WO2020252564A1 - Protection de seringue et système de pompe à perfusion correspondant - Google Patents

Protection de seringue et système de pompe à perfusion correspondant Download PDF

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Publication number
WO2020252564A1
WO2020252564A1 PCT/CA2020/050790 CA2020050790W WO2020252564A1 WO 2020252564 A1 WO2020252564 A1 WO 2020252564A1 CA 2020050790 W CA2020050790 W CA 2020050790W WO 2020252564 A1 WO2020252564 A1 WO 2020252564A1
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WO
WIPO (PCT)
Prior art keywords
syringe
shield
radioactive solution
infusion pump
endcap
Prior art date
Application number
PCT/CA2020/050790
Other languages
English (en)
Inventor
Dominic SIEWKO
James A. Kaufman
Suzanne BISSONNETTE
Riccardo SANTOPIETRO
Paul Donnelly
Original Assignee
Jubilant Draximage Inc.
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 Jubilant Draximage Inc. filed Critical Jubilant Draximage Inc.
Publication of WO2020252564A1 publication Critical patent/WO2020252564A1/fr

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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
    • 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
    • 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
    • A61M2205/32—General characteristics of the apparatus with radio-opaque indicia
    • 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
    • A61M5/1407—Infusion of two or more substances
    • 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
    • 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

Definitions

  • the present invention relates to intravenous radioactive drug delivery, and more particularly to a syringe shield and infusion pump system using the same for intravenous delivery of a radioactive drug to a patient.
  • Radioactive drugs such as metaiodobenzylguanidine (MIBG) combined with radioactive iodine (1-131), are often used in the treatments of cancers and other such afflictions.
  • MIBG metaiodobenzylguanidine
  • radioactive iodine (1-131) are often used in the treatments of cancers and other such afflictions.
  • these drugs are produced in a laboratory, packaged in syringes, then transported to medical facilities so that they can be administered to a patient in need. While effective, these drugs pose numerous dangers to various personnel responsible for its fabrication, transportation, handling and usage. In particular, the medical professionals responsible for the administration of these drugs are at risk of exposure to radioactivity, which may be hazardous for their health. As such, it is essential that the syringes containing these radioactive drugs are covered by a shield-type enclosure fabricated from a material that prevents excessive radioactivity from escaping the syringe to the surrounding environment.
  • current syringe shields typically cover the barrel of the syringe and leave the plunger and the tip of the syringe accessible for manipulation. As a result, radiation will emit therefrom.
  • the current syringe shields are generally round shapes, which can be dangerous due to the risk of them rolling off of a flat surface such as a table when placed on their sides, creating a crushing hazard.
  • a syringe shield for a syringe containing a radioactive solution, the syringe comprising a barrel containing the radioactive solution, a plunger comprising a plunger flange and a plunger stem, and a tip, the syringe shield comprising: a shield body having a first open end and a second open end; wherein the syringe shield is made from a radiation-shielding material; wherein the syringe is insertable in the syringe shield such that the plunger is extendable through the first open end and the tip is adjacent the second open end.
  • the syringe shield further has a first endcap at the first open end of the syringe shield, a second endcap at a second open end of the syringe shield a first casing connected the first endcap where the plunger can move freely from an extended position to a retracted position and vice-versa.
  • the syringe shield has a second casing connected the second endcap. When the first and second casings are connected to the first and second endcaps. The radioactivity contained in the syringe is completed shielded from any angle.
  • the syringe in the syringe shield can be advantageously used without being removed from the syringe shield.
  • both casings are disconnected for using the syringe in its syringe shield.
  • the tip can be connected to a needle or connected to a tubing line through a connector such as a luer lock connector, and the plunger can be actuated by being pushed and pulled manually or through a pump.
  • only the second casing is disconnected for using the syringe in its syringe shield.
  • the tip of the syringe remains accessible and a peristaltic pump can be connected to the tip of the syringe for pulling out the radioactive solution.
  • the syringe shield is shaped to prevent the syringe shield from rolling when placed on a flat surface.
  • This anti-rotation shape can be designed in the first endcap, the second endcap, a collar or in the shield body.
  • an infusion pump system for delivering a radioactive solution to a patient, the radioactive solution contained in a syringe comprising a barrel containing the radioactive solution, a plunger comprising a plunger flange and a plunger stem, and a tip
  • the infusion pump system comprising: an infusion pump comprising an actuator, a plunger driver comprising a plunger groove for receiving the plunger flange, and a shield slot comprising an attachment receiving element; and a syringe shield insertable in the shield slot and comprising a shield body, a first open end of the syringe shield and a second open end of the syringe shield, and a connecting element that is connectable to the receiving element; wherein the syringe shield is made from a radiation-shielding material; wherein the syringe is insertable in the syringe shield such that the plunger is extendable through the first open end and the tip,
  • the radiation-shielding material comprises tungsten. In an embodiment, the radiation-shielding material comprises a combination of lead and tungsten. In an embodiment, the radiation-shielding material comprises a combination of stainless steel and tungsten. In an embodiment, the radiation-shielding material comprises a combination of alloy and tungsten. In an embodiment, the radiation-shielding material comprises a combination of stainless steel, aluminum alloy and tungsten. In an embodiment, the shield body is made of tungsten. In an embodiment, the endcaps are made of aluminum alloy. In an embodiment, the casings are made of aluminum alloy with an internal layer of tungsten.
  • the infusion pump further comprises a second actuator, a second plunger driver and a second slot for receiving a second syringe containing a non-radioactive solution.
  • the non-radioactive solution is used for at least one of the following activities: i) to prime a tubing line interconnecting the syringe tip and the patient for removing air from the tubing line; ii) to be infused to the patient simultaneously with the radioactive solution, iii) to rinse the syringe containing the radioactive solution, and iv) to push any radioactive solution remaining in the tubing line so as to ensure that all the radioactive solution in the syringe has been delivered to the patient.
  • the non-radioactive solution is a saline solution.
  • the system further comprises a first valve connecting a bag containing the non-radioactive solution to the second syringe through a first tubing line, a second tubing line connecting the second syringe to the syringe containing the radioactive solution, and a second valve connecting the tip of the syringe containing the radioactive solution to the patient.
  • the attachment element in the shield slot comprises a plurality of ribs configured to mate with the collar in the first endcap.
  • the system further comprises a first radioactivity detector positioned at a location on the patient tubing line (between the tip and the patient injection site of the radioactive solution) and a second radioactivity detector positioned adjacent to the patient injection site and along the intravenous distribution pathway of the radioactive solution, wherein the distribution of the radioactive solution in the patient is monitorable by comparing readings from the first radioactivity detector and the second radioactivity detector.
  • the infusion pump further comprises a dose calibrator to calibrate the detectors.
  • the first endcap comprises a pin and the shield slot comprises a hole adjacent the attachment element configured to receive the pin to identify the syringe shield.
  • the pin comprises one of a magnetic tag and the hole comprises a reader configured to recognize the tag to identify the syringe shield.
  • the pin and the hole are used to orient the syringe shield in a manner that allows a radio frequency tag in the syringe shield to be recognized by a reader in the infusion pump.
  • said pin is in the endcap or in the shield body.
  • the infusion pump will only function when a valid syringe shield is recognized by the reader.
  • the connecting element is embodied at least one of the first endcap or the second endcap is one of hexagonally or bevel shaped.
  • the syringe shield is dimensioned to receive a syringe containing up to one of thirty milliliters or sixty milliliters of the radioactive solution. In an embodiment, the syringe shield is dimensioned to receive a syringe containing up to one of ten milliliters or hundred milliliters of the radioactive solution.
  • the syringe shield further comprises a first casing connectable to the first endcap and a second casing connectable to the second endcap.
  • the syringe shield comprises a TeflonTM seal between the first casing and the first endcap and/or a TeflonTM seal between the second casing and the second endcap. TeflonTM can be easily cleaned and avoid risk of contamination.
  • the first casing comprises a handle. Said handle is preferably removable.
  • At least one of the first endcap or the second endcap comprises a locking means for securing the corresponding casing thereto.
  • the locking means is a locking pin.
  • the first casing has a hole that provides access to the plunger of the syringe for actuating the plunger when the syringe is inside the syringe shield and the first casing is connected to the first endcap.
  • a cap is provided for closing said hole when access to the plunger is not needed.
  • an infusion pump for infusing to a patient a radioactive solution contained in a syringe comprising a barrel containing the radioactive solution, a plunger comprising a plunger flange and a plunger stem, and a tip, the syringe surrounded by a syringe shield comprising an endcap with a collar, the infusion pump comprising: a shield slot configured to securely receive the syringe shield via an attachment element securable to the collar; an actuator; and a plunger driver comprising a plunger groove for receiving the plunger flange; wherein the plunger driver is actuatable by the actuator to selectively pull and push the plunger into the barrel to deliver the radioactive solution to the patient through the tip.
  • the infusion pump further comprises a second actuator, a second plunger driver and a second slot for receiving a second syringe containing a non-radioactive solution such that the syringe containing the radioactive solution is rinsable with the nonradioactive solution.
  • the non-radioactive solution is a saline solution.
  • the attachment element in the shield slot comprises a plurality of ribs configured to mate with the collar in the endcap of the syringe shield.
  • the infusion pump further comprises a reader adjacent the attachment element configured to identify one of a magnetic or radio-frequency tag in the endcap of the syringe shield or in the barrel of the syringe shield.
  • the infusion pump further comprises a hole adjacent the attachment element configured to receive a pin in the endcap or the shield body of the syringe shield to identify the syringe shield.
  • the infusion pump further comprises a computer, a memory communicatively coupled to the computer when the system is operational, the memory bearing processor-executable instructions, the computer can be programmable so as to infuse predetermined infusion profiles that can be required for different drugs, or as per recommended administration.
  • Programming parameters include constant activity infusion, total volume or diluted volume infusion or total infusion of a desired timeframe for a required dose.
  • a syringe shield insertable in a shield slot of a infusion pump for delivering to a patient a radioactive solution contained in a syringe
  • the syringe shield comprising: a shield body in which the syringe is insertable; a first endcap at a first open end of the syringe shield, the first endcap comprising a collar securable to an attachment element in the shield slot of the infusion pump; and a second endcap at a second open end of the syringe shield; wherein the syringe shield is made from a radiation-shielding material such that the radioactive solution contained in the syringe is shielded by the syringe shield; and wherein the syringe shield is shaped to prevent the syringe shield from rolling when placed on a flat surface.
  • the syringe shield comprises tungsten.
  • the first endcap comprises one of a magnetic or radio-frequency tag identifiable by a reader adjacent the attachment element.
  • the patient tubing line has a valve set for receiving a solution containing at least one of a stress agent or an oral inhibiter.
  • the first endcap comprises a pin insertable in a hole in the shield slot adjacent the attachment element such that the syringe shield is identifiable by the infusion pump.
  • At least one of the first endcap or the second endcap is one of hexagonally or bevel shaped.
  • the syringe shield further comprises TeflonTM seals between a casing and its respective endcap.
  • the syringe shield is dimensioned to receive a syringe containing up to one of thirty milliliters or sixty milliliters of the radioactive solution.
  • the syringe shield is configured to connect to a first casing at the first endcap and a second casing at the second endcap.
  • the first endcap comprises a handle.
  • said handle is removable.
  • At least one of the first endcap or the second endcap comprises a locking means for securing the corresponding casing thereto.
  • the total weight of the syringe shield, the first casing and the second casing together is no more than 50 lbs.
  • the radiation-shielding material provides a proper shielding to the radioactive solution, and wherein said radioactive solution has a radioactivity up to 1 Ci.
  • both casings are also made of a radiation-shielding material, wherein said radiation shielding material can be identical or different from the one of the syringe shield.
  • the radiation shielding material may comprise tungsten, lead, stainless steel, aluminum alloy or a combination thereof.
  • a method for intravenously delivering to a patient a radioactive solution contained in a barrel of a syringe housed in a syringe shield comprising the steps of: securing the syringe shield in a shield slot of a infusion pump; actuating a plunger of the syringe via the infusion pump to inject the radioactive solution into the patient; rinsing the barrel of the syringe with a non-radioactive solution; and injecting said non-radioactive solution from the barrel into the patient.
  • the method for intravenously delivering to a patient a radioactive solution comprises administering a non-radioactive solution simultaneously with the radioactive solution in order to dilute the radioactive solution and infuse a diluted radioactive solution.
  • the method for intravenously delivering to a patient a radioactive solution comprises adding a non-radioactive solution to the radioactive solution contained in the syringe in order to dilute the radioactive solution and infuse a diluted radioactive solution.
  • the infusion pump further comprises a three-way stopcock to connect the syringe containing the radioactive solution and the syringe containing the non-radioactive solution to one tubing line.
  • the method further comprises the steps of: filling a second syringe with the non-radioactive solution; securing the second syringe to a second slot in the infusion pump; and using the non-radioactive solution contained in the second syringe to rinse the barrel of the syringe after injection of the radioactive solution.
  • Figures 1A and 1 B show respective front and side views of an infusion pump system in accordance with a preferred embodiment of the present invention
  • Figure 1 C shows a front view of an infusion pump system in accordance with another preferred embodiment of the present invention.
  • Figure 2 shows a front view of a syringe for the infusion pump system of Figures 1 A and 1 B;
  • Figure 3 shows a front view of a syringe in a syringe shield
  • Figures 4A and 4B show perspective views of various embodiments of an endcap for the syringe shield of Figure 3;
  • Figure 5 shows an enhanced semi-transparent perspective view of the infusion pump system of Figures 1 A and 1 B;
  • Figure 6 shows a top view of an infusion pump system in accordance with an alternate embodiment of the present invention.
  • Figure 7A shows perspective view of a shield slot in an infusion pump for the infusion pump system of Figures 1A and 1 B;
  • Figure 7B shows a semi-transparent, enhanced perspective view of a syringe shield secured to a shield slot for the infusion pump system of Figures 1 A and 1 B;
  • Figure 7C shows an enhanced perspective view of a syringe shield secured to a shield slot for the infusion pump system of Figures 1 A and 1 B;
  • Figures 8A and 8B show respective front and perspective views of a syringe shield in accordance with an alternate embodiment of the present invention
  • Figures 8C and 8D show respective assembled and exploded views of the syringe shield of Figures 8A and 8B with first and second casings;
  • Figure 9 shows a schematic view of an infusion pump system in accordance with an alternate embodiment of the present invention.
  • the infusion pump system 2 generally includes an infusion pump 4 and a syringe shield 6 securely insertable in the infusion pump 4 and configured to house a syringe 8 containing the radioactive material.
  • the syringe shield 6 is made from a radiation shielding material that comprises tungsten, lead, stainless steel, aluminum alloy or a combination thereof.
  • syringe 8 may be handled, packaged, transported and utilized in a safe manner by inserting it in syringe shield 6, as will be discussed in further detail below.
  • syringe 8 contains a high-energy Alpha or Beta therapeutic compound used for various types of therapy, such as radioactive iodine metaiodobenzylguanidine (radioactive l-MIBG).
  • Other therapeutic compounds that can be administered by the system 2 include Lutetium Lu-177 Dotatate, Rhenium-188, Ac-224 isotope compounds, Zr-89 isotope compounds, and Ra-223 isotope compounds.
  • a solution containing at least one of a stress agent or an oral inhibiter is contained in a separate container and is delivered directly into a patient tubing line 86 via an additional valve (not shown).
  • FIG. 1 C there is shown an infusion pump system 2, according to another preferred embodiment of the present invention that is similar to the one shown in Figures 1A and 1 B.
  • a typical syringe 8 includes a barrel 10 containing the radioactive solution, a plunger 12 including a plunger flange 14 and a plunger stem 16, and a tip 18.
  • the syringe shield 6 accommodates the syringe 8, and includes a shield body 20.
  • the first endcap 22 includes a collar 30, illustratively with a flange, to facilitate insertion of the syringe shield 6 into the infusion pump 4, as will be discussed in further detail below.
  • syringe shield 6 includes TeflonTM seals (not shown), which seal each endcap (22 and 26) with its corresponding casing (48 and 50). The use of TeflonTM reduces the risk of contamination versus other seal materials such as rubber.
  • at least one of the first endcap 22 or the second endcap 26 includes a locking means for securing the syringe shield 6.
  • syringe shield 6 is dimensioned to house a syringe 8 of a specific pre-determined capacity.
  • one or more of the first endcap 22 and the second endcap 26 is shaped so that if the syringe shield 6 is placed on a flat surface such that it is resting on the endcaps 22, 26, the syringe shield 6 will be unable to roll.
  • This feature is intended to minimize the risk of the syringe shield 6 rolling off an elevated surface such as a table, thus preventing possible injury, damage or radiation exposure.
  • a shape may be a regular polygon such as a hexagon or an octagon.
  • such a shape may be beveled, examples of which are shown in Figures 3A and 3B.
  • the syringe shield 6 is prevented from rolling by means of an irregular syringe body 20.
  • the syringe body 20 can have a shape that is not a cylindrical shape, or have a flat surface, or a flat bottom 65, or a protruding element that would stops rotation of the syringe shield 6 on a flat surface, such as a table.
  • the infusion pump 4 includes a shield slot 32 for receiving the syringe shield 6.
  • a receiving element 34 in the shield slot 32 receives and connects a connecting element of the syringe shield 6.
  • Said connecting element is preferably embodied by the first endcap 22, by the second endcap 26, a collar 30 or by a structural element along the shield body 20.
  • the receiving element 34 and the connecting element preferably connect or mate, illustratively in a male-female relationship, so as to secure the syringe shield 6 in place.
  • the infusion pump 4 further includes an actuator 36, for example a screw-type linear actuator, driving a plunger driver 38 configured to receive the plunger flange 14 in a plunger groove 40, shown in more detail in Figure 5.
  • actuator 36 to deliver the radioactive drug to the patient, preferably through a tubing line (74) (shown in Figure 9) attached to the tip 18, actuator 36 pushes the plunger 12 into the barrel 10, causing the radioactive drug to exit the syringe 8 through the tip 18.
  • a pair of syringe shields 6, 6’ each dimensioned to accommodate a different sized syringe 8, 8’.
  • the first syringe shield 6 is dimensioned to accommodate a sixty-milliliter syringe 8 whereas the second syringe shield 6’ is dimensioned to accommodate a thirty-milliliter syringe 8’.
  • each syringe shield 6, 6’ includes identically-sized endcaps 22, 22’ and 26, 26’, and the first endcap 22 and thus the plunger 12 is positioned identically in relation to the plunger driver 38.
  • the difference between the different sized syringe shields 6, 6’ thus lie in the length and diameter of their respective shield bodies 20, 20’.
  • the infusion pump 4 may receive syringed shields of varying dimensions without requiring any modifications to the actuator 36, plunger driver 38, shield slot 32 or attachment element 34, regardless of the sized syringe shield 6 chosen.
  • the syringe shield 6 is preferably securable in the shield slot 32 of the infusion pump 4 via the interaction between a connecting element in the first endcap 22 for connecting with the receiving element 34.
  • the attachment element 34 includes a plurality of ribs 42 configured to mate with the connecting element, thus securing the syringe shield 6 in place as exemplified in Figures 4A and 4B.
  • the connecting element can be added to, attached to, grooved into or molded with the first endcap 22, the second endcap 26, the collar 30 or the shield body 20.
  • the connecting element can be, without limitation, a protruding element, a lip, a pin, a cavity, a recess, a groove, or the like, or a plurality of structural elements.
  • a pin 44 in the first endcap 22 may be receivable by a hole 46 adjacent the attachment element 34 to identify the syringe shield 6.
  • the pin 44 may be equipped with one of a magnetic or radio-frequency tag (not shown), and the attachment element 34 or hole 46 may include a reader (not shown) configured to recognize the tag to identify the syringe shield 6.
  • the pin 44 and the hole 46 are used to orient the syringe shield 6 in a manner that allows a radio frequency tag in the syringe shield 6 to be recognized by a reader in the infusion pump 4.
  • the infusion pump 4 may only operate if a corresponding syringe shield 6 has been identified, for example if the magnetic tag or the radio frequency tag is properly aligned with the reader.
  • a first casing 48 is connectable to the first endcap 22 and a second casing 50 is connectable to the second endcap 26, illustratively via threaded connections, to facilitate the handling and transporting of the syringe shield 6.
  • the first endcap 22 and second endcap 26 may each comprise a threaded section 54.
  • the first and second casings 48, 50 are closed at their respective ends to provide additional shielding from the radioactive drug in the syringe 8.
  • a handle 54 may be attachable to the first casing 48 to facilitate the carrying of the syringe shield 6.
  • the handle 54 can be removably attached.
  • the first casing 48 is configured to receive the plunger 12 in an extended position.
  • the plunger 12 in an extended position or a partially extended position when the syringe 8 contains a certain volume of radioactive drug.
  • the infusion pump 4 is configured to receive a second syringe 56 containing a non-radioactive solution such as saline solution.
  • Non-radioactive solution is pumped into a syringe after its drugs have been delivered to rinse the syringe and collect any remaining drug.
  • the non-radioactive solution is then delivered to the patient to ensure that they receive the full dosage of drug they require.
  • the infusion pump 4 includes a second slot 58 adapted to receive the second syringe 56.
  • a second plunger driver 60 drivable by a second actuator 62 is configured to receive the second plunger 64 so that the non-radioactive solution may be pumped out of the second syringe 56.
  • FIG. 9 in addition to Figures 1A, 1 B and 6, an exemplary schematic view of an infusion pump system 2 is shown.
  • the infusion pump 4 is omitted.
  • the radioactive drug is contained in the first syringe 8.
  • Nonradioactive solution is contained in a non-radioactive solution bag 66 and deliverable to the second syringe 56 via a first tubing line 68.
  • a first valve 85 ensures that there is no suction of air or radioactive solution as the second syringe 56 draws non-radioactive solution from the bag 66 through the second valve 70. Once the non-radioactive solution is delivered to the second syringe 56, the second valve 70 is closed.
  • third valve 72 is closed and the non-radioactive solution is pumped from the second syringe 56 to the first syringe 8 via second tubing line 74.
  • the third valve 72 is opened and the non-radioactive solution containing the remaining radioactive drug is pumped into the patient through the patient tubing line 86.
  • the infusion pump 4 may further include an indicator 76 providing information regarding the amount of radioactive drug and non-radioactive solution in the various syringes 8, 56.
  • each of said valves can be either a check-valve (as shown), a stopcock valve, or a pinch valve.
  • a pair of radioactivity detectors or detectors may be provided to ensure that the entire dosage of radioactive drug is properly delivered to the patient.
  • a first radioactivity detector 78 is positioned between the tip 18 of syringe 8 and the injection site 80 of the radioactive drug to the patient, illustratively at the patient’s arm 82.
  • a second radioactivity detector 84 is positioned adjacent to the injection site 80 and along the intravenous distribution pathway of the radioactive drug, for example two inches from the injection site 80. As such, the distribution of the radioactive drug may be monitored by comparing the readings of the first radioactive detector 80 and the second radioactive detector 84.
  • the infusion pump 4 comprises a computer that is configured to stop the infusion of radioactive drug to the patient upon detection that the dose of radioactive drug is not being properly delivered to the patient, and more particularly, when the dose detected by the second radioactivity detector 84 does not correspond to the dose detected by first radioactivity detector 78.
  • the computer is advantageously configured to stop the delivery of a radioactive drug to a patient upon detection that the readings from said first radioactivity detector (78) and said second radioactivity detector (84) have no normal correspondence.
  • a normal correspondence is found when the readings of the first radioactivity detector (78) and second radioactivity detector (84) are identical or similar or within an acceptable range of error (ex. ⁇ 1%) or minus a residual loss.
  • the infusion pump 4 comprises a computer that is configured to stop the infusion of radioactive drug to the patient upon detection of an abnormal accumulation by the radioactivity detector 84.
  • An abnormal accumulation is outside a“normal amount”; and a normal amount is calculated on the basis of the total administered dose of radioactive drug, the flow rate of administered radioactive drug solution, and the expected volume of radioactive drug solution per distance in the patient’s bloodstream.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (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)

Abstract

La présente invention concerne une protection de seringue pour une seringue contenant une solution radioactive et un système de pompe à perfusion servant à administrer la solution radioactive à un patient. La seringue comprend un cylindre contenant la solution radioactive, un piston comprenant une bride de piston et une tige de piston, et une pointe. La protection de seringue est constituée d'un matériau de protection contre les rayonnements et comprend : un corps de protection ayant une première extrémité ouverte et une seconde extrémité ouverte. La seringue peut être introduite dans la protection de seringue de telle sorte que le piston peut s'étendre à travers la première extrémité ouverte et la pointe est adjacente à la seconde extrémité ouverte.
PCT/CA2020/050790 2019-06-19 2020-06-10 Protection de seringue et système de pompe à perfusion correspondant WO2020252564A1 (fr)

Applications Claiming Priority (2)

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US201962863569P 2019-06-19 2019-06-19
US62/863,569 2019-06-19

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Citations (10)

* Cited by examiner, † Cited by third party
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