Systems and interfaces for blood sampling

• US 8,808,202 B2
• Filed: 11/09/2011
• Issued: 08/19/2014
• Est. Priority Date: 11/09/2010
• Status: Active Grant

• Current Assignee: Yourbio Health Incorporated
• Original Assignee: Seventh Sense Biosystems, Inc.
• Inventors: Brancazio, David
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US13/292,254
• Publication Number:
  US 20120123297A1
• Time in Patent Office: 1,014 Days
• Field of Search: 600/583, 600/584, 606181-183, 604/318, 422/102, 220/23.87, 295/271, 294/551, 264/239
• US Class Current: 600/583
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: A61B 10/0064 for taking sweat or sebum samples measuring sweat production A61B5/4266
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• 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 5/150022 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 5/150167 Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150267 Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
• 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 5/150389 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 5/150534 Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
• CPC Class Codes: A61B 5/150732 Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube,
• CPC Class Codes: A61B 5/150946 Means for varying, regulating, indicating or limiting the speed or time of blood collection
• 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 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15115 Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
• 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

Abstract

The present invention generally relates to systems and methods for delivering and/or receiving a substance or substances such as blood from subjects. In one aspect, the present invention is directed to devices and methods for receiving or extracting blood from a subject, e.g., from the skin and/or from beneath the skin, using devices containing a substance transfer component (for example, one or more needles or microneedles) and a reduced pressure or vacuum chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In some embodiments, the device may contain a “snap dome” or other deformable structure, which may be used, at least in part, to urge or move needles or other suitable substance transfer components into the skin of a subject. In some cases, for example, the device may contain a flexible concave member and a needle mechanically coupled to the flexible concave member.

Claims

1. A device for receiving blood or other fluids from a subject, the device comprising:

a flexible concave member moveable between a first configuration and a second configuration;

a needle mechanically coupled to the flexible concave member such that the needle is in a first position when the flexible concave member is in the first configuration and the needle is in a second position when the flexible concave member is in the second configuration;

an applicator region containing the needle at least when the needle is in the second position; and

a self-contained vacuum chamber having a pressure less than atmospheric pressure before the device is applied to the skin of the subject, wherein the device is configured such that movement of the flexible concave member from the first configuration to the second configuration creates a fluid communication pathway between the vacuum chamber and the applicator region.

2. The device of claim 1, wherein the device further comprises a collection chamber positioned on the fluid communication pathway between the vacuum chamber and the applicator region.

3. The device of claim 2, wherein the collection chamber contains an anticoagulant.

4. The device of claim 1, wherein the needle is immobilized directly on the flexible concave member.

5. The device of claim 1, wherein the needle is mechanically coupled to the flexible concave member via a rod.

6. The device of claim 1, wherein the needle is one needle of an array of needles mechanically coupled to the flexible concave member.

7. The device of claim 1, wherein the needle is a microneedle.

8. The device of claim 7, wherein the microneedle has a length of at least 500 micrometers.

9. The device of claim 1, further comprising a retraction mechanism able to move the needle towards the first position after the flexible concave member reaches the second configuration.

10. The device of claim 9, wherein the retraction mechanism comprises a spring and/or an elastic member.

11. The device of claim 1, wherein the first configuration is a concave configuration, and the second configuration is a convex configuration.

12. The device of claim 1, wherein the flexible concave member is able to spontaneously return from the second configuration to the first configuration.

13. The device of claim 1, further comprising an actuator able to move the flexible concave member from the first configuration to the second configuration.

14. The device of claim 1, wherein the flexible concave member comprises a polymer and/or a metal.

15. The device of claim 1, wherein the vacuum chamber has a pressure, prior to introduction of blood or other fluids from the subject, that is less than 100 mmHg below atmospheric pressure.

16. The device of claim 1, wherein the vacuum chamber is a pre-packaged vacuum.

17. The device of claim 1, wherein the flexible concave member is constructed and arranged to move the needle from the first position to the second position at a speed of at least 6 m/s.

18. The device of claim 1, wherein the flexible concave member is constructed and arranged to accelerate the needle from the first position to the second position at a rate of at least 100,000 m/s².

19. The device of claim 1, wherein the flexible concave member is constructed and arranged to move the needle from the first position to the second position in a time of less than 0.002 s.

20. The device of claim 1, wherein the flexible concave member is constructed and arranged such that the first position and the second position are separated by a distance of less than 10 mm.

21. The device of claim 1, wherein the applicator region is a recess of the device.

22. The device of claim 1, wherein the fluid received from the subject is blood.

23. A device for receiving blood or other fluids from a subject, the device comprising:

a flexible concave member moveable between a first configuration and a second configuration;

an actuator able to move the flexible concave member between the first configuration and the second configuration when actuated;

a needle mechanically coupled to the flexible concave member such that the needle is in a first position when the flexible concave member is in the first configuration and the needle is in a second position when the flexible concave member is in the second configuration;

an applicator region containing the needle at least when the needle is in the second position; and

a self-contained vacuum chamber having a pressure less than atmospheric pressure before the device is applied to the skin of the subject, wherein the actuator, when actuated, is able to create a fluid communication pathway between the vacuum chamber and the applicator region.

24. The device of claim 23, wherein the needle is immobilized directly on the flexible concave member.

25. The device of claim 23, further comprising a retraction mechanism able to move the needle towards the first configuration after the flexible concave member reaches the second configuration.

26. The device of claim 23, wherein the first configuration is a concave configuration, and the second configuration is a convex configuration.