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EP-4527293-B1 - BLOOD SEQUESTRATION DEVICE

EP4527293B1EP 4527293 B1EP4527293 B1EP 4527293B1EP-4527293-B1

Inventors

  • LANGDELL, Jeffrey Scott
  • BREINDEL, JAY T.
  • CHHEDA, HARSH D.

Dates

Publication Date
20260513
Application Date
20190607

Claims (15)

  1. A blood sequestration device (500) configured to automatically retract and safely house a sharpened distal tip (528) of a needle (504) following isolation of an initial portion of blood and collection of a subsequent sample of blood from a flow of blood of a patient, the blood sequestration device (500) comprising: a housing (502); a needle (504) operably coupled to the housing (502), the needle (504) having the sharpened distal tip (528), a proximal end (530) and a wall defining a lumen therebetween; characterised in that the device comprises: a needle biasing mechanism (506) operably coupled to the proximal end (530) of the needle (504) and configured to bias the needle (504) from an initial position, in which the sharpened distal tip (528) of the needle (504) protrudes from the housing (502), to a safe position, in which the sharpened distal tip (528) of the needle (504) is housed within the housing (502); and a movable element (508) rotatable relative to the housing (502) between an initial blood sequestration position, a blood collection position, and a needle retraction position, wherein the movable element (508) defines a sequestration chamber (520), a fluid conduit for blood collection, and a chamber (524) configured to retain the needle (504) in the safe position.
  2. The blood sequestration device (500) of claim 1, wherein the movable element (508) defines one or more push tabs (526) configured to protrude from the housing (502) to enable user manipulation of the movable element (508) relative to the housing (502) among the initial blood sequestration position, the blood collection position, and the needle retraction position.
  3. The blood sequestration device (500) of claim 2, wherein the user manipulation of the one or more push tabs (526) in a first direction causes the movable element (508) to rotate from the initial blood sequestration position to the blood collection position.
  4. The blood sequestration device (500) of claim 3, wherein further user manipulation of the one or more push tabs (526) in the first direction causes the movable element (508) to rotate from the blood collection position to the needle retraction position.
  5. The blood sequestration device (500) of claim 1, wherein the movable element (508) defines a first push tab (526A) and a second push tab (526B) configured to protrude from the housing (502) to enable user manipulation of the movable element (508) relative to the housing (502) among the initial blood sequestration position, the blood collection position, and the needle retraction position; AND OPTIONALLY, wherein the user manipulation of the first push tab (526A) in a first direction causes the movable element (508) to rotate from the initial blood sequestration position to the blood collection position; AND FURTHER OPTIONALLY, wherein user manipulation of the second push tab (526B) in a second direction causes the movable element (508) to rotate from the blood collection position to the needle retraction position.
  6. The blood sequestration device (500) of claim 1, wherein the fluid conduit for blood collection is occluded upon rotating the movable element (508) to the needle retraction position.
  7. The blood sequestration device (500) of claim 1, wherein in the needle retraction position the entire movable element (508) is housed within the housing (502) to inhibit user manipulation of the movable element (508) relative to the housing (502).
  8. The blood sequestration device (500) of claim 1, further comprising a catheter operably coupled to the housing (502) and configured to coaxially ride over the needle (504) for positioning within vasculature of the patient.
  9. A blood sequestration device (600)configured to automatically retract and safely house a sharpened distal tip (628) of a needle (604) following isolation of an initial portion of blood from a flow of blood from vasculature of a patient, the blood sequestration device (600) comprising: a housing (602); a needle (604) operably coupled to the housing (602), the needle (604) having the sharpened distal tip (628), a proximal end (630) and a wall defining a lumen therebetween; characterised in that the device comprises: a needle biasing mechanism (606) operably coupled to the proximal end (630) of the needle (604) and configured to bias the needle (604) from an initial position, in which the sharpened distal tip (628) of the needle (604) protrudes from the housing (602) , to a safe position, in which the sharpened distal tip (628) of the needle (604) is housed within the housing (602); a catheter (650) operably coupled to the housing (602) and configured to coaxially ride over the needle (604) for positioning within the vasculature of the patient; and a movable element (608) rotatable relative to the housing (602) between an initial blood sequestration position, a blood collection position and a needle retraction position, wherein the movable element (608) defines a sequestration chamber (620) and a chamber (624) configured to retain the needle (604) in the safe position.
  10. The blood sequestration device (600) of claim 9, wherein the chamber (624) is configured to retain the needle (604) in the safe position, wherein the chamber (624) further defines a fluid conduit for blood collection.
  11. The blood sequestration device (500, 600) of claim 1 or claim 9, wherein the fluid conduit for blood collection is operably coupled to a length of flexible tubing (540, 640) configured to be operably coupled to a blood collection device.
  12. The blood sequestration device (600) of claim 9, wherein the movable element (608) defines one or more push tabs (626) configured to protrude from the housing (602) to enable user manipulation of the movable element (608) relative to the housing (602) between the initial blood sequestration position and the blood collection position.
  13. The blood sequestration device (600) of claim 9, wherein user manipulation of the one or more push tabs (626) causes the movable element (608) to rotate from the initial blood sequestration position to the blood collection position, wherein the needle (604) is retracted to the safe position.
  14. The blood sequestration device (500, 600) of claim 1 or claim 9, wherein the sequestration chamber (520, 620) includes a gas permeable membrane configured to enable gas initially trapped within the sequestration chamber (520, 620) to vent from the sequestration chamber (520, 620) as the initial portion of blood from the flow of blood fills the sequestration chamber (520, 620).
  15. The blood sequestration device (600) of claim 9, wherein in the blood collection position the entire movable element (608) is housed within the housing (602) to inhibit user manipulation of the movable element (608) relative to the housing (602).

Description

RELATED APPLICATION The present application claims the benefit of U.S. Provisional Application No. 62/682,362 filed June 8, 2018. TECHNICAL FIELD The present disclosure relates generally to a device for accessing the bloodstream of a patient, and more particularly to a device and a non claimed method for inhibiting potentially contaminated blood from inclusion in a blood culture test sample. The present invention relates to a blood sequestration device according to the preamble of claim 1 as well as to a blood sequestration device according to the preamble of claim 9. Such a blood sequestration device is known from WO 2016/201406 A1. BACKGROUND A blood culture is the standard test used to detect microbial infections that may be spreading through a patient's bloodstream. The results from a blood culture are used to verify whether or not an infection is present, and, if so, what type (or types) of microorganisms are responsible for the infection. For example, blood cultures can be used to identify the causative microorganisms in severe pneumonia, puerperal fever, pelvic inflammatory disease, neonatal eppiglottitis, sepsis, and fever of unknown origin. During a blood culture, a sample of blood (typically at least 10 mL) is with withdrawn from the patient, often via peripheral venipuncture, and stored in one or more blood culture bottles with a specific media for aerobic and anaerobic organisms. Often more than one sample is taken from different areas of the patient's body to form a blood culture set. The proper collection of blood samples is a critical part of conducting a blood culture. An improper collection procedure, for example from improper or incomplete disinfection of the skin area in or around the venipuncture site or coring of skin containing microorganisms by the needle during insertion, can result in a contaminated blood sample. It is estimated that of the millions of blood culture tests performed on patients each year, roughly one-third of the test results indicate the false presence of microorganisms in the patient's bloodstream (i.e., a false positive). That is, even though microorganisms are found in the patient's blood during the test, those microorganisms were mixed with the blood during the venipuncture procedure. As most caregivers presume that the blood collection procedure was performed correctly, clinicians often treat all positive blood cultures (false or not) with antibiotics. On top of increased patient anxiety and the risks associated with overtreatment, as typical antibiotic treatments range from $4,500 to $10,000, it is estimated that false positive blood cultures significantly add to the cost of healthcare. WO2016/201406 A1 discloses devices and methods for syringe-based fluid transfer for body fluid sampling. US5052403 A discloses a self-contained, safety blood collection system. US9456775 B2 discloses a passive safety I.V. blood collection catheter. US9308353 B2 discloses a needle retraction apparatus. Although various strategies and devices have been implemented to decrease blood culture contamination rates, to this day the estimated number of false positive blood cultures remains quite high. Applicants of the present invention have identified a need for a blood sequestration device to address this concern. SUMMARY OF THE DISCLOSURE According to the present invention, there is provided a blood sequestration device comprising the features of claim 1. There is also provided a blood sequestration device comprising the features of claim 9. The preferred embodiments of the invention are defined in the dependent claims. Embodiments of the present disclosure, which are not according to the present invention, provide a device and method configured to isolate an initial (and potentially contaminated) portion of a blood sample before delivering a balance of the blood sample to an evacuated tube or syringe for use in blood culture testing. In some embodiments, an initial quantity of at least 0.15 mL of blood is sequestered in a manner that enables the remaining flow of blood to be diverted to a blood collection device. In some embodiments, the disclosed device passively diverts the remaining flow of blood after the initial quantity of blood has been sequestered with no moving parts. In some embodiments, the disclosed device can be actively shifted between an initial blood sequestration position and a blood collection position. In some embodiments, a sharp distal tip of the disclosed device can be automatically retracted to a safe position to inhibit unwanted needle sticks. One embodiment of the present disclosure, which is not according to the present invention, provides a blood sequestration device configured to isolate an initial, potentially contaminated portion of blood from a flow of blood from vasculature of a patient, prior to directing the flow of blood to an outlet support where the blood can be accessed. The blood sequestration device can include a body member having an interior