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WO2024249719A1 - Tube d'amorçage jetable stérile - Google Patents

Tube d'amorçage jetable stérile Download PDF

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Publication number
WO2024249719A1
WO2024249719A1 PCT/US2024/031806 US2024031806W WO2024249719A1 WO 2024249719 A1 WO2024249719 A1 WO 2024249719A1 US 2024031806 W US2024031806 W US 2024031806W WO 2024249719 A1 WO2024249719 A1 WO 2024249719A1
Authority
WO
WIPO (PCT)
Prior art keywords
prime
cap
fluid
tube
prime cap
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/US2024/031806
Other languages
English (en)
Inventor
Ian MENEGO
William BARONE
Michael Swantner
Christopher Capone
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bayer Healthcare LLC
Original Assignee
Bayer Healthcare LLC
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
Application filed by Bayer Healthcare LLC filed Critical Bayer Healthcare LLC
Priority to AU2024280577A priority Critical patent/AU2024280577A1/en
Publication of WO2024249719A1 publication Critical patent/WO2024249719A1/fr
Priority to CONC2025/0016117A priority patent/CO2025016117A2/es
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61M39/20—Closure caps or plugs for connectors or open ends of tubes
    • 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
    • A61M39/20—Closure caps or plugs for connectors or open ends of tubes
    • A61M2039/205—Closure caps or plugs for connectors or open ends of tubes comprising air venting means
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/14—Detection of the presence or absence of a tube, a connector or a container in an apparatus
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3306—Optical measuring means
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3306—Optical measuring means
    • A61M2205/3313—Optical measuring means used specific wavelengths
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3317—Electromagnetic, inductive or dielectric measuring means
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3375—Acoustical, e.g. ultrasonic, measuring means
    • 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
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/1011—Locking means for securing connection; Additional tamper safeties
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/007—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests for contrast media
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/14546—Front-loading type injectors
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/14566—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir for receiving a piston rod of the pump
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5086—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile for indicating if defective, used, tampered with or unsterile

Definitions

  • the present disclosure relates generally to prime or purge tubes, such as prime or purge tubes for priming a fluid path set with fluid and/or purging of air from the fluid path set prior to performance of an injection protocol. More specifically, the present disclosure relates to prime or purge tubes for use in priming and/or purging of air from the fluid path set used in a fluid injector system for injecting a contrast media for a contrast enhanced imaging procedure prior to performance of the contrast enhanced imaging procedure.
  • Powered fluid injector systems are widely used in medical imaging procedures such as angiography, computed tomography (CT), and nuclear magnetic resonance (NMR)/magnetic resonance imaging (MRI). Such injector systems provide precision and accuracy of fluid delivery beyond that which is achievable with a manual syringe. Furthermore, powered fluid injector systems offer many safety features to prevent harm to the patient during an injection procedure.
  • Air may be present in syringes or reservoirs of a fluid injector system as packaged from the manufacturer. Additionally, air may accumulate in syringes or reservoirs during automatic or manual filling of syringes or reservoirs from one or more bulk fluid sources. Furthermore, air may be present in an unused fluid path set that is connected to the syringe or reservoir. Any air present in the syringe/reservoir and fluid path set must be purged and the fluid path set must be filled with fluid prior to performance of an injection procedure to avoid injection of air into the vasculature of a patient.
  • a tubing set may be connected to the discharge outlet of the syringe/reservoir, and the fluid injector system may be actuated to prime the system by delivering fluid into the tubing set and ejecting the air from the distal end of the tubing set, until the syringe/reservoir and the tubing set are filled only with fluid.
  • liquid fluid may flow out of the distal end as an indication that all the air have been purged from the system.
  • a prime tube for use with a fluid injector may include a patient tube connector having a proximal end and a distal end, and a prime cap having a proximal end and a distal end.
  • the prime cap may have a sensing region configured for sensing a fluid within a second internal chamber defined in the prime cap.
  • the prime tube further may include a connection interface for removably connecting the distal end of the patient tube connector to the proximal end of the prime cap.
  • the connection interface may include a first connector at the proximal end of the prime cap, and a second connector at the distal end of the patient tube connector.
  • the first connector may include a releasable locking mechanism connected to a sidewall of the prime cap.
  • the second connector may include an engagement feature configured to engage at least a portion of the releasable locking mechanism. Disengagement of the engagement feature from the releasable locking mechanism permits removal of the patient tube connector from the prime cap.
  • a fluid injector system may have at least one fluid container, at least one drive member configured for delivering a fluid from the fluid container to a fluid path set, and a prime tube connected to the fluid path set.
  • the prime tube may have a patient tube connector and a prime cap.
  • the prime cap may have a sensing region configured for sensing a fluid within a second internal chamber defined in the prime cap.
  • a sensing arrangement may be provided for sensing at least one characteristic of the prime tube.
  • the sensing arrangement may include at least one sensor configured to at least one of: sense a presence of the prime tube in a prime tube housing of the fluid injector system and sense at least one property of a fluid in the prime cap.
  • a controller may be configured to control operation of the at least one drive member based on a detection status of the sensing arrangement.
  • a sensing arrangement for a fluid injector system for sensing at least one characteristic of a prime tube having a patient tube connector and a prime cap.
  • the sensing arrangement may include at least one sensor configured to at least one of: sense a presence of the prime cap in a prime tube housing of the fluid injector system; and sense a at least one property of a fluid in the prime cap.
  • a prime cap for priming a fluid path.
  • the prime cap may include a hollow body having a proximal end configured for connecting with a patient tube connector and a distal end configured to be at least partially inserted into a priming container; and a cover enclosing the distal end of the hollow body.
  • the cover may be configured to enclose the distal end and may be configured to open when a pressure differential across the cover exceeds a predetermined threshold.
  • a method of priming a patient line with a fluid using a fluid injector system wherein the patient line is connected to a prime tube having a patient tube connector and a prime cap.
  • the method may include detecting a presence of the prime tube in a prime tube housing of the fluid injector system using a prime tube sensor of the fluid injector system.
  • the method may include actuating a drive member of the fluid injection system to deliver fluid to the prime tube during a priming operation.
  • the method further may include detecting at least one property of the fluid within an internal chamber of the prime cap using a priming status sensor of the fluid injector system.
  • the method may include providing an indication that the patient line is primed with the fluid.
  • a prime tube for use with a fluid injector comprising: a patient tube connector having a proximal end and a distal end; a prime cap having a proximal end and a distal end, wherein the prime cap has a sensing region configured for sensing a fluid within a second internal chamber defined in the prime cap; and a connection interface for removably connecting the distal end of the patient tube connector to the proximal end of the prime cap, the connection interface comprising: a first connector at the proximal end of the prime cap; and a second connector at the distal end of the patient tube connector; wherein the first connector comprises a releasable locking mechanism connected to a sidewall of the prime cap, wherein the second connector comprises an engagement feature configured to engage at least a portion of the releasable locking mechanism, and wherein disengagement of the engagement feature from the releasable locking mechanism permits removal of the patient tube connector from the prime cap.
  • Clause 2 The prime tube according to clause 1, wherein the releasable locking mechanism is a removable strip or a deformable or tearable ring connected to the sidewall of the prime cap by a frangible edge that extends around at least a portion of an outer perimeter of the prime cap.
  • the releasable locking mechanism is a removable strip or a deformable or tearable ring connected to the sidewall of the prime cap by a frangible edge that extends around at least a portion of an outer perimeter of the prime cap.
  • Clause 3 The prime tube according to clause 2, wherein the frangible edge is configured to break upon rotation of the patient tube connector relative to the prime cap.
  • Clause 4 The prime tube according to any of clauses 1 to 3, wherein the patient tube connector comprises a first sidewall defining a first internal chamber between the proximal end and the distal end of the patient tube connector, and wherein the first sidewall is configured to allow sensing of a fluid content of the first internal chamber.
  • Clause 7 The prime tube according to clause 5, wherein second sidewall, at least in the sensing region, is transparent or translucent.
  • Clause 8 The prime tube according to clause 5, wherein second sidewall, at least in the sensing region, comprises a textured surface configured to deflect or scatter the electromagnetic energy.
  • Clause 11 The prime tube according to any of clauses 1 to 10, wherein the distal end of the prime cap comprises a cover.
  • Clause 12 The prime tube according to clause 11, wherein a tortuous path is defined between the cover and the second internal chamber of the prime cap to permit passage of air from the second internal chamber of the prime cap.
  • Clause 13 The prime tube according to any of clauses 1 to 12, wherein the distal end of the patient tube connector comprises a male or a female luer connector, and wherein the male or the female luer connector is at least partially surrounded by a skirt having the second connector thereon.
  • Clause 14 The prime tube according to any of clauses 1 to 13, further comprising at least one gripping element protruding radially outward from a sidewall of at least one of the prime cap and the patient tube connector.
  • Clause 15 The prime tube according to any of clauses 1 to 14, further comprising at least one alignment tab protruding radially outward from a sidewall of the prime cap.
  • a fluid injector system comprising: at least one fluid container; at least one drive member configured for delivering a fluid from the fluid container to a fluid path set; a prime tube connected to the fluid path set, the prime tube having a patient tube connector and a prime cap, wherein the prime cap has a sensing region configured for sensing a fluid within a second internal chamber defined in the prime cap; a sensing arrangement for sensing at least one characteristic of the prime tube, the sensing arrangement comprising at least one sensor configured to at least one of: sense a presence of the prime tube in a prime tube housing of the fluid injector system and sense at least one property of a fluid in the prime cap; and a controller configured to control operation of the at least one drive member based on a detection status of the sensing arrangement.
  • Clause 17 The fluid injector system according to clause 16, wherein the at least one property of the fluid is at least one of fluid type, a transition between air and liquid, and a concentration of contrast.
  • Clause 18 The fluid injector system according to clause 16 or 17, wherein the at least one sensor is a through-beam sensor configured to measure intensity of infrared radiation passing through the prime cap.
  • Clause 19 The fluid injector system according to any of clauses 16 to 18, wherein the at least one sensor comprises an optical camera configured to acquire image data of the prime cap.
  • Clause 20 The fluid injector system according to any of clauses 16 to 19, wherein the at least one sensor comprises an optical emitter and at least one optical receiver.
  • Clause 21 The fluid injector system according to any of clauses 16 to 20, wherein the at least one sensor comprises an optical camera configured to acquire image data of the prime cap.
  • Clause 22 The fluid injector system according to any of clauses 16 to 21, wherein the at least one sensor comprises an ultrasonic emitter on a first side of the prime cap and an ultrasonic receiver on a second side of the prime cap.
  • Clause 23 The fluid injector system according to any of clauses 16 to 22, wherein the at least one sensor comprises an ultrasonic emitter and an ultrasonic receiver on a same side of the prime cap.
  • Clause 24 The fluid injector system according to any of clauses 16 to 23, wherein the at least one sensor comprises a capacitive plate configured to contact at least a portion of the prime cap and measure a change in capacitance of the prime cap due to the at least one property of the fluid in the prime cap.
  • Clause 25 The fluid injector system according to any of clauses 16 to 24, wherein the at least one sensor comprises a piezoelectric transducer configured to contact at least a portion of the prime cap and detect a change in vibratory characteristics of the prime cap due to the the at least one property of the fluid in the prime cap.
  • the at least one sensor comprises a piezoelectric transducer configured to contact at least a portion of the prime cap and detect a change in vibratory characteristics of the prime cap due to the the at least one property of the fluid in the prime cap.
  • Clause 26 The fluid injector system according to any of clauses 16 to 25, wherein the at least one sensor comprises a transducer configured to contact at least a portion of the prime cap and detect a change in outer diameter of the prime cap due to the at least one property of the fluid in the prime cap.
  • the at least one sensor comprises a transducer configured to contact at least a portion of the prime cap and detect a change in outer diameter of the prime cap due to the at least one property of the fluid in the prime cap.
  • a sensing arrangement for a fluid injector system for sensing at least one characteristic of a prime tube having a patient tube connector and a prime cap comprising: at least one sensor configured to at least one of: sense a presence of the prime cap in a prime tube housing of the fluid injector system; and sense a at least one property of a fluid in the prime cap.
  • Clause 28 The sensing arrangement according to clause 27, wherein the at least one sensor is a through-beam sensor configured to measure intensity of infrared radiation passing through the prime cap.
  • Clause 29 The sensing arrangement according to clause 27 or 28, wherein the at least one sensor comprises an optical camera configured to acquire image data of the prime cap.
  • Clause 30 The sensing arrangement according to any of clauses 27 to 29, wherein the at least one sensor comprises an optical emitter and at least one optical receiver.
  • Clause 31 The sensing arrangement according to any of clauses 27 to 30, wherein the at least one sensor comprises an optical camera configured to acquire image data of the prime cap.
  • Clause 32 The sensing arrangement according to any of clauses 27 to 31, wherein the at least one sensor comprises an ultrasonic emitter on a first side of the prime cap and an ultrasonic receiver on a second side of the prime cap.
  • Clause 33 The sensing arrangement according to any of clauses 27 to 32 wherein the at least one sensor comprises an ultrasonic emitter and an ultrasonic receiver on a same side of the prime cap.
  • Clause 34 The sensing arrangement according to any of clauses 27 to 33, wherein the at least one sensor comprises a capacitive plate configured to contact at least a portion of the prime cap and measure a change in capacitance of the prime cap due to the at least one property of the fluid in the prime cap.
  • Clause 35 The sensing arrangement according to any of clauses 27 to 34, wherein the at least one sensor comprises a piezoelectric transducer configured to contact at least a portion of the prime cap and detect a change in vibratory characteristics of the prime cap due to the at least one property of the fluid in the prime cap.
  • the at least one sensor comprises a piezoelectric transducer configured to contact at least a portion of the prime cap and detect a change in vibratory characteristics of the prime cap due to the at least one property of the fluid in the prime cap.
  • Clause 36 The sensing arrangement according to any of clauses 27 to 35, wherein the at least one sensor comprises a transducer configured to contact at least a portion of the prime cap and detect a change in outer diameter of the prime cap due to the at least one property of the fluid in the prime cap.
  • the at least one sensor comprises a transducer configured to contact at least a portion of the prime cap and detect a change in outer diameter of the prime cap due to the at least one property of the fluid in the prime cap.
  • a prime cap for priming a fluid path comprising: a hollow body having a proximal end configured for connecting with a patient tube connector and a distal end configured to be at least partially inserted into a priming container; and a cover enclosing the distal end of the hollow body, wherein the cover is configured to enclose the distal end, and wherein the cover is configured to open when a pressure differential across the cover exceeds a predetermined threshold.
  • Clause 38 The prime cap of according to clause 37, wherein the cover comprises an opening that is normally closed and is openable when the pressure differential across the cover exceeds the predetermined threshold.
  • Clause 39 The prime cap of according to clause 37, wherein the cover comprises a membrane that is configured to burst when the pressure differential across the cover exceeds the predetermined threshold.
  • Clause 40 The prime cap of according to clause 37, wherein the cover comprises a cap movable relative to the distal end of the prime cap, and wherein the cap has a piercing element configured to pierce the membrane when the cap is moved toward the proximal end of the prime cap.
  • Clause 41 The prime cap of according to clause 37, wherein the cover comprises a cover having a first portion connected to the distal end and a second portion connected to the distal end, and wherein the first position is configured to separate from the distal end when the pressure differential across the cover exceeds the predetermined threshold.
  • Clause 42 The prime cap of according to clause 37, wherein the cover comprises a one-way valve.
  • Clause 44 The prime cap according to clause 37, wherein the cover comprises a seal having a pinched portion formed by sealingly connecting opposing sides of a sidewall of the seal.
  • a method of priming a patient line with a fluid using a fluid injector system comprising: detecting a presence of the prime tube in a prime tube housing of the fluid injector system using a prime tube sensor of the fluid injector system; upon detecting the presence of the prime tube in the prime tube housing, actuating a drive member of the fluid injection system to deliver fluid to the prime tube during a priming operation; detecting at least one property of the fluid within an internal chamber of the prime cap using a priming status sensor of the fluid injector system; and upon detecting the at least one property of the fluid within the internal chamber of the prime cap, providing an indication that the patient line is primed with the fluid.
  • Clause 46 The method according to clause 45, further comprising removing the patient tube connector from the prime cap and connecting the patient tube connector to a patient tube.
  • Clause 48 The method according to any of clauses 45 to 47, wherein detecting the presence of the prime tube in the prime tube housing comprises detecting a presence of an alignment tab within an opening of the prime tube housing.
  • Clause 49 The method according to any of clauses 45 to 48, wherein actuating a drive member of the fluid injection system to deliver fluid to the prime tube during a priming operation comprises detecting air within the internal chamber of the prime cap and continuing to actuate the drive member until substantially all of the air exits the prime cap through a cover at the distal end of the prime cap.
  • Clause 50 The method according to clause 49, wherein a tortuous path is defined between the cover and an inner surface of the prime cap to permit passage of the air from the internal chamber of the prime cap.
  • FIG. 1 is a partial perspective view of a fluid injector system according to an example of the present disclosure
  • FIG. 2A is a schematic view of a fluid inj ector system in accordance with an example of the present disclosure
  • FIG. 2B is a partial schematic view of the fluid injector system of FIG. 2A, shown with a prime tube attached to each syringe (various components of FIG. 2A are not shown in FIG. 2B for clarity);
  • FIG. 3B is a perspective cross-sectional view of the prime tube and prime cap shown in FIG. 3A;
  • FIG. 3C is a side view of the prime tube and prime cap shown in FIG. 3A;
  • FIG. 3D is a side cross-sectional view of the prime tube and prime cap shown in FIG. 3C;
  • FIG. 3E is a detailed view of a connection interface between a prime tube and a prime cap in accordance with an example of the present disclosure
  • FIG. 3F is a cross-sectional view of the connection interface between the prime tube and the prime cap shown in FIG. 3E;
  • FIG. 3G is a detailed view of a connection interface between a prime tube and a prime cap in accordance with an example of the present disclosure
  • FIG. 3H is a cross-sectional view of the connection interface between the prime tube and the prime cap shown in FIG. 3G;
  • FIG. 31 is a detailed view of a distal end of the prime tube shown in FIG. 3D;
  • FIG. 4A is a perspective view of a prime tube and prime cap prior to insertion into a prime tube housing of a fluid injector
  • FIG. 4B is a perspective cross-sectional view of the prime tube and prime cap shown in FIG. 4A;
  • FIG. 4C is a side cross-sectional view of the prime tube and prime cap shown in FIG. 4A;
  • FIG. 5A is a perspective view of a prime tube and prime cap inserted into a prime tube housing of a fluid injector
  • FIG. 5B is a cross-sectional view of prime tube and prime cap shown in FIG. 5A;
  • FIG. 5C is a side cross-sectional view of the prime tube and prime cap shown in
  • FIG. 5A
  • FIG. 6A is a perspective view of a prime tube removed from a prime cap and a prime tube housing of a fluid injector
  • FIG. 6B is a cross-sectional view of prime tube and prime cap shown in FIG. 6A;
  • FIG. 7A is a perspective view of a prime cap removed from a prime tube housing of a fluid injector
  • FIG. 7B is a cross-sectional view of the prime cap shown in FIG. 7A;
  • FIG. 8A is a perspective view of a prime tube and a prime cap with a sensing arrangement for sensing a presence of the prime cap on the prime tube and for sensing at least one property of a fluid in the prime cap;
  • FIG. 8B is a cross-sectional perspective view of the prime tube and the prime cap with the sensing arrangement shown in FIG. 8A;
  • FIG. 8C is a perspective view of a prime tube and prime cap inserted into a prime tube housing of a fluid injector that is in fluid communication with a waste container in accordance with an example of the present disclosure
  • FIG. 8D is a cross-sectional view of prime tube and prime cap shown in FIG. 8C;
  • FIG. 8E is a perspective view of a prime tube and prime cap having an integrated waste container in accordance with an example of the present disclosure
  • FIG. 8F is a cross-sectional view of the prime tube and prime cap shown in FIG. 8E;
  • FIG. 9A is a schematic illustration of a sensing arrangement for sensing a presence of fluid in the prime cap in accordance with an example of the present disclosure;
  • FIG. 10B shows changes in sensing and detector output for various conditions of the sensing arrangement shown in FIG. 10 A;
  • FIG. 11A is a schematic illustration of a sensing arrangement for sensing a presence of fluid in the prime cap in accordance with an example of the present disclosure
  • FIG. 11B shows graphs of changes in sensing and detector output for various conditions of the sensing arrangement shown in FIG. 11 A;
  • FIG. 12 is a schematic illustration of a sensing arrangement for sensing a presence of fluid in the prime cap in accordance with an example of the present disclosure
  • FIG. 13A is a schematic illustration of a sensing arrangement for sensing a presence of fluid in the prime cap in accordance with an example of the present disclosure
  • FIG. 13B shows graphs of sensor/detector outputs for various conditions of the sensing arrangement shown in FIG. 13A;
  • FIG. 14A is a schematic illustration of a sensing arrangement for sensing a presence of fluid in the prime cap in accordance with an example of the present disclosure
  • FIG. 14B shows graphs of sensor/detector outputs for various conditions of the sensing arrangement shown in FIG. 14 A;
  • FIG. 15A is a schematic illustration of a sensing arrangement for sensing a presence of fluid in the prime cap in accordance with an example of the present disclosure
  • FIG. 15B shows graphs of sensor/detector outputs for various conditions of the sensing arrangement shown in FIG. 15 A;
  • FIG. 16A is a schematic illustration of a sensing arrangement for sensing a presence of fluid in the prime cap in accordance with an example of the present disclosure
  • FIG. 16B shows a graphical plot of sensor/detector outputs for various conditions of the sensing arrangement shown in FIG. 16 A;
  • FIG. 17A is a schematic illustration of a sensing arrangement for sensing a presence of fluid in the prime cap in accordance with an example of the present disclosure
  • FIG. 17B shows graphs of sensor/detector outputs for various conditions of the sensing arrangement shown in FIG. 17 A;
  • FIG. 18A is a schematic illustration of a sensing arrangement for sensing a presence of fluid in the prime cap in accordance with an example of the present disclosure, with the sensing arrangement shown in a first state;
  • FIG. 18B is a schematic illustration of the sensing arrangement shown in FIG. 18A, with the sensing arrangement shown in a second state;
  • FIG. 19A is a perspective view of a prime cap and a prime reservoir according to an example of the present disclosure.
  • FIG. 19B is a perspective cross-sectional view of the prime cap and prime reservoir shown in FIG. 19A;
  • FIG. 19C is a detailed side cross-sectional view of a membrane at a distal end of the prime cap shown in FIG. 19B;
  • FIG.20A is a perspective cross-sectional view of a prime cap and a prime reservoir according to an example of the present disclosure with a membrane at a distal end of the prime cap shown in a closed configuration;
  • FIG. 20B is a detailed side cross-sectional view of a membrane shown in FIG. 20A;
  • FIG. 21 A is a perspective cross-sectional view of the prime cap and prime reservoir of FIG. 20 A with the membrane at the distal end of the prime cap shown in an open configuration;
  • FIG. 21B is a detailed side cross-sectional view of a membrane shown in FIG. 21 A;
  • FIG. 22A is a perspective cross-sectional view of a prime cap and a prime reservoir according to an example of the present disclosure with a membrane at a distal end of the prime cap shown in a closed configuration;
  • FIG. 22B is a detailed side cross-sectional view of a membrane shown in FIG. 22A;
  • FIG. 23A is a perspective cross-sectional view of the prime cap and prime reservoir of FIG. 23 A with the membrane at the distal end of the prime cap shown in an open configuration;
  • FIG. 23B is a detailed side cross-sectional view of a membrane shown in FIG. 23A;
  • FIG. 24A is a top perspective view of a prime cap according to an example of the present disclosure;
  • FIG. 24B is a bottom perspective view of the prime cap shown in FIG. 24A;
  • FIG. 25A is a perspective cross-sectional view of a prime cap shown in FIG. 24A;
  • FIG. 25B is a perspective cross-sectional view of the prime cap shown in FIG. 25A shown installed on a prime cap;
  • FIG. 25C is a detailed side cross-sectional view of a membrane and a cover at a distal end of the prime cap shown in FIG. 25A, with the cover shown in a first position;
  • FIG. 25D is a detailed side cross-sectional view of a membrane and a cover at a distal end of the prime cap shown in FIG. 25A, with the cover shown in a second position;
  • FIG. 26A is a perspective cross-sectional view of a prime cap and a prime reservoir according to an example of the present disclosure;
  • FIG. 26B is a detailed side cross-sectional view of a membrane at a distal end of the prime cap shown in FIG. 26A prior to being pierced by a piercing member of the prime reservoir;
  • FIG. 26C is a detailed side cross-sectional view of the membrane at the distal end of the prime cap shown in FIG. 26B after being pierced by the piercing member of the prime reservoir;
  • FIG. 27A is a side view of a prime cap and a prime reservoir according to an example of the present disclosure
  • FIG. 27B is a side cross-sectional view of the prime cap and prime reservoir of FIG. 27A taken along line A- A;
  • FIG. 28A is a side view of a prime cap and a prime reservoir according to an example of the present disclosure
  • FIG. 28B is a side cross-sectional view of the prime cap and prime reservoir of FIG. 28A taken along line B-B;
  • FIG. 29A is a side view of a prime cap and a prime reservoir according to an example of the present disclosure.
  • FIG. 29B is a side cross-sectional view of the prime cap and prime reservoir of FIG. 29A taken along line C-C.
  • the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the disclosure as it is oriented in the drawing figures. Spatial or directional terms, such as “left”, “right”, “inner”, “outer”, “above”, “below”, and the like, are not to be considered as limiting as the disclosure can assume various alternative orientations.
  • the singular form of “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. All numbers used in the specification and claims are to be understood as being modified in all instances by the term “about”. The terms “approximately”, “about”, and “substantially” mean a range of plus or minus ten percent of the stated value.
  • the term “at least one of’ is synonymous with “one or more of’.
  • the phrase “at least one of A, B, and C” means any one of A, B, and C, or any combination of any two or more of A, B, and C.
  • “at least one of A, B, and C” includes one or more of A alone; or one or more of B alone; or one or more of C alone; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or one or more of all of A, B, and C.
  • the term “at least two of’ is synonymous with “two or more of’.
  • the phrase “at least two of D, E, and F” means any combination of any two or more of D, E, and F.
  • “at least two of D, E, and F” includes one or more of D and one or more of E; or one or more of D and one or more of F; or one or more of E and one or more of F; or one or more of all of D, E, and F.
  • distal refers to a portion of said component nearest to a patient.
  • proximal refers to a portion of said component nearest to the injector (i.e., the portion of said component farthest from the patient).
  • the term “upstream” refers to a direction away from the patient. For example, if a first component is referred to as being “upstream” of a second component, the first component is located farther away from the patient than the second component.
  • the term “downstream” refers to a direction towards the patient. For example, if a first component is referred to as being “downstream” of a second component, the first component is located nearer to the patient than the second component.
  • first”, second, and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements.
  • the term “at least” is synonymous with “greater than or equal to”.
  • the term “not greater than” is synonymous with “less than or equal to”.
  • CT computed tomography
  • injection systems configured for other pressurized injection protocols, such as angiography (CV), ultrasound, positron emission tomography (PET), and magnetic resonance imaging (MRI) may also incorporate the various examples of the prime or purge tubes described herein.
  • CV angiography
  • PET positron emission tomography
  • MRI magnetic resonance imaging
  • many of the examples or prime or purge tubes described herein are detailed in reference to a syringe or syringe-based fluid injector, it should be understood that other powered injection systems, such as those including pumps such as a peristaltic pump, can be primed using various examples of the prime or purge tubes described herein.
  • the presently described prime cap arrangements are not limited to syringe passed fluid injection systems.
  • prime tube for fluid injector systems.
  • the prime tube is located at a distal end of a fluid line that is fluidly connected to fluid reservoir, such as a syringe or bulk fluid container, and fluid delivery mechanism, such as a syringe actuator (piston) or pumping system (e.g., a peristaltic pump) of a fluid injector and is configured to provide indication that the fluid is line is filled with liquid rather than air prior to initiation of a fluid injection procedure.
  • fluid reservoir such as a syringe or bulk fluid container
  • fluid delivery mechanism such as a syringe actuator (piston) or pumping system (e.g., a peristaltic pump) of a fluid injector and is configured to provide indication that the fluid is line is filled with liquid rather than air prior to initiation of a fluid injection procedure.
  • pumping system e.g., a peristaltic pump
  • FIG. 1 an example of a fluid injector system 2000 is partially illustrated showing features of the main housing of fluid injector system 2000.
  • the fluid injector system 2000 is configured for injection of one or more medical fluids through a fluid path into a patient.
  • the fluid injector system 2000 may include at least one graphical user interface (GUI) 11 through which an operator can input injection parameters for, view the progress of, and/or control the status of an injection procedure.
  • GUI 11 may be in operative communication with a controller 900 (see FIGS. 2A-2B) which sends and receives commands between and receives input from the GUI 11 and fluid injector system 2000.
  • the fluid injector system 2000 may have a prime tube housing 400 having a prime tube slot 402 or other feature configured to interact with any of the various embodiments of the prime tube 300 described herein.
  • the prime tube slot 402 or feature may be shaped to receive at least a portion of a prime tube 300 during a priming operation.
  • the prime tube slot 402 or feature may be configured to place the prime tube 300 in fluid communication with a waste container 404 configured to receiving priming fluid delivered from the prime tube 300 during a priming operation.
  • waste container 404 may be sized to receive fluid from multiple priming procedures conducted over a length of time, such as one or more injection procedures or hospital shifts or injection procedure conducted over 24 hours or any other appropriate length of time.
  • a plurality of priming procedures may be conducted to collect fluid in waste container 404 without having to replace the waste container.
  • suitable non-limiting fluid injector systems and features including syringes, pressure jackets and pressure jacket retention mechanisms, tubing, shut-off valves, controllers, and air detectors, are described in U.S. Provisional Application Serial No. 63/578,287, U.S. Patent Nos. 5,383,858; 7,553,294; 7,666,169; 8,945,051; 9,173,995; 10,022,493; 10,507,319, and 10,549,084, and International PCT Application Nos.
  • PCT/US2013/061275 PCT/US2018/034613; PCT/US2019/028139; PCT/US2020/049885; PCT/US2021/035273; PCT/US2021/019507; PCT/US2021/029963; PCT/US2021/018523; PCT/US2021/037623; PCT/US2021/037574; PCT/US2021/045298; PCT/US2022/017812; PCT/US2022/017900; PCT/US2023/020171; PCT/US2023/025159 and PCT/US2023/035311 which disclosures are hereby incorporated by reference in their entireties.
  • the fluid injector system 2000 has a first fluid path 210A for a medical fluid, such as an imaging contrast media for an injection procedure, and a second fluid path 210B for a flushing fluid, such as saline or Ringer’s lactate.
  • the fluid paths 210A, 210B may be connected to respective outlets 16A, 16B, e.g., nozzles, of syringes 10A, 10B filled with medical fluid F, such as contrast or a flushing agent.
  • medical fluid F is a liquid.
  • the dual syringe fluid injector system 2000 may include an injector housing 12 having two syringe ports 15 configured to engage the syringes 10A, 10B.
  • the syringes 10A, 10B may be retained within corresponding pressure jackets, for example, to prevent pressure-induced swelling of the syringes 10A, 10B.
  • the dual syringe fluid injector system 2000 may further include bulk fluid containers 19A and 19B for filling and refilling the respective syringes 10 A, 10B with imaging contrast media and flushing fluid, respectively.
  • the bulk fluid containers 19A and 19B may be in selective fluid communication with the syringes 10A, 10B via respective bulk fluid paths 216A and 216B and bulk fluid valves 215A and 215B.
  • the fluid injector system 2000 includes one or more pistons 13A, 13B respectively associated with each of syringes 10A, 10B.
  • Each of pistons 13A, 13B is configured to reciprocally drive a respective plunger 14A, 14B within a barrel of their respective syringe.
  • the controller 900 is operatively associated with the injector system 2000, for example, to actuate the pistons 13A, 13B to reciprocatively move the plungers 14A, 14B within the syringes 10A, 10B and thereby execute, control, and halt an injection procedure.
  • the controller 900 would be configured to operate the rotors of the corresponding peristaltic pump.
  • the controller 900 may include at least one processor programmed or configured to actuate the pistons 13A, 13B and various other components of the injector system 2000, such as one or more valves 215A, 215B, to take in and deliver medical fluids according to a programmed protocol (e.g., initiating a priming a patient tubing set and/or delivering a set volume of contrast media and saline at a specified flow rate over a specified time) for an injection procedure.
  • the controller 900 may include computer readable media, such as memory, on which one or more injection protocols may be stored for execution by the at least one processor.
  • the controller 900 may be programmed or configured to execute a filling operation during which the piston 13A, 13B associated with each syringe 10A, 10B is withdrawn toward a proximal end of the syringe 10A, 10B to draw injection fluid F (e.g., imaging contrast media and flushing fluid) into the syringe 10A, 10B from the bulk fluid containers 19A, 19B.
  • injection fluid F e.g., imaging contrast media and flushing fluid
  • controller 900 may be programmed or configured to selectively actuate bulk fluid valves 215A and 215B to establish fluid communication between the respective syringes 10A, 10B and the bulk fluid containers 19A, 19B via bulk fluid paths 216A and 216B to control filling of syringes 10A, 10B with the appropriate injection of medical fluid F.
  • the controller 900 may be further programmed or configured to execute a priming/purging operation, either automatically according to a work flow or after receiving a prompt from a user, to remove any air from the syringes 10A, 10B and the fluid paths 210A, 210B upon completion of the filling operation.
  • a priming/purging operation will be described herein in connection with the various examples of the purge tubes 300 discussed herein.
  • the controller 900 may be further programmed or configured to execute a fluid delivery operation during which the piston 13A, 13B associated with one or both of syringes 10A, 10B is moved toward a distal end of the syringe to inject the medical fluid F into the first fluid path 210A and the second fluid path 210B, respectively.
  • the controller 900 may be programmed or configured to selectively actuate the bulk fluid valves 215A and 215B to establish fluid communication between the syringes 10A, 10B and the patient, via the fluid paths 210A, 210B.
  • the first fluid path 210A and the second fluid path 210B ultimately merge into a patient fluid line 210C, for example with turbulent mixing using a mixing connector according to International PCT Application No. PCT/US2021/019507, in fluid communication with the vasculature of the patient.
  • the fluid injector system 2000 is shown with a prime tube 300 in fluid communication with each of the syringes 10A, 10B, whereas FIG. 1 shows the fluid injector system 2000 with a single prime tube 300 connected to patient fluid line 210C.
  • the fluid injector system 2000 may have the prime tube housing 400 with at least one prime tube slot 402, with each prime tube slot 402 configured to receive a single prime tube 300, as discussed herein with reference to FIG. 1.
  • the prime tube 300 may be fluidly connected to the syringes 10A, 10B after a filling operation in which the syringes 10A, 10B are filled from the bulk fluid containers 19A and 19B and prior to an injection procedure.
  • the fluid injector system 2000 may include a manifold assembly, for example as described in International PCT Application No. PCT/US2022/017812, which allows for filling of syringes 10A, 10B from bulk fluid containers 19A, 19B and delivery of fluid from syringes 10A, 10B with the prime tube according to the various embodiments attached to the fluid path 210C during a filling or priming operation.
  • Other examples may be directed towards priming of at least a portion of the fluid paths 210A, 210B in preparation for a fluid injection procedure.
  • the prime tube 300 may be attached to a distal end of the fluid paths 210A, 210B (as shown in FIG.
  • the prime tube 300 may be attached to a distal end of a newly installed single patient tubing set (attached to the distal end of the multi-use tube set) to ensure priming of the single patient tubing set 210C prior to attaching to a patient catheter.
  • the fluid paths 210A, 210B may be disconnected from the syringes 10A, 10B to allow for connection of the prime tubes 300.
  • the fluid injector system 2000 may be actuated to prime/purge the syringes 10A, 10B of any air by extending the pistons 13A, 13B distally to eject air from the syringes 10A, 10B into the associated prime tubes 300 via the fluid paths 210A, 210B and/or 210C.
  • the controller 900 may be programmed or configured to automatically extend each of the pistons 13A, 13B a predetermined distance, corresponding to a predetermined fluid volume, to eject the predetermined air/fluid volume from each syringe 10A, 10B into the associated prime tubes 300 when the programmed injection protocol requires the priming operation, for example after filling of the syringes 10A, 10B from bulk fluid containers 19A, 19B and before disconnection of the single patient tubing set 210C from the prim tube 300 and connection of the single patient tubing set 210C to the patient catheter.
  • the predetermined air/fluid volume may be selected to ensure that all (or substantially all) of the air in the syringes 10A, 10B is ejected into the prime tubes 300.
  • the predetermined air/fluid volume may be selected based on empirical data of the maximum volume of air within syringes after a fill operation.
  • the predetermined air/fluid volume may include a factor of safety to ensure that even an abnormally high amount of air will be fully ejected from the syringe during the priming/purging operation.
  • the prime tube 300 and associated patient tube connector 302 and prime cap 304 may be configured with a sensing feature, as described herein, that allows for monitoring of the priming operation and detecting air and liquid fluid in the prime cap 300 to determine when substantially all of the air has been ejected from the prime tube 300.
  • the prime tube 300 is shown separate from the rest of the fluid injector system 2000.
  • the prime tube 300 generally includes a patient tube connector 302 and a prime cap 304.
  • the patient tube connector 302 and the prime cap 304 are removably connected together, as discussed herein.
  • the patient tube connector 302 includes a sidewall 310 having a proximal end 312 and a distal end 314 and defining an internal chamber 316, for example a lumen passing through patient tube connector 302 from the proximal end 312 to the distal end 314 and providing fluid communication therethrough.
  • the proximal end 312 of the sidewall 310 is open and may include a first connector 320 configured to connecting to a distal end of one of the fluid paths 210A, 210B, and /or 210C (shown in FIGS. 2A-2B).
  • the first connector 320 may be integrally formed with the distal end of one of the fluid paths 210A, 210B, and/or 210C.
  • the distal end 314 of the patient tube connector 302 is open and has a second connector 321 configured for removably connecting to the prime cap 304.
  • the second connector 321 may include one or more engaging lugs 322 having a profile complementary to at least a portion of a first connector 338 at a proximal end 322 of prime cap 304 to retain the prime cap 304.
  • the distal end 314 of the patient tube connector 302 further may be configured to connect to a fluid path element for delivering fluid to a patient when the prime cap 304 is removed from the patient tube connector 302.
  • distal end 314 of the patient tube connector 302 may have a male or a female luer connector 318.
  • At least one gripping element 325 may protrude radially outward from the sidewall 310 of the patient tube connector 302 to provide a gripping surface to facilitate disconnection of the patient tube connector 302 from the prime cap 304 and/or connection of the patient tube connector 302 with the fluid path element.
  • a pair of opposing gripping elements 325 may be provided to provide a gripping surface for the user in order to enable an easier twisting movement of patient tube connector 302 when disconnecting from prime cap 304 or connecting with the patient catheter.
  • the prime cap 304 includes a sidewall 330 having a proximal end 332 and a distal end 334 and defining an internal chamber 336.
  • the proximal end 332 of the sidewall 330 may include a first connector 338 configured to connecting to the distal end of the patient tube connector 302, for example in the form of a lumen passing through prime cap 304 from the proximal end 332 to the distal end 334 and providing fluid communication therethrough.
  • the distal end 334 of the prime cap 304 may be at least partially closed with a cover 340.
  • cover 340 may include a tortuous pathway, valve, or other pathway to allow gas to flow therethrough but substantially prevent a liquid fluid from flowing therethrough.
  • the cover 340 may be configured to permit passage of air therethrough to evacuate air from the internal chamber 336 before permitting liquid to exit the internal chamber 336. In this manner, the internal chamber 336 can be fully filled with liquid, before any liquid can exit the internal chamber 336 via the cover 340.
  • the internal chamber 336 of the prime cap 304 is in fluid communication with the internal chamber 316 of the patient tube connector 302 when the prime cap 304 is connected to the patient tube connector 302.
  • At least one gripping element 350 or key element 351 may protrude radially outward from at least a portion of sidewall 330 of the prime cap 304 to provide a gripping surface to facilitate removal of patient tube connector 302 from prime cap 304 or providing a keyed connection between prime cap 304 and a complementary keyed insertion portion on prime tube housing 400 on fluid injector system 2000.
  • the internal chamber 316 of the patient tube connector 302 and the internal chamber 336 of the prime cap 304 may have a volume sufficient to hold the predetermined liquid fluid volume ejected from the associated syringe 10A, 10B during the syringe priming/purging operation.
  • the volume defined by the internal chambers 316, 336 may range from 0.1 mL to 10 mL. In specific examples, the volume may be sufficient to account for cases when more than one prime sequence is required, for example, when air bubbles are still observed in the system or to accommodate two or more fluid injection operations.
  • a prime operation may include two injection sequences, a first forceful flow rate with low ejected volumes to remove the majority of air from system and then a second slower flow rate with larger flow volumes, optionally accompanied by tapping or vibrations - either manual by the user or by a vibration feature associated with the fluid injector system 2000, to remove small air bubbles from the syringes or fluid path.
  • the prime cap 304 may have a gripping element 350 protruding radially outward from the sidewall 330.
  • the gripping element 350 may extend radially outward in a direction substantially perpendicular to a major longitudinal axis L of the prime cap 304.
  • the gripping element 350 may be angled at an oblique angle relative to the longitudinal axis L.
  • the gripping element 350 defines a gripping surface 352 configured for being grasped by a user when handling the prime cap 304, such as during installation or removal of the prime cap 304 on the prime tube housing 400 on the fluid injector system 2000 (shown in FIG. 1).
  • the gripping surface 352 may be grasped between the user’s thumb and index finger during installation or removal of the prime cap 304 in the prime tube slot 402 of the prime tube housing 400, as described herein.
  • the gripping surface 352 may have one or more protrusions 354 configured to prevent slippage of the prime cap 304 from the user’s grip while handling the prime cap 304.
  • the gripping element 350 may have a skirt 356 protruding in a proximal direction.
  • the skirt 356 is configured to surround at least a portion of the proximal end 332 of the prime cap 304.
  • the skirt 356 is radially spaced apart from the proximal end 332 of the prime cap 304 such that the distal end 314 of the prime tube connector 302 can be received in a space between the skirt 356 and the proximal end 332.
  • the skirt 356 may be circumferentially continuous or have one or more openings 358 extending therethrough.
  • the skirt 356 may include a reversible connection feature, for example in the form of a threaded surface on an interior surface thereof for providing a reversible connection with a corresponding threaded surface on the prime tube connector 302.
  • the prime cap 304 may have an alignment tab 360 protruding radially outward from the sidewall 330.
  • the alignment tab 360 may extend radially outward in a direction substantially perpendicular to the major longitudinal axis L of the prime cap 304.
  • the alignment tab 360 may be angled at an oblique angle relative to the longitudinal axis L.
  • the alignment tab 360 may be provided on an opposite side of the prime cap 304 to the gripping element alignment tab 360, such that the alignment tab 360 and the gripping element 350 extend in substantially opposite directions from each other.
  • the alignment tab 360 may have at least one alignment groove 362 or other alignment feature or key feature 351 that is configured to align the prime cap 302 relative to the prime tube slot 402 or other corresponding alignment feature on the prime tube housing 400 on the fluid injector system 2000 (shown in FIG. 1) during installation of the prime cap 304.
  • the alignment tab 360 may be tapered such that its width decreases in a direction radially outward from the sidewall 330 of the prime cap 304. Alignment of the prime cap 304 relative to the prime tube slot 402 of the prime tube housing 400 assures proper orientation of the prime cap 304 relative to a sensing arrangement configured for sensing the presence of air and/or liquid within internal chamber 336 of the prime cap 304, as discussed herein.
  • the syringe 10A, 10B may be held in a substantially upright vertical position with the outlet 16A, 16B at the highest point, the syringe 10A, 10B may be primed, e.g., the plunger 13A, 13B moved in the distal direction to expel a portion of the contents of the syringe (i.e., air and small volume medical fluid F), to purge any air from the interior of the syringe 10A, 10B and/or fluid paths 210A, 210B, and/or 210C.
  • the plunger 13A, 13B moved in the distal direction to expel a portion of the contents of the syringe (i.e., air and small volume medical fluid F)
  • the prime cap 304 may be oriented in a vertical position with the distal end pointing upwards to allow any air in prime cap 304 to rise toward the distal end due to buoyancy.
  • air may be dislodged from the various interior surfaces of the syringe and the surface of the plunger 14A, 14B and/or fluid paths 210A, 210B, and/or 210C to ensure that all air is primed from the system. Examples of such methods for dislodging air bubbles (including microbubbles) from interior surfaces or plunger surface are described in International PCT Application No.
  • PCT/US2019/028139 for example, by placing the syringe contents under an at least partial vacuum to coalesce the small air bubbles into larger bubbles and/or vibrating, knocking, or otherwise impacting the syringe, tubing, and/or piston/plunger assembly to dislodge the bubbles.
  • the prime cap 304 may include a cover 340 associated with the distal end 334 of the sidewall 330.
  • the cover 340 may be configured to contact an inner surface 331 of the sidewall 330 such that a tortuous fluid path 341 is defined between the cover 340 and the inner surface 331 of the sidewall 330.
  • cover 340 may be formed from a material having at least one tortuous fluid path therethrough.
  • the tortuous fluid path 341 may be such that the cover 340 is permeable to air and liquid to allow passage of air and liquid through the internal chamber 336 of the prime cap 304 into, for example, the waste container 404 (shown in FIG. 1) during a priming operation.
  • the tortuous fluid path 341 provides a restriction to outlet flow such that the internal chamber 336 may be filled with liquid prior to allowing the liquid to exit the internal chamber 336 through the cover 340. This improves the detection capability of a sensing arrangement configured to detect a presence of liquid within the internal chamber 336 and reduces the amount of waste fluid exiting the prime cap 304.
  • a restriction provided by the tortuous fluid path 341 improves the efficiency of fluid detection since it forces the internal chamber 336 of the prime cap 304 to fill with liquid instead of a air/liquid mixture.
  • the restriction provided by the tortuous fluid path 341 helps the liquid "cling" to the wall of the internal chamber 336 of the prime cap 304 due to surface tension effects. This alternate design could provide fluid detection even without the cover 340.
  • the tortuous fluid path 341 may be configured to prevent further passage of liquid out of internal chamber 336 of prime cap 304.
  • tortuous fluid path 341 may be such that cover 340 is permeable to air but substantially impermeable to liquid to allow passage of air but not liquid through cover 340 of the prime cap 304.
  • cover 340 also prevents contamination of the fluid within internal chamber 336 by preventing outside contaminants from entering internal chamber 336.
  • the tortuous fluid path 341 may be shaped to prevent direct entry of outside microbial contaminants into internal chamber 336 due to conditions outside the prime cap 304, such as air currents. In this manner, cover 340 helps preserve a sterile fluid path from the syringe to patient tube connector 302.
  • the waste container 404 may be integrated with the prime cap 304 and may be sized to receive a volume of liquid from a single priming operation or from multiple priming operations. Alternatively, waste container 404 may be separate from the prime cap 304 and may be sized to receive volumes of liquid from multiple priming operations.
  • cover 340 may be configured to prevent further loss of liquid from the internal chamber 336 when additional liquid is not delivered to the internal chamber 336 under pressure.
  • the cover 340 may be permeable to air and substantially impermeable to liquids.
  • the cover 340 may be a porous material, such as a material having at least one tortuous path or aperture having a cross-sectional area sized to allow to allow passage of air and substantially prohibit passage of a medical fluid through the at least one aperture.
  • air ejected from the syringes 10A, 10B and/or fluid paths 210A, 210B, and/or 210C by pressurization of the syringe contents may flow out of the patient tube connector 302 and the prime cap 304 via the cover 340, while any medical fluid ejected from the syringe 10A, 10B is retained within the internal chamber 316 of the patient tube connector 302 and the internal chamber 336 of the prime cap 304.
  • the cover 340 may be made from a hydrophobic medical grade plastic, such as those commercially available under the trade names Gore-tex® and Porex®, which generally allow passage of gas but not liquid therethrough.
  • the cover 340 may be a solid material defining one or more apertures having a sufficient cross-sectional area to allow the passage of air out of the prime tube 300, but an insufficient cross-sectional area to allow the passage of the liquid.
  • the cover 340 may include an absorbent material, such as cotton or other fibrous material, to absorb and retain the liquid while allowing air to pass out of the prime tube 300.
  • the cover 340 may be a solid member impermeable to all fluids, e.g., air and medical fluids, such that all fluids injected into the patient tube connector 302 and the prime cap 304 from syringe 10A, 10B and/or fluid paths 210A, 210B, and/or 210C are retained within internal chambers 316, 336.
  • fluids e.g., air and medical fluids
  • the internal chamber 336 of the prime cap 304 may be configured to promote or enhance fluid adherence to an inner surface of the internal chamber 336.
  • the internal chamber 336 of the prime cap 304 may have a portion having a reduced internal diameter configured to permit the fluid to cling to the internal surfaces of the internal chamber 336.
  • the inner surface of the internal chamber 336 may have one or more spiral grooves configured to spin the fluid as the fluid flows into the internal chamber 336, thereby enhancing the adherence of the fluid to the inner surface of the internal chamber 336.
  • the internal chamber 336 of the prime cap 304 may have one or more protrusions protruding radially inward relative to the inner surface of the internal chamber 336.
  • the one or more protrusions may be formed as one or more ribs arranged in an axial and/or a radial pattern and configured to divert the fluid toward the inner surface of the internal chamber 336.
  • the inner surface of the internal chamber 336 may have one or more surface texturization features that roughen the inner surface to promote fluid adherence.
  • the internal chamber 336 of the prime cap 304 may be configured to accumulate fluid to a predetermined level, which level would be indicative of a complete purge of the internal chamber 316 of the patient tube connector 302.
  • the prime cap 304 may be configured to be arranged at an oblique angle relative to a vertical orientation of fluid injector system 2000 when engaged with prime tube housing 400 such that fluid is forced to flow along at least an inclined portion of the inner surface of the internal chamber 336.
  • the prime cap 304 may have one or more internal flow diverting features configured to divert a flow of the fluid toward the inner surface of the internal chamber 316.
  • the one or more flow diverting features may be one or more baffles configured to deflect the fluid flow toward the inner surface of the internal chamber 316.
  • the one or more flow diverting features may be a flow diverter in a middle of the internal chamber 316 that is configured to deflect the fluid flow toward the inner surface of the internal chamber 316.
  • the internal chamber 336 of the prime cap 304 may have any combination of the features described herein to promote or enhance fluid adherence to an inner surface of the internal chamber 336.
  • the proximal end 332 of the prime cap 304 has the first connector 338 configured to connecting to the second connector 321 at the distal end 314 of the patient tube connector 302.
  • the first connector 338 on the prime cap 304 may include a releasable locking mechanism, such as a removable strip 342 or other tamper resistant feature that is configured to engage the second connector 321 on the patient tube connector 302 that is configured as an engagement feature, such as a lip 323.
  • the prime cap 304 When the removable strip 342 is engaged with the lip 323, the prime cap 304 is connected to the patient tube connector 302 in such a manner that the prime cap 304 cannot be removed from the patient tube connector 302.
  • a user may presume that a prime tube 300 may have been tampered with and may potentially have been previously used or potentially contaminated with microbial contamination if the removable strip 342 has been damaged or removed.
  • the removable strip 342 is connected to the sidewall 330 of the prime cap 304 by a frangible edge 344 (shown in FIG. 3E) to allow for tearing or separation of the removable strip 342 from the sidewall 330 of the prime cap 304.
  • the removable strip 342 When the removable strip 342 is removed from the sidewall 330 of the prime cap 304 due to tearing or separation of the frangible edge 344, the removable strip 342 can be removed from the lip 323, which permits removal of the prime cap 304 from the patient tube connector 302. Removal of the removable strip 342 may provide tactile feedback to the user that the patient tube connector 302 can be disconnected from the prime cap 304.
  • the removable strip 342 serves as a tamper-evident feature that maintains the sterility of the patient tube connector 302. For example, a user may presume that a prime tube 300 may have been tampered with and may potentially have been previously used or potentially contaminated with microbial contamination if the removable strip 342 has been damaged or removed. Absence of the removable strip 342 serves as an indicator that prime cap 304 may have been removed from the patient tube connector 302.
  • the proximal end 332 of the prime cap 304 has the first connector 338 configured to connecting to the second connector 321 at the distal end 314 of the patient tube connector 302.
  • the first connector 338 on the prime cap 304 may be a deformable ring 343 that is configured to engage the second connector 321 on the patient tube connector 302 that is configured as a lip 323.
  • the deformable ring 343 may be connected to a portion of the sidewall 330 of the prime cap 304 (shown in FIG. 3D) and is configured to deform from a first configuration, in which deformable ring 343 is substantially circular, and a second configuration, in which deformable ring 343 is substantially oval.
  • connection interface between the distal end 314 of the patient tube connector 302 and the proximal end 332 of the prime cap 304 may be embodied as one or more tamper-evident connection interfaces described in International PCT Application No. PCT/US2023/020171.
  • the prime cap 304 is connected to the patient tube connector 302 in such a manner that the prime cap 304 cannot be removed from the patient tube connector 302.
  • the deformable ring 343 is moved to the second configuration, such as by squeezing the deformable ring 343, the deformable ring 343 may be removed from the lip 323, which permits removal of the prime cap 304 from the patient tube connector 302.
  • the threads on patient tube connector 302 be unthreaded from the corresponding threads of prime cap 304 to disconnect the patient tube connector 302.
  • the deformable ring 343 serves as a tamper-evident feature that maintains the sterility of the patient tube connector 302. Absence of the deformable ring 343 serves as an indicator that prime cap 304 may have been removed from the patient tube connector 302.
  • an embodiment of the prime tube 300 including the patient tube connector 302 and the prime cap 304 is configured for insertion into an embodiment of a prime tube slot 402 of a prime tube housing 400 on a fluid injector system 2000 (shown in FIG. 1). While FIGS. 4A-4B show the prime tube 300 and the prime tube housing 400 in a vertical orientation relative to the orientation of the drawing page, it should be noted that, in practice, the prime tube 300 could be arranged horizontally or any convenient orientation for ease of access and use.
  • the prime tube slot 402 may be shaped to receive at least a portion of the prime cap 304 and retain the prime tube 300 during a set-up and/or a priming operation.
  • the prime tube slot 402 has an opening 404 shaped to correspond to an outer shape of at least a portion of the prime cap 304.
  • the opening 404 may be formed as an open slot having an upper portion 404a and a lower portion 404b that that are spaced apart from each other to define the open slot that is configured to slidably receive at least a portion of the prime cap 304.
  • the opening 404 may be shaped to slidably receive the alignment tab 360 of the prime cap 304.
  • An end surface 406 of the prime tube housing 400 may be configured to engage at least a portion of the prime cap 304, such as an end surface 366 of the alignment tab 360, to delimit an insertion length of the prime cap 304 into the opening 404.
  • opening 404 of prime tube slot 402 may define a receiving space having a complementary shape to at least a portion of an outside surface of prime cap 304, such that at least a portion of prime cap 304 may be inserted into the receiving space and indexed to interact with a sensing arrangement within the receiving space of prime tube housing 400.
  • opening 404 of prime tube slot 402 may define a receiving space including a reader capable of reading an indicia, such as a bar code, RFID, QR Code, or other identifying indicia, on prime cap 304 to ensure that the prime cap 304 has not been previously used, is not counterfeit, and is the correct type for interacting and use with the fluid injector system 2000.
  • the controller 900 of fluid injector system 2000 may initiate a priming procedure.
  • the controller 900 may automatically initiate the priming procedure once the prime tube 300 is recognized by the controller 900 as being correctly engaged with the prime tube housing 400.
  • the controller 900 may initiate the priming procedure in response to a user input after the prime tube 300 is recognized by the controller 900 as being correctly engaged with the prime tube housing 400.
  • a priming procedure is initiated, either manually or automatically by the fluid injector system 2000, the medical fluid F from the syringes 10A, 10B is expelled through the outlet 16A, 16B, flows through and/or fluid paths 210A, 210B, and/or 210C, and enters internal chambers 316, 336 of the patient tube connector 302 and the prime cap 304, respectively.
  • any air in the system is ejected from syringes 10A, 10B and/or fluid paths 210A, 210B, and/or 210C by pressurization of the syringe contents may flow out of the patient tube connector 302 and the prime cap 304 via the tortuous fluid path 341 of the cover 340.
  • medical fluid F starts flowing from cover 340, internal chamber 316 of patient tube connector 302 and internal chamber 336 of prime cap 304 are filled with medical fluid F and are void of any air.
  • a sensing arrangement within prime tube housing 400 may be configured to monitor prime cap 304 and determine which substantially all the air has been primed from the system and the system is ready to connect to the patient and initiate a fluid injection protocol.
  • the patient tube connector 302 may be removed from the prime cap 304 to allow for connection of the patient tube connector 302 to a fluid path element for delivering fluid to a patient.
  • the patient tube connector 302 may be removed from the prime cap 304 by breaking or fracturing a tamper resistant feature, such as at least a portion of the removable strip 342, such as due to tearing or separation of the frangible edge 344.
  • Such breaking or fracturing of at least a portion of the removable strip 342 may occur when the patient tube connector 302 is rotated about its longitudinal axis relative to the prime cap 304. For example, by rotating the patient tube connector 302 about its longitudinal axis in a direction of arrows A shown in FIG. 5A, at least a portion of the frangible edge 344 connecting the removable strip 342 to the prime cap 304 may be broken, thereby allowing removal of the patient tube connector 302 from the prime cap 304.
  • FIGS. 6A, 6B when the patient tube connector 302 (tubing not shown) is removed from the prime cap 304, the prime cap 304 remains connected to the prime tube housing 400.
  • the prime cap 304 can be removed from the prime tube housing 400 (FIGS. 7A, 7B), for example by sliding the prime cap 304 in a direction of arrow C to allow insertion of a new prime tube 300 into the prime tube housing 400.
  • the fluid injector system 2000 may include a sensing arrangement 500 for at least one of (A) detecting the presence of the prime cap 304, for example after insertion of prime cap 304 into prime tube housing 400; and (B) detecting at least one property of a fluid in the prime cap 304.
  • properties of a fluid may include one or more of, presence of the prime cap 304, presence of air in the prime cap 304, presence of liquid fluid in the prime cap 304, volume of air within the prime cap 304, volume of liquid fluid within the prime cap 304, fluid type (saline vs.
  • the sensing arrangement 500 may then communicate that at least one property to a user of the fluid injector system 2000, through controller 900
  • the sensing arrangement 500 may be integrated into the prime tube housing 400 on the fluid injector system 2000 such that the sensing arrangement 500 may (A) detect the presence of the prime cap 304 and (B) detect at least one property of a fluid in the prime cap 304 when the prime tube 300 is inserted into the prime tube housing 400.
  • the sensing arrangement 500 may include at least one first sensor 502 (hereinafter referred to as “prime cap sensor 502”) configured for detecting the presence of the prime cap 304 and at least one second sensor 504 (hereinafter referred to as “priming status sensor 504”) configured for detecting a presence of fluid in the prime cap 304.
  • the prime cap sensor 502 and the priming status sensor 504 may be in communication with the controller 900 (shown in FIG. 1).
  • the prime cap sensor 502 may also be combined into the at least one second sensor 504 such that the at least one second sensor 504 may also be able to detect the presence of the prime cap 304.
  • the functions of the prime cap sensor 502 and the priming status sensor 504 may be performed by a single sensor.
  • the prime cap sensor 502 may be an optical time-of-flight sensor that is configured for measuring distance from the sensor to at least one surface of the prime cap 304. If the measured distance detected by the prime cap sensor 502 is within an expected range, the sensor 502 may provide an indication to controller 900 that the prime cap 304 is correctly inserted into the prime tube housing 400 and a priming operation may commence. If the measured distance detected by the prime cap sensor 502 is outside the expected range, this provides an indication that prime cap 304 has not been correctly inserted into the prime tube 400 and the controller may direct a user that the prime cap 304 insertion must be corrected before a priming operation may be commenced.
  • the prime cap sensor 502 may be a through-beam sensor that is configured for measuring the intensity of an infrared radiation beam going through the sidewall 330 of the prime cap 304 for example by measuring an intensity of the electromagnetic radiation at a detector after it has passed through prime cap 304.
  • the prime cap sensor 502 may be an optical camera configured for acquiring image data of an area above the prime cap 304.
  • Image processing software may be used to analyze the image data and determine if the prime cap 304 is present in the prime tube housing 400.
  • Information regarding the presence of the prime cap 304 may be sent to the controller 900, which then may control one or more functions of the fluid injector system 2000.
  • the controller 900 may initiate a priming procedure if the prime cap sensor 502 detects that the prime cap 304 is present in the prime tube housing 400.
  • the controller 900 may prevent initiation of a priming procedure if the prime cap sensor 502 detects that the prime cap 304 is absent from or incorrectly inserted into the prime tube housing 400.
  • the priming status sensor 504 may be in communication with the controller 900 and may be configured to detect one or more of: the presence of the prime cap 304, if the prime cap 304 contains air, if the prime cap 304 contains saline, if the prime cap 304 contains contrast, or other properties of a fluid within prime cap 304.
  • priming status sensor 504 may determine a priming status, e.g., whether the syringes 10A, 10B and/or fluid paths 210A, 210B, and/or 210C have been primed to remove all air therefrom, based on observation and/or measurement of air and/or fluid in the prime cap 304.
  • the priming status sensor 504 may include light emitter/sensors, optical sensors (e.g., cameras), strain gauges, microphones, ammeters, limit switches, pressure transducers, or any other variety of sensor capable of detecting a property of the system 2000 that can be used to determine the priming status.
  • the controller 900 may be programmed or configured to permit performance of an injection procedure only after a successful prime of the syringe 10A, 10B and/or fluid paths 210A, 210B, and/or 210C has been detected, such as when the priming status sensor 504 detects a presence of saline or contrast in the internal chamber 336 of the prime cap 304.
  • the controller 900 may be programmed or configured to prevent performance of an injection procedure until a successful prime of the syringe 10A, 10B and/or fluid paths 210A, 210B, and/or 210C has been detected, such as when the priming status sensor 504 detects a presence of air in the internal chamber 336 of the prime cap 304.
  • the priming status sensor 504 may be a pair of sensors, with a first sensor positioned to detect the priming status of the prime cap 304 and a second sensor (not shown) configured to detect a presence and/or measure a volume of liquid in the waste container 404 (shown in FIG. 8C-8D).
  • the priming status sensor 500 may include at least one emitter 506 configured to emit electromagnetic energy, for example electromagnetic energy have one or more specific wavelengths, and at least one receiver 508 configured to detect the emitted electromagnetic energy. Examples of methods and uses of detectors and receivers of specific wavelengths for determining fluid presence and types are described in International PCT Application Publication Nos.
  • the at least one emitter 506 may be an LED or other suitable source configured for emitting electromagnetic energy in one or more of the visible spectrum, infrared spectrum, ultraviolet spectrums, or at specific wavelengths of light in any of these spectrums
  • the at least one receiver 508 may be a phototransistor or similar detector configured for detecting the electromagnetic energy in one or more of the visible spectrum, infrared spectrum, ultraviolet spectrums or at specific wavelengths of light in any of these spectrums.
  • the at least one emitter 506 and the at least one receiver 508 may be positioned substantially perpendicular relative to a longitudinal axis of the prime cap 304.
  • the at least one emitter 506 may be positioned on opposite side of the sidewall 330 of the prime cap 304 as the at least one receiver 508 such that electromagnetic energy emitted by the at least one emitter 506 passes through the opposing sidewalls 330 of the prime cap 304 and the internal chamber 336 before being received by the at least one receiver 508.
  • the sidewall 330 may be configured to permit passage of the electromagnetic energy therethrough such that the energy emitted from the at least one emitter 506 can be detected by the at least one receiver 508 after passing through the sidewall 330.
  • the at least one receiver 508 is configured to detect the wavelength and/or intensity of the electromagnetic radiation, which is dependent based on whether the prime cap 304 is present between the at least one emitter 506 and the at least one receiver 508 and whether air or liquid (e.g., contrast or flushing agent) is present in internal chamber 336 of prime cap 304.
  • the priming status sensor 504 may be configured for detecting a type of fluid that is within the prime cap 304 (e.g., contrast or flushing agent, or the specific contrast from a plurality of different contrasts, or a concentration of contrast agent in the solution of contrast), see, International PCT Application Publication No. PCT/US2022/017900.
  • FIG. 9B a graph depicting the output of the at least one emitter 506 and the at least one receiver (detector) 508 described herein with reference to FIG. 9A is shown.
  • the intensity of the signal detected by the at least one receiver 508 decreases based on whether the prime cap 304 is present between the at least one emitter 506 and the at least one receiver 508 (i.e., the prime cap 304 is correctly inserted into the prime tube housing 400), based on whether the internal chamber 336 of the prime cap 304 is filled with air due to absorption of some electromagnetic energy by the air, and based on whether the internal chamber 336 of the prime cap 304 is filled with liquid due to absorption of greater amounts of electromagnetic energy by the liquid.
  • the intensity of the signal detected by the at least one receiver 508 may be correlated to a type of liquid within the prime cap 304 (e.g., contrast vs. flushing solution, concentration of contrast, or different types of contrast) due to differences in absorption of the electromagnetic energy by the different liquids.
  • a type of liquid within the prime cap 304 e.g., contrast vs. flushing solution, concentration of contrast, or different types of contrast
  • the presence of the prime cap 304 and the fluid within the internal chamber 336 of the prime cap 304 significantly attenuates the intensity of the signal detected by the at least one receiver 508.
  • the signal detected by the at least one receiver 508 may be used in determining the priming status of the prime cap 304.
  • the priming status sensor 504 may include at least one emitter 506 configured to emit electromagnetic energy and an array 510 of receivers 508 configured to detect electromagnetic energy.
  • the at least one emitter 506 may be an LED configured for emitting electromagnetic energy in the visible spectrum, infrared spectrum, or other region of the electromagnetic spectrum, as described herein
  • the array 510 of receivers 508 may be phototransistors configured for detecting electromagnetic energy in the visible spectrum, or other region of the electromagnetic spectrum, as described herein. Similar to the example shown in FIG.
  • the at least one emitter 506 may be positioned on opposite side of the sidewall 330 of the prime cap 304 such that electromagnetic energy emitted by the at least one emitter 506 passes through the opposing sidewalls 330 of the prime cap 304 and the internal chamber 336 before being received by the one of the receivers 508 in the array 510.
  • the at least one emitter 506 and the at least one receiver 508 may be positioned across from each other at a non-perpendicular angle relative to a longitudinal axis of the prime cap 304.
  • the sensor configuration may use the refraction of the electromagnetic radiation as it passes through the sensing region to determine the presence of prime cap 304 and type of fluid contained within the prime cap 304 as described herein.
  • electromagnetic energy emitted from the at least one emitter 506 will be deflected and refracted based on whether the prime cap 304 is present between the at least one emitter 506 and the at least one receiver 508 and based on whether the internal chamber 336 of the prime cap 304 is filled with air (i.e., “empty”) or filled with liquid.
  • air i.e., “empty”
  • Such deflection/refraction may occur due to, for example, refraction of the beam of electromagnetic energy as it passes through different media (air, sidewall 330 of the prime cap 304, and the specific type of liquid in the internal chamber 336 of prime cap 304).
  • the deflected beam of electromagnetic energy will then be received by a different single or multiple receivers 508a-508c of the array 510.
  • the signal detected by the at least one receiver 508a-508c may be used in determining a priming status of prime cap 304.
  • the priming status sensor 504 may include at least one emitter 506 configured to emit electromagnetic energy and at least one receiver 508 configured to detect electromagnetic energy, similar to the arrangement shown and described herein with reference to FIGS. 9A-9B.
  • the at least one emitter 506 may be positioned on the opposite side of the sidewall 330 of the prime cap 304 relative to the at least one receiver 508 and substantially perpendicular relative to a longitudinal axis of the prime cap 304 such that electromagnetic energy emitted by the at least one emitter 506 passes through the opposing sidewalls 330 of the prime cap 304 and the internal chamber 336 before being received by the at least one receiver 508.
  • At least a portion of the internal or external sidewall 330 on the side of the prime cap 304 which the electromagnetic energy enters the prime cap 304 may have a textured surface 512 configured to scatter or deflect the beam of electromagnetic energy emitted from the at least one emitter 506 as the beam of electromagnetic energy passes through the sidewall 330.
  • a graph depicting the output of the at least one emitter 506 and the at least one receiver (detector) 508 is shown.
  • the intensity of the signal detected by the at least one receiver 508 may be highest when no prime cap 304 is present between the at least one emitter 506 and the at least one receiver 508 because there is not textured surface to scatter the electromagnetic energy.
  • the textured surface 512 of the sidewall 330 may be configured to deflect the beam of electromagnetic energy, thereby reducing the intensity of the signal detected by the at least one receiver 508.
  • the intensity of the signal detected by the at least one receiver 508 may be higher compared to the intensity of the signal when air is present due to the fluid preventing the diffusion of the beam of electromagnetic energy.
  • the signal detected by the at least one receiver 508 may be used in determining a priming status of prime cap 304.
  • the priming status sensor 504 may be an optical camera 514 configured to take image data of the prime cap 304.
  • the optical camera 514 may be configured to detect the presence of a fluid marker 516 provided on the sidewall 330 of the prime cap 304, for example by a molded imprint or a shaped adhesive sticker. At least a portion of the sidewall 330 may be transparent or translucent to permit the optical camera 514 to gather image data of the sidewall 330.
  • the fluid marker 516 is desirably oriented on the side of the sidewall 330 that is opposite to the optical camera 514.
  • the shape of an image of the fluid marker 516 that is visible to the optical camera 516 may change depending on the presence or absence of fluid in the internal cavity 336 of the prime cap 304.
  • the fluid marker 516 having an oval shape may appear to the optical camera 514 to have a circular shape if a liquid fluid is present due to changes in refraction of light due to the presence of the liquid in the prime cap 304.
  • the fluid marker 516 having an oval shape may appear to the optical camera 514 to have an oval shape if air is present due to little or no refraction of light due to the presence of the air in the prime cap 304. If no oval or circle is observed by optical cameral 514, then prime cap 304 must not have been inserted into prime tube housing 400 and the controller 900 notified that the system is not ready for priming. Suitable examples of fluid refraction of oval fluid markers are described in U.S. Patent Nos.
  • fluid marker 516 is specifically disclosed herein, other shapes for fluid marker 516, such as any regular or irregular geometric shape including letters, numbers, and images or trademarks are not precluded.
  • Image data detected by optical camera 514 may be used in determining a priming status of prime cap 304.
  • the priming status sensor 504 may include at least one emitter 506 configured to emit electromagnetic energy and at least one receiver 508 configured to detect electromagnetic energy, similar to what is described herein with reference to FIGS. 9A-9B.
  • the prime cap 304 may have at least one flattened surface running at least a portion of the longitudinal axis of a sidewall of the prime cap 304, for example a sixsided cross-sectional shape with a plurality of angled flat portions 515.
  • the at least one emitter 506 and the at least one receiver 508 may be positioned substantially perpendicular relative to each other and having the at least one flattened surface oriented such that the emitted signal and received signal pass through the at least one flattened surface that is substantially perpendicular to the path of the signal as it passes therethrough.
  • the at least one emitter 506 may be positioned such that electromagnetic energy emitted therefrom is at least partially directed toward one of the angled flat portions 515, which is configured to deflect at least a portion of the incident electromagnetic energy toward the at least one receiver 508.
  • the receiver 508 is configured to detect the intensity of the electromagnetic radiation, which is dependent based on whether prime cap 304 is present between the at least one emitter 506 and the at least one receiver 508 and whether air or liquid is present in internal chamber 336 of prime cap 304.
  • graphical representations depicting the output of the at least one emitter 506 and the at least one receiver (detector) 508 are shown.
  • the intensity of the signal detected by the at least one receiver 508 increases based on whether prime cap 304 is present between the at least one emitter 506 and the at least one receiver 508, wherein no signal is detected due to all of the electromagnetic energy being directed in a direction away from the at least one receiver 508, and based on whether the internal chamber 336 of the prime cap 304 is filled with air or filled with a particular liquid.
  • the signal detected by the at least one receiver 508 may be used in determining the priming status of prime cap 304, i.e., whether prime cap 304 is filled with air or a particular liquid (saline or contrast) as described herein.
  • the priming status sensor 504 may include at least one ultrasonic emitter 520 configured to emit ultrasonic energy and at least one ultrasonic receiver 522 configured to detect ultrasonic energy.
  • the at least one ultrasonic emitter 520 may be positioned on opposite side of the sidewall 330 of the prime cap 304 and substantially perpendicular relative to a longitudinal axis of the prime cap 304 such that ultrasonic energy emitted by the at least one ultrasonic emitter 520 passes through the opposing sidewalls 330 of the prime cap 304 and the internal chamber 336 and its content before being received by the at least one ultrasonic receiver 522.
  • the at least one ultrasonic receiver 522 is configured to detect the intensity of the ultrasonic energy, which may be dependent on whether prime cap 304 is present between the at least one ultrasonic emitter 520 and the at least one ultrasonic receiver 522 and whether air or liquid is present in internal chamber 336 of prime cap 304.
  • graphical representations depicting the output of the at least one ultrasonic emitter 520 and the at least one ultrasonic receiver (detector) 522 are shown.
  • the intensity of the signal detected by the at least one ultrasonic receiver 522 decreases based on whether prime cap 304 is present between the at least one ultrasonic emitter 520 and the at least one ultrasonic receiver 522, based on whether the internal chamber 336 of the prime cap 304 is filled with air, or whether the internal chamber 336 of the prime cap 304 is filled with a particular liquid.
  • the signal detected by the at least one ultrasonic receiver 522 may be used in determining a priming status of prime cap 304.
  • the at least one ultrasonic emitter 520 and the at least one ultrasonic receiver 522 may be positioned on the same side relative to the prime cap 304, instead of on opposite sides as shown in FIGS. 14A, 14B.
  • the ultrasonic energy emitted by the at least one ultrasonic emitter 520 may be reflected by the far sidewall 330 of the prime cap 304 and detected by the at least one ultrasonic receiver 522.
  • the intensity of the signal detected by the at least one ultrasonic receiver 522 depends based on whether the prime cap 304 is present and on whether the internal chamber 336 of the prime cap 304 is filled with air (“empty”) or filled with liquid. No signal is detected when there is no prime cap 304.
  • the near sidewall 330 may be configured to deflect the beam of ultrasonic energy, thereby reducing the intensity of the signal detected by the at least one ultrasonic receiver 522.
  • the intensity of the signal detected by the at least one ultrasonic receiver 522 may be higher compared to the intensity of the signal when air is present due to the ultrasonic energy being reflected off of far sidewall 330.
  • the signal detected by the at least one ultrasonic receiver 522 may be used in determining a priming status of prime cap 304.
  • the priming status sensor 504 may include at least one capacitive plate 524 controlled by the controller 900 according to one embodiment.
  • the at least one capacitive plate 524 may be positioned substantially parallel relative to a longitudinal axis of prime cap 304.
  • the at least one capacitive plate 524 is configured to measure a capacitance/charge level within a detection area 526, which is dependent based on whether prime cap 304 is present in detection area 526 and whether air or a liquid is present in internal chamber 336 of prime cap 304.
  • FIG. 16B a graph depicting the output of the at least one capacitive plate 524 is shown.
  • the intensity of the signal detected by the at least one capacitive plate 524 increases based on whether prime cap 304 is present in the detection area 526 and based on whether internal chamber 336 of prime cap 304 is filled with air or filled with liquid.
  • the presence of the liquid within internal chamber 336 of prime cap 304 amplifies the intensity of the capacitance signal detected by the at least one capacitive plate 524.
  • the signal detected by the at least one capacitive plate 524 may be used in determining a priming status of prime cap 304.
  • the priming status sensor 504 may include at least one piezo transducer 528 controlled by the controller 900.
  • the at least one piezo transducer 528 may be positioned substantially perpendicular relative to the longitudinal axis of the prime cap 304.
  • the at least one piezo transducer 528 is configured to induce vibrations 304 and measure the vibration response of prime cap 304 and the contents of prime cap 304, which is dependent based on whether prime cap 304 is present and whether air or a liquid is present in internal chamber 336 of prime cap 304.
  • FIG. 17B graphical representations depicting the output of the at least one piezo transducer 528 are shown. Initially, the at least one piezo transducer 528 outputs a high-frequency vibration. In there is no prime cap 304 present, the at least one piezo transducer 528 does not receive any vibratory response. The characteristics of the vibratory signal detected by the at least one piezo transducer 528 changes based on whether the internal chamber 336 of the prime cap 304 is filled with air or filled with liquid. Amplitude and frequency of an air-filled prime cap 304 are higher than amplitude and frequency compared to a liquid filled prime cap 304 due to liquid damping the vibration.
  • the type of liquid may impact the vibration response, for example due to a viscosity of the liquid.
  • the signal detected by the at least one piezo transducer 528 may be used in determining a priming status of prime cap 304.
  • the priming status sensor 504 may include at least one spring-loaded pin or biasing sensor 530.
  • the longitudinal axis of the at least one spring-loaded pin sensor 530 may be positioned substantially perpendicular relative to the longitudinal axis of the prime cap 304.
  • a pin 532 of the at least one spring-loaded pin sensor 530 is configured to contact an outer surface of the sidewall 330 of the prime cap 304 and is configured to detect an outward deflection of the sidewall 330 of the prime cap 304 due to capacitance expansion of the sidewall 330 from the pressurized contents.
  • a pressurized fluid F i.e., liquid contrast or flushing agent
  • the pressure of the fluid F causes the sidewall 330 of the prime cap 304 to expand in a radially outward direction, thereby compressing the pin 532 of the at least one spring-loaded pin sensor 530.
  • the compressibility of air results in little or no expansion of sidewall 330 and thus, no compressing of pin 532.
  • the pin sensor 530 may be configured to have a first state where when prime cap 304 is not present, the pin sensor 530 has no compression and when the prime cap 304 is inserted, the sidewall 330 compresses the pin sensor 530 to a second state due to the diameter of prime cap 304, indicating that prime cap 304 has been inserted into prime tube housing 400.
  • the internal chamber 336 may have an internal restriction 337 to increase the fluid pressure within internal chamber 336 when prime cap 304 is filled with fluid.
  • the output of the at least one spring- loaded pin sensor 530 may be used in determining a priming status of prime cap 304.
  • Prime cap 604 is shown in accordance with another example of the present disclosure.
  • the prime cap 604 may be configured for connecting with any of the patient tube connectors 302 described herein with reference to FIGS. 3A-18B.
  • Prime cap 604 may be configured to connect at its distal end with or be at least partially inserted into an interior of a priming reservoir 700.
  • the distal end 634 of the prime cap 604 may be inserted into an opening 702 of priming reservoir 700 such that any liquid primed or purged from the prime cap 604 may enter an interior 704 (see, FIG. 19B) of priming reservoir 700.
  • priming reservoir 700 may be provided as a separate component relative to the prime cap 604 or the fluid injector system 2000. In other embodiments, priming reservoir 700 may be integrated with prime cap 604 and/or fluid injector system 2000. For example, priming reservoir 700 may be connected, such as removably or non-removably connected, to the injector housing. Priming reservoir 700 is configured to receive a volume of liquid primed from prime cap 604 during a priming operation, as described herein.
  • the priming reservoir 700 has a hollow body 706 having a proximal end 708 and a distal end 710 with the interior 704 extending between the proximal and distal ends 708, 710.
  • the distal end 710 is closed while the proximal end 708 has the opening 702.
  • the interior 704 of the priming reservoir 700 may be sized to receive liquid delivered from the prime cap 604 during a plurality of priming operations.
  • the priming reservoir 700 may be sized to receive a total amount of fluid that is discharged during priming operations for fluid injection protocols conducted during a predetermined period of time, such as a length of a hospital or radiologist shift, a 24- hour period, or the like.
  • the volume priming reservoir 700 should be sufficient to account for cases when more than one prime sequence per patient is required, for example, when air bubbles are still observed in the system and a second priming operation must be performed.
  • a prime operation may include two injection sequences, a first forceful flow rate with low ejected volumes of liquid to remove the majority of air from the system and then a second slower flow rate with larger flow volumes, optionally accompanied by tapping or vibrations, to remove small air bubbles, as described herein.
  • the prime cap 604 may include a sidewall 630 having a proximal end 632 and a distal end 634 and defining an internal chamber 636.
  • the proximal end 632 of the sidewall 630 may include a first connector 638 configured to connecting to the distal end of the patient tube connector 302 (shown in FIGS. 3A-3B).
  • the internal chamber 636 of prime cap 604 is in fluid communication with internal chamber 316 of the patient tube connector 302 when prime cap 604 is connected to patient tube connector 602.
  • At least one gripping element 635 may protrude radially outward from sidewall 630 of prime cap 604 to provide a gripping surface to facilitate removal of prime cap 604 from patient tube connector 302.
  • the distal end 634 of prime cap 604 is configured to be at least partially inserted through opening 702 at the proximal end 708 of priming reservoir 700.
  • distal end 634 of prime cap 604 may be positioned such that it is not in physical contact with a sidewall of the hollow body 706 surrounding opening 702.
  • the distal end 634 of prime cap 604 may be in direct physical contact with at least a portion of the hollow body 706 surrounding opening 702.
  • a locking mechanism may be provided for releasably connecting distal end 634 of prime cap 604 to proximal end 708 of the priming reservoir 700.
  • the distal end 634 of the prime cap 604 may include a cover 640.
  • the cover 640 may have a body 644 having an outer surface configured for contacting the inner surface 641 of the distal end 634 of the prime cap 604.
  • the distal end 634 may be open such that the cover 640 is inserted into the open distal end 634.
  • the outer surface of the body 644 of the cover 640 may be engaged with the inner surface 641 of the distal end 634 via friction fit, adhesive, welding, or other mechanical fastening process.
  • a cap may be provided to prevent distal movement of the cover 640 relative to the prime cap 604.
  • the cover 640 may be made from a medical -grade elastomeric material.
  • cover 640 may have an opening 642 that is normally closed such that fluid can be retained within the internal chamber 636 of the prime cap 604.
  • the opening 642 may be provided in a portion of the body 644 of the cover 640 having a first thickness T1 that is smaller than a second thickness T2 of the remaining portion of the body 644.
  • the opening 642 is configured to be openable when a pressure differential between a first side of the opening 642 (e.g., the internal chamber 636 of the prime tube 604) and a second side of the opening 642 (e.g., ambient environment within the interior 704 of the priming reservoir 700) exceeds a predetermined threshold.
  • the opening 642 may be configured to transition from the normally closed configuration to an open configuration when the pressure-differential exceeds a predetermined threshold of 1-10 psi.
  • the opening 642 may be a slit 648 having a first portion 650 and a second portion 652.
  • the first and second portions 650, 652 may contact each other to seal the opening 642 in the normally closed configuration of the opening 642.
  • the first and second portions 650, 652 are configured to at least partially separate from each other, such as by deflecting from each other in a direction of arrows A, thereby defining a fluid path for the fluid to exit the prime cap 604 and enter the priming reservoir 700 (shown in FIG. 19B).
  • the prime cap 604 is shown in accordance with additional examples of the present disclosure.
  • the components of the prime cap 604 shown in FIGS. 20A-21B are substantially similar or identical to the components of the prime cap 604 described herein with reference to FIGS. 19A-19C. Accordingly, reference numerals in FIGS. 20A-21B are used to illustrate identical components of the corresponding reference numerals in FIGS. 19A-19C.
  • FIGS. 19A-19C As the previous discussion regarding the prime cap 604 generally shown in FIGS. 19A-19C is applicable to the prime cap 604 shown in FIGS. 20A-21B, only the relative differences between the prime cap 604 shown in FIGS. 19A-19C and the prime cap 604 shown in FIGS. 20A-21B are discussed hereinafter.
  • the cover 640 may have a membrane 654 extending across the distal end 634 of the prime cap 604.
  • the membrane 654 may be connected to an insert 656 that is inserted into the distal end 634 of the prime cap 604.
  • an outer surface of the insert 656 may be at least partially inserted into the distal end 634 and connected therewith, such as by adhesive, friction fit, welding, or other mechanical connection mechanism.
  • an inner surface of the insert 656 may be connected to an outer surface of the distal end 634.
  • the membrane 654 may be connected directly to the distal end 634 of the prime cap 604.
  • the membrane 654 may be connected to the insert 656 and/or the distal end 634 of the prime cap 604 via an adhesive, welding, or being integrally molded therewith. As shown in FIG. 20B, the membrane 654 may have at least one perforation 658 that defines a weakened region. The membrane 654 is configured to break at the at least one perforation 658 when a pressure differential between a first side of the membrane 654 (e.g., the internal chamber 636 of the prime tube 604) and a second side of the membrane 654 (e.g., ambient environment within the interior 704 of the priming reservoir 700) exceeds a predetermined threshold. For example, the membrane 654 may be configured to burst or break, as shown in FIGS. 21A-21B, when the pressure-differential exceeds a predetermined threshold of 1-10 psi.
  • the prime cap 604 is shown in accordance with additional examples of the present disclosure.
  • the components of the prime cap 604 shown in FIGS. 22A-23B are substantially similar or identical to the components of the prime cap 604 described herein with reference to FIGS. 20A-21B. Accordingly, reference numerals in FIGS. 22A-23B are used to illustrate identical components of the corresponding reference numerals in FIGS. 20A-21B.
  • FIGS. 22A-23B are used to illustrate identical components of the corresponding reference numerals in FIGS. 20A-21B.
  • cover 640 may have a cover 660 extending across the distal end 634 of prime cap 604.
  • cover 660 may be connected to the insert 656 that is inserted into the distal end 634 of prime cap 604.
  • Cover 660 may be connected to the insert 656 via an adhesive, welding, or being integrally molded therewith.
  • cover 660 may be connected directly to the distal end 634 of prime cap 604.
  • a first portion 661a of the cover 660 may be adhered or otherwise connected to the insert 656 in a manner that is less adhered or otherwise connected as a second portion 661b of the cover 660.
  • the first portion 661a of the cover 660 may be configured to separate from the insert 656 and/or the distal end 634 of the prime cap 604 when a pressure differential between a first side of the cover 660 (e.g., the internal chamber 636 of the prime tube 604) and a second side of the cover 660 (e.g., ambient environment within the interior 704 of the priming reservoir 700) exceeds a predetermined threshold while the second portion 661b of the cover 660 remains connected to the insert 656 and/or the distal end 634 of the prime cap 604.
  • a first side of the cover 660 e.g., the internal chamber 636 of the prime tube 604
  • a second side of the cover 660 e.g., ambient environment within the interior 704 of the priming reservoir 700
  • the first portion 661a of the cover 660 may be configured to separate from the insert 656 and/or the distal end 634 of the prime cap 604, as shown in FIGS. 23A-23B, when the pressure-differential exceeds a predetermined threshold of 1-10 psi.
  • the second portion 661b of cover 660 may remain connected to the insert 656 and/or the distal end 634 of prime cap 604.
  • the prime cap 604 is shown in accordance with additional examples of the present disclosure.
  • the components of the prime cap 604 shown in FIGS. 24A-25D are substantially similar or identical to the components of the prime cap 604 described herein with reference to FIGS. 19A-19C. Accordingly, reference numerals in FIGS. 24A-25D are used to illustrate identical components of the corresponding reference numerals in FIGS. 19A-19C.
  • FIGS. 19A-19C As the previous discussion regarding the prime cap 604 generally shown in FIGS. 19A-19C is applicable to the prime cap 604 shown in FIGS. 24A-25D, only the relative differences between the prime cap 604 shown in FIGS. 19A-19C and the prime cap 604 shown in FIGS.
  • the distal end 634 of prime cap 604 may have a cap 662 that is movably connected to the distal end 634.
  • the cap 662 has a proximal end 664 connected to the distal end 634 of the prime cap 604 and a distal end 668 having at least one aperture 670.
  • the cap 662 may be movable between a first position (shown in FIG. 25C) and a second position (shown in FIG. 25D) in a direction of a longitudinal axis of the prime cap 604.
  • the cap 662 may be movable from the first position to the second position due to contact with at least a portion of the priming reservoir 700, such as a ledge 720 extending across the opening 702 (shown in FIG. 25D).
  • the cap 662 may have a piercing element 672 protruding proximally from the distal end 668.
  • the piercing element 672 is configured to pierce through the membrane 654 extending across the distal end 634 of the prime cap 604. For example, when the distal end 634 of the prime cap 604 is inserted into the opening 704 of the priming reservoir 700, the distal end 668 of the cap 662 contacts the ledge 720.
  • the cap 662 may have one or more protrusions 674 that protrude radially inward to form an inner surface of the sidewall of the cap 662.
  • the one or more protrusions 674 may be configured to be received in one or more grooves 676 recessed radially inward into the sidewall of the distal end 634 of the prime cap 604.
  • the one or more protrusions 674 may be configured to be received within the one or more grooves 676 to secure the cap 662 on the distal end 634 of the prime cap 604.
  • the axial spacing between the one or more grooves 676 may correspond to a location of the cap 662 between the first and second positions. In this manner, the cap 662 can be locked in the first position prior to the membrane 654 being pierced by the piercing element 654. Movement of the cap 662 in the proximal direction relative to the prime cap 604 causes the one or more protrusions 674 to be unlocked from a first groove 676 such that the cap 662 can be moved distally until the one or more protrusions 674 is locked in a second groove 676.
  • the location of the one or more protrusions 674 and the one or more grooves 676 may be reversed, such that the o protrusions 674 are provided at the distal end 634 of prime cap 604 and the one or more grooves 676 are provided on the inner surface of cap 662.
  • the piercing element 672 may be provided on the ledge 720 of the priming reservoir 700. In this manner, when the distal end 634 of the prime cap 604 is inserted into the opening 704 of the priming reservoir 700, the membrane 654 of the cap 662 contacts the piercing element 672. Continued distal movement of the prime cap 604 causes the piercing element 672 to pierce through the membrane 654, thereby permitting fluid to exit through the distal end 634 of the prime cap 604.
  • the prime cap 604 is shown in accordance with additional examples of the present disclosure.
  • the components of the prime cap 604 shown in FIGS. 27A-29B are substantially similar or identical to the components of the prime cap 604 described herein with reference to FIGS. 19A-19C. Accordingly, reference numerals in FIGS. 27A-29B are used to illustrate identical components of the corresponding reference numerals in FIGS. 19A-19C.
  • FIGS. 19A-19C As the previous discussion regarding the prime cap 604 generally shown in FIGS. 19A-19C is applicable to the prime cap 604 shown in FIGS. 27A-29B, only the relative differences between the prime cap 604 shown in FIGS. 19A-19C and the prime cap 604 shown in FIGS. 27A-29B are discussed hereinafter.
  • the distal end 634 of the prime cap 604 may include a valve assembly 680.
  • the valve assembly 680 has a housing 682 with a first portion 684 having an outer surface configured for contacting the inner surface 641 of the distal end 634 of the prime cap 604.
  • the housing 682 further has a second portion 686 that is connected to the first portion 684 such that an inner chamber 688 is defined therebetween.
  • a valve member 690 is positioned within the inner chamber 688.
  • the valve member 690 may be operable to permit one-way fluid flow, such as in a direction from the prime cap 604 and into the priming reservoir 700.
  • the valve member 690 may be normally closed and be openable when a pressure differential between a first side of the valve member 690 (e.g., the internal chamber 636 of the prime tube 604) and a second side of the valve member 690 (e.g., ambient environment within the interior 704 of the priming reservoir 700) exceeds a predetermined threshold.
  • the valve member 690 may be configured to transition from the normally closed configuration to an open configuration when the pressure-differential exceeds a predetermined threshold of 1-10 psi.
  • the distal end 634 of the prime cap 604 may include a duck bill valve 692.
  • the duck bill valve 692 has a body 693 with an outer surface configured for contacting the inner surface 641 of the distal end 634 of the prime cap 604.
  • the duck bill valve 692 further has a pair of lips 694 that are normally closed to prevent fluid flow through the duck bill valve 692.
  • the duck bill valve 692 may be operable to permit one-way fluid flow, such as in a direction from the prime cap 604 and into the priming reservoir 700.
  • the duck bill valve 692 may be normally closed and be openable when a pressure differential between a first side of the duck bill valve 692 (e.g., the internal chamber 636 of the prime tube 604) and a second side of the duck bill valve 692 (e.g., ambient environment within the interior 704 of the priming reservoir 700) exceeds a predetermined threshold.
  • the duck bill valve 692 may be configured to transition from the normally closed configuration to an open configuration when the pressure-differential exceeds a predetermined threshold of 0.1-5 psi.
  • the lips 694 are configured to separate from each other to define an opening for permitting fluid flow through the duck bill valve 692.
  • the duck bill valve 692 may be made from an elastomeric, medical grade material.
  • the distal end 634 of the prime cap 604 may include a seal 696 having a pinched portion 698.
  • the seal 696 is inserted into the distal end 634 of the prime cap 604 such that an outer surface contacts the inner surface 641 of the distal end 634 of the prime cap 604.
  • the pinched portion 698 is formed by sealingly connecting opposing sides of a sidewall 699 of the seal 696 to prevent fluid flow through the seal 696.
  • the opposing sides of the sidewall 699 may be connected by adhesive or heat sealing.
  • the seal 696 may be normally closed and be openable when a pressure differential between a first side of the pinched portion 698 (e.g., the internal chamber 636 of the prime tube 604) and a second side of the pinched portion 698 (e.g., ambient environment within the interior 704 of the priming reservoir 700) exceeds a predetermined threshold.
  • the pinched portion 698 may be configured to transition from the normally closed configuration to an open configuration when the pressure-differential exceeds a predetermined threshold of 1-10 psi.
  • the opposing sides of the sidewall 699 at the pinched portion 698 are configured to separate from each other to define an opening for permitting fluid flow through seal 696.
  • seal 696 may be made from a plastic, medical grade material.
  • prime cap 604 described herein with reference to FIGS. 19A-29B may be configured for insertion into a prime tube slot 402 of a prime tube housing 400 on a fluid injector system 2000 (shown in FIG. 1).
  • the prime tube slot 402 may be shaped to receive at least a portion of the prime cap 604 during a priming operation.
  • prime cap 604 described herein with reference to FIGS. 19A-29B may be configured to be used with sensing arrangement 500 detecting a presence of fluid in prime cap 604.
  • sensing arrangement 500 may include at least one priming status sensor 504 configured for detecting a presence of fluid in prime cap 604.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne un tube d'amorçage destiné à être utilisé avec un injecteur de fluide comprenant un connecteur de tube de patient et une interface de connexion pour connecter de manière amovible une extrémité distale du connecteur de tube de patient à une extrémité proximale du capuchon d'amorçage. L'interface de connexion comprend un premier connecteur au niveau de l'extrémité proximale du capuchon d'amorçage, et un second connecteur au niveau de l'extrémité distale du connecteur de tube de patient. Le capuchon d'amorçage peut venir en prise de manière amovible avec un boîtier de tube d'amorçage ayant un agencement de détection pour détecter la présence du capuchon d'amorçage et pour détecter si le capuchon d'amorçage est rempli d'air ou rempli d'un liquide pour surveiller la progression d'une opération d'amorçage.
PCT/US2024/031806 2023-06-01 2024-05-31 Tube d'amorçage jetable stérile Pending WO2024249719A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2024280577A AU2024280577A1 (en) 2023-06-01 2024-05-31 Sterile disposable prime tube
CONC2025/0016117A CO2025016117A2 (es) 2023-06-01 2025-11-21 Tubo de cebado desechable estéril

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363505593P 2023-06-01 2023-06-01
US63/505,593 2023-06-01

Publications (1)

Publication Number Publication Date
WO2024249719A1 true WO2024249719A1 (fr) 2024-12-05

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ID=91738753

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2024/031806 Pending WO2024249719A1 (fr) 2023-06-01 2024-05-31 Tube d'amorçage jetable stérile

Country Status (4)

Country Link
AR (1) AR132849A1 (fr)
AU (1) AU2024280577A1 (fr)
CO (1) CO2025016117A2 (fr)
WO (1) WO2024249719A1 (fr)

Citations (16)

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EP0081655B1 (fr) * 1981-12-01 1985-09-25 Intermedicat Gmbh Dispositif de ventilation pour un système contenant un liquide médical
US5254101A (en) 1992-11-27 1993-10-19 Medrad, Inc. Fluid presence indicator for rotatable syringe
US5383858A (en) 1992-08-17 1995-01-24 Medrad, Inc. Front-loading medical injector and syringe for use therewith
US7553294B2 (en) 2002-05-30 2009-06-30 Medrad, Inc. Syringe plunger sensing mechanism for a medical injector
US7666169B2 (en) 2003-11-25 2010-02-23 Medrad, Inc. Syringe and syringe plungers for use with medical injectors
US8945051B2 (en) 2009-07-24 2015-02-03 Bayer Medical Care Inc. Multi-fluid medical injector system and methods of operation
US9173995B1 (en) 2014-10-28 2015-11-03 Bayer Healthcare Llc Self-orienting syringe and syringe interface
US20150320926A1 (en) * 2014-02-10 2015-11-12 Terumo Cardiovascular Systems Corporation Vented cap for cannula used in perfusion circuit
US10022493B2 (en) 2011-05-12 2018-07-17 Bayer Healthcare Llc Fluid injection system having various systems for controlling an injection procedure
US10137291B2 (en) * 2014-01-31 2018-11-27 Industrie Borla S.P.A. Valved connector for medical lines
US10507319B2 (en) 2015-01-09 2019-12-17 Bayer Healthcare Llc Multiple fluid delivery system with multi-use disposable set and features thereof
US10549084B2 (en) 2014-01-10 2020-02-04 Bayer Healthcare Llc Single-use disposable set connector
US20200324102A1 (en) * 2017-06-21 2020-10-15 Icu Medical, Inc. Priming cap
WO2022036058A1 (fr) * 2020-08-13 2022-02-17 Bayer Healthcare Llc Configurations de tube amorce pour seringue
WO2022103580A1 (fr) * 2020-11-12 2022-05-19 Becton, Dickinson And Company Dispositif de bouchon d'ensemble cathéter, systèmes et procédés

Patent Citations (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0081655B1 (fr) * 1981-12-01 1985-09-25 Intermedicat Gmbh Dispositif de ventilation pour un système contenant un liquide médical
US4452251A (en) 1982-11-05 1984-06-05 Medrad, Inc. Syringe content indicating device
US5383858A (en) 1992-08-17 1995-01-24 Medrad, Inc. Front-loading medical injector and syringe for use therewith
US5383858B1 (en) 1992-08-17 1996-10-29 Medrad Inc Front-loading medical injector and syringe for use therewith
US5254101A (en) 1992-11-27 1993-10-19 Medrad, Inc. Fluid presence indicator for rotatable syringe
US7553294B2 (en) 2002-05-30 2009-06-30 Medrad, Inc. Syringe plunger sensing mechanism for a medical injector
US7666169B2 (en) 2003-11-25 2010-02-23 Medrad, Inc. Syringe and syringe plungers for use with medical injectors
US8945051B2 (en) 2009-07-24 2015-02-03 Bayer Medical Care Inc. Multi-fluid medical injector system and methods of operation
US10022493B2 (en) 2011-05-12 2018-07-17 Bayer Healthcare Llc Fluid injection system having various systems for controlling an injection procedure
US10549084B2 (en) 2014-01-10 2020-02-04 Bayer Healthcare Llc Single-use disposable set connector
US10137291B2 (en) * 2014-01-31 2018-11-27 Industrie Borla S.P.A. Valved connector for medical lines
US20150320926A1 (en) * 2014-02-10 2015-11-12 Terumo Cardiovascular Systems Corporation Vented cap for cannula used in perfusion circuit
US9173995B1 (en) 2014-10-28 2015-11-03 Bayer Healthcare Llc Self-orienting syringe and syringe interface
US10507319B2 (en) 2015-01-09 2019-12-17 Bayer Healthcare Llc Multiple fluid delivery system with multi-use disposable set and features thereof
US20200324102A1 (en) * 2017-06-21 2020-10-15 Icu Medical, Inc. Priming cap
WO2022036058A1 (fr) * 2020-08-13 2022-02-17 Bayer Healthcare Llc Configurations de tube amorce pour seringue
WO2022103580A1 (fr) * 2020-11-12 2022-05-19 Becton, Dickinson And Company Dispositif de bouchon d'ensemble cathéter, systèmes et procédés

Also Published As

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AR132849A1 (es) 2025-08-06
AU2024280577A1 (en) 2025-11-06
CO2025016117A2 (es) 2025-11-28

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