Capillary blood collection device

Abstract

An apparatus for obtaining a blood sample includes a collection container defining a cavity for receiving a blood sample and an adapter defining a cavity for receiving the collection container, the adapter including a retention mechanism for orienting the collection container in a desired position when inserted into the adapter.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the priority of U.S. Provisional Patent Application No. 63 / 216,287, filed on June 29, 2021, entitled "Capillary Blood Collection Device", the entire disclosure of which is incorporated herein by reference.

[0002] The present disclosure generally relates to devices for obtaining biological samples. More particularly, the present disclosure relates to an integrated finger - based capillary blood collection device having the ability to lancet, squeeze, collect, stabilize, and dispense a blood sample by controlled methods on a finger.

Background 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 commonly performed in the medical field is capillary blood collection, which is often done to obtain a blood sample for testing. Certain diseases such as diabetes require regular testing of a patient's blood, for example, to monitor the patient's blood glucose level. Additionally, test kits such as cholesterol test kits often require a blood sample for analysis. The blood collection procedure typically involves pricking a finger or other suitable body part to obtain a blood sample. Generally, the amount of blood required for such tests is relatively small, and usually a small puncture or incision provides sufficient blood volume for these tests. Various types of lancet devices have been developed for puncturing a patient's skin to obtain a capillary blood sample from the patient.

[0004] Many different types of lancet devices are commercially available not only to individual consumers but also to hospitals, clinics, and medical offices. Such devices typically feature a sharp, pointed component, such as a needle, or a sharp-edged component, such as a blade, and are used to quickly puncture or cut a patient's skin to cause a small amount of bleeding. For many people, pricking their own finger with a hand-held needle or blade is often physiologically and psychologically difficult. As a result, lancet devices have evolved into automated devices that puncture or cut a patient's skin when a trigger mechanism is activated. Some devices keep the needle or blade in a waiting position until the trigger is pulled by a user, who may be the patient or a medical professional responsible for drawing blood from the patient. When the trigger is pulled, the needle or blade punctures or cuts the patient's skin, for example, on a finger. Springs are often incorporated into the device to provide the "automatic" force necessary to puncture or cut the patient's skin.

[0005] One type of contact-actuated lancet device, characterized by the automatic ejection of a puncture or cutting element from the device and its automatic retraction into the device, is U.S. Patent No. 9,380,975, owned by Becton, Dickinson and Company, the assignee of this application. The lancet device comprises a housing and a lancet structure having a puncture element. The lancet structure is located within the housing and is suitable for movement between a retaining or pre-actuated position in which the puncture element is held within the housing and a puncture position in which the puncture element extends through the front end of the housing. The lancet device comprises a drive spring located within the housing to bias the lancet structure toward the puncture position and a retaining hub that holds the lancet structure in the retracted position against the bias of the drive spring. The retaining hub comprises a swivel lever that engages with the lancet structure. An actuator within the housing rotates the lever, thereby moving the lancet structure toward the rear end of the housing so as to compress the drive spring at least partially, and releasing the lever from interference engagement with the lancet structure. The received blood sample is then collected or tested, or collected and tested. This testing can be performed using a point-of-care (POC) testing device, or by collecting and transporting the sample to a testing facility.

[0006] Currently, the capillary blood collection workflow is a complex, multi-step process requiring a high level of technical skill. This multi-step nature introduces several variability factors that can lead to sample quality issues such as hemolysis, insufficient sample stabilization, and microclots. The use of a lancet device to acquire blood samples also introduces several variability factors that can affect capillary blood sample acquisition, including, but not limited to, maintaining lancet stability during the procedure, obtaining sufficient blood flow from the puncture site, properly collecting blood, and preventing thrombosis. Some of the most common causes of process variability include: (1) potentially contaminated samples due to improper washing of the lancet incision site and removal of the initial droplet; (2) potentially insufficient sample volume and a large proportion of interstitial fluid due to inconsistent lancet incision site and depth; (3) potentially hemolyzed samples due to accelerated blood extraction (e.g., blood milking) caused by inconsistent compression technique and excessive pressure near the lancet incision site; (4) potentially hemolyzed or contaminated samples due to variations in the transfer interface and collection technique; and (5) potentially microclots due to insufficient mixing of anticoagulants and sample.

[0007] Capillary blood collection is typically performed either by a healthcare professional manually compressing the tissue around the puncture site with their fingers, or by using a vacuum-assisted device to draw blood from the site.

[0008] Manually squeezing a blood sample site is a highly skill-dependent process, resulting in significant variability in success rates and sample quality (measured by hemolysis and blood cell rupture). Healthcare professionals typically adjust compression pressure and number of compressions to compensate for patient-dependent differences in blood flow. Stronger squeezing increases blood flow but also increases hemolysis. Furthermore, the location of the squeeze varies among healthcare professionals due to personal preference, experience, and hand fatigue. Some professionals even employ a process called "milking," where pressure is applied while sliding the finger from the base to the fingertip. This process is not recommended by domestic and international health organizations as it can lead to a decrease in sample quality.

[0009] Vacuum-driven devices standardize blood flow pressure and technique, but typically suffer from poor overall blood flow. The maximum pressure that can be applied is limited by the difference between atmospheric pressure and absolute vacuum (below 14 psi), and the devices operate at only a fraction of absolute vacuum. For reference, the average grip strength for both men and women is 50-100 pounds, illustrating why manual methods are affected by hemolysis rather than blood flow. Vacuum methods also apply consistent pressure, limiting the tissue's ability to replenish blood.

[0010] Therefore, in this art, there is a need for a device capable of controllingly lancet-cutting and compressing a finger, collecting a sample, stabilizing the sample, and subsequently dispensing the sample. In this art, there is also a need for a device that simplifies and streamlines capillary blood collection by eliminating the workflow variability typically associated with low sample quality, including hemolysis and microclots. In this art, there is still a need for closed-system collection and transfer that eliminates blood exposure and device reuse. In this field, there is a further need for a device that (1) introduces flexibility in accommodating different capillary blood collection and transfer containers, (2) has the ability to produce high-quality, uniformly mixed / stabilized capillary blood samples, (3) has the ability to generate in-device plasma from capillary plasma samples, (4) has the ability to collect large volumes of capillary blood samples (>50-500 μL) while reducing pain, (5) includes a unique sample identifier paired with patient information at the time of collection, (6) has the ability to collect capillary blood and perform in-device diagnostics, and (7) has multiple collection ports for collecting blood samples into different containers with the same or different anticoagulants. In this field, there is a further need for a capillary blood collection device that includes standardizing and controlling the position of applied pressure, applying a pressure that is sufficiently high for sufficient blood flow but below the hemolysis threshold, applying a defined rhythmic pressure rather than a consistent pressure so that the finger is filled with blood, increasing the average blood flow velocity, and reducing user fatigue by reducing the maximum force applied by the operator. [Overview of the project] [Problems that the invention aims to solve]

[0011] This disclosure relates to a device for obtaining biological samples, such as a capillary blood collection device, which has the ability to lancet-cut and compress a finger, collect a sample, stabilize the sample, and subsequently dispense the sample in a controlled manner, while satisfying the aforementioned needs. This device also simplifies and streamlines capillary blood collection by eliminating the workflow variability that is typically associated with low sample quality, including hemolysis and microclots. [Means for solving the problem]

[0012] This disclosure includes a self-contained, fully integrated finger-based capillary blood collection device having the ability to lancet-cut and collect and stabilize large volumes of capillary blood samples, for example, up to 500 microliters or more. The device simplifies and streamlines large-volume capillary blood collection by eliminating the workflow steps and variability typically associated with poor sample quality, including hemolysis, microclots, and patient discomfort. The device includes a retractable lancet-cutting mechanism that can lancet-cut the finger, and associated blood flow pathways that ensure the adhesion and movement of capillary blood from the punctured finger site to the collection container. The device also includes a holder that can be periodically squeezed to stimulate, i.e., pump, the blood flow out of the finger, and an anticoagulant deposited in the channel or collection container for stabilizing the collected sample.

[0013] According to one design, the device may comprise individual components such as a holder, lancet, and collection container. According to another design, the lancet and collection container can be integrated into a single device, in which case the device is used together with the holder. According to yet another design, the holder, lancet, and collection container can be integrated into a single system. All of these designs are intended for use as a standalone, disposable device, or in conjunction with an external power source for pain relief control, or both. The capillary blood collection device can function as a platform for various capillary blood collection containers, ranging from small tubes to capillary dispensers, as well as for in-device plasma separation modules. This functionality expands the product's flexibility to a variety of applications, including dispensing into point-of-care (POC) cartridges and transfer to small collection tubes usable with centrifuges and analytical instruments.

[0014] In one embodiment of the present disclosure, an apparatus for acquiring a blood sample may comprise a collection container defining a cavity for receiving the blood sample, and an adapter defining a cavity for receiving the collection container. The adapter comprises a holding mechanism for orienting the collection container to a desired position when inserted into the adapter.

[0015] In one embodiment of the present disclosure, the adapter may comprise at least one projection extending from the end of the adapter. The collection container may define at least one groove configured to receive at least one projection of the adapter. The adapter may be made of a transparent material so that a barcode located inside the collection container is visible through the adapter. The adapter may be made of methyl methacrylate acrylonitrile butadiene styrene. The adapter may comprise a height adjustment member at the bottom of the adapter for raising the height of the collection container in the adapter. The upper edge of the height adjustment member is provided with a sinusoidal cam surface for self-orienting the collection container when inserted into the adapter. The adapter may comprise an axial retaining mechanism and a rotational retaining mechanism.

[0016] In one embodiment of the present disclosure, an apparatus for acquiring a blood sample may comprise a holder for receiving a sample source, the holder having an operating part and a port, a collection container defining a cavity for receiving a blood sample, and an adapter defining a cavity for receiving the collection container.

[0017] In one embodiment of the present disclosure, the adapter may comprise at least one projection extending from the end of the adapter. The collection container may define at least one groove configured to receive at least one projection of the adapter. The adapter may be made of a transparent material so that a barcode located inside the collection container is visible through the adapter. The adapter may be made of methyl methacrylate acrylonitrile butadiene styrene. The adapter may comprise a height adjustment member at the bottom of the adapter for raising the height of the collection container in the adapter. The upper edge of the height adjustment member is provided with a sinusoidal cam surface for self-orienting the collection container when inserted into the adapter. The adapter may comprise an axial retaining mechanism and a rotational retaining mechanism. The adapter may comprise a rotational retaining mechanism. A lancet can be removably connected to a port of the holder, and the sample source can be dissected with the lancet.

[0018] The present invention is also described in the following section.

[0019] Item 1: A device for obtaining a blood sample, comprising a collection container defining a cavity for receiving a blood sample, and an adapter defining a cavity for receiving the collection container, wherein the adapter includes a holding mechanism for orienting the collection container to a desired position when inserted into the adapter.

[0020] Item 2: The apparatus according to Item 1, wherein the adapter comprises at least one projection extending from the end of the adapter.

[0021] Item 3: The apparatus according to Item 2, wherein the collection container defines at least one groove configured to receive at least one projection of the adapter.

[0022] Item 4: The device described in any of Items 1-3, wherein the adapter is made of a transparent material so that the barcode located on the collection container is visible through the adapter.

[0023] Item 5: The apparatus according to item 4, wherein the adapter is made of methyl methacrylate - acrylonitrile - butadiene - styrene.

[0024] Item 6: The apparatus according to any one of claims 1 to 5, wherein the adapter comprises a height adjustment member at the bottom of the adapter for raising the height of the collection container in the adapter.

[0025] Item 7: The apparatus according to any one of claims 1 to 6, wherein a sinusoidal cam surface for self - orienting the collection container when inserted into the adapter is provided at the upper edge of the height adjustment member.

[0026] Item 8: The apparatus according to any one of claims 1 to 7, wherein the adapter comprises an axial holding mechanism and a rotational holding mechanism.

[0027] Item 9: The apparatus according to any one of claims 1 to 8, wherein the adapter comprises a rotational holding mechanism.

[0028] Item 10: An apparatus for obtaining a blood sample, comprising a holder for receiving a sample source, the holder having an operating part and a port, a collection container defining a cavity for receiving the blood sample, and an adapter defining a cavity for receiving the collection container.

[0029] Item 11: The apparatus according to item 10, wherein the adapter comprises at least one protrusion extending from an end of the adapter.

[0030] Item 12: The apparatus according to item 11, wherein the collection container defines at least one groove configured to receive at least one protrusion of the adapter.

[0031] N Item 13: The apparatus according to any one of claims 10 to 12, wherein the adapter is made of a transparent material such that a barcode located on the collection container is visible through the adapter.

[0032] Item 14: The apparatus described in Item 13, wherein the adapter is made of methyl methacrylate acrylonitrile butadiene styrene.

[0033] Item 15: The apparatus according to any one of claims 10 to 14, wherein the adapter is provided with a height adjustment member at the bottom of the adapter for raising the height of the sampling container in the adapter.

[0034] Item 16: The apparatus according to any one of items 10 to 15, wherein the upper edge of the height adjustment member is provided with a sinusoidal cam surface for causing the sampling container to self-orient when inserted into the adapter.

[0035] Item 17: The adapter is the apparatus according to any one of items 10 to 16, comprising an axial holding mechanism and a rotational holding mechanism.

[0036] Item 18: The adapter is an apparatus according to any one of items 10 to 17, comprising a rotational holding mechanism.

[0037] Item 19: The apparatus according to any one of items 10 to 18, further comprising a lancet detachably connected to a port of the holder for dissecting a sample source with the lancet. [Brief explanation of the drawing]

[0038] Figure 1 is a perspective view of a holder according to an embodiment of the present invention.

[0039] Figure 2 is a cross-sectional view of an apparatus and lancet for obtaining a blood sample from a patient's finger, according to another embodiment of the present disclosure.

[0040] Figure 3 is a perspective view of an apparatus and collection container for obtaining a blood sample from a patient's finger, according to another embodiment of the present invention.

[0041] Figure 4 is a perspective view of a collection container received in an adapter according to one embodiment of the present disclosure.

[0042] Figure 5 is a perspective view of a collection container received in an adapter according to another embodiment of the present invention.

[0043] Figure 6 is another perspective view of the adapter shown in Figure 4.

[0044] Figure 7 is another perspective view of the adapter shown in Figure 5.

[0045] Figure 8 is a cross-sectional view of the collection container and adapter shown in Figure 4.

[0046] Figure 9 is a cross-sectional view of the sampling container and adapter shown in Figure 5.

[0047] Figure 10 is a schematic diagram showing the use of a tool to remove the cap of the collection container held in the adapter of Figure 5. [Modes for carrying out the invention]

[0048] The following description is provided to enable those skilled in the art to fabricate and use the embodiments described, which are intended to carry out the present invention. However, various modifications, equivalents, variations, and alternatives will still be readily apparent to those skilled in the art. All such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

[0049] For the purposes of the following description herein, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives are used in relation to the invention as they are oriented in the figures. However, it should be understood that the invention may take on alternative forms and sequences of steps unless expressly specified otherwise. It should also be understood that the specific apparatus and processes shown in the accompanying figures and described in the following specification are merely exemplary embodiments of the invention. Therefore, specific dimensions and other physical characteristics associated with the embodiments disclosed herein are not to be considered limiting.

[0050] This disclosure relates to a device for obtaining biological samples, such as a capillary blood collection device, which has the ability to lancet-cut and compress a finger, collect a sample, stabilize the sample, and subsequently dispense the sample in a controlled manner, while satisfying the aforementioned needs. The device also simplifies and streamlines capillary blood collection by eliminating the workflow variability typically associated with low sample quality, including hemolysis and microclots. The device can be used by healthcare professionals such as physicians and nurses, or by patients who self-apply the device.

[0051] Blood collection is fundamentally performed using pressure-driven flow. The equipment and techniques either lower the pressure outside the blood vessel (vacuum-driven flow) or increase the pressure inside the blood vessel. Both approaches increase the pressure difference between the inside and outside of the blood vessel, thereby increasing the flow rate from inside the blood vessel to the outside where the collection container is located. While soft tissues (fat, skin, muscle tissue, etc.) are perfused with blood, hard tissues and joints have poor perfusion or are too mechanically stable, making it difficult to compress them without causing pain to the patient. Therefore, the location of compression can be important.

[0052] Red blood cells (RBCs) are prone to hemolysis during collection. Hemolysis (RBC destruction) causes cellular contents to leak into the liquid serum of the sample, and the hemoglobin stains the serum red, interfering with colorimetric reactions and contaminating the sample for diagnostic analysis. The amount of hemolysis during blood collection depends not only on hemolysis caused by pressure from physical compression of tissues and blood vessels that can damage cells, but also on cell destruction mediated by shear due to flow rate and flow path. Therefore, hemolysis can be controlled by ensuring that the applied pressure and flow rate are not too high at any point on the finger being compressed.

[0053] This disclosure includes a self-contained, fully integrated finger-based capillary blood collection device having the ability to lancet-cut and collect and stabilize large volumes of capillary blood samples, for example, up to 500 microliters or more. The device simplifies and streamlines large-volume capillary blood collection by eliminating the workflow steps and variability typically associated with poor sample quality, including hemolysis, microclots, and patient discomfort. The device includes a retractable lancet-cutting mechanism that can lancet-cut the finger, and associated blood flow pathways that ensure the adhesion and movement of capillary blood from the punctured finger site to the collection container. The device also includes a holder that can be periodically squeezed to stimulate, i.e., pump, the blood flow out of the finger, and an anticoagulant deposited in the channel or collection container for stabilizing the collected sample.

[0054] According to one design, the device may comprise individual components such as a holder, lancet, and collection container. According to another design, the lancet and collection container can be integrated into a single device, in which case the device is used together with the holder. According to yet another design, the holder, lancet, and collection container can be integrated into a single system. All of these designs are intended for use as a standalone, disposable device, or in conjunction with an external power source for pain relief control, or both. The capillary blood collection device can function as a platform for various capillary blood collection containers, ranging from small tubes to capillary dispensers, as well as for in-device plasma separation modules. This functionality expands the product's flexibility to a variety of applications, including dispensing into point-of-care (POC) cartridges and transfer to small collection tubes usable with centrifuges and analytical instruments.

[0055] Referring to Figures 1 to 3, in an exemplary embodiment, the apparatus 10 of the present disclosure comprises separate components, such as a holder 12 (as shown in Figure 1), a lancet housing or lancet 14 (as shown in Figure 2), and a sampling container 16. In another exemplary embodiment, the semi-integrated apparatus of the present disclosure may have an angled flow and may comprise an integrated lancet housing and sampling container that can be connected to a separate holder. In another exemplary embodiment, the semi-integrated apparatus of the present disclosure may have a linear flow and may comprise an integrated lancet housing and sampling container that can be connected to a separate holder. In another exemplary embodiment, the integrated apparatus of the present disclosure may have an angled flow and may comprise an integrated holder, lancet housing, and sampling container. In another exemplary embodiment, the integrated apparatus of the present disclosure may have a linear flow and may comprise an integrated holder, lancet housing, and sampling container.

[0056] Referring to Figure 1, an exemplary embodiment of a holder 12 of the present disclosure is shown, which can receive a sample source, such as a finger 19, for supplying a biological sample, such as a blood sample 18. The holder 12 of the present disclosure generally comprises a finger receiving section 20 (Figure 1) having a first opening 22, an operating section 24, a port 26 having a second opening 28, and a fingertip guard 30. In one embodiment, the fingertip guard 30 includes a stopper for properly positioning and securing the finger 19 within the holder 12. The fingertip guard 30 further facilitates ensuring that the patient's finger 19 is positioned correctly within the finger receiving section 20 so that the pressure applied to the patient's finger 19 provides adequate blood flow.

[0057] The first opening 22 of the finger receiving portion 20 is configured to receive a sample source, such as a finger 19, for supplying a biological sample, such as a blood sample 18. It is understood that the sample source may include other parts of the body that can be fitted into the first opening 22. The port 26 communicates with the finger receiving portion 20. For example, with the finger 19 received in the holder 12, the port 26 communicates with a portion of the finger 19. The holder 12 of this disclosure can be sized to accommodate fingers of any size.

[0058] 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.

[0059] In one embodiment, the actuation unit 24 is movable between a first position in which the holder 12 defines a first diameter and a second position in which the holder 12 defines a second diameter, the second diameter being smaller than the first diameter. In another embodiment, the actuation unit 24 is movable between a first position in which the holder 12 defines a first ellipse and a second position in which the holder 12 defines a second ellipse, the first ellipse being different from the second ellipse. In this way, with the holder 12 in the second position with a smaller diameter, a portion of the holder 12 is in contact with the sample source, and the actuation unit 24 of the holder 12 can pump or extract, or pump and extract, the blood 18, as will be described in more detail below.

[0060] Referring to Figure 1, in one embodiment, the operating unit 24 includes a contact member 34. When the operating unit 24 is in the first position, the contact member 34 is in the disengaged position, that is, the contact member 34 is positioned in the first position relative to the sample source, for example, a finger 19, and the contact member 34 can make slight contact with the sample source. When the operating unit 24 is in the second position, the contact member 34 is in the engaged position, that is, the contact member 34 is positioned in the second position relative to the sample source, for example, a finger 19, and the contact member 34 makes pressurized contact with the finger 19, allowing the operating unit 24 of the holder 12 to pump or extract, or pump and 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.

[0061] Referring to Figure 1, in one embodiment, the actuation unit 24 includes a pressurizing member 36 for applying pressure to a sample source, such as a finger 19. In one embodiment, the pressurizing member 36 includes a pair of opposing tabs or wings 38. In such embodiments, each tab 38 may include a contact member 34. In one embodiment, the holder 12 includes a movable hinge 42. The movable hinge 42 allows the user to tighten the wings 38 between a first position (passive) and a second position (active). By using the tabs or wings 38 to draw blood 18 from the patient's finger 19, hemolysis can be minimized while maintaining adequate blood flow from the patient's finger 19. The stationary position of the wings 38 and the movable hinge 42 are designed to maintain contact and retention with the smallest patient's finger that can fit within the holder 12, while bending to accommodate the largest patient's finger within the holder 12 without obstructing blood flow.

[0062] Advantageously, the holder 12 of this disclosure allows the user to repeatedly compress and release the wings 38 to pump or extract, or pump and extract, blood 18 from the finger 19 until a desired amount of blood 18 is filled into the collection container 16. The wings 38 are configured to bend to maintain gentle contact with a range of patient finger sizes that can be used with the holder 12 and to hold the holder 12 on the patient's finger 19.

[0063] Advantageously, with the holder 12 placed on the finger 19, the holder 12 defines the position of the lancet incision and finger compression without constricting blood flow. The compression tab or wing 38 provides a predetermined range of compression pressure that is consistently applied across the entire finger 19. In doing so, the holder 12 gently massages the finger in a controlled manner, stimulating blood extraction and minimizing any potential hemolysis.

[0064] Referring to Figure 1, in one embodiment, the holder 12 includes a stabilization extension 40. This provides additional support for the holder 12 to be securely positioned on the finger 19. In one embodiment, the finger receiving portion 20 forms a C-shaped member as a whole and includes a plurality of internal gripping members for further gripping and supporting the holder 12 to be securely positioned on the finger 19. The stabilization extension 40 helps maintain contact with the patient's finger 19 while avoiding blood supply and the knuckles of the patient's finger 19 during use of the holder 12.

[0065] 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 of a flexible material.

[0066] The apparatus 10 for obtaining a blood sample 18 (shown in Figure 3) of the present disclosure comprises a lancet housing or lancet 14 that is detachably connected to a port 26 of a holder 12. Referring to Figure 2, in one embodiment, the lancet housing 14 comprises an inlet or opening 50, an internal space 52, a puncture element 54, an engagement portion 56, a retraction mechanism 58, and a drive spring 60. In one embodiment, the puncture element 54 is movable between a pre-operation position in which the puncture element 54 is held within the internal space 52 of the lancet housing 14 and a puncture position in which at least a portion of the puncture element 54 extends through the inlet 50 of the lancet housing 14 to lancet-cut a portion of the finger 19.

[0067] In one embodiment, the lancet 14 of this disclosure is a contact-actuated lancet and may be configured in accordance with the features disclosed in U.S. Patent Application Publication No. 2006 / 0052809, filed on May 6, 2005, by the same applicant as this application, under the title "Contact-Actuated Lancet Apparatus." The entire disclosure is expressly incorporated herein by reference.

[0068] 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 can be detachably connected 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.

[0069] Referring to Figure 2, in one embodiment, when the holder 12 and the lancet housing 14 are separate components, the lancet housing 14 can be removably connected to the port 26 of the holder 12. In such embodiments, the lancet housing 14 is provided with an engaging portion 56. Referring to Figure 2, 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 locked into the locking portion 32 of the holder 12. In this way, the lancet housing 14 is securely connected and locked to the holder 12, and the puncture element 54 of the lancet housing 14 is activated to lancet incision or puncture a sample source, such as a finger 19. In some embodiments, the port 26 of the holder 12 is provided with a number of ribs for securing and locking the lancet 14 or collection container 16 within the port 26.

[0070] To activate the lancet 14, the lancet 14 is pressed against the finger 19, activating the lancet 14's retraction mechanism 58 to lancet-cut the finger 19. The lancet 14 of this disclosure enables consistent and precise lancet-cutting at a precise depth and in a predetermined location, and ensures sufficient sample volume.

[0071] In one embodiment, the lancet 14 includes a drive spring 60 positioned within the internal space 52 of the lancet housing 14 to bias the puncture element 54 toward the puncture position. After puncture, the puncture element 54 is immediately retracted and securely fixed within the internal space 52 of the lancet housing 14.

[0072] In one embodiment, a lancet 14 of the present disclosure is used to make a lancet incision in the skin of a finger 19, after which a blood sample 18 is pressed into a collection container 16, as will be described in more detail below.

[0073] In one embodiment, the lancet housing 14 of the present disclosure is used to lancet-cut the skin of a finger 19 along a lancet path, and a blood sample 18 then flows along a blood flow path that is at an angle to the lancet path, as will be described in more detail below.

[0074] In one embodiment, the lancet 14 comprises a hollow needle. In such an embodiment, the lancet housing 14 of the present disclosure is used to lancet-cut the skin of the finger 19 along the lance path, and then a blood sample 18 flows through the hollow needle along a parallel blood flow path.

[0075] As shown in Figure 3, the apparatus 10 for obtaining a blood sample 18 according to this disclosure comprises a collection container 16 that is detachably connected to a port 26 of a holder 12. The collection container 16 is defined by 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. Once a desired amount of blood 18 has been collected in the container 16, the blood collection portion 74 is removed from the collection apparatus 10 to transfer the collected sample 18 to a diagnostic instrument or testing device, or to a diagnostic instrument and testing device. Once removed from the collection apparatus 10, the blood collection portion 74 is sealed by the cap or septum 76, protecting the blood sample 18 in the collection cavity 70.

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

[0077] In one embodiment, when the holder 12 and the collection container 16 are separate components, the container 16 is detachably connectable to a port 26 of the holder 12. In such an embodiment, the container 16 is provided with a container engagement portion 72. In one embodiment, the container 16 is pushed into the port 26 of the holder 12 so that the container engagement portion 72 of the container 16 is locked within a locking portion 32 of the holder 12. In this way, the container 16 is securely connected to and locked in the holder 12 so that the blood sample 18 can safely flow from the finger 19 in the holder 12 into the collection cavity 70 of the container 16.

[0078] It can be understood that several types of collection containers 16 can be used with the apparatus 10 of this disclosure. It can also be understood that the collection container 16 can be linked with a separate dispensing unit, or that the collection container 16 can be equipped with an integrated dispensing unit for dispensing blood 18 to the testing device.

[0079] Referring to Figure 1, the use of the apparatus 10 of this disclosure, which has individual components such as a holder 12, a lancet housing or lancet 14, and a sampling container 16, will be described.

[0080] Referring to Figure 1, first the desired finger 19 is cleaned, a holder 12 of a suitable size for the desired finger 19 is selected and placed firmly on the finger 19. Referring to Figure 2, the lancet housing 14 is then 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 so that the engaging portion 56 of the lancet housing 14 is locked in the locking portion 32 of the holder 12. In this way, the lancet housing 14 is firmly connected to and locked in the holder 12 so that the puncture element 54 (Figure 2) of the lancet housing 14 is activated to lancet incise or puncture a sample source, such as the finger 19. With the lancet 14 connected to the port 26 of the holder 12, the lancet 14 is connected to the finger 19.

[0081] When it is desired to activate the lancet 14 to lancet-cut the skin of the finger 19, the lancet 14 is pressed against the finger 19, activating the lancet 14's retraction mechanism 58 (Figure 2) to lancet-cut the finger 19. The lancet 14 of this disclosure consistently provides accurate lancet-cut depth and a predetermined lancet-cut position, thereby ensuring a sufficient sample volume.

[0082] After the finger 19 is lancet-cut and a flow of blood 18 from the finger 19 is established, 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 Figure 3, the container 16 is pushed into the port 26 of the holder 12 so that the container engagement portion 72 of the container 16 is locked in the lock 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 safely flow from the finger 19 in the holder 12 into the collection cavity 70 of the container 16.

[0083] Referring to Figure 1, with the container 16 properly secured to the holder 12 for collecting a blood sample 18, the user can repeatedly compress and release the wings 38 of the holder 12 to pump or extract blood 18 from the finger 19, or pump and extract blood, until the desired amount of blood 18 fills the collection container 16. Advantageously, with the holder 12 placed over the finger 19, the holder 12 defines the position of the lancet incision and finger compression without constricting the blood flow. The compression tab or wings 38 provide a predetermined range of compression pressure that is consistently applied across the entire finger 19. In doing so, the holder 12 gently massages the finger in a controlled manner, stimulating blood extraction and minimizing any potential hemolysis.

[0084] For example, referring to Figure 1, in one embodiment, the operating unit 24 includes a contact member 34. When the operating unit 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, a finger 19. When the operating unit 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 pressurized contact with the sample source, for example, a finger 19, and the operating unit 24 of the holder 12 can pump or extract, or pump and extract, blood 18. For example, when the contact member 34 is in the engaged position, the contact member 34 applies pressure to the sample source.

[0085] Once the desired amount of blood 18 has been collected in the container 16, the blood collection unit 74 is removed from the collection device 10 to transfer the collected sample 18 to a diagnostic device or testing device, or to both a diagnostic device and a testing device. Once removed from the collection device 10, the blood collection unit 74 is sealed with a cap or septum 76 to protect the blood sample 18 in the collection cavity 70.

[0086] The apparatus of this disclosure is compatible with any known laboratory equipment, whether the laboratory equipment is out of clinical practice or a point-of-care laboratory equipment. Various point-of-care laboratory equipment is known in the art. Such point-of-care laboratory equipment comprises test strips, slides, diagnostic cartridges, or other laboratory equipment for testing and analysis. Test strips, slides, and diagnostic cartridges are point-of-care laboratory equipment that receive a blood sample and test the blood for one or more physiological and biochemical conditions. There are many point-of-care equipment that use a cartridge-based architecture for analyzing very small amounts of blood at the bedside without the need to transfer the sample to a laboratory for analysis. This can save time in the long run to obtain results, but it presents different challenges for a highly routine research environment. An example of such a laboratory cartridge is the i-STAT® laboratory cartridge, which is marketed by the Abbott Group. Laboratory cartridges such as the i-STAT® cartridge can be used to test for a variety of conditions, including the presence of chemicals and electrolytes, hematology, blood gas concentrations, coagulation, or cardiac markers. Results of tests using such cartridges are provided to clinicians rapidly.

[0087] The collection container 16 may also contain a blood sample 18 or components of the blood sample 18 placed therein, or a sample stabilizer, such as an anticoagulant, to stabilize the blood sample 18 and its components. The collection container 16 may also include at least one fill line corresponding to a predetermined amount of sample. The collection container may also indicate / measure the amount of blood collected.

[0088] Any of the devices for acquiring blood samples of this disclosure can be used as a standalone, disposable device, or as a device capable of being used in conjunction with an external power source for pain relief control, or both. For example, part of the holder 12 may include an implantable electrode that receives a signal from an external pain control module for providing at least one of thermal, vibration, or transcutaneous electrical nerve stimulation (TENS) for pain relief control. The devices for acquiring blood samples of this disclosure may also include various options for in-device plasma separation. The devices for acquiring blood samples of this disclosure may also include a unique sample identifier that can be paired with patient information at the time of collection. The devices for acquiring blood samples of this disclosure may also include in-device diagnostic feedback at the time of collection. The devices for acquiring blood samples of this disclosure may also use multiple collection ports that allow for dual collection, for example, collection of multiple samples from the same source, and collection of two samples into two separate containers, and treatment of these samples with different sample stabilizers such as anticoagulants.

[0089] The apparatus for obtaining blood samples according to this disclosure significantly simplifies large-volume capillary blood collection from the finger compared to conventional capillary blood collection using lancets and capillaries, eliminating the need for skilled labor. The apparatus according to this disclosure eliminates blood exposure and prevents the reuse of the apparatus.

[0090] The apparatus for obtaining blood samples described herein simplifies and streamlines the collection process, eliminating the need for skilled labor. This is all achieved by a self-contained, closed-system apparatus that, once placed on the finger, provides lancet incision, blood extraction, stabilization, and storage functions all in one unit.

[0091] The apparatus for obtaining blood samples according to this disclosure may be linked with an autonomous unit that provides automated pumping, controlled finger compression, and automated sample labeling and processing.

[0092] Referring to Figure 4, according to one embodiment of the present disclosure, an adapter 80 may be provided for use with the device 10. The adapter 80 may be configured to receive the collection container 16 of the device 10 for automated processing in a blood analyzer or system (not shown). It should be understood that the adapter 80 may be configured for use with known blood analyzers or systems, such as a centrifuge. The device 10 may be designed to be as small as functionally possible for capillary blood collection from a patient's fingertip. While the device 10 is connected to the patient's finger 19 during collection, it is desirable that the device 10 be small and unobtrusive, and to avoid interference with the patient's hand / wrist during lansing (before collection). However, if the size of the device 10 is small, it may not be able to accommodate high-speed sample processing and automated processing on a blood analyzer or system. Therefore, to solve this problem, the adapter 80 can be used with the device 10, thereby converting the device 10 to accommodate high-speed sample processing and automated processing.

[0093] The adapter 80 may define a cavity 82 configured to receive the collection container 16 of the device 10. The adapter 80 may also include projections 84 extending from the ends of the adapter 80. The projections 84 are configured to receive into a groove 86 defined in the collection container 16. The projections 84 may include a latch that fits into the groove 86 to secure the adapter 80 to the collection container 16. In one embodiment, at least one of the projections 84 may extend further than the other projections 84 to engage with the groove 86 and cause the collection container 16 to self-orient within the adapter 80. The collection container 16 can rotate until the projection 84 slides into the groove 86, ensuring that the collection container 16 is oriented to a desired position within the adapter 80.

[0094] In one embodiment of this disclosure, the adapter 80 may be made of a transparent material that allows the user to scan a barcode 88 provided on the collection container 16 received in the adapter 80 for patient / sample identification. The adapter 80 may also include a height adjustment member 90 for raising the blood sample 18 within the collection container 16 to an optimal height for each in-scope instrument. The adapter 80 may have specific functions for blood sample retention based on the requirements of each instrument type. For an ethylenediaminetetraacetic acid (EDTA) instrument (shown in Figure 4), the adapter 80 provides axial retention for automated cell resuspension. The adapter 80 allows for rotational position retention to enable scanning of the barcode 88.

[0095] In another embodiment of the present disclosure, a serum separating tube (SST) adapter 92 is shown and described with reference to Figure 5. The adapter 92 is similar to the adapter 80 described above, but may include different dimensions to accommodate different types of collection containers 16. The adapter 92 may define a cavity 94 configured to receive the collection container 16 of the device 10. The adapter 92 may also include projections 96 extending from the ends of the adapter 92. The projections 96 are configured to be received in a groove 98 defined in the collection container 16. The projections 96 may include a latch that snaps into the groove 98 to secure the adapter 92 to the collection container 16. In one embodiment, at least one of the projections 96 may extend further than the other projections 96 to engage with the groove 98 and cause the collection container 16 to self-orient within the adapter 92. The collection container 16 can be rotated until the projection 96 slides into the groove 98, ensuring that the collection container 16 is oriented to the desired position within the adapter 92. The adapter 92 may be configured to provide a firm rotational orientation to assist in the decapping process. The adapter 92 may also include a height adjustment member 100 for raising the blood sample 18 within the collection container 16 to an optimal height for each in-scope instrument.

[0096] The adapters 80 and 92 are configured to receive the collection container 16 of the device 10 in order to change the outer diameter of the collection container 16. Effectively, the collection container 16 will have the outer diameter of the adapters 80 and 92. By increasing the outer diameter of the collection container 16, the collection container 16 effectively conforms to the dimensional needs of the fixed and operating parts of the blood analyzer or system. The adapters 80 and 92 help to hold the blood sample 18 centered relative to the axes of the adapters 80 and 92.

[0097] Referring to Figures 6 and 7, in further embodiments of the present disclosure, sinusoidal cam-shaped portions 102 and 104 provided on the height adjustment members 90 and 100 of the adapters 80 and 92, respectively, may be provided to automatically orient the sampling container 16 during insertion or installation of the sampling container 16 into the adapters 80 and 92. The ribs on the bottom surface of the sampling container 16 can rest on the upper surface of the sinusoidal cam surfaces 102 and 104 until the ribs of the sampling container 16 fit into the retaining grooves of the height adjustment members 90 and 100. By providing the sinusoidal cam surfaces 102 and 104 on the adapters 80 and 92, the sampling container 16 can be inserted into the adapters 80 and 92 in any orientation, and the sinusoidal cam surfaces 102 and 104 guide the sampling container 16 to a predetermined position, thereby orienting the alignment / holding mechanism of the adapters 80 and 92 toward the sampling container 16. The sinusoidal cam surfaces 102 and 104 can also be used to ensure that the barcode label 88 is in the optimal position for scanning during the automated processing of the collection container 16.

[0098] In some embodiments of this disclosure, the adapters 80, 92 may be made of an optically transparent material (e.g., methyl methacrylate acrylonitrile butadiene styrene (mABS)) so that barcodes can be scanned through the side walls of the adapters 80, 92. By using such a material, the adapters 80, 92 can be reused between multiple collection containers 16 and blood samples 18, each presenting its unique identifier to a blood analyzer or system.

[0099] Referring to Figures 8 and 9, according to embodiments of the present disclosure, the adapters 80, 92 may include height adjustment members 90, 100 for raising the height of the blood sample 18 to an optimal height for scanning the barcode 88 and for raising the bottom of the cavity 70 of the collection container 16 (which holds the blood sample 18) to an optimal height for sample aspiration with minimal dead volume. The bottom offsets 106, 108 of each adapter 80, 92 are specific to the type of each adapter 80, 92 (EDTA / SST).

[0100] Each adapter 80, 92 may be equipped with specific holding mechanisms to enable preparation and execution of automated sample processing using a blood analyzer or system. Adapter 80 may be equipped with an axial holding mechanism and a rotational holding mechanism. The axial holding mechanism fixes the collection container 16 in place and prevents it from coming off the adapter 80 during automated cell resuspension processing. The rotational holding mechanism of adapter 80 allows the blood analyzer or system to rotate the adapter 80 and read the unique barcode 88 on the collection container 16. As shown in Figure 10, in one embodiment of the present disclosure, the rotational holding mechanism provided on adapter 92 firmly holds the collection container 19 in place during decapping processing using a tool 110. The tool 110 can be set around the upper end of the collection container 16 and the cap 76 can be twisted off the collection container 16. Rib-shaped portions on the false bottom of adapter 92 can be fixed in place during decapping processing, or adapter 92 can be held by hand during the decapping operation.

[0101] The adapters 80 and 92, with their specific set of functions, transform the device 10 from a size optimized for fingertip blood collection to a size, position, and constraint optimized for automated processing and sampling via a blood analyzer or system. The adapters 80 and 92 enable processing of blood samples 18 from the device 10 using currently available blood analyzers and systems. Currently available adapters, such as the Microtainer adapter, do not transform the outer diameter of the collection container 16 so that it can be handled during automated processing. Current adapters do not have the functionality to enable decapping while attached to the adapters 80 and 92, nor do they raise the barcode and bottom offset of the blood sample 18 to an optimal height. Furthermore, current adapters do not have a sinusoidal cam surface for automatically orienting the collection container 16 relative to the adapters 80 and 92.

[0102] One embodiment of a capillary blood collection device is shown in the accompanying drawings and described in detail herein, but other embodiments will be obvious to those skilled in the art and will be readily fabricated 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 and not limiting. The invention described herein is defined by the appended claims, and all modifications to the invention that fall within the meaning and equivalence of the claims are encompassed therein.

Claims

1. A device for obtaining blood samples, A collection container defining a cavity for receiving the aforementioned blood sample, The system includes an adapter that defines a cavity for receiving the aforementioned collection container, The adapter is a device that includes a holding mechanism for automatically orienting the sampling container to a desired position when it is inserted into the adapter.

2. The apparatus according to claim 1, wherein the adapter comprises at least one projection extending from the end of the adapter.

3. The apparatus according to claim 2, wherein the sampling container defines at least one groove configured to receive the at least one protrusion of the adapter.

4. The apparatus according to claim 1, wherein the adapter is made of a transparent material so that the barcode located on the collection container can be seen through the adapter.

5. The apparatus according to claim 4, wherein the adapter is made of methyl methacrylate, acrylonitrile, butadiene, and styrene.

6. The apparatus according to claim 1, wherein the adapter is provided with a height adjustment member at the bottom of the adapter for raising the height of the sampling container in the adapter.

7. The apparatus according to claim 1, wherein the upper edge of the height adjustment member is provided with a sinusoidal cam surface for causing the sampling container to self-orient when inserted into the adapter.

8. The apparatus according to claim 1, wherein the adapter comprises an axial holding mechanism and a rotational holding mechanism.

9. The apparatus according to claim 1, wherein the adapter is equipped with a rotational holding mechanism.

Images