Capillary blood collection device
Patent Information
- Application Number
- JP2026177191
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-06-29
- Filing Date
- 2026-07-23
- Publication Date
- 2026-10-16
Smart Images
Figure 2026169288000001_ABST
Abstract
Description
TECHNICAL FIELD
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority of U.S. Provisional Application No. 63 / 216,245, filed June 29, 2021, entitled "CAPILLARY BLOOD COLLECTION DEVICE", the entire disclosure of which is incorporated herein by reference.
[0002] The present disclosure relates generally 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 squeeze a finger in a controlled manner to collect, stabilize, and dispense 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 performed to collect blood samples for testing. For certain diseases such as diabetes, it is necessary to regularly test the patient's blood, for example, 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 typically involves pricking a finger or other suitable body part to obtain a blood sample. Typically, the amount of blood required for such tests is relatively small, and a small puncture or incision will usually yield a sufficient amount of blood for these tests. Various types of lancet devices have been developed for use in puncturing 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-edged component, such as a blade, used to make a rapid puncture or incision in a patient's skin, resulting in a small flow 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 a patient's skin by activating an activation mechanism. In some devices, the needle or blade remains in a standby 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] One 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 Corporation, 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 pivot 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 testing equipment at the point of care (POC), 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 blood sample collection, including but not limited to maintaining lancet retention during the test, obtaining sufficient blood flow from the puncture site, collecting sufficient blood, and preventing coagulation, can introduce several variability issues that affect capillary blood sample collection. Some of the most common causes of variability in the procedure include: (1) insufficient cleaning or initial droplet removal of the puncture site, which may result in contaminated samples; (2) inconsistent puncture location and depth, which may result in insufficient sample volume or excess 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 hemolyzed samples; (4) variations in transport contact surface or collection technique, which may result in hemolyzed or contaminated samples; and (5) insufficient mixing of sample with anticoagulant, which may result in microthrombi.
[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 procedure 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. Squeezing harder 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. [Overview of the Initiative] [Problems that the invention aims to solve]
[0010] Therefore, this field requires devices capable of incising and squeezing fingers, collecting samples, stabilizing samples, and then distributing them in a controlled manner. Furthermore, this field 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 transport 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 blood collection and transfer from different capillaries, (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 (50-500 microliters or more) while reducing pain, (5) includes a unique sample identifier combined with patient information at the time of 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 sufficiently high 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. [Means for solving the problem]
[0011] This disclosure relates to a device for obtaining biological samples, such as a capillary blood collection device, that meets the above needs and has the ability to pinch a finger, collect a sample, stabilize the sample, and then distribute the sample in a controlled manner. This device also simplifies and streamlines capillary blood collection by eliminating workflow variability commonly associated with poor sample quality, including hemolysis and microthrombi.
[0012] This disclosure includes a self-contained, fully integrated finger-based capillary blood collection device capable of dissecting, 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 that are generally 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 adhesion 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 deposited in the channel or collection container to stabilize the collected sample.
[0013] 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 function as a platform for various capillary collection containers, from small tubes to capillary dispensers, as well as onboard plasma separation modules. This functionality expands the product's flexibility to a variety of applications, such as dispensing into point-of-care (POC) cartridges or transferring into small blood collection tubes usable with centrifuges and analyzers.
[0014] In one embodiment of the present disclosure, an apparatus for acquiring a blood sample may include a holder for receiving a sample source, having an operating part and a port; a blood collection device attachment detachably connected to the holder; and a collection container detachably connected to the blood collection device attachment, wherein the collection container defines a collection space, and the collection container includes at least one filling line provided on the surface of the collection container.
[0015] In one embodiment of the present disclosure, at least one filling line may be configured to indicate when a predetermined amount of blood sample has been filled into the collection container. The collection container may include two filling lines provided on the surface of the collection container. At least one filling line of the collection container may be color-coded. At least one filling line of the collection container may have a lighter shade. At least one filling line of the collection container may have a darker shade.
[0016] In one embodiment of the present disclosure, an apparatus for acquiring a blood sample may include a holder for receiving a sample source, having an operating part and a port, and a blood collection attachment detachably connected to the holder, the blood collection attachment including a flash chamber for indicating when a blood sample has been collected from a patient's finger held in the holder.
[0017] In one embodiment of the present disclosure, the blood collection attachment may be made of a transparent material so that the user of the device can visually identify the blood sample flowing through the blood collection attachment. The blood collection attachment may include light ribs on its inner surface to visually indicate when the blood sample is moving within the blood collection attachment.
[0018] In one embodiment of the present disclosure, the apparatus for obtaining a blood sample may include a holder for receiving a sample source, the holder having an operating part and a port, and a lancet detachably connected to the holder, the lancet detachably connected to the holder being positioned relative to the holder so as to obstruct the patient's view.
[0019] In one embodiment of the present disclosure, the holder's port may be configured to obstruct the patient's view of the lancet. When the lancet is connected to the holder, an audible click may be generated to indicate that a positive connection has been established between the lancet and the holder.
[0020] In one embodiment of the present disclosure, the apparatus for obtaining a blood sample may include a holder for receiving a sample source, having an operating part and a port; a blood collection attachment detachably connected to the holder; and a collection container detachably connected to the blood collection attachment, wherein a label placed on the collection container is oriented to obstruct the patient's view of the internal cavity of the collection container.
[0021] In one embodiment of the present disclosure, the label may be positioned on the collection container below the holder. The label covers part of the collection container so that the patient cannot see the blood sample being guided into the collection container.
[0022] The present invention is also disclosed in the following clauses.
[0023] Clause 1: Apparatus for obtaining a blood sample, comprising: a holder for receiving a sample source, having an operating part and a port; a blood collection device attachment detachably connected to the holder; and a collection container detachably connected to the blood collection device attachment, wherein the collection container defines a collection space, and the collection container includes at least one filling line provided on the surface of the collection container.
[0024] Clause 2: The device according to Clause 1, wherein the at least one filling line is configured to indicate that a predetermined amount of blood sample has been filled into the collection container.
[0025] Clause 3: The device according to Clause 1 or Clause 2, wherein the collection container comprises two filling lines provided on the surface of the collection container.
[0026] Clause 4: The device according to any one of Clause 1 to Clause 3, wherein at least one filling line of the collection container is color-coded.
[0027] Clause 5: The device according to any one of Clause 1 to Clause 4, wherein at least one filling line of the collection container has a light hue.
[0028] Clause 6: The device according to Clause 5, wherein at least one filling line of the collection container has a dark hue.
[0029] Clause 7: A device for obtaining a blood sample, comprising a holder for receiving a sample source, the holder having an actuating portion and a port, and a blood collection device attachment removably connected to the holder, wherein the blood collection device attachment comprises a flash chamber that indicates that the blood sample has been collected from a patient's finger held by the holder.
[0030] Clause 8: The device according to Clause 7, wherein the blood collection device attachment is made of a transparent material so that a user of the device can visually identify the blood sample flowing through the blood collection device attachment.
[0031] Clause 9: The device according to Clause 7 or Clause 8, wherein the blood collection device attachment comprises light ribs on its inner surface for visually indicating when the blood sample is moving through the blood collection device attachment.
[0032] Clause 10: Apparatus for obtaining a blood sample, comprising: a holder for receiving a sample source, the holder having an operating part and a port; and a lancet detachably connected to the holder, the lancet positioned relative to the holder such as to obstruct the view of a patient's lancet detachably connected to the holder.
[0033] Clause 11: The apparatus of Clause 10, wherein the holder's port is configured to obstruct the patient's view of the lancet.
[0034] Clause 12: The apparatus according to Clause 10 or Clause 11, wherein when the lancet is connected to the holder, an audible click sound is produced to indicate that a positive connection has been established between the lancet and the holder.
[0035] Clause 13: Apparatus for obtaining a blood sample, comprising: a holder for receiving a sample source, having an operating part and a port; a blood collection device attachment detachably connected to the holder; and a collection container detachably connected to the blood collection device attachment, wherein a label placed on the collection container is oriented to obstruct the patient's view of the internal cavity of the collection container.
[0036] Clause 14: The apparatus as described in Clause 13, wherein the label is positioned on the collection container below the holder.
[0037] Clause 15: The apparatus described in Clause 13 or Clause 14, wherein the label covers part of the collection container and the patient cannot see the blood sample being sent to the collection container. [Brief explanation of the drawing]
[0038] [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 an apparatus and lancet for collecting 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 an apparatus and sample collection container for collecting a blood sample from a patient's finger, according to another embodiment of the present disclosure. [Figure 3] Figure 3 is a perspective view of the apparatus and lancet shown in Figure 2A. [Figure 4] Figure 4 is a side view of the holder and collection container of Figure 1 according to one embodiment of the present disclosure. [Figure 5] Figure 5 is a perspective view of a holder, blood collection attachment, and collection container according to one embodiment of the present disclosure. [Figure 6] Figure 6 is a side view of the holder, blood collection attachment, and collection container shown in Figure 5. [Figure 7] Figure 7 is a front view of the holder, blood collection attachment, and collection container shown in Figure 5. [Figure 8] Figure 8 is a separated view of the blood collection device attachment of Figure 5 according to one embodiment of the present disclosure. [Figure 9] Figure 9 is a separated view of the blood collection device attachment of Figure 5 according to one embodiment of the present disclosure. [Modes for carrying out the invention]
[0039] 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.
[0040] 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 apparatus 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.
[0041] This disclosure relates to a device for obtaining biological samples, such as a capillary blood collection device, that meets the above needs and has the ability to pinch a finger, collect a sample, stabilize the sample, and then distribute the sample in a controlled manner. This device also simplifies and streamlines capillary blood collection by eliminating workflow variability that is commonly associated with low sample quality, including hemolysis and microthrombi.
[0042] 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 the vascular pressure and the external pressure, increasing the flow velocity from inside the vessel to the outside where the collection container is located. Soft tissues (e.g., fat, skin, and muscle tissue) are perfused with blood, while hard tissues and joints are either poorly perfused or too mechanically stable, so the location of the compression can also be important for painless compression of the patient.
[0043] Red blood cells (RBCs) undergo hemolysis during blood collection. Hemolysis (destruction of red blood cells) causes cellular contents to leak into the serum, staining the serum red with hemoglobin and interfering with colorimetric reactions, thus contaminating the sample for diagnostic analysis. The amount of hemolysis during blood collection depends on cell destruction via shear caused by flow rate and flow path, 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.
[0044] This disclosure includes a self-contained, fully integrated finger-based capillary blood collection device capable of dissecting, 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 that are generally 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 adhesion 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 deposited in the channel or collection container to stabilize the collected sample.
[0045] 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 function as a platform for various capillary collection containers, from small tubes to capillary dispensers, as well as for onboard plasma separation modules. This functionality expands the product's flexibility to various applications, such as dispensing into point-of-care (POC) cartridges or transferring into small blood collection tubes usable with centrifuges and analyzers.
[0046] Referring to Figures 1 and 2A, in exemplary embodiments, the apparatus 10 of the Disclosure includes separate components, for example, a holder 12 (as shown in Figure 1), a lancet housing or lancet 14 (as shown in Figure 2A), and a collection container 16. In another exemplary embodiment, the semi-integrated apparatus 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 apparatus 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 apparatus 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 apparatus of the Disclosure may have in-line flow and may include an integrated holder, a lancet housing, and a collection container.
[0047] 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 appropriate location within the finger receiving portion 20 so that pressure applied to the patient's finger 19 results in adequate blood flow.
[0048] 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.
[0049] 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.
[0050] In one embodiment, the operating part 24 is movable between a first position in which the holder 12 defines a first diameter and a second position in which the holder 12 defines a second diameter, the second diameter being smaller than the first diameter. In another embodiment, the operating part 24 is movable between a first position in which the holder 12 defines a first ellipse shape and a second position in which the holder 12 defines a second ellipse shape, the first ellipse shape being different from the second ellipse shape. In this way, with the holder 12 in the second position with a reduced diameter, a portion of the holder 12 contacts the sample source, and the operating part 24 of the holder 12 can pump and / or extract the blood 18, as will be described in more detail below.
[0051] 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 the sample source, e.g., a finger 19, such that the contact member 34 can make slight contact with it. 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, e.g., 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.
[0052] 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 an embodiment, each tab 38 may include a contact member 34. In one embodiment, the holder 12 includes a molded hinge portion 42. The molded hinge portion 42 allows the user to squeeze the wings 38 between a first position (passive) and a second position (active). By using the tabs or wings 38 to draw blood 18 from the patient's finger 19, hemolysis can be minimized while maintaining adequate blood flow from the patient's finger 19. The resting position of the wings 38 and the hinge are designed to maintain contact and retention with the smallest patient's finger that can fit in the holder 12, while bending to accommodate the largest patient's finger in the holder 12 without blood obstruction.
[0053] Advantageously, the holder 12 of this disclosure allows the user to draw blood 18 from the finger 19 and / or repeatedly squeeze and release the wings 38 to extract it until a desired amount of blood 18 fills the collection container 16. The wings 38 are configured to gently contact a variety of patient finger sizes that may be used with the holder 12 and to bend in order to hold the holder 12 on the patient's finger 19.
[0054] Advantageously, when the holder 12 is attached to the finger 19, the holder 12 defines the incision and finger constriction position without restricting blood flow. The constriction tab or wing 38 provides a predetermined range of constriction pressure that is applied consistently 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.
[0055] 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 finger joints during use of the holder 12.
[0056] 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.
[0057] The apparatus 10 for obtaining a blood sample 18 according to the present disclosure (shown in Figures 4-7) includes a lancet housing or lancet 14 that is detachably connected to a port 26 of a holder 12. Referring to Figure 2A, in one embodiment, the lancet housing 14 includes an inlet 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-operated 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 inlet 50 of the lancet housing 14 to incise a portion of the finger 19.
[0058] 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 Apparatus,” and the entire disclosure is expressly incorporated herein by reference.
[0059] 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.
[0060] Referring to Figure 2A, in one embodiment, the holder 12 and the lancet housing 14 are separate components, and 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 cut 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.
[0061] 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 be incised. The lancet 14 of this disclosure ensures sufficient sample volume to consistently provide the correct puncture depth and predefined puncture location.
[0062] 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.
[0063] 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.
[0064] 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 an incision path, and a blood sample 18 then flows through the blood channel at an angle to the incision path, as described in more detail below.
[0065] 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 make an incision in the skin of the finger 19 along an incision path, and the blood sample 18 then flows through the hollow needle along a parallel blood flow path.
[0066] As shown in Figure 2B, the apparatus 10 for acquiring a blood sample 18 according to the present disclosure (shown in Figures 4-6) 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 18 has been collected into the container 16, the blood collector portion 74 is detached from the blood collection device 10 to send the collected sample 18 to a diagnostic and / or testing device. Once detached from the blood collection device 10, the blood collector portion 74 is sealed via the cap or partition 76, protectively sealing the blood sample 18 within the collection cavity 70.
[0067] 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.
[0068] In one embodiment, the holder 12 and the collection container 16 are separate components, and the container 16 is 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 such that the container engagement portion 72 of the container 16 locks into a locking portion 32 of the holder 12. In this way, the container 16 is securely connected to and locked in the holder 12 so that the blood sample 18 can safely flow from the finger 19 in the holder 12 into the collection cavity 70 of the container 16.
[0069] It will be understood that several types of collection containers 16 may be used with the apparatus 10 of this disclosure. It will also be understood that the collection containers 16 may be associated with separate dispensing units, or that the collection containers 16 may include an integrated dispensing unit for dispensing blood 18 to a testing device.
[0070] Next, with reference to Figure 1, the use of the apparatus 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.
[0071] 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 operated 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.
[0072] To activate the lancet 14 in order to incise the skin of the finger 19, the lancet 14 is pressed against the finger 19, and the retractable mechanism 58 (Figure 2A) of the lancet 14 is activated to incise the finger 19. The lancet 14 of this disclosure ensures sufficient sample volume to consistently provide the correct puncture depth and predefined puncture location.
[0073] After incising the finger 19 and draining the blood 18 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 2B, the container 16 is pushed into the port 26 of the holder 12 so that the container engagement portion 72 of the container 16 locks into the locking portion 32 of the holder 12. In this way, the container 16 is securely connected and locked to the holder 12 so that the blood sample 18 can safely flow from the finger 19 inside the holder 12 into the collection cavity 70 of the container 16.
[0074] Referring to Figure 1, with the 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 wings 38 of the holder 12 until the desired amount of blood 18 fills the collection container 16. Advantageously, with the holder 12 attached to the finger 19, the holder 12 defines the incision and squeezing position on the finger without restricting blood flow. The squeezing tab or wings 38 provide a predefined range of squeezing pressure that is consistently applied across the entire finger 19. In doing so, the holder 12 provides a gently controlled massage of the finger 19 that stimulates blood extraction and minimizes potential hemolysis.
[0075] 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 a first position, the contact member 34 is in a disengaged position, i.e., the contact member 34 is in a first position relative to the sample source, e.g., a finger 19. 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 in a 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 blood 18. For example, when the contact member 34 is in the engaged position, the contact member 34 applies pressure to the sample source.
[0076] Once the desired amount of blood 18 has been collected into the container 16, the blood collection unit 74 is detached from the blood collection device 10 to send the collected sample 18 to a diagnostic and / or testing device. Once removed from the blood collection device 10, the blood collection unit 74 is sealed via a cap or partition 76, protectively sealing the blood sample 18 within the collection cavity 70.
[0077] The apparatus of this disclosure is compatible with any known laboratory equipment, whether the laboratory equipment is off-site or point-of-care. Various point-of-care laboratory equipment is known in the art. Such point-of-care laboratory equipment includes test strips, slides, diagnostic cartridges, or other laboratory equipment for testing and analysis. Test strips, slides, and diagnostic cartridges are point-of-care laboratory equipment that receive blood samples and test the blood for one or more physiological and biochemical conditions. Many point-of-care devices employ a cartridge-based structure, allowing for the analysis of small amounts of blood at the bedside without the need to send samples to a laboratory for analysis. This saves time in obtaining results in the long run, but creates different challenges compared to a highly routine laboratory environment. An example of such a laboratory cartridge is Abbott's i-STAT® laboratory cartridge. Laboratory cartridges like 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. Test results using such cartridges are provided to clinicians quickly.
[0078] 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.
[0079] Any of the devices for obtaining blood samples in this disclosure can be used as a standalone, 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 devices for obtaining blood samples in this disclosure may also include various options for onboard plasma separation. The devices for collecting blood samples in this disclosure may also include a unique sample identifier that can be paired with patient information at the time of collection. The devices for collecting blood samples in this disclosure may also include onboard diagnostic feedback at the time of collection. The devices for obtaining blood samples in 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 source, and processing samples with different sample stabilizers such as anticoagulants.
[0080] The apparatus for obtaining blood samples according to this disclosure significantly simplifies the collection of large volumes of capillary blood from the finger compared to conventional capillary blood collection using a lancet and capillary tube, eliminating the need for advanced skills. The apparatus according to this disclosure eliminates blood exposure and prevents the reuse of the apparatus.
[0081] The apparatus 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 attached to a finger, provides the functions of incision, blood extraction, stabilization, and containment in a single unit.
[0082] The apparatus for collecting blood samples according to this disclosure may be associated with an autonomous unit that provides an automatic pump, controlled finger squeezing, and automatic sample labeling and processing.
[0083] Referring to Figure 3, according to one embodiment of the present disclosure, when the lancet 14 is connected to the holder 12, an audible "click" sound may be generated to inform the user that a secure connection between the lancet 14 and the holder 12 has been achieved. The orientation of the port 26 may be positioned so as to obstruct the patient's view of the lancet 14, resulting in a less stressful interaction for the patient when the patient's finger 19 is punctured by the lancet 14. In one embodiment, the body of the port 26 is positioned above the lancet 14 such that when the lancet 14 is inserted into the holder 12, a portion of the holder 12 also obstructs the view of the lancet 14 and the patient's puncture wound site. In another embodiment, the port 26 may be made of a translucent material so as to allow the user to observe the lancet 14 on the patient's finger 19 and the blood flow from the patient's finger 19 after the lancet 14 has punctured the patient's finger 19. This arrangement allows the user to confirm that sufficient puncture has been achieved in the patient's finger 19 by the lancet 14.
[0084] Referring to Figure 4, according to one embodiment of the present disclosure, a label 80, detachably attached to the collection container 16, can be rotated on the collection container 16 to obstruct the patient's view of the internal cavity of the collection container 16. After the collection container 16 is connected to the holder 12 and the patient's finger 19 is drawn out, the blood sample 18 is guided into the collection container 16. To help the patient remain calm and relaxed, the label 80 can be positioned on the outer surface of the collection container 16 to obstruct the patient's view as the blood sample 18 is guided into the collection container 16. Since many patients are afraid or averse to seeing blood, the position of this label 80 prevents the patient from fainting or becoming uncomfortable upon seeing the blood sample in the collection container 16. In one embodiment of the present disclosure, the label 80 is also positioned so that the user or physician can clearly see the blood sample 18 being guided into the collection container 16. The label 80 must not obstruct the user's or physician's line of sight when looking inside the collection container 16. In one embodiment of the present disclosure, the label 80 can be placed on the outer surface of the collection container 16, which is positioned below the holder 12.
[0085] Referring to Figures 5 to 7, according to one embodiment of the present disclosure, the device 10 may also include a flash function to allow the user or physician to immediately identify that blood flow has been obtained within the device 10. In one embodiment of the present disclosure, the device 10 may include a blood collection attachment that is detachably connected between the holder 12 and the collection container 16. The body of the blood collection attachment 82 may be made of a translucent material so that the user or physician can see the internal cavity of the blood collection attachment 82 and the blood sample 18 within it. Furthermore, ribs provided on the inner surface of the blood collection attachment 82 may function as a light pipe or "flash" function for receiving a portion of the blood sample 18, visually indicating to the user or physician that the blood sample 18 is being guided into the collection container 16. The blood collection attachment 82 may be securely fixed to the holder 12 so that the blood sample 18 can be easily seen.
[0086] Referring to Figures 8 and 9, according to another embodiment of the present disclosure, the collection container 16 of the device 10 may include color-coded filling lines 84 to quickly and efficiently inform the user or physician of the type of collection container 16 inserted into the blood collection attachment 82. As shown in Figure 8, in one embodiment of the present disclosure, the collection container 16 may have filling lines 84 of a lighter shade. As shown in Figure 9, in one embodiment of the present disclosure, the collection container 16 may have filling lines 84 of a darker shade. In one embodiment of the present disclosure, the collection container 16 may include at least two filling lines 84 to assist the user or physician in determining the amount of blood collected in the collection container 16. Using at least two filling lines 84 on the collection container 16 improves the user's experience and adherence to rules when collecting blood samples 18. The distance between the filling lines 84 and the thickness of the filling lines 84 can be adjusted as desired. Furthermore, the position of the filling lines 84 on the collection container 16 can be adjusted to correspond to different desired blood volumes in the collection container 16. The thickness, color, and spacing of the filling line 84 can be optimized for a consistent filling experience to maintain sample quality and additive ratios. In one embodiment of the present disclosure, a user or physician can fill the collection container 16 up to the upper end of the bottom filling line 84. Blood splashes from the patient may occur after the patient has reached the upper end of the bottom filling line 84 and the user or physician has stopped squeezing the wings 38 of the holder 12.
[0087] The aforementioned features of device 10 are aimed at improving the ease of use of the device for people with hemophobia, trypanophobia, collection and color blindness.
[0088] 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, having an operating part and a port, A blood collection device attachment is detachably connected to the holder, A collection container that is detachably connected to the blood collection device attachment, wherein the collection container defines a collection space, and the collection container includes at least one filling line and a label provided on the surface of the collection container, Equipped with, The device wherein the label placed on the collection container is oriented so as to obstruct the patient's view of the collection space in the collection container, while allowing the user of the device to clearly see the collection space in the collection container.
2. The apparatus according to claim 1, wherein the at least one filling line is configured to indicate that a predetermined amount of the blood sample has been filled into the collection container.
3. The apparatus according to claim 1, wherein the collection container comprises two filling lines provided on the surface of the collection container.
4. The apparatus according to claim 1, wherein at least one filling line of the collection container is color-coded.
5. The apparatus according to claim 1, wherein at least one filling line of the collection container has a pale color.
6. The apparatus according to claim 5, wherein the at least one filling line of the collection container has a dark color.