Bodily fluid collection devices for collecting high quality blood for complete blood count (CBC) testing, and related methods

Abstract

Devices and methods for withdrawing high-quality bodily fluid, such as blood, from a subject are disclosed herein. In some embodiments, a handheld device bodily fluid collection device can include a housing having an opening, a skin-piercing assembly, and an actuator coupled to the skin-piercing assembly. The actuator can be actuated to cause a blade of the skin-piercing assembly to form an incision in the skin of a patient. Blood can flow into the device through the opening and along a flow path of the collection device to a collection reservoir releasably coupled to the collection device. Some or all of the flow path can be coated with an antifouling or anticoagulant coating having hydrophobic and / or hydrophilic properties to reduce clotting of the blood along the flow path and preserve the quality of the blood for, for example, use in complete blood count (CBC) testing.

Description

BODILY FLUID COLLECTION DEVICES FOR COLLECTING HIGH QUALITY BLOOD FOR COMPLETE BLOOD COUNT (CBC) TESTING, AND RELATED METHODSCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 584,811, filed September 22, 2023, and titled “BODILY FLUID COLLECTION DEVICES FOR COLLECTING HIGH QUALITY BLOOD FOR COMPLETE BLOOD COUNT (CBC) TESTING, AND RELATED METHODS. " which is incorporated herein by reference in its entirety.TECHNICAL FIELD

[0002] The present technology is related to collecting bodily fluid from a subject and, in particular, to handheld bodily fluid collection devices and related methods for collecting high quality blood for complete blood count (CBC) testing.BACKGROUND

[0003] Devices, systems, and methods to collect bodily fluids, such as blood, are widely used in personalized, clinical, and field medical applications. Biological samples are commonly collected using simple lancing devices or more sophisticated devices that require trained personnel (e.g., phlebotomy venipunctures). Transferring bodily fluids to a container, receptacle, or an analysis device often requires several steps, which can be time consuming, prone to error, and / or cumbersome. Moreover, many personalized devices designed for untrained users can only collect low quality7blood samples, which in turn limits the applicability7of such devices.

[0004] High quality blood samples are necessary for some blood tests, such as a complete blood count (CBC), also known as a full blood count (FBC). A CBC comprises a set of medical laboratory tests that provide information about the cells in a person’s blood to look at overall health and find a wide range of conditions. The CBC indicates the counts of white blood cells, red blood cells and platelets, the concentration of hemoglobin, and the hematocrit (the volume percentage of red blood cells). The red blood cell indices, which indicate the average size andhemoglobin content of red blood cells, are also reported, and a white blood cell differential, which counts the different types of white blood cells, may be included.

[0005] The CBC is often carried out as part of a medical assessment and can be used to monitor health or diagnose diseases. The results are interpreted by comparing them to reference ranges, which vary with sex and age. Conditions like anemia and thrombocytopenia are defined by abnormal CBC results. The red blood cell indices can provide information about the cause of a person’s anemia such as iron deficiency and vitamin B12 deficiency, and the results of the white blood cell differential can help to diagnose viral, bacterial, and parasitic infections and blood disorders like leukemia.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Many aspects of the present technology can be better understood w ith reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on clearly illustrating the principles of the present technology.

[0007] Figure 1A is a perspective view of a bodily fluid collection device configured in accordance with embodiments of the present technology.

[0008] Figure IB is a perspective view of the bodily fluid collection device of Figure 1A during use in accordance with embodiments of the present technology.

[0009] Figure 1C is a perspective view illustrating detachment of a collection reservoir from the bodily fluid collection device of Figures 1A and IB in accordance with embodiments of the present technology.

[0010] Figures 2A and 2B are cross-sectional side views of a bodily fluid collection device configured in accordance with embodiments of the present technology7.

[0011] Figure 2C is an exploded view of the bodily fluid collection device of Figures 2A and 2B.

[0012] Figure 3 is a partially transparent side view of a skin-piercing assembly of the bodily fluid collection device of Figures 2A-2C.

[0013] Figures 4A-4D are cross-sectional side views of the bodily fluid collection device of Figures 2A-2C and at different stages of a method of withdrawing bodily fluid from a subject in accordance with embodiments of the technology.

[0014] Figures 5 A and 5B are cross-sectional side views of a bodily fluid collection device configured in accordance with additional embodiments of the present technology.

[0015] Figure 6 is an enlarged cross-sectional side view of the bodily fluid collection device of Figures 5A and 5B configured in accordance with additional embodiments of the present technology.

[0016] Figure 7 is a partially cross-sectional side view of a bodily fluid collection device configured in accordance with another embodiment of the present technology.

[0017] Figure 8A is a cross-sectional side view of a bodily fluid collection device configured in accordance with additional embodiments of the present technology.

[0018] Figures 8B and 8C are isometric side and front views, respectively, of an insertable member of the bodily fluid collection device of Figure 8A configured in accordance with embodiments of the present technology.DETAILED DESCRIPTION

[0019] The present technology is directed generally to devices and methods for withdrawing high-quality bodily fluid, such as blood, from a subject. A handheld device bodily fluid collection device configured in accordance with the present technology can include a housing having an opening, a skin-piercing assembly positioned at least partially within the housing, and an actuator coupled to the skin-piercing assembly. The actuator can be actuated to cause a blade of the skin-piercing assembly to form an incision in the skin of a patient. After forming the incision, blood can flow into the device through the opening and along a flow path of the collection device to a collection reservoir releasably coupled to the collection device. Some or all of the flow path can be coated with an antifouling and / or anticoagulant coating having hydrophobic and / or hydrophilic properties to reduce clotting of the blood along the flow path and preserve the quality of the blood for use in, for example, complete blood count (CBC) testing. In some embodiments, a length of the flow path along which the blood travels can be reduced — or eliminated entirety — such that blood flows quickly / directly into the collection reservoir, which can include an anticoagulant for stabilizing the blood sample.

[0020] Specific details of several embodiments of the present technology are described herein with reference to Figures 1A-8C. However, the present technology may be practiced without some of these specific details. In some instances, well-known structures and techniques often associated with bodily fluid collection devices, CBC tests, anticoagulants, antifoulingcoatings, hydrophilic coatings, hydrophobic coatings, and the like have not been shown in detail so as not to obscure the present technology. The terminology’ used in the description presented below is intended to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific embodiments of the disclosure. Certain terms may even be emphasized below; however, any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this Detailed Description section.

[0021] The accompanying Figures depict embodiments of the present technology and are not intended to be limiting of its scope. The sizes of various depicted elements are not necessarily’ drawn to scale, and these various elements may be arbitrarily enlarged to improve legibility. Component details may be abstracted in the Figures to exclude details such as position of components and certain precise connections between such components when such details are unnecessary for a complete understanding of how to make and use the present technology. Many of the details, dimensions, angles, and other features shown in the Figures are merely illustrative of particular embodiments of the disclosure. Accordingly, other embodiments can have other details, dimensions, angles, and features without departing from the spirit or scope of the present technology.

[0022] The headings provided herein are for convenience only and should not be construed as limiting the subject matter disclosed.A. Select Embodiments of Bodily Fluid Collection Devices

[0023] Figure 1A is a perspective view of a bodily fluid collection device 100 (“device 100”) configured in accordance with embodiments of the present technology’. The device 100 can be handheld with a size that is easily grasped and manipulated by one or both of a patient's hands. Such handheld devices advantageously allow a patient to collect a bodily fluid sample (e.g., a blood sample) without assistance from another individual. In some embodiments, the handheld devices of the present technology can be operated by a layperson outside of a medical setting (e.g., at home or in a field clinic) and without the aid of a medical professional.

[0024] In the illustrated embodiment, the device 100 includes a housing 102 and an actuator 104. The actuator 104 (e.g., a button) can be movable relative to the housing 102 to actuate / initiate withdrawal of a bodily fluid (e.g.. blood) from the patient. The housing 102 is removably coupled to a collection reservoir 106 (e g., a tube, a collection device, a transferdevice, a cartridge, and / or the like) for receiving the bodily fluid withdrawn from the patient. The collection reservoir 106 can act as a removable and standardized container for bodily fluid that can be detached and used in clinical and laboratory equipment or workflows (e.g., for diagnostics and / or biomarker detection).

[0025] Figure IB is a perspective view of the bodily fluid collection device 100 of Figure 1 A in use by the patient in accordance with embodiments of the present technology. To collect a bodily fluid sample, the device 100 is applied to a patient's body, with a bottom surface of the housing 102 positioned against the skin 101 of the patient and the actuator 104 positioned away from the skin 101. Actuating (e.g., pressing, twisting, pulling) the actuator 104 deploys a skinpiercing feature (e.g., a blade, lancet) from within the device 100 to pierce the skin 101. In some embodiments, the device 100 is configured to generate a vacuum within the device 100 that acts against the patient's skin either directly or indirectly, and before and / or after deployment of the skin-piercing feature. Bodily fluid from the resulting incision is withdrawn into the housing 102 and collected into the collection reservoir 106.

[0026] Figure 1C is a perspective view illustrating detachment of the collection reservoir 106 from the bodily fluid collection device 100 of Figures 1A and IB in accordance with embodiments of the present technology7. Once a desired amount of bodily fluid has been collected into the collection reservoir 106, the device 100 is removed from the skin 101, and the collection reservoir 106 is detached from the housing 102. In some embodiments, the device 100 can include one or more features that are generally similar to or identical to the bodily fluid collection devices disclosed in (i) U.S. Patent No. 10,779,757, filed August 3, 2015; (ii) U.S. Patent No. 11,523,805, filed September 21, 2017, and / or (iii) International Patent Application Publication No. WO 2021 / 076846, filed October 16, 2020, each of which is incorporated herein by reference in its entirety.

[0027] Figures 2A and 2B are cross-sectional side views of a bodily fluid collection device 200 (’‘device 200”) in accordance with additional embodiments of the present technology. The cross-sectional side view of Figure 2B is rotated 90 degrees relative to the view shown in Figure 2A. The device 200 is in a pre-deployed position in Figures 2A and 2B. Figure 2C is an exploded view of the device 200 of Figures 2A and 2B. The device 200 can include some features that are at least generally similar in structure and function, or identical in structure and function, to the corresponding features of the device 100 described in detail above with reference to Figures 1 A-1C, and can operate in a generally similar or identical manner to the device 100.

[0028] In some embodiments, the device 200 has some features generally similar or identical to, and / or can operate generally similarly or identically to, any of the bodily fluid collection devices disclosed in (i) U.S. Patent No. 10,426,390, filed December 21, 2016, (ii) U.S. Patent Application No. 16 / 571,028, filed September 13, 2019, (iii) U.S. Patent Application No. 17 / 006,248, filed August 28, 2020, and / or (iv) U.S. Patent No. 11,633,136, filed February 25, 2022, each of which is incorporated herein by reference in its entirety. For example, the device 200 can be handheld with a size that is easily grasped and manipulated by one or both of a subject’s hands. Such handheld devices advantageously allow a subject to collect a bodily fluid sample (e.g., a blood sample) without assistance from another individual. In some embodiments, the device 200 can be operated by a layperson outside of a medical setting (e g., at home or in a field clinic) and without the aid of a medical professional.

[0029] Referring to Figures 2A-2C together, the device 200 includes a housing comprising a first (e.g., lower) housing portion 202 and a second (e.g., upper) housing portion 204 that can be secured together via, for example, an interference fit, adhesives, fasteners, and so on. The first housing portion 202 includes a base 203 and a connector 207 (Figures 2B and 2C). As shown in Figures 2A and 2B, the base 203 includes / defines an opening 209 extending therethrough and opening to an enclosed region 206. The connector 207 can define a channel 208 in fluid communication with the enclosed region 206, and is configured to be removably coupled to a collection reservoir (not shown: e.g., a collection reservoir 506 shown in Figures 5B-8A) for receiving bodily fluid withdrawn from a subject. In some embodiments, an O-ring 223 (Figures 2B and 2C) or other sealing member can be positioned around the connector 207 to sealing engage the collection reservoir. The base 203 of the first housing portion 202 can define / include a fluidic channel 260 (Figure 2B) extending from the opening 209 in the base 203 to the outflow channel 208 in the connector 207. The device 200 further includes an actuator 210 movably coupled to and / or within the first housing portion 202 and / or the second housing portion 204, and a skin-piercing assembly 220 coupled to the actuator 210 and at least partially positioned within the enclosed region 206.

[0030] The skin-piercing assembly 220 includes a casing 222 (e.g., a cartridge) having a trigger portion 224 (e.g., a follower; obscured in Figure 2B) and a blade holder portion 226. As best seen in Figure 2A, the trigger portion 224 includes a first retaining feature 230 projecting toward the blade holder portion 226, and an actuation member 236. Referring again to Figures 2A-2C together, the blade holder portion 226 includes a shaped lower surface 225. The shaped lower surface 225 is described in further detail below with reference to Figure 3. The skin-piercing assembly 220 is coupled to the actuator 210 and positioned over the opening 209 in the base 203 such that movement of the actuator 210 moves the skin-piercing assembly 220 through the enclosed region 206 toward / away from the opening 209. The skin-piercing 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-piercing feature, such as a blade 242 (obscured in Figure 2B), coupled to the drive member 240, and (iii) a first biasing member 244 (e.g.. a torsion spring; omitted in Figure 2A for clarity) operably coupling the drive member 240 to the casing 222. Referring to Figure 2A, the drive member 240 can include a body 245 and a second retaining feature 246 projecting from the body 245 to engage the first retaining feature 230 of the trigger portion 224 in the pre-deployed position. The actuation member 236 of the trigger portion 224 can project generally orthogonal to the drive member 240 and the blade 242.

[0031] In the pre-deployed position shown in Figures 2A and 2B, (i) the first biasing member 244 is biased (e.g., under load) to rotate the drive member 240 about a pivot axis 241 in a counterclockwise direction and (ii) the second retaining feature 246 abuts and engages the first retaining feature 230 to inhibit the drive member 240 (and the blade 242) from pivoting about the pivot axis 241 and to maintain the first biasing member 244 in a biased state. Referring again to Figures 2A-2C. the device 200 further includes a release member 250 (obscured in Figure 2C) coupled to the base 203 within the enclosed region 206. As described in detail below with reference to Figures 4A-4D, movement of the actuator 210 toward the base 203 engages the actuation member 236 of the trigger portion 224 with the release member 250 to drive / flex the first retaining feature 230 away from the second retaining feature 246 to permit the first biasing member 244 to drive the drive member 240 about the pivot axis 241 to drive the blade 242 along / past the lower surface 225 of the casing 222. The device 200 can further include a second biasing member 254 operably coupled between the actuator 210 and the first housing portion 202 and / or the second housing portion 204 and configured to bias and drive the actuator 210 and the skin-piercing assembly 220 away from the base 203.

[0032] In the illustrated embodiment, the device 200 further includes a sealing member 292 coupled between the actuator 210 and the first housing portion 202 and / or the second housing portion 204 and defining a sealed volume 291 (Figures 2A and 2B) over the opening 209 within the enclosed region 206. For example, in the illustrated embodiment the sealing member 292 is secured at / to an interface between the first housing portion 202 and the second housing portion 204. The device 200 can further include a valve 294 (obscured in Figure 2A) extending through the first housing portion 202 and configured to (i) permit air to leave throughthe valve 294 from the sealed volume 291 to outside the device 200 and (ii) inhibit air from entering through the valve 294 from outside the device 200 to within the sealed volume 291. Accordingly, the valve 294 can be a one-way valve, such as an umbrella valve. The sealing member 292 can be a flexible membrane or member that can bend and / or is elastic. Accordingly, downward movement of the actuator 210 toward the base 203 can flex the sealing member 292 to decrease the volume of the sealed volume 291 and drive air through the valve 294 to outside the housing portion 202. Oppositely, upward movement of the actuator 210 in a direction away from the base 203 can flex the sealing member 292 to increase the volume of the sealed volume 291 while the valve 294 inhibits air from entering the sealed volume — thereby decreasing the pressure in the sealed volume 291 during use when the base 203 is sealed against the skin of the subject and a collection reservoir sealingly engages the connector 207. This low pressure can act directly or indirectly against the skin of the subject to draw the skin toward / into the opening 209 to, for example, increase a blood draw volume of the device 200.

[0033] In the illustrated embodiment, the device 200 further includes a removable cap 295 positioned over the actuator 210. The cap 295 can inhibit actuation of the actuator 210 before use, and can be removed to provide access to the actuator 210 and allow use of the device 200. Referring to Figure 2C, in some embodiments, the device 200 further includes a membrane 284 attached to the base 203 (e.g., a lower surface thereof) and spanning laterally across at least a portion of the opening 209 (Figures 2 A and 2B). The membrane 284 can be bendable and / or stretchable (e.g., elastic). For example, the membrane 284 can comprise polyurethane, silicone, and / or other suitably elastic materials. The membrane 284 help facilitate a seal with the skin of a subject and can direct withdrawn bodily fluid thereacross (e.g.. across an upper surface of the membrane 284) to the fluidic channel 260 (Figure 2B). In some embodiments, the membrane 284 includes a pre-cut opening 285 aligned with the blade 242 such that the blade 242 can extend therethrough during deployment. In other embodiments, the opening 285 can comprise a sealed but weakened or frangible line along the membrane 284. In some embodiments, the membrane 284 is relatively thin — for example, having a thickness of less than or equal to about 250 pm, or between about 50-400 pm. In some embodiments, the membrane 284 can be of the type described in detail in U.S. Patent Application No. 16 / 571,028, which was previously- incorporated herein by reference. In some embodiments, a liner layer 286 (e.g.. a protective layer, a sanitary layer) can cover the membrane 284 prior to use, and can be removed (e.g., peeled away) by a subject prior to use.

[0034] Figure 3 is a partially transparent side view of the skin-piercing assembly 220 of the device 200 of Figures 2A-2C. The casing 222 is shown as partially transparent in Figure 3 for clarity. In the illustrated embodiment, a lower portion of the blade holder portion 226 includes a first projection 361, a second projection 363, and agap portion 365 therebetween that collectively define the lower surface 225 (identified via reference numbers 225a-c). More specially, the first projection 361, the second projection 363. and the gap portion 365 define a first lower surface portion 225a. a second lower surface portion 225b, and a third lower surface portion 225c, respectively. In the illustrated embodiment, the first and second lower surface portions 225a-b are each generally planar and extend substantially parallel to a horizontal axis H of the skin-piercing assembly 220 (e.g., an axis extending orthogonal to the direction the skinpiercing assembly 220 moves through the first and second housing portions 202, 204 toward and away from the base 203 as shown in Figures 2A-2C). Accordingly, the first and second lower surface portions 225a-b can be referred to as flat portions and / or the like. In the illustrated embodiment, the third lower surface portion 225c curves upward aw ay from the first and second lower surface portions 225a-b and has a generally curved-trapezoidal shape, and the first and second projections 361, 363 each have a generally trapezoidal or curved trapezoidal shape.

[0035] As described in detail below with reference to Figures 4A-4D, depressing the actuator 210 can move the skin-piercing assembly 220 toward the base 203 such that the lower surface 225 presses against and engages skin of the subject. The skin of the subject can conform to the lower surface 225 of the casing 222 such that the skin fills the gap portion 365 and substantially contacts each of the lower surface portions 225a-c. Before actuation of the drive member 240 (e.g., when the device 200 is in the pre-deployed and partially-deployed positions), the blade 242 can be retained within the casing 222 within / adj acent to the first projection 361. When the drive member 240 is rotated by the first biasing member 244, the blade 242 can sweep across the gap portion 365 before being covered and retained by the second projection 363 — forming an incision 372 within the skin of the subject. In some embodiments, the first and second projections 361, 363 are configured (shaped, sized, positioned) to inhibit the blade 242 from contacting the skin of the subject until the blade 242 reaches and sweeps through the gap portion 365. In other embodiments, the sizes, shapes, etc., of the first, second, and third lower surface portions 225a-c can be different to change the shape of the corresponding incision 372 in the skin of the subject.

[0036] Figures 4A-4D are cross-sectional side views of the device 200 of Figures 2A-2C at different stages of a method of withdrawing bodily fluid from a subject in accordance withembodiments of the technology. The device 200 is in the pre-deployed position in Figure 4A, a partially-deployed position in Figure 4B, a deployed position in Figure 4C, and a post-deployed position in Figure 4D.

[0037] Referring first to Figure 4A, the device 200 can initially be placed against the skin of a subject (not shown) in the pre-deployed position (e.g., a loaded position). More specifically, the base 203 can be positioned against the skin such that the opening 209 is over a portion of the skin. In some embodiments, the base 203 (e.g., a lower surface thereof) sealingly engages the skin around the opening 209 and / or the membrane 284 (Figure 2C; omitted in Figures 4A-4D) sealingly engages the skin around and / or over the opening 209. A collection reservoir can be secured to / over the connector 207 (Figures 2B and 2C) before or after the device 200 is applied against the skin and can sealingly engage the connector 207. Accordingly, the sealed volume 291 can be sealed after the device 200 is applied against the skin with the collection reservoir secured to the connector 207. Further, in the pre-deployed position the second biasing member 254 biases the actuator 210 — and the skin-piercing assembly 220 attached thereto — away from the opening 209 in the base 203 in the direction indicated by the arrow A (e.g., a retraction direction). Additionally, the first biasing member 244 biases the drive member 240 to rotate in the counterclockwise direction. However, the engagement of the first and second retaining features 230, 246 inhibits the drive member 240 (and the blade 242) from pivoting about the pivot axis 241. Accordingly, the skin-piercing assembly 220 is in a loaded or ready -to-fire state.

[0038] Referring next to Figure 4B, the device 200 can be moved from the pre-deployed position to the partially deployed position by moving (e.g., pressing by the subject or another) the actuator 210 toward the base 203 in the direction indicated by the arrow B (e.g., a deployment direction). Moving the actuator 210 moves the skin-piercing assembly 220 through the enclosed region 206 and at least partially through the opening 209 in the base 203. More specifically, in some embodiments the lower surface 225 of the blade holder portion 226 of the casing 222 can extend at least partially through the opening 209 to contact the skin of the subject. As described in detail above with reference to Figure 3, the contoured lower surface 225 can depress the skin of the subject such that the skin conforms to the shape of the lower surface 225. Moreover, in the partially-deployed position, the retaining feature 230 still engages the second retaining feature 246 to inhibit the drive member 240 (and the blade 242) from pivoting about the pivot axis 241. In some embodiments, the actuation member 236 can slightly contact the release member 250 such that the trigger portion 224 is slightly flexed outward away from the blade holder portion 226 and the drive member 240 in the direction of arrow C. Movement of theactuator 210 in the direction indicated by the arrow B also compresses the sealing member 292, thereby reducing the volume of the sealed volume 291 and driving air out of sealed volume 291 through the valve 294 (Figures 2B and 2C).

[0039] Referring next to Figure 4C, the device 200 can be moved from the partially- deployed position to the deployed position by continuing to move the actuator 210 toward the base 203 in the direction indicated by arrow B. Continuing to move the actuator 210 moves the first retaining feature 230 of the trigger portion 224 into engagement with the release member 250 such that the first retaining feature 230 flexes away from and out of engagement with the second retaining feature 246 as indicated by the arrow C. The trigger portion 224 can flex enough to release / disengage the second retaining feature 246 from the first retaining feature 230. When the second retaining feature 246 disengages the first retaining feature 230, the first biasing member 244 is configured to move from a biased stated to an at least partially relaxed state to thereby drive the drive member 240 to pivot about the pivot axis 241. As the drive member 240 pivots, the drive member 240 simultaneously moves (e.g., sweeps) the blade 242 along an arcuate path through and across at least a portion of the opening 209 past the lower surface 225 of the casing to form an incision in the skin of the subject. The shape of the resulting incision can be determined by the shape of the contoured lower surface 225. For example, the incision can have a generally rectangular or other shape. After deployment, the blade 242 can be fully positioned within the casing 222 (e.g., with a tip of the blade 242 covered by the second projection 363). In some embodiments, the blade holder portion 226 includes a stop feature 429 configured to engage the second retaining feature 246 and inhibit further movement of the drive member 240 and the blade 242.

[0040] Referring next to Figure 4D, the device 200 can be moved from the deployed position to the post-deployed position by releasing the actuator 210 to allow the second biasing member 254 to drive the actuator 210 and the skin-piercing assembly 220 away from the base 203 in the direction indicated by the arrow A. The retraction of the actuator 210 can move the skin-piercing assembly 220 out of contact within the skin of the subject and fully into the enclosed region 206. In some embodiments, with reference to Figures 4A and 4D together, the second biasing member 254 can return the actuator 210 to the pre-actuated position. Nevertheless, the device 200 can be configured as a single-use device that cannot be redeployed. For example, in the illustrated embodiment the device 200 is configured such that subsequent actuation of the actuator 210 when the device 200 is in the post-deployed configuration does not pivot the blade 242 into the opening 209. Specifically, the first biasing member 244 is no longerbiased in the post-deployed configuration (e.g., after the drive member 240 is released from the trigger portion 224) and therefore cannot drive the blade 242 through the opening 209.

[0041] Further, retraction of the actuator 210 in the direction of the arrow B drives the sealing member 292 to expand upward with the actuator 210 to increase the volume of the sealed volume 291 . At the same time, the valve 294 (Figure 2B and 2C) inhibits air from entering from outside the device 200 into the sealed volume 291. Accordingly, the expansion / movement of the sealing member 292 decreases the pressure in the sealed volume 291 to generate negative / vacuum pressure within the sealed volume 291. With reference to Figures 2A-2C and 4A-4D, in some aspects of the present technology the vacuum pressure can help draw a bodily fluid (e.g., blood) at least partially (i) from the incision in the skin of the subject, (ii) through the opening 209 into the enclosed region 206, (iii) along an upper surface of the membrane 284, (iv) along the fluidic channel 260, (iv) into the outflow channel 208, and / or (v) into a collection reservoir coupled to the connector 207.B. Select Embodiments of Bodily Fluid Collection Devices Having Features for Preserving Blood Quality and / or for Collecting High-Quality Blood

[0042] High quality blood samples are necessary for some blood tests, such as a CBC test, also known as a full blood count (FBC) test. Typically, blood for such tests is withdrawn from a patient by collecting blood directly from a vein of the patient (e.g., via a venipuncture). It can be challenging to preserve the quality of blood to enable such tests when using handheld collection devices that are operated by a layperson outside of a medical setting (e.g., at home or in a field clinic) and without the aid of a medical professional. For example, the physiology of the patient and / or the mechanics / geometry of handheld collection devices can decrease the quality of a blood sample to the point it is not suitable for a CBC test. More specifically, a blood sample withdrawn from a patient into a handheld collection device will often begin to clot as the incision in the patient closes. Furthermore, the geometry and material properties of the collection device can disrupt the blood sample (e.g., promote clotting thereof) as it is withdrawn into a collection device, thereby degrading the blood sample. In some aspects of the present technology7, a handheld blood collection device in accordance with the present technology7can include features for preserving the quality of a withdrawn blood sample such that the blood sample is suitable for, for example, a CBC test.

[0043] There are several variables important to preserving blood quality when using a blood collection device in accordance with the present technology. These can include, amongothers: (i) the dimensions (e.g., width, length, depth) and shape of the incision formed by the device, (ii) the flow rate of blood from the incision, (iii) the vacuum level within the device for withdrawing the blood from the incision, (iv) the temperature of the skin, (v) the time over which the blood is collected, and (vi) the properties (e.g., mechanics, geometry, hydrophobic properties, hydrophilic properties) of the flow path for the blood. A blood collection device configured in accordance with the present technology can have various features and / or can be operated in a manner to optimize or substantially optimize one or more of these variables for improved blood quality.

[0044] For example, referring to Figures 2A-4D, the device 200 is configured to slice the skin of the patient to form the incision 372 (rather than puncture the skin) via the sweeping motion of the blade 242. Likewise, the dimensions and shape of the incision 372 can be precisely controlled by the shape of the contoured lower surface 225. In some aspects of the present technology, such precise control of the shape and size of the incision can delay coagulation of blood at the site of the incision as compared to, for example, conventional puncture wounds.

[0045] Further, the shape and size of the sealing member 292 can be selected to generate a relatively high level of vacuum within the sealed volume 291. Accordingly, the vacuum within the sealed volume 291 can quickly draw the blood from the incision 372 to the collection reservoir coupled to the connector 207 to inhibit clotting thereof. That is. the device 200 can be configured to dynamically generate a relatively high level of vacuum to increase the flow rate of the blood from the incision 372 to inhibit clotting of the blood.

[0046] Referring to Figures 4A-4D, in some embodiments the method for withdrawing blood from the patient can include withdrawing the blood for a predetermined duration to ensure that only high-quality' blood is collected. For example, the method can include collecting blood in the post-deployed position (Figure 4D) for a predetermined duration, such as for a maximum of about 120 seconds, about 90 seconds, about 60 seconds, or less. After the predetermined duration, the incision 372 (Figure 3) can begin to close as the blood coagulates. Accordingly, in some aspects of the present technology, setting a maximum duration for blood collection can inhibit the collection of blood that has begun to coagulate — making it unsuitable for, for example, a CBC test. After the predetermined duration, the collection reservoir can be removed from the connector 207 (Figures 2B and 2C) and / or the device 200 can be removed from the skin of the patient to stop blood collection in the reservoir.

[0047] Additionally, in some embodiments the method of Figures 4A-4D can include preparing (e.g., heating) the skin of the patient before deploying the blade 242 into the skin of the patient to form the incision 372 (Figure 3). For example, a heating pad, heating gel, hot air, and / or the like can be applied to the skin of the patient to heat the skin before and / or after the device 200 is applied against the skin. The blade 242 can then be deployed to form the incision 372 (as shown in Figure 4C) where the skin has been heated. In some aspects of the present technology, heating the skin can activate a capillary bed below / within the skin, which can help enhance the flow rate of blood from the incision. As set forth above, increasing the flow rate of the blood can inhibit coagulation as the blood is moved to and collected within the reservoir coupled to the connector 207.

[0048] In some embodiments, one or more components of the device can be coated with a material that promotes blood transfer to the collection reservoir coupled to the connector 207, inhibits blood clotting, and / or the like. For example, Figures 5A and 5B are cross-sectional side views of a bodily fluid collection device 500 configured in accordance with additional embodiments of the present technology'. The device 500 can include a number of features generally similar to / identical to the features of the blood collection device 200 described above with reference to Figures 2A-4D. Accordingly, like reference numbers refer to like components. Referring to Figures 5A and 5B together, the device 500 can include a coating 502 (including individually identified first through fifth coatings or coating portions 502a-e, respectively) over one or more surfaces thereof and, in particular, to one or more surfaces configured to come into contact with blood received through the opening 209 from an incision formed in the skin of a patient via the blade 242 (Figure 5A).

[0049] More specifically, in the illustrated embodiment the first coating portion 502a is formed over a portion of the blade holder portion 226 of the skin-piercing assembly 220 including the shaped lower surface 225. The shaped lower surface 225 and / or another portion of the blade holder portion 226 can contact blood in the deployed position shown in Figure 4C. The second coating portion 502b can extend over some or all of the membrane 284 coupled to the base 203. For example, the second coating portion 502b can extend over an upper surface of the membrane 284 within / over the opening 209 in the base 203 such that blood received through the opening is received on the second coating portion 502b. Referring to Figure 5A, the third coating portion 502c can extend over some or all of the blade 242. The blade 242 can contact blood as it sweeps through the skin of the patient to form an incision. Referring to Figure 5B, the fourth coating portion 502d can extend over all or a portion of the fluidic channel 260and the outflow channel 208 in the connector 207. After cutting the skin with the blade 242 (Figure 5 A), the blood can flow over the membrane 284. along the fluidic channel 260, and along the outflow channel 208 to a collection reservoir 506 (e.g., tube). In some embodiments, the collection reservoir 506 further defines a holding or collection volume 509, and the fifth coating portion 502e can be formed over all or a portion of an interior surface of the collection reservoir 506 defining the collection volume 509.

[0050] Referring to Figures 5A and 5B together, the coating 502 (e.g., one or more of the coating portions 502a-e) can comprise antifouling materials, anticoagulants, hydrophilic materials, hydrophobic materials, and / or the like. Where the coating 502 at least partially comprises an antifouling material, the antifouling material can inhibit or even prevent protein and cell adsorption from blood moving over the coating 502 — thereby reducing clotting of the blood. In contrast, in some embodiments, the blade holder portion 226, the membrane 284, the fluidic channel 260, the outflow channel 208 in the connector 207. and / or other components of the device 500 that may contact a blood sample can be formed from silicone, polyurethane, and / or other materials that rapidly adsorb proteins and cells, which could lead to clotting and reduced blood quality. Accordingly, the antifouling material can provide a barrier between the surfaces of the device 500 and a received blood sample that is expected to reduce coagulation induced by the material of the device 500 (e.g., silicone, polyurethane, etc.), thereby prolonging the clotting time and increasing the quality of blood collected. In some embodiments, the antifouling coating can be of the type manufactured by Taproot Medical Technologies of Bothell, Washington.

[0051] Where the coating 502 at least partially comprises an anticoagulant, the anticoagulant is expected to reduce coagulation of a blood sample received by the device 500, thereby prolonging the clotting time and increasing the quality of blood collected. The anticoagulant can comprise ethylenediaminetetraacetic acid (EDTA), hirudin (e.g., a naturally occurring peptide in the salivary7glands of blood-sucking leeches), citrate-theophylline- adenosine-dipyridamole (CTAD), warfarin, and / or the like.

[0052] Additionally, the coating 502 may be hydrophilic and / or hydrophobic. Where the coating 502 is hydrophilic, the coating 502 is expected to attract a received blood sample and be readily wetted by the blood sample. Where the coating 502 is hydrophobic, the coating 502 can repel the received blood sample, causing the blood to bead and roll therealong.

[0053] In some embodiments, the various coating portions 502a-e can comprise different materials with different properties. For example, the first through fourth coating portions 502a- d can comprise an antifouling material that inhibits clotting of blood that contacts and / or flows over / through the blade holder portion 226, the membrane 284, the blade 242, and the fluidic channel 260 and the outflow channel 208, respectively. Likewise, the first through fourth coating portions 502a-d can be hydrophilic and / or hydrophobic to readily route blood from an incision below the opening 209, through the fluidic channel 260 and the outflow channel 208. and into the collection reservoir 506 (e g., as shown by arrows in Figure 5B). Accordingly, the first through fourth coating portions 502a-d can be selected to inhibit clotting of the blood caused by the material properties of the device 500 while also minimizing the time needed for the blood to flow through the device 500 to the collection reservoir 506. In some embodiments, the fifth coating portion 502e comprises an anticoagulant. Accordingly, once the blood is routed to and received within the collection volume 509 of the collection reservoir 506, the blood can mix with the anticoagulant which inhibits clotting of the blood.

[0054] In other embodiments, the coating 502 can be formed over more or less of the device (e.g., over some or all of the surfaces that contact the blood during operation). For example, the coating 502 can be formed over the entirety of the internal surfaces of the device 500 and the collection reservoir 506. The coating 502 can be applied via spraying, dipping, as an adhesive, as a film, and / or the like before or after the device 500 is assembled. For example, the casing 222 can be coated with the first coating portion 502a before or after assembly of the device 500, the membrane 284 can be coated with the second coating portion 502b before or after assembly of the device 500. the blade 242 can be coated with the third coating portion 502c before or after assembly of the device 500, the lower housing portion 202 including the fluidic channel 260 and the outflow channel 208 can be coated with the fourth coating portion 502d before or after assembly of the device 500, etc. In some embodiments, the coating 502 is applied such that it does not contact the skin of the patient during operation of the device 500. For example, the coating 502 can be omitted from the lower surface of the base 203 and / or the lower surface of the membrane 284.

[0055] Referring to Figure 5B, in addition to or alternatively to the fifth coating portion 502e, the collection reservoir 506 can be provided with mixing beads 501 within the collection volume 5. The mixing beads 501 can be formed of plastic, magnetic material, and / or other materials. In some embodiments, the mixing beads 501 are coated with an anticoagulant. After collecting a blood sample within the collection reservoir 506, the collection reservoir 506 can bedetached from the connector 207 and moved (e.g.. shaken) such that the beads 501 move within the blood sample within the collection volume 509 to disperse the anticoagulant throughout the blood sample. In some embodiments, an anticoagulant coating on the beads and / or the fifth coating portion 502e can be configured to release anticoagulant over time to selectively provide anticoagulant to the blood sample over time as, for example, the collection reservoir 506 is shipped to a blood testing facility. In some aspects of the present technology, this can ensure that the blood sample is stable over time (e.g.. during shipping) and remains of high quality. In additional embodiments, the collection volume 509 can include additional compounds or reagents for preserving the blood sample. For example, a diazolidinyl urea compound can be provided within the collection volume 509 to preserve a hematocrit shape of the blood sample.

[0056] In some embodiments, the device 500 can include a fluidic path from the opening 209 to the collection reservoir 506 that minimizes the time needed for a blood sample to flow through the device 500 into the collection reservoir 506. For example, the device 500 can be configured to minimize — or eliminate an entirely — a distance between the collection reservoir 506 and an incision formed by the blade 242 such that the blood can be quickly collected in the collection reservoir 506 including, for example, an anticoagulant (e.g., the fifth coating portion 502e and / or the beads 501) that acts to preserve the blood.

[0057] Figure 6, for example, is an enlarged cross-sectional side view of the bodily fluid collection device 500 of Figures 5A and 5B. In the illustrated embodiment, the collection reservoir 506 extends at least partially through (e g., rather than over) the outflow channel 208 of the connector 207 to and / or proximate to the fluidic channel 260. In some embodiments, the collection reservoir 506 includes a lip 607 that can be aligned with the fluidic channel 260 to provide a smooth transition between the fluidic channel 260 and the collection reservoir 506. Accordingly, blood received through the opening 209 in the base 203 need only flow along the fluidic channel 260 before being received in the collection reservoir 506.

[0058] In some aspects of the present technology, minimizing the distance of the blood path through the device 200 as shown in Figure 6 is expected to increase the quality of blood collected within the collection reservoir 506 by, for example, decreasing the time for the blood to reach the collection volume 509 of the collection reservoir 506 (which can include an anticoagulant, such as the fifth coating portion 502e and / or the beads 501 of Figure 5B), decreasing the distance over w hich the blood flows along surfaces of the device 200, etc. More specifically , in some embodiments the lower housing portion 202 including the fluidic channel260 and the outflow channel 208 is formed via injection molding. Injection molding can cause small lines, creases, ridges, channels, etc., (collectively "‘injection molding features") to form along and / or between the fluidic channel 260 and the outflow channel 208. Such injection molding features can induce turbulence in blood flowing thereover that increases clotting of the blood and / or otherwise degrades the quality of the blood. Accordingly, decreasing the distance of the blood flow path through the device 200 to the collection reservoir 506 is expected to inhibit clotting and thereby increase the quality of blood collected in the collection reservoir 506.

[0059] Figure 7 is a partially cross-sectional side view of a bodily fluid collection device 700 configured in accordance with another embodiment of the present technology. The device 700 can include a number of features generally similar to / identical to the features of the blood collection device 200 described above with reference to Figures 2A-4D. Accordingly, like reference numbers refer to like components. In the illustrated embodiment, the device 700 includes a connector 707 angled relative to the base 203 of the lower housing portion 202 such that the collection reservoir 506 can extend at least partially through the connector 707 at and / or proximate the opening 209. In some embodiments, the connector 707 is angled relative to the base 203 at an acute angle of between about 10°-80°, between about 5°-20°, between about 10°- 30°, between about 10°-20°, about 15°. and / or the like. The lip 607 of the collection reservoir 506 can be positioned adjacent an incision formed in the skin of a patient at the opening 209. Accordingly, blood collected through the opening 209 can flow directly into the collection reservoir 506 from the incision. In some aspects of the present technology, the blood does not flow over any portion of the device 700 (e.g., the fluidic channel 260, the outflow channel 208, etc., of Figures 2A-5B) that could induce turbulence and / or clotting, and the blood is immediately collected in the collection reservoir 506. In some embodiments, the collection reservoir 506 may also include an anticoagulant for preserving the quality7of the collected blood.

[0060] Figure 8A is a cross-sectional side view of a bodily fluid collection device 800 configured in accordance with further embodiments of the present technology. The device 800 can include a number of features generally similar to / identical to the features of the blood collection device 200 described above with reference to Figures 2A-4D. Accordingly, like reference numbers refer to like components. In the illustrated embodiment, the device 800 comprises an insertable member 870 that can be positioned at least partially within the device 800. Figures 8B and 8C are isometric side and front views, respectively, of the insertable member 870 configured in accordance with embodiments of the present technology. Referring to Figures 8A-8C, the insertable member 870 can include a channel portion 872 defining anoutflow- channel 874 and a flow portion 876 defining a fluidic channel 878. The flow' portion 876 can include a projection 877 and define a first lip 879. The channel portion 872 can include a (e.g., a circumferential) flange 871 and define a second lip 873.

[0061] Referring to Figure 8A, the insertable member 870 can be coupled to the device 800 such that (i) the channel portion 872 defines a connector for releasably coupling to the collection reservoir 506 and (ii) the fluidic channel 878 and the outflow channel 874 provide a flow path for blood to flow from the opening 209 to the collection reservoir 506. That is, the channel portion 872, the outflow channel 874. and the fluidic channel 878 can be similar in structure and function to the connector 207, the outflow channel 208, and the fluidic channel 260, respectively, described in detail above with reference to Figures 2A-4D. The insertable member 870 can be coupled (e.g., releasably coupled) to the device 800 by securing the flange 871 against a portion of the lower housing portion 202 (e.g., via a stepped or abutting arrangement) and / or by securing the projection 877 against a portion of the lower housing portion 202 proximate to the opening 209 (e.g., via a stepped or abutting arrangement). For example, the insertable member 870 can be clipped or slotted into the position shown in Figure 8A. When inserted within the device 800, the first lip 879 is positioned at and / or proximate to the opening 209 for receiving blood flow from an incision (not shown) at the opening 209. In some embodiments, the first lip 879 provides a smooth (e.g., non-turbulent) transition for the blood to flow from the incision into the fluidic channel 878. The fluidic channel 878 can receive the blood and route the blood to the outflow' channel 874, which in turn can route the blood to the second lip 873 and into the collection reservoir 506. The second lip 873 can similarly provide a smooth transition for blood to flow from the insertable member 270 into the collection reservoir 506.

[0062] The insertable member 870 can be formed of a material that does not induce or substantially does not induce clotting of the blood, such as polypropylene. Further, in some embodiments, the insertable member 870 can be coated within an antifouling and / or anticoagulant coating having hydrophobic and / or hydrophilic properties as described in detail above with reference to Figures 5 A and 5B. Such a coating can be applied via spraying, dipping, adhesive build up, film build up, and / or the like when the insertable member 870 is not coupled to the device 800. In some aspects of the present technology, this can reduce the risk of contaminating other components of the device 800 (e.g., skin-contacting surfaces) with the coating. Further, the insertable member 870 can be formed to not have any injection molding features such that the insertable member 870 provides a continuous smooth (e.g., non-turbulent)surface. Accordingly, the insertable member 870 is expected to reduce clotting of a received blood sample and preserve the quality of the blood sample while quickly routing the blood to the collection reservoir 506.C. Additional Examples

[0063] The following examples are illustrative of several embodiments of the present technology:1. A device for withdrawing a high-quality blood sample from a subject, the device comprising: a housing including a base having an opening extending therethrough and a connector defining an outflow channel fluidly coupled to the opening in the base, wherein the base is configured to be positioned adjacent skin of the subject; a skin-piercing assembly positioned at least partially within the housing, wherein the skin-piercing assembly includes a casing carry ing a blade and a biasing member operably coupled to the blade, and wherein the casing includes a lower surface; an actuator operably coupled to the skin-piercing assembly and movable from a first position to a second position relative to the housing, wherein — in the first position, the biasing member biases the blade to a pre-deployed position, and movement of the actuator from the first position to the second position is configured to (a) move the lower surface of the casing at least partially through the opening into contact with the skin of the subject and (b) permit the biasing member to drive the blade relative to the lower surface of the casing and at least partially through the opening in the base from the predeployed position to a deployed position to incise the skin of the patient and permit blood to flow from the skin of the subject into the opening in the base and into the outflow7channel; and a coating formed on the blade, the lower surface of the casing, and the outflow channel, wherein the coating is configured to inhibit coagulation of the blood and / or inhibit protein and cell adsorption from the blood.2. The device of example 1 wherein the coating comprises an antifouling material configured to inhibit protein and cell adsorption from the blood.3. The device of example 1 wherein the coating comprises an anticoagulant material configured to inhibit coagulation of the blood.4. The device of any one of examples 1-3 wherein the coating comprises at least one of ethylenediaminetetraacetic acid (EDTA), hirudin, citrate-theophylline-adenosine- dipyridamole (CTAD), and warfarin.5. The device of any one of examples 1-4 wherein the coating is hydrophilic.6. The device of any one of examples 1-4 wherein the coating is hydrophobic.7. The device of any one of examples 1-6, further comprising a collection reservoir configured to be releasably coupled to the connector and having an inner surface defining a volume configured to receive the blood from the outflow channel.8. The device of example 7 wherein the coating is a first coating, and further comprising a second coating formed on the inner surface of the collection reservoir and configured to inhibit coagulation of the blood within the volume of the collection reservoir and / or inhibit protein and cell adsorption from the blood within the volume of the collection reservoir.9. The device of example 8 wherein the first coating comprises an antifouling material configured to inhibit protein and cell adsorption from the blood, and wherein the second coating comprises an anticoagulant configured to inhibit coagulation of the blood within the volume of the collection reservoir.10. The device of any one of examples 7-9, further comprising a plurality of mixing beads positioned within the volume of the collection reservoir.11. The device of example 10 wherein the coating is a first coating, and further comprising a second coating formed on the mixing beads and configured to inhibit coagulation of the blood within the volume of the collection reservoir.12. The device of any one of examples 7-11, further comprising a diazolidinyl urea compound positioned within the volume of the collection reservoir and configured to preserve a hematocrit shape of the blood within the volume of the collection reservoir.13. The device of any one of examples 1-12 further comprising a bendable membrane attached to a lower surface of the base and spanning laterally across at least a portion of the opening, wherein the coating is further formed on the bendable membrane within the opening.14. A device for withdrawing a high-quality blood sample from a subject, the device comprising: a housing including a base having an opening extending therethrough and a connector defining a channel, wherein the base is configured to be positioned adj acent skin of the subject; a collection reservoir configured to extend at least partially through the channel of the connector to releasably couple the collection reservoir to the housing; a skin-piercing assembly positioned at least partially within the housing, wherein the skin-piercing assembly includes a blade and a biasing member operably coupled to the blade; and an actuator operably coupled to the skin-piercing assembly and movable from a first position to a second position relative to the housing, wherein — in the first position, the biasing member biases the blade to a pre-deployed position, and movement of the actuator from the first position to the second position is configured to permit the biasing member to drive the blade at least partially through the opening in the base from the pre-deployed position to a deployed position to incise the skin of the patient and permit blood to flow from the skin of the subject into the opening in the base and into the collection reservoir.15. The device of example 14 wherein the housing further includes a fluidic channel extending from the base to the channel of the connector, and wherein the collection reservoir includes a lip (a) configured to be positioned adjacent the fluidic channel when the collection reservoir is releasably coupled to the housing and (b) shaped to provide a smooth transition between the fluidic channel and the collection reservoir.16. The device of example 14 or example 15 wherein the base of the housing is planar, and wherein the connector extends at an angle of between about 10°-30° relative to the base.17. The device of example 16 wherein the collection reservoir includes a lip configured to be positioned at least partially within the opening in the base adjacent to the skin of the subject when the collection reservoir is releasably coupled to the housing.18. The device of any one of examples 14-17 wherein the collection reservoir includes an anticoagulant positioned therein.19. A method of collecting a blood sample for complete blood count testing, the method comprising: positioning a base of a housing of a handheld blood collection device against skin of the subject, wherein the base has an opening extending therethrough, and wherein the blood collection device includes a collection reservoir releasably coupled to the housing and fluidly connected to the opening via a fluidic path; actuating an actuator of the bodily fluid collection device to move a skin-piercing assembly of the bodily fluid collection device through the housing from a first position to a second position, wherein the skin-piercing assembly includes a casing carrying a blade and a biasing member operably coupled to the blade, wherein the casing includes a lower surface, and wherein — in the first position, the biasing member biases the blade to a pre-deployed position, and movement of the actuator from the first position to the second position (a) moves the lower surface of the casing at least partially through the opening into contact with the skin of the subject and (b) permits the biasing member todrive the blade relative to the lower surface of the casing and at least partially through the opening in the base from the pre-deployed position to a deployed position to incise the skin of the patient; and receiving the blood sample within the collection reservoir from the incision along the fluidic path, wherein the fluidic path includes a coating formed thereon and configured to inhibit coagulation of the blood sample and / or inhibit protein and cell adsorption from the blood sample.20. The method of example 19 wherein the coating is further formed on the blade and on the lower surface of the casing.D. Conclusion

[0064] The above detailed description of embodiments of the present technology are not intended to be exhaustive or to limit the technology to the precise forms disclosed above. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology, as those skilled in the relevant art will recognize. For example, although steps may be presented in a given order, in other embodiments, the steps may be performed in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0065] All numeric values are herein assumed to be modified by the term about whether or not explicitly indicated. The term about, in the context of numeric values, generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (e.g., having the same function and / or result). For example, the term about can refer to the stated value plus or minus ten percent. For example, the use of the term about 100 can refer to a range of from 90 to 110, inclusive. In instances in which the context requires otherwise and / or relative terminology is used in reference to something that does not include, or is not related to, a numerical value, the terms are given their ordinary7meaning to one skilled in the art.

[0066] From the foregoing, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context permits, singular or plural terms may also include the plural or singular term, respectively.

[0067] As used herein, the phrase and / or as in A and / or B refers to A alone, B alone, and A and B. Additionally, the term comprising is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and / or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with some embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.

Claims

CLAIMSI / 'W e claim:

1. A device for withdrawing a high-quality blood sample from a subject, the device comprising: a housing including a base having an opening extending therethrough and a connector defining an outflow channel fluidly coupled to the opening in the base, wherein the base is configured to be positioned adjacent skin of the subject; a skin-piercing assembly positioned at least partially within the housing, wherein the skin-piercing assembly includes a casing carry ing a blade and a biasing member operably coupled to the blade, and wherein the casing includes a lower surface; an actuator operably coupled to the skin-piercing assembly and movable from a first position to a second position relative to the housing, wherein — in the first position, the biasing member biases the blade to a pre-deployed position, and movement of the actuator from the first position to the second position is configured to (a) move the lower surface of the casing at least partially through the opening into contact with the skin of the subject and (b) permit the biasing member to drive the blade relative to the lower surface of the casing and at least partially through the opening in the base from the predeployed position to a deployed position to incise the skin of the subject and permit blood to flow from the skin of the subject into the opening in the base and into the outflow channel; and a coating formed on the blade, the lower surface of the casing, and the outflow channel, wherein the coating is configured to inhibit coagulation of the blood and / or inhibit protein and cell adsorption from the blood.

2. The device of claim 1 wherein the coating comprises an antifouling material configured to inhibit protein and cell adsorption from the blood.

3. The device of claim 1 wherein the coating comprises an anticoagulant material configured to inhibit coagulation of the blood.

4. The device of claim 1 wherein the coating comprises at least one of ethylenediaminetetraacetic acid (EDTA), hirudin, citrate-theophylline-adenosine-dipyridamole (CT AD), and warfarin.

5. The device of claim 1 wherein the coating is hydrophilic.

6. The device of claim 1 wherein the coating is hydrophobic.

7. The device of claim 1, further comprising a collection reservoir configured to be releasably coupled to the connector and having an inner surface defining a volume configured to receive the blood from the outflow channel.

8. The device of claim 7 wherein the coating is a first coating, and further comprising a second coating formed on the inner surface of the collection reservoir and configured to inhibit coagulation of the blood within the volume of the collection reservoir and / or inhibit protein and cell adsorption from the blood within the volume of the collection reservoir.

9. The device of claim 8 wherein the first coating comprises an antifouling material configured to inhibit protein and cell adsorption from the blood, and wherein the second coating comprises an anticoagulant configured to inhibit coagulation of the blood within the volume of the collection reservoir.

10. The device of claim 7, further comprising a plurality of mixing beads positioned within the volume of the collection reservoir.

11. The device of claim 10 wherein the coating is a first coating, and further comprising a second coating formed on the mixing beads and configured to inhibit coagulation of the blood within the volume of the collection reservoir.

12. The device of claim 7, further comprising a diazolidinyl urea compound positioned within the volume of the collection reservoir and configured to preserve a hematocrit shape of the blood within the volume of the collection reservoir.

13. The device of claim 1 further comprising a bendable membrane attached to a lower surface of the base and spanning laterally across at least a portion of the opening, wherein the coating is further formed on the bendable membrane within the opening.

14. A device for withdrawing a high-quality blood sample from a subject, the device comprising: a housing including a base having an opening extending therethrough and a connector defining a channel, wherein the base is configured to be positioned adjacent skin of the subject; a collection reservoir configured to extend at least partially through the channel of the connector to releasably couple the collection reservoir to the housing; a skin-piercing assembly positioned at least partially within the housing, wherein the skin-piercing assembly includes a blade and a biasing member operably coupled to the blade; and an actuator operably coupled to the skin-piercing assembly and movable from a first position to a second position relative to the housing, wherein — in the first position, the biasing member biases the blade to a pre-deployed position, and movement of the actuator from the first position to the second position is configured to permit the biasing member to drive the blade at least partially through the opening in the base from the pre-deployed position to a deployed position to incise the skin of the subject and permit blood to flow from the skin of the subject into the opening in the base and into the collection reservoir.

15. The device of claim 14 wherein the housing further includes a fluidic channel extending from the base to the channel of the connector, and wherein the collection reservoir includes a lip (a) configured to be positioned adjacent the fluidic channel when the collection reservoir is releasably coupled to the housing and (b) shaped to provide a smooth transition between the fluidic channel and the collection reservoir.

16. The device of claim 14 wherein the base of the housing is planar, and wherein the connector extends at an angle of between about 10°-30° relative to the base.

17. The device of claim 16 wherein the collection reservoir includes a lip configured to be positioned at least partially within the opening in the base adjacent to the skin of the subject when the collection reservoir is releasably coupled to the housing.

18. The device of claim 14 wherein the collection reservoir includes an anticoagulant positioned therein.

19. A method of collecting a blood sample for complete blood count testing, the method comprising: positioning a base of a housing of a handheld blood collection device against skin of a subject, wherein the base has an opening extending therethrough, and wherein the blood collection device includes a collection reservoir releasably coupled to the housing and fluidly connected to the opening via a fluidic path; actuating an actuator of the blood collection device to move a skin-piercing assembly of the bodily fluid collection device through the housing from a first position to a second position, wherein the skin-piercing assembly includes a casing carrying a blade and a biasing member operably coupled to the blade, wherein the casing includes a lower surface, and wherein — in the first position, the biasing member biases the blade to a pre-deployed position, and movement of the actuator from the first position to the second position (a) moves the lower surface of the casing at least partially through the opening into contact with the skin of the subject and (b) permits the biasing member to drive the blade relative to the lower surface of the casing and at least partially through the opening in the base from the pre-deployed position to a deployed position to incise the skin of the subject; and receiving the blood sample within the collection reservoir from the incision along the fluidic path, wherein the fluidic path includes a coating formed thereon and configured to inhibit coagulation of the blood sample and / or inhibit protein and cell adsorption from the blood sample.

20. The method of claim 19 wherein the coating is further formed on the blade and on the lower surface of the casing.

Images