Bodily fluid sampling devices

Abstract

Bodily fluid sampling devices are disclosed herein. An example apparatus is rotatable between a first position and a second position, and includes a wall including a top surface and a slot, a spring, and a carrier coupled to spring. The carrier includes a tab abutting the top surface in the first position. The abutment of the tab and the top surface retains the spring in the first position. The tab is aligned with the slot in the second position.

Description

BODILY FLUID SAMPLING DEVICESFIELD OF THE DISCLOSURE

[0001] This disclosure relates generally to personal medical devices fluid extraction and collection devices and, more particularly, to bodily fluid sampling devices.BACKGROUND

[0002] Bodily fluid, such as capillary blood, can be sampled from patients and analyzed to monitor blood sugar levels, test for bloodborne pathogens, and / or test for other blood-related heath metrics. A bodily fluid sampling device includes a skin-piercing device, such as a lancet, to create a small cut in a patient's skin. After creating a small cut, a patient's blood is drawn to the surface into the bodily fluid sampling device.BRIEF DESCRIPTION OF THE DRAWINGS

[0003] FIG. 1 is a perspective view of an example bodily fluid sampling device implemented in accordance with the teachings of this disclosure.

[0004] FIG. 2 is an exploded view of the sampling device of FIG. 1.

[0005] FIG. 3A is a perspective view of the sampling device of FIG. 1 in a first position.

[0006] FIG. 3B is a perspective view of the sampling device of FIG. 1 in a second position.

[0007] FIG. 3C is a perspective view of the sampling device of FIG. 1 in a third position.

[0008] FIG. 4A is a side perspective view of an example body of the sampling device of FIG. 1.

[0009] FIG. 4B is a top perspective view of the body of FIG. 4A.

[0010] FIG. 5 is a cross-sectional view of the sampling device of FIG. 1 in the first position of FIG. 3 A.

[0011] FIG. 6 is a cross-sectional view of the sampling device of FIG. 1 in the second position of FIG. 3B.

[0012] FIG. 7 is a cross-sectional view of the sampling device of FIG. 1 in the third position of FIG. 3C.

[0013] FIG. 8A is a perspective view of another example sampling device in a first position and implemented in accordance with the teachings of this disclosure.

[0014] FIG. 8B is a perspective view of the sampling device of FIG. 8A in a second position.

[0015] FIG. 9A is a perspective view of an example first alternative cover design that can be used in conjunction with the sampling device of FIG. 1 and / or FIG. 8A.

[0016] FIG. 9B is a perspective view of an example second alternative cover design that can be used in conjunction with the sampling device of FIG. 1 and / or FIG. 8 A.

[0017] FIG. 9C is a perspective view of an example third alternative cover design that can be used in conjunction with the sampling device of FIG. 1 and / or FIG. 8A.

[0018] FIG. 9D is a perspective view of an example fourth alternative cover design that can be used in conjunction with the sampling device of FIG. 1 and / or FIG. 8 A.

[0019] FIG. 10A is a perspective view of another example sampling device in a first position and implemented in accordance with the teachings of this disclosure.

[0020] FIG. 10B is a perspective view of the sampling device of FIG. 10A in a second position.

[0021] FIG. 11 is an exploded view of the sampling device of FIGS. 10A and 10B.

[0022] FIG. 12 is a perspective view of the sampling device of FIGS. 10A and 10B and an example sample tube.

[0023] FIG. 13 is a cross-sectional view of the sampling device of FIG. 10A in the first position of FIG. 10A.

[0024] FIG. 14 is a detail view of the skin-piercing element of the sampling device of FIGS. 10A and 10B.

[0025] FIG. 15 is a cross-sectional detail view of the sampling device in the second position of FIG. 10B after the engagement of the skin-piercing element.

[0026] FIG. 16 is a cross-sectional view of the sampling device in the second position of FIG. 10B after the engagement of the skin-piercing element.

[0027] FIG. 17 is a perspective view of another example sampling device implemented in accordance with the teachings of this disclosure.

[0028] FIG. 18 is a perspective view of another example sampling device implemented in accordance with the teachings of this disclosure.

[0029] In general, the same reference numbers will be used throughout the drawing(s) and accompanying written description to refer to the same or like parts. The figures are not necessarily to scale.DETAILED DESCRIPTION

[0030] The sampling and analysis of bodily fluids, such as for example blood, can be used to monitor and / or diagnose a variety of medical conditions. Some people, such as those with diabetes, regularly collect blood samples to monitor for abnormal blood sugar levels. When a small volume of blood is needed, blood can be withdrawn from the capillaries of a person via capillary blood sampling. To extract blood from a capillary, a small incision is made in the surface of the skin. Blood can then be extracted from the incision by, for example, squeezing the skin and / or generating a vacuum to draw blood from the incision. When compared to other types of blood sampling, capillary blood sampling is comparatively less painful and requires less specialized training than other methods of blood sampling (e.g.. arterial sampling, venipuncture sampling, etc.) because blood capillaries are comparatively closer to the surface of the skin. Prior capillary blood sampling devices typically include a comparatively large number of parts to facilitate the coupling of the sampling device to a user’ s skin, the formation of an incision, and the extraction of a sample via the generation of a vacuum. The complexity of prior capillary blood sampling devices increases the material and assembly cost of the prior capillary blood sampling devices. Additionally, some prior capillary blood sampling devices can be difficult and / or awkward to use, which can reduce the ease of use by users of the device.

[0031] Disclosed herein are example sampling devices that are used to extract and collect bodily fluids such as, for example, blood (e.g., capillary blood) and interstitial fluid. Example sampling devices disclosed herein include comparatively fewer components than prior capillary blood sampling devices. An example sampling device disclosed herein includes a piston and a carrier including a lancet. The sampling device may further include a first spring that operates the carrier and lancet to make an incision in the skin of a user. The sampling device may further include a second spring that operates a piston to generate a vacuum within the sampling device, which draws a sample from the incision and into a sample tube. The sampling device may further include a cover. In some examples, the sampling device is operated by twisting or rotating the cover, which causes sequential operation of the first spring and the second spring. Some example sampling devices disclosed herein includes a carrier including a lancet array. Optionally, the sampling device receives a sample tube including a sealed vacuum. The sampling device may further include a spring that operates the carrier and lancet array to make an incision in the skin of a user. The sampling device may further include a body to support other elements of the sampling device. In some examples disclosed herein, the sampling device is operated by pinching or otherwise drawing a handle of the cover toward a plate of thebody, which operates the spring and exposes the vacuum of the sample tube, which extracts a sample thereto.

[0032] Also disclosed herein are example sampling devices that are used to extract and collect bodily fluids such as, for example, blood (e.g., capillary blood) and interstitial fluid. Example sampling devices disclosed herein include comparatively fewer components than prior capillary blood sampling devices. An example sampling device disclosed herein includes a cover, a body, a piston, and a carrier including a lancet. In some examples disclosed herein, the sampling device includes a first spring that operates the carrier and lancet to make an incision in the skin of a user and a second spring that operates a piston to generate a vacuum within the sampling device, which draws a sample from the incision and into a sample tube. In some examples disclosed herein, the sampling device is operated by twisting or rotating the cover, which causes sequential operation of the first spring and the second spring. Another example sampling device disclosed herein includes a cover, a body, and a carrier including a lancet array. In some examples disclosed herein, the sampling device receives a sample tube including a sealed vacuum. In some examples disclosed herein, the sampling device includes a spring that operates the carrier and lancet array to make an incision in the skin of a user. In some examples disclosed herein, the sampling device is operated by pinching or otherwise drawing a handle of the cover toward a plate of the body, which operates the spring and exposes the vacuum of the sample tube, which extracts a sample thereto.

[0033] The sampling devices disclosed herein include sample tubes, which receive the samples extracted by the sampling devices. The sample tubes disclosed herein can include one or more cavities (e.g., two cavities, three cavities, etc.). Such multiple cavities provide for receipt of more than one sample and / or for subjecting the same collected sample to diff erent treatment, such as for processing or storage. In some examples, each cavity can include one or more different anticoagulant(s) (e.g., ethylenediaminetetraacetic acid (EDTA), sodium citrate, or heparin in the form of sodium heparin, lithium heparin, or ammonium heparin, etc.), a same anticoagulant, and / or no anticoagulant. For example, a cavity may include EDTA and sodium citrate. A cavity may include EDTA and heparin. A cavity may include EDTA and sodium heparin. A cavity may include ETDA and lithium heparin. A cavity may include EDTA and ammonium heparin. A cavity may include EDTA, sodium citrate, and heparin. A cavity may include EDTA, sodium citrate, and sodium heparin. A cavity may include EDTA, sodium citrate, and lithium heparin. A cavity may include EDTA, sodium citrate, and ammonium heparin. A cavity may include sodium citrate and heparin. A cavity may include sodium citrate and sodium heparin. A cavity may include sodium citrate and lithium heparin. A cavity’ mayinclude sodium citrate and ammonium heparin. A cavity may include sodium heparin and lithium heparin. A cavity may include sodium heparin and ammonium heparin. A cavity may include lithium heparin and ammonium heparin. A cavity may include sodium heparin, lithium heparin, and ammonium heparin. A cavity' may include sodium heparin, lithium heparin, ammonium heparin, and sodium citrate. A cavity' may include sodium heparin, lithium heparin, ammonium heparin, and EDTA. A cavity may include sodium heparin, lithium heparin, ammonium heparin, sodium citrate, and EDTA. A cavity may include sodium heparin, sodium citrate, and EDTA. A cavity may include lithium heparin, sodium citrate, and EDTA. A cavity may include ammonium heparin, sodium citrate, and EDTA. A cavity may include sodium heparin, lithium heparin, sodium citrate, and EDTA. A cavity may include sodium heparin, ammonium heparin, sodium citrate, and EDTA. A cavity may include lithium heparin, ammonium heparin, sodium citrate, and EDTA. A cavity may include sodium heparin, lithium heparin, and sodium citrate. A cavity may include sodium heparin, ammonium heparin, and sodium citrate. A cavity may include lithium heparin, ammonium heparin, and sodium citrate. A cavity’ may include sodium heparin, lithium heparin, and EDTA. A cavity may include sodium heparin, ammonium heparin, and EDTA. A cavity may include lithium heparin, ammonium heparin, and EDTA. Similarly, some sampling devices disclosed herein include multiple sample tubes (e.g., two sample tubes, etc.). In some examples, the multiple sample tubes provide for receipt of more than one sample and / or for subjecting the same collected sample to different treatment, such as for processing or storage (e.g., by incorporating in the separate sample tubes differing anticoagulant, a same anticoagulant, and / or no anticoagulant).

[0034] As used herein, the orientation of features is described with reference to a cylindrical coordinate system having a vertical direction, circumferential direction, and a radial direction. As used herein, the vertical axis of a sampling device is perpendicular to the base of the sampling device and / or the skin of a user the base sampling device is coupled thereto. As used herein, the vertical axis of the sampling device begins at the center point of the opening of the base of the sampling device, through which the sample flows through. The terms “below” and “above” are used to refer to directions along the vertical axis closer to the base of the sampling device and away from the sampling device, respectively. It should be appreciated that the vertical axis can have any suitable relationship with the gravitational axis, depending on the positioning of the sampling device. Thus, “vertical” is used with reference to how the device is shown in the figures and not necessarily the positioning of the device during operation. As used herein, the radial direction refers to directions in planes perpendicular to the vertical axis. As used herein, the terms “radially inward” and “radially inward” are used interchangeably fordirections in the radial direction that are relatively toward and relatively away from the vertical axis, respectively. As used herein, the circumferential direction refers to the angular orientation of the feature in a planar projection of the base of the sampling device. The term “circumferential” refers to features that are angularly displaced in a plane perpendicular to the vertical axis.

[0035] Examples disclosed herein refer to a sampling device. Sample devices disclosed herein are used to extract and collect bodily fluids such as, for example, blood (e.g., capillary blood) and interstitial fluid.

[0036] FIG. 1 is a perspective view of an example sampling device 100 implemented in accordance with the teachings of this disclosure. The sampling device 100 includes an example cover 102 and an example body 104. The sampling device 100 may further include an example adhesive pad 106. The sampling device 100 may further include an example sample tube 108. In the illustrated example of FIG. 1, the sampling device 100 includes an example cover 102, an example body 104, an example adhesive pad 106, and an example sample tube 108. In some examples, the sample tube 108 is provided separately. The example sampling device 100 can be used to extract a bodily fluid from the skin of a person and store the bodily fluid in the sample tube 108. For example, the sampling device 100 can be used to conduct capillary blood sampling from the skin of a patient. In other examples, the sampling device 100 can be used to extract other fluids from the epidermis of a user (e.g., pus, lymph fluid, interstitial fluids, etc.). The sampling device 100 can be disposed on any portion of the user's body, such as an upper arm, a lower arm, the back, a thigh, etc.

[0037] The cover 102 is a user interface that enables a user of the sampling device 100 to actuate a skin-piercing element and extract a bodily fluid using the sampling device 100. In the illustrated example of FIG. 1, the cover 102 is rotatably coupled to the body 104. In the illustrated example of FIG. 1, the cover 102 includes example surface grooves 109 to facilitate the manual rotation of the cover 102 by a user of the sampling device 100. In other examples, the surface grooves 109 are absent. The interface between the cover 102 and the skin-piercing element of the sampling device 100 is described in conjunction with FIGS. 2-6. The interface between the cover 102 and the body 104 is descnbed in conjunction with FIG. 5. Other example caps that can be used in conjunction with the sampling device 100 as the cover 102 are described in conjunction with FIGS. 9A-9E.

[0038] The body 104 houses the skin-piercing element(s) of the sampling device 100. Skin piercing elements (e.g.. means for skin piercing, etc.) include one or more lancets, one or more microneedles, and / or one or more other elements that can puncture skin and / orcombination of these skin piercing features. In some examples, the skin piercing features are arranged in a pattern such as, for example, a ring, an array, etc. Thus, the sampling device 100 may include a lancet, multiple lancets, a microneedle, multiple microneedles, a ring of lancets, an array of lancets, a ring of microneedles, and / or an array of microneedles, etc.

[0039] The sample tube 108 is releasably couplable to the body 104. The sample tube 108 receives and stores bodily fluids extracted from a user via the sampling device 100. The sample tube 108 includes an example flange 1 10. The sample tube 108 may further include an example chamber 112. In the illustrated example of FIG. 1, the sample tube 108 includes an example flange 110 and an example chamber 112. In some examples, the chamber 112 has a volume of at least ~0.5 milliliters (mL). In other examples, the chamber 112 can have any other suitable volume. In some examples, the flange 110 can facilitate the handling of the tube of a user (e.g., facilitate the carrying of the sample tube 108, facilitate the coupling of the sample tube 108, facilitate supporting the sample tube 108 in a sample tube rack, etc.). In other examples, the flange 110 can be absent.

[0040] In some examples, the adhesive pad 106 is a flexible pad configured to be coupled to the skin of a user of the sampling device 100. In the illustrated example of FIG. 1, the adhesive pad 106 is coupled to the body 104. In some examples, an example lower surface 114 of the adhesive pad 106 includes a medical adhesive (e.g., a biosafe acry lic adhesive, acrylate, methacrylate, an epoxy diacrylate, etc.) that facilitates the releasable coupling of the sampling device 100 to the skin of the user. In some examples, the lower surface 114 can include a lining or backing (e.g., coated paper, etc.) to protect the adhesive portion of the adhesive pad 106 from debris and incidental bonding with unintended surfaces. Prior to the coupling of the sampling device 100 to the skin of the user, the backing of the adhesive pad 106 can be removed. In some examples, the adhesive pad 106 includes an opening (see e.g., FIGS. 5-7) to enable the skinpiercing element of the sampling device 100 to reach the skin of a user of the sampling device 100. The adhesive pad 106 includes any suitable material, such as, for example, woven plastic (e.g., polyethylene, polyurethane, polyvinyl chloride (PVC), etc.), latex, cotton, paper, and / or a combination of materials. In the illustrated example of FIG. 1, the adhesive pad 106 has a general X-shape (e.g., the adhesive pad 106 includes four arms. etc.), which can be used to facilitate the smooth disposition (e.g., without any creases in the adhesive pad 106, etc.) of the sampling device 100 on the skin. In other examples, the adhesive pad 106 can have any other suitable shape (e.g., circular, two-armed, five-armed, ovoid, polygonal, irregularly shaped, etc.). In some examples, a comparatively greater adherence to the skin can be achieved via a larger surface area of the adhesive of the adhesive pad 106. Additionally or alternatively, adherence ofthe sampling device 100 can be done with use of a band (e.g., applied by stretching, wrapping, etc.), and / or via a reusable material fastener such as, for example, hook-and-loop fasteners.

[0041] During the operation of the sampling device 100, the bodily fluid extracted via the sampling device 100 flows into the sample tube 108. The sampling device 100 of FIG. 1 can generate an internal vacuum to pull the bodily fluid into the sample tube 108. An example vacuum generation mechanism is described in conjunction with FIGS. 2-7. Additionally or alternatively, the sample tube 108 can be an evacuated tube (e.g., a Vacutainer® tube). In some examples, the sample tube 108 can include a soft membrane (e.g., a septum, etc.). In some examples, the soft membrane maintains the chamber 112 within the sample tube below atmosphere pressure. In some examples, when the sample tube 108 is coupled to the sampling device 100, the sampling device 100 (e.g.. via a needle disposed therein, etc.) pierces the soft membrane. Piercing the soft membrane causes air and / or fluid (e.g., blood, etc.) from within the sampling device 100 to enter the chamber 112 of the sample tube 108. As such, the sample tube 108 can be used to extract blood from a wound (e.g., incision, prick, etc.) formed in the skin by the sampling device 100.

[0042] The sample tube 108 can include one or more additives that facilitate the storage and testing of the bodily fluid sampled via the operation of the sampling device 100. For example, the sample tube 108 can include one or more additives to assist in the limitation or prevention of the coagulation of collected blood (e.g., heparin, sodium citrate, lithium heparin, etc.), serum collection (e.g., silica particles, serum separating gel. etc.), preparation of the sample for toxicology analysis (e g., ethylenediaminetetraacetic acid (EDTA, etc ), and / or glycolysis prevention (e.g., sodium fluoride, potassium oxalate, etc.). In some examples, the sample tube 108 can include one or more indicators to indicate the additive and / or purpose of the collected sample (e.g., a human and / or machine readable label, a tactile indication, a colored portion, and / or a colored lid, etc.).

[0043] FIG. 2 is an exploded view of the sampling device 100 of FIG. 1. The sampling device 100 includes the cover 102, the body 104, the adhesive pad 106, and the sample tube 108 as disclosed above with FIG. 1. The sampling device 100 also includes an example first spring 202. The sample device 100 may further include an example piston 204. The sampling device 100 may further include an example second spring 206. The sampling device 100 may further include an example carrier 208. The sampling device 100 may further include an example lid 210. In the illustrated example of FIG. 2, the sampling device 100 includes the cover 102, the body 104, the adhesive pad 106. and the sample tube 108 as disclosed above with FIG. 1. Thesampling device 100 also includes an example first spring 202, an example piston 204, an example second spring 206, an example earner 208. and an example lid 210.

[0044] During operation, the first spring 202 generates force to pierce the skin of a user of the sampling device 100. The second spring 206 generates a vacuum to draw blood from pierced skin. In some examples, blood may be drawn by gravity or other means and the sampling device 100 lacks the piston 204 and the second spring 206. Prior to the activation (e.g.. rotation) of the cover 102 by a user of the sampling device 100, the first spring 202 and the second spring 206 are retained in compression within the sampling device 100. Particularly, the first spring 202 is retained in compression between the piston 204 and the carrier 208 and the second spring 206 is retained in compression between the piston 204 and the body 104. The rotation of the cover 102 causes the sequential release of the first spring 202 and the second spring 206 from compression, which actuate the carrier 208 and piston 204, respectively. The operation of the sampling device 100 and springs 202, 206 at different stages of rotation of the cover 102 are described in conjunction with FIGS. 3A-3B and FIGS. 5-7.

[0045] Along with the second spring 206, the piston 204 is used to generate a vacuum during the operation of the sampling device 100. The piston 204 is disposed within the body 104 and the cover 102. The piston 204 includes an internal structure, which contains the springs 202, 206 and the carrier 208, prior to the actuation thereof. In some examples, the piston 204 is generally cylindrically shaped. The internal structure of the piston 204 is described in conjunction with FIGS. 5-7.

[0046] The piston 204 optionally includes one or more piston tabs that interface respective slot(s) of the body 104 of the sampling device. For example, in the illustrated example of FIG. 2, the piston 204 includes an example first piston tab 212A, an example second piston tab 212B, and an example third piston tab 212C, which interface with an example first slot 213A, an example second slot 213B, and an example third slot 213C, respectively, of the body 104. In the illustrated example of FIG. 2, the piston tabs 212A, 212B, 212C extend radially outward from an outer surface of the piston 204. In some examples, the piston tabs 212A, 212B, 212C interface with corresponding features of the cover 102, such that rotation of the cover 102 causes a corresponding rotation of the piston 204. Rotation of the cover 102 and the piston 204 from a first position (e.g., a starting position, etc.) to a first position releases the first spring 202, which causes the formation of an incision via the skin-piercing element 214. Further rotation of the cover 102 and the piston 204 from the second position to a third position releases the second spring 206. which causes the generation of vacuum within the sampling device 100.

[0047] The carrier 208 carries or supports an example skin-piercing element 214. In the illustrated examples of FIG. 2-7. the skin-piercing element 214 carried by the carrier 208 is depicted as a lancet that is coupled to the carrier 208. In other examples, the carrier 208 can include a different type of skin-piercing element, such as a needle, a microneedle, a blade, a needle (or microneedle) array, and / or a lancet array. In the illustrated example of FIG. 2, the carrier 208 is cylindrical. In other examples, the carrier 208 can have other shapes (e.g., a polygonal prism, an oval prism, etc.). In the illustrated example of FIG. 2, the carrier 208 includes an example first carrier tab 216A and an example second carrier tab 216B. The carrier tabs 216A, 216B extend radially outward from an outer surface of the carrier 208. During operation, rotation of the carrier 208, via corresponding rotation of the cover 102 and piston 204 by a user of the sampling device 100, causes the carrier tabs 216A, 216B to circumferentially align with interior slots of the body 104 (e.g., the inner slots 430A, 430B of FIG. 4B, etc ), which releases the first spring 202 from compression. In some examples, after being released, the first spring 202 drives the carrier 208 and skin-piercing element 214 towards an example opening 218 in the adhesive pad 106 and an opening in the body 104 (e.g., the opening 440 of FIGS. 4-7, etc.), which pierces the skin of a user of the sampling device 100.

[0048] During operation, rotation of the piston 204, via corresponding rotation of the cover 102 by a user of the sampling device 100, causes the piston tabs 212A, 212B, 212C to circumferentially align with the slots 213A, 213B, 213C, which releases the second spring 206. In some examples, after being released, the second spring 206 actuates the piston 204, which generates a vacuum within the sampling device 100. In the illustrated example of FIG. 2, the sampling device 100 includes three piston tabs (e.g., the piston tabs 212A, 212B, 212C, etc.) and three corresponding slots (e.g.. the slots 213A, 213B, 213C. etc ). In other examples, the sampling device 100 can include other numbers of tabs (e.g., one tab. two tabs, four tabs, six tabs, etc.) and a corresponding number of slots. The configuration of the slots 213A, 213B, 213C on the body 104 is described in further detail below in conjunction with FIGS. 4A and 4B.

[0049] In some examples, the carrier 208, the skin-piercing element 214, and / or the carrier tabs 216A, 216B are integral (e.g., unitary, etc.). In some examples, the carrier 208. the skin-piercing element 214. and / or the carrier tabs 216A. 216B are composed of a same material (e.g., polystyrene (PS), another plastic, etc.). In some examples, the carrier 208, the skinpiercing element 214, and / or the carrier tabs 216A, 216B can be manufactured via molding (e.g., injection molding, etc.), additive manufacturing, etc. In other examples, the skin-piercing element 214. and / or the carrier tabs 216A. 216B can be discrete components, which are coupled during the manufacturing and / or assembly of the sampling device 100 via one or more fasteningmethods (e.g., a chemical adhesive, an interference fit, a fastener, and / or a mechanical interface, etc.).

[0050] The lid 210 can be disposed on the sample tube 108 after the extraction and collection of a bodily fluid within the sample tube 108. In the illustrated example of FIG. 1, the lid 210 is couplable to the sample tube via an interference fit. In other examples, the lid 210 can be coupled to the sample tube 108 in any other suitable manner (e.g., via threaded coupling, via a chemical adhesive, etc.). In some examples, the lid 210 can be color coded to indicate the type and / or indicated diagnostic analysis of the collected bodily fluid.

[0051] FIG. 3 A is a perspective view of the sampling device 100 of FIGS. 1 in an example first position 300. In the first position 300, the sampling device 100 can be coupled to the skin of a user via the adhesive pad 106 and can be actuated to extract a bodily fluid sample therefrom. The internal condition of the sampling device 100 in the first position 300 is described in conjunction with FIG. 5. In the illustrated example of FIG. 3 A, the cover 102 of the sampling device 100 includes an example cover slot 302, which includes an example first end 304A and an example second end 304B. In the first position 300 of FIG. 3 A, the sample tube 108 of FIG. 1 is adjacent to the second end 304B of the cover slot 302 (e.g., abutting the second end 304B, etc.). In the illustrated example of FIG. 3A, the sampling device 100 includes an example visual indicium 306.

[0052] The visual indicium 306 indicates an instruction for the operation of the sampling device 100. In the illustrated example of FIG. 3. the visual indicium 306 is formed in the body 104 as a recessed portion. In other examples, the visual indicium 306 can be an extruded portion and / or manufactured separately and subsequently disposed on an outer surface of the body 104 (e.g. paint, ink, a sticker, etc.). In the illustrated example of FIG. 3 A, the visual indicium 306 is an arrow indicating a direction of rotation of the cover 102 to cause the operation of the sampling device 100. Additionally or alternatively, the visual indicium 306 can have any other suitable form and / or shape. For example, the visual indicium 306 can include words (e.g., “ROTATE COUNTERCLOCKWISE.” “ROTATE,” etc.) and / or another symbol (e.g., a blood drop, a color code, a sequence of numbers, etc.). In other examples, the visual indicium is absent.

[0053] FIG. 3B is a perspective view of the sampling device 100 of FIG. 1 in an example second position 308. The second position 308 of the sampling device 100 is angularly displaced from the first position 300 of FIG. 3A following an example first rotation 310. The sampling device 100 is moveable between the first position 300 of FIG. 3 A and the second position 308 via the first rotation 310. In the second position 308, the sampling device 100 has been coupledto the skin of a user, and the skin-piercing element (e.g., the skin-piercing element 214 of FIG. 2, etc.) of the sampling device 100 has formed an incision in the skin of a user of the sampling device 100. The internal condition of the sampling device 100 in the second position 308 is described in conjunction with FIG. 6. In the illustrated example of FIG. 3B, the cover 102 has been rotated such that the sample tube 108 of FIG. 1 is disposed at a position between the ends 304A, 304B.

[0054] FIG. 3C is a perspective view of the sampling device 100 of FIG. 1 in an example third position 312. The third position 312 of the sampling device 100 is angularly displaced from the second position 308 of FIG. 3B following an example second rotation 314. The sampling device 100 is moveable between the second position 308 of FIG. 3B and the third position 312 via the second rotation 314 and moveable between the first position 300 of FIG. 3 A and the third position 312 via the first rotation 310 and the second rotation 314. In the third position 312, a vacuum has been formed within the sampling device 100, which has draw n an example sample 316 into the sample tube 108. The internal condition of the sampling device 100 in the third position 312 is described in conjunction with FIG. 7. In the illustrated example of FIG. 3C, the cover 102 has been rotated such that the sample tube 108 is adjacent to the first end 304A (e.g., abutting the first end 304 A, etc.). In some examples, the abutment of the sample tube 108 and the first end 304A prevents further rotation of the cover 102. After the collection of the sample 316 in the sample tube 108, the sample tube 108 can be removed from the sampling device 100, sealed (e.g., sealed via the hd 210 of FIG. 2. etc.) and the sampling device 100 can be removed from the skin of the user by peeling the adhesive pad 106 therefrom.

[0055] FIGS. 4A and 4B are perspective views of body 104 of FIGS. 1 and 2. The body 104 includes an example first wall 402. The body 104 may further include an example second wall 404. The body 104 may further include an example third wall 406. The body 104 may further include an example base 408. The body 104 may further include an example channel 410. The body may further include an example ramp 412. The body may further include an example boss 414. In the illustrated example of FIGS. 4A and 4B, the body 104 includes an example first wall 402. an example second wall 404, an example third wall 406, an example base 408. an example channel 410, an example ramp 412. and an example boss 414.

[0056] The first wall 402 includes at least one inner wall portion and at least one outer wall portion. In the illustrated example of FIGS. 4A and 4B, the first wall 402 includes an example first inner all portion 416A. an example second inner wall portion 416B, an example third inner wall portion 416C, an example first outer wall portion 418A, an example second outer wall portion 418B, and an example third outer wall portion 418C. In some examples, thefirst wall 402 includes at least one top surface (e.g., a top surface), at least one vertical surface, and at least one circumferential surface. In the illustrated example of FIGS. 4A and 4B, the first wall 402 further includes an example top surface 420, an example first vertical surface 422A, an example second vertical surface 422B, an example third vertical surface 422C, an example fourth vertical surface 422D. an example fifth vertical surface 422E, an example sixth vertical surface 422F, an example first circumferential surface 424A, an example second circumferential surface 424B, and an example third circumferential surface 424C. In the illustrated example of FIGS. 4A and 4B, the second wall 404 includes an example body lip 426. In some examples, the third wall 406 includes at least one wall portion and at least one inner slot (e.g., a slot). In the illustrated example of FIGS. 4A and 4B, the third wall 406 includes an example first wall portion 428A, an example second wall portion 428B, an example first inner slot 430A. and an example second inner slot 430B. In the illustrated example of FIGS. 4A and 4B, the first wall 402 defines an example first cavity 432. In the illustrated example of FIGS. 4A and 4B, an example second cavity 434 is disposed between an outer surface of the first wall 402 and inner surface of the second wall 404.

[0057] In the illustrated example of FIGS. 4A and 4B, the walls 402, 404, 406 extend from the base 408. The first wall 402 is configured to receive a cover of the sampling device 100 (e.g., the cover 102 of FIG. 1, etc.) and a piston of the sampling device 100 (e.g., the piston 204 of FIG. 2, etc.). In the illustrated example of FIG. 4A and 4B, the first wall 402 is disposed between the second wall 404 and the third wall 406. That is, the third wall 406 is disposed radially within the first wall 402 and the second wall 404. The first wall 402 extends vertically from the base 408. The outer wall portions 418A, 418B, 418C extend from and are disposed radially outward of the inner wall portions 416A, 416B, 416C, respectively. The top surface 420 of the first wall 402 extends along a top of the inner wall portions 416A, 416B. 416C, 418A. 418B, 418C.

[0058] In the illustrated example of FIGS. 4A and 4B, the first wall 402 includes the slots 213A, 213B, 213C of FIG. 2. The first slot 213A is defined by the first outer wall portion 418A, the third inner wall portion 416C. the first inner wall portion 416A, the first vertical surface 422A, the fourth vertical surface 422D, and the first circumferential surface 424A. The second slot 213B is defined by the second outer wall portion 418B, the first inner wall portion 416A, the second inner wall portion 416B, the second vertical surface 422B, the fifth vertical surface 422E, and the second circumferential surface 424B. The third slot 213C is defined by the third outer wall portion 418C, the second inner wall portion 416B, the third inner wall portion 416C, the third vertical surface 422C, the sixth vertical surface 422F, and the thirdcircumferential surface 424C. In the illustrated example of FIGS. 4A and 4B. the slots 213A, 213B, 213C are generally L-shaped. In other examples, the slots 213A. 213B, 213C can be I- shaped. In the illustrated example of FIGS. 4A and 4B, the gap of the slots 213A, 213B, 213C between the circumferential surfaces 424A, 424B, 424C and the outer wall portions 418A, 418B, 418C, respectively, are configured to receive corresponding ones of tabs of a piston (e.g., the piston tabs 212A, 212B, 212C of the piston 204. etc.).

[0059] During operation of the sampling device 100, respective features of the piston (e.g., the piston tabs 212A, 212B, 212C of FIG. 2, etc.) abut respective ones of the circumferential surfaces 424A, 424B, 424C and rotate circumferentially thereon. When the features become unaligned with the outer wall portions 418A. 418B, 418C (e.g., abut the vertical surfaces 422D. 422E, 422F, etc.), the piston (e.g.. the piston 204 of FIG. 2. etc.) is released, the second spring (e.g., the second spring 206 of FIG. 2, etc.) expands, and the piston fires away from the base 408, which generates a vacuum within the first cavity 432. In the illustrated example, the second wall 404 is the radially outermost wall of the body 104. The second wall 404 is configured to be coupled to a cover of the sampling device 100 (e.g., the cover 102 of FIG. 1, etc.). In the illustrated example of FIGS. 4A and 4B, the second wall 404 includes an example body lip 426, which extends radially outward from a top edge of the second wall 404. In some examples, the body lip 426 of the second wall 404 receives a corresponding feature of the cover of the sampling device 100 to couple the cover to the body 104. In some examples, the second wall 404 is absent.

[0060] The third wall 406 is configured to receive and support a carrier (e g., the carrier 208 of FIG. 2, etc.) and a skin-piercing element (e.g., the skin-piercing element 214 of FIG. 2, etc.) of the sampling device 100. In the illustrated example of FIG. 4, the third wall 406 surrounds the opening 440. The inner slots 430A, 430B extend between an example top edge 438 of the third wall 406 and the base 408 and / or channel 410. The inner slots 430A, 430B are disposed between the circumferential ends of the walls 428A, 428B. During operation of the sampling device 100, a feature of the carrier (e.g., the carrier tabs 216A, 216B of FIG. 2, etc.) abut the top edge 438 and rotate circumferentially thereon. When the features become aligned with the inner slots 430A, 430B. the earner (e.g., the carrier 208 of FIG. 2. etc.) is released, the first spring (e.g., the first spring 202 of FIG. 2, etc.) expands, and the skin-piercing element (e.g., the skin-piercing element 214 of FIG. 2, etc.) fires outward to and through an example opening 440 in the base 408.

[0061] The base 408 supports the components of body 104 and the sampling device 100.In the illustrated example of FIGS. 4A and 4B, the base 408 is generally annular (e.g., circular,cylindrical, etc ). In other examples, the base 408 can have any other suitable shape (e.g., ovoid, polygonal, etc.). In some examples, a surface of the base 408 opposite the walls 402. 404, 406 can receive an adhesive pad (e g., the adhesive pad 106 of FIGS. 1 and 2, etc.) of the sampling device 100.

[0062] The channel 410 is a recessed portion formed in the base 408 between the ramp 412 and the opening 440. The ramp 412 is a portion of material extending from the channel 410 to the boss 414. The channel 410 and ramp 412 facilitate the flow of the sampled bodily fluid between the opening 440 and the boss 414. In some examples, the channel and / or the ramp 412 can include features that bolster flow of the extracted bodily fluid from capillary7action and / or surface tension to the boss 414. In some examples, the channel 410 and / or the ramp 412 are absent.

[0063] The boss 414 extends radially outward from the first wall 402, through the second wall 404, and radially outward from the body 104. The boss 414 is to receive a sample tube (e.g., the sample tube 108 of FIGS. 1-3C. etc ). In the illustrated example of FIG. 4A and 4B. the boss 414 is cylindrically shaped. In other examples, the boss 414 can have a shape suitable to receive a sample tube (e.g., if the sample tube has a different shape, the boss 414 can have a corresponding or complementary7shape, etc.). The boss 414 includes a through hole (e.g., the through hole 530 of FIGS. 5-7, etc.) that extends from an example exterior edge 442 of the boss 414. through the second wall 404 and the first wall 402, and into the first cavity 432. In the illustrated example of FIGS. 4A and 4B. the boss 414 is angled upward relative to the base 408, such that a sample tube coupled to the sampling device 100 is angled upward or outward from the plane of the base 408 and / or the skin of the user of the sampling device.

[0064] FIGS. 5, 6, and 7 is a cross-sectional view of the sampling device 100 of FIG. 1 in the first position 300 of FIG. 3 A, the second position 308 of FIG. 3B, and the third position 312 of FIG. 3C, respectively. The cover 102 of the sampling device 100 includes an interior top surface 502 and an example interior wall 504. The cover 102 may further include an example cover lip 506. The cover 102 may further include an example cover flange 510. In the illustrated examples of FIGS. 5-7, the cover 102 includes an interior top surface 502, an example interior wall 504. an example cover lip 506, and an example cover flange 510. In the illustrated examples of FIGS. 5-7, an example sample chamber 51 1 is defined between the base 408 of the body 104, the first wall 402 of the body 104, and the piston 204. The piston 204 includes one or more piston flanges and one or more piston walls (e.g., a wall or walls). For example, in the illustrated example of FIGS. 5 and 6, the piston 204 includes an example first piston flange 512A, an example second piston flange 512B, an example first piston wall 514 having anexample piston lip 516, an example second piston wall 518. The piston 204 may further include an example spring interface 520 and example openings 522. In the illustrated example of FIGS. 5 and 6, the piston 204 includes an example first piston flange 512A, an example second piston flange 512B, an example first piston wall 514 having an example piston lip 516, an example second piston wall 518, an example spring interface 520, and example openings 522. In the illustrated example of FIGS. 5-7, the boss 414 of FIG. 4 includes an example through hole 530.

[0065] In the illustrated examples of FIGS. 5-7, the cover 102 and the body 104 are coupled together such that the top surface 420 of the first wall 402 of the body 104 abuts the interior top surface 502 of the cover 102. In the illustrated examples of FIGS. 5-7, the cover 102 and the body 104 are coupled via an interface between the body lip 426 and the cover lip 506, which extends radially inward from the interior wall 504. In other examples, the cover lip 506 can be coupled to the body 104 in any other suitable manner. The coupling of the body 104 and the cover 102 via the cover lip 506 and the body lip 426 retains the body 104 and the cover 102 (e.g., prevents the relative translation thereof, etc.) and allows the relative rotation thereof. That is, the interface between the cover lip 506 and the body lip 426 enables the cover 102 to rotate circumferentially about the body 104 and move between the first position 300 of FIGS. 3A and 5, the second position 308 of FIGS. 3B and 6, and the third position 312 of FIG. 3C and 7.

[0066] In the illustrated example of FIGS. 5-7, the first piston tab 212A abuts the cover flange 510. The abutment of the cover flange 510 and the first piston tab 212A causes the piston 204 to undergo counterclockwise rotation when a user rotates the cover 102 counterclockwise. As such, the cover flange 510 transfers torque between the cover 102 and the cover flange 510. In some examples, the cover 102 can include additional flanges that abut one or both of the second piston tab 212B and / or the third piston tab 212C. In some examples, the cover flange 510 and / or the other flanges of the cover 102 can be spaced from the piston 204 in the first position 300 of FIG. 3 A. In some examples, after reaching the second position 308, the cover flange 510 and / or the other flanges of the cover 102 can contact the piston tabs 212A, 212B, 212C.

[0067] The first piston wall 514 is disposed radially outw ard of the second piston wall 518 and the spring interface 520. The first piston wall 514 is the outermost wall of the piston 204. In the illustrated example of FIGS. 5 and 6, the first piston wall 514 includes the piston lip 516, which abuts the first wall 402 of the body 104. The piston lip 516 extends circumferentially around the first piston wall 514. In some examples, the abutment of the piston lip 516 fluidly seals the sample chamber 511 from the atmosphere and other portions of the sampling device 100. During the operation of the sampling device 100. the piston lip 516 reduces (e.g., prevents, etc.) leakage from the sample chamber 51 1. In some examples, the piston lip 516 maintains theradial position of the piston 204 during the operation of the sampling device and reduces friction between the first piston wall 514 and the first wall 402 of the body 104.

[0068] The second piston wall 518 is disposed between the first piston wall 514 and the spring interface 520. The piston flanges 512A, 512B extend from the second piston wall 518. The first piston flange 512A and the second piston flange 512B abut corresponding ones of the first carrier tab 216A (see FIGS. 2 and 7) and the second carrier tab 216B (see FIGS. 2 and 7). Because the cover 102 is rotatably coupled to the piston 204 (e.g. , via the interface between the piston tabs 212A, 212B, 212C and one or more cover flanges, etc.). The abutment of the piston flanges 512A, 512B and the carrier tabs 216A, 216B causes the carrier 208 to undergo counterclockwise rotation when a user rotates the cover 102 counterclockwise. As such, the piston flanges 512A. 512B transfer torque between the piston 204 and the carrier 208. In the illustrated example of FIGS. 5-7, the second spring 206 is disposed between the first piston wall 514 and the second piston wall 518.

[0069] The spring interface 520 receives the first spring 202. In the illustrated example of FIG. 5, the first spring 202 is retained in compression between the spring interface 520 and the earner tabs 216A, 216B. In the illustrated example of FIG 5, an example first end 528A of the first spring 202 is adjacent to the spring interface 520, and an example second end 528B of the first spring 202 is adjacent to the carrier tabs 216A, 216B. In the illustrated example of FIG. 5, the first end 528A of the first spring 202 is coupled to the spring interface 520. For example, the first end 528A of the first spring 202 can be coupled to the spring interface 520 via a chemical adhesive, a mechanical interface (e g., a ridge formed in the spring interface 520, a tab extending from the spring interface 520, etc.), and / or an interference fit.

[0070] In the illustrated example of FIG. 5, the components of the piston 204 (e.g., the spring interface 520, the piston walls 514, 518, the piston lip 516. the piston tabs 212A, 212B, 212C of FIG. 2, etc.) are integral (e.g., unitary, etc.). In other examples, some or all of the components of the piston 204 can be discrete components that are manufactured separately and coupled via one or more suitable coupling methods.

[0071] The piston openings 522 are openings formed on an example top surface 527 of the piston 204 and extend through the second piston wall 518. The piston openings 522 reduce the weight of the piston 204, which reduces the amount of spring force from the second spring 206 used to actuate the piston 204 and the material cost of the piston 204. In the illustrated example of FIGS. 5-7, the piston 204 includes three piston openings (e.g., the piston openings 522, etc.). In other examples, the piston 204 can include any suitable number of piston openings. In other examples, the piston openings 522 are absent.

[0072] FIG. 5 is a cross-sectional view of the sampling device 100 in the first position 300 of FIG. 3 A. The cross-sectional view of FIG. 5 is taken along a cutting plane extending between the base 408 and the A-A line of FIG. 3 A. In the illustrated example of FIG. 5, the sampling device 100 is in a ready-to-operate position (e.g., a pre-fired position, etc.). In the illustrated example of FIG. 5, the piston 204 is in an example first piston position 524 and the carrier 208 is in an example first carrier position 526.

[0073] In the illustrated example of FIG. 5, the carrier 208 is disposed in an example first carrier position 526. In the first carrier position 526 of FIG. 5, the carrier tabs 216A, 216B (see FIGS. 2 and 7) are disposed on the top edge 438 of the third wall 406 of the body 104 and between the third wall 406 of the body 104 and the second piston wall 518 of the piston 204. The abutment of the carrier tabs 216A, 216B on the third wall 406 retains the carrier 208 in the first carrier position 526. The retention of the carrier 208 in the first carrier position 526 retains the first spring 202 in compression.

[0074] In the illustrated example of FIG. 5, the pistons tabs 212A, 212B, 212C are disposed within the slots 213A, 213B, 213C and between corresponding ones of the outer wall portions 418A, 418B, 418C and the circumferential surfaces 424 A, 424B, 424C. In the illustrated example of FIG. 5, the abutment of the piston tabs 212A, 212B, 212C and the vertical surfaces 422 A, 422B, 422C of the outer wall portions 418A, 418B, 418C retains the piston 204 in the first piston position 524. which is spaced from the interior top surface 502 of the cover 102. The retention of the piston 204 in the first piston position 524 retains the second spring 206 in compression.

[0075] Referring now to FIG. 6, the sampling device 100 of FIGS. 1 and 2 is in the second position 308 of FIG. 3B. The cross-sectional view of FIG. 6 is taken along a cutting plane extending between the base 408 and the B-B line of FIG. 3B. In the illustrated example of FIG. 6, the rotation of the cover 102 has moved the carrier tabs 216A, 216B along the top edge 438 of the third wall 406 and into circumferential alignment with the inner slots 430A, 430B, respectively. When the carrier tabs 216A, 216B become aligned with the inner slots 430A, 430B, the compression of the first spring 202 is released, which causes the first spring 202 to exert a force on the carrier 208 and drives the carrier 208 into an example second carrier position 600. In the second carrier position 600, the skin-piercing element 214 is driven through the opening 440, w hich pierces the skin of the user of the sampling device 100.

[0076] Referring now to FIG. 7, the sampling device 100 of FIGS. 1 and 2 is in the third position 312 of FIG. 3C. The cross-sectional view of FIG. 7 is taken along a cutting plane extending between the base 408 and the C-C line of FIG. 3C. In the illustrated example of FIG.7, the rotation of the cover 102 has moved the piston tabs 212A, 212B, 212C along the circumferential surfaces 424A, 424B, 424C. respectively, and into circumferential alignment with the bottom of the vertical portions of the slots 213A, 213B, 213C, respectively (e.g., to a position abutting the vertical surfaces 422D, 422E, 422F, etc.). Because the piston tabs 212A, 212B, 212C are no longer disposed between the outer wall portions 418A, 418B, 418C, the second spring 206 is released from compression and exerts a force on the piston 204. which drives the piston 204 into an example second piston position 700. In the second piston position 700 of FIG. 7, the piston 204 has been displaced toward the interior top surface 502 of the cover 102 and the top surface 420 of the first wall 402. In some examples, because the sample chamber 511 of the body 104 is sealed (e.g.. not in fluid communication with the ambient atmosphere, etc.), the upward movement of the piston 204 increases the volume of the sample chamber 511 and decreases the pressure in the sample chamber 511 (e.g., per Boyle’s law, etc.). The decreased pressure in the sample chamber 511 draws a sample of bodily fluid out of the incision formed by the skin-piercing element 214 in the second position 308 of FIG. 3B and 6 and into the sample chamber 511. In some examples, after entering the sample chamber 511. the sampled bodily fluid flows into the sample tube 108 (e.g., via the vacuum, via capillar}' action, via surface tension, and / or via gravity, etc.).

[0077] FIG. 8A is a perspective view of another example sampling device 800 in an example first position 802 implemented in accordance with the teachings of this disclosure. The sampling device 800 is similar to the sampling device 100 of FIGS. 1 -7, except that the example sampling device 800 includes an example first sample tube 804A and an example second sample tube 804B. In the illustrated example of FIG. 8 A, the sampling device 800 includes an example first boss 806A, and an example second boss 806B. The first sample tube 804A is removably coupled to the first boss 806A. and the second sample tube 804B is removably coupled to the second boss 806B. In the illustrated example of FIG. 8A, the sampling device 800 further includes an example cover 808, an example body 810, and an example adhesive pad 812, which are similar to the cover 102 of FIG. 1, the body 104 of FIG. 1, and the adhesive pad 106 of FIG. 1, respectively, except as noted otherwise. Unlike the sampling device 100 of FIGS. 1-7, the sampling device 800 is configured to extract multiple samples in a single actuation of a skinpiercing element of the sampling device 800 by a spring (e.g., an actuation of a skin-piercing element similar to the skin-piercing element 214 of FIG. 2 by a spring similar to the first spring 202 of FIG. 2, etc.) and generation of vacuum by a piston (e.g., an actuation of a piston similar to the piston 204 of FIG. 2 by a spring similar to the second spring 206 of FIG. 2, etc.). The bosses 806A, 806B are similar to the boss 414 of FIG. 4, which are fluidly coupled to an interiorchamber of the sampling device 800 (e.g., a chamber similar to the sample chamber 511 of FIGS. 5-7, etc.). The bosses 806A. 806B receive the sample tubes 804A, 804B, respectively. In some examples, the internal condition of the sampling device 800 is similar to the internal condition of the sampling device of FIG. 1 described in conjunction with FIGS. 5-7.

[0078] In the illustrated example of FIG. 8A, the sampling device 800 is in the first position 802, which is prior to the actuation of the skin-piercing element of the sampling device 800 and the actuation of the piston of the sampling device 800 (e.g., a position similar to the first position 300 of the sampling device 100 of FIG. 3 A, etc.). The cover 808 includes an example slot 814, similar to the cover slot 302 of FIGS. 3A-3C. In the illustrated example of FIG. 8, the slot 814 has an example first end 816A and an example second end 816B. In the illustrated example of FIG. 8 A. the first sample tube 804A and / or first boss 806A abut the second end 816B, which prevents the clockwise rotation of the sampling device 800. To operate the sampling device 800, a user can rotate the cover 808 in a counterclockwise direction, which causes the actuation of the skin-piercing element and subsequent generation of a vacuum. In the illustrated example of FIG. 8A, the body 810 includes an example indicium 817, which is similar to the visual indicium 306 of FIGS. 3 A and 3B. Like the visual indicium 306 of FIGS. 3A and 3B, the indicium 817 indicates a direction the cover 808 is to be rotated to move the sampling device 800 out of the first position 802 of FIG. 8 A. The indicium 817 can have any suitable form, including words and / or other symbols.

[0079] FIG. 8B is a perspective view of the sampling device 800 of FIG. 8A in an example second position 818. The second position 818 of the sampling device 800 is angularly displaced from the first position 802 of FIG. 8 A following a rotation 820 of the cover 808. The rotation 820 brings the sampling device 800 from the first position 802 of FIG. 8A. through an intermediate position (e.g.. similar to the second position 308 of FIG. 3B. etc.) that causes the actuation of the skin-piercing element of the sampling device 800 (e.g., a position similar to the second position 308 of FIG. 3B, etc.), and to the second position 818. In the second position 818, a vacuum has been formed within the sampling device 800, which has drawn example samples 820A, 820B into the sample tubes 804A, 804B, respectively. In the illustrated example of FIG. 8B, the cover 808 has been rotated such that the second sample tube 804B is adjacent to the first end 816A (e g., abutting the first end 816A, etc ). In some examples, the abutment of the second sample tube 804B and the first end 816A prevents further rotation of the cover 808. After the collection of the samples 820 A, 820B in the sample tubes 804A, 804B, the sample tubes 804A, 804B can be removed from the sampling device 800. sealed (e.g., sealed via a lid similar to the lid 210 of FIG. 2, etc.) and the sampling device 800 can be removed from the skin of theuser by peeling the adhesive pad 812. In some examples, the internal condition of the sampling device 800 is similar to the internal condition of the sampling device 100 of FIG. 1 described in conjunction with FIG. 7.

[0080] FIG. 9A is a perspective view of an example first alternative cover 900 that can be used in conjunction with the sampling device 100 of FIG. 1 and / or the sampling device 800 of FIG. 8A. In the illustrated example of FIG. 9. the first alternative cover 900 includes an example slot 902 similar to the cover slot 302 of FIGS. 3A-3C and the slot 814 of FIGS. 8A and 8B. Like the cover slot 302 of FIGS. 3A-3C and the slot 814 of FIGS. 8A and 8B, the slot, via the abutment of a boss and / or a sample tube, limits the rotation of the first alternative cover 900. In the illustrated example of FIG. 9, the first alternative cover 900 includes example ridges 904. The ridges 904 facilitate the handling, gripping, and / or rotation of the first alternative cover 900 by a user (e.g., the first alternative cover 900 is ergonomic, etc ).

[0081] FIG. 9B is a perspective view of an example second alternative cover 906 that can be used in conjunction with the sampling device 100 of FIG. 1 and / or the sampling device 800 of FIG. 8 A. Like the first alternative cover 900 of FIG. 9A. the second alternative cover 906 includes example ridges 908, which facilitate the handling, gripping, and / or rotation of the second alternative cover 906 (e.g., the second alternative cover 906 is ergonomic, etc.). In some examples, the ridges 908 can be shaped and / or sized for the individual fingers of a user. In the illustrated example of FIG. 9, the second alternative cover 906 does not include a slot similar to the cover slot 302 of FIGS. 3A-3C, the slot 814 of FIGS. 8A. and / or the slot 902 of FIG. 9A. In other examples, the second alternative cover 906 can include a slot that similarly restricts the rotation of the second alternative cover 906. Additionally or alternatively, the rotation of the second alternative cover 906 can be restricted by internal features of the associated sampling device.

[0082] FIG. 9C is a perspective view of a third alternative cover 910 that can be used in conjunction with the sampling device 100 of FIG. 1 and / or the sampling device 800 of FIG. 8A. In the illustrated example of FIG. 9C, the third alternative cover 910 includes an example protrusion 912 formed on an outer surface of the third alternative cover 910. In the illustrated example of FIG. 9C. the protrusion 912 is a physical indicator that indicates the rotational position of the alternative third cover 910. That is, the alignment of the protrusion 912 and an example sample tube 914 can indicate a completion of the rotation of the third alternative cover 910 and / or the extraction of a sample into the sample tube 914. Additionally or alternatively, an example body 916 can include one or more indicium that indicate a start position and / or end position of the rotation of the third alternative cover 910.

[0083] FIG. 9D is a perspective view of an example fourth alternative cover 918 that can be used in conjunction with the sampling device 100 of FIG. 1 and / or the sampling device 800 of FIG. 8A. In the illustrated example, the fourth alternative cover 918 includes an example indicia 920, an example first ridge 922A, and an example second ridge 922B. The example indicia 920 are a visual indicators that indicate the rotational position of the fourth alternative cover 918. That is, the alignment of the indicia 920 and an example sample tube 924 can indicate a completion of the rotation of the fourth alternative cover 918 and / or the extraction of a sample into the sample tube 924. In the illustrated example of FIG. 9D, the indicia 920 is a series of dots of different sizing (e.g., an alignment of the smallest dot and the sample tube 924 indicating a pre-extraction position of the fourth alternative cover 918, an alignment of the largest dot and the sample tube 924 indicating a post-extraction position of the fourth alternative cover 918, etc ). In other examples, the indicia 920 can have any other suitable form (e g., one or more words, an arrow, a series of different shapes, etc.). In the illustrated example of FIG. 9D, the indicia 920 is formed as recessed portions in the fourth alternative cover 918. In other examples, the indicia 920 can be formed via protruding portions of the fourth alternative cover 918 and / or disposed on the fourth alternative cover 918 (e.g., as a sticker, as a paint, etc.).

[0084] The ridges 922 A, 922B facilitate the handling, gripping, and / or rotation of the fourth alternative cover 918. In some examples, the ridges 922A, 922B are sized and / or shaped to receive the individual fingers of a user. In other examples, the ridges 922A, 922B can have any other suitable size and / or shape (e.g., tighter spacing like the ridges 904 of FIG. 9A, etc.). In the illustrated example of FIG. 9D, the fourth alternative cover 918 includes two ridges (e.g., the ridges 922A, 922B, etc.). In other examples, the fourth alternative cover 918 can include other numbers of ridges (e.g., one, three, four, etc.).

[0085] FIG. 10A is a perspective view of another example sampling device 1000 in an example first position 1002 and implemented in accordance with the teachings of this disclosure. The sampling device 1000 includes an example cover 1004. The sampling device 1000 may further include an example body 1006. The sampling device 1000 may further include an example adhesive pad 1008. The sampling device 1000 may further include an example sample tube 1010. In the illustrated example of FIG. 10A. the sampling device 1000 includes an example cover 1004, an example body 1006, an example adhesive pad 1008, and an example sample tube 1010. The adhesive pad 1008 is similar to the adhesive pad 106 of FIGS. 1 and 2, except that the adhesive pad 1008 is sized for the sampling device 1000 and as noted otherwise. In the illustrated example of FIG. 10 A, the cover 1004 includes an example handle 1012, and the body 1006 includes an example plate 1014. Like the sampling device 100 of FIGS. 1 -7, theexample sampling device 1000 can be used to extract a bodily fluid from the skin of a person and store the bodily fluid in the sample tube 1010. For example, the sampling device 1000 can be used to conduct capillary blood sampling from the skin of a patient. In other examples, the sampling device 1000 can be used to extract other fluids from the epidermis of a user (e.g., pus, serum, lymph, interstitial, etc.). The sampling device 1000 can be disposed on a portion of the user’s body such as, for example, the upper arm, the lower arm the thigh, etc. In some examples, the handle 1012 could be incorporated in the cover 102 of the sampling device 100, and the plate 1014 could be incorporated into the body 104 and / or the boss 414 of the sampling device 100.

[0086] The cover 1004 is rotatably coupled to the body 1006, such that the cover 1004 can axially rotate relative to the body 1006. The handle 1012 is a user interface that enables a user of the sampling device 1000 to actuate a skin-piercing element and extract a bodily fluid using the sampling device 1000. In the illustrated example of FIG. 10 A, the handle 1012 extends from the cover 1004 and facilitates the manual rotation of the cover 1004 by a user of the sampling device 1000. In the illustrated example of FIG. 10A, the handle 1012 is a straight planar member that is integral with the cover 1004. In other examples, the handle 1012 can have any other suitable shape (e.g., a cylinder, a prism, L-shaped, etc.) and / or can be a discrete component joined to the cover 1004 (e.g., via one or more chemical adhesives, via one or more fasteners, via one or more interference fits, etc.). In some examples, the handle 1012 can include one or more features (e.g.. ridges, recessed surface features, protruding surface features, etc.) that facilitate the handling of the handle 1012 by a user of the sampling device 1000.

[0087] The handle 1012 enables a user of the sampling device 1000 to operate the sampling device 1000 by placing one or more fingers on the plate 1014 and one or more fingers on the handle 1012 and moving the handle 1012 towards the plate 1014 (e.g.. pinching the handle 1012 toward the plate 1014, via a pinching motion, etc.). That is, the handle 1012 is rotatable from the first position 1002 to another position (see FIG. 10B). A sampling device including an alternative handle is described in conjunction with FIG. 17. In some examples, the handle 1012 can be absent. In some examples, the cover 1004 can include alternative features that facilitate the rotation of the cover 1004 and / or operation of the sampling device 1000 (e.g., a knob, ridges, features of FIGS. 9A-D, etc ). A sampling device including a knob is described in conjunction with FIG. 18.

[0088] The body 1006 houses the skin-piercing elements of the sampling device 1000. The body 1006 includes an example first cylindrical portion 1016. The body 1006 may further include an example second cylindrical portion 1018. The body 1006 may further include anexample base 1020. The body 1006 may further include an example intermediate portion 1021. In the illustrated example of FIG. 10 A, the body 1006 includes an example first cylindrical portion 1016, an example cylindrical portion 1018, an example base 1020, and an example intermediate portion 1021. The first cylindrical portion 1016 extends from the base 1020. The first cylindrical portion 1016 is rotatably coupled to the cover 1004 such that the cover 1004 is able to rotate relative to the first cylindrical portion 1016. The second cylindrical portion 1018 extends from the intermediate portion 1021. In the illustrated example of FIG. 10 A, the plate 1014 extends from an outer surface of the second cylindrical portion 1018. In the illustrated example of FIG. 10A, the intermediate portion 1021 couples the cylindrical portions 1016, 1018. The base 1020 supports the components of body 1006 and the sampling device 1000. In the illustrated example of FIG. 10A. the base 1020 is generally annular (e.g.. circular, cylindrical, etc.). In other examples, the base 1020 can have any other suitable shape (e.g., ovoid, polygonal, etc.).

[0089] In the illustrated example of FIG. 10. the first cylindrical portion 1016 is coupled to the cover 1004, the second cylindrical portion 1018 is coupled to the sample tube 1010, and the base 1020 is coupled to the adhesive pad 1008. In the illustrated example of FIG. 11, the body 1006 is an integral component (e.g., the cylindrical portions 1016, 1018, base 1020, and the intermediate portion 1021 are a unitary' component, etc.). In some examples, some or all of the components of the body can be discrete components that are coupled in any other suitable manner. The internal structures of the cover 1004 and the body 1006 are described in conjunction with FIGS. 12-16.

[0090] The sample tube 1010 receives and stores bodily fluids extracted from a user via the sampling device 1000. In the illustrated example of FIG. 10, the sample tube 1010 is an evacuated tube such as, for example, a Vacutainer® tube. In some examples, the sample tube 1010 can include a soft membrane that maintains an internal chamber of the sample tube at a below atmosphere pressure. In some examples, when the sample tube 1010 is coupled to the sampling device 1000, a needle (see FIGS. 11 and 13) of the sampling device 1000 pierces the soft membrane (e.g., a septum, etc ), which similarly lowers the pressure of portions of the sampling device 1000 in fluid communication with the sample tube 1010. The sample tube 1010 can include a rigid plastic and / or a glass. In some examples, the soft membrane of the sample tube 1010 can be composed of any suitable flexible material, including a plastic, an elastomer, a metal foil, a natural material and / or combination of materials.

[0091] The sample tube 1010 can facilitate the storage and testing of the blood sampled via the operation of the sampling device 1000. For example, the sample tube 1010 can includeone or more additives to assist in the limitation or prevention of the coagulation of collected blood (e.g.. heparin, sodium citrate, lithium heparin, etc.), serum collection (e.g.. silica particles, serum separating gel, etc.), preparation of the sample for toxicology analysis (e.g., EDTA, etc ), and / or glycolysis prevention (e.g., sodium fluoride, potassium oxalate, etc.). In some examples, the sample tube 1010 can include one or more indicators to indicate the additive therein and / or purpose of the collected sample (e.g., a label, a tactile indication, a colored portion, and / or a colored lid, etc.).

[0092] In the illustrated example of FIG. 10 A, the cover 1004 includes an example visual indicium 1019. The visual indicium 1019 indicates an instruction for the operation of the sampling device 1000. In the illustrated example of FIG. 10A, the visual indicium 1019 is formed in the cover 1004 as a recessed portion. In other examples, the visual indicium 1019 can be an extruded portion and / or manufactured separately and subsequently disposed on the surface of the cover 1004 (e.g. paint, a label, etc.). In other examples, the visual indicium 1019 can be formed on an external surface of the body 1006. In the illustrated example of FIG. 10A, the visual indicium 1019 is an arrow indicating a direction of rotation of the cover 1004 to cause the operation of the sampling device 1000. Additionally or alternatively, the visual indicium 1019 can have any other suitable form and / or shape. For example, the visual indicium 1019 can include words (e.g., “ROTATE COUNTERCLOCKWISE,” “ROTATE,” etc.) and / or another symbol (e.g., a blood drop. etc ). In other examples, the visual indicium is absent.

[0093] The first position 1002 of the sampling device 100 is a pre-actuation (e.g.. a prefire position, a pre-extraction position, etc ). The internal condition of the sampling device 1000 in the first position 1002 is described in conjunction with FIG. 13. In the first position 1002, the sampling device 1000 can be coupled to the skin of a user via the adhesive pad 1008 and can be actuated to extract a bodily fluid sample therefrom. In the first position 1002. the handle 1012 is spaced from the plate 1014 (e.g., the handle 1012 is distal to the plate 1014, the handle is angularly spaced from the plate 1014, etc.).

[0094] FIG. 10B is a perspective view of the sampling device 1000 of FIG. 10A in an example second position 1022 after an example rotation 1024. The second position 1022 of the sampling device 1000 is angularly displaced from the first position 1002 of FIG. 10A following the rotation 1024. In some examples, the sampling device 1000 can be rotated by rotating the handle 1012 from the first position 1002 to the second position 1022. The rotation 1024 brings the sampling device 1000 from the from the first position 1002 of FIG. 8 A to the second position 1022. The rotation 1024 causes the actuation of the skin-piercing element of thesampling device 1000 and the vacuum contained within the sample tube 1010 to extend into the body 1006.

[0095] In the second position 1022, the vacuum within the sampling device 1000 draws an example sample 1026 into the sample tube 1010. In the illustrated example of FIG. 10B, the cover 1004 has been rotated such that the handle 1012 is adjacent to the plate 1014 (e.g., abutting the plate 1014, etc.). In some examples, the abutment of the handle 1012 and the plate 1014 prevents further rotation of the cover 1004. After the collection of the sample 1026 in the sample tube 1010, the sample tube 1010 can be removed from the sampling device 1000, sealed (e.g., via a lid, etc.), and the sampling device 1000 can be removed from the skin of the user by peeling the adhesive pad 1008. The internal condition of the sampling device 1000 in the second position 1022 is described in conjunction with FIGS. 14-16.

[0096] FIG. 11 is an exploded view of the sampling device 1000 of FIGS. 10A and 10B. The sampling device 1000 includes the cover 1004 of FIGS. 10A and 10B, the body 1006 of FIGS. 10A and 10B, the adhesive pad 1008 of FIGS. 10A and 10B, and the sample tube 1010 of FIGS. 10A and 10B. The sampling device 1000 may further include an example seal 1102. The sampling device 1000 may further include an example spring 1104. The sampling device 1000 may further include an example carrier 1106. The sampling device 1000 may further include an example needle 1108. The sampling device 1000 may further include an example needle carrier 1109. The sampling device 1000 may further include an example lid 1110. The carrier 1106 includes an example skin-piercing element 1112. The carrier 1106 may further include an example first carrier tab 1114A. The carrier 1106 may further include an example second carrier tab 1114B. The carrier 1106 may further include an example carrier slot 1116. In the illustrated example of FIG. 11, the sampling device 1000 includes the cover 1004 of FIGS. 10A and 10B. the body 1006 of FIGS. 10A and 10B. the adhesive pad 1008 of FIGS. 10A and 10B. the sample tube 1010 of FIGS. 10A and 10B, an example seal 1102, an example spring 1104, an example carrier 1106, an example needle 1108, an example needle carrier 1109, and an example lid 1110. In the illustrated example of FIG. 11, the carrier 1106 includes an example skin -piercing element 1112. an example first carrier tab 1114A, an example second carrier tab 1114B, and an example carrier slot 1116. In the illustrated example of FIG. 11, the body 1006 includes an example cavity 11 18 and an example opening 1120.

[0097] The seal 1102 is rigidly coupled to the cover 1004, such that the rotation of the cover 1004 causes a corresponding rotation of the seal 1102. The seal 1102 extends into the cavity 1118 of the body 1006. In some examples, the seal 1 102 can include a through hole. In some examples, the through hole of the seal 1 102 can facilitate fluid communication betweenthe sample tube 1010 and the cavity 1118. In some examples, the seal 1102 and the cover 1004 can be an integral component. In some examples, the seal 1102 and the cover 1004 can be composed via double injection molding (e.g., 2k molding, etc.). In other examples, the seal 1102 and the cover 1004 can be manufactured separately and coupled together via a mechanical interface, a chemical adhesive, an interference fit, etc.

[0098] During operation, the spring 1104 generates force to pierce the skin of a user of the sampling device 1000. Prior to the rotation of the cover 1004 by a user of the sampling device 1000, the spring 1104 is retained in compression within the sampling device 1000. Particularly, the spring 1104 is retained in compression between an interior wall of the body 1006 and the cover 1004. The rotation of the cover 1004 causes the release of the spring 1104 from compression. The released spring 1104 moves the carrier 1106 and skin-piercing element 1112 toward the skin of the user. The operation of the sampling device 1000 and the spring 1104 are described in conjunction with FIGS. 13-15.

[0099] The carrier 1106 carries the skin-piercing element 1112 (e.g., the skin-piercing element 1112 is disposed on a lower or distal surface of the carrier 1106, etc.). During operation of the sampling device 1000, the carrier 1106 actuates between a retained position, when the sampling device 1000 is in the first position 1002 of FIG. 10A, and a fired position, when the sampling device is in the second position 1022 of FIG. 10B. In the illustrated example of FIG. 11, the carrier 1106 is cylindrical. In other examples, the carrier 1106 can have any other suitable shape (e.g., a polygonal prism, an oval prism, etc.). In the illustrated examples of FIGS. 11 and 13-16, the skin-piercing element 1112 is depicted as a lancet array that is formed integrally with the carrier 1106. In other examples, the lancets of the array can be manufactured separately and coupled to the carrier 1106. Additionally or alternatively, the skin-piercing element 1112 can include one or more other piercing device(s) including, for example, a needle, a blade, an integral lancet, a discrete lancet, and / or a microneedle array.

[0100] In the illustrated example of FIG. 11, the carrier 1106 includes the carrier tabs 1114A, 1114B. The carrier tabs 1114A, 1114B extend radially outward from an outer surface of the carrier 1106. During operation, rotation of the carrier 1106, via corresponding rotation of the cover 1004 by a user of the sampling device 1000, causes the carrier tabs 1114A. 1 114B to circumferentially align with the slots of the body 1006 (e.g., the slots 1402 A, 1402B of FIGS. 14 and 16, etc.), which releases the spring 1104. In some examples, after being released, the spring 1104 drives the carrier 1106 and the skin-piercing element 214 towards an example opening 1121 in the adhesive pad 1008, which pierces the skin of a user of the sampling device 1000.

[0101] In the illustrated example of FIG. 1 1 . the carrier 1106 includes the carrier slot 1116. which facilitates the coupling of the carrier 1106 to the cover 1004. In some examples, the carrier slot 1116 of the carrier 1106 can be received by a corresponding feature of the cover 1004 such that rotation of the cover 1004 causes a corresponding rotation of the carrier 1106. An example of such a feature (e.g., the carrier interface 1302 of FIG. 13, etc.) is described in conjunction with FIG. 13. In other examples, the carrier 1106 can be coupled to the cover 1004 in any other suitable manner (e.g., the carrier 1106 can include a tab that is received by a corresponding slot of the cover 1004, etc.).

[0102] In some examples, the carrier 1106, the skin-piercing element 1112, and / or the carrier tabs 1114A. 1114B are integral (e.g., unitary, etc.). In some examples, the carrier 1 106, the skin-piercing element 1112, and / or the carrier tabs 1114A, 1114B are composed of a same material (e.g., polystyrene (PS), another plastic, etc.). In some examples, the carrier 1106, the skin-piercing element 1112, and / or the carrier tabs 1114A, 1114B can be manufactured via molding (e.g., injection molding, etc.), additive manufacturing, etc. In other examples, the carrier 1 106, the skin-piercing element 1112, and / or the carrier tabs 1114A, 1 114B can be discrete components, which are coupled to the carrier 1106 during the manufacturing of the sampling device 1000.

[0103] The needle 1108 is coupled to the body 1006. When the sample tube 1010 is disposed within the opening 1120 of the body 1006. the needle 1108 punctures the membrane / septum containing the vacuum within the sample tube, which causes air from within the body 1006 to flow into the sample tube 1010, which lowers the pressure within the body 104 (e.g., within the body 1006 and / or the opening 1120, etc.). Additionally or alternatively, the sampling device 1000 can include other devices and / or structures to puncture the septum of the sample tube 1010 (e.g., a knife, etc.).

[0104] The needle carrier 1109 is used to couple the needle 1108 to the body 1006. In the illustrated example of FIG. 11, the needle carrier 1109 is dome-shaped. In other examples, the needle carrier 1109 can have any other suitable shape. In some examples, the needle carrier 1109 can be coupled to the body 1006 via a chemical adhesive (e.g., an ultraviolet light bonded glue, etc.), a fastener, an interference fit. and / or any other suitable fastening method.

[0105] The lid 1110 is coupled to the sample tube 1010 prior to the extraction and collection of a bodily fluid within the sample tube 1010. The lid 1110 is coupled to the body 1006 via the opening 1120. In the illustrated example of FIG. 11, the lid 1110 is configured to be received (e.g., disposed within, etc.) within the opening 1120. In the illustrated example of FIG. 1 1 , the lid 1 1 10 can be coupled to the sample tube via an interference fit. In other examples, thelid 1110 can be coupled to the sample tube 1010 in any other suitable manner (e.g.. via threaded coupling, via a chemical adhesive, etc.). In some examples, the lid 1110 can be colored to indicate the type and / or purpose of the collected bodily fluid.

[0106] FIG. 12 is a perspective view of the sampling device 1000 of FIGS. 10A and 10B, which depict the coupling of the sample tube 1010 of FIG. 10 to the second cylindrical portion 1018 of FIG. 10. In the illustrated example of FIG. 12, the lid 1110 includes an example outer surface 1202, and the opening 1120 of the second cylindrical portion 1018 includes an example inner surface 1204.

[0107] In the illustrated example of FIG. 12, the sample tube 1010 is to undergo an example insertion 1206 along an example tube axis 1208. In the illustrated example of FIG. 12, the plate 1014 extending from the second cylindrical portion 1018 is offset from the tube axis 1208. In the illustrated example of FIG. 12, the sampling device 1000 and the handle 1012 is in the first position 1002. In some examples, when the handle 1012 and the sampling device 1000 are in the second position 1022 of FIG. 10B, the plane of the handle 1012 can be arranged such that the insertion axis lies thereon. In the illustrated example of FIG. 12, the tube axis 1208 is colinear with the major axis of the needle 1108. In other examples, the tube axis 1208 and the needle 1108 can have any other suitable spatial relationship (e.g., the needle 1108 is offset from the tube axis 1208, etc.).

[0108] In the illustrated example of FIG. 12, the opening 1120 is sized to receive the lid 1110. That is, the lid 1110 is configured to be disposed within the opening 1120. In other examples, the lid 1 110 can include an opening that can receive a corresponding boss of the sample tube 1010. In other examples, the sample tube 1010 can be configured to be disposed within the opening 1120 of the second cylindrical portion 1018 without the lid 1110. In the illustrated example of FIG. 12. the outer surface 1202 and the inner surface 1204 are configured to tightly abut to form a seal between sample tube 1010 and the body 1006. For example, the outer surface 1202 and the inner surface 1204 can be sized to form an interference fit between the second cylindrical portion 1018 and / or the lid 1110. In some examples, the inner surface 1204 and / or the outer surface 1202 can include a seal (e.g., an O-ring, etc.), which further improves the efficacy of the seal between the sample tube 1010 and the body 1006. The seal formed by the inner surface 1204 and / or the outer surface 1202 prevents the lower pressure of the sample tube 1010 from dissipating into the ambient atmosphere when the needle 1108 pierces the septum of the sample tube 1010.

[0109] FIG. 13 is a cross-sectional view of the sampling device 1000 of FIG. 1 in the first position 1002 of FIG. 10 A. The cross-sectional view of FIG. 13 is taken along a cuttingplane extending between the base 1020 and the D-D line of FIG. 10A. In the illustrated example of FIG. 13. the sampling device 1000 includes the example cover 1004 of FIGS. 10A-12, the body 104 of FIGS. 10A- 12, the seal 1102, the spring 1104 of FIG. 11, and the carrier 1 106 of FIG. 11. The cover 1004 may further include an example carrier interface 1302. The cover 1004 may further include an example first cover wall 1304. The cover 1004 may further include an example second cover wall 1306 that includes an example cover lip 1308. The cover 1004 may further include an example cover top 1310. In the illustrated example of FIG. 13, the cover 1004 includes an example carrier interface 1302, an example first cover wall 1304, an example second cover wall 1306 that includes an example cover lip 1308, and an example cover top 1310. In the illustrated example of FIG. 13. the body 1006 includes the first cylindrical portion 1016 of FIGS. 10A and 10B that include an example body lip 1312. the second cylindrical portion 1018 of FIGS. 10A and 10B, the base 1020 of FIGS. 10A and 10B, the intermediate portion 1021 of FIGS. 10A and 10B, and an example interior wall 1314. The example interior wall 1314 has an example top surface 1316, defines an example opening 1317, and has an example first channel 1318 extending therethrough. In the illustrated example of FIG. 13. an example second channel 1320 extends through the intermediate portion 1021. In the illustrated example of FIG. 13, the base 1020 defines an example base plane 1322, which forms an example angle 1324 with the tube axis 1208 of FIG. 12. In the illustrated example of FIG. 13, an example sample chamber 1326 is defined between the first cover wall 1304. the base 1020, and the cover top 1310.

[0110] In the illustrated example of FIG. 13. the carrier interface 1302. the first cover wall 1304, and the second cover wall 1306 extend from the cover top 1310 toward the base 1020 of the body 1006. In the illustrated example of FIG. 13, the carrier interface 1302 is disposed at a center of the cover top 1310 and is radially inward of the first cover w all 1304 and the second cover wall 1306. In the illustrated example of FIG. 13, the first cover wall 1304 is disposed radially inward of the second cover wall 1306 and is concentric therewith. In the illustrated example of FIG. 13, the first cover wall 1304 extends from the cover top 1310 to the base 1020 of the body 1006. The first cover wall 1304 is disposed radially inw ard of the seal 1102 and the first cylindrical portion 1016. In the illustrated example of FIG. 13, the cover top 1310 is generally dome-shaped. In other examples, the cover top 1310 can be any other suitable shape (e g., a polygonal prism, a cylinder, etc ). In the illustrated example of FIG. 13, the carrier interface 1302, the first cover wall 1304, and the second cover wall 1306, and the handle 1012 (see FIGS. 10A, 10B, 11 and 12) are integral (e.g., the cover 1004 is a unitary component, etc.). In other examples, some or all of the carrier interface 1302. the first cover wall 1304. and thesecond cover wall 1306, and the handle 1012 can be manufactured separately and joined via one or more chemical adhesives, one or more fasteners, one or more interference fits. etc.

[0111] The interior wall 1314 of the body 1006 retains the carrier 1 106 in a retracted position in the first position 1002 of FIG. 10 A. In the illustrated example of FIG. 13, the interior wall 1314 is radially inward and concentric with the first cover wall 1304, the second cover wall 1306. the seal 1102, and the first cylindrical portion 1016. In the illustrated example of FIG. 13, the interior wall 1314 surrounds the opening 1317. The intenor wall 1314 includes two vertical slots (see FIGS. 14 and 15) that extend through the interior wall 1314 from the base 1020 to the top surface 1316. The vertical slots of the interior wall 1314 are illustrated in FIGS. 14 and 16 and are described in additional detail in conjunction therewith. In the illustrated example of FIG. 13. the interior wall 1314 is integral with the base 1020 of the body 1006. In other examples, the interior wall 1314 can be a discrete component that is joined to the base 1020 of the body 1006 via one or more chemical adhesives, one or more fasteners, one or more interference fits, etc.

[0112] In the illustrated example of FIG. 13. the cover lip 1308 extends radially outward from the second cover wall 1306 and the body lip 1312 extends radially outward from the first cylindrical portion 1016. In the illustrated example of FIG. 13, the cover 1004 and the body 1006 are coupled via an interface between the cover lip 1308 and the body lip 1312. In the illustrated example of FIG. 13, the body lip 1312 is coupled to the cover lip 1308 via an interference fit. In other examples, the cover 1004 can be coupled to the body 1006 in any other suitable manner. The coupling of the body 1006 and the cover 1004 via the cover lip 1308 and the body lip 1312 retains the cover 1004 (e g., prevents translation relative to the body 1006, etc.) and allows the relative rotation thereof. That is, the interface between the cover lip 1308 and the body lip 1312 enables the cover 1004 to rotate about the body 1006 and move between the first position 1002 of FIG. 10A and the second position 1022 of FIG. 10B.

[0113] In the illustrated example of FIG. 13, the carrier tabs 1 114A, 11 14B of the carrier 1106 are disposed on and abut the top surface 1316 of the interior wall 1314 of the body 1006. The abutment of the carrier tabs 1114A, 1114B on the top surface 1316 retains the carrier 1106 in a recessed position associated the first position 1002. The retention of the carrier 208 in the first position 1002 retains the spring 1104 in compression and the skin-piercing element 1112 in a position distal to the opening 1317.

[0114] The seal 1102 is disposed on the first cover wall 1304 (e.g., abutting the first cover wall 1304, coupled to the first cover all 1304, integral with the first cover wall 1304, etc.). In the illustrated example of FIG. 13, the seal 1102 is disposed adjacent and / or below the body lip 1312 of the body 1006. In other examples, the seal 1 102 can extend beyond the bodylip 1312 (e.g., to the cover top 1310, etc ). The seal 1102 and the first cover wall 1304 are disposed between the first channel 1318 and the second channel 1320, which prevents fluid communication between the sample tube 1010 and the sample chamber 1326. That is, in the first position 1002, the seal 1102 prevents the low-pressure region associated with the sample tube 1010 (e.g., the vacuum, etc.) from spreading into the sample chamber 1326.

[0115] The channels 1318. 1320 facilitate the flow of the sample from the sample chamber 1326 to the sample tube 1010. In the illustrated example of FIG. 13, the first channel 1318 extends through the interior wall 1314 of the body 1006. In the illustrated example of FIG. 13, the first channel 1318 extends upward (in the position of FIG. 13) away from the base 1020 and radially outward. In other examples, the first channel 1318 can have other suitable orientations. In the illustrated example of FIG. 13. the first channel 1318 includes an example first end 1328 proximate to the sample chamber 1326 and a second end 1330 proximate to the first cover wall 1304. The second channel 1320 extends through the intermediate portion 1021 of the body 1006. In the illustrated example of FIG. 13, the second channel 1320 extends upward (in the position of FIG. 13) and radially outward. In other examples, the second channel 1320 can have other suitable orientations. In the illustrated example of FIG. 13, the second channel 1320 includes an example first end 1332 proximate to the interior of the first cylindrical portion 1016 and the seal 1102 and the second end 1330 of the first channel 1318. In the illustrated example of FIG. 13. the second channel 1320 includes an example second end 1334 proximate to the interior of the second cylindrical portion 1018 (e.g.. the opening 1120 of FIG. and the sample tube 1010. In the illustrated example of FIG. 13, the needle carrier 1109 is coupled to the second end 1334.

[0116] The example angle 1324 is formed between the base plane 1322 and the tube axis 1208. In some examples, the angular displacement of the tube axis 1208 and the base plane 1322 facilitates the coupling of the sample tube 1010 to the sampling device 1000. In some examples, the example angle 1324 increases the efficacy of guiding the sample (e.g., the sample 1026 of FIG. 10B, etc.) from the sample chamber 1326 into the sample tube 1010. In the illustrated example of FIG. 13, the angle 1324 is an acute angle (e.g., approximately 20 degrees, etc.). In other examples, the angle 1324 can have any suitable angle between 0 degrees and 60 degrees.

[0117] FIG. 14 is a detail cross-sectional view of the carrier 1106 when the second position 1022 is reached after the rotation 1024 of FIG. 10A. The illustrated example of FIG. 14 depicts the relationship between the carrier 1106 and the interior wall 1314 after the sampling device 1000 has been rotated to the second position 1022 of FIG. 10B and before the spring 1 104 has expanded. In the illustrated example of FIG. 14, the carrier 1 106 has been rotated (e g.,via the rotation 1024 of FIG. 10B, etc.) from the first position 1002 of FIG. 10A to the second position 1022 of FIG. 10B. The rotation of the carrier 1106 to second position 1022 has brought the first carrier tab 1114A and the second carrier tab 1114B (see FIGS. 1 1 and 14) into alignment with an example first slot 1402A and an example second slot 1402B (see FIG. 16). The alignment of the first carrier tab 1114A and the first slot 1402A and the second carrier tab 1114B and the second slot 1402B (not visible) releases the spring 1104 from compression, previously maintained by the contact between the carrier tabs 1114 A, 1 114B and the top surface 1316. The decompression of the spring 1104 moves the skin-piercing element 1112 toward an opening on the sampling device 1000 (e.g., the sampling device 1000, etc.) and the skin of the user (e.g., from a position distal to the opening 1121 to a position adjacent to the opening 1121, etc.). In the illustrated example of FIG. 14, the slot 1402A does not extend radially through the interior wall 1314. In other examples, the first slot 1402A and / or the second slot 1402B can extend radially through the interior wall 1314.

[0118] FIGS. 15 and 16 are a cross sectional front detail view and a cross sectional perspective view, respectively, of the sampling device 1000 in the second position 1022 of FIG. 10B. The cross-sectional view of FIG. 15 is taken along a cutting plane extending between the base 1020 and the E-E line of FIG. 10B. The cross-sectional view of FIG. 16 is taken along the cutting planes extending between the base 1020 and the F-F line of FIG. 10B. In the illustrated example of FIG. 15, the first cover wall 1304 includes an example first opening 1502 and the seal 1102 includes an example second opening 1504. In the illustrated example of FIGS. 15 and 16, the handle 1012 has undergone the rotation 1024 of FIG. 10B and is adjacent to (e.g., abutting, etc.) the plate 1014. In the illustrated example of the FIG. 16, the body 1006 includes the first slot 1402A of FIG. 14 and the second slot 1402B. In the illustrated example of FIG. 16, the slots 1402A, 1402B extend vertically and radially through the interior wall 1314. In other examples, the slots 1402A, 1402B can have any other suitable arrangement based on the configuration of the carrier tabs 1114A, 1114B.

[0119] In the illustrated examples of FIGS. 15 and 16, the rotation 1024 of the handle 1012 and the corresponding rotation of the carrier 1106 via the interface between the carrier interface 1302 of the cover 1004 and the carrier slot 1116 from the first position 1002 of FIG. 10A to the second position 1022 of FIG. 10B caused the carrier tabs 11 14A, 1114B to come into alignment with the slots 1402 A, 1402B of the interior wall 1314. The alignment of the carrier tabs 1114A, 1114B, and the slots 1402 A, 1402B releases the compression of the spring 1104, which causes the carrier 1 106 to translate toward the opening 1317. After being released, the spring 1104 drives the carrier 1106 and skin-piercing element 1 112 towards the opening 1317 inthe base 1020 and the adhesive pad 1008 (e.g., to a position adjacent to the opening 1317, etc.), which pierces the skin of a user of the sampling device 1000.

[0120] In the illustrated examples of FIGS. 15 and 16, the rotation of the cover 1004 has rotated the seal 1102 and the first cover wall 1304 (e.g., via the rotation 1024 of FIG. 10B to the second position 1022, etc.). The rotation of the seal 1102 and the first cover wall 1304 has caused the openings 1502, 1504 to come into circumferential alignment with the first channel 1318 and the second channel 1320. The openings 1502, 1504 enable fluid communication between the sample tube 1010 and the sample chamber 1326, which creates a pressure differential between the sample tube 1010 and the sample chamber 1326. Accordingly, in the second position 1022, the first opening 1502 of the first cover wall 1304 and the second opening 1504 of the seal 1102 causes the low-pressure region to be exposed to the sample chamber 1326. Because the sample chamber 1326 has a comparatively higher pressure than the sample tube 1010, air and the extracted sample of bodily fluid flows from the sample chamber 1326, through the first channel 1318, through the first opening 1502 of the first cover wall 1304, through the second opening 1504 of the seal 1102. through the second channel 1320, through the needle 1108, and into the sample tube 1010.

[0121] FIG. 17 is a perspective view of another sampling device 1700 implemented in accordance with the teachings of this disclosure. The example sampling device 1700 of FIG. 17 is similar to the sampling device 1000 of FIGS. 10-16, except as noted otherwise. The example sampling device 1700 includes an example cover 1702. which is similar to the cover 1004 of FIGS. 10A and 10B, except as noted otherwise. The sampling device 1700 may further include an example body 1704, which is similar to the body 1006 of the of FIGS. 10A and 10B, except as noted otherwise. The sampling device 1700 may further include an example sample tube 1706. which is similar to the sample tube 1010 of FIGS. 10A and 10B, except as noted otherwise. The cover 1702 may further include an example handle 1708. The body 1704 may further include an example first cylindrical portion 1710, which is similar to the first cylindrical portion 1016 of FIGS. 10A and 10B, except as noted otherwise. The body 1704 may further include an example second cylindrical portion 1712, which is similar to the second cylindrical portion 1018 of FIGS. 10A and 10B, except as noted otherwise. The body 1704 may further include an example base 1714, which is similar to the base 1020 of FIGS. 10A and 10B, except as noted otherwise. In the illustrated example of FIG. 17, the example sampling device 1700 includes an example cover 1702, an example body 1704, and an example sample tube 1706, which are similar to the cover 1004 of FIGS. 10A and 10B. the body 1006 of FIGS. 10A and 10B, and the sample tube 1010 of FIGS. 10A and 10B, respectively, except as noted otherwise.In the illustrated example of FIG. 17, the cover 1702 includes an example handle 1708. In the illustrated example of FIG. 17. the body 1704 includes an example first cylindrical portion 1710, an example second cylindrical portion 1712, cand an example base 1714, which are similar to the first cylindrical portion 1016 of FIGS. 10A and 10B, the second cylindrical portion 1018 of FIGS. 10A and 10B, and the base 1020 of FIGS. 10A and 10B, respectively, except as noted otherwise. In some examples, the internal structure of the sampling device 1700 is similar to the internal structure of the sampling device 1000 depicted in FIGS. 13-15.

[0122] Like the sampling device 100 of FIGS. 1-7 and the sampling device 1000 of FIGS. 10-16, the example sampling device 1700 can be used to extract a bodily fluid from the skin of a person and store the bodily fluid in the sample tube 1706. For example, the sampling device 1700 can be used to conduct capillary blood sampling from the skin of a patient. In other examples, the sampling device 1700 can be used to extract other fluids from the epidermis of a user (e.g., pus, serum, lymph, interstitial, etc.). The sampling device 1700 can be disposed on any portion of the user’ s body including the upper arm, the lower arm, the thigh, etc. The example sampling device 1700 can be coupled to the skin of the user via an adhesive pad (e.g., an adhesive pad similar to the adhesive pad 1008 of FIGS. 10A and 10B, etc.).

[0123] In the illustrated example of FIG. 17, the cover 1702 is rotatably coupled to the body 1704 via the first cylindrical portion 1710. Like the handle 1012 of the sampling device 1000 of FIGS. 10-16, the handle 1708 of the cover 1702 can be rotated about the first cylindrical portion 1710 to operate the sampling device 1000. That is, the handle 1708 can be used to cause the release of the skin-piercing element of the sampling device 1700 and / or the expansion of the low-pressure region associated with the sample tube 1706. In some examples, the internal structure of the body 1704 can include a feature that mechanically limits the rotation of the cover 1702 relative to the body 1704. For example, an internal wall of the body 1704 can include a flange and / or wall, which is positioned to abut a corresponding feature of the cover 1702 after the skin-piercing element has been released and a sample has been extracted into the sample tube 1706 (e.g., the sampling device 1700 has reached a position like the second position 1022 of FIG. 10B, etc.). In the illustrated example of FIG. 17, the handle 1708 includes an example cavity 1715. The example cavity 1715 reduces the size and weight of the handle 1708. In other examples, the cavity 1715 is absent. In the illustrated example of FIG. 17, the handle 1708 is a prism with a tapered disco-rectangular base (e.g., an airfoil-shaped base, a disco-trapezoid with circular ends, tapered stadium shape, etc.). In other examples, the handle 1708 can have any other suitable shape including a rectangular prism, a prism with a disco-rectangular base, acylinder, a polyhedron, etc. In some examples, the handle 1708 could be incorporated in the cover 102 of the sampling device 100 and / or into the cover 1004 of the sampling device 1000.

[0124] In the illustrated example of FIG. 17, the sample tube 1010 is coupled to body 1704 along an example tube axis 1716 and the base 1714 defines an example base plane 1720. In the illustrated example of FIG. 17, the tube axis 1716 is parallel to the base plane 1720 (e.g., the tube axis 1716 does not intersect with the base plane 1720, etc.). In other examples, the tube axis 1716 does intersect with the base plane 1720. For example, the tube axis 1716 can be angularly displaced from the base plane 1720 (e.g., via an angle similar to the angle 1324 of FIG. 13, via an angle less than 60 degrees, etc ).

[0125] FIG. 18 is a perspective view of another sampling device 1800 implemented in accordance w ith the teachings of this disclosure. The example sampling device 1800 of FIG. 17 is similar to the sampling device 1000 of FIGS. 10-16, except that the sampling device 1800 includes an example knob 1802 instead of a cover and handle (e.g., a cover and handle similar to the cover 1004 and handle 1012 of FIGS. 10A and 10B, etc.) and as otherwise noted. The example sampling device 1800 includes an example body 1804, which is similar to the body 1006 of FIGS. 10A and 10B, except as noted otherwise. The sampling device 1800 may further include an example adhesive pad 1806, which is similar to the adhesive pad 1008 of FIGS. 10A and 10B, except as noted otherwise. The sampling device 1800 may further include an example sample tube 1808, which is similar to the sample tube 1010 of FIGS. 10A and 10B, except as noted otherwise. In the illustrated example of FIG. 18, the example sampling device 1800 includes an example body 1804, an example adhesive pad 1806, and an example sample tube 1808, w hich are similar to the body 1006 of FIGS. 10A and 10B, the adhesive pad 1008 of FIGS. 10A and 10B, and the sample tube 1010 of FIGS. 10A and 10B, respectively, except as noted otherwise. In some examples, the internal structure of the sampling device 1800 is similar to the internal structure of the sampling device 1000 depicted in FIGS. 13-15.

[0126] Like the sampling device 100 of FIGS. 1-7, the sampling device 1000 of FIGS. 10-16, and the sampling device 1700 of FIG. 17, the example sampling device 1800 can be used to extract a bodily fluid from the skin of a person and store the bodily fluid in the sample tube 1808. For example, the sampling device 1800 can be used to conduct capillary blood sampling from the skin of a patient. In other examples, the sampling device 1800 can be used to extract other fluids from the epidermis of a user (e.g., pus, serum, lymph, interstitial, etc.). The sampling device 1800 can be disposed on any portion of the user's body such as the upper arm, the lower arm, the thigh, etc.

[0127] The knob 1802 is rotatably coupled to the body 1804. Like the handle 1012 of the sampling device 1000 of FIGS. 10-16. the knob 1802 can be rotated about the body 1804 to operate the sampling device 1000. That is, the knob 1802 can be used to cause the release of the skin-piercing element of the sampling device 1800 and / or the expansion of the low-pressure region associated with the sample tube 1808. The knob 1802 can be coupled to the body 1804 in any suitable manner, such as a mechanical interface (e.g., a lip interface similar to the interface between the cover lip 1308 of FIG. 13 and the body lip 1312 of FIG. 13, etc.), an interference fit, and / or one or more fasteners. In the illustrated example of FIG. 18, the knob 1802 includes example ridges 1810. The ridges 1810 facilitate the handling, gripping, and / or rotation of the knob 1802 by a user (e.g., the knob 1802 is ergonomic, etc.). In some examples, the ridges 1810 are absent. In some examples, the knob 1802 can include different features to facilitate the rotation of the knob 1802 (e.g., a rotary valve handle, a tab, etc.). In some examples, the knob 1802 could be incorporated in the cover 102 of the sampling device 100 or used in the sampling device 100 in place of the cover 102.

[0128] In the illustrated example of FIG. 18, the internal structure of the sampling device 1800 is disposed within the knob 1802 and / or the body 1804. In some examples, the internal structure of the body 1804 can include a feature that mechanically limits the rotation of the knob 1802 relative to the body 1804. For example, an internal wall of the body 1804 can include a flange and / or wall, which is positioned to abut a corresponding feature of the knob 1802 after the skin-piercing element has been released and a sample has been extracted into the sample tube 1808 (e.g., the sampling device 1800 has reached a position like the second position 1022 of FIG. 10B, etc.).

[0129] The body 1804 partly houses the internal structure of the sampling device 1800 and is coupled to the knob 1802 and the sample tube 1808. In the illustrated example of FIG. 18. the body 1804 is generally dome-shaped. In other examples, the body 1804 can have any other suitable shape.

[0130] Generally, the cover and body components (e.g., the cover 102 of FIG. 14, the body 104 of FIG. 1, the piston 204 of FIG. 2, the cover 1004 of FIG. 10, the body 1006 of FIG. 10. etc.) of the sampling devices described herein can be composed of any suitable rigid material including a plastic (e.g., polypropylene (PP), polyethylene (PE), polyoxymethylene (POM), polybutylene terephthalate (PBT), polyethylene terephthalate (PET), acrylonitrile butadiene styrene (ABS), etc.), a metal, and / or a composite of these and / or other materials. Generally, the needle (e.g. the needle 1108 of FIG. 11, etc.), skin-piercing components (e.g. the skin piercing element 214 of FIG. 2, the skin-piercing element 11 12 of FIG. 2, etc ), and spring components(e.g., the first spring 202 of FIG. 2, the second spring 206 of FIG. 2, the spring 1104 of FIG. 1 1, etc.) can be composed of a metal (e.g.. stainless steel, high carbon steel, alloyed steel, a copper alloy, a nickel alloy, etc ), a high-strength plastic, and / or other materials or combination of materials.

[0131] “Including’" and “comprising” (and all forms and tenses thereof) are used herein to be open ended terms. Thus, whenever a claim employs any form of “include” or “comprise” (e.g., comprises, includes, comprising, including, having, etc.) as a preamble or within a claim recitation of any kind, it is to be understood that additional elements, terms, etc., may be present without falling outside the scope of the corresponding claim or recitation. As used herein, when the phrase “at least” is used as the transition term in, for example, a preamble of a claim, it is open-ended in the same manner as the term “comprising” and “including” are open ended. The term “and / or” when used, for example, in a form such as A, B, and / or C refers to any combination or subset of A, B, C such as (1) A alone, (2) B alone, (3) C alone, (4) A with B, (5) A with C, (6) B with C, or (7) A with B and with C. As used herein in the context of describing structures, components, items, objects and / or things, the phrase “at least one of A and B” is intended to refer to implementations including any of (1) at least one A, (2) at least one B, or (3) at least one A and at least one B. Similarly, as used herein in the context of describing structures, components, items, objects and / or things, the phrase “at least one of A or B” is intended to refer to implementations including any of (1) at least one A, (2) at least one B, or (3) at least one A and at least one B. As used herein in the context of describing the performance or execution of processes, instructions, actions, activities, etc., the phrase “at least one of A and B” is intended to refer to implementations including any of (1) at least one A, (2) at least one B, or (3) at least one A and at least one B. Similarly, as used herein in the context of describing the performance or execution of processes, instructions, actions, activities, etc., the phrase “at least one of A or B” is intended to refer to implementations including any of (1) at least one A, (2) at least one B, or (3) at least one A and at least one B.

[0132] As used herein, singular references (e.g., “a”, “an”, “first”, “second”, etc.) do not exclude a plurality. The term “a” or “an” object, as used herein, refers to one or more of that object. The terms “a” (or “an”), “one or more”, and “at least one” are used interchangeably herein. Furthermore, although individually listed, a plurality of means, elements, or actions may be implemented by, e.g., the same entity' or object. Additionally, although individual features may be included in different examples or claims, these may possibly be combined, and the inclusion in different examples or claims does not imply that a combination of features is not feasible and / or advantageous.

[0133] Unless specifically stated otherwise, descriptors such as “first.” “second,” “third,” etc., are used herein without imputing or otherwise indicating any meaning of priority, physical order, arrangement in a list, and / or ordering in any way, but are merely used as labels and / or arbitrary names to distinguish elements for ease of understanding the disclosed examples. In some examples, the descriptor “first” may be used to refer to an element in the detailed description, while the same element may be referred to in a claim with a different descriptor such as “second” or “third.” In such instances, it should be understood that such descriptors are used merely for identifying those elements distinctly within the context of the discussion (e.g., within a claim) in which the elements might, for example, otherwise share a same name.

[0134] As used herein, “approximately” and “about” modify’ their subjects / values to recognize the potential presence of variations that occur in real world applications. For example, “approximately” and “about” may modify dimensions that may not be exact due to manufacturing tolerances and / or other real world imperfections as will be understood by persons of ordinary skill in the art. For example, “approximately” and “about” may indicate such dimensions may be within a tolerance range of + / - 10% unless otherwise specified herein.

[0135] Bodily fluid sampling devices are disclosed herein. Further examples and combinations thereof include the following:

[0136] Example 1 includes an apparatus to collect bodily fluids, the apparatus rotatable between a first position and a second position, the apparatus comprising a body including a wall, the wall including a top surface, and a slot, a spring, and a carrier coupled to spring, the carrier including a tab, the tab abutting the top surface in the first position, the abutment of the tab and the top surface retaining the spring in the first position, the tab aligned with the slot in the second position.

[0137] Example 2 includes the apparatus of example 1, further including a piston and wherein the spring includes a first end abutting the tab, and a second end abutting the piston.

[0138] Example 3 includes the apparatus of examples 1 or 2, wherein the wall is a first wall, and the piston includes a second wall defining an interior, the spring disposed within the interior.

[0139] Example 4 includes the apparatus of any of examples 1-3. wherein the wall is a first wall, the body further includes a second wall including a first lip, and the apparatus further including a cover including a second lip engaged with the first lip.

[0140] Example 5 includes the apparatus of any of examples 1-4, wherein the first lip is rotatable relative to the second lip.

[0141] Example 6 includes the apparatus of any of examples 1-5, further including a piston and wherein the apparatus is rotatable to a third position, the wall is a first wall, the tab is a first tab, the slot is a first slot, and wherein the body includes a second wall including a second slot, and the piston includes a second tab, the second tab disposed in the second slot, the second tab retained by the second slot in the first position and the second position.

[0142] Example 7 includes the apparatus of any of examples 1-6, wherein the spring is a first spring, the apparatus including a second spring, the second spring retained in compression by an abutment of the second tab and the body in the first position and the second position.

[0143] Example 8 includes the apparatus of any of examples 1-7, wherein the piston includes a third wall, and a fourth wall disposed about the second wall, the second spring disposed between the third wall and the fourth wall.

[0144] Example 9 includes the apparatus of any of examples 1-8, wherein the body includes a boss extending from an outer surface of the body, the boss including a through hole extending to an interior of the body.

[0145] Example 10 includes the apparatus of any of examples 1-9, wherein the second position is between the first position and the third position.

[0146] Example 11 includes the apparatus of any of examples 1-10, wherein the body includes a boss extending from an outer surface of the body, the apparatus including a cover rotatable coupled to the body, the cover including a cover slot, the boss disposed in the slot.

[0147] Example 12 includes the apparatus of any of examples 1-11. wherein the cover slot includes a first end, the boss abutting the first end in the first position, and a second end, the boss abutting the second end in the second position.

[0148] Example 13 includes the apparatus of any of examples 1-12, further including means for skin piercing and wherein the body includes a base including an opening to receive the means for skin piercing when the apparatus is in the second position, the opening aligned with the wall.

[0149] Example 14 includes the apparatus of any of examples 1-13, wherein the slot extends to the base.

[0150] Example 15 includes the apparatus of any of examples 1-14. wherein the means for skin piercing and the carrier are integral.

[0151] Example 16 includes an apparatus to collect bodily fluids, the apparatus including a body including an opening, a cover coupled to the body, a spring disposed within the body, means for piercing a skin of a user coupled to the spring, and a handle extending from the cover, the handle rotatable between a first position and a second position, the means for piercing distalto the opening in the first position, and the spring to move the means for piercing adjacent to the opening in the second position.

[0152] Example 17 includes the apparatus of example 16, wherein the body includes a plate, the handle and the plate radially displaced in the first position, the handle abutting the plate in the second position.

[0153] Example 18 includes the apparatus of any of examples 16-17, wherein the body includes a first cylindrical portion, the spring disposed within the first cylindrical portion, an internal wall disposed radially inward of the first cylindrical portion, and a second cylindrical portion extending from the first cy lindrical portion, the second cy lindrical portion configured to receive a sample tube.

[0154] Example 19 includes the apparatus of any of examples 16-18, wherein the body includes a channel including a first end proximate to a first interior of the first cylindrical portion, and a second end proximate to a second interior of the second cylindrical portion.

[0155] Example 20 includes the apparatus of any of examples 16-19, including a needle coupled to the second end.

[0156] Example 21 includes the apparatus of any of examples 16-20, wherein the opening is a first opening, wherein the internal wall includes a second opening, the second opening aligned with the second end in the second position.

[0157] Example 22 includes the apparatus of any of examples 16-21, wherein the opening is a first opening, further including a seal disposed between the internal wall and the second cylindrical portion, the seal including a second opening aligned second end in the second position.

[0158] Example 23 includes the apparatus of any of examples 16-22, wherein the body includes a base including the opening, the base defining a plane, the second cylindrical portion to receive the sample tube along an axis, the axis and the plane forming an acute angle.

[0159] Example 24 includes the apparatus of any of examples 16-23, wherein the body further includes a wall including a top surface and a slot and further including a carrier coupled to the spring and the cover, the carrier including the means for skin piercing, and a tab. the tab abutting the top surface in the first position, the abutment of the tab and the top surface retaining the spring, the tab aligned with the slot in the second position.

[0160] Example 25 includes the apparatus of any of examples 16-24, wherein the spring includes a first end abutting the tab, and a second end abutting the cover.

[0161] Example 26 includes the apparatus of any of examples 16-25, wherein the cover includes a cover wall extending into the body, the cover wall including a cover lip. the body includes a body lip engaged with the cover lip.

[0162] Example 27 includes the apparatus of any of examples 16-26, wherein the means for skin piercing includes a microneedle array.

[0163] Example 28 includes an apparatus to collect bodily fluids, the apparatus rotatable between a first position and a second position, the apparatus including a wall including a top surface and a slot. The apparatus of example 28 also includes a spring and a carrier coupled to spring, the carrier including a tab, the tab abutting the top surface in the first position, the abutment of the tab and the top surface retaining the spring in the first position, the tab aligned with the slot in the second position.

[0164] Example 29 includes the apparatus of example 28, further including a piston and wherein the spring includes a first end abutting the tab, and a second end abutting the piston.

[0165] Example 30 includes the apparatus of examples 28 or 29, wherein the wall is a first wall, and the piston includes a second wall defining an interior, the spring disposed within the interior.

[0166] Example 31 includes the apparatus of any of examples 28-30, wherein the wall is a first wall, the body further includes a second wall including a first lip, and the apparatus further including a cover including a second lip engaged with the first lip.

[0167] Example 32 includes the apparatus of any of examples 28-31, wherein the first lip is rotatable relative to the second lip.

[0168] Example 33 includes the apparatus of any of examples 28-32, further including a piston and wherein the apparatus is rotatable to a third position, the wall is a first wall, the tab is a first tab, the slot is a first slot, and wherein the body includes a second wall including a second slot, and the piston includes a second tab, the second tab disposed in the second slot, the second tab retained by the second slot in the first position and the second position.

[0169] Example 34 includes the apparatus of any of examples 28-33, wherein the spring is a first spring, the apparatus including a second spring, the second spring retained in compression by an abutment of the second tab and the body in the first position and the second position.

[0170] Example 35 includes the apparatus of any of examples 28-34, wherein the piston includes a third wall, and a fourth wall disposed about the second w all, the second spring disposed between the third wall and the fourth wall.

[0171] Example 36 includes the apparatus of any of examples 28-35, wherein the body includes a boss extending from an outer surface of the body, the boss including a through hole extending to an interior of the body.

[0172] Example 37 includes the apparatus of any of examples 28-36, wherein the second position is between the first position and the third position.

[0173] Example 38 includes the apparatus of any of examples 28-37, wherein the body includes a boss extending from an outer surface of the body, the apparatus including a cover rotatable coupled to the body, the cover including a cover slot, the boss disposed in the slot.

[0174] Example 39 includes the apparatus of any of examples 28-38, wherein the cover slot includes a first end, the boss abutting the first end in the first position, and a second end, the boss abutting the second end in the second position.

[0175] Example 40 includes the apparatus of any of examples 28-39, further including means for skin piercing and wherein the body includes a base including an opening to receive the means for skin piercing when the apparatus is in the second position, the opening aligned with the wall.

[0176] Example 41 includes the apparatus of any of examples 28-40, wherein the slot extends to the base.

[0177] Example 42 includes the apparatus of any of examples 28-41, wherein the means for skin piercing and the carrier are integral.

[0178] Example 43 includes an apparatus to collect bodily fluids, the apparatus including an opening, a cover, a spring, means for piercing a skin of a user coupled to the spring, and a handle extending from the cover, the handle rotatable between a first position and a second position, the means for piercing distal to the opening in the first position, and the spring to move the means for piercing adjacent to the opening in the second position.

[0179] Example 44 includes the apparatus of example 43, further including a plate, the handle and the plate radially displaced in the first position, the handle abutting the plate in the second position.

[0180] Example 45 includes the apparatus of any of examples 43-44, further including a body that includes a first cylindrical portion, the spring disposed within the first cylindrical portion, an internal wall disposed radially inward of the first cylindrical portion, and a second cylindrical portion extending from the first cylindrical portion, the second cy lindrical portion configured to receive a sample tube.

[0181] Example 46 includes the apparatus of any of examples 43-45, wherein the body includes a channel including a first end proximate to a first interior of the first cylindrical portion, and a second end proximate to a second interior of the second cylindrical portion.

[0182] Example 47 includes the apparatus of any of examples 43-46, including a needle coupled to the second end.

[0183] Example 48 includes the apparatus of any of examples 43-47, wherein the opening is a first opening, wherein the internal wall includes a second opening, the second opening aligned with the second end in the second position.

[0184] Example 49 includes the apparatus of any of examples 43-48, wherein the opening is a first opening, further including a seal disposed between the internal wall and the second cylindrical portion, the seal including a second opening aligned second end in the second position.

[0185] Example 50 includes the apparatus of any of examples 43-49, wherein the body includes a base including the opening, the base defining a plane, the second cylindrical portion to receive the sample tube along an axis, the axis and the plane forming an acute angle.

[0186] Example 51 includes the apparatus of any of examples 43-50, wherein the body further includes a wall including a top surface and a slot and further including a carrier coupled to the spring and the cover, the carrier including the means for skin piercing, and a tab, the tab abutting the top surface in the first position, the abutment of the tab and the top surface retaining the spring, the tab aligned with the slot in the second position.

[0187] Example 52 includes the apparatus of any of examples 43-51, wherein the spring includes a first end abutting the tab, and a second end abutting the cover.

[0188] Example 53 includes the apparatus of any of examples 43-52, wherein the cover includes a cover wall extending into the body, the cover wall including a cover lip. the body includes a body lip engaged with the cover lip.

[0189] Example 54 includes the apparatus of any of examples 43-53, wherein the means for skin piercing includes a microneedle array.

[0190] The following claims are hereby incorporated into this Detailed Description by this reference. Although certain example systems, apparatus, articles of manufacture, and methods have been disclosed herein, the scope of coverage of this patent is not limited thereto. On the contrary, this patent covers all systems, apparatus, articles of manufacture, and methods fairly falling within the scope of the claims of this patent.

Claims

What Is Claimed Is:

1. An apparatus to collect bodily fluids, the apparatus rotatable between a first position and a second position, the apparatus comprising: a wall including: a top surface; and a slot; a spring; and a carrier coupled to spring, the carrier including a tab, the tab abutting the top surface in the first position, the abutment of the tab and the top surface retaining the spring in the first position, the tab aligned with the slot in the second position.

2. The apparatus of claim 1, further including a piston and wherein the spring includes: a first end abutting the tab; and a second end abutting the piston.

3. The apparatus of claim 2, wherein the wall is a first wall, and the piston includes a second wall defining an interior, the spring disposed within the interior.

4. The apparatus of any preceding claim, wherein the wall is a first wall, the apparatus further including: a second wall including a first lip; and a cover including a second lip engaged with the first lip.

5. The apparatus of claim 4, wherein the first lip is rotatable relative to the second lip.

6. The apparatus of any preceding claim, further including a piston and wherein the apparatus is rotatable to a third position, the wall is a first wall, the tab is a first tab, the slot is a first slot, and wherein: the apparatus includes a second wall including a second slot; and the piston includes a second tab, the second tab disposed in the second slot, the second tab retained by the second slot in the first position and the second position.

7. The apparatus of claim 6, wherein the spring is a first spring, the apparatus including: a body that includes the first wall and the second wall; anda second spring, the second spring retained in compression by an abutment of the second tab and the body in the first position and the second position.

8. The apparatus of claim 7, wherein the piston includes: a third wall; and a fourth wall disposed about the second wall, the second spring disposed between the third wall and the fourth wall.

9. The apparatus of claim 8, wherein the body includes a boss extending from an outer surface of the body, the boss including a through hole extending to an interior of the body.

10. The apparatus of any of claims 6-9, wherein the second position is between the first position and the third position.

11. The apparatus of any preceding claim, further including: a body that includes the wall, an outer surface, and a boss extending from the outer surface; and a cover rotatable coupled to the body, the cover including a cover slot, the boss disposed in the slot.

12. The apparatus of claim 11, wherein the cover slot includes: a first end, the boss abutting the first end in the first position; and a second end, the boss abutting the second end in the second position.

13. The apparatus of any preceding claim, further including: means for skin piercing; and a base including an opening to receive the means for skin piercing when the apparatus is in the second position, the opening aligned with the wall.

14. The apparatus of claim 13, wherein the slot extends to the base.

15. The apparatus of any of claims 13 or 14, wherein the means for skin piercing and the carrier are integral.

16. An apparatus to collect bodily fluids, the apparatus including: an opening; a cover; a spring; means for piercing a skin of a user coupled to the spring; and a handle extending from the cover, the handle rotatable between a first position and a second position, the means for piercing distal to the opening in the first position, and the spring to move the means for piercing adjacent to the opening in the second position.

17. The apparatus of claim 16, further including a plate, the handle and the plate radially displaced in the first position, the handle abutting the plate in the second position.

18. The apparatus of any of claims 16-17, further including a body that includes: a first cylindrical portion, the spring disposed within the first cylindrical portion; an internal wall disposed radially inward of the first cylindrical portion; and a second cylindrical portion extending from the first cylindrical portion, the second cylindrical portion configured to receive a sample tube.

19. The apparatus of claim 18, wherein the body includes a channel including: a first end proximate to a first interior of the first cylindrical portion; and a second end proximate to a second interior of the second cylindrical portion.

20. The apparatus of claim 19, including a needle coupled to the second end.

21. The apparatus of any of claims 19-20, wherein the opening is a first opening, wherein the internal wall includes a second opening, the second opening aligned with the second end in the second position.

22. The apparatus of any of claims 18-21, wherein the opening is a first opening, further including a seal disposed between the internal wall and the second cylindrical portion, the seal including a second opening aligned second end in the second position.

23. The apparatus of any of claims 18-22, wherein the body includes a base including the opening, the base defining a plane, the second cylindrical portion to receive the sample tube along an axis, the axis and the plane forming an acute angle.

24. The apparatus of any of claims 16-23, further including: a wall including a top surface and a slot; and a carrier coupled to the spring and the cover, the carrier including: the means for skin piercing; and a tab, the tab abutting the top surface in the first position, the abutment of the tab and the top surface retaining the spring, the tab aligned with the slot in the second position.

25. The apparatus of claim 24, wherein the spring includes: a first end abutting the tab; and a second end abutting the cover.

26. The apparatus of any of claims 16-25, further including a body, wherein the cover includes a cover wall extending into the body, the cover wall including a cover lip, the body includes a body lip engaged with the cover lip.

27. The apparatus of any of claims 16-26, wherein the means for skin piercing includes a microneedle array.

28. An apparatus to collect bodily fluids, the apparatus rotatable between a first position and a second position, the apparatus comprising: a wall including: a top surface; and a slot; a spring: and a carrier coupled to spring, the carrier including a tab, the tab abutting the top surface in the first position, the abutment of the tab and the top surface retaining the spring in the first position, the tab aligned with the slot in the second position.

29. The apparatus of claim 28. further including a piston and wherein the spring includes: a first end abutting the tab; anda second end abutting the piston.

30. The apparatus of claim 29, wherein the wall is a first wall, and the piston includes a second wall defining an interior, the spring disposed within the interior.

31. The apparatus of any of claims 28-30, wherein the wall is a first wall, the apparatus further including: a second wall including a first lip; and a cover including a second lip engaged with the first lip.

32. The apparatus of claim 31. wherein the first lip is rotatable relative to the second lip.

33. The apparatus of any of claims 28-32, further including a piston and wherein the apparatus is rotatable to a third position, the wall is a first wall, the tab is a first tab, the slot is a first slot, and wherein: the apparatus includes a second wall including a second slot; and the piston includes a second tab, the second tab disposed in the second slot, the second tab retained by the second slot in the first position and the second position.

34. The apparatus of claim 33. wherein the spring is a first spring, the apparatus including: a body that includes the first wall and the second wall; and a second spring, the second spring retained in compression by an abutment of the second tab and the body in the first position and the second position.

35. The apparatus of claim 34, wherein the piston includes: a third wall; and a fourth wall disposed about the second wall, the second spring disposed between the third wall and the fourth wall.

36. The apparatus of claim 35, wherein the body includes a boss extending from an outer surface of the body, the boss including a through hole extending to an interior of the body.

37. The apparatus of any of claims 33-36, wherein the second position is between the first position and the third position.

38. The apparatus of any of claims 28-37, further including: a body that includes the wall, an outer surface, and a boss extending from the outer surface; and a cover rotatable coupled to the body, the cover including a cover slot, the boss disposed in the slot.

39. The apparatus of claim 38, wherein the cover slot includes: a first end, the boss abutting the first end in the first position; and a second end, the boss abutting the second end in the second position.

40. The apparatus of any of claims 28-39, further including: means for skin piercing; and a base including an opening to receive the means for skin piercing when the apparatus is in the second position, the opening aligned with the wall.

41. The apparatus of claim 40, wherein the slot extends to the base.

42. The apparatus of any of claims 40 or 41, wherein the means for skin piercing and the carrier are integral.

43. An apparatus to collect bodily fluids, the apparatus including: an opening; a cover; a spring: means for piercing a skin of a user coupled to the spring; and a handle extending from the cover, the handle rotatable between a first position and a second position, the means for piercing distal to the opening in the first position, and the spring to move the means for piercing adjacent to the opening in the second position.

44. The apparatus of claim 43, further including a plate, the handle and the plate radially displaced in the first position, the handle abutting the plate in the second position.

45. The apparatus of any of claims 43 or 44. further including a body that includes: a first cylindrical portion, the spring disposed within the first cylindrical portion;an internal wall disposed radially inward of the first cylindrical portion; and a second cylindrical portion extending from the first cylindrical portion, the second cylindrical portion configured to receive a sample tube.

46. The apparatus of claim 45, wherein the body includes a channel including: a first end proximate to a first interior of the first cylindrical portion; and a second end proximate to a second interior of the second cylindrical portion.

47. The apparatus of claim 46, including a needle coupled to the second end.

48. The apparatus of any of claims 46 or 47. wherein the opening is a first opening, wherein the internal wall includes a second opening, the second opening aligned with the second end in the second position.

49. The apparatus of any of claims 45-48, wherein the opening is a first opening, further including a seal disposed between the internal wall and the second cylindrical portion, the seal including a second opening aligned second end in the second position.

50. The apparatus of any of claims 45-49, wherein the body includes a base including the opening, the base defining a plane, the second cylindrical portion to receive the sample tube along an axis, the axis and the plane forming an acute angle.

51. The apparatus of any of claims 43-50, further including: a wall including a top surface and a slot; and a carrier coupled to the spring and the cover, the carrier including: the means for skin piercing; and a tab, the tab abutting the top surface in the first position, the abutment of the tab and the top surface retaining the spring, the tab aligned with the slot in the second position.

52. The apparatus of claim 51, wherein the spring includes: a first end abutting the tab; and a second end abutting the cover.

53. The apparatus of any of claims 43-52, further including a body, wherein the cover includes a cover wall extending into the body, the cover wall including a cover lip. the body includes a body lip engaged with the cover lip.

54. The apparatus of any of claims 43-53, wherein the means for skin piercing includes a microneedle array.

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