CROSS-REFERENCE TO RELATED APPLICATION

[0001] This Application claims the benefit of U.S. Provisional Application Serial No. 63/310,331 filed on February 15, 2022, entitled: MEDICAL DIAGNOSTIC COLLECTOR AND DOCKCING STATION FOR BIOFLUID ANALYSIS; and U.S. Provisional Application Serial No. 63/310,341, filed on February 15, 2022, entitled: ADAPTER FOR OPTICALLY COUPLING A BIOFLUID COLLECTOR TO A DOCKING STATION FOR BIOFLUID ANALYSIS, commonly assigned with the present disclosure and incorporated herein by reference.

TECHNICAL FIELD OF THE DISCLOSURE

[0002] The present disclosure is directed to a biofluid collector that includes a photonic chip and integrated docking station for the rapid detection or presence of an analyte, such as illicit or prescribed drugs, alcohol in a biofluid, such as urine, blood, breath condensate, salvia, or another biofluid, and for detection of pathogens. Adapters are also presented that allow the collector to be inserted into the docking station, if needed. BACKGROUND OF THE INVENTION

[ 0003 ] With the proliferation of the use of illegal and abuse of prescription drugs or driving under the influence of one of these drugs or alcohol , drug and/or alcohol testing has become more common place in many industries and in law enforcement . For example , a person may be required to take a drug test either for purposes of healthcare or employment . One example, a hospital or doctor may request a urine drug screen if they think that a person has been using illegal drugs or misusing prescription drugs . For example , a doctor may request a urine screen to determine if a person is misusing the opioids that the doctor had prescribed to treat their chronic pain . An emergency services staff member may request a urine drug screen if they suspect that a person is behaving strangely or dangerously due to the influence of drugs . Drug and alcohol rehabilitation programs may request urine drug screens to check whether a person is staying sober , and prison officials also require these tests from individuals with histories of drug abuse . Additionally, many sporting officials require urine drug screens to check whether athletes have used performance-enhancing drugs . Many employers also require potential employees to take a drug test before they can be hired. One benefit of the urine drug screen is that it can keep people with drug problems out of jobs that require the ability to be alert and focused . For instance , an air traffic controller , pilot truck driver , or a person operating heavy machinery who uses drugs could put the safety of many people at [ 0004 ] There are two types of urine drug screens . The first, called the immunoassay, can be cost-effective and give results quickly . However , it has drawbacks . For example , it doesn' t pick up on all opioids , and it sometimes gives false positives . A false positive occurs when the test results come back positive for drugs , but there has been no drug use . The second type is gas chromatography/mass spectrometry GC/MS) . This type of test uses the same procedure for getting a urine specimen as the immunoassay, but it is more expensive and takes longer to get test results from the laboratory. For example , depending on the drug for which the test is being conducted, the results may not be available for several hours or several days . Some tests may even take up to 3 to 4 weeks before results are known .

[ 0005 ] Another testing area involves breathalyzers used in law enforcement . There are different types of analyzers presently used. One type is a passive breathalyzer . This type has internal fuel sensors that are designed to detect the presence of alcohol when a motorist exhales near the analyzer . The other type is an active breathalyzer . This type of analyzer requires the driver to blow into a mouthpiece to determine the driver' s body alcohol content . Both types analyze only the presence of or blood-alcohol content of alcohol of the driver . However , neither type of device can analyze any other type of intoxicating substance , such as cannabis . Analysis for these types of drugs require a blood test, which often requires a warrant, by which time , the drug content in the suspect' s body may have depreciated below legal threshold limits . SUMMARY OF THE DISCLOSURE

[ 0006 ] To address the above -dis cussed deficiencies , the present disclosure provides a unique , optically based detection technology that provides for accurate measurements and detection that are direct, rapid, and have increased sensitivity in detection of analytes , such as alcohol or illicit or prescribed drugs .

[ 0007 ] The embodiments , as presented herein , provide a biofluid collection device , herein after "collector ," comprising a body having a volume for holding a biofluid therein . The body has an opening in one end through which a biofluid is received into the body and a base located opposite the open end . Another embodiment of this disclosure discusses a photonic chip, which in one embodiment may be incased in a housing to provide a photonic module . In one embodiment, the photonic chip comprises an integrated planar waveguide formed on a substrate that has an input and output . Positioned on that same substrate are input and output optical fibers that extend, respectively, from the input and outputs of the planar waveguide to optical coupling ends . The substrate extends beyond the perimeter of the waveguide and has v-grooves formed in it that accommodate the input and optical fibers . Input and output optical connectors are located on the ends of the optical fibes . The input and output optical fibers located on the substrate extend from the input and output optical connectors to proximate or abutting the input and output ends of the waveguide , respectively. In one application , the photonic module can be positioned within the base of the biofluid collection device . The biofluid or another analyte can flow into the photonic module and contact the waveguide . The biofluid collection device can then be inserted into an analytical docking for spectral analysis .

[ 0008 ] In another aspect of this disclosure , there are presented embodiments of horizontal or vertical adapters . The horizontal adapter optically couples to a photonic chip horizontally located within a base of the collector . The horizontal adapter can then be inserted into a docking port of a docking station , embodiments of which are discussed below, to provide optical coupling between the collector and the docking station for spectral analysis . The vertical adapter optically couples to a photonic chip vertically located within a base of the collector . The vertical adapter can then be inserted into the docking port of the docking station to provide optical coupling between the collector and the docking station for spectral analysis .

[ 0009 ] This disclosure also discusses embodiments of the above- mentioned docking station . In one embodiment, this disclosure provides embodiments of a portable docking station that comprises , a power source , a laser , microprocessor , and an optical interface located on an exterior face of the docking station that is configured to receive the coupling ends of the photonic chip to provide optical coupling between the photonic chip and the docking station . The interface forms an open optical loop , wherein the optical loop is completed upon insertion of the photonic chip into the optical interface . These embodiments further include an integrated interferometer , including a fixed optical system comprising a beam splitter , interference gratings , a focusing lens , and photodetector . These components of the interferometer are thermally isolated from heat sources , such as the laser and microprocessor , within the docking station . The above-mentioned components are all contained within a compact docking station housing that is easily portable .

[ 0010 ] The foregoing has outlined features so that those skilled in the art may better understand the detailed description that follows . Additional features will be described hereinafter that can form the subject of the claims . Those skilled in the art should appreciate that they can readily use the disclosed conception and specific examples as a basis for designing or modifying other structures for carrying out the same purposes disclosed herein . Those skilled in the art should also realize that such equivalent constructions do not depart from the spirit and scope of the disclosure .

BRIEF DESCRIPTION OF THE DRAWINGS

[ 0011 ] For a more complete understanding of the present invention , reference is now made to the following descriptions taken in conjunction with the accompanying drawings , in which :

[ 0012 ] FIG . 1 illustrates an embodiment of a docking station with a biofluid collector optically coupled to the docking station ; [0013] FIG. 2A illustrates an isometric view of an embodiment of a photonic module housing a photonic chip that can be used in the biofluid collector;

[0014] FIG. 2B illustrates a sectional view of the embodiment of FIG. 2A;

[0015] FIG. 20 illustrates an enlarged partial view of the FIG. 2B;

[0016] FIG. 2D illustrates an overhead view of an embodiment of a waveguide contained within the photonic module;

[0017] FIG. 2E illustrates a schematic sectional view of an example of a waveguide showing the individual waveguide ridges and optional nanoparticles;

[0018] FIG. 3 illustrates an embodiment of a collector with a horizontally oriented photonic module;

[0019] FIG. 4 illustrates an embodiment of a horizontal adapter optically coupled to the horizontally oriented photonic module of the collector of FIG. 3;

[0020] FIG. 5 illustrates an embodiment of a collector with a vertically oriented photonic module;

[0021] FIG. 6A illustrates an embodiment of a vertical adapater optically coupled to vertically oriented photonic module of the collector of FIG. 5;

[0022] FIG. 6B illustrates an exploded view of the positional relationship of the embodiment of FIG. 6A and a docking station; [0023] FIG. 7 illustrates another embodiment of the collector wherein a vertically oriented photonic module is located within the lid of the collector;

[0024] FIG. 8 illustrates a sectional view of an embodiment of a tube collector with the photonic module vertically oriented;

[0025] FIGs . 9A-9E illustrate different embodiments of a test card collector;

[0026] FIGs. 10A and 10B illustrate an embodiment of a condensate collector; and

[0027] FIGs. 11A-11I, illustrate embodiments of different aspectsof an embodiment the docking stations to which the collectors can be optically connected.

DETAILED DESCRIPTION

[ 0028 ] There is a need for a biofluid collector and analytical system that can provide rapid results regarding the detection and quantification of analytes , such as illicit or prescription drugs or alcohol , in body fluids , such as urine , salvia or breath condensate . In other applications , rapid detection of pathogens , such as viruses is also possible . Currently, it can take days , or in some cases , even weeks to get accurate results from current analytical processes that involve urine analysis . In cases when breath condensate is the collection means , results can be near instantaneous , however , those results are limited to certain types of analytes , such as alcohol and cannot detect other analytes , such as cannabis , which may be impairing the driver . By the time blood can be obtained based on a warrant, the amount of cannabis in the individual may have dropped below legal threshold limits , thereby allowing the individual to evade citation or arrest .

[ 0029 ] The various embodiments of the present disclosure provide a biofluid, or body fluid, collector and diagnostic system contained within a portable docking station that provides highly accurate results within minutes and without the need of reagents associated with conventional processes , such the above-mentioned immunoassays or GC/MS systems . Further , breath condensate analysis is not limited to alcohol in that the diagnostic system can provide analysis of any type of drug that is contained within an individual ' s breath . Thus , the embodiments of the present disclosure provide the rapid results offered by an immunoassay or breathalyzers and the accuracy offered by a GC/MS system. These unique features offer healthcare providers employers and law enforcement officials a system that can obtain highly accurate results , for example , within 5 to 10 minutes . This minimized time from collection to results provides better efficiency in a healthcare or law enforcement process decisionmaking process .

[ 0030 ] FIG . 1 is an isometric view of an embodiment of a photonic based analytical system 100 that addresses the above-noted needs . The photonic based analytical system 100 does not require chemicals to conduct the analysis of the target analyte . Instead, the photonic based analytical system 100 using changes in a light spectrum that occurs from a waveguide' s plasmonic interactions with components in the analyte . The illustrated embodiment comprises a docking station 105 and collector 110 that has an interior volume that is capable of holding a biofluid therein optically coupled to the docking station 105. As discussed below, the collector 110 may have several configurations designed to hold the fluid, such as fluid obtained from a subject' s body. Though urine is specifically discussed in this disclosure , it is for illustrative purposes only and other biofluids , such as saliva , blood or blood plasma , or breath condensate , etc . , may be applicable . The collector 110 , which in the illustrative embodiment, is a modified specimen cup, includes a photonic module 115 as described in more detail below. As explained below, the photonic module 115 receives an input optical signal from the docking station 105 and transmits an output optical signal to the docking station 105 , which then analyzes the optical signal to provide qualitative and/or quantitative data regarding the fluid in the collector 110. The photonic module 115 contained within the collector 110 is configured to be received within a docking port 120 of the docking station 105 , through which optical coupling between the photonic module 115 and docking station 105 is achieved. The photonic transmission between the photonic module 115 within the collector 110 and the docking station 105 provides near instantaneous and accurate test results of the analyte within the fluid or condensate , depending on the embodiment of the collector 110 being used. The docking station 105 has a compact, light-weight configuration that makes it portable and suitable for field use or point of use applications .

[ 0031 ] FIGs . 2A and 2B illustrate an isometric view and a sectional view, respectively, of one embodiment of the photonic module 115 . In this illustrated embodiment, the photonic module 115 comprises an optional housing 205 , which may be comprised of a moldable material or other machinable material that provides structural support, such as plastic , metal , or ceramics . The housing 205 has as upper surface 205a that includes an opening 210 through which a biofluid flows from the collector 110 (FIG . 1) . In another embodiment, an optional fluid reservoir 210a may be located over the opening 210 to further expand the volume fluid capacity into which a subject analyte can be placed. In such embodiments , the subject fluid would flow from the optional fluid reservoir 210a and through the opening 210 . The housing 205 prevents fluid from entering the housing 205 except through opening 210 or the optional fluid reservoir 210a , as see in FIG . 2B . In one embodiment, filter 215 is present . In such embodiments , the biofluid flows through the optional filter 215 before flowing onto and wetting the photonic chip 220 that is located under the filter 215 . This optional filter 215 may be comprised of known filtration materials and is present in those embodiments when it is desired to filter out particulates in the biofluid .

[ 0032 ] Input and output optical fibers 225 , shown in dashed lines in FIG . 2A, extend through respective optical connectors 225a and to or near respective input/output ends 220a of the photonic chip 220 , of a waveguide 220b (dashed lines) , as discussed in more detailed below regarding FIG . 2B . In an embodiment, the input and out optical fibers 225 are conventional glass fibers that comprises an inner core and an outer cladding , wherein the inner core and outer cladding have different indexes of refraction between the two materials to cause light to propagate along the inner core . In an embodiment, the input and out optical fibers 225 have a lens located on the end that optically couples with the input and output ends of the photonic chip 220 and are positioned within v-grooves to hold the optical fibers in an optically aligned position with the photonic chip 220 . In one embodiment , the photonic chip 220 , the input and out optical fibers 225 and the optical connectors 225a present a photonic chip assembly 230 , that can be located within the housing 205 of the photonic module 115.

[ 0033 ] In one embodiment, the optical connectors 225a may be a known optical connector type , such as a ferrule . The optical connectors 225a provide strength , rigidity, and support for the input and output fibers 225 when the collector 110 is inserted into the docking station 105 (FIG. 1) . In one embodiment, the optical connectors 225a may be comprised of a ceramic material , however , other known materials may be used, such as metal .

[ 0034 ] The input and out optical fibers 225 have respective a terminal ends that terminate at or proximate the end of the optical connectors 225a and coupling ends positioned proximate the input/output ends 220a of the photonic chip 220 sufficient to provide optical coupling between the photonic chip 220 and the input and out optical fibers 225 . In one embodiment, the input/output ends 220a and input and out optical fibers 225 are separated by several microns , for example , in one embodiment, they may be separated by 10 to 20 microns . However , in other embodiments , the input/output end 220a and optical fibers may abut one another . As mentioned above , in an embodiment, the coupling ends of the input and out optical fibers 225 are lensed, while the terminal ends that extend through the optical connectors 225a are flat . In the embodiment where the lensed ends are present, the lenses improve light coupling from a light source , such as a laser , of the docking station and into the input end of the photonic chip 220 and light emerging from the output end of the photonic chip assembly 230 . In one embodiment, the radius of curvatures of the lenses may be different . For example , in one embodiment, the radius of curvature of the input lens may be half that of the output lens . In such embodiments , the degree of separation may depend on the working distance of the lensed optical fiber . The input/output ends 220a of the photonic chip 220 and the input and out optical fibers 225 have a composition that transmits light along an optical path .

[ 0035 ] As seen in FIG . 2B, the photonic chip 220 is located on the same substrate 235 on which the input and out optical fibers 225 are located thereby forming an integrated V-groove design . In one embodiment, the substrate 235 is located on a base substrate 240 that may comprise a material , such as silica or quartz to provide further structural support to the integrated design . In one embodiment, each of the input and out optical fibers 225 , only one of which is shown in this sectional view, is positioned in a V- groove 235a formed in the substrate 235 and sized to hold the optical fiber 225 , while the optical connector 225a is located within a larger V-groove 235b, also formed in the substrate 235 , sized to hold the optical connector 225a in position on the substrate 235. The optical fiber (s) 225 may be further secured in place by a holding cap 235c, comprised of , for example , of quartz , silica , plastic, or other ridged material , and the optical connector (s) may be held in place by a holding cap 235d comprised of similar materials to that of the holding cap 230c . In one embodiment the substrate 235 may be comprised of silicon . In one embodiment, a trench 245 is located between the input/output ends 220a of the photonic chip 220 and the coupling ends of the optical fiber (s) 225 , as generally shown .

[ 0036 ] FIG . 20 illustrates an enlarged view of an embodiment that further illustrates the trench 245 and the coupling end (s) of the optical fiber (s) 225 positional relationship with the input/ output ends 220a of the photonic chip 220 . In one embodiment, the trench 245 may include a stair-stepped profile , an embodiment of which , is shown in FIG. 2C , to ensure proper offset of the coupling end (s) of the optical fiber (s) 225 from the input/output ends 220a of the photonic chip 220. The input/output ends 220a of the photonic chip 220 are faceted and terminate at or near a faceted surface 220c of the photonic chip 220 . In an embodiment , the faceted surface 220c is a highly polished surface having a near vertical orientation (for example an angle of about 90 °, ±4 } with respect to the longitudinal axis of the optical fiber (s) 225 to aid in a high degree of light coupling between the photonic chip 220 and the optical fiber (s) 225 .

[ 0037 ] The photonic chip 220 used in the various embodiments of this disclosure comprise the waveguide 220b that includes those embodiments as disclosed in US Publication No . 2021/0293716 , filing date of March 17 , 2021 , which is incorporated herein by reference for all intents and purposes . In one such embodiment , as seen in FIG . 2D , the photonic chip 220 comprises a waveguide 250 , that in one embodiment, may have a serpentine configuration of various geometric designs . The waveguide 250 has an optical input fiber 250a and optical output fiber 250b . As discussed above , the optical fibers 250a and 250b optically couple to the coupling ends of the optical fiber (s) 225 , respectively, that extend through and to or near the end of the optical connectors 225a , which are used to optically couple the photonic module 115 located in the collector 110 to the docking station 105. (FIG. 1) .

[0038] FIG. 2E is a schematic sectional view of one embodiment of the waveguide 220b that can be used. In this view, the waveguide 220b is patterned on the substrate 235. In one embodiment, the substrate 235, as discussed above, may be comprised of a known semiconductor material, for example, silicon or silicon dioxide. In an embodiment, the waveguide 220b is patterned to from a planar waveguide, where each ridge 220d has exposed side surfaces 220e and an uppermost surface 220f, as seen in the schematic sectional view of FIG. 2D. In one embodiment, the waveguide 220b may be comprised of a silicon nitride material, such as SiN2, SisNs, SiON, which can be deposited and etched using known lithographic and deposition processes. Silicon nitride is given as an example, but the waveguide 220b may comprise other types of materials, such as Gallium Arsenide, Aluminum Gallium Arsenide, Silicon, Aluminum Oxides, Silicon Oxy-Nitrides, Doped Silicon dioxide (Titanium, Lithium, phosphorus, boron, etc.) , or combinations thereof, are also within the scope of this disclosure.

[0039] In one embodiment, nanoparticles 255, such as silver, gold, copper, platinum, palladium, aluminum, or combinations thereof are located on or ("or" as used herein and in the claims includes conjunctive and disjunctive forms, "and/or") may be located adjacent at least a portion of the ridges 220d of the waveguide 220b, that is, the nanoparticles 255 are close enough the waveguide 220b to enhance the charge transfer, or plasmonic resonance of the optical signal being transmitted by the waveguide 220b . In one embodiment, a concentration of the nanoparticles 255 per square unit surface is greater at or adjacent the side surfaces 220e than on the uppermost surfaces 220f , as generally illustrated in FIG. 2D . For purposes herein and in the claims , "uppermost surface" is the surface of the ridge 220d that extends the furthest from the substrate 235 . In one embodiment , the nanoparticles 255 extend along a sensor portion of the length of the waveguide 220b . The sensor portion is that portion of the waveguide 220b that is uncladded and from which test data is collected and used to determine the test results . The sensor portion may extend the length of the waveguide 220b or only a portion of it .

[ 0040 ] In those embodiments where the nanoparticles 255 are present , their larger concentration adjacent or at the side surfaces 220e improves the plasmonic resonance coupling of light from the waveguide with the analyte to provide improved data collection as it relates to the target analyte . Though metals are mentioned specifically, other highly conductive materials that can be deposited or formed at the nanoscale may also be used. For example , a nanostructured semiconductor surface may also be used to shape the charge transfer , or plasmonic resonance as well . Semiconducting materials that have been considered for use include narrow bandgap materials such as silicon carbide , carbon , or gallium nitride as well as narrower bandgap materials such as germanium, lead selenide , lead telluride , Gallium Antimonide , Gallium Arsenide , Indium

Phosphide . There are additionally, several evolving semiconductors whose nanostructure behaviors may have unique benefits , such as the chalcoginide molybdenum disulfide (M0S2) .

[ 0041 ] FIG . 3 illustrates one embodiment of the collector 110 as in FIG . 1 . In this embodiment , collector 110 is a modified specimen cup 300. It may be comprised of any shapable material , but in one embodiment, the specimen cup 300 comprises plastic . The specimen cup 300 has a body 302 designed to hold a fluid therein and a base 305 that includes a fluid port 310 located in the base 305 through which a test fluid may flow . As used herein and in the claims , a "base" is that portion of the collector 110 in which the photonic module 115 is located . The base 305 has a docking cavity 315 formed in it that serves as a docking cavity and is sized to receive the photonic module 115 therein , embodiments of which are described above . In this embodiment , the photonic module 115 is positioned within the docking cavity 315 and under the fluid port 310 such that it can receive a fluid flow from the body 302 . In the illustrated embodiment , the photonic module 115 is horizontally oriented such the optical path from the photonic chip 220 to the optical connectors 225a is oriented parallel with the diameter of the base 305. This horizontal orientation allows the specimen cup 300 to be inserted into the docking port 120 of the docking station 105 (FIG. 1) in a horizontal orientation with respect to the docking port 120. An adhesive may be used to secure the photonic module 115 within the docking cavity 315 , or the docking cavity 315 may be designed such that the photonic module 115 is secured by a friction fit within the docking cavity 315. [ 0042 ] A known sealing material can be used to form a fluid tight seal between the fluid port 310 and the photonic module 115 . In those embodiments where an adhesive is used, the adhesive may also serve to provide this fluid tight seal . As seen in the illustrated embodiment, the photonic module 115 is inserted in the docking cavity 315 to about half the length of the base 305 . However , in other embodiments , the length of the docking cavity 315 may be such that it positions the optical connectors 225a of the photonic module 115 just within or at the edge of opening of the docking cavity 315 . This position allows the optical connectors to be protected from physical damage , while still be able to be inserted into the docking station for optical connection therewith . The opening 210 of the photonic module 115 is positioned below the fluid port 310 such that biofluid within the specimen cup 300 flows through the opening 210 and onto the photonic chip 220 within the photonic module 115 . This brings the analyte (s) into contact with the waveguide of the photonic chip 220 . Thereafter , quantitative or qualitative photonic analysis in cooperation with the docking station 105 (FIG. 1 ) can be conducted regarding any analyte (s) that may be present in the biofluid .

[ 0043 ] An embodiment of a horizontal adapter 400 is shown in FIG . 4 optically coupled to the photonic module 115 housed in the collector . The horizontal adapter 400 has a mounting body 410. The mounting body 410 includes a coupling end 415 that is configured or sized to be received in the docking cavity 315 of the specimen cup 300 , as seen in FIG . 3. The coupling end 415 includes optical connectors 420 , only of one of which is shown in the side view and that may be of the same type as those described above regarding the photonic module 115. Optical fibers 425 (only one of which is shown) extend from the optical connectors 420 , respectively, and terminate at the ends of respective optical connectors 430 , as generally shown . The terminating ends of the optical fibers 425 may be truncated, lensed, or angled to provide an optical input/output . In one embodiment , the optical connectors 420 may be biased by springs 420a and may be recessed in the mounting body 410 and sized to receive the optical connectors 225a of the photonic module 115 and provide optical coupling therebetween .

[ 0044 ] FIG . 5 illustrates another embodiment of the collector 110 of FIG. 1 . In this embodiment, the collector 110 is a modified collector cup . It may be comprised of any shapable material , but in one embodiment, the collector cup 500 comprises plastic . In contrast to the embodiment of FIG . 3 , the photonic module 115 , embodiments of which are described above , is oriented in a vertical direction or orthogonal to the diameter of the collector base 525 of the collector cup 500. The collector base 525 has an opening 530 (represented by dashed line) located in the collector base 525 that opens into a docking cavity 535 that serves as a docking cavity for the collector cup 500 and for its insertion into the docking station 105 . (FiG . 1 ) . The opening 530 is sized to allow the optical connectors 225a of the photonic module 115 to extend through it and into docking cavity 535. The upper portion of the photonic module 115 , which includes the opening 210 , is sized so that it cannot pass through the opening 530 . The photonic module 115 has shoulders 205b that seat against the bottom of the collector cup 520 , as generally shown in FIG . 5 . A known sealing adhesive can be used to attach and fluidly seal the shoulders 205b against the bottom of the collector cup 500 to prevent leakage from the collector cup 500 . However , other known attachment and sealing means may also be used. For example , the bottom of the collector cup 500 may include an attachment structure molded into the collector base 525 of the collector cup 500 that is designed to hold and seal the photonic module 115 therein . Also , other known sealing means , such as "O" ring seals , a tight friction fit , or similar sealing means may be used.

[ 0045 ] As mentioned above , in the embodiment of FIG . 5 , the photonic module 115 is oriented such that its ' orientation is orthogonal to the collector base 525. This orientation allows the collector cup 500 to be inserted into the docking port of the docking station in an orientation that is vertical with respect to the collector base 525. In such embodiments , the docking station 105 (FIG . 1 ) may be modified or repositioned such that the docking port 120 is oriented to receive the collector cup 500 from a vertical direction . Alternatively, a vertical adapter may be used to position the collector cup 500 in the oriented docking port 120. However , in some applications , the collector cup 500 , once securely sealed with a lid, may be horizontally inserted into the docking station 105 , but care must be taken to make certain that sufficient biofluid is in the collector cup 500 to allow it to flow into the photonic module 115 and contact the photonic chip 220.

[ 0046 ] FIG . 6A illustrates an embodiment of a vertical adapter 600 that may be coupled to the collector cup 500. FIG . 6A illustrates an embodiment of the collector cup 500 optically coupled to the vertical adapter 600. The upper region of the vertical adapter 600 is an optical coupling end that comprises a docking platform 615 that has a protruding coupling structure 615a that, in the illustrated embodiment , is cone-shaped and received within the docking cavity 535 of the collector 110 , as better seen in FIG . 5 . This allows the recessed optical connectors 225a of the photonic module 115 to be inserted into the openings in the docking platform 615 and be optically coupled to optical connectors 610a , 610b recessed into the docking platform 615 . The photonic module 115 is oriented such that the optical connectors 225a extend downward in a general vertical direction . The optical connectors 225a of the photonic module 115 are optically connected to the optical connectors 610ac , 610b that receive optical fibers 615c, 610d . The optical fibers 615c, 615d extend to respective optical connectors 620a , 620b , such as ferrules . The optical fibers 615c, 615d transition from a vertical orientation to a horizontal orientation , as generally shown in FIG. 6A. Optical connectors 620a , 620a are insertable into the docking port 120 of the docking station 105 to provide optical connection between the collector 110 and the docking station 105 , as generally shown in FIG. 6B . As seen , the photonic module 115 extends into the liquid holding volume of the collector 110 , which allows biofluid within the collector 110 to flow into the photonic module 115 and wet or cover the photonic chip 220 (shown in dashed lines) with biofluid.

[ 0047 ] FIG . 7 illustrates another embodiment of the collector 110 . (FIG. 1) . In this embodiment, the photonic module 115 is located within a lid 700 of a collector 110 that is designed to fit on or be attached to a specimen cup 705. In this embodiment the lid 700 comprises a collector base 710 . The collector base 710 has an opening 715 in the center of the lid 700 . The opening 210 of the photonic module 115 protrudes above an interior surface 720 of the collector base 710 and is oriented in a vertical direction in the illustrated embodiment . However , in another embodiment , the photonic module 115 may be oriented in a horizontal direction as previously described regarding other embodiments .

[ 0048 ] When attached to the specimen cup 705 , the biofluid enters through the opening 210 and contacts the waveguide of the photonic chip within the housing 205 . The lid 700 may include threads that correspond to threads located on the outer perimeter of the specimen cup 705 , as generally shown , or other types of known or later discovered attachment means may be used to attach and fluidly seal the lid 700 onto the specimen cup 705. It is important, however that whatever type of attachment means is used that fluid is not able to leak biofluid from between the lid 700 and the specimen cup 705 . In some embodiments a silicon sealing ring may be located about the internal diameter of the lid 700 to enhance the sealing of the lid 700 when attached to the specimen cup 705 . In this embodiment, the biofluid is intended to be deposited into the specimen cup 705 , after which , the lid 700 is sealing attached to the specimen cup 705 . During the analysis process , the specimen cup 705 is inverted to allow the biofluid to flow to and fill the lid 700 , which in turn allows the biofluid to enter the photonic module 115 through opening 210 and contact the photonic chip (not shown) . Depending on the orientation of the photonic module 115 , either the vertical adapter 600 or horizontal adapter 400 , as described above may be used to provide optical connection to the docking station 105. [ 0049 ] FIG . 8 illustrates another embodiment of the collector

110 (FIG . 1 ) . In this embodiment , the collector 110 is a tube 800 , such as a test tube . It may be comprised of any shapable material , but in one embodiment , the tube 800 comprises glass , but other moldable materials , such as plastic, can also be used . The tube 800 includes a tubular body 805 that has a collection end 805a and a docking end 805b . A base 810 of the tube 800 is located on the docking end of the tubular body 605 , which is also the docking end of the tube 800. The tube 800 may also have an optional cap 815 on the collection end 805a of the tubular body through which the biofluid is dispensed into the tube 800 . The cap 815 , for example , may be a rubber cap through which a dispensing needle may be inserted to place the biofluid in the tube 800 , or in another example , it may be a threaded cap that engages corresponding threads on the collection end.

[ 0050 ] The base 810 has an opening 820 through which the photonic module 115 extends into a docking cavity 825 that has a diameter larger than the opening 820 , which forms a space between the interior wall of the base 810 and the outer perimeter of the photonic module 115 , as generally illustrated . The docking cavity 825 opens into a docking port 830 into which the optical connectors 225a of the photonic module 115 extend. As described above regarding other embodiments , a known sealing adhesive can be used to attach and fluidly seal the photonic module 115 within docking cavity 625 to prevent leakage from the tube 800.

[ 0051 ] The docking end 805b is received within the docking cavity 825 and has an opening 835 in it (shown by dashed line) through which a biofluid may flow . In one embodiment , the opening 835 has a diameter the same as the interior diameter of tubular body 805 , which results in an open-ended tube configuration , as generally illustrated . In the illustrated embodiment , the docking end 805b is received within docking cavity 825 , as generally shown , which forms a space into which a biofluid may flow.

[ 0052 ] In the illustrated embodiment, the photonic module 115 is oriented in a vertical direction or orthogonal to the diameter of the base 810 , and parallel with the longest axis of the tubular body 805 . However , in another embodiment , the photonic module 115 may be oriented parallel with the diameter of base 810 and orthogonal with the longest axis of the tubular body 605 , that is in a horizontal orientation like other above -dis cussed embodiments .

[ 0053 ] As mentioned above , in the embodiment of FIG . 8 , the photonic module 115 is oriented such that its ' orientation is orthogonal or vertical to the base 810 . This allows the tube 800 to be inserted into the docking port 120 of the docking station 105 in a vertical orientation . In such embodiments , the docking station 105 (FIG. 1 ) , may be configured or repositioned such that the docking port 120 is oriented to receive the tube 800 from a vertical direction . Alternatively, an adapter may be used to position the tube 800 in a horizontal orientation with respect to the docking port 120. (FIG. 1) . However , even when the photonic module is vertically oriented as described above , the tube 800 , once securely sealed, may be inserted into the docking station 105 horizontally but care must be taken to make certain that sufficient biofluid is in the tube 800 to allow it to flow into the photonic module 115 and contact the photonic chip 220 .

[ 0054 ] In practice , the biofluid is collected into the tube 800 , and it flows to the docking end where it enters the photonic module 115 and contacts the photonic chip 220 . Thereafter , quantitative and/or qualitative photonic analysis can be conducted regarding any analyte (s) that may be in the biofluid in cooperation with the docking station 105 (FIG . 1 ) .

[ 0055 ] FIGs . 9A and 9B illustrate another embodiment of the collector 110. FIG. 9A is an isometric view of one embodiment of a test card collector 900. This embodiment comprises a housing 905 that has a fluid port 910 formed therein , which allows biofluid to flow into the photonic module 115 , shown in dashed line . The photonic module 115 is set within the housing 905 in a docking cavity 915 that serves as a docking port for optically coupling to the docking station 105 (FIG. l) . FIG. 9B is an overhead sectional view of the test card collector 900 of FIG . 9A showing the positional relationship of the photonic module 115 within the docking cavity 915 , though in other embodiments the location of photonic module 115 within the docking cavity 915 may be different from the illustrated embodiment . For example , it may be positioned near the open end of the docking cavity 915.

[ 0056 ] FIG . 90 is a side sectional view of the test card collector 900. As seen in this embodiment, the photonic module 115 is located within the housing 905 and a docking cavity 915 and includes the photonic chip assembly 230 , as previously described. In one embodiment , the photonic module 115 is inset into the docking cavity 915 such that the optical connectors 225a are protected within the docking cavity 915 . However , in another embodiment , as illustrated in FIGs . 9D and 9E , the optical connectors 225a may extend beyond the docking cavity 915 when received within the docking port 120. In such embodiments , the test card collector 900 comprises a housing 920 that has a retractable cover 925 that covers the optical connectors 225a when the test card collector 900 is not engaged with the docking port 120 of the docking station 105 (FIG. 1 ) . In one embodiment , the housing 920 has springs 930 that bias the retractable cover 925 to cover the optical connectors 225a of the photonic chip assembly 230 when the test card collector 900 is not positioned in the docking port 120 of the docking station 105. However , when the test card collector 900 is inserted into the docking port 120 , the retractable cover 925 slides into the housing 920 to expose the optical connector 225 , which allows them to be inserted into an optical connector interface within the docking port 120 and thereby make optical connection between the photonic chip assembly 230 and the docking station 105.

[ 0057 ] FIGs . 10A and 10B, illustrate another embodiment of the collector 110. In this embodiment , the collector 110 is a condensate tube 1000 , an isometric view of which is shown in FIG . 10A. This embodiment includes an intake tube 1005 and one or more exhaust tubes 1010 that extend to and open into a manifold 1015. The intake tube 1005 may include a mouthpiece 1020 into which a donor would exhale the vapor that would travel down the intake tube 1005 , condense into liquid within the manifold 1015 and then proceed out of the condensate tube 1000 by way of the one or more exhaust tubes 1010 . The condensate can flow from the manifold 1015 through fluid passageway 1025 and onto the photonic chip 220 of the photonic chip assembly 230 , (shown in dashed lines) , located in a collector base 1030 of the condensate tube 1000. The photonic chip assembly 230 , may include the photonic module 115 , as discussed above regarding other embodiments , or it may be a photonic chip assembly 230 that is not contained within the photonic module 115 , as generally illustrated in FIG. 10A, and as discussed above regarding other embodiments . Also , the photonic chip assembly 230 or photonic module 115 , may be positioned in a horizontal direction (parallel with the collector base 1030) , as generally illustrated in FIG. 10A, or it may be vertically oriented, that is , along the longitudinal axis of the condensate tube 1000. Depending on the orientation of the photonic chip assembly 230 , the vertical and horizontal adapters ,

-2 R - as discussed above , may be used to optically connect the condensate tube 1000 to the docking station 105 .

[ 0058 ] FIG . 10B illustrates a sectional view of another embodiment of the condensate tube 1000 . In this embodiment the photonic chip assembly 230 is located within the photonic module 115 , as described above regarding other embodiments . As with previously discussed embodiments , the photonic module 115 includes the photonic chip assembly 230. The photonic module 115 is positioned within a docking cavity 1035 and secured in place as with other previously described embodiments . In one embodiment, the condensate tube 1000 may also include a coalescing filter 1040 that covers the intake opening 1010a of the condensate tube 1010 . The intake opening 1010a is the end that opens into the manifold 1015 and through which the non-condensed vapor enter the exhaust tube and exits the condensate tube 1000 . In those embodiments were more than one condensate tube 1010 is present, each condensate tube 1010 may have an associated coalescing filter 1040 .

[ 0059 ] The coalescing filter (s) are generally used to increase the size of the small liquid drops for their separation from gases and liquids . Types of materials that may be used include hydrophilic Nylon or hydrophobic Polypropylene that are may be formed as woven sheets . In one embodiment the coalescing filter 840 is a combination of a hydrophobic sheet followed by hydrophilic sheet . The pore size of the coalescing filter 1040 may vary. However , in one embodiment the pore size is about the same size as the average drop size of the liquid condensing from the condensate . [ 0060 ] The condensate flows down to the bottom of the condensate tube 1000 where it collects on the photonic chip 220. The condensate tube 1000 is then optically coupled to the optical input and output of the docking station 105 (FIG. 1) and qualitative or quantitative analysis is conducted.

[ 0061 ] FIG . 11A illustrates a schematic view of one embodiment of an integrated docking station 1100 . The docking station is integrated because all the components needed to achieve an analyzing spectrum, such as a Raman spectrum, are contained within a single , portable housing . Though the illustrated embodiment has three compartments , other embodiments may comprise fewer or more compartments , for example , the two layered configuration shown in FIG . 1 . Due to its relatively compact size , these compartments are designed to minimize localized thermal generation and provide physical separation required to limit the thermal impact on the performance and behavior of the optics . Moreover , the various heating generating components are preferably arranged to reduce the thermal gradient across the integrated docking station 1100.

[ 0062 ] Reference is made with respect to the embodiment of the integrated docking station 1100 illustrated in FIG. 11A, which for purposes of discussion , is horizontally oriented and in which the compartments are stacked in a vertical fashion . Generally, the integrated docking station 1100 provides the structures to support the operation of a laser , an interferometer/spectrometer and processing circuitry, as needed, to stabilize and tune the laser and calibrate and process the results of the interferometer/spectrometer as needed to analyze a range of substances for target analytes .

[ 0063 ] The integrated docking station 1100 has a compact , lightweight design . For example , in one configuration , the integrated docking station 1100 has a maximum weight of about 6 lbs . and is about 5 inches high x 8 inches wide x 14 inches long . This is just one example of the weight and dimensions of the integrated docking station 1100 , and in other embodiments , these dimensions may either be greater or less than those noted above . In achieving this compact design capable of analyzing a Raman spectrum and providing qualitative or quantitative analytical data of a targeted analyte in a biofluid sample , several aspects that can affect device performance are considered. One such aspect is the thermal gradient that will be generated by the laser and control boards . If the thermal gradient is not properly managed, it can negatively affect the optical components ' and laser' s performances . Another aspect is vibration . The optical components comprising the interferometer are precisely aligned. Thus , it is beneficial to have materials within the integrated docking station 1100 to help dampen any vibrational noise occurring within the integrated docking station 1100 , which can cause slight misalignment and affect the accuracy. In one embodiment, the integrated docking station 1100 uses the principles of Spatial Heterodyne Spectroscopy (SHS) to analyze the analyte based on a Raman spectrum. Spectroscopy, in general , is based on the interaction of light with a material that induces molecular vibrations that result in a light emission , for example , ranging from ~660nm to ~785nm. Generally, the docking station 1100 provides the structure to support the operation of a laser , an interferometer/ spectrometer and processing circuitry to identify unknown constitutes of a target analytes .

[ 0064 ] The integrated docking station 1100 has a thermally conductive top lid 1105 and thermally conductive bottom lid 1110. The side walls 1115 may also be constructed from a thermally conductive material , such as a thermally conductive metal , which in one embodiment may be anodized aluminum or thermal conductive plastics . A laser compartment 1120 , additional embodiments of which are seen in FIG . 11B, contains a laser , laser driver , and laser thermal management components , such as one or more heat sinks or thermal electric cooler (s) , for example a Peltier Cooler . In one embodiment, the laser operates at a wavelength ranging from ~660nm to ~785nm. As seen in the embodiment of FIG . 11B, the heat generating components are mounted to the top lid 1105 , which in one embodiment may external fins (not shown) to improve thermal dissipation . The heat generating components may also be offset from the inner surface of the top lid 1105 with thermally conductive pucks comprised of a thermally conductive material , such as copper or thermal grease . Additionally, in some embodiments this section also contains a microcontroller that , among other things , controls sensors , the thermal electric cooler (s) and the laser , along with providing trigger timing for the image sensor . An optional fiber spool may also be present in the laser compartment 1120 for optical fiber management . One embodiment of the integrated docking station 1100 includes a laser interlock system that prevents the laser from turning on until a collector is optically coupled to the integrated docking station 1100. As discussed below, a microcontroller located in either the upper compartment or lower compartment will include programming and circuitry that is electrically coupled to a switch and activates the laser only when the collector and/or adapter is inserted into the integrated docking station 1100.

[ 0065 ] An optical compartment 1125 , additional embodiments of which are schematically shown in FIG . 11C , contains the optical components that make up the interferometer of the spectrometer and is discussed in more detail below . Among other features , the optical compartment 1125 has hard optic positioned posts and cushioned optic positioning posts , and a camera mount .

[ 0066 ] A processing compartment 1130 , additional embodiments of which are schematically shown in FIG. 11D , contains at least a second controller (PCBs) that also processes data , and may include a digital library of Raman spectrum of various biological or chemical molecules , optional batteries , cooling fans , and various known electrical interfaces , such as UDS ports , ether net ports , or an antenna for wireless transmission used of connecting the integrated docking station 1100 to peripheral components , such as a computer , smart phone , or cloud servers . In one embodiment, the controller is thermally coupled to the bottom lid 1110 of the integrated docking station 1100 by a thermal puck of the same type and composition , as mentioned above . The controller in this compartment is designed and programmed to operate and control the integrated docking station 1100 and interactions occurring in the photonic module when optically coupled to the integrated docking station 1100 .

[ 0067 ] In one embodiment, the various compartments are separated by a thermal baffle plate 1135 to diffuse/conduct thermal energy, reducing the impact of localized heating on the operation of the integrated docking station 1100 . These thermal baffle plates 1135 also provide for controlled placement and vibrational dampening of the optical components . Additionally, thermal isolation spacers 1140 , which may be present in certain embodiments , may also be positioned between the side walls 1115 and the thermal baffle plates 1135 and the top lid 1105 and bottom lid 1110. In one embodiment , these thermal isolation spacers 1140 maybe comprised of plastic or rubber , however , other thermal isolation materials may be used. In addition to aiding in the control of the thermal gradient across the integrated docking station 1100 , they can also provide vibration isolation . In one embodiment, the top lid 1105 helps to facilitate heat removal from the integrated docking station 1100 and from the components contained within each compartment . In such embodiments , the top lid 1105 have include fins on its outer surface to facilitate the dissipation of heat .

[ 0068 ] FIG . HE illustrates an embodiment of the optical compartment 1125. The optical compartment 1125 , in this embodiment , is a unitary structure formed, in one embodiment from a billet, though in other embodiments , it may be constructed of individual structural components . In one embodiment, the optical compartment 1125 is comprised of a material with a high thermal conductivity and good strength and malleability, such as aluminum or thermal conductive plastics . The optical compartment 1125 comprises an interferometer 1145 , which makes up a portion of a spectrometer system. In the illustrated embodiment, the interferometer 1145 comprises a portion of a spectrometer system, for example a Spatial Heterodyne Spectroscopy (SHS) . The spectrometer system comprises the optical compartment 1125 and the processing compartment 1130. [ 0069 ] In the illustrated embodiment, the interferometer 1145 comprises an optics end 1150 and a photodetector end 1155 . The optics end comprises a beam splitter 1150a , interference gratings 1150b , beam expanders 1150c . The optics end 1150 has setting grooves formed with interior side walls of the interferometer that are sized to receive the respective optical components therein and to hold them in a precise position for accurate transmission of an optical signal received by the interferometer 1145. In an embodiment , the gratings have a custom dimension for optimal interference patterns in the 680 to 785nm range with minimal distance for the interference pattern to the photodetector . An epoxy or other known adhesive may be used to further secure the components in their respective setting grooves . As such , the optical components are "fixed" , that is , their positions are not adjustable without disassembly of the optical components . For example , their positions cannot be changed by turning a set screw or otherwise mechanically moving them, as with conventional optical systems . An optical signal is received into the optics end 1150 through optical cable 1150d. [ 0070 ] A cylindrical lens 1160 is positioned between the optics end 1150 and photodetector end 355 and is positioned such that is its focal length focuses the optical signal on the photodetector 1155a , for example a CCD camera , located in the photodetector end 1155. The cylindrical lens 1160 is also received within setting grooves , and its position is also fixed for proper optical alignment . The interferometer 1145 also includes an optical interface 1170 that provides an optical coupling point between the various biofluid collectors , as discussed above and the integrated docking station 1100 . An input fiber 1175 extends from the optical interface 1170 to the laser , which transmits light into the waveguide of the photonic chip, and an output fiber 1180 extends from the optical interface 1170 to the interferometer 1145 , as generally shown . This configuration forms an "open" optical loop , which is completed or closed when the photonic chip or module is plugged into the optical interface . Additionally, the second compartment 1125 may also include an adjustable photodetector mounting plate , details of which are discussed below, that allows the position of the photodetector to be adjusted . Thus , if misalignment occurs , the photodetector can be adjusted to move the photodetector back into proper alignment with the optics , since the optic components themselves are fixed and therefore not adjustable . [ 0071 ] FIG. 11F illustrates a sectional view of an embodiment of the optical interface 1170 . This embodiment comprises a housing 1170a , into which a biofluid collector may be inserted. The housing 1170a is securely attached to the interior of the docking station . Withing housing 1170a is a ferrule connector 1170b that retains connector ferrules 1170c . The connector ferrules 1170c optically align with the optical connectors of the biofluid collector when it is inserted into the housing 1170a . Springs 1170d that are held with the housing 1170a by spring retainers 1170e provide a biasing force against the connector ferrules 1170c when the biofluid connector is inserted into the housing 1170a to provide good optical coupling . The ferrule connector 1170b is held in the housing 1170a by a retainer plate 1170f and screws 1170g . A pushing pin (not shown) may be used to activate a switch , (also not shown) when the collector or collector and adapter are inserted into the optical interface 370. This is one example of a portion of the above- mentioned laser interlock system.

[ 0072 ] FIG . 11G illustrate an embodiment of the adjustable mounting plate 1185 that allows the photodetector to be adjusted with respect to the optics of the interferometer 1145 . In the illustrated embodiment, the mounting plate 1185 comprises spring- loaded pins 1185a that exert a biased force against the mounting plate 1185 that secures the photodetector 1155a to the docking station . Adjustable set screws 1185b oppose each of the spring- loaded pins 1185a , as generally seen in FIG . 11G . The mounting plate 1185 is secured to the docking station by fastening screws 1185d . When misalignment occurs within the interferometer 1145 for some reason , the fastening screws 1185d are loosened, after which the set screws can be used to force the mounting plate 1185 against the respective spring-loaded pins 1185a until , the photodetector is properly aligned with optical components in the optics end 1150 of the interferometer 1145 . Once proper alignment is achieved the fastening screws 1185d can be tightened to hold the photodetector 1155a in its adjusted position .

[ 0073 ] FIG . 11H illustrates a schematic block layout of the interior components of the docking station 105 and collector 110 , which is this embodiment is a test card, which includes the photonic chip 220 , as discussed above . In the illustrated embodiment, the docking station 105 comprises a housing , indicated generally by the dashed line . Contained within the docking station 105 are several components . In the illustrated embodiment , the docking station comprises , the optical interface 1170 , as discussed above , a light source , such as a laser , a laser driver and sensor , a communications chip that is connected to an antenna 1190 for wireless transmission of data , a DPF Driver and Sensor , a Data Processor , an interferometer Driver and Sensor that are coupled to an Interferometer , such as the one discussed above and a power source , all of which are operatively connected to a PCB interface and controller . The data processor when combined with optical data received from the interferometer 1145 forms a spectrometer . When the optical signal is received from the waveguide located in the photonic module 115 , an interference pattern is received by the photodetector 1155a (FIG . HE ) . The data processor uses a Fast Fourier Transform (FFT) algorithm to convert the interference patten into a spectrum, which can then be converted by the data processor into a Raman signal . As used herein and in the claims , operatively coupled means that the components are coupled, either optically, electrically, or wirelessly, or a combination thereof to provide an operative unit for obtaining and analyzing data and providing and/or transmitting test results . As previously, mentioned the waveguide of the photonic chip 220 within the collector 110 optically aligns with the optical components , the laser and interferometer 1145 , of the docking station 105 , as explained above .

[ 0074 ] The photonic circuit of the photonic module 115 , the interferometer , and the FFT spectrometer generate an output spectrum by modulating the radiation in the time domain through interference , which then undergoes a Fourier transformation , as mentioned above . The interference between the signal propagating along the phase modulated arm, and the non-phase modulated arm are reflected to the coupler where the variation in phase causes an amplitude change . When the time-based amplitude information is recorded against the driving voltage or resulting effective path length variation in the modulated arm, it is called an interferogram, I (xeff ) . This Interferogram represents a modulated radiation signal as a function of the change in effective path length between the two arms of the interferometer . In the interferometric photonic circuit , the analog signal is recorded at the photodetector , which encodes the wavelength or the wave number information of the encoded Raman spectrum. A Fourier-transform routine is then performed on the interferogram to recover a Raman spectrum. An advantage of this system is the photonic integrated circuit and stabilized optical source . [ 0075 ] As mentioned above , one embodiment of this disclosure uses the principles of Raman spectroscopy . Raman spectroscopy is a technique in which incident laser light is inelastically scattered from a sample and shifted in frequency by the energy of its characteristic molecular vibrations . The Raman spectrum provides high informational content on the chemical structure of the probed substances , which makes this method an ideal tool for the identification of illicit drugs , pharmaceutical and drug manufacturing monitoring/validation or alcohol detection and identification . However , unlike known process that focus the Raman beam on a single point on a surface containing a targeted subject matter , the embodiments of this disclosure provide a structure that collects data along at least a portion of the length of the waveguide or waveguides , greatly enhancing the quantity and accuracy of the data .

[ 0076 ] In practice , the test fluid is injected into the photonic module 115 , providing confinement of the molecules under test . This confinement ensures the greatest overlap of the molecules with the probe beam. Further , it provides intimate and strong interaction of the molecules with nanostructures along the walls of the waveguide , which provides enhanced Raman Signal strength over known devices and processes .

[ 0077 ] The application of Surface-enhanced Raman spectroscopy (SERS) , to improve signal strength is a modification of Raman spectroscopy. It has been demonstrated as a very capable approach to identify biomolecules , such as a bacterium or viruses . It is based on the enhancement of the Raman scattering signal of certain molecules when they are adsorbed or placed in the proximity of appropriate metallic nanostructures , usually noble metals such as silver , gold, or copper . It has been shown that the SERS approach can yield enhancement factors as large as 10 ¹⁴ -10 ¹⁵ , leading to Raman scattering cross sections larger than those of fluorescent organic dyes or other reagents used in modern test sets or detection panels . [ 0078 ] FIG . Ill schematically illustrates an embodiment of an interferometer , such as a Michaelson Interferometer , and a stabilized optical source , for example a laser , that can be integrated into the docking station 105 , both shown as integrated photonic components . While the approach can employ fiber coupled off the shelf laser diodes operating at ~660nm to ~785nm, the compact spectrometer may include the implementation of one of two configurations to provide the required spectral accuracy and wavelength span to ensure the desired level of repeatability and integration within a compact unit . In another embodiment , the interferometer may be a heterodyne interferometer .

[ 0079 ] The detection and identification of different toxicological drugs is insured by the ability to integrate 5 elements into a relatively small area , such as the illustrated dock station by leveraging photonic manufacturing and packaging techniques . These include : l) the stabilized narrow band optical source to provide a controllable Raman Probe ; 2 ) The evanescently coupled low index contrast waveguides providing controlled overlap of the modal energy traveling external to the waveguide and the metallic nanostructures which provide the photonic enhancement of the Raman Scattering ; 3) Formation of nano structures between and on the waveguides providing a controlled surface region for characterization of the target analyte (drug) ; 4 ) The Integration of microfluidic volume within the photonic module 115 to confine the sample volume relative to the waveguides and enrichment structures ; 5) The ability to integrate a small Fourier transform spectrometer . To ensure that rapid test products can be made available as quickly as possible , the embodiments disclosed herein disclose a path to an early passive test structure that allows the fielding of a simpler version of the test to be delivered in the shortest time possible .

[ 0080 ] The unique benefits that the various embodiments of the test strip detection and identification system include : l ) the ability to confine solutions containing toxicological materials to a micro channel , providing improved interaction cross section between the probe beam and target materials . This provides a system having multiple orders of magnitude improvement in sensitivity over any other approach ; 2) 14 to 15 orders of magnitude increase in signal sensitivity resulting from application of metallic nano structures along the walls of the micro channel providing forced interaction with multiple surfaces and increasing the overall interaction length and accumulated signal strength ; 3) low cost generation , coupling , transmission , processing and detection of the Raman spectrums , application of micro channel integration technologies to support the formation of the localized metallic nanostructures within the channels and their integration with the photonic integrated circuits and the supporting elements to control injection of the probe beam into the micro channel , guide the probe in a controlled manner through the micro channel , and re-couple the probe beam back into the photonic circuit for processing and spectrum extraction ; 4 ) packaging of the sensor into a useable vehicle to allow isolated, real-time single point testing .

[ 0081 ] Examples of embodiments disclosed herein comprise :

[ 0082 ] In one embodiment , this disclosure presents a photonic device . In one embodiment, the photonic device comprises a silicon substrate and a planar waveguide formed on the silicon substrate . The planar waveguide has input and output ends extending from it . Input and output optical fibers are located on the same silicon substrate and within v-grooves formed in the silicon substrate that coupling ends that optically align with the input and output ends of the planar waveguide , respectively . This embodiment further includes optical connectors that each have a coupling end located at an end of the silicon substrate where the input and output optical fibers extend into the optical connectors and terminate at the coupling end of the optical connectors . The silicon substrate , photonic chip, input and output optical fibers , and optical connectors comprise a photonic chip assembly .

[ 0083 ] In another embodiment , this disclosure presents an analytical system. In one embodiment, the analytical system comprises a collector , a photonic device , and docking station . The collector has a body with an interior volume for holding a biofluid therein . The body has an open end through which a biofluid is received into the body and a base located opposite the open end . The base has a fluid port and a docking cavity. The fluid port is positioned to allow a fluid flow from the body into the docking cavity.

[ 0084 ] In this embodiment , the photonic device comprises a silicon substrate and a planar waveguide formed on the silicon substrate . The planar waveguide has input and output ends extending from it . Input and output optical fibers are located on the same silicon substrate and within v-grooves formed in the silicon substrate and that have coupling ends that optically align with the input and output ends of the planar waveguide , respectively . This embodiment further includes optical connectors that each have a coupling end located at an end of the silicon substrate where the input and output optical fibers extend into the optical connectors and terminate at the coupling end of the optical connectors . The silicon substrate , photonic chip , input and output optical fibers , and optical connectors comprise a photonic chip assembly . The photonic chip is positioned within the docking cavity of the collector and under the fluid port to receive a flow of biofluid from the body.

[ 0085 ] The docking station comprises a housing and within that housing is an optical compartment, a laser compartment and a processing compartment thermally insulated from the other . In this embodiment, the optical compartment comprises a beam splitter and first and second gratings , fixed and set at angles to receive an optical signal from the beam splitter . An adjustable photodetector is positioned to receive an optical signal from the beam splitter , and a focusing lens is positioned between the beam splitter and the photodetector . The laser compartment , in this embodiment, comprises a laser and a microcontroller with a thermal baffle plate located between the laser compartment and the optical compartment . The processing compartment comprises a microprocessor , a thermal baffle plate located between the processing compartment and the optical compartment , wherein the optical compartment is positioned between the laser compartment and the processing compartment .

[ 0086 ] Examples of variations of the embodiments provided herein are :

[ 0087 ] Element 1 : wherein the collector has a body with an interior volume for holding a biofluid therein . The body having an open end through which a biofluid is received into the body and a base located opposite the open end . The base has a fluid port and a docking cavity. The fluid port is positioned to allow a fluid flow from the body into the docking cavity wherein the photonic chip is positioned within the docking cavity and under the fluid port to receive a flow of biofluid from the body.

[ 0088 ] Element 2 : wherein the photonic chip assembly is contained within a photonic module , and the photonic module comprises a housing having an upper surface with an opening therein configured to allow a fluid to pass therethrough .

[ 0089 ] Element 3 : wherein the opening in the upper surface of the photonic module is positioned within the base and under the fluid port such that the photonic chip is positioned to receive a flow of biofluid from the body .

[ 0090 ] Element 4 : wherein the silicon substrate has a trench with a faceted surface and the input and output ends of the planar waveguide terminate at the faceted surface , and wherein the trench is located between the input and output ends of the planar waveguide and the input and output ends of the optical fibers , respectively that are optically aligned with the input and output ends of the planar waveguide .

[ 0091 ] Element 5 : wherein the photonic chip further comprises nanoparticles and the planar waveguide has sides and an uppermost surface , and a concentration of the nanoparticles is greater at or adjacent the sides than on the uppermost surface of the planar waveguide .

[ 0092 ] Element 6 : wherein the collector is a specimen cup , a tube , a test card collector , or a condensate tube .

[ 0093 ] Element 7 : wherein the specimen cup comprises a lid having a docking cavity therein and the photonic chip assembly is located within docking cavity of the lid .

[ 0094 ] Element 8 : wherein the photonic chip assembly is oriented vertically with respect to the lid, and a portion of the photonic chip extends above an interior surface of the lid.

[ 0095 ] Element 9 : wherein the specimen cup has a base with a docking cavity, and the photonic chip assembly is located within the docking cavity in a horizontal position . [ 0096 ] Element 10 : further comprising a vertical or horizontal adapter , wherein the collector has a docking cavity formed within the base configured to receive an optical coupling end of the vertical or horizontal adapter therein , and wherein the photonic chip assembly is a vertically oriented photonic chip assembly in the base , or the photonic chip assembly is a horizontally oriented photonic chip assembly in the base , and the vertically oriented photonic chip assembly is optically couplable to the vertical adapter , or the horizontally oriented photonic chip assembly is optically couplable to the horizontal adapter .

[ 0097 ] Element 11 : wherein the collector is a test card collector comprising a housing with a docking cavity formed therein , an upper surface of the housing having a fluid port formed therein , wherein the photonic chip assembly is located within the docking cavity, and the photonic chip is located under the fluid port such that fluid can flow onto the photonic chip through the fluid port .

[ 0098 ] Element 12 : wherein the collector is a test card collector comprising a housing . The photonic chip assembly is located within the housing, and the housing has a fluid port therein . The photonic chip is located under the fluid port to receive a fluid from the fluid port . The test card collector further comprises a retractable cover that is biased to cover the optical connectors of the optical fibers and is retractable into the housing to expose the optical connectors .

[ 0099 ] Element 13 : wherein the collector is a condensate tube having a base and manifold joined to the base . The base has a docking cavity therein in which the photonic chip assembly is located . The condensate tube comprises an intake tube and at least one or more exhaust tubes that extend to the manifold. A fluid passageway extends from the manifold to the base to allow a fluid to flow from the manifold to the photonic chip . The condensate tube further comprises a coalescent filter positioned at an intake end of the at least one or more exhaust tubes . The coalescent filter causes a vapor to collect and condense a vapor into the liquid.

[ 00100 ] Element 14 : wherein the collector is a tube having a docking end comprising a base having a docking cavity in which the photonic chip is located .

[ 00101 ] Element 15 : wherein the photonic chip assembly is contained within a photonic module . The photonic module comprises a housing having an upper surface with an opening therein configured to allow a fluid to pass therethrough .

[ 00102 ] Element 16 : a fluid reservoir is attached to the upper surface of the housing of the photonic module and positioned over the opening to allow fluid to flow from the fluid reservoir , through the opening and into the housing to contact the photonic chip .

[ 00103] Element 17 : wherein the silicon substrate has a trench therein with a faceted surface and the input and output ends of the planar waveguide terminate at the faceted surface , and wherein the trench is located between the input and output ends of the planar waveguide and the input and output ends of the optical fibers , respectively . [ 00104 ] Element 18 : wherein the photonic chip assembly further comprises nanoparticles and the planar waveguide has sides and an uppermost surface , and a concentration of the nanoparticles is greater at or adjacent the sides than on the uppermost surface of the planar waveguide .

[ 00105 ] Although the present invention has been described in detail , those skilled in the art should understand that they can make various changes , substitutions , and alterations herein without departing from the spirit and scope of the invention in its broadest form.