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US-12623222-B2 - Devices for extracting a fluid sample from a closed chamber and methods of use thereof

US12623222B2US 12623222 B2US12623222 B2US 12623222B2US-12623222-B2

Abstract

The invention relates to a device for extracting a fluid sample from a closed chamber and providing access to a volume of the extracted fluid sample for subsequent collection via a sampler device associated with a cartridge for delivering the volume of extracted fluid sample to a compatible diagnostic instrument for analyzing the fluid sample.

Inventors

  • Avishay Bransky
  • Liron Shlomo

Assignees

  • PIXCELL MEDICAL TECHNOLOGIES LTD.

Dates

Publication Date
20260512
Application Date
20181217

Claims (17)

  1. 1 . A device for extracting a fluid sample from a closed chamber having a flexible seal, the device comprising: a first component comprising: a pumping mechanism and a hollow piercing member having a proximal end and an opposing distal piercing tip; and a second component comprising: a flat shaped base positioned opposite and at the distal end of the device relative to the tip of the piercing member, an open reservoir positioned within second component between said base and said first component wherein the bottom of the reservoir proximal to the base comprises an opposing inner top face of the base, the open reservoir comprising a first opening connected to the proximal end of the first component and arranged to receive the fluid sample from the hollow piercing member, wherein the first opening is positioned at an upper part of the reservoir relative to the base, and a second permanent opening in a sidewall extending upwardly from the base, wherein said open reservoir comprising the second permanent opening is arranged to receive and collect the fluid sample from the first component through the first opening.
  2. 2 . The device of claim 1 , wherein the pumping mechanism comprising an abrupt radial increase in diameter to form a protruded step on said piercing member, wherein the protruded step when used with a chamber having a flexible seal wider than the step presses against the flexible seal when the closed chamber is pressed towards the base thereby creating pressure within the closed chamber, causing the fluid sample to be expelled from the closed chamber through the hollow piercing member and into the reservoir.
  3. 3 . The device of claim 1 , wherein the second permanent opening in the sidewall is located proximate a top of reservoir.
  4. 4 . The device of claim 1 , wherein the top of the second permanent opening relative to the base is positioned at the same or at a higher level than the top of the first opening, relative to the base.
  5. 5 . The device of claim 1 , wherein the permanent opening in the sidewall is sized and oriented in an angled orientation relative to the base to permit angled entry of the sample collection tube through the permanent opening.
  6. 6 . The device of claim 1 , wherein said reservoir is arranged to receive and collect the fluid sample from the first component through the first opening until filling capacity is reached while said second permanent opening is open, wherein the first opening is positioned to be in contact and submerged in the fluid sample when said filling capacity is reached, and wherein the second permanent opening is sized to retain the fluid sample within the reservoir by way of capillary forces.
  7. 7 . The device of claim 1 , wherein at least the second component is optically transparent.
  8. 8 . The device of claim 1 , wherein the base portion of the second component is further sized and shaped to exert the pressing with a force directed towards said closed chamber by pressing the closed chamber against the device while said base of the device is on a surface, without the device slipping on the surface.
  9. 9 . The device of claim 1 , wherein the first and second components are integrally formed with each other.
  10. 10 . The device of claim 1 , wherein the first and second components are separate components that operably couple to each other.
  11. 11 . The device of claim 10 , wherein the first and second components are operably coupled to one another by way of a snap-fit connection and the second component comprises one or more teeth that prevent disengagement of the first and second components, wherein the device is shaped receive a fluid sample from the hollow piercing member while the components are coupled by said snap-fit connection.
  12. 12 . The device of claim 2 , wherein said maintaining of filled condition is additionally maintained while device is tilted.
  13. 13 . The device of claim 1 , wherein the second permanent opening in the sidewall is oriented at an angle in relation to the base in the range of approximately 10 degrees to 80 degrees to thereby permit said angled entry.
  14. 14 . The device of claim 1 , wherein the open reservoir is sized and shaped to hold volumes ranging between 0.1 ml to 5 ml.
  15. 15 . The device of claim 1 , wherein the open reservoir is sized and shaped to hold volumes ranging between 100 μl to 120 μl.
  16. 16 . The device of claim 1 , wherein the second permanent opening in a sidewall of the reservoir has a diameter in the range of approximately 1 mm to 5 mm.
  17. 17 . The device of claim 1 , wherein the permanent opening in the sidewall has a geometry to permit the straight entrance to the bottom of the reservoir of a straight tube in an angle relative to the base.

Description

FIELD OF THE INVENTION The invention generally relates to devices for extracting a fluid sample from a closed chamber and methods of use thereof. BACKGROUND Hematology analyzers are used widely in patient and research settings to count and characterize blood cells for disease detection and monitoring. Basic analyzers return a complete blood count (CBC) with a three-part differential white blood cell (WBC) count. Sophisticated analyzers measure cell morphology and can detect small cell populations to diagnose rare blood conditions. More recently, miniature hematology analyzers have been developed. Such miniature systems are portable, which allow for Point of Care sample testing, such as complete blood count (CBC) parameters (including leukocyte differential count). Such systems typically employ a disposable self-contained cartridge and a sampler. The cartridge is used to prepare and measure the sample, while the sampler is used for the accurate collection of the blood sample itself. In certain designs, the sampler includes a capillary for sample collection, which facilitates collecting blood from a finger prick or a small test tube, such as a MINICOLLECT Tube (blood collection tube) sold by Greiner or a VACUTAINER (blood collection tube) sold by Greiner. Collecting a sample from a standard blood collection tube has proven to be very challenging due to the capillary orientation (angle) required in order to fill the capillary using passive capillary action. Tilting the blood sample tube at such an angle may result in spilling the sample out of the tube or smearing the outside of the capillary. Moreover, if the tube is only partially filled (which is usually the case) then the tip of the capillary will not reach the sample unless the tube is tilted almost horizontally, again introducing the risk of spilling the sample or smearing the outside of the capillary. To address that issue, an approach was developed that involved drawing some sample out of the blood sample tube using a pipette and applying it to a clean flat surface. The sample was then drawn into the capillary from the drop of blood formed on the surface. That technique has several drawbacks, such as it requires several cumbersome steps that require expertise and training and requires additional accessories (e.g. pipette, surface, etc.). Additionally, the blood collection tube is required to be opened, exposing the sample to possible contamination. Also, the user is exposed to blood that is on pipette and on the surface. SUMMARY The present invention recognizes the drawbacks of current methods of collecting biological samples and provides devices for safely and efficiently extracting a fluid sample from a closed chamber. Further, the devices and methods of the invention provide for easy access by a capillary, such as those associated with a sampler, to a biological sample that has been extracted from the closed tube without awkward manipulations or positioning of the sample or the capillary. In that manner, the devices and methods of the invention allow for the collection of a sample, such as a blood sample, without opening of the sample collection tube, thereby avoiding contamination issues while also allowing an operator to avoid exposure to the sample that has been collection. Aspects of the invention are accomplished with a device that includes a first component comprising a hollow piercing member and a second component comprising a reservoir arranged to receive a fluid sample from the hollow piercing member. The hollow piercing member is configured to penetrate a seal of a closed chamber that includes a fluid sample (e.g., a blood collection tube), and upon entering the closed chamber, a portion of the fluid sample may flow from the closed chamber, via a pumping action, and through the hollow piercing member, and into the reservoir. The second component of the device includes an opening in a sidewall of the reservoir to permit access to the fluid sample collected in the reservoir. In exemplary embodiments, the opening in the sidewall is generally sized to receive an open end of a capillary tube of a sampler device, and the opening is sized to permit angled entry of the capillary tube therethrough. The reservoir is configured to retain a volume of fluid sample by way of capillary force to thereby prevent undesired flow of fluid sample through the opening in the sidewall. Accordingly, the devices of the present invention are able to extract a fluid sample from a closed chamber while maintaining the chamber in a closed state, thereby preventing risk of contamination to the entirety of the fluid sample stored within the closed chamber and further preventing risk of cross-contamination to the extracted fluid sample. The devices of the invention further allow for relative ease of collection of a volume of fluid sample from the reservoir via a collection tube (i.e., capillary tube) of a sampler device, as the opening in the sidewall allows for proper ali