DELIVERING AND/OR RECEIVING FLUIDS

• US 20120277696A1
• Filed: 04/26/2012
• Published: 11/01/2012
• Est. Priority Date: 04/29/2011
• Status: Active Grant

• Current Assignee: Seventh Sense Biosystems, Inc.
• Original Assignee: Seventh Sense Biosystems, Inc.
• Inventors: Gonzalez-Zugasti, Javier, Boccuti, A. David, Chickering, Donald E. III, Michelman, Mark, Haghgooie, Ramin, Davis, Shawn, Fisher, Greg, Morse, Christopher J., James, Scott, Dadgar, Maisam, Miller, Richard L.
• Granted Patent: US 8,827,971 B2
• Time in Patent Office: Days
• US Class Current: 604/318
• 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, the device comprising:

a fluid transporter including an opening and a flow activator, the flow activator being arranged to cause fluid to be released from the subject;

a deployment actuator constructed and arranged to move the flow activator in a deployment direction; and

a retraction actuator constructed and arranged to move the flow activator in a retraction direction.

2. The device of claim 1, wherein the deployment actuator is attached to the retraction actuator.

3. The device of claim 2, wherein the deployment actuator and retraction actuator are connected via an effector body.

4. The device of claim 1, wherein the deployment actuator is reversibly moveable in deployment and retraction directions.

5. The device of claim 1, wherein the deployment actuator has a concave portion facing the opening prior to movement in the deployment direction, and convex portion facing the opening after movement in the deployment direction.

6. The device of claim 1, wherein the deployment actuator comprises a snap dome.

7. The device of claim 1, wherein the deployment actuator comprises a plurality of lobes.

8. The device of claim 1, wherein the deployment actuator, when actuated, moves in a deployment direction upon the application of a force to the deployment actuator of at least 0.1 Nor at least 0.3 N.

9. The device of claim 1, wherein the deployment actuator comprises a polymer or a metal.

10. The device of claim 1, wherein the deployment actuator has a maximum dimension of no more than 4 cm.

11. The device of claim 1, wherein the deployment actuator, when actuated, moves in a deployment direction at an average speed of at least 1 cm/s, or at least 10 cm/s.

12. The device of claim 1, wherein the deployment actuator, when actuated, moves from a pre-deployment position to a post-deployment position in a period of time of less than about 0.002 seconds.

13. The device of claim 1, 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/second.

14. The device of claim 1, wherein no portion of the deployment actuator moves more than about 5 mm when the deployment actuator, when actuated, moves in a deployment direction.

15. The device of claim 1, wherein the flow activator comprises one or more needles or microneedles.

20. The device of claim 1, wherein the flow activator is fixed to the deployment actuator.

21. The device of claim 20, wherein the flow activator is fixed to the deployment actuator via a transducing structure or membrane.

22. The device of claim 1, further comprising a device actuator able to cause the deployment actuator to move in a deployment direction.

23. The device of claim 22, wherein the device actuator comprises a button or slider.

24. The device of claim 22, wherein when the device actuator comprises at least a first portion manipulatable by a user, and a second portion arranged to move the deployment actuator in a deployment direction.

25. The device of claim 22, wherein at least a portion of the device actuator is able to slide laterally over the deployment actuator to move the deployment actuator in a deployment direction.

26. The device of claim 22, wherein at least a portion of the device actuator is able to be forced downwardly into the deployment actuator to move the deployment actuator in a deployment direction.

27. The device of claim 1, further comprising a device actuator able to cause the retraction actuator to move in a retraction direction.

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

29. The device of claim 28, wherein the spring is in a relatively high-energy state before deployment and a relatively low-energy state after retraction.

30. The device of claim 1, wherein the retraction actuator comprises a coil spring or leaf spring.

31. The device of claim 1, wherein the retraction actuator comprises a multi-legged leaf spring.

32. The device of claim 1, wherein the retraction actuator comprises an elastic member.

33. The device of claim 1, wherein the retraction actuator moves the deployment actuator away from the opening in a retraction direction.

34. The device of claim 1, wherein no portion of the deployment actuator moves more than 10 mm when the retraction actuator moves in a retraction direction.

35. The device of claim 1, wherein the retraction actuator is locked in place after retraction.

36. The device of claim 1, wherein the deployment actuator is actuated by moving the retraction actuator in a retraction direction.

37. The device of claim 1, further comprising a housing including a base and a cover that enclose the deployment and retraction actuators, wherein a portion of the housing defines the opening.

38. The device of claim 37, wherein the housing defines a vacuum source arranged to cause flow of fluid from the opening into the housing.

39. The device of claim 38, further comprising a channel that creates a fluidic coupling between the vacuum source and the opening such that flow caused by the vacuum source is at least partially through the channel.

40. The device of claim 39, further comprising a storage chamber that has a fluidic coupling to the channel so that fluid in the channel enters the storage chamber.

41. The device of claim 38, further comprising a seal arranged to control flow between the vacuum source and the opening.

42. The device of claim 41, wherein a device actuator is arranged to act on the seal to enable flow between the vacuum source and the opening.

43. The device of claim 1, wherein the device includes an indicator to indicate receipt of fluid.

16-19. -19. (canceled)

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

an opening arranged to receive a fluid; and

a flow activator that is at a first distance from the opening before deployment and a second distance from the opening after retraction, the first distance being different from the second distance.

45-57. -57. (canceled)

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

a fluid transporter including an opening and a flow activator, the flow activator being movable for deployment to cause fluid to be released from the subject and being movable for retraction away from the subject; and

an effector that includes only mechanical components and is free of electronic control that moves the flow activator for deployment and retraction, wherein deployment movement of the flow activator occurs substantially faster than retraction movement of the flow activator.

59. The device of claim 58 wherein the effector includes a deployment actuator and a retraction actuator, and wherein the deployment actuator is arranged to move the flow activator in the deployment direction and the retraction actuator is arranged to move the flow activator in the retraction direction.

60. The device of claim 59, wherein the deployment actuator includes a spring element arranged to move the flow activator in the deployment direction, and a retraction actuator includes a spring element arranged to move the flow activator in the retraction direction.

61. The device of claim 59, wherein the deployment actuator and the retraction actuator are attached together.

62. The device of claim 58, wherein the flow activator includes one or more needles.

63. The device of claim 58, further comprising a housing including a base and a cover that enclose the flow activator and the effector, wherein a portion of the housing defines the opening.

64. The device of claim 63, wherein the housing defines a vacuum source arranged to cause flow of fluid from the opening into the housing.

65. The device of claim 64, further comprising a channel that has a fluidic coupling between the vacuum source and the opening such that flow caused by the vacuum source is at least partially through the channel.

66. The device of claim 65, further comprising a storage chamber that has a fluidic coupling to the channel so that fluid in the channel enters the storage chamber.

67. The device of claim 64, further comprising a seal arranged to control flow between the vacuum source and the opening.

68. The device of claim 67, wherein a device actuator is arranged to enable flow between the vacuum source and the opening.

69. The device of claim 68, wherein the device actuator includes a piercing member, the piercing member being arranged to pierce the seal to enable flow between the vacuum source and the opening.

70. The device of claim 58, wherein the device includes an indicator to indicate receipt of fluid.

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

a fluid transporter including an opening and a flow activator, the flow activator being arranged to cause fluid to be released from the subject;

a vacuum source providing a pressure less than ambient pressure; and

a channel creating a fluidic coupling between the opening and the vacuum source,

wherein the flow activator is actuated after enablement of fluid communication between the opening and the vacuum source along the channel.

72. The device of claim 71, wherein the flow activator is retracted after the enablement of fluid communication.

73. The device of claim 71, wherein the flow activator is deployed after the enablement of fluid communication.

74. The device of claim 71, wherein the vacuum source has a pressure, prior to introduction of a bodily fluid from the subject, that is less than about 300 mmHg below atmospheric pressure.

75. The device of claim 71, wherein the vacuum source has a volume of less than about 10 ml.

81. The device of claim 71, further comprising an adhesive positioned on a surface of the device that is applied to the skin of the subject.

82. The device of claim 71, further comprising a storage chamber that has a fluidic coupling to the channel so that fluid in the channel enters the storage chamber.

85. The device of claim 71, further comprising a device actuator, wherein actuation of a device actuator causes enablement of fluid communication and actuation of the flow activator to occur.

86. The device of claim 85, wherein fluid communication between the opening and the vacuum source along the channel is enabled by a piercing member mechanically coupled to the device actuator such that the piercing member is able to move when the device actuator is actuated.

87. The device of claim 85, wherein, after actuation of the device actuator, enablement of fluid communication and actuation of the flow activator is independent of any subsequent force applied to the device actuator.

88. The device of claim 87, further comprising a retraction actuator that moves the flow activator in a retraction direction.

89. The device of claim 88, wherein the retraction actuator comprises a torsion spring.

90. The device of claim 71, wherein the flow activator is actuated by a pressure differential.

76-80. -80. (canceled)

83-84. -84. (canceled)

91. (canceled)

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

a vacuum source providing a pressure less than ambient pressure;

a fluid transporter including an opening and a flow activator arranged to cause fluid to be released from the subject, the flow activator being movable in a deployment direction and a retraction direction; and

a channel creating a fluidic coupling between the opening and the vacuum source, wherein fluid communication between the opening and the vacuum source through the channel is enabled before the flow activator is moved in the retraction direction.

93. The device of claim 92, wherein fluid communication between the opening and the vacuum source through the channel is enabled before the flow activator is moved in the deployment direction.

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

a fluid transporter including an opening and a flow activator, the flow activator being arranged to cause fluid to be released from the subject;

a vacuum source providing a pressure less than ambient pressure;

a channel creating a fluidic coupling between the opening and the vacuum source; and

a device actuator that actuates the flow activator and enables fluid communication between the opening and the vacuum source along the channel.

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

a fluid transporter including a flow activator, the flow activator being arranged to cause fluid to be released from the subject; and

an effector having an initial stored potential energy prior to any deployment movement of the flow activator, the effector being arranged to release the stored potential energy to retract the flow activator.

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

a housing including a flow activator, the flow activator being arranged to cause fluid to be released from the subject and being moveable relative to the housing;

a deployment actuator arranged to move the flow activator in a deployment direction; and

a retraction actuator arranged to move the flow activator in a retraction direction,

wherein the flow activator, the deployment actuator, and the retraction actuator are substantially concentrically aligned.

97. The device of claim 96, furthering comprising a spacer element located between the deployment actuator and the retraction actuator, the spacer element being concentrically aligned with the deployment actuator.

98. The device of claim 96, wherein the deployment actuator is coupled to the flow activator.