Body fluid collection device and related method

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 on February 26, 2021, entitled "BODILY FLUID COLLECTION DEVICES AND RELATED METHODS", which is hereby incorporated by reference in its entirety.

[0002] (Field of the Invention) This technology relates to the collection of bodily fluids from a subject, particularly to handheld bodily fluid collection devices and related methods.

Background Art

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

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

Brief Description of the Drawings

[0005] [Figure 1A] Top perspective view and bottom perspective view of a bodily fluid collection device configured according to an embodiment of this technology. [Figure 1B]These are a top perspective view and a bottom perspective view of a body fluid collection device configured according to an embodiment of this technology. [Figure 2A] This is a side cross-sectional view of the apparatus shown in Figures 1A and 1B along the line 2A-2A in Figure 1A, according to an embodiment of this technology. [Figure 2B] This is a side cross-sectional view of the apparatus shown in Figures 1A and 1B along line 2B-2B in Figure 1A, according to an embodiment of this technology. [Figure 2C] These are exploded views of the apparatus shown in Figures 1A and 1B according to an embodiment of this technology. [Figure 3A] This is a side cross-sectional view of the apparatus along line 2A-2A in Figure 1A at different stages of the method for collecting bodily fluids from a subject according to an embodiment of this technology. [Figure 3B] This is a side cross-sectional view of the apparatus along line 2A-2A in Figure 1A, showing different stages of the method for collecting bodily fluids from a subject according to an embodiment of this technology. [Figure 3C] This is a side cross-sectional view of the apparatus along line 2A-2A in Figure 1A at different stages of the method for collecting bodily fluids from a subject according to an embodiment of this technology. [Figure 3D] This is a side cross-sectional view of the apparatus along line 2A-2A in Figure 1A at different stages of the method for collecting bodily fluids from a subject according to an embodiment of this technology. [Figure 4A] This is a simplified side cross-sectional view of the device along line 2A-2A in Figure 1A, positioned on the skin of a subject at different stages of the method for collecting bodily fluids from a subject according to an embodiment of this technology. [Figure 4B] This is a simplified side cross-sectional view of the device along line 2A-2A in Figure 1A, positioned on the skin of a subject at different stages of the method for collecting bodily fluids from a subject according to an embodiment of this technology. [Figure 4C] This is a simplified side cross-sectional view of the device along line 2A-2A in Figure 1A, positioned on the skin of a subject at different stages of the method for collecting bodily fluids from a subject according to an embodiment of this technology. [Figure 4D]This is a simplified side cross-sectional view of the device along line 2A-2A in Figure 1A, positioned on the skin of a subject at different stages of the method for collecting bodily fluids from a subject according to an embodiment of this technology. [Figure 5A] This is a simplified side cross-sectional view of the device along line 2B-2B in Figure 1A, positioned on the skin of a subject at different stages of the method for collecting bodily fluids from a subject according to an embodiment of this technology. [Figure 5B] This is a simplified side cross-sectional view of the device along line 2B-2B in Figure 1A, positioned on the skin of a subject at different stages of the method for collecting bodily fluids from a subject according to an embodiment of this technology. [Figure 5C] This is a simplified side cross-sectional view of the device along line 2B-2B in Figure 1A, positioned on the skin of a subject at different stages of the method for collecting bodily fluids from a subject according to an embodiment of this technology. [Figure 5D] This is a simplified side cross-sectional view of the device along line 2B-2B in Figure 1A, positioned on the skin of a subject at different stages of the method for collecting bodily fluids from a subject according to an embodiment of this technology. [Figure 6] To illustrate the movement of the device between the pre-deployment position and the partially deployed position, Figures 3A, 4A, and 5A are reproduced side-by-side with Figures 3B, 4B, and 5B. [Figure 7] To illustrate the movement of the device between the deployed position and the deployed position, Figures 3C, 4C, and 5C are reproduced side-by-side with Figures 3D, 4D, and 5D. [Figure 8A] This is an exploded isometric view of a bodily fluid collection device configured according to an additional embodiment of this technology. [Figure 8B] This is an exploded isometric view of a bodily fluid collection device configured according to an additional embodiment of this technology. [Figure 9A] This is a side cross-sectional view of a bodily fluid collection device configured according to an additional embodiment of this technology. [Figure 9B] This is a side cross-sectional view of a bodily fluid collection device configured according to an additional embodiment of this technology. [Figure 9C]Exploded views of the devices of FIGS. 9A and 9B according to embodiments of the present technology. [Figure 10] Side views of the skin penetration assemblies of the devices of FIGS. 9A - 9C according to embodiments of the present technology. [Figure 11A] Enlarged side views of the skin penetration assembly of FIG. 10 according to additional embodiments of the present technology. [Figure 11B] Enlarged side views of the skin penetration assembly of FIG. 10 according to additional embodiments of the present technology. [Figure 11C] Enlarged side views of the skin penetration assembly of FIG. 10 according to additional embodiments of the present technology. [Figure 11D] Enlarged side views of the skin penetration assembly of FIG. 10 according to additional embodiments of the present technology. [Figure 12A] Side cross - sectional views of the devices of FIGS. 9A - 9C at different stages of a method for collecting body fluid from a subject according to embodiments of the present technology. [Figure 12B] Side cross - sectional views of the devices of FIGS. 9A - 9C at different stages of a method for collecting body fluid from a subject according to embodiments of the present technology. [Figure 12C] Side cross - sectional views of the devices of FIGS. 9A - 9C at different stages of a method for collecting body fluid from a subject according to embodiments of the present technology. [Figure 12D] Side cross - sectional views of the devices of FIGS. 9A - 9C at different stages of a method for collecting body fluid from a subject according to embodiments of the present technology. [Figure 13A] Side cross - sectional view of a skin penetration assembly configured according to additional embodiments of the present technology. [Figure 13B] Side side view of a skin penetration assembly configured according to additional embodiments of the present technology.

BRIEF DESCRIPTION OF THE DRAWINGS

[0006] This technology generally relates to apparatus and methods for deploying a skin-penetrating feature, such as a blade with a sharp cutting edge, toward / into the skin of a subject in order to collect bodily fluids (e.g., blood). In some embodiments, the apparatus for collecting bodily fluids from a subject may include a housing having a base configured to be positioned toward the subject's skin. The base may include an opening extending through it for collecting bodily fluids. The apparatus may further include an actuator movable relative to the housing and a skin-penetrating assembly coupled to the actuator. The skin-penetrating assembly may include (i) a casing, (ii) a drive member pivotably mounted within the casing and carrying a blade, and (iii) a biasing member (e.g., a torsion spring) coupling the drive member to the casing. In some embodiments, the actuator may be movable relative to the housing from a pre-deployment position to a deployed position. In the pre-deployment position, the drive member can engage with the casing to maintain the biasing member in a biased configuration. The movement of the actuator from the pre-deployment position to the deployed position can disengage the drive member from the casing, allowing the biasing member to drive the blade at least partially through and / or across the opening in the base, thereby cutting the subject's skin.

[0007] More specifically, in some embodiments, the casing may include a trigger portion spaced apart from the blade holder portion. The drive member may be pivotably mounted within the blade holder portion and may 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 the pre-deployment position. The housing may further include a release member (e.g., a tilted portion) positioned on a base beneath the trigger portion. Movement of the actuator to the deployed position may engage the trigger portion with the release member, deflect the trigger portion away from the blade holder portion, disengage the first and second retaining features, and allow a biasing member to rotate the drive member.

[0008] In some embodiments, the casing may have a molded lower surface that extends at least partially through the opening in the base and is configured to contact the skin in the deployed position. In some embodiments, the lower surface may be able to press down the subject's skin to form the skin into a predetermined shape. In some embodiments, the lower surface may have a gap between two flat portions configured to receive a portion of the subject's skin. In some embodiments, the shape of the lower surface may be approximately concentric (e.g., concentric) with respect to the arched / sweeping path of the blade through the opening. Thus, the resulting incision may have a generally uniform depth and / or rectangular shape. In other embodiments, the shape of the lower surface may be selected based on other desired shapes and / or dimensions of the resulting incision.

[0009] In some embodiments, the housing may include a side wall and a connector extending from the side wall. A collection reservoir (e.g., a tube) may be sealed and attached to the connector for receiving bodily fluids. The housing and actuator may define at least partially a sealed area, and the device may further include a sealing member coupled to the actuator and configured to seal the interface between the actuator and the side wall of the housing. The sealed area may be sealed (e.g., sealed from the environment outside the device) when the device is positioned against the skin of a subject and the collection tube is attached to the connector. In some embodiments, movement of the actuator in the deployment direction toward the base may reduce the volume of the sealed area and advance the sealing member at least partially through or adjacent to a channel in the connector, allowing the pressure within the sealed area to be equalized (i) from the sealed area, (ii) through the sealing member and through the channel, and (iii) through a fluid path extending from between the actuator and the side wall to the outside of the housing. The device may further include a retracting actuator configured to drive the actuator in the retracting direction (e.g., opposite to the deployment direction) from the deployed position to the retracted position. In some embodiments, the retraction of the actuator can increase the volume of the sealed area and advance the sealing member along the upper side wall of the channel so that the pressure within the sealed area is reduced. Thus, in some aspects of the art, the device can automatically ventilate when the actuator is deployed (e.g., when the actuator is pressed by the user) and automatically generate a vacuum when the actuator is retracted (e.g., when the actuator is released by the user).

[0010] Specific details of various embodiments of this technology are described herein with reference to Figures 1A to 13B. However, this technology can be implemented without some of these specific details. In some cases, well-known structures and techniques often associated with bodily fluid collection devices are not shown in detail so as not to obscure this technology. Terms used in the following description are intended to be interpreted in their broadest and most appropriate way, even when used in conjunction with the detailed description of a particular embodiment of this disclosure. Certain terms may even be emphasized below, however any term intended to be interpreted in any limited way is so expressly and specifically defined 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 elements shown are not necessarily drawn to a constant scale, and these various elements may be enlarged as appropriate to improve readability. 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 the present technology is created and used. Many of the details, dimensions, angles, and other features shown in the figures are merely illustrative of specific embodiments of the present disclosure. Other embodiments may have other details, dimensions, angles, and features without departing from the spirit or scope of the present technology.

[0012] Figures 1A and 1B are a top perspective view and a bottom perspective view of a bodily fluid collection device 100 ("Device 100") configured according to embodiments of the present technology, respectively. In some embodiments, Device 100 has several features that are substantially the same as or identical to any of the bodily fluid collection devices disclosed in U.S. Patent Application No. 17 / 006,246, filed on 28 August 2020, entitled "BODILY FLUID COLLECTION DEVICES AND RELATED METHODS," and / or operates substantially the same as or identical to any of those, the whole of which is incorporated herein by reference. For example, Device 100 may be handheld, having a size that can be easily grasped and operated with one or both hands of a subject. Such a handheld device would allow a subject to advantageously collect bodily fluid samples (e.g., blood samples) without assistance from another person. In some embodiments, the bodily fluid collection devices of the present technology can be operated by a layperson outside of a medical setting (e.g., at home or in a field clinic) without the assistance of a medical professional.

[0013] Referring together to Figures 1A and 1B, in the illustrated embodiment, the device 100 includes a first (e.g., lower) housing 102 and a second (e.g., upper) housing 104, which can be fastened together, for example, via a compression fit, adhesive, fasteners, etc. In other embodiments, the first housing 102 and the second housing 104 can be formed integrally together. The first housing 102 and the second housing 104 may have the circular cross-sectional shape shown, but in other embodiments, the first housing 102 and the second housing 104 may have other cross-sectional shapes, such as rectangular, square, linear, polygonal, or irregular cross-sectional shapes. In some embodiments, the second housing 104 may be positioned around the first housing 102 (for example, so that the first housing 102 is nested inside the second housing 104).

[0014] In the illustrated embodiments, the apparatus 100 further includes an actuator 110 movably coupled to and / or located within a first housing 102 and / or a second housing 104. The actuator 110, the first housing 102, and / or the second housing 104 together can define a sealed region 106 (e.g., a sealed space, sealed volume, lumen, chamber). In some embodiments, the actuator 110 is movable to increase / decrease the volume of the sealed region 106. The first housing 102 may include a base 103, a side wall 105 extending from the base 103, and a connector 107 extending from the side wall 105. In some embodiments, the side wall 105 extends substantially perpendicular to the base 103, and / or the connector 107 extends substantially perpendicular to the side wall 105. The base 103 includes / defines an opening 109 extending through it and opening into the sealed region 106. In the illustrated embodiment, the opening 109 is circular, but in other embodiments, the opening 109 may have other shapes such as rectangle, square, straight, polygon, or irregular. The connector 107 may define a channel 108 that communicates fluid with a sealed area 106, and a collection reservoir (not shown, e.g., collection tube / cartridge / reservoir 572 shown in Figures 5A–5D) is configured to be detachably coupled to receive bodily fluids collected from a subject. In some embodiments, the collection reservoir may function as a detachable, standardized container for bodily fluids that can be detached and inserted into clinical and laboratory equipment or workflows (e.g., for diagnostic and / or biomarker detection). In some embodiments, a second housing 104 may include a notched area 101 configured to be positioned around / on top of the connector 107.

[0015] Generally, to collect a bodily fluid sample, the device 100 is applied to the 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 Figure 1A). By operating the actuator 110 (e.g., pressing, twisting, pulling), a skin-penetrating feature (e.g., a blade, lancet) can be deployed from within the device 100 through an opening 109 to penetrate the subject's skin. In some embodiments, the device 100 is configured to generate a vacuum within the device 100 that acts against the subject's skin, either directly or indirectly, and before and / or after the deployment of the skin-penetrating feature. For example, movement of the actuator 110 away from the base 103 can increase the volume of a sealed area 106, generating vacuum pressure within it. The bodily fluid from the resulting incision is collected within the sealed area 106 and collected in a collection reservoir (not shown) detachably coupled to a connector 107.

[0016] Figures 2A and 2B are side cross-sectional views of the device 100 along lines 2A-2A and 2B-2B of Figure 1A, respectively, and Figure 2C is an exploded view of the device 100 configured according to an embodiment of the present art. Referring together to Figures 2A to 2C, the device 100 includes a skin penetration assembly 220 coupled to an actuator 110 and at least partially positioned within a sealed area 106. In Figure 2A, the device 100 is in the pre-deployment position, and in Figure 2B, the device 100 is in the partially deployed position. The device 100 is further movable to the deployed and retracted positions, as will be described in detail below with reference to Figures 3A to 5D.

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

[0018] The trigger portion 224 and / or the blade holder portion 226 may be coupled to the actuator 110 (e.g., its lower surface), so that movement of the actuator 110 moves the skin penetration assembly 220 through the sealed region 106. For example, the upper region 227 of the blade holder portion 226 may be fixed within the corresponding recess portion 212 of the actuator 110 via a press fit, adhesive, and / or fasteners. In other embodiments, the actuator 110 and the casing 222 may be formed integrally together. The skin penetration assembly 220 may be coupled to the actuator 110 by covering the opening 109 in the base 103. In the illustrated embodiment, as best seen in Figure 2B, the opening 109 and the skin penetration assembly 220 are positioned closer to the connector 107 than the opposing portion of the side wall 105. That is, the opening 109 and / or the skin penetration assembly 220 may be offset laterally with respect to the central axis CA of the device 100 (Figure 2B). In other embodiments, the opening 109 and / or the skin penetration assembly 220 may be positioned along or differently relative to the central axis CA.

[0019] Referring again to Figures 2A and 2C, the skin penetration assembly 220 further includes (i) a drive member 240 pivotably / rotatably mounted within the blade holder portion 226 of the casing 222, (ii) a skin penetration 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 other components of the device 100. More specifically, referring to Figures 2A and 2B, the drive member 240 may be located within a channel 228 (Figure 2B) in the blade holder portion 226 and pivotably coupled to the blade holder portion 226 on a pivot axis 241 (e.g., a shaft, rotation axis, or elongated member). In some embodiments, the lower region 229 of the blade holder portion 226 has a maximum width W1 (Figure 2A) that is greater than the width W2 (Figure 2A) of the upper region 227, and the blade 242 can extend further from the pivot axis 241 than the second retaining feature portion 246. In some aspects of the art, this can prevent the second retaining feature portion 246 from extending beyond the lower surface 225 when the blade 242 is triggered to rotate, as will be described in detail below.

[0020] Referring again to Figure 2A, in the illustrated embodiment, the blade 242 has a sharp cutting edge 243 and is fixed to / covering the pivot shaft 241. In other embodiments, other types of skin-penetrating features, including, for example, one or more needles, lancets (e.g., cylindrical or other shaped lancets), and / or other features configured to penetrate the skin of a subject, may be used instead of or in addition to the blade 242. The drive member 240 may include a substantially 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 may be a torsion spring or other suitable biasing member connected between the spring mount 248 and the casing 222 and / or actuator 110. In the pre-deployment and partially-deployed positions shown in Figures 2A and 2B, respectively, (i) the first biasing member 244 is biased (for example, under load) to rotate the drive member 240 counterclockwise around the pivot axis 241, and (ii) the second retaining feature portion 246 protrudes into the channel 232 between the trigger portion 224 and the blade holder portion 226 and contacts the retaining surface 234 of the first retaining feature portion 230. Therefore, the contact between the first retaining feature portion 230 and the second retaining feature portion 246 prevents the drive member 240 (and the blade 242) from pivoting around the pivot axis 241 and maintains the first biasing member 244 in a biased state.

[0021] Continuing to refer to Figure 2A, the device 100 further includes a release member 250 coupled to the base 103 (e.g., its upper surface) of the first housing 102 within a sealed area 106. The release member 250 may be attached to or integrally formed with the first housing 102 and is positioned below (e.g., vertically downward) the trigger portion 224 of the casing 222. In the illustrated embodiment, the release member 250 includes a second operating surface 252. As will be described in detail below with reference to Figures 3A to 4D, the movement of the actuator 110 toward the base 103 drives the first operating surface 236 of the first retaining feature 230 to contact the second operating surface 252 of the release member 250. The first working surface 236 and the second working surface 252 may be configured (e.g., molded, sized, positioned, angled) such that downward movement of the first working surface 236 relative to the second working surface 252 drives / bends the first retaining feature 230 away from the second retaining feature 246, allowing the first biasing member 244 to drive the drive member 240 around the pivot axis 241 to drive the blade 242 along / beyond the curved lower surface 225.

[0022] Referring again to Figures 2A and 2C together, the device 100 may 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 may be coupled to one or more mounts 256 extending from the base 103 or another part of the first housing 102 and may extend around the skin penetration assembly 220 (e.g., radially outward). In some embodiments, the second biasing member 254 is a compression spring, coil spring, etc., configured to bias the actuator 110 away from the base 103 of the housing 102 in the direction indicated by arrow A in Figure 2B. Thus, pressing the actuator 110 toward the base 103 in the direction indicated by arrow B in Figure 2A (e.g., to move the device 100 from the pre-deployment position to the 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) with the stop portion 216 of the second housing 104 in the pre-operation position (Figure 2A). The engagement of the flange 214 with the stop portion 216 prevents the second biasing member 254 from driving the actuator 110 further in the direction of arrow A from its position in the pre-deployment position (e.g., out of the second housing 104).

[0023] In the illustrated embodiment, the device 100 further includes a sealing member 258 positioned 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 may be an O-ring, gasket, etc., positioned on and / or coupled to the flange 214 of the actuator 110. The sealing member 258 can seal-engage with the inner surface 218 of the side wall 105 of the first housing 102 as the actuator 110 moves along the side wall 105 in either direction of arrows A and B.

[0024] As is most commonly seen in Figure 2B, the base 103 of the first housing 102 may define / include a fluid channel 260 extending from an opening 109 in the base 103 to a channel 108 in the connector 107. In some embodiments, the fluid channel 260 may be configured (e.g., molded, sized, angled, positioned, coated) to facilitate the flow of bodily fluids (e.g., blood) from the opening 109 into the channel 108 and / or into a collection reservoir to which it is fluid-connected. In some embodiments, the fluid channel 260 may be configured according to either of the fluid channels described in detail in (i) U.S. Patent Application No. 13 / 949,108, filed July 23, 2013, entitled “METHODS, SYSTEMS, AND DEVICES RELATING TO OPEN MICROFLUIDIC CHANNELS,” and / or (ii) U.S. Patent Application No. 14 / 816,994, filed August 3, 2015, entitled “DEVICES, SYSTEMS AND METHODS FOR GRAVITY-ENHANCED MICROFLUIDIC COLLECTION, HANDLING AND TRANSFERRING OF FLUIDS,” both of which are incorporated herein by reference in their entirety.

[0025] In the illustrated embodiments, the base 103 further includes a narrowed (e.g., razor-shaped) edge 262 adjacent to the fluid channel 260 and at least partially defining the opening 109. In some aspects of the art, the shape (e.g., narrowness) of the edge 262 can prevent bodily fluids from accumulating near the interface between the opening 109 and the fluid channel 260 and / or facilitate the flow of bodily fluids from the opening 109 into the fluid channel 260. Referring to Figure 2A, in some embodiments, the base 103 may further include a notch 264 (e.g., recess, opening, channel) positioned adjacent to the opening 109 and configured (e.g., molded, sized, angled) to receive at least a portion of the skin penetration assembly 120 in a partially deployed position and / or a fully deployed position (e.g., as shown in Figures 3C and 4C).

[0026] Referring again to Figures 2A to 2C, various components of the apparatus 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 penetration assembly 220, the drive member 240, and / or other components of the apparatus 100 can be formed from plastic material by 3D printing, molding (e.g., injection molding), or other methods. In some embodiments, some of the components can be snapped together after being manufactured individually, or fixed together in a different way. For example, the casing 222 of the skin penetration assembly 220 can be manufactured in two parts before being joined together with the drive member 240, the blade 242, and the first biasing member 244 located in the channel 228 between them. Similarly, in some embodiments, the assembled skin-penetrating assembly 220 can first be inserted into the recessed portion 212 of the actuator 110, and then the actuator 110 can be inserted into the first housing 102 with the second biasing member 254 positioned between them, and then the second housing 104 can be positioned on / around the first housing 102 to fix the actuator 110 in place, and so on.

[0027] The operation of the device 100 for collecting bodily fluids (e.g., blood) from a subject is shown in Figures 3A to 5D. More specifically, Figures 3A to 3D are side cross-sectional views of the device 100 along line 2A-2A in Figure 1A according to an embodiment of the art. Figures 4A to 4D are simplified side cross-sectional views of the device 100 cut along line 2A-2A in Figure 1A and positioned against the subject's skin 470 according to an embodiment of the art, and Figures 5A to 5D are simplified side cross-sectional views of the device 100 cut along line 2B-2B in Figure 1A and positioned against the subject's skin 470 according to an embodiment of the art. For clarity, the casing 222 of the skin penetration assembly 220 is shown as partially transparent in Figures 3A to 3D. In Figures 4A to 5D, certain components of the device 100 are omitted to more clearly illustrate the functions of the skin penetration 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 to 4D, and the second housing 104, the second biasing member 254, and the skin penetration assembly 220 are omitted in Figures 5A to 5D.

[0028] In Figures 3A, 4A, and 5A, the device 100 is in the pre-deployment position (which may also be called the first position, ready position, pre-operation position, etc.). In Figures 3B, 4B, and 5B, the device 100 is in the partially deployed position (which may also be called the second position, skin formation position, etc.). Figures 3C, 4C, and 5C show the device 100 in the deployed position (which may also be called the third position, cutting position, skin penetration position, operation position, etc.). In Figures 3D, 4D, and 5D, the device 100 is in the post-deployment position (which may also be called the retracted position, vacuum generation position, post-operation position, fluid collection position, etc.). Figures 3A, 4A, and 5A, and Figures 3B, 4B, and 5B are reproduced side by side in Figure 6, further illustrating the movement of the device 100 between the pre-deployment position and the partially deployed position. Figures 3C, 4C, and 5C, as well as Figures 3D, 4D, and 5D, are reproduced side-by-side in Figure 7 to further illustrate the movement of the device 100 between the deployed position and the post-deployment position.

[0029] Referring first to Figures 3A, 4A, and 5A together, the device 100 can initially be positioned against the subject's skin 470 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 be sealed-engaged to the skin 470 around the opening 109. The collection reservoir 572 (Figure 5A) can be secured to / cover the connector 107 before or after the device 100 is applied to the skin 470 and can be sealed-engaged to the connector 107 (Figure 5A). Thus, the sealed area 106 can be sealed after the device 100 has been applied to the skin with the collection reservoir 572 secured to the connector 107. In some embodiments, the base 103 (e.g., its underside) may include one or more features configured to increase the ability of the device 100 to seal against the subject's skin. In some embodiments, for example, the base 103 may include a flexible film attached thereto (not shown, e.g., film 684 shown in Figures 6A and 6B).

[0030] Referring together to Figures 3A and 4A, as described in detail above with reference to Figure 2A, in the pre-deployment position, the second biasing member 254 (Figure 3A) biases the actuator 110 (and the skin-penetrating assembly 220 attached thereto) away from the opening 109 of the base 103 in the direction indicated by arrow A (e.g., the retraction direction). Furthermore, the first biasing member 244 biases the drive member 240 to rotate in the counterclockwise direction indicated by arrow C in Figure 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 around the pivot axis 241. Thus, the skin-penetrating assembly 220 is in a loaded or ready-to-fire state.

[0031] Referring together to Figures 3B, 4B, and 5B, the device 100 can be moved from a pre-deployment position to a partially deployed position by moving the actuator 110 toward the base 103 in the direction indicated by arrow B (e.g., by being pressed by a subject or something else). Referring together to Figures 3B and 4B, by moving the actuator 110, the skin penetration assembly 220 moves through the sealed area 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 Figure 4B, the casing 222 can press down on the subject's skin 470 to form a curved recess 474 in the skin 470 that conforms to the shape of the lower surface 225. In other embodiments, the lower surface 225 may have other shapes (e.g., including undulating, flat portions, etc.), and the skin 470 may conform to a selected shape. Furthermore, in the partially deployed position, the first retaining feature 230 may be positioned above the release member 250, or slightly in contact with the release member 250, so as to still prevent the drive member 240 (and blade 242) from being released under the bias of the first biasing member 244. Moving the actuator 110 toward the base 103 also increases the load on the second biasing member 254 (e.g., by compression).

[0032] Referring again to Figures 3B, 4B, and 5B together, the movement of the actuator 110 in the direction indicated by arrow B first drives the sealing member 258 along the inner surface 218 of the side wall 105 of the first housing 102. Since the sealed region 106 is sealed (e.g., through sealing engagements 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 side wall 105), the movement of the actuator 110 first increases the pressure within the sealed region 106 as the sealing member 258 moves along the side wall 105, reducing the volume of the sealed region 106. However, referring to Figure 5B, in the partially deployed position, the sealing member 258 may be positioned lower than at least a portion of the channel 108 of the connector 107 (e.g., closer to the base 103). That is, the sealing member 258 may move through at least a portion of the channel 108 and / or be positioned adjacent to the channel 108. As the sealing member 258 passes through the channel 108, 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 side wall 105 to the outside of the device 100 (for example, as shown by the fluid path F in Figure 5B), thus equalizing the pressure within the sealed region 106. Therefore, in some aspects of the art, the device 100 is configured to automatically vent air from the sealed region 106 when the actuator 110 is operated.

[0033] Next, referring together to Figures 3C, 4C, and 5C, the device 100 can be moved from a partially deployed position to a fully deployed position by continuing to move the actuator 110 toward the base 103 in the direction indicated by arrow B. Referring together to Figures 3C and 4C, continuing to move the actuator 110 moves the first retaining feature 230 of the trigger portion 224 to engage with the release member 250, thereby bending away from the second retaining feature 246 and disengaging from it. More specifically, the first working surface 236 and the second working surface 252 may be configured (e.g., shaped, angled, sized, and positioned) to laterally deflect the trigger portion 224 and increase the width of the channel 232 (e.g., the width adjacent to the first retaining feature 230). For example, in the illustrated embodiment, the first working surface 236 and the second working surface 252 are formed as offset inclined sections. The trigger portion 224 can be bent sufficiently to release / disengage the second retaining feature portion 246 from the first retaining feature portion 230 so that the second retaining feature portion 246 is no longer placed on the retaining surface 234.

[0034] When the second retaining feature 246 disengages from the first retaining feature 230, the first biasing member 244 moves from a biased state to at least partially relaxed state, thereby driving the drive member 240 to pivot around the pivot axis 241. When the drive member 240 pivots, it simultaneously moves the blade 242 along an arc-shaped path through and across at least a portion of the opening 109 (e.g., sweeping) (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 to extend (e.g., molded, sized, and positioned) a substantially uniform distance beyond the lower surface 225 of the casing 222 at each point along the path of the blade 242 across the opening 109. That is, for example, the shape of the lower surface 225 can be approximately consistent with (e.g., concentric with) the arched path of the blade 242 (e.g., the tip of the blade). Thus, the resulting incision 472 can have a generally uniform depth. Furthermore, as is most commonly seen in Figure 4D, the incision 472 can have a substantially rectangular shape. As described above, in other embodiments, the lower surface 225 can have other shapes such that the skin 470 conforms to a particular shape of the lower surface 225. In such embodiments, the depth of the incision 472 varies 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 contacts 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 may be configured (e.g., molded, sized, positioned) to enter and / or contact the base 103 within the notch 264. In some aspects of the art, this can ensure that the blade 242 moves through its arched path traversing / passing the opening 109 at a given position, for example, to allow for 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 it has reached the deployed position. In some embodiments, the blade 242 can abut against 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 portion for the blade 242.

[0037] In some embodiments, the blade 242 extends further from the pivot axis 241 than the second retaining feature 246 so that the second retaining feature 246 does not extend beyond the lower surface 225 when the drive member 240 rotates to the deployed position. More specifically, the shape and size of the lower region 229 (e.g., a larger width W2 as shown in Figure 2A) can prevent the second retaining feature 246 from extending beyond the lower surface 225 when the blade 242 rotates. In some aspects of the art, this configuration can prevent the second retaining feature 246 or any other part of the drive member 240 from coming into contact with the user's skin 470 during the deployment / launch of the blade 242.

[0038] Referring to Figure 5C, in the deployed position, the sealed region 106 remains open to the surrounding atmosphere via the fluid path F. Therefore, the continuous movement of the actuator 110 from the partially deployed position to the fully deployed position does not change the pressure within the sealed region 106, which remains at the same pressure as the surrounding environment of the device 100.

[0039] Referring together to Figures 3D and 4D, the device 100 can move from the deployed position to the post-deployed position by releasing the actuator 110, which allows the second biasing member 254 to drive the actuator 110 and the skin penetration assembly 220 away from the base 103 in the direction indicated by arrow A (e.g., the retraction direction). The retraction of the actuator 110 allows the skin penetration assembly 220 to move away from contact within the skin 470 and fully into the sealed area 106. In some embodiments, referring together to Figures 2A and 3D, the second biasing member 254 can return the actuator 110 to the pre-operation position where the flange 214 of the actuator 110 engages with the stop portion 216 of the second housing 104. Nevertheless, the device 100 may be configured as a disposable device that cannot be redeployed. For example, in the illustrated embodiment, the device 100 is configured such that subsequent operation of the actuator 110 when the device 100 is in the post-deployment configuration does not pivot the blade 242 into the opening 109. Specifically, the first biasing member 244 is no longer biased in the post-deployment configuration (for example, 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 may have other features specifically configured to limit the device 100 to single-use. For example, the actuator 110 may be configured as a pass-through actuator that does not re-engage with the skin-penetrating assembly 220 after use.

[0040] Referring together to Figures 3D, 4D, and 5D, the retraction of the actuator 110 in the direction of arrow B drives the sealing member 258 upward along the inner surface 218 of the side wall 105, past the channel 108 of the connector 107 (Figure 5D), substantially eliminating the fluid path F shown in Figures 5B and 5C. That is, the sealing member 258 re-engages with the entire circumference of the inner surface 218 of the side wall 105, and as a result, the sealed region 106 is sealed (e.g., via the sealing engagement between the base 103 and the skin 470, the sealing engagement between the collection reservoir 572 and the connector 107, and the sealing engagement between the sealing member 258 and the side wall 105). Thus, the upward movement of the sealing member 258 along the side wall 105 reduces the pressure within the sealed region 106, creating negative pressure / vacuum pressure within the sealed region 106. As shown in Figure 5D, in some aspects of the present technology, vacuum pressure can assist in drawing body fluid 578 (e.g., blood) at least partially from (i) 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] Figures 8A and 8B are exploded isometric views of a bodily fluid collection device 800 ("Device 800") configured according to an additional embodiment of the present technology. Device 800 may include several features that are generally similar to or identical to those of Device 100, which is described in detail above with reference to Figures 1A to 5D, and may operate in generally similar or identical manner. For example, with reference to Figures 8A and 8B together, in the illustrated embodiment, Device 800 includes (i) a first housing 802, (ii) a second housing 804 configured to be fixed to the first housing 802, (iii) an actuator 810 movable through the first housing 802 and the second housing 804, (iv) a skin penetration assembly 820 coupled to the actuator 810, and (v) a retraction actuator 854. The skin penetration assembly 820 may include a housing 822 (including a first housing portion 822a and a second housing portion 822b, which are individually identified), a drive member 840 coupled to the housing 822 via a deployment actuator 844, and a blade 842 supported by the drive member 840. In some embodiments, the first housing portion 822a and the second housing portion 822b may be “snapped” 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 to the skin of a subject, the actuator 810 is pushed down toward the subject's skin, triggering the deployment actuator 844, which rotates the blade 842 and can incise the skin.

[0042] In the illustrated embodiments, the first housing 802 includes a first channel portion 880 that extends upward from the base 803 of the first housing 802 and at least partially extends over / around the opening 809 within the base 803. The actuator 810 may include a second channel portion 882 that extends downward from the actuator 810 (e.g., its lower surface). The skin penetration assembly 820 may be at least partially positioned 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 assist in guiding the movement of the skin penetration assembly 820 and ensure that the skin penetration assembly 820 remains aligned over the opening 809.

[0043] In the illustrated embodiment, the apparatus 800 further includes a membrane 884 attached to a base 803 (e.g., its underside) and extending laterally over at least a portion of the opening 809. The membrane 884 may be flexible and / or stretchable (e.g., elastic). For example, the membrane 884 may 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, may include a pre-cut opening 885 aligned with the blade 842 so that the blade 842 can penetrate and extend through it during deployment. In other embodiments, the opening 885 may include a sealed but weakened or fragile line along the membrane 884. In some embodiments, the membrane 884 may be relatively thin, for example, about 250 μm or less, or about 50–400 μm thick. In some embodiments, the membrane 884 may 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., a protective layer, a sanitary layer) may cover the membrane 884 before use and may be removed (e.g., peeled off) by the subject before use.

[0044] Figures 9A and 9B are side cross-sectional views of a bodily fluid collection device 900 ("Device 900") configured according to an additional embodiment of the present technology. The side cross-sectional view in Figure 9B is rotated 90 degrees relative to the view shown in Figure 9A. In Figures 9A and 9B, Device 900 is in its undeployed position. Figure 9C is an exploded view of Device 900. Device 900 may include various features that are at least substantially similar, or identical in structure and function to, the corresponding features, structure and function of Device 100 and / or Device 800 described in detail above with reference to Figures 1A to 8, and may operate in substantially similar or identical manner to Device 100 and / or Device 800.

[0045] For example, referring together to Figures 9A and 9C, the device 900 includes a housing comprising a first (e.g., lower) housing portion 902 and a second (e.g., upper) housing portion 904, which can be fastened together via, for example, a compression fit, adhesive, fasteners, etc. The first housing portion 902 includes a base 903 and a connector 907 (Figures 9B and 9C). As shown in Figures 9A and 9B, the base 903 includes / defines an opening 909 extending through it and opening into a sealed area 906. The connector 907 may define a channel 908 that is in fluid communication with the sealed area 906 and is configured to be detachably coupled to a collection reservoir (not shown) for receiving bodily fluids collected from a subject. In some embodiments, an O-ring 993 (Figures 9B and 9C) or other sealing member may be positioned around the connector 907 to seal-engage the collection reservoir. The base 903 of the first housing portion 902 may define / include a fluid channel 960 (Figure 9B) extending from an opening 909 in the base 903 to a channel 908 in the connector 907. The apparatus 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 penetration assembly 920 coupled to the actuator 910 and located at least partially within a sealed region 906.

[0046] The skin penetration assembly 920 includes a casing 922 (e.g., a cartridge) having a trigger portion 924 (e.g., a follower portion obscured in Figure 9B) and a blade holder portion 926. As best seen in Figure 9A, the trigger portion 924 includes a first retaining feature portion 930 projecting toward the blade holder portion 926 and an actuating member 936. Referring again to Figures 9A–9C together, the blade holder portion 926 includes a molded lower surface 925. The molded lower surface 925 is described in more detail below with reference to Figures 10–11D. The skin penetration assembly 920 is coupled to an actuator 910 and is positioned to cover the opening 909 within a base 903 such that the movement of the actuator 910 causes the skin penetration assembly 920 to move toward / away from the opening 909 through a sealed area 906. The skin-penetrating assembly 920 further includes (i) a drive member 940 pivotably / rotatably mounted within the blade holder portion 926 of the casing 922; (ii) a skin-penetrating feature such as a blade 942 (not clearly visible in Figure 9B) coupled to the drive member 940; and (iii) a first biasing member 944 (e.g., a torsion spring, omitted in Figure 9A for clarity) operably coupling the drive member 940 to the casing 922. Referring to Figure 9A, the drive member 940 may include a body 945 and a second retaining feature 946 protruding from the body 945 to engage with a first retaining feature 930 of the trigger portion 924 in a pre-deployment position. The actuating member 936 of the trigger portion 930 may protrude substantially perpendicular to the drive member 940 and the blade 942.

[0047] In the pre-deployment position shown in Figures 9A and 9B, (i) the first biasing member 944 is biased (for example, under load) to rotate the drive member 940 counterclockwise around the pivot axis 941, and (ii) the second retaining feature 946 abuts against and engages with the first retaining feature 930, preventing the drive member 940 (and blade 942) from pivoting around the pivot axis 941 and maintaining the first biasing member 944 in a biased state. Referring again to Figures 9A to 9C together, the device 900 further includes a release member 950 (not clearly visible in Figure 9C) coupled to the base 903 within a sealed region 906. As will be described in detail below with reference to Figures 12A to 12D, the movement of the actuator 910 toward the base 903 engages the actuating member 936 of the trigger portion 924 with the release member 950, driving / bending the first retaining feature portion 930 toward the second retaining feature portion 946, allowing the first biasing member 944 to drive the drive member 940 around the pivot axis 941 to drive the blade 942 toward / beyond the lower surface 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 penetration assembly 920 toward 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, defining a sealed volume 991 (Figures 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 the interface between the first housing portion 902 and the second housing portion 904. The device 900 may further include a valve 994 (not clearly visible in Figure 9A) extending through the first housing portion 902 and configured to (i) allow air to exit the sealed volume 991 through the valve 994 to the outside of the device 900, and (ii) prevent air from entering the sealed volume 991 from the outside of 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 flexible member that can be bent and / or is elastic. Thus, downward movement of the actuator 910 toward the base 903 can bend the sealing member 992, reducing the volume of the sealing volume 991 and driving air out of the housing portion 902 through the valve 994. Conversely, upward movement of the actuator 910 toward away from the base 903 can bend the sealing member 992, increasing the volume of the sealing volume 991, while the valve 994 prevents air from entering the sealing volume, thereby reducing the pressure in the sealing volume 991 during use when the base 903 is sealed against the subject's skin and the collection reservoir is sealed-engaged with the connector 907. As described in detail above, this low pressure can act directly or indirectly against the subject's skin, pulling the skin toward / into the opening 909, for example, increasing the blood collection volume of the device 900.

[0049] In the illustrated embodiment, the device 900 further includes a removable cap 995 positioned on the actuator 910. The cap 995 can prevent the actuator 910 from operating before use, provide access to the actuator 910, and can be removed to enable use of the device 900. In some embodiments, the device 900 may further include a film and / or adhesive 984 (Figure 9C) that at least partially covers the bottom surface of the base 903.

[0050] Figure 10 is a side view of a skin-penetrating assembly 920 of a device 900 configured according to an embodiment of the present technology. The casing 922 is shown as partially transparent in Figure 10 for clarity. In the illustrated embodiment, the lower portion of the blade holder portion 926 includes a first projection 1061, a second projection 1063, and a gap portion 1065 between them, which collectively define the lower surface 925 (identified by reference numerals 925a-c). More specifically, the first projection 1061, the second projection 1063, and the gap portion 1065 define the first lower surface portion 925a, the second lower surface portion 925b, and the third lower surface portion 925c, respectively. In the illustrated embodiment, the first lower portion 925a and the second lower portion 925b are each substantially flat and extend substantially parallel to the horizontal axis H of the skin penetration assembly 920 (for example, the axis that extends perpendicular to the direction in which the skin penetration assembly 920 moves toward and away from the base 903 through the first housing 902 and the second housing 904, as shown in Figures 9A to 9C). Thus, the first lower portion 925a and the second lower portion 925b can be referred to as flat portions and / or similar. In the illustrated embodiment, the third lower portion 925c curves upward away from the first lower portion 925a and the second lower portion 925b and has a substantially curved trapezoidal shape, and the first projection 1061 and the second projection 1063 each have a trapezoidal or substantially curved trapezoidal shape.

[0051] As will be described in detail below with reference to Figures 12A to 12D (and as previously described in detail with reference to Figures 4A to 4D), by pushing down the actuator 910, the skin penetration assembly 920 can be moved toward the base 903 so that the lower surface 925 presses against and engages with the subject's skin. The subject's skin can be fitted to the lower surface 925 of the casing 922 such that the skin fills the gap portion 1065 and substantially contacts each of the lower surface portions 925a to c. Before the drive member 940 is activated (for example, when the device 900 is in the pre-deployment position and the partially deployed position), the blade 942 can be held within / adjacent to the first projection 1061 within the casing 922. As 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 projection 1063, thereby forming an incision 1072 within the subject's skin. In some embodiments, the first projection 1061 and the second projection 1063 are configured (shaped, sized, and positioned) to prevent the blade 942 from contacting the subject's skin until the blade 942 reaches the gap portion 1065 and sweeps through it.

[0052] In some embodiments of this technology, the contour of the lower surface 925 is expected to improve consistency in wound length, wound depth, blood collection, and / or other aspects of wound formation and blood collection of the device 900. The first lower surface portion 925a, the second lower surface portion 925b, and the third lower surface portion 925c may have a first width W1, a second width W2, and a third width W3, respectively. In some embodiments, the first width W1 may 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 smaller than the third width W3. For example, the third width W3 may be about 1.1 to 2.5 times (e.g., about 2.0 times) larger than the first width W1 and the second width W2. Furthermore, the gap portion 1065 may have a depth D that sets / controls the maximum depth of the incision 1072 formed by the blade 942, in combination with the arrangement and size of the blade 942.

[0053] In some embodiments, the shape of any of the first width W1 to the third width W3 and / or the shape of the lower portions 925a to c can be modified to alter the shape of the corresponding incision in the subject's skin. For example, Figures 11A to 11D are enlarged side views of a skin penetration assembly 920 according to an additional embodiment of the art. The casing 922 is shown as partially transparent in Figures 11A to 11D for clarity.

[0054] Referring first to Figure 11A, in the illustrated embodiment, the first projection 1061 and the second projection 1063 each have a more rounded shape than those shown in Figure 10. Furthermore, the first width W1 and the second width W2 of the first and second surface portions 925a and 925b are shorter than those shown in Figure 10, and therefore the third width W3 of the third surface portion 925c is relatively longer than the third width W3 shown in Figure 10. For example, the third width W3 can be about 4.0 to 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 or elongated trapezoidal 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 Figure 10. Thus, the incision portion 1072 resulting from the formation by the blade 942 can have a relatively long width and a short depth.

[0055] Referring now to Figure 11B, in the illustrated embodiment, the first projection 1061 and the second projection 1063 each have a more trapezoidal shape than those shown in Figure 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 those shown in Figure 10 and (ii) longer than those shown in Figure 11A. Thus, the third width W3 of the third surface portion 925c is relatively longer than the third width W3 shown in Figure 10, but shorter than that shown in Figure 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 Figure 10 and longer than the depth of the gap portion 1065 shown in Figure 11A. Furthermore, in the illustrated embodiment, the first projection 1061 and the second projection 1063 are configured (formed, sized, and positioned) to extend / pass alongside portions of the first lower surface portion 925a and the second lower surface portion 925b along their arc-shaped cutting path before the blade 942 reaches and sweeps through the gap portion 1065.

[0056] Referring next to Figure 11C, in the illustrated embodiment, the first width W1 and second width W2 of the first surface portion 925a and the second surface portion 925b are longer than those shown in Figure 10. Therefore, the third width W3 of the third surface portion 925c can be relatively shorter than the third width W3 shown in Figure 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 curve and a longer depth D than the gap portion 1065 shown in Figure 10. Therefore, the incision portion 1072 resulting from the formation by the blade 942 can have a relatively shorter width and a deeper depth than that shown in Figure 10.

[0057] Referring next to Figure 11C, in the illustrated embodiment, the first width W1 and second width W2 of the first surface portion 925a and the second surface portion 925b are longer than those shown in Figure 11C. Therefore, the third width W3 of the third surface portion 925c can be relatively shorter than the third width W3 shown in Figure 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 curve and a longer depth D than the gap portion 1065 shown in Figure 11C. Therefore, the incision portion 1072 resulting from the formation by the blade 942 can have a relatively shorter width and a deeper depth than that shown in Figure 11C.

[0058] Figures 12A to 12D are side cross-sectional views of the apparatus 900 shown in Figures 9A to 9C at different stages of a method for collecting bodily fluids from a subject according to an embodiment of this technology. In Figure 12A, the apparatus 900 is in the un-deployed position; in Figure 12B, it is in the partially-deployed position; in Figure 12C, it is in the fully-deployed position; and in Figure 12D, it is in the fully-deployed position.

[0059] Referring first to Figure 12A, the device 900 can initially be positioned against the skin of a subject (not shown) in a pre-deployment position. More specifically, the base 903 can be positioned 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 be sealed and engaged with the skin around the opening 909. The collection reservoir can be fixed to / covering the connector 907 (Figures 9B and 9C) before or after the device 900 is applied to the skin and can be sealed and engaged with the connector 907. Thus, the sealed volume 991 can be sealed after the device 100 has been applied to the skin with the collection reservoir fixed to the connector 907. Furthermore, in the pre-deployment position, the second biasing member 954 biases the actuator 910 (and the skin-penetrating assembly 920 attached thereto) away from the opening 909 of the base 903 in the direction indicated by arrow A (e.g., the retraction direction). Furthermore, the first biasing member 944 biases the drive member 940 to rotate counterclockwise. However, the engagement of the first retaining feature 930 and the second retaining feature 946 prevents the drive member 940 (and the blade 942) from pivoting around the pivot axis 941. Thus, the skin-penetrating assembly 920 is in a loaded or ready-to-fire state.

[0060] Referring next to Figure 12B, the device 900 can be moved from a pre-deployment position to a partially deployed position by moving the actuator 910 toward the base 903 in the direction indicated by arrow B (e.g., by being pressed by a subject or something else). By moving the actuator 910, the skin-penetrating assembly 920 moves through the sealed area 906 and at least partially through the opening 909 in the base 903. More specifically, in some embodiments, the lower surface 925 of the blade portion 926 of the casing 922 can extend at least partially through the opening 909 to contact the subject's skin 970. As described in detail above with reference to Figures 10-11D, the contoured lower surface 925 can push down the subject's skin so that the skin conforms to the shape of the lower surface 925. Furthermore, in the partially deployed position, the retaining feature 930 still engages with the second retaining feature 946 to prevent the drive member 940 (and blade 942) from pivoting around the pivot axis 941. In some embodiments, the actuator 936 can slightly contact the release member 950 such that the trigger portion 924 is slightly bent outward in the direction of arrow C away from the blade portion 926 and the drive member 940. Movement of the actuator 910 in the direction indicated by arrow B also compresses the sealing member 992, thereby reducing the volume of the sealing volume 991 and expelling air from the sealing volume 991 through the valve 994 (Figures 9B and 9C).

[0061] Referring next to Figure 12C, the device 900 can be moved from a partially deployed position to a fully deployed position by continuing to move the actuator 910 toward the base 903 in the direction indicated by arrow B. As the actuator 910 continues to move, the first retaining feature 930 of the trigger portion 924 moves to engage with the release member 2950, ​​thereby bending away from the second retaining feature 946 and disengaging from the second retaining feature, 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. Once the second retaining feature 946 is disengaged from the first retaining feature 930, the first biasing member 944 moves from a biased state to at least a partially relaxed state, thereby configured to drive the drive member 940 to pivot around the pivot axis 941. As the drive member 940 pivots, it simultaneously moves the blade 942 along an arc-shaped path, passing over the lower surface 925 of the casing and across at least a portion of the opening 909 (e.g., sweeping), to form an incision in the subject's skin. The shape of the resulting incision can be determined by the shape of the contoured lower surface 925, as described in detail above with reference to Figures 10-11D. After deployment, the blade 942 can be fully positioned within the casing 922 (e.g., with the tip of the blade 942 covered by the second projection 1063). In some embodiments, the blade portion 926 includes a stopping feature 1299 configured to engage with a second retaining feature 946 and prevent further movement of the drive member 940 and the blade 942.

[0062] Referring next to Figure 12D, the device 900 can be moved from the deployed position to the post-deployed position by releasing the actuator 910, which allows the second biasing member 954 to drive the actuator 910 and the skin penetration assembly 920 away from the base 903 in the direction indicated by arrow A. Retraction of the actuator 910 can move the skin penetration assembly 920 completely into the sealed area 906, away from contact with the subject's skin. In some embodiments, referring together to Figures 12A and 12D, the second biasing member 954 can return the actuator 910 to the pre-operation position. Nevertheless, the device 900 may be configured as a disposable device that cannot be redeployed. For example, in the illustrated embodiment, the device 900 is configured such that the operation 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 post-deployment configuration (for example, after the drive member 940 is released from the trigger portion 924), and therefore cannot drive the blade 942 through the opening 909.

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

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

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

[0066] In the illustrated embodiment, the drive member 1340 includes a projection 1364, and the casing 1322 includes / defines a track 1362 (e.g., an opening, channel, or elongated path). The projection 1364 extends at least partially into the track 1362 so that the projection 1364 is restricted to moving along the track 1362. The track 1362 may extend between a first end 1361 and a second end 1363 and may 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 (Figure 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 activated, 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 of the track 1362 (e.g., shape, size, length) so that the blade 1326 passes through the lower surface 1325 and into the subject's skin, forming an incision 1372. More specifically, in the illustrated embodiment, the skin penetration assembly 1320 moves laterally from the first end 1361 to the second end 1363 while rotating, causing the blade 1326 to extend beyond the lower surface 1325 as the projection 1364 passes along the intermediate portion 1365 of the track 1362. In some embodiments, the configuration of the intermediate portion 1365 and the lower surface 1325 (e.g., shape, size) can control the depth and / or shape of the incision formed by the blade 1326. In some aspects of this technology, the incision portion 1372 may have a shape similar to any of the incisions 1072 described in detail above with reference to Figures 10-11D.

[0068] The following examples illustrate various embodiments of the present technology. 1. A device for collecting bodily fluids from a subject, wherein the device is A housing comprising a base and an opening member extending from the base, wherein the base has an opening extending through it, A skin-penetrating assembly that is at least partially located within a housing, wherein the skin-penetrating assembly is The trigger portion and the blade holder portion, A drive member pivotably connected to the blade holder portion, A blade supported by a drive member, A skin penetration assembly including a biasing member operably coupled to a drive member, The device comprises an actuator operably coupled to a skin penetration 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 with the trigger portion to maintain the biasing member in a biased configuration. A device in which the movement of an actuator from a first position to a second position is configured such that the trigger portion engages with a release member, disengaging the trigger portion from the drive member, and allowing the biasing member to drive the blade at least partially through an opening in the base. 2. The apparatus according to Embodiment 1, wherein the movement of the actuator from the first position to the second position is configured to engage the trigger portion with the release member and deflect the trigger portion away from the blade holder portion. 3. The apparatus according to Example 1 or Example 2, wherein the blade holder portion includes a lower surface configured to extend at least partially through an opening in the base when the actuator is in a second position. 4. The apparatus according to Embodiment 3, wherein the blade holder includes a first projection, a second projection, and a gap between the first projection and the second projection, the first projection, the second projection, and the gap define the lower surface of the blade holder. 5. The apparatus according to Example 4, wherein the first projection and the second projection each include a substantially flat lower surface. 6. The apparatus according to Example 5, wherein the gap portion has a substantially curved trapezoidal shape. 7. The apparatus according to Example 5, wherein the gap portion has a generally bell-shaped curve. 8. The apparatus according to any one of Examples 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. 9. The apparatus 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. 10. A flexible sealing member is positioned inside the housing and defines the sealing volume within the housing, covering the opening of the base. The apparatus according to any one of Examples 1 to 9, further comprising: a one-way valve coupled to a housing, configured to (a) prevent air from entering the sealing volume from outside the apparatus, and (ii) allow air to exit the sealing volume to the outside of the apparatus.

[0069] 11. A device for collecting bodily fluids from a subject, wherein the device is A housing comprising a base having an opening extending through it, wherein the base is configured to be positioned adjacent to the skin of a subject, A skin-penetrating assembly that is at least partially located within a housing, wherein the skin-penetrating assembly is A casing having a bottom surface, A blade pivotably coupled to the casing, A skin-penetrating assembly including a biasing member operably coupled to the blade and configured to drive the blade relative to its underside, A skin-penetrating assembly comprises an actuator operably coupled to the housing and movable relative to the housing, The actuator is movable to a first position to drive the lower surface of the casing to contact the skin at least partially through the opening in the base, A device in which the actuator is movable to a second position that releases the biasing member, allowing the biasing member to drive the blade along a path through the skin relative to the underside of the casing. 12. The apparatus according to Example 11, wherein the lower surface of the casing has a curved shape. 13. The apparatus according to Example 11 or 12, wherein the lower surface of the casing has a shape that matches the path of the blade so that the blade extends through the skin at a generally uniform depth along the path. 14. The apparatus according to any one of Examples 11 to 13, wherein the casing includes a first projection, a second projection, and a gap between the first projection and the second projection, and the first projection, the second projection, and the gap define the lower surface of the blade holder. 15. The apparatus according to Example 14, wherein the first projection and the second projection each include a substantially flat lower surface. 16. The apparatus according to Example 15, wherein the gap portion has a substantially curved trapezoidal shape. 17. The apparatus according to Example 15, wherein the gap portion has a generally bell-shaped curve. 18. The apparatus according to any one of Examples 15 to 17, wherein the width of the first projection and the width of the second projection are greater than the width of the gap. 19. A casing including a trigger portion and a blade holder portion, wherein the trigger portion is at least partially separated from the blade holder portion, the trigger portion includes a first retaining feature, and the blade holder portion includes a lower surface, A drive member pivotably coupled to the blade holder portion of the casing, the drive member including a second holding feature portion, A blade supported by a drive member, A biasing member is operably coupled between the drive member and the casing, In the pre-deployment position, the second retaining feature is configured to engage with the first retaining feature in order to maintain the biasing member in the loading configuration. A skin-penetrating assembly in which, in the deployed position, a second retaining feature is configured to disengage a first retaining feature in order to allow a biasing member to pivot the blade and pass at least partially through the underside of the casing. 20. The skin-penetrating assembly according to Example 19, wherein the blade portion of the casing includes a first projection, a second projection, and a gap portion between the first projection and the second projection, the first projection, the second projection, and the gap portion define the lower surface of the blade holder, and the first projection and the second projection each include a substantially flat lower surface. 21. A device for collecting bodily fluids from a subject, wherein the device is A housing having side walls and connectors extending from the side walls, An actuator movable relative to the side wall of a housing, wherein the housing and the actuator define at least partially a sealed region, and the connector includes a channel that fluidly communicates with the sealed region; The system comprises a sealing member coupled to an actuator and configured to seal the interface between the actuator and the side wall of the housing, The movement of the actuator in the first direction reduces the volume of the sealed area, causing the sealing member to advance through the channel in the connector at least partially, and allowing the pressure within the sealed area to be equalized via a fluid path that extends (a) from the sealed area, (b) through the sealing member and the channel, and (c) between the actuator and the side wall to the outside of the housing. A device wherein the movement of an actuator in a second direction opposite to the first direction increases the volume of a sealed area and advances the sealing member along the upper side wall of the channel so that the pressure within the sealed area is reduced. 22. The apparatus according to Embodiment 21, further comprising a retraction actuator operably coupled between the housing and the actuator and configured to drive the actuator in a second direction. 23. The apparatus according to Embodiment 22, wherein movement of the actuator in a first direction increases the load on the retracting actuator.

[0070] The above detailed description of embodiments of the Art is not intended to be exhaustive or to limit the Art to the exact forms disclosed above. While specific embodiments and examples of the Art are described above for illustrative purposes, various equivalent modifications are possible within the scope of the Art, as will be apparent to those skilled in the art. For example, while the steps are presented in a given order, alternative embodiments may perform the steps in a different order. Further embodiments may be provided by combining the various embodiments described herein.

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

[0072] Furthermore, unless the word “or” is explicitly limited to mean only a single item that is exclusive to the other items in 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 items in the list, or (c) any combination of items in the list. Furthermore, the term “comprising” is used throughout to mean including at least the enumerated features so as not to exclude any more identical features and / or other features of additional types. While certain embodiments are described herein for illustrative purposes, it will be understood that various modifications can be made without departing from the Art. Furthermore, while some advantages related to certain embodiments of the Art have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments are necessarily required to exhibit such advantages in order to fall within the scope of the Art. Thus, the Disclosure and related Art may encompass other embodiments not expressly illustrated or described herein.

Claims

1. A device for collecting bodily fluids from a subject, wherein the device is A housing comprising a base and an opening member extending from the base, wherein the base has an opening extending through it, A skin penetration assembly, at least partially disposed within the housing, wherein the skin penetration assembly is A trigger portion and a blade holder portion, wherein the blade holder portion includes a lower surface, A drive member movably coupled to the blade holder portion, The blade is supported by the aforementioned drive member, A skin penetration assembly including a biasing member operably coupled to the drive member, The device comprises an actuator operably coupled to the skin penetration 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 with the trigger portion in order to maintain the biasing member in a biased configuration. The apparatus is configured such that the 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, and when the actuator is in the second position, the lower surface of the blade holder portion extends at least partially through the opening in the base.

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

3. The apparatus according to claim 1, wherein the blade holder portion 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 the lower surface of the blade holder portion.

4. The apparatus according to claim 3, wherein each of the first and second protrusions includes a flat lower surface region.

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

6. The apparatus according to claim 4, wherein the gap portion has a bell-shaped curved form.

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

8. The apparatus according to claim 4, wherein the width of the first protrusion and the width of the second protrusion are smaller than the width of the gap portion.

9. A device for collecting bodily fluids from a subject, wherein the device is A housing comprising a base and an open member extending from the base, wherein the base has an opening extending through it, and the housing is configured such that the base is positioned against the skin of the subject, A skin penetration assembly, at least partially disposed within the housing, wherein the skin penetration assembly is The trigger part, A blade holder portion having a lower surface, A drive member movably coupled to the blade holder portion, The blade is supported by the aforementioned drive member, A skin penetration assembly including a biasing member operably coupled to the drive member, A flexible sealing member is disposed within the housing and defines the sealing volume within the housing, covering the opening of the base. A one-way valve coupled to the housing is configured to (a) prevent air from entering the sealing volume from outside the device, and (ii) allow air to exit the sealing volume to the outside of the device. The device comprises an actuator operably coupled to the skin penetration 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 with the trigger portion in order to maintain the biasing member in a biased configuration. The apparatus is configured such that the 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 drive the blade into the skin, and the lower surface of the blade holder portion is configured to extend at least partially through the opening of the base and contact the skin when the actuator is in the second position.

10. A device for collecting bodily fluids from a subject, wherein the device is A housing comprising a base having an opening extending through it, wherein the base is configured to be positioned adjacent to the skin of the subject, A skin penetration assembly, at least partially disposed within the housing, wherein the skin penetration assembly is A casing having a bottom surface, A blade movably coupled to the casing, A skin penetration assembly comprising: a biasing member operably coupled to the blade and configured to drive the blade relative to the lower surface; The skin penetration assembly comprises an actuator operably coupled to the skin penetration assembly and movable relative to the housing, The actuator is movable to a first position to drive the lower surface of the casing to at least partially contact the skin through the opening of the base, The actuator is movable to a second position which releases the biasing member, allowing the biasing member to drive the blade along a path through the skin relative to the lower surface of the casing.

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

12. The apparatus according to claim 10, wherein the lower surface of the casing has a shape that matches the path of the blade so that the blade extends through the skin at a substantially uniform depth along the path.

13. The apparatus according to claim 10, wherein the casing includes a first projection, a second projection, and a gap between the first projection and the second projection, and the first projection, the second projection, and the gap define the lower surface of the casing.

14. The apparatus according to claim 13, wherein each of the first and second protrusions includes a flat lower surface.

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

16. The apparatus according to claim 14, wherein the gap portion has a bell-shaped curved form.

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

18. A device for collecting bodily fluids from a subject, wherein the device is A housing comprising a base configured to be positioned against the skin of a subject, and a release member fixedly coupled to the base and extending from the base, wherein the base has an opening extending through it, A skin penetration assembly, at least partially disposed within the housing, wherein the skin penetration assembly is The trigger part, A blade holder portion having a lower surface, A drive member movably coupled to the blade holder portion, The blade is supported by the aforementioned drive member, A skin penetration assembly including a biasing member operably coupled to the drive member, The device comprises an actuator operably coupled to the skin penetration 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 with the trigger portion in order to maintain the biasing member in a biased configuration. The apparatus is configured such that the 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, and the lower surface of the blade holder portion is configured to extend at least partially through the opening in the base and in contact with the skin when the actuator is in the second position.

19. The apparatus according to claim 18, wherein the trigger portion and the blade holder portion are integrally formed.

20. The apparatus according to claim 18, wherein the housing defines a lumen, and the release member extends upward from the base into the lumen.

21. The apparatus according to 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 according to claim 18, wherein the biasing member is a torsion spring.

23. The apparatus according to claim 18, wherein the actuator is fixedly coupled to the skin penetration assembly.

24. The apparatus according to claim 18, wherein the release member extends upward along the 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. A device for collecting bodily fluids from a subject, wherein the device is A housing comprising a base having an opening extending through it, wherein the base is configured to be positioned adjacent to the skin of the subject, A skin penetration assembly, at least partially disposed within the housing, wherein the skin penetration assembly is A casing having a bottom surface, A skin-penetrating assembly including a blade configured to move relative to the lower surface, The skin penetration assembly comprises an actuator operably coupled to the skin penetration assembly and movable relative to the housing, The actuator is movable to a first position to drive the lower surface of the casing to at least partially contact the skin through the opening of the base, A device wherein the actuator is movable to a second position to allow the blade to move relative to the lower surface of the casing along a path through the skin.

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

27. The apparatus according to claim 25, wherein at least a portion of the lower surface of the casing has a shape that matches the path of the blade so that the blade extends through the skin at a substantially uniform depth along the path.

28. The apparatus according to claim 25, wherein the casing includes a first projection, a second projection, and a gap between the first projection and the second projection, and the first projection, the second projection, and the gap define the lower surface of the casing.

29. The apparatus according to claim 28, wherein each of the first and second protrusions includes a flat lower surface.

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

31. The apparatus according to claim 28, wherein the gap portion has a trapezoidal shape.

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