WO2017001922A1

WO2017001922A1 - Biological sample collection device

Info

Publication number: WO2017001922A1
Application number: PCT/IB2016/001034
Authority: WO
Inventors: Marc Andrew Koska
Original assignee: Marc Andrew Koska
Priority date: 2015-07-02
Filing date: 2016-07-01
Publication date: 2017-01-05

Abstract

A biological sample collection device (10) which is capable of collecting a small volume of a biological fluid for storage, transport, and/or immediate analysis in a controlled manner and without requiring specialized skill. The collection device is configured to collect a small volume (e.g., 0.001 ml to 1.0 ml) of blood, or other body fluid, from a collection site on a patient in the field while remaining sterile and reducing the potential for contamination during the collection process. The collection device further includes an assay assembly provided within the device and configured for immediate analysis of the collected sample.

Description

BIOLOGICAL SAMPLE COLLECTION DEVICE

Cross Reference to Related Applications

This application claims the benefit of and priority to U.S. Provisional Application No. 62/188,138, filed July 2, 2015, the content of which is hereby incorporated by reference herein in its entirety.

Field of the Invention

The present invention generally relates to collection devices, and, more particularly, to a single use biological sample collection device for collecting a small volume of a biological fluid for storage, transport, and/or analysis.

Background

Every year, millions of people become infected and die from a variety of diseases or conditions, many of which are treatable. Diagnostic testing plays a key role in identifying the presence of such treatable diseases and conditions. In particular, the collection of body fluids has long been used to test for and monitor the presence of specific molecules within the fluid, wherein the results of such analyte testing can be used to such diagnose medical diseases and conditions. In order to provide timely and necessary treatment and intervention, it is important to have accurate and rapid diagnostic systems and methods.

One of the most commonly collected and tested body fluids is blood. A blood sample for use in laboratory testing is often obtained by way of venipuncture, which typically involves inserting a hypodermic needle into a vein on the subject. Blood extracted by the hypodermic needle may be drawn directly into a syringe (e.g., 10-20 ml syringe) or into one or more sealed vials (e.g., Vacutainer) for subsequent processing. After the blood sample is collected, the extracted sample is typically packaged and transferred to a processing center for analysis.

Unfortunately, conventional sample collection and testing techniques of bodily fluid samples have drawbacks. For instance, some blood tests require a substantially high volume of blood to be extracted from the subject. Because of the high volume of blood, extraction of blood from alternate sample sites on a subject (e.g., fingerstick, heelstick, etc.), which may be less painful and/or less invasive, are often disfavored as they do not yield the blood volumes needed for conventional testing methodologies. In some cases, patient apprehension associated with venipuncture may reduce patient compliance with testing protocol. Additionally, while some blood tests require only a small volume of blood, traditional collection techniques (e.g., venipuncture) results in a substantially greater volume of blood to be extracted from the subject than is necessary.

Although some collection devices allow for the collection of small volumes of body fluid, such devices also have drawbacks. For example, current small volume collection devices generally consist of a microtainer in which a medical professional (or other operator collecting the fluid) simply lances the test site (e.g., fingertip, heel, etc) and allows blood to collect into the open microtainer. Such small volume devices still present drawbacks, including, but not limited to, pain and trepidation for the patient due to difficulty in controlling incision force and incision depth, multiple steps required for collecting and testing the sample resulting in long acquisition times, specialized training so as to ensure that collection is being performed according to strict standards and requirements to prevent contamination, maintenance of sample integrity during storage and/or transportation, and the like.

Furthermore, in many situations, particularly in developing countries or remote settings, the collection of body fluids may occur outside of a hospital or medical setting and may be performed by a non-professional. As such, the collection of body fluids under those

circumstances may increase the risk of contamination of samples, as well as increase risk of infection and spread of blood-borne diseases, particularly when lances or other incisions devices, which have been previously used and are no longer sterile, are used to collect fluids.

Furthermore, such isolated locations may lack immediate access to testing facilities, thus further delaying diagnosis of a disease and delaying treatment.

Summary

The present invention provides a biological sample collection device that overcomes the drawbacks of current collection devices and methods. In particular, the biological sample collection device of the present invention is capable of collecting a small volume of a biological fluid for storage, transport, and/or immediate analysis in a controlled manner and without requiring specialized training or skill. In particular, the collection device is configured to collect a small volume (e.g., 0.001 ml to 1.0 ml) of blood, or other body fluid, from a collection site on a patient in the field while remaining sterile and reducing the potential for contamination during the collection process. In some embodiments, the collection device further includes an assay assembly provided within the device and configured for immediate analysis of the collected sample. Accordingly, the device of the present invention not only provides for the collection of a sample, but also allows unskilled persons (e.g., non-medical professionals or trained operators) to perform certain analytical procedures outside of a laboratory or testing facility, thereby addressing the need for diagnostic devices in certain settings (e.g., developing countries, remote areas, etc.).

The collection device is configured to allow collection of a sample from a patient in a relatively simple manner, without requiring specialized training for drawing a body fluid into the device. In particular, the collection device is designed such that a person collecting the sample of body fluid (e.g., operator) need only compress or squeeze an elastic reservoir on the device so reduce an interior volume of the reservoir, position an inlet port coupled to one end of the reservoir into contact with a biological fluid at a collection site (e.g., area of patient's body from which fluid is to be collected), and release compression from the reservoir, at which point the resilient reservoir naturally returns to its normal shape, thereby resulting in a suction force at the inlet port and causing the biological to be drawn into the reservoir member to be stored and ready for analysis.

In some embodiments, the collection site may require little or no preparation, such as in the event that sweat, tears, saliva, other secretions are to be collected. However, in the event that blood is to be collected, a lance, or other incision device, may be initially used to pierce a portion of the patient's epidermis so as to cause a globule of blood to arise to the surface, at which point a nozzle coupled to the inlet port may be used to direct the blood into the reservoir upon application of suction force. In some embodiments, the device may include a built-in needle configured to pierce the skin and allow direct collection of a small volume of blood therethrough. The needle may include a micro-needle, for example, such that an operator need only press the device against the surface of the skin with minimal pressure, as the length of the micro-needle is sufficiently minimal (e.g., 0.5 mm to 4 mm) to cause little or no damage, yet still allow a small volume of blood to be drawn through the micro-needle and into the reservoir upon release of compression on the reservoir. The device is shaped and/or sized such that it may be compatible with existing analysis systems configured to detect the presence of a target analyte in the biological fluid sample. More specifically, the collection device may be compatible with commercially available fully or semi- automated analyzing systems configured to received individual samples and perform analysis on such samples. For example, the collection device of the present invention may be shaped or sized to fit directly within a relevant diagnostic machine for testing, wherein the reservoir having a small volume of collected biological fluid may be probed, split, or manipulated by the machine so as to release the collected fluid for subsequent testing.

In some embodiments, the collection device may include an assay assembly provided directly therein and configured for immediate analysis of the collected biological fluid sample. For example, the assay assembly may be positioned within the reservoir and may include one or more reagents or reactants for interacting with the collected biological fluid so as to provide a visual indication (e.g., color output) of the presence of a target analyte based on the interaction.

Accordingly, the collection device of the present invention does not require a trained, skilled healthcare professional for collection of a biological fluid sample and for subsequent diagnostic testing and analysis. As such, the collection device may be particularly useful in situations in which biological fluid samples, such as blood, are to be collected in non-healthcare related facilities (e.g., outside of clinics or hospitals) from a large numbers of individuals over a short period of time by a non-professional. Furthermore, the collection device allows unskilled persons (e.g., non-medical professionals or trained operators) to perform certain analytical procedures outside of a laboratory or testing facility, thereby addressing the need for diagnostic devices in certain settings (e.g., developing countries, remote areas, etc.).

In one aspect, the collection device of the present invention includes a base member and a top member coupled thereto. The base member includes a proximal end and a distal end having an inlet port. The base member further includes a channel providing a fluid pathway extending a length from the inlet port to the proximal end. The top member includes compressible reservoir member having an interior volume in fluid communication with the fluid pathway of the channel. The reservoir member is configured to transition from a normal state to a deformed state upon application of a compression force to the reservoir member. When in the deformed state, the interior volume is reduced when compared to the interior volume when the reservoir member is in the normal state. Upon removal of the compression force from the reservoir member, the reservoir member is configured to return from the deformed state to the normal state, thereby causing a partial vacuum within the interior volume and resulting in a suction force at the inlet port. The suction force allows a biological fluid sample in contact with the inlet port to be drawn into the fluid pathway and into the interior volume of the reservoir member.

The reservoir member generally includes an elastic material configured to return the reservoir member to the normal state upon removal of a compression force therefrom. When in a normal state, the interior volume is at an ambient pressure and, when in a deformed state and the inlet port is in contact with the biological fluid sample, the interior volume is at a reduced pressure relative to an ambient pressure.

In some embodiments, the reservoir member includes a transparent or translucent material configured to provide a view into the interior volume of the reservoir member.

Accordingly, an operator is able to have full visibility of the collection of a fluid sample within the reservoir member. Additionally, in some embodiments, the device further includes an assay assembly positioned within the interior volume of the reservoir member. The assay assembly is configured to detect the presence of a target analyte in the biological fluid sample in real-, or near real-time. The assay assembly may include one or more reagents or reactants configured to interact with the biological fluid sample and provide a visual indication of the presence of the target analyte based on the interaction, such as a color output. Accordingly, the transparent or translucent material further provides visibility to the results of the diagnostic testing performed by the assay assembly within.

In some embodiments, the reservoir member may include a coating on an interior surface thereof, which may include a chemical preservative or enzyme inhibitor. Accordingly, the device may further allow for storage of a collected fluid sample for a given period of time so as to maintain integrity of the sample and prevent degradation.

In some embodiments, the device may further include a needle coupled to the inlet port and configured to pierce a portion of a patient's body to thereby access the biological fluid sample to be collected. The needle may include a hollow needle having a lumen in fluid communication with the inlet port and the fluid pathway of the channel. Accordingly, during collection, the biological fluid sample may be drawn through the needle and into the reservoir member. In some embodiments, the needle may include a micro -needle having a length in the range of 0.5 mm to 4 mm. The interior volume of the reservoir member may be in the range of 0.001 ml to 1.0 ml when in the normal state. Accordingly, the device is configured to collect small volumes of a biological fluid.

Brief Description of the Drawings

FIG. 1 is a top perspective view of a collection device consistent with the present disclosure illustrating the top and base members in an assembled state.

FIG. 2 is a top perspective exploded view of one embodiment of the collection device of

FIG. 1.

FIG. 3 is a side view of the collection device of FIG. 1.

FIG. 4A is a side view of the collection device illustrating positioning of the device relative to the biological fluid sample and compression of the reservoir member so as to transition the reservoir member from a normal state to a deformed state.

FIG. 4B is a side view of the collection device illustrating contact between a nozzle at an inlet port of the collection device and subsequent drawing in of the biological fluid sample upon release of compression from the reservoir member.

FIG. 4C is a side view of the collection device illustrating the reservoir member filled with a small volume of collected biological fluid sample for storage, transport, and/or immediate or subsequent analysis.

FIG. 5A is a side view of the collection device having an integrated needle, illustrating positioning of the device relative to a collection site and compression of the reservoir member so as to transition the reservoir member from the normal state to the deformed state.

FIG. 5B illustrates piercing of the target site (epidermis) with the needle until the needle reaches vasculature and subsequent drawing in of the biological fluid sample from the vasculature upon release of compression from the reservoir member.

Detailed Description

The present invention provides a biological sample collection device that is capable of collecting a small volume of a biological fluid for storage, transport, and/or immediate analysis in a controlled manner and without requiring specialized skill. In particular, the collection device is configured to collect a small volume of blood, or other body fluid, from a collection site on a patient in the field while remaining sterile and reducing the potential for contamination during the collection process. In some embodiments, the collection device further includes an assay assembly provided within the device and configured for immediate analysis of the collected sample. Accordingly, the device of the present invention not only provides for the collection of a sample, but also allows unskilled persons (e.g., non-medical professionals or trained operators) to perform certain analytical procedures outside of a laboratory or testing facility, thereby addressing the need for diagnostic devices in certain settings (e.g., developing countries, remote areas, etc.).

By way of overview, the present invention provides a collection device including a base member and a top member coupled thereto. The base member includes a proximal end and a distal end having an inlet port. The base member further includes a channel providing a fluid pathway extending a length from the inlet port to the proximal end. The top member includes compressible reservoir member having an interior volume in fluid communication with the fluid pathway of the channel. The reservoir member is configured to transition from a normal state to a deformed state upon application of a compression force to the reservoir member. When in the deformed state, the interior volume is reduced when compared to the interior volume when the reservoir member is in the normal state. Upon removal of the compression force from the reservoir member, the reservoir member is configured to return from the deformed state to the normal state, thereby causing a partial vacuum within the interior volume and resulting in a suction force at the inlet port. The suction force allows a biological fluid sample in contact with the inlet port to be drawn into the fluid pathway and into the interior volume of the reservoir member.

The collection device is configured to allow collection of a sample from a patient in a relatively simple manner, without requiring specialized training for drawing a body fluid into the device. In particular, the collection device is designed such that a person collecting the sample of body fluid (e.g., operator) need only compress or squeeze an elastic reservoir on the device so reduce an interior volume of the reservoir, position an inlet port coupled to one end of the reservoir into contact with a biological fluid at a collection site (e.g., area of patient's body from which fluid is to be collected), and release compression from the reservoir, at which point the resilient reservoir naturally returns to its normal shape, thereby resulting in a suction force at the inlet port and causing the biological to be drawn into the reservoir member to be stored and ready for analysis. In some embodiments, the collection site may require little or no preparation, such as in the event that sweat, tears, saliva, other secretions are to be collected. However, in the event that blood, or other internal fluid, is to be collected, a lance, or other incision device, may be initially used to pierce a portion of the patient's epidermis so as to cause a globule of blood to arise to the surface, at which point a nozzle coupled to the inlet port may be used to direct the blood into the reservoir upon application of suction force. In some embodiments, the device may include a built-in needle configured to pierce the skin and allow direct collection of a small volume of blood therethrough. The needle may include a micro-needle, for example, such that an operator need only press the device against the surface of the skin with minimal pressure, as the length of the micro-needle is sufficiently minimal (e.g., 0.5 mm to 4 mm) to cause little or no damage , yet still allow a small volume of blood to be drawn through the micro-needle and into the reservoir upon release of compression on the reservoir.

The device is shaped and/or sized such that it may be compatible with existing analysis systems configured to detect the presence of a target analyte in the biological fluid sample. More specifically, the collection device may be compatible with commercially available fully or semi- automated analyzing systems configured to received individual samples and perform analysis on such samples. For example, the collection device of the present invention may be shaped or sized to fit directly within a relevant diagnostic machine for testing, wherein the reservoir having a small volume of collected biological fluid may be probed, split, or manipulated by the machine so as to release the collected fluid for subsequent testing.

In some embodiments, the collection device may include an assay assembly provided directly thereon and configured for immediate analysis of the collected biological fluid sample. For example, the assay assembly may be positioned within the reservoir and may include one or more reagents or reactants for interacting with the collected biological fluid so as to provide a visual indication (e.g., color output) of the presence of a target analyte based on the interaction.

Accordingly, the collection device of the present invention does not require a trained, skilled healthcare professional for collection of a biological fluid sample and for subsequent diagnostic testing and analysis. As such, the collection device may be particularly useful in situations in which biological fluid samples, such as blood, are to be collected in non-healthcare related facilities (e.g., outside of clinics or hospitals) from a large numbers of individuals over a short period of time by a non-professional. Furthermore, the collection device allows unskilled persons (e.g., non-medical professionals or trained operators) to perform certain analytical procedures outside of a laboratory or testing facility, thereby addressing the need for diagnostic devices in certain settings (e.g., developing countries, remote areas, etc.). The collection device further includes numerous safety features for reducing the risk of contamination of collected samples and to further reduce the potential for reuse, thereby reducing the risk of the spreading blood-borne diseases through reuse.

FIG. 1 is a top perspective view of a collection device 10 consistent with the present disclosure. FIGS. 2 and 3 are top perspective exploded and side views of the collection device 10, respectively. As shown, the collection device 10 may include a base member 12 and a top member 14 coupled thereto. The base member 12 generally includes a proximal end 16 (which may include a port 18) and a distal end 20 having an inlet port 22 configured to receive and allow a biological fluid sample to pass therethrough and into the device 10. The base member 12 may further include a channel formed within a portion thereof (shown as channel 34 in FIG. 2) and providing a fluid pathway extending a length from the inlet port 22 to the proximal end 16. Upon receipt of a biological fluid sample from a collection site, via the inlet port 22, the biological fluid may flow within the pathway provided by the channel 34.

The top member 14 includes a compressible reservoir member 24 having an interior volume configured to receive and store an amount of biological fluid within. The top member 14 includes an inlet 25 and a fluid pathway 26 extending between the inlet 25 and the reservoir member 24. Accordingly, once coupled to the base member 12, the inlet 25 and fluid pathway 26 may substantially correspond to the fluid pathway of the channel 34, thereby cooperating with one another to form a combined single channel pathway from the inlet port 22 to at least the interior volume of the reservoir member 24. More specifically, upon sealing the top member 14 to a portion of the base member 12 along a mounting section 32 (shown in FIG. 2), the top member 14, including the fluid pathway 26, substantially encloses channel 34, so as to allow the interior volume of the reservoir member 24 to be fluid communication with the fluid pathway of the channel 34. Thus, biological fluid passing through the inlet port 22, further passes along the fluid pathway of the channel 34, through the fluid pathway 26 of the top member 14, and into the interior volume of the reservoir member 24 during a collection process, as will be described in greater detail herein. The top member 14 may be coupled to the base member 12 by any known means so as to create a hermetic seal. For example, the base and top members 12, 14 may be sealed with one another via any known adhesives, cements, ultrasonic welding, or thermoplastic bonding techniques. The base and top members 12, 14 are composed of a medical grade material. In some embodiments, the base member 12, the top member 14, or both, may be composed of a thermoplastic polymer, including, but not limited to, polypropylene, polyethylene,

polybenzimidazole, acrylonitrile butadiene styrene (ABS) polystyrene, polyvinyl chloride, PVC, or the like.

The top member 14 may be formed separately from the base member 12, which provides advantages. For example, an advantage of construction of the collection device 10 is that the base and top members may be produced separately from one another, wherein the base member may have a consistent production size and shape, while production of the top member may vary depending on the amount of biological fluid to be collected. For example, certain tests require a certain volume of biological fluid. Accordingly, a first production of top members can be produced so as to have a reservoir having an interior volume corresponding to a volume required or recommended for a first test (e.g., blood glucose test) of a biological fluid (e.g., blood) and a second production of top members can be produced so as to have a reservoir having an interior volume corresponding to volume required or recommended for a second test (e.g., HIV test) of a biological fluid (e.g., blood). Accordingly, different volume amounts of fluid to be collected can be easily produced (producing different top members) while still using a universal production of base members. The top member is then sealed to a base member to provide an assembled collection device.

In some embodiments, the base member 12 may further include a one-way valve 28 positioned within the fluid pathway of the channel 34. The one-way valve 28 may be configured to permit antegrade flow of fluid from port 18 at the proximal end 16 to the inlet port 22, while preventing retrograde flow (e.g., backflow) of fluid from the reservoir member 24 through the valve 28 and through the port 18 at the proximal end 16. For example, the one-way valve 28 may include an open end adjacent to the proximal end 16 and an adjustable outlet end adjacent to the reservoir member 24 and configured to move between a normally closed position and an open position. Accordingly, when in a closed position, the outlet end provides a substantially leak-proof and/or airtight seal so as to prevent any fluid from flowing through the valve 28 from the reservoir 24, such as when biological fluid enters the interior volume of the reservoir member 24. Additionally, the one-way valve 28 further ensures that a specific fluid may be introduced into the reservoir member 24 from the port 18, such as a reagent, stabilizer, and/or preservative to be introduced into the reservoir member 24 after the collection of a biological fluid, while prevent backflow of the biological fluid and additional added fluid. As generally understood, the one-way valve 28 may include any type of valve configured to permit fluid to flow only in a single direction. The one-way valve 28 may include any type of valve having medical grade material and configured to be used with the flow of fluids. For example, the one-way valve 26 may include a Reed valve or a Heimlich valve. In some embodiments, a seal member may cover the port 18 to serve multiple functions.

As will be described in greater detail herein, collection of a biological fluid occurs at the inlet port 22 by way of a suction force at the inlet port 22 caused by the transitioning of the reservoir member 24 between a deformed state to a normal state. In other words, an operator need only squeeze or compress the reservoir member 24, then position the device 10 such that the inlet port 22 is in contact with a biological fluid to be collected, and release compression of the reservoir member 24, thereby resulting in a partial vacuum within the interior volume of the reservoir member 24 and a suction force at the inlet port 22 to draw the biological fluid within. Accordingly, in the event that the device 10 includes the one-way valve 28 as described herein, the device 10 further includes a temporary seal member covering the port 18. The seal member may serve multiple functions. For example, seal member may prevent any contaminants from entering the port 18 and potentially contaminating the collection device 10. Additionally, the seal member, while intact, allows for the suction force to be provided solely at the inlet port 22 when the reservoir member 24 returns to a normal state from a deformed state. In particular, without the seal member covering the port 18, the transition of the reservoir member 24 from a deformed state to a normal state may also result in a suction force at the port 18, which would decrease the suction force at the inlet port 22 where the biological fluid is to be drawn into the device 10.

The seal member may be a single use seal composed of a relatively thin sheet of material (e.g., metal foil, plastic, etc.) may be hermetically sealed to the opening of the port 18. The seal member is configured to rupture upon coupling of a syringe or other device to the port 18, thereby allowing a fluid to enter into the reservoir member 24 via the port 18. For example, as previously described, upon collecting the biological fluid within the reservoir member 24, an operator may couple a syringe, or other device, to the port 18 and dispense a fluid into the device 10, wherein the fluid may include a reagent, stabilizer, and/or preservative to be mixed with the collected biological fluid.

As shown, the top member 14 may further include a second smaller reservoir member 30, which, in some embodiments, may simply act as a valve cover 30, such that, upon coupling the top member 14 to the base member 12, the valve cover 30 substantially encloses the one-way valve 28.

The compressible reservoir member 24 includes an interior volume configured to receive and store a volume of collected biological fluid within by way of the inlet port 22. As generally understood, the collection device 10 may be configured to receive any bodily fluids suspected to contain an analyte of interest, such fluids including, but not limited to, blood, serum, plasma, saliva, sweat, tears, urine, interstitial fluid derived from tissue (e.g. tumorous tissue),

cerebrospinal fluid, bodily secretions, and a combination thereof.

As shown in FIG. 2, the device 10 may further include an assay assembly 36 positioned within the interior volume of the reservoir member 24. The assay assembly 36 is configured to detect the presence of a target analyte in the biological fluid sample in real-, or near real-time. For example, the assay assembly 36 may include one or more reagents or reactants configured to interact with the biological fluid sample and provide a visual indication of the presence of the target analyte based on the interaction. For example, the visual indication may include a color output or the like. As used herein, the term "analyte" may generally refer to any substances in a bodily fluid that can be detected and useful in determining a disease or condition based on the presence, or lack of presence, in a bodily fluid. For example, a target analyte may include, but is not limited to, drugs, prodrugs, pharmaceutical agents, drug metabolites, a biomarker indicative of a disease, a tissue specific marker, a tissue specific enzyme biomarkers, antibodies, serum proteins, cholesterol, polysaccharides, nucleic acids, gene, protein, hormone, and any

combination thereof.

In some embodiments, the device 10 may be devoid of an assay assembly 36, and instead, may be shaped and/or sized to be compatible with existing analysis systems configured to detect the presence of a target analyte in the biological fluid sample. More specifically, the collection device may be compatible with commercially available fully or semi-automated analyzing systems configured to received individual samples and perform analysis on such samples. For example, the collection device 10 of the present invention may be shaped or sized to fit directly within a relevant diagnostic machine for testing, wherein the reservoir 24 having a small volume of collected biological fluid may be probed, split, or manipulated by the machine so as to release the collected fluid for subsequent testing.

In some embodiments, the reservoir member 24 may include a transparent or translucent material configured to provide a view into the interior volume of the reservoir member 24.

Accordingly, an operator is able to have full visibility of the collection of a fluid sample within the reservoir member 24. Additionally, in the event that the device 10 includes the assay assembly 36, the transparent or translucent material further provides visibility to the results of the diagnostic testing performed by the assay assembly 36 within. In particular, an operator may have full visibility to the color output of the test by way of the translucent or transparent reservoir member 24.

As previously described, the second smaller reservoir 30 may simply serve as a cover for the one-way valve 28. However, in other embodiments in which the device 10 is devoid of the valve 28, the second smaller reservoir 30 may house the assay assembly 36 within in addition, or alternatively, to inclusion of an assay assembly 36 within the main reservoir member 24. For example, a small volume of blood may be drawn into the second chamber 30 from the reservoir member 24 via capillary action, and testing of the blood may occur within the second smaller reservoir 30. Accordingly, the second reservoir 30 may also include a transparent or translucent material to allow visibility into the interior and results of the testing.

In some embodiments, the device 10 may be useful for storage of a collected biological fluid sample. Accordingly, the reservoir member 24 may include a coating on an interior surface thereof, which may include a chemical preservative or enzyme inhibitor. Therefore, the device 10 may allow for storage of a collected fluid sample for a given period of time so as to maintain integrity of the sample and prevent degradation.

The collection device 10 is configured to allow collection of a sample from a patient in a relatively simple manner, without requiring specialized training for drawing a body fluid into the device 10. For example, as shown in FIGS. 4A and 4B, the reservoir member 24 is configured to transition from a normal state to a deformed state upon application and release of a compression force to the reservoir member 24. More specifically, as shown in FIG. 4A, the reservoir member 24 generally includes an elastic material configured to allow the reservoir member 24 to transition from a normal state (illustrated in phantom) to a deformed state upon compression force applied thereto (e.g., an operator squeezing the reservoir member 24). Due to the elastic nature of the material, the reservoir member 24 may then return to the normal state upon removal of the compression force therefrom, as shown in FIG. 4B. Accordingly, the collection device 10 is designed such that a person collecting the sample of body fluid need only compress or squeeze an elastic reservoir 24 so reduce an interior volume of the reservoir, position an inlet port 22 into contact with a biological fluid at a collection site (e.g., area of patient's body from which fluid is to be collected), and release compression from the reservoir, at which point the resilient reservoir naturally returns to its normal shape, thereby resulting in a suction force at the inlet port and causing the biological fluid to be drawn into the reservoir member 24 to be stored and ready for analysis.

More specifically, FIG. 4A is a side view of the collection device 10 illustrating positioning of the device 10 relative to the biological fluid sample 42. As previously described, the biological fluid sample may include any bodily fluids suspected to contain an analyte of interest, such fluids including, but not limited to, blood, serum, plasma, saliva, sweat, tears, urine, interstitial fluid derived from tissue (e.g. tumorous tissue), cerebrospinal fluid, bodily secretions, and a combination thereof. In some embodiments, the collection site may require little or no preparation, such as in the event that sweat, tears, saliva, other secretions are to be collected. However, in the event that blood is to be collected, as shown in FIGS. 4A and 4B, a lance, or other incision device, may be initially used to pierce a portion of the patient's epidermis so as to cause a globule of blood 42 to arise to the surface.

When ready, an operator need only position the device 10, specifically the inlet port 22, relative to the globule of blood 42 and compress the reservoir member 24, as indicated by arrow 38. Upon compressing the reservoir member 24, air contained within the interior volume is forced out of the reservoir and out of the inlet port 22, as indicated by arrow 40, thereby reducing the interior volume of the reservoir member 24. Compression results in transitioning of the reservoir member 24 from the normal state, in which the interior volume is at an ambient pressure, to the deformed state, in which the interior volume is at a reduced pressure.

As shown in FIG. 4B, the inlet port 22 may then may contact with the globule of blood 42 and collection of a volume of blood may then occur upon release of compression upon the reservoir member 24. More specifically, upon removal of a compression force from the reservoir member 24, as indicated by arrow 44, the reservoir member 24 is configured to return to the normal state to thereby cause a partial vacuum within the interior volume and a provide suction force at the inlet port 22 so as to allow blood to be drawn into the into the fluid pathway, as indicated by arrow 46, and into the interior volume of the reservoir member 24. Upon collection, the sample 42a may be stored, transported, and/or immediately tested via the assay assembly 36.

In the event that the sample 42a is to be stored or transported, a seal member may then be placed over the inlet port 22 so as to prevent the collected biological fluid sample 42a from leaking from the reservoir member 24 and/or to prevent any contamination of the sample 42a. For example, a single use seal member may be composed of a relatively thin sheet of material (e.g., metal foil, plastic, etc.) may be sealed to the opening of the inlet port 22, thereby preventing contaminants (e.g., gases, fluids, dirt, debris, etc.) from entering the delivery device 10. The seal member may be coupled to the inlet port 22 by any known sealing techniques (e.g., heat, vibration, or adhesive process). The seal member is configured to be durable in the sense that it provides a sufficient seal with the inlet port 22 and prevent contaminants from entering into the device 10 via the inlet port 22 while also being configured to be pliable and rupture upon coupling of the inlet port 22 to a known device that is part of an analysis system so as to allow the sample 42a to be withdrawn and tested.

As shown in FIGS. 4A-4C, the inlet port 22 may generally include a nozzle type member that may be used to direct the blood into the device upon application of suction force. A nozzle or similar member may be useful in instances in which the collection site require little or no preparation, such as in the event that sweat, tears, saliva, other secretions are to be collected or when a lance, or other incision device, is initially used to pierce a portion of the patient's epidermis so as to cause a the fluid to be exposed (e.g., globule of blood).

However, in some embodiments, the device 10 may include a built-in puncturing member, such as a needle, configured to pierce the skin and allow direct collection of a small volume of fluid, such as blood, interstitial fluid, and the like, to flow through the needle and into the device 10 as a result of suction force when releasing compression of the reservoir member 24. For example, as shown in FIGS. 5A and 5B, a device 10 includes an integrated needle 50 coupled to the inlet port 22 and having a tip configured to pierce a portion of a patient's body to thereby access a biological fluid to be collected. The needle 50 may include a micro-needle configured to penetrate a patient's skin down to a predetermined depth (e.g., depth of the dermis so as to penetrate a vasculature layer, such as a bed of capillaries, or the like). In other embodiments, however, the needle 50 may be sized so as to collect a fluid from deeper sites (e.g., intravenous, subcutaneous, intradermal, etc.).

FIG. 5A is a side view of the collection device 50 having an integrated needle, illustrating positioning of the device relative to a collection site and compression of the reservoir member 24 so as to transition the reservoir member from the normal state to the deformed state, as indicated by arrow 52. By compressing the reservoir member 24, air in the interior volume of the reservoir member 24 is expelled through the needle 50, as indicated by arrow 54.

FIG. 5B illustrates piercing of the target site (epidermis) with the needle 50 until the needle reaches vasculature. As previously described, the needle may include a micro-needle, for example, such that an operator need only press the device 10 against the surface of the skin with minimal pressure, as the length of the micro-needle is sufficiently minimal (e.g., 0.5 mm to 4 mm) to cause little or no damage, yet still allow a small volume of blood to be drawn through the micro-needle 50 and into the reservoir upon release of compression on the reservoir.

Accordingly, upon piercing the target site, an operator need only release compression from the reservoir member 24, as indicated by arrow 56, which in turn results in subsequent drawing in of the biological fluid sample into the interior volume of the reservoir member 24, as indicated by arrow 58, as a result of the partial vacuum created when the reservoir member 24 returns to the normal state.

While several embodiments of the present disclosure have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the functions and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the present disclosure. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or

configurations will depend upon the specific application or applications for which the teachings of the present disclosure is/are used.

Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the disclosure described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, the disclosure may be practiced otherwise than as specifically described and claimed. The present disclosure is directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the scope of the present disclosure.

All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and/or ordinary meanings of the defined terms.

The indefinite articles "a" and "an," as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean "at least one."

The phrase "and/or," as used herein in the specification and in the claims, should be understood to mean "either or both" of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Other elements may optionally be present other than the elements specifically identified by the "and/or" clause, whether related or unrelated to those elements specifically identified, unless clearly indicated to the contrary.

Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

The terms and expressions which have been employed herein are used as terms of description and not of limitation, and there is no intention, in the use of such terms and expressions, of excluding any equivalents of the features shown and described (or portions thereof), and it is recognized that various modifications are possible within the scope of the claims. Accordingly, the claims are intended to cover all such equivalents.

Incorporation by Reference

References and citations to other documents, such as patents, patent applications, patent publications, journals, books, papers, web contents, have been made throughout this disclosure. All such documents are hereby incorporated herein by reference in their entirety for all purposes.

Equivalents

Various modifications of the invention and many further embodiments thereof, in addition to those shown and described herein, will become apparent to those skilled in the art from the full contents of this document, including references to the scientific and patent literature cited herein. The subject matter herein contains important information, exemplification and guidance that can be adapted to the practice of this invention in its various embodiments and equivalents thereof.

Claims

Claims What is claimed is:

1. A biological sample collection device comprising:

a base member comprising a proximal end and a distal end having an inlet port, said base member having a channel providing a fluid pathway extending a length from said inlet port to said proximal end; and

a top member coupled to said base member and comprising a compressible reservoir member having an interior volume in fluid communication with said fluid pathway of said channel, said reservoir member configured to transition from a normal state to a deformed state upon application of a compression force to said reservoir member, wherein said interior volume is reduced in said deformed state;

wherein, upon removal of a compression force from said reservoir member, said reservoir member is configured to return from said deformed state to said normal state to thereby cause a partial vacuum within said interior volume and a provide suction force at said inlet port to allow a biological fluid sample in contact with said inlet port to be drawn into said fluid pathway and into said interior volume of said reservoir member.

2. The biological sample collection device of claim 1, wherein, when said reservoir member is in said normal state, said interior volume is at an ambient pressure.

3. The biological sample collection device of claim 1, wherein, when said reservoir member is in said deformed state and said inlet port is in contact with said biological fluid sample, said interior volume is at a reduced pressure relative to an ambient pressure.

4. The biological sample collection device of claim 1, wherein said reservoir member comprises an elastic material configured to return said reservoir member to said normal state upon removal of a compression force therefrom.

5. The biological sample collection device of claim 1, wherein said reservoir member comprises a transparent or translucent material configured to provide a view into the interior volume of said reservoir member.

6. The biological sample collection device of claim 1, further comprising an assay assembly positioned within said interior volume of said reservoir member, said assay assembly configured to detect the presence of a target analyte in said biological fluid sample in real-, or near real-time.

7. The biological sample collection device of claim 6, wherein said assay assembly comprises one or more reagents or reactants configured to interact with said biological fluid sample and provide a visual indication of the presence of said target analyte based on said interaction.

8. The biological sample collection device of claim 7, wherein said visual indication comprises a color output.

9. The biological sample collection device of claim 6, wherein said target analyte is selected from the group consisting of drugs, prodrugs, pharmaceutical agents, drug metabolites, a biomarker indicative of a disease, a tissue specific marker, a tissue specific enzyme biomarkers, antibodies, serum proteins, cholesterol, polysaccharides, nucleic acids, gene, protein, hormone, and any combination thereof.

10. The biological sample collection device of claim 1, wherein said reservoir member comprises a coating on an interior surface thereof, said coating comprising a chemical preservative or enzyme inhibitor.

11. The biological sample collection device of claim 1, further comprising a seal member configured to sealingly engage said inlet port and prevent fluid flow out of said inlet port.

12. The biological sample collection device of claim 1, further comprising a nozzle coupled to said inlet port and configured to contact and direct said biological fluid sample into said inlet port.

13. The biological sample collection device of claim 1, further comprising a needle coupled to said inlet port and configured to pierce a portion of a patient's body to thereby access said biological fluid sample to be collected.

14. The biological sample collection device of claim 13, wherein said needle is a hollow needle having a lumen in fluid communication with said inlet port and said fluid pathway of said channel.

15. The biological sample collection device of claim 14, wherein said needle is a micro-needle having a length in the range of 0.5 mm to 4 mm.

16. The biological sample collection device of claim 1, wherein said interior volume of said reservoir member is in the range of 0.001 ml to 1.0 ml when in said normal state.

17. The biological sample collection device of claim 1, wherein each of said base member and said top member comprises a medical grade material.

18. The biological sample collection device of claim 1, wherein said top member comprises a thermoplastic polymer.

19. The biological sample collection device of claim 1, wherein said biological fluid sample is selected from the group consisting of blood, serum, plasma, saliva, sweat, tears, urine, interstitial fluid derived from tissue, cerebrospinal fluid, bodily secretions, and a combination thereof.

20. The biological sample collection device of claim 1, wherein said device is configured for use with a separate analysis system configured to detect the presence of a target analyte in said biological fluid sample.