JP-7856679-B2 - Capillary blood collection device

Inventors

• アンソニー ブイ．トリス
• ヴラッド ヤクニッシュ
• スコット ウェンゼル
• レスリー ポースチェン
• アレックス エフ．フリッケ
• キショア ケー．ボッカ スリニヴァサ ラオ
• チャールズ ピーター アルトホフ

Assignees

• ベクトン・ディキンソン・アンド・カンパニー

Dates

Publication Date

20260511

Application Date

20220623

Priority Date

20210629

Claims (20)

1. A holder for receiving a sample source, having an operating part and a port, A blood collection attachment is detachably connected to the holder, The system comprises a collection container that defines a collection space and is detachably connected to the blood collection attachment, A device for obtaining a blood sample, wherein a collection container detachment member is provided between the blood collection attachment and the collection container, allowing the collection container to be detachably attached to the blood collection attachment.
2. The device according to claim 1, wherein the collection container comprises a lid including a release tab that releases the collection container from the blood collection attachment when pressed.
3. The device according to claim 2, wherein the lid comprises an elastomer that acts as a spring-loaded locking mechanism to create resistance with the collection container.
4. The device according to claim 2, wherein the lid is connected to the collection container via a living hinge.
5. The device according to claim 4, wherein the living hinge has reduced thickness or has at least one cutout.
6. The device according to claim 2, wherein the blood collection attachment has a protrusion, and the lid defines a recess for receiving the protrusion, thereby locking the collection container inside the blood collection attachment.
7. The device according to claim 2, wherein the lid is provided with at least one guide tab to ensure that the lid is in a desired position on the collection container when the lid is closed.
8. The device according to claim 1, wherein the collection container comprises aligned protrusions extending from its outer surface, and the blood collection attachment defines aligned slots on its inner surface to position the collection container in a desired location when inserted into the blood collection attachment.
9. The device according to claim 1, wherein a rotatable coupling assembly is provided between the holder and the blood collection attachment.
10. The device according to claim 9, wherein the rotatable connecting assembly is arranged so that the collection container rotates relative to the holder between a filling position and a storage position.
11. The rotatable coupling assembly comprises a socket and a post member held together via a friction fit, according to claim 9.
12. The device according to claim 1, wherein the collection container detachment member provides tactile feedback when the collection container is removed from the blood collection attachment.
13. Blood collection attachment, The system comprises a collection container detachably connected to the blood collection attachment, which defines the collection space, A collection container detachment member is provided between the blood collection attachment and the collection container, allowing the collection container to be detachably attached to the collection attachment. A device for obtaining blood samples.
14. The device according to claim 13, wherein the collection container comprises a lid including a release tab that releases the collection container from the blood collection attachment when pressed.
15. The device according to claim 14, wherein the lid comprises an elastomer that acts as a spring-loaded locking mechanism to create resistance with the collection container.
16. The device according to claim 14 , wherein the lid is connected to the collection container via a living hinge.
17. The device according to claim 14 , wherein the blood collection attachment is provided with a protrusion, and the lid defines a recess for receiving the protrusion, thereby locking the collection container inside the blood collection attachment.
18. The device according to claim 16 , wherein the living hinge has reduced thickness or has at least one cutout.
19. The device according to claim 14 , wherein the lid is provided with at least one guide tab to ensure that the lid is in a desired position on the collection container when the lid is closed.
20. The device according to claim 13, wherein the collection container comprises aligned protrusions extending from its outer surface, and the blood collection attachment defines aligned slots on its inner surface to position the collection container in a desired location when inserted into the blood collection attachment.

Description

Cross-reference to related literature This application claims priority to U.S. Provisional Application No. 63/216,252, titled "Capillary Blood Collection Device," filed on 29 June 2021, the entire disclosure of which is incorporated herein by reference. This disclosure relates, in general terms, to a device for obtaining biological samples. More specifically, this disclosure relates to an integrated finger-based capillary blood collection device having the ability to incise and compress a finger with a lancet under controlled conditions, collect, stabilize, and dispense a blood sample. Devices for acquiring and collecting biological samples, such as blood samples, are commonly used in the medical industry. One common blood collection method in the medical field is capillary blood collection, which is often performed to collect blood samples for testing. Certain diseases, such as diabetes, require regular testing of a patient's blood, for example, to monitor their blood glucose levels. In addition, test kits, such as cholesterol test kits, often require blood samples for analysis. Blood collection procedures typically involve puncturing a finger or other suitable body site with a needle to acquire a blood sample. Typically, the amount of blood required for such tests is relatively small, and usually a small puncture or incision provides a sufficient amount of blood for these tests. Various types of lancet devices have been developed for use in puncturing a patient's skin and acquiring capillary blood samples from the patient. Many different types of lancet devices are commercially available to individual consumers as well as to hospitals, clinics, and examination rooms. Such devices typically include a pointed component, such as a needle, or a sharp component, such as a blade, used to create a rapid puncture or incision in the patient's skin to allow for a small outflow of blood. Often, puncturing one's own finger with a handheld needle or blade is physiologically and psychologically difficult for many people. As a result, lancet devices have evolved into automated devices that puncture or cut the patient's skin when a trigger mechanism is activated. In some devices, the needle or blade remains in a ready position until the trigger is released by the user, for example, a healthcare professional responsible for drawing blood from the patient, or the patient themselves. Upon release, the needle or blade punctures or cuts the patient's skin, for example, the skin of a finger. Often, a spring is incorporated into the device to provide the "automatic" force necessary to puncture or cut the patient's skin. One contact-actuated lancet device, characterized by the automatic deployment and retraction of a puncture or cutting element from or into the device, is U.S. Patent No. 9,380,975, owned by the present applicant, Becton, Dickinson and Company. This lancet device includes a housing and a lancet structure having a puncture element. The lancet structure is housed within the housing and can accommodate movement between a pre-retaining or pre-actuated position where the puncture element is held within the housing and a puncture position where the puncture element protrudes through the front end of the housing. The lancet device includes a drive spring housed within the housing for biasing the lancet structure to the puncture position, and a retaining hub for holding the lancet structure in the retracted position against the bias of the drive spring. The retaining hub includes a pivot lever engaged with the lancet structure. An actuator within the housing pivots the lever, thereby moving the lancet structure to the rear end of the housing, compressing the drive spring at least partially, and releasing the lever from interference engagement with the lancet structure. The received blood sample is then collected and/or tested. This testing can be performed by a point-of-care (POC) testing device or by collecting the sample and sending it to a testing facility. Currently, capillary blood collection workflows are complex, multi-step processes requiring a high level of technical skill. The multi-step nature of this process introduces several variations that can lead to sample quality issues such as hemolysis, sample instability, and microclotting. While the use of lancet devices for acquiring blood samples is not limited to capillary blood sample collection, it results in variations in the impact of capillary blood sample collection, including keeping the lancet stationary during the examination, obtaining sufficient blood flow from the puncture site, and properly collecting blood while preventing clots. Some of the most common causes of process variation include: (1) improper lancet incision site cleaning and initial deposit removal, which may result in contaminated samples; (2) inconsistent lancet incision site and depth, which may result in insufficient sample volume and a large proportion of interstitial fluid; (3) inco