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Title:
SYRINGE SHIELD AND AN INFUSION PUMP SYSTEM USING THE SAME
Document Type and Number:
WIPO Patent Application WO/2020/252564
Kind Code:
A1
Abstract:
Syringe shield for a syringe containing a radioactive solution and infusion pump system for delivering the radioactive solution to a patient. The syringe includes a barrel containing the radioactive solution, a plunger comprising a plunger flange and a plunger stem, and a tip. The syringe shield is made from a radiation-shielding material and includes: a shield body having a first open end and a second open end. 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.

Inventors:
SIEWKO DOMINIC (US)
KAUFMAN JAMES A (US)
BISSONNETTE SUZANNE (US)
SANTOPIETRO RICCARDO (CA)
DONNELLY PAUL (CA)
Application Number:
PCT/CA2020/050790
Publication Date:
December 24, 2020
Filing Date:
June 10, 2020
Export Citation:
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Assignee:
JUBILANT DRAXIMAGE INC (CA)
International Classes:
A61M36/08; A61M5/142; A61M36/04
Domestic Patent References:
WO2009000931A12008-12-31
Foreign References:
JP2005287874A2005-10-20
US20060293553A12006-12-28
US20160331998A12016-11-17
US7312465B22007-12-25
US20110178359A12011-07-21
US20160015885A12016-01-21
US20130211248A12013-08-15
US20080200747A12008-08-21
US20070299421A12007-12-27
Attorney, Agent or Firm:
LAVERY, DE BILLY, LLP (CA)
Download PDF:
Claims:
CLAIMS

1. An infusion pump system (2) for delivering a radioactive solution to a patient, the radioactive solution contained in a syringe (8) comprising a barrel (10) containing the radioactive solution, a plunger (12) comprising a plunger flange (14) and a plunger stem (16), and a tip (18), the system (2) comprising:

an infusion pump (4) comprising an actuator (36), a plunger driver (38) comprising a plunger groove (40) for receiving the plunger flange (14), and a shield slot (32) comprising a receiving element (34); and

a syringe shield (6) insertable in said shield slot (32) and comprising a shield body (20), a first open end (24) of said syringe shield (6), a second open end (28) of said syringe shield (6), and a connecting element that connects with said receiving element (34);

wherein said syringe shield (6) is made from a radiation-shielding material;

wherein said syringe shield (6) is shaped to prevent said syringe shield (6) from rolling when placed on a flat surface;

wherein the syringe (8) is insertable in said syringe shield (6) such that the plunger (12) is extendable through said first open end (24) and the tip (18) is adjacent said second open end (28), the radioactive solution in the barrel (10) being shielded by said syringe shield (6), said syringe shield (6) dimensioned to contain the syringe (8); and

wherein said plunger driver (38) is actuatable by said actuator (36) to selectively pull and push the plunger (12) into the barrel (10) to deliver the radioactive solution to the patient through the tip (18).

2. The infusion pump system (2) of claim 1 , wherein said radiation-shielding material comprises tungsten, lead, stainless steel, aluminum alloy or a combination thereof.

3. The infusion pump system (2) of claim 1 , wherein said infusion pump (4) further comprises a second actuator (62), a second plunger driver (60) and a second slot (58) for receiving a second syringe (56) containing a non-radioactive solution such that the syringe (8) containing the radioactive solution is rinsable with said non-radioactive solution.

4. The infusion pump system (2) of claim 3, further comprising a first valve (70) connecting a bag (66) containing said non-radioactive solution to said second syringe (56) through a first tubing line (68), a second tubing line (74) connecting said second syringe (56) to the syringe (8) containing the radioactive solution, a second valve (85) along the second tubing line (74) between a first tubing line (68) and the patient tubing line (86), and a third valve (72) connecting the tip (18) of the syringe (8) containing the radioactive solution to the patient.

5. The infusion pump system (2) of claim 1 , wherein said connecting element in the syringe shield (6) comprises a plurality of ribs (44) configured to connect with said receiving element in said shield slot (32).

6. The infusion pump system (2) of claim 1 , further comprising a first radioactivity detector (78) positioned between the tip (18) and an injection site (80) of the radioactive solution and a second radioactivity detector (84) positioned adjacent to the injection site (80), wherein the distribution of the radioactive solution in the patient is monitorable by comparing readings from said first radioactivity detector (78) and said second radioactivity detector (84).

7. The infusion pump system (2) of claim 6, further comprising a computer that is configured to stop the delivery of a radioactive solution to a patient upon detection that the readings from said first radioactivity detector (78) and said second radioactivity detector (84) have no normal correspondence.

8. The infusion pump system (2) of claim 1 , further comprising a radioactivity detector (84) positioned adjacent to the injection site (80), wherein the reading of the radioactivity detector (84) is indicative of the radioactive solution distribution in the bloodstream of the patient.

9. The infusion pump system (2) of claim 8, further comprising a computer that is configured to stop the delivery of a radioactive solution to a patient upon detection that the reading from said radioactivity detector (84) is indicative of an abnormal accumulation of the radioactive solution at the injection site.

10. The infusion pump system (2) of claim 1 , wherein said syringe shield (6) further comprises a pin (44) and said shield slot (32) comprises a hole (46) adjacent said attachment element (34) configured to receive said pin (44) to identify said syringe shield (6).

1 1. The infusion pump system (2) of claim 10, wherein said pin (44) comprises one of a magnetic or radio-frequency tag and said hole (46) comprises a reader configured to recognize said tag to identify said syringe shield (6).

12. The infusion pump system (2) of claim 1 , wherein the syringe shield (6) further comprises a first endcap (22) at the first open end (24), a second endcap (26) at the second open end (28) or a collar (30); wherein the connecting element is embodied by the first endcap (22), the second endcap (26) or the collar (30); and wherein the first endcap (22), the second endcap (26) or the collar (30) is one of hexagonally or bevel shaped.

13. The infusion pump system (2) of claim 1 , wherein said syringe shield (6) comprises Teflon™ seals.

14. The infusion pump system (2) of claim 1 , wherein said syringe shield (6) is dimensioned to receive a syringe (8) containing up to one of thirty milliliters or sixty milliliters of the radioactive solution.

15. The infusion pump system (2) of claim 1 , wherein the syringe (8) containing the radioactive solution further contains at least one of a stress agent or an oral inhibiter.

16. The infusion pump system (2) of claim 1 , wherein the syringe shield (6) further comprises a locking means for securing said syringe shield (6) to the infusion pump (4).

17. An infusion pump (4) for infusing to a patient a radioactive solution contained in a syringe (8) comprising a barrel (10) containing the radioactive solution, a plunger (12) comprising a plunger flange (14) and a plunger stem (16), and a tip (18), the syringe (8) surrounded by a syringe shield (6) comprising a connecting element, the infusion pump (4) comprising:

a shield slot (32) configured to receive the syringe shield (6) and comprising a receiving element (34) that connects with the connecting element of the syringe shield (6);

an actuator (36); and

a plunger driver (38) comprising a plunger groove (40) for receiving the plunger flange (14);

wherein said plunger driver (38) is actuatable by said actuator (36) to selectively pull and push the plunger (12) into the barrel (10) to deliver the radioactive solution to the patient through the tip (18).

18. The infusion pump (4) of claim 17, further comprising a second actuator (62), a second plunger driver (60) and a second slot (58) for receiving a second syringe (56) containing a non-radioactive solution such that the syringe (8) containing the radioactive solution is rinsable with said non-radioactive solution.

19. The infusion pump (4) of claim 17, wherein the connecting element of the syringe shield (6) comprises a plurality of ribs (42) configured to mate with the receiving element (34) in said shield slot (32).

20. The infusion pump (4) of claim 17, further comprising a reader adjacent said receiving element (34) configured to identify one of a magnetic or radio-frequency tag in the syringe shield (6).

21. The infusion pump (4) of claim 17, further comprising a hole (46) adjacent said receiving element (34) configured to receive a pin (44) the syringe shield (6) to identify the syringe shield (6).

22. A syringe shield (6) for shielding a syringe containing a radioactive solution, the syringe comprising a barrel (10), a plunger (12) and a tip (18), comprising: a shield body (20) in which a syringe (8) is insertable;

a first open end (24) for allowing the plunger of the syringe to extend there through; and

a second open end (28) for rendering the tip of the syringe accessible;

wherein the syringe shield (6) is made from a radiation-shielding material such that a radioactive solution contained in the syringe (8) is shielded by the syringe shield (6); and wherein the syringe shield (6) is shaped to prevent the syringe shield (6) from rolling when placed on a flat surface.

23. The syringe shield (6) of claim 22, wherein the radiation-shielding material provides a proper shielding to the radioactive solution, and wherein said radioactive solution has a radioactivity up to 1 Ci.

24. The syringe shield (6) of claim 22, wherein the radiation-shielding material comprises tungsten, lead, stainless steel, aluminum alloy or a combination thereof.

25. The syringe shield (6) of claim 22, wherein the syringe shield (6) further comprises a first endcap (22) at the first open end (24), a second endcap (26) at the second open end (28), or a collar (30); wherein the connecting element is embodied by the first endcap (22), the second endcap (26) or the collar (30); and wherein least one of said first endcap (22), said second endcap (26) or said collar (30) is one of hexagonally or bevel shaped.

26. The syringe shield (6) of claim 22, wherein the syringe shield (6) is dimensioned to receive a syringe (8) containing up to one of thirty milliliters or sixty milliliters of the radioactive solution.

27. The syringe shield (6) of claim 22, wherein the syringe shield (6) further comprises a first endcap (22) at the first open end (24), a second endcap (26) at the second open end (28), and wherein the syringe shield (6) is configured to connect to a first casing (48) at said first endcap (22) and a second casing (50) at said second endcap (26).

28. The syringe shield (6) of claim 27, further comprising a Teflon™ seal between the first casing (48) and the first endcap (22) and/or a Teflon™ seal between the second casing (50) and the second endcap (26).

29. The syringe shield (6) of claim 27, wherein said first casing (48) comprises a handle (54).

30. The syringe shield (6) of claim 29, wherein said handle (54) is removable.

31. The syringe shield (6) of claim 27, wherein at least one of said first endcap (22) or said second endcap (26) comprises a locking means for securing the first casing (48) to the first endcap (22).

32. The syringe shield (6) of claim 27, wherein at least one of said first endcap (22) or said second endcap (26) comprises a locking means for securing the second casing (50) to the second endcap (26).

33. The syringe shield (6) of claim 27, wherein the syringe shield (6), the first casing (48) and the second casing (50) have a total weight of less than 50 lbs.

34. The syringe shield (6) of claim 33, wherein the radiation-shielding material provides a proper shielding to said radioactive solution, and wherein said radioactive solution has a radioactivity up to 1 Ci.

35. The syringe shield (6) of claim 22, wherein the syringe shield (6) is insertable in a shield slot (32) of an infusion pump (4) for delivering to a patient a radioactive solution contained in said syringe (8) enclosed into the syringe shield (6).

36. The syringe shield (6) of claim 35, wherein said collar (30) is securable to a receiving element (34) in said shield slot (32) of said infusion pump (4).

37. The syringe shield (6) of claim 36, wherein said first endcap (22) comprises one of a magnetic or radio-frequency tag identifiable by a reader adjacent said attachment element (34).

38. The syringe shield (6) of claim 36, wherein said first endcap (22) comprises a pin (44) insertable in a hole (46) in the shield slot (32) adjacent said attachment element (34) such that the syringe shield (6) is identifiable by the infusion pump (4).

39. A method for intravenously delivering to a patient a radioactive solution contained in a barrel (10) of a syringe (8) housed in a syringe shield (6), comprising the steps of:

securing the syringe shield (6) in a shield slot (32) of an infusion pump (4);

actuating a plunger (12) of the syringe (8) via said infusion pump (4) to inject the radioactive solution into the patient;

rinsing the barrel (10) of the syringe (8) with a non-radioactive solution; and injecting the non-radioactive solution from the barrel (10) into the patient.

40. The method of claim 39, further comprising the steps of:

filling a second syringe (56) with said non-radioactive solution;

securing said second syringe (56) to a second slot (58) in said infusion pump (4); and

using said non-radioactive solution contained in said second syringe (56) to rinse the barrel of the syringe (8) after injection of the radioactive solution.

Description:
TITLE OF THE INVENTION

SYRINGE SHIELD AND AN INFUSION PUMP SYSTEM USING THE SAME

FIELD OF THE INVENTION

[0001] 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.

BACKGROUND OF THE INVENTION

[0002] Radioactive drugs, such as metaiodobenzylguanidine (MIBG) combined with radioactive iodine (1-131), are often used in the treatments of cancers and other such afflictions. Typically, 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.

[0003] While various syringe shields currently exist, they are typically sized to house syringes whose volumetric capacities are insufficient to contain a full dose of the radioactive drug. As such, multiple syringes are needed, which requires additional shields and added manipulation steps which complicate and add time to the treatment procedures with additional radiation exposure to workers.

[0004] In addition, 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. Moreover, 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.

[0005] It is thus an object of the present invention to provide a radioactive drug delivery device that limits exposure to radioactivity while minimizing the required manual manipulation steps.

[0006] It is another object of the present invention to provide a syringe shield that can be easily and safely identified by and connected to an infusion pump.

[0007] It is another object of the present invention to provide a syringe shield that can be integrated into an infusion pump.

[0008] It is yet another object of the present invention to provide a syringe shield large enough to house a syringe containing a complete dosage of a radioactive solution for a given treatment. [0009] It is yet another object of the present invention to provide a syringe shield with one or more endcaps shaped to prevent the syringe shield from rolling when placed on its side on a flat surface.

SUMMARY OF THE INVENTION

[0010] In order to address the above and other drawbacks, there is provided 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.

[0011] In an embodiment, 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. In an embodiment, 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.

[0012] In one embodiment, both casings are disconnected for using the syringe in its syringe shield. In this configuration, 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.

[0013] In another embodiment, only the second casing is disconnected for using the syringe in its syringe shield. In this configuration, 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.

[0014] In an embodiment, 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.

[0015] According to the present invention, there is also provided 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, which is adjacent the second open end, the radioactive solution in the barrel being shielded by the syringe shield, the syringe shield dimensioned to contain the syringe; and 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 a patient tubing line connected to the tip of the syringe.

[0016] In an embodiment, 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.

[0017] In an embodiment, 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. In an embodiment, the non-radioactive solution is a saline solution.

[0018] In an embodiment, 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.

[0019] In an embodiment, the attachment element in the shield slot comprises a plurality of ribs configured to mate with the collar in the first endcap.

[0020] In an embodiment, 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. In an embodiment, the infusion pump further comprises a dose calibrator to calibrate the detectors.

[0021] In an embodiment, 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.

[0022] In an embodiment, the pin comprises one of a magnetic tag and the hole comprises a reader configured to recognize the tag to identify the syringe shield.

[0023] In an embodiment, 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. In an embodiment, said pin is in the endcap or in the shield body.

[0024] In an embodiment, the infusion pump will only function when a valid syringe shield is recognized by the reader.

[0025] In an embodiment, the connecting element is embodied at least one of the first endcap or the second endcap is one of hexagonally or bevel shaped.

[0026] In an embodiment, 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.

[0027] In an embodiment, the syringe shield further comprises a first casing connectable to the first endcap and a second casing connectable to the second endcap.

[0028] In an embodiment, the syringe shield comprises a Teflon™ seal between the first casing and the first endcap and/or a Teflon™ seal between the second casing and the second endcap. Teflon™ can be easily cleaned and avoid risk of contamination.

[0029] In an embodiment, the first casing comprises a handle. Said handle is preferably removable.

[0030] In an embodiment, at least one of the first endcap or the second endcap comprises a locking means for securing the corresponding casing thereto. In an embodiment, the locking means is a locking pin.

[0031] In an embodiment, 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. In this embodiment, a cap is provided for closing said hole when access to the plunger is not needed.

[0032] There is also provided 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.

[0033] In an embodiment, 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. In an embodiment, the non-radioactive solution is a saline solution.

[0034] In an embodiment, 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.

[0035] In an embodiment, 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.

[0036] In an embodiment, 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.

[0037] In an embodiment, 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.

[0038] There is also provided 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.

[0039] In an embodiment, the syringe shield comprises tungsten.

[0040] In an embodiment, the first endcap comprises one of a magnetic or radio-frequency tag identifiable by a reader adjacent the attachment element.

[0041] In another embodiment, the patient tubing line has a valve set for receiving a solution containing at least one of a stress agent or an oral inhibiter.

[0042] In an embodiment, 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.

[0043] In an embodiment, at least one of the first endcap or the second endcap is one of hexagonally or bevel shaped.

[0044] In an embodiment, the syringe shield further comprises Teflon™ seals between a casing and its respective endcap.

[0045] In an embodiment, the syringe shield is dimensioned to receive a syringe containing up to one of thirty milliliters or sixty milliliters of the radioactive solution.

[0046] In an embodiment, the syringe shield is configured to connect to a first casing at the first endcap and a second casing at the second endcap.

[0047] In an embodiment, the first endcap comprises a handle. Preferably, said handle is removable.

[0048] In an embodiment, at least one of the first endcap or the second endcap comprises a locking means for securing the corresponding casing thereto.

[0049] In an embodiment, the total weight of the syringe shield, the first casing and the second casing together is no more than 50 lbs.

[0050] In an embodiment, the radiation-shielding material provides a proper shielding to the radioactive solution, and wherein said radioactive solution has a radioactivity up to 1 Ci. Preferably, 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.

[0051] There is also provided 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.

[0052] In an embodiment, 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. In another embodiment, 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.

[0053] In an embodiment, 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.

[0054] In an embodiment, 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.

[0055] Other objects, advantages and features of the present invention will become more apparent upon reading of the following non-restrictive description of specific embodiments thereof, given by way of examples only with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0056] 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;

[0057] Figure 1 C shows a front view of an infusion pump system in accordance with another preferred embodiment of the present invention;

[0058] Figure 2 shows a front view of a syringe for the infusion pump system of Figures 1 A and 1 B;

[0059] Figure 3 shows a front view of a syringe in a syringe shield;

[0060] Figures 4A and 4B show perspective views of various embodiments of an endcap for the syringe shield of Figure 3;

[0061] Figure 5 shows an enhanced semi-transparent perspective view of the infusion pump system of Figures 1 A and 1 B;

[0062] Figure 6 shows a top view of an infusion pump system in accordance with an alternate embodiment of the present invention;

[0063] Figure 7A shows perspective view of a shield slot in an infusion pump for the infusion pump system of Figures 1A and 1 B;

[0064] 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;

[0065] 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;

[0066] Figures 8A and 8B show respective front and perspective views of a syringe shield in accordance with an alternate embodiment of the present invention;

[0067] Figures 8C and 8D show respective assembled and exploded views of the syringe shield of Figures 8A and 8B with first and second casings; and

[0068] Figure 9 shows a schematic view of an infusion pump system in accordance with an alternate embodiment of the present invention.

DETAILED DESCRIPTION

[0069] The present invention is illustrated in further details by the following non-limiting examples.

[0070] Referring to Figures 1A and 1 B, there is shown an infusion pump system for delivering a radioactive drug to a patient for the treatment of various illnesses, generally referred to by the reference numeral 2, according to a preferred 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. To minimize the potential dangers of radiation exposure, the syringe shield 6 is made from a radiation shielding material that comprises tungsten, lead, stainless steel, aluminum alloy or a combination thereof. As such, 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. In an embodiment, 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. In other embodiments, 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).

[0071] Referring now to Figure 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.

[0072] Referring now to Figure 2, as is known in the art, 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.

[0073] Referring now to Figure 3, in addition to Figures 1A to 1 C, the syringe shield 6 accommodates the syringe 8, and includes a shield body 20. The embodiment shown in Figures 1A and 1 B, includes a first endcap 22 at a first open end 24 of the syringe shield 6 and a second endcap 26 at a second open end 28 of the syringe shield 6. As such, once the syringe 8 is inserted into the syringe shield 6, the barrel 8 is aligned with the shield body 20, the plunger 12 is displaceable through the first open end 24 and the tip is positioned adjacent the second open end 28. In an embodiment, 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. In an embodiment, syringe shield 6 includes Teflon™ seals (not shown), which seal each endcap (22 and 26) with its corresponding casing (48 and 50). The use of Teflon™ reduces the risk of contamination versus other seal materials such as rubber. In another embodiment, at least one of the first endcap 22 or the second endcap 26 includes a locking means for securing the syringe shield 6. For optimal efficiency, syringe shield 6 is dimensioned to house a syringe 8 of a specific pre-determined capacity.

[0074] Still referring to Figures 2 and 3 in addition to Figures 4A and 4B, 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. In an embodiment, such a shape may be a regular polygon such as a hexagon or an octagon. In another embodiment, such a shape may be beveled, examples of which are shown in Figures 3A and 3B. In another embodiment as shown in Figure 1 C, the syringe shield 6 is prevented from rolling by means of an irregular syringe body 20. For example, 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.

[0075] Referring once again to Figures 1A to 1 C, 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. As such, 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. Referring additionally to Figure 6, there is shown a pair of syringe shields 6, 6’, each dimensioned to accommodate a different sized syringe 8, 8’. In an embodiment, 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’. In such an embodiment, 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’. As such, 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.

[0076] Referring now to Figures 5 and 7A to 7C, as mentioned above, 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. In an embodiment, 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. In an embodiment shown in Figure 5, 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. In addition, 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. In an embodiment, 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. In an additional embodiment, 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.

[0077] Referring now to Figures 8A to 8D, in an alternate embodiment, 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. As such, 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. In addition, a handle 54 may be attachable to the first casing 48 to facilitate the carrying of the syringe shield 6. In a preferred embodiment, the handle 54 can be removably attached. In an embodiment, 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.

[0078] Referring once again to Figures 1A, 1 B, and 6, in an embodiment, 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. As such, 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.

[0079] Referring now to Figure 9 in addition to Figures 1A, 1 B and 6, an exemplary schematic view of an infusion pump system 2 is shown. For illustrative purposes, the infusion pump 4 is omitted. As discussed above, 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. Once the radioactive drug is delivered to the patient through second tubing line 74 and a patient tubing line 86 through third valve 72, 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. Once the first syringe 8 has been rinsed by the non-radioactive solution, 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. By using a second syringe 56 rather than deliver the non-radioactive solution directly from the non-radioactive solution bag 66 to the first syringe 8, the delivery of non-radioactive solution may be better controlled or regulated, and further allows different options for the order of distribution. In addition, 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. In an embodiment, each of said valves can be either a check-valve (as shown), a stopcock valve, or a pinch valve.

[0080] Still referring to Figure 9, in an alternate embodiment, a pair of radioactivity detectors or detectors (Gamma or Beta) 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. As a person of ordinary skill in the art would understand, blood vessels at the site of injection occasionally burst when the injection occurs, leading the drug to be dispersed locally at the site of injection rather than be distributed by the blood vessels throughout the body as intended. As such, detectors 80, 84 are useful to ensure that the entire dosage of radioactive drug in the syringe 8 is properly administered to the patient. In an embodiment, 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.

[0081] In a further embodiment, only the radioactivity detector 84 is provided and is positioned adjacent to the injection site 80. The reading of this detector 84 is indicative of whether the radioactive drug abnormally accumulates at the injection site. Abnormal accumulation would indicate that the radioactive drug is not correctly delivered into patient’s bloodstream. Advantageously, 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.

[0082] The scope of the claims should not be limited by the preferred embodiments set forth in the examples, but should be given the broadest interpretation consistent with the description as a whole.