Dried blood sample collection device

Abstract

Apparatus and methods are provided for a dried blood sample collection device that facilitates self-testing by an untrained person, such as a patient collecting a sample at home. The blood sample collection device includes an actuator disposed through a distal barrel and a proximal barrel of a pen. A plurality of frits for receiving a blood sample are disposed within a distal end of the actuator. The frits are held in a retracted position within the distal barrel by a biasing mechanism. A push button compresses the biasing mechanism and facilitates extending the frits through a distal opening of the distal barrel. The frits are configured to capture the blood sample and store the sample in a dried state. A suitable desiccant may be used to create the dried state. The actuator is configured to be removed from the blood sample collection device to allow for retrieval of the dried blood sample from the distal end of the actuator.

Description

[Technical field]

[0001] Priority This application claims the benefit of and priority to U.S. Patent Application No. 17 / 677,811, filed February 22, 2022, which is incorporated herein by reference in its entirety.

[0002] Technical Field FIELD OF THE DISCLOSURE Embodiments of the present disclosure relate generally to blood sample collection. More specifically, embodiments of the present disclosure relate to an apparatus and method for dried blood sample collection devices that facilitate self-testing by untrained individuals, such as patients collecting samples at home. [Background technology]

[0003] background Diagnostic blood samples are traditionally taken from patients by medical professionals using a hypodermic syringe or temporary cannula to withdraw a series of separate samples into separate vials. More recently, dried blood spot samples have become a common approach to obtaining diagnostic blood samples. Dried blood samples are generally taken by pricking a finger, heel, or toe with a puncture needle, depositing a drop of blood onto a circle pre-printed on a specially manufactured piece of paper, such as an assay card, and then allowing the blood sample to dry in an open space. Dried blood samples advantageously allow blood samples to be taken by relatively untrained personnel, or even by the patient themselves. For example, an untrained person can perform their own blood glucose self-test by using a finger prick blood spot kit. Summary of the Invention [Problem to be solved by the invention]

[0004] However, a disadvantage of current dried blood samples is that the samples must generally be dried at room temperature for a minimum of 2-3 hours. Additionally, dried blood samples must be protected from humidity and moisture. Another disadvantage is that care must be taken not to contaminate the assay card or to apply too much blood to the card, causing overlap of samples on the card. Thus, there is a need for improved methods and devices for use in blood collection that reduce or eliminate one or more of the above disadvantages. [Means for solving the problem]

[0005] Abstract Apparatus and methods are provided for a dried blood sample collection device that facilitates self-testing by an untrained person, such as a patient collecting a sample at home. The blood sample collection device includes an actuator disposed longitudinally through a distal barrel and a proximal barrel of the pen. A plurality of frits for receiving a blood sample are disposed within a distal end of the actuator. The frits are held in a retracted position within the distal barrel by a biasing mechanism. A push button coupled to the actuator compresses the biasing mechanism and facilitates extending the frits through a distal opening of the distal barrel. The frits are configured to capture the blood sample and preserve the sample in a dry state. A suitable desiccant may be used to create the dry state. The actuator is configured to be removed from the blood sample collection device to allow for retrieval of the dried blood sample from the distal end of the actuator.

[0006] In an exemplary embodiment, the blood sample collection device includes a distal barrel coupled to a proximal barrel, an actuator disposed longitudinally throughout the distal and proximal barrels, one or more frits disposed within a distal end of the actuator, a biasing mechanism for holding the distal end within the interior of the distal barrel, and a push button coupled to a proximal end of the actuator for extending the one or more frits through a distal opening of the distal barrel.

[0007] In another exemplary embodiment, the distal barrel is coupled to the proximal barrel by a plurality of threads. In another exemplary embodiment, the biasing mechanism is disposed between an interior of the distal barrel and a circumferential edge that includes the actuator.

[0008] In another exemplary embodiment, the push button is configured to be pushed distally to extend the one or more frits through the distal opening, hi another exemplary embodiment, the biasing mechanism is configured to retract the one or more frits through the distal opening when the push button is released.

[0009] In another exemplary embodiment, the one or more frits are each configured to capture a blood sample and store the blood sample in a dry state. In another exemplary embodiment, the one or more frits comprise four individual frits removably coupled to a distal end of the actuator. In another exemplary embodiment, any one or more of the one or more frits include a desiccant to create a dry state. In another exemplary embodiment, the collection device is coated with a desiccant to create a dry state. In another exemplary embodiment, any one or more of the one or more frits are configured to hold a blood volume of greater than about 1.0 μL. In another exemplary embodiment, any one or more of the one or more frits are configured to hold a blood volume of about 60 μL in a dry state.

[0010] In another exemplary embodiment, the actuator is configured to be removed from the blood sample collection device to allow the loaded frit to be withdrawn from a distal end of the actuator. In another exemplary embodiment, the actuator includes a tubular casing that houses an extractor. In another exemplary embodiment, the distal end of the extractor is configured to expel the loaded frit from the actuator when a proximal end of the extractor is pushed distally.

[0011] In another exemplary embodiment, each of the one or more frits includes a window disposed at a distal end, hi another exemplary embodiment, the window facilitates drawing blood into adjacent frits without leaking or spreading to adjacent frits.

[0012] In an exemplary embodiment, a method for collecting a blood sample includes obtaining a blood sample collection device including one or more frits, pressing a push button comprising the blood sample collection device to extend the one or more frits through a distal opening, contacting the one or more frits with blood, allowing the blood to flow into the one or more frits, releasing the push button to retract the one or more frits through the distal opening, allowing the blood to dry within the one or more frits, and delivering the blood sample collection device to a test personnel.

[0013] In another exemplary embodiment, the placing includes pressing the blood sampling device longitudinally against the blood to fill one or more of the frits with blood. In another exemplary embodiment, the placing includes pressing a side of a distal end of the blood sampling device against the blood to fill one or more of the frits with blood. In another exemplary embodiment, pressing a side of the distal end includes allowing blood to flow through a window comprising the distal end to one or more of the frits.

[0014] These and other features of the concepts presented herein may be better understood with reference to the drawings, the description, and the appended claims.

[0015] BRIEF DESCRIPTION OF THE DRAWINGS The drawings refer to embodiments of the present disclosure. [Brief description of the drawings]

[0016] [Figure 1] FIG. 1 illustrates a side view of an exemplary embodiment of a dried blood sample collection device in a stored state. [Diagram 2] FIG. 2 illustrates a side view of an exemplary embodiment of a dried blood sample collection device in a recessed configuration suitable for collecting a blood sample. [Diagram 3] FIG. 3 shows a side view of an exemplary embodiment of a dried blood sample collection device in a sample collection configuration after an initial sample of blood has been collected. [Figure 4] FIG. 4 shows a side view of an exemplary embodiment of a dried blood sample collection device in a full sample configuration, where all frits comprising the dried blood sample collection device are filled with dried blood sample. [Diagram 5] FIG. 5 illustrates a side view of an exemplary embodiment of an actuator removed from a dried blood sample collection device. [Figure 6] FIG. 6 shows a side view of an exemplary embodiment of an actuator having multiple dried blood samples removed from the actuator.

[0017] While the present disclosure is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and are herein described in detail. It should be understood that the dried blood sample collection device is not limited to the particular forms disclosed, but rather is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.

[0018] Detailed Description In the following description, numerous specific details are described to provide a thorough understanding of the present disclosure. However, it will be apparent to one skilled in the art that the dried blood sample collection device disclosed herein may be practiced without these specific details. In other cases, specific numerical references such as "first puncture needle" may be made. However, the specific numerical references should not be interpreted as a literal sequential order, but rather that the "first puncture needle" is different from the "second puncture needle". Thus, the specific details described are merely exemplary. The specific details may be varied from the spirit and scope of the present disclosure and still be contemplated to be within the scope of the present disclosure. The term "coupled" is defined as meaning connected directly to a component or indirectly to a component through another component. Furthermore, as used herein, the terms "about," "approximately," or "substantially" with respect to any numerical value or range indicate appropriate dimensional tolerances that allow a portion or collection of components to function for its intended purpose as described herein.

[0019] Typically, dried blood samples are collected by pricking a finger, heel, or toe with a lancing needle, depositing a drop of blood onto a pre-printed circle on a specially manufactured assay card, and then allowing the blood sample to dry. However, a drawback of current dried blood samples is that the sample must generally be allowed to dry for a minimum of 2-3 hours at room temperature. Another drawback is that care must be taken not to contaminate the assay card or to add too much blood to the card, causing overlapping of samples on the card. The embodiments presented herein provide a dried blood sample collection device that eliminates one or more of these drawbacks, thereby facilitating self-testing by untrained persons, such as patients collecting samples at home.

[0020] FIG. 1 illustrates a side view of an exemplary embodiment of a dried blood sample collection tool 100 (hereinafter, "collection tool 100") in a retracted configuration. The collection tool 100 comprises a plurality of frits 104 retractable into a distal opening 106 of a distal barrel 108. The distal barrel 108 is coupled to a proximal barrel 112 by a plurality of threads 116. An actuator 120 is disposed longitudinally throughout the length of the distal barrel 108 and the proximal barrel 112. As shown in FIG. 1, the frit 104 is disposed within a distal end 124 of the actuator 120, while a proximal end 128 of the actuator 120 is disposed within a push button 132 that extends through a proximal opening 136 of the proximal barrel 112. A biasing mechanism 140 within the distal barrel 108 is disposed between an interior of the distal barrel 108 and a peripheral lip 144 that comprises the actuator 120. The biasing mechanism 140 holds the retrieval instrument 100 in the retracted configuration and the frit 104 is drawn through the distal opening 106 and into the distal barrel 108 .

[0021] In the illustrated embodiment, the biasing mechanism 140 comprises a coil spring, however, in other embodiments, it is contemplated that the biasing mechanism 140 may comprise any of a variety of devices suitable for retaining the collection device 100 in the stored configuration, including, but not limited to, in some embodiments, the biasing mechanism 140 may comprise a leaf spring made of a shape memory metal. Additionally, in some embodiments, the biasing mechanism 140 may comprise a small piston that compresses air trapped within a cylinder, which, when expanded, draws the frit 104 through the distal opening 106 and into the distal barrel 108.

[0022] The frit 104 is configured to capture a blood sample and store the blood sample in a dry state for later testing by laboratory personnel. In certain embodiments, the plurality of frits 104 comprises four individual frits 104 removably coupled to the distal end 124 of the actuator 120. It is contemplated that each of the frits 104 is configured to store a volume of blood in a dry state of about 60 microliters (μL). However, in some embodiments, the frit 104 may be configured to hold a blood volume greater than about 1.0 μL. For example, in some embodiments, the frit 104 may be configured to hold a blood volume ranging from about 1.0 μL to about 90 μL. In some embodiments, the frit 104 may include any of a variety of desiccants suitable for rapidly drying the blood sample within the frit 104. Additionally, in some embodiments, the collection device 100 may be coated or bonded with a suitable desiccant to dry the blood sample within the frit 104. In certain embodiments, it is contemplated that the desiccant is capable of rendering the blood sample dry within a period ranging from about 30 minutes to about 2 hours. It is further contemplated that the desiccant may include, but is not limited to, any one or more of montmorillonite clay, silica gel, indicating silica gel, molecular sieves, calcium oxide, calcium sulfate, any combination thereof, and the like.

[0023] In operation, for example, when a practitioner uses the blood collection device 100 to draw a blood sample, the practitioner may begin by depressing the push button 132 into the proximal barrel 112, causing the frit 104 to extend through the distal opening 106 of the distal barrel 108. For example, FIG. 2 shows a side view of the collection device 100 of FIG. 1 in a recessed configuration suitable for drawing a blood sample. In the depressed configuration, the push button 132 is pressed into the proximal opening 136 of the proximal barrel 112, thereby compressing the biasing mechanism 140 and causing the distal frit 148 to extend through the distal opening 106 of the distal barrel 108. Once exposed, the distal frit 148 may be placed in contact with a suitable blood source to receive a blood sample. In certain embodiments, the distal frit 148 may include an incorporated puncture needle, or other suitable device, for puncturing a subject from which a blood sample is to be drawn. However, in some embodiments, a separate needle can be used to flush the blood source prior to using the collection device 100 to retrieve a blood sample.

[0024] Additionally, the collection tool 100 may be used to collect a relatively large blood sample that fills all of the frits 104 at once, or may be used to collect multiple smaller blood samples that fill the frits 104 individually. For example, FIG. 3 illustrates a side view of an exemplary embodiment of the collection tool 100 in a sample collection configuration after a first sample of blood has been collected. As illustrated, the distal frit 148 is filled with an individual blood sample, while the remaining frits 104 are left unfilled for future blood samples. As will be appreciated, the distal frit 148 may be filled with a blood sample by pressing the collection tool 100 longitudinally into a blood source, such as a punctured finger. However, it is contemplated that future blood samples may be collected by pressing the blood source against the sides of the frits 104 to force blood into each frit 104. As shown in FIG. 3, each frit 104 has a window 152 located at the distal end 124 that allows blood to be drawn into the frit 104 without leaking or spreading onto adjacent frits 104.

[0025] Once the frits 104 are suitably filled with blood samples, the collection device 100 may be placed in a stored configuration and then sent to laboratory personnel for testing. For example, FIG. 4 illustrates a side view of an exemplary embodiment of the collection device 100 in a full sample configuration in which all frits 104 comprising the pen are filled with collected blood that is dried. As mentioned herein, the frits 104 may be filled with a single relatively large blood sample that fills all of the frits 104 at once, or the frits 104 may contain multiple smaller, individually collected blood samples. As shown in FIG. 4, the collection device 100 includes multiple filled frits 156 that are stored within the distal barrel 108 through the distal opening 106. As will be appreciated, when the practitioner releases the push button 132, the biasing mechanism 140 pushes the actuator 120 through the proximal opening 136 of the proximal barrel 112, thereby drawing the filled frits 156 into the distal barrel 108. It is contemplated that containing the packed frit 156 within the distal barrel 108 helps to protect the dried blood sample until the frit 156 is removed by laboratory personnel for testing.

[0026] 5 illustrates a side view of an exemplary embodiment of the actuator 120 removed from the collection device 100. The actuator 120 may be removed from the collection device 100 by laboratory personnel while retrieving the loaded frit 156 at the distal end 124 of the actuator 120. As shown in FIG. 5, the actuator 120 includes a tubular casing 160 that houses an extractor 164. A distal end 168 of the extractor 164 is adjacent the loaded frit 156, while a proximal end 172 of the extractor 164 extends beyond a proximal edge 176 of the tubular casing 160. The proximal edge 176 is configured to receive the push button 132 (see FIG. 1 ) such that pressing the push button 132 does not prematurely eject the frit 104 during collection of a blood sample, as discussed with respect to FIG. 3 .

[0027] When the push button 132 is removed, it is as shown in Fig. 5-6, the proximal end 172 of the extractor 164 can be pushed in a distal direction 180 to expel the loaded frit 156 from the distal end 124 of the tubular casing 160. In particular, by pushing the extractor 164 in the distal direction 180, the distal end 168 of the extractor 164 pushes the loaded frit 156 in the distal direction 180. Thus, laboratory personnel can use the extractor 164 to remove and separate the loaded frit 156, as shown in Fig. 6.

[0028] It is contemplated that the collection device 100 is suitable for human blood sampling. In particular, the collection device 100 is suitable for a patient wishing to perform a self-test in a home environment and then mail the collection device 100 to an appropriate laboratory for testing. While the collection device 100 is configured to store a whole blood sample, in an embodiment, it is contemplated that the collection device 100 may be configured to collect and store a serum sample, without limitation. Furthermore, it is understood that the collection device 100 is not limited to human blood sampling, but rather, the collection device 100 may be used for, without limitation, animal blood sampling. For example, the collection device 100 may be used by a dog or cat owner who wishes to perform a blood draw at home before sending a dried sample to a veterinary laboratory. To this end, the blood collection device 100 may be used to draw blood samples from the ears of dogs and cats to facilitate blood sampling. The collection device 100 may be placed in a stored configuration and then mailed to a veterinary laboratory, as discussed herein.

[0029] Although the dried blood sample collection device has been described with respect to certain variations and exemplary figures, those skilled in the art will recognize that the dried blood sample collection device is not limited to the variations or figures described. In addition, where the above methods and steps show certain events occurring in a certain order, those skilled in the art will recognize that the order of certain steps can be changed and such changes are in accordance with variations of the dried blood sample collection device. In addition, some of the steps may be performed simultaneously in a parallel process, where possible, or may be performed sequentially as described above. To the extent there are variations of the dried blood sample collection device that are within the spirit of the present disclosure or equivalent to the dried blood sample collection device found in the claims, the patent is intended to cover those variations as well. Thus, the present disclosure should not be understood to be limited by the specific embodiments described herein, but only by the scope of the appended claims.

Claims

1. 1. A blood sample collection device comprising: a distal barrel coupled to a proximal barrel; an actuator disposed longitudinally throughout the distal and proximal barrels; one or more frits disposed within a distal end of the actuator; a biasing mechanism for retaining the distal tip within the interior of the distal barrel; a push button coupled to a proximal end of the actuator for extending one or more frits through a distal opening of the distal barrel; A blood sample collection device comprising:

2. The blood sample collection device of claim 1 , wherein the distal barrel is coupled to the proximal barrel by a plurality of threads.

3. The blood sample collection device of claim 1 , wherein the biasing mechanism is disposed between an interior of the distal barrel and a circumferential edge comprising the actuator.

4. The blood sample collection device of claim 1 , wherein the push button is configured to be pushed distally to extend one or more frits through the distal opening.

5. The blood sample collection device of claim 4 , wherein the biasing mechanism is configured to draw one or more frits through the distal opening when the push button is released.

6. The blood sample collection device of claim 1 , wherein the one or more frits are each configured to capture a blood sample and store the blood sample in a dry state.

7. The blood sample collection device of claim 6 , wherein the one or more frits include four individual frits removably coupled to a distal end of the actuator.

8. The blood sample collection device of claim 7 , wherein any one or more of the one or more frits includes a desiccant to create a dry condition.

9. 8. The blood sample collection device of claim 7, wherein the collection device is coated with a desiccant to produce a dry condition.

10. The blood sample collection device of claim 6 , wherein any one or more of the one or more frits are configured to hold a blood volume of greater than about 1.0 μL in volume.

11. 11. The blood sample collection device of claim 10, wherein any one or more of the one or more frits are configured to store a volume of about 60 [mu]L of blood in a dry state.

12. 10. The blood sample collection device of claim 1, wherein the actuator is configured to be removed from the blood sample collection device to allow the loaded frit to be withdrawn from a distal end of the actuator.

13. 10. The blood sample collection device of claim 1, wherein the actuator includes a tubular casing that houses the extractor.

14. 14. The blood sample collection device of claim 13, wherein the distal end of the extractor is configured to expel the loaded frit from the actuator when the proximal end of the extractor is pushed distally.

15. 10. The blood sample collection device of claim 1, wherein each of the one or more frits has a window disposed at a distal end.

16. 16. The blood sample collection device of claim 15, wherein the window facilitates drawing of blood into the adjacent frit without leaking or spreading into the adjacent frit.

17. 1. A method for taking a blood sample, comprising: Obtaining a blood sample collection device including one or more frits; depressing a push button comprising the blood sample collection device to extend one or more frits through a distal opening; contacting one or more frits with blood; allowing blood to flow through one or more frits; Releasing the push button to retract the one or more frits through the distal opening; allowing the blood to dry in the one or more frits; The method includes:

18. 20. The method of claim 17, wherein the positioning comprises pressing the blood sampling device longitudinally against the blood to fill the one or more frits with blood.

19. 20. The method of claim 17, wherein the placing comprises pressing a side of the distal end of the blood sampling device against the blood to fill any one of the one or more frits with blood.

20. 20. The method of claim 19, wherein pressing against a side of the distal end includes allowing blood to flow through a window comprising the distal end and into any one of the one or more frits.

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