Body Fluid Collection Devices and Related Methods

Abstract

Disclosed herein are devices and methods for withdrawing bodily fluid from a subject. In some embodiments, the handheld device can include a housing having an opening, a skin piercing assembly, and an actuator coupled to the skin piercing assembly. The skin piercing assembly can include a casing, a drive member pivotally mounted within the casing and carrying a blade, and a biasing member coupling the drive member to the casing. The actuator can be movable from a first position to a second position relative to the housing. In the first position, the drive member can engage with the casing to maintain the biasing member in a biased configuration. Movement of the actuator from the first position to the second position can disengage the drive member from the casing to allow the biasing member to drive the blade at least partially through and / or across the opening in the base.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 154,537, filed February 26, 2021, and entitled “BODILY FLUID COLLECTION DEVICES AND RELATED METHODS,” which is incorporated by reference in its entirety herein.

[0002] FIELD OF THEINVENTION The present technology relates to the collection of bodily fluids from a subject, and in particular to handheld bodily fluid collection devices and associated 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 advanced devices that require trained personnel (e.g., phlebotomy venipuncture). Transferring the bodily fluid to a container, receptacle, or analytical device often requires several steps that 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 fluids, which in turn limits the scope of application of such devices.

[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 description of the drawings]

[0005] [Figure 1A] 1A-1D are top and bottom perspective views of a bodily fluid collection device configured in accordance with an embodiment of the present technology; [Figure 1B]1A-1D are top and bottom perspective views of a bodily fluid collection device configured in accordance with an embodiment of the present technology; [Figure 2A] 2A is a cross-sectional side view of the device of FIGS. 1A and 1B taken along line 2A-2A of FIG. 1A in accordance with an embodiment of the present technology. [Figure 2B] 2B is a cross-sectional side view of the device of FIGS. 1A and 1B taken along line 2B-2B of FIG. 1A in accordance with an embodiment of the present technology. [Figure 2C] 1C is an exploded view of the device of FIGS. 1A and 1B in accordance with an embodiment of the present technology. FIG. [Figure 3A] 2A-2A are side cross-sectional views of a device taken along line 2A-2A of FIG. 1A at different stages of a method for withdrawing bodily fluid from a subject, in accordance with an embodiment of the present technology. [Figure 3B] 2A-2A are cross-sectional side views of a device taken along line 2A-2A of FIG. 1A at different stages of a method for withdrawing bodily fluid from a subject in accordance with an embodiment of the present technology. [Figure 3C] 2A-2A are side cross-sectional views of a device taken along line 2A-2A of FIG. 1A at different stages of a method for withdrawing bodily fluid from a subject, in accordance with an embodiment of the present technology. [Figure 3D] 2A-2A are side cross-sectional views of a device taken along line 2A-2A of FIG. 1A at different stages of a method for withdrawing bodily fluid from a subject, in accordance with an embodiment of the present technology. [Figure 4A] 2A-2A are simplified cross-sectional side views of a device along line 2A-2A of FIG. 1A positioned against a subject's skin at different stages of a method of collecting bodily fluid from a subject, in accordance with an embodiment of the present technology. [Figure 4B] 2A-2A are simplified cross-sectional side views of a device along line 2A-2A of FIG. 1A positioned against a subject's skin at different stages of a method of collecting bodily fluid from a subject, in accordance with an embodiment of the present technology. [Figure 4C] 2A-2A are simplified cross-sectional side views of a device along line 2A-2A of FIG. 1A positioned against a subject's skin at different stages of a method of collecting bodily fluid from a subject, in accordance with an embodiment of the present technology. [Figure 4D]2A-2A are simplified cross-sectional side views of a device along line 2A-2A of FIG. 1A positioned against a subject's skin at different stages of a method of collecting bodily fluid from a subject, in accordance with an embodiment of the present technology. [Figure 5A] 2B-2B are simplified cross-sectional side views of a device along line 2B-2B of FIG. 1A positioned against a subject's skin at different stages of a method of collecting bodily fluid from a subject, in accordance with an embodiment of the present technology. [Figure 5B] 2B-2B are simplified cross-sectional side views of a device along line 2B-2B of FIG. 1A positioned against a subject's skin at different stages of a method of collecting bodily fluid from a subject, in accordance with an embodiment of the present technology. [Figure 5C] 2B-2B are simplified cross-sectional side views of a device along line 2B-2B of FIG. 1A positioned against a subject's skin at different stages of a method of collecting bodily fluid from a subject, in accordance with an embodiment of the present technology. [Figure 5D] 2B-2B are simplified cross-sectional side views of a device along line 2B-2B of FIG. 1A positioned against a subject's skin at different stages of a method of collecting bodily fluid from a subject, in accordance with an embodiment of the present technology. [Figure 6] Figures 3A, 4A and 5A are reproduced in side-by-side configuration with Figures 3B, 4B and 5B to illustrate movement of the device between the pre-deployed and partially deployed positions. [Figure 7] Figures 3C, 4C, and 5C are reproduced in side-by-side configuration with Figures 3D, 4D, and 5D to illustrate movement of the device between the deployed and post-deployed positions. [Figure 8A] 13 is an exploded isometric view of a bodily fluid collection device configured in accordance with an additional embodiment of the present technology. [Figure 8B] 13 is an exploded isometric view of a bodily fluid collection device configured in accordance with an additional embodiment of the present technology. [Figure 9A] 13 is a side cross-sectional view of a bodily fluid collection device configured in accordance with an additional embodiment of the present technology. [Figure 9B] 13 is a side cross-sectional view of a bodily fluid collection device configured in accordance with an additional embodiment of the present technology. [Figure 9C]FIG. 9C is an exploded view of the device of FIGS. 9A and 9B in accordance with an embodiment of the present technology. [Figure 10] FIG. 9C is a side view of a skin piercing assembly of the device of FIGS. 9A-9C in accordance with an embodiment of the present technology. [Figure 11A] FIG. 11 is an enlarged side view of the skin penetration assembly of FIG. 10 in accordance with an additional embodiment of the present technology. [Figure 11B] FIG. 11 is an enlarged side view of the skin penetration assembly of FIG. 10 in accordance with an additional embodiment of the present technology. [Figure 11C] FIG. 11 is an enlarged side view of the skin penetration assembly of FIG. 10 in accordance with an additional embodiment of the present technology. [Figure 11D] FIG. 11 is an enlarged side view of the skin penetration assembly of FIG. 10 in accordance with an additional embodiment of the present technology. [Figure 12A] 9A-9C at different stages of a method for collecting bodily fluid from a subject, in accordance with an embodiment of the present technology. [Figure 12B] 9A-9C at different stages of a method for collecting bodily fluid from a subject, in accordance with an embodiment of the present technology. [Figure 12C] 9A-9C at different stages of a method for collecting bodily fluid from a subject, in accordance with an embodiment of the present technology. [Figure 12D] 9A-9C at different stages of a method for collecting bodily fluid from a subject, in accordance with an embodiment of the present technology. [Figure 13A] FIG. 13 is a side cross-sectional view of a skin piercing assembly configured in accordance with an additional embodiment of the present technology. [Figure 13B] FIG. 13 is a side view of a skin piercing assembly configured in accordance with an additional embodiment of the present technology. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0006] The present technology generally relates to devices and methods for deploying a skin piercing feature, such as a blade having a sharp cutting edge, towards / into a subject's skin to harvest and collect bodily fluid (e.g., blood). In some embodiments, a device for harvesting bodily fluid from a subject can include a housing having a base configured to be placed against the subject's skin. The base can include an opening extending therethrough to collect the bodily fluid. The device can further include an actuator movable relative to the housing and a skin piercing assembly coupled to the actuator. The skin piercing assembly can include (i) a casing, (ii) a drive member pivotally mounted within the casing and carrying the blade, and (iii) a biasing member (e.g., a torsion spring) coupling the drive member to the casing. In some embodiments, the actuator can be movable relative to the housing from a pre-deployed position to a deployed position. In the pre-deployed position, the drive member can engage the casing to maintain the biasing member in a biased configuration. Movement of the actuator from the pre-deployed position to the deployed position can disengage the drive member from the casing to allow the biasing member to drive the blade at least partially through and / or across an opening in the base to incise the subject's skin.

[0007] More specifically, in some embodiments, the casing can include a trigger portion spaced apart from the blade holder portion. The drive member can be pivotally mounted within the blade holder portion and can include a first retaining feature (e.g., a tab or protrusion) that engages with a second retaining feature (e.g., an adjacent tab or protrusion) on the trigger portion to lock the drive member in a pre-deployed position. The housing can further include a release member (e.g., a ramp) disposed on a base below the trigger portion. Movement of the actuator to the deployed position can engage the trigger portion with the release member, bias the trigger portion away from the blade holder portion, disengage the first and second retaining features, and allow the biasing member to rotate the drive member.

[0008] In some embodiments, the casing can have a shaped underside configured to extend at least partially through the opening in the base and contact the skin in the deployed position. In some embodiments, the underside can press down on the subject's skin to form the skin into a predetermined shape. In some embodiments, the underside can have a gap between two flat portions configured to receive a portion of the subject's skin. In some embodiments, the shape of the underside can generally match (e.g., be concentric with) the arcuate / sweep path of the blade through the opening. Thus, the resulting incision can have a generally uniform depth and / or rectangular shape. In other embodiments, the shape of the underside can be selected based on other desired shapes and / or dimensions of the resulting incision.

[0009] In some embodiments, the housing can include a sidewall and a connector extending from the sidewall. A collection reservoir (e.g., a tube) can be sealingly attached to the connector for receiving bodily fluid. The housing and actuator can at least partially define a sealed region, and the device can further include a sealing member coupled to the actuator and configured to seal an interface between the actuator and the sidewall of the housing. The sealed region can be sealed (e.g., sealed from an environment external to the device) when the device is placed against the skin of the subject and the collection tube is attached to the connector. In some embodiments, movement of the actuator in a deployment direction toward the base can reduce a volume of the sealed region and advance the sealing member at least partially through or adjacent to a channel in the connector, allowing pressure within the sealed region to equalize via a fluid path extending (i) from the sealed region, (ii) through the sealing member through the channel, and (iii) between the actuator and the sidewall to the outside of the housing. The device can further include a retraction actuator configured to drive the actuator in a retraction direction (e.g., opposite the deployment direction) from the deployed position to a retracted position. In some embodiments, retraction of the actuator can increase the volume of the sealed region and advance the sealing member along the upper sidewall of the channel such that pressure within the sealed region is reduced. Thus, in some aspects of the present technology, the device can auto-vent upon deployment of the actuator (e.g., upon depression of the actuator by a user) and auto-create a vacuum upon retraction of the actuator (e.g., upon release of the actuator by a user).

[0010] Specific details of various embodiments of the present technology are described herein with reference to Figures 1A-13B. However, the present technology can be practiced without some of these specific details. In some cases, well-known structures and methods often associated with bodily fluid collection devices have not been shown in detail so as not to obscure the present technology. The terms used in the description presented below are intended to be interpreted in their broadest reasonable manner, even when used in conjunction with the detailed description of certain embodiments of the present disclosure. Certain terms may even be emphasized below, however, any terms intended to be interpreted in any limited manner are expressly and specifically defined as such in this detailed description section.

[0011] The accompanying figures illustrate embodiments of the present technology and are not intended to limit its scope. The sizes of the various depicted elements are not necessarily drawn to scale, and these various elements may be arbitrarily enlarged to improve legibility. Details of components may be abstracted in the figures 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 create and use the present technology. Many of the details, dimensions, angles, and other features shown in the figures are merely illustrative of certain 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.

[0012] 1A and 1B are top and bottom perspective views, respectively, of a bodily fluid collection device 100 ("device 100") configured in accordance with an embodiment of the present technology. In some embodiments, device 100 has some features that are generally similar or identical to, and / or operates generally similarly or identically to, any of the bodily fluid collection devices disclosed in U.S. Patent Application No. 17 / 006,246, filed August 28, 2020, entitled "BODILY FLUID COLLECTION DEVICES AND RELATED METHODS," which is incorporated herein by reference in its entirety. For example, device 100 can be handheld, having a size that is easily grasped and operated by one or both hands of a subject. Such a handheld device advantageously allows a subject to collect a bodily fluid sample (e.g., a blood sample) without assistance from another individual. In some embodiments, the bodily fluid collection device 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.

[0013] 1A and 1B together, in the illustrated embodiment, the device 100 includes a first (e.g., lower) housing 102 and a second (e.g., upper) housing 104 that may be secured together, for example, via an interference fit, adhesive, fasteners, or the like. In other embodiments, the first housing 102 and the second housing 104 may be integrally formed together. While the first housing 102 and the second housing 104 may have the illustrated circular cross-sectional shape, in other embodiments, the first housing 102 and the second housing 104 may have other cross-sectional shapes, such as rectangular, square, rectilinear, polygonal, irregular cross-sectional shapes, etc. In some embodiments, the second housing 104 may be disposed around the first housing 102 (e.g., such that the first housing 102 is nested within the second housing 104).

[0014] In the illustrated embodiment, the device 100 further includes an actuator 110 movably coupled to and / or within the first housing 102 and / or the second housing 104. The actuator 110, the first housing 102, and / or the second housing 104 together can define an enclosed area 106 (e.g., enclosed space, enclosed volume, cavity, chamber). In some embodiments, the actuator 110 is movable to increase / decrease the volume of the enclosed area 106. The first housing 102 can include a base 103, a sidewall 105 extending from the base 103, and a connector 107 extending from the sidewall 105. In some embodiments, the sidewall 105 extends generally perpendicular to the base 103 and / or the connector 107 extends generally perpendicular to the sidewall 105. The base 103 includes / defines an opening 109 extending therethrough and opening into the enclosed area 106. In the illustrated embodiment, the opening 109 is circular, but in other embodiments, the opening 109 can have other shapes, such as rectangular, square, rectilinear, polygonal, irregular shapes, etc. The connector 107 can define a channel 108 in fluid communication with the sealed region 106, and a collection reservoir (not shown, e.g., collection tube / cartridge / reservoir 572 shown in Figures 5A-5D) configured to be removably coupled to receive bodily fluid collected from a subject. In some embodiments, the collection reservoir can serve as a removable standardized container for bodily fluid that can be removed and inserted (e.g., for diagnosis and / or biomarker detection) into clinical and laboratory instruments or workflows. In some embodiments, the second housing 104 can include a cutout region 101 configured to be disposed around / over the connector 107.

[0015] In general, to collect a bodily fluid sample, the device 100 is applied to a subject's body (not shown) with the base 103 positioned against the subject's skin and the actuator 110 positioned away from the skin (similar to the configuration illustrated in FIG. 1A). The actuator 110 can be actuated (e.g., pushed, twisted, pulled) to deploy a skin piercing feature (e.g., blade, lancet) from within the device 100 through the opening 109 to pierce the subject's skin. In some embodiments, the device 100 is configured to create a vacuum within the device 100 that acts against the subject's skin, either directly or indirectly, and before and / or after deployment of the skin piercing feature. For example, movement of the actuator 110 away from the base 103 can increase the volume of the sealing region 106 to create a vacuum pressure therein. The resulting bodily fluid from the incision is collected within the sealing region 106 and collected in a collection reservoir (not shown) that is removably coupled to the connector 107.

[0016] 2A and 2B are cross-sectional side views of device 100 taken along lines 2A-2A and 2B-2B, respectively, of FIG. 1A, and FIG. 2C is an exploded view of device 100 configured in accordance with an embodiment of the present technology. Referring together to FIGS. 2A-2C, device 100 includes a skin piercing assembly 220 coupled to actuator 110 and at least partially disposed within sealing region 106. Device 100 is in a pre-deployed position in FIG. 2A, and device 100 is in a partially deployed position in FIG. 2B. Device 100 is further movable to deployed and retracted positions, as described in more detail below with reference to FIGS. 3A-5D.

[0017] 2A, in the illustrated embodiment, the skin piercing assembly 220 includes a casing 222 (e.g., cartridge, housing, enclosure) having a trigger portion 224 and a blade holder portion 226. The casing 222 is shown as partially transparent in FIGS. 2A and 2B for clarity. In the illustrated embodiment, the blade holder portion 226 includes an upper region 227 having a generally rectangular shape that defines a channel 228 (FIG. 2B) and a lower region 229 having a curved or bulbous shape that is defined at least in part by a curved lower edge / surface 225. In the illustrated embodiment, the trigger portion 224 has a generally elongated shape and includes a first retaining feature 230. The trigger portion 224 can be spaced from at least a portion of the blade holder portion 226 to define a channel 232. The first retaining feature 230 may protrude at least partially into the channel 232 in a direction toward the blade holder portion 226 and may include a retaining surface 234 and a first actuating surface 236 .

[0018] The trigger portion 224 and / or the blade holder portion 226 may be coupled to the actuator 110 (e.g., at an underside thereof) such that movement of the actuator 110 moves the skin piercing assembly 220 through the sealed region 106. For example, an upper region 227 of the blade holder portion 226 may be secured within a corresponding recessed portion 212 of the actuator 110 via an interference fit, adhesive, and / or fasteners. In other embodiments, the actuator 110 and the casing 222 may be integrally formed together. The skin piercing assembly 220 may be coupled to the actuator 110 over an opening 109 in the base 103. As best seen in FIG. 2B, in the illustrated embodiment, the opening 109 and the skin piercing assembly 220 are disposed closer to the connector 107 than the opposing portion of the sidewall 105. That is, the opening 109 and / or the skin piercing assembly 220 may be offset laterally relative to a central axis CA (FIG. 2B) of the device 100. In other embodiments, the openings 109 and / or skin piercing assemblies 220 can be positioned differently along or relative to the central axis CA.

[0019] 2A-2C together, the skin piercing assembly 220 further includes (i) a drive member 240 pivotally / rotatably mounted within the blade holder portion 226 of the casing 222, (ii) a skin piercing feature, such as a blade 242, coupled to the drive member 240, and (iii) a first biasing member 244 that operably couples the drive member 240 to the casing 222, the actuator 110, and / or another component of the device 100. More specifically, with reference to FIGS. 2A and 2B, the drive member 240 may be disposed within a channel 228 (FIG. 2B) in the blade holder portion 226 and pivotally coupled to the blade holder portion 226 at a pivot axis 241 (e.g., shaft, axis of rotation, elongated member). In some embodiments, the lower region 229 of the blade holder portion 226 has a maximum width W1 (FIG. 2A) that is greater than the width W2 (FIG. 2A) of the upper region 227, allowing the blade 242 to extend farther from the pivot axis 241 than the second retaining feature 246. In some aspects of the technology, this can prevent the second retaining feature 246 from extending beyond the lower surface 225 when the blade 242 is triggered to rotate, as described in more detail below.

[0020] 2A, in the illustrated embodiment, the blade 242 has a sharp cutting edge 243 and is secured to / over the pivot 241. In other embodiments, other types of skin piercing features can be used in place of or in addition to the blade 242, including, for example, one or more needles, lancets (e.g., cylindrical or other shaped lancets), and / or other features configured to pierce the skin of a subject. The drive member 240 can include a generally circular body 245, a second retaining feature 246 protruding from the body 245, and a spring mount 248 protruding from the body 245. In some embodiments, the first biasing member 244 can be a torsion spring or other suitable biasing member connected between the spring mount 248 and the casing 222 and / or the actuator 110. 2A and 2B , respectively, (i) first biasing member 244 is biased (e.g., under load) to rotate drive member 240 in a counterclockwise direction about pivot axis 241, and (ii) second retaining feature 246 protrudes into channel 232 between trigger portion 224 and blade holder portion 226 and abuts retaining surface 234 of first retaining feature 230. Thus, contact between first retaining feature 230 and second retaining feature 246 prevents drive member 240 (and blade 242) from pivoting about pivot axis 241 and maintains first biasing member 244 in a biased state.

[0021] 2A, the device 100 further includes a release member 250 coupled to the base 103 (e.g., an upper surface thereof) of the first housing 102 within the sealed region 106. The release member 250 may be attached to or integrally formed with the first housing 102 and is disposed below (e.g., vertically below) the trigger portion 224 of the casing 222. In the illustrated embodiment, the release member 250 includes a second actuation surface 252. As described in more detail below with reference to FIGS. 3A-4D, movement of the actuator 110 toward the base 103 may drive the first actuation surface 236 of the first retention feature 230 into contact with the second actuation surface 252 of the release member 250. The first actuating surface 236 and the second actuating surface 252 can be configured (e.g., shaped, sized, positioned, angled) such that downward movement of the first actuating surface 236 relative to the second actuating surface 252 drives / bends the first retaining feature 230 away from the second retaining feature 246 to enable the first biasing member 244 to drive the drive member 240 about the pivot axis 241 to drive the blade 242 along / across the curved lower surface 225.

[0022] 2A-2C together, the device 100 can further include a second biasing member 254 operably coupled between the actuator 110 and the first housing 102. In some embodiments, the second biasing member 254 can be coupled to one or more mounts 256 extending from the base 103 or another portion of the first housing 102 and can extend around (e.g., radially outwardly) the skin piercing assembly 220. In some embodiments, the second biasing member 254 is a compression spring, coil spring, or the like configured to bias the actuator 110 away from the base 103 of the housing 102 in the direction indicated by arrow A in FIG. 2B. Thus, forcing the actuator 110 toward the base 103 in the direction indicated by arrow B in FIG. 2A (e.g., to move the device 100 from a pre-deployed position to a partially deployed position) can increase the load on the second biasing member 254. In the illustrated embodiment, the actuator 110 includes a flange 214 configured to operably engage (e.g., abut) a stop portion 216 of the second housing 104 in the pre-actuated position ( FIG. 2A ). Engagement of the flange 214 with the stop portion 216 prevents the second biasing member 254 from driving the actuator 110 farther in the direction of arrow A (e.g., out of the second housing 104) from its position in the pre-deployment position.

[0023] In the illustrated embodiment, the apparatus 100 further includes a sealing member 258 disposed circumferentially around the actuator 110 and configured to seal the interface between the first housing 102 and the actuator 110. In some embodiments, the sealing member 258 can be an O-ring, gasket, etc. disposed on and / or coupled to the flange 214 of the actuator 110. The sealing member 258 can sealingly engage the inner surface 218 of the sidewall 105 of the first housing 102 as the actuator 110 moves along the sidewall 105 in either direction of arrows A and B.

[0024] 2B, the base 103 of the first housing 102 can define / include a fluid channel 260 that extends from an opening 109 in the base 103 to the channel 108 in the connector 107. In some embodiments, the fluid channel 260 can be configured (e.g., shaped, sized, angled, positioned, coated) to facilitate the flow of bodily fluid (e.g., blood) from the opening 109 into the channel 108 and / or a collection reservoir fluidly connected thereto. In some embodiments, the fluid channel 260 may be configured according to any of the fluid channels described in detail in (i) U.S. patent application Ser. No. 13 / 949,108, filed July 23, 2013, and 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, and entitled "DEVICES, SYSTEMS AND METHODS FOR GRAVITY-ENHANCED MICROFLUIDIC COLLECTION, HANDLING AND TRANSFERRING OF FLUIDS," both of which are incorporated by reference in their entireties herein.

[0025] In the illustrated embodiment, the base 103 further includes a narrowed (e.g., razor-shaped) edge 262 adjacent the fluid channel 260 and at least partially defining the opening 109. In some aspects of the present technology, the shape (e.g., narrowness) of the edge 262 can prevent bodily fluids from pooling proximate the interface between the opening 109 and the fluid channel 260 and / or promote the flow of bodily fluids from the opening 109 into the fluid channel 260. With reference to FIG. 2A, in some embodiments, the base 103 can further include a notch 264 (e.g., recess, opening, channel) disposed adjacent the opening 109 and configured (e.g., shaped, sized, angled) to receive at least a portion of the skin piercing assembly 120 therein in a partially deployed position and / or in a deployed position (e.g., as shown in FIGS. 3C and 4C).

[0026] 2A-2C together, the various components of the device 100 can include metal, plastic, and / or other suitable materials. For example, in some embodiments, the first housing 102, the second housing 104, the actuator 110, the casing 222 of the skin piercing assembly 220, the drive member 240, and / or other components of the device 100 can be 3D printed, molded (e.g., injection molded), or otherwise formed from a plastic material. In some embodiments, some of the components can be manufactured separately and then snapped together or otherwise secured together. For example, the casing 222 of the skin piercing assembly 220 can be manufactured in two pieces before being joined together with the drive member 240, the blade 242, and the first biasing member 244 disposed in the channel 228 therebetween. Similarly, in some embodiments, the assembled skin penetration assembly 220 can first be inserted into the recessed portion 212 of the actuator 110, then the actuator 110 can be inserted into the first housing 102 with the second biasing member 254 disposed therebetween, then the second housing 104 can be placed over / around the first housing 102 to secure the actuator 110 in place, etc.

[0027] The operation of the device 100 for withdrawing bodily fluid (e.g., blood) from a subject is illustrated in Figures 3A-5D. More specifically, Figures 3A-3D are cross-sectional side views of the device 100 taken along line 2A-2A in Figure 1A in accordance with an embodiment of the present technology. Figures 4A-4D are simplified cross-sectional side views of the device 100 taken along line 2A-2A in Figure 1A in accordance with an embodiment of the present technology and placed against a subject's skin 470, and Figures 5A-5D are simplified cross-sectional side views of the device 100 taken along line 2B-2B in Figure 1A in accordance with an embodiment of the present technology. The casing 222 of the skin piercing assembly 220 is shown as partially transparent in Figures 3A-3D for clarity. Certain components of the device 100 are omitted in Figures 4A-5D to more clearly show the functions of the skin piercing assembly 220 and the sealing member 258, respectively. For example, the second housing 104 and the second biasing member 254 are omitted in Figures 4A-4D, and the second housing 104, the second biasing member 254, and the skin penetration assembly 220 are omitted in Figures 5A-5D.

[0028] In Figures 3A, 4A, and 5A, the device 100 is in a pre-deployment position (which may also be referred to as a first position, a ready position, a pre-actuated position, etc.). In Figures 3B, 4B, and 5B, the device 100 is in a partially-deployed position (which may also be referred to as a second position, a skin-forming position, etc.). In Figures 3C, 4C, and 5C, the device 100 is shown in a deployed position (which may also be referred to as a third position, a cutting position, a skin-piercing position, an actuated position, etc.). In Figures 3D, 4D, and 5D, the device 100 is in a post-deployment position (which may also be referred to as a retracted position, a vacuum-generating position, a post-actuated position, a fluid-collecting position, etc.). Figures 3A, 4A, and 5A and Figures 3B, 4B, and 5B are reproduced side-by-side in Figure 6, further illustrating movement of the device 100 between the pre-deployment position and the partially-deployed position. 3C, 4C, and 5C, and 3D, 4D, and 5D are reproduced side-by-side in FIG. 7 to further illustrate movement of device 100 between the deployed and post-deployed positions.

[0029] 3A, 4A, and 5A together, the device 100 can be initially positioned against the skin 470 of the subject in a pre-deployment position. More specifically, the base 103 of the first housing 102 can be positioned against the skin 470 such that the opening 109 is over a portion of the skin 470. In some embodiments, the base 103 (e.g., its underside) can sealingly engage the skin 470 around the opening 109. The collection reservoir 572 (FIG. 5A) can be secured to / over the connector 107 before or after the device 100 is applied against the skin 470, and can sealingly engage the connector 107 (FIG. 5A). Thus, the sealing region 106 can seal after the device 100 is applied against the skin with the collection reservoir 572 secured to the connector 107. In some embodiments, the base 103 (e.g., its underside) can include one or more features configured to increase the ability of the device 100 to seal against the skin of the subject. In some embodiments, for example, base 103 can include a flexible membrane (not shown, eg, membrane 684 shown in Figures 6A and 6B) attached thereto.

[0030] 3A and 4A together, as described in detail above with reference to FIG. 2A, in the pre-deployed position, the second biasing member 254 (FIG. 3A) biases the actuator 110 (and the skin piercing assembly 220 attached thereto) away from the opening 109 in the base 103 in the direction indicated by arrow A (e.g., the retracting direction). Additionally, the first biasing member 244 biases the drive member 240 to rotate in the counterclockwise direction indicated by arrow C in FIG. 4A. However, the engagement of the first retaining feature 230 and the second retaining feature 246 prevents the drive member 240 (and the blade 242) from pivoting about the pivot axis 241. Thus, the skin piercing assembly 220 is in a loaded or ready-to-fire state.

[0031] 3B, 4B, and 5B together, the device 100 can be moved from a pre-deployed position to a partially deployed position by moving (e.g., pushed by the subject or another) the actuator 110 in a direction indicated by arrow B (e.g., a deployment direction) toward the base 103. Referring to FIGS. 3B and 4B together, moving the actuator 110 moves the skin piercing assembly 220 through the sealed region 106 and at least partially through the opening 109 in the base 103. More specifically, in some embodiments, the curved lower surface 225 of the casing 222 can extend at least partially through the opening 109 to contact the subject's skin 470. In some embodiments, as shown in FIG. 4B, the casing 222 can press down on the subject's skin 470 to form a curved depression 474 in the skin 470 that matches the shape of the lower surface 225. In other embodiments, the lower surface 225 can have other shapes (e.g., including contoured, flat portions, etc.) and the skin 470 can conform to the selected shape. Additionally, in the partially deployed position, the first retaining feature 230 can be disposed above or slightly contact the release member 250 such that the first retaining feature 230 still prevents the drive member 240 (and blade 242) from releasing under the bias of the first biasing member 244. Moving the actuator 110 toward the base 103 also increases (e.g., compresses) the load on the second biasing member 254.

[0032] 3B, 4B, and 5B together, movement of the actuator 110 in the direction indicated by arrow B initially drives the sealing member 258 along the inner surface 218 of the sidewall 105 of the first housing 102. Because the sealed area 106 is sealed (e.g., via sealing engagement between the base 103 and the skin 470, between the collection reservoir 572 and the connector 107, and between the sealing member 258 and the sidewall 105), movement of the actuator 110 initially increases the pressure within the sealed area 106 as the sealing member 258 moves along the sidewall 105 to reduce the volume of the sealed area 106. However, with reference to FIG. 5B, in the partially deployed position, the sealing member 258 may be positioned lower (e.g., closer to the base 103) than at least a portion of the channel 108 of the connector 107. That is, the sealing member 258 may move at least partially through the channel 108 and / or may be positioned adjacent to the channel 108. As the sealing member 258 passes through the channel 108, pressure within the sealed region 106 is equalized as air is vented from the sealed region 106 into the channel 108 and from the channel 108 between the actuator 110 and the inner surface 218 of the sidewall 105 to the outside of the device 100 (e.g., as shown by fluid path F in FIG. 5B). Thus, in some aspects of the present technology, the device 100 is configured to automatically vent air from the sealed region 106 upon actuation of the actuator 110.

[0033] 3C, 4C, and 5C together, the device 100 can be moved from the partially deployed position to the deployed position by continuing to move the actuator 110 in the direction indicated by arrow B toward the base 103. Referring to FIGS. 3C and 4C together, continuing to move the actuator 110 moves the first retaining feature 230 of the trigger portion 224 into engagement with the release member 250, whereby the first retaining feature 230 flexes away from and disengages from the second retaining feature 246. More specifically, the first actuation surface 236 and the second actuation surface 252 can be configured (e.g., shaped, angled, sized, positioned) to laterally deflect the trigger portion 224 to increase the width of the channel 232 (e.g., adjacent the first retaining feature 230). For example, in the illustrated embodiment, the first actuation surface 236 and the second actuation surface 252 are formed as offset ramps. The trigger portion 224 can be bent sufficiently to release / disengage the second retaining feature 246 from the first retaining feature 230 such that the second retaining feature 246 no longer rests on the retaining surface 234.

[0034] When the second retaining feature 246 disengages from the first retaining feature 230, the first biasing member 244 is configured to move from a biased state to an at least partially relaxed state, thereby driving the drive member 240 to pivot about the pivot axis 241. As the drive member 240 pivots, it simultaneously moves (e.g., sweeps) the blade 242 along an arcuate path through and across at least a portion of the opening 109 (leading with the sharp cutting edge 243) to form an incision 472 in the subject's skin 470. In the illustrated embodiment, the blade 242 and the blade holder portion 226 of the casing 222 are configured (e.g., shaped, sized, and positioned) such that the blade 242 extends a generally uniform distance beyond the underside 225 of the casing 222 at each point along its path across the opening 109. That is, for example, the shape of the lower surface 225 can generally match (e.g., be concentric with) the arcuate path of the blade 242 (e.g., the tip of the blade). Thus, the resulting incision 472 can have a generally uniform depth. Further, as best seen in FIG. 4D , the incision 472 can have a generally rectangular shape. As noted above, in other embodiments, the lower surface 225 can have other shapes such that the skin 470 conforms to the particular shape of the lower surface 225. In such embodiments, the depth of the incision 472 will vary based on the selected shape of the lower surface 225. Thus, the shape and size of the lower surface 225 can be selected based on the desired shape and depth of the resulting incision.

[0035] In some embodiments, the casing 222 can contact the base 103 in the deployed position to precisely control the position of the blade 242 when it is released. For example, the casing 222 can be configured (e.g., shaped, sized, positioned) to enter and / or contact the base 103 within the notch 264. In some aspects of the technology, this can ensure that the blade 242 travels through its arcuate path across / through the opening 109 at a predetermined location, for example, to allow precise control of the depth and / or shape of the resulting incision 472.

[0036] In some embodiments, the first biasing member 244 is configured to reach a relaxed state after moving the blade 242 to the position shown in Figures 3C and 4C. In such embodiments, the first biasing member 244 can prevent the blade 242 from rotating in either a clockwise or counterclockwise direction after the deployed position is reached. In some embodiments, the blade 242 can abut a portion of the casing 222 and / or another portion of the device 100 in the deployed position to prevent the first biasing member 244 from continuing to rotate the blade 242. That is, for example, the casing 222 can provide a stop for the blade 242.

[0037] In some embodiments, the blade 242 extends farther from the pivot axis 241 than the second retaining feature 246 such that the second retaining feature 246 does not extend beyond the lower surface 225 when the drive member 240 is rotated to the deployed position. More specifically, the shape and size of the lower region 229 (e.g., the larger width W2 shown in FIG. 2A ) can prevent the second retaining feature 246 from extending beyond the lower surface 225 upon rotation of the blade 242. In some aspects of the present technology, this configuration can prevent the second retaining feature 246 or any other portion of the drive member 240 from contacting the user's skin 470 during deployment / firing of the blade 242.

[0038] 5C, in the deployed position, the sealed region 106 remains open to the atmosphere surrounding the device 100 via fluid path F. Thus, continued movement of the actuator 110 from the partially deployed position to the deployed position does not change the pressure within the sealed region 106, which remains at equal pressure to the environment surrounding the device 100.

[0039] 3D and 4D together, the device 100 can be moved from the deployed position to the post-deployed position by releasing the actuator 110 and allowing the second biasing member 254 to drive the actuator 110 and the skin piercing assembly 220 away from the base 103 in the direction indicated by arrow A (e.g., a retraction direction). Retraction of the actuator 110 can move the skin piercing assembly 220 out of contact within the skin 470 and fully within the sealing region 106. In some embodiments, referring to FIGS. 2A and 3D together, the second biasing member 254 can return the actuator 110 to a pre-actuated position in which the flange 214 of the actuator 110 engages the stop portion 216 of the second housing 104. Nevertheless, the device 100 can be configured as a disposable device that cannot be redeployed. For example, in the illustrated embodiment, the device 100 is configured such that subsequent actuation of the actuator 110 when the device 100 is in the deployed configuration does not pivot the blade 242 into the opening 109. Specifically, the first biasing member 244 is no longer biased in the deployed configuration (e.g., after the drive member 240 is released from the trigger portion 224) and therefore cannot drive the blade 242 through the opening 109. In other embodiments, the device 100 can have other features that are specifically configured to limit the device 100 to single use. For example, the actuator 110 can be configured as a pass-through actuator that does not re-engage the skin piercing assembly 220 after use.

[0040] 3D, 4D, and 5D together, retraction of the actuator 110 in the direction of arrow B drives the sealing member 258 upwardly along the inner surface 218 of the sidewall 105, past the channel 108 of the connector 107 (FIG. 5D), substantially eliminating the fluid path F shown in FIGS. 5B and 5C. That is, the sealing member 258 again sealingly engages the entire periphery of the inner surface 218 of the sidewall 105, such that the sealed area 106 is sealed (e.g., via the sealing engagement of the base 103 with the skin 470, the sealing engagement of the collection reservoir 572 with the connector 107, and the sealing engagement of the sealing member 258 with the sidewall 105). Thus, the upward movement of the sealing member 258 along the sidewall 105 reduces the pressure in the sealed area 106, creating a negative / vacuum pressure in the sealed area 106. As shown in FIG. 5D, in some aspects of the present technology, the vacuum pressure can assist in drawing bodily fluid 578 (e.g., blood), at least in part, (i) from the incision 472, (ii) through the opening 109 into the sealed area 106, (iii) along the fluid channel 260, (iv) into the channel 108, and / or (v) into the collection reservoir 572.

[0041] 8A and 8B are exploded isometric views of a bodily fluid collection device 800 ("device 800") configured in accordance with an additional embodiment of the present technology. Device 800 may include certain features generally similar or identical to those of device 100 described in detail above with reference to FIGS. 1A-5D and may operate in a generally similar or identical manner. For example, referring together to FIGS. 8A and 8B, in the illustrated embodiment, device 800 includes (i) a first housing 802, (ii) a second housing 804 configured to be secured to first housing 802, (iii) an actuator 810 movable through first housing 802 and second housing 804, (iv) a skin piercing assembly 820 coupled to actuator 810, and (v) a retraction actuator 854. The skin piercing assembly 820 can include a housing 822 (including individually identified first and second housing portions 822a and 822b), a drive member 840 coupled to the housing 822 via a deployment actuator 844, and a blade 842 carried by the drive member 840. In some embodiments, the first and second housing portions 822a and 822b can be "snap-fitted" or otherwise fastened together to secure the drive member 840, the blade 842, and the deployment actuator 844 therein. When the device 800 is applied against the skin of a subject, the actuator 810 can be depressed against the subject's skin, triggering the deployment actuator 844 to rotate the blade 842 and incise the skin.

[0042] In the illustrated embodiment, the first housing 802 includes a first channel portion 880 that extends upwardly from a base 803 of the first housing 802 and at least partially over / around an opening 809 in the base 803. The actuator 810 can include a second channel portion 882 that extends downwardly from the actuator 810 (e.g., at its underside). The skin piercing assembly 820 can be at least partially disposed within the first channel portion 880 and / or the second channel portion 882. In some embodiments, the first channel portion 880 and the second channel portion 882 can help guide the movement of the skin piercing assembly 820 and can ensure that the skin piercing assembly 820 remains aligned over the opening 809.

[0043] In the illustrated embodiment, the device 800 further includes a membrane 884 attached to the base 803 (e.g., on its underside) and extending laterally across at least a portion of the opening 809. The membrane 884 can be bendable and / or stretchable (e.g., elastic). For example, the membrane 884 can include polyurethane, silicone, and / or other suitable elastic materials. The membrane 884 helps to facilitate sealing with the subject's skin, and in some embodiments can include a pre-cut opening 885 aligned with the blade 842 so that the blade 842 can extend through during deployment. In other embodiments, the opening 885 can include a sealed but weakened or frangible line along the membrane 884. In some embodiments, the membrane 884 can be relatively thin, for example having a thickness of about 250 μm or less, or about 50-400 μm. In some embodiments, membrane 884 can be of the type described in detail in U.S. Patent Application No. 18 / 571,028, filed September 13, 2019, entitled "BODILY FLUID COLLECTION DEVICES AND RELATED METHODS," which is incorporated herein by reference in its entirety. In some embodiments, a liner layer 886 (e.g., protective layer, hygienic layer) can cover membrane 884 prior to use and can be removed (e.g., peeled off) by the subject prior to use.

[0044] 9A and 9B are cross-sectional side views of a bodily fluid collection device 900 ("device 900") constructed in accordance with an additional embodiment of the present technology. The cross-sectional side view of FIG. 9B is rotated 90 degrees relative to the view shown in FIG. 9A. Device 900 is in a pre-deployed position in FIGS. 9A and 9B. FIG. 9C is an exploded view of device 900. Device 900 can include various features that are at least generally similar or identical in structure and function to corresponding features of device 100 and / or device 800 described in detail above with reference to FIGS. 1A-8, and can operate in a generally similar or identical manner as device 100 and / or device 800.

[0045] For example, referring together to FIGS. 9A-9C, device 900 includes a housing comprising a first (e.g., lower) housing portion 902 and a second (e.g., upper) housing portion 904 that can be secured together, for example, via an interference fit, adhesive, fasteners, or the like. First housing portion 902 includes a base 903 and a connector 907 (FIGS. 9B and 9C). As shown in FIGS. 9A and 9B, base 903 includes / defines an opening 909 extending therethrough and opening into sealing region 906. Connector 907 can define a channel 908 in fluid communication with sealing region 906 and is configured to be removably coupled to a collection reservoir (not shown) for receiving bodily fluid collected from a subject. In some embodiments, an O-ring 993 (FIGS. 9B and 9C) or other sealing member can be disposed about connector 907 to sealingly engage the collection reservoir. The base 903 of the first housing portion 902 can define / include a fluid channel 960 ( FIG. 9B ) extending from an opening 909 in the base 903 to a channel 908 in the connector 907. The device 900 further includes an actuator 910 movably coupled to and / or within the first housing portion 902 and / or the second housing portion 904, and a skin piercing assembly 920 coupled to the actuator 910 and disposed at least partially within the enclosed region 906.

[0046] The skin piercing assembly 920 includes a casing 922 (e.g., cartridge) having a trigger portion 924 (e.g., following parts obscured in FIG. 9B) and a blade holder portion 926. As best seen in FIG. 9A, the trigger portion 924 includes a first retention feature 930 that protrudes toward the blade holder portion 926 and an actuation member 936. Referring again to FIGS. 9A-9C together, the blade holder portion 926 includes a shaped lower surface 925. The shaped lower surface 925 is described in further detail below with reference to FIGS. 10-11D. The skin piercing assembly 920 is coupled to an actuator 910 and positioned over an opening 909 in the base 903 such that movement of the actuator 910 moves the skin piercing assembly 920 toward / away from the opening 909 through the sealed region 906. The skin piercing assembly 920 further includes (i) a drive member 940 pivotally / rotatably mounted within the blade holder portion 926 of the casing 922, (ii) a skin piercing feature such as a blade 942 (obscured in FIG. 9B ) coupled to the drive member 940, and (iii) a first biasing member 944 (e.g., a torsion spring, omitted in FIG. 9A for clarity) operably coupling the drive member 940 to the casing 922. With reference to FIG. 9A , the drive member 940 can include a body 945 and a second retaining feature 946 protruding from the body 945 to engage with the first retaining feature 930 of the trigger portion 924 in the pre-deployed position. The actuation member 936 of the trigger portion 930 can protrude generally perpendicular to the drive member 940 and the blade 942.

[0047] 9A-9B, (i) the first biasing member 944 is biased (e.g., under a load) to rotate the drive member 940 in a counterclockwise direction about the pivot axis 941, and (ii) the second retaining feature 946 abuts and engages the first retaining feature 930, preventing the drive member 940 (and blade 942) from pivoting about the pivot axis 941 and maintaining the first biasing member 944 in the biased state. Referring again to FIGS. 9A-9C together, the device 900 further includes a release member 950 (obscured in FIG. 9C) coupled to the base 903 within the sealing region 906. 12A-12D , movement of the actuator 910 towards the base 903 engages the actuation member 936 of the trigger portion 924 with the release member 950 to drive / bend the first retaining feature 930 away from the second retaining feature 946, allowing the first biasing member 944 to drive the drive member 940 about the pivot axis 941 to drive the blade 942 along / across the underside 925 of the casing 922. The device 900 may further include a second biasing member 954 operably coupled between the actuator 910 and the first housing portion 902 and / or the second housing portion 904 and configured to bias and drive the actuator 910 and the skin piercing assembly 920 away from the base 903.

[0048] In the illustrated embodiment, the device 900 further includes a sealing member 992 coupled between the actuator 910 and the first housing portion 902 and / or the second housing portion 904 and defining a sealed volume 991 (FIGS. 9A and 9B) above the opening 909 in the sealed region 906. For example, in the illustrated embodiment, the sealing member 992 is fixed to / at the interface between the first housing portion 902 and the second housing portion 904. The device 900 may further include a valve 994 (not visible in FIG. 9A) extending through the first housing portion 902 and configured to (i) allow air to exit the sealed volume 991 to the outside of the device 900 through the valve 994 and (ii) prevent air from entering the sealed volume 991 from outside the device 900 through the valve 994. Thus, the valve 994 may be a one-way valve, such as an umbrella valve. The sealing member 992 may be a flexible membrane or member that is bendable and / or elastic. Thus, downward movement of the actuator 910 towards the base 903 may bend the sealing member 992, decreasing the volume of the sealed volume 991 and driving air out of the housing portion 902 through the valve 994. Conversely, upward movement of the actuator 910 away from the base 903 may bend the sealing member 992, increasing the volume of the sealed volume 991 while the valve 994 prevents air from entering the sealed volume, thereby reducing the pressure within the sealed volume 991 during use when the base 903 is sealed against the subject's skin and the collection reservoir sealingly engages the connector 907. As explained in detail above, this reduced pressure may act directly or indirectly against the subject's skin to draw the skin towards / into the opening 909, for example, to increase the blood draw of the device 900.

[0049] In the illustrated embodiment, the device 900 further includes a removable cap 995 disposed over the actuator 910. The cap 995 can prevent actuation of the actuator 910 prior to use and can be removed to provide access to the actuator 910 and enable use of the device 900. In some embodiments, the device 900 can further include a membrane and / or adhesive 984 (FIG. 9C) at least partially covering a bottom surface of the base 903.

[0050] 10 is a side view of a skin piercing assembly 920 of a device 900 configured in accordance with an embodiment of the present technology. The casing 922 is shown as partially transparent in FIG. 10 for clarity. In the illustrated embodiment, the lower portion of the blade holder portion 926 includes a first protruding portion 1061, a second protruding portion 1063, and a gap portion 1065 therebetween, which collectively define a lower surface 925 (identified by reference numerals 925a-c). More specifically, the first protruding portion 1061, the second protruding portion 1063, and the gap portion 1065 define a first lower surface portion 925a, a second lower surface portion 925b, and a third lower surface portion 925c, respectively. In the illustrated embodiment, the first and second lower surface portions 925a and 925b are each generally flat and extend substantially parallel to the horizontal axis H of the skin piercing assembly 920 (e.g., an axis extending perpendicular to the direction in which the skin piercing assembly 920 moves through the first and second housings 902 and 904 toward and away from the base 903, as shown in FIGS. 9A-9C). Thus, the first and second lower surface portions 925a and 925b can be referred to as flat portions and / or the like. In the illustrated embodiment, the third lower surface portion 925c curves upwardly away from the first and second lower surface portions 925a and 925b and has a generally curved trapezoidal shape, and the first and second protrusions 1061 and 1063 each have a trapezoidal or generally curved trapezoidal shape.

[0051] As described in more detail below with reference to Figures 12A-12D (and as described in more detail above with reference to Figures 4A-4D), depressing the actuator 910 can move the skin piercing assembly 920 towards the base 903 such that the underside 925 presses against and engages the subject's skin. The subject's skin can conform to the underside 925 of the casing 922 such that the skin fills the gap portion 1065 and substantially contacts each of the underside portions 925a-c. Prior to actuation of the drive member 940 (e.g., when the device 900 is in the pre-deployed and partially deployed positions), the blade 942 can be retained within the casing 922 within / adjacent to the first projection 1061. When the drive member 940 is rotated by the first biasing member 944, the blade 942 can sweep across the gap portion 1065 before being covered and held by the second protrusion 1063, forming an incision 1072 in the subject's skin. In some embodiments, the first protrusion 1061 and the second protrusion 1063 are configured (shaped, sized, positioned) to prevent the blade 942 from contacting the subject's skin until the blade 942 reaches and sweeps through the gap portion 1065.

[0052] In some aspects of the present technology, the contour of the underside 925 is expected to improve consistency in wound length, wound depth, blood collection, and / or other aspects of the wound formation and blood collection of the device 900. The first underside portion 925a, the second underside portion 925b, and the third underside portion 925c can have a first width W1, a second width W2, and a third width W3, respectively. In some embodiments, the first width W1 can be equal to or approximately the same as the second width W3. In some embodiments, the first width W1 and the second width W2 are less than the third width W3. For example, the third width W3 can be about 1.1 to 2.5 times (e.g., about 2.0 times) greater than the first width W1 and the second width W2. Additionally, the gap portion 1065 can have a depth D that, in combination with the placement and size of the blade 942, sets / controls the maximum depth of the incision 1072 formed by the blade 942.

[0053] In some embodiments, any of the first width W1 through third width W3 and / or the shape of the lower surface portions 925a-c can be altered to change the shape of the corresponding incision in the subject's skin. For example, Figures 11A-11D are enlarged side views of a skin piercing assembly 920 in accordance with additional embodiments of the present technology. The casing 922 is shown as partially transparent in Figures 11A-11D for clarity.

[0054] Referring first to FIG. 11A, in the illustrated embodiment, the first protrusion 1061 and the second protrusion 1063 each have a rounder shape than that shown in FIG. 10. Furthermore, the first width W1 and the second width W2 of the first and second surface portions 925a-b are shorter than those shown in FIG. 10, and thus the third width W3 of the third surface portion 925c is relatively longer than the third width W3 shown in FIG. 10. For example, the third width W3 can be about 4.0-5.0 times (e.g., about 4.5 times) larger than the first width W1 and the second width W2. Thus, the gap portion 1065 can have a relatively more rectangular shape or an elongated trapezoid shape. In some embodiments, the depth D of the gap portion 1065 can be shorter than the depth of the gap portion 1065 shown in FIG. 10. Thus, the resulting incision 1072 formed by the blade 942 can have a relatively longer width and shorter depth.

[0055] 11B, in the illustrated embodiment, the first protrusion 1061 and the second protrusion 1063 each have a trapezoidal shape rather than that shown in FIG. 11A. Furthermore, the first width W1 and the second width W2 of the first surface portion 925a and the second surface portion 925b are (i) shorter than that shown in FIG. 10 and (ii) longer than that shown in FIG. 11A. Thus, the third width W3 of the third surface portion 925c is relatively longer than the third width W3 shown in FIG. 10 but shorter than that shown in FIG. 11A. For example, the third width W3 can be about 2.5 to 3.5 times (e.g., about 3.1 times) larger than the first width W1 and the second width W2. In some embodiments, the depth D of the gap portion 1065 can be shorter than the depth of the gap portion 1065 shown in FIG. 10 and longer than the depth of the gap portion 1065 shown in FIG. 11A. Further, in the illustrated embodiment, the first protrusion 1061 and the second protrusion 1063 are configured (shaped, sized, positioned) such that the blade 942 extends / passes by a portion of the first lower surface portion 925a and the second lower surface portion 925b along its arcuate cutting path before reaching and sweeping through the gap portion 1065.

[0056] 11C, in the illustrated embodiment, the first width W1 and the second width W2 of the first surface portion 925a and the second surface portion 925b, respectively, are longer than those shown in FIG. 10. Thus, the third width W3 of the third surface portion 925c can be relatively shorter than the third width W3 shown in FIG. 10. For example, the first width W1 and the second width W2 can be about 1.0 to 1.2 times (e.g., about 1.1 times) larger than the third width W3. Furthermore, in the illustrated embodiment, the gap portion 1065 has a more bell-shaped curved shape and a longer depth D than the gap portion 1065 shown in FIG. 10. Thus, the resulting incision 1072 formed by the blade 942 can have a relatively shorter width and a deeper depth than those shown in FIG. 10.

[0057] 11C, in the illustrated embodiment, the first width W1 and the second width W2 of the first surface portion 925a and the second surface portion 925b are longer than those shown in FIG. 11C. Thus, the third width W3 of the third surface portion 925c can be relatively shorter than the third width W3 shown in FIG. 11C. For example, the first width W1 and the second width W2 can be about 1.2 to 1.5 times (e.g., about 1.3 times) larger than the third width W3. Furthermore, in the illustrated embodiment, the gap portion 1065 has a more bell-shaped curved shape and a longer depth D than the gap portion 1065 shown in FIG. 11C. Thus, the resulting incision 1072 formed by the blade 942 can have a relatively shorter width and a deeper depth than those shown in FIG. 11C.

[0058] 12A-12D are cross-sectional side views of the device 900 of Figures 9A-9C at different stages of a method of withdrawing bodily fluid from a subject in accordance with an embodiment of the present technology. In Figure 12A, the device 900 is in a pre-deployed position, in Figure 12B, in a partially deployed position, in Figure 12C, in a deployed position, and in Figure 12D, in a post-deployed position.

[0059] Referring initially to FIG. 12A, the device 900 can be initially placed against the skin of a subject (not shown) in a pre-deployment position. More specifically, the base 903 can be placed against the skin such that the opening 909 covers a portion of the skin. In some embodiments, the base 903 (e.g., its underside) can sealingly engage the skin around the opening 909. The collection reservoir can be secured to / over and sealingly engaged with the connector 907 (FIGS. 9B and 9C) before or after the device 900 is applied against the skin. Thus, the sealed volume 991 can be sealed after the device 100 is applied against the skin with the collection reservoir secured to the connector 907. Additionally, in the pre-deployment position, the second biasing member 954 biases the actuator 910 (and the skin piercing assembly 920 attached thereto) away from the opening 909 in the base 903 in the direction indicated by arrow A (e.g., the retracting direction). Additionally, the first biasing member 944 biases the drive member 940 to rotate in a counterclockwise direction. However, the engagement of the first retaining feature 930 and the second retaining feature 946 prevents the drive member 940 (and blade 942) from pivoting about the pivot axis 941. Thus, the skin piercing assembly 920 is in a loaded or ready-to-fire state.

[0060] 12B, the device 900 can be moved from a pre-deployed position to a partially deployed position by moving (e.g., pushed by the subject or another) the actuator 910 toward the base 903 in a direction indicated by arrow B (e.g., a deployment direction). Moving the actuator 910 moves the skin piercing assembly 920 through the sealed region 906 and at least partially through the opening 909 in the base 903. More specifically, in some embodiments, the underside 925 of the blade portion 926 of the casing 922 can extend at least partially through the opening 909 to contact the skin 970 of the subject. As described in detail above with reference to FIGS. 10-11D, the contoured underside 925 can press down on the subject's skin such that the skin conforms to the shape of the underside 925. Further, in the partially deployed position, the retaining feature 930 is still engaged with the second retaining feature 946 to prevent the drive member 940 (and blade 942) from pivoting about the pivot axis 941. In some embodiments, the actuation member 936 can slightly contact the release member 950 such that the trigger portion 924 is slightly bent outwardly and away from the blade portion 926 and the drive member 940 in the direction of arrow C. Movement of the actuator 910 in the direction indicated by arrow B also compresses the sealing member 992, thereby decreasing the volume of the sealed volume 991 and expelling air from the sealed volume 991 through the valve 994 (FIGS. 9B and 9C).

[0061] 12C, the device 900 can be moved from the partially deployed position to the deployed position by continuing to move the actuator 910 in the direction indicated by arrow B towards the base 903. As the actuator 910 continues to move, the first retaining feature 930 of the trigger portion 924 moves into engagement with the release member 2950, ​​which causes the first retaining feature 930 to bend away from and out of engagement with the second retaining feature 946, as indicated by arrow C. The trigger portion 924 can bend sufficiently to release / disengage the second retaining feature 946 from the first retaining feature 930. As the second retaining feature 946 disengages from the first retaining feature 930, the first biasing member 944 is configured to move from a biased state to an at least partially relaxed state, thereby driving the drive member 940 to pivot about the pivot axis 941. As the drive member 940 pivots, the drive member 940 simultaneously moves (e.g., sweeps) the blade 942 along an arcuate path past the underside 925 of the casing and across at least a portion of the opening 909 to form an incision in the subject's skin. The shape of the resulting incision can be determined by the shape of the contoured underside 925, as described in detail above with reference to FIGS. 10-11D. After deployment, the blade 942 can be fully disposed within the casing 922 (e.g., with the tip of the blade 942 covered by the second protrusion 1063). In some embodiments, the blade portion 926 includes a stop feature 1299 configured to engage the second retention feature 946 and prevent further movement of the drive member 940 and the blade 942.

[0062] 12D, the device 900 can be moved from the deployed position to the post-deployed position by releasing the actuator 910 and allowing the second biasing member 954 to drive the actuator 910 and the skin piercing assembly 920 away from the base 903 in the direction indicated by arrow A. Retraction of the actuator 910 can move the skin piercing assembly 920 away from contact within the subject's skin and completely into the sealing region 906. In some embodiments, referring together to FIGS. 12A and 12D, the second biasing member 954 can return the actuator 910 to a pre-actuation position. Nevertheless, the device 900 can be configured as a disposable device that cannot be redeployed. For example, in the illustrated embodiment, the device 900 is configured such that actuation of the actuator 910 when the device 900 is in the post-deployed configuration does not pivot the blade 942 into the opening 909. Specifically, the first biasing member 944 is no longer biased in the deployed configuration (e.g., after the drive member 940 is released from the trigger portion 924) and therefore is unable to drive the blade 942 through the opening 909.

[0063] Additionally, retraction of actuator 910 in the direction of arrow B drives sealing member 992 to expand upward with actuator 910, increasing the volume of sealed volume 991. At the same time, valve 994 (FIGS. 9B and 9C) prevents air from entering sealed volume 991 from outside device 900. Thus, expansion / movement of sealing member 992 reduces pressure within sealed volume 991, creating a negative / vacuum pressure within sealed volume 991. Referring together to FIGS. 9A, 9B and 12A, 12D, in some aspects of the present technology, the vacuum pressure can assist in drawing bodily fluid (e.g., blood), at least in part, (i) from an incision in the subject's skin, (ii) through opening 909 into sealed region 906, (iii) along fluid channel 960, (iv) into channel 908, and / or (v) into a collection reservoir coupled to connector 907.

[0064] In other embodiments, bodily fluid collection devices constructed in accordance with the present technology can have (i) a skin piercing assembly that drives a blade or other skin piercing feature through an opening in other ways, and / or (ii) additional features to control the length and / or depth of an incision. Figures 13A and 13B are, for example, side cross-sectional and side views, respectively, of a skin piercing assembly 1320 constructed in accordance with additional embodiments of the present technology. The skin piercing assembly 1320 is in a pre-deployed position in Figure 13A and in a deployed position in Figure 13B. The skin piercing assembly 1320 can (i) be incorporated into one or more of the devices 100, 800, and / or 900 described in detail above with reference to Figures 1A-12D. Similarly, skin penetration assembly 1320 may include various features that are at least generally similar in structure and function to or identical in structure and function to the corresponding features of skin penetration assemblies 120, 620 and / or 920 described in detail above with reference to Figures 1A-12D, and may operate in a manner generally similar or identical to skin penetration assemblies 120, 620 and / or 920.

[0065] 13A and 13B together, in the illustrated embodiment, the skin piercing assembly 1320 includes a casing 1322 that includes a lower surface 1325 and includes a drive member 1340 movably mounted therein. A blade 1342 is coupled to the drive member 1340, and a biasing member (not shown) may operably couple the drive member 1340 to the casing 1322. The biasing member is configured to drive the blade 1342 past the lower surface 1325 and into the skin of the subject, as described in detail above.

[0066] In the illustrated embodiment, the drive member 1340 includes a protrusion 1364 and the casing 1322 includes / defines a track 1362 (e.g., an opening, a channel, an elongated path). The protrusion 1364 extends at least partially into the track 1362 such that the protrusion 1364 is constrained to move along the track 1362. The track 1362 can extend between a first end 1361 and a second end 1363 and can have a length and shape (e.g., varying heights) selected to correspond to the desired path of the blade 1342 and the corresponding size (e.g., length, depth) of the incision 1372 ( FIG. 13A ) formed by the blade 1326. In the illustrated embodiment, the track 1362 curves downward between the first end 1361 and the second end 1363.

[0067] When the drive member 1340 is actuated, a biasing member (not shown) can drive the drive member along the track 1362 from the first end 1361 to the second end 1363. The path of the blade 1342 is controlled / defined by the configuration (e.g., shape, size, length) of the track 1362 to deploy the blade 1326 past the lower surface 1325 and into the skin of the subject to form an incision 1372. More specifically, in the illustrated embodiment, the skin piercing assembly 1320 moves laterally from the first end 1361 to the second end 1363 while rotating, deploying the blade 1326 beyond the lower surface 1325 as the protrusion 1364 passes along the intermediate portion 1365 of the track 1362. In some embodiments, the configuration (e.g., shape, size) of the intermediate portion 1365 and the lower surface 1325 can control the depth and / or shape of the incision formed by the blade 1326. In some aspects of the present technology, the incision 1372 can have a similar shape to any of the incisions 1072 described in detail above with reference to Figures 10-11D.

[0068] The following examples are illustrative of various embodiments of the present technology. 1. A device for collecting a body fluid from a subject, the device comprising: a housing including a base and a release member extending from the base, the base having an opening extending therethrough; A skin piercing assembly at least partially disposed within the housing, the skin piercing assembly comprising: a trigger portion and a blade holder portion; a drive member pivotally coupled to the blade holder portion; a blade carried by a drive member; a skin piercing assembly including a biasing member operably coupled to the drive member; an actuator operably coupled to the skin piercing assembly and movable from a first position to a second position relative to the housing; In the first position, the drive member is configured to engage the trigger portion to maintain the biasing member in the biased configuration; The device is configured such that movement of the actuator from the first position to the second position engages the trigger portion with the release member and disengages the trigger portion from the drive member to allow the biasing member to at least partially drive the blade through the opening in the base. 2. The device of example 1, wherein movement of the actuator from the first position to the second position is configured to engage the trigger portion with the release member to bias the trigger portion away from the blade holder portion. 3. The device of example 1 or example 2, wherein the blade holder portion includes a lower surface configured to extend at least partially through the opening in the base when the actuator is in the second position. 4. The apparatus of example 3, wherein the blade holder includes a first protrusion, a second protrusion, and a gap portion between the first protrusion and the second protrusion, the first protrusion, the second protrusion, and the gap portion defining a lower surface of the blade holder. 5. The device of example 4, wherein the first protrusion and the second protrusion each include a substantially flat lower surface. 6. The device of example 5, wherein the gap portion has a generally curved trapezoidal shape. 7. The device of example 5, wherein the gap portion has a generally bell-shaped curved shape. 8. The device according to any one of embodiments 5 to 7, wherein the width of the first protrusion and the width of the second protrusion are greater than the width of the gap portion. 9. The device according to any one of Examples 5 to 7, wherein the width of the first protrusion and the width of the second protrusion are smaller than the width of the gap portion. 10. a flexible sealing member disposed within the housing and covering the opening in the base to define a sealed volume within the housing; The device of any one of Examples 1-9, further comprising a one-way valve coupled to the housing and configured to (a) prevent air from entering the sealed volume from outside the device, and (ii) allow air to exit from the sealed volume to outside the device.

[0069] 11. A device for collecting a body fluid from a subject, the device comprising: a housing including a base having an opening extending therethrough, the base configured to be placed adjacent to the skin of a subject; A skin piercing assembly at least partially disposed within the housing, the skin piercing assembly comprising: a casing having a lower surface; a blade pivotally coupled to the casing; a biasing member operably coupled to the blade and configured to drive the blade against the undersurface; and an actuator operably coupled to the skin piercing assembly and movable relative to the housing; an actuator movable to a first position to drive a lower surface of the casing at least partially through the opening in the base into contact with the skin; The device, wherein the actuator is movable to a second position releasing the biasing member to allow the biasing member to drive the blade against the underside of the casing along a path through the skin. 12. The apparatus of example 11, wherein the underside of the casing has a curved shape. 13. The device of example 11 or 12, wherein the underside of the casing has a shape that conforms to the path of the blade such that the blade extends through the skin at a generally uniform depth along the path. 14. An apparatus described in any one of Examples 11 to 13, wherein the casing includes a first protrusion, a second protrusion, and a gap portion between the first protrusion and the second protrusion, and the first protrusion, the second protrusion, and the gap portion define a lower surface of the blade holder. 15. The device of example 14, wherein the first protrusion and the second protrusion each include a substantially flat lower surface. 16. The device of example 15, wherein the gap portion has a generally curved trapezoidal shape. 17. The device of example 15, wherein the gap portion has a generally bell-shaped curved shape. 18. The device described in any one of embodiments 15 to 17, wherein the width of the first protrusion and the width of the second protrusion are greater than the width of the gap portion. 19. a casing including a trigger portion and a blade holder portion, the trigger portion being at least partially spaced from the blade holder portion, the trigger portion including a first retention feature, and the blade holder portion including a lower surface; a drive member pivotally coupled to the blade holder portion of the casing, the drive member including a second retention feature; a blade carried by a drive member; a biasing member operatively coupled between the drive member and the casing; In the pre-deployed position, the second retaining feature is configured to engage the first retaining feature to maintain the biasing member in the loaded configuration; A skin piercing assembly, wherein in the deployed position, the second retaining feature is configured to disengage the first retaining feature to allow the biasing member to pivot the blade at least partially through the underside of the casing. 20. A skin penetration assembly as described in Example 19, wherein the blade portion of the casing includes a first protrusion, a second protrusion, and a gap portion between the first protrusion and the second protrusion, the first protrusion, the second protrusion, and the gap portion define a lower surface of the blade holder, and the first protrusion and the second protrusion each include a substantially flat lower surface. 21. A device for collecting a body fluid from a subject, the device comprising: a housing having a side wall and a connector extending from the side wall; an actuator movable relative to a sidewall of the housing, the housing and the actuator at least partially defining a sealed area, the connector including a channel in fluid communication with the sealed area; a sealing member coupled to the actuator and configured to seal an interface between the actuator and a sidewall of the housing; movement of the actuator in a first direction reduces a volume of the sealed region and advances the sealing member at least partially through a channel in the connector, allowing pressure within the sealed region to equalize via a fluid path extending (a) from the sealed region, (b) through the sealing member, through the channel, and (c) between the actuator and the sidewall to an exterior of the housing; The apparatus, wherein movement of the actuator in a second direction opposite the first direction increases the volume of the sealed region and advances the sealing member along the upper sidewall of the channel such that pressure within the sealed region is reduced. 22. The apparatus of example 21, further comprising a retraction actuator operably coupled between the housing and the actuator and configured to drive the actuator in the second direction. 23. The apparatus of example 22, wherein movement of the actuator in a first direction increases the load on the retract actuator.

[0070] The above detailed description of the embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the precise form disclosed above. Although specific embodiments and examples of the present technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the present technology, as those skilled in the art will recognize. For example, while steps are presented in a given order, alternative embodiments may perform steps in a different order. Various embodiments described herein may be combined to provide further embodiments.

[0071] From the above, it will be understood that, although specific embodiments of the present technology are described herein for illustrative purposes, well-known structures and functions have not been shown or described in detail in order to avoid unnecessarily obscuring the description of the embodiments of the present technology. Where the context permits, singular or plural terms may also include the respective plural or singular terms.

[0072] Furthermore, unless the word "or" is expressly limited to mean only a single item in relation to a list of two or more items, the use of "or" in such a list should be interpreted as including (a) any 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 the inclusion of at least the recited features, without excluding any more of the same features and / or other features of additional types. Although specific embodiments have been described herein for illustrative purposes, it will also be understood that various modifications may be made without departing from the technology. Furthermore, although advantages associated with some embodiments of the technology have been described in the context of these embodiments, other embodiments may also exhibit such advantages, and not all embodiments necessarily exhibit such advantages to fall within the scope of the technology. Thus, the present disclosure and related technology may encompass other embodiments not expressly shown or described herein.

Claims

1. 1. An apparatus for collecting a bodily fluid from a subject, the apparatus comprising: a housing including a base and a release member extending from the base, the base having an opening extending therethrough; A skin piercing assembly at least partially disposed within the housing, the skin piercing assembly comprising: a trigger portion and a blade holder portion, the blade holder portion including a lower surface; a drive member pivotally coupled to the blade holder portion; a blade carried by the drive member; a skin piercing assembly including: a biasing member operably coupled to the drive member; an actuator operably coupled to the skin piercing assembly and movable from a first position to a second position relative to the housing; in the first position, the drive member is configured to engage the trigger portion to maintain the biasing member in a biased configuration; the actuator is configured to engage the trigger portion with the release member to disengage the trigger portion from the drive member and enable the biasing member to drive the blade at least partially through the opening in the base, and wherein a lower surface of the blade holder portion is configured to extend at least partially through the opening in the base when the actuator is in the second position.

2. 2. The device of claim 1, wherein movement of the actuator from the first position to the second position is configured to engage the trigger portion with the release member and bias the trigger portion away from the blade holder portion.

3. 2. The apparatus of claim 1, wherein the blade holder includes a first protrusion, a second protrusion, and a gap portion between the first protrusion and the second protrusion, the first protrusion, the second protrusion, and the gap portion defining the lower surface of the blade holder.

4. The apparatus of claim 3 , wherein the first protrusion and the second protrusion each include a flat lower surface region.

5. The apparatus of claim 4 , wherein the gap portion has a curved trapezoidal shape.

6. The device of claim 4 , wherein the gap portion has a bell-shaped curved shape.

7. The apparatus of claim 4 , wherein a width of the first protrusion and a width of the second protrusion are greater than a width of the gap portion.

8. The apparatus of claim 4 , wherein a width of the first protrusion and a width of the second protrusion are less than a width of the gap portion.

9. 1. An apparatus for collecting a bodily fluid from a subject, the apparatus comprising: a housing including a base and a release member extending from the base, the base having an opening extending therethrough; A skin piercing assembly at least partially disposed within the housing, the skin piercing assembly comprising: a trigger portion and a blade holder portion; a drive member pivotally coupled to the blade holder portion; a blade carried by the drive member; a skin piercing assembly including: a biasing member operably coupled to the drive member; a flexible sealing member disposed within the housing and covering the opening in the base to define a sealed volume within the housing; a one-way valve coupled to the housing and configured to (a) prevent air from entering the sealed volume from outside the device, and (ii) allow air to exit the sealed volume to outside the device; an actuator operably coupled to the skin piercing assembly and movable from a first position to a second position relative to the housing; in the first position, the drive member is configured to engage the trigger portion to maintain the biasing member in a biased configuration; the device is configured such that movement of the actuator from the first position to the second position engages the trigger portion with the release member and disengages the trigger portion from the drive member, allowing the biasing member to at least partially drive the blade through the opening in the base.

10. 1. An apparatus for collecting a bodily fluid from a subject, the apparatus comprising: a housing including a base having an opening extending therethrough, the base configured to be placed adjacent to the skin of the subject; A skin piercing assembly at least partially disposed within the housing, the skin piercing assembly comprising: a casing having a lower surface; a blade pivotally coupled to the casing; a biasing member operatively coupled to the blade and configured to drive the blade against the lower surface; and an actuator operatively coupled to the skin piercing assembly and movable relative to the housing; the actuator is movable to a first position to actuate the lower surface of the casing at least partially through the opening in the base into contact with the skin; The actuator is movable to a second position releasing the biasing member to allow the biasing member to drive the blade against the underside of the casing along a path through the skin.

11. The apparatus of claim 10 , wherein the lower surface of the casing has a curved shape.

12. 11. The device of claim 10, wherein the underside of the casing has a shape that conforms to the path of the blade such that the blade extends through the skin at a generally uniform depth along the path.

13. 11. The apparatus of claim 10, wherein the casing includes a first protrusion, a second protrusion, and a gap portion between the first protrusion and the second protrusion, the first protrusion, the second protrusion, and the gap portion defining the lower surface of the casing.

14. The apparatus of claim 13 , wherein the first protrusion and the second protrusion each include a flat lower surface.

15. The apparatus of claim 14 , wherein the gap portion has a curved trapezoidal shape.

16. The device of claim 14 , wherein the gap portion has a bell-shaped curved shape.

17. The apparatus of claim 14 , wherein a width of the first protrusion and a width of the second protrusion are greater than a width of the gap portion.

18. 1. An apparatus for collecting a bodily fluid from a subject, the apparatus comprising: a housing including a base configured to be placed against the skin of a subject and a release member fixedly coupled to and extending from the base, the base having an opening extending therethrough; A skin piercing assembly at least partially disposed within the housing, the skin piercing assembly comprising: a trigger portion and a blade holder portion; a drive member pivotally coupled to the blade holder portion; a blade carried by the drive member; a skin piercing assembly including: a biasing member operably coupled to the drive member; an actuator operably coupled to the skin piercing assembly and movable from a first position to a second position relative to the housing; in the first position, the drive member is configured to engage the trigger portion to maintain the biasing member in a biased configuration; the device is configured such that movement of the actuator from the first position to the second position engages the trigger portion with the release member and disengages the trigger portion from the drive member, allowing the biasing member to at least partially drive the blade through the opening in the base.

19. The device of claim 18 , wherein the trigger portion and the blade holder portion are integrally formed.

20. 20. The device of claim 18, wherein the housing defines a lumen, and the release member extends upwardly from the base into the lumen.

21. 20. The device of claim 18, wherein the trigger portion includes a first end fixedly coupled to the blade holder portion and a second end configured to bend relative to the blade holder portion.

22. The apparatus of claim 18 , wherein the biasing member is a torsion spring.

23. The apparatus of claim 18 , wherein the actuator is fixedly coupled to the actuator.

24. 20. The device of claim 18, wherein the release member extends upwardly along a longitudinal axis of the housing, and the actuator is movable between the first position and the second position in a direction parallel to the longitudinal axis.

25. 1. An apparatus for collecting a bodily fluid from a subject, the apparatus comprising: a housing including a base having an opening extending therethrough, the base configured to be placed adjacent to the skin of a subject; A skin piercing assembly at least partially disposed within the housing, the skin piercing assembly comprising: a casing having a lower surface; a skin piercing assembly including: a blade configured to move relative to the lower surface; an actuator operatively coupled to the skin piercing assembly and movable relative to the housing; the actuator is movable to a first position to actuate the lower surface of the casing at least partially through the opening in the base into contact with skin; The device, wherein the actuator is movable to a second position to allow the blade to be driven against the underside of the casing along a path through the skin.

26. 26. The apparatus of claim 25, wherein at least a portion of the lower surface of the casing has a curved shape.

27. 26. The device of claim 25, wherein at least a portion of the lower surface of the casing has a shape that conforms to the path of the blade such that the blade extends through the skin at a generally uniform depth along the path.

28. 26. The apparatus of claim 25, wherein the casing includes a first protrusion, a second protrusion, and a gap portion between the first protrusion and the second protrusion, the first protrusion, the second protrusion, and the gap portion defining the lower surface of the casing.

29. 30. The apparatus of claim 28, wherein the first protrusion and the second protrusion each include a flat lower surface.

30. The apparatus of claim 28 , wherein the gap portion has a curved shape.

31. 30. The apparatus of claim 28, wherein the gap portion has a curved trapezoidal shape.

32. 1. A skin piercing assembly configured to be at least partially disposed within an apparatus for withdrawing bodily fluid from a subject, the skin piercing assembly comprising: a casing including a trigger portion and a blade holder portion, the trigger portion including a first end fixedly coupled to the blade holder portion and a second end at least partially spaced from the blade holder portion, the second end of the trigger portion including a first retaining feature, and the blade holder portion including a lower surface; a drive member pivotally coupled to the blade holder portion of the casing, the drive member including a second retention feature; a blade carried by the drive member; a biasing member operatively coupled between the drive member and the casing; in a pre-deployed position, the second retaining feature is configured to engage the first retaining feature to maintain the biasing member in a loaded configuration; A skin penetration assembly, wherein in a deployed position, the second retaining feature is configured to disengage the first retaining feature to allow the biasing member to pivot the blade at least partially through the underside of the blade holder portion.

33. 33. The device of claim 32, wherein the trigger portion and the blade holder portion are integrally formed.

34. 33. The device of claim 32, wherein in the deployed position, the second end of the trigger portion is configured to bend away from the blade holder portion.

35. 33. The device of claim 32, wherein the casing is movable along a longitudinal axis from the pre-deployed position to the deployed position.

36. 33. The apparatus of claim 32, wherein at least a portion of the lower surface of the casing has a curved shape.

37. 33. The apparatus of claim 32, wherein the biasing member is a torsion spring.

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