Delivering and/or receiving fluids

• US 8,821,412 B2
• Filed: 11/19/2012
• Issued: 09/02/2014
• Est. Priority Date: 03/02/2009
• Status: Active Grant

• Current Assignee: Yourbio Health Incorporated
• Original Assignee: Seventh Sense Biosystems, Inc.
• Inventors: Gonzalez-Zugasti, Javier, Boccuti, A. David, Chickering, Donald E. III, Michelman, Mark, Haghgooie, Ramin, Davis, Shawn, James, Scott, Dadgar, Maisam, Fisher, Greg, Miller, Richard L., Morse, Christopher J., Bernstein, Howard, Levinson, Douglas A.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US13/680,351
• Publication Number:
  US 20130079666A1
• Time in Patent Office: 652 Days
• Field of Search: 600/584, 600/583, 604/46, 604/500, 604/180
• US Class Current: 600/583
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: A61B 10/007 for taking urine samples measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006
• 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 5/14532 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 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• 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 5/150221 Valves
• 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 5/150374 Details of piercing elements or protective means for preventing accidental injuries by such piercing elements double-ended hollow needles A61B5/150473, A61B5/150389; single-ended hollow needles A61B5/150503, A61B5/150389
• 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 5/150755 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 5/150977 Arrays of piercing elements for simultaneous piercing
• 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 5/15113 : Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 : comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• 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 5/15188 : Constructional features of reusable driving devices
• CPC Class Codes: A61B 5/154 : Devices using pre-evacuated means
• CPC Class Codes: A61B 5/411 : Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/685 : Microneedles
• CPC Class Codes: A61M 1/38 : Removing constituents from donor blood and storing or returning remainder to body , e.g. for transfusion
• CPC Class Codes: A61M 2037/0023 : Drug applicators using microneedles
• CPC Class Codes: A61M 37/0015 : by using microneedles
• CPC Class Codes: A61M 5/00 : Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16
• CPC Class Codes: G16H 10/40 : for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass

Abstract

The present invention generally relates to receiving bodily fluid through a device opening. In one aspect, the device includes a flow activator arranged to cause fluid to be released from a subject. A deployment actuator may actuate the flow activator in a deployment direction, which may in turn cause fluid release from a subject. The flow activator may also be moved in a retraction direction by a retraction actuator. In one aspect, the device may include a vacuum source that may help facilitate fluid flow into the opening of the device and/or may help facilitate fluid flow from the opening to a storage chamber. In one aspect, a device actuator may enable fluid communication between the opening and the vacuum source and the flow activator may be actuated after the enablement of fluid communication.

Claims

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

a housing including a device actuator and an opening to receive fluid into the housing;

a pre-packaged vacuum chamber in the housing, the vacuum chamber having a volume that is at a pressure less than ambient pressure prior to actuation of the device actuator, the vacuum chamber being fluidly coupleable to the opening via a flow path to cause fluid to be drawn into the opening and toward the vacuum chamber along the flow path;

a flow control element positioned along the flow path that prevents fluid communication between the vacuum chamber and the opening prior to actuation of the device actuator, the flow control element being configured to enable fluid communication between the opening and the vacuum chamber after actuation of the device actuator and permit fluid flow from the opening toward the vacuum chamber along the flow path;

a plurality of microneedles arranged in an array and arranged to be inserted into a subject to cause fluid to be released from the subject;

a deployment actuator to move the plurality of microneedles in a deployment direction toward or through the opening, the deployment actuator being configured to move the plurality of microneedles in the deployment direction in response to actuation of the device actuator; and

a retraction actuator to move the plurality of microneedles in a retraction direction away from the opening, the retraction actuator being configured to move the plurality of microneedles in the retraction direction in response to actuation of the device actuator.

2. The device of claim 1, wherein the retraction actuator has an initial stored potential energy prior to any deployment movement of the deployment actuator, and wherein release of the stored potential energy causes movement of the plurality of microneedles in the retraction direction.

3. The device of claim 1, wherein a distance between the deployment actuator and the opening is smaller than a distance between the retraction actuator and the opening.

4. The device of claim 1, further comprising a membrane that attaches the plurality of microneedles to the housing and separates the vacuum chamber from the opening.

5. The device of claim 1, wherein the deployment actuator includes a bistable element coupled to the plurality of microneedles and arranged to move from a first stable state to a second stable state in response to actuation of the device actuator, where motion of the bistable element from the first stable state to the second stable state moving between bistable states causes the plurality of microneedles to move in a deployment direction toward or through the opening, and wherein the bistable element is incapable of moving from the second stable state to the first stable state in the absence of an external force on the bistable element.

6. The device of claim 5, wherein the bistable element comprises a snap dome.

7. The device of claim 1, wherein the retraction actuator comprises a leaf spring.

8. The device of claim 1, wherein the flow control element is a seal.

9. The device of claim 8, further comprising a piercing member enclosed by the housing, wherein actuation of the device actuator causes the piercing member to move and pierce the seal.

10. The device of claim 1, further comprising a channel that provides fluid communication between the vacuum chamber and the opening.

11. The device of claim 1, further comprising a membrane positioned between the vacuum chamber and the opening that permits passage of air but prevents passage of liquids into the vacuum chamber.

12. The device of claim 1, wherein the device actuator, the deployment actuator and the flow control element are arranged such that actuation of the device actuator causes the plurality of microneedles to reach the subject after fluid communication between the opening and the vacuum chamber is enabled.

13. The device of claim 1, wherein the deployment actuator is arranged to move the plurality of microneedles in the deployment direction at a higher speed than the retraction actuator is arranged to move the plurality of microneedles in the retraction direction.

28. The device of claim 1, further comprising a storage chamber that is separate and distinct from the vacuum chamber.

29. The device of claim 1, further comprising a release element that contacts the deployment actuator to deploy the plurality of microneedles in response to actuation of the device actuator and releases potential energy stored in the retraction actuator in response to actuation of the device actuator.

30. The device of claim 1, wherein the vacuum chamber is at a pressure that is less than 50 mmHg below atmospheric pressure prior to actuation of the device actuator.

14. A device for receiving fluid from a subject, comprising:

a housing including a device actuator and an opening to receive fluid into the housing;

a pre-packaged vacuum chamber in the housing, the vacuum chamber having a volume at a pressure less than ambient pressure prior to actuation of the device actuator, the vacuum chamber being fluidly coupleable to the opening via a flow path to cause fluid to be drawn into the opening and toward the vacuum chamber along the flow path and the device being configured to enable fluid communication between the opening and the vacuum chamber after actuation of the device actuator;

a membrane positioned along the flow path between the vacuum chamber and the opening that permits passage of air but prevents passage of liquids from entering the vacuum chamber;

a plurality of microneedles arranged to be inserted into a subject to cause fluid to be released from the subject;

a deployment actuator to move the plurality of microneedles in a deployment direction toward or through the opening, the deployment actuator being configured to move the plurality of microneedles in the deployment direction in response to actuation of the device actuator; and

a retraction actuator to move the plurality of microneedles in a retraction direction away from the opening, the retraction actuator being configured to move the plurality of microneedles in the retraction direction in response to actuation of the device actuator.

15. The device of claim 14, further comprising a flow control element that prevents fluid communication between the opening and the vacuum chamber, the flow control element being configured to enable fluid communication between the opening and the vacuum chamber after actuation of the device actuator.

16. The device of claim 14, wherein the retraction actuator has an initial stored potential energy prior to any deployment movement of the deployment actuator, and wherein release of the stored potential energy causes movement of the plurality of microneedles in the retraction direction.

17. The device of claim 14, wherein the deployment actuator includes a bistable element coupled to the plurality of microneedles, the bistable element being arranged to move from a first stable state to a second stable state in response to actuation of the device actuator, motion of the bistable element from the first stable state to the second stable state moving the plurality of microneedles in a deployment direction toward or through the opening, and wherein the bistable element is incapable of moving from the second stable state to the first stable state in the absence of an external force on the bistable element.

18. The device of claim 14, wherein the device actuator and the deployment actuator are arranged such that actuation of the device actuator causes the plurality of microneedles to reach the subject after fluid communication between the opening and the vacuum chamber is enabled.

31. The device of claim 14, wherein the vacuum chamber is at a pressure that is less than 50 mmHg below atmospheric pressure prior to actuation of the device actuator.

32. The device of claim 14, further comprising a release element that contacts the deployment actuator to deploy the plurality of microneedles in response to actuation of the device actuator and releases potential energy stored in the retraction actuator in response to actuation of the device actuator.

19. A device for receiving fluid from a subject, comprising:

a housing including a device actuator and an opening to receive fluid into the housing;

a vacuum chamber in the housing at a pressure less than ambient pressure prior to actuation of the device actuator, the device being configured to enable fluid communication between the opening and the vacuum chamber after actuation of the device actuator;

a plurality of microneedles arranged in an array and arranged to be inserted into a subject to cause fluid to be released from the subject, wherein the plurality of microneedles are moveable relative to the housing;

a deployment actuator including a bistable element arranged to move from a first stable state to a second stable state in response to actuation of the device actuator, wherein the bistable element is coupled to the plurality of microneedles such that motion of the bistable element from the first stable state to the second stable state moves the plurality of microneedles in a deployment direction toward or through the opening, and wherein the bistable element is incapable of moving from the second stable state to the first stable state in the absence of an external force on the bistable element; and

a retraction actuator to move the plurality of microneedles in a retraction direction away from the opening, the retraction actuator being configured to move the plurality of microneedles in the retraction direction in response to actuation of the device actuator.

20. The device of claim 19, wherein the deployment actuator, when actuated, moves from a pre-deployment position to a post-deployment position at a peak acceleration of at least 100,000 meters/second².

21. The device of claim 19, wherein a distance between the deployment actuator and the opening is smaller than a distance between the retraction actuator and the opening.

22. The device of claim 19, wherein the bistable element comprises a snap dome.

23. The device of claim 19, further comprising a channel that provides fluid communication between the vacuum chamber and the opening.

24. The device of claim 19, further comprising a membrane positioned between the vacuum chamber and the opening that permits passage of air but prevents passage of liquids into the vacuum chamber.

25. The device of claim 19, wherein the deployment actuator is arranged to move the plurality of microneedles in the deployment direction at a higher speed than the retraction actuator is arranged to move the plurality of microneedles in the retraction direction.

26. The device of claim 19, further comprising a flow control element that prevents fluid communication between the opening and the vacuum chamber, the flow control element being configured to enable fluid communication between the opening and the vacuum chamber after actuation of the device actuator.

27. The device of claim 26, wherein the device actuator, the deployment actuator and the flow control element are arranged such that actuation of the device actuator causes the plurality of microneedles to reach the subject after fluid communication between the opening and the vacuum chamber is enabled.