SYSTEMS AND METHODS FOR COLLECTING FLUID FROM A SUBJECT

• US 20120277697A1
• Filed: 04/26/2012
• Published: 11/01/2012
• Est. Priority Date: 04/29/2011
• Status: Active Grant

• Current Assignee: Yourbio Health Incorporated
• Original Assignee: Seventh Sense Biosystems, Inc.
• Inventors: Haghgooie, Ramin, Chickering, Donald E. III, Davis, Shawn, Michelman, Mark, Chu, Li Yang
• Granted Patent: US 9,295,417 B2
• Time in Patent Office: Days
• US Class Current: 604/319
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• 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 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• 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 5/150503 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 5/150969 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: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

Systems and methods for delivering to and/or receiving fluids or other materials, such as blood or interstitial fluid, from subjects, e.g., from the skin. Beading disruptors and/or capillaries may be used for facilitating the transport of fluids from a subject into a device. Beading disruptors may disrupt the “pooling” of bodily fluids such as blood on the surface of the skin and help influence flow in a desired way. A capillary may conduct flow of fluid in the device, e.g., to an inlet of a channel or other flow path that leads to a storage chamber. A vacuum (reduced pressure relative to ambient) may be used to receive fluid into the device, e.g., by using relatively low pressure to draw fluid into the inlet of a channel leading to a storage chamber. The vacuum source may be part of the device.

Claims

1. A device for receiving bodily fluid from a subject, the device comprising:

a fluid transporter arranged to receive bodily fluid on skin of a subject at an opening;

a channel having an inlet in fluid communication with the fluid transporter; and

a beading disruptor located with respect to the fluid transporter to interact with fluid entering the opening of the fluid transporter and influence flow of the fluid to the inlet.

2. The device of claim 1, wherein the fluid transporter includes a recess in fluid communication with the opening.

5. The device of claim 1, wherein the beading disruptor comprises one or more protrusions.

8. The device of claim 1, wherein the fluid transporter includes a recess defined by a wall and in fluid communication with the opening, and the beading disruptor includes at least one protrusion that extends from the wall into the recess.

14. The device of claim 8, wherein a portion of the at least one protrusion is arranged to move away from the opening when contacted by a skin surface entering the opening.

15. The device of claim 8, wherein the beading disruptor is arranged to resist movement of a skin surface into the recess.

16. The device of claim 1, wherein the fluid transporter includes a flow activator having one or more needles.

23. The device of claim 1, further comprising a vacuum source and a seal arranged to control a fluid communication pathway between the vacuum source and the inlet.

27. The device of claim 1, wherein the device has a mass of no more than about 25 g.

29. The device of claim 1, wherein the fluid transporter includes a capillary structure adjacent the beading disruptor and arranged to conduct fluid to the inlet.

3-4. -4. (canceled)

6-7. -7. (canceled)

9-13. -13. (canceled)

17-22. -22. (canceled)

24-26. -26. (canceled)

28. (canceled)

30. A device for receiving bodily fluid from a subject, the device comprising a fluid transporter having a recess and an opening arranged to collect bodily fluid on skin of a subject, the fluid transporter including a flow activator in the recess arranged to interact with the skin at the opening to release the bodily fluid and an at least partially open capillary extending along a surface of the recess arranged to conduct flow of the bodily fluid.

31. The device of claim 30, further comprising a channel with an inlet, and wherein the capillary is in fluidic communication with the inlet.

33. The device of claim 30, wherein the capillary is fully open to the recess.

40. The device of claim 30, wherein the capillary is oriented in a plane that is substantially parallel to the opening.

41. The device of claim 30, wherein the recess has a volume of no more than about 2 ml.

42. The device of claim 30, wherein the device further comprises a beading disruptor adjacent the capillary.

44. The device of claim 42, wherein the beading disruptor comprises one or more protrusions.

48. The device of claim 30, further comprising a channel having an inlet in fluid communication with the capillary, a vacuum source and a seal arranged to control a fluid communication pathway between the vacuum source and the inlet.

32. (canceled)

34-39. -39. (canceled)

43. (canceled)

45-47. -47. (canceled)

49. (canceled)

50. A method of receiving bodily fluid from a subject, the method comprising:

applying, to the skin of a subject, a device comprising a fluid transporter having a recess and a flow activator, a channel having an inlet in fluid communication with the recess, and a vacuum source having a pressure less than ambient pressure, the recess positioned to collect bodily fluid on the skin of the subject that is released by the flow activator;

receiving a bodily fluid from the skin into the recess; and

moving the bodily fluid in the recess into the channel and toward the vacuum source due to a difference in pressure between the recess and the vacuum source.

51. A method of receiving bodily fluid from a subject, the method comprising:

applying, to the skin of a subject, a device comprising a fluid transporter having a recess and a flow activator, a channel having an inlet in fluid communication with the recess, and a vacuum source having a reduced pressure less than ambient pressure, the fluid transporter positioned to collect bodily fluid on the skin of the subject that is released by the flow activator;

opening a flow path between the recess and the vacuum source;

blocking the inlet with at least a portion of a bodily fluid in the recess received from the subject;

increasing a pressure within the recess relative to a pressure in the vacuum source; and

moving the bodily fluid towards the vacuum source due to a difference in pressure between the recess and the vacuum source.

52-77. -77. (canceled)