Oral fluid collection device and method

Abstract

The present invention relates to an oral fluid sample collection method and device comprising: a shroud having a first face and a second face; an elastomeric nipple having an outer surface and defining a nipple interior, the elastomeric nipple extending from the first face of the shroud; and a reservoir component comprising a reservoir having a reservoir interior extending from the second face of the shroud. The elements are interconnected by a plurality of fluid conduit / valve combinations, including a first combination allowing flow from the nipple interior to an atmospheric vent port disposed on an outer surface of the oral fluid collection device; a second combination allowing flow from the reservoir interior to the nipple interior; and a third combination allowing flow from a collection port disposed on the outer surface of the nipple to an exit port in the reservoir interior.

Description

Background Technology Technical Field

[0002] This invention relates to apparatus and methods for obtaining oral fluid samples from human subjects. More specifically, this invention relates to apparatus, kits, and methods for obtaining saliva samples from subjects, including infants and premature infants.

[0003] Related technologies

[0004] Analytical testing of bodily fluids is commonly used to help diagnose a wide range of disease conditions. Blood, urine, and saliva tests are quite common. Testing requires the collection of bodily fluids, which are then analyzed at the collection site or, more commonly, at an approved testing facility.

[0005] Where possible, there is an incentive to replace invasive blood tests with non-invasive saliva testing due to convenience, cost, and other benefits. Blood tests require invasive blood collection, such as with a syringe. When collecting blood, a technician (such as a nurse or phenographer) must typically be present. This increases the complexity and cost of the testing process compared to non-invasive saliva collection.

[0006] In addition, most people experience significant needle aversion. Infants, children, and to some extent the elderly are generally reluctant to use needles.

[0007] Despite advances in using saliva to diagnose many conditions that previously required blood samples, devices designed to collect saliva samples from adults may not be suitable for pediatric and neonatal patients. These patients have smaller mouths and cannot follow instructions. Furthermore, significant safety concerns arise because the collector must be manufactured to prevent any possibility of dislodgement in the mouth and the resulting choking hazard. Additionally, all components must be designed to prevent damage to the oral cavity.

[0008] In summary, non-invasive saliva collection for analyte testing offers advantages over complex and expensive invasive blood collection. There is a need for a safe saliva sample collection device, particularly to meet the specific needs of pediatric and neonatal patients. Summary of the Invention

[0009] A safe oral fluid sample collection device has been designed, particularly to meet the specific needs of pediatric and neonatal patients. The device includes: a shield having a first and a second surface; an elastomeric nipple having an outer surface and defining an interior nipple, extending from the first surface of the shield; and a reservoir component extending from the second surface of the shield, including a reservoir having an interior reservoir. These elements are interconnected by a plurality of fluid conduits / valve combinations, the plurality of fluid conduits including: a first fluid conduit having a first one-way valve operatively connected to and allowing flow from the interior of the nipple to an atmospheric discharge port disposed on the outer surface of the oral fluid collection device; a second fluid conduit having a second one-way valve operatively connected to and allowing flow from the interior of the reservoir to the interior of the nipple; and a third fluid conduit having a third one-way valve operatively connected to and allowing flow from a collection port disposed on the outer surface of the nipple to an outlet port within the reservoir.

[0010] One method for collecting oral fluids includes:

[0011] (a) Remove the oral fluid collection device from the packaging;

[0012] (b) Insert a nipple with an initial static volume into the subject's mouth;

[0013] (c) Deform the nipple to force fluid from the inside of the nipple to the atmospheric discharge port;

[0014] (d) Allowing the nipple to expand toward the initial static volume, thereby drawing fluid from inside the reservoir and reducing the fluid pressure in the reservoir components; and

[0015] (e) Oral fluid is aspirated from the subject's mouth into the reservoir via a collection port. Additional devices, kits, and methods are also disclosed. Attached Figure Description

[0016] Figure 1 This is a top front perspective view of the oral fluid collection device of the present invention;

[0017] Figure 2 yes Figure 1 Top rear perspective view of an oral fluid collection device;

[0018] Figure 3 yes Figure 1 Side view of an oral fluid collection device;

[0019] Figure 4 yes Figure 1 Top front exploded perspective view of the oral fluid collection device;

[0020] Figure 5 yes Figure 1 Top rear exploded perspective view of the oral fluid collection device; and

[0021] Figure 6 yes Figure 1 A partial cross-sectional side view of an oral fluid collection device. Detailed Implementation

[0022] As used in this specification and claims, the term "oral fluid" and its variations refer to bodily fluids (liquids) present in the oral cavity. Oral fluid is a mixture of saliva and "oral mucosal exudate." Saliva is produced by the salivary glands. Oral mucosal exudate enters the oral cavity through capillaries across the buccal mucosa.

[0023] As used in this specification and claims, the term "collected fluid" and variations thereof refer to oral fluid (liquid) collected by the device.

[0024] As used in this specification and claims, the term "elastomer nipple" and variations thereof refer to a device nipple having a defined shape and being able to deform under load and return to its defined shape when the load is removed.

[0025] As used in this specification and claims, the term "outer surface of the device" refers to any outwardly facing surface of the device during use with an elastomeric nipple disposed in the oral cavity of a subject.

[0026] This invention relates to an apparatus and method for obtaining oral fluid samples from human subjects, particularly infants. The apparatus is designed to use the subject's non-nutritive sucking (NNS) movements to create a partial vacuum within the apparatus, which draws oral care fluid from the subject's mouth into a reservoir within the apparatus.

[0027] The device includes a shield, an elastomeric nipple extending from a first side of the shield, and a reservoir portion extending from the other side of the shield. Both the nipple and the reservoir have corresponding interiors and define corresponding volumes. The device also has three fluid conduits, each with an associated one-way valve. A first conduit / valve assembly allows airflow from the interior of the nipple to an atmospheric discharge port located on the outer surface of the device. A second conduit / valve assembly allows airflow from the reservoir to the interior of the nipple. A third conduit / valve assembly allows oral fluid to flow from a collection port located on the outer surface of the nipple (placed in the subject's mouth during use) to the reservoir, reaching an outlet port located within the reservoir.

[0028] The shield is arranged and constructed to prevent the subject from attempting to bring the entire device into their mouth, and thus to limit the portion of the device that can be brought into the subject's mouth from those parts of the device that remain outside the mouth during use.

[0029] Similar to a conventional pacifier, the shield has a main plane orientation that is substantially parallel to the subject's lips during use. The shield optionally includes multiple ventilation holes through its thickness, which may allow air to pass through if the subject breathes through their mouth, or provide other aesthetic or functional benefits.

[0030] The material used to manufacture the pacifier shield is not critical and can include conventional pacifier shield materials, such as non-toxic plastic materials. Exemplary plastics include, but are not limited to, polyethylene terephthalate (PET), high-density polyethylene (HDPE), low-density polyethylene (LDPE), or polypropylene (PP).

[0031] The shield can be formed using any useful plastic molding process, including but not limited to injection molding, thermoforming, etc.

[0032] The elastomeric nipple extends from one side of the shield in a direction substantially perpendicular to the main plane of the shield. The elastomeric nipple has an outer surface and an orifice formed in the outer surface. As described above, the elastomeric nipple also defines an interior. The interior is hollow, consisting of voids capable of receiving fluid.

[0033] The materials used to manufacture elastomeric nipples are not critical and can include conventional pacifier elastomeric nipple materials, such as non-toxic elastomers. However, it is desirable to control the stiffness of the elastomeric nipples produced therefrom so that the nipple can deform as described in more detail below. Exemplary elastomer materials include, but are not limited to, rubber (natural or latex), silicone, or soft plastics. Rubber, silicone, and soft plastics are easily deformable and therefore effective in deforming through non-nutritive sucking movements (NNS) when the elastomeric nipple is in the subject's mouth. In non-nutritive sucking, the subject's tongue typically travels with characteristic peristaltic movements (e.g., a wavy movement from left to right).

[0034] Elastomer nipples can be formed using any useful plastic molding process, including but not limited to injection molding, thermoforming, and liquid silicone injection molding.

[0035] It may be desirable to choose the same material for both the shield and the nipple. This is useful for integrating these components and eliminating secondary connections between the two parts, which could otherwise be points of failure. In such a construction, both the shield and the nipple can be made of silicone or soft plastics, including but not limited to thermoplastic elastomers or low-hardness polyurethanes.

[0036] The elastomeric nipple can be attached to the shield using a variety of methods, which can vary depending on the materials used for both components. Available methods include, but are not limited to, mechanical interference fits, fasteners / clamps, bonding (e.g., adhesives, solvents, and / or heat, including ultrasonic bonding). Of course, if the elastomeric nipple and the shield are made of the same material, they can be formed together in a single operation. Alternatively, the shield and the elastomeric nipple can be injection molded onto a reinforcing element to provide appropriate rigidity to the shield.

[0037] The reservoir is associated with the second side of the shield and is positioned outside the subject's mouth during use. As described above, the reservoir defines an interior space capable of receiving fluid, in which oral fluids (such as saliva) collected by the device are stored.

[0038] The reservoir may also have at least one deformable region, which may be one or more walls or portions of one or more walls. The reservoir interior defines an initial reservoir interior under ambient conditions, wherein at least one deformable region is in a static condition. As described below regarding the operation of the device, at least one deformable region is capable of elastic deformation to allow the reservoir volume to decrease below the initial volume under certain operating conditions and to return to its static state upon restoration of normal operating conditions.

[0039] The reservoir may also contain a non-toxic, stabilizing buffer solution. The presence of the stabilizing buffer solution allows the collected fluid for analysis to remain for several days or even weeks after collection. The buffer solution may be provided inside the reservoir or added to the reservoir.

[0040] Because oral fluids (such as saliva) contain proteins and other biological materials that can adhere to the inner walls of reservoirs, these inner walls can be coated with substances that prevent these proteins and other biological materials from adhering to them.

[0041] For testing to be performed, the oral fluid collected by the device must be transferred from the device to a testing facility. The testing facility can be part of a home testing system or it can be located remotely. Therefore, the testing fluid must be extracted from the device. This can be done by removing the reservoir from the device and transporting it to the testing facility, especially if the facility is remote. A convenient container for transporting the collected fluid is the reservoir itself. Alternatively, the collected fluid can be transferred from the reservoir to a delivery vial. Finally, the collected fluid can be removed from the delivery container via a syringe or other useful transfer device.

[0042] The reservoir may be included in a reservoir component arranged and configured for removable engagement with the cover.

[0043] In addition to collecting oral fluids, the reservoir also functions as a liquid / gas separator. As described in more detail below, the reservoir retains the oral fluids collected by the device and separates the oral fluid flow from the air (gas) flow passing through the device.

[0044] To aid in liquid / gas separation, the reservoir may be equipped with baffles to restrict the movement of the collected fluid to the second conduit / valve assembly described below.

[0045] The materials used to manufacture the reservoir are not critical and may include conventional materials such as non-toxic plastics. Exemplary plastics include, but are not limited to, polyethylene terephthalate (PET), high-density polyethylene (HDPE), low-density polyethylene (LDPE), polypropylene (PP), or polyurethane.

[0046] The reservoir can be formed using any useful plastic molding process, including but not limited to injection molding, thermoforming, etc. The reservoir can also be manufactured using standard plastic manufacturing techniques such as injection molding. At least one deformable region can be made of an elastomeric material, such as rubber, silicone, and soft plastics, including but not limited to thermoplastic elastomers or low-hardness polyurethane.

[0047] The first conduit / valve assembly allows airflow from the inside of the nipple to an atmospheric vent port located on the outer surface of the device. Depending on the specific details and arrangement of the device, the atmospheric vent port may be located on the shield or, optionally, on the housing of the reservoir. The location of the one-way valve along the path of the first conduit is not critical. It can be positioned to enhance the effective sterilization of the device.

[0048] The second conduit / valve assembly allows airflow from the device's reservoir to the inside of the nipple. Similarly, the location of the one-way valve along the path of the second conduit is not critical. It can be positioned to enhance the device's effective sterilization.

[0049] The second conduit opening is located in the reservoir wall in a position designed to minimize its exposure to the collected fluid.

[0050] The third conduit / valve assembly allows oral fluid to flow from the collection port located on the outer surface of the nipple (placed in the subject's mouth during use) to the reservoir, and then to the outlet port located in the reservoir.

[0051] The outlet port can be located in the central portion inside the reservoir to provide an air gap between the outlet port and the liquid surface of the previously collected oral fluid in the reservoir. Therefore, the previously collected oral fluid will not prevent new oral fluid contaminants from flowing out of the outlet port.

[0052] As will be described below, with reference to the accompanying drawings, the outlet port of the third catheter is located in the central portion inside the reservoir to provide an air gap between the outlet port and any previously collected oral fluid.

[0053] The oral fluid collection device described above collects and captures oral fluids, such as saliva and oral mucosal exudate. Gases in the oral cavity can also be collected, but the fluid conduit / valve element in the device typically allows large quantities of these gases to pass through the system via an atmospheric discharge port, while only the oral fluid remains inside the reservoir.

[0054] The oral fluid collection device described above can be manufactured, packaged, and sold as a single-use, integrated device. Packaging protects the oral fluid collection device from contamination and damage, as it keeps the device and / or its components safe during transport from the manufacturer to the consumer.

[0055] However, a preferred system is a kit consisting of a durable section and multiple separately packaged reservoir sections. In this kit, the durable section includes a shield and an elastomeric nipple (and associated tubing / valve elements), and the separately packaged reservoir sections include a reservoir and any optional housing to enclose the reservoir (and associated tubing / valve elements). Thus, the reservoir sections are removed from their packaging and assembled with the durable section for use. Alternatively, a device may be packaged in a fully assembled state with additional, separately packaged reservoir sections. After use, the reservoir sections are removed from the durable section, and the collected fluid is subsequently transported for analysis.

[0056] The reservoir portion is arranged and constructed for detachable engagement with the durable portion. Thus, a first reservoir portion can be engaged with the durable portion for initial sampling of a subject and detached from the durable portion. The durable portion can be appropriately cleaned and / or sterilized, and a second reservoir portion can be unpacked and engaged with the durable portion for a second sampling of a subject, or even sampling of a second subject. Examples of engagements available in such detachable engagements include, but are not limited to, screws, pins, bayonets, hooks, and clamps.

[0057] Optionally, the skin and mouth contact elements can be disposable, possibly including an elastomeric nipple and a protective liner positioned towards the lips during use, and may even include a reservoir and tubing. The structural shield components and reservoir housing, however, can be reusable (durable). This allows for the integration of additional components into the durable parts.

[0058] Consumers can also be offered refilled packaging that includes multiple pre-packaged storage units and non-durable parts.

[0059] Consumer-available oral fluid collection kits may also include one or more containers or packages for delivering the reservoir to testing facilities (testing laboratories, hospitals, clinics, medical testing facilities) for analysis. The oral fluid collection kit may also include operating instructions for transporting the reservoir portion to the testing facility. Thus, the reservoir portion may be sealed and placed in a package supplied to the consumer within the kit for delivery via mail or delivery service. The supplied package may be pre-addressed and may also be thermally insulated to protect the collected oral fluid from extreme temperatures that could affect oral fluid analysis. The supplied return package may optionally incorporate a sensor that can be used by the testing laboratory to verify that the reservoir has not been exposed to extreme temperatures.

[0060] The oral fluid collection device described above is used in methods for collecting oral fluid. At the initial point, the pressure inside the nipple, inside the reservoir, and in the subject's mouth or oral cavity is equal.

[0061] If the oral fluid collection device is included in the packaging, the oral fluid collection device and / or its components are removed from the packaging (and assembled if necessary). As with conventional pacifiers, the elastomeric nipple is inserted into the subject's mouth. The subject's non-nutritive sucking (NNS) movements on the elastomeric nipple cause deformation (collapse) of the elastomeric nipple. This deformation forces fluid or air from the inside of the nipple to an atmospheric discharge port, where it is expelled into the atmosphere. The fluid follows a path from the inside of the nipple into a first fluid conduit and associated first one-way valve, and ultimately exits the oral fluid collection device through an atmospheric discharge port located on the outer surface of the device. The first one-way valve prevents air from outside the oral fluid collection device from backfilling the inside of the nipple via the atmospheric discharge port.

[0062] Next, the deformed elastomer nipple is inflated back to its original shape. During non-nutritive sucking, the infant's tongue moves with a peristaltic motion, alternately increasing and then removing the load on the elastomer nipple. As the elastomer nipple re-inflates, the pressure inside the nipple decreases. To rebalance the pressure between the inside of the nipple and the inside of the reservoir, gas must flow from the inside of the reservoir into the inside of the nipple. The gas follows a path from the inside of the reservoir into a second fluid conduit and an associated second one-way valve, and finally into the inside of the nipple.

[0063] Because gas has been removed from the inside of the oral fluid collection device, the pressure inside the nipple and reservoir is lower than the pressure in the subject's mouth. To rebalance the fluid pressure between the reservoir and the subject's mouth, fluid or air must be returned to the reservoir. The source of the fluid is the subject's mouth. Oral fluid or saliva is drawn from the subject's mouth into the reservoir. The path followed by the oral fluid is from the mouth, through the collection port located on the outer surface of the nipple, into the third fluid conduit, through the third one-way valve, and finally into the reservoir.

[0064] Similarly, the reservoir may also have at least one deformable region that deforms to reduce the internal volume of the reservoir. When the at least one deformable region returns to its resting state, a pressure difference is created between the oral cavity and the interior of the reservoir. As discussed above, in order to rebalance the fluid pressure inside the reservoir and in the subject's oral cavity, fluid flows from the subject's oral cavity into the reservoir, as discussed above.

[0065] Furthermore, at least one deformable zone in the reservoir allows a moderate vacuum (negative pressure) to accumulate within the reservoir, particularly if the collection port is blocked by the subject's tongue, as continuous sucking cycles still remove gas from the elastomeric nipple. This at least one deformable zone deforms further with each cycle, accumulating mechanical stress within it, which can then provide increased negative pressure when the collection port is not blocked and the at least one deformable zone returns to its resting state.

[0066] Analysis of oral fluid collected by the oral fluid collection device can be performed at the collection location, such as in a home testing kit, or in multiple testing laboratories located in hospitals, clinics, and medical testing facilities.

[0067] When analysis is performed in a testing laboratory outside the home, the collected fluid must be transported to the testing site. Therefore, the entire device containing the collected fluid can be transported to the testing site. Alternatively, the reservoir section can be separated from the durable section.

[0068] For analysis of oral fluids, they must be removed from the reservoir. The collected fluid can be removed from the reservoir by syringe, by puncturing the reservoir that has been sealed for transport, or by an opening created in the reservoir when the reservoir portion is removed from the durable part.

[0069] The subject matter disclosed in this invention will now be described more fully below with reference to the accompanying drawings and examples, and thus this disclosure will be thorough and complete. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the subject matter to which this invention pertains.

[0070] Referring now to the accompanying drawings, the same reference numerals in the drawings denote corresponding parts in several views. Figures 1 to 6 This is a view of the oral fluid collection device of the present invention. Figure 1 and Figure 2 These are the top front perspective view and the top rear perspective view of the oral fluid collection device 10. Figure 3 This is a side view of device 10. Figure 4 and Figure 5 These are the top front exploded perspective view and the top rear exploded perspective view of device 10, respectively. Finally, Figure 6 This is a partial cross-sectional side view of the oral fluid collection device 10.

[0071] exist Figure 1 The image shows an elastomeric nipple 60 extending from the first surface 22 of the shield 30. Figure 2 A storage component 90 extending from the second surface 24 of the first component 20 is shown.

[0072] Figure 3 This is a side view of the oral fluid collection device 10, showing the device 10 with two components (first component 20 and reservoir component 90). Figure 4 and Figure 5 A first component 20 is shown, having three elements (shield 30, nipple element 50, and clamp 70). As will be described later, the three elements can be assembled to form the first component 20.

[0073] The shield 30 has a first surface 22 and a second surface 32 opposite to the first surface. The shield 30 also has an opening 34, a ventilation hole 36, and an alignment pin 38.

[0074] The nipple element 50 has an elastomer nipple 60 and an alignment guide hole 58. The elastomer nipple 60 has an outer nipple surface 62 pointing toward the subject's mouth and an inner nipple surface 66.

[0075] The clamp 70 has a first surface 72, a second surface 24, a second fluid conduit 54, an outlet port 67, a connector 73, an orifice 74, an alignment guide hole 78, a first check valve 82, a second check valve 84, a third check valve 86, and an atmospheric vent port 88. The connector 73 is shown extending from the second surface 24 of the clamp 70 and has the orifice 74 and the outlet port 67. The first check valve 82, the second check valve 84, and the third check valve 86 are disposed on the surface of the first surface 72 of the clamp 70. The atmospheric vent port 88 is disposed on the surface of the second surface 24 of the clamp 70 and is exposed to the atmosphere. Although the atmospheric vent port 88 is disposed on the surface of the second surface 24 of the clamp 70, it can be located on any outer surface of the oral fluid collection device 10.

[0076] When the oral fluid collection device 10 is assembled, three fluid conduits are formed. These fluid conduits carry fluid between the components and... Figure 6 As shown in the diagram, when the nipple element 50 and the clamp 70 are connected, a first fluid conduit 52 is formed extending from the nipple interior 66 to the first one-way valve 82. The first fluid conduit 52 and the first one-way valve 82 are operatively connected and allow fluid to flow from the nipple interior 66 to the atmospheric discharge port 88.

[0077] A second fluid conduit 54 extends from the reservoir interior 98 to a second check valve 84. The second fluid conduit 54 and the second check valve 84 are operatively connected and allow fluid to flow from the reservoir interior 98 to the nipple interior 66.

[0078] The nipple element 50 also has a first portion of a third fluid conduit 56a, while the clamp 70 has a second portion of a third fluid conduit 56b. When the oral fluid collection device 10 is assembled, the third fluid conduit is formed, and oral fluid is transported from the subject's mouth to the reservoir component 90 of the oral fluid collection device 10.

[0079] The shield 30 and clamp 70 may be made of infant-safe materials such as plastic.

[0080] The nipple element 50 may be made of infant-safe materials, such as rubber (natural or latex), silicone, or soft plastic.

[0081] The shield 30, nipple element 50, and clamp 70 can be manufactured using standard plastic manufacturing techniques such as injection molding.

[0082] The first component 20 of the oral fluid collection device 10 is assembled as follows: The nipple element 50 is aligned with the shield 30 such that the elastomeric nipple 60 of the nipple element 50 passes through the orifice 34 of the shield 30, and the aligner pin 38 of the shield 30 passes through the aligner guide hole 58 of the nipple element 50. The elastomeric nipple 60 now extends from the first surface 22 of the shield 30, and therefore from the first surface 22 of the first component 20.

[0083] The clamp 70 is aligned with the nipple element 50 such that the alignment guide hole 78 of the clamp 70 is aligned with the alignment pin 38 of the cover 30.

[0084] The shield 30, nipple element 50, and clamp 70 are held together by fastener 102. The aligner pin 38 of the shield 30 has internal threads, and the fastener 102 is a screw fastener. Other types of fasteners include bolts and pins. Alternatively, the three elements of the first part 20 of the oral fluid collection device 10 may be bonded together using adhesive, heat sealing, etc.

[0085] The accompanying drawings also show a reservoir component 90 of the oral fluid collection device 10. The reservoir component 90 has a proximal end 91, a distal end 92, sidewalls 96, and a connector 93 with an orifice 94. The connector 93 extends from the proximal end 91 of the reservoir component 90. A rear cover 95 is disposed at the distal end 92 of the reservoir component 90. The reservoir component 90 also has a reservoir interior 98, which is a void volume in which oral fluids (such as saliva) captured by the oral fluid collection device 10 are stored.

[0086] The reservoir component 90 can also be manufactured using standard plastic manufacturing techniques such as injection molding. The back cover 95 can be made of an elastomeric material such as rubber, silicone, and soft plastic, thereby giving the reservoir component 90 at least one deformable area.

[0087] To complete the assembly of the oral fluid collection device 10, the first component 20 and the reservoir component 90 are attached such that the reservoir component 90 extends from the second surface 24 of the cover 30. The outer surface of the connector 73 of the clamp 70 is male-threaded, while the inner surface of the orifice 94 on the reservoir component 90 is female-threaded. Therefore, the first component 20 and the reservoir component 90 are screwed together to complete the assembly of the oral fluid collection device 10. Alternatively, the outer surface of the connector 73 of the clamp 70 may be female-threaded, while the inner surface of the orifice 94 on the reservoir component 90 may be male-threaded. Alternatively, the first component 20 and the reservoir component 90 are snapped together, or there is a resistance fit or a bayonet fit between the connector 73 and the orifice 94.

[0088] Figure 6 This is a partial cross-sectional side view of the oral fluid collection device 10. As previously described, a first fluid conduit 52 extends from the nipple interior 66 to a first one-way valve 82. The first fluid conduit 52 and the first one-way valve 82 are operatively connected and allow fluid to flow from the nipple interior 66 to the atmospheric discharge port 88.

[0089] A second fluid conduit 54 extends from the reservoir interior 98 to a second check valve 84. The second fluid conduit 54 and the second check valve 84 are operatively connected and allow fluid to flow from the reservoir interior 98 to the nipple interior 66.

[0090] The third fluid conduit, comprising a first portion of the third fluid conduit 56a and a second portion of the third fluid conduit 56b, extends from a collection port 64 located on the outer surface 62 of the nipple, through a third check valve 86, and a connector 73. The third check valve 86 is operatively connected to the first portion of the third fluid conduit 56a and the second portion of the third fluid conduit 56b, and it allows fluid to flow from the collection port 64 through an outlet port 67 into the reservoir interior 98.

[0091] The outlet port 67 is located in the central part of the storage unit 98. Figure 6 In this work, the dashed circle marked "c" represents the straight-line distance from the proximal end 91, distal end 92, and sidewall 96 of the reservoir component 90. The dashed circle "c" is defined as 75% of the straight-line distance from any point on the proximal end 91, distal end 92, and sidewall 96. In this work, the central portion of the reservoir interior 98 is defined as any location within the reservoir interior 98 that is greater than 25% of the straight-line distance from any point on the proximal end 91, distal end 92, and sidewall 96 of the reservoir component 90 to the circle "c".

[0092] For example, in Figure 6 In this configuration, the outlet port 67 is configured to be greater than approximately 75% of the straight-line distance from any point on the proximal end 91 to the circle "c", greater than approximately 100% of the straight-line distance from any point on the distal end 92 to the circle "c", and greater than approximately 60% of the straight-line distance from any point on the side wall 96 to the circle "c". Therefore, the outlet port 67 is defined to be located in the central portion of the reservoir interior 98.

[0093] The advantage of placing the outlet port 67 in the central part of the reservoir interior 98 is that the oral fluid collected in the reservoir interior 98 will not prevent newer fluid from flowing out of the outlet port 67.

[0094] Furthermore, connector 73 and its associated orifice 74 protrude into the reservoir interior 98 and form baffle 76. Baffle 76 provides a liquid / gas separation barrier to prevent fluid collected in the reservoir interior 98 from contacting the second one-way valve 84 and flowing from the reservoir interior 98 into the nipple interior 66. Oral fluid in the nipple interior 66 can affect the ability of the oral fluid collection device 10 to collect additional oral fluid. The central location of orifice 74 in the reservoir interior 98 also allows the pacifier to operate in most orientations.

[0095] The oral fluid collection device 10 described with reference to the accompanying drawings can be used in methods for collecting oral fluid for analysis. This method is generally as described above. The following explains how the device shown in the drawings can be used in this general method.

[0096] At the initial point, the pressure inside the nipple (66), inside the reservoir (98), and in the subject's (infant's) mouth or oral cavity are equal.

[0097] If the oral fluid collection device 10 is included in the packaging, the consumer first removes it from the packaging. The elastomeric nipple 60 is then inserted into the subject's mouth. The subject's non-nutritive sucking (NNS) movements on the elastomeric nipple 60 cause deformation (collapse) of the elastomeric nipple 60. This deformation forces fluid or air from the nipple interior 66 to the atmospheric discharge port 88, where it is expelled into the atmosphere. The fluid follows a path from the nipple interior 66 into the first fluid conduit 52, through the first one-way valve 82, and finally exits the oral fluid collection device 10 through the atmospheric discharge port 88. The first one-way valve 82 prevents air from outside the oral fluid collection device 10 from backfilling the nipple interior 66 via the atmospheric discharge port 88.

[0098] Next, the deformed elastomer nipple 60 is expanded back to its original shape. During non-nutritive sucking, the infant's tongue moves with a peristaltic motion, which alternately increases and then removes the load on the elastomer nipple 60. As the elastomer nipple 60 expands again, the pressure inside the nipple 66 decreases. To rebalance the pressure between the nipple interior 66 and the reservoir interior 98, gas must flow from the reservoir interior 98 to the nipple interior 66. The gas follows a path from the reservoir interior 98 into the second fluid conduit 54, through the second one-way valve 84, and finally into the nipple interior 66.

[0099] Since the gas has been removed from the inside 66 of the nipple and the inside 98 of the reservoir in the oral fluid collection device 10, the pressure inside the nipple 66 and the inside 98 of the reservoir is lower than the pressure in the subject's mouth. Now, in order to rebalance the fluid pressure between the inside 98 of the reservoir and the subject's mouth, fluid or air must be returned to the inside 98 of the reservoir. The source of the fluid is the subject's mouth. Oral fluid or saliva is drawn from the subject's mouth into the inside 98 of the reservoir. The path followed by the oral fluid is from the mouth, through the collection port 64 located on the outer surface 62 of the nipple, into the third fluid conduit (56a and 56b), through the third one-way valve 86, and finally into the inside 98 of the reservoir.

[0100] As previously mentioned, the reservoir interior 98 is where oral fluids (such as saliva) captured by the oral fluid collection device 10 are stored. The collected fluids can now be analyzed to help diagnose disease states within the body.

[0101] When analysis is performed at a testing laboratory outside the home, saliva must be transported to the testing location. After collecting oral fluid using the oral fluid collection device 10, the entire device can be transported to the testing location. Alternatively, after collecting oral fluid using the oral fluid collection device 10, the first component 20 and the reservoir component 90 can be separated firstly by removing the reservoir component 90 from the first component 20. The outer surface of the connector 73 of the clamp 70 is male-threaded, while the inner surface of the orifice 94 on the reservoir component 90 is female-threaded. Therefore, the first component 20 and the reservoir component 90 are screwed together to complete the assembly of the oral fluid collection device 10. Unscrewing the first component 20 and the reservoir component 90 is a method of separating the components of the oral fluid collection device 10.

[0102] For analysis of oral fluids, the fluid must be removed from the reservoir component 90. In some embodiments, the oral fluid to be detected is removed from the reservoir component 90 of the oral fluid collection device 10 by puncturing the reservoir component 90 with a syringe. Thus, the first component 20 and the reservoir component 90 can be separated by unscrewing, and the syringe is used to remove the collected fluid.

[0103] If the reservoir component 90 of the oral fluid collection kit is intended for delivery to a testing laboratory (hospital, clinic, medical testing facility) for analysis, then the reservoir component 90 and the first component 20 are separated when sufficient oral fluid has been collected in the reservoir component 90. The reservoir component 90 can be sealed by providing a sealing device on the orifice 94. Figure 4 As shown, the inner surface of the orifice 94 on the reservoir component 90 is female-threaded. Therefore, a plug with an external male thread can be used to seal the reservoir component 90. The reservoir component 90 can be housed in a kit supply package for shipment via mail or delivery service. The supplied package can be pre-addressed and can also be thermally insulated to protect the oral fluid collected in the reservoir component 90 from extreme temperatures that could affect oral fluid analysis.

[0104] Example

[0105] A sample oral fluid collection device 10 was manufactured to test the design. The shield 30, clamp 70, and reservoir component 90 were formed using conventional rapid prototyping technology. All were manufactured on an Objet Polyjet rapid prototyping machine (Stratasys GmbH, Rheinmunster, DE) using a rigid, opaque polyjet photopolymer sold under the trade name VeroWhitePlus RGD835 (Stratasys GmbH, Rheinmunster, DE). Prototype molds and a product under the trade name DragonSkin were used. TMThe elastomer components (shown as elastomer nipple 60 and back cover 95) were molded using silicone casting resin sold by 30 (Smooth-On, Inc., Macungie, PA). First one-way valve 82, second one-way valve 84, and third one-way valve 86 were supplied by Minivalve, Inc. (Cleveland, OH). These components were assembled using four standard stainless steel screws. Once assembled, the fluid handling capacity of the device was tested by immersing the collection port 64 in a beaker of water and then applying continuous compressive force to the elastomer nipple 60. It was observed that with continuous compression on the elastomer nipple 60, fluid flow was generated and fluid accumulated in the reservoir component 90.

[0106] The scope of the invention described herein and protected by the claims is not limited to the specific embodiments disclosed herein, as these embodiments are intended to illustrate several aspects of the invention. Any equivalent embodiments are intended to be within the scope of the invention. In fact, various modifications of the invention will become apparent to those skilled in the art from the foregoing description, in addition to those shown and described herein. Such modifications are also intended to fall within the scope of the appended claims. All publications cited herein are incorporated by reference in their entirety.

Claims

1. An oral fluid collection device, comprising: (a) A protective cover having a first surface and a second surface; (b) An elastomer nipple having an outer surface and defining an interior nipple, the elastomer nipple extending from the first surface of the shield; (c) A reservoir component extending from the second side of the cover, the reservoir component including a reservoir having a reservoir interior; (d) A first fluid conduit having a first one-way valve, the first one-way valve being operatively connected to and allowing flow from inside the nipple to an atmospheric discharge port disposed on the outer surface of the oral fluid collection device; (e) a second fluid conduit having a second one-way valve operatively connected to and allowing flow from the interior of the reservoir to the interior of the nipple; and (f) A third fluid conduit having a third one-way valve operatively connected to and allowing flow from a collection port disposed on the outer surface of the nipple to an outlet port inside the reservoir.

2. The oral fluid collection device of claim 1, wherein the reservoir component is arranged and configured for removable engagement with the shield.

3. The oral fluid collection device according to claim 1, wherein the reservoir component further includes at least one deformable region.

4. The oral fluid collection device according to claim 1, wherein the reservoir component further includes a housing to enclose the reservoir.

5. The oral fluid collection device according to claim 1, wherein the reservoir component is provided with a buffer solution inside the reservoir.

6. The oral fluid collection device of claim 1, wherein the outlet port is arranged and configured to provide an air gap between the liquid in the outlet port and the liquid inside the reservoir.

7. A method for collecting oral fluid, comprising: (a) Remove the oral fluid collection device according to claim 1 from the packaging; (b) Insert the nipple, having an initial static volume, into the oral cavity of the subject; (c) Deform the nipple to force fluid from inside the nipple to the atmospheric discharge port; (d) Allowing the nipple to expand toward the initial static volume, thereby drawing fluid from inside the reservoir and reducing the fluid pressure in the reservoir components; as well as (e) Oral fluid is drawn from the subject’s mouth into the reservoir through the collection port.

8. The method of claim 7, wherein the oral fluid comprises saliva.

9. The method of claim 7, further comprising removing the reservoir component from the cover.

10. The method of claim 9, further comprising adding a buffer solution to the interior of the reservoir.

11. The method of claim 7, wherein the reservoir component is provided with a buffer solution inside the reservoir.

12. The method according to claim 10 or 11, further comprising analyzing the oral fluid.

13. An oral fluid collection kit, comprising: (a) A durable component, said durable component comprising: (i) a protective cover having a first surface and a second surface; and (ii) an elastomeric nipple having an outer surface and defining an interior nipple, the elastomeric nipple extending from the first surface of the shield; and (b) A plurality of attachable storage components arranged and configured to be removably engaged to the cover, each attachable storage component including a storage unit having a storage unit interior; The assembly of one of the plurality of attachable reservoir components with the durable component defines an oral fluid collection device, the oral fluid collection device having: (1) a first fluid conduit having a first one-way valve operatively connected to and allowing flow from inside the nipple to an atmospheric discharge port disposed on an outer surface of the oral fluid collection device; (2) a second fluid conduit having a second one-way valve operatively connected to and allowing flow from inside the reservoir to inside the nipple; and (3) a third fluid conduit having a third one-way valve operatively connected to and allowing flow from a collection port disposed on the outer surface of the nipple to an outlet port inside the reservoir.

14. The oral fluid collection kit of claim 13, wherein each of the plurality of attachable reservoir components is individually packaged.

15. The oral fluid collection kit of claim 13, wherein the reservoir component further comprises at least one deformable region.

16. The oral fluid collection kit of claim 13, wherein the reservoir component further includes a housing to enclose the reservoir.

17. The oral fluid collection kit of claim 13, wherein the reservoir component is provided with a buffer solution inside the reservoir.

18. The oral fluid collection kit of claim 13, wherein the outlet port is located in the central portion inside the reservoir.

19. The oral fluid collection kit of claim 13, further comprising operational instructions for transporting the reservoir to a testing facility.

20. A method for collecting oral fluid, comprising: (a) Remove one of the attachable reservoir components from the packaging of the oral fluid collection kit according to claim 13; (b) Assemble the oral fluid collection device by attaching the attachable reservoir component of step (a) to the durable component; (c) Insert the nipple, having an initial static volume, into the oral cavity of the subject; (d) Deform the nipple to force fluid from inside the nipple to the atmospheric discharge port; (e) Allowing the nipple to expand toward the initial static volume, thereby drawing fluid from inside the reservoir and reducing the fluid pressure in the reservoir components; as well as (f) Oral fluid is drawn from the subject’s mouth into the reservoir through the collection port.

21. The method of claim 20, wherein the oral fluid comprises saliva.

22. The method of claim 20, further comprising removing the reservoir component from the cover.

23. The method of claim 22, further comprising adding a buffer solution to the reservoir.

24. The method of claim 20, wherein the reservoir component is provided with a buffer solution inside the reservoir.

25. The method of claim 23 or 24, further comprising analyzing the oral fluid.

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