Device and method for biological fluid collection

Abstract

Certain aspects of the present disclosure provide devices for collecting biological fluids, such as blood. In certain embodiments, the device includes a capillary fluidly connected to a stem. The device also includes a holder through which an operator manipulates the device. The capillary includes an indicia that indicates a level at which the capillary is filled by the biological fluid via capillary force when the capillary is placed in contact with the biological fluid without application of an external force, such as a vacuum force. The holder is used by an operator to manipulate the device, and the stem is used to dispense the collected biological fluid by applying a dispensing force by the operator, such as by gripping the stem. Methods of collecting biological fluids using the collection devices described herein are also provided.

Description

Technical Field

[0001] Diagnostic methods generally involve obtaining and analyzing a biological fluid from a subject and processing the biological fluid to detect and / or quantify a diagnostic analyte, such as a biomarker indicative of a disease. Blood and its derived biological fluids, such as plasma and serum, are commonly used biological fluids for diagnostic purposes. There is a need for devices and methods for easily collecting biological fluids, particularly preselected / desired volumes of biological fluids. Summary of the invention

[0002] The present disclosure provides a device for collecting biological fluids such as blood. In certain aspects, the device disclosed herein includes a capillary connected to a stem by a fluid. The device also includes a holder, through which an operator manipulates the device. The capillary includes a mark, and when the capillary is placed in contact with the biological fluid without applying an external force such as a vacuum force, the mark indicates the level at which the biological fluid fills the capillary via capillary force. In some cases, the holder includes a generally flat member, and the operator can pick up the device by, for example, holding the generally flat member between the thumb and index finger. By applying a dispensing force by the operator, for example, by clamping the stem, the stem can be used to distribute the collected biological fluid. In some cases, the size of the capillary is such that a preselected / desired volume of biological fluid is collected when the biological fluid fills the capillary from the tip of the capillary to the mark. In some cases, the mark is a high contrast mark, such as a dark mark.

[0003] Also described are methods of collecting biological fluids using the collection devices described herein. In some aspects, the method includes contacting the biological fluid with an open end of a capillary, thereby allowing the biological fluid to fill the capillary via capillary action. In some cases, the biological fluid fills the capillary until a mark, such as a high contrast mark. In some such cases, a preselected / desired volume of the biological fluid is collected in the capillary. The method also includes applying a dispensing force on the stem to dispense the collected biological fluid. This dispensing can be performed to introduce the biological fluid into an analytical device, such as a lateral flow assay device. BRIEF DESCRIPTION OF THE DRAWINGS

[0004] Figure 1 A biological fluid collection device 10 is shown according to one embodiment.

[0005] Figure 2 A biological fluid collection device 20 is shown according to one embodiment. DETAILED DESCRIPTION

[0006] Aspects of the present disclosure include collection devices for collecting biological fluids, such as blood. Methods of using the collection devices to collect biological fluids, such as blood, are also provided.

[0007] Before describing the present apparatus and method in more detail, it is to be understood that the present disclosure is not limited to the particular embodiments described, as embodiments may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting.

[0008] Where a numerical range is provided, it is understood that each intervening value to one-tenth of the unit of the lower limit between the upper and lower limits of the range and any other stated or intervening value within the range are included within the apparatus and methods unless the context clearly dictates otherwise. The upper and lower limits of these smaller ranges may be independently included in the smaller ranges and are also encompassed within the apparatus and methods, subject to any specifically excluded limits in the ranges. Where the range includes one or two limits, ranges excluding either or both of those included limits are also included in the apparatus and methods.

[0009] Certain ranges are given herein where a numerical value is preceded by the term "about". The term "about" is used herein to provide literal support for the exact number preceding it, as well as a number that is close to or approximately preceding the term. In determining whether a number is close to or approximately a specifically recited number, a close or approximately unrecited number may be a number that provides a substantial equivalent to the specifically recited number in the context in which it is presented.

[0010] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present disclosure belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present devices and methods, representative devices and methods are now described.

[0011] The present disclosure may be understood more readily by reference to the following detailed description of the desired embodiments and embodiments included herein.In the following specification and appended claims, reference will be made to a number of terms which shall be defined to have the following meanings.

[0012] Although specific terms are used in the following description for the sake of clarity, these terms are intended only to refer to the specific structures of the embodiments selected for illustration in the drawings, and are not intended to define or limit the scope of the present disclosure. In the following drawings and the following description, it should be understood that the same reference numerals represent components with the same functions.

[0013] The term "comprising" is used herein as requiring the presence of specified components and permitting the presence of other components. The term "comprising" should be interpreted to include the terms "consisting essentially of" and "consisting of." "Consisting essentially of" permits the presence of the specified components, as well as other components that do not change the function / structure of the specified components. "Consisting of" permits the presence of the specified components, as well as any adhesives or other bonding mechanisms for attaching the listed components.

[0014] Numerical values ​​should be construed to include values ​​that are the same when reduced to the same number of significant figures and values ​​that differ from the stated value by less than experimental error obtained from routine measurement techniques of the type described in this application to determine the value.

[0015] All ranges disclosed herein are inclusive of the endpoints and are independently combinable (e.g., a range "from 2 grams to 10 grams" includes the endpoints 2 grams and 10 grams, and all intermediate values). The endpoints of the ranges and any values ​​disclosed herein are not limited to the exact ranges or values; they are imprecise enough to include values ​​close to these ranges and / or values.

[0016] The modifier "about" used in conjunction with a quantity is inclusive of the stated value and has the meaning dictated by the context. When used in the context of a range, the modifier "about" should also be considered to disclose a range defined by the absolute values ​​of the two endpoints. For example, a range from about "2 to about 10" also discloses a range from "2 to 10". The term "about" can refer to plus or minus 10% of the specified number. For example, "about 10%" can mean a range from 9% to 11%, and "about 1" can mean from 0.9-1.1.

[0017] It should be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. It should also be noted that the claims may be drafted to exclude any optional elements. Thus, this statement is intended to serve as antecedent basis for use of exclusive terminology such as "solely," "only," and the like in conjunction with the recitation of claim elements or use of a "negative" limitation.

[0018] As will be apparent to those skilled in the art after reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features that can be readily separated or combined with the features of any of the other multiple embodiments without departing from the scope or spirit of the present apparatus and methods. Any recited method may be performed in the order of events recited or in any other order that is logically possible.

[0019] Device

[0020] As described above, separate aspects of the present invention provide devices for collecting biological fluids, such as blood.

[0021] exist Figure 1 and 2 An exemplary collection device is depicted in .

[0022] exist Figure 1 The exemplary device 10 disclosed in includes a capillary 12 fluidly connected to a stem 14. The capillary 12 includes an open end 11 and a marker 13. Figure 1 In the embodiment, the mark 13 is a high contrast mark, for example, a dark mark. In some cases, the mark can be a notch, a raised ring, etc. that is easily visible to the operator.

[0023] In some cases, when the capillary is placed in contact with the biological fluid without applying an external force such as a vacuum force, the markings in the capillary indicate the level at which the biological fluid fills the capillary via capillary forces. The stem can be used to dispense the collected biological fluid by applying a dispensing force by an operator, such as by pinching the stem.

[0024] In some cases, the size of the capillary is such that a preselected / desired volume of biological fluid is collected when the biological fluid fills the capillary from the tip of the capillary to the mark. Such a preselected / desired volume of biological fluid can be 1 μL to 200 μL, such as 1 μL to 150 μL, 3 μL to 100 μL, 4 μL to 50 μL, 5 μL to 45 μL, 10 μL to 40 μL, 15 μL to 35 μL, 20 μL to 30 μL, or about 25 μL.

[0025] Figure 1 The exemplary device also includes a holder 15 by which the operator manipulates the device. In some cases, the holder is a generally flat member, and the operator can pick up the device by holding the generally flat member, for example, between the thumb and index finger. The holder may include a contour 16 that facilitates the operator to manipulate the device, for example, by preventing the device from slipping from the operator's fingers.

[0026] The stem 14 allows the biological fluid collected in the capillary to be dispensed. For example, an operator can apply a dispensing force by pressing the stem.

[0027] The devices described herein can be made of any suitable material, such as rubber, plastic, and silicone. In some cases, the material is transparent or translucent so that an operator can observe the biological fluid collected in the capillary.

[0028] method

[0029] Also described are methods of collecting biological fluids using the collection devices described herein. The biological fluid can be any desired biological fluid, and includes blood, serum, plasma, urine, saliva, sweat, tears, sputum, etc. Those skilled in the art can easily envision additional biological fluids that can be collected using the devices and methods disclosed herein, and such embodiments are within the scope of the present disclosure.

[0030] In some aspects, the method includes contacting a biological fluid, such as blood, with the open end 11 of the capillary, thereby allowing the biological fluid to fill the capillary 12 via capillary action. In some cases, the biological fluid fills the capillary up to a mark, such as a high contrast mark.

[0031] In some cases, the method further comprises applying a dispensing force on the stem to dispense the collected biological fluid. The operator may apply the dispensing force by pressing the stem. This dispensing may be performed to introduce the biological fluid into an analytical device, such as a lateral flow assay device. The analytical device may be used to detect and / or quantify an analyte in the biological fluid.

[0032] The foregoing only illustrates the principle of the present disclosure. It should be understood that those skilled in the art will be able to design various schemes, although not explicitly described or shown herein, these schemes embody the principle of the present invention and are included in the spirit and scope of the present invention. In addition, all examples and conditional language described herein are mainly intended to help readers understand the principle of the present invention and contribute by the inventor to deepen the concept of this field, and will be interpreted as not limited to such specific examples and conditions of narration. In addition, all statements of the principles, aspects and embodiments of the present invention and its specific examples described herein are intended to cover both equivalents of its structure and function. In addition, it is intended that such equivalents include currently known equivalents and equivalents developed in the future, that is, any element developed to perform the same function, regardless of the structure. Therefore, the scope of the present invention is not intended to be limited to the exemplary embodiments shown and described herein. On the contrary, the scope and spirit of the present invention are embodied by the appended claims.

Claims

1. A device comprising: a capillary tube connected to the stem-like fluid; as well as a holder by which an operator manipulates the device; Wherein the capillary tube comprises a marking, wherein when the capillary tube is placed in contact with a biological fluid without applying an external force, the marking indicates a level at which the biological fluid fills the capillary tube via capillary forces.

2. The device according to claim 1, wherein: The marking is a high contrast marking.

3. The device according to claim 2, wherein: The high contrast markings are dark colored markings.

4. The device according to claim 2, wherein: The marking is a notch or a raised ring.

5. The device according to any one of claims 1 to 4, wherein: The capillary is sized such that a preselected / desired volume of the biological fluid is collected as the biological fluid fills the capillary from the tip of the capillary to the mark.

6. The device of claim 5, wherein the preselected / desired volume is 1 μL to 200 μL, 1 μL to 150 μL, 3 μL to 100 μL, 4 μL to 50 μL, 5 μL to 45 μL, 10 μL to 40 μL, 15 μL to 35 μL, 20 μL to 30 μL, or about 25 μL.

7. The device according to any one of claims 1 to 6, wherein: The holder is a generally planar member configured to be picked up by an operator by holding the generally planar member.

8. The device according to any one of claims 1 to 7, wherein: The holder includes contours to facilitate manipulation of the device by an operator.

9. The device according to claim 8, wherein: The contour prevents the device from slipping from the operator's fingers.

10. The device according to any one of claims 1 to 9, wherein: The device is made of a material selected from rubber, plastic and silicone.

11. The device according to any one of claims 1 to 10, wherein: The device is made of translucent or transparent material.

12. A method of collecting a biological fluid in the device of any one of claims 1 to 11, the method comprising contacting the biological fluid with the open end of the capillary tube, thereby allowing the biological fluid to fill the capillary tube via capillary action.

13. The method according to claim 12, comprising: The capillary is filled with the biological fluid up to the mark.

14. The method according to claim 12 or 13, further comprising: A dispensing force is applied to the stem to dispense the collected biological fluid.

15. The method according to claim 14, comprising: The biological fluid is dispensed to introduce the biological fluid into an analytical device.

16. The method according to claim 15, wherein: The analytical device is a lateral flow assay device.

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