Capillary Blood Collection Device

A device for obtaining a blood sample may include a holder for receiving a sample source, the holder having an actuation portion and a port; a container engagement portion connected to the holder; and a collection container removably connectable to the container engagement portion, the container defining a collection cavity, wherein the actuation portion comprises at least two wings that are angled relative to a patient's finger held in the holder to create a pressure gradient towards a fingertip of the patient's finger.

BACKGROUND OF THE INVENTION

Field of the Invention

The present disclosure relates generally to a device for obtaining a biological sample. More particularly, the present disclosure relates to an integrated finger-based capillary blood collection device with the ability to lance and squeeze a finger, collect, stabilize, and dispense a blood sample in a controlled manner.

Description of Related Art

Devices for obtaining and collecting biological samples, such as blood samples, are commonly used in the medical industry. One type of blood collection that is commonly done in the medial field is capillary blood collection which is often done to collect blood samples for testing. Certain diseases, such as diabetes, require that the patient's blood be tested on a regular basis to monitor, for example, the patient's blood sugar levels. Additionally, test kits, such as cholesterol test kits, often require a blood sample for analysis. The blood collection procedure usually involves pricking a finger or other suitable body part in order to obtain the blood sample. Typically, the amount of blood needed for such tests is relatively small and a small puncture wound or incision normally provides a sufficient amount of blood for these tests. Various types of lancet devices have been developed which are used for puncturing the skin of a patient to obtain a capillary blood sample from the patient.

Many different types of lancet devices are commercially available to hospitals, clinics, doctors' offices, and the like, as well as to individual consumers. Such devices typically include a sharp-pointed member such as a needle, or a sharp-edged member such as a blade, that is used to make a quick puncture wound or incision in the patient's skin in order to provide a small outflow of blood. It is often physiologically and psychologically difficult for many people to prick their own finger with a hand-held needle or blade. As a result, lancet devices have evolved into automatic devices that puncture or cut the skin of the patient upon the actuation of a triggering mechanism. In some devices, the needle or blade is kept in a standby position until it is triggered by the user, who may be a medical professional in charge of drawing blood from the patient, or the patient himself or herself. Upon triggering, the needle or blade punctures or cuts the skin of the patient, for example, on the finger. Often, a spring is incorporated into the device to provide the “automatic” force necessary to puncture or cut the skin of the patient.

One type of contact activated lancet device that features automatic ejection and retraction of the puncturing or cutting element from and into the device is U.S. Pat. No. 9,380,975, which is owned by Becton, Dickinson and Company, the assignee of the present application. This lancet device includes a housing and a lancet structure having a puncturing element. The lancet structure is disposed within the housing and adapted for movement between a retaining or pre-actuated position wherein the puncturing element is retained within the housing, and a puncturing position wherein the puncturing element extends through a forward end of the housing. The lancet device includes a drive spring disposed within the housing for biasing the lancet structure toward the puncturing position, and a retaining hub retaining the lancet structure in the retracted position against the bias of the drive spring. The retaining hub includes a pivotal lever in interference engagement with the lancet structure. An actuator within the housing pivots the lever, thereby moving the lancet structure toward the rearward end of the housing to at least partially compress the drive spring, and releasing the lever from interference engagement with the lancet structure. The blood sample that is received is then collected and/or tested. This testing can be done by a Point-of-Care (POC) testing device or it can be collected and sent to a testing facility.

Currently, capillary blood collection workflow is a complex multi-step process requiring high skill level. The multi-step nature of this process introduces several variables that could cause sample quality issues such as hemolysis, inadequate sample stabilization, and micro-clots. The use of lancet devices for obtaining blood samples can result in several variables that effect the collection of the capillary blood sample, including, but not limited to, holding the lancet still during the testing, obtaining sufficient blood flow from the puncture site, adequately collecting the blood, preventing clotting, and the like. Some of the most common sources of process variability are: (1) inadequate lancing site cleaning and first drop removal which can potentially result in a contaminated sample; (2) inconsistent lancing location and depth which could potentially result in insufficient sample volume and a large fraction of interstitial fluid; (3) inconsistent squeezing technique and excessive pressure near the lancing site to promote blood extraction (e.g., blood milking) which could potentially result in a hemolyzed sample; (4) variable transfer interfaces and collection technique which could potentially result in a hemolyzed or contaminated sample; and (5) inadequate sample mixing with an anticoagulant which could potentially result in micro-clots.

Capillary collection blood draws are typically performed by health care workers either using their fingers to manually squeeze the tissue around the puncture site or by a device using vacuum pressure to pull blood from the site.

Manually squeezing the collection site is a highly technique dependent process that leads to very large variation in success rate and sample quality (as measured by hemolysis—blood cell rupture). Health care workers typically adjust the pressure and rate at which they squeeze to compensate for patient-dependent differences in blood flow. Squeezing harder helps blood flow more quickly but also increases hemolysis. The location of squeezing also varies between health care workers depending on personal preference, experience, and hand fatigue. Some workers may even perform a process called “milking” of fingers, where they apply pressure starting at the base of the finger and slide towards the tip of finger. This process is discouraged as leading to poor sample quality by domestic and international health organizations.

Vacuum-powered devices standardize the pressure and technique of blood flow, but are typically plagued by poor overall blood flow. The maximum pressure than can be applied is limited by the difference between atmospheric pressure and absolute vacuum (˜14 psi), and devices only operate at a fraction of absolute vacuum. For reference, grip strength of men and women range from 50-100 lbs. on average, illustrating why manual methods are instead affected by hemolysis rather than flow. Vacuum methods also apply consistent pressure, limiting the ability of the tissue to replenish with blood.

Thus, there is a need in the art for a device that has the ability to lance and squeeze the finger, collect the sample, stabilize the sample, and subsequently dispense the sample in a controlled manner. There is also a need in the art for a device that simplifies and streamlines the capillary blood collection by eliminating workflow variabilities which are typically associated with low sample quality including hemolysis and micro-clots. There is still a further need in the art for a closed system collection and transfer that eliminate blood exposure and device reuse. There is still a further need in the art for a device that: (1) introduces flexibility in the accommodation of different capillary blood collection and transfer container; (2) has the capability to generate high quality uniformly mixed/stabilized capillary blood samples; (3) has the capability to generate on-board plasma from capillary plasma samples; (4) has the capability to collect large capillary blood samples (>50-500 μL) at reduced pain; (5) contains a unique sample identifier that is paired with patient information at the time of collection; (6) has the capability to collect capillary blood and perform on-board diagnostics; and (7) has multiple collection ports to collect a blood sample into different containers having the same or different anticoagulants. There is a further need in the art for a capillary blood collection device that includes a standardized and controlled location of applied pressure, an applied pressure that is high enough for adequate blood flow but below hemolysis thresholds, a defined rhythmic application of pressure rather than consistent pressure to allow blood to replenish in the finger, increasing average blood flow rate, and a reduced user fatigue by lowering maximum applied force by the operator.

SUMMARY OF THE INVENTION

The present disclosure is directed to a device for obtaining a biological sample, such as a capillary blood collection device, which meets the needs set forth above and has the ability to lance and squeeze the finger, collect the sample, stabilize the sample, and subsequently dispense the sample in a controlled manner. The device also simplifies and streamlines the capillary blood collection by eliminating workflow variabilities which are typically associated with low sample quality including hemolysis and micro-clots.

The present disclosure includes a self-contained and fully integrated finger-based capillary blood collection device with ability to lance, collect, and stabilize high volume capillary blood sample, e.g., up to or above 500 microliters. The device simplifies and streamlines high volume capillary blood collection by eliminating workflow steps and variabilities which are typically associated with low sample quality including hemolysis, micro-clots, and patient discomfort. The device comprises a retractable lancing mechanism that can lance the finger and an associated blood flow path which ensures attachment and transfer of the capillary blood from the pricked finger site to the collection container. The device also includes a holder that can be cyclically squeezed to stimulate, i.e., pump, blood flow out of the finger and also an anticoagulant deposited in the flow path or collection container to stabilize collected sample.

According to one design, the device can comprise discrete components such as a holder, a lancet, and a collection container. According to another design, the lancet and collection container can be integrated into one device which is then used with the holder. According to yet another design, the holder, lancet, and collection container can be integrated into a single system. Any of these designs are envisioned to be used as a self-standing disposable device and/or in association with an external power source for pain reduction control. The capillary blood collection device can serve as a platform for various capillary blood collection containers ranging from small tubes to capillary dispensers, as well as on-board plasma separation modules. This capability extends the product flexibility to various applications including dispensing to a Point-of-Care (POC) cartridge or to a small collection tube transfer which can be used in a centrifuge or an analytical instrument.

In one embodiment of the present disclosure, a device for obtaining a blood sample may include a holder for receiving a sample source, the holder having an actuation portion and a port; a container engagement portion connected to the holder; and a collection container removably connectable to the container engagement portion, the container defining a collection cavity, wherein the actuation portion comprises at least two wings that are angled relative to a patient's finger held in the holder to create a pressure gradient towards a fingertip of the patient's finger.

In one embodiment of the present disclosure, the at least two wings may be positioned on the holder at a position proximal of a fingernail of the patient's finger and distal from a first knuckle of the patient's finger. Each of the at least two wings may include a touch pad that ensures a user squeezes the wings at a desired location. The holder may include a stability extension portion provided on a proximal end of the holder. The stability extension portion may include at least one retention bump that extends inwardly from an inner surface of the stability extension portion to contact the patient's finger held in the holder. At least one wing of the at least two wings may include an anti-touch protrusion that extends outwardly from an outer surface of the wings. The anti-touch protrusion may be positioned beneath a touch pad of the at least one wing to ensure a user grips the at least one wing at the touch pad and not beneath the touch pad. A proximal end of the holder may include a flared edge to receive the patient's finger. A transition portion may be positioned between the holder and the container engagement portion to receive at least a portion of the patient's finger during use of the device. A distal end of the holder may include a curved edge to receive a patient's fingertip while allowing the patient's fingernail to extend past the distal end of the holder. The holder may include a finger receiving portion that includes at least one bulge on an outer surface of the finger receiving portion to prevent pressure on an arterial blood supply of the patient's finger held in the finger receiving portion.

In one embodiment of the present disclosure, a device for obtaining a blood sample may include a holder for receiving a sample source, the holder having an actuation portion and a port; and a container engagement portion connected to the holder; wherein the actuation portion comprises at least two wings that are angled relative to a patient's finger held in the holder to create a pressure gradient towards a fingertip of the patient's finger.

In one embodiment of the present disclosure, the at least two wings may be positioned on the holder at a position proximal of a fingernail of the patient's finger and distal from a first knuckle of the patient's finger. Each of the at least two wings may include a touch pad that ensures a user squeezes the wings at a desired location. The holder may include a stability extension portion provided on a proximal end of the holder. The stability extension portion may include at least one retention bump that extends inwardly from an inner surface of the stability extension portion to contact the patient's finger held in the holder. At least one wing of the at least two wings may include an anti-touch protrusion that extends outwardly from an outer surface of the wings. The anti-touch protrusion may be positioned beneath a touch pad of the at least one wing to ensure a user grips the at least one wing at the touch pad and not beneath the touch pad. A proximal end of the holder may include a flared edge to receive the patient's finger. A transition portion may be positioned between the holder and the container engagement portion to receive at least a portion of the patient's finger during use of the device. A distal end of the holder may include a curved edge to receive a patient's fingertip while allowing the patient's fingernail to extend past the distal end of the holder. The holder may include a finger receiving portion that includes at least one bulge on an outer surface of the finger receiving portion to prevent pressure on an arterial blood supply of the patient's finger held in the finger receiving portion.

In one embodiment of the present disclosure, a device for obtaining a blood sample may include a holder for receiving a sample source, the holder having an actuation portion and a port; a container engagement portion connected to the holder; a collection container removably connectable to the container engagement portion, the collection container defining a collection cavity; and a lancet device removably connected to the container engagement portion, wherein the actuation portion comprises at least two wings that are angled relative to a patient's finger held in the holder to create a pressure gradient towards a fingertip of the patient's finger.

In one embodiment of the present disclosure, a method of operating a device for obtaining a blood sample may include the steps of providing the device for operation by a user, the device comprising: a holder for receiving a sample source, the holder having an actuation portion and a port; and a container engagement portion connected to the holder; wherein the actuation portion comprises at least two wings that are angled relative to a patient's finger held in the holder to create a pressure gradient towards a fingertip of the patient's finger; squeezing the at least two wings together to create the pressure gradient on the patient's fingertip, wherein the at least two wings are squeezed between 0.25 seconds and 1 second; holding the at least two wings closed together up to 0.5 seconds; releasing pressure on the at least two wings up to 0.5 seconds; and holding open the at least two wings up to 1 second.

The present invention is also described in the following clauses:

Clause 1: A device for obtaining a blood sample, the device comprising: a holder for receiving a sample source, the holder having an actuation portion and a port; a container engagement portion connected to the holder; and a collection container removably connectable to the container engagement portion, the container defining a collection cavity, wherein the actuation portion comprises at least two wings that are angled relative to a patient's finger held in the holder to create a pressure gradient towards a fingertip of the patient's finger.

Clause 2: The device of Clause 1, wherein the at least two wings are positioned on the holder at a position proximal of a fingernail of the patient's finger and distal from a first knuckle of the patient's finger.

Clause 3: The device of Clause 1 or 2, wherein each of the at least two wings includes a touch pad that ensures a user squeezes the wings at a desired location.

Clause 4: The device of any of Clauses 1-3, wherein the holder further comprises a stability extension portion provided on a proximal end of the holder.

Clause 5: The device of Clause 4, wherein the stability extension portion includes at least one retention bump that extends inwardly from an inner surface of the stability extension portion to contact the patient's finger held in the holder.

Clause 6: The device of any of Clauses 1-5, wherein at least one wing of the at least two wings includes an anti-touch protrusion that extends outwardly from an outer surface of the wings.

Clause 7: The device of Clause 6, wherein the anti-touch protrusion is positioned beneath a touch pad of the at least one wing to ensure a user grips the at least one wing at the touch pad and not beneath the touch pad.

Clause 8: The device of any of Clauses 1-7, wherein a proximal end of the holder includes a flared edge to receive the patient's finger.

Clause 9: The device of any of Clauses 1-8, wherein a transition portion is positioned between the holder and the container engagement portion to receive at least a portion of the patient's finger during use of the device.

Clause 10: The device of any of Clauses 1-9, wherein a distal end of the holder includes a curved edge to receive a patient's fingertip while allowing the patient's fingernail to extend past the distal end of the holder.

Clause 11: The device of any of Clauses 1-10, wherein the holder includes a finger receiving portion that includes at least one bulge on an outer surface of the finger receiving portion to prevent pressure on an arterial blood supply of the patient's finger held in the finger receiving portion.

Clause 12: A device for obtaining a blood sample, the device comprising: a holder for receiving a sample source, the holder having an actuation portion and a port; and a container engagement portion connected to the holder; wherein the actuation portion comprises at least two wings that are angled relative to a patient's finger held in the holder to create a pressure gradient towards a fingertip of the patient's finger.

Clause 13: The device of Clause 12, wherein the at least two wings are positioned on the holder at a position proximal of a fingernail of the patient's finger and distal from a first knuckle of the patient's finger.

Clause 14: The device of Clause 12 or 13, wherein each of the at least two wings includes a touch pad that ensures a user squeezes the wings at a desired location.

Clause 15: The device of any of Clauses 12-14, wherein the holder further comprises a stability extension portion provided on a proximal end of the holder.

Clause 16: The device of Clause 15, wherein the stability extension portion includes at least one retention bump that extends inwardly from an inner surface of the stability extension portion to contact the patient's finger held in the holder.

Clause 17: The device of any of Clauses 12-16, wherein at least one wing of the at least two wings includes an anti-touch protrusion that extends outwardly from an outer surface of the wings.

Clause 18: The device of Clause 17, wherein the anti-touch protrusion is positioned beneath a touch pad of the at least one wing to ensure a user grips the at least one wing at the touch pad and not beneath the touch pad.

Clause 19: The device of any of Clauses 12-18, wherein a proximal end of the holder includes a flared edge to receive a patient's finger.

Clause 20: The device of any of Clauses 12-19, wherein a transition portion is positioned between the holder and the container engagement portion to receive at least a portion of the patient's finger during use of the device.

Clause 21: The device of any of Clauses 12-20, wherein a distal end of the holder includes a curved edge to receive a patient's fingertip while allowing the patient's fingernail to extend past the distal end of the holder.

Clause 22: The device of any of Clauses 12-21, wherein the holder includes a finger receiving portion that includes at least one bulge on an outer surface of the finger receiving portion to prevent pressure on an arterial blood supply of the patient's finger held in the finger receiving portion.

Clause 23: A device for obtaining a blood sample, the device comprising: a holder for receiving a sample source, the holder having an actuation portion and a port; a container engagement portion connected to the holder; a collection container removably connectable to the container engagement portion, the collection container defining a collection cavity; and a lancet device removably connected to the container engagement portion, wherein the actuation portion comprises at least two wings that are angled relative to a patient's finger held in the holder to create a pressure gradient towards a fingertip of the patient's finger.

Clause 24: A method of operating a device for obtaining a blood sample, the method comprising: providing the device for operation by a user, the device comprising: a holder for receiving a sample source, the holder having an actuation portion and a port; and a container engagement portion connected to the holder; wherein the actuation portion comprises at least two wings that are angled relative to a patient's finger held in the holder to create a pressure gradient towards a fingertip of the patient's finger; squeezing the at least two wings together to create the pressure gradient on the patient's fingertip, wherein the at least two wings are squeezed between 0.25 seconds and 1 second; holding the at least two wings closed together up to 0.5 seconds; releasing pressure on the at least two wings up to 0.5 seconds; and holding open the at least two wings up to 1 second.

DESCRIPTION OF THE INVENTION

The present disclosure is directed to a device for obtaining a biological sample, such as a capillary blood collection device, which meets the needs set forth above and has the ability to lance and squeeze the finger, collect the sample, stabilize the sample, and subsequently dispense the sample in a controlled manner. The device also simplifies and streamlines the capillary blood collection by eliminating workflow variabilities which are typically associated with low sample quality including hemolysis and micro-clots. The device may be used by any healthcare professionals, including nurses and doctors, or patients for self-applications when using the device.

Blood collection is fundamentally driven by pressure-driven flow. Devices or techniques either reduce the pressure outside the blood vessel (vacuum-powered flow) or increase the pressure inside the vessels. Both approaches increase the difference between the blood vessel pressure and external pressure, and increase the flow rate from inside the vessel to outside where the collection container is present. The location of squeezing can also be critical, as soft tissues (e.g. fat, skin, and musculature) are perfused with blood while hard tissues and joints are poorly perfused or are too mechanically stable to compress without patient pain.

Red blood cells (RBCs) are subject to hemolysis during collection. Hemolysis (RBC destruction) contaminates samples for diagnostic analysis, both by spilling cell contents into the liquid serum of the sample and by coloring the serum red via hemoglobin and interfering with colorimetric reactions. The amount of hemolysis during collection is driven by shear-mediated destruction of the cells due to flow rate and flow path as well as pressure-driven hemolysis where physical compression of tissues and vessels can damage cells. Hemolysis can therefore be controlled by ensuring that applied pressures and flows are not too high in any of the locations of the finger being squeezed.

The present disclosure includes a self-contained and fully integrated finger-based capillary blood collection device with ability to lance, collect, and stabilize high volume capillary blood sample, e.g., up to or above 500 microliters. The device simplifies and streamlines high volume capillary blood collection by eliminating workflow steps and variabilities which are typically associated with low sample quality including hemolysis, micro-clots, and patient discomfort. The device comprises a retractable lancing mechanism that can lance the finger and an associated blood flow path which ensures attachment and transfer of the capillary blood from the pricked finger site to the collection container. The device also includes a holder that can be cyclically squeezed to stimulate, i.e., pump, blood flow out of the finger and also an anticoagulant deposited in the flow path or collection container to stabilize collected sample.

According to one design, the device can comprise discrete components such as a holder, a lancet, and a collection container. According to another design, the lancet and collection container can be integrated into one device which is then used with the holder. According to yet another design, the holder, lancet, and collection container can be integrated into a single system. Any of these designs are envisioned to be used as a self-standing disposable device and/or in association with an external power source for pain reduction control. The capillary blood collection device can serve as a platform for various capillary blood collection containers ranging from small tubes to capillary dispensers, as well as on-board plasma separation modules. This capability extends the product flexibility to various applications including dispensing to a Point-of-Care (POC) cartridge or to a small collection tube transfer which can be used in a centrifuge or an analytical instrument.

Referring toFIGS.9and10, in an exemplary embodiment, a device10of the present disclosure includes discrete components, e.g., a holder12(as shown inFIGS.1-5), a lancet housing or lancet14, and a collection container16. In another exemplary embodiment, a semi-integrated device of the present disclosure may include an at-angle flow and include an integrated lancet housing and collection container which can be connected with a separate holder. In another exemplary embodiment, a semi-integrated device of the present disclosure may have an in-line flow and include an integrated lancet housing and collection container which can be connected with a separate holder. In another exemplary embodiment, an integrated device of the present disclosure may have an at-angle flow and include an integrated holder, lancet housing, and collection container. In another exemplary embodiment, an integrated device of the present disclosure may have an in-line flow and include an integrated holder, lancet housing, and collection container.

Referring toFIGS.1-5, exemplary embodiments of holders12of the present disclosure that are able to receive a sample source, e.g., a finger19, for supplying a biological sample, such as a blood sample18(shown inFIG.9), are shown and described. A holder12of the present disclosure generally includes a finger receiving portion20having a first opening22(FIG.1), an actuation portion24, a port26having a second opening28, and a finger end guard30. In one embodiment, the finger end guard30provides a stop portion for properly aligning and securing a finger19within the holder12. The finger end guard30further assists in ensuring the patient's finger19is placed at a proper position within the finger receiving portion20so that applied pressure to the patient's finger19will result in adequate blood flow. In one embodiment of the present disclosure, the finger end guard30may have a curved fingertip rest that ensures the patient's finger19stops at an end of the finger receiving portion20while permitting the patient's finger nail to clear the end of the finger receiving portion20. The finger receiving portion20permits use of the holder12with artificial and natural fingernail styles present in the patient population.

The first opening22of the finger receiving portion20is configured for receiving a sample source, e.g., a finger19, for supplying a biological sample, such as a blood sample18. It can be appreciated that the sample source could include other parts of the body capable of fitting within the first opening22. The port26is in communication with the finger receiving portion20. For example, with a finger19received within the holder12, the port26is in communication with a portion of the finger19. A holder12of the present disclosure can be sized to accommodate all finger sizes.

The second opening28of the port26is configured for receiving a lancet housing14and a collection container16as described in more detail below. In one embodiment, the port26includes a locking portion32for securely receiving the lancet housing14and the collection container16within the port26.

In one embodiment, the actuation portion24is transitionable between a first position in which the holder12defines a first diameter and a second position which the holder12defines a second diameter, wherein the second diameter is less than the first diameter. In one embodiment, the actuation portion24is transitionable between a first position in which the holder12defines a first elliptical shape, and a second position in which the holder12defines a second elliptical shape, wherein the first elliptical shape is different than the second elliptical shape. In this manner, with the holder12in the second position with a reduced diameter, a portion of the holder12contacts the sample source and the actuation portion24of the holder12is able to pump and/or extract blood18as described in more detail below.

Referring toFIGS.1,3, and4, in one embodiment, the actuation portion24includes a contact member34. Referring toFIG.7, with the actuation portion24in the first position, the contact member34is in a disengaged position, i.e., the contact member34is provided in a first position with respect to a sample source, e.g., the finger19, such that the contact member34may be in slight contact therewith. Referring toFIG.7, with the actuation portion24in the second position, the contact member34is in an engaged position, i.e., the contact member34is provided in a second position with respect to the sample source, e.g., the finger19, such that the contact member34is in an applied pressure contact with the finer19, and the actuation portion24of the holder12is able to pump and/or extract blood18. For example, with the contact member34in the engaged position, the contact member34exerts a pressure on the sample source.

Referring toFIGS.1-5, in one embodiment, the actuation portion24includes a pumping member36for applying pressure to the sample source, e.g., the finger19. In one embodiment, the pumping member36comprises a pair of opposed tabs or wings38. In such an embodiment, each tab38may include a contact member34. Referring toFIGS.1and3, in one embodiment, the holder12includes a living hinge portion42. The living hinge portion42allows a user to squeeze the wings38between a first position (passive state) (FIG.7) and a second position (active state) (FIG.7). The use of the tabs or wings38to draw blood out of a patient's finger19minimizes hemolysis while maintaining an adequate flow of blood from the patient's finger19. A resting position and hinge of the wings38are designed to maintain contact and retention with the smallest patient finger that can fit into a holder12while flexing to accommodate the largest patient fingers within a holder12without blood occlusion. In one embodiment, the wings38may be positioned on the finger receiving portion20at a position located proximal of a patient's fingernail and distal of a patient's first knuckle to avoid hard tissues on the patient's finger19.

Advantageously, the holder12of the present disclosure allows a user to repeatedly squeeze and release the wings38to pump and/or extract blood18from a finger19until a desired amount of blood18is filled in a collection container16. The wings38are configured to flex to maintain gentle contact with a range of patient finger sizes that may be used with the holder12and to retain the holder12on the patient's finger19. The wings38may also provide active pressure features for the holder12. In one embodiment, the wings38may have a length, thickness, and angle optimized for ideal squeeze pressure on the patient's finger19. In one embodiment, the location of the wings38on the holder12ensure that soft tissue of the patient's finger19is put under pressure while avoiding hard tissues in the patient's finger19, such as the patient's knuckles. Further, in one embodiment, an angle between the wings19and patient's finger19tapers to create a pressure gradient towards the patient's fingertip to aid in blood flow from the patient's finger19. The angle of the wings38relative to the natural taper of the finger19creates a small pressure gradient from distal to proximal end of the finger19, ensuring the direction of flow is towards the fingertip while avoiding finger milking per international best practices for sample quality.

In one embodiment, the wings38may also include touch pads86on an outer surface thereof to be gripped by the user of the holder12. The touch pads86may ensure that users squeeze the wings38at the correct desired location for proper squeeze pressure, comfort, and hemolysis when drawing blood from the patient's finger19. In one embodiment, the wings38may also include anti-touch protrusions88that extend from an outer surface of the wings38. In one embodiment, the anti-touch protrusions88are positioned on the wings38beneath the touch pads86. The anti-touch protrusions88extend outwardly from the wings38and are positioned and configured to discourage users from squeezing too low on the wings38and applying too much pressure to the wings38. The anti-touch protrusions88ensure the user does not grip the wings38too low to allow the wings38to flex as needed for proper pressure application. Users may be instructed to know that, once the anti-touch protrusions88are contacted, the user's grip must be moved upwards closer to the touch pads86to ensure proper pressure is being applied to the patient's finger19.

Advantageously, with the holder12placed onto a finger19, the holder12does not constrict the blood flow and defines lancing and finger squeezing locations. The squeezing tabs or wings38provide a pre-defined range of squeezing pressure that is consistently applied throughout a finger19. By doing so, the holder12provides a gentle controlled finger massage that stimulates blood extraction and minimizes any potential hemolysis.

Referring toFIG.1, in one embodiment, the holder12includes a stability extension portion40. This provides additional support for the holder12to be securely placed onto a finger19. In one embodiment, the finger receiving portion20forms a generally C-shaped member and includes a plurality of inner gripping members for providing additional grip and support for the holder12to be securely placed onto a finger19. The stability extension portion40assists in maintaining contact with the patient's finger19during use of the holder12while avoiding the blood supply and knuckles of the patient's finger19.

In one embodiment, the finger receiving portion20is formed of a flexible material. In some embodiments, the finger receiving portion20and the port26are formed from a flexible material.

A device10for obtaining a blood sample18of the present disclosure includes a lancet housing or lancet14that is removably connectable to a port26of a holder12. Referring toFIG.10, in one embodiment, the lancet housing14includes an inlet or opening50, an interior52, a puncturing element54, an engagement portion56, a retractable mechanism58, and a drive spring60. In one embodiment, the puncturing element54is moveable between a pre-actuated position wherein the puncturing element54is retained within the interior52of the lancet housing14and a puncturing position wherein at least a portion of the puncturing element54extends through the inlet50of the lancet housing14to lance a portion of a finger19.

In one embodiment, the lancet14of the present disclosure is a contact activated lancet and may be constructed in accordance with the features disclosed in U.S. Patent Application Publication No. 2006/0052809 filed May 6, 2005, entitled “Contact Activated Lancet Device”, and commonly assigned with the present application, the entire disclosure of which is hereby expressly incorporated herein by reference thereto.

In one embodiment, the lancet housing14may be a separate component from the holder12and the collection container16. In some embodiments, the collection container16and the lancet housing14form a single component that is removably connectable to the port26of the holder12. In some embodiments, the collection container16, the lancet housing14, and the holder12form a single component.

Referring toFIG.10, in one embodiment, with the holder12and the lancet housing14being separate components, the lancet housing14is removably connectable to the port26of the holder12. In such an embodiment, the lancet housing14includes an engagement portion56. Referring toFIG.10, in one embodiment, the lancet housing14is pushed into the port26of the holder12such that the engagement portion56of the lancet housing14is locked within the locking portion32of the holder12. In this manner, the lancet housing14is securely connected and locked to the holder12such that the puncturing element54of the lancet housing14can be activated to lance or puncture a sample source, e.g., a finger19. In some embodiments, the port26of the holder12includes a plurality of ribs for securing and locking the lancet14or the collection container16in the port26.

To activate the lancet14, the lancet14is pushed against a finger19to activate a retractable mechanism58of the lancet14to lance a finger19. The lancet14of the present disclosure consistently delivers correct lancing depth and a pre-defined lancing location, thus ensuring a sufficient sample volume.

In one embodiment, the lancet14includes a drive spring60disposed within the interior52of the lancet housing14for biasing the puncturing element54toward the puncturing position. After puncturing, the puncturing element54is immediately retracted and safely secured within the interior52of the lancet housing14.

In one embodiment, the lancet14of the present disclosure is used to lance the skin of a finger19and then a blood sample18is squeezed into a collection container16as described in more detail below.

In one embodiment, the lancet housing14of the present disclosure is used to lance the skin of a finger19along a lance path and then a blood sample18flows down a blood flow path at an angle to the lance path as described in more detail below.

In one embodiment, the lancet14can include a hollow needle. In such an embodiment, the lancet housing14of the present disclosure is used to lance the skin of a finger19along a lance path and then a blood sample18flows along a parallel blood flow path through the hollow needle.

As shown inFIGS.9and11, a device10for obtaining a blood sample18of the present disclosure includes a collection container16that is removably connectable to the port26(shown inFIG.1) of the holder12. With specific reference toFIG.11, the collection container16defines a collection cavity70for receiving a blood sample18(shown inFIG.9), a container engagement portion72, a blood collector portion74, and a cap or septum76. Once a desired amount of blood18is collected within the container16, a blood collector portion74is detached from the collection device10in order to send a collected sample18to a diagnostic instrument and/or testing device. The blood collector portion74is sealed via the cap or septum76once removed from the collection device10to protectively seal the blood sample18within the collection cavity70.

In one embodiment, the collection container16may be a separate component from the holder12and the lancet housing14. In some embodiments, the collection container16and the lancet housing14form a single component that is removably connectable to the port26of the holder12. In some embodiments, the collection container16, the lancet housing14, and the holder12form a single component.

In one embodiment, with the holder12and the collection container16being separate components, the container16is removably connectable to the port26of the holder12. In such an embodiment, the container16includes a container engagement portion72. In one embodiment, the container16is pushed into the port26of the holder12such that the container engagement portion72of the container16is locked within the locking portion32of the holder12. In this manner, the container16is securely connected and locked to the holder12such that a blood sample18can safely flow from the finger19within the holder12to the collection cavity70of the container16.

It can be appreciated that several types of collection containers16can be used with the device10of the present disclosure. It can also be appreciated that the collection container16can be associated with a separate dispensing unit or the collection container16can include an integral dispensing portion for dispensing the blood18to a testing device.

Referring toFIGS.1-5,9, and10, use of a device10of the present disclosure having discrete components, e.g., a holder12, a lancet housing or lancet14, and a collection container16, will now be described.

Referring toFIG.3, first a desired finger19is cleaned and a holder12having an appropriate size for the desired finger19is selected and placed onto the finger19securely. Next, referring toFIG.10, a lancet housing14is connected to the port26of the holder12. As discussed above, the lancet housing14is pushed into the port26of the holder12such that the engagement portion56of the lancet housing14is locked within the locking portion32of the holder12. In this manner, the lancet housing14is securely connected and locked to the holder12such that the puncturing element54of the lancet housing14can be activated to lance or puncture a sample source, e.g., a finger19. With the lancet14connected to the port26of the holder12, the lancet is in communication with the finger19.

When it is desired to activate the lancet14to lance the skin of a finger19, the lancet14is pushed against a finger19to activate a retractable mechanism58of the lancet14to lance a finger19. The lancet14of the present disclosure consistently delivers correct lancing depth and a pre-defined lancing location, thus ensuring a sufficient sample volume.

After the finger19is lanced to create blood18flow from the finger19, the lancet14is removed from the holder12and the collection container16is pushed into the port26of the holder12. Referring toFIG.11, the container16is pushed into the port26of the holder12such that the container engagement portion72of the container16is locked within the locking portion32of the holder12. In this manner, the container16is securely connected and locked to the holder12such that a blood sample18can safely flow from the finger19within the holder12to the collection cavity70of the container16.

Referring toFIGS.7and8, with the container16properly secured to the holder12for collection of a blood sample18, a user is able to repeatedly squeeze and release the wings38of the holder12to pump and/or extract blood18from a finger19until a desired amount of blood18is filled in a collection container16. Advantageously, with the holder12placed onto a finger19, the holder12does not constrict the blood flow and defines lancing and finger squeezing locations. The squeezing tabs or wings38provide a pre-defined range of squeezing pressure that is consistently applied throughout a finger19. By doing so, the holder12provides a gentle controlled finger19massage that stimulates blood extraction and minimizes any potential hemolysis.

For example, referring toFIGS.7and8, in one embodiment, the actuation portion24includes a contact member34. Referring toFIG.7, with the actuation portion24in the first position, the contact member34is in a disengaged position, i.e., the contact member34is in the first position with respect to the sample source, e.g., the finger19. Referring toFIG.7, with the actuation portion24in the second position, the contact member34is in an engaged position, i.e., the contact member34is in the second position and in applied pressure contact with a sample source, e.g., the finger19, and the actuation portion24of the holder12is able to pump and/or extract blood18. For example, with the contact member34in the engaged position, the contact member34exerts a pressure on the sample source.

Once a desired amount of blood18is collected within the container16, a blood collector portion74is detached from the collection device10in order to send a collected sample18to a diagnostic instrument and/or testing device. The blood collector portion74is sealed via the cap or septum76once removed from the collection device10to protectively seal the blood sample18within the collection cavity70.

The devices of the present disclosure are compatible with any known testing device, whether the testing device is off-site or a point-of-care testing device. 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 bedside 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.

The collection container16may also contain a sample stabilizer, e.g., an anticoagulant, to stabilize a blood sample and/or a component of a blood sample disposed therein. The collection container16may also include at least one fill line(s) corresponding to a predetermined volume of sample. The collection container may also indicate/meter a collected volume of blood.

In another exemplary embodiment, a device for obtaining a blood sample18of the present disclosure has an at-angle flow and includes an integrated holder12, lancet housing14, and collection container16. In such an embodiment, a user does not have to connect a separate lancet housing14to the port26of the holder12, remove the lancet14after lancing the skin of a finger19, and then connect a collection container16to the port26of the holder12. Instead, the lancet housing14is permanently secured within the port26of the holder12. The lancet housing14includes a blood flow channel. The collection container16is secured to the lancet housing14and includes a blood collector portion74that is removably connectable to a portion of the lancet housing14.

In one embodiment, with the container16connected to the lancet housing14, the longitudinal axis of the lancet housing14is at an angle to the longitudinal axis104of the container16. In one embodiment, the lancet housing14is used to lance the skin of a finger19along a lance path and then a blood sample18flows down a blood flow path at an angle to the lance path.

Any of the devices for obtaining a blood sample of the present disclosure can be used as a self-standing disposable device and/or in association with an external power source for pain reduction control. For example, a portion of holder12may include embedded electrodes which receive a signal from an external pain control module to deliver at least one of heat, vibration, or transcutaneous electrical nerve stimulation (TENS) for pain reduction control. The devices for obtaining a blood sample of the present disclosure may also include various options for on-board plasma separation. The devices for obtaining a blood sample of the present disclosure may also include a unique sample identifier that can be paired with patient information at the time of collection. The devices for obtaining a blood sample of the present disclosure may also include on-board diagnostic feedback at the time of collection. A device for obtaining a blood sample of the present disclosure may also allow for dual collection, e.g., the collection of two samples into two separate containers, using multiple collection ports which enable the collection of multiple samples from the same source and treating the samples with different sample stabilizers, such as anticoagulants.

A device for obtaining a blood sample of the present disclosure significantly simplifies and de-skills large volume capillary collection from a finger relative to the conventional capillary collection using lancet and capillary tube. The devices of the present disclosure eliminate blood exposure and prevents device reuse.

The devices for obtaining a blood sample of the present disclosure simplify, deskill, and streamline the collection process. This is all achieved by a self-contained closed system device which after it is placed onto a finger will provide lancing, blood extraction, stabilization, and containment functions, all in one unit.

The devices for obtaining a blood sample of the present disclosure may be associated with a self-standing unit that provides automated pumping, controlled finger squeezing, and automated sample labeling and processing.

With reference toFIGS.1-5, according to various embodiments of the present disclosure, additional features of the holder12are shown and described. In one embodiment, the holder12may include passive pressure features that assist in drawing a blood sample18from the patient's finger19. The passive pressure features are designed to aid and ensure proper positioning of the holder12before and during use of the holder12for blood collection without restricting blood flow. The holder12may include a flared edge80provided on the opening22of the finger-receiving portion20. The flared edge80may create a comfortable position for the patient's finger19to rest upon instead of a sharp corner. Instead, the flared edge80may include a rounded or curved edge that assists in providing a comfortable resting space for the patient's finger19.

In one embodiment, the holder12may include at least two bulges82that extend from an outer surface of the finger receiving portion20. The bulges82may have rounded edges and may be configured to prevent pressure on the arterial blood supply of the patient's finger19that is positioned in the finger receiving portion20.

In one embodiment, holder12may also include at least one retention bump84provided on the stability extension portion40. In one embodiment, the stability extension portion40includes two retention bumps84. The retention bump84may extend from an inner surface of the stability extension portion40to engage and contact the patient's finger19when positioned in the finger receiving portion20. The retention bumps84may have a curved surface so as to provide a comfortable engagement with the patient's finger19. The retention bumps84may be provided to secure the holder12to the patient's finger19without restricting arterial blood supply to the patient's finger19.

In one embodiment, as shown inFIG.4, a transition90from the finger receiving portion20to the opening28allows for expansion of the patient's finger19under pressure during squeezing of the wings38without a flow restriction or hemolysis. The transition90permits a portion of the patient's finger19to extend into the opening28to allow the finger to expand under pressure in the finger receiving portion20. By permitting this expansion of the patient's finger19, a restriction of the blood flow from the patient's finger19and hemolysis is avoided.

With reference toFIG.6, according to one embodiment of the present disclosure, a method of using the holder12to draw blood from a patient's finger19is described. The method of use of the holder12has been described above in detail, while the following disclosure describes a specific squeezing rhythm for using the holder12to ensure an adequate and desired volume of blood is drawn from the patient's finger19. It is to be understood, however, that any number of squeezing rhythms can be used with the holder12including faster, slower, more varied, and different pressured rhythms. In one embodiment, the squeezing rhythm first includes squeezing the wings38of the holder12towards one another to apply pressure to the patient's finger19. In one embodiment, the wings38are squeezed a minimum 0.25 seconds and a maximum of 1 second to close the wings38towards one another. In one embodiment, the wings38are then held closed with one another. The wings38may be held together in the closed position for up to 0.5 seconds. In one embodiment, the wings38may not be held in the closed position and, instead, are squeezed closed and then released open. In one embodiment, the wings38may be released open in 0.5 seconds. The wings38may then be held in the open position for up to 1 second. It is also contemplated that the wings38may not be allowed to rest in the open position and, instead, are squeezed closed again after being released from the closed position.

As shown inFIG.6, according to one embodiment of the present disclosure, a squeezing rhythm for the holder12is shown and described. The wings38may be squeezed closed and released to an open position in a pumping manner. It is also contemplated that the wings38may be held in the closed position for a duration of time before being released to the open position. The wings38move between a state of passive pressure, which includes the resting fit of the holder12on the finger19which allows the holder12to stay firmly in place without restricting blood flow, and an active pressure, which includes the pressure applied by the user and the holder12to cause blood to flow from the finger19without hemolyzing or compromising the blood sample. In one embodiment of the present disclosure, it is desired that the user apply a predetermined desired pressure to the wings38to quickly peak to the desired pressure without an overshoot in pressure. An overshoot in pressure is realized by squeezing the wings38of the holder12too quickly. Therefore, a more uniform pressure applied to the wings38is desired to avoid an overshoot in pressure, which may result in an undesired blood flow from the patient's finger19. Further shown inFIG.6, a slow release of the wings38is typically not desired as it creates a slower refill for the blood flow in the patient's finger19. Instead, a quicker release of the wings38is desired to quickly drop pressure on the patient's finger19to allow for a faster refill of blood flow through the patient's finger19. The passive and active pressure features, and the rhythm of moving between the active squeezed state and passive rest state, work together as a system to control how and where the finger19is squeezed to provide blood flow rates equivalent to expert capillary collection healthcare professionals at less than 25% of the average hemolysis.

With reference toFIGS.7and8, the different states or positions of the holder12are shown to detail blood flow and discomfort in relation to the pressure applied to the patient's finger19. The graphical illustration inFIG.8illustrates a contact pressure in relation to blood production achieved from the patient's finger19and the eventual discomfort and pain experienced by the patient upon extended pressure. The graphical illustration charts the pressure applied around the circumference of the patient's finger during a squeeze of the holder12. The graphical illustration shows that the further around the circumference of the patient's finger19from a bottom dermis portion of the patient's finger19the pressure is applied, the more pain and discomfort is experienced by the patient, especially in the hard tissue areas of the finger19.

The present holder12provides advantages over conventional capillary blood collection devices. The holder12is configured to align with a patient's finger19features, ensuring that the holder12consistently and securely remains in place and applies pressure in the correct location. This feature was accomplished by analyzing several sources of anatomical information (finger width and length, knuckle and artery locations) to limit squeezing to soft tissues near the collection site while avoiding pressure on hard tissues or blood vessels. Further, the wings38are configured to apply pressure in two stages. The first stage has pressure on the finger increased proportionally to the applied pressure. However, as intensity increases, the wings38begin to flex and bend until they touch and cannot displace any further. This allows enough pressure to have adequate blood flow but limits maximum pressure to avoid hemolysis. This avoids issues with health care workers squeezing harder to promote flow and vacuum methods applying too little pressure. The prescribed squeezing rhythm is also prescribed to allow blood to refill the fingertip. This avoids user variation from manual techniques and consistent pressure by vacuum methods which do not allow capillary beds to be replenished.

The finger-squeezing wings38further define the pressure location and can only be operated one way. The wings38also have the pads86to promote proper finger placement and operation by workers and anti-touch features to avoid improper operation. This prevents the use of the improper “milking” technique and ensures correct operation of the wings38, which both contribute to better hemolysis. The wings38further act as levers, meaning users apply a lower peak force to close the wings38and instead travel further during the squeezing motion than squeezing the finger19directly. This turns manual squeezing from a small displacement, high force motion which is prone to fatigue to a larger displacement, lower force motion more suitable to routine use.

The device was designed to apply pressure to the soft tissues of the fingertip, limit the peak pressure applied spatially on the finger, and maximize the average pressure applied across the tissue within empirically determined hemolysis limits. Limiting applied pressure to soft-tissues lowered the maximum force required to generate blood. Reducing the peak pressure applied to individual regions of the finger (e.g. side, top, bottom) would contribute to hemolysis or patient pain. Maximizing average pressure ensured that blood flow would still be adequate to have practical capillary blood collection.

The wings38also limit user fatigue and maximum pressure applied by acting as deformable levers. Levers typically function by exchanging force for displacement: users must squeeze across a longer travel distance but the force required is much lower than squeezing the finger directly. This reduces user fatigue which is typically driven by peak force generated.

However, the wings38are also designed to flex. When force is initially applied to the wings38, the soft tissues of the finger compress and squeeze blood out like a sponge. As blood leaves and the soft tissues compress further, they stiffen and require more force to continue squeezing. This regime of squeezing has diminished value for blood flow but can contribute greatly to hemolysis as pressure increases rapidly. As this occurs, the force applied on the wings38increases proportionally. In this regime the wings38begin to act as a classic cantilever beam under a point load—the ends of the wing38begin deflecting in addition to the angular displacement of the wing38. This causes the wings38to quickly touch each other and limit the total amount of displacement, thus limiting the maximum pressure applied more than geometrically stiff, non-flexing wings. The wings38have the added benefit of only deflecting when soft tissues have been compressed enough, that is, only when blood has been adequately squeezed from the finger and further squeeze pressure would be detrimental.

According to one embodiment of the present disclosure, the patient's finger19and/or the holder12may be disinfected before use of the device10and the holder12. The goal of cleaning/disinfection is to minimize the risk of infection or irritation of the collection site, following skin puncture and blood collection. The patient's ring finger or middle finger may be the puncture site for the lancet14. Therefore, before puncturing the patient's finger19and/or inserting the patient's finger19into the holder12, the patient's finger19may be disinfected with an alcohol wipe. In some examples, the collection site of the patient's finger, the proximal tissues such as the adjacent fingers and the rest of the patient's hand, and/or at least the puncture site and the palm of the patient's hand with as much of the surround area may be disinfected with the alcohol wipe. 70% Isopropyl alcohol and water may be used to disinfect the patient's finger19and the holder12, or 70% ethyl alcohol and water may be used to disinfect the patient's finger19and the holder12. The alcohol may be permitted to dry for at least 10 seconds to ensure evaporation. Complete drying is necessary to prevent additional pain during lancing and avoid additional sample hemolysis leading to reduced sample quality.

In another embodiment of the present disclosure, the holder12may be disinfected with an alcohol wipe. In particular, a 70% alcohol wipe may be used to disinfect the holder. The finger receiving portion20, the actuation portion24, and any other remaining portions of the holder12may be wiped with the alcohol wipe to disinfect the surfaces of the holder12. The disinfection of the patient's finger19and the holder12assists in preventing introduction or reintroduction of contaminants into or onto patient's finger19. Since the puncture site of the patient's finger19will rest in the opening28of the holder, the disinfected portion of the patient's finger19will have no need to contact a surface of the holder12, thereby further assisting in preventing contamination of the patient's finger19. In another embodiment of the present disclosure, instead of using an alcohol wipe, a swap and a 70% alcohol solution dispenser may be used to disinfect the patient's finger19and/or the holder12. In particular, the swap may be used to wipe the surfaces of the finger receiving portion20and other portions of the holder12until there is a sheen on the surfaces of the holder12to indicate that the holder12has been properly disinfected.

Capillary collection blood draws are typically performed by health care workers either using their fingers to manually squeeze the tissue around the puncture site or by a device using vacuum pressure to pull blood from the site. However, capillary blood collection is an uncommon blood collection technique for the purposes of core lab panel testing especially in adults due to volume and sample quality issues. Venipuncture and venous blood are the gold standard, with capillary blood samples only used as a substitute when a venous sample cannot be acquired. The classic example is neonatal blood testing where large accessible veins are not available for blood collection via venipuncture. Capillary blood would be acquired in this case using a lancet, targeting the heel of the infant. Prior to capillary collection via the heel-stick method, the heel is first cleaned. This is accomplished most commonly using an alcohol wipe and gauze. However, collection occurs directly into a capillary tube and does not utilize a Yoda finger cuff or analogous device to aid the health care worker during sample collection, and therefore no device cleansing step exists.

Previous art/practice utilizes an alcohol wipe to disinfect the collection site followed immediately by sample collection, which is true for venipuncture and conventional capillary collection. However, the immediate advancement to collection can lead to additional pain experienced by the patient due to the alcohol sting, but more importantly can also impact sample quality via increased hemolysis. This issue may be addressed by wiping the wet alcohol spot with a gauze, which effectively dries the area but can reintroduce contaminants and elevate the risk of infection.

Disinfection and cleansing of the puncture site acts to reduce the bacterial load and minimize the risk of nosocomial infections. The use of alcohols (ethanol or isopropanol) act by dehydrating microorganisms and denaturing proteins when in direct contact. The solutions (generally 70% alcohol) are also quite volatile and as a result only requires a short evaporation period before the disinfected site is free for blood collection. These features make for a great disinfection solution, leaving no residue or artifact behind if proper directions are followed.

While an embodiment of a capillary blood collection device is shown in the accompanying figures and described hereinabove in detail, other embodiments will be apparent to, and readily made by, those skilled in the art without departing from the scope and spirit of the invention. Accordingly, the foregoing description is intended to be illustrative rather than restrictive. The invention described hereinabove is defined by the appended claims and all changes to the invention that fall within the meaning and the range of equivalency of the claims are to be embraced within their scope.