Devices and methods for collecting and stabilizing biological samples

• US 10,463,347 B2
• Filed: 09/08/2017
• Issued: 11/05/2019
• Est. Priority Date: 06/10/2014
• Status: Active Grant

• Current Assignee: Dxterity Diagnostics Incorporated
• Original Assignee: Dxterity Diagnostics Incorporated
• Inventors: Terbrueggen, Robert, Beach, Scott Gordon
• Primary Examiner(s): Bhat, Narayan K
• Application Number:
  US15/699,980
• Publication Number:
  US 20180153522A1
• Time in Patent Office: 788 Days
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2560/0406 specially shaped apparatus housings
• CPC Class Codes: B01L 1/52 Transportable laboratories; Field kits
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2200/0689 Sealing
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/021 Identification, e.g. bar codes
• CPC Class Codes: B01L 2300/022 Transponder chips
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/047 Additional chamber, reservoir
• CPC Class Codes: B01L 2300/0609 Holders integrated in container to position an object
• CPC Class Codes: B01L 2300/0672 Integrated piercing tool
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0832 cylindrical, tube shaped
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2300/123 Flexible; Elastomeric
• CPC Class Codes: B01L 2400/0683 mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/5029 using swabs

Abstract

The present invention generally relates to devices and methods for collecting and stabilizing biological samples, and more particularly, for collecting and stabilizing blood or other bodily fluids from a user'"'"'s fingertip, earlobe, heel or other locations. The present invention also relates to sample collection devices that simplify the process for mixing the biological samples with an additive or additives, provide for efficient storage and safe transport of the samples, and provide for easy access to the samples for subsequent processing.

Claims

1. A device for collecting and stabilizing a biological sample, the device comprising:

(a) a housing comprising an open end portion, a closed end portion, and an interior space;

(b) a retainer insertable into the interior space of the housing, the retainer comprising a vessel for receiving a solution and a penetrable seal for enclosing the solution within the vessel; and

(c) a collector removably engagable with the open end portion of the housing and capable of sealingly closing the open end portion of the housing, the collector comprising a stem portion insertable into the housing, wherein the stem portion comprising;

a first segment;

a second segment formed with a cavity for accommodating an absorbent member for collecting the biological sample; and

a partition disposed between the first segment and the second segment for preventing the absorbent member from being pushed into the first segment when the collector is engaging or engaged with the open end portion of the housing, wherein the partition is made of a porous material or formed with at least one hole or slot to allow the first segment in fluidic communication with the second segment,

wherein when the collector is engaged with the open end portion of the housing, the absorbent member is received in the housing and the second segment of the stem portion of the collector breaks the penetrable seal of the retainer that has been inserted into the interior space of the housing and propels the solution to flow through the absorbent member, thereby releasing the biological sample from the absorbent member and facilitating mixing of the biological sample with the solution.

2. The device of claim 1, wherein the collector further comprises:

a body portion serving as a handle when taking the biological sample and as a seal when engaging or engaged with the open end portion of the housing

wherein the stem portion is fixedly coupled with the body portion or monolithically formed with the body portion, wherein

the first segment is proximal to the body portion the second segment is distal to the body portion.

3. The device of claim 1, wherein the collector further comprises a plasma membrane for generating plasma from the biological sample, wherein the plasma membrane is disposed within the second segment of the stem portion.

4. The device of claim 1, wherein:

the first segment is formed with one or more open slots to allow the released biological sample and the propelled solution flow through.

5. The device of claim 1, wherein:

the first segment proximal to the body portion is formed with a reservoir for facilitating mixing of the biological sample with the solution and accommodating the mixture of the biological sample and the solution.

6. The device of claim 2, wherein the collector further comprises:

a penetrable septum for preventing the mixture of the biological sample and the solution from flowing out through the body portion.

7. The device of claim 6, wherein the penetrable septum is disposed within the body portion and adjacent to the stem portion.

8. The device of claim 1, wherein the collector further comprises:

a first elastomeric seal disposed on an exterior surface of the second segment of the stem portion, wherein the first elastomeric seal provides sealing between the exterior surface of the second segment of the stem portion and an interior surface of the retainer when the collector is engaging or engaged with the open end portion of the housing.

9. The device of claim 1, wherein the second segment of the stem portion includes a tooth protruded from an edge of the second segment of the stem portion to facilitate breaking the penetrable seal of the retainer when the collector is engaging or engaged with the open end portion of the housing.

10. The device of claim 1, wherein the second segment of the stem portion includes a rib formed circumferentially on an exterior surface of the second segment of the stem portion, the rib performing one or more of the following:

(i) acting as a plunger to assist propelling the solution to flow through the absorbent member when the collector is engaging or engaged with the open end portion of the housing, and (ii) assisting in sealing between the second segment of the stem portion and the retainer.

11. The device of claim 2, wherein the body portion comprises one or more pins formed on a side wall of the body portion and proximal to the stem portion for screwing the collector to the housing.

12. The device of claim 2, wherein the body portion comprises two pins formed on a side wall of the body portion and proximal to the stem portion for screwing the collector to the housing, wherein the two pins are opposite to each other.

13. The device of claim 2, wherein:

the body portion comprises at least one detention on a side wall of the body portion; and

the housing comprises at least one slot formed at the open end portion,

wherein the at least one detention is received by the at least one slot when the collector is engaged with the housing, thereby preventing unintentional removal of the collector from the housing after the collector is engaged with the housing.

14. The device of claim 13, wherein:

the at least one detention comprises two clips formed on the side wall of the body portion and opposite to each other; and

the at least one slot comprises two slot corresponding to the two clips.

15. The device of claim 1, wherein the vessel has an open top and a closed bottom, and a central portion of the closed bottom is recessed inwardly toward the open top such that the central portion of the closed bottom compresses the absorbent member when the collector is engaging or engaged with the open end portion of the housing, thereby squeezing the biological sample out of the absorbent member.

16. The device of claim 1, wherein the vessel has an open top, a closed bottom, and a column protruded from a central portion of the closed bottom toward the open top such that the column of the closed bottom compresses the absorbent member when the collector is engaging or engaged with the open end portion of the housing, thereby squeezing the biological sample out of the absorbent member.

17. The device of claim 1, wherein the retainer further comprises a solution retention disposed between the solution received in the vessel and the penetrable seal.

18. The device of claim 1, wherein the vessel of the retainer is tapered with an open top wider than a closed bottom.

19. The device of claim 1, wherein the vessel of the retainer comprises a reservoir adjacent to the open top for facilitating mixing of the biological sample with the solution and accommodating the mixture of the biological sample and the solution.

20. The device of claim 1, wherein:

the housing comprises a first seat formed on an interior surface of the housing for supporting the retainer once the retainer is inserted into the interior space of the housing, and

the vessel comprises a first flange formed on an exterior surface of the vessel of the retainer to abut the first shoulder.

21. The device of claim 1, wherein the open end portion of the housing are threaded with internal threads to facilitate engagement with the collector and/or insertion of the retainer.

22. The device of claim 1, wherein the closed end portion of the housing is formed with (i) a groove extended radially inwardly from an exterior surface of the closed end portion of the housing, (ii) a shoulder or flange extended radially outwardly from the exterior surface of the closed end portion of the housing, (iii) a recess at a bottom of the closed end portion of the housing, or (iv) combination thereof for retaining the housing in a rack when processed using a liquid handling robot.

23. The device of claim 1, wherein the housing comprises at least one slot and the collector comprises at least one detention corresponding to the at least one slot of the housing for interlocking the collector with the housing.

24. The device of claim 1, further comprising one or more of the following:

(i) a 2D Data Matrix Bar Code printed on or attached to a bottom of the housing or an exterior surface of the housing, (ii) a readable product identification printed on or attached to the bottom of the housing or the exterior surface of the housing, and (iii) a radio-frequency identification (RFID) tag printed on or attached to the bottom of the housing or the exterior surface of the housing.

25. A kit for health care, comprising:

(a) a collector comprising;

a first segment;

a second segment formed with a cavity for accommodating an absorbent member for collecting a biological sample; and

a partition disposed between the first segment and the second segment for preventing the absorbent member from being pushed into the first segment when the collector is engaging or engaged with the open end portion of the housing, wherein the partition is made of a porous material or formed with at least one hole or slot to allow the first segment in fluidic communication with the second segment;

(b) a housing comprising an open end portion, an closed end portion, and an interior space; and

(c) a retainer insertable into the interior space of the housing, the retainer comprising a vessel for receiving a solution and a penetrable seal for enclosing the solution within the vessel,

wherein, the collector is removably engagable with the open end portion of the housing and capable of sealingly closing the open end portion of the housing, and

wherein, when the collector is engaged with the open end portion of the housing, the absorbent member is received in the housing and the second segment of the stem portion of the collector breaks the penetrable seal of the retainer that has been inserted into the interior space of the housing and propels the solution to flow through the absorbent member, thereby releasing the biological sample from the absorbent member and facilitating mixing of the biological sample with the solution.

26. A method for collecting and stabilizing a biological sample, the method comprising:

(a) providing a collector, a housing, and a retainer insertable into the housing, wherein the collector comprises;

a first segment;

a second segment formed with a cavity to accommodate an absorbent member for collecting the biological sample; and

a partition disposed between the first segment and the second segment for preventing the absorbent member from being pushed into the first segment when the collector is engaging or engaged with an open end portion of the housing, wherein the partition is made of a porous material or formed with at least one hole or slot to allow the first segment in fluidic communication with the second segment;

(b) collecting the biological sample by the absorbent member; and

(c) sealingly engaging the collector with the housing,

wherein, the sealingly engaging of the collector with the housing breaks a penetrable seal of the retainer that has been inserted into an interior space of the housing and propels a solution retained in the retainer to flow through the absorbent member, thereby releasing the biological sample from the absorbent member and facilitating mixing of the biological sample with the solution.

27. A device for collecting and stabilizing a biological sample, the device comprising:

(a) a housing comprising an open end portion, a closed end portion, and an interior space;

(b) a retainer insertable into the interior space of the housing, the retainer comprising;

a vessel containing a stabilizing buffer, wherein the vessel comprises an open top and a closed bottom, and

a penetrable seal sealing the open top of the vessel, thereby enclosing the stabilizing buffer within the vessel; and

(c) a collector removably engageable with the open end portion of the housing and sized to sealingly close the open end portion of the housing, the collector comprising an absorbent member for collecting the biological sample,

wherein said stabilizing buffer stabilizes nucleic acids in said biological sample from degradation and comprises one or more of a denaturant, a reducing agent, a surfactant, a pH buffer, and a chelator; and

wherein when the collector is engaged with the open end portion of the housing, the absorbent member is received in the housing, wherein the collector breaks the penetrable seal of the retainer that has been inserted into the interior space of the housing and the closed bottom of the retainer remains closed such that said stabilizer buffer is propelled to flow through the absorbent member, thereby releasing the biological sample from the absorbent member and facilitating mixing of the biological sample with the stabilizer buffer.

28. A device according to claim 27 wherein said stabilizing buffer comprises a denaturant comprising a chaotropic agent.

29. A device according to claim 28 wherein said chaotropic agent is selected from the group consisting of guanidinium hydrochloride and guanidinium isothiocyantate.

30. A device according to claim 29 wherein said chaotropic agent is at a concentration such that the cells in said biological sample are lysed.