WO2024058938A1 - Système de cathéter intégré conçu pour l'échantillonnage du sang - Google Patents

Système de cathéter intégré conçu pour l'échantillonnage du sang Download PDF

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Publication number
WO2024058938A1
WO2024058938A1 PCT/US2023/031422 US2023031422W WO2024058938A1 WO 2024058938 A1 WO2024058938 A1 WO 2024058938A1 US 2023031422 W US2023031422 W US 2023031422W WO 2024058938 A1 WO2024058938 A1 WO 2024058938A1
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WO
WIPO (PCT)
Prior art keywords
port
catheter
extension tube
proximal
blood
Prior art date
Application number
PCT/US2023/031422
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English (en)
Inventor
Jonathan Karl Burkholz
Erica E. Neumann
Original Assignee
Becton, Dickinson And Company
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US18/238,967 external-priority patent/US20240082546A1/en
Application filed by Becton, Dickinson And Company filed Critical Becton, Dickinson And Company
Publication of WO2024058938A1 publication Critical patent/WO2024058938A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/15003—Source of blood for venous or arterial blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150221—Valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150251—Collection chamber divided into at least two compartments, e.g. for division of samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150992—Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2058—Connecting means having multiple connecting ports
    • A61J1/2062—Connecting means having multiple connecting ports with directional valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068—Venting means
    • A61J1/2075—Venting means for external venting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/223—Multiway valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M2039/229—Stopcocks

Definitions

  • Arterial catheterization is a vital procedure that is used ubiquitously in the hospital setting, both in critically injured and perioperative patients. It is estimated that more than eight million arterial catheters are placed yearly in the United States. Arterial catheters can continuously and accurately measure blood pressure as well as heart rate and pulse contour to allow for immediate recognition of aberrant hemodynamic events and initiation of appropriate treatment. Arterial catheters also provide samples for blood gas analysis without the morbidity associated with repeat arterial puncture. However, use of current arterial catheters can result in significant blood leakage during insertion into an artery of a patient, which can endanger a user. Moreover, current arterial catheters may be difficult to secure, maintain, and flush.
  • the present disclosure relates generally to vascular access devices, systems, and methods.
  • the present disclosure relates to a catheter system configured for blood sampling, such as, for example, arterial blood sampling, as well as related devices and methods.
  • the catheter system may also be configured for blood pressure monitoring and/or blood gas sampling.
  • the catheter system may provide near-patient access for more accurate hemodynamic measurements and improved delivery of an instrument, such as a secondary catheter and/or a sensor, into a blood vessel, which may include an artery or a vein.
  • the catheter system may be referred to as an “integrated” catheter system, meaning that the catheter system includes extension tubing (e.g., an extension set) that provides a fluid pathway to the catheter.
  • the catheter system may be similar the NEXIVATM Closed IV Catheter System, the NEXIVATM DIFFUSICSTM Closed IV Catheter System, or the PEGASUSTM Safety Closed IV Catheter System (all available from Becton Dickinson & Company of Franklin Lakes, New Jersey) or another suitable integrated catheter system in terms of one or more components and/or operation.
  • the catheter system may include a guidewire for improved catheter insertion success.
  • the catheter system may reduce blood exposure when inserted the catheter into an artery of a patient.
  • the catheter system may include a catheter adapter, which may include a distal end, a proximal end, a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter.
  • the catheter adapter may also include a side port between the distal end of the catheter adapter and the proximal end of the catheter adapter and in fluid communication with the lumen.
  • the catheter system may include a catheter extending from the distal end of the catheter adapter.
  • the catheter system may include a first extension tube, which may include a distal end and a proximal end.
  • the distal end of the first extension tube may be integrated with the side port of the catheter adapter.
  • the distal end of the first extension tube may be permanently or non- removably coupled to the side port, such as, for example, via adhesive, bonding, a non-luer coupling, or another suitable permanent or non-removable coupling.
  • the catheter system may include an access connector, which may be configured to provide near-patient access.
  • the access connector may include a distal port, a proximal port, and a side port between the distal port and the proximal port.
  • the distal port and the proximal port may be aligned with a longitudinal axis of the access connector.
  • the side port may be angled with respect to the longitudinal axis of the access connector.
  • the proximal end of the first extension tube may be integrated with the distal port of the access connector.
  • the catheter system may include a second extension tube, which may include a distal end and a proximal end.
  • the distal end of the second extension tube may be integrated with the side port of the access connector.
  • the first extension tube may be shorter than the second extension tube, such that the first extension tube facilitates advancement of a secondary catheter and/or sensor through the first extension tube.
  • the longitudinal axis of the access connector, the first extension tube, and the side port may be configured to align to form the straight path, which may facilitate advancement of the secondary catheter and/or the sensor within the catheter system.
  • the first extension tube may be rigid or semi-rigid, which may facilitate advancement of the secondary catheter and/or the sensor therethrough.
  • the proximal port may include a female luer, which may facilitate coupling of a blood sampling device to the access connector.
  • the proximal port may include another suitable connector.
  • the blood sampling device may be coupled to the proximal port.
  • the blood sampling device may include a catheter advancement device such as, for example, the PTVOTM Needle-Free Blood Collection Device, available from Becton, Dickinson & Company of Franklin Lakes, New Jersey.
  • the blood sampling device may include another suitable blood sampling device.
  • the catheter system may include a three-way stopcock valve, which may include a first port, a second port opposite the first port, and a third port.
  • the third port may be perpendicular to the first port and the second port.
  • the proximal end of the second extension tube may be coupled to the first port of the three-way stopcock valve.
  • the proximal end of the second extension tube may be integrated with the first port, which may reduce a risk of fluid exposure to a user.
  • the catheter system may include a fluid pathway within at least the catheter, the catheter adapter, the first extension tube, the access connector, and the second extension tube.
  • the second port, the third port, and the proximal port of access connector may be configured to provide access to the fluid pathway of the catheter system.
  • the catheter system may include one or more other access points to the fluid pathway from a surrounding environment.
  • the catheter system may not include other access points to the fluid pathway from a surrounding environment, which may limit potential bacterial contamination.
  • the proximal port may be used for nearpatient blood sample collection, the second port may be used to facilitate line clearance with a single flush, and the third port may be used for temporarily withdrawing blood from the patient to ensure a high-quality sample.
  • the catheter system may include a pre-filled flush syringe coupled to the second port such that closing of the second port, such as by rotating a central hub of the three-way stopcock valve, prevents fluid communication between the pre-filled flush syringe and the fluid pathway.
  • a temporary discard sample syringe may be coupled to the third port such that closing of the third port, such as by rotating the central hub of the three- way stopcock valve, prevents fluid communication between the temporary discard sample syringe and the fluid pathway.
  • the temporary discard sample syringe may be configured for temporary blood withdrawal.
  • the catheter system may include a pressure monitoring device.
  • the pressure monitoring device may be disposed between the second port and the pre-filled flush syringe, which may facilitate flushing of the catheter system via a single flush.
  • the proximal end of the second extension tube may be integrated with an adapter, which may be configured to couple to one or more of the pre-filled flush syringe, the temporary discard sample syringe, and the three-way stopcock valve.
  • the adapter may be coupled to a needleless connector, which may reduce a risk of bacterial contamination.
  • a proximal end of the adapter may include a single port or a dual port.
  • the catheter system may be compact, easing usage, and may improve workflow when collecting an arterial or venous blood sample.
  • a method of blood collection may include coupling the pre-filled flush syringe and the temporary discard sample syringe to the catheter system and closing the second port.
  • the method may include pulling blood into the temporary discard sample syringe.
  • the method may include closing the first port.
  • the method may include collecting blood in the blood sampling device, which may be coupled to the proximal port of the access connector.
  • the blood sampling device may include a heparinized syringe, and blood may then be dispensed to an arterial blood gas (ABG) test cartridge for point of care (POC) blood testing.
  • ABS arterial blood gas
  • POC point of care
  • the blood sampling device may include a catheter advancement device.
  • the method may include advancing a secondary catheter and/or a sensor of the catheter advancement device through the catheter of the catheter system.
  • the method may include closing the second port another time.
  • the method may include returning the blood pulled into the temporary discard syringe into a patient.
  • the method may include turning the three-way stopcock valve to an open position and pushing the pre-fdled flush syringe to clear the catheter system with a single flush.
  • the catheter system may include the pressure monitoring device, which may be disposed between the second port and pre-fdled flush syringe or another suitable location.
  • a method of blood collection may include inserting the catheter system into a blood vessel of a patient.
  • the method may include advancing a secondary catheter of a catheter advancement device through the catheter.
  • the catheter advancement device may be coupled to the proximal port of the access connector.
  • the longitudinal axis of the access connector, the first extension tube, and the side port are configured to align to form the straight path and advancing the secondary catheter of the catheter advancement device through the catheter may include advancing the secondary catheter through the straight path.
  • the blood vessel may be an artery.
  • Figure 1 is an upper perspective view of an example catheter system, according to some embodiments.
  • Figure 2A is an upper perspective view of the catheter system, illustrating an example three-way stopcock valve, an example pre-filled flush syringe, and an example temporary discard sample syringe, according to some embodiments;
  • Figure 2B is an upper perspective view of the catheter system, illustrating the three-way stopcock valve, according to some embodiments
  • Figure 2C is an enlarged upper perspective view of a portion of the catheter system, according to some embodiments;
  • Figure 3 A is an upper perspective view of the catheter system, illustrating the temporary discard sample syringe after a temporary discard sample is taken, according to some embodiments;
  • Figure 3B is an upper perspective view of the catheter system, illustrating blood collection in an example blood sampling device, according to some embodiments;
  • Figure 3C is an upper perspective view of the catheter system, illustrating dispensing of blood from the blood sampling device onto an arterial blood gas (ABG) test cartridge for point of care (POC) blood testing, according to some embodiments;
  • ABS arterial blood gas
  • POC point of care
  • Figure 3D is an upper perspective view of the catheter system, illustrating return of the blood pulled into the temporary discard syringe into a patient, according to some embodiments;
  • Figure 3E is an upper perspective view of the catheter system, illustrating flushing of the catheter system, according to some embodiments.
  • Figure 4A is an upper perspective view of the catheter system, illustrating an example adapter that includes a proximal end having dual ports, according to some embodiments;
  • Figure 4B is an upper perspective view of the catheter system, illustrating the adapter dual luer ports, according to some embodiments
  • Figure 4C is an upper perspective view of the catheter system, illustrating the three-way stopcock valve, according to some embodiments.
  • Figure 4D is an upper perspective view of the catheter system, illustrating the three-way stopcock valve, according to some embodiments.
  • Figure 5A is an upper perspective view of the adapter, illustrating the proximal end having dual luer ports, according to some embodiments;
  • Figure 5B is a cross-sectional view of the adapter, illustrating the proximal end having dual luer ports, according to some embodiments;
  • Figure 6A is an upper perspective view of the catheter system, illustrating an example needleless connector coupled to an example pressure monitoring device, according to some embodiments;
  • Figure 6B is an upper perspective view of the catheter system, illustrating the example needleless connector between the pre-filled flush syringe and the pressure monitoring device, according to some embodiments;
  • Figure 7 is an upper perspective view of the catheter system coupled to a hemodynamic monitoring system, according to some embodiments.
  • Figure 8 is an upper perspective view of the catheter system coupled to a closed, near patient arterial blood sampling system, according to some embodiments.
  • a catheter system 10 may be configured for blood sampling, such as, for example, arterial blood sampling.
  • the catheter system 10 may also be configured for blood pressure monitoring and/or blood gas sampling.
  • the catheter system 10 may provide nearpatient access for more accurate hemodynamic measurements and improved delivery of an instrument, such as a secondary catheter and/or a sensor, into a blood vessel, which may include an artery or a vein.
  • the catheter system 10 may be referred to as an “integrated” catheter system, meaning that the catheter system includes extension tubing (e.g., an extension set) that provides a fluid pathway to the catheter.
  • the catheter system 10 may be similar the NEXIVATM Closed IV Catheter System, the NEXIVATM DIFFUSICSTM Closed IV Catheter System, or the PEGASUSTM Safety Closed TV Catheter System (all available from Becton Dickinson & Company of Franklin Lakes, New Jersey) or another suitable integrated catheter system in terms of one or more components and/or operation.
  • the catheter system 10 may include an arterial catheter system configured for insertion into an artery.
  • the catheter system 10 may include significant improvements to existing arterial catheter systems by dramatically reducing blood exposure and infection risk, providing a user with improved artery access confirmation, and improving an overall experience of a patient.
  • Some existing arterial catheter systems such as, for example, the Teleflex ARROW® Integrated Arterial Catheter, may not provide effective artery access confirmation or blood control, which may result in placement procedures with significant blood exposure risk, infection risk, clean-up costs, and poor patient experience.
  • the Teleflex ARROW® Integrated Arterial Catheter includes a non-rigid, slotted tube out of which significant amounts of blood may leak, increasing a risk of blood exposure to the user.
  • the catheter system 10 may include one or more of the following, which may provide advantages over the prior art: arterial blood sampling with reduced blood exposure; blood pressure monitoring; blood gas sampling; near-patient access for use of a secondary catheter and/or sensor; blood control configured to operate under arterial pressure; a guidewire; and magnetic introducer needle guidance technology.
  • the catheter system 10 may include a catheter adapter 12, which may include a distal end 14, a proximal end 16, a lumen extending through the distal end 14 of the catheter adapter 12 and the proximal end 16 of the catheter adapter 12.
  • the catheter adapter 12 may also include a side port 18 between the distal end 14 of the catheter adapter 12 and the proximal end 16 of the catheter adapter 12 and in fluid communication with the lumen.
  • the catheter system 10 may include a catheter 19 extending from the distal end 14 of the catheter adapter 12.
  • the catheter 19 may include an arterial catheter, a peripherally-inserted central catheter, a midline catheter, a peripheral intravenous catheter, or another suitable catheter.
  • the catheter system 10 may include an introducer needle 21 coupled to a needle hub 23.
  • the catheter 19 may include an “over-the- needle” catheter, and the introducer needle 21 may extend through the catheter 19 to assist in insertion of the catheter 19 into the blood vessel of the patient.
  • the needle hub 23 may be uncoupled from the catheter adapter 12, and the introducer needle 21 may be removed.
  • the catheter system 10 may include a first extension tube 20, which may include a distal end 22 and a proximal end 24.
  • the distal end 22 of the first extension tube 20 may be integrated with the side port 18 of the catheter adapter 12, which may reduce a risk of fluid exposure to a user.
  • the distal end 22 of the first extension tube 20 may be permanently or non-removably coupled to the side port 18, such as, for example, via adhesive, bonding, a non-luer coupling, or another suitable permanent or non-removable coupling.
  • blood may flow into the first extension tube 20 in response to insertion of the introducer needle 21 and the catheter 19 entering the blood vessel.
  • the first extension tube 20 may provide improved confirmation of blood vessel entry.
  • the catheter system 10 may include an access connector 26, which may be configured to provide near-patient access.
  • the access connector 26 may include a distal port 28, a proximal port 30, and a side port 32 between the distal port 28 of the access connector 26 and the proximal port 30 of the access connector 26.
  • the distal port 28 and the proximal port 30 may be aligned with a longitudinal axis 34 of the access connector 26.
  • the side port 32 may be angled with respect to the longitudinal axis 34 of the access connector.
  • the side port 32 may be angled between 15 to 165 degrees with respect to the longitudinal axis 34 and may form a T-shape or a Y-shape.
  • the side port 32 may be on a left side or a right side of the access connector 26 and/or may be configured to direct the second extension tube 36 away from an insertion site of the catheter into the blood vessel.
  • the proximal end 24 of the first extension tube 20 may be integrated with the distal port 28 of the access connector 26, which may reduce a risk of fluid exposure to the user.
  • the proximal end 24 of the first extension tube 20 may be permanently or non-removably coupled to the distal port 28, such as, for example, via adhesive, bonding, a non-luer coupling, or another suitable permanent or non-removable coupling.
  • the catheter system 10 may include a second extension tube 36, which may include a distal end 38 and a proximal end 40.
  • the distal end 38 of the second extension tube 36 may be integrated with the side port 32 of the access connector 26, which may reduce a risk of fluid exposure to the user.
  • the distal end 38 of the second extension tube 36 may be permanently or non-removably coupled to the side port 32, such as, for example, via adhesive, bonding, a non-luer coupling, or another suitable permanent or non-removable coupling.
  • the first extension tube 20 may be shorter than the second extension tube 36, which may facilitate advancement of a secondary catheter and/or sensor through the first extension tube 20. Tn some embodiments, the first extension tube 20 may be less than or equal to 1 inch, less than or equal to 2 inches, or less than or equal to 3 inches, for example. In some embodiments, the longitudinal axis 34 of the access connector 26, the first extension tube 20, and the side port 18 may be configured to align to form the straight path, which may facilitate advancement of the secondary catheter and/or the sensor within the catheter system 10.
  • the first extension tube 20 may be rigid or semi-rigid and/or may include a particular or targeted thickness, which may facilitate advancement of the secondary catheter and/or the sensor therethrough and provide sufficient stiffness or noncompliance to transmit a more accurate pressure pulse, resulting in a more accurate pressure measurement.
  • the proximal port 30 may include a female luer, which may facilitate coupling of a blood sampling device to the access connector 26.
  • the proximal port 30 may include another type of connector.
  • the blood sampling device 42 may be coupled to the proximal port 30.
  • the proximal port 30 may be colored red to indicate the proximal port 30 provides access to an artery.
  • the blood sampling device 42 may include a vacuum tube or a syringe.
  • the blood sampling device 42 may include a probe and/or a sensor.
  • the blood sampling device 42 may include a catheter advancement device such as, for example, the PIVOTM Needle-Free Blood Collection Device, available from Becton, Dickinson & Company of Franklin Lakes, New Jersey.
  • the blood sampling device 42 may include another suitable blood sampling device.
  • the blood sampling device 42 may be configured to advance the secondary catheter and/or the sensor through the straight path and/or through the catheter 19 into a blood vessel of the patient, such as an artery, for example.
  • the catheter system 10 may include a three-way stopcock valve 44, which may include a first port 46, a second port 48 opposite the first port 46, and a third port 50.
  • a central hub 52 of the three-way stopcock valve 44 may be rotated to selectively open or close fluid flow through the first port 46, the second port 48, and the third port 50, as is known in the art.
  • the proximal end 40 of the second extension tube 36 may be coupled to the first port 46 of the three-way stopcock valve 44.
  • the proximal end 40 of the second extension tube 36 may be integrated with the first port 46, which may reduce a risk of fluid exposure to the user.
  • the proximal end 40 of the second extension tube 36 may be permanently or non-removably coupled to the first port 46, such as, for example, via adhesive, bonding, a non-Luer coupling, or another suitable permanent or non-removable coupling.
  • the second port 48 and/or the third port 50 may include luers, such as, for example, female luers, which may facilitate coupling to a device.
  • the catheter system 10 may include a fluid pathway within at least the catheter 19, the catheter adapter 12, the first extension tube 20, the access connector 26, and the second extension tube 36.
  • the second port 48, the third port 50, and the proximal port 30 of access connector 26 may be configured to provide access to the fluid pathway of the catheter system 10.
  • the catheter system 10 may include one or more other access points to the fluid pathway from a surrounding environment. In some embodiments, the catheter system 10 may not include other access points to the fluid pathway from a surrounding environment, which may limit potential bacterial contamination.
  • one or more of the first port 46, the second port 48, the third port 50 may be non-removable and/or monolithically formed as a single unit with a body of the three- way stopcock valve 44 in which the central hub 52 rotates.
  • one or more of the second port 48, the third port 50, and the proximal port 30 may include a removable needleless connector coupled to a non-removable portion of the respective port.
  • needleless connector may reduce a risk of bacterial contamination.
  • the proximal port 30 may be used for near-patient blood sample collection
  • the second port 48 may be used to facilitate clearance of the catheter system 10, including the fluid pathway, with a single flush
  • the third port 50 may be used for temporarily withdrawing blood from the patient to ensure a high-quality sample.
  • one or more of the adapter 58, the first port 46, the second port 48, and the third port 50 may include a vent plug or an end cap.
  • the catheter system 10 may include a pre-filled flush syringe 54 coupled to the second port 48 such that closing of the second port 48, such as by rotating the central hub 52 of the three-way stopcock valve 44, prevents fluid communication between the pre-filled flush syringe 54 and the fluid pathway.
  • a temporary discard sample syringe 56 may be coupled to the third port 50 such that closing of the third port 50, such as by rotating the central hub 52 of the three-way stopcock valve 44, prevents fluid communication between the temporary discard sample syringe 56 and the fluid pathway.
  • the temporary discard sample syringe 56 may be configured for temporary blood withdrawal from the patient.
  • the proximal end 40 of the second extension tube 36 may be integrated with an adapter 58, which may be configured to couple to one or more of the pre-filled flush syringe 54, the temporary discard sample syringe 56, and the three-way stopcock valve 44.
  • the adapter 58 may be coupled to a needleless connector 60, which may reduce a risk of bacterial contamination.
  • needleless connector may refer to the MAXZEROTM Needleless Connector (available from Becton, Dickinson & Company) or another suitable removable, needleless connector as is known in the art, which may be designed to reduce the risk of bacterial contamination.
  • the catheter system 10 may include a pressure monitoring device 62, which may include a pressure transducer.
  • the pressure transducer may include the TRANSP AC® IV Disposable Pressure Transducer (available from ICU Medical) or any other suitable pressure transducer.
  • the pressure monitoring device 62 may be disposed between the second port 48 and the pre-fdled flush syringe 54, which may facilitate flushing of the catheter system 10 via a single flush.
  • the pre-filled flush syringe 54 when the second port 48 is open, the temporary discard sample syringe 56 and blood sampling device 42 are removed, and the pre-filled flush syringe 54 is activated by depressing a plunger of the pre-filled flush syringe 54, fluid within the syringe may travel through the pressure monitoring device 62 and clear the second port 48, the third port 50, the first port 46, the second extension tube 36, the access connector 26 (including the side port 32, the proximal port 30, and the distal port 28), the catheter adapter 12, and the catheter 19.
  • the fluid within the pre-filled flush syringe 54 may include saline or another suitable flush solution.
  • a configuration of the catheter system 10 to clear with the single flush may reduce an amount of the fluid needed for flushing.
  • the catheter system 10 may be compact, easing usage, and may improve workflow when collecting an arterial or venous blood sample.
  • a method of blood collection may include inserting the catheter 19 of the catheter system 10 into the blood vessel, such as a vein or artery, of the patient. In some embodiments, one or more steps of the method may be performed while monitoring arterial blood pressure via the pressure monitoring device 62. Tn some embodiments, the method of blood collection may include coupling the pre- filled flush syringe 54 and/or the temporary discard sample syringe 56 to the catheter system 10. In some embodiments, the method may include closing the second port 48 (which may leave the third port 50 and the first port 46 open), as illustrated, for example, in Figure 3A.
  • the method may include pulling blood from the blood vessel into the temporary discard sample syringe 56. This may be accomplished by pulling a plunger of the temporary discard sample syringe 56. As illustrated, for example, in Figure 3B, in some embodiments, after pulling blood into the temporary discard sample syringe 56, the method may include closing the first port 46. In some embodiments, after closing the first port 46, the method may include collecting blood in the blood sampling device 42, which may be coupled to the proximal port 30 of the access connector 26.
  • the blood sampling device 42 may include a catheter advancement device configured to advance a secondary catheter to extend a life of the catheter 19 and/or provide blood sampling.
  • the catheter advancement device may include the PIVOTM Needle-Free Blood Collection Device, available from Becton, Dickinson & Company of Franklin Lakes, New Jersey, or another suitable catheter advancement device.
  • the method may include advancing the secondary catheter and/or a sensor of the catheter advancement device through the catheter 19 of the catheter system 10.
  • the blood sampling device 42 may include a heparinized syringe, and blood withdrawn into the heparinized syringe by withdrawing a plunger of the heparinized syringe may then be dispensed to an arterial blood gas (ABG) test cartridge for point of care (POC) blood testing.
  • ABSG arterial blood gas
  • POC point of care
  • the method may include closing the second port 48 another time (which may leave the third port 50 and the first port 46 open).
  • the method may include returning the blood pulled into the temporary discard sample syringe 56 into the patient, such as by depressing the plunger of the temporary discard sample syringe 56.
  • the method may include after returning the blood pulled into the temporary discard sample syringe 56 into the patient, turning the three-way stopcock valve 44 to an open position (such that each of the third port 50, the second port 48, and the first port 46 are open) and pushing the pre-filled flush syringe 54 to clear the catheter system 10 with the single flush.
  • the catheter system 10 may include the pressure monitoring device 62, which may be disposed between the second port 48 and the pre-filled flush syringe 54 or another suitable location.
  • a proximal end 64 of the adapter 58 may include a single port or dual ports.
  • the proximal end 64 may include the dual port, which may include a luer port 66a and a luer port 66b (as illustrated in Figure 4A, for example).
  • the dual ports may include a T-shape or a Y- shape.
  • the luer port 66a and/or the luer port 66b may include a female luer to facilitate removable coupling to another device.
  • a vent plug 70 may be disposed within the luer port 66a, which may allow venting of air but reduce a risk of bacterial contamination.
  • the luer port 66b may include a septum therein, which may reduce the risk of bacterial contamination.
  • the luer port 66b may be coupled to a connector that may include a collar. Tn some embodiments, the collar may include one or more threads on the collar, and thus, the collar may facilitate a secure connection.
  • one of the dual ports of the proximal end 64 may be coupled to the temporary discard sample syringe to temporarily withdraw a blood sample prior to blood sampling from the proximal port 30 of the access connector 26, to which a particular blood sampling device may be coupled (such as, for example, the PIVOTM Needle-Free Blood Collection Device, available from Becton, Dickinson & Company of Franklin Lakes, New Jersey).
  • a particular blood sampling device such as, for example, the PIVOTM Needle-Free Blood Collection Device, available from Becton, Dickinson & Company of Franklin Lakes, New Jersey.
  • the catheter system 10 may be cleared with the single flush by activating the pre-fdled flush syringe.
  • another of the dual ports of the proximal end 64 may be coupled to the prefilled flush syringe.
  • the dual ports may allow the temporary discard sample syringe and the pre-filled flush syringe to be coupled to the proximal end 64 at a same time.
  • one or more of the dual ports may include a removable needleless connector coupled to a non-removable portion of a respective one of the dual ports.
  • the needleless connector may reduce a risk of bacterial contamination.
  • the pre-filled flush syringe and/or the temporary discard sample syringe may be coupled to the proximal end 64 via the needleless connector.
  • the proximal end 64 may include the dual port, which may include two luer ports 66a, 66b. As illustrated, in some embodiments, the luer port 66a and/or the luer port 66b may be coupled to a connector that may include a collar. Tn some embodiments, the collar may include one or more threads on the collar, and thus, the collar may facilitate a secure connection. In some embodiments, the proximal end 64 of the adapter 58 and/or needleless connectors coupled thereto do not need to include ports that are compatible with the PTVOTM Needle-Free Blood Collection Device, because the PTVOTM Needle-Free Blood
  • the second extension tube 36 may be more flexible than the first extension tube 20, which may allow it to bend and decrease a risk of disturbing the insertion site when the user couples a device to the proximal end 64. In some embodiments, the second extension tube 36 may be longer than the first extension tube 20 to decrease the risk of disturbing the insertion site when the user couples a device to the proximal end 64.
  • the first port 46 may include a luer, such as, for example, a female luer. In some embodiments, this may allow a needleless connector 60 (such as illustrated, for example, in Figure 4D) to be coupled to and disposed between the first port 46 and the adapter 58, which may decrease a risk of bacterial contamination.
  • a needleless connector 60 such as illustrated, for example, in Figure 4D
  • the dual ports may include an offset side port 72 from an axial port 74 axially aligned with a longitudinal axis 76 of the adapter 58.
  • the offset side port 72 may be non-planar with the axial port 74 and may facilitate flushing by creating turbulence.
  • the offset side port 72 may correspond to the luer port 66a of Figures 4A-4B and/or the luer port 66b of Figures 4A-4B in terms of one or more features and/or operation.
  • the axial port 74 may correspond to the luer port 66a of Figures 4A-4B and/or the luer port 66b of Figures 4A-4B in terms of one or more features and/or operation.
  • an inner lumen of the adapter 58 may include one or more fluid deflection ramps 78, which may create turbulence and enhance flushing. Additionally or alternatively, in some embodiments, the fluid deflection ramps 78 may be disposed within the proximal port 30 of the access connector 26 to create turbulence and enhance flushing at a near-patient port.
  • the pressure monitoring device 62 may be operatively coupled to a pressure transducer electrical connector 80, which may extend from the pressure monitoring device 62 (see also Figures 3A-3E).
  • a proximal end of the pressure monitoring device 62 may be coupled to a needleless connector 60, which may reduce a risk of bacterial contamination.
  • the pre-filled flush syringe 54 may be coupled to the pressure monitoring device 62 or the needleless connector 60, which may facilitate flushing of the catheter system 10 via the single flush.
  • the pressure monitoring device 62 may be coupled to the third port 50 or another suitable location.
  • the pressure monitoring device 62 may be coupled to the third port 50 or the proximal port 30 of the access connector 26 to provide accurate measurements due to proximity to the blood vessel.
  • the needleless connector 60 and/or a fluid delivery line may be coupled to the pressure monitoring device 62.
  • Figure 6B illustrates the pre-filled flush syringe 54 coupled to a proximal end of the needleless connector 60
  • Figure 6A illustrates the proximal end of the needleless connector 60 free, according to some embodiments.
  • the first extension tube 20 and/or the second extension tube 36 may be rigid or semi-rigid.
  • the second extension tube 36 may be rigid or semi-rigid, which may facilitate a more accurate pressure measurement at the pressure monitoring device 62.
  • the pressure monitoring device 62 coupled to the three-way stopcock valve 44 may provide a benefit of monitoring arterial pressure at a point much closer to the patient than existing systems, which may facilitate a more accurate pressure measurement at the pressure monitoring device 62.
  • the catheter system 10 is coupled to a hemodynamic monitoring system 82, which may be operatively coupled to one or more hemodynamic monitoring system sensors 84.
  • a second sampling port 86 may provide an alternate or additional location than the access connector 26 for blood sampling.
  • the second sampling port 86 may be used in perioperative and surgical settings. The second sampling port 86 may be eliminated due to presence of the access connector 26, negating a need for the second sampling port 86 in some embodiments.
  • the temporary discard sample syringe 88 may be secured to the hemodynamic monitoring system 82 along with the hemodynamic monitoring system sensors 84, if desired.
  • a line 90 which may include pressure tubing, may be fluidically connected to the catheter system 10 via a connector 92.
  • the line 90 may be coupled to a blood clearing system 94, which may be near patient and/or closed.
  • the blood clearing system 94 may be in-line and may facilitate collection of a temporary blood draw volume that may be later reinfused or pushed back into the patient.
  • a shutoff valve 97 may be closed, preventing fluid communication with the line 90 and aspiration of blood from the reservoir.
  • a blood sample may be collected from the proximal port 30 of the access connector 26.
  • the blood sample may be collected using the blood sampling device 42, which may include a catheter advancement device such as, for example, the PIVOTM Needle-Free Blood Collection Device, available from Becton, Dickinson & Company of Franklin Lakes, New Jersey.
  • the shutoff valve 97 may be opened and the plunger 95 of the blood clearing system 94 may be depressed or pushed down to reinfuse the temporary blood draw volume within the reservoir into the patient.
  • the blood clearing system 94 within the catheter system 10 may not include a blood sampling port other than the proximal port 30 of the access connector 26, which may provide near-patient blood collection and may also facilitate use of the catheter system 10 with the catheter advancement device.

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Abstract

Un système de cathéter peut comprendre un adaptateur de cathéter, qui peut comprendre un orifice latéral. Le système de cathéter peut comprendre un cathéter, un premier tube d'extension ayant une extrémité distale et une extrémité proximale, et un second tube d'extension ayant une extrémité distale et une extrémité proximale. L'extrémité distale du premier tube d'extension peut être intégrée à l'orifice latéral de l'adaptateur de cathéter. Le système de cathéter peut comprendre un connecteur d'accès, qui peut comprendre un orifice distal, un orifice proximal et un orifice latéral. L'extrémité proximale du premier tube d'extension peut être intégrée à l'orifice distal du connecteur d'accès. L'extrémité distale du second tube d'extension peut être intégrée à l'orifice latéral du connecteur d'accès. Le premier tube d'extension peut être plus court que le second tube d'extension.
PCT/US2023/031422 2022-09-12 2023-08-29 Système de cathéter intégré conçu pour l'échantillonnage du sang WO2024058938A1 (fr)

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US202263405700P 2022-09-12 2022-09-12
US63/405,700 2022-09-12
US18/238,967 2023-08-28
US18/238,967 US20240082546A1 (en) 2022-09-12 2023-08-28 Integrated catheter system configured for blood sampling

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150011910A1 (en) * 2012-05-30 2015-01-08 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
US20200078564A1 (en) * 2018-09-10 2020-03-12 Becton, Dickinson And Company Peripheral intravenous catheter assembly having an extension set
US20200230353A1 (en) * 2019-01-18 2020-07-23 Becton, Dickinson And Company Catheter delivery device and related systems and methods
US20210085927A1 (en) * 2019-09-24 2021-03-25 Bard Access Systems, Inc. Integrated Acute Central Venous Catheter and Peripherally Inserted Venous Catheter
WO2022098589A1 (fr) * 2020-11-06 2022-05-12 Becton, Dickinson And Company Méthodes, systèmes, et dispositifs de prélèvement sanguin

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150011910A1 (en) * 2012-05-30 2015-01-08 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
US20200078564A1 (en) * 2018-09-10 2020-03-12 Becton, Dickinson And Company Peripheral intravenous catheter assembly having an extension set
US20200230353A1 (en) * 2019-01-18 2020-07-23 Becton, Dickinson And Company Catheter delivery device and related systems and methods
US20210085927A1 (en) * 2019-09-24 2021-03-25 Bard Access Systems, Inc. Integrated Acute Central Venous Catheter and Peripherally Inserted Venous Catheter
WO2022098589A1 (fr) * 2020-11-06 2022-05-12 Becton, Dickinson And Company Méthodes, systèmes, et dispositifs de prélèvement sanguin

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