Capillary blood collection device

Abstract

The device for collecting a blood sample comprises a holder for receiving a sample source, the holder having an actuator and a port, a container engagement portion connected to the holder, and a collection container removably connectable to the container engagement portion, the collection container defining a collection cavity, the actuator having at least two wings angled relative to a patient's finger held in the holder to create a pressure gradient toward the tip of the patient's finger.

Description

[[TECHNICAL FIELD]]

[0001] Cross-Reference to Related Application This application claims priority to U.S. Provisional Application No. 63 / 216,223, entitled "Capillary Blood Collection Device", filed on June 29, 2021, the entire disclosure of which is incorporated herein by reference in its entirety. Field of the Invention The present disclosure relates generally to an apparatus for obtaining a biological sample. More specifically, the present disclosure relates to an integrated finger-based capillary blood collection device having the capability of puncturing and compressing a finger, collecting, stabilizing and dispensing a blood sample in a controlled manner. [[BACKGROUND ART]]

[0002] Description of Related Art Devices for obtaining and collecting biological samples such as blood samples are commonly used in the medical industry. One type of blood collection commonly performed in the medical field is capillary blood collection, which is often performed to collect a blood sample for testing. Certain diseases, such as diabetes, for example, require that a patient's blood be tested periodically to monitor the patient's blood glucose level. Furthermore, test kits such as cholesterol test kits often require a blood sample for analysis. Blood collection procedures typically require puncturing a finger or other suitable body part to obtain a blood sample. Typically, the volume of blood required for such tests is relatively small, and usually a small puncture wound or incision provides a sufficient volume of blood for these tests. Various types of lancet devices have been developed that are used to puncture a patient's skin to obtain a capillary blood sample from the patient.

[0003] Many different types of lancet devices are commercially available to individual consumers as well as to hospitals, clinics, hospitals, and others. Such devices typically contain a sharp component, such as a needle or a blade, which is used to make a quick puncture or incision in the patient's skin to cause a small amount of blood to flow out. For many people, pricking their own finger with a handheld needle or blade is often physiologically and psychologically difficult. As a result, lancet devices have evolved into automated devices that puncture or incise the patient's skin when a trigger mechanism is activated. In some devices, the needle or blade is held in a waiting position until it is triggered by a user, which may be a medical professional responsible for drawing blood from the patient or the patient themselves. Triggering causes the needle or blade to puncture or incise the patient's skin, for example, the patient's finger. Often, a spring is incorporated into the device to provide the "automatic" force necessary to puncture or incise the patient's skin.

[0004] One type of contact-actuated lancet device, characterized by automatically extending and retracting a puncture or cutting element from and into the device, is U.S. Patent No. 9,380,975 (Patent Document 1), owned by Becton Dickinson & Company, the assignee of this application. The lancet device includes a housing and a lancet structure having a puncture element. The lancet structure is located within the housing and is 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 located within the housing that biases 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 pivot lever that intercepts and 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, compressing the drive spring at least partially and releasing the lever from interference engagement with the lancet structure. The received blood sample is then collected and / or tested. This testing may be performed in a point-of-care (POC) testing device, and it may also be collected and sent to a testing facility.

[0005] Currently, the capillary blood collection workflow is a complex, multi-step process requiring a high level of skill. The nature of the multiple steps in this process introduces several variability that can lead to sample quality issues such as hemolysis, insufficient sample stabilization, and microcoagulation. The use of a lancet device for collecting blood samples can introduce several variability that affect the collection of capillary blood samples, including, but not limited to, keeping the lancet stationary during the test, obtaining sufficient blood flow from the puncture site, properly collecting blood, preventing blood coagulation, and other conditions. The most common causes of process variability are: (1) improper cleaning of the puncture site and removal of the initial drop, which may result in a potentially contaminated sample; (2) mismatch in puncture location and depth, which may result in a potentially insufficient sample volume and a large fraction of interstitial fluid; (3) inconsistent compression techniques or excessive pressure near the puncture site to facilitate blood collection (e.g., blood milking), which may result in a potentially hemolytic sample; (4) variable transfer interfaces and collection methods, which may result in a potentially hemolytic or contaminated sample; and (5) insufficient sample mixing with anticoagulants, which may result in a potentially microcoagulable sample.

[0006] Capillary blood collection is typically performed either by a healthcare professional manually compressing the tissue surrounding the puncture site with their fingers, or by an instrument that uses vacuum pressure to draw blood from the site.

[0007] Manually compressing the collection site is a highly skill-dependent process that results in very large variability in success rates and sample quality (measured by hemolysis—the rupture of blood cells). Healthcare workers typically adjust the pressure and speed of compression to compensate for differences in blood flow among patients. Stronger compression helps to increase blood flow but also increases hemolysis. The location of compression also varies among healthcare workers depending on personal preference, experience, and hand fatigue. Some workers may even perform a technique called "milking" of the fingers, in which they begin applying pressure at the base of the finger and slide it towards the fingertip. This process is not recommended by national and international health organizations as it leads to a decrease in sample quality.

[0008] Vacuum-applying devices standardize blood flow pressure and technique, but are typically plagued by a reduction in 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 devices operate only at fractions of absolute vacuum. For reference, the average grip strength of men and women ranges from 50 to 100 pounds, which illustrates why manual methods are affected more by hemolysis than by flow. Also, the vacuum method applies a constant pressure, limiting the tissue's ability to refill with blood. [Prior art documents] [Patent Documents]

[0009] [Patent Document 1] U.S. Patent No. 9,380,975 [Patent Document 2] U.S. Patent Application Publication No. 2006 / 0052809 [Overview of the Initiative] [Problems that the invention aims to solve]

[0010] Therefore, in this art there is a need for a device that has the ability to puncture and compress a finger in a controlled manner, collect a sample, stabilize the sample, and then distribute the sample. Also in this art there is a need for a device that simplifies and streamlines capillary blood collection by eliminating workflow variability, which is usually associated with low sample quality, including hemolysis and microcoagulation. Furthermore, in this art there is a further need for a closed-system collection and transfer that eliminates blood exposure and device reuse. Furthermore, in this field, there is a further need for a device that (1) introduces flexibility in accommodating different capillary blood collection and transport containers, (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 volumes of capillary blood samples (>50-500pL) with reduced 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 onboard diagnosis, 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 capillary blood collection devices that include standardized and controlled pressure application, applied pressure that is sufficiently high for adequate blood flow but below the hemolytic threshold, application of a defined rhythmic pressure rather than a constant pressure that allows blood to refill the finger, increased average blood flow, and reduced user fatigue by reducing the maximum force applied by the operator. [Means for solving the problem]

[0011] Summary of the Invention This disclosure relates to devices for obtaining biological samples, such as capillary blood collection devices, which have the ability to meet the above-mentioned needs and to puncture and compress a finger in a controlled manner, collect a sample, stabilize the sample, and then distribute the sample. The devices also simplify and streamline capillary blood collection by eliminating workflow variations that are typically associated with low sample quality, including hemolysis and microcoagulation.

[0012] This disclosure includes a built-in, fully integrated, finger-based capillary blood collection device capable of puncturing, collecting, and stabilizing 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 workflow steps and variability that are typically associated with poor sample quality, including hemolysis, microcoagulation, and patient discomfort. The device comprises an extendable puncture mechanism through which a finger can be punctured, and associated blood channels to ensure adhesion and transfer of capillary blood from the punctured finger site to a collection container. The device also includes a holder that can be periodically compressed to facilitate, i.e., pump, blood flow from the finger, and an anticoagulant is introduced into the channel or collection container to stabilize the collected sample.

[0013] According to one design, the device may consist of separate components such as a holder, lancet, and collection container. According to another design, the lancet and collection container may be integrated into a single device, which is used together with the holder. According to yet another design, the holder, lancet, and collection container may be integrated into a single system. All of these designs are intended to be used as a self-contained, disposable device and / or in combination with an external power supply for pain relief control. The capillary blood collection device can function as a platform for a variety of capillary blood collection containers ranging from small tubes to capillary dispensers, as well as for mounted plasma separation modules. This functionality extends the product's flexibility to a variety of applications, including point-of-care (POC) cartridges or small collection tube transfers that may be used with centrifuges and analytical instruments.

[0014] In one embodiment of the present disclosure, a device for collecting a blood sample comprises a holder for receiving a sample source, the holder having an actuation part and a port, a container engagement part connected to the holder, and a collection container that can be detachably connected to the container engagement part, the container comprising a collection container defining a collection cavity, wherein the actuation part comprises at least two wing portions that are angled with respect to a patient's finger held in the holder and generate a pressure gradient toward the fingertip of the patient's finger.

[0015] In one embodiment of the present disclosure, at least two wings may be positioned in the holder proximal to the nail of the patient's finger and distal to the first joint of the patient's finger. Each of the at least two wings may include a touchpad to ensure that the user presses the wing in a desired position. The holder may include a stabilizing extension provided at the proximal end of the holder. The stabilizing extension may include at least one retaining bump extending inward from the inner surface of the stabilizing extension and in contact with the patient's finger held in the holder. At least one of the at least two wings may include a contact prevention projection extending outward from the outer surface of the wing. The contact prevention projection may be positioned below the touchpad of at least one wing to ensure that the user presses the at least one wing at the touchpad, rather than below the touchpad. The proximal end of the holder may include an outward curved end for receiving the patient's finger. A transition section may be positioned between the holder and the container engagement section to receive at least a portion of the patient's finger during use of the device. The distal end of the holder may include a curved rim for receiving the patient's fingertip while allowing the patient's nail to extend beyond the distal end of the holder. The holder may include a finger rest with at least one bulge on the outer surface of the finger rest to prevent pressure on the arterial blood supply of the patient's finger held in the finger rest.

[0016] In one embodiment of the present disclosure, an apparatus for collecting a blood sample may include a holder for receiving a sample source, the holder having an actuation part and a port, the container engagement part being connected to the holder, and the actuation part having at least two angled wings with respect to the patient's finger held in the holder to generate a pressure gradient toward the fingertip of the patient's finger.

[0017] In one embodiment of the present disclosure, at least two wings may be positioned in the holder proximal to the nail of the patient's finger and distal to the first joint of the patient's finger. Each of the at least two wings may include a touchpad to ensure that the user can securely press the wing in a desired position. The holder may include a stabilizing extension provided at the proximal end of the holder. The stabilizing extension may include at least one retaining bump extending inward from the inner surface of the stabilizing extension and in contact with the patient's finger held in the holder. At least one of the at least two wings may include a contact prevention projection extending outward from the outer surface of the wing. The contact prevention projection may be positioned below the touchpad of at least one wing to ensure that the user grasps at least one wing at the touchpad, not below the touchpad. The proximal end of the holder may include an outward curved end for receiving the patient's finger. A transition section may be positioned between the holder and the container engagement section to receive at least a portion of the patient's finger during use of the device. The distal end of the holder may include a curved rim for receiving the patient's fingertip while allowing the patient's nail to extend beyond the distal end of the holder. The holder may include a finger rest that includes at least one bulge on the outer surface of the finger rest to prevent pressure on the arterial blood supply of the patient's finger held in the finger rest.

[0018] In one embodiment of the present disclosure, an apparatus for collecting a blood sample may include a holder for receiving a sample source, the holder having an actuation part and a port; a container engagement part connected to the holder; a collection container that can be detachably connected to the container engagement part, the collection container defining a collection cavity; and a lancet device detachably connected to the container engagement part, wherein the actuation part comprises at least two wings angled with respect to the patient's finger held in the holder to generate a pressure gradient toward the fingertip of the patient's finger.

[0019] In one embodiment of the present disclosure, a method of operating an apparatus for obtaining a blood sample includes the step of providing the apparatus for operation by a user, the apparatus may comprise a holder for receiving a sample source, the holder comprising an actuating portion having an actuating part and a port, and a container engaging portion connected to the holder, the actuating part comprising at least two wings angled relative to a patient's finger held in the holder to generate a pressure gradient towards the fingertip of the patient's finger, providing the apparatus; pressing the at least two wings together to generate a pressure gradient at the patient's fingertip, the at least two wings being pressed for between 0.25 seconds and 1 second to generate the pressure gradient; holding the at least two wings closed for up to 0.5 seconds; releasing pressure from the at least two wings for up to 0.5 seconds; and holding the at least two wings open for up to 1 second.

[0020] The present invention is also described in the following items.

[0021] Item 1: An apparatus for collecting a blood sample, the apparatus comprising: a holder for receiving a sample source, the holder having an actuating portion and a port; a container engaging portion connected to the holder; and a collection container that can be detachably connected to the container engaging portion, the collection container defining a collection cavity; wherein the actuating portion comprises at least two wings angled relative to a patient's finger held in the holder, the wings generating a pressure gradient towards the fingertip of the patient's finger.

[0022] Item 2: The apparatus according to Item 1, wherein the at least two wings are arranged on the holder at a position proximal to the nail of the patient's finger and distal to the first joint of the patient's finger.

[0023] Item 3: The apparatus according to Item 1 or 2, wherein each of the at least two wings comprises a touch pad that ensures a user can reliably press the wings at a desired position.

[0024] Item 4: The apparatus according to any one of Items 1 to 3, wherein the holder further comprises a stabilizing extension provided at a proximal end of the holder.

[0025] Item 5: The apparatus according to Item 4, wherein the stabilizing extension comprises at least one holding bump extending inwardly from an inner surface of the stabilizing extension to contact a patient's finger held in the holder.

[0026] Item 6: The apparatus according to any one of Items 1 to 5, wherein at least one wing of the at least two wings comprises a contact prevention protrusion extending outward from an outer surface of the wing.

[0027] Item 7: The apparatus according to Item 6, wherein the contact prevention protrusion is disposed below a touch pad of the at least one wing, and ensures that a user grasps the at least one wing at the touch pad instead of below the touch pad.

[0028] Item 8: The apparatus according to any one of Items 1 to 7, wherein a proximal end of the holder comprises an outwardly bent end for receiving the patient's finger.

[0029] Item 9: The apparatus according to any one of Items 1 to 8, wherein a transition portion is disposed between the holder and the container engaging portion, and receives at least a part of the patient's finger during use of the apparatus.

[0030] Item 10: The apparatus according to any one of Items 1 to 9, wherein a distal end of the holder comprises a curved edge for receiving a fingertip of the patient while allowing the patient's nail to extend beyond the distal end of the holder.

[0031] Item 11: The apparatus according to any one of items 1 to 10, wherein the holder includes a finger receiving portion having at least one bulge on the outer surface of the finger receiving portion, and the apparatus prevents pressure on the arterial blood supply of the patient's finger held in the finger receiving portion.

[0032] Item 12: Apparatus for collecting a blood sample, wherein the apparatus comprises a holder for receiving a sample source, the holder having an actuation part and a port, and a container engaging part connected to the holder, the actuation part comprising at least two wings angled with respect to the patient's finger held in the holder to generate a pressure gradient toward the fingertip of the patient's finger.

[0033] Item 13: The apparatus according to Item 12, characterized in that the at least two wing portions are positioned in the holder proximal to the fingernail of the patient's finger and distal to the first joint of the patient's finger.

[0034] Item 14: The apparatus according to item 12 or 13, wherein each of the at least two wing portions includes a touchpad that ensures the user presses the wing portion at a desired position.

[0035] Item 15: An apparatus according to any one of items 12 to 14, wherein the holder further comprises a stabilizing extension provided at the proximal end of the holder.

[0036] Item 16: The apparatus according to Item 15, wherein the stabilizing extension includes at least one retaining bump extending inward from the inner surface of the stabilizing extension and in contact with the patient's finger held in the holder.

[0037] Item 17: A device according to any one of items 12 to 16, characterized in that at least one of the at least two blades includes a contact prevention projection extending outward from the outer surface of the blade.

[0038] Item 18: The device according to Item 17, wherein the contact prevention projection is positioned below the touchpad of the at least one wing portion, ensuring that the user grips the at least one wing portion at the touchpad, rather than below the touchpad.

[0039] Item 19: A device according to any one of items 12 to 18, wherein the proximal end of the holder includes an outwardly curved end for receiving a patient's finger.

[0040] Item 20: The apparatus according to any one of items 12 to 19, wherein a transition portion is positioned between the holder and the container engagement portion, and is capable of receiving at least a portion of the patient's fingers during use of the apparatus.

[0041] Item 21: The apparatus according to any one of items 12 to 20, wherein the distal end of the holder includes a curved edge, allowing the patient's fingernail to extend beyond the distal end of the holder, and the apparatus is characterized in that it receives the patient's fingertip.

[0042] Item 22: The apparatus according to any one of items 12 to 21, wherein the holder includes a finger receiving portion having at least one bulge on the outer surface of the finger receiving portion, and the apparatus prevents pressure on the arterial blood supply of the patient's finger held in the finger receiving portion.

[0043] Item 23: Apparatus for collecting a blood sample, the apparatus comprising a holder for receiving a sample source, the holder having an actuation part and a port, a container engagement part connected to the holder, and a collection container that can be detachably connected to the container engagement part, the collection container comprising a collection container defining a collection cavity and a lancet device detachably connected to the container engagement part, the actuation part comprising at least two wings angled with respect to the patient's finger held in the holder to generate a pressure gradient toward the fingertip of the patient's finger.

[0044] Item 24: A method for operating a device for collecting a blood sample, the method comprising the steps of: providing a device for operation by a user, the device being a holder for receiving a sample source, the holder comprising: a holder having an actuation part and a port; and a container engaging part connected to the holder, the actuation part comprising at least two wing portions angled with respect to the patient's finger held in the holder, and generating a pressure gradient toward the fingertip of the patient's finger; and generating the pressure gradient by pressing the at least two wing portions together to generate a pressure gradient toward the fingertip of the patient, wherein the at least two wing portions are pressed together for a period of 0.25 seconds to 1 second; holding the at least two wing portions closed for a maximum of 0.5 seconds; releasing the pressure on the at least two wings for a maximum of 0.5 seconds; and holding the at least two wings open for a maximum of 1 second. [Brief explanation of the drawing]

[0045] [Figure 1] This is a perspective view of a holder according to one embodiment of the present invention. [Figure 2] Figure 1 is a top view of the holder. [Figure 3] This is a side view of the holder in Figure 1. [Figure 4] This is a front view of the holder shown in Figure 1. [Figure 5] This is a rear view of the holder shown in Figure 1. [Figure 6] This is a graph illustrating the pumping method used by the holder shown in Figure 1. [Figure 7] This is a schematic diagram showing the transition of the holder in Figure 1 between the passive and active states. [Figure 8] This graph shows the measurement of blood production and discomfort when using the holder shown in Figure 1. [Figure 9] This is a perspective view of an apparatus and collection container for collecting a blood sample from a patient's finger, according to another embodiment of the present disclosure. [Figure 10] This is a cross-sectional view of an apparatus and lancet for collecting a blood sample from a patient's finger, according to another embodiment of the present disclosure. [Figure 11] This is a perspective view of an apparatus and sample collection container for collecting a blood sample from a patient's finger, according to another embodiment of the present disclosure. [Modes for carrying out the invention]

[0046] Description of the Invention The following description is provided to enable those skilled in the art to construct and use the described embodiments intended for the implementation of the invention. However, various modifications, equivalents, variations, and substitutes will remain readily apparent to those skilled in the art. All such modifications, variations, equivalents, and substitutes are intended to be within the spirit and scope of the invention.

[0047] In the following, for illustrative purposes, the terms “upward,” “downward,” “right,” “left,” “vertical,” “horizontal,” “upper,” “lower,” “lateral,” and “vertical,” and their derivatives, will be relevant to the present invention as they are oriented in the drawings. However, it should be understood that the present invention may envision alternative modifications and sequences of processes unless explicitly specified otherwise. Furthermore, it should be understood that the specific apparatus and processes shown in the accompanying drawings and described in the following specification are merely illustrative embodiments of the present invention. Accordingly, specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be considered limiting.

[0048] This disclosure relates to a device for obtaining biological samples, such as a capillary blood collection device, which has the ability to meet the above-mentioned needs and to puncture and compress a finger in a controlled manner, collect a sample, stabilize the sample, and then dispense the sample. The device also simplifies and streamlines capillary blood collection by eliminating workflow variations that are typically associated with poor sample quality, including hemolysis and microcoagulation. The device may be used by healthcare professionals, including nurses and physicians, or by patients who self-administer the device.

[0049] Blood collection is fundamentally driven by pressure-driven flow. The device or technique either lowers the pressure outside the blood vessel (vacuum-driven flow) or increases the pressure inside the vessel. Both approaches increase the pressure difference between the vessel and the outside, increasing the flow rate from the inside of the 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 may not be perfused adequately or may be too mechanically stable to compress without causing pain to the patient; therefore, the location of compression can also be important.

[0050] Red blood cells (RBCs) undergo hemolysis during collection. Hemolysis (RBC destruction) contaminates samples for diagnostic analysis by scattering cellular contents into the liquid serum of the sample or by causing the serum to turn red due to hemoglobin, thus interfering with colorimetric reactions. The amount of hemolysis during collection is driven not only by shear destruction of cells due to flow rate and flow path, but also by pressure-driven hemolysis, where physical compression of tissues and blood vessels can damage cells. Therefore, hemolysis can be controlled by ensuring that the applied pressure and flow are not too high at any point on the finger being compressed.

[0051] This disclosure includes a built-in, fully integrated, finger-based capillary blood collection device capable of puncturing, collecting, and stabilizing 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 workflow steps and variability that are typically associated with poor sample quality, including hemolysis, microcoagulation, and patient discomfort. The device comprises an extendable puncture mechanism that can puncture a finger and associated blood channels that ensure the adhesion and transfer of capillary blood from the punctured finger site to a collection container. The device also includes a holder that can be periodically compressed to facilitate, i.e., pump, blood flow from the finger, and an anticoagulant introduced into the channel or collection container to stabilize the collected sample.

[0052] According to one design, the device may comprise separate components such as a holder, lancet, and collection container. According to another design, the lancet and collection container are integrated into a single device, which can be 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 for pain relief control. The capillary blood collection device can function as a platform for various capillary blood collection containers, ranging from small tubes to capillary dispensers, and mounted plasma separation modules. This functionality extends the product's flexibility to a variety of applications, including point-of-care (POC) cartridges and dispensing into small collection tubes that can be used with centrifuges and analytical instruments.

[0053] Referring to Figures 9 and 10, in exemplary embodiments, the apparatus 10 of the Disclosure includes separate components, for example, a holder 12 (shown in Figures 1-5), a lancet housing or lancet 14, and a collection container 16. In another exemplary embodiment, the semi-integrated apparatus of the Disclosure may include an integrated lancet housing and collection container that includes an inclined flow and can be connected to a separate holder. In another exemplary embodiment, the semi-integrated apparatus of the Disclosure may include an integrated lancet housing and collection container that has a horizontal flow and can be connected to a separate holder. In another exemplary embodiment, the integrated apparatus of the Disclosure may include an integrated holder, lancet housing, and collection container that have an inclined flow. In another exemplary embodiment, the integrated apparatus of the Disclosure may include an integrated holder, lancet housing, and collection container that have a horizontal flow.

[0054] Referring to Figures 1-5, 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 (shown in Figure 9), are shown and described. The holder 12 of the present disclosure generally includes a finger receiving section 20 having a first opening 22 (Figure 1), an operating section 24, a port 26 having a second opening 28, and a fingertip guard 30. In one embodiment, the fingertip guard 30 provides a stopper for properly positioning and securing the finger 19 within the holder 12. The fingertip guard 30 further helps ensure 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 results in proper blood flow. In one embodiment of the present disclosure, the fingertip guard 30 may have a curved fingertip rest that ensures the patient's finger 19 stops at the end of the finger receiving section 20 while allowing the patient's fingernail to pass over the end of the finger receiving section 20. The finger rest 20 allows the holder 12 to be used with artificial and natural fingernail styles present in the patient population.

[0055] 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 connects to the finger receiving portion 20. For example, when a finger 19 is received in the holder 12, the port 26 connects to a portion of the finger 19. The holder 12 of this disclosure may be sized to fit any finger size.

[0056] 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 into the port 26.

[0057] 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 one 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. Thus, 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 actuation unit 24 of the holder 12 can pump out and / or draw out blood 18, as will be described in more detail below.

[0058] Referring to Figures 1, 3, and 4, in one embodiment, the actuator 24 includes a contact portion 34. Referring to Figure 7, when the actuator 24 is in a first position, the contact portion 34 is in a disengaged position, i.e., the contact portion 34 is provided in a first position relative to the sample source, e.g., a finger 19, and as a result, the contact portion 34 may be in a state of slight contact with it. Referring to Figure 7, when the actuator 24 is in a second position, the contact portion 34 is in an engaged position, i.e., the contact portion 34 is provided in a second position relative to the sample source, e.g., a finger 19, and as a result, the contact portion 34 is in pressurized contact with the finger 19, and the actuator 24 of the holder 12 can pump out and / or draw out blood 18. For example, when the contact portion 34 is in the engaged position, the contact portion 34 exerts pressure on the sample source.

[0059] Referring to Figures 1-5, in one embodiment, the actuation unit 24 includes a pump unit 36 ​​for applying pressure to a sample source, such as a finger 19. In one embodiment, the pump unit 36 ​​comprises a pair of opposing tabs or wings 38. In such embodiments, each tab 38 may include a contact portion 34. Referring to Figures 1 and 3, in one embodiment, the holder 12 includes a living hinge 42. The living hinge 42 allows the user to press the wings 38 against each other between a first position (passive state) (Figure 7) and a second position (active state) (Figure 7). The use of the tabs or wings 38 to draw blood from the patient's finger 19 minimizes hemolysis while maintaining adequate blood flow from the patient's finger 19. The resting position and hinge of the wings 38 are designed to flex to accommodate the largest patient's finger in the holder 12 without causing blood occlusion, while maintaining contact and retention with the smallest possible patient's finger that can fit into the holder 12. In one embodiment, the wing portion 38 may be positioned on the finger receiving portion 20 at a location proximal to the patient's nail and distal to the patient's first joint, in order to avoid hard tissue on the patient's finger 19.

[0060] Advantageously, the holder 12 of this disclosure allows the user to repeatedly press and release the wings 38 until a desired amount of blood 18 fills the collection container 16, thereby discharging and / or drawing blood 18 from the finger 19. The wings 38 are configured to bend to maintain gentle contact with a range of patient finger sizes and to hold the holder 12 on the patient's finger 19, which can be used with the holder 12. The wings 38 can also provide an active pressure mode to the holder 12. In one embodiment, the wings 38 may have a length, thickness, and angle optimized for an ideal compression pressure on the patient's finger 19. In one embodiment, the position of the wings 38 on the holder 12 ensures that the soft tissue of the patient's finger 19 is placed under pressure while avoiding the hard tissue of the patient's finger 19, such as the patient's joint. Furthermore, in one embodiment, the angle between the wings 38 and the patient's finger 19 is tapered to create a pressure gradient toward the patient's fingertip and assist blood flow from the patient's finger 19. The angle of the wing portion 38 relative to the natural taper of the finger 19 generates a small pressure gradient from the distal end to the proximal end of the finger 19, ensuring that the flow direction is toward the fingertip, while avoiding finger milking in accordance with international best practices for sample quality.

[0061] In one embodiment, the wing portion 38 may also be provided with a touchpad 86 on its outer surface, which is grasped by the user of the holder 12. The touchpad 86 ensures that the user grasps the wing portion 38 in the correct desired position for appropriate gripping pressure, comfort, and hemolysis when drawing blood from the patient's finger 19. In one embodiment, the wing portion 38 may also include a contact prevention projection 88 extending from the outer surface of the wing portion 38. In one embodiment, the contact prevention projection 88 is positioned on the wing portion 38 below the touchpad 86. The contact prevention projection 88 extends outward from the wing portion 38 and is positioned and configured to prevent the user from pressing the wing portion 38 too low or applying excessive pressure to the wing portion 38. The contact prevention projection 88 ensures that the user does not press the wing portion 38 too low so that the wing portion 38 bends in response to the application of appropriate pressure. The user may be instructed to know that once the contact prevention projection 88 is made contact, the user's grip needs to be moved upward closer to the touchpad 86, and the touchpad 86 ensures that appropriate pressure is applied to the patient's finger 19.

[0062] Advantageously, with the holder 12 positioned on the finger 19, the holder 12 defines the puncture site and finger compression site without restricting blood flow. The indentation tab or wing portion 38 defines a predetermined range of pressure that is consistently applied across the entire finger 19. In doing so, the holder 12 provides a gentle, controlled finger massage that facilitates blood extraction and minimizes potential hemolysis.

[0063] Referring to Figure 1, in one embodiment, the holder 12 includes a stabilizing extension 40, which provides additional support for the holder 12 to be securely positioned on the finger 19. In one embodiment, the finger receiving portion 20 includes a plurality of internal gripping members that form a substantially C-shaped member and provide additional gripping and support for the holder 12 to be securely positioned on the finger 19. The stabilizing extension 40 helps maintain contact with the patient's finger 19 while avoiding blood supply and the joints of the patient's finger 19 during use of the holder 12.

[0064] In one embodiment, the finger rest 20 is formed of a flexible material. In some embodiments, the finger rest 20 and the port 26 are formed of a flexible material.

[0065] The apparatus 10 for collecting a blood sample 18 according to the present disclosure includes a lancet housing or lancet 14 which can be detachably connected to a port 26 of a holder 12. Referring to Figure 10, in one embodiment the lancet housing 14 includes an entrance or opening 50, an interior 52, a puncture member 54, an engagement portion 56, an extension mechanism 58, and a drive spring 60. In one embodiment the puncture member 54 is movable between a pre-operation position in which the puncture member 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 member 54 extends through the entrance 50 of the lancet housing 14 and punctures a portion of a finger 19.

[0066] In one embodiment, the lancet 14 of this disclosure is a contact-actuated lancet and may be configured in accordance with the embodiments disclosed in Patent Document 2, filed May 6, 2005, entitled “Contact-Acting Lancet Apparatus,” which is assigned with this application and whose entire disclosure is expressly incorporated herein by reference.

[0067] 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.

[0068] Referring to Figure 10, in one embodiment, the holder 12 and the lancet housing 14 are separate components, and the lancet housing 14 may be removably connected to the port 26 of the holder 12. In such embodiments, the lancet housing 14 includes an engaging portion 56. Referring to Figure 10, in one embodiment, the lancet housing 14 is pushed into the port 26 of the holder 12, and as a result, 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 to and locked in the holder 12, and as a result, the puncture member 54 of the lancet housing 14 can be operated to puncture or insert 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.

[0069] To activate the lancet 14, it is pressed against the finger 19, activating the extension mechanism 58 of the lancet 14 and piercing the finger 19. The lancet 14 of this disclosure consistently achieves the correct puncture depth and a predetermined puncture location, thus ensuring a sufficient sample volume.

[0070] In one embodiment, the lancet 14 includes a drive spring 60 located inside the lancet housing 14 52 to bias the puncture member 54 toward the puncture position. After puncture, the puncture member 54 is immediately retracted and securely fixed inside the lancet housing 14 52.

[0071] In one embodiment, the lancet 14 of the present disclosure is used to puncture the skin of a finger 19, and a blood sample 18 is then squeezed into a collection container 16, as will be described in more detail below.

[0072] In one embodiment, the lancet housing 14 of the present disclosure is used to puncture the skin of a finger 19 along a puncture path, as described in more detail below, and a blood sample 18 then flows down the blood flow path at an angle to the puncture path.

[0073] In one embodiment, the lancet 14 may include a hollow needle. In such an embodiment, the lancet housing 14 of the present disclosure is used to puncture the skin of a finger 19 along a puncture pathway, and the blood sample 18 then flows through the hollow needle along a parallel blood flow path.

[0074] As shown in Figures 9 and 11, the blood sample collection device 10 of the present disclosure includes a collection container 16 which can be detachably connected to a port 26 (shown in Figure 1) of a holder 12. Referring particularly to Figure 11, the collection container 16 defines a collection cavity 70 for receiving a blood sample 18 (shown in Figure 9), a container engagement portion 72, a blood collection portion 74, and a cap or septum 76. Once the desired amount of blood 18 has been collected in the container 16, the blood collection portion 74 is detached from the collection device 10 to send the collected sample 18 to a diagnostic instrument and / or testing device. Once detached from the collection device 10, the blood collection portion 74 is sealed via the cap or septum 76, sealing to protect the blood sample 18 within the collection cavity 70.

[0075] 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.

[0076] In one embodiment, the holder 12 and the collection container 16 are separate components, and the container 16 may be detachably connected to a port 26 of the holder 12. In such an embodiment, the container 16 includes a container engagement portion 72. In one embodiment, the container 16 is pushed into the port 26 of the holder 12, and as a result, the container engagement portion 72 of the container 16 is locked into a locking portion 32 of the holder 12. In this way, the container 16 is securely connected and locked to the holder 12, and as a result, the blood sample 18 can safely flow from the finger 19 in the holder 12 to the collection cavity 70 of the container 16.

[0077] It may be understood that several types of collection containers 16 may be used with the apparatus 10 of this disclosure. It may 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 18 to a testing device.

[0078] Next, with reference to Figures 1-5, 9, and 10, the use of the apparatus 10 of the present disclosure, having individual components such as a holder 12, a lancet housing or lancet 14, and a collection container 16, will be described.

[0079] Referring to Figure 3, first, the desired finger 19 is cleaned, and a holder 12 of the appropriate size for the desired finger 19 is selected and securely positioned on the finger 19. Next, referring to Figure 10, 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, and 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 to and locked in the holder 12, and as a result, the puncture member 54 of the lancet housing 14 can be activated to puncture or insert a sample source, for example, the finger 19. Once the lancet 14 is connected to the port 26 of the holder 12, the lancet connects to the finger 19.

[0080] When it is desired to activate the lancet 14 to puncture the skin of the finger 19, the lancet 14 is pressed against the finger 19, and the extension mechanism 58 of the lancet 14 is activated to puncture the finger 19. The lancet 14 of this disclosure consistently achieves the correct puncture depth and a predetermined puncture position, and thus ensures a sufficient sample volume.

[0081] After the finger 19 is punctured and a flow of blood 18 is generated 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 11, the container 16 is pushed into the port 26 of the holder 12 and the container engagement portion 72 of the container 16 is locked into the lock portion 32 of the holder 12. In this way, the container 16 is securely connected and locked to the holder 12, and as a result, the blood sample 18 can safely flow from the finger 19 in the holder 12 to the collection cavity 70 of the container 16.

[0082] Referring to Figures 7 and 8, once the container 16 is properly secured to the holder 12 for collecting a blood sample 18, the user can repeatedly press and release the wings 38 of the holder 12 to draw and / or draw blood 18 from the finger 19 until the desired amount of blood 18 fills the collection container 16. Advantageously, with the holder 12 positioned on the finger 19, the holder 12 does not restrict blood flow and defines the puncture and finger compression positions. The pressing tab or wings 38 provide a predetermined compression pressure that is consistently applied throughout the entire finger 19. In doing so, the holder 12 provides a gentle, controlled massage of the finger 19 that facilitates blood drawout and minimizes any potential hemolysis.

[0083] For example, referring to Figures 7 and 8, in one embodiment, the actuator 24 includes a contact portion 34. Referring to Figure 7, when the actuator 24 is in the first position, the contact portion 34 is in the disengaged position, i.e., the contact portion 34 is in the first position relative to the sample source, e.g., a finger 19. Referring to Figure 7, when the actuator 24 is in the second position, the contact portion 34 is in the engaged position, i.e., the contact portion 34 is in the second position and is in pressurized contact with the sample source, e.g., a finger 19, and the actuator 24 of the holder 12 can pump out and / or draw out blood 18. For example, when the contact portion 34 is in the engaged position, the contact portion 34 applies pressure to the sample source.

[0084] 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 send the collected sample 18 to a diagnostic instrument and / or testing device. Once removed from the collection device 10, the blood collection unit 74 is sealed via a cap or septum 76 to protect the blood sample 18 within the collection cavity 70.

[0085] The apparatus of this disclosure is compatible with any known laboratory equipment, whether the laboratory equipment is an off-site laboratory or a point-of-care laboratory. Various point-of-care laboratory equipment is known in the art. Such point-of-care laboratory equipment includes laboratory strips, slides, diagnostic cartridges, or other laboratory equipment for testing and analysis. Laboratory strips, slides, and diagnostic cartridges are point-of-care laboratory equipment that receive a blood sample and test one or more physiological and biochemical conditions of that blood. There are many point-of-care equipment that use a cartridge-based structure to analyze small amounts of blood at the bedside without the need to send the sample to the laboratory for analysis. This saves time in obtaining results over a long period of time, but presents a different set of challenges compared to a very conventional laboratory environment. An example of such laboratory cartridges is the Abbott Group's "i-STAT" laboratory cartridge. 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. The results of tests using such cartridges are provided to clinicians quickly.

[0086] The collection container 16 may also contain a sample stabilizer, such as an anticoagulant, to stabilize the blood sample and / or components of the blood sample placed inside it. 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.

[0087] In another exemplary embodiment, the apparatus for collecting a blood sample 18 of the present disclosure includes a holder 12, a lancet housing 14, and a collection container 16, which have an angled flow and are integrated. In such an embodiment, the user does not need to connect a separate lancet housing 14 to a port 26 of the holder 12, remove the lancet 14 after puncturing the skin of the finger 19, and then connect the collection container 16 to a port 26 of the holder 12. Instead, the lancet housing 14 is permanently fixed within the port 26 of the holder 12. The lancet housing 14 includes a blood flow path. The collection container 16 includes a blood collection unit 74 which is fixed to the lancet housing 14 and can be detachably connected to a portion of the lancet housing 14.

[0088] In one embodiment, when the container 16 is connected to the lancet housing 14, the longitudinal axis of the lancet housing 14 is at an angle with respect to the longitudinal axis 104 of the container 16. In one embodiment, the lancet housing 14 is used to puncture the skin of the finger 19 along the puncture path, and the blood sample 18 then flows down the blood flow path at an angle with respect to the puncture path.

[0089] Any of the blood sample collection devices of this disclosure may be used as a self-contained, disposable device and / or in combination with an external power supply for pain relief control. For example, part of holder 12 may include an implantable electrode that receives a signal from an external pain control module and delivers at least one of heat, vibration, or transcutaneous electrical nerve stimulation (TENS) for pain relief control. The blood sample collection devices of this disclosure may also include various options for onboard plasma separation. The blood sample collection devices of this disclosure may also include a unique sample identifier that can be combined with patient information at the time of collection. The blood sample collection devices of this disclosure may also include onboard diagnostic feedback at the time of collection. The blood sample collection devices of this disclosure may also allow for dual collection, e.g., collection of two samples into two separate containers using multiple collection ports, enabling the collection of multiple samples from the same source, and processing of samples with different sample stabilizers such as anticoagulants.

[0090] The blood sample collection device of this disclosure significantly simplifies the collection of large quantities of capillaries from the finger compared to conventional capillary collection using lancets and capillaries, eliminating the need for advanced skills. The device of this disclosure eliminates exposure to blood and prevents the reuse of the device.

[0091] The blood sample collection device of this disclosure simplifies and streamlines the collection process, eliminating the need for advanced technical skills. This is all achieved by a self-contained, closed system device that, after being attached to the finger, will provide the functions of puncture, blood extraction, stabilization, and storage, all in a single unit.

[0092] The blood sample collection apparatus of this disclosure may be associated with a self-contained unit that provides automatic pumping, controlled finger pressing, and automated sample labeling and processing.

[0093] Referring to Figures 1-5, additional embodiments of the holder 12 are shown and described according to various embodiments of the present disclosure. In one embodiment, the holder 12 may include a passive pressure mode that assists in collecting a blood sample 18 from a patient's finger 19. The passive pressure mode is designed to assist and ensure proper positioning of the holder 12 before and during use for blood collection without restricting blood flow. The holder 12 may include an outer curved end 80 provided at the opening 22 of the finger receiving portion 20. The outer curved end 80 may provide a comfortable position for the patient's finger 19 to be placed on, instead of a sharp corner. Alternatively, the outer curved end 80 may include a rounded or curved edge that helps provide a comfortable resting space for the patient's finger 19.

[0094] In one embodiment, the holder 12 may include at least two bulges 82 extending from the outer surface of the finger receiving portion 20. The bulges 82 may have rounded ends and may be configured to prevent pressure on the arterial blood supply of the patient's finger 19 positioned within the finger receiving portion 20.

[0095] In one embodiment, the holder 12 may also include at least one retaining bump 84 provided on the stabilizing extension 40. In one embodiment, the stabilizing extension 40 includes two retaining bumps 84. The retaining bumps 84 extend from the inner surface of the stabilizing extension 40 and engage with and contact the patient's finger 19 when the patient's finger 19 is placed within the finger receiving portion 20. The retaining bumps 84 may have a curved surface to provide a comfortable engagement with the patient's finger 19. The retaining bumps 84 may be provided to secure the holder 12 to the patient's finger 19 without restricting the supply of arterial blood to the patient's finger 19.

[0096] In one embodiment, as shown in Figure 4, the transition 90 from the finger receiving portion 20 to the opening 28 allows the patient's finger 19 to swell under the pressure of the wings 38 pressing against each other without restricting blood flow or causing hemolysis. The transition 90 allows a portion of the patient's finger 19 to extend into the opening 28, and allows the finger to swell under the pressure within the finger receiving portion 20. By allowing this swelling of the patient's finger 19, restriction of blood flow from the patient's finger 19 and hemolysis are avoided.

[0097] Referring to Figure 6, a method of using the holder 12 to collect blood from a patient's finger 19 according to one embodiment of the present disclosure is described. The method of using the holder 12 is described in detail above, but the following disclosure describes specific compression rhythms for using the holder 12 to ensure that an appropriate and desired amount of blood is collected from the patient's finger 19. However, it should be understood that any number of compression rhythms, including faster, slower, more varied, and different pressure rhythms, may be used with the holder 12. In one embodiment, the compression rhythm first involves pressing the wings 38 of the holder 12 toward each other to apply pressure to the patient's finger 19. In one embodiment, the wings 38 are pressed toward each other for a minimum of 0.25 seconds and a maximum of 1 second. In one embodiment, the wings 38 are then held in the closed position toward each other. The wings 38 may be held in the closed position for a maximum of 0.5 seconds. In one embodiment, the wing portion 38 does not have to be held in the closed position; instead, it is pressed into a closed position and then released into an open position. In one embodiment, the wing portion 38 may be released into an open position for 0.5 seconds. Thereafter, the wing portion 38 may be held in the open position for a maximum of 1 second. Alternatively, the wing portion 38 may not be allowed to remain in the open position; instead, after being released from the closed position, it may be pressed into a closed position again.

[0098] As shown in Figure 6, according to one embodiment of the present disclosure, a compression rhythm for the holder 12 is shown and described. The wings 38 can be pressed into a closed position and released into an open position in a pumping manner. It is also conceivable that the wings 38 may be held in the closed position for a period of time before being released into the open position. The wings 38 move between a passive pressure state, which includes the stationary fit of the holder 12 onto the finger 19, allowing the holder 12 to remain firmly in place without restricting blood flow, and an active pressure state, which includes pressure applied by the user and the holder 12, resulting in blood flowing from the finger 19 without hemolysis or damage to the blood sample. In one embodiment of the present disclosure, it is desirable that the user apply a predetermined desired pressure to the wings 38 in order to quickly reach the desired pressure without pressure overshoot. Pressure overshoot is realized by pressing the wings 38 of the holder 12 too quickly. Therefore, a more uniform pressure applied to the wing 38 is desirable to avoid pressure overshoot, which can result in undesirable blood flow from the patient's finger 19. Furthermore, as shown in Figure 6, a slow release of the wing 38 is generally undesirable because it results in a slower refill of blood flow within the patient's finger 19. Instead, a faster release of the wing 38 is desirable to rapidly reduce the pressure on the patient's finger 19 and allow for a faster refill of blood flow through the patient's finger 19. The passive and active pressure modes, and the rhythm of movement between the active pressing state and the passive resting state, work together as a system to control where and how the finger 19 is compressed, providing a blood flow velocity with an average hemolysis of less than 25%, comparable to that of a professional capillary harvesting medical specialist.

[0099] Referring to Figures 7 and 8, different states or positions of the holder 12 are shown to illustrate in detail the blood flow and discomfort associated with the pressure applied to the patient's finger 19. The graph in Figure 8 shows the contact pressure associated with blood production from the patient's finger 19 and the resulting discomfort and pain experienced by the patient due to the increased pressure. The graph shows the pressure applied around the patient's finger while the holder 12 is compressed. The graph shows that the further the pressure is applied around the patient's finger 19 from the lowest layer of dermis, the more pain and discomfort the patient experiences, especially in the hard tissue areas of the finger.

[0100] The holder 12 of this disclosure offers advantages over conventional capillary blood collection devices. The holder 12 is configured to align with the characteristics of the patient's finger 19, ensuring that the holder 12 remains firmly in place and applies pressure to the correct location at all times. This aspect was achieved by analyzing several anatomical sources (width and length of the finger, location of joints and arteries) to limit pressure on soft tissue near the collection site while avoiding pressure on hard tissue and blood vessels. Furthermore, the wings 38 are configured to apply pressure in two stages. The first stage has pressure on the finger, which increases proportionally to the pressure applied. However, as the intensity increases, the wings 38 begin to flex and bend until they make contact and can no longer be displaced. This allows sufficient pressure to have adequate blood flow but limits the maximum pressure to avoid hemolysis. This avoids the problem of medical personnel compression where applying too little pressure makes it more difficult to promote flow and vacuum. The prescribed compression rhythm is also prescribed to allow the fingertip to be refilled with blood. This avoids user variability from manual techniques and consistent pressure from vacuum methods, which do not allow the capillary bed to be refilled.

[0101] The finger-tightening wings 38 further define the pressure position and can be operated in only one direction. The wings 38 also have a pad 86 to facilitate proper finger placement and operator operation, and a contact prevention structure to avoid improper operation. This prevents the use of improper "milking" techniques and ensures the correct operation of the wings 38, both of which contribute to better hemolysis. The wings 38 also function as a lever, which means that the user applies a lower peak force to close the wings 38, instead moving the fingers 19 further during the compression action than direct compression. This changes manual compression from a fatigue-prone small displacement, large force movement to a larger displacement, small force movement that is more suitable for everyday use.

[0102] The device is designed to apply pressure to the soft tissue of the fingertip within an empirically determined hemolytic limit, limiting the localized peak pressure applied to the finger and maximizing the average pressure applied to the entire tissue. Limiting the pressure applied to the soft tissue reduced the maximum force required to generate blood. Reducing the peak pressure applied to individual areas of the finger (sides, top, bottom, etc.) would contribute to hemolysis and patient pain. Maximizing the average pressure ensured that blood flow would still be sufficient for actual capillary blood collection.

[0103] The wing section 38 also acts as a deformable lever, limiting user fatigue and the maximum pressure applied. A lever typically works by exchanging force for displacement, requiring the user to apply pressure over a longer travel distance, but with a much smaller force than directly applying pressure with the fingers. This reduces user fatigue typically caused by the peak force generated.

[0104] However, the wing sections 38 are also designed to bend. When force is first applied to the wing sections 38, the soft tissue of the finger compresses like a sponge, squeezing out the blood. As blood flows out and the soft tissue is further compressed, it hardens and requires a greater force to continue the compression. This compression method reduces the value of blood flow but can contribute significantly to hemolysis because the pressure rises rapidly. When this happens, the force applied to the wing sections 38 also increases proportionally. In this method, the wing sections 38 begin to function as a classic cantilever under point load, and the ends of the wing sections 38 begin to deflect in addition to the angular displacement of the wing sections 38. This causes the wing sections 38 to rapidly come into contact with each other, limiting the total amount of displacement and thus limiting the maximum pressure that can be applied compared to a geometrically rigid, non-flexible wing. The wing sections 38 have the added advantage of deflecting only when the soft tissue is sufficiently compressed, i.e., when blood has been adequately squeezed out of the finger and any further compression pressure would be harmful.

[0105] According to one embodiment of the present disclosure, the patient's finger 19 and / or the holder 12 may be disinfected before use of the device 10 and the holder 12. The purpose of cleaning / disinfection is to minimize the risk of infection or irritation of the collection site after skin puncture and blood collection. The patient's ring finger or middle finger may be the puncture site for the lancet 14. Therefore, before puncturing the patient's finger 19 and / or before inserting the patient's finger 19 into the holder 12, the patient's finger 19 may be disinfected with an alcohol wipe. In some examples, the collection site on the patient's finger, proximal tissue such as adjacent fingers, and the rest of the patient's hand, and / or at least the puncture site and the palm of the patient's hand, along with most of the surrounding area, may be disinfected with an alcohol wipe. 70% isopropyl alcohol and water may be used to disinfect the patient's finger 19 and the holder 12, and 70% ethyl alcohol and water may be used to disinfect the patient's finger 19 and the holder 12. The alcohol may be allowed to dry for at least 10 seconds to ensure evaporation. Complete drying is necessary to prevent additional pain during puncture and to avoid additional sample hemolysis that could lead to a decrease in sample quality.

[0106] In another embodiment of the present disclosure, the holder 12 may be disinfected with an alcohol wipe. In particular, a 70% alcohol wipe may be used to disinfect the holder. The finger rest 20, the working part 24, and all other remaining parts of the holder 12 may be wiped with an alcohol wipe to disinfect the surface of the holder 12. Disinfection of the patient's finger 19 and the holder 12 helps to prevent the introduction or reintroduction of contaminants into or onto the patient's finger 19. Since the puncture site of the patient's finger 19 will be placed within the opening 28 of the holder, there is no need for the disinfected part of the patient's finger 19 to come into contact with the surface of the holder 12, thereby further helping to prevent contamination of the patient's finger 19. In another embodiment of the present disclosure, instead of using an alcohol wipe, a water brush and a 70% alcohol solution dispenser may be used to disinfect the patient's finger 19 and / or the holder 12. In particular, a water brush may be used to wipe the surface of the finger rest 20 and other parts of the holder 12 until a glossy finish is present on the surface of the holder 12, indicating that the holder 12 has been properly disinfected.

[0107] Capillary blood collection is typically performed by a healthcare professional manually compressing the tissue surrounding the puncture site with their finger, or by a device that uses vacuum pressure to draw blood from the site. However, capillary blood collection is an uncommon blood collection technique, particularly for the purpose of core lab panel testing in adults, due to issues of volume and sample quality. Venous puncture and venous blood are the optimal standard, and capillary blood samples are used only as an alternative when venous samples cannot be obtained. A classic example is blood testing of newborns when a large, accessible vein is unavailable for blood collection by venous puncture. In this case, the infant's heel would be targeted, and capillary blood would be obtained using a lancet. Before capillary collection using the heel stick method, the heel is first cleaned. This is most commonly done using alcohol wipes and gauze. However, collection occurs directly within the capillaries, and no finger cuffs or similar devices are used to assist the healthcare professional during sample collection; therefore, there is no device cleaning process.

[0108] Traditional techniques / practices involve using an alcohol wipe to disinfect the sampling site, followed immediately by sample collection, which also applies to venipuncture and conventional capillary sampling. However, this immediate progression to collection can lead to further pain experienced by the patient due to the alcohol sting, and more importantly, it can affect sample quality due to increased hemolysis. This problem can be solved by wiping the wet alcohol spot with gauze, which effectively dries the area but can reintroduce contaminants and increase the risk of infection.

[0109] Disinfection and cleaning of the puncture site reduce the bacterial load and minimize the risk of hospital-acquired infection. The use of alcohol (ethanol or isopropanol) works by dehydrating microorganisms and denaturing proteins upon direct contact. The solution (typically 70% alcohol) is also highly volatile, requiring only a short evaporation time before the disinfected site is clear enough for blood collection. These embodiments, when used correctly, provide an excellent disinfection solution that leaves no residue or artifacts.

[0110] One embodiment of a capillary blood collection device is shown in the accompanying drawings and described in detail above, but other embodiments will be obvious to those skilled in the art and easily fabricated without departing from the scope and spirit of the invention. Therefore, 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 equivalents of the claims should be encompassed within that scope.

Claims

1. A device for collecting blood samples, wherein the device, A holder for receiving a sample source, wherein the holder has an operating part and a port, A container engagement portion connected to the holder, A collection container that can be removably connected to the container engagement portion, wherein the collection container comprises a collection container that defines a collection cavity, The device is characterized in that the operating part comprises at least two wing portions angled in the longitudinal direction of the patient's finger with respect to the patient's finger held horizontally in the holder, the angle between the wing portions and the patient's finger tapering to generate a pressure gradient toward the fingertip of the patient's finger, thereby directing blood flow toward the fingertip.

2. The apparatus according to claim 1, characterized in that the at least two wing portions are positioned in the holder proximal to the fingernail of the patient's finger and distal to the first joint of the patient's finger.

3. The apparatus according to claim 1, wherein each of the at least two wing portions includes a touchpad that ensures the user presses the wing portion against the desired position.

4. The apparatus according to claim 1, wherein the holder further comprises a stabilizing extension provided at the proximal end of the holder.

5. The apparatus according to claim 4, wherein the stabilizing extension includes at least one retaining bump extending inward from the inner surface of the stabilizing extension so as to contact the patient's finger held in the holder.

6. The apparatus according to claim 1, wherein at least one of the at least two wing portions includes a contact prevention projection extending outward from the outer surface of the wing portion.

7. The device according to claim 6, wherein the contact prevention projection is positioned below the touchpad of the at least one wing portion, ensuring that the user grips the at least one wing portion at the touchpad, not below the touchpad.

8. The apparatus according to claim 1, wherein the proximal end of the holder includes an outwardly curved end for receiving the patient's finger.

9. The apparatus according to claim 1, wherein the transition portion is disposed between the holder and the container engagement portion, and the apparatus receives at least a portion of the patient's fingers during use.

10. The apparatus according to claim 1, wherein the distal end of the holder includes a curved edge for receiving the patient's fingertip, while allowing the patient's nail to extend beyond the distal end of the holder.

11. The apparatus according to claim 1, wherein the holder includes a finger receiving portion having at least one bulge on the outer surface of the finger receiving portion, and is characterized in that it prevents pressure on the arterial blood supply of the patient's finger held in the finger receiving portion.

12. A device for collecting blood samples, wherein the device, A holder for receiving a sample source, wherein the holder has an operating part and a port, The holder is equipped with a container engagement portion connected to it, The device is characterized in that the operating part comprises at least two wing portions angled in the longitudinal direction of the patient's finger with respect to the patient's finger held horizontally in the holder, the angle between the wing portions and the patient's finger tapering to generate a pressure gradient toward the fingertip of the patient's finger, thereby directing blood flow toward the fingertip.

13. The apparatus according to claim 12, characterized in that the at least two wing portions are positioned in the holder proximal to the nail of the patient's finger and distal to the first joint of the patient's finger.

14. The apparatus according to claim 12, wherein each of the at least two wing portions includes a touchpad that ensures the user presses the wing portion against the desired position.

15. The apparatus according to claim 12, wherein the holder further comprises a stabilizing extension provided at the proximal end of the holder.

16. The apparatus according to claim 15, wherein the stabilizing extension includes at least one retaining bump that extends inward from the inner surface of the stabilizing extension and contacts the patient's finger held in the holder.

17. The apparatus according to claim 12, characterized in that at least one of the at least two wing portions includes a contact prevention projection extending outward from the outer surface of the wing portion.

18. The device according to claim 17, wherein the contact prevention projection is positioned below the touchpad of the at least one wing portion, ensuring that the user grips the at least one wing portion at the touchpad, not below the touchpad. A device that does this.

19. The apparatus according to claim 12, wherein the proximal end of the holder includes an outwardly curved end for receiving a patient's finger.

20. The apparatus according to claim 12, wherein the transition portion is disposed between the holder and the container engagement portion, and is capable of receiving at least a portion of the patient's fingers during use of the apparatus.

21. The apparatus according to claim 12, wherein the distal end of the holder includes a curved edge, allowing the patient's fingernail to extend beyond the distal end of the holder while receiving the patient's fingertip.

22. The apparatus according to claim 12, wherein the holder includes a finger receiving portion having at least one bulge on the outer surface of the finger receiving portion, and is characterized in that it prevents pressure on the arterial blood supply of the patient's finger held in the finger receiving portion.

23. A device for collecting blood samples, wherein the device, A holder for receiving a sample source, wherein the holder has an operating part and a port, A container engagement portion connected to the holder, A collection container that can be removably connected to the container engagement portion, wherein the collection container defines a collection cavity, The container engagement portion is detachably connected to a lancet device, The device is characterized in that the operating part comprises at least two wing portions angled in the longitudinal direction of the patient's finger with respect to the patient's finger held horizontally in the holder, the angle between the wing portions and the patient's finger tapering to generate a pressure gradient toward the fingertip of the patient's finger, thereby directing blood flow toward the fingertip.

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