Capillary blood collection device

Abstract

A device for acquiring a blood sample, comprising a holder for receiving a sample source, the holder comprising a collector attachment having an operating part and a port, and being removable and pivotably connected to the holder. The collector attachment comprises a channel defined within the collector attachment and extending from a first end of the collector attachment to an opposing second end, and a blood guide member formed as a projection within the channel.

Description

Technical Field

[0001] This application claims the priority of U.S. Provisional Application No. 63 / 455,314, titled "Capillary Blood Collection Device", filed on March 29, 2023, the entire disclosure of which is incorporated herein by reference.

[0002] The present disclosure generally relates to devices for obtaining biological samples. More specifically, the present disclosure relates to an integrated finger-based capillary blood collection device that can incise and constrict a finger in a controlled manner to collect, stabilize, and distribute a blood sample.

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 collect a blood sample for testing purposes. In certain diseases such as diabetes, for example, it is necessary to regularly test a patient's blood 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 sufficient blood for these tests. Various types of lancet devices have been developed for piercing a patient's skin to obtain a capillary blood sample from the patient.

[0004] Many different types of lancet devices are commercially available to hospitals, clinics, medical offices, and individual consumers. Such devices typically include a pointed component, such as a needle, or a sharp component, such as a blade, which is used to quickly create a puncture wound or a rapid incision in the patient's skin, resulting in a small outflow of blood. For many people, pricking their own finger with a needle or blade held by hand is often physiologically and psychologically difficult. As a result, lancet devices are evolving into automated devices that puncture or incise the patient's skin by activating an activation mechanism. Depending on the device, the needle or blade remains in a waiting position until activated by a healthcare professional responsible for drawing blood from the patient, or by the patient themselves. Once activated, the needle or blade punctures or incises the patient's skin, for example, a finger. Often, a spring is incorporated into the device to provide the "automatic" force necessary to puncture or incise the patient's skin.

[0005] A type of contact-actuated lancet device, characterized by automatically extending or retracting a puncture or cutting element from the device, is described in U.S. Patent No. 9,380,975, owned by Becton, Dickinson and Company, the assignee of this application. The lancet device includes a housing and a lancet structure having a puncture element. The lancet structure is positioned within the housing and adapted to move between a retaining position 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 includes a drive spring positioned 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 biasing force of the drive spring. The retaining hub includes a pivoting lever that contact-engages with 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 contact-engagement with the lancet structure. Next, the collected blood samples are collected and / or tested. This testing can be performed using point-of-care (POC) testing devices, or by sending the collected samples to a testing facility.

[0006] Currently, capillary blood collection is a complex, multi-step procedure requiring a high level of skill. This multi-step nature leads to several variability issues that can result in sample quality problems such as hemolysis, insufficient sample stabilization, and microthrombi. The use of lancet devices for acquiring blood samples still involves several variability issues in capillary blood sampling, including, but not limited to, holding the lancet during the procedure, obtaining sufficient blood flow from the puncture site, collecting sufficient blood, and preventing coagulation. Some of the most common causes of process variability include: (1) insufficient cleaning of the puncture site or removal of the first drop, which may result in a contaminated sample; (2) inconsistent puncture location and depth, which may result in an insufficient amount of sample or a large amount of interstitial fluid; (3) inconsistent squeezing technique or excessive pressure near the puncture site when facilitating blood extraction (e.g., hemo-squeezing), which may result in a hemolyzed sample; (4) variations in the transport contact surface or collection technique, which may result in a hemolyzed or contaminated sample; and (5) insufficient mixing of the sample with the anticoagulant, which may result in a blood clot.

[0007] Capillary blood collection is typically performed by a healthcare professional, either by manually squeezing the tissue around the puncture site with their finger, or by using a device that draws blood from the puncture site using vacuum pressure.

[0008] Manually squeezing the blood collection site is a highly skill-dependent process that results in significant variability in success rates and sample quality (measured by hemolysis—the rupture of blood cells). Healthcare professionals typically adjust the pressure and speed of squeezing to compensate for patient-dependent differences in blood flow. Stronger squeezing increases blood flow but also increases hemolysis. The squeezing location also varies among healthcare professionals, depending on personal preference, experience, and hand fatigue. Some workers even perform a technique called "finger squeezing," which involves applying pressure from the base of the finger and sliding it towards the fingertip. This technique is not recommended by health organizations, both domestically and internationally, 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 (~14 psi), and the device operates only in a fraction of absolute vacuum. For reference, the average grip strength of men and women ranges from 50 to 100 pounds (22.7 to 45.4 kg), illustrating why manual methods are affected by hemolysis rather than blood flow. Vacuum methods also apply a consistent pressure, limiting the tissue's ability to fill it with blood.

[0010] Therefore, this field requires devices capable of incising and squeezing fingers, collecting samples, stabilizing samples, and then distributing them in a controlled manner. This field also requires devices that simplify and streamline capillary blood collection by eliminating workflow variability, which typically relates to low sample quality, including hemolysis and microthrombi. There remains a further need in this field for closed systems for collection and transfer that eliminate blood exposure and device reuse. There is still a need in the art for a device that (1) introduces flexibility when accommodating containers for collecting and transferring different capillary blood samples, (2) has the ability to produce high-quality, uniformly mixed / stabilized capillary blood samples, (3) has the ability to produce onboard plasma from capillary plasma samples, (4) has the ability to collect large capillary blood samples (larger than 50-500 μL) while reducing pain, (5) includes a unique sample identifier combined with patient information at collection, (6) has the ability to collect capillary blood and perform onboard diagnostics, and (7) has multiple collection ports for collecting blood samples into different containers with the same or different anticoagulants. There is also a further need in the art for a capillary blood collection device that includes a standardized and controlled position of the acting pressure, an acting pressure high enough for proper blood flow but below the hemolysis threshold, a defined rhythmic action of pressure rather than a consistent pressure to allow blood to be replenished in the finger, an increase in mean blood flow velocity, and a reduction in user fatigue by reducing the maximum acting pressure by the operator. [Overview of the project]

[0011] In one non-limiting embodiment or aspect of the present disclosure, a device for acquiring a blood sample may include a holder for receiving a sample source, the holder may include a collector attachment having an operating part and a port, and which is detachably and pivotably connected to the holder, the collector attachment may include a channel defined within the collector attachment and extending from a first end of the collector attachment to an opposing second end, and a blood guide member formed as a projection within the channel.

[0012] In other non-limiting embodiments or aspects of this disclosure, a collection container may be detachably connected to a collector attachment. A blood guide member may extend beyond the end of the channel. The collector attachment may include a blood pillar provided adjacent to the holder to receive initial droplets of blood delivered from the holder. The collector attachment may include a blood flush window formed integrally with the collector attachment. The collector attachment may include a lock snap projection configured to snap into a lock engagement with a lock portion on the holder. The collector attachment may be held in place by the holder via a snap-fit ​​connection. The blood guide member may be configured to direct droplets of blood from the collector attachment to a dry blood spot collection sheet or lateral flow test strip device. The collector attachment may be configured to pivot between a first stationary position and a second working position. In the first stationary position, the collector attachment may be detached from the opening of the holder, and in the second working position, the collector attachment may be aligned with the opening of the holder.

[0013] In other non-limiting embodiments or aspects of the present disclosure, a collector attachment for a device for acquiring a blood sample may include a channel defined within the collector attachment and extending from a first end of the collector attachment to an opposing second end; a blood guide member formed as a projection within the channel; and a projection extending from the collector attachment and configured to engage with a recess in a holder.

[0014] In other non-limiting embodiments or aspects of this disclosure, a collection container may be detachably connected to a collector attachment. A blood guide member may extend beyond the end of the channel. The collector attachment may include a blood pillar provided adjacent to the holder to receive initial droplets of blood being fed from the holder. The collector attachment may include a blood flush window formed integrally with the collector attachment. The collector attachment may include a lock snap projection configured to snap into a lock engagement with a lock portion on the holder. The collector attachment may be held in place by the holder via a snap-fit ​​connection. The blood guide member may be configured to guide droplets of blood from the collector attachment onto a dry blood spot collection sheet. The collector attachment may be configured to pivot between a first stationary position and a second operating position. In the first stationary position, the collector attachment may be detached from the opening of the holder, and in the second operating position, the collector attachment may be aligned with the opening of the holder.

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

[0016] Clause 1: A device for obtaining a blood sample, comprising a holder for receiving a sample source, the holder comprising a holder having an operating part and a port, and a collector attachment detachably and pivotably connected to the holder, the collector attachment comprising a channel defined within the collector attachment and extending from a first end of the collector attachment to an opposing second end, and a blood guide member formed as a projection or recess within the channel.

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

[0018] Clause 3: The device according to Clause 1 or Clause 2, wherein the blood guide member extends beyond the end of the channel.

[0019] Clause 4: The device according to any one of Clauses 1 to 3, wherein the collector attachment further comprises a blood pillar provided adjacent to the holder and receiving an initial droplet of blood delivered from the holder.

[0020] Clause 5: The device according to any one of Clauses 1 to 4, wherein the collector attachment further comprises a blood flush window formed integrally with the collector attachment.

[0021] Clause 6: The device according to any one of Clauses 1 to 5, further comprising a lock snap projection configured to snap into a lock engagement with the lock portion of the holder.

[0022] Clause 7: The device according to any one of Clauses 1 to 6, wherein the collector attachment is held on the holder via a snap-fit ​​connection.

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

[0024] Clause 9: The device according to any one of Clauses 1 to 8, wherein the collector attachment is configured to pivot between a first stationary position and a second operating position.

[0025] Clause 10: The device according to Clause 9, wherein in the first stationary position, the collector attachment is removed from the opening of the holder, and in the second operating position, the collector attachment is aligned with the opening of the holder.

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

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

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

[0029] Clause 14: The collector attachment according to any one of clauses 11 to 13, wherein the collector attachment is provided adjacent to the holder and further comprises a blood pillar for receiving an initial droplet of blood sent from the holder.

[0030] Clause 15: The collector attachment according to any one of clauses 11 to 14, wherein the collector attachment further comprises a blood flush window formed integrally with the collector attachment.

[0031] Clause 16: The collector attachment according to any one of clauses 11 to 15, further comprising a lock snap protrusion configured to snap into a lock engagement with a lock portion on the holder.

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

[0033] Clause 18: The collector attachment according to any one of Clauses 11 to 17, wherein the blood guide member is configured to guide droplets of blood from the collector attachment onto a dry blood spot collection sheet or lateral flow test strip device.

[0034] Clause 19: The collector attachment according to any one of Clauses 11 to 18, wherein the collector attachment is configured to pivot between a first stationary position and a second operating position.

[0035] Clause 20: The collector attachment according to Clause 19, wherein in the first stationary position, the collector attachment is removed from the opening of the holder, and in the second operating position, the collector attachment is aligned with the opening of the holder.

[0036] Clause 21: The collector attachment according to any one of Clauses 11 to 20, further comprising a collection medium removably inserted into the blood pathway of the collector attachment. [Brief explanation of the drawing]

[0037] [Figure 1] Figure 1 is a perspective view of a holder according to one embodiment of the present invention. [Figure 2A] Figure 2A is a cross-sectional view of a device and lancet for obtaining a blood sample from a patient's finger, according to another embodiment of the present disclosure. [Figure 2B] Figure 2B is a perspective view of the device and collection container of Figure 1 according to another embodiment of the present disclosure. [Figure 3] Figure 3 is a perspective view of a holder and collector attachment according to another embodiment of the present disclosure. [Figure 4] Figure 4 is another perspective view of the holder and collector attachment shown in Figure 3. [Figure 5] Figure 5 is a side view of the holder and collector attachment shown in Figure 3, with the collector attachment in a stationary position. [Figure 6]Figure 6 is a perspective view of the holder and collector attachment shown in Figure 3, with the collector attachment in the operating position. [Figure 7] Figure 7 is a top view of the holder and collector attachment shown in Figure 3. [Figure 8] Figure 8 is a front view of the holder and collector attachment shown in Figure 3. [Figure 9] Figure 9 is another side view of the holder and collector attachment shown in Figure 3. [Figure 10] Figure 10 is a perspective view of the holder and collector attachment shown in Figure 3, used with a dried blood spot collection sheet. [Figure 11] Figure 11 is a perspective view of the holder and collector attachment of Figure 3 used with a collection container according to another embodiment of the present disclosure. [Figure 12] Figure 12 is a perspective view of the holder and collector attachment of Figure 3 used with another collection container according to another embodiment of the present disclosure. [Figure 13] Figure 13 is a perspective view of a collector attachment according to another non-limiting embodiment or aspect of the present disclosure. [Figure 14] Figure 14 is a perspective view of a collector attachment according to another non-limiting embodiment or aspect of the present disclosure. [Figure 15] Figure 15 is a perspective view of a collector attachment according to another non-limiting embodiment or aspect of the present disclosure. [Figure 16] Figure 16 is a perspective view of a collector attachment according to another non-limiting embodiment or aspect of the present disclosure. [Figure 17] Figure 17 is a perspective view of a collector attachment according to another non-limiting embodiment or aspect of the present disclosure. [Figure 18] Figure 18 is a perspective view of a collector attachment according to another non-limiting embodiment or aspect of the present disclosure. [Figure 19] Figure 19 is a perspective view of a collector attachment according to another non-limiting embodiment or aspect of the present disclosure. [Figure 20] Figure 20 is a perspective view of a collector attachment according to another non-limiting embodiment or aspect of the present disclosure. [Modes for carrying out the invention]

[0038] The following description is provided to enable those skilled in the art to create and use the described embodiments intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutes will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutes are intended to fall within the spirit and scope of the invention.

[0039] Hereinafter, for explanatory purposes, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives are used in relation to the present invention as oriented in the drawings. However, it will be understood that the present invention may presuppose various alternative modifications unless expressly otherwise specified. It should also be understood that the specific devices and processes shown in the accompanying drawings and described below are merely exemplary embodiments of the present invention. Therefore, specific dimensions and other physical features relating to the embodiments disclosed herein should not be considered limiting.

[0040] This disclosure relates to a device for obtaining a biological sample, such as a capillary blood collection device, that meets the above needs and has the ability to prick a finger, squeeze the finger, collect a sample, stabilize the sample, and then distribute the sample in a controlled manner. The device also simplifies and streamlines capillary blood collection by eliminating workflow variability that is commonly associated with low sample quality, including hemolysis and microthrombi.

[0041] Blood collection is fundamentally driven by pressure-driven flow. The device or technique either reduces the pressure outside the blood vessel (vacuum-driven flow) or increases the pressure inside the blood vessel. Both approaches increase the difference between vascular pressure and external pressure, increasing the flow velocity from inside the vessel to the outside where the collection container is located. The location of the constriction can also be important for compression without causing pain to the patient, as 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.

[0042] Red blood cells (RBCs) undergo hemolysis during collection. Hemolysis (destruction of red blood cells) contaminates the sample for diagnostic analysis by releasing cellular contents into the serum, staining the serum red with hemoglobin, and interfering with colorimetric reactions. The amount of hemolysis during blood collection depends on cell destruction via shear caused by flow rate and channel, and hemolysis due to pressure from physical compression of tissues and blood vessels that damages cells. 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.

[0043] This disclosure includes a self-contained, fully integrated, finger-mounted capillary blood collection device capable of puncturing, collecting, and stabilizing large volumes of capillary blood samples, e.g., up to 500 microliters or more. The device simplifies and streamlines large-volume capillary blood collection by eliminating workflow steps and variability commonly associated with sample quality degradation, such as hemolysis, microthrombi, and patient discomfort. The device comprises a retractable dissection mechanism capable of dissecting a finger and associated blood channels to ensure the attachment and transfer of capillary blood from the dissected finger site to a collection container. The device also includes a holder that can be periodically squeezed to stimulate, i.e., pump, blood flow from the finger, and an anticoagulant placed in the channel or collection container to stabilize the collected sample.

[0044] According to one design, the device can consist of separate 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 and used together with the holder. According to yet another design, the holder, lancet, and collection container can be integrated into a single system. Any of these designs is intended to be used as a self-contained, disposable device and / or in combination with an external power supply to reduce pain. The capillary blood collection device can serve as a platform for a variety of capillary collection containers, from small tubes to capillary dispensers, as well as for onboard plasma separation modules. This capability extends the product's flexibility to a variety of applications, including dispensing of POC cartridges or small collection tube transfers that can be used with centrifuges or analytical instruments.

[0045] Referring to Figures 1 and 2, in an exemplary embodiment, the device 10 of the Disclosure includes separate components, for example, a holder 12 (as shown in Figure 1), a lancet housing or lancet 14, and a collection container 16. In another exemplary embodiment, the semi-integrated device of the Disclosure may include at-angle flow and may include an integrated lancet housing and collection container connectable to a separate holder. In another exemplary embodiment, the semi-integrated device of the Disclosure may have in-line flow and may include an integrated lancet housing and collection container connectable to a separate holder. In another exemplary embodiment, the integrated device of the Disclosure may have at-angle flow and may include an integrated holder, a lancet housing, and a collection container. In another exemplary embodiment, the integrated device of the Disclosure may have in-line flow and may include an integrated holder, a lancet housing, and a collection container.

[0046] Referring to Figure 1, exemplary embodiments of a holder 12 of the present disclosure capable of receiving a sample source, such as a finger 19, for supplying a biological sample, such as a blood sample 18, are shown and described. The holder 12 of the present disclosure generally includes a finger receiving portion 20 having a first opening 22 (Figure 1), an operating 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 stopping portion for properly positioning and securing the finger 19 within the holder 12. The finger end guard 30 further assists in ensuring that the patient's finger 19 is positioned in the correct location within the finger receiving portion 20 so that pressure applied to the patient's finger 19 results in adequate blood flow.

[0047] 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 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, when the finger 19 is 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 any finger size.

[0048] The second opening 28 of 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, port 26 includes a locking portion 32 for securely receiving the lancet housing 14 and the collection container 16 within port 26.

[0049] In one embodiment, the actuarial portion 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 one embodiment, the actuarial portion 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, when the holder 12 is in the second position having a reduced diameter, a portion of the holder 12 is in contact with the sample source, and the actuarial portion 24 of the holder 12 can pump and / or extract the blood sample 18, as will be described in more detail below.

[0050] Referring to Figure 1, in one embodiment, the operating part 24 includes a contact member 34. When the operating part 24 is in a first position, the contact member 34 is in a disengaged position, i.e., the contact member 34 is positioned in a first position relative to, for example, a finger 19, such that the contact member 34 can make slight contact with the sample source. When the operating part 24 is in a second position, the contact member 34 is in an engaged position, i.e., the contact member 34 is positioned in a second position relative to the sample source, for example, a finger 19, such that the contact member 34 is in pressure contact with the finger 19, and the operating part 24 of the holder 12 can draw out and / or 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.

[0051] Referring to Figure 1, in one embodiment, the working part 24 includes a pump member 36 for applying pressure to a sample source, such as a finger 19. In one embodiment, the pump member 36 consists of a pair of opposing tabs or wings 38. In such embodiments, each tab or wing 38 may include a contact member 34. In one embodiment, the holder 12 includes a living hinge portion 42. The living hinge portion 42 allows the user to squeeze the tab or wing 38 between a first position (passive) and a second position (active). By using the tab or wing 38 to draw a blood sample 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 and hinge of the tab or wing 38 are designed to maintain contact and retention with the smallest patient finger 19 that can fit in the holder 12, while bending to accommodate the largest patient finger 19 in the holder 12 without blood obstruction.

[0052] Advantageously, the holder 12 of this disclosure allows a user to repeatedly compress and release the tab or wing 38 to draw up and / or extract a blood sample 18 from a finger 19 until a desired amount of blood sample 18 is filled into the collection container 16. The tab or wing 38 is configured to maintain gentle contact with a patient's finger of various sizes which may be used with the holder 12 and to bend to hold the holder 12 on the patient's finger 19.

[0053] 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 predetermined range of constriction pressure that is consistently applied across the entire finger 19. In doing so, the holder 12 provides a gentle, controlled finger massage that stimulates blood extraction and minimizes potential hemolysis.

[0054] Referring to Figure 1, in one embodiment, the holder 12 includes a stabilization extension 40. This provides additional support for securely attaching the holder 12 to the finger 19. In one embodiment, the finger receiving portion 20 forms a generally C-shaped member and includes a plurality of inner gripping members to provide additional grip and support for securely resting the holder 12 on the finger 19. The stabilization extension 40 helps maintain contact with the patient's finger 19 while avoiding blood supply to the patient's finger 19 and the finger joints during use of the holder 12.

[0055] 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.

[0056] As shown in Figure 2A, the device 10 for obtaining a blood sample 18 of the present disclosure may include a lancet housing or lancet 14 that is detachably connected to a port 26 of a holder 12. In one embodiment, the lancet housing 14 includes an entrance or opening 50, an interior 52, a puncture element 54, an engagement portion 56, a retractable mechanism 58, and a drive spring 60. In one embodiment, the puncture element 54 is movable between a pre-actuated position in which the puncture element 54 is held within the interior 52 of the lancet housing 14 and a puncture position in which at least a portion of the puncture element 54 extends through the entrance 50 of the lancet housing 14 to incise a portion of the finger 19.

[0057] In one embodiment, the lancet 14 of this disclosure is a contact-activated lancet, which may be configured according to features assigned in common with this application, disclosed in U.S. Patent Application Publication No. 2006 / 0052809, filed on May 6, 2005, entitled “Contact-Activated Lancet Device,” and the entire disclosure is expressly incorporated herein by reference.

[0058] 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.

[0059] Referring to Figure 2A, in one embodiment, when the holder 12 and the lancet housing 14 are separate components, the lancet housing 14 is detachably connectable to the port 26 of the holder 12. In such embodiments, the lancet housing 14 includes an engaging portion 56. Referring to Figure 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 locks 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 so that the puncture element 54 of the lancet housing 14 can be activated to incise or puncture a sample source, such as a finger 19. In some embodiments, the port 26 of the holder 12 includes a number of ribs for securing and locking the lancet 14 or collection container 16 within the port 26.

[0060] To activate the lancet 14, the lancet 14 is pressed against the finger 19 to activate the retractable mechanism 58 of the lancet 14, causing the finger 19 to incise. The lancet 14 of this disclosure ensures sufficient sample volume to consistently provide the correct puncture depth and predefined puncture location.

[0061] In one embodiment, the lancet 14 includes a drive spring 60 located inside the lancet housing 14 52 to bias the puncture element 54 toward the puncture position. After puncture, the puncture element 54 is immediately retracted and securely fixed inside the lancet housing 14 52.

[0062] In one embodiment, the lancet 14 of the present disclosure is used to make an incision in the skin of a finger 19, and a blood sample 18 is then squeezed into a collection container 16, as described in more detail below.

[0063] In one embodiment, the lancet housing 14 of the present disclosure is used to make an incision in the skin of a finger 19 along a lance path, after which a blood sample 18 flows through the blood channel at an angle to the incision path, as described in further detail below.

[0064] Referring to Figure 2A, in one embodiment, the lancet 14 includes a hollow needle 62. In such an embodiment, the lancet housing 14 of the present disclosure is used to puncture the skin of a finger 19 along the lance path, and the blood sample 18 then flows along a parallel blood flow path through the hollow needle 62, as will be described in more detail below.

[0065] As shown in Figure 2B, the device 10 for acquiring a blood sample 18 of this disclosure includes a collection container 16 that is detachably connected to a port 26 of a holder 12. The collection container 16 defines a collection cavity 70 for receiving the blood sample 18, a container engagement portion 72, a blood collector portion 74, and a cap or partition 76. Once a desired amount of blood sample 18 has been collected in the collection container 16, the blood collector portion 74 is detached from the collection device 10 to transfer the collected blood sample 18 to a diagnostic instrument and / or testing device. Once detached from the collection device 10, the blood collector portion 74 is sealed via the cap or partition 76, protectively sealing the blood sample 18 in the collection cavity 70.

[0066] In one embodiment, the collection container 16 may be a separate component from the holder 12 and the lancet housing 14. In some embodiments, the collection container 16 and the lancet housing 14 form a single component that 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.

[0067] In one embodiment, when the holder 12 and the collection container 16 are separate components, the collection container 16 is detachably connectable to a port 26 of the holder 12. In such an embodiment, the collection container 16 includes a container engagement portion 72. In one embodiment, the collection container 16 is pushed into the port 26 of the holder 12 such that the container engagement portion 72 of the collection container 16 locks into a locking portion 32 of the holder 12. In this way, the collection container 16 is securely connected and locked to the holder 12 so that a blood sample 18 can safely flow from the finger 19 in the holder 12 into the collection cavity 70 of the collection container 16.

[0068] It will be understood that several types of collection containers 16 may be used with the device 10 of this disclosure. It will also be understood that the collection container 16 may be associated with a separate dispensing unit, or that the collection container 16 may include an integrated dispensing unit for dispensing blood samples 18 into the test device.

[0069] Next, with reference to Figure 1, the use of the device 10 of this disclosure having individual components, for example, a holder 12, a lancet housing or lancet 14, and a collection container 16, will be described.

[0070] Referring to Figure 1, first, the desired finger 19 is cleaned, and a holder 12 of the appropriate size for the desired finger 19 is selected and securely fitted onto the finger 19. Next, referring to Figure 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 so that the engaging portion 56 of the lancet housing 14 locks 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 so that the puncture element 54 (Figure 2A) of the lancet housing 14 can be activated to incise or puncture a sample source, for example, the finger 19. With the lancet 14 connected to the port 26 of the holder 12, the lancet 14 communicates with the finger 19.

[0071] To activate the lancet 14 in order to incise the skin of the finger 19, the lancet 14 is pressed against the finger 19 to activate the retractable mechanism 58 (Figure 2A) of the lancet 14, thereby incising the finger 19. The lancet 14 of this disclosure provides accurate, consistent puncture depth and pre-determined puncture location, and ensures sufficient sample volume.

[0072] After puncturing the finger 19 and allowing blood 18 to flow from the finger 19, the lancet 14 is removed from the holder 12 and the collection container 16 is pushed into the port 26 of the holder 12. Referring to Figure 8, the collection container 16 is pushed into the port 26 of the holder 12 so that the container engagement portion 72 of the collection container 16 locks into the locking portion 32 of the holder 12. In this way, the collection 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 collection container 16.

[0073] Referring to Figure 1, with the collection container 16 properly secured to the holder 12 for collecting a blood sample 18, the user can draw and / or extract blood 18 from the finger 19 by repeatedly squeezing and releasing the tab or wing 38 of the holder 12 until the collection container 16 is filled with the desired amount of blood 18. Advantageously, when the holder 12 is placed over the finger 19, it does not restrict blood flow and does not define the lancening and finger compression position. The squeezing tab or wing 38 provides a predefined range of squeezing pressure that is consistently applied across the entire finger 19. In doing so, the holder 12 provides a gentle, controlled finger 19 massage that stimulates blood extraction and minimizes potential hemolysis.

[0074] For example, referring to Figure 1, in one embodiment, the operating part 24 includes a contact member 34. When the operating part 24 is in the first position, the contact member 34 is in the disengaged position, i.e., the contact member 34 is in the first position relative to the sample source, e.g., a finger 19. When the operating part 24 is in the second position, the contact member 34 is in the engaged position, i.e., the contact member 34 is in the second position and is in pressurized contact with the sample source, e.g., a finger 19, and the operating part 24 of the holder 12 can draw out and / or extract a blood sample 18. For example, when the contact member 34 is in the engaged position, the contact member 34 applies pressure to the sample source.

[0075] When the blood collection unit 74 is removed from the collection device 10, it is sealed via a cap or partition 76, protecting the blood sample 18 in the collection cavity 70.

[0076] The devices of this disclosure are compatible with any known test devices, whether the test device is off-site or a POC test device. Various POC test devices are known in the art. Such POC test devices include test strips, slides, diagnostic cartridges, or other test devices for testing and analysis. Test strips, slides, and diagnostic cartridges are POC test devices that receive a blood sample and test that blood for one or more physiological and biochemical conditions. There are many POC devices that use a cartridge-based architecture to analyze very small amounts of blood at the bedside without the need to send the sample to the lab for analysis. This saves time to obtain results in the long term, but creates different challenges than in a highly routine laboratory environment. An example of such a test cartridge is the i-STAT® test cartridge from the Abbot Group. Using test cartridges such as the i-STAT® cartridge, a variety of conditions can be tested, including the presence of chemicals and electrolytes, hematology, blood gas concentrations, coagulation, or cardiac markers. Test results using such cartridges are provided to clinicians quickly.

[0077] The collection container 16 may also contain a sample stabilizer, such as an anticoagulant, to stabilize the blood sample 18 and / or the components of the blood sample 18 placed therein. The collection container 16 may also include at least one filling line corresponding to a predetermined amount of sample. The collection container may also display / measure the amount of blood collected.

[0078] Any of the blood sample acquisition devices of this disclosure can be used as a self-contained, disposable device and / or in conjunction with an external power source for pain relief control. For example, part of holder 12 may include an implantable electrode that receives signals from an external pain control module and provides at least one of thermal, vibration, or transcutaneous electrical nerve stimulation (TENS) for pain relief control. The blood sample acquisition devices of this disclosure may include various options for onboard plasma separation. The blood sample acquisition devices of this disclosure may also include a unique sample identifier that can be paired with patient information at the time of collection. The blood sample acquisition devices of this disclosure may also include onboard diagnostic feedback at the time of collection. The blood sample acquisition devices of this disclosure may also enable dual collection, e.g., collecting two samples into two separate containers, using multiple collection ports that allow for the collection of multiple samples from the same supply source, and processing samples with different sample stabilizers such as anticoagulants.

[0079] The device for obtaining blood samples according to this disclosure significantly simplifies and eliminates the need for skill in large-volume capillary collection from the finger compared to conventional capillary collection using lancets and capillary tubes. The device according to this disclosure eliminates blood exposure and prevents device reuse.

[0080] The device for collecting blood samples described herein simplifies, streamlines, and rationalizes the collection process. This is all achieved by a self-contained, closed-system device that, after being fitted to a finger, provides the functions of incision, blood extraction, stabilization, and containment in a single unit.

[0081] The device for collecting blood samples according to this disclosure may be associated with an autonomous unit that provides an automated pump, controlled finger squeezing, and automated sample labeling and processing.

[0082] Referring to Figure 3, according to one non-limiting embodiment or aspect of the present disclosure, the collector attachment 100 may be used in conjunction with the holder 12 for controlled dry blood spot collection. In one example, the collector attachment 100 may be made of molded plastic. The collector attachment 100 may be pivotably attached to the holder 12 at a pivot point in the form of a recess 102 (see Figure 5). The collector attachment 100 may include a projection 104 that snaps into the recess 102 for the holder 12, allowing the collector attachment 100 to rotate or pivot relative to the holder 12. As shown in Figure 5, in a first position, the collector attachment 100 may be held in a stationary position where the collector attachment 100 is not aligned with the second opening 28 of the holder 12. As shown in Figure 6, in the second position, the collector attachment 100 can be held in an operational position where it aligns with the second opening 28 of the holder 12 to receive a biological sample from the patient's finger held in the holder 12. During use of the device 10, the lancet 14 can be held in the second opening 28 of the holder 12 to puncture the patient's finger. During this operation, the collector attachment 100 can be held in the first position so as not to interfere with the lancet 14. After the lancet 14 is removed from the holder 12, the collector attachment 100 can be rotated or pivoted to the second position to operably connect to the holder 12 and assist in guiding the biological sample from the patient's finger into a collection tray, collection sheet 118, or collection container 16. In one example, the collector attachment 100 can be used instead of a collection container 16 to deposit the biological sample from the patient's finger directly into the collection tray or collection sheet 118. The collector attachment 100 enables controlled dry blood spot collection, as well as collection into a microtainer with high sample quality and low hemolysis.

[0083] Referring to Figure 3, according to one non-limiting embodiment or aspect of the present disclosure, the collector attachment 100 may define a channel 108 extending through the collector attachment 100. In a second position, the channel 108 may be aligned with a second opening 28 of the holder 12 to receive a biological sample from the holder 12. The collector attachment 100 may also include a lock snap projection 110 extending from the outer surface of the collector attachment 100. The lock snap projection 110 may snap onto a lock portion 32 of the holder 12. The lock snap projection 110 may also be pushed inward to release the collector attachment 100 from the lock portion 32, allowing the collector attachment 100 to rotate or pivot to a first or stationary position.

[0084] In one non-limiting embodiment or aspect of the present disclosure, the collector attachment 100 may include a blood pillar 112 defined in the channel 108. The blood pillar 112 may be a short pillar positioned near the first end or upper end of the channel 108 to receive a first droplet of the biological sample received from the holder 12.

[0085] In one non-limiting embodiment or aspect of the present disclosure, at least a portion of the collector attachment 100 may include a blood flush window 114 formed integrally with it. The blood flush window 114 may form part of the collector attachment 100 and may be made of a transparent or translucent material to allow the user to see that a biological sample is directed into the collector attachment 100. When a biological sample is directed into the collector attachment 100, the biological sample may “flash” or splash into the blood flush window 114, indicating that the biological sample has begun to flow into the collector attachment 100.

[0086] In one non-limiting embodiment or aspect of the present disclosure, the collector attachment 100 may also include a blood guide member 116 formed in the channel 108. The blood guide member 116 may extend from one end of the channel 108 to an opposing second end of the channel 108. In one example, the blood guide member 116 may extend beyond the second end or lower end of the channel 108 so that the blood guide member 116 extends outward from the channel 108. The blood guide member 116 may be formed as a projection extending from the inner surface of the channel 108. In another non-limiting embodiment or aspect of the present disclosure, the blood guide member 116 may be a recess defined on the inner surface of the channel 108. During use of the device 10, the blood guide member 116 is configured to receive and guide a biological sample from the holder 12 through the channel 108 into a collection tray, collection sheet 118, or collection container 16, as desired. The biological sample adheres to the blood guide member 116 and flows along the blood guide member 116 in a predetermined direction, ensuring accurate flow of the biological sample from the holder 12 to the collection tray, collection sheet 118, or collection container 16. By extending the blood guide member 116 through the lower end of the blood pillar 112, the biological sample is guided along the blood guide member 116 and dripped from the lower end of the blood guide member 116. By dripping from the lower end of the blood guide member 116, the user can more accurately deposit the biological sample onto the collection tray, collection sheet 118, or collection container 16 when the holder 12 is not directly attached to the collection container 16. In one example, as shown in Figure 10, the blood guide member 116 may be used to easily guide blood droplets onto a controlled-dry blood spot sample collection sheet 118 while the user continues to generate blood by squeezing the holder 12.

[0087] Referring to Figures 11 and 12, according to one non-limiting embodiment or aspect of the present disclosure, the blood guide member 116 is sized such that it can be directly connected to a micro-tainer or collection container 16 (in one example, an ETDA map (microtube for automated processing) tube) to allow direct collection of a biological sample into the sample collection container 16. In one example, the micro-tainer or collection container 16 may be pressed onto the blood guide member 116 by friction fitting so that the micro-tainer or collection container 16 can be easily removed from the blood guide member 116 after it has been filled with a biological sample by slowly twisting the micro-tainer or collection container 16 without the risk of blood splashing.

[0088] The collector attachment 100 enables controlled collection of dry blood spot samples, simplifying the user's process of producing blood from a patient's finger, and then guiding the blood sample to a target area such as a collection sheet 118. The collector attachment 100 also enables controlled collection of high-quality (low-hemolytic) blood samples 18 into a microtainer or collection container 16, such as a MAP tube. The versatility of the collector attachment 100 in conjunction with the holder 12 enables standardization of capillary blood collection techniques for both dry blood spot and liquid blood samples in atypical blood collection environments, such as home blood collection. The collector attachment 100 also helps eliminate the need for skilled blood collection techniques to collect high-quality (low-hemolytic) blood samples from a patient's finger.

[0089] Referring to Figure 13, according to another non-limiting embodiment or aspect of the present disclosure, the collector attachment 100 may be used to control the adhesion of blood droplets on the Lateral Flow Test Strip Device 120.

[0090] Referring to Figure 14, according to another non-limiting embodiment or aspect of the present disclosure, the collector attachment 100 may include a collection medium 122 that is removably inserted into the blood collection pathway. In some examples, the collection medium 122 may be a sponge or a porous plug. The collection medium 122 may block the blood collection pathway and, after being sufficiently filled with a blood sample, may be deposited into the collection container 16.

[0091] Referring to Figure 15, according to another non-limiting embodiment or aspect of the present disclosure, the collector attachment 100 may have a shortened blood guide member 116 that does not extend outside the channel 108. In this example, the distal end of the blood guide member 116 may be inclined or angled.

[0092] Referring to Figure 16, according to another non-limiting embodiment or aspect of the present disclosure, the collector attachment 100 may have at least one channel or recess 124, 126 defined on the inner surface of channel 108. In one example, two channels or recesses 124, 126 may be defined on the inner surface of channel 108. The channels or recesses 124, 126 can operate in a manner (fashion) similar to that of the blood guide member 116 to guide blood droplets from the collector attachment 100 to the blood collection device.

[0093] Referring to Figure 17, according to another non-limiting embodiment or aspect of the present disclosure, the collector attachment 100 may define a notch 128 within the channel 108 to function as a blood guide member for blood droplets. In this example, the notch 128 acts like a fountain pen for distributing blood droplets on or within the blood collection device.

[0094] Referring to Figure 18, according to another non-limiting embodiment or aspect of the present disclosure, the collector attachment 100 may also have different widths relative to the blood pathway 130 in order to accommodate different volumes of blood flow.

[0095] Referring to Figure 19, according to another non-limiting embodiment or aspect of the present disclosure, the collector attachment 100 may also define a thin exit point 132 at the distal end of the channel 108. The exit point 132 may be a recess or channel defined on the inner surface of the channel 108. The exit point 132 may help guide blood droplets from the collector attachment 100 to the blood collection device.

[0096] Referring to Figure 20, according to another non-limiting embodiment or aspect of the present disclosure, the collector attachment 100 may also include a counterforce touch point 134. The touch point 134 may be used to assist in securing and detaching the collector attachment 100 from the blood collection device.

[0097] One embodiment of a capillary blood collection device is shown in the accompanying drawings and described in detail herein, but other embodiments will be apparent to those skilled in the art and will be readily fabricated without departing from the scope and spirit of the invention. Accordingly, the foregoing description is intended to be illustrative rather than restrictive. The invention as described above is defined by the appended claims, and all modifications to the invention that fall within the meaning and equivalence of the claims are encompassed within those scopes.

Claims

1. A device for obtaining blood samples, A holder for receiving a sample source, wherein the holder has an operating part and a port, A collector attachment is detachably and pivotably connected to the holder, Includes, The aforementioned collector attachment is, A channel defined in the collector attachment and extending from a first end of the collector attachment to an opposing second end, A blood guide member formed as a projection or recess within the channel, A device that includes this.

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

3. The device according to claim 1, wherein the blood guide member extends beyond the end of the channel.

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

5. The device according to claim 1, wherein the collector attachment further comprises a blood flush window formed integrally with the collector attachment.

6. The device according to claim 1, wherein the collector attachment further comprises a lock snap projection configured to snap into a locked engagement state with the lock portion of the holder.

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

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

9. The device according to claim 1, wherein the collector attachment is configured to pivot between a first stationary position and a second operating position.

10. In the first stationary position, the collector attachment is removed from the opening of the holder. The device according to claim 9, wherein in the second operating position, the collector attachment is aligned with the opening of the holder.

11. A collector attachment for a device for acquiring blood samples, The aforementioned collector attachment is, A channel defined within the collector attachment and extending from a first end of the collector attachment to an opposing second end, A blood guide member formed as a projection or recess within the channel, A projection extending from the collector attachment and configured to engage with a recess in the holder, A collector attachment, including [the specified part of the attachment].

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

13. The collector attachment according to claim 11, wherein the blood guide member extends beyond the end of the channel.

14. The collector attachment according to claim 11, further comprising a blood pillar provided adjacent to the holder to receive initial droplets of blood sent from the holder.

15. The collector attachment according to claim 11, further comprising a blood flush window formed integrally with the collector attachment.

16. The collector attachment according to claim 11, further comprising a lock snap projection configured to snap into a locked engagement state with a lock portion on the holder.

17. The collector attachment according to claim 11, wherein the collector attachment is held in the holder via a snap-fit ​​connection.

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

19. The collector attachment according to claim 11, wherein the collector attachment is configured to pivot between a first stationary position and a second operating position.

20. In the first stationary position, the collector attachment is removed from the opening of the holder. The collector attachment according to claim 19, wherein in the second operating position, the collector attachment is aligned with the opening of the holder.

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