Systems, devices, and methods for bodily fluid sample collection
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61B-005/15
A61B-005/151
A61B-005/154
출원번호
US-0320471
(2014-06-30)
등록번호
US-9427184
(2016-08-30)
발명자
/ 주소
Holmes, Elizabeth A.
Chen, Michael
Ko, Pey-Jiun
Burd, Tammy
Lath, Adrit
McHale, Patricia
출원인 / 주소
Theranos, Inc.
인용정보
피인용 횟수 :
0인용 특허 :
50
초록▼
Bodily fluid sample collection systems, devices, and method are provided. The device may comprise a first portion comprising at least a sample collection channel configured to draw the fluid sample into the sample collection channel via a first type of motive force. The sample collection device may
Bodily fluid sample collection systems, devices, and method are provided. The device may comprise a first portion comprising at least a sample collection channel configured to draw the fluid sample into the sample collection channel via a first type of motive force. The sample collection device may include a second portion comprising a sample container for receiving the bodily fluid sample collected in the sample collection channel, the sample container operably engagable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the container provides a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channel into the container.
대표청구항▼
1. A device for collecting a bodily fluid sample, the device comprising: a first portion comprising at least two sample collection channels configured to capture bodily fluid sample formed on a surface of a subject by drawing the fluid sample into the sample collection channels via a first type of m
1. A device for collecting a bodily fluid sample, the device comprising: a first portion comprising at least two sample collection channels configured to capture bodily fluid sample formed on a surface of a subject by drawing the fluid sample into the sample collection channels via a first type of motive force, wherein one of the sample collection channels has an interior coating designed to mix with the fluid sample and another of the sample collection channels has another interior coating chemically different from said interior coating;a second portion comprising a plurality of sample containers for receiving the bodily fluid sample collected in the sample collection channels, the sample containers operably engagable to be in fluid communication with the collection channels, whereupon when fluid communication is established, the containers provide a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channels into the containers. 2. The device of claim 1, wherein the first portion is formed from an optically transmissive material. 3. The device of claim 1, wherein the second portion contains an optical indicator that provides a visual indication of whether the sample has reached the sample container in the second portion. 4. The device of claim 1, wherein containers are arranged such that mixing of the fluid sample between the containers does not occur. 5. The device of claim 1 wherein the first type of motive force comprises capillary force. 6. The device of claim 1 further comprising at least one vent to allow for flow in said sample collection channels. 7. The device of claim 1, wherein the interior coating comprises ethylenediaminetetraacetic acid (EDTA) and the another interior coating is different from EDTA. 8. The device of claim 1, wherein the interior coating comprises citrate and the another interior coating is different from citrate. 9. The device of claim 1, wherein the interior coating comprises heparin and the another interior coating is different from heparin. 10. The device of claim 1 wherein the second motive force comprises vacuum force. 11. The device of claim 1 wherein the bodily fluid sample is capillary blood. 12. The device of claim 1 wherein the sample containers are integrated together by way of a common holder. 13. The device of claim 1 wherein the sample containers are integrally formed with one another. 14. The device of claim 1, wherein the bodily fluid sample comprises a capillary blood sample. 15. The device of claim 1 further comprising at least one adapter channel operably engagable to create fluid communication between one of the collection channels and one of the sample containers. 16. The device of claim 15, wherein said at least one adapter channel has an adapter channel cross-sectional area smaller than a sample collection channel cross-sectional area. 17. The device of claim 15, wherein the device is further configured to enable fluid flow through the adapter channel that mixes the bodily fluid sample with anticoagulant prior to the sample entering one of the sample containers and without repeatedly tilting or agitating the device. 18. The device of claim 15, wherein the adapter channel has a non-coring penetrating end. 19. The device of claim 1, wherein the at least two sample collection channels comprise molded channels formed in the first portion. 20. The device of claim 1 wherein at least one of the channels further comprises a hydrophobic coating. 21. The device of claim 1 wherein said channels are configured to receive the bodily fluid sample from an interface on the first portion, wherein the interface comprises a shaped front end configured to engage target tissue on the subject. 22. The device of claim 1 further comprising a lancet having an actuator to extend at least one portion of the lancet beyond a distal end of the first portion of the device. 23. The device of claim 22, wherein the actuator comprises a spring. 24. The device of claim 22, wherein the actuator comprises a spring-driven cam mechanism. 25. The device of claim 1, wherein at least one of the sample containers comprises a transparent material. 26. The device of claim 1, wherein at least one of the sample containers comprises a translucent material. 27. The device of claim 1, wherein at least one of the sample collection channels has a polygonal cross-sectional shape in a plane substantially perpendicular to a fluid flow within said at least one of the sample collection channels. 28. The device of claim 1, wherein at least one of the sample collection channels has an elliptical cross-sectional shape in a plane substantially perpendicular to a fluid flow within said at least one of the sample collection channels. 29. The device of claim 1, wherein at least one of the sample collection channels has a circular cross-sectional shape in a plane substantially perpendicular to a fluid flow within said at least one of the sample collection channels. 30. The device of claim 1, wherein each of the sample containers further comprises a cap. 31. The device of claim 30, wherein at least a portion of the cap fits into a portion of one of the sample containers. 32. The device of claim 1, wherein the sample containers are discrete containers, each individually separable from the first portion. 33. The device of claim 1, wherein at least one of the sample containers has a reverse-plunger type configuration wherein a movable plunger portion defines at least one surface of a sample chamber of one of the sample containers. 34. The device of claim 33, wherein the movable plunger portion has a contact area comprising a material having a hardness greater than other material along a perimeter of the plunger. 35. The device of claim 1, wherein the device is further configured mix the bodily fluid sample with the interior coating prior to the sample entering one of the sample containers and doing so without having to repeatedly tilt or agitate the device. 36. A device for collecting a fluid sample from a subject, comprising: (a) a body comprising a first collection channel and a second collection channel, the first collection channel comprising a first opening and a second opening, and being configured to capture sample formed on a surface of the subject by drawing a bodily fluid via capillary action from the first opening towards the second opening;(b) a base, engagable with the body, wherein the base supports a sample container, the sample container being engageable with the collection channel, having an interior with a vacuum therein and having a cap configured to receive a channel; and(c) an adaptor channel, having a first opening and a second opening, the first opening being configured to contact the second opening of the collection channel, and the second opening being configured to penetrate the cap of the sample container;wherein the interior of the first collection channel is coated with a first anticoagulant different from a second anticoagulant of the second collection channel. 37. The device of claim 36, wherein the first anticoagulant is ethylenediaminetetraacetic acid (EDTA) and the second anticoagulant is different from EDTA. 38. The device of claim 36, wherein the first anticoagulant is citrate and the second anticoagulant is different from citrate. 39. The device of claim 36, wherein the first anticoagulant is heparin and the second anticoagulant is different from heparin. 40. The device of claim 39, wherein the base is a window that allows a user to see the container in the base. 41. The device of claim 36, wherein the body is formed from an optically transmissive material. 42. The device of claim 36, wherein the base contains an optical indicator that provides a visual indication of whether the sample has reached the sample container in the base. 43. The device of claim 36, wherein the at least two sample collection channels comprise molded channels formed in the body. 44. The device of claim 36, wherein the body comprises a first portion and a second portion which mate to define said at least two sample collection channels. 45. The device of claim 36 wherein at least one of the channels further comprises a hydrophobic coating. 46. The device of claim 36, wherein the sample container has a reverse-plunger type configuration wherein a movable plunger portion defines at least one surface of a sample chamber of the sample container. 47. The device of claim 46, wherein the movable plunger portion has a contact area comprising a material having a hardness greater than other material along a perimeter of the plunger. 48. The device of claim 36, wherein the device is further configured mix the bodily fluid sample with the first anticoagulant prior to the sample entering the sample container and doing so without having to repeatedly tilt or agitate the device. 49. The device of claim 36, wherein the device is further configured to enable fluid flow through the adaptor channel that mixes the bodily fluid sample with one of anticoagulants prior to the sample entering the sample container and without repeatedly tilting or agitating the device.
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