Biological fluid sampling device

A biological fluid sampling device adapted to receive a blood sample and includes a housing having a reservoir disposed therein and a first cavity in fluid communication with the reservoir is disclosed. The biological fluid sampling device includes a first test element removably receivable within the first cavity and a lancet having a puncturing element. Additionally, the housing may include a second cavity in fluid communication with the reservoir and a second test element removably receivable within the second cavity. With the blood sample received within the reservoir of the biological fluid sampling device, the first test element and the second test element are adapted to receive a portion of the blood sample. In this manner, the biological fluid sampling device allows for a blood sample to be collected on a plurality of test elements simultaneously. In one embodiment, the biological fluid sampling device contains a sample stabilizer.

BACKGROUND OF THE INVENTION

1. Field of the Disclosure

The present disclosure relates generally to devices, assemblies, and systems adapted for use with vascular access devices. More particularly, the present disclosure relates to devices, assemblies, and systems adapted for collecting biological samples for use in point-of-care testing.

2. Description of the Related Art

Blood sampling is a common health care procedure involving the withdrawal of at least a drop of blood from a patient. Blood samples are commonly taken from hospitalized, homecare, and emergency room patients either by finger stick, heel stick, or venipuncture. Blood samples may also be taken from patients by venous or arterial lines. Once collected, blood samples may be analyzed to obtain medically useful information including chemical composition, hematology, or coagulation, for example.

Blood tests determine the physiological and biochemical states of the patient, such as disease, mineral content, drug effectiveness, and organ function. Blood tests may be performed in a clinical laboratory or at the point-of-care near the patient. One example of point-of-care blood testing is the routine testing of a patient's blood glucose levels which involves the extraction of blood via a finger stick and the mechanical collection of blood into a diagnostic cartridge. Thereafter, the diagnostic cartridge analyzes the blood sample and provides the clinician a reading of the patient's blood glucose level. Other devices are available which analyze blood gas electrolyte levels, lithium levels, and ionized calcium levels. Some other point-of-care devices identify markers for acute coronary syndrome (ACS) and deep vein thrombosis/pulmonary embolism (DVT/PE).

Despite the rapid advancement in point-of-care testing and diagnostics, blood sampling techniques have remained relatively unchanged. Blood samples are frequently drawn using hypodermic needles or vacuum tubes attached to a proximal end of a needle or a catheter assembly. In some instances, clinicians collect blood from a catheter assembly using a needle and syringe that is inserted into the catheter to withdraw blood from a patient through the inserted catheter. These procedures utilize needles and vacuum tubes as intermediate devices from which the collected blood sample is typically withdrawn prior to testing. These processes are thus device intensive, utilizing multiple devices in the process of obtaining, preparing, and testing blood samples. Each additional device increases the time and cost of the testing process.

Point-of-care testing devices allow for a blood sample to be tested without needing to send the blood sample to a lab for analysis. Thus, it is desirable to create a device that provides an easy, safe, reproducible, and accurate process with a point-of-care testing system.

SUMMARY OF THE INVENTION

The present disclosure provides a biological fluid sampling device adapted to receive a blood sample and includes a housing having a reservoir disposed therein and a first cavity in fluid communication with the reservoir. The biological fluid sampling device of the present disclosure incorporates the concepts of lancing, blood collection, and multiple test strip collection. The biological fluid sampling device includes a first test element removably receivable within the first cavity and a lancet having a puncturing element. Additionally, the housing may include a second cavity in fluid communication with the reservoir and a second test element removably receivable within the second cavity. With the blood sample received within the reservoir of the biological fluid sampling device, the first test element and the second test element are adapted to receive a portion of the blood sample. In this manner, the biological fluid sampling device allows for a blood sample to be collected on a plurality of test elements simultaneously. For example, the biological fluid sampling device allows for only a single stick on a patient and collection of a blood sample into multiple test strips for a point-of-care testing device. In one embodiment, a portion of the biological fluid sampling device contains a sample stabilizer to promote efficient mixing with the blood sample. The sample stabilizer can be an anticoagulant, or a substance designed to preserve a specific element within the blood such as, for example, RNA, protein analyte, or other element.

In accordance with an embodiment of the present invention, a biological fluid sampling device includes a housing having an inlet port, a reservoir disposed within the housing and in fluid communication with the inlet port, and a first cavity in fluid communication with the reservoir. The device also includes a first test element removably receivable within the first cavity, and a puncturing element, a portion of which is disposed within the housing and adapted for movement between a pre-actuated position wherein the puncturing element is retained within the housing, and a puncturing position wherein the puncturing element extends through the inlet port of the housing.

In certain configurations, the biological fluid sampling device is adapted to receive a blood sample. The housing may include an upper portion and a lower portion, with the inlet port provided within the lower portion. The device may also include an adhesive disposed on a bottom surface of the lower portion. The reservoir may be adapted to receive the blood sample via the inlet port. The upper portion may be a resiliently deformable member and the upper portion may be transitionable between an undeformed position and a deformed position. Actuation of the upper portion from the undeformed position to the deformed position may move the puncturing element from the pre-actuated position to the puncturing position. After the puncturing element moves to the puncturing position, the upper portion returns to its undeformed position and returns the puncturing element to the pre-actuated position. When the blood sample is received within the reservoir, the first test element is adapted to receive a portion of the blood sample.

In additional configurations, the housing also includes a second cavity in fluid communication with the reservoir. A second test element may be removably receivable within the second cavity. The device may also include a check valve in the upper portion. Optionally, a first portion of the housing may include a first sample stabilizer. A second portion of the housing may also include a second sample stabilizer.

In accordance with another embodiment of the present invention, a biological fluid sampling device includes a housing having an inlet port, a reservoir disposed within the housing and in fluid communication with the inlet port, a first cavity in fluid communication with the reservoir, and a second cavity in fluid communication with the reservoir. The device also includes a first test element removably receivable within the first cavity, a second test element removably receivable within the second cavity, and a puncturing element. A portion of the puncturing element is disposed within the housing and adapted for movement between a pre-actuated position, wherein the puncturing element is retained within the housing and a puncturing position wherein the puncturing element extends through the inlet port of the housing.

In accordance with yet another embodiment of the present invention, a biological fluid sampling device adapted to receive a blood sample includes a housing having a resiliently deformable upper portion, a lower portion, and an inlet port within the lower portion. The device also includes a reservoir disposed within the housing and in fluid communication with the inlet port. The reservoir is adapted to receive the blood sample via the inlet port. The device also includes a first cavity in fluid communication with the reservoir. The upper portion of the housing is transitionable between an undeformed position and a deformed position. The device also includes a first test element removably receivable within the first cavity, and a puncturing element, a portion of which is disposed within the housing and adapted for movement between a pre-actuated position wherein the puncturing element is retained within the housing and a puncturing position wherein the puncturing element extends through the inlet port of the housing. Actuation of the upper portion from the undeformed position to the deformed position moves the puncturing element from the pre-actuated position to the puncturing position. After the puncturing element moves to the puncturing position, the upper portion returns to its undeformed position and returns the puncturing element to the pre-actuated position. When the blood sample is received within the reservoir, the first test element is adapted to receive a portion of the blood sample.

In certain configurations, the device includes an adhesive disposed on an outside surface of the lower portion. The housing may also include a second cavity in fluid communication with the reservoir, and a second test element may be removably receivable within the second cavity. When the blood sample is received within the reservoir, the first test element may be adapted to receive a first portion of the blood sample and the second test element may be adapted to receive a second portion of the blood sample. The device may also include a check valve in the upper portion.

In accordance with yet another embodiment of the present invention, a biological fluid testing system for a blood sample includes a biological fluid sampling device adapted to receive the blood sample. The biological fluid sampling device includes a housing having a resiliently deformable upper portion, a lower portion, an inlet port at the lower portion, and a reservoir disposed within the housing and in fluid communication with the inlet port. The reservoir is adapted to receive the blood sample via the inlet port. The device also includes a first cavity in fluid communication with the reservoir. The upper portion of the housing is transitionable between an undeformed position and a deformed position. The device also includes a first test element removably receivable within the first cavity, and a puncturing element. A portion of the puncturing element is disposed within the housing and is adapted for movement between a pre-actuated position wherein the puncturing element is retained within the housing and a puncturing position wherein the puncturing element extends through the inlet port of the housing. Actuation of the upper portion from the undeformed position to the deformed position moves the puncturing element from the pre-actuated position to the puncturing position. After the puncturing element moves to the puncturing position, the upper portion returns to its undeformed position and returns the puncturing element to the pre-actuated position. When the blood sample is received within the reservoir, the first test element is adapted to receive a portion of the blood sample. The system also includes a biological fluid testing device adapted to receive the first test element for closed transfer of the blood sample from the first test element to the biological fluid testing device.

In certain configurations, the blood testing device includes a point-of-care testing device. The housing may also include a second cavity in fluid communication with the reservoir, and a second test element may be removably receivable within the second cavity. When the blood sample is received within the reservoir, the first test element may be adapted to receive a portion of the blood sample and the second test element may be adapted to receive a portion of the blood sample.

DETAILED DESCRIPTION

Various point-of-care testing devices are known in the art. Such point-of-care testing devices include test strips, glass slides, diagnostic cartridges, or other testing devices for testing and analysis. Test strips, glass slides, and diagnostic cartridges are point-of-care testing devices that receive a blood sample and test that blood for one or more physiological and biochemical states. There are many point-of-care devices that use cartridge based architecture to analyze very small amounts of blood at the point of care without the need to send the sample to a lab for analysis. This saves time in getting results over the long run but creates a different set of challenges versus the highly routine lab environment. Examples of such testing cartridges include the i-STAT® testing cartridge from the Abbot group of companies. Testing cartridges such as the i-STAT® cartridges may be used to test for a variety of conditions including the presence of chemicals and electrolytes, hematology, blood gas concentrations, coagulation, or cardiac markers. The results of tests using such cartridges are quickly provided to the clinician.

However, the samples provided to such point-of-care testing cartridges are currently manually collected with an open system and transferred to the point-of-care testing cartridge in a manual manner that often leads to inconsistent results, or failure of the cartridge leading to a repeat of the sample collection and testing process, thereby negating the advantage of the point-of-care testing device. Accordingly, a need exists for a system for collecting and transferring a sample to a point-of-care testing device that provides safer, reproducible, and more accurate results. Accordingly, a point-of-care collecting and transferring system of the present disclosure will be described hereinafter. A system of the present disclosure enhances the reliability of the point-of-care testing device by: 1) incorporating a more closed type of sampling and transfer system; 2) minimizing open exposure of the sample resulting in improved operator safety and reducing chance of exposure to blood-borne pathogens; 3) improving sample quality by blocking sample contact with a skin surface of a patient or the atmosphere, both of which can cause analytical errors; 4) improving the overall ease of use; 5) separating the sample at the point of collection; and 6) allowing for the introduction of multiple, non-chemically compatible additives or sample stabilizers from a single lancing action.

FIGS. 1-7illustrate an exemplary embodiment of the present disclosure. The biological fluid sample device, such as a blood sampling device of the present disclosure incorporates the concepts of lancing, blood collection, and multiple test strip collection. Referring toFIGS. 1-7, a biological fluid sampling device, such as a blood sampling device10of the present disclosure, is adapted to receive a plurality of test elements12and includes a lancet structure14. The blood sampling device10is adapted to receive a blood sample16(FIG. 6) and the test elements12are adapted to receive a portion of the blood sample16. In this manner, the blood sampling device10of the present disclosure allows for a blood sample to be collected on a plurality of test elements simultaneously. For example, the blood sampling device10allows for only a single stick on a patient and collection of a blood sample into multiple test strips for a point-of-care testing device.

FIGS. 1-8illustrate an exemplary embodiment of the present disclosure. Referring toFIGS. 1-8, a biological fluid testing system, such as a blood testing system20of the present disclosure, includes a blood sampling device10and a blood testing device or point-of-care testing device200. The blood sampling device10is adapted to receive a plurality of test elements12and includes a lancet structure14. The blood sampling device10is adapted to receive a blood sample16(FIG. 6) and the test elements12are adapted to receive a portion of the blood sample16. In this manner, the blood sampling device10of the present disclosure allows for a blood sample to be collected on a plurality of test elements simultaneously. For example, the blood sampling device10allows for only a single stick on a patient and collection of a blood sample into multiple test strips for a point-of-care testing device200. The blood testing device200is adapted to receive a test element12to analyze the blood sample and obtain test results.

Referring toFIGS. 1-7, the blood sampling device10generally includes a housing30having an upper portion32and a lower portion34. The upper portion32and the lower portion34are secured theretogether such that significant relative movement between the upper portion32and the lower portion34is prevented. The housing30defines a central aperture35therethrough the upper portion32and the lower portion34. The lancet structure14is positioned within the central aperture35as shown inFIGS. 1-6. The housing30includes a lancet engagement portion39for securing the lancet structure14within the central aperture35as shown inFIGS. 5 and 6. The housing30also includes a docking portion43located around a portion of the upper portion32and the lower portion34. The docking portion43is secured to the upper portion32and the lower portion34such that significant relative movement between the docking portion43and the upper portion32and the lower portion34is prevented.

The upper portion32includes a dome-shaped surface36and the lower portion34includes a bottom surface38. Referring toFIGS. 3, 5, and 6, the bottom surface38includes an adhesive so that the blood sampling device10can be secured onto a skin surface S of a patient where a blood sample will be accessed. In one embodiment, the adhesive of the bottom surface38is protected by a peel-off layer, similar to an adhesive bandage, which would be removed before placing the blood sampling device10on the skin surface S of the patient's body. A hydrogel or other layer (not shown) could be included to provide some thickness to the bottom surface38of the lower portion34and help improve the stability of the adhesive seal. Additionally, in one embodiment, the adhesive could include a chemistry to create a more liquid-tight seal, similar to painter's tape technology, where wetting from the paint itself causes a chemical reaction with the adhesive to create a more water-tight barrier to prevent the paint from seeping under the tape.

The upper portion32is a resiliently deformable member that is transitionable between an undeformed position (FIGS. 3 and 6) and a deformed position (FIGS. 4 and 5) as will be discussed in more detail below. The upper portion32is formed of a flexible material such that the upper portion32can be depressed by pressure applied by a user. After the pressure is removed, the upper portion32returns to its original or undeformed position and its domed-shape. In one embodiment, the upper portion32of the housing30includes a vent or check valve52to allow air to be expelled upon depression of the dome-shaped upper portion32.

Referring toFIGS. 1-7, the housing30of the blood sampling device10generally includes an inlet port40defined through the bottom surface38of the lower portion34and a reservoir or fluid channel42disposed within the housing30and in fluid communication with the inlet port40. The reservoir or fluid channel42may have a variety of different shapes and sizes to accommodate a blood sample that can then be dispersed to a plurality of test strips received within respective test strip docks. In this manner, the blood sampling device10of the present disclosure allows for a blood sample to be collected on a plurality of test strips simultaneously. For example, the blood sampling device10allows for only a single stick on a patient and collection of a blood sample into multiple test strips for a point-of-care testing device as discussed in more detail below.

The housing30also includes a first cavity or first test strip dock44having a first outlet port45, a second cavity or second test strip dock46having a second outlet port47, a third cavity or third test strip dock48having a third outlet port49, and a fourth cavity or fourth test strip dock50having a fourth outlet port51. The first test strip dock44, the second test strip dock46, the third test strip dock48, and the fourth test strip dock50extend through the docking portion43and a portion of the upper portion32and the lower portion34of the housing30. In one embodiment, the first test strip dock44, the second test strip dock46, the third test strip dock48, and the fourth test strip dock50may extend through the docking portion43and between the upper portion32and the lower portion34of the housing30. Each of the first test strip dock44, the second test strip dock46, the third test strip dock48, and the fourth test strip dock50are in fluid communication with the reservoir or fluid channel42disposed within the housing30.

AlthoughFIGS. 1-7illustrate the housing30of the blood sampling device10having four test strip docks, it is envisioned that the housing30can contain any number of test strip docks. For example, in one embodiment, the housing30of the blood sampling device10may include more than four test strip docks that can each receive a test element therein.

Each of the first test strip dock44, the second test strip dock46, the third test strip dock48, and the fourth test strip dock50are sized and adapted to receive a test strip or test element12therein. For example, a first test element or first test strip60that includes a first end62, a second end64, and a blood receiving cavity66is removably receivable within the first test strip dock44as shown inFIGS. 1 and 2. The blood receiving cavity66of the first test element60is adapted to receive a portion of a blood sample contained within the reservoir42of the housing30of the blood sampling device10. A second test element or second test strip70that includes a first end72, a second end74, and a blood receiving cavity76is removably receivable within the second test strip dock46as shown inFIGS. 1 and 2. The blood receiving cavity76of the second test element70is adapted to receive a portion of a blood sample contained within the reservoir42of the housing30of the blood sampling device10. Furthermore, a third test element or third test strip80that includes a first end82, a second end84, and a blood receiving cavity86is removably receivable within the third test strip dock48as shown inFIGS. 1 and 2. The blood receiving cavity86of the third test element80is adapted to receive a portion of a blood sample contained within the reservoir42of the housing30of the blood sampling device10. Also, a fourth test element or fourth test strip90that includes a first end92, a second end94, and a blood receiving cavity96is removably receivable within the fourth test strip dock50as shown inFIGS. 1 and 2. The blood receiving cavity96of the fourth test element90is adapted to receive a portion of a blood sample contained within the reservoir42of the housing30of the blood sampling device10. Thus, each of the test strip docks are configured to receive a test strip therein and position the test strip in fluid communication with an inner portion of the blood sampling device10, i.e., the reservoir42.

Referring toFIGS. 1-6, the blood sampling device10also includes a lancet or lancet structure14that may be secured within the central aperture35of the housing30. The lancet14generally includes a first end100, a second end102, a top or handle portion104adjacent the first end100, a bottom or lancet portion106adjacent the second end102, and a housing engagement portion108. The housing engagement portion108engages the lancet engagement portion39of the housing for securing the lancet14to the housing30within central aperture35as shown inFIGS. 5 and 6. Referring toFIGS. 5 and 6, a portion of the lancet14is disposed within the housing30of the blood sampling device10. The lancet portion106includes a puncturing element110having a puncturing end112. The puncturing end112is adapted for puncturing the skin surface S of a patient (FIG. 5), and may define a pointed end, a blade edge, or a similar cutting mechanism. The puncturing end112may include a preferred alignment orientation, such as with a pointed end of a blade aligned in a specific orientation.

The lancet14is adapted for movement between a pre-actuated position (FIGS. 3 and 6) wherein the puncturing element110including the puncturing end112is retained within the housing30and a puncturing position (FIGS. 4 and 5) wherein the puncturing end112of the puncturing element110extends through the inlet port40of the housing30to puncture a skin surface S of a patient to draw a blood sample as discussed in more detail below.

In one embodiment, the housing30of the blood sampling device10may include a self-sealing dock that would allow an external lancet to be removably received within the housing30. The external lancet could be either pre-integrated into the packaged device or introduced separately by a user before using the blood sampling device10of the present disclosure.

Referring toFIG. 8, a blood testing device or point-of-care testing device200generally includes a test strip reader202, a receiving port204for receiving a test strip12, and a viewing window206. The blood testing device200is adapted to receive a test element12to analyze the blood sample and obtain test results. The receiving port204of the point-of-care testing device200allows for the closed transfer of a blood sample from a test element12to the point-of-care testing device200.

Referring toFIGS. 1-8, use of a blood sampling device of the present disclosure will now be described. Initially, each of the test strip docks receive a test strip therein to position each of the test strips in fluid communication with an inner portion of the blood sampling device10, i.e., the reservoir42. For example, referring toFIGS. 1 and 2, the first end62of the first test strip60can be placed within the first outlet port45of the first test strip dock44until the first test strip60is received within the first test strip dock44. The first end72of the second test strip70can be placed within the second outlet port47of the second test strip dock46until the second test strip70is received within the second test strip dock46. Also, the first end82of the third test strip80can be placed within the third outlet port49of the third test strip dock48until the third test strip80is received within the third test strip dock48. Furthermore, the first end92of the fourth test strip90can be placed within the fourth outlet port51of the fourth test strip dock50until the fourth test strip90is received within the fourth test strip dock50.

Referring toFIG. 3, upon selecting a site, a clinician can adhere the adhesive on the bottom surface38of the lower portion34of the housing30onto a skin surface S of a patient where a blood sample will be accessed over a selected sampling site as shown inFIG. 3.

Referring toFIGS. 3-5, a user or an operator may then apply pressure to the dome-shaped surface36of the upper portion32of the housing30to actuate the upper portion32from the undeformed position (FIGS. 3 and 6) to the deformed position (FIGS. 4 and 5). Actuation of the upper portion32from the undeformed position (FIGS. 3 and 6) to the deformed position (FIGS. 4 and 5) moves the lancet14from the pre-actuation position (FIGS. 3 and 6) to the puncturing position (FIGS. 4 and 5) thereby causing the lancing of the skin surface S of the patient by the puncturing end112of the lancet14as shown inFIG. 5. When the upper portion32of the housing30is depressed, the puncturing end112of the lancet14cuts into the skin surface S of the patient's body and capillary blood begins to flow into the inlet port40of the housing30.

After lancing and release of the pressure for the lancing action, the domed shape of the upper portion32begins to relax and returns to its original shape or undeformed position. This return of the upper portion32to its undeformed position creates a gentle vacuum during the process that helps to draw out the capillary blood through the inlet port40and to the reservoir or fluid channel42of the housing30. With the upper portion32of the housing30returned to its undeformed position and with the blood sample16received within the reservoir42as shown inFIG. 6, the blood sample16is directed to flow through the reservoir42and to the test strip docks such that the test elements60,70,80,90each receive a portion of the blood sample16. In one embodiment, the reservoir or fluid channel42may include microfluidic pathways integrated therein to direct the blood sample16to the test strips60,70,80,90by capillary action. The blood receiving cavities66,76,86,96are adapted to receive a portion of the blood sample therein.

Referring toFIG. 7, with the blood sample transferred to the test strips or test elements60,70,80,90, a user or operator may then grasp the second end64of the first test strip60, for example, and pull the first test element60from the first test strip dock44of the housing32. Next, referring toFIG. 8, the collected blood sample within the first test strip60is transferred to the test strip reader202of the point-of-care testing device200to analyze the collected blood and obtain test results for tests such as glucose, cholesterol, or other blood sample results. Referring toFIG. 8, the receiving port204of the point-of-care testing device200allows for the closed transfer of a blood sample from the first test element60to the point-of-care testing device200. In one embodiment, the viewing window206of the test strip reader202may indicate to an operator desired information. For example, the viewing window206may indicate what the point-of-care testing device200is analyzing the blood sample for.

In one embodiment, a portion of the blood sampling device10contains a sample stabilizer to promote efficient mixing with the blood sample. The sample stabilizer, can be an anticoagulant, or a substance designed to preserve a specific element within the blood such as, for example, RNA, protein analyte, or other element. In one embodiment, the sample stabilizer is provided within the inlet port40of the housing30of the blood sampling device10and/or any area where a primary blood sample is collected. In another embodiment, the sample stabilizer is provided in a portion of any of the reservoirs or fluid channels42of the housing30of the blood sampling device10and/or along any portion of a liquid path that the blood sample travels. In other embodiments, the sample stabilizer may be provided in any of the test strip docks of the blood sampling device10. In one embodiment, each of the fluid channels, reservoirs, test strip docks, and/or each of the test elements could each include a different sample stabilizer. In this manner, a single blood sample could be used for a variety of different tests, each of which could introduce an appropriate, and potentially unique, sample stabilizer for a desired use. A blood sampling device of the present disclosure provides flexibility in the nature of the additives and/or sample stabilizers introduced for a blood sample.

Referring toFIG. 5, upon actuation of the lancet14to puncture the skin surface S, no or minimal blood will seep between the stick site and the housing30of the blood sampling device10, and, importantly, any seeped blood will not subsequently enter the blood sampling device10.

Collection using the blood sampling device10of the present disclosure allows “closed system” capillary blood collection with the following advantages, such as avoiding exposure of the operator or patient to the blood and avoiding exposure of the blood to atmosphere and potentially better preservation of in vivo blood gas concentrations. Also, the blood sampling device10of the present disclosure incorporates the concepts of lancing, blood collection, and multiple test strip collection. The blood sampling device10of the present disclosure allows for a blood sample to be collected on a plurality of test elements simultaneously. For example, the blood sampling device10allows for only a single stick on a patient and collection of a blood sample into multiple test strips for a point-of-care testing device. This ability to collect a single blood sample into multiple test strips reduces the anxiety and discomfort to the patient.