Sample collection device, system and method for extracting and collecting a sample of a fluid of a user

Abstract

A sample collection device for collecting a blood sample of a patient, the sample collection device including a first partially deformable shell and a second at least partially pierceable shell with a pre-packaged vacuum sealed between the first shell and the second shell. The second shell may additionally hold a sample container and an automatic mechanical cutting mechanism including a rotatable cutting blade and an actuator spring, the actuator spring being actuatable by pressing the first shell, thereby releasing and rotating the cutting blade. By pressing the first shell, the pre-packaged vacuum is released to a collection opening of the second shell such that the vacuum effects a suction effect so that blood coming out of the incision created by the rotatable cutting blade leaks into the sample container.

Description

CROSS-REFERENCE TO RELATED APPLICATION[0001]The present application claims priority to European Patent Application No. 19208831.8 filed on Nov. 13, 2019. The entire contents of the above-listed application are hereby incorporated by reference for all purposes.TECHNICAL FIELD[0002]Embodiments of the subject matter disclosed herein relate to a sample collection device for collecting a sample of a fluid of a user, e.g. blood, in particular capillary blood. Specifically, a system and a method for extracting and collecting this sample.BACKGROUND AND SUMMARY[0003]Venipuncture is a blood collection method where the vein is punctured by a hollow needle and blood is collected into a tube. This method allows collection of large and high quality blood samples into tubes. Several tubes can be filled during one blood sampling. Furthermore, these tubes are compatible with highly automated blood analyzers, which can analyze thousands of samples per day. These high throughputs capabilities answer t...

AI Technical Summary

Benefits of technology

The patent describes a cap that can be used on a sample container. This cap has a mechanism to make a small incision in it. The same cap can then be used to seal the sample container after it has been collected. This cap helps to safely transport the sample.

Problems solved by technology

Moreover, risks are associated with puncturing the vein: if the vein is fragile or if the gesture is not performed properly, it can result in a hematoma.

There is also a risk of needle-stick injury, which may expose the healthcare professionals to blood-borne diseases.

While this technique does not require highly trained professional and can be performed by the patient himself, it is very difficult to collect more than 100 μl of blood and to perform many analyses per sample.

Moreover, the blood collected into glass capillaries or through other devices, cannot be analyzed by automated analyzers, used by central laboratories, which require a minimum dead volume of blood of 100 μl to 200 in μl a single tube.

Squeezing too hard may result in haemolysis (damage of the red blood cells) and dilution of the blood sample by the interstitial fluid, contained in spaces between the tissue cells.

For these reasons, and to keep a good blood quality, the use of finger prick is generally limited to the collection of small volumes of blood.

This device is complicated, as it comprises several electronics components.

Vasodilation then allows excessive amount of blood to be extracted from the wound created by the blade.

Additionally, another effect that makes the cut painless is the fact that the skin is stretched when the device is performing the cut.

Images