Biological sample collection device

Abstract

A device for collecting a sample includes a housing having an interface configured to contact an anatomy and a cavity extending from the interface such that the interface surrounds the cavity. A channel extending into the housing and a body defines a vacuum chamber in fluid communication with the channel. An actuator coupled to the housing causes a vacuum plunger to translate within the vacuum chamber and a piercer coupled to the body and translatable along an axis. The piercer is engageable with the anatomy of the subject in to create a wound in the anatomy of the subject. A collection chamber coupled to the housing includes an inlet in fluid communication with the channel. In response to the interface being coupled to the anatomy and the force being applied to the actuator, a pressure within the vacuum chamber decreases and the piercer creates the wound in the subject.

Description

BIOLOGICAL SAMPLE COLLECTION DEVICECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 531,763, filed on August 9, 2023, the entirety of which is incorporated by reference herein.TECHNOLOGICAL FIELD

[0002] The present disclosure generally relates to systems and methods for collecting biological samples.BACKGROUND

[0003] Sample collection devices may be configured to collect cells and other biological material including, for example, from blood, from urine, from plasma, from saliva, etc.SUMMARY

[0004] At set of embodiments relate to a collection device for collecting a biological sample. The collection device includes a housing having an interface configured to contact an anatomy of a subject. The housing further includes a cavity extending from the interface such that the interface surrounds the cavity. The collection device includes a channel extending into the housing and a body defining a vacuum chamber. The vacuum chamber is in fluid communication with the channel. An actuator is coupled to the housing. The actuator is translatable from a first actuator position to a second actuator position in response to a force being applied to the actuator. A vacuum plunger is translatable within the vacuum chamber between a first vacuum plunger position and a second vacuum plunger position. A piercer is coupled to the body and is translatable along an axis between a first piercer position and a second piercer position. The piercer is engageable with the anatomy of the subject in the second piercer position to create a wound in the anatomy of the subject. A collection chamber coupled to the housing. The collection chamber includes an inlet in fluid communication with the channel.

[0005] According to various embodiment, in response to the interface being coupled to the anatomy and the force being applied to the actuator the vacuum plunger translates from the first vacuum plunger position to the second vacuum plunger position, thereby causing a pressure within the vacuum chamber to decrease. Further, in response to the interface being coupled to the anatomy and the force being applied to the actuator, the piercer translates from the first piercer position to the second piercer position to create the wound in the subject.

[0006] Another set of embodiments relate to a collection container for collecting a biological sample. The collection container includes a collection chamber defining an inner volume configured to receive the biological sample and a cap coupled to the collection chamber and selectively coupleable with housing of a device. The cap includes an inlet port in fluid communication with an outlet of the device and an inlet chamber extending from the inlet port to the inner volume of the collection chamber. The cap further includes an inlet tube positioned within the inlet chamber. The inlet tube is transformable from a compressed state to an extended state, wherein the inlet port is in fluid communication with the inner volume of the collection chamber while the inlet tube is in the compressed state and the inlet tube inhibits flow of the sample from the inlet port to the inner volume of the collection chamber while the inlet tube is in the extended state.

[0007] This summary is illustrative only and should not be regarded as limiting.BRIEF DESCRIPTION OF THE FIGURES

[0008] The disclosure will become more fully understood from the following detailed description, taken in conjunction with the accompanying figures, wherein like reference numerals refer to like elements, in which:

[0009] FIG. 1 A illustrates a rear perspective view of a sample collection device, according to an example embodiment.

[0010] FIG. IB illustrates a front perspective view of the sample collection device of FIG. 1A.

[0011] FIG. 2A illustrates a rear perspective view of a sample collection device, according to another example embodiment.

[0012] FIG. 2B illustrates a front perspective view of the sample collection device of FIG. 2A.

[0013] FIG. 2C illustrates a partial rear perspective view of the sample collection device of FIG. 2A.

[0014] FIG. 3 illustrates an exploded view of the sample collection device of FIGS. 1 A and IB.

[0015] FIG. 4 illustrates an exploded view of a top portion of the sample collection device of FIGS. lA and IB.

[0016] FIG. 5 illustrates a perspective view of a guide ring of the sample collection device of FIGS. lA and IB.

[0017] FIG. 6 illustrates a perspective view of a plunger catch of the sample collection device of FIGS. 1A and IB.

[0018] FIG. 7 illustrates a perspective view of a plunger usable with the sample collection device of FIGS. 1A and IB and the sample collection device of FIGS. 2A-2C.

[0019] FIG. 8 illustrates a cross-sectional side view of the plunger of FIG. 7.

[0020] FIG. 9 illustrates an exploded view of a top middle of the sample collection device of FIGS. lA and IB.

[0021] FIG. 10A illustrates a perspective view of a piercer usable with the sample collection device of FIGS. 1 A and IB and the sample collection device of FIGS. 2A-2C.

[0022] FIG. 10B illustrates an exploded of the piercer of FIG. 10 A.

[0023] FIG. 11 A illustrates a perspective view of another piercer usable with the sample collection device of FIGS. 1 A and IB and the sample collection device of FIGS. 2A-2C.

[0024] FIG. 1 IB illustrates an exploded view of the piercer of FIG. 11 A.

[0025] FIG. 12A illustrates a perspective view of a body of the sample collection device ofFIGS. 1 A and IB.

[0026] FIG. 12B illustrates a perspective view of a body usable with the sample collection device of FIGS. 1 A and IB and the sample collection device of FIGS. 2A-2C, according to an example embodiment.

[0027] FIG. 12C illustrates a perspective view the body of FIG. 12B.

[0028] FIG. 13 illustrates a top perspective view of a mount and a removable collection chamber of the sample collection device of FIGS. 1A and IB.

[0029] FIG. 14 illustrates a top view of a body of the sample collection device of FIGS. 1 A and IB.

[0030] FIG. 15 illustrates a top cross-sectional view of a body and a piercer of the sample collection device of FIGS. 1 A and IB.

[0031] FIG. 16 illustrates a bottom view of a body of the sample collection device of FIGS. 1A and IB.

[0032] FIG. 17 illustrates a bottom view of a mount of the sample collection device of FIGS. 1 A and IB.

[0033] FIG. 18A illustrates a perspective view of a removable collection chamber of the sample collection device of FIGS. 1A and IB.

[0034] FIG. 18B illustrates a cross sectional view of a removable collection chamber of the sample collection device of FIGS. 1 A and IB.

[0035] FIG. 19 illustrates an exploded view of a removable collection chamber of the sample collection device of FIGS. 1A and IB.

[0036] FIG. 20A illustrates a cross-sectional side view of the sample collection device of FIGS. 1 A and IB in a first orientation.

[0037] FIG. 20B illustrates a cross-sectional side view of the sample collection device of FIGS. 1 A and IB with the collection chamber being removed.

[0038] FIG. 21 illustrates a cross-sectional side view of the sample collection device of FIGS. 1 A and IB.

[0039] FIG. 22 illustrates a cross-sectional side view of the sample collection device of FIG. 1 A and IB.

[0040] FIG. 23 illustrates a cross-sectional view of another sample collection device, according to an example embodiment.

[0041] FIG. 24 illustrates a cross-sectional view of the sample collection device of FIG. 23 with an alternate collection container.

[0042] FIG. 25 illustrates a cross-sectional view of another sample collection device, according to an example embodiment.

[0043] FIG. 26 illustrates another cross-sectional view of the sample collection device of FIG. 25 with an alternate collection container.

[0044] FIG. 27 illustrates a perspective view of a cap usable with a collection container, according to an example embodiment.

[0045] FIG. 28 illustrates an exploded view of the cap of FIG. 27.

[0046] FIG. 29 illustrates another exploded view of the cap of FIG. 27.

[0047] FIG. 30 illustrates a cross-sectional view of the cap of FIG. 27 in a first orientation.

[0048] FIG. 31 illustrates a cross-sectional view of the cap of FIG. 27 in a second orientation.

[0049] FIG. 32 illustrates a cross-sectional view of the sample collection device of FIG. 2A.

[0050] FIG. 33 illustrates an exploded view of an actuator assembly of the sample collection device of FIG. 2 A.

[0051] FIG. 34 illustrates a perspective view of the actuator assembly of the sample collection device of FIG. 2 A.

[0052] FIG. 35 illustrates a perspective view of the actuator assembly of the sample collection device of FIG. 2 A.

[0053] FIG. 36 illustrates a perspective view of the actuator assembly of the sample collection device of FIG. 2 A.

[0054] FIG. 37 illustrates a perspective view of a release damper, according to an example embodiment.

[0055] FIG. 38 illustrates an exploded view of the release damper of FIG. 37.

[0056] FIG. 39 illustrates a perspective view of a release damper assembly, according to an example embodiment.

[0057] FIG. 40 illustrates an exploded view of the release damper assembly of FIG. 39.

[0058] FIG. 41 illustrates a partial view of the release damper assembly of FIG. 39.

[0059] FIG. 42 illustrates a flow diagram of an example sample collection process.DETAILED DESCRIPTION

[0060] Before turning to the figures, which illustrate certain exemplary embodiments in detail, it should be understood that the present disclosure is not limited to the details or methodology set forth in the description or illustrated in the figures. It should also be understood that the terminology used herein is for the purpose of description only and should not be regarded as limiting.

[0061] For example, in the following detailed description, reference is made to the accompanying drawings, which form part of the present disclosure. The embodiments described in the drawings and description are intended to be examples and not limiting. As used herein, the term “example” means “serving as an example or illustration” and should not necessarily be construed as preferred or advantageous over other embodiments. Other embodiments may be utilized and modifications may be made without departing from the scope of the subject matter presented herein. Aspects of the disclosure, as described and illustrated herein, can be arranged, combined, and designed in a variety of different configurations, all of which are explicitly contemplated and form part of this disclosure.

[0062] Referring generally to the figures, a sample collection device for collecting a sample is shown and described. The device is configured to engage an anatomy of a subject (e.g., a tissue of a person, etc.). The device is further be configured to create a wound (e.g., lesion, cut, laceration, puncture, etc.) in the subject to release a sample (e.g., a blood sample, etc.). The device collects the blood sample from the subject for subsequent testing and analysis to be performed using the blood sample.

[0063] The device may be configured to engage with the anatomy of a subject proximate the wound creation site. For example, the sample collection device includes an interface covered with a gel that creates a seal with the skin of the subject, which may reduce the likelihood or prevent blood from escaping the seal created by the interface. Further, the sample collection device may include a removable collection chamber that is configured to collect the blood sample and can be shipped or otherwise provided to a testing facility for further analysis. In various embodiments, the device is implemented with a detection system, for example to facilitate detecting the presence, absence, and / or quality of one or more substances or materials (e.g., analytes).

[0064] Referring now to FIGS. 1 A and IB, a sample collection device 100 is shown, according to an example embodiment. The sample collection device 100 is configured to engage (e.g., contact, interface, etc.) an anatomy of a subject (e.g., a tissue of the subject) to expose the sample collection device 100 to a sample (e.g., of the subject). The sample collection device 100 is configured to create a wound in the anatomy (e.g., lesion, cut, laceration, puncture, etc.) and expose the sample collection device 100 to a sample (e.g., blood sample) released from the wound such that the sample collection device 100 collects a blood sample from the subject. The sample collection device 100 is configured to collect a controlled or predetermined amount (e.g., volume, mass, etc.) of the blood sample with a collection chamber 350. It should be understood that while the sample collection device 100 is described herein as being exposed to a blood sample, in various example embodiments the sample is another suitable biological material (e.g., plasma, cellular material, mucous, etc.).

[0065] Still referring to FIGS. 1 A and IB, the sample collection device 100 includes a housing 102. The housing 102 contains (e.g., houses, holds, contains, encompass, etc.) one or more components of the sample collection device 100. The housing 102 includes a firstportion (e.g., a top portion, an upper portion, etc.), shown as upper housing 104 and a second portion (e.g., a bottom portion, a lower portion, etc.), shown as lower housing 106.

[0066] The housing 102 includes an interface 108. The interface 108 is configured to engage (e.g., contact, interface, etc.) the anatomy of the subject to facilitate collecting the sample using the sample collection device 100. For example, a gel may be applied to some or all of the interface 108 to facilitate engaging the anatomy of the subject. The gel may have adhesive properties that allow the interface 108 to be coupled to the skin of the subject. The gel may create a seal around the skin of the subject to contain the sample within the borders of the interface 108. Further, the gel may have anti coagulation properties that reduce the chance of coagulation or a blood sample proximate the interface 108.

[0067] The interface 108 is coupled to the upper housing 104 and the lower housing 106 and extends (e.g., laterally, along an axis, etc.) from the upper housing 104 and / or the lower housing 106. In example embodiments, the interface 108 is formed as a component of the housing 102, such that the housing 102 defines the interface 108, the upper housing 104, and / or the lower housing 106.

[0068] The interface 108 includes an engagement surface 110 and a cavity 112. In particular embodiments, and as shown in FIGS. 1A and IB, the engagement surface 110 is a planar surface and is configured to engage (e.g., contact, interface, etc.) the anatomy of a subject. According to various other embodiments, the engagement surface 110 may be angled or include curvature, which may facilitate coupling the sample collection device 100 to an anatomy having a corresponding angle or curvature.

[0069] The engagement surface 110 engages the tissue of a subject to form a flush interface with the tissue. In an example embodiment, the engagement surface 110 is configured to engage with the tissue of a subject proximate a wound creation site and / or forms a seal with the skin of the subject, which may reduce the likelihood or prevents blood from escaping the interface 108. The engagement surface 110 is shown as a smooth oval shape (e.g., see FIGS. 1 A and 3), however, in other example embodiments the engagement surface is another suitable shape (e.g., square, rectangular, circular, etc.) and / or has another suitable configuration (e.g., concave, convex, textured, etc.).

[0070] In an example embodiment, the cavity 112 extends from the engagement surface 110 (e.g., into the housing 102) and forms a space (e.g., void, opening, etc.) between an anatomy of a subject and a surface of the cavity 112. The cavity 112 forms a space between the tissue of a subject and a surface of the cavity 112 when the tissue engages the engagement surface 110. In various example embodiments, the cavity 112 forms a space between the cavity 112 and the tissue of a subject. For example, the cavity 112 (e.g., an edge, interior surface) may engage the tissue of a subject when the tissue is drawn to the engagement surface 110 and / or the cavity 112 (e.g., via a sealed engagement between the tissue and the interface 108). In this regard, in various example embodiments the cavity 112 facilitates forming a seal with the skin of the subject to reduce the likelihood and / or prevent the sample from escaping the interface 108, as discussed above.

[0071] As shown, the cavity 112 is circular and positioned at a center of the engagement surface 110 (e.g., see FIGS. 1 A and 3), however, in various example embodiments the cavity 112 is another suitable shape (e.g., square, rectangular, keyed, ellipse shape, etc.) and / or has another suitable configuration (e.g., at a top, bottom, lateral, etc. portion of the engagement surface 110).

[0072] The interface 108 includes an interface inlet 114 and a channel, shown as collection channel 116. The interface inlet 114 extends from the cavity 112 into the housing 102 and forms an opening in the cavity 112. The interface inlet 114 allows movement of a substance or component into / out of the sample collection device 100 (e.g., a blood sample, a piercer, etc.), for example to create a wound in the anatomy of a subject and / or expose the sample collection device 100 to a sample. The interface inlet 114 is shown as a circular inlet positioned at a center of the cavity 112. However, in various example embodiments the interface inlet 114 is another suitable shape and / or has another suitable configuration (e.g., at a top, bottom, lateral, etc. portion of the cavity 112).

[0073] The collection channel 116 extends from the cavity 112 into the housing 102 and is configured to receive a sample. The collection channel 116 is an elongated channel positioned at a bottom of the interface inlet 114 and is configured to receive a sample from the interface inlet 114 and / or a subject. The collection channel 116 defines an opening or channel outlet at an interior (e.g., into the housing 102) and / or bottom surface of the collection channel 116. The collection channel 116 is in fluid communication with one ormore channels of the sample collection device 100, for example to enable movement of a sample from the collection channel 116 to components of the sample collection device 100, as discussed below. The interface inlet 114 and the collection channel 116 form a keyed shape or configuration (e.g., see FIG. 1 A) and the interface inlet 114 directs a flow of a sample to the collection channel 116. However, in various example embodiments the interface inlet 114 and the collection channel 116 form another suitable shape and / or have another suitable configuration.

[0074] In example embodiments, the interface inlet 114 and / or the collection channel 116 include a matrix or substrate. The matrix or substrate includes a layer of gel (e.g., silicone gel, hydrogel, etc.) having anti -coagulant materials, for example to prevent or inhibit alterations to the characteristics of the sample (e.g., clotting, etc.). The matrix is positioned around a surface of the interface inlet 114 and / or the collection channel 116 (e.g., an interior surface, etc.). In example embodiments, the matrix coats the entire surface of the interface inlet 114 and / or the collection channel 116. However, in other embodiments, the matrix coats just a portion of the interface inlet 114 and / or the collection channel 116 (e.g., an exterior surface of the interface inlet 114, a bottom and / or side surface of the collection channel 116, etc.). It should be appreciated that the matrix or substrate located proximate the interface inlet 114 / and / or the collection channel 116 may share one or more properties with the gel applied to some or all of the interface 108.

[0075] Referring now to FIGS. 2A and 2B, a sample collection device 700 is shown, according to another example embodiment. The sample collection device 700 may share one or more characteristics with any of the other sample collection devices described herein (e.g., the sample collection device 100). For example, the sample collection device 700 is configured to engage (e.g., contact, interface, etc.) an anatomy of a subject (e.g., a tissue of the subject) to expose the sample collection device 700 to a sample (e.g., of the subject). The sample collection device 700 may utilize one or more of the components included in the sample collection device 100. Further, the sample collection device 100 may utilize one or more components of the sample collection device 700.

[0076] The sample collection device 700 is configured to create a wound in the anatomy (e.g., lesion, cut, laceration, puncture, etc.) and expose the sample collection device 700 to a sample (e.g., blood sample) released from the wound such that the sample collection device700 can collect a blood sample from the subject. The sample collection device 700 is configured to collect a controlled or predetermined amount (e.g., volume, mass, etc.) of the blood sample with a collection tube 950. While the sample collection device 700 is described herein as being exposed to a blood sample, in various example embodiments, the sample is another suitable biological material (e.g., plasma, cellular material, mucous, etc.).

[0077] Still referring to FIGS. 2A and 2B, the sample collection device 700 includes a housing 702. The housing 702 contains (e.g., house, hold, contain, encompass, etc.) one or more components of the sample collection device 700. The housing 702 includes a first portion (e.g., a top portion, an upper portion, etc.), shown as upper housing 704 and a second portion (e.g., a bottom portion, a lower portion, etc.), shown as lower housing 706.

[0078] The housing 702 includes an interface 708. The interface 708 is configured to engage (e.g., contact, interface, etc.) the anatomy of the subject to facilitate collecting the sample using the sample collection device 700.

[0079] The interface 708 includes an engagement surface 710 and a cavity 712. In an example embodiment, the cavity 712 extends from the engagement surface 710 (e.g., into the housing 702) and forms a space (e.g., void, opening, etc.) between an anatomy of a subject and a surface of the cavity 712. The cavity 712 forms a space between the tissue of a subject and a surface of the cavity 712 when the tissue engages the engagement surface 710.

[0080] The interface 708 includes an interface inlet 714. The interface inlet 714 extends from the cavity 712 into the housing 702 and forms an opening in the cavity 712. The interface inlet 714 allows movement of a substance or component into / out of the sample collection device 700 (e.g., a blood sample, a piercer, etc.), for example to create a wound in the anatomy of a subject and / or expose the sample collection device 700 to a sample. An outer portion interface inlet 714 is shown to be circular (e.g., without a slot formed in the side of the interface inlet 714).

[0081] Referring now to FIG. 2C, a collection channel 716 extends from the cavity 712 into the housing 702 and is configured to receive a sample. The collection channel 716 includes a ramped surface configured to direct flow of the sample from the interface inlet 714 to within the housing 702 (see also FIG. 32).

[0082] Referring back to FIG. 2B, the sample collection device 700 includes an actuator 720. The actuator 720 (e.g., a button, knob, lever, switch, etc.) is coupled to the housing 702 (e.g., the upper housing 704) and is configured to receive a force (e.g., via a user, operator, machine, etc.). The actuator 720 is configured to translate along an axis 701 from a first actuator position to a second actuator position (e.g., in response to receiving an input force from a user or operator of the sample collection device 700). The actuator 720 engages components of the sample collection device 700 to facilitate the sample collection device 700 engaging an anatomy of a subject and / or exposing the sample collection device 700 to a sample, as described below.

[0083] The actuator 720 is further configured to rotate about the axis 701 between a locked position (e.g., as shown in FIG. 2B) and an unlocked position (e.g., as shown in FIG. 35). In the locked position, the actuator 720 is prevented (e.g., via one or more projections) from translating along the axis from the first actuator position to the second actuator position. Therefore, when the actuator 720 is in the locked position, the risk of inadvertent actuation of the actuator 720 may be reduced.

[0084] The actuator 720 further includes an indicator 798 configured to provide an indication of a position of the actuator 720 (e.g., the locked position or the unlocked position). For example, the indicator 798 may align with a locked indicator 794 displayed on the housing 702 when the actuator 720 is in the locked position. Further, the indicator 798 may align with an unlocked indicator 796 displayed on the housing 702 when the actuator 720 is in the unlocked position.

[0085] Referring to FIGS. 3 and 4, the sample collection device 100 includes an actuator 120. The actuator 120 (e.g., a button, knob, lever, switch, etc.) is coupled to the housing 102 (e.g., the upper housing 104) and is configured to receive a force (e.g., via a user, operator, machine, etc.). The actuator 120 is configured to translate along an axis 50 (e.g., see FIG. 4) from a first actuator position to a second actuator position (e.g., in response to receiving an input force from a user or operator of the sample collection device 100). The actuator 120 engages components of the sample collection device 100 to facilitate the sample collection device 100 engaging an anatomy of a subject and / or exposing the sample collection device 100 to a sample, as described below.

[0086] The actuator 120 includes a guide groove 122 and an activation groove 124 (e.g., see FIG. 4). The guide groove 122 receives a guide projection to guide and / or control movement of the actuator 120 (e.g., along the axis 50, etc.). The activation groove 124 receives an activation projection to activate and / or control movement of one or more components of the sample collection device 100 (e.g., a plunger catch, a plunger, etc.). In an example embodiment, the actuator 120 includes a plurality of guide grooves 122 and / or activation grooves 124. However, in other embodiments the actuator 120 includes a single guide groove 122 and / or a single activation groove 124.

[0087] Referring to FIG. 4, the guide groove 122 extends vertically from a bottom (e.g., bottom edge, bottom surface, etc.) of the actuator 120 (e.g., toward a top edge, top surface, etc. of the actuator 120). The guide groove 122 extends from the bottom of the actuator 120 along an axis that is aligned with the axis 50. The activation groove 124 also extends vertically from a bottom of the actuator 120 (e.g., toward a top edge, a top surface, etc. of the actuator 120). The activation groove 124 extends from a bottom of the actuator 120 along an axis that is not aligned with the axis 50. For example, the activation groove 124 extends along an axis that is angled relative to the axis 50 (e.g., 25, 30, 45, 60, 70, etc. degrees). The guide groove 122 and / or the activation groove 124 extend a controlled or predetermined distance from a bottom of the actuator 120 (e.g., see FIG. 4), for example to provide controlled or limited movement of the actuator 120.

[0088] The actuator 120 also includes an engagement projection, shown as foot 126. The foot 126 extends laterally from a bottom of the actuator 120. The foot 126 is configured to engage the housing 102 (e.g., the upper housing 104). For example, the foot 126 is configured to engage an interior surface of the upper housing 104 to form a seal within the housing 102 (e.g., between the actuator 120 and the upper housing 104). The foot 126 also engages an upper ledge of the upper housing 104 to limit or restrict movement of the actuator 120 (e.g., upward movement of the actuator 120 relative to the upper housing 104). In an example embodiment, the actuator 120 includes a plurality of feet 126. However, in various example embodiments the actuator 120 includes a single foot 126.

[0089] Referring to FIGS. 3-5, the sample collection device 100 includes a retention or guide member, shown as guide ring 130. The guide ring 130 is coupled to one or more components of the sample collection device 100 (e.g., the actuator 120, a plunger catch,etc.). The guide ring 130 includes a projection (e.g., a protrusion, flange, ridge, lip, etc.), shown as guide projection 132 (e.g., see FIG. 5). The guide projection 132 is coupled with the guide groove 122 to guide or control movement of the actuator 120. For example, the guide projection 132 is received at the guide groove 122 and guides movement of the actuator 120 along the axis 50 between a first actuator position and a second actuator position. The guide ring 130 is shown to include a plurality of guide projections 132 (e.g., see FIG. 5). However, in various example embodiments the guide ring 130 includes a single guide projection 132.

[0090] Referring to FIGS. 3-6, the sample collection device 100 includes a catch or lock, shown as plunger catch 140, according to example embodiments. The plunger catch 140 is movably coupled with one or more components of the sample collection device 100 (e.g., the actuator 120, a plunger, etc.) to control movement of a component of the sample collection device 100 (e.g., a plunger). The plunger catch 140 includes an activation projection (e.g., a protrusion, flange, ridge, lip, etc.), shown as activation projection 142 and a release groove or channel, shown as plunger channel 144 (e.g., see FIG. 6). The activation projection 142 is received at the activation groove 124 of the actuator 120 and the plunger channel 144 is configured to receive a projection of a plunger (e.g., the plunger projection 152 of the vacuum plunger 150), discussed below. The activation projection 142 includes an angled or slanted face or surface (e.g., see FIG. 6) to be received at the activation groove 124.

[0091] As indicated above, in a first configuration (e.g., a first actuator position) the activation projection 142 is received at the activation groove 124 of the actuator 120 and the plunger catch 140 engages a plunger projection (e.g., at a ledge of body of the plunger catch 140). As the actuator 120 moves between the first actuator position and a second actuator position (e.g., translates along the axis 50 into the upper housing 104, etc.), the activation projection 142 moves within the activation groove 124 and rotates the plunger catch 140 (e.g., relative to the actuator 120). As the plunger catch 140 rotates, the plunger catch 140 (e.g., ledge, etc.) releases the plunger projection 152 to the plunger channel 144 such that the plunger channel 144 receives the plunger projection 152. With the plunger projection 152 received at the plunger channel 144, the plunger projection 152 is able to move within the plunger channel 144, and the vacuum plunger 150 is pushed by an actuator biasingmember 180 (e.g., a coil spring) from a first vacuum plunger position to a second vacuum plunger position along the axis 50 (e.g., vertically via an actuator or driver, etc.).

[0092] As described below, the vacuum plunger 150 defines one of the boundaries of a chamber (e.g., the vacuum chamber 306 shown in FIGS. 21) formed within the sample collection device 100. As the vacuum plunger 150 translates towards the second vacuum plunger position, the volume of the vacuum chamber 306 increases, thereby reducing the pressure within the vacuum chamber 306. According to various embodiments, prior to actuating the vacuum plunger 150, the vacuum chamber 306 is at atmospheric pressure. Thus, the pressure differential within the vacuum chamber 306 is generated in response to a translation of the vacuum plunger 150.

[0093] Referring to FIGS. 4-8, the sample collection device 100 includes a vacuum plunger 150, according to example embodiments. The vacuum plunger 150 is configured to translate relative to one or more components of the sample collection device 100 (e.g., the plunger catch 140, a chamber wall, etc.). The vacuum plunger 150 includes a plunger projection 152, which is configured to guide movement of the vacuum plunger 150. For example, the plunger projection 152 is configured to be received at the plunger channel 144 to guide movement of the vacuum plunger 150 relative to the plunger catch 140. The plunger projection 152 extends from and along an exterior surface of the vacuum plunger 150 (e.g., see FIGS. 4 and 7). In an example embodiment, the vacuum plunger 150 includes a plurality of plunger projections 152. However, in various example embodiments the vacuum plunger 150 includes a single plunger projection 152.

[0094] Referring to FIG. 8, the vacuum plunger 150 includes a pusher or plunger receiver, shown as plunger channel 154. The plunger channel 154 is sized to receive a pusher or piston (e.g., a plunger, etc.) to form a pressurized space within the plunger channel 154 to inhibit or restrict movement of the vacuum plunger 150. The plunger channel 154 extends from a top of the vacuum plunger 150 (e.g., toward a bottom of the vacuum plunger 150) and is positioned at a central portion of the vacuum plunger 150.

[0095] The vacuum plunger 150 also includes an actuator or driver receiver, shown as driver channel 156. The driver channel 156 is configured to receive an actuator or driver (e.g., a spring, etc.) to facilitate movement of the vacuum plunger 150. The driver channel156 extends from a bottom of the vacuum plunger 150 (e.g., toward a top of the vacuum plunger 150) and is positioned inward relative to an exterior wall or surface of the vacuum plunger 150.

[0096] The vacuum plunger 150 further includes a release receiver, shown as pin channel 158. The pin channel 158 is configured to receive a release pin (e.g., a pin, dowel, rod, peg, etc.) to position the release pin (e.g., to selectively couple components of the sample collection device 100). The pin channel 158 extends from a bottom of the vacuum plunger 150 (e.g., toward a top of the vacuum plunger 150) and is positioned within the vacuum plunger 150 (e.g., between the driver channel 156 and the plunger channel 154). As will be discussed in greater detail below, a driver (e.g., a spring) is configured to activate in the driver channel 156 to cause translation of the vacuum plunger 150 (e.g., vertically along the axis 50), resulting in the plunger channel 154 receiving a plunger to form a pressurized space within the plunger channel 154 and moving a pin (e.g., via the pin channel 158) to release a component of the sample collection device 100 (e.g., a piercer) to engage the tissue of a subject and / or expose the sample collection device 100 to a sample.

[0097] Referring still to FIG. 8, the vacuum plunger 150 includes a groove or channel, shown as a sealing channel 160. The sealing channel 160 is configured to receive a sealing member (e.g., ring, sealing ring, etc.) to create a seal between the vacuum plunger 150 and one or more components of the sample collection device 100. For example, the sealing channel 160 (e.g., the sealing member, etc.) engages (e.g., couple, interface with, etc.) an inner wall of a chamber to create a seal between the vacuum plunger 150 and the chamber wall.

[0098] The sealing channel 160 (e.g., the sealing member, etc.) is configured to engage the inner wall of the chamber to form a sealed space within the chamber and limit or inhibit a flow of air between the vacuum plunger 150 and the chamber wall, as discussed below. The sealing channel 160 extends around a circumference of the vacuum plunger 150 and is positioned at a bottom of the vacuum plunger 150 (e.g., adjacent a bottom surface, opening, ledge, lip, etc.). In various example embodiments, the sealing channel 160 is otherwise positioned and / or arranged at the vacuum plunger 150 (e.g., in a helical or spiral configuration, at a central portion of the vacuum plunger 150, etc.).

[0099] Referring now to FIG. 9, the sample collection device 100 includes a pusher or piston, shown as a damper plunger 170. As shown in FIGS. 20A and 20B, the damper plunger 170 is coupled with the actuator 120 and extends from a top of the actuator 120 toward a bottom or interior of the actuator 120. The damper plunger 170 moves or translate within the housing 102 along the axis 50 (e.g., via the actuator 120) between a first plunger position and a second plunger position. The damper plunger 170 is configured to translate within the plunger channel 154 of the vacuum plunger 150 to form a space or opening between the damper plunger 170 and a bottom surface of the plunger channel 154 (see e.g., FIGS 20A and 20B). In an example embodiment, the space between the damper plunger 170 and the plunger channel 154 is configured to have an elevated or increased pressure as the damper plunger 170 translates into the plunger channel 154, as discussed below.

[0100] The damper plunger 170 includes a shock or absorber, shown as absorber 172, extending around an exterior of the damper plunger 170. The damper plunger 170 also includes a channel extending along a length of the damper plunger 170, shown as relief channel 174 and an obstruction or relief check, shown as damper 176. The damper plunger 170 further includes a sealing member or sealing ring 178 (e.g., see FIGS. 20A and 20B), coupled to a bottom portion of the damper plunger 170. The absorber 172 and / or sealing ring 178 is / are configured to engage a surface of the plunger channel 154 (e.g., an interior surface or wall) to create an engagement or seal between the damper plunger 170 and the plunger channel 154. The relief channel 174 is configured to receive or permit a flow of fluid through the damper plunger 170. The damper 176 is positioned within the relief channel 174 and is configured to inhibit or restrict the flow of fluid through the damper plunger 170.

[0101] As will be discussed in greater detail below, after the damper plunger 170 is received by the plunger channel 154, the absorber 172 and / or the sealing ring 178 is / are configured to seal a space between the damper plunger 170 and an interior of the plunger channel 154 (e.g., having an elevated or increased pressure). The relief channel 174 and damper 176 are configured to permit a controlled flow of air from the space, through the damper plunger 170 and to an exterior of the plunger channel 154 so as to control movement of the vacuum plunger 150 (e.g., via a controlled decrease in pressure in the space between the damper plunger 170 and the plunger channel 154). According to variousembodiments, a porous material is positioned within the relief channel 174 to further resist the flow of air through the relief channel 174.

[0102] The absorber 172 and / or the interaction between the damper plunger 170 and the plunger channel 154 function to reduce a speed at which the vacuum plunger 150 is released from the original position. Since the release pin 182 is coupled to the vacuum plunger 150, slowing the speed at which the vacuum plunger 150 is released may delay the release of the piercer 200. By delaying the release of the piercer 200, the pressure differential created by the release of the vacuum plunger 150 may have sufficient time to develop and pull the skin of the subject taught (e.g., proximate the engagement surface 110). According to various embodiments, allowing sufficient time for the skin to be pulled taught (e.g., indexed) may result in more consistent piercing of the skin by the piercer 200. For example, if the skin is not taught, the skin may not be pierced to a desired depth. Further, pulling the skin taught proximate the engagement surface 110 may result in less pain being experienced by the subject as the skin is pierced. It should be appreciated that the sample collection device 100 may include one of the absorber 172 or the damper plunger 170 to slow the release of the vacuum plunger 150 (see, e.g., FIGS. 23-26).

[0103] Referring still to FIG. 9, the sample collection device 100 includes an actuator or driver, shown as actuator biasing member 180. The actuator biasing member 180 has elastic properties and is configured to move between one or more states of compression and / or extension (e.g., a first state of compression, a second state of non-compression or extension, etc.). The actuator biasing member 180 is coupled to one or more components of the sample collection device 100 and is configured to move or translate the one or more components. For example, the actuator biasing member 180 is received by the driver channel 156 of the vacuum plunger 150 and is configured to move or translate the vacuum plunger 150 along the axis 50 (e.g., between a first plunger position and a second plunger position). In an example embodiment, the actuator biasing member 180 is a compression spring. However, in various example embodiments the actuator biasing member 180 is another suitable spring (e.g., an extension spring, a torsion spring, a disk spring, etc.) and / or another suitable driver or actuator.

[0104] The sample collection device 100 also includes a release member or rod, shown as release pin 182. The release pin 182 is an elongated structure and is configured toselectively couple one or more components of the sample collection device 100 (e.g., the vacuum plunger 150, a piercer, a housing, etc.) to facilitate releasing a component of the sample collection device 100 (e.g., a piercer) to engage the tissue of a subject. The release pin 182 is received by the pin channel 158 and is configured to move or translate within the housing 102 (e.g., along with the vacuum plunger 150) along an axis aligned with the axis 50 (e.g., between a first pin position and a second pin position). In an example embodiment, the release pin 182 is an elongated cylindrical structure. However, in various embodiments the release pin 182 is a dowel, a rod, a peg, a pole, a stick, a shaft, another suitable elongated structure, or another suitable release member or component (e.g., a hook, tab, nob, catch, etc.).

[0105] Referring still to FIG. 9, the sample collection device 100 includes one or more sealing members or sealing components, shown as a first sealing ring 184 and a second sealing ring 186. The first sealing ring 184 and the second sealing ring 186 are configured to engage components of the sample collection device 100 to create an interface or seal. For example, the first sealing ring 184 is coupled to the vacuum plunger 150 (e.g., the sealing channel 160, etc.) and is configured to engage a wall of a chamber to create a seal between the vacuum plunger 150 and the chamber wall. The second sealing ring 186 is coupled to the release pin 182 and is configured to engage a wall of the pin channel 158 to create a seal between the release pin 182 and the wall of the pin channel 158.

[0106] In an example embodiment, the first sealing ring 184 and the second sealing ring 186 define a diameter that is the same or slightly larger than a diameter of a component to which rings 184, 186 are coupled (e.g., an exterior diameter of the vacuum plunger 150, the release pin 182, an interior diameter of a chamber wall, the pin channel 158, etc.). As such, the first sealing ring 184 and the second sealing ring 186 are configured to compress when coupled to components to create a seal. The first sealing ring 184 and the second sealing ring 186 are formed of a flexible material, such as rubber or polyvinyl. The first sealing ring 184 and the second sealing ring 186 may be received and / or coupled to the vacuum plunger 150 or the release pin 182, respectively, or the first sealing ring 184 and the second sealing ring 186 may be formed by over-molding the first sealing ring 184 and the second sealing ring 186 to one or more components (e.g., the vacuum plunger 150, the release pin 182). As described herein, additional sealing members or sealing components (e.g., the sealing ring178) have the same or similar features as first sealing ring 184 and the second sealing ring186.

[0107] Referring now to FIGS. 9-10B, the sample collection device 100 includes a penetration or puncture device, shown as piercer 200. The piercer 200 is configured to selectively translate within a channel of the sample collection device 100 and selectively engage an anatomy of a subject (e.g., a tissue). The piercer 200 is further configured to create a wound (e.g., a lesion, cut, laceration, puncture, etc.) in the tissue of the subject to release a sample (e.g., blood sample) and expose the sample collection device 100 to the sample. It should be appreciated that the piercer 200 is configured to be used with the sample collection device 100 and the sample collection device 700. For example, the piercer 200 is configured to translate within both the housing 300 and the housing 1300 discussed further below with respect to FIGS. 12A-12C.

[0108] The piercer 200 includes a base 202 and an extension 204. The base 202 defines an axis 52 (see FIGS. 10A and 10B) of the piercer 200 and the extension 204 extends from the base 202 along the axis 52. The base includes an aperture 206 extending through the base 202 (e.g., along an axis this is perpendicular to the axis 52). The aperture 206 selectively receives the release pin 182 to control movement or translation of the piercer 200, as discussed below. The aperture 206 is positioned at a rear portion of the base 202. However, in other example embodiments the aperture 206 is positioned at another location of the base 202 and / or is otherwise configured (e.g., at a middle, extending horizontally across the base, etc.).

[0109] The extension 204 includes an engagement interface 208 and a pierce or puncture member, shown as blade 210. The engagement interface 208 is a planar surface positioned at an end of the extension 204 and is configured to engage (e.g., contact, interface, etc.) the anatomy of a subject. The engagement interface 208 engages a tissue of the subject to form a flush (e.g., event, level, etc.) interface with the tissue. The blade 210 is coupled with the engagement interface 208 and extends a distance from the engagement interface 208 (e.g., perpendicular to, away from the extension 204). The blade 210 includes a sharp or pointed tip and is configured to puncture the tissue of the subject.

[0110] A desired wound depth is accomplished based on the distance between the engagement surface 208 and the end of the blade 210. For example, the engagement interface 208 may contact the tissue of the subject as the piercer 200 is released towards the subject such that the length of the blade 210 extending form the engagement interface 208 defines a wound depth. It should be appreciated that various piercers 200 designed for varying piercing depths may be used with the same sample collection device 100. In this sense, the piercer 200 and the corresponding piercing depth may be selected based on a desired application.[OHl] The sharp or pointed tip of the blade 210 is configured to create a wound in the tissue to release the sample and / or expose the sample collection device 100 to the sample. In an example embodiment, the blade 210 extends a distance (e.g., 1.5 mm, 2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm, 4.5 mm, etc.) from the engagement interface 208, such that when the engagement interface 208 engages the tissue, the blade 210 penetrates a distance into the tissue to cause the subject to release the sample. In an example embodiment, the piercer 200 is a lancet having two blades (e.g., side-by-side, staggered, etc.). However, in various example embodiments the piercer 200 is another suitable piercing device having another number and / or configuration of blades 210 (e.g., a single blade 210, three blades 210 positioned in a triangular configuration, four blades 210 positioned in a square configuration, five blades 210 positioned in a pentagonal shape, etc.).

[0112] The piercer 200 also includes a translation protuberance or protrusion, shown as projection 212, and a hold or brace, shown as catch 214. The projection 212 extends from a side of the base 202 and is configured to guide or control movement of the piercer 200. For example, the projection 212 is received by a guide (e.g., receiver, etc.) of a channel (e.g., a piercer channel, etc.) and is guides movement of the piercer 200 through the channel. The piercer 200 includes a plurality of projections 212 extending from opposing sides of the base 202. However, in various example embodiments the piercer 200 includes another suitable number of projections 212 otherwise arranged (e.g., a single projection 212 extending from a top of the base 202, four projections 212 extending radially from an exterior of the base 202, etc.).

[0113] The catch 214 is positioned at an exterior of the base 202 (e.g., between the base 202 and the extension 204) and is configured to couple one or more actuators (e.g., shown as afirst actuator biasing member 220 and a second actuator biasing member 222) to the piercer 200. The first actuator biasing member 220 and the second actuator biasing member 222 have elastic properties and are configured to transition between one or more states of compression and / or extension, similar to the actuator biasing member 180. For example, the first actuator biasing member 220 and the second actuator biasing member 222 are shown as coil springs, according to an example embodiment. As will be discussed below, the first actuator biasing member 220 and the second actuator biasing member 222 are configured to move or translate the piercer 200 between one or more piercer positions (e.g., a first piercer position, a second piercer position, etc.) to drive the piercer 200 to engage the tissue of a subject and / or retract the piercer 200 within the sample collection device 100.

[0114] Referring now to FIGS. 11 A and 1 IB, the sample collection device 700 includes a penetration or puncture device, shown as piercer 1200. The piercer 1200 is configured to selectively translate within a channel of the sample collection device 700 and selectively engage an anatomy of a subject (e.g., a tissue). The piercer 1200 is further configured to create a wound (e.g., a lesion, cut, laceration, puncture, etc.) in the tissue of the subject to release a sample (e.g., blood sample) and expose the sample collection device 700 to the sample. The piercer 1200 may share one or more characteristics with any of the other piercers described herein (e.g., the piecer 200). It should be appreciated that the piercer 1200 is configured to be used with the sample collection device 100 and the sample collection device 700. For example, the piercer 1200 is configured to translate within both the housing 300 and the housing 1300 discussed further below with respect to FIGS. 12A- 12C.

[0115] The piercer 1200 includes an aperture 1206. The aperture 206 selectively receives a release pin (e.g., the release pin 182) to control movement or translation of the piercer 1200, as discussed herein.

[0116] The piercer 1200 includes an engagement interface 1208 and a pierce or puncture member, shown as blade 1210, extending from the engagement interface 208. The engagement interface 208 is a planar surface positioned at an end of the extension 204 and is configured to engage (e.g., contact, interface, etc.) a structure (e.g., the anatomy of a subject, a shoulder defined by the housing 702, etc.) to prevent further translation of the piercer 1200. For example, the engagement interface 1208 engages a tissue of the subject toform a flush (e.g., event, level, etc.) interface with the tissue. The blade 1210 is coupled with the engagement interface 1208 and extends a distance from the engagement interface 1208. The blade 1210 includes a sharp or pointed tip and is configured to puncture the tissue of the subject. A desired wound depth is accomplished based on the distance between the engagement surface 1208 and an end of the blade 1210.

[0117] The piercer 1200 includes a pair of translation protuberances or protrusions, shown as a first projection 1212a and a second projection 1212b, and corresponding holds or braces, shown a first catch 1214a and a second catch 1214b, extending from the first projection 1212a and the second projection 1212b, respectively. The first projection 1212a and the second projection 1212b define a side of the piercer 1200 and are configured to guide or control movement of the piercer 1200. For example, the first projection 1212a and the second projection 1212b are received by a guide (e.g., receiver, etc.) of a channel (e.g., a piercer channel, etc.) and is guides movement of the piercer 1200 through the channel. The first projection 1212a and the second projection 1212b define opposing sides of the piercer 1200.

[0118] The first catch 1214a and the second catch 1214b are configured to couple one or more actuators (e.g., shown as a first actuator biasing member 1222a and a second actuator biasing member 1222b) to the piercer 1200. The first actuator biasing member 1222a and the second actuator biasing member 1222b are configured to transition between one or more states of compression and / or extension. The first actuator biasing member 1222a and the second actuator biasing member 1222b are configured to move or translate the piercer 1200 between one or more piercer positions (e.g., a first piercer position, a second piercer position, etc.) to drive the piercer 1200 to engage the tissue of a subject and / or retract the piercer 1200 within the sample collection device 700. According to various embodiments, positioning the first actuator biasing member 1222a and the second actuator biasing member 1222b proximate the sides of the piercer 1200 may reduce the likelihood of the first actuator biasing member 1222a and the second actuator biasing member 1222b obstructing a portion of the sample flow path.

[0119] Referring now to FIGS. 12A and 13, the sample collection device 100 includes a collection body or housing, shown as body 300, and a collection mount, shown as mount 400. In an example embodiment, the body 300 is configured to movably couple the vacuumplunger 150 to create a change (e.g., decrease) in pressure in a vacuum chamber 306 of the sample collection device 100 to create a seal between the interface 108 and the tissue of a subject. It should be appreciated that the body 300 is configured to be used with the sample collection device 100 and the sample collection device 700. For example, the body 300 is configured to interface with the vacuum plunger 152 to create a pressure differential within the sample collection device 100 and within the sample collection device 700.

[0120] The body 300 is also coupled to the mount 400 and is configured to facilitate movement of a sample from the subject to a collection chamber, shown as a collection chamber 350. The mount 400 is configured to removably couple one or more collection chambers (e.g., collection chamber 350) to facilitate collecting one or more quantities of a sample. In an example embodiment, the body 300 and the mount 400 are coupled such that components of the body 300 and the mount 400 are in communication (e.g., fluid communication) to form a sealed interface between the sample collection device 100 and the tissue, receive a sample, collect a controlled amount of the sample and provide an indication that the controlled amount of the sample has been collected, as discussed below.

[0121] Referring to FIG. 12A, the body 300 includes a base 302 and a wall or sidewall, shown as chamber wall 304. The chamber wall 304 extends vertically from the base 302 and defines an interior volume (e.g., space, opening, chamber, etc.), shown as a vacuum chamber 306. The chamber wall 304 is coupled to one or more components of the sample collection device 100. For example, the chamber wall 304 is coupled to the plunger catch 140 to position the plunger catch 140 relative the vacuum plunger 150 (e.g., see FIGS. 20A). The chamber wall 304 is also configured to engage the vacuum plunger 150 (e.g., the first sealing ring 184) to form a space or volume between the vacuum plunger 150 and the base 302, as discussed below.

[0122] Referring to FIGS. 12A and 13-16, the body 300 includes a piercer or collection channel, shown as channel 310. The channel 310 is positioned at a bottom of the body 300 (e.g., a bottom of the chamber wall 304, the vacuum chamber 306) and extends across the body 300 along an axis 54 (e.g., see FIGS. 14-16). The channel 310 includes a channel inlet 312 and a rear wall 314 opposite the channel inlet 312 (e.g., along the channel 310). The channel inlet 312 forms an opening in the channel 310 to allow movement of a component out of / into the sample collection device 100 (e.g., the piercer 200) to create a wound in theanatomy of a subject. The channel inlet 312 also allows a sample to flow into the sample collection device 100 (e.g., a collection channel), as discussed below. In an example embodiment, the body 300 is coupled to the interface 108 and the channel inlet 312 and the interface inlet 114 are in communication (e.g., fluid communication). In various example embodiments, the channel inlet 312 and the interface inlet 114 form a single (e.g., unified) inlet.

[0123] The channel 310 includes a piercer guide 322 that extends along a length of the channel 310 and a release member aperture, shown as pin aperture 324, that extends through the channel 310. The piercer guide 322 is positioned along an inside, lateral edge of the channel 310 and extends the channel 310 along an axis that is aligned with the axis 54. The piercer guide 322 is configured to receive a component of the piercer 200 (e.g., the projection 212) to guide or control movement of the piercer 200 (e.g., within or out of the channel 310). The channel 310 includes two piercer guides 322 on opposing (e.g., opposite) sides of the channel 310; however, in other example embodiments the channel 310 includes another number of piercer guides 322, each having another suitable configuration. The pin aperture 324 extends through the channel 310 (e.g., along an axis perpendicular to the axis 54) forming an opening or hole through the channel 310. The pin aperture 324 is configured to selectively couple (e.g., receive) a release member (e.g., the release pin 182) to control movement or translation of the piercer 200. The pin aperture 324 is positioned toward a rear portion of the body 300 (e.g., see FIGS. 14 and 15); however, in other example embodiments the pin aperture 324 is otherwise positioned and / or configured.

[0124] As indicated above, the channel 310 is configured to receive the piercer 200 (e.g., see FIG. 15) and / or control or guide movement of the piercer 200 (e.g., between a first piercer position and a second piercer position). The channel 310 is also configured to receive one or more drivers (e.g., springs 220 and 222). The springs 220 and 222 are coupled to the piercer 200 and / or components of the channel 310, to facilitate movement of the piercer 200 within and / or out of the channel 310. The first actuator biasing member 220 is coupled to the rear wall 314 of the channel 310 and the catch 214 of the piercer 200. The second actuator biasing member 222 is coupled to the channel 310 (e.g., a forward stop, etc.) and the catch 214 (e.g., see FIG. 15).

[0125] In an example embodiment, in a first piercer position (e.g., the piercer 200), the release pin 182 is received by the pin aperture 324 and the aperture 206, such that movement of the piercer 200 is restricted or restrained. In the first piercer position, the first actuator biasing member 220 is in a compressed state (e.g., compressed between the rear wall 314 and the piercer 200) and the second actuator biasing member 222 is in an expanded state (e.g., expanded between a stop of the channel 310 and the piercer 200). In response to movement or translation of the release pin 182 (e.g., out of the pin aperture 324, the aperture 206), the first actuator biasing member 220 expands (e.g., transitions to a noncompressed state) to move or translate the piercer 200 within the channel 310 (e.g., along the axis 54). The first actuator biasing member 220 is configured to move the piercer 200 to a second piercer position (e.g., with a portion of the piercer 200 outside the channel 310) to engage the piercer 200 with an anatomy of a subject. The second actuator biasing member 222 is configured to provide a counter-force to limit or restrict movement of the piercer 200 (e.g., within the channel 310, out of the channel 310, etc.) to return the piercer 200 back to the channel 310 after the piercer 200 engages the anatomy of the subject.

[0126] Referring still to FIGS. 12A and 13-16, the body 300 also includes a collection channel 330. The collection channel 330 extends along a bottom of the channel 310 and is configured to receive a sample (e.g., a blood sample of a subject). As noted above, the body 300 couples to the interface 108 such that the collection channel 330 is in fluid communication with the collection channel 116. For example, the collection channel 116 receives a sample (e.g., from the interface inlet 114 and / or a subject) and directs the sample to the collection channel 330. In various example embodiments, the collection channel 116 and the collection channel 330 form a single (e.g., unified) collection channel. The collection channel 330 includes an opening or channel outlet 332 (e.g., see FIG. 15) at an interior (e.g., into the body 300) and / or bottom surface of the collection channel 330. In various example embodiments, the channel outlet 332 and the collection channel 116 are a single channel outlet. The channel outlet 332 is in communication (e.g., fluid communication) with an inlet 402 of the mount 400 (e.g., see FIG. 17) and directs the sample to the inlet 402 and / or to the collection chamber 350, as discussed below.

[0127] The body 300 also includes an inlet channel 334 (e.g., see FIG. 16). The inlet channel 334 is in communication (e.g., fluid communication) with an outlet 404 of themount 400 (e.g., see FIG. 17) and is configured to receive a portion of the sample from the outlet 404 and / or the collection chamber 350, as discussed below. The inlet channel 334 is positioned on a bottom surface of the body 300 and is configured to interface with an outlet channel 434 of the mount 400 (e.g., see FIG. 17). In an example embodiment, the inlet channel 334 of the body 300 and the outlet channel 434 of the mount 400 form a single (e.g., unified) channel. The inlet channel 334 is in communication (e.g., fluid communication) with an indicator channel 336 via an opening (e.g., see FIGS. 14-15).

[0128] In an example embodiment, the indicator channel 336 is configured to receive the sample from the inlet channel 334 to provide an indication of an amount of sample in the collection chamber 350. As will be discussed in greater detail below, in an example embodiment once the collection chamber 350 is filled to a controlled or predetermined amount, a portion of the sample (e.g., overflow, excess, etc.) flows through the outlet 404 of the mount 400, to the outlet channel 434 of the mount 400 (and the inlet channel 334 of the body 300) and to the indicator channel 336, indicating that the collection chamber 350 is filled to the controlled or predetermined amount.

[0129] According to various embodiments, a portion of the sample flow path (e.g., the outlet 404, the outlet channel 434, the reservoir channel 406, the chamber opening 340, an end of the indicator channel 336, etc.) includes a hydrophobic stop configured to resist flow of the sample. For example, a portion of the sample flow path that is downstream a portion the indicator channel 336 (e.g., the portion that is visible via the viewing component) may be include a hydrophobic stop configured to prevent the sample from flowing beyond the hydrophobic stop. As a blood sample flows towards the stop, a hydrophobic coating may resist the flow of the blood sample, thereby slowing the flow of the blood sample such that a portion of the blood sample proximate the stop begins to clot. The clotting forms a membrane that prevents the sample from flowing beyond the membrane, thereby preventing overcollection of the sample.

[0130] The indicator channel 336 extends along a portion of the body 300 (e.g., see FIGS. 14-15) proximate the exterior of the body 300. The indicator channel 336 extends along the body 300 in a semi-circular pattern; however, in other example embodiments the indicator channel 336 is otherwise configured or arranged (e.g., includes a cavity or void for the sample to collect, etc.).

[0131] In an example embodiment, the indicator channel 336 is provided within a viewing component 190 (e.g., see FIG. 9). At least an outer portion of the viewing component 190 is formed of a transparent or clear material to allow a user or operator to view or otherwise observe a sample within the indicator channel 336. The indicator channel 336 is configured to receive the sample such that a user or operator of the sample collection device 100 is able to view at least a portion of the sample via the viewing component 190 when such portion is within the indicator channel 336, thus providing to the user an indication of a status (e.g., fill level, etc.) of the sample within the collection chamber 350. In an example embodiment, when the indicator channel 336 is filled with a predetermined amount of sample (e.g., 50, 60, 75, 80, 90, 100, etc. percent full), it provides an indication that the collection chamber 350 is filled with the controlled or predetermined amount. As such, the indicator channel 336 and / or the viewing component 190 provide a visual indication (e.g., to a user, operator, etc.) when the collection chamber 350 contained a controlled amount of the sample.

[0132] The body 300 further includes an outlet channel 338 (e.g., see FIG. 16). The outlet channel 338 is in communication (e.g., fluid communication) with the indicator channel 336 and is configured to receive a portion of the sample from the indicator channel 336. The outlet channel 338 is also in communication (e.g., fluid communication) with a reservoir channel 406 of the mount 400 (e.g., see FIG. 17). The outlet channel 338 is positioned on a bottom surface of the body 300 and is configured to interface with the reservoir channel 406 of the mount 400. In an example embodiment, the outlet channel 338 of the body and the reservoir channel 406 of the mount 400 form a single (e.g., unified) channel.

[0133] Referring now to FIGS. 12B and 12C, an alternate body 1300 is shown, according to an example embodiment. The body 1300 is configured to movably couple the vacuum plunger 150 to create a change (e.g., decrease) in pressure in a vacuum chamber 1316 of a sample collection device to create a seal between an interface 108 and the tissue of a subject. The body 1300 includes a piercer channel or collection channel, shown as channel 1310. It should be appreciated that the body 1300 may be configured to be used with the sample collection device 100 and the sample collection device 700. For example, the body 1300 is configured to interface with the vacuum plunger 152 to create a pressure differential within the sample collection device 100 and within the sample collection device 700.

[0134] The body 1300 includes a sample inlet 1336 and a sample outlet 1338. The sample inlet 1336 is configured to receive a sample from the channel 1310. When assembled (e.g., as a part of the sample collection device 700, as a part of the sample collection device 100, etc.), the sample inlet 1336 and the sample outlet 1338 are in fluid communication with a groove in the viewing window 790 (see FIG. 2A). The collected sample can be viewed via the viewing window 790 as the sample flows from the sample inlet 1336, through an indication channel (e.g., defined by the groove in the viewing window 790), and out of the sample outlet 1338. Since the indication channel is defined by a single groove, the volume of the sample collected within the indication channel may be reduced (e.g., compared to an indication channel defined by a groove in the viewing window 790 and a groove in the body).

[0135] Referring to FIGS. 14-16, the body 300 also includes a chamber opening 340. The chamber opening 340 is in communication (e.g., fluid communication) with the outlet channel 338 (e.g., see FIG. 16). The chamber opening 340 is also in communication (e.g., fluid communication) with the reservoir channel 406 of the mount 400.

[0136] The chamber opening 340 is further in communication (e.g., via the outlet channel 338, the reservoir channel 406, etc.) with the indicator channel 336 (e.g., provided within the viewing component 190), the inlet channel 334 (e.g., and the outlet channel 434 of the mount 400), the outlet 404, and / or and the collection chamber 350. The chamber opening 340 extends through the base 302 of the body 300 between the vacuum chamber 306 and the outlet channel 338. In an example embodiment, the chamber opening 340 is configured to permit movement of fluid (e.g., a gas mixture, air, a combination of air and vapor, etc.) between the outlet channel 338 (e.g., the reservoir channel 406, the indicator channel 336, the inlet channel 334, the outlet channel 434, the outlet 404, and / or the collection chamber 350) and the vacuum chamber 306 to draw fluid from components of the sample collection device 100 and / or alter (e.g., decrease) a pressure within the sample collection device 100.

[0137] For example, the collection chamber 350 is coupled to the body 300 (e.g., via the mount 400), and the vacuum plunger 150 is positioned within the vacuum chamber 306. The vacuum plunger 150 is coupled with the chamber wall 304 to form a sealed interface between the vacuum plunger 150 and the chamber wall and forms a space or void between the vacuum plunger 150 and the base 302. Upon releasing the vacuum plunger 150 (e.g., viathe actuator 120, the plunger catch 140), the actuator biasing member 180 expands to move the vacuum plunger 150 vertically along the axis 50 within the vacuum chamber 306.

[0138] As the vacuum plunger 150 moves, the space (e.g., volume) between the vacuum plunger 150 and the base 302 increases, causing fluid (e.g., a gas mixture, air, a combination of air and vapor, etc.) to be drawn through the chamber opening 340 and into the space (e.g., into the vacuum chamber 306). Since the chamber opening 340 is in fluid communication with other channels and / or outlets of the sample collection device 100, the chamber opening 340 receives fluid from the collection chamber 350 (e.g., via the outlet channel 338, the reservoir channel 406, the indicator channel 336, the viewing component 190, the inlet channel 334, the outlet channel 434, the outlet 404, etc.). As fluid is drawn from the collection chamber 350, a pressure within the collection chamber 350 changes (e.g., decreases, etc.). In example embodiments, the change in pressure in the collection chamber 350 (e.g., decrease) further draws fluid from other components of the sample collection device 100. For example, the collection chamber 350 draws air from the space between the cavity 112 and the tissue of the subject (e.g., via the inlet 402, the interface inlet 114, the channel inlet 312, etc.) to draw the tissue toward the sample collection device 100 and / or create a sealed interface between the interface 108 and the tissue of the subject.

[0139] Referring now to FIG. 17, the sample collection device 100 includes the mount 400 and the collection chamber 350. The mount 400 is coupled with the body 300 and is configured to receive a sample. The mount 400 is also coupled with the collection chamber 350 and is configured to distribute the sample to the collection chamber 350. The collection chamber 350 is removably coupled with the mount 400 and is configured to receive a controlled or predetermined amount of the sample. As noted above, the mount 400 is configured to receive one or more collection chambers 350 to facilitate collecting a biological sample using one or more types of collection chambers 350 (e.g., a standard chamber, a self-sealing chamber, a dry sample cartridge, etc.).

[0140] The mount 400 includes the inlet 402. The inlet 402 is in communication (e.g., fluid communication) with the channel outlet 332 of the body 300 and is configured to receive the sample from the body 300 (e.g., the collection channel 330). The inlet 402 is also in communication with the collection chamber 350 (e.g., see FIGS. 18A-19) and is configured to provide the sample to the collection chamber 350.

[0141] The mount 400 also includes the outlet 404. The outlet 404 is in communication (e.g., fluid communication) with an outlet port 362 of the collection chamber 350 (e.g., see FIGS. 18A and 18B) and is configured to receive excess sample from the collection chamber 350. The outlet 404 is also in communication (e.g., fluid communication) with the outlet channel 434 and is configured to provide excess sample from the collection chamber 350 to the outlet channel 434. The outlet channel 434 is in fluid communication (e.g., fluid communication) with the indicator channel 336 and is configured to provide the sample to the indicator channel 336.

[0142] The mount 400 further includes the reservoir channel 406 (e.g., see FIG. 17), which is in communication (e.g., fluid communication) with an outlet of the indicator channel 336. The reservoir channel 406 is configured to receive a sample from the indicator channel 336 to house the sample within the reservoir channel 406. The reservoir channel 406 is also in communication with the chamber opening 340 and is configured to permit the flow of fluid from the reservoir channel 406 to and / or through the chamber opening 340. As noted above, in various example embodiments the vacuum plunger 150 is configured to draw (e.g., pull, etc.) fluid through the chamber opening 340 (e.g., from the reservoir channel 406, the indicator channel 336, the outlet channel 434, the outlet 404, the collection chamber 350, the inlet 402, a space between the cavity 112 and the tissue of a subject, etc.), to alter (e.g., decrease) a pressure within the collection chamber 350 and / or create a sealed interface between the sample collection device 100 and the tissue of the subject.

[0143] Referring to FIGS. 18A-19, the collection chamber 350 includes a cap 352, a distributor 354, and a collection container 356. The cap 352 is configured to removably couple the mount 400 and is configured to receive a sample from the mount 400 (e.g., via the inlet 402). The cap 352 includes an inlet port 360, which is in fluid communication with the inlet 402 of the mount 400 and is configured to receive the sample from the inlet 402. The cap 352 further includes an inlet channel 372 extending from the inlet port 360 and an inlet tube 364 positioned within the inlet channel 372. The cap 352 further includes an outlet channel 374 extending from the outlet port 362 and an outlet tube 366 positioned within the outlet channel 374.

[0144] The inlet port 360 is selectively in fluid communication with the distributor 354 and is configured to provide the sample to the distributor 354. The distributor 354 is configuredto facilitate a flow of a sample between the cap 352 (e.g., via the mount 400) and the collection container 356. The collection container 356 is configured to receive the sample from the distributor 354 and is configured to contain a controlled or predetermined amount (e.g., volume) of the sample. In an example embodiment, the collection container 356 is configured to house 1 mL of the sample; however, in other example embodiments the collection container 356 is configured to house another suitable amount of the sample (e.g., 0.2 mL, 0.3 mL, 0.4 mL, 0.5 mL, 0.6 mL, 0.7 mL, 0.8 mL, 0.9 mL, 1.0 mL, 1.1 mL, 1.2 mL, 1.5 mL, etc.).

[0145] The collection container 356 is also configured to provide a portion of the sample to the distributor 354. After a predetermined amount of the sample is collected, the excess sample is received by the distributor 354 such that the excess sample can be released from the outlet port 362. For example, when the collection container 356 is coupled to the mount 400 and the predetermined volume of the sample, the excess sample may flow through the distributor 354, around the outlet tube 366 through the outlet channel 374, out of the outlet port 362, through the outlet 404 of the mount 400 and to a viewing component 190 of the sample collection device 100, as discussed further herein.

[0146] As shown in FIG. 18B, the cap 352 includes the inlet tube 364 positioned within the inlet channel 372 and the outlet tube 366 positioned within the outlet channel 374. The inlet tube 364 and the outlet tube 366 are configured to selectively inhibit a flow of a sample into and / or out of the collection container 356. The inlet tube 364 is positioned within the inlet port 360 of the distributor 354 and is configured to control (e.g., selectively prevent) a flow of fluid (e.g., a sample) between the inlet port 360 and the collection container 356. The outlet tube 366 is positioned within the outlet port 362 and the distributor 354 and is configured to control (e.g., selectively prevent) a flow of fluid (e.g., a sample) between the outlet port 362 and the collection container 356.

[0147] In an example embodiment, the inlet tube 364 and the outlet tube 366 are formed of a flexible, resilient material and are configured to transition between one or more states or configurations (e.g., an open and restricted configuration, a compressed and extended configuration, etc.). For example, in a first configuration (e.g., a distribution, open, compressed, etc. configuration, etc.) the inlet tube 364 and the outlet tube 366 are configured to allow a flow of fluid through the inlet channel 372 and the outlet channel 374,respectively. In the first configuration, the inlet tube 364 and the outlet tube 366 are compressed, such that the ends of the inlet tube 364 and the outlet tube 366 allow flow of the sample around the inlet tube 364 and the outlet tube 366 and through the respective channel. In a second configuration (e.g., a seal, closed, extended, etc. configuration) the inlet tube 364 and the outlet tube 366 are configured to prevent or otherwise inhibit the flow of the sample. In the second configuration, the inlet tube 364 and the outlet tube 366 are in an extended state, such that an end of the inlet tube 364 prevents or otherwise inhibits flow into the inlet channel 372 and the outlet tube 366 prevents or otherwise inhibits flow out of the outlet channel 374.

[0148] As discussed further below with respect to FIG. 20B, when the cap 352 is coupled with the mount 400, an inlet projection 452 and an outlet projection 454 of the mount are at least partially received within the inlet channel 372 and the outlet channel 374, respectively. As the inlet projection 452 and the outlet projection 454 extend into the inlet channel 372 and the outlet channel 374, the inlet tube 364 and the outlet tube 366 transform from an extended state to a compressed state, such that the inlet tube 364 permits a flow of sample into the collection container 356 (e.g., from the inlet 402) and the outlet tube 366 permits a flow of sample out of the collection container 356 (e.g., to the outlet 404).

[0149] After the collection container 356 receives a controlled or predetermined amount of sample (e.g., as indicated by the sample being visible via the viewing component 190, the collection chamber 350 (e.g., the cap 352) can be removed from the mount 400. When the cap 352 is removed from the mount 400, the inlet tube 364 and the outlet tube 366 expand to the extended state (e.g., non-compressed), such that the inlet tube 364 and the outlet tube 366 inhibit flows of the sample out of the collection container 356 (e.g., to the inlet port 360 and / or the outlet port 362). Thus, according to various embodiments, when the collection chamber 350 is decoupled from the mount 400, the inlet tube 364 and the outlet tube 366 seal the sample within the collection container 356.

[0150] Referring now to FIG. 20A a cross-sectional view of an assembled sample collection device is shown. In an example embodiment, the sample collection device of FIG. 20A is the sample collection device 100 of FIGS. 1A and IB. The sample collection device 100 of FIG. 20A includes some or all of the components described above, which have the same orsimilar features. According to various example embodiments, the sample collection device100 of FIG. 20A is an assembled sample collection device in a pre-collection configuration.

[0151] Referring to FIG. 20A, the sample collection device 100 includes the housing 102 (e.g., the upper housing 104 and the lower housing 106) containing the components of the sample collection device 100. At a middle portion of the housing 102, the sample collection device 100 includes the body 300 coupled with the mount 400 (e.g., proximate a bottom portion of the body 300) and the interface 108 (e.g., at a forward portion of the body 300). The body 300 includes the channel 310 extending along the axis 54 (e.g., at the base 302) and the chamber wall 304 extending vertically (e.g., from the base 302 along the axis 50) and defining the vacuum chamber 306. The channel 310 also includes the channel inlet 312, which is in communication with the interface inlet 114 of the interface 108. The channel inlet 312 and / or the interface inlet 114 allow a component of the sample collection device 100 (e.g., the piercer 200) to engage the tissue of a subject and expose the sample collection device 100 to the sample.

[0152] The body 300 is coupled with the vacuum plunger 150. The body 300 (e.g., the vacuum chamber 306) receives the vacuum plunger 150 and forms a space (e.g., void, opening, etc.) between the vacuum plunger 150 and the base 302. The first sealing ring 184 is coupled with an interior surface of the chamber wall 304 and forms a sealed interface between the vacuum plunger 150 and the chamber wall 304. At a middle portion of the vacuum plunger 150, the driver channel 156 receives the actuator biasing member 180 and the pin channel receives the release pin 182. The actuator biasing member 180 is coupled with a surface of the base 302 and is in a compressed or semi-compressed state (e.g., a first spring state). The release pin 182 extends through the pin aperture 324 (e.g., in the channel 310), the aperture 206 of the piercer 200 and is received at the pin opening 410 of the mount 400 (e.g., in a first release pin position). With the release pin 182 coupled with the channel 310, the piercer 200 and the mount 400, the release pin 182 restricts movement of the piercer 200 (e.g., within the channel 310). At a top portion of the vacuum plunger 150, the vacuum plunger 150 is coupled with the plunger catch 140 via the plunger projection 152 (e.g., in a first plunger position), such that vertical movement or translation of the vacuum plunger 150 along the axis 50 is limited or restricted. The plunger catch 140 is also coupledwith the guide ring 130. And the plunger catch 140 and the guide ring 130 are coupled with the actuator 120, via the activation groove 124 and the guide groove 122, respectively.

[0153] The actuator 120 is coupled with the damper plunger 170. The damper plunger 170 is coupled with a top of the actuator 120 and extends vertically along the axis 50 toward an interior of the housing 102 (e.g., the vacuum plunger 150). The damper plunger 170 includes the relief channel 174 extending the length of the damper plunger 170 and the damper 176 is positioned within the relief channel 174. The damper plunger 170 is aligned with the plunger channel 154 of the vacuum plunger 150, such that when the vacuum plunger 150 and / or the damper plunger 170 move vertically (e.g., the damper plunger 170 toward the vacuum plunger 150, the vacuum plunger 150 toward the plunger, etc.) the absorber 172 and / or the sealing ring 178 of the damper plunger 170 is / are configured to engage an interior surface of the plunger channel 154 to form a pressurized space between the damper plunger 170 and a bottom surface of the plunger channel 154.

[0154] Referring still to FIG. 20A, the piercer 200 (e.g., in a first piercer position) is positioned in the channel 310. The projections 212 of the piercer 200 are coupled with (e.g., received by) the piercer guides 322. The piercer 200 is also coupled with the first actuator biasing member 220, which is coupled with rear wall 314 of the channel 310 and the second actuator biasing member 222, which is coupled with the channel 310. The first actuator biasing member 220 is in a compressed or semi-compressed state (e.g., a first spring position) and the second actuator biasing member 222 is in a non-compressed, or expanded state (e.g., a first spring position). The aperture 206 of the piercer 200 (e.g., in the first piercer position) receives the release pin 182, such that movement or translation of the piercer 200 within the channel 310 is limited or restricted.

[0155] The body 300 is coupled with the mount 400 and the interface 108. The collection channel 116 of the interface 108 is in communication with the collection channel 330 of the body 300. In various example embodiments, the collection channel 116 is, or includes, the collection channel 330. The collection channel 330 includes a channel outlet 332, which is in communication with the inlet 402. The inlet 402 is further in communication with the inlet port 360 (e.g., of the cap 352), which is in communication with an interior volume of the collection container 356 (e.g., via the distributor 354, etc.). The collection container 356is also in communication with the outlet port 362 (e.g., of the cap 352, via the distributor 354), which is in communication with the outlet 404.

[0156] The outlet 404 is in communication with the outlet channel 434 of the mount 400 and / or the inlet channel 334 of the body 300. The outlet channel 434 and the inlet channel 334 may form a single (e.g., unified) channel. The outlet channel 434 (e.g., the inlet channel 334) is also in communication with the indicator channel 336, which is provided within the viewing component 190. The indicator channel 336 is in communication with the outlet channel 338 of the body 300 and / or the reservoir channel 406 of the mount 400. The outlet channel 338 and the reservoir channel 406 may form a single (e.g., unified) channel. The outlet channel 338 and / or the reservoir channel 406 are further in communication with the chamber opening 340. The chamber opening 340 extends through the base 302 (e.g., to the vacuum chamber 306) to place an interior portion of the vacuum chamber 306 in communication with the outlet channel 338 and / or the reservoir channel 406 (e.g., via the chamber opening 340).

[0157] Referring now to FIGS. 20A-22, the sample collection device is implemented to collect a sample. The sample collection device 100 is configured to receive an actuation action (e.g., a force from a user or operator). In response, the sample collection device 100 is configured to form an engagement or sealed interface between the tissue of a subject and the sample collection device 100, engage the tissue of the subject to form a sample collection site and collect a controlled or predetermined amount of a sample from the subject. In example embodiments, the sample collection device 100 is configured to receive a single actuation action and implement the aforementioned features in response to the single actuation action.

[0158] FIG. 20 A illustrates the sample collection device 100 in an assembled configuration. The sample collection device 100 of FIG. 20 A is shown in a pre-collection configuration. With the sample collection device 100 in the pre-collection configuration, the sample collection device 100 engages an anatomy of a subject. The interface 108 contacts the tissue of a subject such that the engagement surface 110 forms a flush (e.g., even, level, etc.) interface with the tissue, and the cavity 112 forms a space (e.g., void, opening, etc.) between tissue and an interior surface of the cavity 112. With the interface 108 engaged with the tissue, the actuator 120 receives an actuation action (e.g., a vertically downward force on atop portion of the actuator 120) from a user, operator, or other external source. In an example embodiment, the actuator 120 receive a single actuation action. In other example embodiments, the actuator 120 is configured to receive a plurality of actuation actions.

[0159] In the example embodiment shown in FIG. 20A, the engagement surface 110 is parallel to the axis 50. However, according to alternative embodiments, the engagement surface 110 may be angled with respect to the axis 50. For example, the interface 108 may be angled such that the engagement surface 110 forms a non-zero angle (e.g., a 5 degree angle, a 10 degree angle, a 15 degree angle, etc.). An angled interface 108 may facilitate engaging the anatomy of the subject at a desired location.

[0160] Further, in the example embodiment shown in FIG. 20 A, the collection chamber 350 extends in a direction that is parallel to the axis 50. However, according to alternative embodiments, the collection chamber 350 may extend at a non-zero angle (e.g., a 5 degree angle, a 10 degree angle, a 15 degree angle, etc.) when coupled to the mount 400, which may make it easier for a user of the sample collection device 100 to view the contents of the collection chamber while the interface 108 engages the anatomy of the subject.

[0161] In an example embodiment, in response to the force the actuator 120 translates vertically along the axis 50 (e.g., into the housing 102). The guide groove 122 of the actuator 120 engages the guide projection 132 of the guide ring 130 and guides the actuator 120 within the housing 102. The activation groove 124 of the actuator 120 engages the activation projection 142 of the plunger catch 140 and rotates the plunger catch 140. As the plunger catch 140 rotates, the plunger catch 140 releases (e.g., disengages, etc.) the plunger projection 152 of the vacuum plunger 150 and moves to plunger projection 152 to the plunger channel 144 of the plunger catch 140. With the plunger projection 152 in the plunger channel 144, the plunger catch 140 no longer restricts or inhibits movement of the vacuum plunger 150. The actuator biasing member 180 moves to a non-compressed state (to a second spring position) within the driver channel 156, causing the vacuum plunger 150 to move within the housing 102 along the axis 50 (e.g., toward the upper housing 104, the actuator 120).

[0162] As the vacuum plunger 150 translates, the damper plunger 170 engages the plunger channel 154 of the vacuum plunger 150. The absorber 172 and / or the sealing ring 178engages an inner surface of a wall of the plunger channel 154 and forms a sealed interface between the damper plunger 170 (e.g., absorber 172, sealing ring 178, etc.) and the wall of the plunger channel 154. The damper plunger 170 also engages the plunger channel 154 to form a space or void between the damper plunger 170 and a bottom surface of the plunger channel 154. As the actuator biasing member 180 expands to drive the vacuum plunger 150, the space (e.g., volume) between the damper plunger 170 and the plunger channel 154 decreases and air moves toward and / or through the relief channel 174. The damper 176 is positioned within the relief channel 174 and inhibits or restricts the flow of air through the relief channel 174. In this regard, the relief channel 174 and / or the damper 176 is / are configured to control the release of air from the sealed space between the damper plunger 170 and the plunger channel 154, to control a speed of the translation of the vacuum plunger 150.

[0163] At the same time, as the vacuum plunger 150 translates vertically, the space between the vacuum plunger 150 and the base 302 expands and the open space (e.g., volume) within the vacuum chamber 306 increases. As noted above, the first sealing ring 184 of the vacuum plunger 150 is coupled with an interior surface of the chamber wall 304 and forms a sealed interface between the vacuum plunger 150 and the chamber wall 304. As the vacuum plunger 150 translates, a pressure gradient between the vacuum chamber 306 and other components of the sample collection device 100 draw air into the vacuum chamber 306 (e.g., via the chamber opening 340). For example, air is drawn through the chamber opening 340 from the outlet channel 338 (or reservoir channel 406), the indicator channel 336, the inlet channel 334 (or the outlet channel 434), the outlet 404, and / or the collection chamber 350. As air is drawn from the collection chamber 350, the collection chamber 350 experiences a change in pressure (e.g., a decrease).

[0164] Further, as the vacuum plunger 150 translates, air is drawn from the collection chamber 350 (e.g., as discussed above), which is drawn from the inlet 402 of the mount 400, the collection channel 330 (or the collection channel 116), and / or the space between the cavity 112 and the tissue of the subject. As air is drawn from the space between the cavity 112 and the tissue of the subject, a pressure gradient (e.g., decrease in pressure) draws the tissue against the interface 108 (e.g., the engagement surface 110, the cavity 112, etc.) to form an engagement or sealed interface between the interface 108 at the tissue. Inthis regard, movement of the vacuum plunger 150 is configured to draw air from components of the sample collection device 100 create a seal between the sample collection device 100 and the tissue and / or to decrease a pressure within the collection chamber 350.

[0165] Referring now to FIG. 20B, a cross sectional view of the sample collection device with the collection chamber 350 removed is shown. As shown, the mount 400 includes an inlet projection 452 extending from the inlet 402 and an outlet projection 454 extending from the outlet 404. As is discussed further above (see e.g., FIG. 18B), when a collection chamber 350 is coupled to mount 400, the inlet projection 452 extends into the inlet channel 372 (see FIG. 18B) and the outlet projection 454 extends into the outlet channel 374, thereby causing the inlet tube 364 and the outlet tube 366 to transform from the extended state to the compressed state. As discussed further herein, the inlet tube 364 and the outlet tube 366 inhibit flow through the inlet channel 372 and the outlet channel 374, respectively, while in the extended state. Thus, coupling the collection chamber 350 to the mount 400 may cause each of the inlet tube 364 and the outlet tube 366 to transform from the extended state to the compressed state such that the sample can flow through the inlet channel 372 and / or the outlet channel 374 (e.g., around the inlet tube 372 and the outlet channel 374, respectively).

[0166] Referring now to FIGS. 20A and 20B, as the vacuum plunger 150 translates vertically within the housing 102, the release pin 182 is configured to translate along with the vacuum plunger 150. The release pin 182 translates vertically along an axis aligned with the axis 50 (e.g., sliding along the pin aperture 324 of the channel 310). When the vacuum plunger 150 reaches a second plunger position (e.g., see FIGS. 20A and 20B), the release pin 182 disengages the pin opening 410 of the mount 400 and the aperture 206 of the piercer 200 (e.g., in a second release pin position). With the release pin 182 no longer restricting or inhibiting movement of the piercer 200, the first actuator biasing member 220 expands (e.g., transitions to a non-compressed state, a second spring state), to drive the piercer 200 within and / or from the channel 310. In an example embodiment, as the spring drives the piercer 200 from the channel 310, the engagement interface 208 engages the tissue of the subject to form a flush interface with the tissue. The blade 210 also engages (e.g., puncture) the tissue of the subject to create a wound in the tissue. With a woundformed in the tissue of the subject, a sample flows from the subject and exposes the sample collection device 100 to the sample.

[0167] As a sample flows from the subject, the interface inlet 114 and / or the collection channel 116 is / are configured to receive the sample. The interface inlet 114 directs the sample to the collection channel 116. In some example embodiments, the interface inlet 114 directs the sample to the collection channel 330, which communicates the sample to the channel outlet 332. The sample is then communicated to the inlet 402, received by the inlet port 360 and communicated around the inlet tube 364 and through the inlet channel 372. The inlet channel 372 communicates the sample to the distributor 354, which directs the sample to the collection chamber 350 (e.g., for filling). In an example embodiment, the collection chamber 350 receives a controlled or predetermined amount of sample (e.g. 0.2 mL, 0.3 mL, 0.4 mL, 0.5 mL, 0.6 mL, 0.7 mL, 0.8 mL, 0.9 mL, 1.0 mL, 1.1 mL, 1.2 mL, 1.5 mL, etc.).

[0168] Referring now to FIG. 22, as the collection chamber 350 collects the sample, the piercer 200 retracts within the channel 310. The second actuator biasing member 222 provides a counter-force against the driving force of the first actuator biasing member 220 to retract the piercer 200 back within the channel 310 (e.g., to a third position). In some example embodiments, a flow of the sample to the collection chamber 350 also causes the piercer 200 to retract within the channel 310. For example, an introduction of fluid into the sample collection device 100 (e.g., the sample, air from an inlet opening into the channel 310, a gap between the pin aperture 324 and the release pin 182, etc.) cause a gradual increase in pressure within the sample collection device 100, causing the piercer 200 to retract within the channel 310.

[0169] After the collection chamber 350 receives the sample, a portion of the sample flows through the outlet 404 (e.g., via the distributor 354, the outlet port 362, etc.), to the outlet channel 434 (or the inlet channel 334) and to the indicator channel 336. As the sample flows to the indicator channel 336, the indicator channel 336 (e.g., formed in the viewing component 190) fills with the sample. The viewing component 190 provides an indication to a user or operator of a status (e.g., fill status, fill level, etc.) of the collection chamber 350. For example, when the viewing component 190 (e.g., the indicator channel 336) isfilled, or to a predetermined threshold (e.g., 50, 60, 75, 80, 90, etc. percent full), it indicates that the collection chamber 350 is filled to a controlled amount.

[0170] When the collection chamber 350 (e.g., the collection container 356) is filled to the controlled or predetermined amount, the collection chamber 350 is removed (e.g., decoupled) from the mount 400 for subsequent testing and analysis. When the collection chamber 350 (e.g., the cap 352) is removed from the mount 400, the inlet tube 364 and the outlet tube 366 are configured to control (e.g. stop, restrict, etc.) a flow of the sample out of the collection container 356. The inlet tube 364 and the outlet tube 366 transition to a second configuration (e.g., non-compressed) and inhibit a flow of the sample through the inlet tube 364 and the outlet tube 366. In this regard, when the collection chamber 350 is filled to the controlled or predetermined amount and removed from the mount 400, the inlet tube 364 and the outlet tube 366 restrict a flow of sample from the collection container 356 to maintain or sustain the controlled or predetermined amount of sample in the collection chamber 350.

[0171] Referring now to FIG. 23, a cross-sectional view of a sample collection device 600 is shown, according to another example embodiment. The sample collection device 600 is configured to engage an anatomy of a subject and collect a biological sample from the subject. The sample collection device 600 may share one or more characteristics with any of the other sample collection devices described herein (e.g., the sample collection device 100).

[0172] As shown, the sample collection device 600 includes a damper plunger 170. The damper plunger 170 is configured to delay the release of the piercer 200 until after a sufficient pressure differential is achieved proximate the wound site, as described above. However, unlike the sample collection device 100 described above, the sample collection device 600 does not include an absorber (e.g., the absorber 172 shown in FIG. 20A).

[0173] The sample collection device 600 further includes a release aperture 650 formed in the mount 400. The release aperture 650 is configured to allow air to pass from outside the vacuum chamber 306 into the vacuum chamber 306 after actuation of the sample collection device 600. For example, as described further herein, the sample collection device 600 may engage an anatomy of a subject and the sample collection device 600 may be actuated togenerate a pressure differential within the vacuum chamber 306 and release the piercer 200 to create a wound in the subject. After the release pin 182 is released, ambient air may be introduced into the vacuum chamber 306 via the release aperture 650. As air is introduced into the vacuum chamber 306, the pressure differential within the vacuum chamber 306 may be gradually reduced.

[0174] Further, the sample collection device 600 includes a release damper 652 proximate an inlet of the release aperture 650. The release damper 652 is configured to reduce the flow rate of air through the release aperture 650 to controllably reduce the pressure differential within the vacuum chamber 306. The release damper 652 may include an air penetrable membrane, a foam material, a mesh material, or any other material configured to reduce the flow rate of air through the release aperture 650.

[0175] According to various embodiments, gradually reducing the pressure differential encourages the sample to flow through the sample flow path (e.g., into a collection chamber 800). Further, gradually reducing the pressure differential may facilitate disengaging the sample collection device 600 from the subject after the sample has been collected. For example, reducing the pressure differential may reduce the force required to disengage the sample collection device 600 from the subject.

[0176] Further, the sample collection device 600 is configured to receive the collection chamber 800 at an angled orientation. For example, the interface 108 defines an interface axis 611 and the collection chamber 800 extends from the sample collection device 600 at a non-zero angle with respect to the interface axis 601. An inlet tube 604 extends along an inlet axis 603 and into the collection chamber 800 such that the inlet axis 603 and the interface axis 611 define a non-zero angle (e.g., 5 degrees, 10 degrees, 15 degrees, etc.).

[0177] Further, an outlet tube 602 extends along an outlet axis 601 and into the collection chamber 800 such that the outlet axis 601 and the interface axis 611 define a non-zero angle (e.g., 5 degrees, 10 degrees, 15 degrees, etc.).

[0178] According to various embodiments, as the collection tube 800 is coupled to the sample collection device 600, a sealing member 802 translates from a closed orientation to an open orientation such that openings in the sealing member 802 align with openings in the cap member 804. For example, a projection of the sample collection device 600 may engagethe sealing member 802 as the collection tube 800 is coupled to the sample collection device 600, thereby causing the sealing member 802 to translate to the open orientation. The openings in the sealing member 802 and the openings in the cap member 804 receive the inlet tube 604 and the outlet tube 602 such that the collection chamber 800 can receive the sample from the sample collection device 600.

[0179] According to various embodiments, the sealing member 802 is biased towards the closed orientation. For example, a spring member may bias the sealing member 802 towards the closed orientation. Thus, when the collection chamber 800 is disengaged from the sample collection device 600, the sealing member 802 translates back to the closed orientation to seal the collected sample within the collection chamber 800.

[0180] According to various embodiments, the volume of sample the collection chamber 800 is configured to collect depends upon the depth the outlet tube 602 extends into the collection chamber 800. For example, as the collection chamber 800 fills with a sample, the outlet tube 602 allows excess sample to be released from the collection chamber 800 (e.g., into an indication channel at least partially defined by a viewing component to provide an indication that the collection chamber 800 is full).

[0181] Referring now to FIG. 24, the sample collection device 600 is shown coupled to an alternate collection chamber 900. As shown, the collection chamber 900 engages the sample collection device 600 in an angled orientation in a similar manner as the collection chamber 800 shown in FIG. 23.

[0182] The inlet tube 604 and the outlet tube 602 extend into the collection chamber 900 to allow sample to flow into and out of the collection chamber 900 while the sample collection device 600 is coupled to the collection chamber 900. The inlet tube 604 and the outlet tube 602 are received within openings in a cap member 902 of the collection chamber 900 when the collection chamber 900 is coupled to the sample collection device 600.

[0183] Referring now to FIGS. 25 and 26, a cross-sectional view of another sample collection device 1000 is shown, according to an example embodiment. The sample collection device 1000 is configured to engage an anatomy of a subject and collect a biological sample from the subject. The sample collection device 1000 may share one ormore characteristics with any of the other sample collection devices described herein (e.g., the sample collection device 100, the sample collection device 600, etc.).

[0184] The sample collection device 1000 is shown to include an absorber 172. The absorber 172 is configured to delay the release of the piercer 200 until after a sufficient pressure differential is achieved proximate the wound site, as described above. However, unlike the sample collection device 100 described above, the sample collection device 600 does not include a damper plunger (e.g., the damper plunger 170 shown in FIG. 20A).

[0185] As shown in FIG. 25, the sample collection device 1000 is configured to couple with collection chamber 800 in an angled orientation in a similar manner as described above with respect to FIG. 23. Further, as shown in FIG. 26, the sample collection device 1000 is configured to couple with the collection chamber 900 in a similar manner as described above with respect to FIG. 24.

[0186] Referring now to FIGS. 27-31, a cap 1100 is shown, according to an example embodiment. The cap 1100 is usable in conjunction with a collection chamber, such as any of the collection chambers discussed herein, to collect a biological sample from a subject. The cap 1100 is configured to transform between an open orientation (see, e.g., FIG. 31) and a closed orientation (see, e.g., FIG. 30). For example, a sealing member 1150 may be biased towards a closed orientation such that the cap 1100 is in the closed orientation unless a force acts upon the sealing member 1150. For example, a projection of a sample collection device may engage the sealing member 1150 when the cap 1100 is coupled to the sample collection device, thereby causing the cap 1100 to transform to the open orientation, thereby allowing the sample to flow into and out of the collection chamber coupled to the cap 1100.

[0187] The cap 1100 includes a coupling member 1110, a first body member 1120, a second body member 1130 and a base 1140. The coupling member 1110 is configured to be received by a sample collection device to couple the cap 1100 to the sample collection device. As shown in FIG. 27, the first body member 1120 and the second body member 1130 define a first aperture 1102 and a second aperture 1104. The sealing member 1150 is exposed via the first aperture 1102 and the second aperture 1104 such that a projection of the sample collection device engages the sealing member 1150 via the first aperture 1102 and the second aperture 1104.

[0188] Referring now to FIGS. 28-29, exploded views of the cap 1100 are shown. The coupling member 1110 includes an inlet tube 1112 and an outlet tube 1114 configured to receive an inlet tube and an outlet tube of a sample collection device to allow a biological sample to flow into and out of a collection chamber coupled to the cap 1100. The sealing member 1150 includes projections 1152 configured to engage the inlet tube 1112 and the outlet tube 1114 when the sealing member is in the closed orientation. The projections 1152 may prevent or otherwise inhibit flow of the sample through the inlet tube 1112 and / or the outlet tube 1114 when the sealing member 1150 is in the closed orientation, thereby sealing off the inner volume of the collection chamber from the outside environment.

[0189] The cap 1100 further includes a pair of O-rings 1154 coupled to the sealing member 1150. The O-rings 1154 may facilitate translation of the sealing member 1150 between the closed orientation and the open orientation and / or prevent leakage of the sample around the sealing member 1150.

[0190] Referring now to FIG. 32, a cross sectional view of the sample collection device 700 is shown. The sample collection device 700 includes a guide ring 730 positioned within the housing 702. The guide ring 730 may share one or more characteristics with the guide ring 130 described herein. The guide ring 730 is configured to engage a plunger catch 740. The plunger catch 740 may share one or more characteristics with the plunger catch 740 described herein. As discussed further below with respect to FIGS. 33-36, the actuator 720 engages with the guide ring 730 and the plunger catch 740 to lock or unlock the actuator 720 and prevent the actuator 720 from being actuated a second time.

[0191] The sample collection device 700 further includes a mount 1400. The mount may share one or more characteristics with the mount 400 described herein. The mount 1400 includes a release aperture 1450 configured to allow ambient air into the sample flow path (e.g., after the vacuum plunger 150 is released and a pressure differential is created within the sample flow path). By allowing ambient air into the sample flow path, the pressure differential may gradually be reduced, thereby facilitating flow of the sample through the sample flow path.

[0192] The sample collection device 700 further includes a release damper 1452 proximate an inlet of the release aperture 1450. As discussed further with respect to FIGS. 37-41, therelease damper 1452 is configured reduce the flow rate of air through the release aperture 1450 to controllably reduce the pressure differential within the vacuum chamber 306. For example, the damper 1452 is configured to allow air into the system in a controlled manner in order to generate a pressure differential, directing airflow and sample through the flow path.

[0193] The sample collection device 700 further includes a collection tube interface, shown as interface 1306. The interface 1306 is configured to couple the sample collection device 700 to a collection tube 950. The interface 1306 includes an inlet 1304 configured to allow the sample to flow within the collection tube 950 and an outlet 1302 configured to allow the sample to flow out of the collection tube 950 (e.g., to the indication channel). According to various embodiments, the interface 1306 is coupled to the mount 1400 via a weld (e.g., an ultrasonic weld). By welding the interface 1306 to the mount 1400, an additional sealing member, such as a gasket, may not be needed to prevent sample from leaking out of the desired flow path as the sample is collected.

[0194] Referring now to FIGS. 33-36, an actuator assembly of the sample collection device 700 is shown. As best shown in FIG. 33, the actuator assembly includes the actuator 720, the guide ring 730, the plunger catch 740, the damper plunger 170, and the vacuum plunger 150. The actuator 720 is configured to engage the guide ring 730 and the plunger catch 740 to lock or unlock the actuator 720 and prevent the actuator 720 from being actuated a second time. It should be appreciated that the actuator assembly shown in FIGS. 33-36 may also be configured to be used with the sample collection device 100.

[0195] The actuator 720 includes a window 1710. As is discussed further herein, the window 1710 is configured to receive a projection (e.g., a projection 1744 of the plunger catch 740) to prevent the actuator 720 from being actuated a second time, such that the sample collection device 700 is intended from single use.

[0196] The actuator 720 further includes a shoulder 1714. The shoulder 1714 is configured to engage a projection (e.g., a projection 1732 of the guide ring 730) to selectively prevent the actuator 720 from being actuated (e.g., when the actuator 720 is in the locked position).

[0197] The actuator 720 further includes a channel 1712. The channel 1712 is configured to receive a projection (e.g., the projection 1732 of the guide ring 730) as the actuator isdepressed, thereby allowing the actuator 720 to be actuated (e.g., when the actuator 720 is in the unlocked position).

[0198] The guide ring 730 includes the plurality of projections 1732 extending radially from the guide ring 730. The guide ring 730 further includes a plurality of protrusions 1734 extending in a downward direction (e.g., in a direction perpendicular to the projection 1732). Each protrusion 1734 is configured to be received within a pair of protrusions 1742 of the plunger catch 740 to restrict relative movement between the plunger catch 740 and the guide ring 730.

[0199] The plunger catch 740 includes a plurality of projections 1744 extending radially from the plunger catch 740. As discussed further herein, the projections 1744 are configured to be received within the windows 1710 in the actuator 720 during actuation of the sample collection device 700.

[0200] Referring now to FIG. 34, the actuator 720 is shown in the locked position. In the locked position, a plurality of projections 1732 of the guide ring 730 each individually engage the shoulders 1714 of the actuator 720, thereby preventing the actuator 720 from being depressed.

[0201] As shown, a surface 1717 extending from the shoulder 1714 to the channel 1712 is angled such that a sidewall 1719 of the channel 1712 and the surface 1717 define an angle 1713. As shown, the angle 1713 is an acute angle. When the actuator 720 is rotated to the unlocked position (e.g., shown in FIG. 35), an end of the sidewall 1719 extends below a top surface of the projection 1732 such projection 1732 engages the sidewall 1719 to prevent the actuator 720 from being rotated back to the locked position.

[0202] Referring now to FIG. 35, the actuator 720 is shown in the unlocked position. For example, a user of the sample collection device 700 may rotate the actuator 720 from the locked position to the unlocked position. In the unlocked position, the projection 1732 aligns with the channel 1712 of the actuator 720, thereby allowing the actuator 720 to be depressed by the user. As the user depresses the actuator 720, the projection 1732 translates within the channel 1712.

[0203] As the actuator 720 is depressed, the projection 1744 of the plunger catch 740 translates towards the window 1710 in actuator 720. For example, the projection 1744 includes an angled surface 1747 configured to allows the projection to engage an inner surface of the actuator 720 and translate towards the window 1710 until the vacuum plunger 150 is released. As the vacuum plunger 150 is released, the piercer 1200 is released, thereby creating a wound in the subject, as described further herein.

[0204] Referring now to FIG. 36, the actuator 720 is shown in the fully depressed state (e.g., a post actuation state). When the actuator 720 is in the fully depressed state, the projection 1732 engages an end of the channel 1712. Further, the projection 1744 is received within the window 1710. The projection 1744 includes a shoulder 1748 configured to engage a portion of the window 1710 to prevent the actuator 720 from translating upwards, thereby preventing the actuator 720 from being actuated a second time.

[0205] Referring now to FIGS. 37 and 38, a perspective view and an exploded view of the release damper 1452 are shown, according to an example embodiment. The release damper 1452 is shown to include a first layer 1454, a second layer 1456, and a third layer 1458 positioned between the first later and the second layer. The first layer 1454 and the second layer 1456 may be formed of a solid (e.g., non-porous) material. For example, first layer 1454 and the second layer 1456 may be formed of an adhesive material (e.g., tape, 3M PSA®, etc.). The third layer 1458 may be formed of a porous material (e.g., a membrane, a PTFE membrane, a POREX Virtek® PTFE membrane, etc.).

[0206] As best shown in FIG. 38, the second layer 1456 includes an aperture 1460. When the sample collection device 700 is assembled, the aperture 1460 may align with a release aperture (e.g., the release aperture 650, the release aperture 1450, etc.) such that ambient air is introduced into the sample flow path via the aperture 1460. The ambient air then passes through the third layer 1458, which may resist the flow of the ambient air such that the third layer 1458 acts as a damper. The porosity of the third layer 1458 may be selected based on a desired flow rate of ambient air through the release aperture.

[0207] Referring now to FIGS. 39 and 40, a perspective view and an exploded view of the release damper assembly 1462 are shown, according to an example embodiment. The release damper assembly 1462 may be formed by coupling a plurality of first layers 1454 toa plurality of second layer 11456 with a plurality of third layers 1458 positioned therebetween.

[0208] The first layer 1454 includes a plurality of perforations 1474 and the second layer 1456 include a plurality of perforations 1476. With reference to FIG. 41, the individual release dampers 1452 may be separated from the remainder of the release damper assembly 1462 by making cuts along a first axis 1451 and a second axis 1453 (e.g., along the perforations 1474, 1476).

[0209] Referring now to FIG. 42, a flow diagram of a process 500 of implementing a sample collection is shown. Any or all steps of the process 500 are implemented using some or all of the features of the sample collection devices described herein.

[0210] At 502, an interface of a sample collection device is positioned so as to engage an anatomy of a subject. For example, the sample collection device 100 in a first configuration (e.g., a pre-collection configuration, etc.) may be coupled to (e.g., engages, couples, etc.) a skin of a subject. The interface 108 engage the tissue such that the engagement surface 110 forms a flush (e.g., even, level, etc.) interface with the tissue, and the cavity 112 forms a space between the tissue and the interior surface of the cavity 112.

[0211] At 504, an actuation action is received. With the interface 108 engaged with the tissue, the actuator 120 receives an actuation action a downward force on a top portion of the actuator 120 (e.g., from a user or operator). The actuator 120 receives a single actuation action (e.g., force) the causes the actuator 120 to depress or translate downward within the housing 102. As described further herein, a single actuation action being received by a sample collection device (e.g., the sample collection device 100) causes both a vacuum to be formed (e.g., within the vacuum chamber 306) and a wound to be created (e.g., by causing the blade 210 to puncture the skin of the subject). Further, the sample collection device may be configured to stop collecting the sample after a predetermined volume has been collected. Thus, a user’s experience may be simplified as a result of the single actuation action creating a vacuum, creating a wound, and stopping over-collection of the sample.

[0212] At 506, the anatomy of the subject is drawn towards the sample collection device. In response to the actuator 120 receiving an actuation force, the vacuum plunger 150 isreleased and driven within the vacuum chamber 306 (e.g., by the actuator biasing member 180), thereby creating a pressure differential within the vacuum chamber 306. Since a seal is formed between the sample collection device 100 and the anatomy proximate the interface 108, and the cavity 112 is in fluid communication with the vacuum chamber 306, the space between the cavity 112 and the anatomy experiences a decrease in pressure too.

[0213] In various embodiments, air is drawn from the space between the anatomy and the cavity 112, thereby pulling the tissue towards the interface inlet 114. By pulling the skin taught proximate the wound site, the pain experienced by the user may be decreased (e.g., compared to loose skin).

[0214] As the vacuum plunger 150 is driven within the vacuum chamber 306, the damper plunger 170 engages the vacuum plunger 150 to restrict movement of vacuum plunger 150. The damper plunger 170 controls (e.g., restrict, limit, slow, etc.) translation of the vacuum plunger 150 to ensure formation of the sealed engagement or coupling between the interface 108 and the tissue before the wound is created. In this sense, the damper plunger 170 may delay the release of the piercer 200 until after a sufficient pressure differential is achieved proximate the wound site.

[0215] At 508, a wound is created in the anatomy of the subject to release a sample. As discussed above, the vacuum plunger 150 is driven within the vacuum chamber 306, the release pin 182 translates along with the vacuum plunger 150. When the vacuum plunger 150 (e.g., the release pin 182) reaches a predetermined position (e.g., a second plunger position, a second pin position, etc.), the release pin 182 disengages the aperture 206 of the piercer 200. With the piercer 200 unrestrained, the first actuator biasing member 220 drives the piercer 200 along the channel 310 and into the tissue of the subject. The first actuator biasing member 220 can drive a portion of the piercer 200 out of the channel 310 and into the tissue of the subject. The engagement interface 208 of the piercer 200 engages the tissue to form a flush interface with the tissue and the blade 210 punctures the tissue to form a wound in the tissue. With a wound formed in the tissue, a sample flows from the subject and exposes the sample collection device 100 to the sample.

[0216] At 510, a controlled amount of the sample is collected. As the sample flows from the subject, the interface 108 (e.g., the interface inlet 114, the collection channel 116) receivesthe sample. The sample is communicated through the collection channel 116 and to the inlet 402. The sample passes through the inlet 402 and to the collection chamber 350 (e.g., the collection container 356). The collection container 356 is configured to fill with the sample, until the collection container 356 has received a controlled amount of the sample. Once the collection container 356 receives the controlled amount of the sample, a portion of the sample (e.g., excess, overflow, etc.) flows through the outlet 404, to the indicator channel 336 such that the sample in the indictor channel 336 is visible via the viewing component 190. The viewing component 190 provides an indication of a status (e.g., fill level, etc.) of the collection chamber 350. For example, the viewing component 190 may fill with the sample, indicating that the collection container 356 has received the controlled amount of the sample. The collection chamber 350 is then removed (e.g., de-coupled) from the mount 400 for subsequent testing an analysis. In an example embodiment, when the collection chamber 350 is removed from the mount 400, the cap 352 (e.g., the inlet tube 364 and the outlet tube 366) is configured to restrict flow of the sample from the collection container 356, thereby maintaining or sustaining the controlled amount of the sample in the collection chamber 350.

[0217] At 512, the filled collection chamber 350 is decoupled from the sample collection device 100. As discussed above, when the collection chamber 350 is decoupled from the sample collection device 100, the inlet tube 364 and the outlet tube 366 expand from a collapsed state to an expanded state to prevent or otherwise inhibit the flow of the sample out of the inlet port 360 or the outlet port 362 of the collection chamber 350.

[0218] In example embodiments, the sample collection device 100 or any of its components described herein may be packaged individually or as a kit. In an example embodiment, the kit includes one sample collection device 100. In another example embodiment, the kit includes one sample collection device 100 and one collection chamber 350. In other example embodiments, the kit includes any number of collection devices 100 (e.g., 5, 10, 50, 100, etc.) and / or any number of collection chambers 350 (e.g., 5, 10, 50, 100, etc.). The components of the kit can be pre-packaged and / or arranged for use (e.g., the sample collection device 100 in the pre-collection configuration, the collection chamber 350 coupled with the mount 400, etc.). The components of the kit may be pre-packaged and arranged for use (e.g., the collection chamber 350 is to be selected and / or coupled to thesample collection device 100). In some example embodiments, the kit includes a number of the sample collection devices 100 (e.g., 5, 10, 50, 100, etc.), and / or a variety of any number of collection chambers 350 (e.g., standard collection chamber, self-sealing collection chamber, a dry sample collection chamber, etc.).

[0219] In example embodiments, the sample collection device 100 is designed for single use and is disposable. Such configurations are expected to promote sanitary use of the system, as the components are exposed to the sample are disposable. In other example embodiments, the sample collection device 100 is designed for multi-use. The sample collection device 100 may be configured to receive one or more collection chambers 350 throughout the life of the sample collection device 100, such that a plurality of samples are collected using the sample collection device 100. In this regard, the sample collection device 100 may be formed of material that are configured to be easily cleaned or sanitized (e.g., autoclavable, etc.).

[0220] Unless otherwise defined, each technical or scientific term used herein has the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. In accordance with the claims that follow and the disclosure provided herein, the following terms are defined with the following meanings, unless explicitly stated otherwise.

[0221] As used in the specification and claims, the singular form “a”, “an” and “the” include both singular and plural references unless the context clearly dictates otherwise. For example, the term “a molecule” may include, and is contemplated to include, a plurality of molecules. At times, the claims and disclosure may include terms such as “a plurality,” “one or more,” or “at least one;” however, the absence of such terms is not intended to mean, and should not be interpreted to mean, that a plurality is not conceived.

[0222] It should be noted that the term “example” and variations thereof, as used herein to describe various embodiments, are intended to indicate that such embodiments are possible examples, representations, or illustrations of possible embodiments (and such terms are not intended to connote that such embodiments are necessarily extraordinary or superlative examples).

[0223] The term “coupled” and variations thereof, as used herein, means the joining of two members directly or indirectly to one another. Such joining may be stationary (e.g.,permanent or fixed) or moveable (e.g., removable or releasable). Such joining may be achieved with the two members coupled directly to each other, with the two members coupled to each other using a separate intervening member and any additional intermediate members coupled with one another, or with the two members coupled to each other using an intervening member that is integrally formed as a single unitary body with one of the two members. If “coupled” or variations thereof are modified by an additional term (e.g., directly coupled), the generic definition of “coupled” provided above is modified by the plain language meaning of the additional term (e.g., “directly coupled” means the joining of two members without any separate intervening member), resulting in a narrower definition than the generic definition of “coupled” provided above. Such coupling may be mechanical, electrical, or fluidic.

[0224] References herein to the positions of elements (e.g., “top,” “bottom,” “above,” “below”) are merely used to describe the orientation of various elements in the FIGURES. It should be noted that the orientation of various elements may differ according to other example embodiments, and that such variations are intended to be encompassed by the present disclosure.

[0225] Although the figures and description may illustrate a specific order of method steps, the order of such steps may differ from what is depicted and described, unless specified differently above. Also, two or more steps may be performed concurrently or with partial concurrence, unless specified differently above.

[0226] As used herein, the term “comprising” or “comprises” is intended to mean that the devices, systems, and methods include the recited elements, and may additionally include any other elements.

[0227] Although the foregoing has included detailed descriptions of some embodiments by way of illustration and example, it will be readily apparent to those of ordinary skill in the art in light of the teachings of these embodiments that numerous changes and modifications may be made without departing from the spirit or scope of the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A collection device for collecting a biological sample, comprising: a housing having: an interface configured to contact an anatomy of a subject; and a cavity extending from the interface such that the interface surrounds the cavity; a channel extending into the housing; a body defining a vacuum chamber, the vacuum chamber in fluid communication with the channel; an actuator coupled to the housing, the actuator translatable from a first actuator position to a second actuator position in response to a force being applied to the actuator; a vacuum plunger translatable within the vacuum chamber between a first vacuum plunger position and a second vacuum plunger position; a piercer coupled to the body and translatable along an axis between a first piercer position and a second piercer position, the piercer engageable with the anatomy of the subject in the second piercer position to create a wound in the anatomy of the subject; and a collection chamber coupled to the housing, the collection chamber including an inlet in fluid communication with the channel, wherein, in response to the interface being coupled to the anatomy and the force being applied to the actuator: the vacuum plunger translates from the first vacuum plunger position to the second vacuum plunger position, thereby causing a pressure within the vacuum chamber to decrease; and the piercer translates from the first piercer position to the second piercer position to create the wound in the subject.

2. The collection device of claim 1, further comprising a mount coupled with the body and in fluid communication with the channel, the mount removably coupleable with the collection chamber.

3. The collection device of claim 2, wherein the first collection chamber is a selfsealing collection chamber.

4. The collection device of claim 1, wherein, in response to the interface being coupled to the anatomy and the force being applied to the actuator, the pressure within the cavity decreases.

5. The collection device of claim 1, further comprising a damper plunger coupled to the housing, the vacuum plunger defining a damper plunger channel fluidly isolated from the vacuum chamber and sized to receive the damper plunger, wherein, in response to the interface being coupled to the anatomy and the force being applied to the actuator, the damper plunger translates into the damper plunger channel, causing a damper plunger channel pressure to increase within the damper plunger channel.

6. The collection device of claim 5, wherein the damper plunger includes a relief channel extending through the damper plunger such that fluid within the damper plunger channel is released via the relief channel as pressure within the damper plunger channel increases.

7. The collection device of claim 1, further comprising an indicator channel in fluid communication with an outlet of the collection chamber such that the biological sample is received within the indicator channel in response to a controlled volume of the sample being received within the collection chamber, wherein the indicator channel is viewable from outside the housing such that the biological sample is viewable when at least a portion thereof is in the indicator channel.

8. The collection device of claim 7, wherein the channel is in fluid communication with the vacuum chamber via the indicator channel.

9. The collection device of claim 1, wherein the interface includes a gel configured to connect the interface with the anatomy of the subject.

10. The collection device of claim 1, wherein the channel includes a layer of an anticoagulating material.

11. The collection device of claim 10, wherein the anti-coagulating material is a hydrophilic material configured to increase a speed of a flow of the biological sample through the channel.

12. The collection device of claim 1, further comprising: a first biasing member configured to bias the piercer towards the second position; and a release pin coupled to the vacuum plunger and sized to be received within a piercer aperture in the piercer while the vacuum plunger is in the first vacuum plunger position to inhibit the piercer from translating, wherein in response to the vacuum plunger translating from the first vacuum plunger position to the second vacuum plunger position, the release pin translates out of the piercer aperture such that a first biasing member causes the piercer to translate from the first piercer position to the second piercer position.

13. The collection device of claim 12, further comprising a second biasing member configured to bias the piercer towards the first position, wherein, in response to the piercer translating from the first piercer position to the second piercer position, the first biasing member and the second biasing member cause the piercer to translate to a third piercer position between the first piercer position and the second piercer position.

14. The collection device of claim 1, wherein the collection chamber is a first collection chamber of a plurality of different types of collection chambers, each of the plurality of different types of collection chambers being individually removably coupleable to the housing.

15. A collection container for collecting a biological sample, comprising: a collection chamber defining an inner volume configured to receive the biological sample; a cap coupled to the collection chamber and selectively coupleable with a housing of a device, the cap including: an inlet port in fluid communication with an outlet of the device, an inlet chamber extending from the inlet port to the inner volume of the collection chamber; andan inlet tube positioned within the inlet chamber, the inlet tube transformable from a compressed state to an extended state, wherein the inlet port is in fluid communication with the inner volume of the collection chamber while the inlet tube is in the compressed state and the inlet tube inhibits flow of the sample from the inlet port to the inner volume of the collection chamber while the inlet tube is in the extended state.

16. The collection container of claim 15, wherein the cap further includes: an outlet port in fluid communication with an inlet of the device, an outlet chamber extending from the inner volume of the collection chamber to the outlet port; and an outlet tube positioned within the outlet chamber, the outlet tube transformable from a compressed state to an extended state, wherein the outlet port is in fluid communication with inner volume of the collection chamber while the outlet tube is in the compressed state and the outlet tube inhibits flow of the sample from the inner volume of the collection chamber to the outlet port while the inlet tube is in the extended state.

17. The collection container of claim 15, wherein in the inlet tube extends to the extended position while the cap is decoupled from the device.

18. The collection container of claim 15, wherein the inlet channel receives a projection of the device while the cap is coupled to the device such that the inlet tube is compressed from the extended state to the compressed state in response to the projection being received within the inlet channel.

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