Blood collection device with automated front-end functions

Abstract

A collection container for holding a blood sample, comprising a tube defining a collection cavity, a lid provided at one end of the collection cavity, and a cover member for covering at least a part of the side surface of the collection container near the lid, the cover member covering the outer peripheral surface of the collection container and configured to create a uniform and smooth surface around the circumference of the collection container.

Description

Technical Field

[0001] The present disclosure generally relates to devices for obtaining biological samples. More specifically, the present disclosure relates to an integrated finger-based capillary blood sampling device that can incise and constrict a finger in a controlled manner to collect, stabilize, and dispense a blood sample.

Background Art

[0002] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 344,381, titled "Blood Collection Device with Front - End Automation Features," filed on May 20, 2022, the entire disclosure of which is hereby incorporated by reference in its entirety.

[0003] Devices for obtaining and collecting biological samples such as blood samples are commonly used in the medical industry. One type of blood collection commonly performed in the medical field is peripheral blood collection, which is often done to collect a blood sample for testing purposes. In certain diseases such as diabetes, for example, a patient's blood needs to be regularly tested to monitor the patient's blood glucose level. Additionally, test kits such as cholesterol test kits often require a blood sample for analysis. Blood collection typically involves pricking a finger or other suitable body site to obtain a blood sample. Typically, the amount of blood required for such tests is relatively small, and a small puncture or incision usually provides an adequate amount of blood for these tests. Various types of lancet devices have been developed for piercing a patient's skin to obtain a peripheral blood sample.

[0004] Many different types of lancet devices are commercially available for hospitals, clinics, doctor's offices, etc., as well as for individual consumers. Such devices typically include a pointed member such as a needle, or a sharp member such as a blade, which is used to quickly create a puncture wound or make an incision in the patient's skin to cause a small amount of blood to flow out. To simplify peripheral blood collection, lancet devices have evolved into automatic devices that puncture or incise the patient's skin upon actuation of a trigger mechanism. In some devices, the needle or blade is held in a standby position until it is triggered by the user. When triggered, the needle or blade punctures or incises the patient's skin, such as the skin of a finger. In many cases, a spring is incorporated into the device to provide the "automatic" force necessary to puncture or incise the patient's skin.

[0005] One type of contact-actuated lancet device characterized by automatically protruding or retracting a piercing element or an incision element from the device is U.S. Patent No. 9,380,975 owned by Becton, Dickinson and Company, the assignee of the present application. This lancet device includes a housing and a lancet structure having a piercing element. The lancet structure is adapted to move between a holding position or a pre-activated position where the piercing element is held within the housing and a piercing position where the piercing element extends through the front end of the housing. The lancet device includes a drive spring disposed within the housing for biasing the lancet structure toward the piercing position and a retaining hub for holding the lancet structure in the retracted position against the biasing force of the drive spring. The retaining hub includes a pivot lever that interferes with and engages the lancet structure. An actuator within the housing pivots the lever, thereby moving the lancet structure toward the rear end of the housing, at least partially compressing the drive spring, and releasing the lever from interference engagement with the lancet structure. The received blood sample is then collected and / or tested. This testing can be performed by a point-of-care (POC) testing device, or the blood sample can be collected and sent to a testing facility.

[0006] The use of a lancet device for peripheral blood collection can be complex and requires a high skill level for healthcare workers performing the blood collection procedure. The multi-step nature of the peripheral blood collection process can introduce some variability that may cause sample quality issues such as hemolysis, inadequate sample stabilization, and microthrombi. The use of a lancet device to obtain a blood sample can lead to some variability resulting in the collection of a peripheral blood sample, including but not limited to holding the lancet still during the test, obtaining sufficient blood flow from the puncture site, collecting enough blood, preventing clotting, etc. Some of the most common causes of operator variability are: (1) inadequate cleaning of the puncture site and removal of the first drop, which can result in a contaminated sample; (2) inconsistent puncture location and depth, which can result in an inadequate amount of sample or a high interstitial fluid content; (3) inconsistent squeezing technique and excessive pressure near the puncture site when promoting blood extraction (e.g., blood squeezing), which can result in a hemolyzed sample; (4) variations in transfer contact surfaces and collection techniques, which can result in a hemolyzed or contaminated sample; and (5) inadequate mixing of the sample with an anticoagulant, which can result in microthrombi.

[0007] During the assembly and / or use of the blood collection device, an automated arm can be used to pick up the blood collection device and position it at a desired location. Features on the blood collection device, including a protruding latch on the cap, a protruding living hinge on the cap, and / or a protruding U-shaped rib for removing the cap, can cause problems with pick-and-place automated arms. Accordingly, there is a current need in the art for a blood collection device that includes a front-end function to improve the automatic movement and fixation of the blood collection device to a pair of automated arms.

Prior Art Documents

Patent Documents

[0008]

Patent Document 1

SUMMARY OF THE INVENTION

[0009] According to one aspect of the present disclosure, a collection container for holding a blood sample may include a tube having an open end, a closed bottom end, and side walls extending therebetween defining a collection cavity, a lid removably engagable with the open end of the tube, and a cover member for covering at least a portion of the outer surface of the tube proximate the lid, the cover member circumferentially covering at least a portion of the outer side surface of the collection container and configured to create a uniform smooth surface around the circumference of the collection container.

[0010] According to one aspect of the present disclosure, the lid may include a release tab that releases the collection container from a blood sampler attachment when pressed. The lid may be connected to the collection container via a living hinge. The cover member may be integrally formed with the collection container. The cover member may include a coloring agent for identifying the cover member. The coloring agent may be yellow. The diameter of the lid may be larger than the diameter of the tube. An extension portion may be removably attached to the lower end of the tube.

[0011] According to one aspect of the present disclosure, a collection container for holding a blood sample is a tube having an open end, a closed bottom end, and side walls extending therebetween defining a collection cavity, the side walls defining an outer side surface, the tube including a lid removably engagable with the open end of the tube, and a plurality of axial ribs configured to cover at least a portion of the outer side surface of the tube proximate the lid, the plurality of axial ribs circumferentially covering at least a portion of the outer side surface and configured to create a more uniform band-shaped smooth surface around the circumference of the collection container.

[0012] According to one aspect of the present disclosure, the lid may include a release tab that, when pressed, releases the collection container from the blood sampler attachment. The lid may be connected to the collection container via a living hinge. A plurality of axial ribs may be integrally formed with the collection container. The plurality of axial ribs may include a coloring agent for identifying the plurality of axial ribs. The coloring agent may be yellow. The diameter of the lid may be larger than the diameter of the tube. The extension portion may be removably attached to the lower end of the tube.

[0013] According to one aspect of the present disclosure, a collection container for holding a blood sample is a tube having an open end, a closed bottom end, and a side wall extending therebetween that defines a collection cavity, the side wall defining an outer side surface, the tube, a lid removably engagable with the open end of the tube, and an extension portion removably engagable with a portion of the tube, the extension portion extending over the closed bottom end and configured to increase the overall length of the tube. The extension portion can be removably engaged with the tube via a friction fit, an annular snap fit connection, a threaded connection, a bayonet connection, or an ultrasonic welding connection.

[0014] According to one aspect of the present disclosure, a collection container for holding a blood sample is a tube having an open end, a closed bottom end, and a side wall extending therebetween that defines a collection cavity, the side wall defining an outer side surface, the tube, a lid removably engagable with the open end of the tube, a cover member for covering at least a portion of the outer side surface of the tube proximate to the lid, and a plurality of ribs disposed on the cover member and configured to cover at least a portion of the cover, the cover and the plurality of ribs being configured to circumferentially cover at least a portion of the outer surface to create a more uniform band-like smooth surface around the collection container.

[0015] The present invention is further defined in the following clauses.

[0016] Clause 1: A collection container for holding a blood sample, the container being a tube having an open end, a closed bottom end, and side walls extending therebetween defining a collection cavity, the side walls defining an outer side surface, a lid removably engagable with the tube, and a cover member for covering at least a portion of the outer side surface of the tube proximate the lid, the cover member configured to circumferentially cover at least a portion of the outer side surface of the collection container and create a uniform smooth surface around the circumference of the collection container, the collection container comprising the cover member.

[0017] Clause 2: The collection container according to clause 1, wherein the lid includes a release tab that releases the collection container from a blood collection device attachment when pressed.

[0018] Clause 3: The collection container according to clause 1 or clause 2, wherein the lid is connected to the collection container via a living hinge.

[0019] Clause 4: The collection container according to any one of clauses 1 to 3, wherein the cover member is integrally formed with the collection container.

[0020] Clause 5: The collection container according to any one of clauses 1 to 4, wherein the cover member includes a coloring agent for identifying the cover member.

[0021] Clause 6: The collection container according to clause 5, wherein the coloring agent is yellow.

[0022] Clause 7: The collection container according to any one of clauses 1 to 6, wherein the diameter of the lid is larger than the diameter of the tube.

[0023] Clause 8: The collection container according to any one of clauses 1 to 7, further comprising an extension portion removably attached to the bottom end of the tube.

[0024] Clause 9: A collection container for holding a blood sample, the tube having an open end, a closed bottom end, and side walls extending therebetween defining a collection cavity, the side walls defining an outer side surface, a lid removably engagable with the tube, and a plurality of axial ribs configured to cover at least a portion of the outer side surface of the tube proximate the lid, the plurality of axial ribs configured to circumferentially cover at least a portion of the outer side surface and create a uniform band-shaped smooth surface around the circumference of the collection container, the collection container comprising the plurality of axial ribs.

[0025] Clause 10: The collection container according to clause 9, wherein the lid includes a release tab that, when pressed, releases the collection container from a blood sampler attachment.

[0026] Clause 11: The collection container according to clause 9 or clause 10, wherein the lid is connected to the collection container via a living hinge.

[0027] Clause 12: The collection container according to any one of clauses 9 to 11, wherein the plurality of axial ribs are integrally formed with the collection container.

[0028] Clause 13: The collection container according to any one of clauses 9 to 12, wherein the plurality of axial ribs include a colorant that identifies the plurality of axial ribs.

[0029] Clause 14: The collection container according to clause 13, wherein the colorant is yellow.

[0030] Clause 15: The collection container according to any one of clauses 9 to 14, wherein the diameter of the lid is greater than the diameter of the tube.

[0031] Clause 16: The collection container according to any one of clauses 9 to 15, further comprising an extension portion removably attached to the bottom end of the tube.

[0032] Clause 17: A collection container for holding a blood sample, the container being a tube having an open end, a closed bottom end, and side walls extending therebetween that define a collection cavity, the side walls defining an outer side surface, a lid removably engagable with the tube, and an extension portion removably engagable with a portion of the tube, the extension portion extending over the closed bottom end and increasing the overall length of the tube.

[0033] Clause 18: The collection container according to clause 17, wherein the extension portion is removably engagable with the tube via a friction fit, an annular snap-fit connection, a screw connection, a bayonet connection, or an ultrasonic welding connection.

[0034] Clause 19: A collection container for holding a blood sample, the container comprising a tube having an open end, a closed bottom end, and side walls extending therebetween that define a collection cavity, the side walls defining an outer side surface, a lid removably engagable with the open end of the tube, a cover member for covering at least a portion of the outer side surface of the tube proximate the lid, and a plurality of ribs disposed on the cover member and configured to cover at least a portion of the lid, the cover and the plurality of ribs being configured to circumferentially cover at least a portion of the outer surface to create a more uniform circumferential smooth surface around the collection container.

Brief Description of the Drawings

[0035]

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Figure 10A

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DETAILED DESCRIPTION OF THE INVENTION

[0036] The following description is provided to enable one of ordinary skill in the art to make and use the described embodiments contemplated for carrying out the present invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to one of ordinary skill 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.

[0037] For purposes of explanation hereinafter, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and derivatives thereof shall relate to the present invention as oriented in the drawings. However, it will be understood that the present invention may contemplate various alternative variations unless explicitly specified to the contrary. It should also be understood that the specific devices and processes shown in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Therefore, the specific dimensions and other physical characteristics associated with the embodiments disclosed herein should not be considered limiting.

[0038] The present disclosure is directed to a device for obtaining a biological sample, such as a capillary blood sampling device, that meets the above needs and has the ability to incise and constrict a finger, collect a sample, stabilize the sample, and then dispense the sample in a controlled manner. This device also simplifies and rationalizes capillary blood sampling by eliminating variations in the workflow commonly associated with low sample quality, including hemolysis and microthrombi.

[0039] Blood collection is basically driven by a pressure-driven flow. The device or technique is either to reduce the extravascular pressure (vacuum-driven flow) or to increase the intravascular pressure. Both approaches increase the difference between the vascular pressure and the external pressure, and increase the flow rate from inside the blood vessel to the outside where the collection container is present. Soft tissues (e.g., fat, skin, and muscle tissue) are perfused with blood, while hard tissues and joints are either poorly perfused or too mechanically stable, so the position of constriction can also be important for compression without causing pain to the patient.

[0040] Red blood cells (RBCs) undergo hemolysis during collection. Hemolysis (red blood cell destruction) contaminates the sample for diagnostic analysis by causing the cell contents to flow out into the serum, coloring the serum red by hemoglobin, and interfering with the colorimetric reaction. The amount of hemolysis during blood collection depends on cell destruction via shear due to flow rate and flow path, and hemolysis due to pressure that damages cells by physical compression of tissues and blood vessels. Therefore, hemolysis can be controlled by ensuring that the applied pressure and flow rate are not too high at any position of the finger being compressed.

[0041] The present disclosure includes a self - contained and fully integrated finger - based capillary blood collection device that has the ability to incise and collect and stabilize a large - volume capillary blood sample, e.g., up to 500 microliters or more. This device simplifies and rationalizes the collection of a large amount of capillary blood by eliminating the steps and variations in the workflow generally associated with sample quality degradation, such as hemolysis, micro - thrombus, and patient discomfort. The device consists of a retractable incision mechanism capable of incising the finger and associated blood flow paths that ensure the adhesion and transfer of capillary blood from the incised finger site to the collection container. This device also includes a holder that can periodically constrict to stimulate, i.e., pump, blood flow from the finger, and an anticoagulant deposited in the flow path or collection container to stabilize the collected sample.

[0042] According to one design, the device can consist of individual components such as a holder, a lancet, and a collection container. According to another design, the lancet and the collection container can be integrated into one device and used with a holder. According to yet another design, the holder, the lancet, and the collection container can be integrated into a single system. Any of these structures is envisioned to be used as a self - contained disposable device and / or in combination with an external power source for pain relief control. The capillary blood sampling device can function as a platform for various capillary collection containers from small tubes to capillary dispensers, as well as for an on - board plasma separation module. This functionality extends the flexibility of the product for various applications such as dispensing into a point - of - care (POC) cartridge and transferring into small blood collection tubes that can be used in a centrifuge or an analytical device.

[0043] Referring to FIGS. 1 and 2A, in an exemplary embodiment, the device 10 of the present disclosure includes separate components, such as a holder 12 (as shown in FIG. 1), a lancet housing or lancet 14 (as shown in FIG. 2A), and a collection container 16 (as shown in FIG. 2B). In another exemplary embodiment, the semi - integrated device of the present disclosure may include an at - angle flow and may include an integrated lancet housing and collection container that can be connected to a separate holder. In another exemplary embodiment, the semi - integrated device of the present disclosure may have an in - line flow and may include an integrated lancet housing and collection container that can be connected to a separate holder. In another exemplary embodiment, the integrated device of the present disclosure may have an at - angle flow and may include an integrated holder, lancet housing, and collection container. In another exemplary embodiment, the integrated device of the present disclosure may have an in - line flow and may include an integrated holder, lancet housing, and collection container.

[0044] Referring to FIG. 1, an exemplary embodiment of a holder 12 of the present disclosure that can receive a sample source for supplying a biological sample such as a blood sample 18, for example, a finger 19, is shown and described. The holder 12 of the present disclosure generally includes a finger receiving portion 20 having a first opening 22 (FIG. 1), an actuating 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 fixing the finger 19 within the holder 12. The finger end guard 30 further assists in ensuring that the patient's finger 19 is disposed at an appropriate position within the finger receiving portion 20 such that pressure applied to the patient's finger 19 results in appropriate blood flow.

[0045] The first opening 22 of the finger receiving portion 20 is configured to receive a sample source for supplying a biological sample such as a blood sample 18, for example, a finger 19. It can be understood that the sample source can include other portions of the body that can fit within the first opening 22. The port 26 communicates with the finger receiving portion 20. For example, with the finger 19 received within the holder 12, the port 26 communicates with a portion of the finger 19. The holder 12 of the present disclosure can be sized to accommodate any finger size.

[0046] The second opening 28 of the port 26 is configured to receive the lancet housing 14 and the collection container 16, as will be 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.

[0047] In one embodiment, the actuating part 24 is movable between a first position where the holder 12 defines a first diameter and a second position where the holder 12 defines a second diameter, and the second diameter is smaller than the first diameter. In one embodiment, the actuating part 24 is movable between a first position where the holder 12 defines a first elliptical shape and a second position where the holder 12 defines a second elliptical shape, and the first elliptical shape is different from the second elliptical shape. In this way, with the holder 12 in the second position where the diameter is reduced, a part of the holder 12 contacts the sample source, and the actuating part 24 of the holder 12 can pump and / or extract the blood 18, as will be described in more detail below.

[0048] Referring to FIG. 1, in one embodiment, the actuating part 24 includes a contact member 34. With the actuating part 24 in the first position, the contact member 34 is in a disengaged position, that is, the contact member 34 is provided at a first position relative to a sample source, such as the finger 19, so that the contact member 34 can contact it slightly. When the actuating part 24 is in the second position, the contact member 34 is in an engaged position, that is, the contact member 34 is provided at a second position relative to the sample source, such as the finger 19, so that the contact member 34 is in pressure contact with the finger 19, and the actuating part 24 of the holder 12 can suck out and / or extract the blood 18. For example, when the contact member 34 is in the engaged position, the contact member 34 applies pressure to the sample source.

[0049] Referring to FIG. 1, in one embodiment, the actuating portion 24 includes a pump member 36 for applying pressure to a sample source, e.g., finger 19. In one embodiment, the pump member 36 consists of a pair of opposing tabs or wings 38. In such an embodiment, each tab 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 the user to squeeze the wings 38 between a first position (passive state) and a second position (active state). By using the tabs or wings 38 to draw blood 18 from the patient's finger 19, hemolysis can be minimized while maintaining an appropriate flow of blood from the patient's finger 19. The rest position and hinge of the wings 38 are designed to maintain contact and hold with the smallest patient finger that can fit within the holder 12 while bending to accommodate the largest patient finger within the holder 12 without blood occlusion.

[0050] Advantageously, the holder 12 of the present disclosure allows the user to repeatedly squeeze and release the wings 38 to suck out and / or extract blood 18 from the finger 19 until a desired amount of blood 18 has filled the collection container 16. The wings 38 are configured to gently contact various patient finger sizes that can be used with the holder 12 and bend to hold the holder 12 on the patient's finger 19.

[0051] Advantageously, with the holder 12 attached to the finger 19, the holder 12 defines an incision and a constriction position without restricting blood flow. The constriction tabs or wings 38 provide a predetermined range of constriction pressure that is consistently applied across the entire finger 19. By doing so, the holder 12 provides a gently controlled finger massage that stimulates blood extraction and minimizes potential hemolysis.

[0052] Referring to FIG. 1, in one embodiment, the holder 12 includes a stability extension 40. This provides additional support for securely mounting the holder 12 on the finger 19. In one embodiment, the finger receiving portion 20 generally forms a C-shaped member and includes a plurality of inner grip members for providing additional grip and support for securely placing the holder 12 on the finger 19. The stability extension 40 assists in maintaining contact with the patient's finger 19 while avoiding the blood supply and finger joints of the patient's finger 19 during use of the holder 12.

[0053] 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.

[0054] The device 10 for obtaining a blood sample 18 of the present disclosure includes a lancet housing or lancet 14 removably connectable to the port 26 of the holder 12. In one embodiment, the lancet housing 14 includes an inlet or opening 50, an interior 52, a piercing element 54, an engagement portion 56, a retractable mechanism 58, and a drive spring 60. In one embodiment, the piercing element 54 is movable between a pre-activated position in which the piercing element 54 is held within the interior 52 of the lancet housing 14 and a piercing position in which at least a portion of the piercing element 54 extends through the inlet 50 of the lancet housing 14 and incises a portion of the finger 19.

[0055] In one embodiment, the lancet 14 of the present disclosure is a contact-activated lancet and may be configured in accordance with the features disclosed in Patent Document 1 filed on May 6, 2005, entitled "Contact Activated Lancet Device" and assigned in common with the present application, the entire disclosure of which is hereby expressly incorporated by reference herein.

[0056] In one embodiment, the lancet housing 14 can 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.

[0057] Referring to FIG. 2A, in one embodiment, when the holder 12 and the lancet housing 14 are 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 engaging 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 engaging portion 56 of the lancet housing 14 is fixed within the locking portion 32 of the holder 12. In this way, the lancet housing 14 is firmly connected and locked to the holder 12 so that the piercing element 54 of the lancet housing 14 can be actuated to incise or pierce a sample source, such as a finger 19. In some embodiments, the port 26 of the holder 12 includes a plurality of ribs for fixing and locking the lancet 14 or the collection container 16 within the port 26.

[0058] To operate the lancet 14, the lancet 14 is pressed against the finger 19 to operate the retractable mechanism 58 of the lancet 14 and incise the finger 19. The lancet 14 of the present disclosure consistently provides a correct incision depth and a predefined incision position, ensuring a sufficient sample volume.

[0059] In one embodiment, the lancet 14 includes a drive spring 60 disposed within the interior 52 of the lancet housing 14 to bias the piercing element 54 towards the piercing position. After piercing, the piercing element 54 is immediately retracted and securely fixed within the interior 52 of the lancet housing 14.

[0060] In one embodiment, the lancet 14 of the present disclosure is used to incise the skin of the finger 19, and then the blood sample 18 is drawn into the collection container 16 as described in further detail below.

[0061] In one embodiment, the lancet housing 14 of the present disclosure is used to incise the skin of the finger 19 along an incision path, and then the blood sample 18 flows at an angle to the incision path along a blood flow path as described in further detail below.

[0062] In one embodiment, the lancet 14 can include a hollow needle. In such an embodiment, the lancet housing 14 of the present disclosure is used to incise the skin of the finger 19 along an incision path, and then the blood sample 18 (shown in FIG. 2B) flows through the hollow needle along a parallel blood flow path.

[0063] As shown in FIG. 2B, the device 10 for obtaining the blood sample 18 of the present disclosure includes a collection container 16 removably connectable to the port 26 of the holder 12. In one configuration, the collection container 16 can be a collection container of any size, such as a microtube, adapted to fit within the profile of a standard tube collection container of 13×75 mm, 13×100 mm, or 16×100 mm. The collection container 16 defines a collection cavity 70 for receiving the blood sample 18, a container engagement portion 72, a blood collection portion 74, and a cap or septum 76. When the desired amount of blood 18 is collected into the container 16, the blood collection portion 74 is detached from the collection device 10 to send the collected sample 18 to a diagnostic device and / or an inspection device. When the blood collection portion 74 is removed from the collection device 10, it is sealed via the cap or septum 76 to protectively seal the blood sample 18 within the collection cavity 70.

[0064] In one embodiment, the collection container 16 can be a component separate 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 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.

[0065] In one embodiment, the holder 12 and the collection container 16 are separate components, and the container 16 is removably connectable to the port 26 of the holder 12. In such an embodiment, the container 16 includes a container engagement portion 72. In one embodiment, the container 16 is pushed into the port 26 of the holder 12 such that the container engagement portion 72 of the container 16 is locked within the lock portion 32 of the holder 12. In this way, the container 16 is securely connected to and locked to the holder 12 so that the blood sample 18 can flow safely from the finger 19 within the holder 12 to the collection cavity 70 of the container 16.

[0066] It will 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 that the collection container 16 can include an integral dispensing portion for dispensing the blood 18 to a test device. The collection container 16 can be a stand-alone container or can include a false bottom to enable compatibility with instruments with a conventional larger volume collection container. Optionally, the bottom of the collection container 16 can be hemispherical or can include a partially rounded portion.

[0067] Next, with reference to FIG. 1, the use of the device 10 of the present disclosure having individual components, such as the holder 12, the lancet housing or lancet 14, and the collection container 16, will be described.

[0068] Referring to FIG. 1, first, the desired finger 19 is cleaned, and a holder 12 having an appropriate size for the desired finger 19 is selected and firmly attached to the finger 19. Next, referring to FIG. 2A, the lancet housing 14 is connected to the port 26 of the holder 12. As described above, the lancet housing 14 is pushed into the port 26 of the holder 12 such that the engaging portion 56 of the lancet housing 14 is locked within the locking portion 32 of the holder 12. In this way, the lancet housing 14 is firmly connected and locked to the holder 12 so that the piercing element 54 (FIG. 2A) of the lancet housing 14 can be actuated to incise or pierce a sample source, e.g., the finger 19. With the lancet 14 connected to the port 26 of the holder 12, the lancet 14 communicates with the finger 19.

[0069] If it is desired to actuate the lancet 14 to incise the skin of the finger 19, the lancet 14 is pressed against the finger 19 to actuate the retractable mechanism 58 (FIG. 2A) of the lancet 14 to incise the finger 19. The lancet 14 of the present disclosure consistently provides an accurate incision depth and a pre-defined incision position, ensuring a sufficient sample volume.

[0070] After piercing the finger 19 to allow blood 18 to flow out of the finger 19, the lancet 14 is removed from the holder 12, and a collection container 16 is pushed into the port 26 of the holder 12. Referring to FIG. 8, the container 16 is pushed into the port 26 of the holder 12 such that the container engaging portion 72 of the container 16 is fixed within the locking portion 32 of the holder 12. In this way, the container 16 is securely connected and locked to the holder 12 so that the blood sample 18 can flow safely from the finger 19 within the holder 12 into the collection cavity 70 of the container 16.

[0071] Referring to FIG. 1, with the container 16 properly fixed to the holder 12 for collecting the blood sample 18, the user can repeatedly squeeze and release the wings 38 of the holder 12 to suck out and / or extract the blood 18 from the finger 19 until the desired amount of blood 18 fills the collection container 16. Advantageously, when the holder 12 is attached to the finger 19, the holder 12 defines the incision and finger constriction positions without restricting blood flow. The constriction tab or wing 38 provides a defined range of constriction pressure that is uniformly applied across the entire finger 19. By doing so, the holder 12 provides a gently controlled massage of the finger 19 that stimulates blood extraction and minimizes potential hemolysis.

[0072] For example, referring to FIG. 1, in one embodiment, the actuating portion 24 includes a contact member 34. When the actuating portion 24 is in the first position, the contact member 34 is in the disengaged position, that is, the contact member 34 is in the first position relative to the sample source, for example, the finger 19. When the actuating portion 24 is in the second position, the contact member 34 is in the engaged position, that is, the contact member 34 is in the second position and is in pressure contact with the sample source, for example, the finger 19, and the actuating portion 24 of the holder 12 can suck out and / or extract the blood 18. For example, when the contact member 34 is in the engaged position, the contact member 34 applies pressure to the sample source.

[0073] When the desired amount of blood 18 has been collected into the container 16, the blood collection unit 74 is detached from the collection device 10 to send the collected sample 18 to a diagnostic device and / or an inspection device. When the blood collection unit 74 is removed from the collection device 10, it is sealed via a cap or partition 76 to protectively seal the blood sample 18 within the collection cavity 70.

[0074] The devices of the present disclosure are compatible with any known test device, whether the test device is off-site or a point-of-care test device. Various point-of-care test devices are known in the art. Such point-of-care test devices include test strips, slide glasses, diagnostic cartridges, or other test devices for testing and analysis. Test strips, slide glasses, and diagnostic cartridges are point-of-care test instruments that receive a blood sample and test the blood for one or more physiological and biochemical conditions. There are numerous point-of-care devices that employ a cartridge-based structure and can analyze a very small amount of blood beside the bed without the need to send the sample to a laboratory for analysis. This can save time in obtaining results in the long run, but creates different challenges than a highly routine laboratory environment. An example of such a test cartridge is the Abbott i-STAT® test cartridge. Test cartridges such as the i-STAT® cartridge can be used to test for various conditions including the presence of chemicals and electrolytes, hematology, blood gas concentrations, coagulation, or cardiac markers. Test results using such cartridges are provided quickly to clinicians.

[0075] The collection container 16 may also include a sample stabilizer, such as an anticoagulant, to stabilize the blood sample 18 and / or the components of the blood sample 18 disposed therein. The collection container 16 may also include at least one fill line corresponding to a predetermined amount of sample. The collection container can also display / measure the amount of blood collected.

[0076] Any device for obtaining a blood sample of the present disclosure can be used as a self - contained disposable device and / or in association with an external power source for pain reduction control. For example, a part of the holder 12 may include an embedded electrode that receives a signal from an external pain control module and provides at least one of heat, vibration, transcutaneous electrical nerve stimulation (TENS) for pain reduction control. The devices for obtaining a blood sample of the present disclosure may include various options for onboard plasma separation. The devices for collecting 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 collecting a blood sample of the present disclosure may also include on - board diagnostic feedback at the time of collection. The devices for obtaining a blood sample of the present disclosure may enable dual collection, for example, collecting two samples into two separate containers, using multiple collection ports to collect multiple samples from the same source, and processing the sample with different sample stabilizers such as anticoagulants.

[0077] The devices for obtaining a blood sample of the present disclosure greatly simplify the collection of a large volume of capillary blood from a finger compared to conventional capillary sampling using a lancet and capillary tube, and do not require advanced technology. The devices of the present disclosure eliminate blood exposure and prevent reuse of the device.

[0078] The devices for collecting a blood sample of the present disclosure simplify, streamline, and rationalize the collection process. This is all achieved by a self - contained closed - system device that provides the functions of incision, blood extraction, stabilization, and containment in one unit after being attached to the finger.

[0079] The devices for collecting a blood sample of the present disclosure may be associated with a self - contained unit that provides an automatic pump, a controlled finger constriction, and automatic sample labeling and processing.

[0080] Referring to FIGS. 3 - 5, according to one embodiment of the present disclosure, a collection container separation member 80 is shown and will be described in detail. The collection container separation member 80 can be an intuitive release mechanism that allows a user to press - release the member 80 to release the collection container 16 from the blood sampler attachment 82 removably connected to the holder 12. The collection container separation member 80 provides the user with a tactile feedback indicating that the collection container 16 has been removed from the blood sampler attachment 82.

[0081] Referring to FIG. 6, according to one embodiment of the present disclosure, the collection container separation member 80 can include a release tab 84 that allows a user to cut the collection container 16 from the blood sampler attachment 82. In one embodiment, the release tab 84 can be pushed inward by the user to release the collection container 16 from the blood sampler attachment 82 after the blood sample 18 has been withdrawn from the patient. When the release tab 84 is pushed by the user, the collection container 16 can be pulled away from the blood sampler attachment 82. The release tab 84 can include a latch mechanism that prevents contamination of the surface contacting the blood sample 18 within the collection container 16. Since the release tab 84 must be actively engaged by the user to release the collection container 16, the release tab 84 prevents accidental release of the collection container 16 from the blood sampler attachment 82. In one embodiment, the release tab 84 can have a bright color or pattern that visually identifies to the user that the release tab 84 must be pushed to release the collection container 16 from the blood sampler attachment 82. In one embodiment, the release tab 84 functions as a "lever" to unlock the collection container separation member 80. In one embodiment of the present disclosure, the blood sampler attachment 82 can also protect the sealing surface of the lid 86 from contamination until the collection container 16 is removed and the lid 86 closes over the collection container 16. In one embodiment of the present disclosure, the latch mechanism of the lid 86 can be blocked by the blood sampler attachment 82 and provides an anti - tampering mechanism for identifying tampering of the lid 86.

[0082] Referring to FIG. 7, according to one non-limiting aspect or example of the present disclosure, the blood collection device 10 may also include features that assist in securing or picking up the blood collection device 10 by an automated machine or device. Due to some features of the blood collection device 10, obstacles or obstructions may occur in the arm of the automatic pick-up machine attempting to pick up the blood collection device 10. Therefore, a cover member such as the cover 100 may be provided around the outer periphery of the collection container 16 to create a uniform radial surface for gripping and / or holding the collection container 16 during pick-and-place automation. The cover 100 may extend around the entire outer periphery of the upper portion of the collection container 16. In one example, the cover 100 may be an overmold of a rigid plastic or semi-rigid elastomer material. The cover 100 is configured to improve the ability of the arm or gripper of an automated machine or device to grip the collection container 16 for transportation or repositioning. The cover 100 may be formed as a single monolithic piece or as a plurality of pieces connected to each other. The cover may be opaque in color to assist in tube recognition. The cover may also provide uniform axial symmetry around the circumference of at least a portion of the outer surface of the collection container 16, such as adjacent to the open end.

[0083] Referring to FIG. 8, according to one non-limiting aspect or example of the present disclosure, the blood collection device 10 may include alternative features that assist in securing or picking up the blood collection device 10 by an automated machine or device. Instead of the cover 100 described above, a plurality of axial ribs 102 may be disposed around the circumference of the upper portion of the collection container 16 to create a uniform radial surface for gripping and / or holding the collection container 16 during pick-and-place automation. The plurality of axial ribs 102 may extend around the entire outer circumference of the collection container 16. The longitudinal axis of each axial rib 102 may extend parallel to the longitudinal axis of the collection container 16. The axial ribs 102 ensure that there are no one or two protruding edges on the collection container 16 and instead include a more uniform and smooth surface. The axial ribs 102 are configured to fill the negative space under various protrusions on the collection container 16, including the negative space under the lid latch and living hinge. The axial ribs 102 may be made of a rigid plastic or semi-rigid elastomeric material. The axial ribs 102 may be provided on the collection container 16 during the primary molding of the collection container 16 or may be provided as an overmolded feature on the collection container 16. In another example, instead of the axial ribs 102, a plurality of rings may be disposed along the length of the upper portion of the collection container 16 to create a more uniform and smooth surface that can be more easily gripped by the arm or gripper of an automated pick-and-place machine or device. The rings may be radial rings that extend around the outer circumference of the upper portion of the collection container 16.

[0084] Referring to FIGS. 9A and 9B, according to one non-limiting embodiment or example, the collection container 16 may include additional or alternative features to assist in identifying the collection container 16 for the vision system of a pick-and-place automation machine or device. In some embodiments, the vision system may be operated to determine a specific color of the cap of the collection container 16 to ensure that the desired collection container 16 is being gripped and / or picked up. This determination of the cap color is an important front-end step for the successful automation of the pick-and-place machine or device. To assist in ensuring that a uniform color is presented to the vision system for the optical recognition of the collection container type, the cover 100 of the collection container 16 may be formed or manufactured with a colorant to match the surrounding portion of the collection container 16. In some examples, due to the various protruding angled features of the collection container 16, a uniform color distribution is not achieved at the top of the collection container 16. Thus, by using a colorant on the cover 100, a larger uniform area of the desired colorant is presented to ensure that the vision system can optically recognize the colorant within the collection container 16. In one example, the colorant can be molded in-color with the existing cap body of the collection container 16 or on a similarly colored cap body. In one example shown in FIG. 9B, the entire cover 100 and the entire cap body of the collection container 16 can be made of the same colorant. In one example, the cover 100 and the cap body can be made of a yellow colorant. The yellow colorant can be a plain yellow, or a different shade or yellow translucency. Also contemplated is that colors other than yellow can be used with the cover 100 and the cap body. As shown in FIGS. 10A and 10B, according to one non-limiting embodiment or aspect of the present disclosure, the axial ribs 102 of the collection container 16 may also include a colorant, such as a yellow colorant, to provide a uniform color distribution across the cap body of the collection container 16. The color of the axial ribs 102 can be matched to the color of the surrounding cap body.

[0085] Referring to FIGS. 11 and 12, according to one non-limiting aspect or example of the present disclosure, additional features may be included on the collection container 16 to assist in the interaction with pick-and-place machines or devices. In some pick-and-place machines or devices, the overall tube height of the collection container 16 must be achieved to fit and interact properly with the pick-and-place machine or device. Further, some pick-and-place machines or devices require a single wall of plastic on the collection container 16 to accurately evaluate the liquid level and sample volume within the collection container 16. As shown in FIGS. 11 and 12, the collection container 16 can be adapted to increase the height of the entire tube while presenting only a single wall of plastic for liquid level sensing within the pick-and-place machine or device. In one example, an extension portion 106 may be provided that attaches to the bottom of the collection container 16. The extension portion 106 may be an adapter that can be connected to any existing collection container. The extension portion 106 may have an arm 108 that is used to actively connect to the bottom of the collection container 16. The arm 108 may be removably attached to the collection container 16 or may be integrally formed. By attaching the extension portion 106 only to the bottom of the collection container 16, the single wall of plastic is maintained for the collection container 16 for liquid level sensing. The connection between the extension portion 106 and the collection container 16 creates a uniform surface to give the appearance of a uniform "extended" collection container 16.

[0086] The extension portion 106 may be included at the time of manufacture as a permanent feature of the collection container 16 or as an accessory attached after collection and before sending for laboratory processing. The extension portion 106 may be secured to the collection container 16 by a friction fit connection, an annular snap fit connection, a threaded connection, a bayonet connection, or an ultrasonic welding connection. Alternatively, the collection container 16 can be enhanced to create a longer "false bottom" that eliminates the need for an accessory extender component.

[0087] Referring to FIG. 13, according to one non-limiting aspect or example of the present disclosure, additional features may be included in the collection container 16 to assist in the interaction with a pick-and-place machine or device. In some pick-and-place machines or devices, the collection container 16 must have a cap with a diameter larger than the bottom of the collection container 16 in order to properly fit and interact with the pick-and-place machine or device. Since the cap of the collection container 16 has a larger diameter than the tube of the collection container 16, the automated process of the pick-and-place machine or device is improved to determine the orientation of the tube within the pick-and-place machine or device and is automatically sorted for the correct orientation. A collection container 16 without this diameter difference does not allow for automatic discrimination because the assembly has a uniform outer diameter. As shown in FIG. 13, according to one example, the collection container 16 may include a cap 110 having a diameter D1 that is larger than the diameter D2 of the tube 112 of the collection container 16. The difference in diameter enables sorting of the orientation in an automated workflow using a pick-and-place machine or device. Due to the difference in diameter, the pick-and-place machine or device can distinguish between the top (cap 110) and the bottom (tube 112) of the collection container 16.

[0088] Referring to FIG. 14, according to a non-limiting embodiment or aspect of the present disclosure, a collection container 16 having a combination of a cover 100 and a plurality of axial ribs 102 is shown and will be described in detail. In some pick-and-place machines or devices, the overall tube height of the collection container 16 must be achieved to fit and interact properly with the pick-and-place machine or device. Further, some pick-and-place machines or devices require a single wall of plastic on the collection container 16 to accurately evaluate the liquid level and sample volume within the collection container 16. As shown in FIG. 14, the collection container 16 can be adapted to increase the height of the entire tube while presenting only a single wall of plastic for liquid level sensing within the pick-and-place machine or device. In one example, an extension portion 106 may be provided that attaches to the bottom of the collection container 16. The extension portion 106 may be an adapter that can connect to any existing collection container. The extension portion 106 may have an arm 108 that is used to actively connect to the bottom of the collection container 16. The arm 108 may be removably attached to the collection container 16 or may be integrally formed. By attaching the extension portion 106 only to the bottom of the collection container 16, the single wall of plastic is maintained for the collection container 16 for liquid level sensing. The connection between the extension portion 106 and the collection container 16 creates a uniform surface to give the appearance of a uniform "extended" collection container 16.

[0089] The collection container 16 shown in FIG. 14 may include a cover member (such as cover 100) provided around the outer periphery of the collection container 16 to create a uniform radial surface for gripping and / or holding the collection container 16 during pick and place automation. The cover 100 may extend around the entire outer periphery of the upper portion of the collection container 16. In one example, the cover 100 may be an overmold of a rigid plastic or semi-rigid elastomeric material. The cover 100 is configured to improve the ability of the arm or gripper of an automated machine or device to grip the collection container 16 for transport or repositioning. The cover 100 may be formed as a single monolithic piece or as a plurality of pieces connected to each other. The cover may be opaque in color to assist in tube recognition. The cover may also provide uniform axial symmetry around the circumference of at least a portion of the outer surface of the collection container 16, such as adjacent to the open end.

[0090] In addition to the cover 100, the collection container 16 may also have a plurality of axial ribs 102 disposed around the circumference at the top of the collection container 16 to create a uniform radial surface for gripping and / or holding the collection container 16 during pick and place automation. The plurality of axial ribs 102 may extend around the entire outer circumference of the collection container 16. The longitudinal axis of each axial rib 102 may extend parallel to the longitudinal axis of the collection container 16. The axial ribs 102 ensure that there are no one or two protruding edges on the collection container 16 and instead include a more uniform and smooth surface. The axial ribs 102 are configured to fill the negative space under various protrusions on the collection container 16, including the negative space under the lid latch and the living hinge. The axial ribs 102 may be made of rigid plastic or semi-rigid elastomeric material. The axial ribs 102 may be provided on the collection container 16 during the primary molding of the collection container 16 or may be provided as overmolded features on the collection container 16. In another example, instead of the axial ribs 102, a plurality of rings may be disposed along the length at the top of the collection container 16 to create a more uniform and smooth surface that can be more easily gripped by the arm or gripper of an automated pick and place machine or device. The rings may be radial rings that extend around the outer circumference at the top of the collection container 16.

[0091] Also, it is contemplated that the cover 100 and the axial ribs 102 shown in FIG. 14 may include the color differences shown and described in connection with FIGS. 9A-10B.

[0092] One embodiment of the capillary blood sampling device is shown in the accompanying drawings and described in detail herein, but 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 limiting. The invention described above is defined by the appended claims, and all changes to the invention within the meaning and scope of equivalence of the claims are included within their scope.

Claims

1. A collection container for holding a blood sample, the collection container comprising: A tube having an open end, a closed bottom end, and side walls extending therebetween defining a collection cavity, the side walls including a tube defining an outer side surface, and A lid removably engagable with the open end of the tube; and A cover member for covering at least a portion of the outer side surface of the tube proximate the lid; provided with; The cover member circumferentially covers at least a portion of the outer side surface of the collection container and is configured to create a uniform smooth surface around the circumference of the collection container.

2. The collection container according to claim 1, wherein the lid includes a release tab that, when pressed, releases the collection container from a blood sampler attachment.

3. The collection container according to claim 1, wherein the lid is connected to the collection container via a living hinge.

4. The collection container according to claim 1, wherein the cover member is integrally formed with the collection container.

5. The collection container according to claim 1, wherein the cover member includes a colorant for identifying the cover member.

6. The collection container according to claim 5, wherein the colorant is opaque and / or translucent.

7. The collection container according to claim 1, wherein the diameter of the lid is larger than the diameter of the tube.

8. The collection container according to claim 1, further comprising an extension portion removably attached to the bottom end of the tube.

9. A collection container for holding a blood sample, the collection container comprising: A tube having an open end, a closed bottom end, and side walls extending therebetween defining a collection cavity, said side walls defining an outer side surface, a tube, A lid removably engageable with said open end of said tube, A plurality of ribs configured to cover at least a portion of said outer side surface of said tube proximate said lid, Comprising, Said plurality of ribs are configured to circumferentially cover at least a portion of said outer side surface to create a more uniform band-like smooth surface around the circumference of said collection container, a collection container. **Claim 10** The collection container according to claim 9, wherein said plurality of ribs are arranged axially. **Claim 11** The collection container according to claim 9, wherein said lid includes a release tab that, when pressed, releases said collection container from a blood sampler attachment. **Claim 12** The collection container according to claim 9, wherein said lid is connected to said collection container via a living hinge. **Claim 13** The collection container according to claim 9, wherein said plurality of ribs are integrally formed with said collection container. **Claim 14** The collection container according to claim 9, wherein said plurality of ribs include a coloring agent for identifying said plurality of ribs. **Claim 15** The collection container according to claim 14, wherein said coloring agent is opaque and / or translucent. **Claim 16** The collection container according to claim 9, wherein the diameter of said lid is larger than the diameter of said tube. **Claim 17** The collection container according to claim 9, further comprising an extension portion removably attached to the bottom end of said tube. **Claim 18** A collection container for holding a blood sample, said collection container comprising A tube having an open end, a closed bottom end, and side walls extending therebetween that define a collection cavity, the side walls defining an outer side surface, the tube, A lid removably engagable with the open end of the tube, An extension portion removably engagable with a portion of the tube, the extension portion extending over the closed bottom end and configured to increase the overall length of the tube, the extension portion, A collection container comprising. **Claim 19** The collection container according to claim 18, wherein the extension portion is removably connected to the tube via a friction fit, an annular snap fit connection, a screw connection, a bayonet connection, or an ultrasonic welding connection. **Claim 20** A collection container for holding a blood sample, the collection container comprising A tube having an open end, a closed bottom end, and side walls extending therebetween that define a collection cavity, the side walls defining an outer side surface, the tube, A lid removably engagable with the open end of the tube, A cover member for covering at least a portion of the outer side surface of the tube proximate the lid, A plurality of ribs disposed on the cover member and configured to cover at least a portion of the cover, Comprising, The cover and the plurality of ribs are configured to circumferentially cover at least a portion of the outer side surface to create a more uniform band-like smooth surface around the circumference of the collection container, the integrated container.

Images