Delivering and / or Receiving Fluids

Abstract

To provide a mechanism suited for delivering and / or receiving fluids.SOLUTION: The present invention generally relates to receiving bodily fluid through a device opening. 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 embodiment, a device for receiving fluid from a subject comprises: a fluid transporter including an opening and a flow activator, the flow activator being arranged to cause the fluid to be released from a subject; a deployment actuator structured and arranged to move the flow activator in a deployment direction; and a retraction actuator structured and arranged to move the flow activator in a retraction direction.SELECTED DRAWING: Figure 5

Description

[Technical field]

[0001] The present invention relates generally to systems and methods for delivering and / or receiving fluids or other substances, such as blood or interstitial fluid, from a subject, for example, to or from the skin and / or beneath the skin. [Background technology]

[0002] Phlebotomy or venipuncture is the process of obtaining intravenous access or obtaining a sample of venous blood for the purpose of intravenous therapy. The process is typically performed by medical practitioners, including paramedics, phlebotomists, doctors, nurses, etc. Most equipment includes, for example, a Vacutainer. TM (Becton, Dickinson and company) and Vacuette TM Obtaining blood from a subject involves the use of evacuated (vacuum) tubes, such as the (Greiner Bio-One GmBH) system. Other equipment includes hypodermic needles, syringes, etc. However, such procedures are complex, require advanced training of the practitioner, and often cannot be performed in non-medical settings. Thus, there remains a need for improved methods of obtaining blood or other fluids from or through the skin. Summary of the Invention [Problem to be solved by the invention]

[0003] In some embodiments, the present invention relates generally to devices and methods for receiving fluids from a subject, such as receiving and separating blood to form plasma or serum. The subject matter of the present invention in some cases involves correlated products, alternative solutions to a particular problem, and / or multiple different uses of one or more systems and / or components. [Means for solving the problem]

[0004] In one aspect of the invention, the device includes a fluid transporter arranged to cause fluid to be expelled from a subject. The flow activator can be moved in a deployment direction by a deployment actuator. The flow activator can also be moved in a retraction direction by a retraction actuator. In one aspect, the flow activator can be at a different distance from the opening pre-deployment than its distance from the opening after retraction.

[0005] In another aspect of the invention, an effector including only mechanical components moves the flow activator for deployment and retraction, the deployment movement can occur at a substantially higher speed than the retraction movement.

[0006] In another aspect of the invention, a device may include a fluid transporter including an opening and a flow activator arranged to cause fluid to be expelled from a subject, and a vacuum source providing a pressure less than ambient pressure. The device may also include a channel fluidly coupled between the opening and the vacuum source. In one aspect of the invention, the flow activator is actuated after fluid communication between the opening along the channel and the vacuum source is enabled. In one aspect of the invention, fluid communication between the opening along the channel and the vacuum source is enabled before the flow activator is moved in a retracted direction. In another aspect, a device actuator that actuates the flow activator also enables fluid communication between the opening along the channel and the vacuum source.

[0007] In another aspect of the invention, the effector may have an initial stored potential energy prior to any deployment movement of the flow activation body, and the effector may be arranged to release the stored potential energy to retract the flow activation body.

[0008] In another aspect of the invention, the flow activator, the retraction actuator, and the deployment actuator may be concentrically aligned with one another. In addition, the device may include a spacer element that is also concentrically aligned with the flow activator, the retraction actuator, and the deployment actuator.

[0009] In another aspect, the invention includes a method of making one or more of the embodiments described herein, e.g., a device for receiving a fluid. In yet another aspect, the invention includes a method of using one or more of the embodiments described herein, e.g., a device for receiving a fluid.

[0010] Other advantages and novel features of the present invention will become apparent from the following detailed description of various non-limiting embodiments of the invention when considered in conjunction with the accompanying drawings. In the event that the specification and a document incorporated by reference include conflicting and / or inconsistent disclosure, the specification shall control. In the event that two or more documents incorporated by reference include conflicting and / or inconsistent disclosure with respect to each other, the document having the later effective date shall control.

[0011] Non-limiting embodiments incorporating one or more aspects of the present invention are described, by way of example, with reference to the accompanying drawings, which are schematic and not necessarily intended to be drawn to scale. In the drawings, each identical or nearly identical component shown is typically represented by a single numeral. For clarity, not every component is labeled in every drawing, nor are every component of each embodiment of the present invention shown labeled, as illustration is not necessary to enable a person skilled in the art to understand the invention. For example, the present invention provides the following: (Item 1) 1. A device for receiving a fluid from a subject, the device comprising: a fluid transporter including an opening and a flow activator, the flow activator arranged to allow fluid to be expelled from the subject; a deployment actuator constructed and arranged to move the flow activator in a deployment direction; a retraction actuator constructed and arranged to move the flow activator in a retraction direction; A device comprising: (Item 2) Item 1 . The device of item 1 , wherein the deployment actuator is attached to the retraction actuator. (Item 3) 3. The device of claim 2, wherein the deployment actuator and the retraction actuator are connected via an effector body. (Item 4) 2. The device of claim 1, wherein the deployment actuator is reversibly movable in deployment and retraction directions. (Item 5) Item 2. The device of item 1, wherein the deployment actuator has a concave portion facing the opening before movement in the deployment direction and a convex portion facing the opening after movement in the deployment direction. (Item 6) Item 1, wherein the deployment actuator comprises a snap dome. (Item 7) Item 1 , the device wherein the deployment actuator comprises multiple lobes. (Item 8) Item 1 . The device of item 1 , wherein the deployment actuator, when actuated, moves in a deployment direction in response to application of a force of at least 0.1 N or at least 0.3 N to the deployment actuator. (Item 9) 2. The device of claim 1, wherein the deployment actuator comprises a polymer or a metal. (Item 10) 2. The device of claim 1, wherein the deployment actuator has a maximum diameter of 4 cm or less. (Item 11) Item 1. The device of item 1, wherein the deployment actuator, when actuated, moves in the deployment direction at an average velocity of at least 1 cm / sec or at least 10 cm / sec. (Item 12) Item 1, wherein the deployment actuator, when actuated, moves from a pre-deployment position to a post-deployment position in a period of less than about 0.002 seconds. (Item 13) The deployment actuator, when actuated, has a velocity of at least 100,000 meters per second 2 2. The device of claim 1, which moves from a pre-deployment position to a post-deployment position with a peak acceleration of (Item 14) Item 1 , wherein the deployment actuator, when actuated, when moving in a deployment direction, no portion of the deployment actuator moves more than about 5 mm. (Item 15) Item 1, the device comprising one or more needles or microneedles. (Item 16) Item 16. The device according to item 15, wherein at least some of the needles or microneedles are solid or hollow. (Item 17) Item 16. The device of item 15, wherein at least some of the needles or microneedles have a length of less than about 5 millimeters. (Item 18) Item 16. The device of item 15, wherein at least some of the needles or microneedles have a maximum penetration into the subject's skin of about 1 mm or less. (Item 19) Item 16. The device of item 15, wherein at least some of the needles or microneedles have a minimum penetration into the subject's skin of at least about 500 micrometers. (Item 20) Item 1 , the device comprising: a flow activator secured to the deployment actuator; (Item 21) 21. The device of claim 20, wherein the flow activator is secured to the deployment actuator via a conversion structure or membrane. (Item 22) Item 14. The device of item 1, further comprising a device actuator capable of moving the deployment actuator in a deployment direction. (Item 23) 23. The device of claim 22, wherein the device actuator comprises a button or a slider. (Item 24) 23. The device of claim 22, wherein the device actuator comprises at least a first portion operable by a user and a second portion arranged to move the deployment actuator in a deployment direction. (Item 25) Item 23. The device of item 22, wherein at least a portion of the device actuator is capable of sliding laterally over the deployment actuator to move the deployment actuator in a deployment direction. (Item 26) 23. The device of claim 22, wherein at least a portion of the device actuator is capable of being urged downwardly into the deployment actuator to move the deployment actuator in a deployment direction. (Item 27) Item 14. The device of item 1, further comprising a device actuator capable of moving the retraction actuator in a retraction direction. (Item 28) Item 1 , wherein the retraction actuator comprises a spring. (Item 29) Item 30. The device of item 28, wherein the spring is in a relatively high energy state before deployment and in a relatively low energy state after deployment. (Item 30) Item 1 , wherein the retraction actuator comprises a coil spring or a leaf spring. (Item 31) Item 1 , wherein the retraction actuator comprises a multi-legged leaf spring. (Item 32) Item 1 , the device comprising: a retraction actuator comprising a resilient member. (Item 33) Item 1 . The device of item 1 , wherein the retraction actuator moves the deployment actuator in a retraction direction away from the opening. (Item 34) 2. 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. (Item 35) 2. The device of claim 1, wherein the retraction actuator is locked in position after retraction. (Item 36) Item 1 . The device of item 1 , wherein the deployment actuator is actuated by moving the retraction actuator in a retraction direction. (Item 37) Item 1 . The device of item 1 , further comprising a housing including a base and a cover, the base and cover enclosing the deployment and retraction actuators, and a portion of the housing defining the opening. (Item 38) Item 38. The device of item 37, wherein the housing defines a vacuum source arranged to cause fluid flow from the opening into the housing. (Item 39) Item 39. The device of item 38, further comprising a channel creating a fluid connection between the vacuum source and the opening, wherein flow induced by the vacuum source is at least partially through the channel. (Item 40) 40. The device of claim 39, further comprising a storage chamber having a fluid connection to the channel, wherein fluid in the channel enters the storage chamber. (Item 41) Item 39. The device of item 38, further comprising a seal arranged to control flow between the vacuum source and the opening. (Item 42) Item 42. The device of item 41, wherein a device actuator is arranged to act on the seal to allow flow between the vacuum source and the opening. (Item 43) 2. The device of claim 1, wherein the device includes an indicator for indicating receipt of fluid. (Item 44) 1. A device for receiving a fluid from a subject, the device comprising: an opening arranged to receive a fluid; a flow activator that is a first distance from the opening before deployment and a second distance from the opening after deployment, the first distance being different from the second distance; A device comprising: (Item 45) Item 45. The device of item 44, wherein the first distance is smaller than the second distance. (Item 46) Item 45. The device of item 44, wherein the flow activator comprises one or more needles. (Item 47) Item 45. The device of item 44, further comprising an effector arranged to move the flow activator in a deployment direction and a retraction direction. (Item 48) Item 48. The device of item 47, wherein the effector includes a deployment actuator and a retraction actuator attached together, the deployment actuator arranged to move the flow activation body at least the first distance in the deployment direction, and the retraction actuator arranged to move the flow activation body at least the second distance in the retraction direction. (Item 49) Item 49. The device of item 48, wherein the deployment actuator moves the flow activation body in the deployment direction at a higher velocity than the retraction actuator moves the flow activation body in the retraction direction. (Item 50) Item 45. The device of item 44, further comprising a housing including a base and a cover, the base and cover enclosing the flow activator, and a portion of the housing defining the opening. (Item 51) Item 51. The device of item 50, wherein the housing defines a vacuum source arranged to induce fluid flow from the opening into the housing. (Item 52) Item 52. The device of item 51, further comprising a channel having a fluid connection between the vacuum source and the opening, wherein flow induced by the vacuum source is at least partially through the channel. (Item 53) 53. The device of claim 52, further comprising a storage chamber having a fluid connection to the channel, wherein fluid in the channel enters the storage chamber. (Item 54) Item 52. The device of item 51, further comprising a seal arranged to control flow between the vacuum source and the opening. (Item 55) Item 51. The device of item 50, further comprising an effector arranged to move the flow activator in a deployment direction and a retraction direction, the effector arranged to allow flow between the vacuum source and the opening. (Item 56) Item 45. The device of item 44, further comprising a deployment actuator including a spring element arranged to move the flow activation body at least the first distance in the deployment direction, and a retraction actuator including a spring element arranged to move the flow activation body at least the second distance in the retraction direction. (Item 57) Item 45. The device of item 44, wherein the device includes an indicator for indicating receipt of fluid. (Item 58) 1. A device for receiving a fluid from a subject, the device comprising: a fluid transporter including an opening and a flow activator, the flow activator movable for deployment to cause fluid to be expelled from the subject and movable for retraction away from the subject; an effector including only mechanical components and no electronic controls, the effector moving the flow activation body for deployment and retraction, the deployment movement of the flow activation body occurring at a substantially higher speed than the retraction movement of the flow activation body; A device comprising: (Item 59) Item 59. The device of item 58, wherein the effector includes a deployment actuator and a retraction actuator, the deployment actuator arranged to move the flow activation body in a deployment direction and the retraction actuator arranged to move the flow activation body in a retraction direction. (Item 60) Item 60. The device of item 59, wherein the deployment actuator includes a spring element arranged to move the flow activation body in the deployment direction, and the retraction actuator includes a spring element arranged to move the flow activation body in the retraction direction. (Item 61) 60. The device of claim 59, wherein the deployment actuator and the retraction actuator are attached together. (Item 62) Item 59. The device of item 58, wherein the flow activator comprises one or more needles. (Item 63) Item 59. The device of item 58, further comprising a housing including a base and a cover, the base and cover enclosing the flow activator and the effector, and a portion of the housing defining the opening. (Item 64) Item 64. The device of item 63, wherein the housing defines a vacuum source arranged to cause fluid flow from the opening into the housing. (Item 65) Item 65. The device of item 64, further comprising a channel having a fluid connection between the vacuum source and the opening, wherein flow induced by the vacuum source is at least partially through the channel. (Item 66) Item 66. The device of item 65, further comprising a storage chamber having a fluid connection to the channel, wherein fluid in the channel enters the storage chamber. (Item 67) Item 65. The device of item 64, further comprising a seal arranged to control flow between the vacuum source and the opening. (Item 68) Item 68. The device of item 67, wherein a device actuator is arranged to allow flow between the vacuum source and the opening. (Item 69) Item 69. The device of item 68, wherein the device actuator includes a piercing member arranged to pierce the seal to allow flow between the vacuum source and the opening. (Item 70) Item 59. The device of item 58, wherein the device includes an indicator for indicating receipt of fluid. (Item 71) 1. A device for receiving a fluid from a subject, the device comprising: a fluid transporter including an opening and a flow activator, the flow activator arranged to allow fluid to be expelled from the subject; a vacuum source providing a pressure below ambient pressure; a channel creating a fluid connection between the opening and the vacuum source; Equipped with The flow activator is actuated after fluid communication is established between the opening along the channel and the vacuum source. (Item 72) Item 72. The device of item 71, wherein the flow activator is retracted after the fluid communication is enabled. (Item 73) Item 72. The device of item 71, wherein the flow activator is deployed after the fluid communication is enabled. (Item 74) 72. The device of claim 71, wherein the vacuum source has a pressure of about 300 mmHg or more below atmospheric pressure prior to the introduction of bodily fluid from the subject. (Item 75) Item 72. The device of item 71, wherein the vacuum source has a volume of less than about 10 ml. (Item 76) Item 72. The device of item 71, further comprising an effector arranged to move the flow activator in a deployment direction and a retraction direction. (Item 77) Item 77. The device of item 76, wherein the effector includes a deployment actuator and a retraction actuator attached together, the deployment actuator arranged to move the flow activation body in the deployment direction and the retraction actuator arranged to move the flow activation body in the retraction direction. (Item 78) Item 78. The device of item 77, wherein the deployment actuator moves the flow activation body in the deployment direction at a higher velocity than the retraction actuator moves the flow activation body in the retraction direction. (Item 79) Item 77. The device of item 76, further comprising a housing including a base and a cover, the base and cover enclosing the flow activator and the effector, and a portion of the housing defining the opening. (Item 80) 80. The device of claim 79, wherein the vacuum source is defined by the housing and is arranged to cause a flow of fluid from the opening into the housing. (Item 81) 72. The device of claim 71, further comprising an adhesive positioned on a surface of the device, the surface of the device being applied to the skin of the subject. (Item 82) 72. The device of claim 71, further comprising the storage chamber having a fluid connection to the channel, wherein fluid in the channel enters the storage chamber. (Item 83) Item 72. The device of item 71, further comprising a seal arranged to control flow between the vacuum source and the opening. (Item 84) Item 84. The device of item 83, further comprising an effector arranged to move the flow activator in a deployment direction and a retraction direction. (Item 85) 72. The device of claim 71, further comprising a device actuator, actuation of which enables fluid communication and causes actuation of said flow activator to occur. (Item 86) Item 86. The device of item 85, wherein fluid communication between the opening along the channel and the vacuum source is enabled by the puncture member, the puncture member being mechanically coupled to the device actuator such that the puncture member can move when the device actuator is actuated. (Item 87) Item 86. The device of item 85, wherein fluid communication is enabled following actuation of the device actuator and actuation of the flow activator is independent of any subsequent force applied to the device actuator. (Item 88) Item 88. The device of item 87, further comprising a retraction actuator for moving the flow activator in a retraction direction. (Item 89) Item 91. The device of item 88, wherein the retraction actuator comprises a torsion spring. (Item 90) Item 72. The device of item 71, wherein the flow activator is actuated by a pressure differential. (Item 91) 72. The device of claim 71, wherein the device includes an indicator for indicating receipt of fluid. (Item 92) 1. A device for receiving a fluid from a subject, the device comprising: a vacuum source providing a pressure below ambient pressure; a fluid transporter including an opening and a flow activator arranged to allow fluid to be expelled from the subject, the flow activator being movable in a deployment direction and a retraction direction; a channel creating a fluid connection between the opening and the vacuum source; Equipped with A device wherein fluid communication between the opening through the channel and the vacuum source is enabled before the flow activator is moved in the retreating direction. (Item 93) Item 93. The device of item 92, wherein fluid communication between the opening through the channel and the vacuum source is enabled before the flow activator is moved in the deployment direction. (Item 94) 1. A device for receiving a fluid from a subject, the device comprising: a fluid transporter including an opening and a flow activator, the flow activator arranged to allow fluid to be expelled from the subject; a vacuum source providing a pressure below ambient pressure; a channel creating a fluid connection between the opening and the vacuum source; a device actuator that activates the flow activator to allow fluid communication between the opening through the channel and the vacuum source; A device comprising: (Item 95) 1. A device for receiving a fluid from a subject, the device comprising: a fluid transporter including a flow activator, the flow activator arranged to cause fluid to be expelled from the subject; an effector having an initial stored potential energy prior to any deployment movement of the flow activation body, the effector being arranged to release the stored potential energy to retract the flow activation body; A device comprising: (Item 96) 1. A device for receiving a fluid from a subject, the device comprising: a housing including a flow activator arranged to cause fluid to be expelled from the subject and movable relative to the housing; a deployment actuator arranged to move the flow activator in a deployment direction; a retraction actuator arranged to move the flow activator in a retraction direction; Equipped with A device, wherein the flow activator, the deployment actuator, and the retraction actuator are substantially concentrically aligned. (Item 97) Item 97. The device of item 96, further comprising a spacer element located between the deployment actuator and the retraction actuator, the spacer element being concentrically aligned with the deployment actuator. (Item 98) Item 97. The device of item 96, wherein the deployment actuator is coupled to the flow activation body. [Brief description of the drawings]

[0012] [Figure 1] FIG. 1 is a perspective view of a fluid receiving device according to an aspect of the invention. [Diagram 2] FIG. 2 is a perspective view of the back of the device shown in FIG. [Diagram 3] FIG. 3 is a perspective view of the device shown in FIG. 1 with the cover removed. [Figure 4] FIG. 4 is a cross-sectional view of the device shown in FIG. [Diagram 5] FIG. 5 is an exploded view of the device shown in FIG. [Figure 6] 6A-6C show a sequence of three states of the flow activator of the device of FIG. [Figure 7A] FIG. 7A is a close-up view of the effector, including retract and deploy actuators in a particular arrangement. [Figure 7B] FIG. 7B is a reverse view of the arrangement shown in FIG. 7A. [Figure 8] FIG. 8 is a close up view of a release element for the retraction actuator of the device shown in FIG. [Figure 9] FIG. 9 is an enlarged view of a portion of the retraction actuator of the device shown in FIG. [Figure 10] FIG. 10 is an enlarged view of a region of the device shown in FIG. 1 illustrating the relationship between the reservoir and the vacuum source. [Figure 11] FIG. 11 is a perspective view of a device in another embodiment of the invention having separate retractor and seal actuator portions. [Figure 12] FIG. 12 is an enlarged view of the retractor and seal actuator portions of the device shown in FIG. [Figure 13] FIG. 13 is an exploded view of the device shown in FIG. [Figure 14] FIG. 14 is a cross-sectional view of the device shown in FIG. [Figure 15] FIG. 15 is a perspective view of a device in yet another embodiment of the invention with the cover removed and having a rotatable release element. [Figure 16] FIG. 16 is a close-up of the ramp engagement region in the device shown in FIG. [Figure 17] FIG. 17 is an exploded view of the device shown in FIG. [Figure 18] FIG. 18 is a cross-sectional view of the device shown in FIG. [Figure 19] FIG. 19 is a perspective view of a device in yet another embodiment of the invention having a sliding trigger tip. [Figure 20] FIG. 20 is a perspective view of the backside of the device shown in FIG. [Figure 21] FIG. 21 is a perspective view of the device shown in FIG. 19 with the cover removed. [Figure 22] 22 is a perspective view of the device shown in FIG. 19 with the cover removed and at a different angle than the view shown in FIG. [Figure 23A] FIG. 23A is a close-up of the trigger bridge from the device shown in FIG. [Figure 23B] FIG. 23B is a perspective view of the underside of the expansion shown in FIG. 23A. [Figure 24] FIG. 24 is an exploded view of the device shown in FIG. [Diagram 25] FIG. 25 is a cross-sectional view of the device shown in FIG. [Figure 26A] 26A-26D show various arrangements for connecting a flow activator to a deployment actuator. [Figure 26B] 26A-26D show various arrangements for connecting a flow activator to a deployment actuator. [Figure 26C] 26A-26D show various arrangements for connecting a flow activator to a deployment actuator. [Figure 26D] 26A-26D show various arrangements for connecting a flow activator to a deployment actuator. [Figure 27] FIG. 27 is a cross-sectional view of a device in yet another embodiment of the invention having a hollow spike for vacuum release. [Figure 28] FIG. 28 is a perspective view of the device shown in FIG. 27 with the cover removed. [Figure 29] FIG. 29 is a close-up view of a release element including a resistance arm. [Diagram 30] FIG. 30 is another cross-sectional view of a device similar to that shown in FIG. 27 depicting flexion of the release element. [Diagram 31] FIG. 31 is a close-up view of the actuation ring of the release element having tapered legs. [Figure 32A] FIG. 32A depicts the initial contact between the release element and the effector. [Figure 32B] FIG. 32B depicts the interference engagement between the actuation ring and the effector of the release element as the actuation ring begins to contact the deployment actuator. [Diagram 33] FIG. 33 is an overhead view of the device with indicia. [Diagram 34] FIG. 34 is a perspective view of the device shown in FIG. 33 with the cover removed. [Diagram 35] FIG. 35 is a perspective view of the underside of a device in yet another embodiment of the invention having an access port. [Figure 36A]FIG. 36A is an enlarged view of an access port similar to that shown in FIG. [Figure 36B] FIG. 36B is a close-up view of a pipette interacting with an access port similar to that shown in FIG. [Figure 37] FIG. 37 is a close-up view of a pipette interacting with an access port and a storage chamber. [Figure 38] FIG. 38 is a back view of the device with a seal covering the access port. [Figure 39] FIG. 39 is a perspective view of a device in yet another embodiment of the invention having a rotatable release element that interacts with the device cover. [Figure 40A] FIG. 40A is a close-up view of the device shown in FIG. 39 with the cover removed. [Figure 40B] FIG. 40B is a perspective view shown in FIG. 40A with the retraction actuator and effector hidden from view. [Diagram 41] FIG. 41 is a close-up view of the view shown in FIG. 40A with the device cover shown in perspective. [Diagram 42] 42 is an enlarged view of a portion of the device cover from the device shown in FIG. [Diagram 43] 43 is a perspective view of the spinner lamp of the device shown in FIG. 39 interacting with a device cover, with the device cover shown in phantom. [Diagram 44] FIG. 44 is a perspective view of a device with the cover removed in yet another embodiment of the invention having a release element and a torsion spring. [Diagram 45] FIG. 45 is a close-up view of the effector and deployment actuator from the device shown in FIG. [Figure 46A] 46A is a bottom perspective view of a release element from the device shown in FIG. [Figure 46B] FIG. 46B is a side view of the device shown in FIG. 44 with the base hidden and the torsion spring and effector shown in perspective. [Figure 47]FIG. 47 is a cross-sectional view of a device in yet another embodiment of the invention having a protective cap. [Figure 48] Figures 48A-G are close-up views of various spike geometries. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] Aspects of the invention are not limited in application to the details of construction and arrangement of components set forth in the following description or illustrated in the drawings. For example, although an illustrative embodiment relating to piercing the skin and receiving blood released from the pierced skin is discussed below, aspects of the invention are not limited to use with devices that pierce the skin and / or receive blood. Other embodiments may be employed, such as devices that receive other bodily fluids without piercing, and aspects of the invention may be practiced or carried out in various ways. Also, the phraseology and terminology used herein are for the purpose of description and should not be considered limiting.

[0014] FIG. 1 illustrates a fluid receiving device 1 incorporating various aspects of the present invention. Although FIG. 1 incorporates many of the aspects of the present invention, any suitable number of aspects of the present invention may be incorporated into the fluid receiving device. Thus, the aspects of the present invention may be used alone or in any suitable combination with each other. This illustrative embodiment includes a cover 20 and a base 100 that may be joined together and cooperate to encapsulate various parts of the device 1 and support one or more external features, such as a device actuator 10 used to cause the device 1 to receive fluid from a subject. The base 100 and cover 20 may be formed from or otherwise include polyester (PCTA or PETG) or other polymers with low gas permeability. Although the device actuator 10 in this embodiment is arranged to be actuated by a user (e.g., by pressing with a finger), the device actuator 10 may be arranged for actuation in other ways, such as by a mechanical, electrical signal, or other suitable arrangement to cause the fluid receiving device 1 to receive fluid from a subject. Actuation of the device actuator 10 may occur automatically, for example, in response to an elapsed timer or other stimulus or condition, or manually. In some embodiments, the device actuator 10 may include a push button as shown, a sliding button as discussed further below, a touch screen interface, a switch, or other user-actuable arrangement, or the like. In some cases, the device actuator 10 allows for only one actuation of the device 1, e.g., the device actuator 10 may be locked in a position that prevents further actuation, or may allow the device 1 to be actuated multiple times.

[0015] According to one aspect of the invention, the device 1 may include a fluid transporter that receives fluid from a subject. The fluid transporter may include an applicator region where bodily fluid from the body may accumulate. In some embodiments, the applicator region may be a recess or depression in the base of the device that may receive fluid from the surface of the skin. The applicator region may have any suitable shape. For example, the applicator region may be generally hemispherical, semi-oval, rectangular, irregular, etc. Further details regarding the applicator region may be found in U.S. and International patent applications, each entitled "Systems and Methods for Collecting a Fluid from a Subject," filed on even date herewith, which are incorporated herein by reference in their entireties. Also incorporated herein by reference in their entireties is U.S. Provisional Patent Application No. 61 / 480,960, by Haghgooie et al., entitled "Systems and Methods for Collecting a Fluid from a Subject," filed on April 29, 2011.

[0016] The fluid transporter may include an opening of any size and / or geometry configured to receive a fluid into the device. For example, the opening may be in a two-dimensional plane, or the opening may include a three-dimensional cavity, hole, groove, slit, etc. In some embodiments, the fluid transporter may also include a flow activator, such as one or more microneedles, arranged to cause the fluid to be expelled from the subject, for example, by piercing the skin of the subject. In some embodiments, the enclosure may define at least a portion of the fluid transporter, where the fluid may partially or completely fill an enclosure surrounding the flow activator.

[0017] It should be noted that a flow activator need not be included in all embodiments, as the device may not necessarily employ a mechanism for causing fluid ejection from the subject. For example, the device may receive fluid that has already been ejected, such as by another cause, such as cutting or abrasion, fluid ejection by a separate and independent device, such as a separate lancet, open fluid access, such as during a surgical procedure, etc. Additionally, fluid may be introduced into the device via urination, spitting, pouring fluid into the device, etc. If included, the flow activator may physically pierce, puncture, and / or abrade, chemically ablate, corrode, and / or stimulate, emit and / or produce electromagnetic, acoustic, or other waves, and otherwise operate to eject fluid from the subject. The flow activator may include a moving mechanism, such as moving a needle, or may not require movement to function. For example, the flow activator may include a jet injector or "hypospray" that delivers fluid under pressure to the subject, a pneumatic system that delivers and / or receives fluid, a hygroscopic agent that adsorbs or absorbs fluid, a reverse ion photolysis system, ultrasound, or a transducer that emits heat, radio frequency, and / or laser energy, etc., none of which necessarily require movement of the flow activator to expel fluid from the subject.

[0018] FIG. 2 shows the backside of the fluid receiving device 1 of FIG. 1 with the fluid transporter 120 including the opening 130, the applicator area 131, and the flow activator 90. In this embodiment, the flow activator 90 includes one or more needles. As described in more detail below, the needles can be extended from the opening 130 to pierce the skin of a subject, and then retracted into the opening to allow blood or other fluids to enter the opening 130. That is, to use the device 1 to receive blood from a subject, the base 100 can be placed on the skin such that the opening 130 is adjacent to the skin. The device actuator 10 can then be pressed down to deploy the needles, piercing the skin and expelling the blood. The blood can enter the openings and be collected in the storage chamber 140. In one embodiment, the blood flows into the storage chamber 140 as a result of a relatively low pressure (vacuum) in the device 1, which draws the blood from the opening 130 into the storage chamber 140 (see FIG. 4).

[0019] The needles may be of any suitable width, length, and / or other size, and each needle may be solid or hollow. The needles may have any suitable cross-section (e.g., perpendicular to the direction of penetration), such as circular, square, oval, elliptical, rectangular, rounded rectangular, triangular, polygonal, hexagonal, irregular, etc. In some embodiments, the needles may have a length of about 5 mm or less. Additional information regarding alternative needle arrangements is provided below.

[0020] In this embodiment (FIG. 4), activation of the device actuator 10 causes the flow activator 90 to expel blood or other fluid from the subject, which is then received at the opening 130. The blood or other fluid may then be collected in one or more chambers 140. Collection of the blood or other fluid may occur in any suitable manner, such as by absorption, capillary action, suction, or other means. In this illustrative embodiment, activation of the device actuator 10 causes the seal 76 to open so that the blood or other fluid may flow from the opening 130 through the channel (see FIG. 4, element 110) to the chamber 140. As will be described further below, the device 1 may include a vacuum source that draws the blood or other fluid from the opening 130 into the chamber 140 when the seal 76 opens. That is, the opening of the seal 76 may introduce a relatively low pressure into the chamber 140, which draws the blood or other fluid from the opening 130 into the chamber 140.

[0021] In one aspect of the invention, the flow activator may be actuated by a deployment actuator and a retraction actuator. For example, the flow activator may be movable and the movement of the flow activator may be caused by a deployment actuator and a retraction actuator. The deployment actuator may move the flow activator in a deployment direction toward the skin and / or other surface of the subject, and the retraction actuator may move the flow activator in a retraction direction away from the skin and / or body of the subject. As discussed in more detail below, providing separate actuators for deployment and retraction movement may provide advantages, in some cases, such as allowing the flow activator to move at different speeds for deployment and retraction, allowing the actuator to perform other additional functions such as opening a fluid flow path for blood or other fluids, allowing the flow activator to start or end at different locations within the device before and after deployment. The deployment actuator and the retraction actuator may each include any number of suitable components, such as buttons, switches, levers, sliders, dials, compression springs, Belleville springs, servos, rotary or linear electric motors, and / or pneumatic devices, or other suitable devices. Also, the deployment and retraction actuators may be the same type or different types of devices, and each actuator may operate manually, mechanically, electrically, pneumatically, electromagnetically, or other suitable modes of operation, and may or may not require user input for activation.

[0022] According to aspects of the invention, an effector may be arranged to cause deployment and / or retraction movement of the flow activation body. For example, the effector may include both a deployment actuator and a retraction actuator. The effector may be formed from or otherwise include polyester (PETG or PCTA), acetal resin, acrylonitrile butadiene styrene (ABS), and the like. FIGS. 3, 4, and 5 respectively illustrate a perspective view, a partial cross-sectional view, and an exploded view of the device 1 of FIG. 1 with the cover 20 removed from the base 100. In this embodiment, the device 1 includes an effector 50 that includes a retraction actuator 40 and a deployment actuator 60 and is movable up and down relative to the base 100 along the effector guide 104. The deployment actuator 60 is attached to the flow activation body 90 via a membrane 72 (see FIG. 4) such that downward movement of the deployment actuator 60 may cause the flow activation body 90 to at least partially extend from the opening 130. (As discussed further below, the membrane 72 may separate the vacuum source 156 in the device 1 from the opening 130 such that a relatively low pressure is maintained at the vacuum source 156 until it is controllably opened to cause flow into the storage chamber 140. The vacuum source 156 may be in the form of a sealed vacuum chamber). In this embodiment, the deployment actuator 60 has a generally dome-shaped shape with a central hole that receives a portion of the membrane 72 that attaches the deployment actuator 60 to the flow activator 90 (e.g., as in the case of a Belleville spring). (In this embodiment, the flow activator 90 is attached to the deployment actuator 60 via the membrane 72, although the flow activator 90 may be connected directly to the deployment actuator 60, for example, via a vertical post or other structure extending from the flow activator 90 to the deployment actuator 60.) The deployment actuator 60 may initially be arranged in the downwardly concave configuration shown in FIG. 4 and moved to the upwardly concave configuration, for example, by a user pushing the device actuator 10, causing the release element 30 to push a central portion of the deployment actuator 60 downward.The deployment actuator 60 may be made of any suitable material and configuration that rapidly moves from a concave downward configuration to a concave upward configuration to rapidly expand the flow activator 90 from the opening 130 and pierce the skin or other surface of the subject. Although the deployment actuator 60 in this embodiment is arranged as a flexible spring with a dome shape, the deployment actuator 60 may be any suitable shape and / or size. For example, the deployment actuator 60 may be circular (having no "legs" as opposed to the four legs shown in FIG. 5), oval, triangular (having three legs), square (four legs with straight sides between each leg), pentagonal (five legs), hexagonal (six legs), spider-legged, star-shaped, clover-shaped (with any number of lobes, e.g., 2, 3, 4, 5, etc.), sawtooth disk or wave-shaped, etc. The deployment actuator 60 may have a central hole as shown, or another feature, such as a dimple or button, in the center or elsewhere in some embodiments. The deployment actuator 60 may be made of any suitable material, such as stainless steel (e.g., 301, 301LN, 304, 304L, 304LN, 304H, 305, 312, 321, 321H, 316, 316L, 316LN, 316Ti, 317L, 409, 410, 430, 440A, 440B, 440C, 440F, 904L), carbon steel, spring steel, spring brass, phosphor bronze, beryllium copper, titanium, titanium alloy steel, chrome vanadium, nickel alloy steel (e.g., Monel 400, Monel K 500, Inconel 600, Inconel 718, Inconel x), or the like. 750, etc.), polymers (e.g., polyvinyl chloride, polypropylene, polycarbonate, etc.), composites or laminates (including, for example, fiberglass, carbon fiber, bamboo, Kevlar, etc.), and the like.

[0023] In some embodiments, all portions of the deployment actuator may move less than a distance as the deployment actuator moves in a deployment direction toward the opening 130. In some embodiments, all portions of the deployment actuator may move less than about 10 mm, less than about 5 mm, less than about 3 mm, less than about 2 mm, or less than about 1 mm.

[0024] The retraction actuator 40 in this embodiment includes a reversibly deformable structure in the form of a leaf spring, although, like the deployment actuator 60, other arrangements are possible, such as coil springs, foam, elastic bladders, etc. The retraction actuator may be formed from or otherwise include any suitable material, for example, 1095 spring steel or 301 stainless steel, or other spring materials such as 1074 / 1075, 5160, 9255 spring steel, etc. The retraction actuator 40 is attached to the deployment actuator 60 via the effector body 50 such that when the retraction actuator 40 is released in response to actuation of the device actuator 10, the retraction actuator 40 (and other portions of the effector 50) can move away from the opening 130 along the effector guide 104. This retraction movement also pulls the flow activation body 90 and the deployment actuator 60 away from the opening. Specifically, prior to actuation of the device 1, the retraction actuator 40 is in a compressed state that stores potential energy, as shown at least in part in FIGS. 4 and 5. That is, the center of the retraction actuator 40 is pressed downward during assembly such that the four arms of the retraction actuator 40 are elastically deformed. The retraction actuator 40 is held in this depressed state by the ears 103 (see FIGS. 8 and 9) of the retraction actuator 40 engaging the base 100 until the device 1 is actuated. However, when the device actuator 10 is pressed down during device actuation, the arms 31 of the release element 30 engage the tabs 41 to release the ears 103 from the base 100, allowing the center portion of the retraction actuator 40 to move in a retraction direction away from the opening 130. Because the deployment actuator 60 and the flow activation body 90 are attached to the retraction actuator 40, movement of the retraction actuator 40 upwardly away from the opening 13 retracts the flow activation body 90 from the opening 130. In addition, movement of the retraction actuator 40 upwardly away from the opening 130 may also move the deployment actuator 60 in a retraction direction away from the opening 130. In some embodiments, all portions of the deployment actuator 60 may move less than a certain distance when the deployment actuator 60 moves in the retraction direction away from the opening 130 .In some embodiments, all portions of the deployment actuator may move less than about 10 mm, less than about 5 mm, less than about 3 mm, less than about 2 mm, or less than about 1 mm.

[0025] In some embodiments, as shown in FIG. 4, a spacer element 32 is located between the deployment actuator 60 and the retraction actuator 40. The spacer element 32 may help eliminate a gap between the deployment actuator 60 and the release element 30. Actuation of the device actuator 10 may cause the release element 30 to depress the spacer element 32, which in turn may push the deployment actuator 60 forward, causing the deployment actuator 60 to move the flow activation body 90 in the deployment direction. In some embodiments, the flow activation body 90, the deployment actuator 60, the retraction actuator 40, and the spacer element 32 are substantially concentrically aligned.

[0026] By providing both a deployment actuator 60 and a retraction actuator 40 for the flow activation body 90, the flow activation body 90 can be controlled to have any suitable movement for both deployment and retraction. For example, the flow activation body 90 can be moved more rapidly in the deployment direction than in the retraction direction, which has been found to potentially reduce pain when piercing the skin to release blood. That is, the deployment actuator 60 can be arranged to move relatively quickly from a concave downward to a concave upward configuration to quickly insert the flow activation body 90 into the skin or another surface. The flow activation body 90 can then be more slowly pulled out of the skin by the retraction actuator 40, as controlled by a relatively lower force exerted on the flow activation body 90 by the retraction actuator 40 than by the deployment actuator 60, for example, by a damped movement of the retraction actuator 40 or other suitable arrangement. In other embodiments, having separate deployment and retraction actuators can allow for a shorter range of motion in one direction, such as the deployment direction, than another direction, such as the retraction direction. For example, by moving the flow activator 90 a relatively short distance for deployment, the deployment actuator 60 may be made relatively compact, yet generate a suitably high force to insert the flow activator 90 into the skin. In contrast, a relatively long distance traveled by the flow activator 90 during retraction may suitably withdraw the activator 90 to allow a pool or other collection of blood to enter a cavity or other space for receipt by the device 1. Additionally, a short deployment distance may minimize alignment errors inherent to long travel distances.

[0027] Thus, in one aspect of the invention, the flow activator may be located at an initial pre-deployment distance from the skin or another surface that is different from the final post-retraction distance between the flow activator and the skin or other surface. While this aspect can be provided in many different ways, such as by a motor, servo, or automated device as part of the effector, the effector 50 of the embodiment of Figures 1-5 may provide an arrangement in which the flow activator 90 is located relatively close to the opening 130 prior to deployment and relatively far away from the opening 130 after deployment. Figures 6A-6C show a series of schematic diagrams of three states of the device 1 of Figures 1-5, including an initial state prior to deployment of the flow activator 90, an intermediate state in which the flow activator is extended or otherwise positioned from the opening 130 to cause the ejection of fluid from the target skin or other surface, respectively, and a final state in which the flow activator 90 is retracted.

[0028] As can be seen in FIG. 6A, the pre-deployment distance 181 between the opening 130 and the flow activation body 90 is relatively small, such as 1 mm or less. In this state, the retraction actuator 40 is compressed and the deployment actuator 60 is in a concave downward arrangement. As shown in FIG. 6B, the deployment actuator 60 is inverted to an upward concave configuration such that the flow activation body 90 is deployed. The retraction actuator 40 may also be further compressed, for example, by a user depressing the release element 30, although in other embodiments, the retraction actuator 40 need not be further compressed or deformed. As shown in FIG. 6C, the post-retraction distance 183 between the opening 130 and the flow activation body 90 may be greater, and in some cases significantly greater, than the pre-deployment distance 181. For example, the post-retraction distance 183, at which the flow activation body 90 is fully retracted from the opening 130, may be 2-3 mm or more. The retraction of the flow activation body 90 from the opening 130 may provide a space in which blood or other fluids released from the subject may collect and / or be received by the device 1. However, other arrangements in which the post-retraction distance is less than or the same as the pre-deployment distance are possible, and all aspects of the invention are not necessarily limited in this respect.

[0029] 7A and 7B show top and bottom perspective views of the effector 50 of the embodiment of FIGS. 1-5 to help better illustrate how the motion of the effector 50 is controlled. As shown in FIG. 7A, the retraction actuator 40 has eight legs radiating from a central body having a central hole. Two of the shorter legs attach the retraction actuator 40 to the effector body 50 via two posts 52 that extend through holes 46 in the retraction actuator 40. The diameter of the post heads 52 can be made larger than the holes 46, thus securing the retraction actuator 40 to the effector body 50. The retraction actuator 40 can alternatively be attached to the effector body 50 by adhesive (e.g., tape, liquid), mechanical fastening (e.g., interference fit, slot / groove, screws), or thermal methods (e.g., heat staking), and is not limited in this regard. The other leg 48 of the retraction actuator 40 may remain free to flex relative to the effector body 50, for example, to provide retraction movement of the effector 50. Two of the legs 48 include ears 103 that engage the base 100 and serve to hold the retraction actuator 40 in a compressed initial position prior to deployment of the flow activation body 90. A space or gap 43 is provided between the ears 103 and the effector body 50 to allow the ears 103 to move toward the body to engage the base 100. As described above and shown in FIG. 7B, the deployment actuator 60 includes a central bore 66 and lobes 62 that are retained within grooves 56 of the effector body 50. The deployment actuator 60 is attached to the effector body 50, but a central portion 64 of the deployment actuator 60 remains displaceable relative to the effector body 50 such that the deployment actuator 60 may move to deploy the flow activation body 90.

[0030] As discussed above, the effector 50 is mounted on the base 100 and may be guided in motion via effector guides 104 that protrude from the base 100. FIG. 8 shows a close-up view of the retract actuator 40 illustrating how it engages with the base 100 in a compressed initial state, while FIG. 9 shows a close-up view of ears 103 on two of the legs 48 of the retract actuator 40 that engage with the base 100 to hold the retract actuator 40 in a compressed initial state. Once the effector 50 is suitably held by the effector guides 104, the effector 50 is pushed downwardly to position the ears 103 of the tabs 41 under corresponding protrusions 101 on the base 100. Once the ears 103 are engaged with the protrusions 101, the effector 50 may be released such that the spring force of the legs 48 urges the effector 50 to move upward in the retracted direction. However, with the ear portions 103 engaged with the protrusions 101, the effector 50 is held in a compressed state. In this pre-deployment arrangement, the flow activation body 90 may be at an initial pre-deployment distance 181 (see FIG. 6 ) from the opening 130. In some embodiments, this pre-deployment distance 181 may be arranged such that actuation of the deployment actuator 60 will cause the flow activation body 90 to reach the skin of the subject and allow the flow activation body 90 to penetrate and / or pierce the skin to cause fluid flow. Thus, pre-loading the retraction actuator 40 in an initial semi-compressed state may hold the flow activation body 90 at a pre-deployment distance 181 that allows the flow activation body 90 to be ready for deployment upon actuation of the device actuator 10.

[0031] 8 also illustrates how the retraction actuator 40 may be released to retract the flow activation body 90. When the device actuator 10 and release element 30 are moved downward, the arm 31 of the release element 30 may engage the tab 41 such that the angled portion of the arm 31 pushes the tab 41 outward and away from the effector body 50. This releases the ear portion 103 from the protrusion 101 and allows the effector 50 to move upward under the bias of the deformed leg of the retraction actuator 40. The release element 30 may be formed from or otherwise include polyester (PETG or PCTA), acetal resin, acrylonitrile butadiene styrene (ABS), and the like. In this embodiment, the retraction actuator 40 is shown engaging with the base 100 via a releasable latch arrangement including ears 103 and protrusions 101, however, other arrangements are possible, such as a releasable lever, a sliding release, a detent, a wedge, or a magnet that is separable by reversing polarity, as the invention is not limited in this respect.

[0032] In another aspect of the invention, the effector may have an initial stored potential energy prior to any deployment movement of the flow activation body. That is, the effector may have stored spring energy or other mechanical energy, stored chemical energy, stored electrical energy, etc., stored in an elastically deformed element, for example, that is used to deploy and / or retract the flow activation body or cause other movement of other components of the fluid receiving device. As explained above, prior to deployment of the flow activation body 90, the retraction actuator 40 may be held in a compressed state by engagement of the ear portions 103 of the legs 48 with the protruding elements 101 on the base 100. Compression of the retraction actuator 40 stores potential energy in the retraction actuator 40 that can be used for different operations, such as retracting the flow activation body 90. Thus, having the retraction actuator 40 in an initial compressed state allows the retraction actuator 40 to store potential energy and become ready for actuation without requiring energy to be input into the system upon actuation of the device.

[0033] In another aspect of the invention, the flow activator may move faster in the deployment direction than in the retraction direction. In the embodiments discussed above, the deployment actuator 60 may be arranged to move rapidly, e.g., bi-stable, from an initial pre-deployment position to a deployed position. In contrast, the retraction actuator 40 may have, e.g., a relatively low spring constant or other characteristics, and may be arranged to move the flow activator 90 at a slower rate during at least a portion of the retraction movement. In one set of embodiments, the flow activator 90 may be deployed at a rate of at least about 0.1 cm / sec, at least about 0.3 cm / sec, about 1 cm / sec, at least about 3 cm / sec, at least about 10 cm / sec, at least about 30 cm / sec, at least about 1 m / sec, at least about 2 m / sec, at least about 3 m / sec, at least about 4 m / sec, at least about 5 m / sec, at least about 6 m / sec, at least about 7 m / sec, at least about 8 m / sec, at least about 9 m / sec, at least about 10 m / sec, at least about 12 m / sec, etc., at the point where the flow activator 90 first contacts the skin. Without being bound by any theory, it is believed that a relatively fast deployment rate may increase the ability of the flow activator to penetrate the skin (without deforming the skin or causing the skin to move in response) and / or reduce the amount of pain felt upon application of the flow activator to the skin. Any suitable method of controlling the penetration rate into the skin may be used, including those described herein.

[0034] Retraction of the flow activation body 90 may occur at a slower rate than deployment, for example, to help reduce any pain associated with withdrawal of the flow activation body 90. If the retraction actuator 40 includes only mechanical elements that are not electrically controlled, as is the case for example with springs, elastic members, collapsible foam, etc., the springs or other elements may be designed or otherwise arranged to provide a desired retraction rate. Alternatively, other mechanical elements, such as one or more dampers, may be provided to control the retraction rate. Other electrically controlled systems, such as some servos, pneumatic systems, etc., may incorporate open or closed loop control to provide a desired retraction rate. In the case of manually operated retraction actuators, the user may be able to control the rate of retraction. For example, a retraction actuator in the form of a spring may retract more slowly if force is gradually removed from the device actuator. However, if force is abruptly removed (e.g., the user suddenly releases the device actuator), retraction may occur more quickly, although the fastest possible retraction rate may still be slower than the deployment rate.

[0035] In some aspects, the fluid receiving device may include one or more chambers or containers 140 for holding fluid received from a subject. In some cases, the chambers may be in fluid communication with one or more fluid transporters and / or one or more fluid channels. For example, the fluid receiving device may include a chamber for collecting fluid withdrawn from the subject (e.g., for storage and / or subsequent analysis), a chamber for containing fluid for delivery to the subject (e.g., optionally including blood, saline, drugs, hormones, vitamins, pharmaceuticals, etc.), etc.

[0036] In one aspect of the invention, the device may include a vacuum source. The vacuum (subambient pressure) may help facilitate fluid flow into the opening 130 of the device and / or may help draw the skin into the opening 130 to contact the flow activator 90 and / or may help facilitate fluid flow from the opening 130 to the chamber 140. In some cases, the vacuum source may be self-contained within the device, i.e., the device does not need to be connected to an external vacuum source (e.g., household vacuum) during use of the device to draw blood or interstitial fluid from and / or under the skin. For example, as shown in FIG. 4, in one set of embodiments, the vacuum source may include a vacuum source 156 that has a pressure lower than ambient pressure before blood (or other fluid) is drawn into the device, i.e., the vacuum source 156 may be at a "negative pressure" (i.e., negative with respect to ambient pressure) or a "reduced pressure" (or simply "vacuum"). For example, when the ambient pressure is at atmospheric pressure, the vacuum in the vacuum source may be at least about 50 mmHg, at least about 100 mmHg, at least about 150 mmHg, at least about 200 mmHg, at least about 250 mmHg, at least about 300 mmHg, at least about 350 mmHg, at least about 400 mmHg, at least about 450 mmHg, at least about 500 mmHg, at least 550 mmHg, at least 600 mmHg, at least 650 mmHg, at least about 700 mmHg, or at least about 750 mmHg, i.e., lower than the ambient atmospheric pressure. However, it should be understood that in other embodiments, other pressures may be used and / or different methods may be used to generate other pressures (greater than or less than atmospheric pressure). As a non-limiting example, an external vacuum or mechanical device may be used as the vacuum source. For example, the device may include an internal vacuum source and / or may be connectable to a vacuum source external to the device, such as a vacuum pump or an external (line) vacuum source. In some cases, the vacuum may be created manually, e.g., by manipulating a syringe pump, plunger, etc., or the low pressure may be created mechanically or automatically, e.g., using a piston pump, syringe, valve, Venturi tube, manual (mouth) suction, etc.

[0037] Thus, in some cases, the device may be "pre-packaged" with a suitable vacuum source (e.g., a pre-evacuated vacuum source 156), for example, in one embodiment, the device may be applied to the skin and activated in some manner to create and / or access the vacuum source. In some embodiments, a built-in vacuum source may be actuated in some manner to create a vacuum within the device. For example, the built-in vacuum source may include a mechanical device such as a piston, syringe, vacuum pump capable of creating a vacuum within the device, and / or a chemical or other reactant that can react to increase or decrease pressure, which can create a pressure differential associated with the pressure regulator with the aid of a mechanical or other means driven by the reaction. A chemical reaction may also drive a mechanical actuation, with or without a change in pressure based on the chemical reaction itself. A built-in vacuum source may also include an expanding foam, a shape memory material, and the like.

[0038] In some cases, the device includes an interface 105 (see Figs. 2, 4, and 5) that can help the device apply a vacuum to the skin and / or opening 130. The interface 105 can be, for example, a suction cup, a layer of hydrogel material such as Katecho 10G or other suitable hydrogel, or a circular bowl placed on the surface of the skin, and the vacuum can be applied to the portion of the skin exposed to the device 1 by the interface 105. In one set of embodiments, the interface is part of a support structure, for example, the base 100. The interface 105 can be formed from any suitable material, for example, a polymer such as glass, rubber, silicone, polyurethane, nitrile rubber, EPDM rubber, neoprene, etc. In some cases, the seal between the interface 105 and the skin can be enhanced (e.g., to reduce leakage), for example, using vacuum grease, petrolatum, gel, adhesive, etc. In some cases, interface 105 can be relatively small, e.g., having a diameter of less than about 5 cm, less than about 4 cm, less than about 3 cm, less than about 2 cm, less than about 1 cm, less than about 5 mm, less than about 4 mm, less than about 3 mm, less than about 2 mm, or less than about 1 mm. Interface 105 can be circular, although other shapes are possible, e.g., square, star-shaped (having 5, 6, 7, 8, 9, 10, 11, etc. points), teardrop-shaped, oval, rectangular, etc.

[0039] In some embodiments, a vacuum from a vacuum source can facilitate the movement of blood or other fluid from the opening of the fluid transporter to the reservoir. In the embodiment of FIGS. 1-5, a vacuum can be stored in a bulk of the vacuum source 156 (e.g., the space enclosed between the device cover 20, the base 100, and the membrane 72). The vacuum in the vacuum source 156 can be selectively coupled to the reservoir chamber 140 to draw fluid at the opening 130 into the channel 110 and into the chamber 140. For example, as can be seen in FIG. 5, one or more channels 110 can be formed in the base 100 or otherwise provided between the opening 130 and the reservoir chamber 140. The channel 110 can be covered on the upper side by the lower surface of the channel plate 80. In some embodiments, the channel plate 80, the membrane 72, and the seal 76 can form a single piece. (Additional configuration options for channel 110 are discussed below.) In addition to helping to define channel 110, channel plate 80 may also help to define at least a portion of the cavity in fluid transport body 120, a portion of storage chamber 140, vacuum inlet 154 and flow path 150 used to control flow between vacuum source 156 and storage chamber 140, and the flow path between channel 110 and storage chamber 140. That is, as shown in FIGS. 4 and 10, channel plate 80 helps to define the flow path between opening 130 and vacuum source 156 such that flow from opening 130 may pass through channel 110 to opening 144 in channel plate 80 that connects channel 110 and storage chamber 140. Opening 144 may include a filter, a hydrophobic element (e.g., to help prevent aqueous fluid in storage chamber 140 from subsequently exiting chamber 140), a one-way valve, or may be completely unobstructed. 10, flow can also occur from the storage chamber 140, through a passage 150 in the channel plate 80, to a vacuum inlet 154. The vacuum inlet 154 is usually closed by a seal 76, which may be part of the membrane 72, which also serves to isolate the vacuum source 156 from the opening 130 and other potential outlets for the low pressure in the vacuum source 156.4, when the retraction actuator 40 is in a compressed initial state, the seal 76 is engaged with one of the legs 48 (seal leg 49) of the retraction actuator 40 such that the seal leg 49 pushes the seal 76 into contact with the vacuum inlet 154 to close the passageway 150 and prevent communication between the vacuum source 156 and the storage chamber 140. However, once the retraction actuator 40 is released, the seal leg 49 may move upward and / or the force of the seal leg 49 on the seal 76 may be reduced to the point that the vacuum inlet 154 opens for flow from the storage chamber 140 to the vacuum source 156. Thus, once the seal 76 opens the vacuum inlet 154, the vacuum source 156 may draw fluid (e.g., air and / or liquid) from the storage chamber 140 such that the fluid in the channel 110 is drawn into the storage chamber 140. Although not shown, a hydrophobic membrane or other suitable element may be provided at the vacuum inlet 154 or other suitable location (such as in the passageway 150) to prevent liquid from flowing from the storage chamber 140 into the vacuum source 156.

[0040] According to one aspect of the invention, fluid communication between the opening of the fluid transport body and the vacuum source may be enabled in response to actuation of the flow activator or prior to actuation of the flow activator. For example, depression of the device actuator 10 may enable communication between the vacuum source 156 and the storage chamber 140 / opening 130. Although other arrangements are possible, in the illustrative embodiment of Figs. 1-10, once the flow activator 90 is actuated (e.g., deployment and retraction are initiated), the seal 76 may be coupled to the seal leg 49 of the retraction actuator 40 such that the seal 76 may be released from the vacuum inlet 154 to enable fluid communication between the vacuum source 156 and the storage chamber 140. In this embodiment, as the flow activator 90 is retracted, the seal leg 49 of the retraction actuator 40 moves away from the vacuum inlet 154 (or at least reduces pressure on the seal 76), although it is possible to arrange for the opening of the seal 76 upon deployment of the flow activator 90 or at any other point in the movement of the flow activator 90, as well as before movement begins or after movement is completed. For example, flow between the vacuum source 156 and the storage chamber 140 can be enabled by piercing a membrane or foil, for example, with deployment of the flow activator 90 or upon full retraction of the flow activator 90. In one embodiment, a membrane seal can be located at the opening 130, and the flow activator 90 itself can serve to pierce the membrane and enable flow from the opening 130 to the vacuum source 156. This piercing can thus serve to expose the fluid at the opening 130 to a vacuum to draw the fluid into the storage chamber 140. Of course, the membrane seal can be located at a location other than the opening 130, such as the vacuum inlet 154, and a separate piercing element, such as a spike on the release element 30, can be used to pierce the membrane. Other arrangements are possible, such as activating a vacuum source (such as a chemical vacuum source or a vacuum pump) in response to activation of the flow activator. For example, the retraction actuator 40 can be coupled to a syringe such that as the retraction actuator 40 moves in the retraction direction, a piston is moved to create a suction in the storage chamber 140.

[0041] As will be appreciated from the above description, in another aspect of the invention, the flow activator may be moved in a deployment direction to deploy the flow activator and moved in a retraction direction to retract the flow activator and allow fluid communication between the vacuum source and the opening of the fluid transporter. In the illustrative embodiment described above, as the flow activator 90 is retracted, the seal 76 may be released from the vacuum inlet 154. Opening of the flow passage in the seal 76 may occur at the start of retraction, during retraction, and / or after retraction is completed. In some embodiments, the seal 76 and the flow activator 90 may both be moved in the same retraction direction by a retraction actuator. That is, during retraction, the flow activator 90 may be retracted and the seal 76 may be lifted to allow fluid communication between the vacuum source 156 and the device opening 130 through the channel 110. The seal 76 may be formed from or otherwise include latex or other flexible materials such as thermoplastic elastomers (TPEs) or polyurethanes. In other embodiments, the force on the seal 76 may be released sufficiently to cause flow from the storage chamber 140 to the vacuum source 156 to the relatively low pressure in the vacuum source 156. Thus, the seal 76 does not necessarily need to be lifted away from the vacuum inlet 154, but instead may act as a type of check valve with a desired crack pressure, allowing flow from the storage chamber 140 to the vacuum source 156, but otherwise preventing flow through the inlet 154, with a suitable pressure differential existing across the seal 76. Other arrangements for opening fluid communication during retraction of the flow activator are possible, such as a spike on the retract actuator 40 that punctures a membrane to open fluid communication. In another embodiment, an electrical switch may be opened or closed by the retract actuator to activate a vacuum source (such as a pump). In another embodiment, movement of the retract actuator may release a latch or other device, which allows a spring-loaded syringe piston or other device to move, creating the desired vacuum. In another embodiment, retraction movement of the retract actuator 40 itself may move the syringe piston or other device to provide the desired vacuum.Thus, allowing fluid communication between a vacuum source and an opening in a fluid transporter does not necessarily involve the opening of a valve or other device to block flow, but may instead involve the creation of a suitable vacuum to induce flow. Other arrangements are possible.

[0042] In another aspect of the invention, the effector that deploys and / or retracts the flow activator may also enable fluid communication between the opening of the fluid transporter and the vacuum source. Providing a single component or assembly for deploying and / or retracting the flow activator and opening fluid communication between the fluid transporter and the vacuum source may provide a fluid receiving device that is simpler in operation or construction in some embodiments. For example, a single device such as retract actuator 40 in the embodiment of FIGS. 1-10 may serve to retract and open the flow path. This may reduce the parts required to construct the fluid receiving device, reducing cost and / or assembly complexity. Of course, the effector does not necessarily have to perform both deployment and retraction functions, but instead may provide only deployment or only retraction while enabling fluid communication. For example, in embodiments in which the flow activator is not retracted after deployment, but instead is allowed to remain embedded in the skin to draw fluid when a vacuum is applied to the flow activator, the effector may, for example, only deploy the flow activator and enable fluid communication between the opening of the fluid transporter and the vacuum source. As discussed above, allowing fluid communication between the opening of the fluid transport body and the vacuum source can be provided in different ways, such as by opening a valve or similar structure (such as seal 76), puncturing a membrane, activating a vacuum source (such as moving a syringe plunger or similar element), activating a chemically operated vacuum source, etc.

[0043] In another aspect of the invention, the flow activator and the vacuum seal may be attached together, for example, as part of a single integral structure or component. For example, as shown in Figures 4 and 5, a flow activator 90 may be attached to the membrane 72, for example, by co-molding the flow activator 90 with the membrane, adhering the flow activator 90 to the membrane, etc., while the seal 76 is formed from a portion of the membrane 72 itself. Such an arrangement may facilitate assembly and reduce the number of components in the fluid receiving device 1.

[0044] As discussed above, the flow enabled by the movement of the seal 76 can cause flow along the channel 110 to the storage chamber 140. The channel 110 can be formed, at least in part, by a single component, e.g., an etched substrate or molded unit such as the base 100. The channel can have any cross-sectional shape, e.g., circular, oval, triangular, irregular, square, or rectangular (with any aspect ratio), and can be covered or uncovered (i.e., open to the external environment surrounding the channel). The channel 110 can be of any length. In some cases, the channel 110 can be a simple two-dimensional opening that creates a fluid connection between the opening 130 and another container, such as a vacuum source or a storage container. In these cases, the channel may not have any length at all (e.g., as in the case of a two-dimensional opening). In embodiments in which the channel is completely covered, at least a portion of the channel can have a cross-section that is completely enclosed, and / or the entire channel can be completely enclosed along its entire length, except for its inlet and outlet.

[0045] A channel may have any aspect ratio (length to average cross-sectional dimension), for example, at least about 2:1, more typically at least about 3:1, at least about 5:1, at least about 10:1, etc. As used herein, "cross-sectional dimension" in reference to a fluidic or microfluidic channel is measured in a direction generally perpendicular to fluid flow within the channel. A channel will generally include characteristics that facilitate control over fluid transport, for example, structural characteristics and / or physical or chemical characteristics (hydrophobic vs. hydrophilic), and / or other characteristics that can exert forces (e.g., restraining forces) on the fluid. The fluid within the channel may partially or completely fill the channel. In some cases, the fluid may be held or restrained in some manner within the channel or a portion of the channel, for example, using surface tension (e.g., such that the fluid is held within the channel within a meniscus, such as a concave or convex meniscus). In a part or substrate, some (or all) of the channels may be less than a particular size, for example, in some cases having a maximum dimension perpendicular to fluid flow of less than about 5 mm, less than about 2 mm, less than about 1 mm, less than about 500 microns, less than about 200 microns, less than about 100 microns, less than about 60 microns, less than about 50 microns, less than about 40 microns, less than about 30 microns, less than about 25 microns, less than about 10 microns, less than about 3 microns, less than about 1 micron, less than about 300 nm, less than about 100 nm, less than about 30 nm, or less than about 10 nm, or even less. In one embodiment, the channels are capillaries.

[0046] In one set of embodiments, the device may include a microfluidic channel. As used herein, the prefixes "microfluidic," "microscopic," "microscale," "micro" (e.g., as in "microchannel"), and the like generally refer to an element or part having a width or diameter of less than about 1 mm, and in some cases less than about 100 microns (micrometers). In some embodiments, larger channels may be used in place of or in conjunction with microfluidic channels for any of the embodiments discussed herein. For example, channels having widths or diameters of less than about 10 mm, less than about 9 mm, less than about 8 mm, less than about 7 mm, less than about 6 mm, less than about 5 mm, less than about 4 mm, less than about 3 mm, or less than about 2 mm may be used in some cases. In some cases, an element or part includes a channel through which a fluid can flow. In all embodiments, the specified width may be a minimum width (i.e., a width as specified where the part can have a larger width in a different dimension) or a maximum width (where the part can have a width not wider than that specified, but a larger length). Thus, for example, a microfluidic channel may have an average cross-sectional dimension (e.g., perpendicular to the direction of fluid flow in the microfluidic channel) of less than about 1 mm, less than about 500 microns, less than about 300 microns, or less than about 100 microns. In some cases, a microfluidic channel may have an average diameter of less than about 60 microns, less than about 50 microns, less than about 40 microns, less than about 30 microns, less than about 25 microns, less than about 10 microns, less than about 5 microns, less than about 3 microns, or less than about 1 micron.

[0047] Fluids received from and / or under the skin of a subject will often contain various analytes in the body that are important for diagnostic purposes, e.g., markers for various medical conditions, such as glucose (e.g., for diabetes). Other example analytes include ions such as sodium, potassium, chloride, calcium, magnesium, and / or bicarbonate (e.g., for determining dehydration), gases such as carbon dioxide or oxygen, H+ (i.e., pH), metabolites such as urea, blood urea nitrogen, or creatinine, hormones such as estradiol, estrone, progesterone, progestins, testosterone, androstenedione, or cholesterol (e.g., for determining pregnancy, illicit drug use, etc.). Other examples include insulin, or hormone levels. Still other analytes include, but are not limited to, high density lipoprotein ("HDL"), low density lipoprotein ("LDL"), albumin, alanine aminotransferase ("ALT"), aspartate aminotransferase ("AST"), alkaline phosphatase ("ALP"), bilirubin, lactate dehydrogenase, etc. (e.g., for liver function tests), luteinizing hormone or beta human chorionic gonadotropin (hCG) (e.g., for fertility tests), prothrombin (e.g., for coagulation tests), troponin, BNT, or B-type natriuretic peptide, etc. (e.g., as cardiac markers), infectious disease markers such as for influenza, respiratory syncytial virus, or RSV, etc.

[0048] The fluid receiving device 1 may include one or more sensors for detecting one or more properties of the fluid received from the subject. The sensors may be located in any suitable manner or location relative to the device, such as in the storage chamber 140, in the channel 110, on the cover 20, etc. For example, the device 1 may include a pH sensor, a light sensor, an oxygen sensor, a sensor capable of detecting the concentration of a substance, etc. Non-limiting examples of sensors useful in the present invention include dye-based detection systems, affinity-based detection systems, microfabricated gravimetric analyzers, CCD cameras, photodetectors, optical microscope systems, electrical systems, thermocouples and thermistors, pressure sensors, etc. Those skilled in the art will be able to identify other suitable sensors. The sensor may include a colorimetric detection system, which in some cases may be external to the device or in some cases may be microfabricated into the device. As an example of a colorimetric detection system, if a dye or fluorescent entity is used (e.g., in the particles), the colorimetric detection system may be capable of detecting a change or shift in frequency and / or intensity of the dye or fluorescent entity.

[0049] In one set of embodiments, the sensor may be a test strip, such as a commercially available test strip. Examples of test strips include, but are not limited to, glucose test strips, urine test strips, pregnancy test strips, and the like. Test strips typically include a band, piece, or strip of paper or other material and will include one or more regions capable of determining an analyte, for example, via binding of the analyte to a diagnostic or reactive entity capable of interacting with and / or associating with the analyte. For example, the test strip may include various enzymes or antibodies, glucose oxidase, and / or ferricyanide, and the like. Depending on the type of test strip, the test strip may be capable of determining, for example, glucose, cholesterol, creatinine, ketones, blood, protein, nitrite, pH, urobilinogen, bilirubin, white blood cells, luteinizing hormone, and the like. Test strips may be used in any number of different ways. In some cases, the test strip may be obtained commercially and inserted into the device, e.g., before or after receiving blood, interstitial fluid, or other fluid from the subject. In embodiments in which the device uses a test strip as a sensor, e.g., so that the device itself determines the analyte, at least a portion of the blood or other fluid may be exposed to the test strip to determine the analyte. In some cases, the device may be sold with a preloaded test strip, or the user may be required to insert the test strip into the device (and optionally replace the test strip between uses). In some cases, the test strip may form an integral part of the device that is not removable by the user. In some embodiments, after exposure to blood or other fluid drawn from the subject, the test strip may be removed from the device and determined externally, e.g., using other equipment capable of determining the test strip, e.g., a commercially available test strip reader.

[0050] In some embodiments, the device may include a separation membrane that is impermeable to blood cells and other substances. Fluid received from a subject flows through the separation membrane, and the received fluid may include components of various sizes. For example, the device may receive blood, including blood cells, clotting factors, proteins, and plasma, among other components. While larger components such as blood cells and other larger substances may not be able to pass through the separation membrane, the plasma may pass freely. In some embodiments, the plasma is collected into a storage chamber. If an anticoagulant is not introduced to the plasma, the plasma, including clotting factors such as fibrinogen, may clot, thereby resulting in a solid clot component and a liquid component. This liquid component is known as serum, which is plasma without fibrinogen or other clotting factors. The serum may be collected via separation or other suitable methods from the storage chamber, leaving the clot in the storage chamber. If an anticoagulant is introduced to the plasma, the plasma does not clot, and instead, the plasma may be collected from the storage chamber. Thus, the embodiments described throughout this specification may be used to produce plasma or serum. Further details regarding plasma and serum production can be found in U.S. and international patent applications entitled "Plasma or Serum Production and Removal of Fluids Under Reduced Pressure," filed on even date herewith, which are incorporated herein by reference in their entireties. Also, U.S. Provisional Patent Application No. 61 / 480,941, by Haghgooie et al., entitled "Plasma or Serum Production and Removal of Fluids Under Reduced Pressure," filed on April 29, 2011, is incorporated herein by reference in its entirety.

[0051] In some embodiments, the device may be connected to an external device for determining at least a portion of the device, the fluid removed from the device, analytes suspected to be present in the fluid, etc. For example, the device may be connected to an external analysis device and the fluid may be removed from the device for later analysis, or the fluid may be analyzed in situ within the device, for example, by adding one or more reactive entities to the device, for example, to a storage chamber or to an analysis chamber within the device. In some embodiments, an assay disk 200 or membrane may be included in the storage chamber 140, as shown in FIG. 4. In one embodiment, the external device may have a port or other suitable surface for mating with a port or other suitable surface on the device, and may remove blood, interstitial fluid, or other fluid from the device using any suitable technique, for example, using vacuum or pressure, etc. The blood or other fluid may be removed by the external device and optionally stored and / or analyzed in some manner. For example, in one set of embodiments, the device may include an outlet port for removing fluid (e.g., blood) from the device. In some embodiments, the fluid contained in the storage chamber in the device can be removed from the device and stored for later use or analyzed outside the device. In some cases, the outlet port can be separate from the fluid transporter. In some cases, the outlet port can be in fluid communication with a vacuum source, which can also serve as a fluid reservoir in some cases. Other methods for removing blood, interstitial fluid, or other fluids from the device include, but are not limited to, removal using a vacuum line, a pipette, extraction through a septum instead of an outlet port, etc. In some cases, the device can also be placed in a centrifuge and subjected to various gravitational forces (e.g., at least 50 g centripetal force) to cause, for example, separation of cells or other materials within the fluid in the device.

[0052] The device may include an anticoagulant or stabilizer for stabilizing fluids drawn from and / or under the skin. As a specific, non-limiting example, an anticoagulant may be used on blood drawn from the skin. Examples of anticoagulants include, but are not limited to, heparin, citrate, thrombin, oxalate, ethylenediaminetetraacetic acid (EDTA), sodium polyanethol sulfonate, dextrose citrate. Other agents may be used in conjunction with or in place of the anticoagulant, such as stabilizers, e.g., solvents, diluents, buffers, chelating agents, enzyme inhibitors (e.g., protease or nuclease inhibitors), antioxidants, binders, preservatives, antimicrobial agents, etc. Examples of preservatives include, e.g., benzalkonium chloride, chlorobutanol, parabens, or thimerosal. Non-limiting examples of antioxidants include ascorbic acid, glutathione, lipoic acid, uric acid, carotene, alpha-tocopherol, ubiquinol, or enzymes such as catalase, superoxide dismutase, or peroxidase. Examples of antimicrobial agents include, but are not limited to, ethanol or isopropyl alcohol, azides, and the like. Examples of chelating agents include, but are not limited to, ethylene glycol tetraacetic acid or ethylenediaminetetraacetic acid. Examples of buffers include phosphate buffers, such as those known to those of skill in the art.

[0053] In one set of embodiments, at least a portion of the device may be colored to indicate the anticoagulant contained within the device. In some cases, the color used is indicative of the Vacutainers TM , Vacuettes TMor may be the same or equivalent to those used commercially for other commercially available phlebotomy devices. For example, light purple and / or purple may indicate ethylenediaminetetraacetic acid, light blue may indicate citrate, dark blue may indicate ethylenediaminetetraacetic acid, green may indicate heparin, gray may indicate fluoride and / or oxalate, orange may indicate thrombin, yellow may indicate sodium polyanetholesulfonate and / or citrate dextrose, black may indicate citrate, brown may indicate heparin, etc. However, in other embodiments, other coloring systems may be used.

[0054] Other coloring systems, not necessarily indicative of anticoagulant, may be used in other embodiments of the invention. For example, in one set of embodiments, the device is colored to indicate the recommended site of body use of the device, e.g., a first color indicating a device suitable for placement on the back, a second color indicating a device suitable for placement on the leg, a third color indicating a device suitable for placement on the arm, etc.

[0055] As mentioned, in one set of embodiments, the device of the present invention as discussed herein can be shipped to another location for analysis. In some cases, the device can include an anticoagulant or stabilizer contained within the device, for example, within a storage chamber for the fluid. Thus, for example, fluid such as blood or interstitial fluid drawn from the skin and / or under the skin can be transported to a chamber (e.g., a storage chamber) within the device, and then the device or a portion of the device (e.g., a module) can be shipped to another location for analysis. Any form of shipping can be used, for example, via mail.

[0056] ALTERNATIVE EMBODIMENTS Alternative embodiments that may incorporate one or more aspects of the present invention are discussed further below.

[0057] It should be understood that various components of the fluid receiving device may be modified in different ways and the embodiments discussed with respect to Figs. 1-10 should not be used to limit aspects of the present invention. For example, in one alternative embodiment, the retraction actuator 40 of the device 1 may include two separate elements. Figs. 11-14 show an embodiment in which the retraction actuator 40 includes a retractor portion 42 and a seal actuator portion 44. As shown in Figs. 11 and 12, the retractor portion 42 and the seal actuator portion 44 are stacked and coupled to the effector body 50 via five posts 52. Any number of posts may be used. The posts 52 may be formed from or otherwise include polyester (PETG or PCTA) or other polymers such as ABS, acetal resin, polystyrene, etc. Alternatively, the retractor portion 42 and the seal actuator portion 44 may be coupled to the effector body 50 via a single post, glue, tape, or other adhesive, etc. FIG. 12 shows that the retractor portion 42 includes legs 48 that can bend freely relative to the effector 50. The seal actuator portion 44 includes tabs 41 and seal legs 49 that are coupled to a seal 76. Both the retractor portion 42 and the seal actuator portion 44 have essentially the same characteristics as the retract actuator 40 otherwise described above. By separating the retract actuator 40 into two portions, each can be designed and constructed to have the desired characteristics. For example, in some embodiments, it may be desirable to have the legs 48 made of a highly elastic material, while the tabs 41 and seal legs 49 can be made of a less elastic material, for example, to help release the seal 76 as the retract actuator 40 moves upward. In addition, as shown in FIG. 13, the membrane 72 can be made independently of the seal 76, for example, the seal 76 can be formed as part of the seal legs 49 of the actuator 40. In some embodiments, the flow activator 90 may be mechanically coupled to the deployment actuator 60 via a transmission structure 94, such as a post, rod, or the like.As shown in FIG. 13, the post 94 is connected to the membrane 72, the flow activation body 90, and the deployment actuator 60, and can be made relatively rigid or inflexible, for example, to help transfer movement from the deployment actuator 60 to the flow activation body 90 with little loss. FIGS. 15-18 show yet another embodiment very similar to the embodiment of FIGS. 1-10, but in which the latch arrangement used to hold the retraction actuator 40 in an initial compressed state is modified. In this illustrative embodiment, the device 1 includes a rotatable release element 170 that rotates relative to the base 100 during operation of the device. (The rotatable release element 170 and corresponding portions of the base 100 replace the tabs 41 of the release element 30 and retraction actuator 40 of the embodiment of FIGS. 1-10.) The spinner ramps 174 of the release element 170 initially engage the lockout ramps 161 of the effector guide 104 to hold the rotatable release element 170 in place prior to actuation of the device 1. 16 shows a close-up view of the initial engagement prior to actuation of device 1. However, when rotatable release element 170 is moved toward base 100 during device actuation (e.g., pressing device actuator 10), release element 170 rotates slightly such that spinner ramp 174 slides and passes lockout ramp 161 as release element 170 moves toward base 100. (The slight rotation of release element 170 may be caused by a sloped or other angled surface on element 170 contacting a corresponding sloped or other surface on base 100 such that downward movement of release element 170 upon actuation of device actuator 10 causes the desired rotation.) Thereafter, when pressure on release element 170 is released by the user, spinner release ramp 175 engages base release ramp 160 as release element 170 moves upward such that spinner release ramp 175 rotates rotatable release element 170 to pass base release ramp 160. This may allow the retraction actuator 40 to retract, for example, to retract the flow activator 90. In still other embodiments, the fluid receiving device 10 may be arranged in other ways, as suggested above.For example, in one embodiment shown in Figs. 19-25, the fluid receiving device 1 includes a horizontal sliding trigger 304 that can be actuated by a user or otherwise by finger depression. Similar to the embodiment described above and shown in Figs. 19 and 20, the device 1 includes a cover 20 and a base 100, and fluid received at the opening 130 of the fluid transporter 120 can be conducted to the storage chamber 140 by a channel 110 (not shown). Figs. 21 and 22 show the internal components of the device 1. An O-ring seal 340 can be located on the trigger shaft 306 of the trigger 304. In another embodiment, a deformable membrane can form the seal. In use, sliding the trigger 304 backwards toward the trailing edge 102 of the base 100 causes the trigger shaft 306 to push the trigger pin 332 along with the trigger pin cover 334 (see Fig. 22). This motion slides the carriage 330 rearward along guides 360 (see FIG. 21 ) on the base 100 toward the trailing edge 102 of the base 100. The guides 360 may be etched into the base 100, protrude from the base 100, or have any other suitable arrangement.

[0058] As the carriage 330 moves rearward, a trigger bridge 336 connected to the carriage 330 moves rearward relative to the effector body 50. The underside of the trigger bridge 336 includes a trigger tab 338, as can be seen in FIGS. 23A and 23B. As the trigger bridge 336 moves rearward, the trigger tab 338 engages a protrusion 339 (see FIG. 24) on the effector body 50 such that the trigger tab 338 moves the effector body 50 downward an amount sufficient to actuate a deployment actuator 60 having a configuration such as that in the embodiment described above. This causes the deployment actuator 60 to deploy the flow activation body 90, for example, to extend the needle from the opening 130. Continued movement of the carriage 330 in the rearward direction causes the retraction actuator of the trigger (in the form of a wedge 350) to slide under a lifting post 370 on the effector body 50. As the wedge 350 slides under the lifting post 370, the effector 50 is lifted upwardly and away from the base 100, thereby retracting the flow activation body 90, which is attached to the effector body 50 via the deployment actuator 60, and the membrane 72, in a manner similar to the embodiments described above. The trigger tab 338 may be received within an opening 380 in the effector body 50, allowing a central portion of the effector body 50 to flex upwardly and further retract the flow activation body 90.

[0059] According to one aspect, the connection of the flow actuator to the deployment actuator, as proposed above, can be made in a variety of different ways. For example, FIG. 26A shows a schematic arrangement in which the posts 94 used to connect the flow activator (not shown) to the membrane 72 and / or the deployment actuator 60 can be made by adhesive 400. In another embodiment shown in FIG. 26B, the posts 94 can be received into cavities (or holes) in the membrane 72 as well as holes in the deployment actuator 60. The engagement of the posts 94 with the respective holes or cavities can be made in any suitable manner, such as by interference or friction fit, adhesive, riveting, etc. In this embodiment, the posts 94 have a rivet-type head that is engaged with the cavity of the membrane 72 by adhesive 400 and engages with the hole in the deployment actuator 60. The rivet head of the posts 94 can be formed by a plastically deforming portion of the posts 94, or the posts 94 can include a flexible material arranged such that the top portion of the rivet head can be elastically deformed and forced through the hole of the actuator 60. FIG. 26C shows yet another embodiment in which the membrane 72 is joined to the deployment actuator by expanding a portion of the membrane 72 through an opening in the actuator 60 and shrinking or otherwise deforming the portion of the membrane 72 that extends through the opening. Alternatively, a clip, band, or other element may be fastened onto the membrane portion to maintain engagement of the membrane and the actuator 60. A post 94 may be attached to both the membrane and the actuator as part of the same process, for example, a portion of the post may function as a clip or band. FIG. 26D shows an embodiment with a two-part post 94 in which the membrane 72 is captured between two portions of the post. The top of the post extends through a hole in the deployment actuator 60 or is heat staked to create an interference fit between the post and the deployment actuator 60. A portion of the post 94 may be forced through an opening at the connection point, thereby engaging the deployment actuator 60.

[0060] According to one aspect, the sequence of operations for deploying and retracting the flow activation body, releasing the vacuum, and receiving the fluid may be arranged in various orders. In some embodiments, releasing the vacuum before deployment of the flow activation body may help to reduce the pressure differential across the deployment actuator, thereby increasing the insertion depth of the flow activation body. For example, in some embodiments, the sequence of operations may be arranged as follows: vacuum is generated first, then deployment of the flow activation body, and finally retraction of the flow activation body. In some cases, fluid reception may occur before or after retraction, as this aspect is not limited in this respect. In some cases, fluid reception may begin before retraction, but will not be completed until during or after retraction. In some cases, fluid reception will not begin until during or after retraction. Vacuum release may be accomplished in a variety of different ways, as described in previous embodiments. For example, in one embodiment, a spike 510 is attached to the end of the arm 33 of the release element 30, as shown in FIGS. 27-30. The vacuum may be stored in the majority of the space enclosed by the vacuum source 156, e.g., the cover 20, the base 100, and the membrane 72. Initially, the seal 512 may prevent communication between the vacuum source 156 and the opening 130. Upon downward movement of the device actuator 10, the spike 510 also moves in a downward direction, piercing the seal 512 and entering the dead volume 514. The spike 510 may be partially hollow and may include a vacuum inlet channel 511 that may help ensure flow between the vacuum source 156 and the dead volume 514. As a result, piercing the seal 512 with the spike 510 effectively opens communication between the vacuum source 156 and the opening 130. This initial application of a vacuum or other relatively low pressure in the area near the opening 130 may draw the skin into or closer to the opening. Later, further downward movement of the device actuator 10 causes the actuation ring 540 to contact and actuate the deployment actuator 60. As described in the previous embodiment, actuation of the deployment actuator 60 may cause the flow activator 90 to at least partially expand or otherwise move from the opening 130 to pierce the subject's skin and release fluid.Fluid may enter the opening 130, and the vacuum released from the vacuum source 156 may draw the fluid towards and / or into the storage chamber 140. A hydrophobic stop membrane 516 that allows the passage of air but prevents the passage of liquid (such as liquids including water) may be positioned between the storage chamber 140 and the dead volume 514. As a result, the hydrophobic stop membrane 516 may prevent liquid in the storage chamber 140 from entering the dead volume 514 and the vacuum source 156. When the storage chamber 140 is filled with liquid, the hydrophobic stop membrane 516 may effectively cooperate with the filled storage chamber 140 to seal communication between the vacuum source 156 and the opening 130. After deployment of the flow activation body 90, the effector 50 and the retraction actuator (here consisting of the locking portion 45 and the retractor 42, see FIG. 28) may cooperate to retract the flow activation body 90 as described in the previous embodiment. Similar to the embodiment of FIG. 12 discussed previously, here the retraction actuator may comprise two separate components, a locking portion 45 and a retractor 42. However, in this embodiment, the locking portion 45 differs from the seal actuator portion 44 of FIG. 12 because the locking portion 45 does not have the additional seal leg 49 used to close the communication between the vacuum source 156 and the opening 130. According to one aspect, there may be a time delay between the vacuum release and the deployment of the flow activation body to allow for pressure equilibrium across the deployment actuator prior to deployment of the flow activation body. In one embodiment, the release element may be arranged to exhibit increased resistance to downward vertical movement, thereby creating a time delay between the vacuum release and the deployment of the flow activation body. For example, as shown in FIG. 29, the release element 30 may include a resistance arm 33 in addition to the release arm 31. The resistance arm 33 may include a leg 34. As shown in FIG. 30, as the release element 30 moves in the downward deployment direction, the legs 34 may contact the base 100, causing the latch release 30 to bend radially outward, thereby generating lateral movement of the spikes 510 to facilitate tearing the seal 512 for vacuum release.After the vacuum is released, contact between the legs 34 and the base 100 may also provide increased resistance to downward vertical movement, which may delay deployment of the flow activation body 90 by delaying contact between the actuation ring 540 and the deployment actuator 60.

[0061] According to one aspect, holding the device effector firmly to the base of the device can help reduce energy loss when the deployment actuator is actuated. In some cases, stress on the effector or poor fit between components can cause the effector to be positioned incorrectly instead of being firmly pressed down against the base. In some circumstances, imprecise positioning of the effector can reduce energy transfer to the deployment actuator and flow activation body during actuation of the device. In one embodiment, an interference fit between the release element and the effector can serve to press the effector down flush against the base of the device, thereby ensuring proper positioning of the effector. In one example, as shown in FIG. 30, the device actuator 10 can be attached or otherwise coupled directly to the release element 30. An actuation ring 540 can be present at the base of the release element 30. The base of the release element 30 can engage the effector 50 with an interference fit between the actuation ring 540 and the effector 50. As shown in FIG. 31, the actuation ring 540 may include legs 542 that are tapered for increased lateral flexibility. FIG. 32A depicts the initial contact between the release element 30 and the effector 50 prior to deployment of the flow activation body, where the actuation ring 540 has not yet contacted the deployment actuator 60. As the release element 30 moves further downward, it is engaged with the effector 50 in an interference fit, as shown in FIG. 32B. FIG. 32B depicts the release element 30 and effector 50 immediately prior to deployment of the flow activation body, where the actuation ring 540 has achieved initial contact with the deployment actuator 60. The interference fit allows for the direct application of pressure to the effector 50 prior to actuation of the deployment actuator 60 to ensure that the effector is held securely against the base. Such an arrangement helps ensure correct positioning of the effector and may allow energy to be translated directly from the device actuator 10 and the release element 30 to the deployment actuator 60. Of course, other arrangements are possible as this aspect is not limited in this respect.For example, the effector may be held firmly against the device base by a wave or coil spring located under the release element, by a leaf spring, coil spring, foam, elastic bladder, or other suitable features molded onto the underside of the release element.

[0062] According to one aspect, the device may activate an indication when fluid reception is complete. Such an indication may inform the user that the device can be removed from the skin. In one embodiment, a visual indication may be provided by indicator 520, as shown in Figs. 27, 33, and 34. Indicator 520 may change color when fluid reception is complete. In one example, indicator 520 may change from clear to the color of the received fluid. As shown in Figs. 27 and 34, indicator 520 may include a flat disk of space that can receive and hold fluid. Indicator 520 may be in open communication with storage chamber 140. During fluid reception, when the fluid reaches the top of storage chamber 140, the fluid may enter passage 522 connecting storage chamber 140 to indicator 520. The fluid may enter passage 522 and proceed through it into indicator 520 by capillary action, wicking, pressure differential, or via any other suitable force. In some cases, the indicator 520 may include a solid or liquid substance that changes color upon contact with the received fluid. In this way, the user may receive an indication that fluid reception is complete without actually seeing the received fluid. For example, the indicator 520 may change to a different color than the actual collected fluid. In some embodiments, the device may include an indicator cover 521, which may be transparent or translucent to allow the user to view the indicator 520. In some embodiments, the indicator cover 521 may be colored to change the appearance of the color of the fluid. In some cases, the indicator cover 521 may be removable. Of course, it should be understood that the indication may be visual, audible, or tactile, as this aspect is not limited in this respect. For example, filling of the storage chamber 140 may trigger the device to emit an audible sound indicating that fluid reception is complete. In some cases, the audible sound may be a mechanical click due to interaction between the device actuator, release element, effector, retraction actuator, deployment actuator, and / or flow activation body. In some cases, the audible sound may be an alarm that is triggered by fluid reaching the top of the storage chamber 140 .Alternatively or in addition, the user may receive haptic feedback indicating that fluid reception is complete. For example, the device actuator, release element, effector, retraction actuator, deployment actuator, and / or flow activation body may be arranged to interact such that the user-actuated device actuator experiences a sudden increase or decrease in physical resistance from the device actuator. As another example, the device components may include detent-type interactions that provide haptic feedback to the user. Furthermore, the indication, feedback, and / or alarm may occur at any point in the device actuation process, as the indication is not limited to completion of fluid reception. For example, the device may enable an indication when the vacuum is released, when the flow activation body is deployed and / or retracted, when fluid reception has begun, etc. The device may also enable an indication or alarm when an insufficient amount of fluid has been received or if the type of fluid received is inappropriate.

[0063] According to one aspect, the device may allow a user to access fluid received in a storage chamber of the device. In some embodiments, an access port connected to the storage chamber may allow a user to directly access the fluid in the storage chamber. In one embodiment, the access port 530 may be located at the base of the device, as shown in FIG. 35. Of course, it should be understood that the access port 530 may be located anywhere on the device, as this aspect is not limited in this respect. In some embodiments, the user may remove the fluid using various tools, such as a pipette, capillary tube, or other suitable tool. In some embodiments, the user may access the fluid in the storage chamber without removing the fluid from the chamber. For example, the user may measure the pH of the fluid by contacting a strip of pH paper with the fluid. In another example, the user may request access to the collected fluid to add a substance or chemical to the fluid while it is held in the storage chamber. In some embodiments, the access port 530 may be shaped to allow for the insertion of different shaped objects, such as strips as well as pipettes or capillaries. In one example, as shown in Figs. 36A-B, the access port 530 may include holes 532 to receive cylindrical objects such as pipettes and capillaries, and may include slots 534 to receive rectangular or wide objects such as strips. Of course, other shapes and geometries of the access port are possible, such as simple holes, slots, square holes, or multiple holes, as this aspect is not limited in this respect. In some embodiments, the access port may be positioned to increase the ease of fluid removal from the storage chamber. In one example, as shown in Fig. 37, the access port 530 may be positioned near a sidewall 531 of the storage chamber 140. Locating the access port 530 away from the center of the storage chamber 140 may help reduce forces such as capillary action that may cause fluid to resist removal from the storage chamber. Alternatively, or in addition, the bottom of the storage chamber may be arranged at an angle such that fluid is forced to slope downward toward the access port.The storage chamber 140 may further include a circular groove running around the bottom perimeter 535 of the storage chamber where the bottom of the storage chamber meets the sidewall 531. Such a groove may urge fluid towards the access port 530 via wicking, capillary action, or other suitable forces. In some embodiments, a seal may prevent fluid from flowing through the access port. In one example, the seal may be located on the inside of the storage chamber, in which case a user pierces the seal with a pipette or other suitable tool. In another example, as shown in FIG. 38, the seal 536 may be located on the outside of the storage chamber on the base 100, in which case a user may peel or pierce the seal to access the fluid in the storage chamber. Of course, it should be understood that other methods of sealing the access port are possible as this aspect is not limited in this respect.

[0064] In an alternative embodiment, the rotatable release element may be arranged to allow vacuum release prior to deployment of the flow activator. Figures 39-43 show an example of a device with a rotatable release element. In these figures, the device is depicted in a retracted state after deployment. The device includes a rotatable release element 170 that can rotate freely relative to the device actuator 10 (see Figures 40A-B). The device actuator 10 is attached to the spike 510 such that downward movement of the device actuator 10 causes downward movement of the spike 510, which then pierces the seal 512 for vacuum release. As previously discussed, piercing the seal 512 opens communication between the vacuum source and the device opening, allowing vacuum to be applied to the device opening. The device actuator 10 also includes a tab 566 (see Figures 41 and 42) that interacts with a sliding groove 554 formed on the device cover 20 to vertically constrain the movement of the device actuator 10. The rotatable release element 170 includes a spinner ramp 562 that interacts with a pre-deployment lockout 556 and a cover ramp 552 (see FIGS. 41 and 42) formed on the cover 20. As shown in FIG. 40B, the retraction actuator 40 and the effector 50 are hidden from view to show that the rotatable release element 170 also includes an actuation ring 540 that actuates the deployment actuator 60 upon contact with the top surface of the deployment actuator 60. (In FIG. 40B, the deployment actuator 60 is shown in its post-deployment state and is thus arranged concavely downwardly away from the actuation ring 540.) Prior to deployment, the spinner ramp 562 is held within the pre-deployment lockout 556 such that the actuation ring 540 on the release element 170 is held at a close distance to the top surface of the deployment actuator 60. The engagement between the spinner ramp 562 and the pre-deployment lockout 556 also locks the retraction actuator 40 in a compressed, high energy state.Depressing the device actuator 10 in the downward direction first causes the spike 510 to puncture the seal 512 for vacuum release, then causes the actuation ring 540 on the release element 170 to contact and actuate the deployment actuator 60, which may deploy the flow activation body as discussed in the previous embodiment. At the same time, pressing the device actuator 10 in the downward direction also causes the spinner ramp 562 to pass the pre-deployment lockout 556, releasing the retract actuator 40 from its compressed high energy state. The retract actuator 40 releases its stored potential energy as it decompresses by moving in the upward retraction direction. It slides the spinner ramp 562 against the cover ramp 552 in the upward direction. As a result, the entire rotatable element 170 rotates clockwise as it also moves upward in the retraction direction. The upward movement of the retract actuator 40 retracts the flow activation body as described in the previous embodiment. Eventually, as shown in FIG. 43, when the spinner ramp 562 reaches the end of the cover ramp 552, the engagement edge 560 of the spinner ramp 562 engages the post-deployment lockout 550 to lock the device in the retracted state.

[0065] According to one aspect, actuation of the flow activation body may occur directly in response to the release of a vacuum without requiring additional external actuation. In one embodiment, a pressure differential across the deployment actuator may cause the deployment actuator to deploy the flow activation body. In previously discussed embodiments, such as the embodiment of Figs. 1-5, a vacuum may be stored in a majority of the space enclosed by the vacuum source 156, e.g., the device cover 20, the base 100, and the membrane seal 72. However, according to this aspect, in one embodiment, atmospheric or ambient pressure is stored in the space enclosed by the cover, the base, and the membrane seal, rather than the vacuum source. The vacuum source is stored elsewhere, either within the device or outside the device, rather than above the deployment actuator. As a result, prior to actuation of the device, the pressure at the top surface of the deployment actuator is at atmospheric or ambient pressure instead of vacuum pressure. By opening communication between the vacuum source and the device opening, the bottom surface of the deployment actuator may be exposed to vacuum pressure, thereby creating a pressure differential across the deployment actuator, such as atmospheric or ambient pressure above the deployment actuator and vacuum pressure below. A pressure differential across the deployment actuator may actuate the deployment actuator and subsequently cause deployment of the flow activation body. Such an arrangement may allow the vacuum to reach the device opening prior to deployment of the flow activation body.

[0066] According to one aspect, the sequence of events starting from the initial actuation of the device to the end of receipt of fluid can be user independent, meaning that the entire sequence of events occurs automatically after the initial trigger, regardless of the amount of subsequent pressure, torque, speed, impact, or other force applied to the device actuator after the trigger. In one embodiment, the device can include a torsion spring that allows for a user independent sequence of actuation events. For example, as shown in FIG. 44, the device 1 includes a torsion spring 570 that can act as a retraction actuator. In FIG. 44, the device 1 is depicted in its pre-deployed, high energy state with a coil torsion spring 570 attached to a cam 571. Potential energy can be stored in the coil torsion spring 570, and the spring can be attached to the cam 571 such that the spring is biased to rotate the cam 571 in a counterclockwise direction. The engagement between the end of the actuator arm 574 and a lockout protrusion 572 attached to the cam 571 prevents the cam 571 from rotating, thereby preventing the torsion spring 570 from unwinding. The device actuator 10 may be actuated by a downward force, causing the end of the actuator arm 574 to slide downward perpendicularly against the lockout protrusion 572. Once the end of the actuator arm 574 slides down and clears the underside of the lockout protrusion 572, the cam 571 is free to rotate, allowing the torsion spring 570 to unwind and release its stored potential energy. The release of the torsion spring 570 may act as a trigger, which all subsequent user-independent events follow. The unwinding of the torsion spring 57 rotates the cam 571 in a counterclockwise direction. The cam 571 may be attached to a spike 510 that tears a seal (not shown) covering the dead volume 514, opening communication between the vacuum source and the opening of the device. As shown in FIG. 45, the effector 50 may be attached to the deployment actuator 60 via a holder 580 and a groove 56. In addition, the effector 50 may include an effector tab 578. 46A-B, the release element 30 can include an actuation ring 540 and a release element tab 576. As shown in FIG.During rotation of cam 571 in a counterclockwise direction, tab 578 interacts with the profile of lower track 588. Because lower track 588 is inclined upward at the end of its profile, tab 578 is pushed upward by lower track 588. As a result, effector 50 is raised vertically upward in a retracting direction. Similarly, release element tab 576 of release element 30 cooperates with upper track 586. During rotation of cam 571 in a counterclockwise direction, tab 576 interacts with the profile of upper track 586. Because upper track 586 is inclined downward, tab 576 is pushed downward by upper track 586. As a result, the release element 30 is lowered vertically downward in the deployment direction, causing the actuation ring 540 of the release element 30 to contact and actuate the deployment actuator 60 (see Figs. 46A-B), thereby actuating the flow activation body (not shown) in the manner described in the previous embodiment. Because the track 586 is inclined upward at the end of the profile, the release element 30 is raised vertically upward in the retraction direction. After actuation of the deployment actuator 60, both the release element 30 and the effector 50 are lifted in the retraction direction due to the upward inclination of both the upper track 586 and the lower track 588, thereby causing retraction of the deployment actuator 60 and the flow activation body (not shown) connected to the effector 50. Of course, it should be understood that other suitable arrangements for achieving a user-independent sequence of events are possible, as this aspect is not limited in this respect.

[0067] According to one aspect, the device may include protective features or mechanisms used to avoid accidental or premature actuation. In one embodiment, the protective features may include a physical barrier or cover that prevents actuation of the device actuator. For example, as shown in FIG. 47, the device may include a cap 600 with a spacer ring 602 that prevents compression of the device actuator 10. The cap 600 may be removed by the user when the device is ready to be actuated. In one embodiment, the protective features may be incorporated into the device actuator or other components of the device. For example, the device actuator may include a lost motion type arrangement in which the device actuator must move a predetermined distance before deployment of the deployment actuator is triggered. In another example, the device actuator may require the application of a minimum pressure or torque before actuation occurs. In yet another example, the device actuator may include a safety lock type arrangement in which the user must first twist the device actuator before depressing it. Of course, it should be understood that other methods of avoiding accidental actuation are possible as this aspect is not limited in this respect. Additionally, the safety features described above may be combined in any manner within a single device.

[0068] Some of the previously described embodiments include spikes that are used to pierce the seal to open communication between the vacuum source and the device opening. According to one aspect, a wide variety of spike geometries are possible. For example, Figures 48A-G depict various possible spike geometries such as a cylinder with a pointer at the end (Figure 48A), a cylinder with a slanted end (Figure 48B), a bifurcated arrangement (Figure 48C), a hollow cylinder with a beveled tip (Figure 48D), a simple cylinder that may be solid or hollow (Figure 48E), a pointed spike with a press-fit portion (Figure 48F), and a V-shaped spike groove with a longitudinal groove (Figure 48G). Of course, it should be understood that any geometry suitable for seal piercing or tearing may be used for the spike geometry, as this aspect is not limited in this respect.

[0069] Further details regarding the optional array of needles that may be included as part of the flow activator are provided below.

[0070] As mentioned above, the needles contained in the flow activator can be arranged in a variety of different ways depending on the intended application. For example, the needles can have a length of less than about 5 mm, less than about 4 mm, less than about 3 mm, less than about 2 mm, less than about 1 mm, less than about 800 micrometers, less than about 600 micrometers, less than about 500 micrometers, less than about 400 micrometers, less than about 300 micrometers, less than about 200 micrometers, less than about 175 micrometers, less than about 150 micrometers, less than about 125 micrometers, less than about 100 micrometers, less than about 75 micrometers, less than about 50 micrometers, less than about 10 micrometers, etc. The needles may also have a maximum cross-sectional dimension of less than about 5 mm, less than about 4 mm, less than about 3 mm, less than about 2 mm, less than about 1 mm, less than about 800 micrometers, less than about 600 micrometers, less than about 500 micrometers, less than about 400 micrometers, less than about 300 micrometers, less than about 200 micrometers, less than about 175 micrometers, less than about 150 micrometers, less than about 125 micrometers, less than about 100 micrometers, less than about 75 micrometers, less than about 50 micrometers, less than about 10 micrometers, etc. For example, in one embodiment, the needles may have a rectangular cross-section with dimensions of 175 micrometers by 50 micrometers. In one set of embodiments, the needles may have an aspect ratio of length to maximum cross-sectional dimension of at least about 2:1, at least about 3:1, at least about 4:1, at least 5:1, at least about 7:1, at least about 10:1, at least about 15:1, at least about 20:1, at least about 25:1, at least about 30:1, etc.

[0071] In one embodiment, the needle is a microneedle. Typically, a microneedle will have an average cross-sectional dimension (e.g., diameter) of less than about 1 millimeter. It should be understood that the reference to "needle" or "microneedle" as discussed herein is by way of example and for ease of presentation only, and that in other embodiments, more than one needle and / or microneedle may be present in any of the descriptions herein. As an example, microneedles such as those disclosed in U.S. Patent No. 6,334,856, issued Jan. 1, 2002 to Allen et al., entitled "Microneedle Devices and Methods of Manufacture and Use Thereof," may be used to deliver and / or withdraw fluids (or other substances) to and / or from a subject. Microneedles may be hollow or solid and may be formed from any suitable material, such as metals, ceramics, semiconductors, organics, polymers, and / or composites. Examples include, but are not limited to, medical grade stainless steel, titanium, nickel, iron, gold, tin, chromium, copper, alloys of these or other metals, silicon, silicon dioxide, and polymers of hydroxy acids such as lactic acid and glycolic acid, polymers including polylactides, polyglycolides, polylactide-co-glycolides, and copolymers with polyethylene glycols, polyanhydrides, polyorthoesters, polyurethanes, polybutyric acid, polyvaleric acid, polylactide-co-caprolactone, polycarbonates, polymethacrylic acid, polyethylene vinyl acetate, polytetrafluoroethylene, polymethyl methacrylate, polyacrylic acid, or polyesters.

[0072] In some cases, two or more needles or microneedles may be used. For example, an array of needles or microneedles may be used, and the needles or microneedles may be arranged in an array in any suitable configuration, such as a periodic, random configuration, etc. In some cases, the array may have 3 or more, 4 or more, 5 or more, 6 or more, 10 or more, 15 or more, 20 or more, 35 or more, 50 or more, 100 or more, or any other suitable number of needles or microneedles. Typically, the microneedles will have an average cross-sectional dimension (e.g., diameter) of less than about 1 micron.

[0073] One skilled in the art will appreciate that in one embodiment, the needles may be aligned relative to the skin or other surface for these purposes, including introducing the needle into the skin at an angle other than 90° relative to the surface of the skin, i.e., introducing one or more needles into the skin at an angle to limit the depth of penetration, however, in other embodiments the needle may enter the skin or other surface at approximately 90°.

[0074] In some cases, the needles (or microneedles) are arranged in an array with a density of needles of about 0.5 needles / mm 2 From 10 pieces / mm 2 and in some cases, the density is about 0.6 fibers / mm 2 Approximately 5 lines / mm 2 Between, about 0.8 lines / mm 2 Approximately 3 lines / mm 2 Between, about 1 line / mm 2 Approximately 2.5 lines / mm 2 The needles may be in an array selected to be between about 1 mm, about 0.9 mm, about 0.8 mm, about 0.7 mm, about 0.6 mm, about 0.5 mm, about 0.4 mm, about 0.3 mm, about 0.2 mm, about 0.1 mm, about 0.05 mm, about 0.03 mm, about 0.01 mm, etc. In some cases, the needles may be positioned in the array such that no two needles are closer than about 1 mm, about 0.9 mm, about 0.8 mm, about 0.7 mm, about 0.6 mm, about 0.5 mm, about 0.4 mm, about 0.3 mm, about 0.2 mm, about 0.1 mm, about 0.05 mm, about 0.03 mm, about 0.01 mm, etc.

[0075] In another set of embodiments, the needle (or microneedle) may be selected such that the area of ​​the needle (determined by determining the area of ​​penetration or puncture on the surface of the subject's skin by the needle) allows for sufficient flow of fluid to and from the subject's skin and / or under the skin. The needle may be selected to have a smaller or larger area (or smaller or larger diameter), so long as the contact area of ​​the needle to the skin allows for sufficient blood flow from the subject's skin to the device. For example, in certain embodiments, the needle may be selected to have a diameter of at least about 500 nm, depending on the application. 2 , at least about 1,000 nm 2 , at least about 3,000 nm 2 , at least about 10,000 nm 2, at least about 30,000 nm 2 , at least about 100,000 nm 2 , at least about 300,000 nm 2 , at least about 1 micron 2 , at least about 3 microns 2 , at least about 10 microns 2 , at least about 30 microns 2 , at least about 100 microns 2 , at least about 300 microns 2 , at least about 500 microns 2 , at least about 1,000 microns 2 , at least about 2,000 microns 2 , at least about 2,500 microns 2 , at least about 3,000 microns 2 , at least about 5,000 microns 2 , at least about 8,000 microns 2 , at least about 10,000 microns 2 , at least about 35,000 microns 2 , at least about 100,000 microns 2 At least about 300,000 microns 2 , at least about 500,000 microns 2 , at least about 800,000 microns 2 , at least about 8,000,000 microns 2 and the like.

[0076] The needle or microneedle may have any suitable length, and the length may depend on the application in some cases.For example, a needle designed to penetrate only the epidermis may be shorter than a needle designed to penetrate the dermis as well or extend into the dermis or under the skin.In some embodiments, the needle or microneedle may have a maximum penetration into the skin of about 3 mm or less, about 2 mm or less, about 1.75 mm or less, about 1.5 mm or less, about 1.25 mm or less, about 1 mm or less, about 900 microns or less, about 800 microns or less, about 750 microns or less, about 600 microns or less, about 500 microns or less, about 400 microns or less, about 300 microns or less, about 200 microns or less, about 175 microns or less, about 150 microns or less, about 125 microns or less, about 100 microns or less, about 75 microns or less, about 50 microns or less, etc. In certain embodiments, the needles or microneedles may be selected to have a maximum penetration into the skin of at least about 50 micrometers, at least about 100 micrometers, at least about 300 micrometers, at least about 500 micrometers, at least about 1 mm, at least about 2 mm, at least about 3 mm, etc.

[0077] In one set of embodiments, the needle (or microneedle) may be coated. For example, the needle may be coated with a substance that is delivered when the needle is inserted into the skin. For example, the coating may include heparin, anticoagulants, anti-inflammatory compounds, pain relievers, antihistamine compounds, etc. to aid blood flow from the subject's skin, or the coating may include a drug or other therapeutic agent, such as those described herein. The drug or other therapeutic agent may be one used for local delivery (e.g., at or near the area where the coated needle or microneedle is applied) and / or the drug or other therapeutic agent may be one intended for systemic delivery within the subject.

[0078] Although aspects of the present invention have been described with reference to various illustrative embodiments, such aspects are not limited to the described embodiments. Thus, it is apparent that many alternatives, modifications, and variations of the described embodiments will be apparent to those skilled in the art. Thus, the embodiments as described herein are intended to be illustrative rather than restrictive. Various modifications may be made without departing from the spirit of the aspects of the present invention.

Claims

1. 1. A device for receiving a fluid from a subject, the device comprising: A device actuator; a flow activator arranged to cause fluid to be expelled from the subject; A vacuum source; a deployment actuator operatively coupled to the device actuator and the flow activation body, the deployment actuator configured to move the flow activation body in a deployment direction; a retraction actuator operably coupled to the device actuator and the flow activation body, the retraction actuator configured to move the flow activation body in a retraction direction; Including, The device, wherein the deployment actuator moves the flow activation body a first distance and the retraction actuator moves the flow activation body a second distance, the first distance being less than the second distance.

2. The device of claim 1 , wherein the deployment actuator comprises a spring.

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

4. The device of claim 1 , wherein a vacuum is generated from the vacuum source during operation of the device.

5. The device of claim 1 , wherein the vacuum from the vacuum source is created manually.

6. The device of claim 1 , wherein the flow activator comprises at least one needle.

7. The device of claim 6 , wherein the at least one needle comprises a plurality of microneedles.

8. The device of claim 1 , further comprising a device interface that provides a seal against the skin.

9. The device of claim 8 , wherein the device interface comprises an adhesive.

10. The device of claim 1 , wherein actuating the device actuator comprises depressing the device actuator.

11. The device of claim 1 , wherein the retraction actuator is configured to move the deployment actuator in the retraction direction.

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