Patent Publication Number: US-2023142316-A1

Title: Dermal Patch with a Diagnostic Test Strip

Description:
RELATED APPLICATIONS 
     The present application is a continuation-in-part of U.S. patent application Ser. No. 17/903,802 (entitled Dual Lever Dermal Patch System and filed on Sep. 6, 2022), Ser. No. 17/500,873 (entitled Mono Dose Dermal Patch for Pharmaceutical Delivery and filed on Oct. 13, 2021), Ser. No. 17/994,454 (entitled Dermal Patch for Collecting a Physiological Sample and filed on Nov. 28, 2022), Ser. No. 17/971,142 (entitled Dermal Patch for Collecting a Physiological Sample and filed on Oct. 21, 2022), and Ser. No. 17/991,284 (entitled Dermal Patch for Collecting a Physiological Sample with Removable Vial and filed on Nov. 21, 2022). Each of these applications is herein incorporated by reference in its entirety. 
    
    
     TECHNICAL FIELD 
     The present teachings are generally directed to dermal patches that can be employed to detect a biomarker in a drawn physiological sample. 
     BACKGROUND 
     Biomarkers are increasingly employed for diagnosis of various disease conditions as well as for assessing treatment protocols. In many cases, it is important to monitor the level of the biomarker over time (e.g., to assess the progression of a disease). The temporal monitoring of biomarkers via conventional techniques includes drawing a physiological fluid sample from a subject. These techniques may be cumbersome and painful to the subject. For example, the invasive nature of drawing a blood sample form a subject can cause discomfort and may lead to less cooperation from a subject, especially children, rendering multiple measurements of a target analyte (e.g., a biomarker) difficult. 
     Conventional devices allow for continuous monitoring of a target analyte (e.g., glucose monitors) typically suffer from several shortcomings, such as low sensitivity and/or specificity. Therefore, there is still a need for dermal patches for the detection a target analyte. 
     SUMMARY 
     Aspects of the present disclosure address the above-referenced problems and/or others. 
     In one aspect, a system for analyzing a physiological sample includes a cartridge configured to attach to the skin of a subject. The cartridge includes a processing fluid pack that is configured to release a processing fluid stored therein, a diagnostic test strip, and a vacuum pin. The system further includes a lancet with a needle, wherein the lancet is configured to deploy the needle upon engagement with the cartridge to draw a physiological sample from the subject. The vacuum pin is configured to create a vacuum within the cartridge to draw the released processing fluid and the drawn physiological sample to the diagnostic test strip. In some embodiments, the drawn physiological sample and the released processing fluid interact to form a processed physiological sample and the diagnostic test strip is configured to detect a biomarker within the processed physiological sample. In other embodiments, the vacuum pin is moveable between an undeployed position and a deployed position at which the vacuum pin creates the vacuum within the dermal patch when in the deployed position. In some embodiments, the strength of the vacuum generated via movement of the pin is related, e.g., it is proportional on, a distance travelled by the vacuum pin. 
     In some embodiments, the cartridge further includes a vacuum chamber, wherein the vacuum pin is moveable between the undeployed position and the deployed position within the vacuum chamber. In other embodiments, the cartridge further includes a physiological sample channel in open communication with the vacuum chamber, wherein the physiological sample channel is configured to carry the drawn physiological sample, and wherein the vacuum draws the physiological sample to the diagnostic test strip via the physiological sample channel. In other embodiments, the cartridge further includes a moveable button that is configured to compress the processing fluid pack. In some embodiments, the button is configured to move from a locked position to a deployed position, and the cartridge is configured to prevent the button from compressing the processing fluid pack when the button is in the locked position and is configured to allow the button to compress the processing fluid pack when the button is in the deployed position. In other embodiments, the cartridge further includes a piercing element, and the button is configured to compress the processing fluid pack into the piercing element to rupture the processing fluid pack, thereby releasing a processing fluid contained in the fluid pack. 
     In certain embodiments, the lancet is configured to automatically deploy the needle upon engagement with the cartridge. In other embodiments, the lancet is configured to automatically retract the needle into a housing of the lancet after deployment. In certain embodiments, the system further comprises a computer system configured to image the diagnostic test strip and determine a result of a test associated with the diagnostic test strip based on the image. In other embodiments, the system also includes an electronic medical record database that stores a plurality of electronic medical records, the cartridge further includes a quick response code, and the computer system is configured to associate the quick response code with an electronic medical record within the electronic medical record database. In other embodiments, the computer system is configured to update the associated electronic medical record with the determined result. In certain embodiments, the processing fluid stored in the processing fluid pack includes a lysing agent. In other embodiments the processing fluid stored in the processing fluid pack includes other reagents (e.g., detergents, surfactants, etc.). In other embodiments, the processing fluid pack includes a buffer, including without limitation, TBS-T, Tris Buffered Saline-Tween, and TENT, and Tris Buffered saline with EDTA. In other embodiments, the processing fluid can be a buffer solution to neutralize pH. In other embodiments, the diagnostic test strip is a lateral flow test strip. 
     In another aspect, a method for analyzing a physiological sample, affixing a cartridge to the skin of a subject, inserting a lancet with a needle into the cartridge, wherein inserting the lancet into the cartridge deploys the needle to draw a physiological sample from the subject, moving a vacuum pin to create a vacuum within the cartridge which draws the drawn physiological sample to the diagnostic test strip, and rupturing a processing fluid pack of the cartridge to release a processing fluid to the diagnostic test strip. In certain embodiments, the method further includes moving a button of the cartridge to a deployed position to compress the processing fluid pack into a piercing element of the cartridge thereby rupturing the processing fluid pack. In other embodiments, inserting the lancet into the cartridge causes the lancet to automatically deploy the needle. 
     In yet another aspect, a cartridge configured to attach to skin of a subject includes a processing fluid pack that is configured to release a processing fluid stored therein, a diagnostic test strip, a vacuum pin, and a lancet with a needle. The lancet is configured to deploy the needle upon engagement with the cartridge to draw a physiological sample from the subject. The vacuum pin is configured to create a vacuum within the cartridge to draw the released processing fluid and the drawn physiological sample to the diagnostic test strip. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Aspects of the present disclosure may take form in various components and arrangements of components, and in various steps and arrangements of steps. The drawings are only for illustration purpose of preferred embodiments of the present disclosure and are not to be considered as limiting. 
       Features of embodiments of the present disclosure will be more readily understood from the following detailed description take in conjunction with the accompanying drawings in which: 
         FIGS.  1 A and  1 B  depict a dermal patch system in accordance with an exemplary embodiment of the present disclosure; 
         FIGS.  2 A and  2 B- 7 A and  7 B  depict a cartridge of the dermal patch system in accordance with an exemplary embodiment of the present disclosure; 
         FIGS.  8 A and  8 B  depict a base of the cartridge that includes a processing fluid pack and a diagnostic test strip in accordance with an exemplary embodiment of the present disclosure; 
         FIGS.  9  and  10    depict a lancet of the dermal patch system in accordance with an exemplary embodiment of the present disclosure 
         FIGS.  11 A and  11 B  depict a housing of the lancet in accordance with an exemplary embodiment of the present disclosure; 
         FIGS.  12 A and  12 B  depict a cap of the lancet in accordance with an exemplary embodiment of the present disclosure; 
         FIG.  13    depicts an inner sleeve of the lancet in accordance with an exemplary embodiment of the present disclosure; 
         FIG.  14    depicts a needle frame in accordance with an exemplary embodiment of the present disclosure; 
         FIGS.  15 A and  15 B- 22 A and  22 B  depict a cover of the cartridge of the dermal patch system in accordance with an exemplary embodiment of the present disclosure; 
         FIGS.  23 A and  23 B- 40 A and  40 B  depict a base of the dermal patch system in accordance with an exemplary embodiment of the present disclosure; 
         FIG.  41    depicts a lancet receiving element of the base of the dermal patch system in accordance with an exemplary embodiment of the present disclosure; 
         FIGS.  42 A and  42 B  depict a vacuum pin of the dermal patch system in accordance with an exemplary embodiment of the present disclosure; 
         FIGS.  43 A and  43 B- 45    depict a button of the dermal patch system in accordance with an exemplary embodiment of the present disclosure; 
         FIGS.  46 A and  46 B  depict a test strip support with a diagnostic test strip in accordance with an exemplary embodiment of the present disclosure; 
         FIGS.  47 A,  47 B,  48 A, and  48 B  depict a test strip support in accordance with an exemplary embodiment of the present disclosure; 
         FIG.  49    depicts the lancet of the dermal patch system in an undeployed position in accordance with an exemplary embodiment of the present disclosure; 
         FIG.  50    depicts the lancet of the dermal patch system in a deployed position in accordance with an exemplary embodiment of the present disclosure; 
         FIG.  51    depicts the lancet of the dermal patch system in a retracted position in accordance with an exemplary embodiment of the present disclosure; 
         FIG.  52    depicts the lancet coupled to the cartridge, wherein the lancet is in a deployed position in accordance with an exemplary embodiment of the present disclosure; 
         FIG.  53    depicts the lancet coupled to the cartridge, wherein the lancet is in a refracted position in accordance with an exemplary embodiment of the present disclosure; 
         FIG.  54    depicts the lancet coupled to the cartridge, wherein a vacuum pin of the cartridge is in a deployed position in accordance with an exemplary embodiment of the present disclosure; 
         FIG.  55    depicts the lancet coupled to the cartridge, wherein a button and a vacuum pin of the cartridge are in a deployed position in accordance with an exemplary embodiment of the present disclosure; 
         FIG.  56    diagrammatically depicts an electronic medical record database, a computer system, and a dermal patch system with a quick response (“QR”) code in accordance with an exemplary embodiment of the present disclosure; 
         FIG.  57    diagrammatically depicts a computer system in accordance with an exemplary embodiment of the present disclosure; 
         FIG.  58    diagrammatically depicts a cloud computing environment in accordance with an exemplary embodiment of the present disclosure; and 
         FIG.  59    is a flow chart of a method for running a diagnostic test on a drawn physiological sample in accordance with an exemplary embodiment of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     The present disclosure generally relates to a dermal patch that may be utilized to detect a biomarker in a physiological sample. 
     In some embodiments, a dermal patch may be used to perform a diagnostic test by detecting an analyte in a physiological sample. Dermal patches disclosed herein may allow a user to perform a diagnostic test in a variety of environments (e.g., in the home, in the field, in a medical facility, etc.). 
     Various terms are used herein in accordance with their ordinary meanings in the art, unless otherwise indicated. 
     The term “about,” as used herein, denotes a deviation of at most 10% relative to a numerical value. For example, about 100 μm means in the range of 90 μm-110 μm. 
     The term “substantially,” as used herein, refers to a deviation, if any, of at most 10% from a complete state and/or condition. 
     The term “subject” as used herein refers to a human subject or an animal subject (i.e., chicken, pig, cattle, dog, cat, etc.). 
     The term “physiological sample,” as used herein, includes fluid drawn from a subject and includes, but is not limited to, blood and interstitial fluid. 
     The term “lancet,” as used herein refers broadly to an element that can be used to provide a passageway, or facilitate the production of a passageway, in the skin for drawing a physiological sample. 
     The term “transparent,” as used herein, indicates that light can substantially pass through an object (e.g., a window) to allow visualization of a material disposed behind the object. For example, in some embodiments, a transparent object allows the passageway of at least 70%, or at least 80%, or at least 90% of visible light therethrough. 
     The term “vacuum,” as used herein, refers to a pressure less than atmospheric pressure and more particularly to a pressure that can facilitate the movement of a fluid (e.g., a physiological sample) within a dermal patch. 
     The term “needle” as used herein, refers to a component with a pointed tip that is configured to pierce an outer surface of an element (e.g., skin of a subject) to provide a passageway. 
     The term “diagnostic test strip” refers to a band/piece/strip of paper or other material configured to determine the presence or absence of a biomarker in a physiological sample. 
     The term “biomarker” refers to a biological molecule that is an indicator of a biological state or condition. 
     The present disclosure generally relates to a device, which is herein also referred to as a dermal patch or a dermal patch system, for detecting a biomarker in a physiological sample (e.g., bodily fluids such as blood, interstitial fluids, etc.) from a subject. In some embodiments discussed below, such a dermal patch system can include a cartridge that can be affixed to a subject&#39;s skin (e.g., via an adhesive layer) and a separate lancet that can be engaged with the cartridge to puncture the skin, thereby providing a passageway for extracting the physiological sample. As discussed in more detail below, the lancet can include a housing in which at least one needle that is configured for puncturing the skin is disposed. The lancet can further include a mechanism that can be transitioned between at least two states. In one state (herein referred to as a locked state), the mechanism retains the needle within the lancet in an undeployed position when the lancet is not engaged with the cartridge. When the lancet is coupled to the cartridge, the mechanism transitions to a second state (herein referred to as a released state). In the released state, the mechanism allows the needle to be deployed for puncturing the skin. For example, in some embodiments, the mechanism can include an upper locking portion that can retain an upper spring that is coupled to a needle platform (to which a needle is mounted) in a compressed state, thereby preventing the needle from transitioning into a deployed position. Further, the mechanism can include an upper interference member that prevents the movement of the needle platform when the mechanism is in the locked state. 
     The engagement of the lancet with the cartridge results in an automatic transition of the mechanism from the locked state to the released state, which transitions the needle into a deployed position in which the needle extends beyond the lancet and the cartridge housing to puncture the subject&#39;s skin. In some embodiments, the engagement of the lancet with the cartridge causes the upper locking member to release the needle platform, which in turn allows the upper spring to decompress and thus push down the needle platform thereby deploying the needle. In some embodiments, the mechanism can further include a lower interference member that restricts the downward movement of the needle platform, when the needle platform is released. In this manner the extent of the penetration of the needle into the skin can be controlled. In certain embodiments, the mechanism can also include a lower locking member that retains a lower spring in a compressed state. The downward movement of the needle platform can cause the release of the lower locking member to allow the lower spring to decompress and exert a restoring force on the needle platform to cause the retraction of the needle into the lancet housing. 
     In this manner, the lancet remains safe before it is engaged with the cartridge as the lancet is not capable of deploying the needle when the lancet is not engaged with the cartridge. Furthermore, in this manner, the lancet remains safe after drawing a physiological sample as the needle automatically retracts back into the lancet after being deployed. 
     Referring now to  FIGS.  1 A and  1 B , a dermal patch system  10  is shown in accordance with an exemplary embodiment. The dermal patch system  10  includes a cartridge  12  that can be affixed to a subject&#39;s skin via an adhesive layer  14 . ( FIGS.  4 A and  4 B ). The dermal patch system  10  also includes a lancet  100  that can engage with the cartridge  12  to deploy a needle disposed within the lancet  100 . 
     The dermal patch system  10  includes a lancet  100 , a cartridge  12  that can be affixed to a subject&#39;s skin via an adhesive layer  14  ( FIGS.  4 A and  4 B ). As will be discussed in further detail herein, the lancet  100  can engage with the cartridge  12  to deploy a needle disposed within the lancet housing to puncture the subject&#39;s skin thereby drawing a physiological sample from the subject. 
     The cartridge  12  includes a cover  200  and a base  300  that can couple to the cover  200 . For example, the cover  200  and the base  300  can be formed as two or more separate components that are removably coupled to one another (e.g., via a snap fitting). In other embodiments, the cover  200  and the base  300  form an integral unitary cartridge  12 . In some of these embodiments, the cover  200  can be bonded or coupled to the base  300  via an adhesive, laser welding, heat sealing, heat activated adhesive, etc. The dermal patch system  10  also includes a vacuum pin  400 . As will be discussed in further detail herein, the vacuum pin  400  can be disposed within the cartridge  12  and is configured to create a vacuum within the cartridge  12 . 
     The cartridge  12  may be formed using a variety of suitable materials including, but not limited to, polymeric materials (e.g., polyolefins, polyethylene terephthalate (PET), polyurethanes, polynorbornenes, polyethers, polyacrylates, polyamides (Polyether block amide also referred to as Pebax®), polysiloxanes, polyether amides, polyether esters, trans-polyisoprenes, polymethyl methacrylates (PMMA), cross-linked trans-polyoctylenes, cross-linked polyethylenes, cross-linked polyisoprenes, cross-linked polycyclooctenes, inorganic-organic hybrid polymers, co-polymer blends with polyethylene and Kraton®, styrene-butadiene co-polymers, urethane-butadiene co-polymers, polycaprolactone or oligo caprolactone co-polymers, polylactic acid (PLLA) or polylactide (PL/DLA) co-polymers, PLLA-polyglycolic acid (PGA) co-polymers, photocross linkable polymers, etc.). In some embodiments, some of the cover  200  may be formed of poly(dimethylsiloxane) (PDMS) to allow visibility of components disposed within the cartridge  12 . 
     With particular reference to  FIGS.  6 A and  6 B , the cartridge  12  further includes a sealed processing fluid pack  16  that is disposed in the base  300  of the cartridge  12  and a button  500  that extends through the cover  200 . The processing fluid pack  16  is disposed within the cartridge  12  and contains a processing fluid (e.g., TBS-T, Tris Buffered Saline-Tween, and TENT, Tris Buffered saline with EDTA, etc.) for processing a physiological sample drawn form a subject. The processing fluid pack  16  is formed of a frangible membrane. As will be discussed in further detail herein, the button  500  is configured to apply a pressure upon the processing fluid pack  16  which causes the processing fluid pack  16  to rupture thereby releasing the processing fluid. 
     The cartridge  12  also includes a test strip support  600  that is configured to retain a diagnostic test strip  18 . The test strip support  600  is configured to couple to the base  300  such that the diagnostic test strip  18  ( FIG.  8 B ) is disposed within the cartridge  12  when the test strip support  600  is coupled to the base  300 . The cartridge  12  further includes a film  20  ( FIG.  8 B ) disposed on the base  300 . As will be discussed in further detail herein, the film  20  seals at least a portion of the base  300 . 
     Referring now to  FIGS.  9  and  10   , the lancet  100  is shown in accordance with an exemplary embodiment. The lancet  100  includes a housing  102  in which various components of the lancet are disposed and a cap  104  that is coupled to the housing  102 . The lancet  100  can further include an inner sleeve  106  within the housing  102  and a needle frame  108  that is disposed within the inner sleeve  106  and onto which a needle  110  is mounted. The lancet  100  also can include an injection spring  112  and a retraction spring  114  that move a needle of the lancet between various positions. 
     With particular reference to  FIGS.  11 A and  11 B , the housing  102  includes a side wall  116  and a bottom wall  118 . The side wall  116  includes an outer surface  116   a  and an opposed inner surface  116   b . The bottom wall  118  includes an outer surface  118   a  and an opposed inner surface  118   b . The side wall  116  extends vertically from the bottom wall  118 . The side wall  116  has a generally cylindrical shape and the bottom wall  118  is generally circular in shape and is concentric relative to a longitudinal axis of the generally cylindrical side wall and covers a lower opening formed by the generally cylindrical side wall. The inner surface  116   b  of the side wall  116  and the inner surface  118   b  of the bottom wall  118  define an inner volume  120 . 
     The outer surface  116   a  defines a notch  122  that extends circumferentially around the outer surface  116   a  of the side wall  116 . As will be discussed in further detail herein, the notch  122  is shaped and dimensioned to couple to a locking member of the cartridge  12  via a snap fit. The housing  102  further includes a rim  124  that extends circumferentially around the outer surface  116   a  of the side wall  116 . The inner surface  116   b  defines a first and second column  126  that extend vertically from the inner surface  118   b  of the bottom wall  118 . The columns  126  includes an inner surface  126   a  and a top surface  126   b . The inner surface  126   a  extends vertically between the inner surface  118   b  of the bottom wall  118  and the top surface  126   b . The top surface  126   b  extends longitudinally between the inner surface  116   b  of the side wall  116  and the inner surface  126   a.    
     As will be discussed in further detail herein, before the lancet  100  is inserted into the cartridge  12  the columns  126  retain the needle  110  of the lancet  100  in an undeployed position. 
     The bottom wall  118  defines an aperture  128  that extends through the bottom wall  118 . Stated another way, the aperture  128  extends between the outer surface  118   a  and the inner surface  118   b  of the bottom wall  118 . As will be discussed in further detail herein, when the lancet is activated via engagement with the cartridge  12 , the needle of the lancet  100  is activated to extend through the aperture  128  and puncture the subject&#39;s skin thereby providing a passageway through which a physiological sample can be drawn from a subject. 
     With particular reference to  FIGS.  12 A and  12 B  the cap  104  includes a top wall  130  with an outer surface  130   a  and an opposed inner surface  130   b . The cap  104  also includes a side wall  132  with an outer surface  132   a  and an opposed inner surface  132   b . The top wall  130  extends longitudinally from and perpendicular to the side wall  132 . The side wall  132  extends vertically from and perpendicular to the top wall  130 . The top wall  130  and the side wall  132  are generally circular in shape and are concentric with one another. The cap  104  also includes an inner cylinder  134  with an outer surface  134   a  and an opposed inner surface  134   b . The inner cylinder  134  extends vertically from and perpendicular to the top wall  130 . The inner cylinder  134  is concentric with the top wall  130  and the side wall  132 . 
     When the cap  104  is coupled to the housing  102  the side wall  132  extends into the inner volume  120  of the housing  102  and at least a portion of the side wall  132  contacts the inner surface  116   b  of the side wall  116  such that the cap  104  couples to the housing  102  via an interference fit. 
     As depicted in  FIG.  13   , the inner sleeve  106  includes a side wall  136  and a bottom wall  138 . The side wall  136  includes an outer surface  136   a  and an opposed inner surface  136   b . The bottom wall  138  includes an outer surface  138   a  and an opposed inner surface  138   b . The side wall  136  extends vertically from the bottom wall  138 . The side wall  136  is substantially cylindrical and the bottom wall  138  are generally circular in shape and are concentric with one another. The inner surface  136   b  of the side wall  136  and the inner surface  138   b  of the bottom wall  138  define an inner volume  140 . The inner surface  136   b  defines a plurality of columns  142  each of which extends vertically from and perpendicular to the inner surface  138   b  of the bottom wall  138 . As will be discussed in further detail herein, when the needle frame  108  is in a deployed position, a portion of the needle frame  108  rests upon the columns  142 . 
     The inner sleeve  106  further includes a plurality of ledges  144  that extend circumferentially about the side wall  136 . Each ledge  144  includes a top surface  144   a , an opposed bottom surface  144   b  and an outer surface  144   c  that extends between the top surface  144   a  and the bottom surface  144   b . The inner sleeve  106  also includes a plurality of locking members  146  that extend from the inner surface  136   b  of the side wall  136 . As will be discussed in further detail herein, the proximal end of the locking members  146  retains the retraction spring  114  in a compressed state in absence of engagement between the lancet  100  and the cartridge  12 . The side wall  136  further defines a plurality of openings  148  that extend through the side wall  136 . Stated another way, the openings  148  extend between the outer surface  136   a  and the inner surface  136   b  of the side wall  136 . Each of the openings  148  are aligned with a proximal end of a locking member  146  to allow the proximal end of a locking member  146  to extend therethrough. 
     The bottom wall  138  defines an aperture  150  that extends through the bottom wall  138 . Stated another way, the aperture  150  extends between the outer surface  138   a  and the inner surface  138   b  of the bottom wall  138 . The aperture  150  is concentric with the aperture  128  of the housing  102 . As will be discussed in further detail herein, when in a deployed position, the needle  110  of the lancet  100  extends through the aperture  150  of the inner sleeve  106  as well as the aperture  128  of the housing  102 . 
     As depicted in  FIG.  14   , the needle frame  108  includes a first cylinder  152  and a second cylinder  154  disposed vertically above the second cylinder  154 . The first cylinder  152  includes a bottom surface  152   a  and an outer surface  152   b . The second cylinder  154  is disposed vertically above the first cylinder  152  and the third cylinder  156  is disposed vertically above the second cylinder  154 . The first cylinder  152  includes a bottom surface  152   a  and an outer surface  152   b  and the second cylinder  154  includes a bottom surface  154   a , an outer surface  154   b  and a top surface  154   c . The third cylinder  156  includes an outer surface  156   a  and a top surface  156   b . Similarly, the protrusion  158  includes an outer surface  158   a  and a top surface  158   b.    
     The bottom surface  152   a  of the first cylinder  152  extends circumferentially about the outer surface  152   b  of the first cylinder. The outer surface  152   b  of the first cylinder  152  extends vertically between the bottom surface  152   a  of the first cylinder  152  and the bottom surface  154   a  of the second cylinder  154 . The bottom surface  154   a  of the second cylinder  154  extends at an angle longitudinally between the outer surface  152   b  of the first cylinder and the outer surface  154   b  of the second cylinder  154 . The outer surface  154   b  extends vertically between the bottom surface  154   a  and the top surface  154   c  of the second cylinder  154 . The top surface  154   c  of the second cylinder  154  extends longitudinally between the outer surface  154   b  of the second cylinder and the outer surface  156   a  of the third cylinder  156 . The outer surface  156   a  extends vertically between the top surface  154   c  of the second cylinder and the top surface  156   b  of the third cylinder. The top surface  156   b  of the third cylinder extends longitudinally between the outer surface  156   a  of the third cylinder  156  and the outer surface  158   a  of the protrusion  158 . The outer surface  158   a  extends vertically between the top surface  156   b  of the third cylinder and the top surface  158   b  of the protrusion  158 . The top surface  158   b  of the protrusion  158  extends across a proximal end of the outer surface  158   a.    
     The injection spring  112  ( FIG.  10   ) extends vertically between the cap  104  and the needle frame  108 . More specifically, a distal end of the injection spring  112  contacts the inner surface  130   b  of the top wall  130  and a proximal end of the injection spring  112  contacts the top surface  154   c  of the second cylinder  154 . The distal end of the injection spring  112  extends circumferentially around the outer surface  134   a  of the inner cylinder  134 . The proximal end of the injection spring  112  extends circumferentially around the third cylinder  156  and around the protrusion  158 . 
     The needle frame  108  supports the needle  110 . In some embodiments, the needle  110  is molded into the first cylinder  152  or is attached to the bottom surface  152   a  of the first cylinder  152  (e.g., via an adhesive). 
     Referring now to  FIGS.  15 A and  15 B- 22 A and  22 B , the cover  200  is shown in accordance with an exemplary embodiment. 
     In this embodiment, the cover  200  includes a top wall  202  and a side wall  204 . The side wall  204  extends vertically from and perpendicular to the top wall  202 . The top wall  202  extends longitudinally from and perpendicular to the side wall  204 . The top wall  202  includes an outer surface  202   a  and an opposed inner surface  202   b . The side wall  204  includes an outer surface  204   a  and an opposed inner surface  204   b.    
     The cover  200  further includes a vertical wall  206  and a horizontal wall  208 . The vertical wall  206  extends vertically between and perpendicular to the top wall  202  and the horizontal wall  208 . The horizontal wall  208  extends longitudinally between and perpendicular to the side wall  204  and the vertical wall  206 . The vertical wall  206  includes an outer surface  206   a  and an opposed inner surface  206   b . The horizontal wall  208  includes an outer surface  208   a  and an opposed inner surface  208   b  ( FIG.  17 B ). 
     The top wall  202  defines a lancet aperture  210  and a button aperture  212 . The lancet aperture  210  and the button aperture  212  are generally circular in shape and extend through the top wall  202 . Stated another way, the lancet aperture  210  and the button aperture  212  extend between the outer surface  202   a  and the inner surface  202   b  of the top wall  202 . The lancet aperture  210  is shaped and dimensioned to accommodate at least a portion of the lancet  100 . As will be discussed in further detail herein, the lancet aperture  210  allows the lancet  100  to couple to the base  300 . That is, the lancet aperture  210  is shaped to accommodate the lancet  100  such that the lancet  100  can be engaged with the cartridge  12 . 
     The horizontal wall  208  defines a sample viewing aperture  214  and a test strip viewing aperture  216 . The sample viewing aperture  214  and the test strip viewing aperture  216  extend through the horizontal wall  208 . Stated another way, the sample viewing aperture  214  and the test strip viewing aperture  216  extend between the outer surface  208   a  and the inner surface  208   b . The sample viewing aperture  214  and the test strip viewing aperture  216  allow a user of the dermal patch system  10  to view components (e.g., the diagnostic test strip  18 ) disposed within the dermal patch system  10 . In some embodiments, the cover  200  can further include a transparent window(s) (not shown), e.g., formed of PDMS, that extends across the sample viewing aperture  214  and the test strip viewing aperture  216 . 
     The horizontal wall  208  further includes a test result indicator  218  and a control indicator  220  disposed on the outer surface  208   a . As will be discussed in further detail herein, the test result indicator  218  and the control indicator  220  can be used to determine the presence or absence of a biomarker. 
     With particular reference to  FIGS.  16 A and  16 B , the side wall  204  defines U-shaped opening  222 , which extends through the side wall  204 . Stated another way, the U-shaped opening  222  extends between the outer surface  204   a  and the inner surface  204   b  of the side wall  204 . The U-shaped opening  222  is shaped and dimensioned to accommodate at least a portion of the vacuum pin  400 . As will be discussed in further detail herein, U-shaped opening  222  allows the vacuum pin  400  to be received by a receptacle (which can be in the form of a channel) within the cartridge  12 . That is, the U-shaped opening  222  is shaped to accommodate the vacuum pin  400  such that at least a portion of the vacuum pin  400  can extend through the side wall  204  to be disposed within a receptacle provided in the base  300 . 
     With reference to  FIGS.  18 A and  18 B , the cover  200  further includes a U-shaped locking member  224  and a plurality of projection members  226 . The U-shaped locking member  224  is aligned with the U-shaped opening  222 . The U-shaped locking member  224  extends vertically from and perpendicular to the inner surface  202   b  of the top wall  202 . When the cover  200  is coupled to the base  300 , the U-shaped locking member  224  retains the vacuum pin  400  within the base  300  and allows the vacuum pin  400  to move a predetermined distance while remaining within the cartridge  12 . The plurality of projection members  226  extend vertically from and perpendicular to the inner surface  202   b  of the top wall  202 . The plurality of projection members  226  are disposed around the perimeter of the lancet aperture  210 . As will be discussed in further detail herein, the plurality of projection members  226  help secure the cover  200  to the base  300 . 
     The cover  200  also includes a button guide  228  that is generally circular in shape. The button guide  228  extends from and perpendicular to the inner surface  202   b  of the top wall  202 . The button guide  228  extends circumferential around the button aperture  212 . 
     The button guide  228  includes a plurality of vertical grooves  230  that extend vertically along an inner surface of the button guide  228  and a plurality of horizontal grooves  232  that extend horizontally along the inner surface of the button guide  228 . Each vertical groove  230  is in open communication with a horizontal groove  232  and each vertical groove  230 . Furthermore, each vertical groove  230  extends to a proximal end of the button guide  228 . 
     The cover  200  further includes a plurality of locking members  234 . The locking members  234  extend vertically from and perpendicular to the inner surface  204   b  of the side wall  204 . As will be discussed in further detail herein, the locking members  234  couple the cover  200  to the base  300 . The cover  200  also includes a support structure  236 , which extends vertically from and perpendicular to the inner surface  208   b  of the horizontal wall  208 . The support structure  236  extends around the viewing aperture  214  and the test strip viewing aperture  216  in such a manner that the support structure  236  does not prevent a user from viewing components disposed within the cartridge  12  when the cover  200  is coupled to the base  300 . 
     In some embodiments, as depicted in  FIGS.  15 A,  15 B,  16 A, and  16 B , the cover  200  can include a quick response (“QR”) code  22  disposed on the outer surface  202   a  of the top wall  202 . As will be discussed in further detail herein, the QR code  22  can be associated with an electronic medical record (“EMR”) stored in an electronic medical record database and may aid in preserving a chain of custody of the cartridge  12 . 
     Referring now to  FIGS.  23 A and  23 B- 40 A and  40 B , the base  300  is shown in accordance with an exemplary embodiment. In this embodiment, the base  300  includes a bottom wall  302  with a top surface  302   a , an opposed bottom surface  302   b , and an outer surface  302   c  that extends between the top surface  302   a  and the bottom surface  302   b . The top surface  302   a  and the bottom surface  302   b  extend perpendicularly to the outer surface  302   c . The outer surface  302   c  extends perpendicular to and vertically between the top surface  302   a  and the bottom surface  302   b . The bottom wall  302  and the side wall  204  of the cover  200  have the same perimeter shape such that when the cover  200  is coupled to the base  300 , outer surface  302   c  of the base  300  and the outer surface  204   a  of the cover  200  are flush with one another. Furthermore, when the cover  200  is coupled to the base  300 , the side wall  204  contacts the top surface  302   a  of the bottom wall  302 . 
     The base  300  further includes a rim  304  with an outer surface  304   a , an opposed inner surface  304   b , and a top surface  304   c  that extends between the outer surface  304   a  and the inner surface  304   b . The top surface  304   c  extends perpendicularly to and longitudinally between the outer surface  304   a  and the inner surface  304   b . The outer surface  304   a  and the inner surface  304   b  extend vertically from and perpendicular to the top surface  302   a  of the bottom wall  302  such that the outer surface  304   a  and the inner surface  304   b  extend between the top surface  302   a  and the top surface  304   c . The rim  304  is contoured such that when the cover  200  is coupled to the base, at least a portion of the side wall  204  contacts at least a portion of the rim  304 . More specifically, at least a portion of the inner surface  204   b  of the side wall  204  contacts at least a portion of the outer surface  304   a  of the rim  304 . 
     The base  300  further includes a plurality of extensions  306  that extend vertically from and perpendicular to the rim  304 . The extensions  306 , the bottom wall  302  and the rim  304  define gaps  308 . The gaps  308  and therefore the extensions  306 , are shaped to accept a locking member  234  such that an extension  306  couples to a locking member  234  via a snap fitting thereby coupling the cover  200  to the base  300 . 
     The base  300  also includes a vacuum pin receptacle  310  that extends vertically from and perpendicular to the top surface  302   a  of the bottom wall  302 . The vacuum pin receptacle  310  includes an opening  312  and a chamber  314  that are each shaped to accept the vacuum pin  400  such that at least a portion of the vacuum pin  400  may be disposed within the vacuum pin receptacle  310 . The vacuum pin receptacle  310  also includes a gap  316  that is shaped and dimensioned to accommodate the arms of the U-shaped locking member  224 . That is, when the cover  200  is coupled to the base  300 , the arms of the U-shaped locking member  224  extend through and are disposed within the gap  316 . 
     The base  300  also includes a needle aperture  318  that is generally circular in shape. The needle aperture  318  extends through the bottom wall  302 . Stated another way, the needle aperture  318  extends between the top surface  302   a  and the bottom surface  302   b  of the bottom wall  302 . As will be discussed in further detail herein, when the cover  200  is coupled to the base  300  and when the cartridge  12  is adhered to a subject, the needle aperture  318  allows the needle  110  of the lancet  100  to extend through the bottom wall  302  to puncture the subject&#39;s skin, thereby allowing extraction of a physiological sample from the subject. 
     The base  300  further includes a lancet receiving element  320  that is shaped and dimensioned to accept the distal end of the lancet  100 . With particular reference to  FIG.  41   , the lancet receiving element  320  includes an outer circular projection  322  and an inner circular projection  324  with each extending vertically from and perpendicular to the top surface  302   a  of the bottom wall  302 . The outer circular projection  322  includes an outer surface  322   a , an opposed inner surface  322   b , and a top surface  322   c  that extends between the outer surface  322   a  and the inner surface  322   b . The top surface  322   c  extends perpendicular to and longitudinally between the outer surface  322   a  and the inner surface  322   b . The outer surface  322   a  and the inner surface  322   b  extend vertically from and perpendicular to the top surface  302   a  of the bottom wall  302  such that the outer surface  322   a  and the inner surface  322   b  extend between the top surface  302   a  and the top surface  322   c . The outer circular projection  322  is shaped to accept the lancet  100 . 
     The inner circular projection  324  is disposed around the needle aperture  318  and includes an outer surface  324   a , an opposed inner surface  324   b , and a top surface  324   c  that extends between the outer surface  324   a  and the inner surface  324   b . The top surface  324   c  extends perpendicular to and longitudinally between the outer surface  324   a  and the inner surface  324   b . The outer surface  324   a  and the inner surface  324   b  extend vertically from and perpendicular to the top surface  302   a  of the bottom wall  302  such that the outer surface  324   a  and the inner surface  324   b  extend between the top surface  302   a  and the top surface  324   c . Furthermore, the outer circular projection  322  and the inner circular projection  324  circular projection are concentric with one another. As will be discussed in further detail herein, when the lancet  100  is engaged with the base  300 , the top surface  324   c  of the inner circular projection contacts a portion of the lancet  100  which allows the lancet  100  to release the needle  110  so as to puncture the skin, thereby allowing the extraction of a physiological sample from the subject&#39;s skin. 
     With continued reference to  FIGS.  23 A and  23 B , the base  300  further includes a plurality of locking members  326  ( FIG.  41   ) that extend vertically from and perpendicular to the top surface  322   c  of the outer circular projection  322 . For the sake of clarity, one of the locking members  326  is not shown in  FIGS.  23 A and  23 B . Each locking member  326  includes a hook  328  ( FIG.  41   ) that extends inwardly from a top of a locking member  326  towards the inner circular projection  324 . As will be discussed in further detail herein, the hooks  328  of the locking members  326  couple to the lancet  100  to retain the lancet  100  within the base  300 . The locking members  326  are equally spaced around the outer circular projection  322  thereby defining a gap between the locking members  326 . When the cover  200  is coupled to the base  300 , the projection members  226  extend between the locking members  326  in these gaps thereby coupling the cover  200  to the base  300 . 
     The base  300  includes a diagnostic test strip housing  330 . The diagnostic test strip housing  330  extends vertically from and perpendicular to the top surface  302   a  and includes an outer surface  330   a  an opposed inner surface  330   b  and a vertical surface  330   c . The vertical surface  330   c  extends perpendicular to and vertically between the inner surface  330   b  and the bottom surface  302   b . The inner surface  330   b  and vertical surface  330   c  define an inner volume  332  of the diagnostic test strip housing  330 . The diagnostic test strip housing  330  further includes an opening  334  that extends between the outer surface  330   a  and the inner surface  330   b . When the cover  200  is coupled to the base  300  the opening  334  is positioned vertically below the test strip viewing aperture  216 . 
     The base  300  further includes a physiological sample well  336  and a physiological sample channel  338  with a first portion  338   a , a second portion  338   b , a third portion  338   c , and a fourth portion  338   d.    
     The first portion  338   a  extends from the physiological sample well  336 . As will be discussed in further detail herein, the physiological sample channel  338  is a fluidic channel that is configured to carry a physiological sample extracted from a subject. The physiological sample well  336  and the first portion  338   a  of the physiological sample channel  338  are open with respect to the bottom surface  302   b  of the bottom wall  302 . Stated another way, the physiological sample well  336  and the first portion  338   a  of the physiological sample channel  338  do not include a bottom surface. The physiological sample well  336  is in open communication with the needle aperture  318 . As will be discussed in further detail herein, when drawing a physiological sample, a needle of the lancet  100  extends through the needle aperture  318  and through the physiological sample well  336  to pierce the skin of the subject. 
     The second portion  338   b  of the physiological sample channel  338  extends vertically from and perpendicular to the first portion  338   a . The second portion  338   b  extends through the bottom wall  302  and the diagnostic test strip housing  330 . That is, the second portion  338   b  extends between the bottom surface  302   b  of the bottom wall  302  and the outer surface  330   a  of the diagnostic test strip housing  330 . 
     The third portion  338   c  extends longitudinally from and perpendicular to the second portion  338   b . The third portion  338   c  extends along the outer surface  330   a  of the diagnostic test strip housing  330 . The third portion  338   c  of the physiological sample channel  338  is open with respect to the outer surface  330   a  of the diagnostic test strip housing  330 . Stated another way, the third portion  338   c  of the physiological sample channel  338  does not include a top surface. The third portion  338   c  includes a reservoir  340 . When the cover  200  is coupled to the base  300 , the reservoir  340  is disposed below the sample viewing aperture  214  which allows a user of the dermal patch system  10  to view a drawn physiological sample within the reservoir  340 . 
     The fourth portion  338   d  of the physiological sample channel  338  extends vertically from and perpendicular to the third portion  338   c . The fourth portion  338   d  extends between outer surface  330   a  and the inner surface  330   b  of the diagnostic test strip housing  330  such that the physiological sample channel  338  is in open communication with the inner volume  332 . 
     The base  300  further includes a vacuum channel  342  that is in fluid communication with the chamber  314  of the vacuum pin receptacle  310 . A first portion  342   a  of the vacuum channel  342  extends from the chamber  314  and extends vertically within the base  300 . A second portion  342   b  of the vacuum channel  342  extends longitudinally from and perpendicular to the first portion  342   a  of the vacuum channel  342  such that the second portion  342   b  of the vacuum channel  342  extends along the bottom surface  302   b  of the bottom wall  302 . Similar to the physiological sample well  336  and the first portion  338   a  of the physiological sample channel  338 , the second portion  342   b  of the vacuum channel  342  is open with respect to the bottom surface  302   b  of the bottom wall  302 . The vacuum channel  342  further includes a third portion  342   c  that extends vertically from and perpendicular to the second portion  342   b . The third portion  342   c  extends vertically along the vertical surface  330   c  of the diagnostic test strip housing  330 . The vacuum channel  342  is in open communication with the inner volume  332  of the diagnostic test strip housing  330 . As such, the vacuum channel  342  is in open communication with the physiological sample well  336  via the inner volume  332  and the physiological sample channel  338 . 
     The base  300  further includes a depression  344  and a plurality of piercing elements  346  that extend vertically from the depression  344 . The base  300  also includes a buffer aperture  348  that extends between the depression  344  and the inner surface  330   b.    
     As previously discussed herein, the first portion  338   a  and the third portion  338   c  of the physiological sample channel  338  are open. As depicted in  FIGS.  4 A and  4 B , the adhesive layer  14  is disposed on the bottom surface  302   b  of the bottom wall  302  thereby sealing the first portion  338   a  of the physiological sample channel  338 . Furthermore, as depicted in  FIGS.  8 A and  8 B , the film  20  is disposed on the outer surface  330   a  of the diagnostic test strip housing  330  thereby sealing the third portion  338   c  of the physiological sample channel  338 . 
     With reference to  FIGS.  42 A and  42 B , the vacuum pin  400  is shown in accordance with an exemplary embodiment. The vacuum pin  400  is generally cylindrical in shape and extends between a proximal end  402  and a distal end  404 . The vacuum pin  400  includes a barrel  406  that defines the proximal end  402  and a handle  408  that defines the distal end  404 . The vacuum pin  400  also includes a first and second flat surface  410  between the barrel  406  and the handle  408 . The flat surfaces  410  extend longitudinally between a first rim  412  and a second rim  414 . The flat surfaces  410  extend perpendicular to and longitudinally between the rims  412  and  414 . 
     The barrel  406  includes a first groove  416  and a second groove  416  shaped and dimensioned to accommodate a first and second elastomeric O-ring  418 . When the vacuum pin  400  is disposed within the vacuum pin receptacle  310 , the elastomeric O-rings  418  contact the inner surface of the chamber  314  such that the vacuum pin  400  creates an airtight seal within the chamber  314 . This seal allows for the application of positive or negative pressure as needed. 
     The vacuum pin  400  may be moved within or completely removed from vacuum pin receptacle  310 . When the vacuum pin  400  is transitioned from an undeployed portion (i.e., a position in which the vacuum pin  400  is fully inserted within the chamber  314  of the vacuum pin receptacle  310 ) to a deployed position (i.e., when the vacuum pin is moved within the vacuum pin receptacle away from the center of the base  300 ), a volume between the proximal end  402  of the vacuum pin  400  and the chamber  314  increases thereby creating a negative pressure within the chamber  314  which in turn causes the creation of a negative pressure within the physiological sample channel  338  via the vacuum channel  342  and the diagnostic test strip housing  330 . Stated another way, when the vacuum pin  400  is moved from the undeployed position to the to the deployed position, the vacuum pin  400  creates a vacuum within the base  300  which draws a physiological sample from the physiological sample well  336  to the diagnostic test strip  18 . 
     As previously discussed herein, the cover  200  includes a U-shaped locking member  224 . When the cover  200  is coupled to base  300  the arms of the U-shaped locking member  224  extend through the gap  316  of the vacuum pin receptacle  310 . Furthermore, when the vacuum pin  400  is in the undeployed position, the arms of the U-shaped locking member  224  are disposed between the rims  412  and  414 . When the vacuum pin  400  is moved to the deployed position, the arms of the U-shaped locking member  224  contact the first rim  412  thereby preventing the vacuum pin  400  from moving further. As previously discussed, moving the vacuum pin  400  to the deployed position creates a vacuum within the base  300 . Accordingly, the extent of movement of the vacuum pin  400  permitted by the U-shaped locking member  224  can determine the strength of a vacuum created within the base  300 . The rims  412  and  414  are separated by a given distance. In other embodiments of the vacuum pin  400 , the rims  412  and  414  are separated by a difference distance. This distance determines the extent by which the vacuum pin  400  can be removed from the vacuum pin receptacle  310  and as such can determine the strength of a vacuum created within the base  300 . Hence, increasing or decreasing a distance between rims  412  and  414  increases or decreases the strength of a vacuum that can be created by the vacuum pin  400 . The strength or amount of vacuum may also be increased by increasing a length of the vacuum pin receptacle  310 , by increasing length of the vacuum pin  400 , and/or by increasing the diameter of the vacuum pin receptacle  310 . 
     With reference to  FIGS.  43 A,  43 B- 45    the button  500  is depicted in accordance with an exemplary embodiment. The button  500  includes a top wall  502  with an outer surface  502   a  and an opposed inner surface  502   b . The button  500  also includes a side wall  504  with an outer surface  504   a  and an opposed inner surface  504   b . The top wall  502  extends longitudinally from and perpendicular to the side wall  504 . The side wall  504  extends vertically from and perpendicular to the top wall  502 . The top wall  502  and the side wall  504  have generally circular cross sections and are concentric with one another. The inner surface  502   a  of the top wall  502  and the inner surface  504   a  of the side wall  504  define an inner volume  506  of the button  500 . 
     The button  500  also includes a cylinder  508  that extends vertically from and perpendicular to the inner surface  502   b  of the top wall  502 . The cylinder  508  is concentric with the top wall  502  and the side wall  504 . The button  500  also includes a plurality of protrusions  510  that extend from the outer surface  504   a  of the side wall  504 . The protrusions  510  couple the button  500  to the cover  200 . 
     With reference to  FIGS.  46 A and  46 B , the test strip support  600  and the diagnostic test strip  18  is shown in accordance with an exemplary embodiment. 
     As shown in  FIGS.  47 A,  47 B,  48 A, and  48 B , the test strip support  600  includes an L-shaped base  602  with a first portion  602   a  and a second portion  602   b  that is perpendicular the first portion  602   a.    
     The base  602  includes a top surface  602   c , an opposed bottom surface  602   d , and a side surface  602   e  that extends vertically between and perpendicular the top surface  602   c  and the bottom surface  602   d . The side surface  602   e  gives the base  602  a height substantially that matches a height of the bottom wall  302  of the base  300 . As such when the test strip support  600  is coupled to the base  300 , the top surface  602   c  of the base  602  is flush with the top surface  302   a  of the bottom wall  302  and the bottom surface  602   d  of the base  602  is flush with the bottom surface  302   b  of the bottom wall  302 . 
     The first portion  602   a  of the base  602  is shaped and dimensioned to support the diagnostic test strip  18 . Furthermore, the base  602  includes a plurality of protrusions  604  that extend vertically from and perpendicular to the top surface  602   c  of the base  602 . When the diagnostic test strip  18  is disposed on the test strip support  600 , the diagnostic test strip  18  rests upon the protrusions  604 . The protrusions  604  can prevent the test strip  18  from delaminating (i.e., the protrusions  604  can ensure that layers of the test strip  18  contact one another such that the physiological sample can transfer from one layer to another). 
     The second portion  602   b  of the base  602  includes a well  606  that extends vertically from and perpendicular to the top surface  602   c  of the base  602 . When the test strip support  600  is coupled to the base  300 , the well  606  extends into the inner volume  332  of the diagnostic test strip housing  330  and is positioned vertically below the buffer aperture  348 . Furthermore, the well  606  is shaped and dimensioned to accept a processing fluid from the processing fluid pack  16  via the buffer aperture  348 . A bottom surface of the well  606  is angled toward the first portion  602   a  of the base  602  and therefore directs a received fluid towards the diagnostic test strip  18  when the diagnostic test strip  18  is disposed on the first portion  602   a  of the base  602 . 
     As depicted in  FIGS.  49 - 51   , the lancet  100  is moveable between a first position (also referred to as an “undeployed position”) ( FIG.  49   ), a second position (also referred to as a “deployed position”) ( FIG.  50   ), and a third position (also referred to as a “retracted position”) ( FIG.  51   ). 
     In the undeployed position (before the lancet  100  is inserted into the cartridge  12 ;  FIG.  49   ) the injection spring  112  and the retraction spring  114  are in a compressed state. In the compressed state, the retraction spring  114  extends vertically between the bottom wall  138  and a proximal end of the locking members  146 . More specifically, a distal end of the retraction spring  114  contacts a lower surface of the proximal end of the locking members  146  and a proximal end of the retraction spring  114  contacts the inner surface  138   b  of the bottom wall  138 . 
     When in the undeployed position the outer surface  144   c  contacts the inner surface  126   a  of the columns  126  which compresses the side wall  136  inwardly. Furthermore, the bottom surface  154   a  of the second cylinder  154  contacts and rests upon the top surfaces  144   a  of the ledges  144  such that the ledges  144  supports the needle frame  108  in the undeployed position. In this position, the injection spring  112  is prevented from decompressing (due to the second cylinder  154  resting upon the ledges  144 ) and the needle  110  is disposed completely within the inner volume  140  of the inner sleeve  106 . 
     When the lancet  100  is inserted into the cartridge  12 , the engagement of the lancet with the cartridge  12  causes the lancet  100  to automatically move from the undeployed position to the deployed position. 
     When the lancet  100  is coupled to the base  300  ( FIGS.  52 - 55   ), the inner circular projection  324  extends through the aperture  128  to contact the bottom wall  138 . Specifically, the top surface  324   c  of the inner circular projection  324  contacts the outer surface  138   a  of the bottom wall  138  which forces the inner sleeve  106  to move vertically upward in the direction of arrow A ( FIG.  50   ) within the housing  102 . This vertical movement causes the ledges  144  to extend vertically above the top surfaces  126   b  of the columns  126 . Moving beyond the top surfaces  126   b  of the columns  126  allows the side wall  136  to decompress and expand in the direction of arrow B ( FIG.  50   ) and extend toward the inner surface  116   b  of the side wall  116 . In this position, the bottom surface  144   b  of the ledges  144  rest upon the top surfaces  126   b  of the columns  126  and the outer surfaces  144   c  of the ledges  144  contacts the inner surface  116   b  of the side wall  116 . Furthermore, when the lancet  100  is inserted into the cartridge  12 , the hooks  328  of the locking members  326  are disposed within and coupled to the notch  122  via a snap fit. 
     The expansion of the side wall  136  causes the inner volume  140  of the inner sleeve  106  to have a larger width relative to when the inner sleeve  106  is in the undeployed position such that at least a portion of the side wall  136  has a larger width than the second cylinder  154  (the widest portion of the needle frame  108  which allows the needle frame  108  move vertically downward in the direction of arrow C) ( FIG.  50   ). 
     Furthermore, the injection spring  112  also causes the needle frame  108  to move in the direction of arrow C as the ledges  144  no longer prevent the injection spring  112  from expanding. The force applied by the injection spring  112  causes the needle frame  108  (and therefore the needle  110 ) to travel with a force that is sufficient to cause the needle  110  to puncture the skin of a subject wearing the dermal patch system  10 . Stated another way, the injection spring  112  causes the needle  110  to extend through the aperture  150  of the inner sleeve  106 , through the aperture  128  of the housing  102 , and through the needle aperture  318  of the base  300  to puncture the skin of a subject. In the deployed position, the bottom surface  154   a  of the second cylinder  154  rests upon the columns  142  and at least a portion of the outer surface  154   b  of the second cylinder  154  contacts the inner surface  136   b  of the side wall  136 . 
     While moving in the direction of arrow C, the outer surface  152   b  contacts the locking members  146  which causes a proximal portion of locking members  146  that is aligned with an opening  148  to extend into the opening. In this position, the locking members  146  no longer contact the retraction spring  114  thereby allowing the retraction spring  114  to decompress and expand. When decompressed, the retraction spring  114  contacts the outer surface  152   b  of the first cylinder  152  which causes needle frame  108  to also move in the direction of arrow D ( FIG.  51   ). That is after moving to the deployed position, the retraction spring  114  causes the needle  110  to retract back into the inner volume  140  of the inner sleeve  106  via the aperture  150  of the base  300  and the apertures  128  and  150  of the lancet  100 . After penetrating the skin of a subject, the refraction spring  114  causes the needle  110  to automatically retract back into the housing of the lancet  100  thereby placing the lancet  100  in the retraced position. 
     As previously discussed herein, the lancet includes a mechanism can be transition the lancet between a locked state and a released state. In various embodiments, this mechanism includes the columns  126 , the ledges  144 , and the locking members  146 . An upper locking portion of the mechanism refers to the columns  126  and the ledges  144  while a locker locking portion refers to the locking members  146  as the columns  126  and the ledges  144  can be positioned vertically above the locking members  146 . The term upper interference portion refers to the top surface  144   a  of the ledges  144  as this surface interferes with the needle frame&#39;s  108  ability to transition to the deployed position when the mechanism is in the locked state. As used herein, a lower interference member refers to the columns  142  as the columns  142  interfere with the needle frame&#39;s  108  ability to further extend beyond a desired position. 
     In use, after affixing the cartridge  12  to the skin of the subject, a user of the dermal patch system  10  inserts the lancet into the cartridge  12  which causes the needle  110  to move to the deployed position and puncture the subject&#39;s skin and draw a physiological sample. After the needle  110  retracts into the lancet  100 , the drawn physiological sample pools within the physiological sample well  336  of the base  300 . 
     As depicted in  FIGS.  52 - 55   , the button  500  is moveable between a first position (also referred to as a “locked” position) ( FIGS.  52  and  53   ), a second position (also referred to as an “unlocked” position), and a third position (also referred to as a “deployed” position) ( FIGS.  54  and  55   ). 
     In the locked position, the protrusions  510  are disposed between and within the horizontal grooves  232  of the button guide  228 . In this position, the horizontal grooves  232  prevent a user of the dermal patch system  10  from moving the button  500  into the deployed position. A user of the dermal patch system  10  can rotate the button  500  to the unlocked position. In the unlocked position the protrusions  510  are aligned with the vertical grooves  230  of the button guide  228  and the horizontal grooves  232  do not prevent a user from moving the button  500  into the deployed position. That is, in the unlocked position, a user of the dermal patch system  10  may move the button  500  into the deployed position by pressing the button  500 . When moving to the deployed position, the protrusions  510  travel downward within the vertical grooves  230 . 
     Moving the button  500  to the deployed position places at least a portion of the processing fluid pack  16  within the inner volume  506  and causes the cylinder  508  to compress the processing fluid pack  16  into the piercing elements  346  which causes the processing fluid pack  16  to rupture and release the stored processing fluid. The released processing fluid travels to the diagnostic test strip  18  via the buffer aperture  348  and the well  606 . The well  606  can slow the flow of the processing fluid from the processing fluid pack  16  and allows the processing fluid to be more easily wicked by the diagnostic test strip  18  which may mimic the rate at which a diagnostic test strip outside of the dermal patch system  10 . 
     A user of the dermal patch system  10  may move the button  500  to the deployed position thereby releasing the processing fluid before or after drawing the physiological sample. 
     When the physiological sample is within the physiological sample well  336  and before rupturing the processing fluid pack  16 , a user of the dermal patch system  10  can pull the vacuum pin  400  in the direction of arrow E ( FIG.  55   ) to move the vacuum pin  400  from a first position (also referred to as an “undeployed” position) ( FIGS.  52 - 54   ) to a second position ( FIG.  55   ) (also referred to as an “deployed” position). Moving the vacuum pin  400  to the deployed position creates a vacuum within the vacuum channel  342  which causes the drawn physiological sample to travel to the diagnostic test strip  18  via the physiological sample channel  338 . In some such embodiments, the flow of the drawn physiological sample can be aided by capillary action, gravity and wicking action. As previously discussed herein, en route to the diagnostic test strip  18 , the drawn physiological sample passes through the reservoir  340 . The user may verify the drawn physiological sample is traveling to the diagnostic test strip  18  by verifying at least a portion of the drawn physiological sample is within the reservoir  340  via the sample viewing aperture  214 . 
     After pulling the vacuum pin  400 , the user pushes the button  500  which releases the processing fluid and causes the processing fluid to mix and interact with the physiological sample to form a processed physiological sample. The processed physiological sample is washed across the diagnostic test strip  18 . The processed physiological sample can be configured to facilitate the detection of a target biomarker of interest, if any, in the processed physiological sample via the diagnostic test strip  18 . By way of example, when the physiological sample is the blood, the processing fluid can include an anti-coagulant to prevent coagulation of the drawn sample prior to its analysis. In some cases, the processing fluid can include a lysing agent for lysing cells present in a drawn sample, e.g., to allow analysis of genetic materials, e.g., DNA and/or RNA segments, within the cell. 
     The diagnostic test strip  18  can include, but is not limited to, a lateral flow assay, a Bio-marker sensing chip, and Iso-thermal amplification technology. 
     In an embodiment wherein the diagnostic test strip  18  is a lateral flow assay ( FIGS.  3 A and  3 B ), the diagnostic test strip  18  includes a nitrocellulose membrane  24  with a line of test capture antibodies  26  ( FIGS.  46 A and  46 B ) specific to a desired biomarker and a line of control capture antibodies  28  ( FIGS.  46 A and  46 B ). When the diagnostic test strip  18  is disposed within the cartridge  12 , the line of test capture antibodies  26  is aligned with test result indicator  218  and the line of control capture antibodies  28  is aligned with the control indicator  220  which allows a user to visually determine if a biomarker (e.g., HbA1c, Cardiac Troponin, CBC, Creatinine, Infectious diseases, etc.) is present in the drawn physiological sample by viewing the diagnostic test strip  18  via the test strip viewing aperture  216 . 
     In some embodiments, after the diagnostic test strip  18  includes the processed physiological sample, the user can remove the dermal patch system  10  from the skin of the subject and can send the dermal patch system to a medical professional. The medical professional can then view the diagnostic test strip  18  to determine if a biomarker is present in the drawn physiological sample. 
     With reference to  FIG.  56   , in some embodiments wherein the dermal patch system  10  includes the QR code  22 , a user of a computer system  30  may scan the QR code  22  to determine a test to perform on the stored physiological sample and/or to view and/or update an EMR  32  that is associated with the QR code  22 . In these embodiments, the EMR  32  is stored in an EMR database  34  that is in communication with the computer system  30 . Furthermore, the QR code  22  may be employed to preserve the chain of custody of the dermal patch system  10 . 
     In these embodiments, the computer system  30  may include an application that provides access to the EMR database  34  via a network connection and allows a user to photograph of scan the QR code  22 . As shown in  FIG.  56   , the EMR database  34  includes a plurality of EMRs  32  each of which is associated with an individual subject. The application causes the computer system  30  to scan or retrieve an image of the QR code  22 , analyze the QR code  22  and associate the QR code  22  with an EMR  32 . In some embodiments, the computer system  30  may then update the associated EMR  32  to indicate a diagnostic test has been run on the drawn physiological sample. The computer system  30  may automatically update the EMR  32  automatically or based on a user input. In some embodiments, after associating an EMR  32  with the QR code  22 , the computer system  30  may analyze information within the EMR  32  to determine a diagnostic test that associated with the diagnostic test strip  18  and in some embodiments, the computer system  30  may utilize image recognition software to determine a result of the diagnostic test by determining the presence or absence of a test line on the diagnostic test strip  18  in an in an image captured by the computer system  30 . In these embodiments, the computer system  30  may automatically update the associated EMR  32  to indicate the determined result. 
     Referring now to  FIG.  57   , a computer system  700  is shown in accordance with an exemplary embodiment. The computer system  700  may serve as any computer system disclosed herein (e.g., the computer system  30 ). As used herein a computer system (or device) is any system/device capable of receiving, processing, and/or sending data. Computer systems include, but are not limited to, microprocessor-based systems, personal computers, servers, hand-held computing devices, tablets, smartphones, multiprocessor-based systems, mainframe computer systems, virtual reality (“VR”) headsets and the like. 
     As shown in  FIG.  57   , the computer system  700  includes one or more processors or processing units  702 , a system memory  704 , and a bus  706  that couples the various components of the computer system  700  including the system memory  704  to the processor  702 . The system memory  704  includes a computer readable storage medium  708  and volatile memory  710  (e.g., Random Access Memory, cache, etc.). As used herein, a computer readable storage medium includes any media that is capable of storing computer readable; program instructions and is accessible by a processor. The computer readable storage medium  708  includes non-volatile and non-transitory storage media (e.g., flash memory, read only memory (ROM), hard disk drives, etc.). Computer program instructions as described herein include program modules (e.g., routines, programs, objects, components, logic, data structures, etc.) that are executable by a processor. Furthermore, computer readable program instructions, when executed by a processor, can direct a computer system to function in a particular manner such that a computer readable storage medium comprises an article of manufacture. Specifically, the computer readable program instructions when executed by a processor can create a means for carrying out at least a portion of the steps of the methods disclosed herein. 
     The bus  706  may be one or more of any type of bus structure capable of transmitting data between components of the computer system  700  (e.g., a memory bus, a memory controller, a peripheral bus, an accelerated graphics port, etc.). 
     The computer system  700  may further include a communication adapter  712  which allows the computer system  700  to communicate with one or more other computer systems/devices via one or more communication protocols (e.g., Wi-Fi, BTLE, etc.) and in some embodiments may allow the computer system  700  to communicate with one or more other computer systems/devices over one or more networks (e.g., a local area network (LAN), a wide area network (WAN), a public network (the Internet), etc.). 
     In some embodiments, the computer system  700  may be connected to one or more external devices  714  and a display  716 . As used herein, an external device includes any device that allows a user to interact with a computer system (e.g., mouse, keyboard, touch screen, etc.). An external device  714  and the display  716  may be in communication with the processor  702  and the system memory  704  via an Input/Output (I/O) interface  718 . 
     The display  716  may display a graphical user interface (GUI) that may include a plurality of selectable icons and/or editable fields. A user may use an external device  714  (e.g., a mouse) to select one or more icons and/or edit one or more editable fields. Selecting an icon and/or editing a field may cause the processor  702  to execute computer readable program instructions stored in the computer readable storage medium  708 . In one example, a user may use an external device  714  to interact with the computer system  700  and cause the processor  702  to execute computer readable program instructions relating to at least a portion of the steps of the methods disclosed herein. 
     Referring now to  FIG.  58   , a cloud computing environment  800  is depicted in accordance with an exemplary embodiment. The cloud computing environment  800  is connected to one or more user computer systems  802  and provides access to shared computer resources (e.g., storage, memory, applications, virtual machines, etc.) to the user computer systems  802 . As depicted in  FIG.  58   , the cloud computing environment includes one or more interconnected nodes  804 . Each node  804  may be a computer system or device local processing and storage capabilities. The nodes  804  may be grouped and in communication with one another via one or more networks. This allows the cloud computing environment  800  to offer software services to the one or more computer services to the one or more user computer systems  802  and as such, a user computer system  802  does not need to maintain resources locally. 
     In one embodiment, a node  804  includes computer readable program instructions for carrying out various steps of various methods disclosed herein. In these embodiments, a user of a user computer system  802  that is connected to the cloud computing environment may cause a node  804  to execute the computer readable program instructions to carry out various steps of various methods disclosed herein. 
     Referring now to  FIG.  59   , a method  900  for running a diagnostic test on a drawn physiological sample is shown in accordance with an exemplary embodiment. 
     At  902 , a user (e.g., a medical professional, a subject, etc.) applies the cartridge  12  to the skin of the subject via the adhesive layer  14  at a suitable location (e.g., on a leg, arm, etc.) as previously discussed herein. 
     At  904 , the user inserts the lancet  100  into the cartridge  12  thereby causing the needle  110  of the lancet  100  to draw a physiological sample (e.g., a blood sample, a sample of interstitial fluid, etc.) from the subject as previously discussed herein. 
     At  906 , the user moves the vacuum pin  400  from the undeployed position to the deployed position to draw the drawn physiological sample to the diagnostic test strip  18  as previously discussed herein. 
     At  908 , the user ruptures the processing fluid pack  16  by moving the button  500  from the locked position to the deployed position, wherein the drawn physiological sample interacts with the released processing fluid to form a processed physiological sample as previously discussed herein 
     At  910 , the user removes the dermal patch system  10  from the skin of the subject and determines the presence or absence of a biomarker in the drawn physiological sample by viewing the test strip as previously discussed herein. 
     At  912 , a user of the computer system  30  scans the QR code  22  and photographs the diagnostic test strip  18  as previously discussed herein. 
     At  914 , the computer system  30  or another computer system that is in communication with the computer system  30  associates the QR code  22  with an EMR  32  and updates the associated EMR  32  to indicate a diagnostic test has been performed on the drawn physiological sample. In one embodiment, the computer system  30  automatically updates the associated EMR  32 . In another embodiment, the user of the computer system  30  updates the associated EMR  32 . Furthermore, at  914  the user of the computer system  30  photographs the diagnostic test strip  18  and the computer system  30  associates the photograph with the EMR  32  in the EMR database  34 . In one embodiment, the computer system  30  or another computer system connected to the EMR database  34  analyzes the photograph to determine the result of the diagnostic test (i.e., the presence or absence of a biomarker in the drawn physiological sample) and updates the associated EMR  32  to include the determined result. 
     As previously discussed, some of the steps of the various methods disclosed herein may be implemented by way of computer readable instructions, encoded or embedded on computer readable storage medium (which excludes transitory medium), which, when executed by a processor(s), cause the processor(s) to carry out various steps of the methods of the present disclosure. 
     While various embodiments have been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive; embodiments of the present disclosure are not limited to the disclosed embodiments. Other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing embodiments of the present disclosure, from a study of the drawings, the disclosure, and the appended claims. 
     In the claims, the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. A single processor or other processing unit may fulfill the functions of several items recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measured cannot be used to advantage. Any reference signs in the claims should not be construed as limiting the scope.