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 generally relates to systems and methods for transporting and / or receiving fluids or other substances, such as blood or interstitial fluid, from a subject, for example, to and / or from the skin and / or subcutaneous tissue.

Background Art

[0002] Phlebotomy or venipuncture is the process of obtaining intravenous access or obtaining a sample of venous blood for the purpose of intravenous therapy. This process is typically practiced by medical practitioners, including paramedics, phlebotomists, physicians, nurses, etc. Most equipment involves the use of evacuated (vacuum) tubes, such as, for example, the Vacutainer TM (Becton, Dickinson and compamy) and Vacuette TM (Greiner Bio-One GmBH) systems, etc., to obtain blood from a subject. Other equipment includes hypodermic needles, syringes, etc. However, such procedures are complex, require advanced training of the practitioner, and in many cases cannot be performed in a non-medical environment. Therefore, there is still a need for an improvement in the method of obtaining blood or other fluids from or through the skin.

Summary of the Invention

Problems to be Solved by the Invention

[0003] In some embodiments, the present invention generally relates 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 may, in some cases, involve correlated products, alternative solutions to specific problems, and / or multiple different uses of one or more systems and / or components.

Means for Solving the Problems

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

[0005] In another aspect of the invention, an effector that includes only mechanical components moves the fluid 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, the device can include a fluid transporter that includes an opening and a fluid activator arranged to allow fluid to be released from a subject, and a vacuum source that provides a pressure lower than the ambient pressure. The device can also include a channel that is fluidly connected between the opening and the vacuum source. In one aspect of the invention, the fluid 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 fluid activator is moved in the retraction direction. In another aspect, the device actuator that actuates the fluid activator also enables fluid communication between the opening along the channel and the vacuum source.

[0007] In another aspect of the invention, the effector can have an initial stored potential energy before any deployment movement of the fluid activator. The effector can be arranged to release the stored potential energy to retract the fluid activator.

[0008] In another aspect of the invention, the fluid activator, the retraction actuator, and the deployment actuator can be arranged concentrically with each other. Additionally, the device can include a spacer element that is also arranged concentrically with the fluid activator, the retraction actuator, and the deployment actuator.

[0009] In another aspect, the present invention includes a method of making one or more of the embodiments described herein, such as a device for receiving a fluid. In yet another aspect, the present invention includes a method of using one or more of the embodiments described herein, such as 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 present invention when considered in conjunction with the accompanying drawings. If the present specification and the incorporated documents include contradictory and / or conflicting disclosures, the present specification shall prevail. If two or more incorporated documents include contradictory and / or conflicting disclosures with respect to each other, the document having the most recent effective date shall prevail.

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

Brief Description of the Drawings

[0012]

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[0013] Aspects of the present invention are not limited in application to the details of the arrangement of structures and components described in the following description or illustrated in the drawings. For example, illustrative embodiments regarding piercing the skin and receiving blood released from the pierced skin are discussed below, but aspects of the present invention are not limited to uses with devices that pierce the skin and / or receive blood. Other embodiments, such as devices that receive other body fluids without piercing, may be employed, and aspects of the present invention may be practiced or carried out in various ways. Also, the expressions and terms used herein are for the purpose of explanation and should not be regarded as limiting.

[0014] FIG. 1 shows a fluid receiving device 1 incorporating various aspects of the present invention. FIG. 1 incorporates many aspects of the present invention, although 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 exemplary embodiment includes a cover 20 and a base 100, which are joined together to enclose the various components of the device 1 and may cooperate to 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 the cover 20 may be formed of or otherwise include a polyester (PCTA or PETG) or other polymer with a low gas permeability. The device actuator 10 in this embodiment is arranged to be actuated by a user (e.g., by pressing with a finger), although the device actuator 10 may be arranged for actuation by other means, such as by a machine, an 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, e.g., 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 discussed further below, a touch screen interface, a switch, or other user-actuable arrangement. In some cases, the device actuator 10 may allow the device 1 to be actuated only once, e.g., the device actuator 10 may be locked in a position preventing further actuation, or may allow the device 1 to be actuated multiple times.

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

[0016] The fluid transporter may include an opening of any size and / or geometric shape configured to receive fluid within 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 fluid activator, such as one or more microneedles, arranged to cause fluid to be released from the subject, for example, by piercing the subject's skin. In some embodiments, where the fluid may partially or completely fill an enclosure surrounding the fluid activator, the enclosure may define at least a portion of the fluid transporter.

[0017] Note that since the device may not necessarily employ a mechanism for causing fluid release from the subject, the fluid activator need not be included in all embodiments. For example, the device may receive fluid that has already been released due to another cause such as cutting or wear, fluid release by a separate and independent device such as a separate lancet, open fluid access during surgery, etc. In addition, the fluid may be introduced into the device via urination, vomiting, pouring fluid into the device, etc. When included, the fluid activator may operate differently to physically penetrate, puncture, and / or abrade, chemically exfoliate, corrode, and / or irritate, emit and / or generate electromagnetic, acoustic, or other waves, and cause fluid to be released from the subject. The fluid activator may include, for example, a movable mechanism that moves a needle, or may not require movement to function. For example, the fluid activator may include a jet injector or "hypo spray" that transports fluid to the subject under pressure, a pneumatic system that transports and / or receives fluid, a moisture absorbent that adsorbs or absorbs fluid, an inverse ion photorecisis system, ultrasonic waves, or a transducer that emits heat, radio frequency, and / or laser energy, none of which necessarily require movement of the fluid activator to cause fluid to be released from the subject.

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

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

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

[0021] In one aspect of the present invention, the fluid activator can be actuated by a deployment actuator and a retraction actuator. For example, the fluid activator can be movable, and the movement of the fluid activator can be caused by the deployment actuator and the retraction actuator. The deployment actuator can move the fluid activator in the deployment direction towards the skin and / or other surface of the subject, and the retraction actuator can move the fluid activator in the retraction direction away from the skin and / or body of the subject. As will be discussed in more detail below, providing separate actuators for deployment and retraction movement can, in some cases, allow the fluid activator to move at different speeds for deployment and retraction, allow the actuators to perform other additional functions such as opening a fluid flow path for blood or other fluids, and allow the fluid activator to start or end at different positions within the device before and after deployment, etc. The deployment actuator and the retraction actuator can 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 actuator and the retraction actuator can be of the same type or different types of devices. Each actuator can operate manually, mechanically, electrically, pneumatically, electromagnetically, or in other suitable modes of operation, and may or may not require user input for activation.

[0022] According to an aspect of the present invention, the effector can be arranged to cause the deployment and / or retraction movement of the flow activator. For example, the effector can include both a deployment actuator and a retraction actuator. The effector can be formed from or alternatively include polyester (PETG or PCTA), acetal resin, acrylonitrile butadiene styrene (ABS), etc. Figures 3, 4, and 5 respectively illustrate a perspective view of the device 1 of Figure 1, a partial cross-sectional view of the device 1, and an exploded view of the device 1 with the cover 20 removed from the base 100. In this embodiment, the device 1 includes a retraction actuator 40 and a deployment actuator 60, and an effector 50 that is movable vertically with respect to the base 100 along the effector guide 104. The deployment actuator 60 is attached to the flow activator 90 via a membrane 72 such that a downward movement of the deployment actuator 60 can at least partially expand the flow activator 90 from the opening 130. (As will be further discussed below, the membrane 72 can separate the vacuum source 156 in the device 1 from the opening 130 such that a relatively low pressure is maintained by the vacuum source 156 until it is controllably opened to cause flow into the storage chamber 140. The vacuum source 156 can be in the form of a sealed vacuum chamber.) In this embodiment, the deployment actuator 60 has a generally dome shape with a central hole that receives a portion of the membrane 72 that attaches the deployment actuator 60 to the flow activator 90 (for example, 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, but the flow activator 90 can be directly connected to the deployment actuator 60 via, for example, a vertical post or other structure extending from the flow activator 90 to the deployment actuator 60.) The deployment actuator 60 is initially arranged in the downwardly concave configuration shown in Figure 4 and can be moved to the upwardly concave configuration, for example, by the user pressing the device actuator 10 such that the central portion of the deployment actuator 60 is pushed downwardly against the release element 30.The deployment actuator 60 can be made of a suitable material and configuration that rapidly expands the flow activator 90 from the aperture 130 and rapidly moves from a downwardly concave configuration to an upwardly concave configuration to pierce the skin or other surface of the subject. The deployment actuator 60 in this embodiment is arranged as a flexible spring with a dome shape, but the deployment actuator 60 can be of any suitable shape and / or size. For example, the deployment actuator 60 can be circular (without "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 - leg shaped, star - shaped, clover - shaped (e.g., with any number of lobes such as 2, 3, 4, 5, etc.), serrated disk or corrugated, etc. The deployment actuator 60 can, in some embodiments, have a central or other location with a central hole, or other features such as a depression or button as shown. The deployment actuator 60 can be formed from any suitable material, such as metals (e.g., 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, chromium vanadium, nickel alloy steel (e.g., Monel 400, Monel K 500, Inconel 600, Inconel 718, Inconel x 750, etc.)), polymers (e.g., polyvinyl chloride, polypropylene, polycarbonate, etc.), composites or laminates (e.g., including fiberglass, carbon fiber, bamboo, Kevlar, etc.) or otherwise can contain them.

[0023] In some embodiments, all parts of the deployment actuator can move less than a certain distance when the deployment actuator moves in the deployment direction towards the aperture 130. In some embodiments, all parts of the deployment actuator can 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, but other arrangements such as coil springs, foams, elastic bladders, etc. are possible, like the deployment actuator 60. The retraction actuator can be formed from any suitable material, for example, 1095 spring steel or 301 stainless steel, or other spring materials such as 1074 / 1075, 5160, 9255 spring steel, or alternatively can include them. When the retraction actuator 40 is released in response to the operation of the device actuator 10, the retraction actuator 40 (and other parts of the effector 50) can move away from the opening 130 along the effector guide 104. The retraction actuator 40 is attached to the deployment actuator 60 via the effector body 50. This retraction movement also pulls away the flow activator 90 and the deployment actuator 60 from the opening. Specifically, as shown at least partially in FIGS. 4 and 5, before the operation of the device 1, the retraction actuator 40 is in a compressed state storing potential energy. That is, the center of the retraction actuator 40 is pushed downward during assembly so that the four arms of the retraction actuator 40 are elastically deformed. The retraction actuator 40 is held in this depressed state by the ear portion 103 (see FIGS. 8 and 9) of the retraction actuator 40 that engages the base 100 until the device 1 is actuated. However, when the device actuator 10 is pushed down during device operation, the arm 31 of the release element 30 engages the tab 41 to release the ear portion 103 from the base 100, allowing the central portion of the retraction actuator 40 to move away from the opening 130 in the retraction direction. Since the deployment actuator 60 and the flow activator 90 are attached to the retraction actuator 40, the upward movement of the retraction actuator 40 away from the opening 13 causes the flow activator 90 to retract from the opening 130. Additionally, the upward movement of the retraction actuator 40 away from the opening 130 can also move the deployment actuator 60 in the retraction direction away from the opening 130. In some embodiments, all parts of the deployment actuator 60 can move less than a certain distance when the deployment actuator 60 moves away from the opening 130 in the retraction direction.In some embodiments, all parts 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, the spacer element 32 is positioned between the deployment actuator 60 and the retraction actuator 40. The spacer element 32 may serve to eliminate the gap between the deployment actuator 60 and the release element 30. Actuation of the device actuator 10 may cause the spacer element 32 to be pushed down against the release element 30, which in turn may push the deployment actuator 60 forward and cause the fluid activator 90 to move in the deployment direction relative to the deployment actuator 60. In some embodiments, the fluid activator 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 fluid activator 90, the fluid activator 90 can be controlled to have any suitable movement for both deployment and retraction. For example, the fluid activator 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 rapidly from a downwardly concave configuration to an upwardly concave configuration to quickly insert the fluid activator 90 into the skin or another surface. Thereafter, the fluid activator 90 can be more slowly withdrawn from the skin by the retraction actuator 40 such that it is controlled, for example, by the damped movement of the retraction actuator 40 or other suitable arrangement, by a relatively low force exerted on the fluid activator 90 by the retraction actuator 40 as compared to the deployment actuator 60. In other embodiments, having separate deployment and retraction actuators can allow for a shorter movable range in one direction, such as the deployment direction, than in another direction, such as the retraction direction. For example, by moving the fluid activator 90 a relatively short distance for deployment, the deployment actuator 60 can be made relatively small but can suitably generate a high force to insert the fluid activator 90 into the skin. In contrast, the relatively long distance moved by the fluid activator 90 during retraction can suitably pull the activator 90 out to allow a pool of blood or other collection to enter a cavity or other space for receipt by the device 1. Additionally, the short deployment distance can minimize alignment errors inherent in the long movement distance.

[0027] Thus, in one aspect of the present invention, the fluid activator can be positioned at an initial pre-deployment distance from the skin or another surface that is different from the final retracted distance between the fluid activator and the skin or other surface. This aspect can be provided in many different ways, such as by a motor, servo, or automated device as part of the effector. However, the effector 50 of the embodiment of FIGS. 1-5 can provide an arrangement where the fluid activator 90 is relatively close to the opening 130 before deployment and relatively far from the opening 130 after deployment. FIGS. 6A-6C show a series of schematic views of three states of the device 1 of FIGS. 1-5, including the initial state before deployment of the fluid activator 90, an intermediate state where the fluid activator is expanded from or otherwise positioned relative to the opening 130 to cause the release of fluid from the target skin or other surface, and a final state where the fluid activator 90 is retracted.

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

[0029] Figures 7A and 7B show a top perspective view and a bottom perspective view of the effector 50 of the embodiment of FIGS. 1-5, and are helpful for better illustrating the method by which the movement of the effector 50 is controlled. As shown in FIG. 7A, the retraction actuator 40 has eight legs that radiate 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 the hole 46 of the retraction actuator 40. The diameter of the post head 52 is made larger than the hole 46, and thus the retraction actuator 40 can be fixed to the effector body 50. The retraction actuator 40 can alternatively be attached to the effector body 50 by an adhesive (e.g., tape, liquid), mechanical fastening (e.g., interference fit, slot / groove, screw), or thermal method (e.g., heat caulking), and is not limited in this regard. The other legs 48 of the retraction actuator 40 can remain free to bend relative to the effector body 50, for example, to provide a retraction movement of the effector 50. Two of the legs 48 include ear portions 103 that engage the base 100 and serve to hold the retraction actuator 40 in an initial position compressed prior to the deployment of the fluid activator 90. A space or gap 43 is provided between the ear portion 103 and the effector body 50 to allow the ear portion 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 hole 66 and lobes 62 that are held within the groove 56 of the effector body 50. The deployment actuator 60 is attached to the effector body 50, but the central portion 64 of the deployment actuator 60 remains displaceable relative to the effector body 50 such that the deployment actuator 60 can move to deploy the fluid activator 90.

[0030] As discussed above, the effector 50 can be mounted on the base 100 and guided in its movement via an effector guide 104 protruding from the base 100. FIG. 8 shows a close-up view of the retraction actuator 40 illustrating how the retraction actuator 40 engages the base 100 in an initial state where the retraction actuator 40 is compressed, while FIG. 9 shows a close-up view of ear portions 103 on two of the legs of the retraction actuator 40 that engage the base 100 to hold the retraction actuator 40 in the compressed initial state. When the effector 50 is suitably held by the effector guide 104, the effector 50 is pushed downward so that the ear portion 103 of the tab 41 can be positioned under the corresponding protrusion 101 on the base 100. When the ear portion 103 is engaged with the protrusion 101, the effector 50 can be released such that the spring force of the legs 48 biases the effector 50 to move upward in the retraction direction. However, by engaging the ear portion 103 with the protrusion 101, the effector 50 is held in the compressed state. In this pre-deployment arrangement, the fluid activator 90 can be at an initial pre-deployment distance 181 (see FIG. 6) from the opening 130. In some embodiments, this pre-deployment distance 181 can be arranged such that actuation of the deployment actuator 60 causes the fluid activator 90 to reach the subject's skin and enables the fluid activator 90 to penetrate and / or puncture the skin to cause fluid flow. Thus, by preloading the retraction actuator 40 in the initial semi-compressed state, the fluid activator 90 can be held at the pre-deployment distance 181 that enables the fluid activator 90 to be ready for deployment upon actuation of the device actuator 10.

[0031] FIG. 8 also illustrates a way in which the retraction actuator 40 can be released to retract the flow activator 90. When the device actuator 10 and the release element 30 are moved downward, the inclined portion of the arm 31 of the release element 30 can engage the tab 41 such that it pushes the tab 41 outwardly and away from the effector body 50. This releases the lug portion 103 from the projection 101 and allows the effector 50 to move upward under the biasing of the deformed leg portion of the retraction actuator 40. The release element 30 can be formed of, or otherwise include, polyester (PETG or PCTA), acetal resin, acrylonitrile butadiene styrene (ABS), etc. In this embodiment, the retraction actuator 40 is shown engaging the base 100 via a releasable latch arrangement including the lug portion 103 and the projection 101, but the invention is not limited in this regard, and other arrangements such as a releasable lever, sliding release, detent, wedge, or a magnet that is separable by reversing polarity are possible.

[0032] In another aspect of the present invention, the effector may have an initial stored potential energy prior to any deployment movement of the fluid activator. That is, the effector may have stored spring energy, or for example, other mechanical energy stored in an elastically deformed element, stored chemical energy, stored electrical energy, etc., which is used to deploy and / or retract the fluid activator or cause other movement of other components of the fluid receiving device. As described above, prior to the deployment of the fluid activator 90, the retraction actuator 40 may be held in a compressed state by the engagement of the ear portion 103 of the leg portion 48 with the protruding element 101 on the base 100. The 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 fluid activator 90. Thus, by having the retraction actuator 40 in an initial compressed state, it enables the retraction actuator 40 to store potential energy and be ready for operation without requiring energy to be input into the system during the operation of the device.

[0033] In another aspect of the present invention, the fluid 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., bistably, from the initial pre-deployment position to the deployment 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 fluid activator 90 at a slower speed during at least a portion of the retraction movement. In a set of embodiments, the fluid activator 90 may deploy at a speed of at least about 0.1 cm / second, at least about 0.3 cm / second, about 1 cm / second, at least about 3 cm / second, at least about 10 cm / second, at least about 30 cm / second, at least about 1 m / second, at least about 2 m / second, at least about 3 m / second, at least about 4 m / second, at least about 5 m / second, at least about 6 m / second, at least about 7 m / second, at least about 8 m / second, at least about 9 m / second, at least about 10 m / second, at least about 12 m / second, etc., at the point where the fluid activator 90 first contacts the skin. Without being bound by any theory, it is contemplated that a relatively fast deployment speed may increase the ability of the fluid activator to penetrate the skin (without deforming the skin or causing the skin to move in response) and / or may decrease the amount of pain felt by the application of the fluid activator to the skin. Any suitable method for controlling the penetration speed into the skin, including those described herein, may be used.

[0034] The retraction of the fluid activator 90 can occur at a slower rate than deployment, for example, to help reduce any pain associated with the withdrawal of the fluid activator 90. When the retraction actuator 40 includes only mechanically controlled elements that are not electrically controlled, such as in the case of a spring, elastic member, foldable foam, etc., the spring or other element can be designed or otherwise arranged to provide the desired rate of retraction. Alternatively, other mechanical elements, such as one or more dampers, can be provided to control the rate of withdrawal. Some other electrically controlled systems, such as some servos, pneumatic systems, etc., can incorporate open or closed loop control to provide the desired rate of retraction. In the case of a manually operated retraction actuator, the user may be able to control the rate of retraction. For example, a retraction actuator in the form of a spring can retract more slowly when the force is gradually removed from the device actuator. However, if the force is removed suddenly (e.g., the user suddenly releases the device actuator), the retraction can occur more rapidly, but the maximum possible rate of retraction can still be slower than the deployment rate.

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

[0036] In one aspect of the present invention, the device may include a vacuum source. The vacuum (pressure below ambient) can help facilitate fluid flow into the opening 130 of the device and / or can help draw the skin into the opening 130 for contact with the flow activator 90 and / or can help facilitate fluid flow from the opening 130 to the chamber 140. In some cases, the vacuum source may be built-in within the device, i.e., the device does not need to be connected to an external vacuum source (e.g., a household vacuum) during use of the device to draw blood or interstitial fluid from the skin and / or from under the skin. For example, as shown in FIG. 4, in one set of embodiments, the vacuum source may include a vacuum source 156 having 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 "negative pressure" (i.e., negative with respect to ambient pressure) or "reduced pressure" (or simply having a "vacuum"). For example, if the ambient pressure is at atmospheric pressure, the vacuum in the vacuum source can 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 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 produce other pressures (greater than or less than atmospheric pressure). By way of non-limiting example, an external vacuum or mechanical device can be used as the vacuum source. For example, the device may be provided with 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 can be created manually, e.g., by operating a syringe pump, plunger, etc., or the low pressure can 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 can be “pre-packaged” with a suitable vacuum source (e.g., a pre-evacuated vacuum source 156), and in one embodiment, for example, the device can be activated in some manner to be applied to the skin, create, and / or access the vacuum source. In some embodiments, a built-in vacuum source can be operated in some manner to create a vacuum within the device. For example, the built-in vacuum source can include mechanical devices such as pistons, syringes, vacuum pumps capable of creating a vacuum within the device, and / or chemicals or other reactants that can react to increase or decrease pressure to form a pressure differential associated with a pressure regulator with the aid of a mechanically driven or other means driven by a reaction. The chemical reaction can also drive mechanical operation with or without a change in pressure based on the chemical reaction itself. The built-in vacuum source can also include expandable foams, shape memory materials, 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 the opening 130. The interface 105 can be, for example, a suction cup, a layer of a hydrogel material such as Katecho 10G or other suitable hydrogel, or a circular bowl disposed 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, part of 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., leakage reduced) using, for example, vacuum grease, petroleum jelly, gel, adhesive, etc. In some cases, the interface 105 can be relatively small, for example, 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. The interface 105 can be circular, but other shapes are also possible, such as square, star-shaped (having 5, 6, 7, 8, 9, 10, 11, etc. tips), teardrop-shaped, oval, rectangular, etc.

[0039] In some embodiments, the vacuum from the vacuum source can facilitate the movement of blood or other fluid from the opening of the fluid transporter to the storage container. In the embodiments of FIGS. 1-5, the vacuum can be stored in a majority 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 connected to the storage chamber 140 so as to draw the 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 storage 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 component. (Additional configuration options for the channel 110 are discussed below.) The channel plate 80 not only serves to define the channel 110, but also at least a portion of the cavity in the fluid transporter 120, a portion of the storage chamber 140, the vacuum inlet 154 and the flow path 150 used to control the flow between the vacuum source 156 and the storage chamber 140, and the flow path between the channel 110 and the storage chamber 140 can be defined. That is, as shown in FIGS. 4 and 10, the channel plate 80 serves to define the flow path between the opening 130 and the vacuum source 156 such that the flow from the opening 130 can pass through the channel 110 to the opening 144 in the channel plate 80 that connects the channel 110 and the storage chamber 140. The opening 144 can include a filter, a hydrophobic element (e.g., useful for preventing the aqueous fluid in the storage chamber 140 from later exiting the chamber 140), a one-way valve, or may not completely block anything. As can be seen in FIG. 10, the flow can also occur from the storage chamber 140 through the passage 150 in the channel plate 80 to the vacuum inlet 154. The vacuum inlet 154 is typically closed by the seal 76 and can be part of the membrane 72, which also serves to isolate the vacuum source 156 from other potential outlets to the low pressure in the opening 130 and the vacuum source 156.As can be seen in FIG. 4, when the retraction actuator 40 is in its compressed initial state, the seal leg 49 presses the seal 76 into contact with the vacuum inlet 154 so as to close the passage 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 can move upwardly and / or the force of the seal leg 49 on the seal 76 can be reduced to the point where 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 can 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 can be provided at the vacuum inlet 154 or other suitable location (such as in the passage 150) to prevent liquid from flowing from the storage chamber 140 into the vacuum source 156.

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

[0041] As can be understood from the above description, in another aspect of the present invention, the fluid activator is moved in the deployment direction to deploy the fluid activator, and is retracted while being moved in the retraction direction to enable fluid communication between the vacuum source and the opening of the fluid transporter. In the exemplary embodiments described above, as the fluid activator 90 is retracted, the seal 76 can be released from the vacuum inlet 154. The opening of the flow path in the seal 76 can occur at the start of retraction, during retraction, and / or after retraction is complete. In some embodiments, both the seal 76 and the fluid activator 90 can be moved in the same retraction direction by a retraction actuator. That is, during retraction, the fluid activator 90 can be retracted and the seal 76 can be lifted to enable fluid communication between the vacuum source 156 and the device opening 130 through the channel 110. The seal 76 can be formed of latex, or other flexible materials such as thermoplastic elastomer (TPE) or polyurethane, or alternatively can include them. In other embodiments, the force on the seal 76 can be sufficiently released to create a flow from the storage chamber 140 to the vacuum source 156 at a relatively low pressure in the vacuum source 156. Thus, the seal 76 does not necessarily have to be lifted from the vacuum inlet 154, but instead can act as a kind of check valve with a desired cracking pressure that allows a suitable pressure differential to exist across the seal 76 and enables flow from the storage chamber 140 to the vacuum source 156 while otherwise blocking flow through the inlet 154. Other arrangements for opening fluid communication during retraction of the fluid activator are possible, such as spikes on the retraction actuator 40 that pierce a membrane to open fluid communication. In another embodiment, an electrical switch can be opened or closed by the retraction actuator to activate a vacuum source (such as a pump). In another embodiment, the movement of the retraction actuator can release a latch or other device, which enables a spring-loaded syringe piston or other device to move to create the desired vacuum. In another embodiment, the retraction movement of the retraction actuator 40 itself can move a syringe piston or other device to provide the desired vacuum.Thus, enabling fluid communication between a vacuum source and an opening of a fluid transporter does not necessarily involve the opening of a valve or other device that blocks flow, but instead may involve the creation of a suitable vacuum to cause flow. Other arrangements are possible.

[0042] In another aspect of the present invention, an effector that deploys and / or retracts a flow activator may also enable fluid communication between an opening of a fluid transporter and a vacuum source. By providing a single component or assembly that deploys and / or retracts a flow activator and opens fluid communication between a fluid transporter and a vacuum source, in some embodiments, a fluid receiving device with a simpler operation or structure may be provided. For example, a single device such as the retraction actuator 40 in the embodiments of FIGS. 1-10 can function to retract and open a flow path. This can reduce the parts required for constructing a fluid receiving device and reduce cost and / or assembly complexity. Of course, the effector does not necessarily have to perform both deployment and retraction functions, but instead may enable fluid communication and provide only deployment or only retraction. For example, in embodiments where the flow activator is not retracted after deployment and instead is allowed to remain embedded in the skin when a vacuum is applied to the flow activator to draw out fluid, for example, the effector can function only to deploy the flow activator and enable fluid communication between an opening of a fluid transporter and a vacuum source. As discussed above, enabling fluid communication between an opening of a fluid transporter and a vacuum source can be provided in different ways, such as by opening a valve or similar structure (such as the seal 76), puncturing a membrane, operating 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 present invention, the flow activator and the vacuum seal can be attached together, for example, as part of a single integral structure or component. For example, as shown in FIGS. 4 and 5, the flow activator 90 can 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 part of the membrane 72 itself. Such an arrangement can 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 into the storage chamber 140. The channel 110 can be formed, at least in part, by a single component, such as an etched substrate or a molding unit, such as the base 100. The channel can have any cross-sectional shape, such as circular, oval, triangular, irregular, square, or rectangular (having 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 (as in the case of a two-dimensional opening, for example). In embodiments where the channel is fully covered, at least a portion of the channel can have a cross-section that is fully enclosed, and / or the entire channel can be fully enclosed along its entire length, except at its inlet and outlet.

[0045] The channels can have any aspect ratio (length to average cross-sectional dimension), e.g., an aspect ratio of 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" with reference to a fluid or microfluidic channel is measured in a direction generally perpendicular to the fluid flow within the channel. The channels will generally include properties that facilitate control over fluid transport, e.g., structural properties and / or physical or chemical properties (hydrophobic versus hydrophilic), and / or other properties that can exert a force (e.g., a restraining force) on the fluid. The fluid within the channel can partially or completely fill the channel. In some cases, the fluid can be held or constrained within the channel or a portion of the channel in some manner, e.g., using surface tension (e.g., such that the fluid is held within the channel within a meniscus such as a concave or convex meniscus). For a component or substrate, some (or all) of the channels can be below a particular size, e.g., in some cases 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 less, having a maximum dimension perpendicular to the fluid flow. In one embodiment, the channel is a capillary.

[0046] In one set of embodiments, the device may include a microfluidic channel. As used herein, prefixes such as "microfluidic", "microscopic", "microscale", "micro" (such as in the case of "microchannel") generally refer to elements or components 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 instead of, or in combination with, the microfluidic channels for any of the embodiments discussed herein. For example, channels having a width or diameter 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 certain instances. In some cases, an element or component includes a channel through which fluid can flow. In all embodiments, the specified width may be the minimum width (i.e., the width specified where the component can have a larger width at different dimensions), or the maximum width (where the component can have a length greater than, but not a width greater than, that specified). 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, the 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 often contain various analytes in the body that are important for diagnostic purposes, such as markers for various medical conditions such as glucose (e.g., for diabetes). Other examples of analytes are ions such as sodium, potassium, chloride, calcium, magnesium, and / or bicarbonate (e.g., for determining dehydration), gases such as carbon dioxide or oxygen, H+ including metabolites such as (i.e., pH), urea, blood urea nitrogen, or creatinine, hormones such as estradiol, estrone, progesterone, progestin, testosterone, androstenedione (e.g., for determining pregnancy, illegal drug use, etc.), or cholesterol. Other examples include insulin or hormone levels. Still other analytes include high density lipoprotein (「HDL」), low density lipoprotein (「LDL」), albumin, alanine aminotransferase (「ALT」), aspartic acid 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 a cardiac marker), and infectious disease markers such as for influenza, respiratory syncytial virus, or RSV, etc., but are not limited thereto.

[0048] The fluid receiving device 1 may include one or more sensors for detecting one or more characteristics of the fluid received from the subject. The sensors may be located in the storage chamber 140, in the channel 110, on the cover 20, or in any suitable manner or location with respect to the device. For example, the device 1 may include a pH sensor, an optical sensor, an oxygen sensor, a sensor capable of detecting the concentration of a substance, and the like. 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, and the like. One of ordinary skill in the art will be able to identify other suitable sensors. The sensors may optionally include a colorimetric detection system that may be external to the device or, in some cases, microfabricated into the device. As an example of a colorimetric detection system, when a dye or fluorescent entity is used (e.g., in particles), the colorimetric detection system may be capable of detecting a change or shift in the frequency and / or intensity of the dye or fluorescent entity.

[0049] In one set of embodiments, the sensor can be a test strip, e.g., a commercially available test strip. Examples of test strips include, but are not limited to, glucose test strips, urine test strips, pregnancy test strips, etc. The test strip typically includes a strip, piece, or snippet of paper or other material and will include one or more regions capable of determining an analyte, e.g., via binding of the analyte to a diagnostic agent or reactive entity capable of interacting and / or associating with the analyte. For example, the test strip can include various enzymes or antibodies, glucose oxidase, and / or hexacyanoferrate, etc. The test strip can be capable of determining, depending on the type of test strip, e.g., glucose, cholesterol, creatinine, ketones, blood, proteins, nitrites, pH, urobilinogen, bilirubin, white blood cells, luteinizing hormone, etc. The test strip can be used in any number of different ways. In some cases, the test strip is commercially available and can be inserted into the device, e.g., before or after receiving blood, interstitial fluid, or other fluid from a subject. For example, in embodiments where the device uses the test strip as a sensor such that the device itself determines the analyte, at least a portion of the blood or other fluid can be exposed to the test strip to determine the analyte. In some cases, the device can be sold with a pre-loaded test strip or the user may need to insert the test strip into the device (and optionally, replace the test strip during use). In some instances, the test strip can 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 a subject, the test strip is removed from the device and can be determined externally, e.g., using another device capable of determining the test strip, e.g., a commercially available test strip reader.

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

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

[0052] The device may include an anticoagulant or a stabilizer for stabilizing fluids withdrawn from the skin and / or subcutaneous tissue. As specific non-limiting examples, the anticoagulant can be used for blood withdrawn from the skin. Examples of anticoagulants include, but are not limited to, heparin, citrate, thrombin, oxalate, ethylenediaminetetraacetic acid (EDTA), sodium polyanetholesulfonate, and citrate dextrose. For example, other agents such as solvents, diluents, buffers, chelating agents, enzyme inhibitors (e.g., protease or nuclease inhibitors), antioxidants, binders, preservatives, antibacterial agents, etc., as stabilizers, can be used in combination with or instead of the anticoagulant. Examples of preservatives include, for example, 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 antibacterial agents include, but are not limited to, ethanol or isopropyl alcohol, azide, etc. 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 skilled in the art.

[0053] In a set of embodiments, at least a portion of the device can be colored to indicate the anticoagulant contained within the device. In some cases, the color used is Vacutainers TM , Vacuettes TM、or may be the same as or equivalent to those commercially used for other commercially available venipuncture devices. For example, light purple and / or purple may indicate ethylenediaminetetraacetic acid, bright 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 dextrose citrate, black may indicate citrate, brown may indicate heparin, etc. However, in other embodiments, other coloring systems may be used.

[0054] Other coloring systems that do not necessarily indicate anticoagulants may be used in other embodiments of the present invention. For example, in one set of embodiments, the device is colored to indicate the recommended body use site 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 noted above, in one set of embodiments, the devices of the present invention as discussed herein may be shipped to another location for analysis. In some cases, the device may contain an anticoagulant or stabilizer contained within the device, e.g., within a storage chamber for fluid. Thus, for example, a fluid such as blood or interstitial fluid withdrawn from the skin and / or subcutaneous tissue may 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) may be shipped to another location for analysis. For example, any form of shipping via mail may be used.

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

[0057] The various components of the fluid receiving device can be modified in different ways, and it should be understood that 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 device 1 can 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 connected to the effector body 50 via five posts 52. Any number of posts can be used. The posts 52 can be formed from polyester (PETG or PCTA) or other polymers such as ABS, acetal resin, polystyrene, or can alternatively include them. Alternatively, the retractor portion 42 and the seal actuator portion 44 can be connected 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 with respect to the effector 50. The seal actuator portion 44 includes a tab 41 and a seal leg 49 that is connected to the seal 76. Both the retractor portion 42 and the seal actuator portion 44 otherwise have essentially the same features as the retraction actuator 40 described above. By separating the retraction actuator 40 into two parts, each can be designed and constructed to have the desired features. For example, in some embodiments, it may be desirable to have legs 48 made of a highly elastic material, while the tab 41 and the seal leg 49 can be made of a less elastic material, for example, to help release the seal 76 as the retraction actuator 40 moves upward. Additionally, 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 leg 49 of the actuator 40. In some embodiments, the fluid activator 90 can be mechanically connected 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 coupled to the membrane 72, the flow activator 90, and the deployment actuator 60 and can be made relatively rigid or non-flexible, for example, to help transmit movement from the deployment actuator 60 to the flow activator 90 with little loss. FIGS. 15 - 18 show yet another embodiment that is very similar to the embodiments of FIGS. 1 - 10, but with a modified latch arrangement used to hold the retraction actuator 40 in an initial compressed state. 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 corresponding portions of the rotatable release element 170 and the base 100 replace the release element 30 and the tab 41 of the retraction actuator 40 in the embodiment of FIGS. 1 - 10.) The spinner ramp 174 of the release element 170 first engages the lockout ramp 161 of the effector guide 104 to hold the rotatable release element 170 in place prior to operation of the device 1. FIG. 16 shows a close-up view of the initial engagement prior to operation of the device 1. However, when the rotatable release element 170 is moved toward the base 100 during device operation (e.g., depression of the device actuator 10), as the release element 170 moves toward the base 100, the spinner ramp 174 slides and the release element 170 rotates slightly so as to pass through the lockout ramp 161. (The downward movement of the release element 170 during operation of the device actuator 10 can be caused by an inclined or other angled surface on the element 170 such that the slight rotation of the release element 170 contacts a corresponding inclination or other surface of the base 100 to cause the desired rotation.) Thereafter, when the pressure on the release element 170 is released by the user, as the release element 170 moves upward, the spinner release ramp 175 engages the base release ramp 160 such that the rotatable release element 170 rotates so as to pass through the base release ramp 160. This may enable the retraction actuator 40 to retract, for example, to retract the flow activator 90. In yet other embodiments, the fluid receiving device 10 can be arranged in other ways, as proposed 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 the user or otherwise by pressing with a finger. Similar to the embodiments 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 by the channel 110 to a storage chamber 140 (not shown). FIGS. 21 and 22 show the internal components of the device 1. An O-ring seal 340 can be positioned 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 rearward toward the trailing edge 102 of the base 100 causes the trigger pin 332, together with the trigger pin cover 334, to be pushed on the trigger shaft 306 (see FIG. 22). This movement slides the carriage 330 rearward along a guide 360 on the base 100 (see FIG. 21) toward the trailing edge 102 of the base 100. The guide 360 can be etched into the base 100, protruded from the base 100, or have any other suitable arrangement.

[0058] As the carriage 330 moves rearward, the trigger bridge 336 connected to the carriage 330 moves rearward relative to the effector body 50. The back surface 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 in an amount sufficient to move the effector body 50 downward to operate a deployment actuator 60 having a configuration such as that in the embodiment described above. This causes, for example, the flow activator 90 to be deployed to the deployment actuator 60 to expand the needle from the opening 130. Continued movement of the carriage 330 in the rearward direction slides a trigger retraction actuator (in the form of a wedge 350) under the lifting strut 370 on the effector body 50. As the wedge 350 slides under the lifting strut 370, the effector 50 is lifted upward away from the base 100, thereby retracting the flow activator 90 and the membrane 72 attached to the effector body 50 via the deployment actuator 60 in a manner similar to the above-described embodiment. The trigger tab 338 may be received within an opening 380 in the effector body 50, allowing the central portion of the effector body 50 to bend upward and allowing further retraction of the flow activator 90.

[0059] According to one aspect, the connection of the fluid actuator to the deployment actuator can be done in a variety of different ways, as proposed above. For example, FIG. 26A shows a schematic arrangement in which the post 94 used to connect the fluid activator (not shown) to the membrane 72 and / or the deployment actuator 60 can be made by an adhesive 400. In another embodiment shown in FIG. 26B, the post 94 can be received into cavities (or holes) within the membrane 72 as well as holes within the deployment actuator 60. The engagement of the post 94 with each hole or cavity can be done in any suitable way, such as by interference fit or friction fit, adhesive, riveting, etc. In this embodiment, the post 94 is engaged with the cavity of the membrane 72 by an adhesive 400 and has a rivet-type head that engages with the hole within the deployment actuator 60. The rivet head of the post 94 can be formed by a plastically deformed portion of the post 94, or the post 94 can include a flexible material arranged such that the upper portion of the rivet head is elastically deformed and pushed 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 within 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 can be clamped onto the membrane portion to maintain the engagement of the membrane and the actuator 60. The post 94 can be attached to both the membrane and the actuator as part of the same process, for example, a portion of the post can function as a clip or band. FIG. 26D shows an embodiment with a two-piece post 94 where the membrane 72 is captured between two portions of the post. The top portion of the post extends through a hole within the deployment actuator 60 or is heat-sealed to create an interference fit between the post and the deployment actuator 60. A portion of the post 94 is pushed through the opening at the connection point, thereby allowing it to engage with the deployment actuator 60.

[0060] According to one aspect, the order of operations related to the deployment and retraction of the fluid activator, vacuum release, and fluid reception can be arranged in various sequences. In some embodiments, a vacuum release prior to the deployment of the fluid activator can help reduce the pressure differential across the deployment actuator, thereby increasing the insertion depth of the fluid activator. For example, in some embodiments, the order of operations can be arranged as follows: a vacuum is generated first, then the fluid activator is deployed, and finally the fluid activator is retracted. Optionally, fluid reception can occur before or after retraction as this aspect is not limited in this regard. Optionally, fluid reception can begin prior to retraction but will not be completed until during or after retraction. Optionally, fluid reception will not begin until during or after retraction. Vacuum release can be achieved in a variety of different ways as described in previous embodiments. For example, in one embodiment, as shown in FIGS. 27 - 30, a spike 510 is attached to the end of an arm 33 of the release element 30. The vacuum can be stored in a large portion of the space enclosed by the vacuum source 156, e.g., the cover 20, the base 100, and the membrane 72. Initially, a seal 512 can prevent communication between the vacuum source 156 and the opening 130. When the device actuator 10 moves downward, the spike 510 also moves in the downward direction, punctures the seal 512, and enters the dead volume 514. The spike 510 can be partially hollow and can include a vacuum inlet channel 511 that can help ensure fluid flow between the vacuum source 156 and the dead volume 514. As a result, by piercing the seal 512 with the spike 510, communication between the vacuum source 156 and the opening 130 is effectively opened. This initial application of a vacuum or other relatively low pressure in the region near the opening 130 can draw the skin into the opening or closer to the opening. Later, further downward movement of the device actuator 10 brings the activation ring 540 into contact with the deployment actuator 60 and activates it. As described in previous embodiments, activation of the deployment actuator 60 can cause the fluid activator 90 to expand at least partially from the opening 130 or otherwise move in a manner that punctures the subject's skin and releases fluid.The fluid can enter the opening 130, and the vacuum released from the vacuum source 156 can 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 liquids (such as liquids including water) can be positioned between the storage chamber 140 and the dead volume 514. As a result, the hydrophobic stop membrane 516 can prevent the 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 can effectively cooperate with the filled storage chamber 140 to seal the communication between the vacuum source 156 and the opening 130. After the deployment of the fluid activator 90, the effector 50 and the retraction actuator (here consisting of the locking portion 45 and the retractor 42, see Figure 28) can cooperate to retract the fluid activator 90 as described in the previous embodiments. Similar to the embodiment of Figure 12 discussed previously, here the retraction actuator can include two separate components such as the locking portion 45 and the retractor 42. However, in this embodiment, since 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, the locking portion 45 is different from the seal actuator portion 44 of Figure 12. According to one aspect, there can be a time delay between the vacuum release and the deployment of the fluid activator to allow for pressure equilibrium across the deployment actuator before the deployment of the fluid activator. In one embodiment, a release element can be arranged to exhibit increased resistance to downward vertical movement, thereby creating a time delay between the vacuum release and the deployment of the fluid activator. For example, as shown in Figure 29, the release element 30 can include a resistance arm 33 in addition to the release arm 31. The resistance arm 33 can include a leg 34. As shown in Figure 30, as the release element 30 moves in the downward deployment direction, the leg 34 can contact the base 100, bend the latch release 30 radially outward, thereby generating a lateral movement of the spike 510 to facilitate tearing of the seal 512 for vacuum release.After the vacuum release, the contact between the leg portion 34 and the base 100 can also provide an increased resistance to downward vertical movement that can delay the deployment of the fluid activator 90 by delaying the contact between the actuating ring 540 and the deployment actuator 60.

[0061] According to one aspect, firmly holding the device effector 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 a poor fit between components can cause the effector to be inaccurately positioned instead of being firmly pushed down against the base. In certain situations, inaccurate positioning of the effector can reduce the transfer of energy to the deployment actuator and the fluid activator during operation of the device. In one embodiment, the interference fit between the release element and the effector can serve to push the effector 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 directly attached or otherwise coupled to the release element 30. An actuating 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 using an interference fit between the actuating ring 540 and the effector 50. As shown in FIG. 31, the actuating ring 540 can 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 fluid activator, where the actuating ring 540 has not yet contacted the deployment actuator 60. As the release element 30 moves further downward, the release element 30 engages the effector 50 in an interference fit, as shown in FIG. 32B. FIG. 32B depicts the release element 30 and the effector 50 immediately prior to deployment of the fluid activator, where the actuating ring 540 has achieved initial contact with the deployment actuator 60. The interference fit allows for direct application of pressure to the effector 50 prior to actuation of the deployment actuator 60 to ensure that the effector is firmly held against the base. Such an arrangement can help ensure proper positioning of the effector and may allow energy to translate directly and parallel from the device actuator 10 and the release element 30 to the deployment actuator 60. Of course, other arrangements are possible since this aspect is not limited in this regard.For example, the effector can be firmly held against the device base by a wave spring or coil spring located under the release element, by a leaf spring, coil spring, foam, elastic bladder, or other suitable feature formed on the back surface of the release element.

[0062] According to one aspect, the device may enable an indication when the receipt of fluid is complete. Such an indication may notify the user that the device can be removed from the skin. In one embodiment, as shown in FIGS. 27, 33, and 34, a visual indication may be provided by indicator 520. Indicator 520 may change color when the receipt of fluid is complete. In one example, indicator 520 may change from transparent 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 receipt of fluid, when the fluid reaches the top of storage chamber 140, the fluid may enter passageway 522 that connects storage chamber 140 to indicator 520. The fluid may enter passageway 522 and proceed through it into indicator 520 by capillary action, suction, pressure differential, or via any other suitable force. In some cases, indicator 520 may include a solid or liquid substance that changes color when it contacts the received fluid. In this way, the user may receive an indication that the receipt of fluid is complete without actually seeing the received fluid. For example, indicator 520 may change to a color different from the actual collected fluid. In some embodiments, the device may include an indicator cover 521 that may be transparent or translucent to enable the user to view indicator 520. In some embodiments, indicator cover 521 may be colored to change the appearance of the color of the fluid. In some cases, indicator cover 521 may be removable. It should be understood that the indication may be visual, audible, or tactile, as this aspect is not limited in this regard. For example, filling of storage chamber 140 may trigger the device to emit an audible sound indicating that the receipt of fluid is complete. In some cases, the audible sound may be a mechanical click sound due to an interaction between a device actuator, release element, effector, retraction actuator, deployment actuator, and / or fluid activator. In some cases, the audible sound may be an alarm triggered by the fluid reaching the top of storage chamber 140.Alternatively, or in addition, the user may receive tactile feedback indicating that receipt of the fluid is complete. For example, a user-actuated device actuator, release element, effector, retraction actuator, deployment actuator, and / or flow activator 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 components of the device may include a detent-type interaction that provides tactile feedback to the user. Further, since the indication is not limited to the completion of fluid receipt, the indication, feedback, and / or alarm may occur at any point in the device actuation process. For example, the device may enable an indication when a vacuum is released, when a flow activator is deployed and / or retracted, when receipt of the fluid is initiated, and the like. The device may also enable an indication or alarm when an insufficient amount of fluid is received or when the type of fluid received is inappropriate.

[0063] According to one aspect, the device may enable a user to access a fluid received within a storage chamber of the device. In some embodiments, an access port connected to the storage chamber may enable a user to directly access the fluid within the storage chamber. In one embodiment, as shown in FIG. 35, the access port 530 may be located at the base of the device. 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 regard. 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 within the storage chamber without removing the fluid from the chamber. For example, the user may measure the pH of the fluid by contacting a pH strip with the fluid. In another example, the user may require access to the collected fluid to add a substance or chemical to the fluid while the fluid is being held within the storage chamber. In some embodiments, the access port 530 may be shaped to allow the insertion of slivers as well as objects of different shapes such as pipettes or capillary tubes. In one example, as shown in FIGS. 36A - B, the access port 530 may include a hole 532 to receive cylindrical objects such as pipettes and capillary tubes, and may include a slot 534 to receive rectangular or wide objects such as slivers. 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 regard. 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 the sidewall 531 of the storage chamber 140. Positioning the access port 530 away from the center of the storage chamber 140 may help reduce forces such as capillary action that can resist the removal of fluid from the storage chamber. Alternatively, or in addition, the bottom of the storage chamber may be arranged to slope such that the fluid is inclined downwardly towards the access port.The storage chamber 140 may further include a circular groove extending around the periphery 535 of the bottom of the storage chamber where the bottom of the storage chamber contacts the side wall 531. Such a groove may urge fluid toward the access port 530 via suction, capillary action, or other suitable forces. In some embodiments, the seal may prevent fluid from flowing through the access port. In one example, the seal may be located inside the storage chamber, in which case the 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 outside the storage chamber on the base 100, in which case the user may peel or pierce the seal to access the fluid in the storage chamber. It should of course be understood that other methods of sealing the access port are possible since this aspect is not limited in this regard.

[0064] In one alternative embodiment, a rotatable release element can be arranged to allow vacuum release prior to deployment of the fluid activator. FIGS. 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 with respect to the device actuator 10 (see FIGS. 40A - B). The device actuator 10 is attached to a spike 510 such that downward movement of the device actuator 10 causes downward movement of the spike 510, which in turn punctures a seal 512 for vacuum release. As previously discussed, puncturing 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 FIGS. 41 and 42) that interacts with a sliding groove 554 formed on the device cover 20 to restrict movement of the device actuator 10 in the vertical direction. The rotatable release element 170 includes a spin ramp 562 that interacts with a pre - deployment lockout 556 and a cover ramp 552 formed on the cover 20 (see FIGS. 41 and 42). As shown in FIG. 40B, the retraction actuator 40 and the effector 50 are hidden from view, indicating that the rotatable release element 170 also includes an activation ring 540 that activates 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 deployed state and is thus arranged downwardly and recessed away from the activation ring 540.) Prior to deployment, the spin ramp 562 is held within the pre - deployment lockout 556 such that the activation ring 540 on the release element 170 is held at a distance close to the top surface of the deployment actuator 60. The engagement between the spin 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 seal 512 to puncture the spike 510 for vacuum release, and then causes the actuating ring 540 on the release element 170 to contact and actuate the deployment actuator 60, whereby a flow activator can be deployed as discussed in previous embodiments. At the same time, depressing the device actuator 10 in the downward direction also passes the pre-deployment lockout 556 through the spin ramp 562, releasing the retraction actuator 40 from its compressed high-energy state. As the retraction actuator 40 moves in the upward retraction direction and decompresses, it releases its stored potential energy. The spin ramp 562 is slid relative to 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 retraction actuator 40 retracts the flow activator as described in previous embodiments. Finally, when the spin ramp 562 reaches the end of the cover ramp 552 as shown in FIG. 43, the engagement edge 560 of the spin ramp 562 engages the post-deployment lockout 550 to lock the device in the retracted state.

[0065] According to one aspect, the operation of the fluid activator can occur in direct response to a vacuum release without requiring additional external actuation. In one embodiment, a pressure differential across the deployment actuator can cause the fluid activator to deploy within the deployment actuator. In embodiments such as those of FIGS. 1-5, in previously discussed embodiments, a vacuum could be stored in a majority of the space enclosed by the vacuum source 156, such as the device cover 20, the base 100, and the membrane seal 72. However, according to this aspect, in one example, atmospheric or ambient pressure is stored in the space enclosed by the cover, the base, and the membrane seal, rather than a vacuum source. The vacuum source is stored in a different location, either inside or outside the device, rather than above the deployment actuator. As a result, prior to operation 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 the communication between the vacuum source and the device opening, the bottom surface of the deployment actuator is 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. The pressure differential across the deployment actuator can actuate the deployment actuator and later cause the deployment of the fluid activator. Such an arrangement can allow a vacuum to reach the device opening prior to deployment of the fluid activator.

[0066] According to one aspect, a series of events from the initial actuation of the device to the end of fluid reception can be user-independent, meaning that after an initial trigger, the entire series of events will occur automatically regardless of the subsequent pressure, torque, speed, impact, or magnitude of other forces applied to the device actuator after the trigger. In one embodiment, the device can include a torsion spring that enables a user-independent series of operating events. For example, as shown in FIG. 44, device 1 includes a torsion spring 570 that can function as a retraction actuator. In FIG. 44, device 1 is depicted in its high-energy state prior to deployment, 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 rotation of the cam 571, thereby preventing the torsion spring 570 from unwinding. The device actuator 10 can be actuated by a downward force, sliding the end of the actuator arm 574 downward perpendicular to the lockout protrusion 572. Once the end of the actuator arm 574 slides downward and passes under the lower surface of the lockout protrusion 572, the cam 571 can rotate freely, allowing the torsion spring 570 to unwind and release its stored potential energy. The release of the torsion spring 570 can function as a trigger for all subsequent user-independent events. The unwinding of the torsion spring 57 causes the cam 571 to rotate in a counterclockwise direction. The cam 571 can be attached to a spike 510 that tears a seal (not shown) covering the dead volume 514, opening the communication between the vacuum source and the opening of the device. As shown in FIG. 45, the effector 50 can be attached to the deployment actuator 60 via a holder 580 and a groove 56. Additionally, the effector 50 can include an effector tab 578. As shown in FIGS. 46A - B, the release element 30 can include an actuating ring 540 and a release element tab 576. As shown in FIG. 44, the effector tab 578 can cooperate with a downward path 588.During rotation of the cam 571 in the counterclockwise direction, the tab 578 interacts with the profile of the lower path 588. Since the lower path 588 slopes upward at the end of its profile, the tab 578 is pushed upward by the lower path 588. As a result, the effector 50 is raised in the vertically upward retraction direction. Similarly, the release element tab 576 of the release element 30 cooperates with the upper path 586. During counterclockwise rotation of the cam 571, the tab 576 interacts with the profile of the upper path 586. Since the profile of the upper path 586 slopes downward, the tab 576 is pushed downward by the upper path 586. As a result, the release element 30 is vertically lowered in the deployment direction, bringing the actuating ring 540 of the release element 30 into contact with the deployment actuator 60 and actuating it (see FIGS. 46A - B), thereby actuating a fluid activator (not shown) in the manner described in the previous embodiments. Since the path 586 slopes upward at the end of its profile, the release element 30 is raised in the vertically upward retraction direction. After actuation of the deployment actuator 60, both the release element 30 and the effector 50 are lifted in the retraction direction by the upward slopes of both the upper path 586 and the lower path 588, thereby causing retraction of a fluid activator (not shown) connected to the deployment actuator 60 and the effector 50. Of course, it should be understood that since this aspect is not limited in this regard, other suitable arrangements are possible to achieve a user - independent series of events.

[0067] According to one aspect, the device may include protection features or mechanisms used to avoid accidental or premature activation. In one embodiment, the protection feature may include a physical barrier or cover that prevents the activation of the device actuator. For example, as shown in FIG. 47, the device may include a cap 600 having a spacer ring 602 that prevents the compression of the device actuator 10. The cap 600 can be removed by the user when the device is ready to be activated. In one embodiment, the protection feature 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 where the device actuator has to move a predetermined distance before the deployment of the deployment actuator is triggered. In another example, the device actuator may require the application of a minimum pressure or torque before activation occurs. In yet another example, the device actuator may include a safety lock type arrangement where the user has to first twist it before pressing down on the device actuator. Of course, it should be understood that since this aspect is not limited in this regard, other ways of avoiding accidental activation are possible. Additionally, the safety features described above can be combined in any manner within a single device.

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

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

[0070] As noted above, the needles included in the flow activator can be arranged in a variety of different ways depending on the intended use. For example, the needles can have lengths 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 600 micrometers, less than 500 micrometers, less than 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 can also have maximum cross-sectional dimensions 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 600 micrometers, less than 500 micrometers, less than 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 can have a rectangular cross-section with dimensions of 175 micrometers × 50 micrometers. In a set of embodiments, the needles can 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, the microneedle will have an average cross-sectional dimension (e.g., diameter) of less than about 1 millimeter. References to "needle" or "microneedle" as discussed herein are for ease of presentation only, and it should be understood that in other embodiments, more than one needle and / or microneedle may be present in any of the descriptions herein. By way of example, microneedles such as those disclosed in U.S. Patent No. 6,334,856, issued January 1, 2002, to Allen et al., "Microneedle Devices and Methods of Manufacture and Use Thereof," can be used to transport fluid (or other substances) to and / or withdraw from a subject. The microneedles can be hollow or solid and can be formed from any suitable material, such as metals, ceramics, semiconductors, organics, polymers, and / or composites. Examples include 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, polylactide, polyglycolide, polymers including polylactide-co-glycolide, and copolymers with polyethylene glycol, polyanhydrides, polyorthoesters, polyurethanes, polybutyric acid, polyvaleric acid, polylactide-co-caprolactone, polycarbonate, polymethacrylic acid, polyethylene vinyl acetate, polytetrafluoroethylene, polymethyl methacrylate, polyacrylic acid, or polyester, but are not limited thereto.

[0072] In some cases, two or more needles or microneedles can be used. For example, an array of needles or microneedles can be used, and the needles or microneedles can be arranged in the array in any suitable configuration, such as periodic, random, etc. In some cases, the array can have three or more, four or more, five or more, six or more, ten or more, fifteen or more, twenty or more, thirty-five or more, fifty or more, one hundred 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 of ordinary skill in the art, in one embodiment, can arrange needles on the skin or other surface for these purposes, including introducing the needle into the skin at an angle other than 90° with respect to the surface of the skin, i.e., introducing one or more needles into the skin obliquely so as to limit the penetration depth. However, in another embodiment, the needle can enter the skin or other surface at about 90°.

[0074] In some cases, the needles (or microneedles) are such that the density of the needles in the array is between about 0.5 needles / mm 2 and 10 needles / mm 2 and, in some cases, the density is selected to be between about 0.6 needles / mm 2 and about 5 needles / mm 2 between about 0.8 needles / mm 2 and about 3 needles / mm 2 between about 1 needle / mm 2 and about 2.5 needles / mm 2 and so on, and can be present in the array. In some cases, the needles can be positioned within the array such that two needles are not 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 needles (or microneedles) can be selected such that the area of the needle (determined by determining the area of the penetration or perforation on the surface of the subject's skin by the needle) allows for a sufficient flow rate of the fluid that reciprocates through the subject's skin and / or subcutaneous tissue. The needle can be selected to have a smaller or larger area (or a smaller or larger diameter) as long as the contact area of the needle with the skin allows for a sufficient blood flow from the subject's skin to the device. For example, in one embodiment, the needle is at least about 500 nm 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 can be selected to have a composite skin penetration area such as etc.

[0076] The needle or microneedle can have any suitable length, which may in some cases depend on the application. For example, a needle designed to penetrate only the epidermis may be shorter than a needle designed to penetrate the dermis or extend into the dermis or subcutaneous tissue. In certain embodiments, the needle or microneedle can have a maximum penetration depth 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 micrometers or less, about 150 micrometers or less, about 125 micrometers or less, about 100 micrometers or less, about 75 micrometers or less, about 50 micrometers or less, etc. In certain embodiments, the needle or microneedle can be selected to have a maximum penetration depth 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 a set of embodiments, the needle (or microneedle) can be coated. For example, the needle can be coated with a substance that is delivered when the needle is inserted into the skin. For example, the coating can include heparin, anticoagulants, anti-inflammatory compounds, analgesics, high histamine compounds, etc. to assist blood flow from the subject's skin, or the coating can include a drug or other therapeutic agent such as those described herein. The drug or other therapeutic agent can be for local delivery (e.g., to or in the vicinity of the area to which the coated needle or microneedle is applied) and / or the drug or other therapeutic agent can be intended for systemic delivery within the subject.

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

Claims

【Claim 1】 The invention described in the drawings, etc.

Images