Bodily fluid collection devices and related methods

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 August 30, 2019, and entitled "BODILY FLUID COLLECTION DEVICES AND RELATED METHODS," which is incorporated herein by reference in its entirety.

[0002] The present technology relates to the collection of bodily fluids from patients, and in particular to handheld bodily fluid collection devices and related methods. [Background technology]

[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 lancing devices or more sophisticated devices (e.g., phlebotomy venipuncture) that require trained personnel. Transferring the bodily fluid to a container, receptacle, or analytical device often requires several steps, which can be time-consuming, error-prone, and / or cumbersome. Furthermore, many personal devices designed for untrained users are only capable of acquiring very limited amounts of bodily fluid, which in turn limits the scope of application of such devices. Summary of the Invention

[0004] Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present technology. [Brief explanation of the drawings]

[0005] [Figure 1A] 1 is a perspective view of a bodily fluid collection device configured in accordance with an embodiment of the present technology; [Figure 1B] 1 is a perspective view of a bodily fluid collection device in use. FIG. [Figure 1C] FIG. 10 is a perspective view illustrating the separation of the collection reservoir from the bodily fluid collection device. [Figure 2] 1A-1C is a partial schematic cross-sectional side view of the bodily fluid collection device of FIGS. 1A-1C, in accordance with an embodiment of the present technology. [Figure 3A] 1A-1C illustrating various stages of a procedure for withdrawing bodily fluid from a patient, in accordance with an embodiment of the present technology; [Figure 3B] 1A-1C illustrating various stages of a procedure for withdrawing bodily fluid from a patient, in accordance with an embodiment of the present technology; [Figure 3C] 1A-1C illustrating various stages of a procedure for withdrawing bodily fluid from a patient, in accordance with an embodiment of the present technology; [Figure 3D] 1A-1C illustrating various stages of a procedure for withdrawing bodily fluid from a patient, in accordance with an embodiment of the present technology; [Figure 4] 1A-1C including a fluid channel for directing bodily fluid to a collection reservoir in accordance with an embodiment of the present technology. FIG. [Figure 5A] 1A-1C, including microfluidic channels for directing bodily fluid to a collection reservoir, in accordance with an embodiment of the present technology. FIG. [Figure 5B] 1A-1C, including microfluidic channels for directing bodily fluid to a collection reservoir, in accordance with an embodiment of the present technology. FIG. [Figure 6A] 1A-1C, including a flexible membrane, and illustrating various stages of a procedure for withdrawing bodily fluid from a patient, according to an embodiment of the present technology; [Figure 6B] 1A-1C, including a flexible membrane, and illustrating various stages of a procedure for withdrawing bodily fluid from a patient, according to an embodiment of the present technology; [Figure 6C]1A-1C, including a flexible membrane, and illustrating various stages of a procedure for withdrawing bodily fluid from a patient, according to an embodiment of the present technology; [Figure 7] 10 is a partial schematic side cross-sectional view of a bodily fluid collection device configured in accordance with an additional embodiment of the present technology. [Figure 8A] 12 is a side cross-sectional view of a bodily fluid collection device configured in accordance with an additional embodiment of the present technology. [Figure 8B] FIG. 10 is a side view of a skin piercing assembly of a bodily fluid collection device. [Figure 8C] FIG. 10 is a rear view of the retaining feature and base portion of the bodily fluid collection device. [Figure 9A] 8A-8C illustrating various stages of a procedure for withdrawing bodily fluid from a patient, in accordance with an embodiment of the present technology. [Figure 9B] 8A-8C illustrating various stages of a procedure for withdrawing bodily fluid from a patient, in accordance with an embodiment of the present technology. [Figure 9C] 8A-8C illustrating various stages of a procedure for withdrawing bodily fluid from a patient, in accordance with an embodiment of the present technology. [Figure 9D] 8A-8C illustrating various stages of a procedure for withdrawing bodily fluid from a patient, in accordance with an embodiment of the present technology. [Figure 9E] 8A-8C illustrating various stages of a procedure for withdrawing bodily fluid from a patient, in accordance with an embodiment of the present technology. [Figure 10] 12 is a side cross-sectional view of a bodily fluid collection device configured in accordance with an additional embodiment of the present technology. [Figure 11A] 10A-10C are partial cross-sectional side views of a bodily fluid collection device in a pre-deployed configuration and a deployed configuration, respectively, configured in accordance with an additional embodiment of the present technology; [Figure 11B] 10A-10C are partial cross-sectional side views of a bodily fluid collection device in a pre-deployed configuration and a deployed configuration, respectively, configured in accordance with an additional embodiment of the present technology; [Figure 11C] FIG. 11C is a top view of the housing of the bodily fluid collection device of FIGS. 11A and 11B. [Figure 11D] 11D is a side cross-sectional view of the housing taken along line 11D of FIG. 11C. [Figure 12A] 11A and 11B taken along line 12A in FIG. 11A, and showing the fluid collection device in a pre-deployment position, a deployed position, and a deployed position, respectively, in accordance with an embodiment of the present technology. [Figure 12B] 11A and 11B taken along line 12A in FIG. 11A, and showing the fluid collection device in a pre-deployment position, a deployed position, and a deployed position, respectively, in accordance with an embodiment of the present technology. [Figure 12C] 11A and 11B taken along line 12A in FIG. 11A, and showing the fluid collection device in a pre-deployment position, a deployed position, and a deployed position, respectively, in accordance with an embodiment of the present technology. [Figure 13] FIG. 10 is a partially transparent side view of a skin piercing assembly coupled to a portion of a housing of a bodily fluid collection device configured in accordance with an additional embodiment of the present technology. [Figure 14A] 14A-14D are side views of the skin piercing assembly of FIG. 13 in a pre-deployed position, during deployment, and deployed position, respectively, in accordance with an embodiment of the present technology. [Figure 14B] 14A-14D are side views of the skin piercing assembly of FIG. 13 in a pre-deployed position, during deployment, and deployed position, respectively, in accordance with an embodiment of the present technology. [Figure 14C] 14A-14D are side views of the skin piercing assembly of FIG. 13 in a pre-deployed position, during deployment, and deployed position, respectively, in accordance with an embodiment of the present technology. [Figure 15A] 10A-10C are perspective and cross-sectional side views, respectively, of a skin piercing assembly coupled to a portion of a housing of a bodily fluid collection device and configured in accordance with an additional embodiment of the present technology; [Figure 15B] 10A-10C are perspective and cross-sectional side views, respectively, of a skin piercing assembly coupled to a portion of a housing of a bodily fluid collection device and configured in accordance with an additional embodiment of the present technology; [Figure 15C] 15A and 15B in accordance with an embodiment of the present technology. DETAILED DESCRIPTION OF THE INVENTION

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

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

[0008] Specific details of several 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 have not been shown in detail so as not to obscure the present technology. The terminology used in the description provided below is intended to be interpreted in its broadest reasonable manner, even when used in conjunction with detailed descriptions of certain specific embodiments of the present disclosure. Specific terms may even be emphasized below; however, any terminology intended to be interpreted in any limited manner is clearly and specifically defined as such in this Detailed Description 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 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 location of components and specific precise connections between such components when such details are not necessary for a complete understanding of how to make and use the technology. Many of the details, dimensions, angles, and other features shown in the drawings are merely illustrative of particular embodiments of the present disclosure. Thus, other embodiments may have other details, dimensions, angles, and features without departing from the spirit or scope of the present technology.

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

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

[0012] 1B is a perspective view of bodily fluid collection device 100 in use by a patient. To collect a bodily fluid sample, device 100 is applied to the patient's body with the bottom of housing 102 positioned against the patient's skin 101 and actuator 104 positioned away from skin 101. Actuating actuator 104 (e.g., pushing, twisting, pulling) deploys a skin-piercing feature (e.g., blade, lancet) from within device 100 to pierce skin 101. In some embodiments, device 100 is configured to create a vacuum within device 100 that acts against the patient's skin, either directly or indirectly, and before and / or after deployment of the skin-piercing feature. Bodily fluid from the resulting incision is drawn into housing 102 and collected in reservoir 106.

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

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

[0015] An opening 216 (e.g., aperture, collection site) can extend through the base portion 210 between the upper surface 211 a and the lower surface 211 b 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 211 a and the lower surface 211 b, 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 a shape / profile that curves inwardly in the direction from the lower surface 211 b to the upper surface 211 a. In other embodiments, portion 213 of base portion 210 can have other shapes / profiles, such as an inwardly sloping linear profile, an outwardly curving curved profile, an outwardly sloping linear profile, or a substantially vertical profile. In some embodiments, opening 216 can be fluidly connected to a fluid channel (e.g., a microfluidic channel) formed in, on, and / or through base portion 210, as described in detail with reference to Figures 4 and 5. During use of device 100, the fluid channel can direct bodily fluid from opening 216 to reservoir 106 (Figures 1A-1C).

[0016] In the illustrated embodiment, the skin penetration assembly 220 includes a drive member 222 coupled to a first biasing member 224 (not visible in FIG. 2 and therefore shown in dashed lines). 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 / pivotally mounted within the lumen 214 of the housing 102. For example, the first biasing member 224 may be a torsion spring or other suitable biasing member connected between the drive member 222 and the 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 or near the second portion 221b of the drive member 222 such that the drive member 222 is pivotable about a pivot axis P (e.g., in the direction indicated by arrow A).

[0017] Skin piercing assembly 220 may further include (i) a skin piercing feature 226 coupled to drive member 222 at or near second portion 221b of drive member 222, and (ii) a release member 228 (e.g., a tab, bar, protrusion) coupled to first portion 221a of drive member 222. In the illustrated embodiment, skin piercing feature 226 is a blade having a sharp cutting edge 227. In other embodiments, skin piercing feature 226 is a needle, a lancet (e.g., a cylindrical or other shaped lancet), or other feature configured to pierce the patient's skin 101 ( FIG. 1B ). In some embodiments, skin piercing assembly 220 may include multiple skin piercing features (e.g., multiple offset blades for creating various cutting patterns). Release member 228 is configured to engage plunger 230 to maintain skin piercing assembly 220 in the biased (e.g., coiled) configuration shown in FIG. 2. More specifically, in the illustrated embodiment, plunger 230 includes a base portion 232 (e.g., an upper portion) and a sidewall portion 234 extending from base portion 232 (e.g., extending generally perpendicular to and downwardly away from base portion 232). In some embodiments, base portion 232 and sidewall portion 234 can at least partially define a lumen 236 in which skin piercing assembly 220 is positioned. Plunger 230 can further include a restraining portion 238 (e.g., a protrusion, a flange) extending downwardly away from base portion 232 and defining a channel 239 together with sidewall portion 234. In the illustrated embodiment, when the skin piercing assembly 220 is in the biased configuration, the release member 228 of the skin piercing assembly 220 is at least partially positioned within the channel 239 such that the restraining portion 238 of the plunger 230 engages the release member 228 and prevents the drive member 222 (and the skin piercing feature 226) from pivoting about the pivot axis P in the direction indicated by arrow A.

[0018] In the illustrated embodiment, plunger 230 is operably coupled to (i) actuator 104 and (ii) a second biasing member 240 (e.g., a compression spring) configured to drive plunger 230 away from base portion 210 of housing 102 and through lumen 214 (e.g., in the direction indicated by arrow B). For example, base portion 232 of plunger 230 may be coupled to actuator 104. Similarly, plunger 230 may include a flange portion 235 that projects outwardly away from sidewall portion 234, and second biasing member 240 may be coupled between flange portion 235 and base portion 210 of housing 102. In other embodiments, plunger 230 may be operably coupled to second biasing member 240 in other manners. For example, the flange portion 235 can protrude inward from the sidewall portion 234 of the plunger 230 so that the second biasing member 240 is positioned at least partially 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, therefore, exerts a biasing force against the plunger 230. Thus, when the device 100 is in the pre-deployed 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-deployed configuration, the device 100 may further include a locking mechanism 242 (shown schematically) configured to lock the position of the plunger 230 within the housing 102. The actuator 104 may be operably coupled to the locking mechanism 242 and configured such that actuation of the actuator 104 selectively unlocks the locking mechanism 242 to allow the second biasing member 240 to 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, pushing and / or pulling the actuator 104 upward and / or downward can unlock the locking mechanism 242 and release the plunger 230. In some embodiments, the locking mechanism 242 can include one or more engagement features (e.g., flanges, grooves) positioned on / between the actuator 104 and the housing 102 (e.g., the inner surface of the housing sidewall portion 212). Thus, for example, twisting the actuator 104 and / or translating the actuator 104 within the lumen 214 can unlock the actuator 104 and the plunger 230 operatively coupled thereto. In other embodiments, the actuator 104 can be slidably coupled to the housing 102 such that the actuator 104 can slide (e.g., horizontally) out of engagement with 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 the sidewall portion 234 of the plunger 230 and the sidewall portion 212 of the housing 102. The sealing member 244 may include an O-ring, a lip seal, a quad ring, a rolling membrane, or the like, 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 the sealing member 244 is driven upward (e.g., in the direction of arrow B) by the plunger 230 when the locking mechanism 242 is unlocked and a vacuum is created, for example, within a portion of the lumen 214 of the housing 102 adjacent the opening 216.

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

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

[0023] 3B shows device 100 in a partially deployed configuration (e.g., a second configuration) after actuator 104 has been actuated to unlock locking mechanism 242 (FIG. 3A) and release plunger 230. In the illustrated embodiment, second biasing member 240 drives plunger 230 upward (e.g., in the direction of arrow B) through lumen 214 and away from base portion 210 of housing 102. Plunger 230 is also driven upward relative to skin piercing assembly 220 such that restraining portion 238 of plunger 230 moves relative to release member 228 of skin piercing assembly 220. That is, as plunger 230 moves upward relative to skin piercing assembly 220, release member 228 moves from a position near an upper end portion of channel 239 to a position near a lower end portion of channel 239. Nevertheless, in the partially deployed configuration shown in FIG. 3B, the restraining portion 238 of the plunger 230 still engages the release member 228 of the skin penetration assembly 220 such that the skin penetration assembly 220 remains in the biased configuration and the drive member 222 does not pivot about the pivot axis P.

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

[0025] 3C shows device 100 in a deployed configuration (e.g., a third configuration, a cutting configuration) after continuing to move plunger 230 upward within lumen 214 of housing 102. In the illustrated embodiment, second biasing member 240 drives plunger 230 upward (e.g., in the direction of arrow B) through lumen 214 until restraining portion 238 of plunger 230 is spaced from and no longer engages release member 228 of skin penetration assembly 220. That is, the relaxed length of second biasing member 240 may be long enough to allow second biasing member 240 to drive plunger 230 upward until release member 228 is no longer positioned within channel 239. When the skin piercing 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 piercing feature 226 to pivot downward toward / 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 and incise the skin 101 positioned therein. In some aspects of the present technology, the release member 228 is released from within the channel 239 instantaneously or near-instantaneously, which can increase the velocity of the skin piercing feature 226 to facilitate, for example, a cleaner incision, less pain for the patient, and / or a larger retraction volume.

[0026] The position of the skin piercing assembly 220 with respect to the opening 216, as well as the relative size and / or shape of the skin piercing 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 approximately 3 millimeters long and approximately 2 millimeters deep, or approximately 5 millimeters long and approximately 1 millimeter deep. Additionally, the height H of the restraining portion 238 of the plunger 230 can be selected to provide a desired level of vacuum prior to release and triggering of the skin piercing assembly 220. For example, increasing the height H can increase the size of the sealed volume within the lumen 214 of the housing 102, and therefore the vacuum pressure generated, before the skin piercing assembly 220 is moved out of engagement with the plunger 230 and triggered to rotate. Conversely, decreasing the height H can cause more vacuum pressure to be generated during and / or after the skin piercing feature 226 incises the skin 101. For example, in some embodiments, height H can be selected to be just large enough to secure skin piercing assembly 220 in the pre-deployed configuration (FIG. 3A). In such embodiments, plunger 230 quickly disengages skin piercing assembly 220 as it is driven upward so that substantially all of the vacuum pressure is generated after skin piercing assembly 220 begins to pivot.

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

[0028] 3D , when the skin 101 is incised, bodily 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 top surface 211 a of the base portion 210 of the housing 102. In some aspects of the present technology, vacuum pressure generated within the device 100 prior to cutting the skin 101 with the skin piercing feature 226 can increase capillary action within the skin 101 and therefore increase the amount of bodily fluid 346 that is sampled / collected. Similarly, a high rotational speed of the skin piercing feature 226 can increase the amount of bodily fluid 346 that is sampled / collected, while making the procedure relatively painless for the patient.

[0029] The amount of bodily fluid 346 drawn into the device 100, also known as the "draw volume," may be sufficiently large for downstream testing and analysis of the bodily fluid 346, for example, for diagnostics and / or biomarker detection performed on a blood sample. As used herein, draw volume may refer to the maximum volume of bodily fluid that can be collected from a specified percentage of a patient population, e.g., at least 90% of the patients. In some embodiments, the draw volume of the device 100 may be 100-1000 μL (e.g., about 600-700 μL). In another aspect of the present technology, the device 100 is configured to draw bodily fluid 346 in a relatively short time compared to conventional devices. For example, in some embodiments, the device 100 can collect a 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 the retracted configuration does not pivot skin piercing feature 226 into opening 216. Specifically, first biasing member 224 is no longer biased in the retracted configuration and therefore cannot drive skin piercing feature 226 toward opening 216. In other embodiments, device 100 can have other features specifically configured to limit device 100 to disposable use. For example, actuator 104 can be configured as a pass-through actuator that does not re-engage skin piercing assembly 220 after use.

[0031] In some embodiments, device 100 can include one or more fluidic features configured to facilitate the transfer / movement of bodily 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 illustrate various fluidic features for directing bodily fluid 346 from opening 216 to reservoir 106 in accordance with embodiments of the present technology.

[0032] 4 , the device 100 can include a fluid channel 450 formed in and / or on the base portion 210 of the housing 102 and configured to fluidly couple the reservoir 106 to the opening 216 of the housing 102. 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 shown by arrow G). Thus, in some embodiments, the fluid channel 450 is configured (e.g., sized and shaped) to direct the bodily 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 bodily fluid 346. In some aspects of the present technology, the fluid channel 450 imparts substantially no shear forces to the bodily fluid 346. This can improve the quality of the bodily fluid 346 for testing purposes (e.g., diagnostic blood tests). In some embodiments, all or a portion of the fluid channel 450 can be sloped, for example, sloped upwardly away from the opening 216 toward the reservoir 106. In some embodiments, the slope can be selected so that gravity is still large enough to drive the bodily fluid 346 from the opening 216 into 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 promote the flow of the bodily fluid 346 from the opening 216 toward the reservoir 106 without capillary forces.

[0033] 2-4 together, the skin piercing assembly 220 can be 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 piercing 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 ), a direction generally perpendicular to the fluid channel 450 (e.g., as shown by arrow I2 in FIG. 4 ), and / or 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., rectilinear, polygonal, irregular) and / or can have different sizes.

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

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

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

[0037] 6A-6C are side cross-sectional views of device 100 including flexible membrane 660 and illustrate various stages of a procedure for withdrawing bodily fluid (e.g., blood) from a patient in accordance with additional embodiments of the present technology. Referring initially to FIG. 6A, flexible membrane 660 can be affixed to underside 211b of 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 comprise 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 completely sealed prior to use. In some embodiments, flexible membrane 660 can be relatively thin, for example, having a thickness of about 250 μm or less, or about 50-400 μm. In some embodiments, the flexible membrane 660 may be of the type described in detail in U.S. Patent Application No. 16 / 571,028, filed September 13, 2019, entitled "BODILY FLUID COLLECTION DEVICES AND RELATED METHODS," which is incorporated herein by reference in its entirety.

[0038] 6A, device 100 is initially placed against the patient's skin 101 in a pre-deployed configuration with device 100 fully sealed. More specifically, the underside of flexible membrane 660 can be positioned against skin 101. In some embodiments, flexible membrane 660 contacts and bonds 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 sealing against skin 101.

[0039] 6B shows device 100 in a partially deployed configuration after actuator 104 has been actuated to unlock locking mechanism 242 (FIG. 6A) and release plunger 230. In the illustrated embodiment, second biasing member 240 drives sealing member 244 upward through housing 102, creating 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 and / or lumen 214 of housing 102 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, assuming a curvature similar to that of flexible membrane 660. Thus, flexible membrane 660 can control the curvature of skin 101. In some embodiments, the portion 213 of the base portion 210 that abuts / defines the opening 216 has a shape that facilitates movement of the flexible membrane 660 and the skin 101 into the opening 216.

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

[0041] In other embodiments, other structures may 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 may include a rigid dome or other structure coupled to the lower surface 211b.

[0042] 7 is a partial schematic side cross-sectional view of a bodily fluid collection device 700 ("device 700") configured in accordance with an additional embodiment of the present technology. Device 700 may include substantially similar features as, and may operate substantially similarly to, device 100, described in detail with reference to FIGS. 1A-3D. For example, in the illustrated embodiment, device 700 includes a housing 702, an actuator 704, a skin-piercing assembly 720, and a plunger 730. Housing 702 includes a base portion 710 having an opening 716 configured to be positioned adjacent the skin of a patient. Actuator 704 is operable to unlock a locking mechanism 742 (shown diagrammatically) and release plunger 730, which may be driven upwardly through housing 702 by a first biasing member 740. The upward movement of plunger 730 moves plunger 730 out of engagement with skin-piercing assembly 720. When the plunger 730 is disengaged from the skin piercing assembly 720, the second biasing member 724 can drive the skin piercing assembly 720 to pivot such that the skin piercing feature 726 sweeps at least partially through / along the opening 716 and pierces the patient's skin.

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

[0044] 8A is a side cross-sectional view of a bodily fluid collection device 800 ("device 800") configured in accordance with an additional embodiment of the present technology. Device 800 is shown in a pre-deployed configuration in FIG. 8A. Device 800 may include certain features similar to, and may operate similarly to, device 100 and / or device 700, described in detail with reference to FIGS. 1A-7. For example, in the illustrated embodiment, device 800 includes a housing 802, an actuator 804, a skin piercing assembly 820, and a plunger 830.

[0045] In the illustrated embodiment, housing 802 includes a base portion 810 and first and second sidewall portions 812a, 812b extending from base portion 810 (e.g., extending generally perpendicular to and upwardly away from base portion 210). Base portion 810 and first sidewall portion 812a together define a lumen 814 in which skin penetration assembly 820 and plunger 830 are at least partially positioned. During use of device 800, an underside of base portion 810 is configured to be positioned against and / or adjacent to a patient's skin (e.g., skin 101 shown in FIG. 1B ). Opening 816 can extend through base portion 810 such that opening 816 abuts the patient's skin 101 during use of device 800. 4 and 5, opening 816 can be fluidly connected to one or more fluid channels formed in, on, and / or through base portion 810. During use of device 800, one or more fluid channels can direct bodily fluid from opening 816 to a reservoir and / or detection site. In some embodiments, opening 816 is configured (e.g., shaped and sized) to facilitate retraction of the patient's skin 101 into and / or toward lumen 814 during use of device 800.

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

[0047] More specifically, Figure 8B is a side view of skin piercing assembly 820 removed from housing 802, and Figure 8C is a rear view of retaining feature 880 and base portion 810 of housing 802 shown in Figure 8A in accordance with an embodiment of the present technology. Referring together to Figures 8A-8C, drive member 822 is generally circular and includes a notch 882 (e.g., a cutout) including a notch surface 884. Retaining feature 880 may be generally U-shaped and includes: (i) a pair of legs 886 (individually identified as first leg 886a and second leg 886b) extending from base portion 810 of housing 802, and (ii) a cross member 888 extending between legs 886 and spanning opening 816 in base portion 810. 8A , the underside 889 of the cross member 888 is configured to engage / contact the notched surface 884 of the drive member 822 to prevent the drive member 822 (and skin piercing feature 826) from pivoting about pivot axis Q in the direction indicated by arrow C. In other embodiments, the skin piercing assembly 820 and / or the retaining feature 880 may have a different shape, configuration, etc., such that, in the pre-deployed configuration, the retaining feature 880 is configured to prevent the skin piercing assembly 820 from pivoting.

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

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

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

[0051] Various components of device 800 may comprise metal, plastic, and / or other materials. For example, in some embodiments, housing 802, actuator 804, plunger 830, drive member 822, and / or other components of device 800 may be 3D printed, molded (e.g., injection molded), or otherwise formed from a plastic material. In some embodiments, device 800 may be manufactured to have the pre-deployment configuration shown in FIG. 8A.

[0052] 9A-9E are side cross-sectional views of device 800 illustrating various stages of a procedure for withdrawing bodily fluid (e.g., blood) from a patient in accordance with additional embodiments of the present technology. Referring initially to FIG. 9A, device 800 is initially placed against the patient's skin 101 in the pre-deployed configuration shown in FIG. 8A. More specifically, the underside of base portion 810 of housing 802 can be positioned against skin 101 such that opening 816 is adjacent skin 101. In some embodiments, base portion 810 of housing 802 can form a seal with the patient's skin 101 such that lumen 872 formed within housing 802 by sealing member 870 is sealed from the environment surrounding device 800.

[0053] FIG. 9B shows the device 800 in a partially deployed configuration after the actuator 804 has been depressed in the direction of arrow E to drive 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 press 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 out of engagement with 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 , depression of the actuator 804 contracts / shrinks the sealing member 870, reducing the volume within the sealed lumen 872. In some embodiments, when actuator 804 is depressed, air is expelled from lumen 872 through valve 890. Additionally, depression of actuator 804 compresses second biasing member 840, which in turn exerts a biasing force against plunger 830. In other embodiments, depression of actuator 804 can also drive skin piercing assembly 820 partially through lumen 814 toward base portion 810 (e.g., a predetermined distance).

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

[0055] 9D shows device 800 in a pre-retracted configuration after continued rotation of skin piercing assembly 820. In the illustrated embodiment, first biasing member 824 causes drive member 822 to drive about pivot axis Q until (i) skin piercing feature 826 sweeps past opening 816 and is no longer in contact with the patient's skin 101, and (ii) skin piercing feature 826 contacts plunger 830. In other embodiments, skin piercing assembly 820 can be configured (e.g., shaped and sized) such that skin piercing feature 826 does not contact plunger 830 in the pre-retracted configuration, contacts retaining feature 880 in the pre-retracted configuration, and / or contacts another portion of device 800 in the pre-retracted configuration. 9D , when the skin 101 is incised, bodily fluid 946 (e.g., blood) flows from the skin 101 into the device 800, for example, into the lumen 814 of the housing 102 and / or onto the top surface of the base portion 810 of the housing 102. In some aspects of the present technology, a high rotational speed of the skin piercing feature 826 can increase the amount of bodily fluid 946 that is sampled / collected, while making the procedure relatively painless for the patient.

[0056] FIG. 9E shows the device in a retracted configuration with the second biasing member 840 driving 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 / elongates. In some aspects of the present technology, increasing the volume within the lumen 872 creates reduced pressure (e.g., vacuum pressure) therein because the valve 890 does not allow air into the lumen 872 during expansion of the lumen 872. 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 bodily fluid 946 into device 800. In some aspects of the present technology, sealing member 870 and valve 890 thereby increase the draw volume of device 800. In some embodiments, the draw volume of device 800 can be 100-1000 μL (e.g., 600-700 μL). In another aspect of the present technology, device 800 is configured to draw bodily fluid 946 in a relatively short time compared to conventional devices. For example, in some embodiments, 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, device 800 is configured as a disposable device. For example, in the illustrated embodiment, device 800 is configured such that actuation of actuator 804 when device 800 is in the retracted configuration does not pivot skin piercing feature 826 into opening 816. Specifically, first biasing member 824 is no longer biased in the retracted configuration and therefore cannot drive skin piercing feature 826 toward opening 816.

[0058] 10 is a side cross-sectional view of a bodily fluid collection device 1000 ("device 1000") configured in accordance with an additional embodiment of the present technology. Device 1000 is shown in a pre-deployed configuration in FIG. 10. Device 1000 may include certain features similar to, and may operate similarly to, device 800, described in detail with reference to FIGS. 8A-9E. For example, in the illustrated embodiment, device 1000 includes housing 802, actuator 804, skin piercing assembly 820, and plunger 830.

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

[0060] In the illustrated embodiment, plunger 830 includes a protrusion 1033 (e.g., arm, release portion) that extends downwardly away from base portion 832 and has an angled release surface 1037. During use of device 1000, actuator 804 is configured to be pushed / depressed downwardly to drive plunger 830 through lumen 814 of housing 802 and toward base portion 810 of housing 802. When actuator 804 is depressed, release surface 1037 of protrusion 1033 is configured to contact / engage retaining feature 1080 (e.g., an edge portion of horizontal portion 1088) and deflect retaining feature 1080 to disengage from drive member 822 of skin piercing assembly 820 such that first biasing member 824 can drive drive member 822 to pivot. More specifically, protrusion 1033 can deflect retaining feature 1080 in the direction indicated by arrow F, disengaging it from the plane of rotation of skin piercing assembly 820. Thus, compared to the embodiment shown in FIGS. 8A-9E , release surface 1037 is rotated (e.g., by about 90 degrees) relative to release surface 837 of protrusion 833. In some aspects of the present technology, this can help prevent retaining feature 1080 from interfering with skin piercing assembly 820 during rotation of skin piercing assembly 820. In other embodiments, protrusion 1033 can be configured to contact skin piercing assembly 820 and deflect skin piercing assembly 820 out of engagement with (e.g., stationary) retaining feature 1080.

[0061] 11A and 11B are partial cross-sectional side views of a bodily fluid collection device 1100 ("device 1100") in a pre-deployed configuration (e.g., a pre-actuated position) and a deployed configuration (e.g., an actuated position), respectively, configured in accordance with an additional embodiment of the present technology. Device 1100 may include certain features substantially similar to and / or operate substantially similar to devices 100, 700, 800, and / or 1000 described in detail with reference to FIGS. 1A-10. Referring together to FIGS. 11A and 11B, for example, device 1100 includes a housing 1102, an actuator 1104, a skin piercing 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 underside of the base portion 1110 is configured to be positioned against and / or adjacent to the 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] 11C is a top view of the housing 1102 in accordance with 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 together to FIGS. 11C and 11D, 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 may include a wall or other structure defining a recess 1181 and an opening 1183. The skin penetration assembly mount 1184 may include a first portion 1185 and a second portion 1187 spaced from the first portion 1185. In the illustrated embodiment, the opening 1116 is fluidly connected to an outflow channel 1152 extending through the sidewall via a fluid channel 1150 formed in, on, and / or through the base portion 1110. The collection reservoir 1106 (omitted from FIG. 11D for clarity) can be releasably coupled to the outflow channel 1152 to receive the flow of bodily fluid from the opening 1116 via the fluid channel 1150.

[0064] 11A and 11B , the device 1100 can further include a first biasing member 1140 (e.g., a compression spring) positioned at least partially within the groove 1118 and operably coupled between the housing 1102 and the actuator 1104. In the pre-deployed position shown in FIG. 11A , the first biasing member 1140 is in a relaxed or unbiased state. To move the device 1100 to the deployed position shown in FIG. 11B , a user can press / depress the actuator 1104 downward 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 secured to the housing 1102 within the groove 1118 such that the sealing member 1170 extends across and fluidly seals the lumen 1114.

[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 a recess 1181 in the plunger guide 1180. The upper portion 1132 can be operably coupled to the actuator 1104 and the sealing member 1170 such that downward movement (e.g., pushing) of the actuator 1104 drives the plunger 1130 toward the base portion 1110. More specifically, 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., shapes, dimensions, couplings).

[0066] In the illustrated embodiment, the skin piercing assembly 1120 includes a drive member 1122 (e.g., driver) having a retaining portion 1121 (partially visible in FIGS. 11A and 11B ), a mount portion 1123, and a hub portion 1125. The retaining portion 1121 and the mount portion 1123 can each have a circular cross-sectional shape, and the retaining portion 1121 can have a smaller diameter than the mount portion 1123. The mount portion 1123 can define an annular channel or groove 1128 extending at least partially therearound (e.g., separated by a pair of adjacent ridges or flanges). Referring together to FIGS. 11A-11D , the drive member 1122 can be rotatably coupled to a skin piercing assembly mount 1184. For example, the mount portion 1123 can be coupled to a first portion 1185 of the skin piercing 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 piercing 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 in FIGS. 12A-12C as second biasing member 1224) such that the drive member 1122 is rotatably / pivotally attached to the skin piercing 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 mount portion 1123) and the sidewall portion 1112, the second portion 1187, and / or another portion of the housing 1102.

[0067] In the illustrated embodiment, the mount portion 1123 further includes a radially protruding release member 1129 (e.g., a tab, bar, protrusion, 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 described in more detail below with reference to FIGS. 12A-12C , the release member 1129 is configured to engage a trigger portion 1134 of the plunger 1130 in the pre-deployment position to prevent rotation of the drive member 1122.

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

[0069] 12A-12C are side cross-sectional views of the lumen 1114 of the device 1100 taken along line 12A of FIG. 11A and show the device 1100 in a pre-deployed position, a deployed position, and a deployed position, respectively, in accordance with an embodiment of the present technology. Referring initially to FIGS. 11A and 12A together, in the pre-deployed position, the second biasing member 1224 is in a biased position (e.g., stores energy), and the release member 1129 of the mounting portion 1123 engages 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 piercing assembly 1120. To move the device 1100 to the deployed position to, for example, withdraw bodily fluids from the patient, the base portion 1110 of the device 1100 can initially be placed against the skin of a patient with the device 1100 in the pre-deployed position. The user can then actuate (eg, depress) actuator 1104 in the direction of arrow F (FIG. 11B) against the biasing force of first biasing member 1140.

[0070] 11A, 11B, and 12B together, depressing the actuator 1104 drives the plunger 1130 and sealing member 1170 downward through the lumen 1114 toward the base portion 1110. As the plunger 1130 moves downward, the trigger portion 1134 is driven through the recess 1181 in 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, for example, in a counterclockwise direction 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. 11B and 12C together, as plunger 1130 continues to be depressed, release member 1129 disengages (e.g., slides thereby) from trigger portion 1134, allowing second biasing member 1224 to drive drive member 1122 to rotate in a clockwise direction as indicated by arrow C. As drive member 1122 rotates, a portion of cutting edge 1127 of skin piercing feature 1126 that extends beyond cutting surface 1193 can be driven through opening 1116 to contact and incise skin located therein / beneath.

[0071] 11A and 11B, and as described above, the cutting surface 1193 can contact the skin and define the maximum size (e.g., depth, length) of the incision. In some embodiments, the configuration (e.g., height or shape) of the skin mount 11844 can be selected to position the skin penetration assembly 1120 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 approximately 0.5-1.5 millimeters deep and approximately 3-7 millimeters long.

[0072] 3D , the skin piercing assembly 1120 can continue to rotate to a retracted configuration in which the skin piercing feature 1126 rotates past 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 piercing assembly 1120 no longer engages the plunger 1130 (e.g., via engagement of the trigger portion 1134 with the release member 1129). Thus, subsequent actuation of the actuator 1104 will not push the skin piercing feature 1126 out of the opening 1116.

[0073] In some embodiments, when a 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, which can create a vacuum pressure that can help draw bodily fluids from the incision and into the fluid channel 1150.

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

[0075] In the illustrated embodiment, the skin piercing assembly 1320 includes a driver 1322 having a protrusion 1364. A skin piercing feature 1326 (e.g., a blade) can be coupled to the driver 1322. The housing 1302 includes / defines a track 1362 (e.g., an opening, channel, elongated path), with the protrusion 1364 extending partially into the track 1362 to restrict the protrusion 1364 for movement 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., varying heights) selected to correspond to the desired path of the skin piercing feature 1326 and the corresponding size (e.g., length, depth) of the incision made by the skin piercing feature 1326. In the illustrated embodiment, for example, the track 1362 includes a raised central portion 1365.

[0076] In some embodiments, the driver 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 extending between the housing 1302 and the protrusion 1364, and the skin piercing assembly 1320 is in a deployed position with the torsion spring in a relaxed state. FIGS. 14A-14C are side views of the housing 1302 and the skin piercing assembly 1320 in a pre-deployed position, a deployed position, and a deployed position, respectively, in accordance with an embodiment of the present technology. Referring together to FIGS. 13-14C , the first end portion 1361 of the track 1362 can include a notch 1367 (e.g., a retention surface, a retention feature) configured (e.g., shaped, sized) to engage with the protrusion 1364 in the pre-deployed position such that the skin piercing assembly 1320 is locked in the pre-deployed position with the biasing member 1368 in a biased state. The protrusion 1364 and / or another feature of the skin piercing assembly 1320 can be operatively coupled to an actuator or other feature of the bodily fluid collection device, and the actuator can be actuated to disengage the protrusion 1364 from the notch 1367. Upon actuation, the biasing member 1368 can drive the skin piercing assembly 1320 along a path controlled / defined by the configuration (e.g., shape, size, length) of the track 1362 through an opening in the housing (not shown) to deploy the skin piercing feature 1326, for example, to incise the skin of a patient positioned thereunder.

[0077] In the illustrated embodiment, for example, the skin piercing assembly 1320 moves laterally from the first end portion 1361 toward the second end portion 1363 while the protrusions 1364 rotate through the openings and deploy the skin piercing features 1326 as they pass 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 piercing features 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] 15A and 15B are perspective and cross-sectional side views, respectively, of a skin piercing assembly 1520 coupled to a portion of a housing 1502 of a bodily fluid collection device configured in accordance with an additional embodiment of the present technology. In some embodiments, the skin piercing assembly 1520 (i) 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 (ii) can include substantially similar or identical features as the skin piercing assemblies 120, 720, 820, 1020, 1120, and / or 1320.

[0079] In the illustrated embodiment, the skin piercing assembly 1520 includes a driver 1522 positioned at least partially over the opening 1516 of the housing 1502. A skin piercing 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 in accordance with an embodiment of the present technology. Referring together to FIGS. 15A-15C, the housing 1502 can include / define a first track 1562a and a second track 1562b (e.g., openings, channels, elongated pathways, collectively "tracks 1562"). The driver 1522 of the skin piercing assembly 1520 can include a first protrusion 1564a extending at least partially into the first track 1562a and a second protrusion 1564b (collectively "protrusion 1564") extending finally partially into the second track 1562b. The protrusions 1564 can be constrained for movement along the tracks 1562. The tracks 1562 can each have a configuration (e.g., length, shape) selected to correspond to the desired path of the skin piercing feature 1526 and the corresponding size (e.g., length, depth) of the incision made by the skin piercing feature 1526. For example, the tracks 1562 can each extend between a first end portion 1561 and a second end portion 1563 and have varying 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 operably coupled to the housing 1502 via one or more biasing members 1568 (e.g., individually identified first and second biasing members 1568a and 1568b). In the illustrated embodiment, the biasing members 1568 are tension springs, and the skin penetration assembly 1520 is in a pre-deployed position with the tension springs in a biased state. In some embodiments, the first biasing member 1568a extends between the housing 1502 and a location of the driver 1522 at or adjacent to the first protrusion 1564a, and the second biasing member 1568b extends between the housing 1502 and a location of the driver 1522 at or adjacent to 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, first end portion 1561 of first track 1562a can include a notch 1567 (e.g., a retaining surface, a retaining feature) configured (e.g., shaped) to engage first protrusion 1564a in a pre-deployed position such that skin piercing assembly 1520 is locked in the pre-deployed position with biasing member 1568 in a biased state. Release member 1528 is configured to releasably engage a feature of the bodily fluid collection device, such as a restraining portion of the plunger (e.g., restraining portion 238 shown in FIGS. 2-3D), a retaining feature (e.g., retaining feature 880 shown in FIGS. 8A-9E and / or retaining feature 1080 shown in FIG. 10), and / or a trigger portion of the plunger (e.g., trigger portion 1134 shown in FIGS. 11A-12C). The bodily fluid collection device can be actuated to actuate (e.g., push down) the release member 1528 to unlock the protrusion 1564 from the track 1562. After actuation, the biasing member 1568 can drive (e.g., pull) the skin piercing assembly 1520 from the first end portion 1561 toward the second end portion 1563, along the track 1562, and through the opening 1516 to deploy the skin piercing feature 1526, for example, to incise the skin of a patient positioned thereunder.

[0082] In other embodiments, biasing member 1568 may be other types of biasing members configured to drive skin piercing assembly 1520. For example, biasing member 1568 may be a compression spring configured to push skin piercing assembly 1520 along track 1562.

[0083] The following examples illustrate some embodiments of the present technology. 1. A device for collecting a body fluid from a patient, the device comprising: a housing including a base having an opening extending therethrough; a skin piercing assembly positioned at least partially within the housing, the skin piercing assembly including a skin piercing feature and a biasing member; a plunger positioned at least partially within the housing and movable from a first position to a second position; In the first position, the plunger is configured to engage the skin piercing assembly to maintain the biasing member in the biased configuration; The device, wherein movement of the plunger from the first position to the second position disengages the plunger from the skin piercing assembly and allows the biasing member to drive the skin piercing feature at least partially through the opening in the base. 2. The device of 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 device of example 2, wherein the biasing member is a first biasing member and further comprising a second biasing member operably coupled between the actuator and the housing, the second biasing member configured to bias the plunger toward the first position. 4. The device of example 3, wherein the first biasing member is a torsion spring and the second biasing member is a compression spring. 5. A device described in any one of Examples 1 to 4, wherein the plunger includes a trigger portion and the skin penetration assembly includes a drive member having a protrusion, and the trigger portion engages with the protrusion in a first position to maintain the biasing member in a biased configuration. 6. The device of example 5, wherein 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 past the protrusion, allowing the biasing member to drive the skin-piercing feature at least partially through the opening in the base. 7. The device of any one of Examples 1 to 6, wherein the biasing member is a first biasing member and further comprises a second biasing member operably coupled between the plunger and the housing, the second biasing member configured to drive the plunger from the first position to the second position. 8. The device of example 7, wherein the second position is farther away from the base than the first position. 9. The device of example 7 or example 8, further comprising a locking mechanism operably coupled to the plunger and configured to selectively maintain the second biasing member in the biased configuration. 10. The device of example 9, further comprising a release actuator operably coupled to the locking mechanism, wherein actuation of the release actuator unlocks the locking mechanism and allows the second biasing member to drive the plunger from the first position to the second position. 11. The device of any one of Examples 1-10, further comprising a flexible sealing member coupled to the housing and positioned within the housing to define a sealed volume. 12. The device of any one of Examples 1-11, wherein the biasing member is a torsion spring. 13. The device of any one of Examples 1-12, wherein the skin-piercing feature is a blade. 14. The device of any one of Examples 1-13, wherein the biasing member is configured to rotate the skin-piercing feature relative to the housing. 15. The device of any one of Examples 1-14, wherein the skin-piercing assembly further includes a driver, the biasing member is operably coupled between the driver and the housing, and the skin-piercing feature is coupled to the driver. 16. The device of example 15, wherein the skin-piercing feature is a blade having a cutting edge, a portion of the cutting edge being directly bonded to the driver. 17. The device of any one of Examples 1 to 16, further comprising a flexible membrane coupled to the base of the housing across the opening, wherein in the second position, the plunger is configured to disengage from the skin piercing assembly to allow the biasing member to drive the skin piercing feature at least partially through the opening in the base to pierce the flexible membrane. 18. A reservoir releasably coupled to the housing; 18. The device of any one of Examples 1-17, further comprising a fluid channel configured to direct bodily fluid from the opening to the reservoir. 19. A device for collecting a body fluid from a patient, the device comprising: a housing including a base having an opening extending therethrough; a skin piercing assembly positioned at least partially within the housing, the skin piercing assembly including a drive member, a blade coupled to the drive member, and a biasing member; an actuator movable relative to the housing; a plunger rotatably coupled to the housing and having a pre-deployment position; 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 and allows the first biasing member to rotate the blade at least partially through an opening in the base. 20. A device for collecting a body fluid from a patient, the device comprising: a housing including a base having an opening extending therethrough; a skin piercing assembly positioned at least partially within the housing, the skin piercing assembly including a skin piercing feature and a biasing member; a retaining feature configured to engage the skin piercing assembly to maintain the biasing member in the biased configuration; The device comprises: a plunger positioned at least partially within the housing, the plunger movable through the housing to engage and deflect the retention feature to disengage from the skin piercing assembly and allow the biasing member to drive the skin piercing feature at least partially through the opening in the base. 21. A device for collecting body fluids from a patient, the device comprising: a housing including a base having an opening extending therethrough; a skin piercing assembly positioned at least partially within the housing, the skin piercing assembly including a skin piercing feature and a first biasing member; a plunger positioned at least partially within the housing; a second biasing member coupled to the plunger and configured to drive the plunger through the housing from the 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 piercing assembly to maintain the first biasing member in the biased configuration; The device, wherein movement of the plunger from the first position to the second position disengages the plunger from the skin piercing assembly to allow the first biasing member to drive the skin piercing feature at least partially through the opening in the base. 22. The device of example 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 device of example 22, wherein the second biasing member is configured to drive the sealing member and the plunger from the first position to the second position to create a vacuum pressure within at least a portion of the housing. 24. The device of any one of Examples 21-23, wherein the first biasing member is a torsion spring. 25. The device of any one of examples 21-24, wherein the second biasing member is a compression spring. 26. The device of any one of Examples 21-25, wherein the skin-piercing feature is a blade. 27. A device described in any one of Examples 21 to 26, wherein the first biasing member is configured to rotate the skin-piercing feature. 28. A device described in any one of Examples 21 to 27, wherein the skin penetration assembly further includes a driver, the first biasing member is coupled between the driver and the housing, and the skin penetration feature is coupled to the driver. 29. A device described in any one of Examples 21 to 28, wherein the skin penetration assembly further includes a release member, and wherein the plunger includes a restraining portion configured to engage with the release member when the plunger is in the first position to maintain the first biasing member in the biased configuration. 30. The device of example 29, wherein the plunger includes an upper portion and the restraining portion projects downward from the upper portion toward the base of the housing. 31. The device of example 29, wherein the plunger includes a sidewall portion projecting downward from the top portion toward the base of the housing, the sidewall portion and the restraining portion defining a channel therebetween, and the release member is restrained within the channel when the plunger is in the first position. 32. The device of any one of Examples 21-31, further comprising a flexible membrane coupled to the base of the housing across the opening, wherein in the second position, the plunger is configured to disengage from the skin piercing assembly to allow the first biasing member to drive the skin piercing feature at least partially through the opening in the base to pierce the flexible membrane. 33. The device of any one of Examples 21-32, further comprising a locking mechanism operably coupled to the plunger and configured to selectively maintain the second biasing member in the biased configuration. 34. The device of example 33, further comprising a release actuator operably coupled to the locking mechanism, wherein actuation of the release actuator unlocks the locking mechanism and allows the second biasing member to drive the plunger through the housing from the first position to the second position. 35. The device of any one of Examples 21 to 34, a reservoir releasably coupled to the housing; The device of any one of Examples 21 to 34, further comprising a fluid channel configured to direct bodily fluid from the opening to the reservoir.

[0084] The above detailed description of embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the precise forms disclosed above. While specific embodiments of and examples of the technology have been described above for illustrative purposes, those skilled in the art will recognize that various equivalent modifications are possible within the scope of the technology. For example, while steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0085] From the foregoing, it will be appreciated that, although specific embodiments of the technology have been described herein for illustrative purposes, 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 expressly limited to mean only a single item exclusive of the other items in a list of two or more items, the use of "or" in such a list shall be interpreted as including (a) a single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Furthermore, the term "comprising" is used throughout to mean including at least the recited features, without excluding any greater number of additional types of the same and / or other features. While specific embodiments have been described herein for illustrative purposes, it will be understood that various modifications can be made without departing from the present technology. Furthermore, while advantages associated with some embodiments of the present technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments necessarily need to exhibit such advantages to fall within the scope of the present technology. Thus, the present disclosure and related technology may encompass other embodiments not explicitly shown or described herein.

Claims

1. 1. An apparatus for collecting a bodily fluid from a patient, the apparatus comprising: a housing including a base having an opening extending therethrough; a skin piercing assembly positioned at least partially within the housing, the skin piercing assembly including a skin piercing feature and a biasing member; a plunger positioned at least partially within the housing and movable from a first position to a second position; In the first position, the plunger is configured to engage the skin piercing assembly to maintain the biasing member in a biased configuration; wherein movement of the plunger from the first position to the second position disengages the plunger from the skin piercing assembly and allows the biasing member to drive the skin piercing feature at least partially through the opening in the base.

2. 10. The device of claim 1, further comprising an actuator operatively 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. 3. The device of claim 2, wherein the biasing member is a first biasing member, and further comprising a second biasing member operably coupled between the actuator and the housing, the second biasing member configured to bias the plunger toward the first position.

4. 4. The device of claim 3, wherein the first biasing member is a torsion spring and the second biasing member is a compression spring.

5. 2. The device of claim 1, wherein the plunger 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 biasing member in the biased configuration.

6. 6. The device of claim 5, wherein 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 over the protrusion, allowing the biasing member to drive the skin-piercing feature at least partially through the opening in the base.

7. 2. The device of claim 1, wherein the biasing member is a first biasing member and further comprises a second biasing member operably coupled between the plunger and the housing, the second biasing member configured to drive the plunger from the first position to the second position.

8. The apparatus of claim 7 , wherein the second position is farther away from the base than the first position.

9. 8. The device of claim 7, further comprising a locking mechanism operably coupled to the plunger and configured to selectively maintain the second biasing member in a biased configuration.

10. 10. The device of claim 9, further comprising a release actuator operably coupled to the locking mechanism, wherein actuation of the release actuator unlocks the locking mechanism and allows the second biasing member to drive the plunger from the first position to the second position.

11. The device of claim 1 , further comprising a flexible sealing member coupled to the housing and positioned within the housing to define a sealed volume.

12. The device of claim 1 , wherein the biasing member is a torsion spring.

13. The device of claim 1 , wherein the skin-piercing feature is a blade.

14. The device of claim 1 , wherein the biasing member is configured to rotate the skin-piercing feature relative to the housing.

15. 10. The device of claim 1, wherein the skin-piercing assembly further includes a driver, the biasing member operably coupled between the driver and the housing, and the skin-piercing feature coupled to the driver.

16. 16. The device of claim 15, wherein the skin piercing feature is a blade having a cutting edge, a portion of the cutting edge being directly joined to the driver.

17. 2. The device of claim 1, further comprising a flexible membrane coupled to the base of the housing across the opening, wherein in the second position the plunger is configured to disengage from the skin piercing assembly to allow the biasing member to drive the skin piercing feature at least partially through the opening in the base to pierce the flexible membrane.

18. a reservoir releasably coupled to the housing; The device of claim 1 , further comprising a fluid channel configured to direct bodily fluid from the opening to the reservoir.

19. 1. An apparatus for collecting a bodily fluid from a patient, the apparatus comprising: a housing including a base having an opening extending therethrough; a skin piercing assembly positioned at least partially within the housing, the skin piercing assembly including a drive member, a blade coupled to the drive member, and a biasing member; an actuator movable relative to the housing; a plunger rotatably coupled to the housing and having a pre-deployment position; 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 and allows the first biasing member to rotate the blade at least partially through the opening in the base.

20. 1. An apparatus for collecting a bodily fluid from a patient, the apparatus comprising: a housing including a base having an opening extending therethrough; a skin piercing assembly positioned at least partially within the housing, the skin piercing assembly including a skin piercing feature and a biasing member; a retaining feature configured to engage the skin piercing assembly to maintain the biasing member in a biased configuration; a plunger positioned at least partially within the housing, the plunger movable through the housing to engage and deflect the retention feature to disengage from the skin piercing assembly and allow the biasing member to drive the skin piercing feature at least partially through the opening in the base.

21. 1. An apparatus for collecting a bodily fluid from a patient, the apparatus comprising: a housing including a base having an opening extending therethrough; a skin piercing assembly positioned at least partially within the housing, the skin piercing assembly including a skin piercing feature and a first biasing member; a plunger positioned at least partially 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 piercing 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 piercing assembly and allows the first biasing member to drive the skin piercing feature at least partially through the opening in the base.

22. 22. The device of claim 21, further comprising a sealing member positioned between the housing and the plunger and configured to seal an interface between the housing and the plunger.

23. 23. The device of claim 22, wherein the second biasing member is configured to drive the sealing member and the plunger from the first position to the second position to create a vacuum pressure within at least a portion of the housing.

24. 22. The device of claim 21, wherein the first biasing member is a torsion spring.

25. 22. The device of claim 21, wherein the second biasing member is a compression spring.

26. 22. The device of claim 21, wherein the skin-piercing feature is a blade.

27. 22. The device of claim 21, wherein the first biasing member is configured to rotate the skin-piercing feature.

28. 22. The device of claim 21, wherein the skin-piercing assembly further includes a driver, the first biasing member coupled between the driver and the housing, and the skin-piercing feature coupled to the driver.

29. 22. The device of claim 21, wherein the skin penetration assembly further includes a release member, and wherein the plunger includes a restraining portion configured to engage the release member to maintain the first biasing member in the biased configuration when the plunger is in the first position.

30. 30. The device of claim 29, wherein the plunger includes an upper portion, and the constraining portion projects downwardly from the upper portion toward the base of the housing.

31. 30. The device of claim 29, wherein the plunger includes a sidewall portion projecting downward from the top portion toward the base of the housing, the sidewall portion and the restraining portion defining a channel therebetween, and the release member is restrained within the channel when the plunger is in the first position.

32. 22. The device of claim 21, further comprising a flexible membrane coupled to the base of the housing across the opening, wherein in the second position the plunger is configured to disengage from the skin piercing assembly to allow the first biasing member to drive the skin piercing feature at least partially through the opening in the base to pierce the flexible membrane.

33. 22. The device of claim 21, further comprising a locking mechanism operably coupled to the plunger and configured to selectively maintain the second biasing member in a biased configuration.

34. 22. The device of claim 21, further comprising a release actuator operably coupled to the locking mechanism, wherein actuation of the release actuator unlocks the locking mechanism and allows the second biasing member to drive the plunger through the housing from the first position to the second position.

35. a reservoir releasably coupled to the housing; 22. The device of claim 21, further comprising a fluid channel configured to direct bodily fluid from the opening to the reservoir.

Images