EP-4734846-A1 - DEVICES AND METHOD FOR BIOFLUID COLLECTION

Abstract

Certain aspects of the disclosure provide devices for collecting biofluids, such as blood. In certain embodiments, the device comprises a capillary tube fluidically connected to a bulb. The device also comprises a holder through which an operator manipulates the device. The capillary tube comprises a marker, which indicates the level to which a biofluid fills the capillary tube via capillary force when the capillary tube is placed in contact with a biofluid without the application of an outside force, such as vacuum force. The holder is used by an operator to manipulate the device and the bulb is used to dispense the collected biofluid by the application by an operator of a dispensing force, for example, by pinching the bulb. Methods for collecting biofluids using the collection devices described herein to are also provided.

Inventors

• GOU, LIJIAN
• GAO, Qibiao
• CHEN, JET
• HU, LIN
• HU, HAIYAN
• WEN, Susan
• LV, Meiqiao
• XUE, Joe
• XU, Lijiao
• YAO, Chenxue

Assignees

• Abbott Rapid Diagnostics International Unlimited Company

Dates

Publication Date

20260506

Application Date

20240722

Claims (16)

1. A device comprising: a capillary tube fluidically connected to a bulb, and a holder through which an operator manipulates the device, wherein the capillary tube comprises a marker, wherein the marker indicates the level to which a biofluid fills the capillary tube via capillary force when the capillary tube is placed in contact with a biofluid without the application of an outside force.
2. The device of Claim 1, wherein the marker is a high contrast marker.
3. The device of Claim 2, wherein the high contrast marker is a dark colored marker.
4. The device of Claim 2, wherein the marker is a notch or an elevated ring.
5. The device of any one of Claims 1 to 4, wherein the dimensions of the capillary tube are such that a pre-selected/desired volume of the biofluid is collected when the biofluid fills the capillary tube from the tip of the capillary tube to the marker.
6. The device of Claim 5, wherein the pre-selected/desired volume of 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 of any one of Claims 1 to 6, wherein the holder is a substantially flat member configured for an operator to pick up the device by holding the substantially flat member.
8. The device of any one of Claims 1 to 7, wherein the holder comprises contours that facilitate manipulation of the device by an operator.
9. The device of Claim 8, wherein the contours avoid slipping of the device from the operator’s fingers.
10. The device of any one of Claims 1 to 9, wherein the device is made from a material selected from rubber, plastic, and silicone.
11. The device of any one of Claims 1 to 10, wherein the device is made from a translucent or transparent material.
12. A method of collecting a biofluid in a device of any one of Claims 1 to 11, the method comprising contacting the biofluid with the open end of the capillary tube thereby allowing the biofluid to fill the capillary tube via capillary action.
13. The method of Claim 12, comprising filling the capillary tube with the biofluid till the marker.
14. The method of Claim 12 or 13, further comprise applying a dispensing force on the bulb to dispense the collected biofluid.
15. The method of Claim 14, comprising dispensing the biofluid to introduce the biofluid into an analytical device.
16. The method of Claim 15, wherein the analytical device is a lateral flow assay device.

Description

DEVICES AND METHOD FOR BIOFLUID COLLECTION INTRODUCTION Diagnostic methods typically involve obtaining and analyzing biofluids from subjects and processing the biofluids for detection and/or quantification of diagnostic analytes, such as biomarkers indicative of diseases. Blood and its derivative biofluids, such as plasma and serum, are commonly used biofluids for diagnostic purposes. Devices and methods for easily collecting biofluids, particularly, pre-selected/desired volumes of biofluids are desired. SUMMARY The disclosure provides devices for collecting biofluids, such as blood. In certain aspects, the device disclosed herein comprises a capillary tube fluidically connected to a bulb. The device also comprises a holder through which an operator manipulates the device. The capillary tube comprises a marker, which indicates the level to which a biofluid fills the capillary tube via capillary force when the capillary tube is placed in contact with a biofluid without the application of an outside force, such as vacuum force. In some cases, the holder comprises a substantially flat member and an operator can pick up the device by holding the substantially flat member, for example, between the thumb and the index finger. The bulb can be used to dispense the collected biofluid by application by an operator of a dispensing force, for example, by pinching the bulb. In certain cases, the dimensions of the capillary tube are such that a pre-selected/desired volume of a biofluid is collected when the biofluid fills the capillary tube from the tip of the capillary tube to the marker. In some cases, the marker is a high contrast marker, such as a dark colored marker. Methods for collecting biofluids using the collection devices described herein to are also described. In some aspects, the method comprises contacting a biofluid with the open end of the capillary tube thereby allowing the biofluid to fill the capillary tube via capillary action. In some  cases, the biofluid fills the capillary tube till the marker, such as a high contrast marker. In certain such cases, a pre-selected/desired volume of a biofluid is collected in the capillary tube. The methods further comprise applying a dispensing force on the bulb to dispense the collected biofluid. Such dispensing can be done to introduce the biofluid into an analytical device, for example, a lateral flow assay device. BRIEF DESCRIPTION OF THE FIGURES FIG. 1 depicts a biological fluid collection device 10 according to one embodiment. FIG. 2 depicts a biological fluid collection device 20 according to one embodiment. DETAILED DESCRIPTION Aspects of the present disclosure include collection devices for collecting biofluids, for example, blood. Methods for using the collection devices to collect biofluids, for example, blood, are also provided. Before the present devices and methods are described in greater detail, it is to be understood that the present disclosure is not limited to particular embodiments described, as such 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. Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the devices and methods. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also encompassed within the devices and methods, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the devices and methods. Certain ranges are presented herein with numerical values being preceded by the term “about. ” The term “about” is used herein to provide literal support for the exact number that it precedes, as well as a number that is near to or approximately the number that the term precedes. In determining whether a number is near to or approximately a specifically recited number, the near or approximating un-recited number may be a number which, in the context in which it is presented, provides the substantial equivalent of the specifically recited number. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this 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. The present disclosure may be understood more readily by reference to the following detailed description of desired em