15 wherein:

the unused collection medium unrolls from the unused bobbin, the unrolled collection medium is passed across and exposed to the outflow end of the channel part and collects the sample onto the exposed unused collection medium; and

the used collection medium rolls around the used bobbin.

17. The device according to claim 15 wherein the used bobbin is enclosed within the unused bobbin.

18. The device according to claim 15 wherein the unused bobbin is enclosed the within the used bobbin.

19. The device according to claim 15 wherein the unused bobbin and the used bobbin are positioned without one bobbin being enclosed by another.

20. The device according to claim 1, wherein the collection medium includes a disc, the disc comprising a collection surface area for collecting the sample and the disc being coupled to a motor that rotates the disc in steps in such a way that with each actuation, the disc exposes an unused disc area to the outflow end of the channel part.

21. The device according to claim 1, further comprising:

an illuminating means for illuminating a sample area on the collection medium,

the sample area being defined by the area of the collection medium on which the sample is deposited;

a detector for detecting a signal from the sample area; and

a processor coupled with the detector for processing the signal and determining properties, such as sample volume, associated with the sample.

23. The device according to claim 1, wherein the device comprises a cassette including the channel, flow direction controller, and curvature/linear tube portion.

24. The device according to claim 1, wherein the device comprises a cassette including the channel, flow direction controller, curvature/linear tube portion, collection medium, unused bobbin, and used bobbin.

25. The device according to claim 23 wherein the cassette further comprises the flow controller.

26. The device according to claim 23 wherein the cassette is sealable, sterlizable and disposable.

27. The device according to claim 1, further comprising a separating film coil providing a reagents/protective layer over the sample area to prevent contamination of the sample.

22. A compact sample recording medium comprising:

an unused bobbin comprising an unused collection medium rolled around the unused bobbin;

an used bobbin adapted to rotate and comprising a used collection medium rolled around the used bobbin;

wherein, the unused collection medium unrolls from the unused bobbin and collects a sample, defining the used collection medium, while moving towards used bobbin; and

either the used bobbin is enclosed within the unused bobbin or the unused bobbin is enclosed within the used bobbin.

28. A method for sampling a fluid, comprising passing the fluid through a channel;

maintaining flow of the fluid in the channel using a fluid controller;

changing the direction of the flow of the fluid towards a collection medium; and

delivering a portion of the fluid as a sample onto the collection medium using the fluid controller.

29. The method according to claim 28, wherein the channel includes an inflow channel, an outflow channel and a channel part positioned between the inflow channel and the outflow channel.

30. The method according to claim 28, further comprising controlling the position the channel part using the flow direction controller in at least two positions such that in a first position the channel part forms a closed loop of fluid flow in the channel and in a second position the channel part faces the collection medium and allows delivery of the portion of the fluid as the sample onto the collection medium.

31. The method according to claim 28, further comprising controlling the position the channel part using the flow direction controller in at least two positions such that in a first position the channel part forms an open loop of fluid flow in the channel and in a second position the channel part faces the collection medium and allows delivery of the portion of the fluid as the sample onto the collection medium.

32. The method according to claim 28, further comprising controlling the position the channel part using the flow direction controller in at least two positions such that in a first position the channel part forms an open loop of fluid flow in the channel and in a second position the channel part faces the collection medium and allows delivery of the portion of the fluid as the sample onto the collection medium.

33. The method according to claim 28, further comprising compressing a curvature/linear tube portion of the inflow channel using the flow controller for maintaining the flow in the channel and for delivering the portion of fluid from an outflow end of the channel part onto the collection medium when the channel part is in the second position.

34. The method according to claim 28, wherein the collection medium comprises an unused collection medium and a used collection medium comprising the collection medium containing the sample.

35. The method according to claim 28, further comprising rotating a used bobbin using a drive means such that the collection medium unrolls from an unused bobbin having the unused collection medium and the used collection medium rolls around the used bobbin.

36. The method according to claim 28, further comprising:

unrolling the unused collection medium from the unused bobbin, passing across and exposing the unused collection medium to the channel part and collecting the sample on the exposed unused collection medium; and

rolling the used collection medium around the used bobbin.

37. The method according to claim 28, further comprising:

illuminating a sample area on the collection medium using an illuminating means, the sample area being defined by the area of the collection medium on which the sample is deposited;

detecting a signal from the sample area using a detector; and

processing the signal using a processor coupled with the detector for determining properties, such as sample volume, associated with the sample.