Blood collection kit with multiple sizes of blood collection devices, and related sizing systems and methods.

Abstract

A kit of parts for obtaining capillary blood samples includes a plurality of capillary blood collection devices of different sizes and a sizing tool that identifies which of the plurality of blood collection devices to use with a particular patient's finger. Each blood collection device of the plurality of blood collection devices can include a finger holder having a finger receiving portion designed for a unique ideal finger size and configured for use with fingers within a unique size range. Further, the plurality of devices are configured such that a majority of fingers in a patient population fall within one of the unique size ranges of the plurality of capillary blood collection devices.

Description

[Technical Field]

[0001] The present disclosure generally relates to devices for obtaining biological samples. More particularly, the present disclosure relates to finger-based capillary blood collection devices, which may be provided as a set or kit comprising a plurality of devices of different sizes optimized to fit most individuals in a potential patient population. The present disclosure is also directed to systems and methods for determining correct sizing of such blood collection devices. [Background Art]

[0002] The present application claims priority to U.S. Provisional Patent Application No. 63 / 216,230, filed June 29, 2021, entitled "Blood Collection Kit with Blood Collection Devices of Multiple Sizes and Associated Sizing Systems and Methods", the entire disclosure of which is incorporated herein by reference.

[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 a blood sample for testing. Certain conditions, such as diabetes, require that a patient's blood be tested periodically, 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 procedures typically involve pricking 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 a small puncture or incision usually yields a sufficient volume 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 needle-like or blade-like sharp-pointed component used to make a rapid puncture or incision in the patient's skin to provide a small outflow of blood. To simplify capillary blood collection, lancet devices have evolved into automated devices that puncture or cut the patient's skin by the activation of a trigger mechanism. In some devices, the needle or blade remains in a waiting position until triggered by the user. When triggered, the needle or blade punctures or cuts the patient's skin, for example, a finger. Often, a spring is incorporated into the device to provide the "automatic" force required to puncture or cut the patient's skin.

[0005] One type of contact-actuated lancet device, characterized by the automatic ejection and retraction of a puncture or cutting element from and into the device, is U.S. Patent No. 9,380,975, owned by Becton, Dickinson and Company, the assignee of this application. The lancet device 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 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 interferingly engages with the lancet structure. An actuator within the housing swings 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 interfering engagement with the lancet structure. Next, the received blood sample is collected and / or tested. This test can be performed using a Point-of-Care (POC) testing device, or it can be collected and sent to a testing facility.

[0006] The use of lancet devices for capillary blood collection can be complex, requiring a high level of skill from the healthcare professional performing the procedure. The multi-step nature of the capillary blood collection process can introduce several variables that may lead to sample quality issues such as hemolysis, insufficient sample stabilization, and microthrombi. The use of lancet devices to acquire blood samples can introduce several variables that affect capillary blood sample acquisition, including, but not limited to, keeping the lancet still during the examination, obtaining sufficient blood flow from the puncture site, properly collecting the blood, and preventing coagulation. The most common causes of process variability include: (1) insufficient washing of the lanzing site and removal of the first droplet, which can result in potentially contaminated samples; (2) inconsistent lanzing position and depth, which can result in potentially insufficient sample volume and excessive interstitial fluid; (3) inconsistent squeeze techniques or excessive pressure near the lanzing site to facilitate blood collection, which can result in potentially hemolyzed samples; (4) variations in the transfer interface and collection technique, which can result in hemolyzed or contaminated samples; and (5) insufficient sample mixing with anticoagulants, which can result in microthrombi.

[0007] Capillary blood collection devices and assemblies have been developed to simplify the capillary blood collection process, such as finger-based capillary blood collection devices configured to aryten and compress a finger, collect a blood sample, stabilize it, and dispense it in a controlled manner; however, problems related to the quality of the blood sample can still occur. Attempting to perform a blood collection procedure using a device that is not the correct size for the patient's finger can exacerbate such blood sample quality problems. For example, an incorrectly sized blood collection device may apply pressure to the patient's finger in an inaccurate or inconsistent manner, resulting in poor blood flow from the punctured finger. Also, using an incorrectly sized blood collection device for a patient's finger can increase patient discomfort. The blood collection devices, sizing systems, and methods of this disclosure are configured to improve the sizing of blood collection devices to improve the quality of the blood sample. [Prior art documents] [Patent Documents]

[0008] [Patent Document 1] U.S. Patent No. 9,380,975 [Patent Document 2] U.S. Patent Application Publication No. 2019 / 0216380 [Patent Document 3] U.S. Patent Application Publication No. 2019 / 0223772 [Patent Document 4] International Patent Application Publication No. 2020 / 167746 [Overview of the initiative] [Means for solving the problem]

[0009] According to one aspect of the present disclosure, a kit of components for obtaining capillary blood samples includes a plurality of capillary blood collection devices of different sizes and a sizing tool for determining which of the plurality of blood collection devices to use on a particular patient's finger. Each of the plurality of blood collection devices may include a finger holder having a finger receiving portion configured for use on fingers within a specific size range, designed for a particular ideal finger size. Furthermore, the plurality of blood collection devices are configured such that the majority of fingers in a patient population fall within one of the specific size ranges of the plurality of capillary blood collection devices.

[0010] According to another aspect of the present disclosure, a method for performing a plurality of blood collection devices sized for use on the finger sizes of at least the majority of patients in a patient population includes the steps of: determining the inherent size range of each of the plurality of blood collection devices; determining the inherent ideal size of each of the plurality of blood collection devices, wherein the inherent ideal size of each device is within the determined inherent size range of each of the plurality of blood collection devices; and making the plurality of blood collection devices having dimensions corresponding to the determined inherent ideal size of each of the plurality of blood collection devices.

[0011] According to another aspect of the present disclosure, a computer implementation method for determining the correct blood collection device size for a patient's finger includes: receiving at least one image of the patient's finger using at least one computer processor; and processing the received at least one image using the at least one computer processor to determine at least one dimension of the patient's finger. The method further includes causing the at least one computer processor to provide an output device with a visual indication of the plurality of blood collection devices having a unique finger size range for use on the patient's finger, determined at least in part on the determined dimension of the at least one patient's finger and the unique size range of the plurality of blood collection devices.

[0012] Next, non-limiting exemplary embodiments of the embodiments of this disclosure are described in the following numbered sections.

[0013] Item 1. A kit of components for obtaining a capillary blood sample, wherein the kit comprises: A kit comprising multiple capillary blood collection devices of different sizes and a sizing tool for identifying which of the multiple blood collection devices to use on a particular patient's finger, wherein each of the multiple blood collection devices comprises a finger holder with a finger receiving portion configured for use on fingers within a specific size range, which is designed for a specific ideal finger size, and the specific size range of the multiple blood collection devices is selected such that the majority of fingers in a patient population fall within one of the specific size ranges of the multiple capillary blood collection devices.

[0014] Item 2. The kit according to Item 1, wherein the ideal finger size comprises an ideal finger width, an ideal finger height, and / or an ideal finger length, and the inherent size range comprises a range of finger widths, a range of finger heights, and / or a range of finger lengths.

[0015] Item 3. The kit according to item 1 or 2, wherein the finger holder of the blood collection device further comprises an actuation unit and a port.

[0016] Item 4. Each of the blood collection devices is the finger A container engagement portion connected to a holder, and a collection container that can be detachably connected to the container engagement portion, Collection The kit according to claim 3, further comprising: a collection container defining a collection cavity, the operating part comprising at least two wings configured to generate pressure on the patient's finger located within the finger receiving part.

[0017] Item 5. The kit according to any one of items 1 to 4, wherein at least 95% of the fingers of the patients in the patient population are within one of the intrinsic size ranges.

[0018] Item 6. The patient population comprises a population of all adult patients residing in a selected geographical region, wherein the finger sizes of the patient population are , positive conform to a normal distribution, the kit according to any one of Items 1 to 5.

[0019] Item 7. The difference between the maximum value and the minimum value of each of the unique size ranges is equal to each other, the kit according to any one of Items 1 to 6.

[0020] Item 8. The unique ideal finger size of each of the plurality of blood collection devices is equal between the maximum value and the minimum value of each of the unique size ranges, the kit according to Item 7.

[0021] Item 9. The unique size ranges of the plurality of blood collection devices are selected such that the fingers of an equal number of patients in the patient population fall within the unique size range of each of the plurality of blood collection devices, the kit according to any one of Items 1 to 8.

[0022] Item 10. The unique ideal finger size of each of the plurality of blood collection devices is the minimum value of the unique size range of each of the plurality of blood collection devices, the kit according to any one of Items 1 to 9.

[0023] Item 11. The unique ideal finger size of each of the plurality of blood collection devices is the maximum value of the unique size range of each of the plurality of blood collection devices, the kit according to any one of Items 1 to 9.

[0024] Item 12. The unique ideal finger size of each of the plurality of blood collection devices is larger than the median value of the unique size range of each of the plurality of blood collection devices, the kit according to any one of Items 1 to 9.

[0025] Item 13. The unique ideal finger size of each of the plurality of blood collection devices is selected such that the ratio of loose fit to tight fit for finger sizes falling within the unique size range is the same for each of the plurality of blood collection devices, the kit according to any one of Items 1 to 9.

[0026] Item 14. The kit according to any one of items 1 to 13, wherein the kit comprises at least four different sizes of blood collection devices.

[0027] Item 15. The kit according to any one of items 1 to 14, wherein the sizing tool includes a sizing card for size exclusion determination, the sizing card having a plurality of elliptical openings, each of which is sized to correspond to the maximum value of the intrinsic size range of one of the plurality of blood collection devices.

[0028] Item 16. The kit according to item 15, wherein each of the plurality of elliptical openings comprises a major axis corresponding to the maximum finger width and a minor axis corresponding to the maximum finger height of the unique size range of one of the plurality of blood collection devices.

[0029] Item 17. The sizing tool is configured to directly measure at least one of the width, height, and / or length of the patient's finger. A little A kit as described in any one of items 1 through 14, including at least one measuring tool.

[0030] Item 18. The kit according to any one of items 1 to 14, wherein the sizing tool comprises a computer processor configured to receive an image of at least one of the patient's finger, process the received image to determine at least one of the finger width, finger height and / or finger length of the patient's finger, and cause an output device to display instructions on which of the plurality of blood collection devices to use on the patient's finger, determined at least in part on the finger width, finger height and / or finger length of the patient's finger determined by processing the image and the inherent size ranges of the plurality of blood collection devices.

[0031] Item 19. A method for performing a plurality of blood collection devices sized for use on the finger sizes of at least the majority of patients in a patient population, the method comprising: determining an inherent size range for each of the plurality of blood collection devices; determining an inherent ideal size for each of the plurality of blood collection devices, wherein the inherent ideal size for each of the plurality of blood collection devices is within the determined inherent size range for each of the plurality of blood collection devices; and making the plurality of blood collection devices having dimensions corresponding to the determined inherent ideal size for each of the plurality of blood collection devices.

[0032] Item 20. A computer implementation method for determining the correct blood collection device size for a patient's finger, the same as above. Computer implementation A computer implementation method comprising: receiving at least one image of a patient's finger with at least one computer processor; processing the received image with at least one computer processor to determine at least one dimension of the patient's finger; and causing an output device to provide a visual indication of the plurality of blood collection devices having a unique finger size range for use on the patient's finger, determined at least in part based on the determined dimension of the patient's finger and the unique size range of the plurality of blood collection devices. [Brief explanation of the drawing]

[0033] [Figure 1A] Figure 1A is a perspective view of a capillary blood collection device and collection container for obtaining a blood sample from a patient's finger, according to one aspect of the present disclosure. [Figure 1B] Figure 1B is a cross-sectional view of a capillary blood collection device and lancet according to one aspect of the present disclosure. [Figure 1C] Figure 1C is a perspective view of a holder for a capillary blood collection device according to one aspect of the present disclosure. [Figure 1D] Figure 1D is a schematic diagram showing a top view of the holder shown in Figure 1C, which is connected to the patient's finger for performing a blood sampling procedure. [Figure 1E] Figure 1E is another schematic diagram showing a front view of the holder in Figure 1C that is connected to the patient's finger. [Figure 2] Figure 2 is a schematic diagram showing a set of blood collection devices of different sizes that can be used for capillary blood collection from a patient, and a sizing tool for identifying the blood collection device to be used for the patient, according to one aspect of the present disclosure. [Figure 3] Figure 3 is an annotated graph showing an exemplary device size range and an ideal size for a set of devices of different sizes according to one aspect of the present disclosure. [Figure 4] Figure 4 is an annotated graph showing another example of a device size range and ideal size for a set of devices of different sizes according to one aspect of the present disclosure. [Figure 5A] Figure 5A is a flowchart showing the steps of a computer implementation method for sizing a blood collection device according to one aspect of the present disclosure. [Figure 5B] Figure 5B is a schematic diagram of a patient's finger that can be captured by a camera used to determine the dimensions of the finger, according to one aspect of the present disclosure. [Figure 5C] Figure 5C is an example of a screen that can be displayed on an output device that indicates to the user what size blood sampling device should be used on a particular patient's finger, according to one aspect of the present disclosure. [Modes for carrying out the invention]

[0034] The following description is provided to enable those skilled in the art to carry out 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 included within the spirit and scope of the invention.

[0035] Hereafter, for the purpose of explanation, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” and “longitudinal,” and their derivatives, shall be used in the same orientation as in the drawings in relation to the present invention. However, it should be understood that the present invention may take alternative modifications and step sequences unless explicitly specified otherwise. Furthermore, it should be understood that the specific devices and processes shown in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Therefore, the specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be considered limiting.

[0036] This disclosure is directed toward a blood collection device 10 (shown in Figures 1A–E) and / or a set or kit 62 (shown in Figure 2) of the blood collection device 10 that is sized to correctly fit as many patients as possible. As those skilled in the art will understand, with many products that come in different sizes, such as clothing, there is usually no safety concern in having multiple people try them on for a fit. Furthermore, if there is a concern about the correct size, the user or wearer can discard the product rather than continue to use an improperly sized product. However, in the case of medical devices such as the blood collection device 10, safety concerns can arise from using a device 10 that is improperly sized on a patient's finger. Furthermore, discarding a medical device such as the blood collection device 10 because the device is not the correct size for a particular patient is inefficient and increases the cost of such devices and the medical procedures that use the device 10. The devices, systems, and methods disclosed herein aim to improve the sizing of the blood collection device 10 and to ensure that the correct sized blood collection device 10 is used for each patient.

[0037] In one aspect, the disclosure relates to a method for designing and / or manufacturing a capillary blood collection device 10, which includes a finger cuff or holder 12 sized to comfortably fit as many patients in a population (i.e., a normal distribution of adult finger and / or hand sizes) in order to reduce the occurrence of problems that may arise when a capillary blood collection procedure is performed using an improperly sized device 10. For example, if the holder 12 or finger cuff is too loose, the holder 12 or cuff may move or fall off during the blood collection procedure. If the holder 12 or finger cuff is too tight, the device 10 may restrict blood flow or cause discomfort to the patient. As used herein, “population” can refer to a defined subset of humans, such as all adult finger sizes. Adult finger sizes generally follow a normal distribution or a bell curve, as described herein. “Population” can also refer to a subset of humans based on sex (i.e., all male adults), geographical location (i.e., all adults residing in the United States), ethnicity (i.e., all white adults), or any other subset of the population that may be selected by those skilled in the art.

[0038] In another aspect, the disclosure relates to a set or kit 62 of multiple blood collection devices 10 of different sizes (i.e., small devices, medium devices, large devices, and extra-large devices), where each device 10 in the set or kit 62 is configured to be used for a specific size range of finger size (i.e., finger width, height, and / or length). As used herein, the “specific” size range of a device 10 in the set or kit 62 refers to a size range that is different from the size ranges of other devices 10 in the set or kit 62. In some examples, the specific size ranges for the blood collection devices 10 in the set or kit 62 are all different, meaning that the specific size ranges for the devices 10 in the set or kit 62 do not overlap at all. In other examples, the specific size ranges for the devices 10 in the set or kit 62 may overlap by a small amount, such as 5%, 10%, or 15%. Generally, the specific size ranges for the devices 10 in the set or kit 62 are continuous, meaning, for example, that there is no gap in finger size between the small device and the medium device. Furthermore, preferably, the size range is selected such that one of the devices 10 in the set of devices 10 or kit 62 is safe and comfortable to use for at least the majority of the population (i.e., at least 50% of the population), or preferably, the substantial majority of the population (i.e., at least 90%, 95%, 97.5%, or 99%) of the possible finger sizes.

[0039] In another aspect, the disclosure also relates to a method and measuring tool for determining the correct sizing of a blood collection device 10 so that a user can determine which device 10 from a set or kit 62 of blood collection devices 10 to use on a particular patient's finger. The user could be, for example, a trained healthcare professional familiar with blood collection procedures (i.e., a phlebotomist, nurse, or similarly trained healthcare professional). In another example, the user could be a healthcare professional who has no experience with blood collection but is capable of performing minor procedures, such as a pharmacist or pharmacy technician. In yet another example, the user could be a patient using the blood collection device 10 for self-collection of a blood sample. The measuring tool could include, for example, a manually operated measuring tool (i.e., a ruler, caliper, and similar measuring devices), as well as an automated method based on the processing of computer-captured images for determining the precise dimensions of a patient's finger. The measuring instrument could also include sizing cards, rings, loops, and similar instruments for determining the correct sizing based on size exclusions. As will be further described in this specification, “size exclusion” can refer to a method by which correct sizing is determined by inserting the patient’s finger through an opening corresponding to the smallest or largest acceptable finger size for one of the devices 10 in the set of blood collection devices 10 or kit 62. If the patient’s finger does not fit into an opening, an opening corresponding to another device 10 is tried. In this way, the user can determine which size device 10 to use for a particular patient’s finger without determining the exact dimensions of the patient’s finger. Blood sampling device

[0040] An example of a blood collection device 10 having dimensions that can be optimized to properly fit patients within a defined size range is shown in Figures 1A-1E. The blood collection device 10 can be a self-contained, fully integrated finger-based capillary blood collection device capable of examining, collecting, and stabilizing large-volume capillary blood samples of up to 500 microliters or more. The blood collection device 10 can also be a device formed from separable components (i.e., a finger cuff or holder 12, a lance, and a sample container) that can be connected and / or used together to acquire a blood sample. Several additional exemplary capillary blood collection devices and assemblies that can be modified for use with the systems and methods of this disclosure are described in U.S. Patent Application Publication No. 2019 / 0216380, entitled “Device for Obtaining a Blood Sample,” U.S. Patent Application Publication No. 2019 / 0223772, entitled “Device for the Attached Flow of Blood,” and International Patent Application Publication No. 2020 / 167746, entitled “Capillary collector with rotatable connection,” each of which is incorporated herein by reference in its entirety.

[0041] Referring to Figures 1A and 1B, an exemplary blood collection device 10 includes an integrated holder 12 (also referred to herein as a finger cuff), a lancet housing or lancet 14 (shown in Figure 1B) for puncturing the patient's finger 19 (shown in Figures 1D and 1E), and a collection container 16 (shown in Figure 1A). In other examples, the blood collection device 10 may be provided as a semi-integrated device 10, for example, including an integrated lancet housing 14 and collection container 16 that can be connected to a separate holder 12. In other examples, the semi-integrated device may have inline flow, as well as an integrated lancet housing and collection container that can be connected to a separate holder.

[0042] The holder 12 is configured to receive a sample source, such as a patient's finger 19, for supplying a biological sample, such as a blood sample. As shown in Figures 1C-1E, the holder 12 generally includes a finger receiving section 20 having a first opening 22, an operating section 24, a port 26 having a second opening 28, and a fingertip guard 30. The first opening 22 may have a width W1 (shown in Figures 1D and 1E) corresponding to the maximum finger width of the finger 19 usable with the device 10. The first opening 22 may also have a height H1 (shown in Figure 1E), which corresponds to the maximum finger height of the finger 19 usable with the device 10. The finger receiving section 20 may also have a length L1 (shown in Figure 1D), which corresponds to the maximum finger length of the finger 19 usable with the device 10 (i.e., finger length from fingertip to second knuckle). If the patient's finger 19 is larger than the width W1, height H1, and / or length L1, then a different size blood collection device 10 and / or holder 12 should be used for that patient.

[0043] The fingertip guard 30 is configured to provide a stopper for properly aligning 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 rest 20 so that the pressure applied to the patient's finger 19 provides sufficient blood flow. The fingertip guard 30 may have a curved fingertip rest that ensures the patient's finger 19 is securely held in place at the end of the finger rest 20, while allowing the patient's fingernail to clear the end of the finger rest 20. The finger rest 20 allows the holder 12 to be used with the styles of artificial and natural fingernails present in the patient population.

[0044] A first opening 22, having a width W1 and a height H1, is configured to receive a sample source, such as a finger 19. The sample source may also include other parts of the body that can fit into the first opening 22, such as a toe or other limb. A port 26 communicates with the finger receiving portion 20. For example, when a finger 19 is received in the holder 12, the port 26 communicates with a portion of the finger 19. As will be described in more detail herein, the holder 12 can be sized for use in a specific subset of patients. For example, a small holder 12 may be appropriately sized for the lower quarter of patients. Medium and large holders 12 can be sized for use in the middle lower quarter (25% to 50%) and the middle upper quarter (50% to 75%) of patients, respectively.

[0045] The second opening 28 of port 26 is configured to receive a lancet housing or lancet 14 (shown in Figure 1B) and a collection container 16 (shown in Figure 1A). In some examples, port 26 further includes a locking mechanism 32 for securely receiving the lancet housing or lancet 14 and the collection container 16 into port 26.

[0046] The actuation part 24 of the device 10 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. Furthermore, in the first position, the holder 12 defines a first ellipse shape. In the second position, 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 (i.e., the finger 19), and the actuation part 24 of the holder 12 can pump and / or extract blood, as will be described in more detail below.

[0047] In some examples, the actuation unit 24 includes a contact member 34. When the actuation unit 24 is in a first position, the contact member 34 is in a released position, i.e., the contact member 34 is positioned in a first position relative to the sample source such that the contact member 34 can make slight contact with it. When the actuation unit 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 finger 19, so that the contact member 34 makes pressurized contact with the finger 19, and the actuation unit 24 of the holder 12 can pump and / or extract blood. For example, when the contact member 34 is in the engaged position, the contact member 34 applies pressure to the sample source.

[0048] In some examples, the actuation section 24 includes a pumping member 36 for applying pressure to the finger 19, such as a pair of opposing tabs or wings 38. Each wing 38 may include a contact member 34. The holder 12 may also include a living hinge section 42. The living hinge section 42 allows the user to squeeze the wings 38 between a first position (passive) and a second position (active). Using the tabs or wings 38 to draw blood from the patient's finger 19 is considered to minimize hemolysis while maintaining sufficient blood flow from the patient's finger 19. The stationary position and hinge of the wings 38 are designed to maintain contact and retention with the smallest patient's finger that can fit into the holder 12, while bending to accommodate the largest patient's finger within the holder 12 without blood occlusion. In some examples, the wings 38 may be positioned on the finger receiving section 20 at a location proximal to the patient's nail and distal to the patient's first joint to avoid hard tissue on the patient's finger 19.

[0049] The holder 12 can be configured to allow the user to repeatedly squeeze and release the wings 38 to pump and / or extract blood from the finger 19 until a desired amount of blood fills the collection container 16. The wings 38 are configured to flex to maintain gentle contact with a range of the patient's fingers that may be used with the holder 12 and to hold the holder 12 on the patient's finger 19. The wings 38 may also provide an active pressure function to the holder 12.

[0050] In some examples, the holder 12 may include a stabilization extension 40, which provides additional support for securely positioning the holder 12 on the finger 19. In one example, the finger receiving portion 20 forms a generally C-shaped member and includes multiple inner gripping members to provide additional grip and support for securely positioning the holder 12 on the finger 19. The stabilization extension 40 helps maintain contact between the holder 12 and the patient's finger 19 during use, while avoiding the blood supply and joints of the patient's finger 19.

[0051] The blood collection device 10 for obtaining a blood sample also includes a lancet housing or lancet 14 (shown in Figure 1B) that is detachably connected to a port 26 of the holder 12. Referring to Figure 1B, the lancet housing or lancet 14 may include an entrance or opening 50, an interior 52, a puncture element 54, an engagement portion 56, a retractable mechanism 58, and a drive spring 60. The puncture element 54 is movable between a pre-actuated position in which the puncture element 54 is held within the interior 52 of the lancet housing 14 and a puncture position in which at least a portion of the puncture element 54 extends through the entrance 50 of the lancet housing or lancet 14 and punctures a portion of the finger 19. In one example, the lancet 14 of this disclosure is a contact-activated lancet and may be configured according to the features disclosed in U.S. Patent No. 9,380,975, titled "Contact Activated Lancet Device," which is incorporated herein by reference in its entirety.

[0052] In some examples, the holder 12 and the lancet housing or lancet 14 are separate components that can be detachably connected to the port 26 of the holder 12. In such examples, the lancet housing or lancet 14 includes an engaging portion 56. The lancet housing or lancet 14 can be pushed into the port 26 of the holder 12 such that the engaging portion 56 of the lancet housing or lancet 14 locks 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 so that the puncture element 54 of the lancet housing 14 can be operated to puncture or puncture a sample source, e.g., a finger 19. In some examples, 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.

[0053] To activate the lancet 14, the lancet 14 is pressed against the finger 19, activating the retractable mechanism 58 and drive spring 60 of the lancet 14, causing the finger 19 to puncture. After puncture, the puncture element 54 is immediately retracted and securely fixed inside the lancet housing 14 52. Once the finger 19 is punctured, a blood sample is squeezed from the finger 19 into the collection container 16. The collection container 16 may also contain a sample stabilizer, such as an anticoagulant, to stabilize the blood sample and / or the components of the blood sample placed within it. The collection container 16 may also contain at least one filling line corresponding to a predetermined amount of sample. The collection container 16 may display / measure the amount of blood collected.

[0054] To use the capillary blood collection device 10 shown in Figure 1A-1E, first wash the desired finger 19, select a holder 12 of the appropriate size for the desired finger 19, and firmly place it on the finger 19. Next, the lancet housing or lancet 14 is connected to the port 26 of the holder 12. As previously mentioned, the lancet housing or lancet 14 is pushed into the port 26 of the holder 12 so that the engaging portion 56 of the lancet housing or lancet 14 is locked into the locking portion 32 of the holder 12. In this way, the lancet housing or lancet 14 is securely connected and locked to the holder 12 so that the puncture element 54 of the lancet housing 14 can be operated to aryten or puncture the finger 19. With the lancet 14 connected to the port 26 of the holder 12, the lancet 14 communicates with the finger 19.

[0055] If 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 to activate the retractable mechanism 58 of the lancet 14 to puncture the finger 19. After puncturing the finger 19 and generating blood flow from the finger 19, the lancet 14 is removed from the holder 12 and the collection container 16 is pushed into the port 26 of the holder 12. With the container 16 properly secured in the holder 12 for blood sample collection, the user repeatedly squeezes and releases the wings 38 of the holder 12 to pump and / or extract blood from the finger 19 until the desired amount of blood is collected in 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 lancening and finger squeezing positions. The squeezing tab or wings 38 provide a predetermined range of squeezing pressure that is consistently applied across the entire finger 19. In doing so, the holder 12 provides a gentle, controlled finger massage that stimulates blood extraction and minimizes potential hemolysis.

[0056] Once the desired amount of blood has been collected in the container 16, the blood collector unit, including the collection container 16, can be removed from the collection device 10 to send the collected sample to a diagnostic device and / or testing device. To protect the blood sample in the collection container 16, the blood collector unit, once removed from the blood collection device 10, can be sealed via a cap or septum. Multiple sizes of capillary blood collection sets or kits

[0057] The holder 12 and blood collection device 10 described above offer advantages over conventional capillary blood collection devices. In particular, the holder 12 is configured to conform to the characteristics of the patient's finger, ensuring that the holder 12 remains consistently and securely in place and applies pressure to the correct location. This feature is achieved by analyzing several anatomical sources (width and length of the finger, location of finger joints and arteries) to limit pressure on soft tissue near the collection site while avoiding compression of hard tissue or blood vessels. Furthermore, the wing 38 is configured to apply pressure in two stages. In the first stage, the pressure on the finger increases proportionally to the applied pressure. However, as the intensity increases, the wing 38 begins to flex and bend until it can no longer be displaced further. This two-stage pressure application provides sufficient pressure to ensure adequate blood flow, but the maximum pressure is limited to avoid hemolysis.

[0058] To achieve these advantages in how pressure is applied to the finger 19 during blood collection, it is important that the holder 12 is the correct size for the patient's finger, that is, that the holder 12 is neither too loose nor too tight for it to function properly. For example, if the holder 12 is too loose, it may move around or come off the finger 19 during blood collection. If the holder 12 is too tight, it may restrict blood flow or cause discomfort to the patient.

[0059] Since it is not practical to manufacture holders 12 in an unlimited number of sizes, the set or kit 62 includes a discrete number of holders 12 of different sizes. For example, as shown in Figure 2, the set or kit 62 of blood collection devices 10a, 10b, 10c, 10d could include device 10a with a small-sized holder 12a, device 10b with a medium-sized holder 12b, device 10c with a large-sized holder 12c, and device 10d with an extra-large-sized holder 12d. The different-sized devices 10a, 10b, 10c, 10d are designed to fit different inherent size ranges of finger size. For example, the different sizes of devices 10a, 10b, 10c, 10d may be made to fit individuals with different finger lengths (i.e., the distance between the fingertip and the second joint of the finger used in the puncture procedure) and / or different finger widths and / or heights. In particular, the sizes of the different components of devices 10a, 10b, 10c, and 10d, for example, the width W1 and / or height H1 of the first opening 22 and / or the length L1 of the finger rest 20, can be different for each size of device 10a, 10b, 10c, and 10d to accommodate a specific size range.

[0060] As described above, the inherent size ranges of devices 10a, 10b, 10c, and 10d are selected so that the majority, or preferably substantially majority, of the fingers in a patient population fall within one of the inherent size ranges of the blood collection devices 10a, 10b, 10c, and 10d. Furthermore, as will be described in more detail below, the inherent size ranges of devices 10a, 10b, 10c, and 10d of different sizes may be optimized, for example, based on the normal population distribution of finger sizes, to ensure that one of the devices 10a, 10b, 10c, and 10d comfortably fits as many finger sizes as possible in the population.

[0061] Continuing to refer to Figure 2, the set or kit 62 may also include a sizing tool 64 for determining which of several blood sampling devices 10a, 10b, 10c, and 10d to use for a particular patient's finger 19. In some examples, the sizing tool 64 is a measuring tool 66, such as a ruler or caliper, for directly measuring the dimensions of the patient's finger 19. In particular, the measuring tool 66 is configured to come into direct contact with the patient's finger 19 to obtain measurements of the patient's finger 19 (i.e., width, height, and / or length). In other examples, the sizing tool 64 may be a computer device 68 that includes a computer processor for processing an image of the patient's finger 19 to determine the dimensions of the patient's finger 19, as will be described in more detail below. In other examples, as will be described in more detail below, the sizing tool 64 is a sizing card 70 configured to determine appropriate sizing information for the patient's finger 19 by size exclusion. Methods for optimizing the size range

[0062] The dimensions of the different sizes of devices 10a, 10b, 10c, and 10d can be determined, for example, from size charts and other anatomical data of average-sized adult and / or pediatric patients. For example, the smallest device 10a can be sized to fit the finger width, height, and / or length corresponding to the 25th percentile of an average adult. Similarly, the medium device 10b can be sized for a person whose hand and / or finger size falls between the 25th and 50th percentiles, the large device 10c can be sized for a person whose hand and / or finger size falls between the 50th and 75th percentiles, and the extra-large device 10d can be sized for a person whose finger size falls between the 75th and 100th percentiles. In some examples, the size range of devices 10a, 10b, 10c, and 10d can be further optimized, for example, to minimize the mismatch between the holder size and the person's finger size for as many individuals as possible in a population. In other examples, the size range can be optimized so that substantially equal numbers of people in a group use each of the device sizes 10a, 10b, 10c, and 10d.

[0063] The inventors have determined numerous methods for determining the unique size range of each blood collection device 10a, 10b, 10c, 10d in set 62, and for determining the dimensions (i.e., width W1, height H1, and / or length L1) of the holders 12a, 12b, 12c, 12d for each blood collection device 10a, 10b, 10c, 10d in set 62.

[0064] One simple solution for determining the size is to determine the range of human finger dimensions from minimum to maximum for the entire patient population and divide that range equally based on the total number of devices 10a, 10b, 10c, and 10d in the set or kit 62. For example, if the expected range of finger width for the population is 10.0 mm to 20.0 mm and the set 62 contains four different sizes of capillary blood collection devices 10a, 10b, 10c, and 10d, then the size range (i.e., the difference between the maximum and minimum values ​​for each intrinsic size range) could be 2.5 mm for each blood collection device 10a, 10b, 10c, and 10d. For example, the size range of finger width could be small (10 mm to 12.5 mm); medium (12.6 mm to 15.0 mm); large (15.1 mm to 17.5 mm); and extra-large (17.6 mm to 20.0 mm). Furthermore, each device 10a, 10b, 10c, and 10d can be designed to a precise dimension, referred to herein as the “inherent ideal finger size” dimension, for fingers having widths that fall between the inherent size ranges of each device 10a, 10b, 10c, and 10d. Specifically, the small device 10a can be designed to fit an inherent ideal finger width of 11.25 mm. The medium device 10b can be designed to fit an inherent ideal finger width of 13.75 mm. The large device 10c can be designed to fit an inherent ideal finger width of 16.25 mm. The extra-large device 10d can be designed to fit an inherent ideal finger width of 18.75 mm. This size distribution ensures that, for any finger width in the entire population (10.0 mm to 20.0 mm), the patient’s actual finger width is within ±1.25 mm of the inherent ideal finger width for one of the devices 10a, 10b, 10c, and 10d. Therefore, each patient is more likely to find a suitable device than if a single general-purpose device were used for all patients and finger widths. Furthermore, as will be understood by those skilled in the art, within the scope of this disclosure, it is possible to perform the same process to design devices 10a, 10b, 10c, and 10d for a range of finger height and / or finger length sizes.

[0065] Referring to Figure 3, the drawback of this simple approach to determining the size range and ideal finger size for each device 10a, 10b, 10c, and 10d is that the finger sizes of the population generally follow a normal distribution or a bell curve, meaning that the majority of patients' finger sizes (width, height, and / or length) are close to the mean (50th percentile) finger size. Therefore, if the entire finger size range of the population is divided into three or four unique size ranges for different devices 10a, 10b, 10c, and 10d, the majority of patients will use the intermediate size of the device, and fewer patients will use the outer (i.e., smallest or largest) size of the device.

[0066] Furthermore, applying this simple approach to determine the unique size range and unique ideal size for each device 10a, 10b, 10c, and 10d, the percentage of patients with a loose or tight fit will differ for the different devices 10a, 10b, 10c, and 10d in the set or kit 62. For example, as shown in Figure 3, for the medium-sized device 10b, device 10b is tight for 60% of users and loose for 40% of users. In contrast, for the large device 10c, device 10c is loose for 60% of users and tight for 40% of users. Such inconsistent sizing experiences can confuse users, such as healthcare professionals, leading to perceptions that certain sizes are too tight or too loose, and potentially requiring adjustments outside of the recommended size range. For example, users may come to believe that the medium-sized device 10b is often too tight for patients, leading them to use the large device 10c for some patients, even though such sizing is actually inappropriate.

[0067] Referring to Figure 4, another method for determining the intrinsic size range and intrinsic ideal finger size (width, height, and / or length) of each device 10a, 10b, 10c, and 10d involves an optimization algorithm based on a population-weighted size distribution to better fit the majority of patients. As shown in Figure 4, the optimization method produces a smaller size range (i.e., a smaller difference between the maximum and minimum values ​​of the size range) for the intermediate devices (i.e., medium-sized device 10b and large device 10c) than for the outer devices (i.e., small device 10a and extra-large device 10d). Specifically, the intrinsic size range of each device 10a, 10b, 10c, and 10d can be optimized so that the same number of people (i.e., 25% of the population) or substantially the same number of people (i.e., 20% to 30% of the population) use each device 10a, 10b, 10c, and 10d in the set of 62. Beneficial in this way, changing the size range ensures that patients are distributed equally or substantially equally across device sizes, enabling more balanced production and use of device sizes.

[0068] Furthermore, as shown in Figure 4, the ideal finger size for each device 10a, 10b, 10c, and 10d is not in the middle of the size range, as in Figure 3. Instead, the ideal finger size specific to each device 10a, 10b, 10c, and 10d is weighted based on the population distribution so that the loose-fit / tight-fit ratio is the same for all devices 10a, 10b, 10c, and 10d. For example, as shown in Figure 4, the ideal finger size specific to each device 10a, 10b, 10c, and 10d can be selected such that each device 10a, 10b, 10c, and 10d is loose for 75% of the size range and tight for 25% of the finger sizes within each size range. In contrast, in the example in Figure 3, the loose-fit / tight-fit ratio differs for each device 10a, 10b, 10c, and 10d, which could cause confusion for users, such as healthcare professionals, and / or lead them to disregard the sizing recommendations provided by the sizing tools and methods of this disclosure.

[0069] The optimization of the size ranges and ideal finger sizes for devices 10a, 10b, 10c, and 10d can be achieved by an iterative method and penalty function based on the misfit between randomly selected finger sizes and ideal finger sizes. In some examples, the calculated misfit can be weighted based on the population distribution. Furthermore, optimization may occur with additional solution constraints, such as preventing misfits greater than a certain threshold for each size range and / or forcing a loose / tight ratio, as previously mentioned. Beneficially, the optimization method balances the size ranges by population and fit, giving a good fit to the maximum possible number of patients. Moreover, the optimization method can balance the ideal finger sizes specific to each device to ensure that each size has a similar population distribution of loose and tight fits.

[0070] More specifically, the optimization method involves calculating how much a random finger size differs from the ideal finger size for a particular blood collection device. Using this approach, a misfit penalty is calculated for each possible finger size within each size range. As used herein, “misfit” refers to the difference between a randomly selected finger size and the dimensions (finger width, height, and / or length) of holders 12a, 12b, 12c, and 12d. The misfit penalty can be calculated in various ways. For example, the misfit penalty can be based on an absolute misfit for each random finger size within the range. The misfit penalty can also be based on a population-weighted misfit that takes into account both the absolute misfit for each random finger size and the frequency of the random finger size within the population. Therefore, the population-weighted misfit penalty can be large for small differences between the random finger size and the ideal finger size if the random finger size is very common within the population. If random finger sizes occur rarely within a population, and there is a large difference between random finger sizes and ideal finger sizes, the population-weighted misfit penalty may be relatively small.

[0071] To optimize the unique size range and unique ideal finger size of each device 10a, 10b, 10c, 10d in a set or kit 62, a mathematical algorithm or approach attempts to minimize the misfit penalty for all possible finger sizes within each size range. The final result of such optimization is, preferably, to provide a set or kit 62 of blood collection devices 10a, 10b, 10c, 10d of different sizes and to ensure that: (i) all fingers do not exceed a certain maximum level of misfit for at least one of the available device sizes; (ii) the majority of patient finger sizes within each size range are as close as possible to the ideal finger size for that size range; (iii) for a consistent collection experience, the proportion of patients with a loose fit or a tight fit is the same across all device sizes; and / or (iv) each device size achieves a blend of maximum and / or average misfits.

[0072] In some examples, size range optimization can be calculated by following the steps of the optimization loop: (i) set and / or adjust the unique size range for each device 10a, 10b, 10c, 10d in set 62; (ii) set and / or adjust the unique ideal finger size for each device 10a, 10b, 10c, 10d in set 62; (iii) calculate the misfit for all possible finger sizes within each size range; (iv) multiply each calculated misfit by the likelihood of the finger size (based on the collective distribution); (v) sum up the misfit penalties for the size range over all possible finger sizes within the size range. (vi) calculate; (vii) sum the misfit penalties to determine the total misfit penalty for all devices 10a, 10b, 10c, and 10d in the set or kit 62; (vii) compare the total misfit penalty for all devices 10a, 10b, 10c, and 10d in the set or kit 62 to the previous iteration of the optimization loop; (viii) if the difference between the current iteration and the previous iteration is small (i.e., less than a given value), complete the optimization loop; if the difference between the current iteration and the previous iteration is large (i.e., greater than a given value), adjust the loop inputs (size range for each range and / or ideal finger size) and rerun the optimization loop.

[0073] The optimization loop or model can be mathematically represented by a summation equation that includes the following inputs: the distribution of finger measurements of interest (e.g., finger width, height, and / or length) for the population; the percentage of the distribution covered by the model (e.g., excluding the minimum and maximum 2% of fingers for the population); the number of device sizes / ranges included in the set or kit 62; and optionally, constraints on the ideal finger size for each device.

[0074] In some cases, mathematical optimization models can be driven by the following fundamental equations:

[0075]

number

[0076] The variables in the equation above refer to the following inputs: the ideal finger size for each device (DeviceSize), a random finger size within the size range of each device (x), and the probability of a particular finger size based on the population finger size distribution (PDF(x)). As this function shows, the calculated sum of misfits is weighted based on the population distribution to optimize the fit for the largest number of patients. Alternatively, by adjusting the finger distribution, the distribution can be weighted evenly instead of penalizing the absolute difference between the device and the finger.

[0077] The misfit between the device size and the patient's finger is summed up over the device size range (from DeviceNRangeMin to DeviceNRangeMax). The same calculation is performed for the desired number of sizes and summed up over the entire size range (Size1 to MaxSize). This sum is the initial starting value for misfit. The model then iteratively updates the device size and device size range to minimize the sum, typically using the Newton-Raphson method, the Levenberg-Marquardt method, or other optimization techniques for continuous functions. When the model converges to the lowest sum of misfit, the size is optimized to best fit given the input criteria.

[0078] As mentioned above, this model can also be further constrained by other control functions. In some examples, the unique ideal finger size for each device 10a, 10b, 10c, 10d is defined at a specific position within the device's size range. For example, the ideal finger size can be placed at the maximum value of the range (all fingers are loosely fitted), the minimum value of the range (all fingers are tightly fitted), a defined loose-fit / tight-fit ratio based on the population distribution, or other criteria. As mentioned above, for each size range and devices 10a, 10b, 10c, 10d, it is possible to optimize the model so that devices 10a, 10b, 10c, 10d are tight for 25% of the population and loose for 75% of the population. In this way, the model can adjust the size range only during optimization, and the ideal finger size will be automatically placed based on the criteria. The following formula can be used to calculate the loose-fit percentage for each possible finger size within the size range.

[0079]

number

[0080] The model can also be constrained to limit the absolute device misfit for each possible finger size within a certain range. For example, for a finger width size range from 12.5 mm to 15.0 mm, the model can be constrained so that the maximum possible misfit is 2.0 mm, regardless of what the collective weighting model for ideal finger size determines. Constraining absolute misfit means that at least a minimum level of comfort is achieved for all patients. Sizing tools, technologies, and systems

[0081] It is anticipated that a healthcare professional or another user will be responsible for correctly determining the patient's finger size in order to decide which blood collection device 10a, 10b, 10c, or 10d from the set or kit 62 to use for a particular blood collection procedure. The inventors have identified a number of different devices, methods, and systems to assist users in correctly determining the size of a patient's finger 19 in order to decide which device 10a, 10b, 10c, or 10d from the set or kit 62 to use for a particular patient.

[0082] A simple method for device sizing is a contact measurement method in which the user directly determines the finger size parameter to determine which blood collection device 10a, 10b, 10c, 10d to use for a particular patient. For example, the user can directly measure a specific location on the patient's finger 19 using a measuring tool 66 (i.e., a ruler, caliper, or any other measuring tool). Once the specific dimensions of the patient's finger 19 are known, the user can determine which device 10a, 10b, 10c, 10d from the set 62 to use on the patient, based on the determined (i.e., calculated and / or optimized) size range for each device 10a, 10b, 10c, 10d.

[0083] In other examples, a sizing method or algorithm may be executed by a computer device 68 to determine the correct sizing. A flowchart illustrating the computer process for sizing is shown in Figure 5A. As shown in Figure 5A, in step 210, the computer processor receives an image of the patient's finger to be punctured for a blood sampling procedure. The image may be a digital image captured by a digital camera, such as a camera attached to a smartphone or tablet computer, as is known in the art. An exemplary image that may be provided to the computer processor is shown in Figure 5B. As shown in Figure 5B, the finger 19 is positioned on graph paper to help determine the dimensions of the finger.

[0084] In step 212, the computer processor processes the image to determine one or more dimensions of the finger, such as the width, height, and / or length of the finger. Various image processing techniques for determining the dimensions of a finger captured in a digital image will be known to those skilled in the art. For example, the image processing may include processing the image to identify pixels in the image that represent the finger, and determining the number of pixels for the width and / or length of the finger. Alternatively, the image processing may include identifying other objects in the image, such as a box on graph paper of a known size, and determining the number of pixels corresponding to the height or width of the box. Based on this pixel information, the computer processor can determine the dimensions of the finger.

[0085] In step 214, image processing may further include detecting abnormalities on the finger that would render the finger unsuitable for use in the blood sampling procedure. For example, the computer processor may process the image to identify cuts, bruises, or abrasions on the finger. If the identified cuts, bruises, or abrasions are determined to be serious, the computer processor may output a warning and / or instructions prompting the user to select another finger to use for the blood sampling procedure.

[0086] In step 216, one or more finger dimensions are compared to the size ranges of different devices 10a, 10b, 10c, and 10d in set 62 to determine which device 10a, 10b, 10c, or 10d best fits the patient's finger. The finger dimensions can also be compared to the ideal finger size for the selected device. Based on this comparison, it is possible to determine whether the selected device 10a, 10b, 10c, or 10d is too tight or too loose compared to the ideal finger size specific to each device.

[0087] In step 218, once the correct device has been determined, the computer processor may cause an output device to provide a display to the user (e.g., a healthcare professional or another user performing the blood sampling procedure) indicating which device from set 62 to use. For example, the output device may be a computer's visual display or a portable electronic device such as a smartphone or computer tablet. An exemplary screen 80 that can be shown to the user is provided in Figure 5C. As shown in Figure 5C, the screen 80 includes an icon or image 82 of the selected device. The screen 80 may also include a numerical display 84 that identifies the selected device. In some examples, the screen 80 may also include a visual display 86 showing the correspondence between the determined dimensions of the patient's finger and the intrinsic ideal finger size of the selected device. This visual display 86 may be used to inform the patient whether the selected device feels tight or loose, helping to manage the patient's expectations about how the selected device will feel when worn on the patient's finger. The screen 80 may also include warnings regarding cuts or abrasions on the patient's finger detected by image processing, and / or recommendations that another finger should be used for the blood sampling procedure.

[0088] Referring again to Figure 2, another option for determining device sizing is the size exclusion method, which compares the size of the finger to be punctured to the minimum or maximum acceptable size (i.e., maximum finger width, height, and / or length) of each size of blood collection devices 10a, 10b, 10c, and 10d. As previously stated, size exclusion refers to an examination to compare the patient's finger to the minimum or maximum acceptable size of each range in order to determine a proper fit, without determining the actual dimensions of the patient's finger (e.g., finger width, height, and / or length). For example, the patient's finger may be able to be inserted through the opening or another feature corresponding to the maximum size of the smallest device 10a. If the patient's finger cannot pass through the opening or feature, the patient's finger is too large for the smallest blood collection device 10a. In that case, the patient should try inserting their finger through the opening or feature of the other devices 10b, 10c, and 10d until they find the appropriate device size.

[0089] In some cases, size exclusion testing can be performed using a sizing card 70. The sizing card 70 can be a flat card containing an oval opening 72 sized to accommodate the different sizes of the blood collection devices 10a, 10b, 10c, and 10d of set 62. The card 70 can be formed from laminated cardboard or from any other convenient material that has sufficient strength to maintain its shape so that the devices are reusable and can be disinfected between uses, for example, with alcohol wipes or wet tissues. Alternatively, the sizing card 70 can be disposable, meaning that it is intended to be used only for one blood collection procedure and patient and then discarded. In such cases, the disposable sizing card 70 can be made from a less substantial material, such as thin cardboard or paper. The opening 72 can be provided on the sizing card 70 in any convenient orientation. For example, the openings 72 can be arranged as vertical lines, horizontal lines, squares (e.g., a 2x2 arrangement of openings 72), or any other variety of arrangements (as shown in Figure 2).

[0090] In some examples, the opening is an elliptical opening 72 having a major axis D1 corresponding to the maximum finger width usable for devices 10a, 10b, 10c, and 10d. The opening 72 may also include a minor axis D2 corresponding to the maximum acceptable finger height for each device 10a, 10b, 10c, and 10d. The opening 72 may further include a notch 74 at the top of each opening 72. The purpose of the notch 74 is to facilitate the patient inserting and / or removing a finger from the opening 72 during sizing.

[0091] In some cases, the major axis D1 and minor axis D2 of the upper opening 72 correspond to the maximum allowable dimensions of the small-sized blood collection device 10a. The lower opening 72 may have major axis D1 and minor axis D2 corresponding to the maximum allowable dimensions of the extra-large-sized blood collection device 10d. To use the sizing card 70, the user assists the patient in inserting their finger through the upper opening 72 of the sizing card 70 to determine if the small device 10a is appropriate for the patient. If the patient's finger passes through the upper opening 72 to the first joint or slightly past the first joint, the small device 10a should be used for that particular patient. If the patient's finger does not pass through the upper opening 72 to the first joint or slightly past the first joint, the patient's finger is inserted into the openings 72 of the medium-sized device 10b, the large device 10c, and the extra-large device 10d to determine which opening 72 allows the patient's finger to pass to the first joint or slightly past the first joint. Generally, the user should use blood collection devices 10a, 10b, 10c, and 10d of a size that corresponds to the smallest opening 72 that allows the patient's finger to pass through the opening 72 to or slightly past the first joint of the finger.

[0092] Continuing to refer to Figure 2, in some examples, the sizing card 70 may also include instructions 76 for using the sizing card 70 to determine the correct sizing of the blood collection devices 10a, 10b, 10c, and 10d. As shown in Figure 2, the instructions 76 are printed directly on the card (i.e., for healthcare workers and / or patients) indicating that the patient's finger should pass through the opening 72 to or slightly beyond the first knuckle. Providing clear and easily accessible instructions is thought to reduce the possibility of user error and improve compliance (i.e., that the user and / or patient use the device size indicated by the sizing card 70).

[0093] In some examples, the blood collection devices 10a, 10b, 10c, and 10d of set 62 are marked with numbers or other indicators to help the user identify the correct device for a particular blood collection procedure. For example, as shown in Figure 1C, the numbers or indicators can be molded onto the devices 10. In some examples, the small device 10a may be designated with the number "1", the medium device 10b with the number "2", the large device 10c with the number "3", and the extra-large device with the number "4". As shown in Figure 2, the sizing card 70 includes numbers printed adjacent to the openings 72 so that the user knows which opening 72 corresponds to which device 10a, 10b, 10c, or 10d. In other examples, devices 10a, 10b, 10c, and 10d may be identified by letters (i.e., S, M, L, and EX) or other visual indicators or drawings to help the user determine which device 10a, 10b, 10c, or 10d in the set or kit 62 should be used on a particular patient's finger.

[0094] In some examples, colors may be used to indicate the size of each device 10a, 10b, 10c, and 10d. For example, a small device 10a may be coated and / or molded with pink material, a medium device 10b may be coated and / or molded with orange material, a large device 10c may be coated and / or molded with green material, and an extra-large device 10d may be coated and / or molded with blue material. In such cases, to improve user compliance, the sizing card 70 may be designed in a color corresponding to the color of the blood collection devices 10a, 10b, 10c, and 10d. For example, the area 78 of the sizing card 70 surrounding each opening 72 may be a color corresponding to the color of the devices 10a, 10b, 10c, and 10d. Specifically, a pink square or rectangle may be provided surrounding the upper opening 72, which corresponds to the small device 10a. Similarly, it is possible to provide an orange square or rectangle surrounding the opening 72 for a medium-sized device, a green square or rectangle surrounding the large opening 72, and a blue square or rectangle surrounding the extra-large opening 72.

[0095] In some cases, it is possible to select the colors printed on the sizing card 70 (i.e., pink, orange, green, blue) and / or the hue or shade of each color so that a group of people with color blindness can use the sizing card 70. In particular, it is possible to select the colors and / or shades of the materials or coatings of devices 10a, 10b, 10c, 10d, as well as the colors and / or shades printed on the sizing card 70, so that people with deuteranopia (green color blindness), protia (red color blindness), tertia (blue color blindness), and / or total color blindness can distinguish between different colors and / or shades. In many cases, it is assumed that people with color blindness can distinguish between the different colors (i.e., pink, orange, green, blue) printed on the sizing card 70 shown in Figure 2. However, while the color combinations in Figure 2 are considered appropriate for many users, it is understood that other color combinations may be used for specific users within the scope of this disclosure and / or will be identifiable by those skilled in the art.

[0096] Different examples of sets or kits of blood collection devices and associated sizing systems and methods are shown in the accompanying figures and described in detail herein, but other examples will be apparent to those skilled in the art and will be readily fabricated by those skilled in the art without departing from the scope and spirit of the invention. Accordingly, the foregoing description is intended to be illustrative rather than restrictive. The invention as described herein is defined by the appended claims, and all modifications of the invention that fall within the meaning of the claims and equivalent scope are encompassed therein.

Claims

1. A kit of components for obtaining a capillary blood sample, the kit comprises: Multiple capillary blood collection devices of different sizes, A sizing tool to determine which of multiple blood sampling devices to use on a specific patient's finger, Equipped with, Each of the plurality of blood collection devices comprises a finger holder with a finger receiving portion designed for a specific ideal finger size and configured for use with fingers within a specific size range. The inherent size ranges of the plurality of blood collection devices are selected such that the majority of fingers of a patient population following a normal distribution fall within one of the inherent size ranges of the plurality of capillary blood collection devices. The sizing tool includes a computer processor configured to receive at least one image of the patient's finger, process the received at least one image to determine at least one of the finger width, finger height, and / or finger length of the patient's finger, and cause an output device to display instructions on which of the multiple blood collection devices to use on the patient's finger, which are determined at least partially based on the finger width, finger height, and / or finger length of the patient's finger determined by processing the at least one image and the unique size ranges of the multiple blood collection devices. kit.

2. The aforementioned ideal finger size comprises an ideal finger width, an ideal finger height, and / or an ideal finger length, and the aforementioned inherent size range comprises a range of finger widths, a range of finger heights, and / or a range of finger lengths. The kit according to claim 1.

3. The finger holder of the blood collection device further comprises an operating part and a port. The kit according to claim 1.

4. Each of the aforementioned blood collection devices is The container engagement portion connected to the aforementioned finger holder, A sampling container that can be detachably connected to the container engagement portion, wherein the sampling container defines a sampling cavity, Furthermore, The operating part comprises at least two wings configured to generate pressure on the patient's finger located within the finger receiving part. The kit according to claim 3.

5. At least 95% of the fingers of the patients in the aforementioned patient population fall within one of the aforementioned unique size ranges. The kit according to claim 1.

6. The aforementioned patient population includes all adult patients residing in the selected geographical area. The kit according to claim 1.

7. The difference between the maximum and minimum values ​​of each of the aforementioned intrinsic size ranges is equal to each other. The kit according to claim 1.

8. The unique ideal finger size of the plurality of blood collection devices is equal to the maximum and minimum values ​​of each of the unique size ranges. The kit according to claim 7.

9. The unique size range of the plurality of blood collection devices is selected such that the fingers of an equal number of patients in the patient population fall within the unique size range of each of the plurality of blood collection devices. The kit according to claim 1.

10. The inherent ideal finger size of the plurality of blood collection devices is the minimum value of the inherent size range of each of the plurality of blood collection devices. The kit according to claim 1.

11. The inherent ideal finger size of the plurality of blood collection devices is the maximum value of the inherent size range of each of the plurality of blood collection devices. The kit according to claim 1.

12. The inherent ideal finger size of the plurality of blood collection devices is greater than the median of the inherent size range of each of the plurality of blood collection devices. The kit according to claim 1.

13. The inherent ideal finger size of the plurality of blood collection devices is selected such that the ratio of loose fit to tight fit for finger sizes within the inherent size range is the same for each of the plurality of blood collection devices. The kit according to claim 1.

14. The kit comprises at least four different sizes of blood collection devices. The kit according to claim 1.

15. The sizing tool includes a sizing card for size exclusion determination, the sizing card having a plurality of elliptical openings, each of which is sized to correspond to the maximum value of the unique size range of one of the plurality of blood collection devices. The kit according to claim 1.

16. Each of the plurality of elliptical openings comprises a major axis corresponding to the maximum finger width and a minor axis corresponding to the maximum finger height of the unique size range of one of the plurality of blood collection devices, The kit according to claim 15.

17. The sizing tool includes at least one measuring tool configured to directly measure at least one of the width, height, and / or length of the patient's finger. The kit according to claim 1.

18. A computer implementation method for determining the correct blood collection device size for a patient's finger, wherein the computer implementation method is: The system includes receiving at least one image of the patient's finger using at least one computer processor, The at least one computer processor processes the received at least one image to determine the dimensions of at least one of the patient's fingers, The at least one computer processor causes the output device to provide a visual indication of the plurality of blood collection devices having a unique finger size range for use on the patient's finger, which is determined at least partially based on the dimensions of at least one of the patient's fingers and the unique size range of the plurality of blood collection devices. Computer implementation methods, including those mentioned above.

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