Device for collecting body fluid

Abstract

To provide devices and methods for withdrawing bodily fluid from a patient.SOLUTION: Devices and methods for withdrawing bodily fluid from a patient are disclosed herein. In some embodiments, a handheld device can include a housing having an opening, and a skin-piercing assembly and a plunger positioned at least partially within the housing. The skin-piercing assembly can include a blade and a biasing member, such as a torsion spring. The plunger can be movable relative to the housing from a first position to a second position. In the first position, the plunger can engage the skin-piercing assembly to maintain the biasing member in a biased configuration. Movement of the plunger from the first position to the second position can disengage the plunger from the skin-piercing assembly to permit the first biasing member to drive a skin-piercing feature through and / or across an opening in a base.SELECTED DRAWING: Figure 11A

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of U.S. Provisional Patent Application No. 62 / 894,531, filed on August 30, 2019, entitled "BODILY FLUID COLLECTION DEVICES AND RELATED METHODS", which is hereby incorporated by reference in its entirety.

[0002] This technology relates to the collection of bodily fluids from patients, particularly to handheld bodily fluid collection devices and related methods.

Background Art

[0003] Devices, systems, and methods for collecting bodily fluids such as blood are widely used in personal, clinical, and field medical applications. Biological samples are typically collected using simple puncture devices or more advanced devices that require trained personnel (e.g., venipuncture). Transferring bodily fluids to a container, receptacle, or analytical device often requires several steps, which can be time - consuming, error - prone, and / or cumbersome. Additionally, many personal use devices designed for untrained users can only obtain a very limited amount of bodily fluid, thereby limiting the scope of application of such devices.

Summary of the Invention

[0004] Many aspects of this technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on clearly showing the principles of this technology.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0006] The present technology generally relates to devices and methods for deploying skin penetration features towards / into a patient's skin to collect and gather body fluid (e.g., blood). In some embodiments, a device for collecting body fluid from a patient can include a housing that includes a base configured to be positioned against the patient's skin. The base can include an opening extending therethrough for collecting body fluid. A skin penetration assembly and a plunger can be at least partially positioned within the housing. The skin penetration assembly can include a drive member, a skin penetration feature (e.g., a blade) coupled to the drive member, and a biasing member coupled to the drive member. The plunger can be configured to move from a first position to a second position relative to the housing. In the first position, the plunger can engage the drive member of the skin penetration assembly to maintain the first biasing member in a biased configuration. When the first biasing member is in the biased configuration, the skin penetration feature can be rotated away from the opening of the base. However, movement of the plunger from the first position to the second position can disengage the plunger from the drive member and allow the first biasing member to drive the skin penetration feature through at least a portion of the opening of the base to incise the subject's skin. In some aspects of the present technology, the device can be used to quickly and easily obtain a sufficient volume of body fluid for downstream testing and analysis.

[0007] In some embodiments, the base of the housing is configured to seal against the skin of the subject. The device can further include a sealing member operably coupled to the plunger such that movement of the plunger from a first position to a second position increases the sealed volume within the housing to generate a vacuum pressure. In some embodiments, the vacuum pressure can be generated before the plunger is disengaged from the skin penetration assembly and the skin penetration feature is driven into the skin. In such embodiments, the vacuum pressure can at least partially draw the skin into the opening, for example, increasing the volume of the bodily fluid to be collected. In other embodiments, the vacuum pressure can be generated during and / or after the plunger is disengaged from the skin penetration assembly, and the skin penetration feature is driven into the skin.

[0008] Specific details of some embodiments of the present technology are described herein with reference to FIGS. 1A-15C. However, the present technology can be practiced without some of these specific details. In some cases, well-known structures and techniques often associated with bodily fluid collection devices are not shown in detail so as not to obscure the present technology. The terminology used in the following description is intended to be interpreted in its broadest reasonable manner even if used in conjunction with a detailed description of specific embodiments of the present disclosure. Certain terms may even be emphasized below, however, any terminology intended to be interpreted in any limited way is specifically defined as such in this "Detailed Description of the Invention" section.

[0009] The accompanying drawings illustrate embodiments of the present technology and are not intended to limit its scope. The sizes of the various elements shown are not necessarily drawn to a fixed scale, and these various elements may be arbitrarily enlarged to improve visibility. Details of components may be abstracted in the drawings to exclude details such as the position of components and specific exact connections between such components when such details are not necessary to fully understand the method of making and using the present technology. Many of the details, dimensions, angles, and other features shown in the drawings are merely illustrative of particular embodiments of the present disclosure. Accordingly, other embodiments may have other details, dimensions, angles, and features without departing from the spirit or scope of the present technology.

[0010] Figure 1A is a perspective view of a body fluid collection device 100 (the "device 100") configured in accordance with an embodiment of the present technology. The device 100 can be handheld and sized to be easily grasped and operated with one or both hands of a patient. Such a handheld device enables a patient to advantageously collect a body fluid sample (e.g., a blood sample) without assistance from another individual. In some embodiments, the handheld device of the present technology can be operated by a layperson outside of a medical setting (e.g., at home or at a field clinic) without the aid of a medical professional.

[0011] In the illustrated embodiment, the device 100 includes a housing 102 and an actuator 104. The actuator 104 (e.g., a button) is movable relative to the housing 102 and actuates / starts the collection of body fluid from the patient. The housing 102 is removably coupled to a collection reservoir 106 (e.g., a tube or cartridge) for receiving the body fluid collected from the patient. The reservoir 106 functions as a removable and standardized container for body fluids that can be separated and inserted into clinical and laboratory equipment or workflows (e.g., for diagnosis and / or biomarker detection).

[0012] Figure 1B is a perspective view of the body fluid collection device 100 during use by a patient. To collect a body fluid sample, the device 100 is applied to the patient's body with the bottom surface of the housing 102 positioned against the patient's skin 101 and the actuator 104 positioned away from the skin 101. By actuating (e.g., pushing, twisting, pulling) the actuator 104, a skin penetration feature (e.g., blade, lancet) is deployed from within the device 100 and penetrates the skin 101. In some embodiments, the device 100 is configured to generate a vacuum within the device 100 that acts against the patient's skin, either directly or indirectly, and either before and / or after deployment of the skin penetration feature. Body fluid from the resulting incision is collected into the housing 102 and then into the reservoir 106.

[0013] Figure 1C is a perspective view showing separation of the reservoir 106 from the device 100. When a desired amount of body fluid has been collected into the reservoir 106, the device 100 is removed from the skin 101 and the reservoir 106 is separated from the housing 102.

[0014] Figure 2 is a partial schematic side cross-sectional view of the device 100 of FIGS. 1A - 1C according to an embodiment of the present technology. The device 100 is in a pre-deployment configuration in FIG. 2. The device 100 includes a housing 102, an actuator 104, a skin penetration assembly 220, and a plunger 230 (e.g., platform, release member, inner housing). In the illustrated embodiment, the housing 102 includes a base portion 210 and a sidewall portion 212 extending from the base portion 210 (e.g., extending substantially perpendicular to the base portion 210 and upwardly away from the base portion 210). The base portion 210 and the sidewall portion 212 together define a lumen 214 (e.g., opening, cavity) in which the skin penetration assembly 220 and the plunger 230 are at least partially positioned. The base portion 210 further includes an upper surface 211a facing (e.g., opening into) the lumen 214 and a lower surface 211b opposite the upper surface 211a. During use of the device 100, the lower surface 211b is configured to be positioned against and / or adjacent to the patient's skin 101 (FIG. 1B).

[0015] The opening 216 (e.g., aperture, collection site) can extend through the base portion 210 between the upper surface 211a and the lower surface 211b such that the opening 216 abuts the patient's skin 101 during use of the device 100. In some embodiments, the opening 216 can have a cross-sectional dimension (e.g., width, area) that varies between the upper surface 211a and the lower surface 211b, for example, to facilitate drawing the patient's skin 101 into and / or towards the lumen 214 during use of the device 100. For example, in the illustrated embodiment, a portion 213 (e.g., sidewall) of the base portion 210 that abuts / defines the opening 216 has an inwardly curved shape / profile in a direction from the lower surface 211b to the upper surface 211a. In other embodiments, the portion 213 of the base portion 210 can have other shapes / profiles such as an inwardly sloping linear profile, an outwardly curved profile, an outwardly sloping linear profile, or a substantially vertical profile. In some embodiments, as described in detail with reference to FIGS. 4 and 5, the opening 216 can be in fluid connection with a fluid channel (e.g., a microfluidic channel) formed within, on, and / or through the base portion 210. During use of the device 100, the fluid channel can direct body fluid from the opening 216 to the reservoir 106 (FIGS. 1A - 1C).

[0016] In the illustrated embodiment, the skin penetration assembly 220 includes a drive member 222 coupled to a first biasing member 224 (shown in dashed lines because it is not visible in FIG. 2). In some embodiments, the first biasing member 224 couples the drive member 222 to the housing 102 such that the drive member 222 is rotatably / pivotably mounted within the lumen 214 of the housing 102. For example, the first biasing member 224 can be a torsion spring or other suitable biasing member connected between the drive member 222 and a sidewall portion 212 of the housing 102 and / or another portion of the housing 102. More specifically, the drive member 222 can include a generally elongated body extending between a first portion 221a and a second portion 221b, and the first biasing member 224 can be coupled to the second portion 221b of the drive member 222, or near thereto, such that the drive member 222 is pivotable about a pivot axis P (e.g., in the direction indicated by arrow A).

[0017] The skin penetration assembly 220 may further include (i) a skin penetration feature 226 coupled to the drive member 222 at or near a second portion 221b of the drive member 222, and (ii) a release member 228 (e.g., a tab, bar, protrusion) coupled at or near a first portion 221a of the drive member 222. In the illustrated embodiment, the skin penetration feature 226 is a blade having a sharp cutting edge 227. In other embodiments, the skin penetration feature 226 is a needle, a lancet (e.g., a cylindrical or other shaped lancet), or other feature configured to penetrate the patient's skin 101 (FIG. 1B). In some embodiments, the skin penetration assembly 220 can include a plurality of skin penetration features (e.g., a plurality of offset blades for generating various cutting patterns). The release member 228 is configured to engage the plunger 230 to maintain the skin penetration assembly 220 in the biased (e.g., wound) configuration shown in FIG. 2. More specifically, in the illustrated embodiment, the plunger 230 includes a base portion 232 (e.g., an upper portion) and a sidewall portion 234 extending from the base portion 232 (e.g., extending substantially perpendicular to the base portion 232 and downwardly away from the base portion 232). In some embodiments, the base portion 232 and the sidewall portion 234 can at least partially define a lumen 236 in which the skin penetration assembly 220 is positioned. The plunger 230 can further include a restraint portion 238 (e.g., a protrusion, flange) extending downwardly away from the base portion 232 and defining a channel 239 together with the sidewall portion 234. In the illustrated embodiment, when the skin penetration assembly 220 is in the biased configuration, the release member 228 of the skin penetration assembly 220 is at least partially positioned within the channel 239 such that the restraint portion 238 of the plunger 230 engages the release member 228 and the drive member 222 (and the skin penetration feature 226) does not pivot about the pivot axis P in the direction indicated by arrow A.

[0018] In the illustrated embodiment, the plunger 230 is operatively coupled to (i) the actuator 104 and (ii) a second biasing member 240 (e.g., a compression spring) configured to drive the plunger 230 away from the base portion 210 of the housing 102 through the lumen 214 (e.g., in the direction indicated by arrow B). For example, the base portion 232 of the plunger 230 can be coupled to the actuator 104. Similarly, the plunger 230 can include a flange portion 235 that projects outwardly away from the sidewall portion 234, and the second biasing member 240 can be coupled between the flange portion 235 and the base portion 210 of the housing 102. In other embodiments, the plunger 230 can be operatively coupled to the second biasing member 240 in other ways. For example, the flange portion 235 can project inwardly from the sidewall portion 234 of the plunger 230 such that the second biasing member 240 is at least partially positioned within the lumen 236 of the plunger 230, or the second biasing member 240 can extend between the base portion 232 of the plunger 230 and the housing 102.

[0019] In the illustrated embodiment, the second biasing member 240 is in a compressed / biased configuration and thus exerts a biasing force against the plunger 230. Thus, when the device 100 is in the pre-deployment state shown in FIG. 2, both the first biasing member 224 and the second biasing member 240 are in a biased state. To maintain / lock the device 100 in the pre-deployment configuration, the device 100 can further include a locking mechanism 242 (shown schematically) configured to lock the position of the plunger 230 within the housing 102. The actuator 104 is operably coupled to the locking mechanism 242, and actuation of the actuator 104 can selectively unlock the locking mechanism 242 such that the second biasing member 240 can drive the plunger 230 upward in the direction indicated by arrow B. Thus, in some embodiments, the actuator 104 may be referred to as a release member, release actuator, or release mechanism. In some embodiments, the locking mechanism 242 can be unlocked and the plunger 230 released by pushing and / or pulling the actuator 104 upward and / or downward. In some embodiments, the locking mechanism 242 can include one or more engagement features (e.g., flanges, grooves) positioned on / therebetween the actuator 104 and the housing 102 (e.g., the inner surface of the side wall portion 212 of the housing). Thus, for example, by turning the actuator 104 and / or translating the actuator 104 within the lumen 214, the actuator 104 and the plunger 230 operably coupled thereto can be unlocked. In other embodiments, the actuator 104 can be slidably coupled to the housing 102 such that the actuator 104 can slide (e.g., horizontally) to disengage from the plunger 230, thereby releasing the plunger 230. In yet other embodiments, the locking mechanism 242 can be a mechanical or electrical switch.

[0020] In the illustrated embodiment, the device 100 further includes a sealing member 244 positioned between a side wall portion 234 of the plunger 230 and a side wall portion 212 of the housing 102. The sealing member 244 can include an O-ring, a lip seal, a quad ring, a rolling diaphragm, etc., and is configured to seal the interface between the plunger 230 and the housing 102. In some embodiments, the flange portion 235 of the plunger 230 engages the sealing member 244 such that when the lock mechanism 242 is unlocked and a vacuum is created, for example, within a portion of the lumen 214 of the housing 102 adjacent to the opening 216, the plunger 230 drives the sealing member 244 upward (e.g., in the direction of arrow B).

[0021] The various components of the device 100 can include metal, plastic, and / or other suitable materials. For example, in some embodiments, the housing 102, the actuator 104, the plunger 230, the drive member 222, and / or other components of the device 100 are formed from a plastic material by 3D printing, molding (e.g., injection molding), or other methods. In some embodiments, the device 100 can be manufactured to have the pre-deployment configuration shown in FIG. 2.

[0022] Figures 3A - 3D are side cross-sectional views of the device 100 showing various stages of a procedure for collecting body fluid (e.g., blood) from a patient according to an embodiment of the present technology. Referring first to FIG. 3A, the device 100 is first placed against the patient's skin 101 in the pre-deployment configuration (e.g., the first configuration, the initial configuration, the biased configuration) shown in FIG. 2. More specifically, the lower surface 211b of the base portion 210 of the housing 102 can be positioned against the skin 101. In some embodiments, the base portion 210 of the housing 102 can form a seal with the patient's skin 101 such that (i) the opening 216 of the housing 102 is sealed from the environment around the device 100, and (ii) the device 100 includes a sealed volume within a portion of the lumen 214 of the housing 102.

[0023] Figure 3B shows the device 100 in a partially deployed configuration (e.g., the second configuration) after the actuator 104 is actuated to unlock the locking mechanism 242 (Figure 3A) and release the plunger 230. In the illustrated embodiment, the second biasing member 240 drives the plunger 230 upwardly (e.g., in the direction of arrow B) through the lumen 214 away from the base portion 210 of the housing 102. The plunger 230 is also driven upwardly relative to the skin penetration assembly 220 such that the restraint portion 238 of the plunger 230 moves relative to the release member 228 of the skin penetration assembly 220. That is, when the plunger 230 moves upwardly relative to the skin penetration assembly 220, the release member 228 moves from a position near the upper end portion of the channel 239 to a position near the lower end portion of the channel 239. Nevertheless, in the partially deployed configuration shown in Figure 3B, the restraint portion 238 of the plunger 230 still engages the release member 228 of the skin penetration assembly 220 to maintain the biased configuration of the skin penetration assembly 220 and prevent the drive member 222 from pivoting about the pivot axis P.

[0024] In the illustrated embodiment, the second biasing member 240 also drives the sealing member 244 upwardly through the housing 102, thereby increasing the sealed volume within the lumen 214 of the housing 102. In some aspects of the present technique, increasing the sealed volume within the lumen 214 creates a reduced pressure (e.g., a vacuum) therein. In some embodiments, the reduced pressure can draw the skin 101 at least partially into the opening 216 as shown in Figure 3B. That is, the reduced pressure can deflect the skin 101 into the opening 216 and / or into the lumen 214 of the housing 102. In some embodiments, the portion 213 of the base portion 210 that abuts / defines the opening 216 has a shape / profile that facilitates movement of the skin 101 into the opening 216.

[0025] Figure 3C shows the device 100 in a deployed configuration (e.g., a third configuration, an incised configuration) after the plunger 230 continues to move upward within the lumen 214 of the housing 102. In the illustrated embodiment, the second biasing member 240 drives the plunger 230 upward (e.g., in the direction of arrow B) through the lumen 214 until the restraint portion 238 of the plunger 230 is spaced apart from and no longer engages the release member 228 of the skin penetration assembly 220. That is, the relaxed length of the second biasing member 240 can be long enough to enable the second biasing member 240 to drive the plunger 230 upward until the release member 228 is no longer positioned within the channel 239. When the skin penetration assembly 220 is no longer constrained by the plunger 230, the first biasing member 224 drives the drive member 222 to pivot about the pivot axis P (e.g., in the direction of arrow A). This movement of the drive member 222 causes the skin penetration feature 226 to pivot downward toward and into the opening 216 and the skin 101. As shown, all or a portion of the cutting edge 227 can move through the opening 216 and contact the skin 101 positioned therein to make an incision. In some aspects of the present technology, the release member 228 is released instantaneously or substantially instantaneously from within the channel 239, thereby increasing the speed of the skin penetration feature 226 and facilitating, for example, a cleaner incision, reduced patient pain, and / or a greater draw-in volume.

[0026] The position of the skin penetration assembly 220 relative to the opening 216, as well as the relative size and / or shape of the skin penetration feature 226, can be varied to change the size of the incision. For example, the device 100 can be configured to create an incision in the skin 101 that is about 3 millimeters in length and about 2 millimeters in depth, or about 5 millimeters in length and about 1 millimeter in depth. Additionally, the height H of the restraint portion 238 of the plunger 230 can be selected to provide a desired level of vacuum prior to the release and trigger of the skin penetration assembly 220. For example, increasing the height H can cause the skin penetration assembly 220 to move out of engagement with the plunger 230 and increase the size of the sealed volume within the lumen 214 of the housing 102, and thus the vacuum pressure generated, before it is triggered to rotate. Conversely, decreasing the height H can allow for more vacuum pressure to be generated during and / or after the skin penetration feature 226 incises the skin 101. For example, in some embodiments, the height H can be selected to be just large enough to secure the skin penetration assembly 220 in its pre-deployment configuration (FIG. 3A). In such embodiments, the plunger 230 quickly disengages from the skin penetration assembly 220 when driven upward such that substantially all of the vacuum pressure is generated after the skin penetration assembly 220 begins to pivot.

[0027] Figure 3D shows the device 100 in a retracted configuration (e.g., a fourth configuration) after continuing to rotate the skin penetration assembly 220 within the lumen 214 of the housing 102. In the illustrated embodiment, the first biasing member 224 drives the drive member 222 to pivot about the pivot axis P until (i) the skin penetration feature 226 sweeps beyond the opening 216 and no longer contacts the patient's skin 101, and (ii) the first portion 221a of the drive member 222 (e.g., the release member 228) contacts the sidewall portion 234 of the plunger 230. In other embodiments, the drive member 222 can be configured (e.g., shaped and sized) to further rotate about the pivot axis P such that, for example, the drive member 222 does not contact the plunger 230 in the retracted configuration. Further, in the retracted configuration, the skin penetration assembly 220 is vertically spaced from the base 210 of the housing 102. In some aspects of the present technology, such a gap can facilitate the movement of body fluid 346 into the device 100.

[0028] As shown in Figure 3D, when the skin 101 is incised, body fluid 346 (e.g., blood) flows from the skin 101 into the device 100, for example, into the lumen 214 of the housing 102 and / or onto the upper surface 211a of the base portion 210 of the housing 102. In some aspects of the present technology, the vacuum pressure generated within the device 100 prior to cutting the skin 101 using the skin penetration feature 226 can increase capillary action within the skin 101 and thus increase the amount of body fluid 346 collected. Similarly, a high rotational speed of the skin penetration feature 226 can increase the amount of body fluid 346 collected while making the procedure relatively painless for the patient.

[0029] The amount of body fluid 346 drawn into device 100, also known as the "draw volume", may be sufficient for testing and analysis downstream of body fluid 346, for example, for diagnosis and / or biomarker detection performed on a blood sample. As used herein, the draw volume may refer to the maximum volume of body fluid that can be collected from a designated percentage of a patient population, for example, from at least 90% of patients. In some embodiments, the draw volume of device 100 can be 100 - 1000 μL (e.g., about 600 - 700 μL). In another aspect of the present technology, device 100 is configured to draw body fluid 346 in a relatively short time compared to conventional devices. For example, in some embodiments, device 100 can collect the draw volume in less than about 1 minute, less than about 45 seconds, less than about 30 seconds, or less than about 15 seconds.

[0030] In some embodiments, device 100 is configured as a disposable device. For example, in the illustrated embodiment, device 100 is configured such that actuation of actuator 104 when device 100 is in a retracted configuration does not pivot skin penetration feature 226 into opening 216. Specifically, first biasing member 224 is no longer biased in the retracted configuration and thus cannot drive skin penetration feature 226 towards opening 216. In other embodiments, device 100 can have other features specifically configured to limit device 100 to single use. For example, actuator 104 can be configured as a through-pass actuator that does not re-engage skin penetration assembly 220 after use.

[0031] In some embodiments, device 100 can include one or more fluid features configured to facilitate the transfer / movement of body fluid 346 from opening 216 to reservoir 106 (FIGS. 1A - 1C). For example, FIGS. 4 - 5B are top cross-sectional views of housing 102 and reservoir 106 and show various fluid features for directing body fluid 346 from opening 216 to reservoir 106 according to embodiments of the present technology.

[0032] Referring to FIG. 4, the device 100 can include a fluid channel 450 that is formed within and / or on a base portion 210 of the housing 102 and that is configured to fluidly couple the opening 216 of the housing 102 to the reservoir 106. In some embodiments, during use of the device 100, the device 100 can be aligned with a gravitational field such that the reservoir 106 is positioned below the opening 216 (e.g., as indicated by arrow G). Thus, in some embodiments, the fluid channel 450 is configured (e.g., sized and shaped) to direct a body fluid 346 (FIG. 3D) from the opening 216 to the reservoir 106 via gravity. In some such embodiments, the fluid channel 450 is not configured to impart capillary forces to the body fluid 346. In some aspects of the present technology, the fluid channel 450 does not substantially impart shear forces to the body fluid 346. This can improve the quality of the body fluid 346 for testing purposes (e.g., diagnostic blood tests). In some embodiments, all or a portion of the fluid channel 450 can be tilted, for example, tilted upwardly away from the opening 216 and toward the reservoir 106. In some embodiments, the tilt can be selected such that gravity is still sufficiently large to drive the body fluid 346 from the opening 216 to the reservoir 106. In some embodiments, the base portion 210 of the housing 102 can be coated with a hydrophobic (e.g., superhydrophobic) material that helps to facilitate the flow of the body fluid 346 from the opening 216 toward the reservoir 106 without capillary forces.

[0033] Referring to FIGS. 2 - 4 together, the skin penetration assembly 220 is configured (e.g., sized, shaped, and positioned) to sweep across / through the opening 216 in any direction to create an incision in the patient's skin 101 having any selected orientation relative to the fluid channel 450. For example, the skin penetration assembly 220 can be configured to incise the patient's skin 101 in a direction generally parallel to the fluid channel 450 (e.g., as shown by arrow I1 in FIG. 4), in a direction generally perpendicular to the fluid channel 450 (e.g., as shown by arrow I2 in FIG. 4), and / or in a direction angled relative to the fluid channel 450 (e.g., as shown by arrow I3 in FIG. 4). In the illustrated embodiment, the opening 216 has a generally circular cross-sectional shape. In other embodiments, the opening 216 can have other cross-sectional shapes (e.g., linear, polygonal, irregular) and / or different sizes.

[0034] Referring to FIG. 5A, the device 100 can include a microfluidic channel 552 formed within and / or on a base portion 210 of the housing 102 and configured to fluidly couple an opening 216 of the housing 102 to the reservoir 106. In some embodiments, the microfluidic channel 552 is an open channel (e.g., including a base surface, sidewalls, and an elongated opening on / opposite the base surface) configured to apply capillary forces to the body fluid 346 (FIG. 3D). The microfluidic channel 552 can be of the type described in detail in (i) U.S. Patent Application No. 13 / 949,108, filed Jul. 23, 2013, entitled "METHODS, SYSTEMS, AND DEVICES RELATING TO OPEN MICROFLUIDIC CHANNELS", and / or (ii) U.S. Patent Application No. 14 / 816,994, filed Aug. 3, 2015, entitled "DEVICES, SYSTEMS AND METHODS FOR GRAVITY-ENHANCED MICROFLUIDIC COLLECTION, HANDLING AND TRANSFERRING OF FLUIDS". Both of these applications are hereby incorporated by reference in their entirety. In some embodiments, during use of the device 100, the device 100 can be aligned with the gravitational field such that the reservoir 106 is positioned below the opening 216 (e.g., as indicated by arrow G). Thus, in some embodiments, the microfluidic channel 552 is configured (e.g., sized and shaped) to direct the body fluid 346 from the opening 216 to the reservoir 106 via capillary forces, gravity, or both capillary forces and gravity.

[0035] In some embodiments, device 100 can include one or more additional microfluidic channels 554 (shown in phantom) configured to direct body fluid 346 from opening 216 to reservoir 106. That is, for example, device 100 can include a microfluidic network configured to direct body fluid 346 to reservoir 106. Similarly, referring together to FIGS. 2-3D and 5A, skin penetration assembly 220 is configured (e.g., sized, shaped, and positioned) to sweep in any direction across / through opening 216 to create an incision in patient's skin 101 having any desired orientation with respect to microfluidic channel 552 and / or microfluidic channel 554.

[0036] Referring to FIG. 5B, opening 216 can be a portion of microfluidic channel 556 that extends through / along base portion 210 of housing 102 to reservoir 106. Referring together to FIGS. 2-3D and 5B, skin penetration assembly 220 is configured (e.g., sized, shaped, and positioned) to sweep across / through opening 216 along the length of microfluidic channel 556 to create an opening in skin 101. Thus, microfluidic channel 556 can extend completely through base portion 210 and can be defined by opposing sidewalls configured such that at least blade 226 sweeps through microfluidic channel 556. In some embodiments, microfluidic channel 556 is configured to apply capillary force to body fluid 346 (FIG. 3D). In some aspects of the present technique, by incising skin 101 within microfluidic channel 556, the time required for body fluid 346 to flow from the incision to reservoir 106 can be reduced.

[0037] Figures 6A-6C are side cross-sectional views of device 100 including flexible membrane 660 and illustrate various stages of a procedure for collecting bodily fluid (e.g., blood) from a patient, according to an additional embodiment of the present technique. Referring first to FIG. 6A, flexible membrane 660 can be attached to the lower surface 211b of the base portion 210 of housing 102 and can span laterally across opening 216. Flexible membrane 660 can be bendable and / or stretchable (e.g., elastic). For example, flexible membrane 660 can include polyurethane, silicone, and / or other suitable elastic materials. Flexible membrane 660 can seal lumen 214 of housing 102 to create a sealed volume within housing 102. Thus, device 100 can be fully sealed prior to use. In some embodiments, flexible membrane 660 can be relatively thin, e.g., having a thickness of about 250 μm or less, or about 50-400 μm. In some embodiments, flexible membrane 660 can be of the type described in detail in U.S. Patent Application No. 16 / 571,028, filed Sep. 13, 2019, entitled "BODILY FLUID COLLECTION DEVICES AND RELATED METHODS", which application is hereby incorporated by reference in its entirety.

[0038] As shown in FIG. 6A, device 100 is first placed against patient's skin 101 in a pre-deployment configuration with device 100 fully sealed. More specifically, the lower surface of flexible membrane 660 can be positioned against skin 101. In some embodiments, flexible membrane 660 contacts and adheres to skin 101 to provide an airtight seal against skin 101. An adhesive (not shown) can be applied to the bottom surface of flexible membrane 660 to facilitate a seal against skin 101.

[0039] FIG. 6B shows device 100 in a partially deployed configuration after actuator 104 has been actuated to unlock lock mechanism 242 (FIG. 6A) and release plunger 230. In the illustrated embodiment, second biasing member 240 drives sealing member 244 upwardly through or using lug 102 to create a reduced pressure (e.g., vacuum pressure) within lumen 214 of housing 102. The vacuum pressure within housing 102 can pull flexible membrane 660 at least partially into opening 216 of housing 102 and / or lumen 214 such that flexible membrane 660 assumes a curved shape. Due to the seal between skin 101 and flexible membrane 660, skin 101 is also pulled toward, into, and / or through opening 216 and assumes a curvature similar to that of flexible membrane 660. Thus, flexible membrane 660 can control the curvature of skin 101. In some embodiments, portion 213 of base portion 210 that abuts / openings 216 has a shape that facilitates movement of flexible membrane 660 and skin 101 into opening 216.

[0040] FIG. 6C shows the device 100 in a deployed configuration after the first biasing member 224 has driven the drive member 222 to pivot the skin penetration feature 226 toward the opening 216. This movement of the drive member 222 causes the skin penetration feature 226 to pivot downwardly toward and / or into the flexible membrane 660 and the skin 101 within the opening 216. As shown, all or a portion of the cutting edge 227 can sweep through and incise the flexible membrane 660 and the skin 101 positioned at the opening 216. In other embodiments, the flexible membrane 660 can optionally include an aperture through which the skin penetration feature 226 can pass. In some aspects of the present technology, the flexible membrane 660 provides enhanced control over a wider area of the skin and thus is expected to enable the device 100 to access more capillaries and increase the volume of body fluid 346 that can be collected. The flexible membrane 660 can also provide assistance in collecting the body fluid 346 near the incision point to prevent or at least reduce the body fluid 346 from traveling on / along the patient's skin 101. In some aspects of the present technology, the flexible membrane 660 can, for example, cause the body fluid 346 to travel more rapidly from the patient's wound to the reservoir 106 (FIGS. 1A-1C) compared to a device without the flexible membrane 660. In some embodiments, the flexible membrane 660 can enable the rapid delivery of an anticoagulant material after the body fluid 346 has been extracted from the capillaries. In some embodiments, the base portion 210 of the housing 102 and / or the flexible membrane 660 (e.g., the upper surface of the flexible membrane 660 positioned within the opening 216) can be coated with a hydrophobic (e.g., superhydrophobic) material that helps to facilitate the flow of the body fluid 346 from the opening 216 toward the reservoir 106 (FIGS. 1A-1C) without capillary forces.

[0041] In other embodiments, other structures can be coupled to and / or formed on the lower surface 211b of the base portion 210 of the housing 102. For example, the device 100 can include a rigid dome or other structure coupled to the lower surface 211b.

[0042] FIG. 7 is a partial schematic side cross-sectional view of a body fluid collection device 700 (the “device 700”) configured in accordance with an additional embodiment of the present technique. The device 700 can include features substantially similar to those of the device 100 described in detail with reference to FIGS. 1A - 3D and can operate in substantially the same manner as the device 100. For example, in the illustrated embodiment, the device 700 includes a housing 702, an actuator 704, a skin penetration assembly 720, and a plunger 730. The housing 702 includes a base portion 710 having an opening 716 configured to be positioned adjacent to a patient's skin. The actuator 704 is operable to unlock a lock mechanism 742 (shown schematically) and release a plunger 730 that can be driven upwardly through the housing 702 by a first biasing member 740. Upon upward movement of the plunger 730, the plunger 730 moves to disengage from the skin penetration assembly 720. When the plunger 730 is disengaged from the skin penetration assembly 720, a second biasing member 724 drives the skin penetration assembly 720 such that the skin penetration feature 726 can pivot to sweep at least partially through / along the opening 716 and penetrate the patient's skin.

[0043] However, in the illustrated embodiment, the device 700 includes a sealing member 770 (e.g., rather than the sealing member 244) that is positioned over the opening 716 and forms a lumen 772 within the device 700. In some embodiments, the sealing member 770 is coupled between the plunger 730 (e.g., the sidewall portion 734 of the plunger 730) and the housing 702 (e.g., the base portion 710 of the housing 702). The sealing member 770 can be a flexible membrane that can bend and / or is elastic. Thus, upward movement of the plunger 730 (e.g., in the direction of arrow B) can stretch the sealing member 770 and increase the volume of the lumen 772, thereby reducing the pressure within the lumen 772 during use when the base portion 710 is sealed against the patient's skin. As will be described in detail with reference to FIGS. 3A - 3D and 6A - 6C, this low pressure can act directly or indirectly against the patient's skin to draw the skin toward / into the opening 716, for example, increasing the draw volume of the device 700.

[0044] FIG. 8A is a side cross-sectional view of a body fluid collection device 800 (the "device 800") configured according to an additional embodiment of the present technique. The device 800 is, in FIG. 8A, in a pre-deployment configuration. The device 800 can include some features that are substantially similar to the device 100 and / or the device 700 described in detail with reference to FIGS. 1A - 7 and can operate substantially similarly to the device 100 and / or the device 700. For example, in the illustrated embodiment, the device 800 includes a housing 802, an actuator 804, a skin penetration assembly 820, and a plunger 830.

[0045] In the illustrated embodiment, the housing 802 includes a base portion 810 and first and second sidewall portions 812a and 812b extending from the base portion 810 (e.g., extending generally perpendicular to and away from the base portion 210 in an upward direction). The base portion 810 and the first sidewall portion 812a together define a lumen 814 in which the skin penetration assembly 820 and the plunger 830 are at least partially positioned. During use of the device 800, the lower surface of the base portion 810 is configured to be positioned against and / or adjacent to the skin of a patient (e.g., the skin 101 shown in FIG. 1B). The opening 816 can extend through the base portion 810 such that the opening 816 abuts the skin 101 of the patient during use of the device 800. In some embodiments, as described in detail with reference to FIGS. 4 and 5, the opening 816 can be in fluid communication with one or more fluid channels formed within, on, and / or through the base portion 810. During use of the device 800, the one or more fluid channels can direct body fluid from the opening 816 to a reservoir and / or a detection site. In some embodiments, the opening 816 is configured (e.g., shaped and sized) to facilitate the drawing of the skin 101 of the patient into and / or toward the lumen 814 during use of the device 800.

[0046] In the illustrated embodiment, the skin penetration assembly 820 includes (i) a drive member 822 coupled to a first biasing member 824 (shown in dashed lines because it is not visible in FIG. 8A), and (ii) a skin penetration feature 826 coupled to the drive member 822. In the illustrated embodiment, the skin penetration feature 826 is a blade having a sharp cutting edge 827. In other embodiments, the skin penetration feature 826 is a needle, a lancet, or other feature configured to penetrate the patient's skin 101. In some embodiments, the first biasing member 824 couples the drive member 822 to the housing 802 such that the drive member 822 is rotatably / pivotably mounted within the lumen 814 of the housing 802 and is configured to pivot about a pivot axis Q (e.g., in the direction indicated by arrow C). For example, the first biasing member 824 can be a torsion spring or other suitable biasing member connected between the drive member 822 and the second side wall portion 812b of the housing 802 and / or another portion of the housing 802. In the illustrated embodiment, the device 800 further includes a retention feature 880 configured to hold the skin penetration assembly 820 in a pre-deployment configuration in which the first biasing member 824 is biased (e.g., wound).

[0047] More specifically, FIG. 8B is a side view of the skin penetration assembly 820 removed from the housing 802, and FIG. 8C is a rear view of the retaining feature 880 and the base portion 810 of the housing 802 shown in FIG. 8A according to an embodiment of the present technology. Referring to FIGS. 8A - 8C together, the drive member 822 is generally circular and includes a notch 882 (e.g., a cutout) that includes a notch surface 884. The retaining feature 880 may be generally U-shaped and includes (i) a pair of legs 886 (individually identified as a first leg 886a and a second leg 886b) extending from the base portion 810 of the housing 802, and (ii) a cross member 888 extending between the legs 886 and spanning the opening 816 of the base portion 810. In the pre-deployment configuration shown in FIG. 8A, the lower surface 889 of the cross member 888 engages / contactsthe notch surface 884 of the drive member 822 so that the drive member 822 (and the skin penetration feature 826) is configured not to pivot about the pivot axis Q in the direction indicated by arrow C. In other embodiments, the skin penetration assembly 820 and / or the retaining feature 880 may have different shapes, configurations, etc. such that in the pre-deployment configuration, the retaining feature 880 is configured so that the skin penetration assembly 820 does not pivot.

[0048] Referring again to FIG. 8A, in the illustrated embodiment, the plunger 830 is operably coupled to (i) the actuator 804 and (ii) a second biasing member 840 (e.g., a compression spring) configured to drive / bias the plunger 830 away from the base portion 810 of the housing 802 (e.g., in the direction indicated by arrow D). For example, the plunger 830 can include (i) a base portion 832 coupled to the actuator 804, (ii) a side wall portion 834 extending from the base portion 832 (e.g., extending generally perpendicular to the base portion 832 and downwardly away from the base portion 832), and (iii) a flange portion 835 protruding outwardly away from the side wall portion 834. The second biasing member 840 can be coupled between the flange portion 835 and the base portion 810 of the housing 802.

[0049] The plunger 830 can further include a protrusion 833 (e.g., an arm, a release portion) that extends downwardly away from the base portion 832 and has an angled release surface 837. As will be described in detail below with reference to FIGS. 9A-9E, during use of the device 800, the actuator 804 is pushed downwardly (e.g., in the direction indicated by arrow E) / depressed through the lumen 814 of the housing 802 towards the base portion 810 of the housing 802 and against the biasing force of the second biasing member 840 to drive the plunger 830. When the actuator 804 is depressed, the release surface 837 of the protrusion 833 contacts the retention feature 880 (e.g., the cross member 888 shown in FIG. 8C) and deflects the retention feature 880 to disengage it from engagement with the drive member 822 of the skin penetration assembly 820, whereupon the first biasing member 824 is configured to drive the drive member 822 to pivot about the pivot axis Q. In some embodiments, the skin penetration assembly 820 is translationally mounted within the lumen 814 of the housing 802 such that when the actuator 804 is depressed, the skin penetration assembly 820 engages and drives the skin penetration assembly 820 towards the opening base portion 810 of the housing 802.

[0050] In the illustrated embodiment, the device 800 is coupled to a housing 802 (e.g., a second side wall portion 812b of the housing 802) and a plunger 830, and further includes a sealing member 870 that forms a lumen 872 within the device 800. The sealing member 870 can be a flexible membrane that can bend / extend during movement of the plunger 830 to change the volume of the lumen 872. In some embodiments, the device 800 can include a valve 890 coupled to the lumen 872, e.g., via an opening or hole 831 in a base portion 832 of the plunger 830. The valve 890 can allow air to escape from within the lumen 872 when the volume of the lumen 872 decreases (e.g., when the plunger 830 moves in the direction of arrow E), but prevent air from entering the lumen 872 when the volume of the lumen 872 increases (e.g., when a second biasing member 840 drives the plunger 830 and the sealing member 870 away from the base portion 810 in the direction of arrow D), and can be a one-way valve. During use of the device 800, the valve 890 can facilitate creation of a low-pressure region (e.g., a vacuum) within the lumen 872 that acts directly or indirectly against the patient's skin 101.

[0051] The various components of the device 800 can include metal, plastic, and / or other materials. For example, in some embodiments, the housing 802, the actuator 804, the plunger 830, the drive member 822, and / or other components of the device 800 can be formed from a plastic material by 3D printing, molding (e.g., injection molding), or other methods. In some embodiments, the device 800 can be manufactured to have a pre-deployment configuration as shown in FIG. 8A.

[0052] Figures 9A-9E are side cross-sectional views of apparatus 800 showing various stages of a procedure for collecting body fluid (e.g., blood) from a patient, according to additional embodiments of the present technology. Referring first to FIG. 9A, apparatus 800 is first placed against a patient's skin 101 in the pre-deployment configuration shown in FIG. 8A. More specifically, the lower surface of the base portion 810 of the housing 802 can be positioned against the skin 101 such that the opening 816 is adjacent to the skin 101. In some embodiments, the base portion 810 of the housing 802 can form a seal with the patient's skin 101 such that the lumen 872 formed within the housing 802 by the sealing member 870 is sealed from the environment around the apparatus 800.

[0053] FIG. 9B shows apparatus 800 in a partially deployed configuration after the actuator 804 has been pushed downward in the direction of arrow E, driving the plunger 830 downward through the lumen 814 of the housing 802 toward the base portion 810. In some embodiments, the patient can use one or more fingers to push the actuator 804 downward. In the illustrated embodiment, the protrusion 833 contacts the cross member 888 of the retention feature 880 and deflects the retention feature 880 to disengage it from the drive member 822 of the skin penetration assembly 820. More specifically, the release surface 837 of the protrusion 833 can deflect the retention feature 880 laterally such that the lower surface 889 of the cross member 888 no longer engages the notch surface 884 of the drive member 822. As further shown in FIG. 9B, pushing down on the actuator 804 contracts / narrows the sealing member 870 and reduces the volume within the sealed lumen 872. In some embodiments, when the actuator 804 is pushed down, air is expelled from the lumen 872 through the valve 890. Further, pushing down on the actuator 804 compresses the second biasing member 840, which then exerts a biasing force against the plunger 830. In other embodiments, pushing down on the actuator 804 can also drive the skin penetration assembly 820 through the lumen 814 partially toward the base portion 810 (e.g., by a predetermined distance).

[0054] When the skin penetration assembly 820 is no longer constrained by the retention feature 880, the first biasing member 824 drives the drive member 822 to pivot about the pivot axis Q (e.g., in the direction of arrow C). For example, FIG. 9C shows the device 800 in a deployed configuration where movement of the drive member 822 pivots the skin penetration feature 826 downwardly toward and into the opening 816 and the skin 101. As shown, all or a portion of the cutting edge 827 can move through the opening 816 and contact and incise the skin 101 positioned therein. The position of the skin penetration assembly 820 relative to the opening 816, as well as the relative size and / or shape of the skin penetration feature 826, can be varied to change the size of the incision. In some aspects of the technology, the drive member 822 is released instantaneously or nearly instantaneously from within the retention feature 880, thereby increasing the speed of the skin penetration feature 826 and facilitating, for example, a cleaner incision, reduced patient pain, and / or a greater draw-in volume.

[0055] FIG. 9D shows the device 800 in its pre-retraction configuration after the skin penetration assembly 820 has been rotated continuously. In the illustrated embodiment, the first biasing member 824 drives the drive member 822 to pivot about pivot axis Q until (i) the skin penetration feature 826 sweeps beyond the opening 816 and no longer contacts the patient's skin 101, and (ii) the skin penetration feature 826 contacts the plunger 830. In other embodiments, the skin penetration assembly 820 can be configured (e.g., shaped and sized) such that the skin penetration feature 826 does not contact the plunger 830 in the pre-retraction configuration, contacts the retention feature 880 in the pre-retraction configuration, and / or contacts another portion of the device 800 in the pre-retraction configuration. As shown in FIG. 9D, when the skin 101 is incised, body fluid 946 (e.g., blood) flows from the skin 101 into the device 800, e.g., into the lumen 814 of the housing 102 and / or onto the upper surface of the base portion 810 of the housing 102. In some aspects of the present technology, the high rotational speed of the skin penetration feature 826 can increase the amount of body fluid 946 collected, while making the procedure relatively painless for the patient.

[0056] FIG. 9E shows a device in a retracted configuration where a second biasing member 840 drives the plunger 830 upward in the direction of arrow E through the lumen 814 of the housing 802. For example, the second biasing member 840 can drive the plunger 830 upward after the patient releases the actuator 804. As the plunger 830 moves upward, the volume within the sealed lumen 872 increases as the sealing member 870 expands / extends. In some aspects of the present technology, since the valve 890 does not allow air to enter the lumen 872 during the expansion of the lumen 872, increasing the volume within the lumen 872 creates a reduced pressure (e.g., a vacuum pressure) therein. In some embodiments, the reduced pressure can draw the skin 101 at least partially into the opening 816 (e.g., as shown in FIGS. 3B - 3D). That is, the reduced pressure can deflect the skin 101 into the opening 816 and / or into the lumen 814 of the housing 802. Alternatively or additionally, the reduced pressure can assist in drawing the body fluid 946 into the device 800. In some aspects of the present technology, the sealing member 870 and the valve 890 thereby increase the draw volume of the device 800. In some embodiments, the draw volume of the device 800 can be 100 - 1000 μL (e.g., 600 - 700 μL). In another aspect of the present technology, the device 800 is configured to draw the body fluid 946 in a relatively short time compared to conventional devices. For example, in some embodiments, the device 800 can collect the draw volume in less than about 1 minute, less than about 45 seconds, less than about 30 seconds, or less than about 15 seconds.

[0057] In some embodiments, the device 800 is configured as a disposable device. For example, in the illustrated embodiment, the device 800 is configured such that actuation of the actuator 804 when the device 800 is in the retracted configuration does not pivot the skin penetration feature 826 into the opening 816. Specifically, the first biasing member 824 is no longer biased in the retracted configuration and thus cannot drive the skin penetration feature 826 toward the opening 816.

[0058] Figure 10 is a side cross-sectional view of a body fluid collection device 1000 (the "device 1000") configured in accordance with an additional embodiment of the present technology. The device 1000 is in a pre-deployment configuration in FIG. 10. The device 1000 can include some features substantially similar to those of the device 800 described in detail with reference to FIGS. 8A-9E and can operate substantially similarly to the device 800. For example, in the illustrated embodiment, the device 1000 includes a housing 802, an actuator 804, a skin penetration assembly 820, and a plunger 830.

[0059] In the illustrated embodiment, the device 1000 further includes a retaining feature 1080 (e.g., a shelf) configured to hold the skin penetration assembly 820 in a pre-deployment configuration in which a first biasing member 824 is biased (e.g., wound). The retaining feature 1080 can include a vertical portion 1086 (e.g., a leg) extending from a base portion 810 of the housing 802 and a horizontal portion 1088 (e.g., a cross member). In the pre-deployment configuration, the horizontal portion 1088 engages a notch 882 (FIGS. 8A and 8B) of the drive member 822 to prevent the drive member 822 (and the skin penetration feature 826) from pivoting into the opening 816.

[0060] In the illustrated embodiment, the plunger 830 extends downwardly away from the base portion 832 and includes a protrusion 1033 (e.g., an arm, release portion) having an angled release surface 1037. During use of the device 1000, the actuator 804 is configured to be pushed downwardly / depressed through the lumen 814 of the housing 802 toward the base portion 810 of the housing 802 to drive the plunger 830. When the actuator 804 is depressed, the release surface 1037 of the protrusion 1033 contacts / engages the retaining feature 1080 (e.g., an edge portion of the horizontal portion 1088) and deflects the retaining feature 1080 to disengage it from engagement with the drive member 822 of the skin penetration assembly 820, such that the first biasing member 824 is configured to drive the drive member 822 for pivoting. More specifically, the protrusion 1033 is configured to deflect the retaining feature 1080 in the direction indicated by arrow F to move it out of the rotational plane of the skin penetration assembly 820. Thus, compared to the embodiments shown in FIGS. 8A - 9E, the release surface 1037 is rotated (e.g., by about 90 degrees) relative to the release surface 837 of the protrusion 833. In some aspects of the present technology, this can help to ensure that the retaining feature 1080 does not interfere with the skin penetration assembly 820 during rotation of the skin penetration assembly 820. In other embodiments, the protrusion 1033 can be configured to contact the skin penetration assembly 820 and deflect the skin penetration assembly 820 to disengage it from engagement with the (e.g., stationary) retaining feature 1080.

[0061] Figures 11A and 11B are partial cross-sectional side views of a body fluid collection device 1100 (the "device 1100") in a pre-deployment configuration (e.g., a pre-operational position) and a deployed configuration (e.g., an operational position), respectively, constructed in accordance with additional embodiments of the present technology. The device 1100 can include some features substantially similar to the devices 100, 700, 800, and / or 1000 described in detail with reference to FIGS. 1A - 10, and / or can operate substantially similarly to the devices 100, 700, 800, and / or 1000. Referring to FIGS. 11A and 11B together, for example, the device 1100 includes a housing 1102, an actuator 1104, a skin penetration assembly 1120 (not shown in cross-section in FIGS. 11A and 11B), a plunger 1130, and a sealing member 1170.

[0062] In the illustrated embodiment, the housing 1102 includes a base portion 1110 and a sidewall portion 1112 extending from the base portion 1110. The base portion 1110 and the sidewall portion 1112 together define a lumen 1114 in which the skin penetration assembly 1120 and the plunger 1130 are at least partially positioned. During use of the device 1100, the lower surface of the base portion 1110 is configured to be positioned against and / or adjacent to a patient's skin (e.g., the skin 101 shown in FIG. 1B). The opening 1116 can extend through the base portion 1110 such that the opening 1116 abuts the patient's skin during use of the device 1100. The housing 1102 can further define a channel or groove 1118 extending around the sidewall portion 1112.

[0063] FIG. 11C is a top view of the housing 1102 according to an embodiment of the present technology, and FIG. 11D is a cross-sectional side view of the housing 1102 taken along line 11D of FIG. 11C. Referring to FIGS. 11C and 11D together, the housing 1102 further includes a plunger guide 1180 and a skin penetration assembly mount 1184 (e.g., a saddle) extending from and / or coupled to the base portion 1110. The plunger guide 1180 can include a wall or other structure defining a recess 1181 and an opening 1183. The skin penetration assembly mount 1184 can include a first portion 1185 and a second portion 1187 spaced apart from the first portion 1185. In the illustrated embodiment, the opening 1116 is fluidly connected to an outflow channel 1152 extending through the side wall via a fluid channel 1150 formed within, on, and / or through the base portion 1110. A collection reservoir 1106 (omitted in FIG. 11D for clarity) can be releasably coupled to the outflow channel 1152 to receive the flow of body fluid from the opening 1116 via the fluid channel 1150.

[0064] Referring again to FIGS. 11A and 11B, the device 1100 can further include a first biasing member 1140 (e.g., a compression spring) at least partially positioned within the groove 1118 and operably coupled between the housing 1102 and the actuator 1104. In the pre-deployment position shown in FIG. 11A, the first biasing member 1140 is in a relaxed or un-biased state. To move the device 1100 to the deployed position shown in FIG. 11B, the user can push / press down the actuator 1104 downwardly toward the base portion 1110 against the biasing force of the first biasing member 1140. In some embodiments, an end portion 1171 of the sealing member 1170 can be fixed to the housing 1102 within the groove 1118 such that the sealing member 1170 extends across the lumen 1114 and provides a fluid seal.

[0065] In the illustrated embodiment, the plunger 1130 includes an upper portion 1132, a trigger portion 1134 (e.g., a lower portion, not visible in FIG. 11B), and an elongated central portion 1136 extending between the upper portion 1132 and the trigger portion 1134. The trigger portion 1134 can be at least partially positioned within the recess 1181 of the plunger guide 1180. The downward movement (e.g., pushing) of the actuator 1104 can operably couple the upper portion 1132 to the actuator 1104 and the sealing member 1170 to drive the plunger 1130 toward the base portion 1110. More specifically, the actuation of the actuator 1104 can drive the trigger portion 1134 of the plunger 1130 through the recess 1181. In other embodiments, the plunger 1130 can have other configurations (e.g., shape, dimensions, coupling).

[0066] In the illustrated embodiment, the skin penetration assembly 1120 includes a drive member 1122 (e.g., a driver) having a retaining portion 1121 (partially invisible in FIGS. 11A and 11B), a mounting portion 1123, and a hub portion 1125. The retaining portion 1121 and the mounting portion 1123 can each have a circular cross-sectional shape, and the retaining portion 1121 can have a smaller diameter than the mounting portion 1123. The mounting portion 1123 can define an annular channel or groove 1128 that at least partially extends around it (e.g., separated by a pair of adjacent ridges or flanges). Referring to FIGS. 11A-11D together, the drive member 1122 can be rotatably coupled to the skin penetration assembly mount 1184. For example, the mounting portion 1123 can be coupled to the first portion 1185 of the skin penetration assembly mount 1184 by positioning (e.g., seating) the groove 1128 on / across the first portion 1185. In some embodiments, the second portion 1187 of the skin penetration assembly mount 1184 can engage the retaining portion 1121 to further secure the drive member 1122 to the housing 1102. In some embodiments, the drive member 1122 can be rotatably coupled to the housing 1102 via a second biasing member (not visible in FIGS. 11A and 11B but shown as the second biasing member 1224 in FIGS. 12A-12C) such that the drive member 1122 is rotatably / pivotably attached to the skin penetration assembly mount 1184. For example, the second biasing member 1224 can be a torsion spring or other suitable biasing member connected between the drive member 1122 (e.g., the retaining portion 1121 and / or the mounting portion 1123) and another portion of the sidewall portion 1112, the second portion 1187, and / or the housing 1102.

[0067] In the illustrated embodiment, the mounting portion 1123 further includes a radially projecting release member 1129 (e.g., tab, bar, projection, fin). In the pre-deployment position shown in FIG. 11A, the release member 1129 is configured (e.g., shaped, sized, positioned) to extend through the opening 1183 of the plunger guide 1180 and into the recess 1181. As will be described in more detail below with reference to FIGS. 12A-12C, the release member 1129 is configured to engage the trigger portion 1134 of the plunger 1130 in the pre-deployment position to prevent rotation of the drive member 1122.

[0068] Referring again to FIGS. 11A and 11B, the skin penetration assembly 1120 can further include a skin penetration feature 1126 coupled to a hub portion 1125. In the illustrated embodiment, the skin penetration feature 1126 is a blade having a sharp cutting edge 1127 (not visible in FIG. 11B). In other embodiments, the skin penetration feature 1126 can be a needle, a lancet (e.g., a cylindrical or other shaped lancet), or other feature configured to penetrate the patient's skin. In some embodiments, the skin penetration assembly 1120 can include a plurality of skin penetration features (e.g., multiple offset blades for generating various cutting patterns). In the illustrated embodiment, the skin penetration feature 1126 is secured to the hub portion 1125 via a post 1190 and a junction 1192. The junction 1192 can include a weld, an adhesive, a press, and / or other junctions and can be positioned at a portion of the cutting edge 1127. In some aspects of the present technology, positioning the junction 1192 at the cutting edge 1127 can help ensure that the skin penetration feature 1126 does not move during operation, thereby ensuring a reliable cutting depth and length. In the illustrated embodiment, the hub portion 1125 further includes a cutting surface 1193 and the skin penetration feature 1126 projects beyond the cutting surface 1193. During operation of the device 1100, the cutting surface 1193 can abut the patient's skin. Thus, the distance that the skin penetration feature 1126 projects beyond the cutting surface 1193 can define the maximum cutting depth of the skin penetration assembly 1120 and can be adjusted / selected based on the desired cutting depth.

[0069] Figures 12A - 12C are side cross-sectional views of lumen 1114 of device 1100 taken along line 12A of FIG. 11A, and show device 1100 in the pre-deployment position, during deployment, and in the deployed position, respectively, according to an embodiment of the present technology. First, referring to FIGS. 11A and 12A together, in the pre-deployment position, the second biasing member 1224 is in a biased position (e.g., storing energy), and the release member 1129 of the mount portion 1123 engages with the trigger portion 1134 of the plunger 1130 to maintain the second biasing member 1224 in the biased position, thereby preventing rotation of the skin penetration assembly 1120. To move device 1100 to the deployed position, for example, to collect body fluid from a patient, the base portion 1110 of device 1100 can first be placed against the patient's skin with device 1100 in the pre-deployment position. Next, the user can actuate (e.g., push down) actuator 1104 in the direction of arrow F (FIG. 11B) against the biasing force of the first biasing member 1140.

[0070] Referring together to FIGS. 11A, 11B, and 12B, when the actuator 1104 is depressed, the plunger 1130 and the sealing member 1170 are driven downwardly through the lumen 1114 toward the base portion 1110. As the plunger 1130 moves downwardly, the trigger portion 1134 is driven through the recess 1181 of the plunger guide 1180. Initially, as shown in FIG. 12B, the trigger portion 1134 engages the release member 1129 and drives the drive member 1122 to rotate counterclockwise, for example, as indicated by arrow CW, against the biasing force of the second biasing member 1224. Thus, the downward movement of the plunger 1130 can increase the energy stored by the second biasing member 1224. Referring together to FIGS. 11B and 12C, as the plunger 1130 is continuously depressed, the release member 1129 disengages from the trigger portion 1134 (e.g., by sliding therewith), enabling the second biasing member 1224 to drive the drive member 1122 to rotate in the clockwise direction indicated by arrow C. As the drive member 1122 rotates, a portion of the cutting edge 1127 of the skin penetration feature 1126 extending beyond the cutting plane 1193 is driven through the opening 1116 and can contact and incise the skin positioned therein / below.

[0071] Referring to FIGS. 11A and 11B and as described above, the cutting plane 1193 can contact the skin and define the maximum size (e.g., depth, length) of the incision. In some embodiments, the skin mount 11844 can be configured (e.g., height or shape) and the skin penetration assembly 1120 positioned relative to the opening 1116 to further vary the size of the incision. In some embodiments, for example, the device 1100 can be configured to create an incision that is about 0.5 to 1.5 millimeters deep and about 3 to 7 millimeters long.

[0072] Similar to the embodiments described in detail above with reference to FIGS. 3D, the skin penetration assembly 1120 can continue to rotate to a retracted configuration in which the skin penetration feature 1126 rotates over the opening 1116 and is secured within the lumen 1114. In the retracted configuration, the second biasing member 1224 releases at least a portion of its stored energy, and the skin penetration assembly 1120 is no longer engaged with the plunger 1130 (e.g., via engagement with the release member 1129 of the trigger portion 1134). Thus, subsequent actuation of the actuator 1104 will not push the skin penetration feature 1126 out of the opening 1116.

[0073] In some embodiments, when the user releases the actuator 1104, the first biasing member 1140 can drive the plunger 1130, the sealing member 1170, and the actuator 1104 upward in the direction of arrow G (FIG. 11B). Moving the sealing member 1170 upward can increase the sealed volume within the lumen 1114, thereby creating a vacuum pressure that can assist in drawing body fluid from the incision into the fluid channel 1150.

[0074] In other embodiments, a body fluid collection device configured in accordance with the present technology can have (i) a skin penetration assembly that drives a blade or other skin penetration feature through an opening in some other manner and / or (ii) additional features for controlling the length and / or depth of the incision. For example, FIG. 13 is a partially transparent side view of a skin penetration assembly 1320 coupled to a portion of a housing 1302 of a body fluid collection device according to an additional embodiment of the present technology. The housing 1302 is shown partially transparently in FIG. 13 for clarity. In some embodiments, the skin penetration assembly 1320 can be incorporated into (i) one or more of the devices 100, 700, 800, 1000, and / or 1100 described in detail with reference to FIGS. 1A-12C and / or (ii) can include features that are substantially similar or identical to those of the skin penetration assemblies 120, 720, 820, 1020, and / or 1120.

[0075] In the illustrated embodiment, the skin penetration assembly 1320 includes a driver 1322 having a protrusion 1364. The skin penetration feature 1326 (e.g., a blade) can be coupled to the driver 1322. The housing 1302 includes / delineates a track 1362 (e.g., an opening, a channel, an elongate path), and the protrusion 1364 extends partially into the track 1362 such that the protrusion 1364 is restricted to move along the track 1362. The track 1362 can extend between a first end portion 1361 and a second end portion 1363 and can have a length and shape (e.g., various heights) selected to correspond to a desired path of the skin penetration feature 1326 and a corresponding size (e.g., length, depth) of the incision made by the skin penetration feature 1326. In the illustrated embodiment, for example, the track 1362 includes a raised central portion 1365.

[0076] In some embodiments, the drive body 1322 is operably coupled to the housing 1302 via a biasing member 1368. In the illustrated embodiment, the biasing member 1368 is a torsion spring that extends between the housing 1302 and the protrusion 1364, and the skin penetration assembly 1320 is in a deployed position where the torsion spring is in a relaxed state. FIGS. 14A - 14C are side views of the housing 1302 and the skin penetration assembly 1320 in a pre-deployment position, a mid-deployment position, and a deployed position, respectively, according to embodiments of the present technology. Referring together to FIGS. 13 - 14C, the first end portion 1361 of the track 1362 is configured (e.g., shaped, sized) to engage a notch 1367 (e.g., retaining surface, retaining feature) of the protrusion 1364 at the pre-deployment position such that the skin penetration assembly 1320 is locked at the pre-deployment position with the biasing member 1368 in a biased state. Another feature of the protrusion 1364 and / or the skin penetration assembly 1320 can be operably coupled to another feature of the actuator or the body fluid collection device to actuate the actuator to disengage the protrusion 1364 from the notch 1367. After actuation, the biasing member 1368 drives the skin penetration assembly 1320 along a path controlled / delineated by the configuration (e.g., shape, size, length) of the track 1362 through an opening in the housing (not shown) to deploy the skin penetration feature 1326 to, for example, incise the skin of a patient positioned thereunder.

[0077] In the illustrated embodiment, for example, the skin penetration assembly 1320 rotates through an opening and moves laterally from the first end portion 1361 toward the second end portion 1363 while deploying the skin penetration feature 1326 as the protrusion 1364 passes along the central portion 1365. In some embodiments, the configuration of the central portion 1365 can control the depth of the incision made by the skin penetration feature 1326. For example, increasing the height of the central portion 1365 can decrease the depth of the incision, while conversely, decreasing the height of the central portion 1365 can increase the depth of the incision.

[0078] Figures 15A and 15B are, respectively, a perspective side view and a cross-sectional side view of a skin penetration assembly 1520 coupled to a portion of a housing 1502 of a body fluid collection device configured in accordance with additional embodiments of the present technology. In some embodiments, the skin penetration assembly 1520 can be incorporated into one or more of the devices 100, 700, 800, 1000, and / or 1100 described in detail with reference to FIGS. 1A - 12C, and / or can include features that are substantially similar or identical to those of the skin penetration assemblies 120, 720, 820, 1020, 1120, and / or 1320.

[0079] In the illustrated embodiment, the skin penetration assembly 1520 includes a driver 1522 positioned at least partially over an opening 1516 of the housing 1502. A skin penetration feature 1526 (e.g., a blade) can be coupled to the driver 1522. FIG. 15C is a side cross-sectional view of the housing 1502 according to an embodiment of the present technology. Referring to FIGS. 15A - 15C together, the housing 1502 can include / delineate a first track 1562a and a second track 1562b (e.g., an opening, a channel, an elongate path, collectively referred to as "track 1562"). The driver 1522 of the skin penetration assembly 1520 can include a first protrusion 1564a that extends at least partially into the first track 1562a and a second protrusion 1564b (collectively referred to as "protrusions 1564") that extends at least partially into the second track 1562b. The protrusions 1564 can be restricted to move along the track 1562. The tracks 1562 can each have a configuration (e.g., length, shape) selected to correspond to a desired path of the skin penetration feature 1526 and a corresponding size (e.g., length, depth) of an incision made by the skin penetration feature 1526. For example, the tracks 1562 can each extend between a first end portion 1561 and a second end portion 1563 and can have various heights therebetween. The tracks 1562 can have the same or different configurations.

[0080] In some embodiments, the driver 1522 includes a release member 1528 (e.g., a tab or protrusion) and is operatively coupled to the housing 1502 via one or more biasing members 1568 (e.g., a first biasing member 1568a and a second biasing member 1568b that are individually identified). In the illustrated embodiment, the biasing member 1568 is a tension spring, and the skin penetration assembly 1520 is in a pre-deployment position where the tension spring is biased. In some embodiments, the first biasing member 1568a extends between the housing 1502 and the position of the driver 1522 at or near the first protrusion 1564a, and the second biasing member 1568b extends between the housing 1502 and the position of the driver 1522 at or near the second protrusion 1564b. In other embodiments, the driver 1522 can be coupled to the housing via a single biasing member or more than two biasing members.

[0081] In some embodiments, the first end portion 1561 of the first track 1562a includes a notch 1567 (e.g., a retaining surface, a retaining feature) configured (e.g., shaped) to engage the first protrusion 1564a at a pre-deployment position such that the skin penetration assembly 1520 is locked in a pre-deployment position with the biasing member 1568 biased. The release member 1528 is configured to releasably engage features of the body fluid collection device such as a restraining portion of a plunger (e.g., the restraining portion 238 shown in FIGS. 2 - 3D), a retaining feature (e.g., the retaining feature 880 shown in FIGS. 8A - 9E and / or the retaining feature 1080 shown in FIG. 10), and / or a trigger portion of a plunger (e.g., the trigger portion 1134 shown in FIGS. 11A - 12C). Actuating the body fluid collection device can actuate (e.g., depress) the release member 1528 to unlock the protrusion 1564 from the track 1562. After actuation, the biasing member 1568 drives (e.g., pulls) the skin penetration assembly 1520 along the track 1562 from the first end portion 1561 towards the second end portion 1563, through the opening 1516, to deploy the skin penetration feature 1526 to, for example, incise the skin of a patient positioned thereunder.

[0082] In other embodiments, the biasing member 1568 can be another type of biasing member configured to drive the skin penetration assembly 1520. For example, the biasing member 1568 can be a compression spring configured to push the skin penetration assembly 1520 along the track 1562.

[0083] The following examples illustrate some embodiments of the present technology. 1. An apparatus for collecting body fluid from a patient, the apparatus comprising: a housing including a base, the base having an opening extending therethrough, the housing; and a skin penetration assembly at least partially positioned within the housing, the skin penetration assembly including a skin penetration feature and a biasing member, the skin penetration assembly; and a plunger at least partially positioned within the housing and movable from a first position to a second position, the plunger being configured to engage the skin penetration assembly to maintain the biasing member in a biased configuration at the first position, and a movement of the plunger from the first position to the second position disengages the plunger from the skin penetration assembly and enables the biasing member to drive the skin penetration feature at least partially through the opening in the base. 2. The apparatus according to Example 1, further comprising an actuator operably coupled to the plunger, wherein movement of the actuator in a direction toward the base drives the plunger from the first position to the second position. 3. The biasing member is a first biasing member, and the apparatus according to Example 2 further comprises a second biasing member operably coupled between the actuator and the housing, the second biasing member being configured to bias the plunger to the first position. 4. The apparatus according to Example 3, wherein the first biasing member is a torsion spring and the second biasing member is a compression spring. ​5. The plunger includes a trigger portion, the skin penetration assembly includes a drive member having a protrusion, and the trigger portion engages with the protrusion at a first position to maintain the biasing member in a biased configuration, the apparatus according to any one of Examples 1 to 4. 6. Movement of the plunger from the first position to the second position (a) drives the trigger portion against the protrusion against the biasing force of the biasing member, and then (b) drives the trigger portion beyond the protrusion to enable the biasing member to drive at least partially through the opening of the base to drive the skin penetration feature, the apparatus according to Example 5. 7. The biasing member is a first biasing member, and further includes a second biasing member operably coupled between the plunger and the housing, and the second biasing member is configured to drive the plunger from the first position to the second position, the apparatus according to any one of Examples 1 to 6. 8. The second position is farther away from the base than the first position, the apparatus according to Example 7. 9. Further includes a locking mechanism operably coupled to the plunger and configured to selectively maintain the second biasing member in a biased configuration, the apparatus according to Example 7 or Example 8. 10. Further includes a release actuator operably coupled to the locking mechanism, and actuation of the release actuator unlocks the locking mechanism to enable the second biasing member to drive the plunger from the first position to the second position, the apparatus according to Example 9. 11. Further includes a flexible sealing member coupled to the housing and positioned within the housing to define a sealed volume, the apparatus according to any one of Examples 1 to 10. 12. The biasing member is a torsion spring, the apparatus according to any one of Examples 1 to 11. 13. The skin penetration feature is a blade, the apparatus according to any one of Examples 1 to 12. 14. The biasing member is configured to rotate the skin penetration feature relative to the housing, the apparatus according to any one of Examples 1 to 13. 15. The skin penetration assembly further includes a driver, the biasing member is operably coupled between the driver and the housing, and the skin penetration feature is coupled to the driver, the device according to any one of embodiments 1 to 14. 16. The skin penetration feature is a blade having a cutting edge, and a portion of the cutting edge is directly joined to the driver, the device according to embodiment 15. 17. The device further includes a flexible membrane coupled to the base of the housing across an opening, and in a second position, the plunger disengages from the skin penetration assembly such that the biasing member drives the skin penetration feature through at least a portion of the opening in the base to form a hole in the flexible membrane, the device according to any one of embodiments 1 to 16. 18. A reservoir releasably coupled to the housing, and a fluid channel configured to direct body fluid from the opening to the reservoir, the device according to any one of embodiments 1 to 17. 19. A device for collecting body fluid from a patient, the device comprising a housing including a base, the base having an opening extending therethrough, the housing, a skin penetration assembly at least partially positioned within the housing, the skin penetration assembly including a drive member, a blade coupled to the drive member, and a biasing member, the skin penetration assembly, an actuator movable relative to the housing, a plunger rotatably coupled to the housing and having a pre-deployment position, and in the pre-deployment position, the plunger engages the drive member to prevent rotation of the blade, movement of the actuator in a direction toward the base disengages the plunger from the drive member such that a first biasing member drives the blade through at least a portion of the opening in the base to rotate the blade, the device. 20. A device for collecting body fluid from a patient, the device comprising A housing including a base, the base having an opening extending therethrough, the housing, A skin penetration assembly at least partially positioned within the housing, the skin penetration assembly including a skin penetration feature and a biasing member, the skin penetration assembly, A retaining feature configured to engage the skin penetration assembly to maintain the biasing member in a biased configuration, A plunger at least partially positioned within the housing, the plunger being movable through the housing and engaging the retaining feature to deflect the retaining feature to disengage from the skin penetration assembly, enabling the biasing member to drive the skin penetration feature at least partially through the opening in the base, the device comprising the plunger. 21. A device for collecting body fluid from a patient, the device comprising: A housing including a base, the base having an opening extending therethrough, the housing, A skin penetration assembly at least partially positioned within the housing, the skin penetration assembly including a skin penetration feature and a first biasing member, the skin penetration assembly, A plunger at least partially positioned within the housing, A second biasing member coupled to the plunger and configured to drive the plunger through the housing from a first position to a second position that is farther from the base than the first position, In the first position, the plunger is configured to engage the skin penetration assembly to maintain the first biasing member in a biased configuration, Movement of the plunger from the first position to the second position disengages the plunger from the skin penetration assembly, enabling the first biasing member to drive the skin penetration feature at least partially through the opening in the base, the device. 22. The apparatus according to embodiment 21, further comprising a sealing member positioned between the housing and the plunger and configured to seal the interface between the housing and the plunger. 23. The apparatus according to embodiment 22, wherein the second biasing member is configured to drive the sealing member and the plunger from a first position to a second position to generate a vacuum pressure within at least a portion of the housing. 24. The apparatus according to any one of embodiments 21 to 23, wherein the first biasing member is a torsion spring. 25. The apparatus according to any one of embodiments 21 to 24, wherein the second biasing member is a compression spring. 26. The apparatus according to any one of embodiments 21 to 25, wherein the skin penetration feature is a blade. 27. The apparatus according to any one of embodiments 21 to 26, wherein the first biasing member is configured to rotate the skin penetration feature. 28. The apparatus according to any one of embodiments 21 to 27, wherein the skin penetration assembly further includes a drive body, the first biasing member is coupled between the drive body and the housing, and the skin penetration feature is coupled to the drive body. 29. The apparatus according to any one of embodiments 21 to 28, wherein the skin penetration assembly further includes a release member, the plunger includes a restraint portion, and the restraint portion is configured to engage the release member when the plunger is in the first position to maintain the first biasing member in a biased configuration. 30. The apparatus according to embodiment 29, wherein the plunger includes an upper portion, and the restraint portion projects downward from the upper portion toward the base of the housing. 31. The apparatus according to embodiment 29, wherein the plunger includes a sidewall portion that projects downward from the upper portion toward the base of the housing, the sidewall portion and the restraint portion define a channel therebetween, and the release member is constrained within the channel when the plunger is in the first position. 32. Further comprising a flexible membrane coupled to the base of the housing across the opening, wherein in the second position, the plunger disengages from the skin penetration assembly such that the first biasing member is configured to drive the skin penetration feature at least partially through the opening in the base to create a hole in the flexible membrane, the apparatus according to any one of embodiments 21 - 31. 33. Further comprising a locking mechanism operably coupled to the plunger and configured to selectively maintain the second biasing member in a biased configuration, the apparatus according to any one of embodiments 21 - 32. 34. Further comprising a release actuator operably coupled to the locking mechanism, wherein actuation of the release actuator unlocks the locking mechanism such that the second biasing member is configured to drive the plunger through the housing from the first position to the second position, the apparatus according to embodiment 33. 35. The apparatus according to any one of embodiments 21 - 34, a reservoir releasably coupled to the housing, and a fluid channel configured to direct body fluid from the opening to the reservoir, the apparatus according to any one of embodiments 21 - 34.

[0084] The foregoing detailed description of embodiments of the technology is not intended to be exhaustive or to limit the technology to the precise forms disclosed above. Specific embodiments of the technology and examples of the technology have been described above for illustrative purposes, but as will be recognized by those of ordinary skill in the art, various equivalent modifications are possible within the scope of the technology. For example, steps are presented in a given order, but alternative embodiments may perform the steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0085] From the foregoing, specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context permits, singular or plural terms may also include plural or singular terms, respectively.

[0086] Furthermore, unless the term "or" is explicitly limited to mean only a single item excluded from the other items in a list of two or more items, the use of "or" in such a list is to be construed as including (a) a single item in the list, (b) all items in the list, or (c) any combination of items in the list. Further, the term "comprising" is used throughout to mean including at least the recited features so that any additional number of the same function and / or other types of functions are not excluded. Although specific embodiments have been described herein for purposes of illustration, it will be understood that various modifications can be made without departing from the technology. Further, although the advantages associated with some embodiments of the technology are described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments necessarily exhibit such advantages in order to fall within the scope of the technology. Accordingly, the present disclosure and related technologies can include other embodiments not explicitly shown or described herein.

Claims

1. An apparatus for collecting body fluid from a patient, the apparatus comprising: a housing including a base, the base having an opening extending therethrough; a skin penetration assembly at least partially positioned within the housing, the skin penetration assembly including a blade and a first spring; an elongate member at least partially positioned within the housing and movable from a first position to a second position; an actuator operably coupled to the elongate member and configured to move the elongate member from the first position to the second position; a second spring operably coupled between the actuator and the housing and positioned within the housing, the second spring configured to apply a biasing force to the elongate member in a direction away from the base and orthogonal to the base to bias the elongate member toward the first position; in the first position, the elongate member is configured to engage the skin penetration assembly to maintain the first spring in a biased configuration; movement of the elongate member from the first position to the second position disengages the elongate member from the skin penetration assembly, enabling the first spring to drive the blade at least partially through the opening in the base, the apparatus.

2. The apparatus of claim 1, wherein movement of the actuator in a direction toward the base drives the elongate member from the first position to the second position.

3. The apparatus of claim 1, wherein the first spring is a torsion spring and the second spring is a compression spring.

4. The apparatus of claim 1, wherein the elongate member includes a trigger portion and the skin penetration assembly includes a drive member having a protrusion, the trigger portion engaging the protrusion in the first position to maintain the first spring in the biased configuration.

5. The movement of the elongate member from the first position to the second position is (a) driving the trigger portion against the biasing force of the first spring and against the protrusion, and then (b) driving the trigger portion beyond the protrusion to enable the first spring to drive the blade at least partially through the opening in the base, the apparatus of claim 4.

6. An apparatus for collecting a body fluid from a patient, the apparatus comprising a housing including a base, the base having an opening extending therethrough, the housing; a skin penetration assembly at least partially positioned within the housing, the skin penetration assembly including a blade and a first spring, the skin penetration assembly; an elongate member at least partially positioned within the housing and movable from a first position to a second position, wherein in the first position, the elongate member is configured to engage the skin penetration assembly to maintain the first spring in a biased configuration, wherein movement of the elongate member from the first position to the second position disengages the elongate member from the skin penetration assembly to enable the first spring to drive the blade at least partially through the opening in the base, the elongate member; a second spring operably coupled between the elongate member and the housing, the second spring being configured to drive the elongate member from the first position to the second position, the second spring; An apparatus comprising.

7. The apparatus of claim 6, wherein the second position is further from the base than the first position.

8. The apparatus of claim 6, further comprising a locking mechanism operably coupled to the elongate member and configured to selectively maintain the second spring in a biased configuration.

9. The apparatus of claim 8, further comprising a release actuator operably coupled to the locking mechanism, the actuation of the release actuator unlocking the locking mechanism to enable the second spring to drive the elongate member from the first position to the second position.

10. The device according to claim 1, further comprising a flexible sealing member that is coupled to the housing and positioned within the housing to define a sealed volume.

11. The device according to claim 1, wherein the first spring is a torsion spring.

12. The device according to claim 1, wherein the first spring is configured to rotate the blade relative to the housing.

13. The device according to claim 1, wherein the skin penetration assembly further includes a drive body, the first spring is operably coupled between the drive body and the housing, and the blade is coupled to the drive body.

14. The device according to claim 13, wherein the blade has a cutting edge, and a portion of the cutting edge is directly joined to the drive body.

15. A device for collecting body fluid from a patient, the device comprising: a housing including a base, the base having an opening extending therethrough; a skin penetration assembly at least partially positioned within the housing, the skin penetration assembly including a blade and a spring; an elongate member at least partially positioned within the housing and movable from a first position to a second position; at the first position, the elongate member is configured to engage the skin penetration assembly to maintain the spring in a biased configuration; movement of the elongate member from the first position to the second position disengages the elongate member from the skin penetration assembly and enables the spring to drive the blade at least partially through the opening in the base of the housing; a flexible membrane coupled to the base of the housing across the opening; and at the second position, the elongate member is configured to disengage from the skin penetration assembly and enable the spring to drive the blade at least partially through the opening in the base of the housing to pierce the flexible membrane.

16. a reservoir releasably coupled to the housing; and a fluid channel configured to direct body fluid from the opening to the reservoir. The device according to claim 15.

17. An apparatus for collecting body fluid from a patient, the apparatus comprising: A housing including a base, the base having an opening extending therethrough; a housing; A skin penetration assembly at least partially positioned within the housing, the skin penetration assembly including a drive member rotatably coupled to the housing, a blade coupled to the drive member, and a spring; a skin penetration assembly; An actuator movable relative to the housing; An elongate member at least partially positioned within the housing and movable from a first position to a second position; In the first position, the elongate member engages the drive member to prevent rotation of the blade; Movement of the actuator in a direction towards the base moves the elongate member from the first position to the second position to disengage the drive member, allowing the spring to rotate the blade at least partially through the opening in the base; an apparatus.

18. An apparatus for collecting body fluid from a patient, the apparatus comprising: A housing including a base, the base having an opening extending therethrough; a housing; A skin penetration assembly at least partially positioned within the housing, the skin penetration assembly including a blade and a spring; a skin penetration assembly; A retaining feature configured to engage the skin penetration assembly to maintain the spring in a biased configuration; An elongate member at least partially positioned within the housing, the elongate member being movable through the housing to engage the retaining feature and deflect the retaining feature to disengage the skin penetration assembly, allowing the spring to drive the blade at least partially through the opening in the base; an apparatus comprising: an elongate member.

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