SYSTEMS AND METHODS FOR COLLECTION AND/OR MANIPULATION OF BLOOD SPOTS OR OTHER BODILY FLUIDS

• US 20170127991A1
• Filed: 05/17/2016
• Published: 05/11/2017
• Est. Priority Date: 04/29/2011
• Status: Active Grant

• Current Assignee: Yourbio Health Incorporated
• Original Assignee: Seventh Sense Biosystems, Inc.
• Inventors: Bernstein, Howard, Chickering, III, Donald E., Davis, Shawn, Gong, Ping, Horton, Kristin, James, Scott
• Granted Patent: US 11,253,179 B2
• Time in Patent Office: 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 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/1438 using pre-evacuated means
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• 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 5/150969 : Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/150984 : Microneedles or microblades
• CPC Class Codes: A61B 5/151 : Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: A61B 5/15105 : Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15142 : Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/154 : Devices using pre-evacuated means
• CPC Class Codes: A61M 1/34 : Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3486 : Biological, chemical treatment, e.g. chemical precipitation; treatment by absorbents
• CPC Class Codes: A61M 1/3687 : Chemical treatment A61M1/3675 takes precedence
• CPC Class Codes: A61M 2202/0415 : Plasma
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: B01L 2300/0672 : Integrated piercing tool
• CPC Class Codes: B01L 2300/0681 : Filter
• CPC Class Codes: B01L 2300/0816 : Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/087 : Multiple sequential chambers
• CPC Class Codes: B01L 2300/0874 : Three dimensional network
• CPC Class Codes: B01L 2400/049 : vacuum
• CPC Class Codes: B01L 2400/0655 : pinch valves
• CPC Class Codes: B01L 2400/0688 : surface tension valves, capillary stop, capillary break
• CPC Class Codes: B01L 3/502753 : characterised by bulk separation arrangements on lab-on-a-chip devices, e.g. for filtration or centrifugation separation in general B01D; microapparatus for analysis using electrophoresis G01N27/44791; sample preparation G01N1/28
• CPC Class Codes: G01N 33/18 : Water
• CPC Class Codes: G01N 33/1826 : Organic contamination in water

Abstract

The present invention generally relates to systems and methods for receiving blood (or other bodily fluids) from a subject, e.g., from or beneath the skin of a subject. In some cases, the blood (or other bodily fluids) may be deposited on a membrane or other substrate. For example, blood may be absorbed in a substrate, and dried in some cases to produce a dried blood spot. In one aspect, the present invention is generally directed to devices and methods for receiving blood from a subject, e.g., from the skin, using devices including a substance transfer component (which may contain, for example, one or more microneedles), and directing the blood on a substrate, e.g., for absorbing blood. The substrate, in some embodiments, may comprise filter paper or cotton-based paper. After absorption of some blood onto the substrate, the substrate may be removed from the device and shipped or analyzed. In some cases, the device itself may be shipped or analyzed. For example, in some embodiments, a portion of the device may be sealed such that the substrate is contained within an airtight portion of the device, optionally containing desiccant. Other aspects are generally directed at other devices for receiving blood (or other bodily fluids), kits involving such devices, methods of making such devices, methods of using such devices, and the like.

Claims

1-32. -32. (canceled)

33. A method, comprising:

applying a device to the skin of a subject, wherein the device applies reduced pressure to the skin of the subject using a pre-packaged vacuum chamber;

withdrawing blood from the skin of the subject into the device such that at least a portion of the blood contacts a substrate comprising paper for absorbing the blood; and

removing the substrate containing the absorbed blood from the device.

34. The method of claim 33, further comprising drying the substrate containing the absorbed blood prior to removing the substrate containing the absorbed blood from the device.

35. The method of claim 33, further comprising drying the substrate containing the absorbed blood after removing the substrate containing the absorbed blood from the device.

36. The method of claim 33, wherein withdrawing blood from the skin of the subject into the device further comprises contacting a second portion of the blood with a second substrate for absorbing the blood.

37. The method of claim 33, wherein the device comprises:

a substance transfer component for receiving blood from the skin of the subject; and

a vacuum chamber having an internal pressure less than atmospheric pressure before the device is applied to the skin of the subject.

38. The method of claim 37, wherein the substrate is a blood spot membrane.

39. The method of claim 37, wherein the substrate comprises filter paper.

40. The method of claim 37, wherein the substrate comprises cotton-based paper.

41. The method of claim 37, wherein the substrate comprises cotton linter paper.

42. The method of claim 37, wherein the device further comprises a recess, wherein the recess contains the substrate for absorbing blood.

43. The method of claim 37, wherein the substrate for absorbing blood is positioned proximate the vacuum chamber.

44. The method of claim 37, wherein the substrate has an area of no more than about 5 cm².

45. The method of claim 37, wherein the device comprises a plurality of substrates for absorbing blood received from the subject.

46. The method of claim 37, wherein the device further comprises desiccant.

47. The method of claim 37, wherein a portion of the device is sealable to create an airtight portion surrounding the substrate for absorbing blood.

48. The method of claim 47, wherein a portion of the device comprises a movable portion that sealingly creates the airtight portion when moved into position.

49. The method of claim 37, wherein the device comprises a cover for covering at least a portion of the substance transfer component.

50. The method of claim 37, wherein the device further comprises a tracking apparatus.

51. The method of claim 37, wherein the substrate further comprises a stabilizer.

52. The method of claim 51, wherein the stabilizer comprises a chelating agent.

53. The method of claim 51, wherein the stabilizer comprises an enzyme inhibitor.

54. The method of claim 51, wherein the stabilizer comprises a lysing agent.