WO2024206113A1

WO2024206113A1 - Capillary blood collection device

Info

Publication number: WO2024206113A1
Application number: PCT/US2024/021083
Authority: WO
Inventors: Charles Peter Althoff
Original assignee: Becton, Dickinson And Company
Priority date: 2023-03-29
Filing date: 2024-03-22
Publication date: 2024-10-03

Abstract

A device for obtaining a blood sample, the device including a holder for receiving a sample source, the holder having an actuation portion and a port, and a collector attachment removably and pivotally connected to the holder. The collector attachment includes a channel defined in the collector attachment and extending from a first end to an opposing second end of the collector attachment, and a blood guide member formed as a protrusion in the channel.

Description

CAPILLARY BLOOD COLLECTION DEVICE

CROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to United States Provisional Application No. 63/455,314 entitled “Capillary Blood Collection Device” filed March 29, 2023, the entire disclosure of which is hereby incorporated by reference.

BACKGROUND OF THE INVENTION

Field of the Invention

[0002] 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

[0003] 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 medical 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.

[0004] 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.

[0005] 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. Patent 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 releases 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.

[0006] 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 techniques 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.

[0007] 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.

[0008] 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.

[0009] 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.

[0010] 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 eliminates 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 containers; (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 (> 50-500pL) 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

[0011] In one non-limiting embodiment or aspect 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 collector attachment removably and pivotally connected to the holder, the collector attachment may include a channel defined in the collector attachment and extending from a first end to an opposing second end of the collector attachment, and a blood guide member formed as a protrusion in the channel.

[0012] In another non-limiting embodiment or aspect of the present disclosure, a collection container may be removably connected to the collector attachment. The blood guide member may extend past an end of the channel. The collector attachment may include a blood pillar provided adjacent the holder to receive initial droplets of blood directed from the holder. The collector attachment may include a blood flash window formed integral with the collector attachment. The collector attachment may include a locking snap protrusion that is configured to snap into a locking engagement with a locking portion on the holder. The collector attachment may be held on the holder via a snap-fit connection. The blood guide member may be configured to direct droplets of blood from the collector attachment onto a dried blood spot collection sheet or lateral flow test strip device. The collector attachment may be configured to pivot between a first, resting position and a second, activated position. In the first, resting position, the collector attachment may be removed from an opening of the holder, and wherein, in the second, activated position, the collector attachment may be aligned with the opening of the holder.

[0013] In another non-limiting embodiment or aspect of the present disclosure, a collector attachment for a device for obtaining a blood sample may include a channel defined in the collector attachment and extending from a first end to an opposing second end of the collector attachment; a blood guide member formed as a protrusion in the channel; and a protrusion extending from the collector attachment and configured for engagement with a recess in a holder.

[0014] In another non-limiting embodiment or aspect of the present disclosure, a collection container may be removably connected to the collector attachment. The blood guide member may extend past an end of the channel. The collector attachment may include a blood pillar provided adjacent the holder to receive initial droplets of blood directed from the holder. The collector attachment may include a blood flash window formed integral with the collector attachment. The collector attachment may include a locking snap protrusion that is configured to snap into a locking engagement with a locking portion on the holder. The collector attachment may be held on the holder via a snap-fit connection. The blood guide member may be configured to direct droplets of blood from the collector attachment onto a dried blood spot collection sheet. The collector attachment may be configured to pivot between a first, resting position and a second, activated position. In the first, resting position, the collector attachment may be removed from an opening of the holder, and wherein, in the second, activated position, the collector attachment may be aligned with the opening of the holder.

[0015] The present invention is also described in the following clauses:

[0016] 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; and a collector attachment removably and pivotally connected to the holder, the collector attachment comprising: a channel defined in the collector attachment and extending from a first end to an opposing second end of the collector attachment; and a blood guide member formed as a protrusion or recess in the channel.

[0017] Clause 2: The device of clause 1, further comprising a collection container removably connected to the collector attachment.

[0018] Clause 3: The device of clause 1 or clause 2, wherein the blood guide member extends past an end of the channel.

[0019] Clause 4: The device of any of clauses 1-3, wherein the collector attachment further comprises a blood pillar provided adjacent the holder to receive initial droplets of blood directed from the holder.

[0020] Clause 5: The device of any of clauses 1-4, wherein the collector attachment further comprises a blood flash window formed integral with the collector attachment.

[0021] Clause 6: The device of any of clauses 1-5, wherein the collector attachment further comprises a locking snap protrusion that is configured to snap into a locking engagement with a locking portion on the holder. [0022] Clause 7: The device of any of clauses 1-6, wherein the collector attachment is held on the holder via a snap-fit connection.

[0023] Clause 8: The device of any of clauses 1-7, wherein the blood guide member is configured to direct droplets of blood from the collector attachment onto a dried blood spot collection sheet or a lateral flow test strip device.

[0024] Clause 9: The device of any of clauses 1-8, wherein the collector attachment is configured to pivot between a first, resting position and a second, activated position.

[0025] Clause 10: The device of clause 9, wherein, in the first, resting position, the collector attachment is removed from an opening of the holder, and wherein, in the second, activated position, the collector attachment is aligned with the opening of the holder.

[0026] Clause 11: A collector attachment for a device for obtaining a blood sample, the collector attachment comprising: a channel defined in the collector attachment and extending from a first end to an opposing second end of the collector attachment; a blood guide member formed as a protrusion or recess in the channel; and a protrusion extending from the collector attachment and configured for engagement with a recess in a holder.

[0027] Clause 12: The collector attachment of clause 11, further comprising a collection container removably connected to the collector attachment.

[0028] Clause 13: The collector attachment of clause 11 or clause 12, wherein the blood guide member extends past an end of the channel.

[0029] Clause 14: The collector attachment of any of clauses 11-13, wherein the collector attachment further comprises a blood pillar provided adjacent the holder to receive initial droplets of blood directed from the holder.

[0030] Clause 15: The collector attachment of any of clauses 11-14, wherein the collector attachment further comprises a blood flash window formed integral with the collector attachment.

[0031] Clause 16: The collector attachment of any of clauses 11-15, wherein the collector attachment further comprises a locking snap protrusion that is configured to snap into a locking engagement with a locking portion on the holder.

[0032] Clause 17: The collector attachment of any of clauses 11-16, wherein the collector attachment is held on the holder via a snap-fit connection.

[0033] Clause 18: The collector attachment of any of clauses 11-17, wherein the blood guide member is configured to direct droplets of blood from the collector attachment onto a dried blood spot collection sheet or lateral flow test strip device. [0034] Clause 19: The collector attachment of any of clauses 11-18, wherein the collector attachment is configured to pivot between a first, resting position and a second, activated position.

[0035] Clause 20: The collector attachment of clause 19, wherein, in the first, resting position, the collector attachment is removed from an opening of the holder, and wherein, in the second, activated position, the collector attachment is aligned with the opening of the holder.

[0036] Clause 21: The collector attachment of any of any of clauses 11-20, further comprising a collection media removably inserted into the collector attachment blood path.

BRIEF DESCRIPTION OF THE DRAWINGS

[0037] FIG. 1 is a perspective view of a holder in accordance with an embodiment of the present invention.

[0038] FIG. 2A is a cross-sectional view of the device of FIG. 1 for obtaining a blood sample from a patient’s finger and a lancet in accordance with another embodiment of the present disclosure.

[0039] FIG. 2B is a perspective view of the device of FIG. 1 and a collection container in accordance with another embodiment of the present disclosure.

[0040] FIG. 3 is a perspective view of a holder and a collector attachment in accordance with another embodiment of the present disclosure.

[0041] FIG. 4 is another perspective view of the holder and the collector attachment of FIG.

3.

[0042] FIG. 5 is a side view of the holder and the collector attachment of FIG. 3 with the collector attachment in a resting position.

[0043] FIG. 6 is a perspective view of the holder and the collector attachment of FIG. 3 with the collector attachment in an activated position.

[0044] FIG. 7 is a top view of the holder and the collector attachment of FIG. 3.

[0045] FIG. 8 is a front view of the holder and the collector attachment of FIG. 3.

[0046] FIG. 9 is another side view of the holder and the collector attachment of FIG. 3.

[0047] FIG. 10 is a perspective view of the holder and the collector attachment of FIG. 3 in use with a dried blood spot collection sheet.

[0048] FIG. 11 is a perspective view of the holder and the collector attachment of FIG. 3 in use with a collection container in accordance with another embodiment of the present disclosure. FIG. 12 is a perspective view of the holder and the collector attachment of FIG. 3 in use with another collection container in accordance with another embodiment of the present disclosure. [0049] FIG. 13 is a perspective view of a collector attachment according to another nonlimiting embodiment or aspect of the present disclosure.

[0050] FIG. 14 is a perspective view of a collector attachment according to another nonlimiting embodiment or aspect of the present disclosure. FIG. 15 is a perspective view of a collector attachment according to another non-limiting embodiment or aspect of the present disclosure.

[0051] FIG. 16 is a perspective view of a collector attachment according to another nonlimiting embodiment or aspect of the present disclosure.

[0052] FIG. 17 is a perspective view of a collector attachment according to another nonlimiting embodiment or aspect of the present disclosure.

[0053] FIG. 18 is a perspective view of a collector attachment according to another nonlimiting embodiment or aspect of the present disclosure.

[0054] FIG. 19 is a perspective view of a collector attachment according to another nonlimiting embodiment or aspect of the present disclosure.

[0055] FIG. 20 is a perspective view of a collector attachment according to another nonlimiting embodiment or aspect of the present disclosure.

DESCRIPTION OF THE INVENTION

[0056] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

[0057] For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume alternative variations and step sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting. [0058] 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.

[0059] 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.

[0060] 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.

[0061] The present disclosure includes a self-contained and fully integrated finger-based capillary blood collection device with the ability to lance, collect, and stabilize high volume capillary blood samples, 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 the collected sample. [0062] 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 onboard plasma separation modules. This capability extends the product flexibility to various applications including dispensing to a POC cartridge or to a small collection tube transfer which can be used in a centrifuge or an analytical instrument.

[0063] Referring to FIGS. 1 and 2, in an exemplary embodiment, a device 10 of the present disclosure includes discrete components, e.g., a holder 12 (as shown in FIG. 1), a lancet housing or lancet 14, and a collection container 16. In another exemplary embodiment, a semiintegrated 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.

[0064] Referring to FIG. 1 , an exemplary embodiment of a holder 12 of the present disclosure that is able to receive a sample source, e.g., a finger 19, for supplying a biological sample, such as a blood sample 18, is shown and described. A holder 12 of the present disclosure generally includes a finger receiving portion 20 having a first opening 22 (FIG. 1), an actuation portion 24, a port 26 having a second opening 28, and a finger end guard 30. In one embodiment, the finger end guard 30 provides a stop portion for properly aligning and securing a finger 19 within the holder 12. The finger end guard 30 further assists in ensuring the patient’s finger 19 is placed at a proper position within the finger receiving portion 20 so that applied pressure to the patient’s finger 19 will result in adequate blood flow.

[0065] The first opening 22 of the finger receiving portion 20 is configured for receiving a sample source, e.g., a finger 19, for supplying a biological sample, such as a blood sample 18. It can be appreciated that the sample source could include other parts of the body capable of fitting within the first opening 22. The port 26 is in communication with the finger receiving portion 20. For example, with a finger 19 received within the holder 12, the port 26 is in communication with a portion of the finger 19. A holder 12 of the present disclosure can be sized to accommodate all finger sizes.

[0066] The second opening 28 of the port 26 is configured for receiving a lancet housing 14 and a collection container 16 as described in more detail below. In one embodiment, the port 26 includes a locking portion 32 for securely receiving the lancet housing 14 and the collection container 16 within the port 26.

[0067] In one embodiment, the actuation portion 24 is transitionable between a first position in which the holder 12 defines a first diameter and a second position which the holder 12 defines a second diameter, wherein the second diameter is less than the first diameter. In one embodiment, the actuation portion 24 is transitionable between a first position in which the holder 12 defines a first elliptical shape, and a second position in which the holder 12 defines a second elliptical shape, wherein the first elliptical shape is different than the second elliptical shape. In this manner, with the holder 12 in the second position with a reduced diameter, a portion of the holder 12 contacts the sample source and the actuation portion 24 of the holder 12 is able to pump and/or extract a blood sample 18 as described in more detail below.

[0068] Referring to FIG. 1, in one embodiment, the actuation portion 24 includes a contact member 34. With the actuation portion 24 in the first position, the contact member 34 is in a disengaged position, i.e., the contact member 34 is provided in a first position with respect to a sample source, e.g., the finger 19, such that the contact member 34 may be in slight contact therewith. With the actuation portion 24 in the second position, the contact member 34 is in an engaged position, i.e., the contact member 34 is provided in a second position with respect to the sample source, e.g., the finger 19, such that the contact member 34 is in an applied pressure contact with the finger 19, and the actuation portion 24 of the holder 12 is able to pump and/or extract a blood sample 18. For example, with the contact member 34 in the engaged position, the contact member 34 exerts a pressure on the sample source.

[0069] Referring to FIG. 1, in one embodiment, the actuation portion 24 includes a pumping member 36 for applying pressure to the sample source, e.g., the finger 19. In one embodiment, the pumping member 36 comprises a pair of opposed tabs or wings 38. In such an embodiment, each tab or wing 38 may include a contact member 34. In one embodiment, the holder 12 includes a living hinge portion 42. The living hinge portion 42 allows a user to squeeze the tabs or wings 38 between a first position (passive state) and a second position (active state). The use of the tabs or wings 38 to draw a blood sample 18 out of a patient’ s finger 19 minimizes hemolysis while maintaining an adequate flow of blood from the patient’s finger 19. A resting position and hinge of the tabs or wings 38 are designed to maintain contact and retention with the smallest patient finger 19 that can fit into a holder 12 while flexing to accommodate the largest patient finger 19 within a holder 12 without blood occlusion.

[0070] Advantageously, the holder 12 of the present disclosure allows a user to repeatedly squeeze and release the tabs or wings 38 to pump and/or extract a blood sample 18 from a finger 19 until a desired amount of the blood sample 18 is filled in a collection container 16. The tabs or wings 38 are configured to flex to maintain gentle contact with a range of patient finger sizes that may be used with the holder 12 and to retain the holder 12 on the patient’s finger 19.

[0071] Advantageously, with the holder 12 placed onto a finger 19, the holder 12 does not constrict the blood flow and defines lancing and finger squeezing locations. The squeezing tabs or wings 38 provide a pre-defined range of squeezing pressure that is consistently applied throughout a finger 19. By doing so, the holder 12 provides a gentle controlled finger massage that stimulates blood extraction and minimizes any potential hemolysis.

[0072] Referring to FIG. 1, in one embodiment, the holder 12 includes a stability extension portion 40. This provides additional support for the holder 12 to be securely placed onto a finger 19. In one embodiment, the finger receiving portion 20 forms a generally C-shaped member and includes a plurality of inner gripping members for providing additional grip and support for the holder 12 to be securely placed onto a finger 19. The stability extension portion 40 assists in maintaining contact with the patient’s finger 19 during use of the holder 12 while avoiding the blood supply and knuckles of the patient’s finger 19.

[0073] In one embodiment, the finger receiving portion 20 is formed of a flexible material. In some embodiments, the finger receiving portion 20 and the port 26 are formed from a flexible material.

[0074] As shown in FIG. 2A, a device 10 for obtaining a blood sample 18 of the present disclosure may include a lancet housing or lancet 14 that is removably connectable to a port 26 of a holder 12. In one embodiment, the lancet housing 14 includes an inlet or opening 50, an interior 52, a puncturing element 54, an engagement portion 56, a retractable mechanism 58, and a drive spring 60. In one embodiment, the puncturing element 54 is moveable between a pre-actuated position wherein the puncturing element 54 is retained within the interior 52 of the lancet housing 14 and a puncturing position wherein at least a portion of the puncturing element 54 extends through the inlet 50 of the lancet housing 14 to lance a portion of a finger 19.

[0075] In one embodiment, the lancet 14 of 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.

[0076] In one embodiment, the lancet housing 14 may be a separate component from the holder 12 and the collection container 16. In some embodiments, the collection container 16 and the lancet housing 14 form a single component that is removably connectable to the port 26 of the holder 12. In some embodiments, the collection container 16, the lancet housing 14, and the holder 12 form a single component.

[0077] Referring to FIG. 2A, in one embodiment, with the holder 12 and the lancet housing 14 being separate components, the lancet housing 14 is removably connectable to the port 26 of the holder 12. In such an embodiment, the lancet housing 14 includes an engagement portion 56. Referring to FIG. 2A, in one embodiment, the lancet housing 14 is pushed into the port 26 of the holder 12 such that the engagement portion 56 of the lancet housing 14 is locked within the locking portion 32 of the holder 12. In this manner, the lancet housing 14 is securely connected and locked to the holder 12 such that the puncturing element 54 of the lancet housing 14 can be activated to lance or puncture a sample source, e.g., a finger 19. In some embodiments, the port 26 of the holder 12 includes a plurality of ribs for securing and locking the lancet 14 or the collection container 16 in the port 26.

[0078] To activate the lancet 14, the lancet 14 is pushed against a finger 19 to activate a retractable mechanism 58 of the lancet 14 to lance a finger 19. The lancet 14 of the present disclosure consistently delivers correct lancing depth and a pre-defined lancing location, thus ensuring a sufficient sample volume.

[0079] In one embodiment, the lancet 14 includes a drive spring 60 disposed within the interior 52 of the lancet housing 14 for biasing the puncturing element 54 toward the puncturing position. After puncturing, the puncturing element 54 is immediately retracted and safely secured within the interior 52 of the lancet housing 14.

[0080] In one embodiment, the lancet 14 of the present disclosure is used to lance the skin of a finger 19 and then a blood sample 18 is squeezed into a collection container 16 as described in more detail below. [0081] In one embodiment, the lancet housing 14 of the present disclosure is used to lance the skin of a finger 19 along a lance path and then a blood sample 18 flows down a blood flow path at an angle to the lance path as described in more detail below.

[0082] Referring to FIG. 2A, in one embodiment, the lancet 14 includes a hollow needle 62. In such an embodiment, the lancet housing 14 of the present disclosure is used to lance the skin of a finger 19 along a lance path and then a blood sample 18 flows along a parallel blood flow path through the hollow needle 62 as described in more detail below.

[0083] As shown in FIG. 2B, a device 10 for obtaining a blood sample 18 of the present disclosure includes a collection container 16 that is removably connectable to the port 26 of the holder 12. The collection container 16 defines a collection cavity 70 for receiving a blood sample 18, a container engagement portion 72, a blood collector portion 74, and a cap or septum 76. Once a desired amount of the blood sample 18 is collected within the collection container 16, a blood collector portion 74 is detached from the collection device 10 in order to send a collected blood sample 18 to a diagnostic instrument and/or testing device. The blood collector portion 74 is sealed via the cap or septum 76 once removed from the collection device 10 to protectively seal the blood sample 18 within the collection cavity 70.

[0084] In one embodiment, the collection container 16 may be a separate component from the holder 12 and the lancet housing 14. In some embodiments, the collection container 16 and the lancet housing 14 form a single component that is removably connectable to the port 26 of the holder 12. In some embodiments, the collection container 16, the lancet housing 14, and the holder 12 form a single component.

[0085] In one embodiment, with the holder 12 and the collection container 16 being separate components, the collection container 16 is removably connectable to the port 26 of the holder 12. In such an embodiment, the collection container 16 includes a container engagement portion 72. In one embodiment, the collection container 16 is pushed into the port 26 of the holder 12 such that the container engagement portion 72 of the collection container 16 is locked within the locking portion 32 of the holder 12. In this manner, the collection container 16 is securely connected and locked to the holder 12 such that a blood sample 18 can safely flow from the finger 19 within the holder 12 to the collection cavity 70 of the collection container 16.

[0086] It can be appreciated that several types of collection containers 16 can be used with the device 10 of the present disclosure. It can also be appreciated that the collection container 16 can be associated with a separate dispensing unit or the collection container 16 can include an integral dispensing portion for dispensing the blood sample 18 to a testing device. [0087] Referring to FIG. 1, use of a device 10 of the present disclosure having discrete components, e.g., a holder 12, a lancet housing or lancet 14, and a collection container 16, will now be described.

[0088] Referring to FIG. 1, first a desired finger 19 is cleaned and a holder 12 having an appropriate size for the desired finger 19 is selected and placed onto the finger 19 securely. Next, referring to FIG. 2A, a lancet housing 14 is connected to the port 26 of the holder 12. As discussed above, the lancet housing 14 is pushed into the port 26 of the holder 12 such that the engagement portion 56 of the lancet housing 14 is locked within the locking portion 32 of the holder 12. In this manner, the lancet housing 14 is securely connected and locked to the holder 12 such that the puncturing element 54 (FIG. 2A) of the lancet housing 14 can be activated to lance or puncture a sample source, e.g., a finger 19. With the lancet 14 connected to the port 26 of the holder 12, the lancet 14 is in communication with the finger 19.

[0089] When it is desired to activate the lancet 14 to lance the skin of a finger 19, the lancet 14 is pushed against a finger 19 to activate a retractable mechanism 58 (FIG. 2A) of the lancet 14 to lance a finger 19. The lancet 14 of the present disclosure consistently delivers correct lancing depth and a pre-defined lancing location, thus ensuring a sufficient sample volume.

[0090] After the finger 19 is lanced to create blood 18 flow from the finger 19, the lancet 14 is removed from the holder 12 and the collection container 16 is pushed into the port 26 of the holder 12. Referring to FIG. 2B, the collection container 16 is pushed into the port 26 of the holder 12 such that the container engagement portion 72 of the collection container 16 is locked within the locking portion 32 of the holder 12. In this manner, the collection container 16 is securely connected and locked to the holder 12 such that a blood sample 18 can safely flow from the finger 19 within the holder 12 to the collection cavity 70 of the collection container 16.

[0091] Referring to FIG. 1, with the collection container 16 properly secured to the holder 12 for collection of a blood sample 18, a user is able to repeatedly squeeze and release the tabs or wings 38 of the holder 12 to pump and/or extract blood 18 from a finger 19 until a desired amount of blood 18 is filled in a collection container 16. Advantageously, with the holder 12 placed onto a finger 19, the holder 12 does not constrict the blood flow and defines lancing and finger squeezing locations. The squeezing tabs or wings 38 provide a pre-defined range of squeezing pressure that is consistently applied throughout a finger 19. By doing so, the holder 12 provides a gentle controlled finger 19 massage that stimulates blood extraction and minimizes any potential hemolysis. [0092] For example, referring to FIG. 1, in one embodiment, the actuation portion 24 includes a contact member 34. With the actuation portion 24 in the first position, the contact member 34 is in a disengaged position, i.e., the contact member 34 is in the first position with respect to the sample source, e.g., the finger 19. With the actuation portion 24 in the second position, the contact member 34 is in an engaged position, i.e., the contact member 34 is in the second position and in applied pressure contact with a sample source, e.g., the finger 19, and the actuation portion 24 of the holder 12 is able to pump and/or extract a blood sample 18. For example, with the contact member 34 in the engaged position, the contact member 34 exerts a pressure on the sample source.

[0093] Once a desired amount of blood 18 is collected within the container 16, a blood collector portion 74 is detached from the collection device 10 in order to send a collected blood sample 18 to a diagnostic instrument and/or testing device. The blood collector portion 74 is sealed via the cap or septum 76 once removed from the collection device 10 to protectively seal the blood sample 18 within the collection cavity 70.

[0094] The devices of the present disclosure are compatible with any known testing device, whether the testing device is off-site or a POC testing device. Various POC testing devices are known in the art. Such POC 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 POC testing devices that receive a blood sample and test that blood for one or more physiological and biochemical states. There are many POC 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.

[0095] The collection container 16 may also contain a sample stabilizer, e.g., an anticoagulant, to stabilize a blood sample 18 and/or a component of a blood sample 18 disposed therein. The collection container 16 may 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. [0096] 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 holder 12 may 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.

[0097] 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 a lancet and capillary tube. The devices of the present disclosure eliminate blood exposure and prevents device reuse.

[0098] 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.

[0099] 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.

[0100] With reference to FIG. 3, according to one non-limiting embodiment or aspect of the present disclosure, a collector attachment 100 may be used in conjunction with the holder 12 for controlled dried blood spot collection. In one example, the collector attachment 100 may be a molded plastic. The collector attachment 100 may be pivotally attached to the holder 12 at a pivot point in the form of a recess 102 (see FIG. 5). The collector attachment 100 may include a protrusion 104 that may be snap fit into the recess 102 for the holder 12 to allow the collector attachment 100 to rotate or pivot relative to the holder 12. As shown in FIG. 5, in a first position, the collector attachment 100 may be held in a resting position in which the collector attachment 100 is not aligned with the second opening 28 of the holder 12. As shown in FIG. 6, in a second position, the collector attachment 100 may be held in an activated position in which the collector attachment 100 is aligned with the second opening 28 of the holder 12 to receive a biological sample from the patient’s finger held in the holder 12. During use of the device 10, the lancet 14 may be held in the second opening 28 of the holder 12 to puncture the patient’s finger. During this operation, the collector attachment 100 may be held in the first position so as not to interfere with the lancet 14. After the lancet 14 has been disconnected from the holder 12, the collector attachment 100 may be rotated or pivoted into the second position to operatively connect to the holder 12 and to assist in directing the biological sample from the patient’s finger to a collection tray, collection sheet 118, or collection container 16. In one example, the collector attachment 100 may be used in lieu of a collection container 16 to deposit biological samples from the patient’s finger directly to the collection tray or collection sheet 118. The collector attachment 100 allows for controlled dried blood spot collection, as well as collection into a microtainer with high sample-quality and low hemolysis. [0101] With reference to FIG. 3, according to one non-limiting embodiment or aspect of the present disclosure, the collector attachment 100 may define a channel 108 that extends through the collector attachment 100. In the second position, the channel 108 may be aligned with the second opening 28 of the holder 12 to receive the biological sample from the holder 12. The collector attachment 100 may also include a locking snap protrusion 110 that extends from an outer surface of the collector attachment 100. The locking snap protrusion 110 may snap into the locking portion 32 of the holder 12. The locking snap protrusion 110 may also be pressed inwardly to release the collector attachment 100 from the locking portion 32 to allow the collector attachment 100 to rotate or pivot into the first or resting position.

[0102] In one non-limiting embodiment or aspect of the present disclosure, the collector attachment 100 may include a blood pillar 112 defined in the channel 108. The blood pillar 112 may be a short post that is positioned near the first end or top end of the channel 108 to receive the first droplets of the biological sample that are received from the holder 12.

[0103] In one non-limiting embodiment or aspect of the present disclosure, at least a portion of the collector attachment 100 may include a blood flash window 114 formed integral therewith. The blood flash window 114 may form part of the collector attachment 100 and may be made of a transparent or semi-transparent material to allow a user to see the biological sample being directed into the collector attachment 100. As the biological sample is directed into the collector attachment 100, the biological sample may “flash” or splash into the blood flash window 114 indicating that the biological sample has begun to flow into and through the collector attachment 100. [0104] In one non-limiting embodiment or aspect of the present disclosure, the collector attachment 100 may also include a blood guide member 116 formed in the channel 108. The blood guide member 116 may extend from one end of the channel 108 to an opposing second end of the channel 108. In one example, the blood guide member 116 may extend past the second end or bottom end of the channel 108 such that the blood guide member 116 extends outside of the channel 108. The blood guide member 116 may be formed as a protrusion that extends from an inner surface of the channel 108. In another non-limiting embodiment or aspect of the present disclosure, the blood guide member 116 may be a recess defined in the inner surface of the channel 108. During use of the device 10, the blood guide member 116 is configured to receive and direct the biological sample from the holder 12 through the channel 108 and into the collection tray, collection sheet 118, or collection container 16, as desired. The biological sample adheres to the blood guide member 116 and flows along the blood guide member 116 in a predetermined direction to ensure accurate flow of the biological sample from the holder 12 to the collection tray, collection sheet 118, or the collection container 16. By extending the blood guide member 116 past the bottom end of the blood pillar 112, the biological sample will be directed along the blood guide member 116 and drip from the bottom end of the blood guide member 116. By dripping from the bottom end of the blood guide member 116, a user can more accurately deposit the biological sample in the collection tray, collection sheet 118, or collection container 16 when the holder 12 is not directly attached to a collection container 16. In one example, as shown in FIG. 10, the blood guide member 116 may be used to easily direct blood droplets onto a dried blood spot sample collection sheet 118 in a controlled manner while the user continues to produce blood by squeezing the holder 12.

[0105] With reference to FIGS. 11 and 12, according to one non-limiting embodiment or aspect of the disclosure, the blood guide member 116 is sized such that the blood guide member 116 permits direct connection of a microtainer or collection container 16 (in one example, an ETDA MAP (microtube for automated processing) tube) for direct collection of the biological sample into the sample collection container 16. In one example, the microtainer or collection container 16 may be pressed over the blood guide member 116 with a friction fit so the microtainer or collection container 16 may be easily removed from the blood guide member 116 after the microtainer or collection container 16 is filled with the biological sample by gently twisting the microtainer or collection container 16 without a blood splatter risk.

[0106] The collector attachment 100 allows for controlled collection of dried blood spot samples with simplification for the user in production of blood from a patient’s finger and then directing the blood sample to a target area, such as a collection sheet 118. The collector attachment 100 also allows for controlled collection of high quality (low hemolysis) blood samples 18 into a microtainer or collection container 16, such as a MAP tube. The versatility of the collector attachment 100 in concert with the holder 12 allows for standardization of capillary blood collection techniques for both dried blood spots and liquid blood samples in non-typical blood collection environments, such as at-home collection. The collector attachment 100 also assists in eliminating the need for skilled phlebotomist technique for blood collection from a patient’s finger with high-quality (low hemolysis) blood samples.

[0107] With reference to FIG. 13, in accordance with another non-limiting embodiment or aspect of the present disclosure, the collector attachment 100 may be used to control the deposit blood droplets onto a lateral flow test strip device 120.

[0108] With reference to FIG. 14, in accordance with another non-limiting embodiment or aspect of the present disclosure, the collector attachment 100 may include a collection media 122 that is removably inserted into the blood collection path. In some examples, the collection media 122 may be a sponge or a porous plug. The collection media 122 may block the blood collection path and then may be deposited in a collection container 16 after being sufficiently filled with a blood sample.

[0109] With reference to FIG. 15, in accordance with another non-limiting embodiment or aspect of the present disclosure, the collector attachment 100 may have a shortened blood guide member 116 that does not extend outside of the channel 108. In this example, a distal end of the blood guide member 116 may be sloped or angled.

[0110] With reference to FIG. 16, in accordance with another non-limiting embodiment or aspect of the present disclosure, the collector attachment 100 may have at least one channels or recesses 124, 126 defined in the inner surface of the channel 108. In one example, two channels or recesses 124, 126 may be defined in the inner surface of the channel 108. The channels or recesses 124, 126 may operate in a similar fashion as the blood guide member 116 to direct blood droplets from the collector attachment 100 to a blood collection device.

[0111] With reference to FIG. 17, in accordance with another non-limiting embodiment or aspect of the present disclosure, the collector attachment 100 may define a cut-out 128 in the channel 108 to act as a blood guide member for the blood droplets. In this example, the cut-out 128 acts similar to a fountain pen for dispensing droplets of blood onto or into a blood collection device.

[0112] With reference to FIG. 18, in accordance with another non-limiting embodiment or aspect of the present disclosure, it is also contemplated that the collector attachment 100 may have different widths for the blood path 130 to accommodate different volumes of blood flow. [0113] With reference to FIG. 19, in accordance with another non-limiting embodiment or aspect of the present disclosure, the collector attachment 100 may also define a thin-out exit point 132 at a distal end of the channel 108. The exit point 132 may be a recess or channel defined in the inner surface of the channel 108. The exit point 132 may assist in directing blood droplets from the collector attachment 100 to a blood collection device.

[0114] With reference to FIG. 20, in accordance with another non-limiting embodiment or aspect of the present disclosure, the collector attachment 100 may also include a counter-force touch point 134. The touch point 134 may be used to assist in securing and detaching the collector attachment 100 from a blood collection device.

[0115] 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.

Claims

THE INVENTION CLAIMED IS:

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; and a collector attachment removably and pivotally connected to the holder, the collector attachment comprising: a channel defined in the collector attachment and extending from a first end to an opposing second end of the collector attachment; and a blood guide member formed as a protrusion or recess in the channel.

2. The device of claim 1, further comprising a collection container removably connected to the collector attachment.

3. The device of claim 1, wherein the blood guide member extends past an end of the channel.

4. The device of claim 1, wherein the collector attachment further comprises a blood pillar provided adjacent the holder to receive initial droplets of blood directed from the holder.

5. The device of claim 1, wherein the collector attachment further comprises a blood flash window formed integral with the collector attachment.

6. The device of claim 1, wherein the collector attachment further comprises a locking snap protrusion that is configured to snap into a locking engagement with a locking portion on the holder.

7. The device of claim 1, wherein the collector attachment is held on the holder via a snap -fit connection.

8. The device of claim 1, wherein the blood guide member is configured to direct droplets of blood from the collector attachment onto a dried blood spot collection sheet or lateral flow test strip device.

9. The device of claim 1, wherein the collector attachment is configured to pivot between a first, resting position and a second, activated position.

10. The device of claim 9, wherein, in the first, resting position, the collector attachment is removed from an opening of the holder, and wherein, in the second, activated position, the collector attachment is aligned with the opening of the holder.

11. A collector attachment for a device for obtaining a blood sample, the collector attachment comprising: a channel defined in the collector attachment and extending from a first end to an opposing second end of the collector attachment; a blood guide member formed as a protrusion or recess in the channel; and a protrusion extending from the collector attachment and configured for engagement with a recess in a holder.

12. The collector attachment of claim 11, further comprising a collection container removably connected to the collector attachment.

13. The collector attachment of claim 11, wherein the blood guide member extends past an end of the channel.

14. The collector attachment of claim 11, wherein the collector attachment further comprises a blood pillar provided adjacent the holder to receive initial droplets of blood directed from the holder.

15. The collector attachment of claim 11, wherein the collector attachment further comprises a blood flash window formed integral with the collector attachment.

16. The collector attachment of claim 11, wherein the collector attachment further comprises a locking snap protrusion that is configured to snap into a locking engagement with a locking portion on the holder.

17. The collector attachment of claim 11, wherein the collector attachment is held on the holder via a snap-fit connection.

18. The collector attachment of claim 11, wherein the blood guide member is configured to direct droplets of blood from the collector attachment onto a dried blood spot collection sheet or lateral flow test strip device.

19. The collector attachment of claim 11, wherein the collector attachment is configured to pivot between a first, resting position and a second, activated position.

20. The collector attachment of claim 19, wherein, in the first, resting position, the collector attachment is removed from an opening of the holder, and wherein, in the second, activated position, the collector attachment is aligned with the opening of the holder.