Dried blood sample collecting device
By providing a blood sample collection device including an actuator and melt, the problems of long drying time and easy contamination and overlapping of samples in the existing dry blood sample collection methods are solved, and a simplified self-detection and efficient drying process are achieved.
Patent Information
- Application Number
- CN202380035362.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-02-22
- Filing Date
- 2023-02-21
- Publication Date
- 2025-04-15
AI Technical Summary
Existing dry blood sample collection methods require drying at room temperature for 2-3 hours, and need to prevent moisture and moisture, and the samples are prone to contamination and overlap.
A blood sample collection device is provided, including an actuator and a plurality of melts, which are held in the retracted position by a biasing mechanism, which pushes the biasing mechanism to extend the melt to receive the blood and dry it through a desiccant.
The device allows untrained personnel to self-test, reduces drying time, avoids sample contamination and overlap, and simplifies the collection and storage of blood samples.
Smart Images
Figure CN119836264A_ABST
Abstract
Description
priority
[0001] This application claims the benefit of and priority to U.S. Patent Application No. 17 / 677,811, filed on February 22, 2022, the entire contents of which are incorporated herein by reference. Technical Field
[0002] Embodiments of the present disclosure generally relate to the collection of blood samples. More specifically, embodiments of the present disclosure relate to apparatus and methods for drying blood sample collection devices, which facilitate self-testing by untrained personnel, such as patients collecting samples at home. Background Art
[0003] Diagnostic blood samples are routinely obtained from patients by medical practitioners using hypodermic syringes or temporary cannulas to extract a series of discrete samples into separate vials. Recently, dried blood spot samples have become a popular method for obtaining diagnostic blood samples. Usually by pricking a finger, heel or toe with a lancet, dropping blood on a pre-printed circle on a specially manufactured paper (such as an assay card), and then allowing the blood sample to dry in an open space to collect the dried blood sample. Dried blood samples advantageously enable blood samples to be collected by relatively untrained personnel or even by the patient himself. For example, untrained individuals can perform blood self-tests on their own blood glucose levels using a finger prick blood spot test kit.
[0004] However, a disadvantage of current dried blood samples is that the samples must typically be dried at room temperature for a minimum of 2-3 hours. In addition, dried blood samples must be protected from moisture and water. Another disadvantage is that care must be taken not to contaminate the assay card or apply too much blood to the card, resulting in overlapping samples on the card. Therefore, there is a need for an improved method and apparatus for blood sampling that reduces or eliminates one or more of the above-mentioned disadvantages. Summary of the invention
[0005] Provided is an apparatus and method for a dried blood sample collection device, which facilitates self-testing by untrained personnel such as patients who collect samples at home. The blood sample collection device includes an actuator longitudinally arranged through the distal barrel and proximal barrel of a pen. A plurality of frits (frits, sieve plates) for receiving blood samples are arranged in the distal end of the actuator. The frit is held in a retracted position in the distal barrel by a biasing mechanism. A button coupled to the actuator facilitates compressing the biasing mechanism and extending the frit through the distal opening of the distal barrel. The frit is configured to take a blood sample and store the sample in a dried state. A suitable desiccant can be used to cause the dried state. The actuator is configured to be removed from the blood sample collection device so that the dried blood sample can be retrieved from the distal end of the actuator.
[0006] In an exemplary embodiment, a blood sample collection device includes: a distal barrel portion, which is connected to a proximal barrel portion; an actuator, which is longitudinally arranged throughout the distal barrel portion and the proximal barrel portion; one or more fuses, which are arranged in the distal end of the actuator; a biasing mechanism, which is used to retain the distal end within the interior of the distal barrel portion; and a button, which is connected to the proximal end of the actuator and is used to extend the one or more fuses through the distal opening of the distal barrel portion.
[0007] In another exemplary embodiment, the distal barrel portion is coupled to the proximal barrel portion by a plurality of threads. In another exemplary embodiment, the biasing mechanism is disposed between an interior of the distal barrel portion and a circumferential lip constituting the actuator.
[0008] In another exemplary embodiment, the button is configured to be pushed in the distal direction to extend the one or more melts through the distal opening. In another exemplary embodiment, the biasing mechanism is configured to withdraw the one or more melts through the distal opening when the button is released.
[0009] In another exemplary embodiment, one or more melts are each configured to ingest a blood sample and store the blood sample in a dried state. In another exemplary embodiment, the one or more melts include four separate melts removably coupled to the distal end of the actuator. In another exemplary embodiment, any one or more of the one or more melts include a desiccant for causing a dried state. In another exemplary embodiment, the collection device is coated with a desiccant to cause a dried state. In another exemplary embodiment, any one or more of the one or more melts are configured to retain an amount of blood greater than about 1.0 μL. In another exemplary embodiment, any one or more of the one or more melts are configured to store an amount of about 60 μL of blood in a dried state.
[0010] In another exemplary embodiment, the actuator is configured to be removed from the blood sample collection device so that the filled melt can be retrieved from the distal end of the actuator. In another exemplary embodiment, the actuator includes a tubular housing that houses the extractor. In another exemplary embodiment, the distal end of the extractor is configured to eject the filled melt from the actuator when the proximal end of the extractor is pressed in the distal direction.
[0011] In another exemplary embodiment, each of the one or more melts is accompanied by a window disposed in the distal end. In another exemplary embodiment, the window facilitates blood to be drawn into the adjacent melt without leaking or diffusing into the nearby melt.
[0012] In an exemplary embodiment, a method for collecting a blood sample includes: obtaining a blood sample collection device including one or more melts; pressing a button constituting the blood sample collection device to extend the one or more melts through a distal opening; placing the one or more melts in contact with blood; allowing the blood to flow into the one or more melts; releasing the button to retract the one or more melts through the distal opening; allowing the blood to become dry in the one or more melts; and sending the blood sample collection device to a tester.
[0013] In another exemplary embodiment, placing includes pressing the blood sample collection device longitudinally against the blood to fill the one or more melts with blood. In another exemplary embodiment, placing includes pressing the sides of the distal end of the blood sample collection device against the blood to fill any of the one or more melts with blood. In another exemplary embodiment, pressing the sides of the distal end includes allowing blood to flow into any of the one or more melts through a window constituting the distal end.
[0014] These and other features of the concepts presented herein may be better understood with reference to the drawings, description and appended claims. BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The accompanying drawings relate to embodiments of the present disclosure, wherein:
[0016] Figure 1 illustrates a side view of an exemplary embodiment of a dried blood sample collection device in a retracted configuration;
[0017] Figure 2 illustrates a side view of an exemplary embodiment of a dried blood sample collection device in a depressed configuration suitable for collecting a blood sample;
[0018] Figure 3 illustrates a side view of an exemplary embodiment of a dried blood sample collection device in a sample collection configuration after a first blood sample has been collected;
[0019] Figure 4 illustrates a side view of an exemplary embodiment of a dried blood sample collection device in a full sample configuration, wherein all of the melts making up the dried blood sample collection device are filled with a dried blood sample;
[0020] Figure 5 A side view illustrating an exemplary embodiment of an actuator removed from a dried blood sample collection device; and
[0021] Figure 6 A side view of an exemplary embodiment of an actuator is shown with a plurality of dried blood samples removed from the actuator.
[0022] Although 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 will be described in detail herein. The dried blood sample collection device should be understood not to be 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 present disclosure. DETAILED DESCRIPTION
[0023] In the following description, many specific details are set forth in order to provide a thorough understanding of the present disclosure. However, it will be apparent to one of ordinary skill in the art that the dried blood sample collection device disclosed herein can be practiced without these specific details. In other cases, specific numerical references may be made, such as a "first lancet". However, the specific numerical references should not be interpreted as a literal order, but rather as a "first lancet" being different from a "second lancet". Therefore, the specific details set forth are merely exemplary. The specific details may differ from the spirit and scope of the present disclosure and are still contemplated to be within the spirit and scope of the present disclosure. The term "connection" is defined as meaning to be directly connected to a member or indirectly connected to the member through another member. In addition, as used herein, the terms "about", "approximately" or "substantially" for any numerical value or range indicate a suitable dimensional tolerance that allows the assembly of parts or members to be used for its intended purpose as described herein.
[0024] Generally, dried blood samples are collected by pricking a finger, heel or toe with a lancet, dropping blood on a pre-printed circle on a specially manufactured assay card, and then allowing the blood sample to dry. However, a disadvantage of current dried blood samples is that the sample must usually be dried at room temperature for a minimum of 2-3 hours. Another disadvantage is that care must be taken not to contaminate the assay card or apply too much blood to the card, resulting in overlapping samples on the card. Embodiments proposed herein provide dried blood sample collection devices that eliminate one or more of these disadvantages, thereby facilitating self-testing by untrained personnel such as patients who collect samples at home.
[0025] Figure 1 A side view of an exemplary embodiment of a dried blood sample collection device 100 (hereinafter referred to as "collection device 100") in a retracted configuration is shown. The collection device 100 includes a plurality of melts 104 that can be retracted 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 longitudinally disposed throughout the length of the distal barrel 108 and the proximal barrel 112. Figure 1, the melt 104 is disposed within the distal end 124 of the actuator 120, while the proximal end 128 of the actuator 120 is disposed within a button 132 extending through a proximal opening 136 of the proximal barrel 112. A biasing mechanism 140 within the distal barrel 108 is disposed between the interior of the distal barrel 108 and a circumferential lip 144 constituting the actuator 120. The biasing mechanism 140 holds the collection device 100 in a retracted configuration in which the melt 104 is withdrawn into the distal barrel 108 through the distal opening 106.
[0026] Although the biasing mechanism 140 comprises a coil spring in the illustrated embodiment, it is contemplated that in other embodiments, the biasing mechanism 140 may comprise any of a variety of devices suitable for retaining the collection device 100 in the retracted configuration, but is not limited thereto. For example, 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 inside the cylinder so that when the trapped air expands, the melt 104 is withdrawn through the distal opening 106 into the distal barrel 108.
[0027] Melt 104 is configured to take blood sample and store the blood sample in a dried state for later detection by laboratory personnel. In some embodiments, multiple melts 104 include four separate melts 104 removably connected to the distal end 124 of actuator 120. It is conceivable that each of melts 104 is configured to store blood in an amount of about 60 microliters (μL) in a dried state. However, in some embodiments, melt 104 may be configured to maintain blood in an amount greater than about 1.0 μL. For example, in some embodiments, melt 104 may be configured to maintain blood in an amount ranging between about 1.0 μL and about 90 μL. In some embodiments, melt 104 may include any of various desiccants suitable for causing blood samples to dry quickly in melt 104. In addition, in some embodiments, collection device 100 may be coated or connected with a suitable desiccant to cause the blood sample in melt 104 to present a dried state. It is contemplated that in some embodiments, the desiccant may cause the blood sample to be dried within a time period ranging between about 30 minutes and about 2 hours. In addition, it is contemplated that the desiccant may include any one or more of montmorillonite clay, silica gel (indicating silica gel), molecular sieves, calcium oxide, calcium sulfate, any combination thereof, etc., but is not limited thereto.
[0028] In operation, such as when a practitioner uses the collection device 100 to collect a blood sample, the practitioner may begin by pressing the button 132 into the proximal barrel 112 to cause the melt 104 to extend through the distal opening 106 of the distal barrel 108. For example, Figure 2The diagram is shown in a depressed configuration suitable for collecting a blood sample. Figure 1 100 . In the depressed configuration, the button 132 is pushed into the proximal opening 136 of the proximal barrel 112, thereby compressing the biasing mechanism 140 and extending the distal melt 148 through the distal opening 106 of the distal barrel 108. Once exposed, the distal melt 148 can be placed in contact with a suitable blood source to receive a blood sample. In some embodiments, the distal melt 148 may include an incorporated lancet or other suitable device for puncturing a subject from whom a blood sample is to be collected. However, in some embodiments, a separate lancet may be used to cause a blood source to flow before the collection device 100 is used to retrieve a blood sample.
[0029] In addition, the collection device 100 can be used to retrieve a relatively large blood sample that fills all of the melt 104 at once or multiple smaller blood samples that individually fill the melt 104. For example, Figure 3 A side view of an exemplary embodiment of the collection device 100 is illustrated in a sample collection configuration after a first blood sample has been collected. As shown, the distal melt 148 is filled with a single blood sample, while the remaining melts 104 are unfilled for future blood samples. As will be appreciated, the distal melt 148 may be filled with a blood sample by pressing the collection device 100 longitudinally into a blood source, such as a punctured finger. However, it is contemplated that future blood samples may be collected by pressing a blood source against the sides of the melts 104 to cause blood to flow into each melt 104 to be filled. Figure 3 As shown in FIG. 1 , each melt 104 is accompanied by a window 152 disposed in the distal end 124 , whereby blood may be drawn into the melt 104 without leaking or diffusing into nearby melts 104 .
[0030] Once the melt 104 has been desirably filled with a blood sample, the collection device 100 can be placed in a retracted configuration and then sent to laboratory personnel for testing. Figure 4 A side view of an exemplary embodiment of a collection device 100 is shown in a full sample configuration in which all of the melts 104 that make up the pen have been filled with dried sampled blood. As mentioned herein, the melts 104 can be filled with a single relatively large blood sample that fills all of the melts 104 at once, or the melts 104 can contain multiple smaller, individually collected blood samples. Figure 4, the collection device 100 includes a plurality of filled melts 156 that are retracted into the distal barrel 108 through the distal opening 106. As will be appreciated, when the practitioner releases the button 132, the biasing mechanism 140 pushes the actuator 120 through the proximal opening 136 of the proximal barrel 112, thereby withdrawing the filled melts 156 into the distal barrel 108. It is contemplated that the filled melts 156 are contained within the distal barrel 108 for protecting the dried blood sample until the melts 156 are removed by laboratory personnel for testing.
[0031] Figure 5 A side view of an exemplary embodiment of the actuator 120 removed from the collection device 100 is shown. The actuator 120 may be removed from the collection device 100 by laboratory personnel during retrieval of the filled melt 156 at the distal end 124 of the actuator 120. Figure 5 As shown in FIG. 1 , the actuator 120 includes a tubular housing 160 that houses an extractor 164. A distal end 168 of the extractor 164 is adjacent to the filled melt 156, while a proximal end 172 of the extractor 164 extends beyond a proximal edge 176 of the tubular housing 160. The proximal edge 176 is configured to receive the button 132 (see FIG. 1 ). Figure 1 ) so that pressing the button 132 during the blood sample collection will not prematurely eject the fuse 104, as described with respect to Figure 3 discussed.
[0032] Once the button 132 is removed, as Figure 5 to Figure 6 , the proximal end 172 of the extractor 164 can be pressed in the distal direction 180 to eject the filled melt 156 out of the distal end 124 of the tubular housing 160. In particular, pressing the extractor 164 in the distal direction 180 causes the distal end 168 of the extractor 164 to push the filled melt 156 in the distal direction 180. In this manner, laboratory personnel can use the extractor 164 to remove and separate the filled melt 156, such as Figure 6 As shown in .
[0033] It is conceivable that the collection device 100 is suitable for human blood sampling. In particular, the collection device 100 is suitable for patients who wish to perform self-testing in a home environment and then mail the collection device 100 to a suitable laboratory for testing. It is conceivable that although the collection device 100 is configured to store whole blood samples, in some embodiments, the collection device 100 may be configured to collect and store serum samples, but is not limited to this. In addition, it should be understood that the collection device 100 is not limited to human blood sampling, but the collection device 100 can be used for animal blood sampling, but is not limited to this. For example, the collection device 100 can be used by dog or cat owners who wish to perform blood sampling at home before sending the dried sample to a veterinary laboratory. To this end, the collection device 100 can be used to extract blood samples from the ears of dogs and cats for easy blood sampling. The collection device 100 can be placed in the retracted structure discussed herein and then mailed to a veterinary laboratory.
[0034] Although the dried blood sample collection device has been described according to specific variations and illustrative drawings, those of ordinary skill in the art will recognize that the dried blood sample collection device is not limited to the described variations or drawings. In addition, where the methods and steps described above indicate certain events occurring in a certain order, those of ordinary skill in the art will recognize that the order of certain steps may be modified and that such modifications are consistent with variations of the dried blood sample collection device. In addition, when possible, certain steps may be performed simultaneously in a parallel process and sequentially as described above. To the extent that 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 seen in the claims, this patent will also be intended to cover those variations. Therefore, the present disclosure should be understood to be not limited by the specific embodiments described herein, but only by the scope of the appended claims.
Claims
1. A blood sample collection device, comprising: a distal barrel portion, the distal barrel portion being coupled to the proximal barrel portion; an actuator disposed longitudinally throughout the distal barrel and the proximal barrel; one or more melts disposed within a distal end of the actuator; a biasing mechanism for retaining the distal end within the interior of the distal barrel; and A button is coupled to the proximal end of the actuator for extending the one or more melts through the distal opening of the distal barrel.
2. The blood sample collection device according to claim 1, wherein: The distal barrel is coupled to the proximal barrel by a plurality of threads.
3. The blood sample collection device according to claim 1, wherein: The biasing mechanism is disposed between an interior of the distal barrel and a circumferential lip forming the actuator.
4. The blood sample collection device according to claim 1, wherein: The button is configured to be pushed in a distal direction to extend the one or more melts through the distal opening.
5. The blood sample collection device according to claim 4, wherein: The biasing mechanism is configured to withdraw the one or more melts through the distal opening when the button is released.
6. The blood sample collection device according to claim 1, wherein: The one or more melts are each configured to ingest a blood sample and store the blood sample in a dried state.
7. The blood sample collection device according to claim 6, wherein: The one or more melts include four separate melts removably coupled to the distal end of the actuator.
8. The blood sample collection device according to claim 7, wherein: Any one or more of said one or more melts comprises a desiccant for causing said dried state.
9. The blood sample collection device according to claim 7, wherein: The collecting device is coated with a desiccant to induce the dried state.
10. The blood sample collection device according to claim 6, wherein: Any one or more of the one or more melts are configured to hold an amount of blood greater than about 1.0 μL.
11. The blood sample collection device according to claim 10, wherein: Any one or more of the one or more melts are configured to store an amount of about 60 μL of blood in a dried state.
12. The blood sample collection device according to claim 1, wherein: The actuator is configured to be removed from the blood sample collection device to enable retrieval of the filled melt from the distal end of the actuator.
13. The blood sample collection device according to claim 1, wherein: The actuator includes a tubular housing that houses an extractor.
14. The blood sample collection device according to claim 13, wherein: The distal end of the extractor is configured to eject the filled melt from the actuator when the proximal end of the extractor is pressed in a distal direction.
15. The blood sample collection device according to claim 1, wherein: Each of the one or more melts is accompanied by a window disposed in the distal end.
16. The blood sample collection device according to claim 15, wherein: The window facilitates blood to be drawn into the adjacent melt without leaking or diffusing into nearby melt.
17. A method for collecting a blood sample, comprising: obtaining a blood sample collection device comprising one or more melts; depressing a button forming the blood sample collection device to extend the one or more melts through the distal opening; placing the one or more melts in contact with blood; allowing the blood to flow into the one or more melts; releasing the button to retract the one or more melts through the distal opening; as well as The blood is allowed to dry in the one or more melts.
18. The method according to claim 17, wherein: Placing includes pressing the blood sample collection device longitudinally against the blood to fill the one or more melts with blood.
19. The method according to claim 17, wherein: Placing includes pressing a side of a distal end of the blood sample collection device against the blood to fill any of the one or more melts with blood.
20. The method according to claim 19, wherein: Depressing a side of the distal end includes allowing the blood to flow into any of the one or more melts through a window forming the distal end.