Automated blood sampling device

• US 9,730,625 B2
• Filed: 03/02/2015
• Issued: 08/15/2017
• Est. Priority Date: 03/02/2015
• Status: Active Grant

• Current Assignee: Google LLC (Alphabet Inc.)
• Original Assignee: Verily Life Sciences LLC (Alphabet Inc.)
• Inventors: Krasnow, Benjamin David, Smith, Peter Howard, Peeters, Eric
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US14/635,643
• Publication Number:
  US 20160256095A1
• Time in Patent Office: 897 Days
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150076 by heating
• 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 5/150229 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150839 Aesthetic features, e.g. distraction means to prevent fears of child patients
• CPC Class Codes: A61B 5/150854 long distance, e.g. between patient's home and doctor's office
• 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 5/150977 Arrays of piercing elements for simultaneous piercing
• CPC Class Codes: A61B 5/15109 Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• 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 5/15125 comprising a vacuum or compressed fluids
• CPC Class Codes: A61B 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• CPC Class Codes: A61B 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15163 : Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/15176 : Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/681 : Wristwatch-type devices

Abstract

Devices are provided to automatically access blood from beneath or within skin. These devices include an injector configured to drive a needle into the skin and subsequently to retract the needle from the skin. These devices additionally include a seal to which suction is applied. To drive the needle into the skin, the needle is first driven through the seal, creating at least one hole in the seal. The suction applied to the seal acts to draw blood from the puncture formed in the skin by the needle, through the at least one hole in the seal, and to a sensor, blood storage element, or other payload. These devices can be wearable and configured to automatically access blood from skin, for example, to access blood from the skin at one or more points in time while a wearer of a device is sleeping.

Claims

1. A system comprising:

a needle;

an injector, wherein the injector is coupled to the needle, and wherein the injector is configured to drive the needle into the skin to form a puncture in skin and subsequently to retract the needle from the skin;

a suction source, wherein the suction source comprises an evacuated volume; and

a seal, wherein the seal is coupled to the suction source such that the seal receives suction provided by the suction source, wherein the injector is configured to drive the needle through the seal to form at least one hole in the seal when the seal is receiving suction provided by the suction source, and wherein the suction provided by the suction source is sufficient to draw blood from the formed puncture in the skin through the formed at least one hole in the seal.

2. The system of claim 1, wherein the injector comprises:

a chamber, wherein the needle is disposed at least partially within the chamber;

a piston disposed in the chamber, wherein the needle is coupled to the piston, and wherein the piston is configured to slidably move within the chamber; and

a propellant, wherein the propellant is configured to slidably move the piston within the chamber to drive the needle to pierce the seal and to further drive the needle into skin.

3. The system of claim 2, wherein the propellant comprises nitrocellulose, and wherein the injector driving the needle into skin comprises the injector igniting the nitrocellulose.

4. The system of claim 2, wherein the injector driving the needle into skin comprises the injector igniting the propellant using a resistive heating element.

5. The system of claim 2, wherein the injector includes at least one vent, wherein the vent is configured to allow the propellant to vent out of the injector such that the piston and needle can retract from the skin subsequent to the needle being driven into the skin.

6. The system of claim 1, further comprising at least one further needle, wherein the injector is coupled to the at least one further needle, and wherein the injector is configured to drive the at least one further needle into the skin to form at least one further puncture in the skin and subsequently to retract the at least one further needle from the skin, and wherein the injector is configured to drive the at least one further needle through the seal to form at least one further hole in the seal.

7. The system of claim 1, wherein the seal comprises a concave depression, wherein the injector is configured to drive the needle through the concave depression of the seal to form at least one hole in the seal, and wherein the suction provided by the suction source is sufficient to suction the skin into the concave depression.

8. The system of claim 1, wherein the suction source comprises an evacuated volume having a pressure less than approximately 50 kilopascal.

9. The system of claim 1, further comprising a blood storage element, wherein the suction provided by the suction source is sufficient to draw blood through the formed at least one hole in the seal to the blood storage element, and wherein the blood storage element is configured to store blood drawn by the suction to the blood storage element.

10. The system of claim 1, further comprising a sensor, wherein the sensor is configured to detect a property of blood to which the sensor is exposed, wherein the suction provided by the suction source is sufficient to draw blood through the formed at least one hole in the seal to the sensor.

11. The system of claim 1, further comprising a conformal layer, wherein the conformal layer is configured to conform to the skin such that the suction provided by the suction source through the formed at least one hole in the seal applies suction to the skin proximate the at least one hole in the seal.

12. The system of claim 1, wherein the system comprises a body-mountable device, wherein the body-mountable device is configured to be mounted to a surface of the skin, and wherein the system further comprises a controller configured to operate the injector to drive the needle into the skin.

13. The system of claim 12, wherein the needle, injector, and suction source are disposed in a first sampling section of the body-mountable device, and wherein the body-mountable device further comprises one or more additional sampling sections, each additional sampling section including a respective needle, injector, and suction source.

14. A method comprising:

mounting a system to skin, wherein the system comprises;

a needle,

a suction source, wherein the suction source comprises an evacuated volume, and

a seal, wherein the seal is coupled to the suction source such that the seal receives suction provided by the suction source; and

operating the injector to drive the needle into skin to form a puncture in the skin and subsequently to retract the needle from the skin, wherein operating the injector to drive the needle into the skin further comprises driving the needle through the seal to form at least one hole in the seal when the seal is receiving suction provided by the suction source, and wherein the suction provided by the suction source is sufficient to draw blood from the formed puncture in the skin through the formed at least one hole in the seal.

15. The method of claim 14, wherein the injector comprises:

(a) a chamber, wherein the needle is disposed at least partially within the chamber,

(b) a piston disposed in the chamber, wherein the needle is coupled to the piston, and wherein the piston is configured to slidably move within the chamber, and

(c) a propellant, wherein the propellant is configured to slidably move the piston within the chamber to drive the needle to pierce the seal and further to drive the needle into skin,

wherein operating the injector to drive the needle into the skin comprises igniting the propellant.

16. The method of claim 14, wherein the system further comprises a sensor, wherein the suction provided by the suction source is sufficient to draw blood through the formed at least one hole in the seal to the sensor, and further comprising:

operating the sensor to detect a property of blood to which the sensor is exposed.

17. The method of claim 14, wherein the body-mountable device further comprises a blood storage element, wherein the suction provided by the suction source is sufficient to draw blood through the formed at least one hole in the seal to the blood storage element, wherein the blood storage element is configured to store blood drawn by the suction to the blood storage element, and further comprising:

providing the blood stored by the blood storage element to a sensing device; and

operating the sensing device to detect a property of the blood provided to the sensing device.

18. A system comprising:

a needle, wherein the needle is hollow;

an injector, wherein the injector is coupled to the needle, and wherein the injector is configured to drive the needle into skin to form a puncture in the skin;

a collection chamber;

a suction source, wherein the suction source comprises an evacuated volume, and wherein the suction source is coupled to the needle such that, subsequent to the injector driving the needle into the skin, the suction source provides suction, through the hollow needle, sufficient to draw blood from the formed puncture in the skin, through the hollow needle, into the collection chamber; and

a seal, wherein the seal is coupled to the suction source such that the seal receives suction provided by the suction source, and wherein the injector is configured to drive the needle through the seal to form at least one hole in the seal when the seal is receiving suction provided by the suction source.

19. The system of claim 18, further comprising a sensor, wherein the sensor is configured to detect a property of blood to which the sensor is exposed, wherein the suction provided by the suction source is sufficient to draw blood into the system to the sensor.

20. The system of claim 18, wherein the injector comprises:

a chamber, wherein the needle is disposed at least partially within the chamber;

a piston disposed in the chamber, wherein the needle is coupled to the piston, and wherein the piston is configured to slidably move within the chamber; and

a propellant, wherein the propellant is configured to slidably move the piston within the chamber to drive the needle to pierce the seal and to further drive the needle into skin.