Radiolabeled Treatment Infusion System, Apparatus, And Methods Of Using The Same Patent Application (2025)

U.S. patent application number 12/936083 was filed with the patent office on 2011-05-26 for radiolabeled treatment infusion system, apparatus, and methods of using the same. This patent application is currently assigned to Molecular Insight Pharmaceuticals, Inc.. Invention is credited to Daniel L. Yokell.

RADIOLABELED TREATMENT INFUSION SYSTEM, APPARATUS, AND METHODS OFUSING THE SAME

Abstract

Described herein are methods and devices for infusion of aradioactive compound, such as yttrium-90 radiolabeled somatostatinpeptide or analog. A radiation shield defining a shielded cavitysuitable for storing a radioactive substance includes a firstaperture providing external access to the shielded cavity and asecond aperture suitable for transferring a dosage vial into andout of the shielded cavity. A removable shielded plug and panel areadapted to shield respective apertures of the radiation shield. Atleast one dose of a radiolabeled compound stored in a vial in theradiation shield is delivered through a fluid communication channelat a rate of about 500 mL/hour. The fluid communication channel iswashed after delivery, such that the process substantially reducesradiation exposure during infusion of the radiolabeled compoundinto a patient.

Related U.S. Patent Documents

Claims

1. A shielded enclosure suitable for reducing radiation exposureduring infusion of a radioactive substance comprising: a radiationshield defining a shielded cavity suitable for storing a vialcontaining at least one dose of a radioactive substance, theradiation shield further defining a first aperture providingexternal access to the shielded cavity and a second aperturesuitable for transferring the vial into and out of the shieldedcavity; a shielded plug removably attachable to the radiationshield and adapted to shield the first aperture when attachedthereto; and a shielded panel removably attachable to the radiationshield and adapted to shield the second aperture when attachedthereto, the radiation shield together with the shielded plug andthe shielded panel when attached, forming a substantiallycontinuous shielded cavity, the radiation shielding suitable forreducing radiation exposure during infusion of the radioactivesubstance from the vial to a patient.

2. The shielded enclosure of claim 1, wherein the radiation shieldcomprises a plurality of different shielding layers, the shieldedplug and shielded panel, when attached to the radiation shield,preserving continuity the same plurality of different shieldinglayers about the substantially continuous shielded cavity.

3. The shielded enclosure of claim 2, wherein each of the pluralityof different shielding layers is formed from a respective materialselected from a group of materials consisting of: metals; aluminum;lead; steel; stainless steel; tungsten; titanium; metal alloys;leaded glass; polymers; polycarbonate materials; solids formed fromsynthetic resins; and wood.

4. The shielded enclosure of claim 2, wherein the radiation shieldcomprise an inner layer of polycarbonate material and an outerlayer of metal.

5. The shielded enclosure of claim 4, wherein the metal isaluminum.

6. The shielded enclosure of claim 1, further comprising aattachment element allowing the shielded enclosure to be suspendedfrom an intravenous (IV) pole.

7. The shielded enclosure of claim 1, further comprising a vialstored within the shielded cavity, the vial containing at least onedose of a radioactive substance, the vial including an access portsubstantially aligned with the first aperture when stored withinthe shielded cavity.

8. The shielded enclosure of claim 7, wherein the radioactivesubstance is a radioconjugate comprising an yttrium-90 radiolabeledsomatostatin peptide or analog.

9. A method of administering a radiolabeled compound to a patientcomprising: placing a reservoir containing at least one dose of aradioactive compound in a shielded enclosure having a fluid accessport; providing a fluid communication channel between the reservoirand a patient; delivering at least one dose of the radiolabeledcompound through the fluid communication channel at a rate of about500 mL/hour; and washing the fluid communication channel afterdelivery of the radiolabeled compound, wherein radiation exposureduring infusion of the radiolabeled compound into a patient issubstantially reduced.

10. The method of claim 9, wherein the act of washing the fluidcommunication channel comprises flushing a saline solution throughthe fluid communication channel.

11. The method of claim 9, wherein the shielded enclosure comprisesan interior polycarbonate layer and an exterior aluminum layer.

12. The method of claim 9, wherein the radiolabeled substance isyttrium-90 radiolabeled somatostatin peptide or analog.

13. The method of claim 9, further comprising delivering anon-radiolabeled compound through the fluid communication channelat a rate of about 500 mL/hour.

14. The method of claim 13, wherein delivery of the radiolabeledcompound and the non-radiolabeled compound occur in succession.

15. An intravenous injection apparatus comprising: a firstreservoir storing a first non-radioactive compound; a first fluidline in fluid communication between the first reservoir and apatient-side needle; a second reservoir storing a saline solution;a second fluid line in fluid communication with the patient-sideneedle; and a vial shield surrounding a vial containing aradioactive compound, the vial in fluid communication with thesecond fluid line, the apparatus operable to inject a dose ofradioactive compound into a living subject operably coupled to thesecond end of the fluid line.

16. The intravenous injection apparatus of claim 15, wherein thevial shield comprises a substantially continuous aluminum shieldinglayer and a substantially continuous polycarbonate materialshielding layer; the vial shield further comprising an accessaperture providing access through the shielding layers.

17. The intravenous injection apparatus of claim 15, wherein theradioactive compound is a radioconjugate comprising an yttrium-90radiolabeled somatostatin peptide or analog.

18. The intravenous injection apparatus of claim 15, wherein thenon-radioactive compound comprises a diluted nutrient preparationcontaining amino acids.

19. The intravenous injection apparatus of claim 15 furthercomprising a dual channel infusion pump, a first channel of thepump adapted for infusing a fluid through the first fluid line anda second channel of the pump adapted for infusing a fluid throughthe second fluid line.

20. A method for reducing radiation exposure during infusion of aradioactive compound into a patient comprising: storing a vialcontaining at least one dose of a radioactive compound in ashielded enclosure having an aperture blocked by a shielded accessplug; removing the shielded access plug from shielded enclosurethereby exposing the aperture; coupling an intravenous (IV) fluidline between the vial containing the at least one dose of aradioactive compound and the patient, the coupling occurringthrough the exposed aperture; infusing at least a portion of the atleast one dose of a radioactive compound into the patient throughthe IV fluid line.

21. The method of claim 20, wherein the radioactive compound is aradioconjugate comprising an yttrium-90 radiolabeled somatostatinpeptide or analog

22. The method of claim 20, further comprising infusing anon-radioactive compound into the patient through at least apatient proximal portion of the IV fluid line.

23. The method of claim 20, wherein the non-radioactive compoundbeing a diluted nutrient preparation containing amino acids andradioactive compound being a radioconjugate comprising anyttrium-90 radiolabeled somatostatin peptide or analog are eachinfused alternately into the patient through at least a portion ofthe IV fluid line.

24. The method of claim 20, further comprising suspending theshielded enclosure containing at least one dose of a radioactivecompound from an IV pole.

Description

BACKGROUND OF THE INVENTION

[0001] The present invention relates generally to the field ofintravenous administration of substances to a patient and moreparticularly to administration of radioactive substances to thepatient.

[0002] Radiopharmacology is the study and preparation ofradiopharmaceuticals, i.e., radioactive pharmaceuticals.Radiopharmaceuticals are used in the field of nuclear medicine astracers in the diagnosis and treatment of many diseases.

[0003] Radiotherapy can also be delivered through infusion (intothe bloodstream) or ingestion. Examples are the infusion ofmetaiodobenzylguanidine (MIBG) to treat neuroblastoma, of oraliodine-131 to treat thyroid cancer or thyrotoxicosis, and ofhormone-bound lutetium-177 and yttrium-90 to treat neuroendocrinetumors (peptide receptor radionuclide therapy). Another example isthe injection of radioactive glass or resin microspheres into thehepatic artery to radioembolize liver tumors or livermetastases.

[0004] Radiolabeled macromolecules have also been and are beingdeveloped. Radioimmunotherapeutic agents, for example, FDA-approvedIbritumomab tiuxetan (Zevalin.RTM.), which is a monoclonal antibodyanti-CD20 conjugated to a molecule of Yttrium-90, TositumomabIodine-131 (Bexxar.RTM.), which conjugates a molecule of Iodine-131to the monoclonal antibody anti-CD20, were the firstradioimmunotherapy agents approved for the treatment of refractorynon-Hodgkin's lymphoma.

[0005] Although radiolabeled agents are being developed and areincreasingly more effective at treating particular diseases anddisorders, they involve certain risks, especially to health careprofessionals, and especially when required in large doses.Improved methods and devices are needed for the delivery ofradiolabeled therapeutics.

SUMMARY OF THE INVENTION

[0006] Described herein are infusion systems and methods fordelivering a radiopharmaceutical agent to a subject, such that anadministering health care professional does not get exposed to apotentially deleterious amount of radiation. The systems andmethods described herein allow for combined, i.e., increasedradiation doses to be delivered to the subject. The systems andmethods of the present invention are useful in either diagnostic ortherapeutic applications. The infusion systems of the presentinvention can be used to deliver any radiopharmaceutical agent thathas a potentially deleterious amount of radiation, alone or incombination with one or more other substances.

[0007] One embodiment of the invention relates to a shieldedenclosure suitable for reducing radiation exposure during infusionof a radioactive substance. The shielded enclosure includes aradiation shield defining a shielded cavity suitable for storing avial containing at least one dose of a radioactive substance. Theradiation shield further defines a first aperture providingexternal access to the shielded cavity and a second aperturesuitable for transferring the vial into and out of the shieldedcavity. The shielded enclosure further includes shielded plug and ashielded panel. The shielded plug is removably attachable to theradiation shield and adapted to shield the first aperture whenattached thereto. Similarly, the shielded panel is also removablyattachable to the radiation shield and adapted to shield the secondaperture when attached thereto. The radiation shield together withthe shielded plug and the shielded panel when attached, form asubstantially continuous shielded cavity, providing radiationshielding suitable for reducing radiation exposure during infusionof the radioactive substance from the vial to a patient.

[0008] In some embodiments, the radiation shield includes more thanone different shielding layers. The shielded plug and shieldedpanel are also configured, when attached to the radiation shield,to preserve continuity of the more than one different shieldinglayers about the substantially continuous shielded cavity. In someembodiments, each of the more than one shielding layers is formedfrom a respective material selected from a group of materialsconsisting of: metals; aluminum; lead; steel; stainless steel;tungsten; titanium; metal alloys; leaded glass; polymers;polycarbonate materials; solids formed from synthetic resins; andwood. In some embodiments, each of the more than one shieldinglayers is formed from one or more non-porous materials selectedfrom, e.g., but not limited to, metals, metal alloys, amorphousmaterials, such as glass, and hard plastic, or derivatives thereof.In some embodiments, the radiation shield includes an inner layerof polycarbonate material and an outer layer of metal, such asaluminum. In some embodiments, the radiation shield includes anattachment element allowing it to be suspended, for example, froman intravenous (IV) pole. The vial stored within the shieldedcavity contains at least one dose of a radioactive substance andhas an access port substantially aligned with the first aperturewhen stored within the shielded cavity. The radioactive substancecan be a yttrium-90 radiolabeled somatostatin peptide oranalog.

[0009] Another embodiment of the invention relates to a process foradministering a radiolabeled compound to a patient. The processincludes placing a reservoir containing at least one dose of aradioactive compound in a shielded enclosure having a fluid accessport. A fluid communication channel is provided between thereservoir and a patient. At least one dose of the radiolabeledcompound is delivered through the fluid communication channel at arate of about 500 mL/hour. The fluid communication channel iswashed after delivery of the radiolabeled compound, such that theprocess substantially reduces radiation exposure during infusion ofthe radiolabeled compound into a patient.

[0010] In some embodiments, a saline solution is flushed throughthe fluid communication channel to wash the fluid communicationchannel. In some embodiments, the shielded enclosure includes aninterior polycarbonate layer and an exterior aluminum layer. Insome embodiments, the radiolabeled substance is yttrium-90radiolabeled somatostatin peptide or analog. In some embodiments, anon-radiolabeled compound is also delivered through the fluidcommunication channel at a rate of about 500 mL/hour. Delivery ofthe radiolabeled compound and the non-radiolabeled compound canoccur in succession.

[0011] Another embodiment of the invention relates to anintravenous injection apparatus including a first reservoir storinga first non-radioactive compound, a first fluid line in fluidcommunication between the first reservoir and a patient-sideneedle. The injection apparatus also includes a second reservoirstoring a saline solution, a second fluid line in fluidcommunication with the patient-side needle, and a vial shieldsurrounding a vial containing a radioactive compound. The vial isin fluid communication with the second fluid line, such that theapparatus is configured to inject a dose of radioactive compoundinto a living subject operably coupled to the second end of thefluid line.

[0012] In some embodiments, the vial shield comprises asubstantially continuous aluminum shielding layer and asubstantially continuous polycarbonate material shielding layer;the vial shield further including an access aperture providingaccess through the shielding layers. In some embodiments, theradioactive compound is a radioconjugate including an yttrium-90radiolabeled somatostatin peptide or analog. In some embodiments,the non-radioactive compound includes a diluted nutrientpreparation containing amino acids. In some embodiments, theintravenous injection apparatus further includes a dual channelinfusion pump. A first channel of the pump is adapted for infusinga fluid through the first fluid line and a second channel of thepump adapted for infusing a fluid through the second fluidline.

[0013] Yet another embodiment of the invention relates to a processfor reducing radiation exposure during infusion of a radioactivecompound into a patient. The process includes storing a vialcontaining at least one dose of a radioactive zo compound in ashielded enclosure having an aperture blocked by a shielded accessplug. The shielded access plug is removed from shielded enclosurethereby exposing the aperture. An intravenous (IV) fluid line iscoupled between the vial containing the at least one dose of aradioactive compound and the patient, the coupling occurringthrough the exposed aperture. At least a portion of the at leastone dose of a radioactive compound is infused into the patientthrough the IV fluid line.

[0014] In some embodiments, the radioactive compound is aradioconjugate including an yttrium-90 radiolabeled somatostatinpeptide or analog. In some embodiments, a non-radioactive compoundis also infused into the patient through at least a patientproximal portion of the IV fluid line. In some embodiments infusingboth radioactive and non-radioactive compounds, the non-radioactivecompound is a diluted nutrient preparation containing amino acidsand the radioactive compound is a radioconjugate comprising anyttrium-90 radiolabeled somatostatin peptide or analog, each beinginfused alternately into the patient through at least a portion ofthe IV fluid line. In some embodiments, the shielded enclosurecontaining at least one dose of a radioactive compound is suspendedfrom an IV pole.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The foregoing and other objects, features and advantages ofthe invention will be apparent from the following more particulardescription of preferred embodiments of the invention, asillustrated in the accompanying drawings in which like referencecharacters refer to the same parts throughout the different views.The drawings are not necessarily to scale, emphasis instead beingplaced upon illustrating the principles of the invention.

[0016] FIG. 1 is a schematic representation of an embodiment of ainfusion system configured for intravenously administering aradioactive substance.

[0017] FIG. 2 is an exploded perspective view of an embodiment of avial shield.

[0018] FIGS. 3A and 3B are side and bottom views, respectively, ofthe exemplary open-ended radiation-shielded vessel shown in FIG.2.

[0019] FIGS. 4A and 4B are top and side views, respectively, of theexemplary radiation-shielded plug shown in FIG. 2.

[0020] FIGS. 5A and 5B are top and side views, respectively, of theexemplary removable radiation-shielded cover shown in FIG. 2.

[0021] FIG. 5C is a sectional view along A-A of the embodiment ofthe removable radiation-shielded cover illustrated in FIG. 5A.

[0022] FIG. 6 is a flow diagram of an embodiment of a process forintravenously administering a radioactive substance.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] The invention pertains to systems and processes foradministering a radioactive substance to a patient. The systems andprocesses of the invention are useful in both diagnostic (e.g., invivo imaging) and therapeutic applications. The radioactivesubstance may be formulated as a radiolabeled imaging agent or aradiolabeled therapeutic agent. In one embodiment the radioactivesubstance is a radiolabeled imaging agent, such as such as anyttrium-90 radiolabeled somatostatin peptide or analog.Alternatively or in addition, the radioactive substance isformulated or combined with one or more other substances to form aradiotherapeutic substance. A suitable delivery system includes,for example, a pump to deliver the radioactive substance at adesired infusion rate. For example, the pump can be configured toinfuse a peptide or analog at a rate of, for example, about 500mL/hour. The systems and processes optionally include provisionsfor washing or otherwise flushing at least that portion of theintravenous (IV) tubing exposed to the radioactive substance afterdelivery of the radioactive substances, e.g., radiolabeled peptideor analog.

[0024] A radioconjugate consisting of the octreotide derivativeedotreotide labeled with yttrium 90 (Y-90) has potentialradiotherapeutic uses. Similar to octreotide, yttrium Y-90edotreotide binds to somatostatin receptors (SSTRs), especiallytype 2 receptors, present on the cell membranes of many types ofneuroendocrine tumor cells, delivering tissue-specific,beta-emitting nuclide Y-90-mediated cytotoxicity to SSTR-positivecells. Ythium Y-90 edotreotide is produced by substituting tyrosinefor phenylalanine at the 3 position of the somatostatin analogueoctreotide and chelating the substituted octreotide to Y-90 viadodecanetetraacetic acid (DOTA).

[0025] Onalta.RTM. (Molecular Insight Pharmaceuticals, Cambridge,Mass. USA) is a radiotherapeutic product for the treatment ofcancer. Formerly known as OctreoTher, Onalta.RTM. is the brand namefor edotreotide, an yttrium-90 (Y-90) radiolabeled somatostatinpeptide. Somatostatin is a hormone distributed throughout the bodythat acts as a regulator of endocrine and nervous system functionby inhibiting the secretion of several other hormones such asgrowth hormones, insulin and gastrin. Onalta.RTM. is useful for theradiotherapeutic treatment of metastatic carcinoid and pancreaticneuroendocrine cancer in patients whose symptoms are not controlledby conventional somatostatin analog therapy. Somatostatin analogtherapy (or octreotide or sandostatin) is used to alleviate thesymptoms associated with carcinoid syndrome.

[0026] A schematic representation of an embodiment of a infusionsystem configured for intravenously administering a radioactivesubstance is illustrated in FIG. 1. An IV setup 100 includes aprimary IV supply or bag 102 suspended from a top portion of an IVpole 104. The primary IV bag 102 includes a drip chamber 106coupled to a distal end of primary IV tubing 108. The proximal endof the primary IV tubing 108 terminates in a respective port of afluid junction 110, sometimes referred to as a "Y-site." An IVtubing extension 112 is coupled between a respective port of theY-site 110 and a patient (not shown). The primary IV tubing 108 isrouted through a first channel of a dual-channel infusion pump 114.The infusion pump 114 is positioned between the primary IV bag 102and the Y-site 110 and configured to infuse a first non-radioactivesubstance from the primary IV bag 102 into the patient. Aflow-control valve 116, such as a roller valve, is positionedbetween the infusion pump 114 and the drip chamber 106 of theprimary IV bag 102, which can be used to establish a desired flowrate of the non-radioactive substance.

[0027] The IV setup 100 also includes a secondary IV supply or bag118 suspended from the top portion of the IV pole 104. Thesecondary IV bag 118 is coupled to a distal end of secondary IVtubing 120. The proximal end of the secondary IV tubing 120terminates in a respective port of the Y-site 110. The secondary IVtubing 120 is routed through a second channel of the dual-channelinfusion pump 114. The infusion pump 114 is similarly positionedbetween the secondary IV bag 118 and the Y-site 110 and configuredto infuse a second non-radioactive substance from the secondary IVbag 118 into the patient. An access port 122, sometimes referred toas an injection port is positioned along the secondary IV tubing120, between the infusion pump 114 and the secondary IV bag 118.The access port 122 provides a location for fluid access to a fluidchannel of the secondary IV tubing 120. In some embodiments, a flowcontrol device, such as a slide clamp or "A clamp" 124 ispositioned along the secondary IV tubing 120, between the accessport 122 and the secondary IV bag 118, which can be used tointerrupt or otherwise control flow of fluid from the secondary IVbag. Alternatively or in addition, a flow-control valve (notshown), such as a roller valve, is positioned between the accessport 122 and the secondary IV bag 118.

[0028] The IV setup 100 further includes shielded container, suchas a vial shield 126 suspended from the top portion of the IV pole104. The vial shield 126 includes an interior shielded region sizedand shaped to accommodate therein a patient dose vial 127. Patientdose vials 127 intended for use in the vial shield 126, generallycontain a radioactive substance. Each patient dose vial 127 alsoincludes at least one fluid access port. For example, the fluidaccess port can be a piercable region, such as the vial septum of acommon dose vial. When the patient dose vial 127 is positionedwithin the vial shield 126, the vial septum, is aligned with aresealable vial shield aperture. In some embodiments, the patientdose vial 127 includes a vent allowing for pressure equalization ofan interior of the patient dose vial 127 and the surroundingenvironment. The vial shield 126 allows for safe handling andadministration of radioactive substances, the particular shieldingproperties being designed to greatly reduce exposure to non-patientindividuals from radioactive material contained within the patientdose vials 127.

[0029] The shielded patient dose vial 129 is coupled to a distalend of a length of auxiliary IV tubing 128. An extraction apparatus133 is used to provide fluid communication between a patient dosecontained in the patient dose vial 129 and the auxiliary IV tubing128. The extraction apparatus can use suction or vacuum action. Insome embodiments, the extraction apparatus is a piercing cannula,such as a hypodermic needle or IV spike 133. A drip chamber 130 istypically positioned between the distal end of the auxiliary IVtubing 128 and the resealable aperture of the shielded patient dosevial 129. The proximal end of the auxiliary IV tubing 128terminates in a fluid connector 132 adapted for fluid communicationthrough the access port 122, thereby providing fluid access betweenthe auxiliary IV tubing 128 and the secondary IV tubing 120. Aflow-control valve 134, such as a roller valve, is positionedbetween the fluid connector 132 and the drip chamber 130 of theinfusion shielded patient dose vial 129, which can be used toestablish a desired flow rate of the radioactive substance. Thesecondary IV bag 118 is suspended from the top of the IV pole 104by way of an extension 136, such the secondary IV bag 118 isrelatively lower than the shielded patient dose vial 129.

[0030] The secondary IV bag 118 is configured to infuse a secondnon-radioactive substance from the secondary IV bag 118, throughthe Y-site 110, into the IV tubing extension 112 and ultimatelyinto the patient. An access port 122, sometimes referred to as aninjection port, is positioned along the secondary IV tubing 120,between the infusion pump 114 and the secondary IV bag 118. Theaccess port 122 provides a location for fluid access to a fluidchannel of the secondary IV tubing 120. In some embodiments, a flowcontrol device, such as a slide clamp or "A clamp" 124 ispositioned along the secondary IV tubing 120, between the accessport 122 and the secondary IV bag 118. Alternatively or inaddition, a flow-control valve (not shown), such as a roller valve,is positioned between the access port 122 and the secondary IV bag118. In some embodiments, one or more of the IV tubing extensionand at least proximal portion of the secondary IV tubing areradiation shielded.

[0031] In operation, the IV setup 100 allows a radioactive solutionto be infused from the patient dose vial 127 to the patient throughan IV access site. The access site can include without restrictionan antecubital or equivalent vein. Generally, any IV suitableaccess site, such as a central catheter, can also be used. Amultiport fluid coupling, such as the Y-site 110, allows more thanone IV sources to be injected into a patient through the same IVaccess site. The primary IV bag 102 is hung from the IV stand 104,and spiked using an infusion pump primary set 108. An infusion settypically includes a spike, a drip chamber, and a plastic highpressure tube, with the spike configured to pierce an IV fluidreservoir, such as the primary IV bag 102. The primary IV tubing isthen primed, to remove air. In some embodiments, a check valve isincluded along the IV tubing. Alternatively or in addition, theinfusion set includes a vent. For example, a vent 131 can beprovided on the IV spike 133, or top portion of the drip chamber130 to provide venting when necessary. Since the patient dose vial127 may have rigid or semi-rigid walls, equalization of thepressure across the walls is required to allow fluid transfer withthe shielded patient dose vial 129. In such instances, a separatevent can be provided on the patient dose vial 129 itself.

[0032] The primary IV tubing 108 is inserted into the primarychannel of a dual channel infusion pump, with a patient end of thetubing attached to a first port of the Y-site 110. In an exemplaryembodiment, the primary IV bag 102 includes a non-radioactivesolution 103, such as a nutrient preparation. For example, theprimary IV bag 102 includes about 1000 mL of a 7% nutrientpreparation 103 containing amino acids, such as Aminosyn.RTM. IIamino acid solution (Aminosyn is a registered trademark of Hospira,Inc. of Lake Forest, Ill.).

[0033] An infusion rate of fluid flowing from the primary IV bag102 through the primary IV tubing 108 is set at or otherwiseadjusted to a preferred infusion rate using generally wellunderstood techniques for adjusting infusion rates. For example, aninfusion rate of the 7% Aminosyn.RTM. II amino acid is set at arecommended infusion rate of about 500 mL per hour. The firstchannel of the dual channel infusion pump 114 is adjusted to beginthe infusion of Aminosyn.RTM. through the primary line and tomaintain infusion for a primary infusion interval, e.g., for atleast 30 minutes.

[0034] The secondary IV bag 118 is hung from the IV stand 104, thesecondary IV bag 118 is also spiked using an infusion pumpsecondary set. The secondary tubing 120 is then primed tosubstantially remove any air within the line. For example, thesecondary IV bag 118 includes about a 100 mL of 0.9% sodiumchloride solution 119 for injection. The secondary IV tubing 120 isinserted into the secondary channel (Channel 2) on the dual channelinfusion pump 114 with its patient end attached to a second port ofthe Y-Site 110.

[0035] Infusion of the first non-radioactive substance, e.g., the7% Aminosyn.RTM. II amino acid solution infusion, is commenced forprimary infusion interval and then paused. An infusion rate for thesecondary IV bag 118 is set at a respective infusion rate usinggenerally well understood techniques for setting or otherwiseadjusting the rate. For example, the infusion rate of the 0.9%Sodium Chloride Solution (Channel 1) is set at about 500 mL perhour. Infusion of the secondary IV bag contents 119 is initiatedand allowed to run for a relatively brief interval, e.g., for a fewminutes to ensure that flow from the secondary IV bag is acceptable(e.g., desired flow rate).

[0036] The shielded patient dose vial 129 includes a vial shield126 having an interior shielded cavity containing a patient dosevial 127. The patient dose vial 127, in turn, includes aradioactive substance 125 to be administered to the patient. Theshielded patient dose vial 129 is hung from the IV stand 104. Usingan extension hanger 136, the secondary IV bag 118 is lowered, suchthat the secondary IV bag 118, e.g., containing the 0.9% sodiumchloride, is positioned below the level of the patient dose vial127.

[0037] The secondary set fluid connector 132 attached to a proximalend of the auxiliary IV tubing 128 line is insert the connector 122positioned along the secondary IV tubing 120, at a height above thepump 114. A flow control device, such as a roll clamp 134 ispositioned along the auxiliary IV tubing and adjusted allow toallow saline solution from the secondary IV bag to prime theauxiliary IV tubing 128. The roll clamp 134 is closed once thesaline has reached the drip chamber 130 of the auxiliarytubing.

[0038] The patient dose vials 127 containing the radioactivesubstance 125, e.g., Onalta.RTM. (Y-90 Edotreotide), is invertedand placed within the infusion shield 126. An access plug isremoved from a bottom of the infusion shield 126 providing accessto an injection port of the patient dose vial 127 containedtherein. The patient dose vial 127 is then spiked inside theinfusion shield 126 with the auxiliary IV set spike 133. Theshielded patient dose vial 129 is hung from the IV stand 104 and avent cap 131 opened. The arrangement of the secondary IV 118 bagcontaining the sodium chloride solution 119 and the patient dosevial 127 positioned and attached as described herein is sometimesreferred to as a "piggy back" arrangement. When the secondary IVbag 118 and the shielded patient dose vial 129 are connected andpositioned as described, the patient dose 125 will infuse first(higher pressure), and when depleted, automatically be followed byinfusion of the secondary IV bag contents 119 in a substantiallyuninterrupted manner.

[0039] The infusion pump is suitably configured, e.g., using apiggy-back setting when available, to set or otherwise adjust aninfusion rate of the radioactive substance 125, e.g., Onalta.RTM.(Y-90 Edotreotide) at the desired infusion rate. For the exemplaryOnalta.RTM. (Y-90 Edotreotide), the fill volume in the patient dosevial is about 86 mL, and a recommended infusion rate is about 500mL per hour. The infusion of Onalta.RTM. (Y-90 Edotreotide) can beadjusted to occur over 10 minutes at the recommended rate. Infusionof the radioactive substance can be adjusted by the roll clamp onthe auxiliary IV tubing line. To begin infusion, the roll clamp onthe auxiliary IV tubing line is released.

[0040] Once infusion of the radioactive substance 125, e.g.,Onalta.RTM. (Y-90 Edotreotide), has finished and the saline 119 hasrestarted, flow of the saline 119 can be interrupted using a clamp,such as the A-clamp 124 positioned along the secondary line 120 andabove the injection site. The saline line is clamped above a checkvalve (not shown), when provided, to administer any remainingOnalta.RTM. in the auxiliary line--infusion of saline 119 stops,while infusion of any residual radioactive substance empties atleast the auxiliary IV line 128. The clamp 124 is released once thecontents of the auxiliary IV line 128 have been administered.Infusion of the saline can be restarted to infuse any residualOnalta.RTM. from the patient end of the secondary IV tubing 120,and avoid any mixing of the primary IV contents 103 with theradioactive drug product 125.

[0041] The radioactive material 125 provided in the shieldedpatient dose vial 129 can be an imaging agent, such as aradiopharmaceutical composition for in-vivo imaging. Exemplaryradiopharmaceutical compositions include Zemiva.RTM. (iodofilticacid 1123) used in the a detection and management of cardiacischemia by imaging metabolic changes in the heart, and Trofex.RTM.used in the detection monitoring or therapy of prostate cancer viabinding to prostate-specific membrane anginen (PSMA). Alternativelyor in addition, the radioactive material can be a therapeuticmaterial, such as a radiopharmaceutical composition for treatingcancer. Exemplary radiotherapeutic materials include Azedra.RTM.(Ultratrace.RTM. iobenguane 1131) used in the treatment ofneuroendocrine tumors using a tumor's norepinephrine uptakemechanism, Solazed.RTM. (1-131 labeled benzamide) used in thetreatment of metastatic melanoma based on melanin-binding smallmolecule, and Onalta.RTM. (yttrium-90 radiolabeled somatostatinpeptide analog, such as an edotreotide) used in the treatment ofcarcinoid tumors using receptor-based radiotherapuetic.Zemiva.RTM., Trofex.RTM., Azedra.RTM., Solazed.RTM.,Ultratrace.RTM. and Onalta.RTM. are registered trademarks ofMolecular Insight Pharmaceuticals, Inc. of Cambridge, Mass.

[0042] In some embodiments, the radioactive material 125 providedin the shielded patient dose vial 129 can include aradiopharmacological agent labeled with an isotope selected fromthe group consisting of one or more of: Technetium-99m(technetium-99m), Iodine-123, Iodine-125 and Iodine-131,Thallium-201, Gallium-67, Yttrium-90, Samarium-153, Strontium-89,Phosphorous-32, Rhenium-186, Lutetium-177, Fluorine-18 andIndium-111 and/or an isotope as summarized in Table 1 below.

TABLE-US-00001 TABLE 1 Isotope ExemplaryDiagnostic/Therapeutic/Medical Use Molybdenum-99 Used as the`parent` in a generator to produce technetium-99m. Technetium-99mUsed in to image the skeleton and heart muscle in particular, butalso for brain, thyroid, lungs (perfusion and ventilation), liver,spleen, kidney (structure and filtration rate), gall bladder, bonemarrow, salivary and lacrimal glands, heart blood pool, infectionand numerous specialized medical studies. Bismuth-213 Used for TAT.Chromium-51 Used to label red blood cells and quantify gastro-intestinal protein loss. Cobalt-60 Formerly used for external beamradiotherapy. Copper-64 Used to study genetic diseases affectingcopper metabolism, such as Wilson's and Menke's diseases.Dysprosium-165 Used as an aggregated hydroxide for synovectomytreatment of arthritis. Erbium-169 Use for relieving arthritis painin synovial joints. Holmium-166 Being developed for diagnosis andtreatment of liver tumors. Iodine-125 Used in cancer brachytherapy(prostate and brain), also diagnostically to evaluate thefiltration rate of kidneys and to diagnose deep vein thrombosis inthe leg. It is also widely used in radio- immuno-assays to show thepresence of hormones in tiny quantities. Iodine-131 Widely used intreating thyroid cancer and in imaging the thyroid; also indiagnosis of abnormal liver function, renal (kidney) blood flow andurinary tract obstruction. A strong gamma emitter, but used forbeta therapy. Iridium-192 Supplied in wire form for use as aninternal radiotherapy source for cancer treatment (used thenremoved). Iron-59 Used in studies of iron metabolism in the spleen.Lutetium-177 Lu-177 is increasingly important as it emits justenough gamma for imaging while the beta radiation does the therapyon small (e.g., endocrine) tumors. Its half-life is long enough toallow sophisticated preparation for use. Palladium-103 Used to makebrachytherapy permanent implant seeds for early stage prostatecancer. Phosphorus-32 Used in the treatment of polycythemia vera(excess red blood cells). Beta emitter. Potassium-42 Used for thedetermination of exchangeable potassium in coronary blood flow.Rhenium-186 Used for pain relief in bone cancer. Beta emitter withweak gamma for imaging. Rhenium-188 Used to beta irradiate coronaryarteries from an angioplasty balloon. Samarium-153 Sm-153 is veryeffective in relieving the pain of secondary cancers lodged in thebone. Also very effective for prostate and breast cancer. Betaemitter. Selenium-75 Used in the form of seleno-methionine to studythe production of digestive enzymes. Sodium-24 For studies ofelectrolytes within the body. Strontium-89 Very effective inreducing the pain of prostate and bone cancer. Beta emitter.Xenon-133 Used for pulmonary (lung) ventilation studies.Ytterbium-169 Used for cerebrospinal fluid studies in the brain.Yttrium-90 Used for cancer brachytherapy and as silicate colloidfor the relieving the pain of arthritis in larger synovial joints.Pure beta emitter. Radioisotopes of cesium, gold and ruthenium arealso used in brachytherapy. Carbon-11, These are positron emittersused in PET for Nitrogen-13, studying brain physiology andpathology, in Oxygen-15, particular for localizing epileptic focus,and in Fluorine-18 dementia, psychiatry and neuropharmacologystudies. They also have a significant role in cardiology. F-18 inFDG has become very important in detection of cancers and themonitoring of progress in their treatment, using PET. Cobalt-57Used as a marker to estimate organ size and for in- vitrodiagnostic kits. Gallium-67 Used for tumor imaging and localizationof inflammatory lesions (infections). Indium-111 Used forspecialist diagnostic studies, e.g., brain studies, infection andcolon transit studies. Iodine-123 Increasingly used for diagnosisof thyroid function, it is a gamma emitter without the betaradiation of I-131. Krypton-81m from Kr-81m gas can yieldfunctional images of Rubidium-81 pulmonary ventilation, e.g., inasthmatic patients, and for the early diagnosis of lung diseasesand function. Rubidium-82 Convenient PET agent in myocardialperfusion imaging. Strontium-92 Used as the `parent` in a generatorto produce Rb-82. Thallium-201 Used for diagnosis of coronaryartery disease other heart conditions such as heart muscle deathand for location of low-grade lymphomas.

[0043] Alternatively or in addition, the radioactive material 125can be selected from the group consisting of one or more ofBexxar.RTM. (Iodine 1-131 Tositumomab), Zevalin.RTM.(Yttrium Y-90Ibritumomab Tiuxetan), Quadramet.RTM. (Samarium Sm-153 Lexidronam),Strontium-89 chloride, Phosphorous-32, Rhenium-186hydroxyethlidene, Samarium-153 lexidronam, I-131. Bexxar.RTM. is aregistered trademark of SmithKline Beecham Corporation ofPhiladelphia, Pa. Zevalin.RTM. is a registered trademark of CellTherapeutics, Inc. of Seattle, Wash., and Quadramet.RTM. is aregistered trademark of Cytogen Corporation of Princeton, N.J.

[0044] More than one vial of radioactive substance can beadministered, if necessary, to fulfill the total patient dose. Whenadministering two or more patient dose vials, the same piggybackarrangement can be used. Namely, once the contents of the firstpatient dose vial 127 have been emptied, a second patient dose vial127', e.g., containing a second dose of Onalta.RTM. (Y-90Edotreotide), is inverted and spiked after being suitablypositioned within the infusion shield 126. The shielded patientdose vial 129 the second patient dose vial 127' is hung from the IVstand 104 and the auxiliary IV tubing 128 re-primed. Radioactivecontents 125' of the second patient dose vial 127' can be infusedat the same rate of 500 mL per hour, or at a different rate, ifnecessary. Once the contents of the patient dose vial(s) have beeninfused, the auxiliary and secondary lines 128, 120 can be flushedwith the zo remainder of the 0.9% sodium chloride bag 118. Once thesecondary IV tubing line 120 has been flushed with the remainder ofthe 0.9% sodium chloride bag 118, infusion of contents of theprimary IV bag 102, e.g., the Aminosyn.RTM. Amino Acid 103, isresumed at a respective infusion rate. The respective infusion rateof the Aminosyn.RTM. Amino Acid 103 may be the same as the previousrate of about 500 mL per hour, or at a different rate.

[0045] An exploded perspective view of an embodiment of a vialshield 200 is illustrated in FIG. 2. The infusion shield 200includes an open-ended shielded vessel 202 having a relatively wideopening 204 for removal and replacement of patient dose vials 127(FIG. 1). This relatively wide opening 204 can be placed at one endof the shielded vessel 202, such as the top end as illustrated. Inthe exemplary embodiment, the infusion shield 200 has a generallycylindrical shape, defining a substantially cylindrical interiorshielded chamber. In some embodiments, the dimensions of theinterior shielded chamber are selected according to dimensions andshape of patient dose vials to be stored therein. For example, thedimensions can be selected to allow for supportively storing thepatient dose vial with little or no gaps to ensure a snug fit.Other container shapes are possible, such as polygons, ellipsoids,etc.

[0046] The infusion shield 200 includes a shielded lid 208configures for removable attachment to the relatively wide opening204 of the shielded vessel 202. Removal of the shielded lid 208allows for access to the interior shielded chamber of theopen-ended vessel 202 through the relatively wide opening 204, forexample, to insert and remove patient dose vials containingradioactive material. The shielded vessel 202 includes anattachment feature to facilitate removable attachment of theshielded lid 208 from the shielded vessel 202. For example, theattachment feature includes a thread 206, suitably positioned withrespect to the relatively wide opening 204, and the shielded lid208 includes a complementary attachment feature, such as acomplementary thread to allow for removable attachment of theshielded lid 208 from the shielded vessel 202. In some embodiments,the shielded lid 208 includes an attachment mechanism to facilitateremovable attachment of the infusion shield 200 to an IV stand. Theattachment mechanism can include an eyelet 210, or other suitableanchor, hook, handle attached to support the infusion shield 200 inthe upright position during use. As illustrated, the eyelet 210 isattached at the center of a top exposed surface of the shielded lid208.

[0047] The infusion shield 200 further includes a removableshielded plug 212 allowing controlled access to an interior regionof the infusion shield 200 when removed. For example, removal ofthe shielded plug 212 exposes a relatively small aperture providingan access channel to a patient dose vial stored therein. Suchaccess can be obtained by a spike of an IV tubing set, allowingfluid communication via the IV tubing to the patient dose vialstored therein. In the exemplary embodiment, the removable shieldedplug 212 includes an inner shielded bung 214 configured forinsertion into a receptacle provided along the bottom surface ofthe open-ended shielded vessel 202. A suitable removable fasteningarrangement, e.g., a threaded arrangement, is used for removableattachment of the shielded plug 212 from the infusion shield 200.The threaded arrangement can also be used to engage a portion of aninterconnected IV set, such as a Luer lock style threadedarrangement.

[0048] FIGS. 3A and 3B are side and bottom views, respectively, ofthe exemplary open-ended radiation-shielded vessel 202 shown inFIG. 2. The open-ended vessel 202 includes a radiation-shieldedbottom wall 220 disposed opposite the relatively wide open end 204.An elongated radiation-shielded side wall 222 extends between thebottom wall 222 and the open end 224. The bottom and side walls220, 222 are suitably formed to provide an acceptable level ofradiation shielding for patients and clinicians to patient dosagevials including radioactive substances, such as Onalta.RTM. (Y-90Edotreotide). Radiation materials suitable for shielding includemetals, such as aluminum, lead, steel, stainless steel, tungsten,titanium, metal alloys, leaded glass, polymers, Lexan.RTM.(polycarbonate material), Plexiglas.RTM., Lucite.RTM. (syntheticresin materials), and even wood, provided alone or in combination.Plexiglas.RTM. is a registered trademark of Arkema France Corp. ofColombes, France. Lexan.RTM. is a registered trademark of SabicInnovative Plastics IP B.V. Company of Pittsfield, Mass. andLucite.RTM. is a registered trademark of Lucite International, Inc.of Cordova, Tenn. In the illustrated embodiment, the bottom andside walls 220, 222 are formed using multiple layers of differentmaterials. In particular, the walls 220, 222 include an outer layerof a metal, such as aluminum 224 and an inner layer of a glass orpolymer, such as Lexan.RTM. 226. The inner and outer layers 226,224 extend substantially uninterrupted except for the open end 204and an access port 228 centrally located in the bottom wall 220.The access port 228 includes a threaded aperture 230 extendingthrough the outer aluminum layer 224 of the bottom wall 220 and acoaxial aperture 232 extending through the inner, Lexan layer 226of the bottom wall 220.

[0049] The shape and dimensions of the infusion shield 200 can beselected depending upon factors, such as patient dose vial size andshape. An exemplary patient dose vial 240 is illustrated inphantom, stored within the cavity of the shield. The patient dosevial 240 is positioned such that an access port, e.g., a septum, ispositioned adjacent to the coaxial aperture 232. For the exemplary86 mL patient dose of Onalta.RTM. (Y-90 Edotreotide), the externalheight `H` of the side wall 222 measured from the outer surface ofthe bottom wall 220 to the open end 204 is about 4.4 inches. Theinner height `D` of the side wall 222 measured from the innersurface of the bottom wall 220 to the open end 204 is about 3.89inches. The outer diameter `OD` of the open-ended vessel 202 isabout 2.98 inches. The inner diameter `ID.sub.1` of the vesselchamber is about 2.07 inches at the open end 204. The innerdiameter `ID.sub.2` of the aluminum layer 224 is about 2.468(-0.003 in., +0.002 in.).

[0050] FIGS. 4A and 4B are top and side views, respectively, of theexemplary radiation-shielded plug shown in FIG. 2. The IV portshielded plug 212 includes a support member 217, such as the flatdisk shaped support member 217 illustrated, onto which two or morebung elements 216, 214 are securely attached. Each bung element216, 214 is composed of a respective radiation shielding material,each configured to complete a respective portion of the shield ofthe open-ended vessel 202 when the plug 212 is inserted into the IVaccess aperture 228. In the illustrative example, an outer bungelement 216 is a disk shaped plug of metallic shield material, suchas aluminum, sized and shaped to fit snugly into the aluminumaperture in the outer shield layer 224 of the IV access aperture228. An inner bung element 214 positioned along a top surface ofthe lower bung element 216 is a cylindrical shaped plug of polymershield material, such as Lexan.RTM.. The inner bung element 214 issized and shaped to fit snugly into the Lexan aperture in the innershield layer 226 of the IV access aperture 228.

[0051] Each of the bung elements 214, 216 are securely attached tothe support member 217. A screw, such as the flathead screw 221shown in FIG. 4A can be used to fasten the various elements 214,216, 217 of the shielded plug 212 together as shown. Alternativelyor in addition, one or more other fastening means may be employed,such as chemical glues and epoxies, rivets, staples, welds,etc.

[0052] The IV port shielded plug 212 further includes a fasteningfeature to allow removable attachment of the plug 212 to theopen-ended shielded vessel 202. In the exemplary embodiment, theouter bung element 216 includes a peripheral thread around at leasta portion of the perimeter of the disk. The thread is sized andshaped according to a complementary thread provided on 230 alongthe outer shield of the IV access aperture 228. Thus, the shieldedplug 212 can be fastened to the bottom of the shielded vessel 202by aligning the inner bung element 214 with the IV access aperture228, inserting the shielded plug 212 partially into the IV accessaperture 228, and engaging the threads of the outer bung element216 with threads along the outer shield of the IV access aperture228. A frictional surface, such as a knurl 219 can be providedalong at least a portion of the outer perimeter of the supportingmember 217, to form a grip for a thumbwheel, allowing for easyinsertion and removal of the plug 212. Other fastening features arepossible, such as threads along the upper bung element 214, threadsalong the supporting member to engage complementary threads alongthe bottom wall 220 of the shielded vessel 202, and other fasteningmembers, such as screws, clips, etc. When inserted into the IVaperture 228 and secured to the shielded vessel 202, the shieldedplug 212 substantially fills the IV aperture 228 in such a mannerthat the corresponding portions of the inner and outer shieldlayers 226, 224 are substantially continuous. Thus, in thisexample, the inner shield 226 of the bottom wall 220 issubstantially continuous as is the outer shield 224.

[0053] FIGS. 5A and 5B are top and side views, respectively, of theexemplary removable shielded panel or cover 300 shown in FIG. 2,and FIG. 5C is a sectional view along A-A of the embodiment of theremovable radiation-shielded lid illustrated in FIG. 5A. Theshielded cover 300 is sized and shaped to cover the relatively wideopening 204 (FIG. 3A) of the open-ended shielded vessel 202 (FIG.3A), which is in turn sized and shaped to allow transfer of apatient dose vial 240 (FIG. 3A) into and out of the shieldedinterior region of the vessel 202.

[0054] In the exemplary embodiment, the shielded cover 300 is diskshaped, as in a jar lid. The shielded cover 300 includes an outerlayer 301 the same type of shield material used in as the outerlayer 224 (FIG. 3A) of the shielded vessel 202. The same ordifferent materials can be used. A first cavity 312 is providedalong a bottom surface of the shielded cover 300. The first cavity312 is sized and shaped to form a relatively snug fit with an outerperimeter of the relatively wide opening 204 of the open-endedshielded vessel 202. In some embodiments, a side wall of the firstcavity 312 includes one or more threads allowing a threadedengagement with a complementary thread 206 of the relatively wideopening 204.

[0055] The shielded cover 300 also includes a second cavity 313extending away from the open end of the first cavity 312. Thecavity is sized and shaped to accommodate a plug 314 or layer ofthe same shielding material as used for the inner layer 226 (FIG.3A) of the shielded vessel 202. In the exemplary embodiment, thesecond cavity is disk-shaped to accommodate a disk 314 ofLexan.RTM. having approximately the same thickness as the innerlayer 226 of the shielded vessel 202. The thickness of the shieldedcover 300 adjacent to the Lexan disk 314 is at least as thick orthicker than the thickness of the outer layer 224 of the shieldedvessel 202 to maintain shield uniformity around the entire shieldedcavity when the shielded cover 300 is attached to the shieldedvessel 202. In particular, the size and shape of the Lexan disk 314is sufficient to cover the relatively wide opening 214 of theopen-ended shielded vessel 202, for example having an outerdiameter ID.sub.2 (FIG. 3A).

[0056] In some embodiments, the shielded cover 300 includes anattachment element to facilitate hanging or otherwise supportingthe vial shield during use. In the illustrative example, theshielded cover 300 includes an eyelet 308 centrally located alongan outer, top surface of the shielded cover and extending away fromthe surface. The eyelet 308 may include a threaded shank 318 forfastening it to a threaded aperture 302 provided in the lid 301. Alocking nut 310 may be included to further secure attachment of theeyelet 308 to the shielded cover 300.

[0057] FIG. 6 is a flow diagram of an embodiment of a process 400for intravenously administering a radiolabeled substance. A dosagevial of radiolabeled substance is stored in shielded enclosure at402. An access plug is removed from shielded enclosure at 404. IVtubing is coupled between shielded vial and patient at 406. A doseof radiolabeled substance is delivered to a patient at 408, and theIV tubing is purged with saline solution at 410.

[0058] After infusion is completed, the auxiliary IV set, thesecondary IV set, and patient dose vial(s) should be disposed ofappropriately. For example, these components should be returned toradiopharmacy such that any residual activity can be measured andrecorded on a Case Report Form (CRF).

[0059] Onalta.RTM. (Y-90 Edotreotide), which is also know as90Y-DOTA-tyr3-Octreotide, is administered by intravenous infusionto patients with refractory somatostatin-receptor positive tumorsbecause of the large volume of the radiopharmaceutical therapy (86mL or greater).

[0060] The Onalta.RTM. (Y-90 Edotreotide) infusion system (FIG. 1)allows for ease of administration of an Amino Acid solution and theOnalta.RTM. therapy through the same IV access site on the patient.The system has been designed to deliver the maximal amount ofOnalta.RTM. therapy, while at the same time minimizing theradiation exposure to the staff through an innovative, proprietaryAluminum-Lexan Onalta.RTM. vial shield. The infusion systemutilizes a standard dual-channel IV pump, which is commonly foundin hospitals and clinics. All of the disposable infusion componentsused in the administration of Onalta.RTM. are standard,off-the-shelf components, which should be readily available in anyhospital.

[0061] Although a dual channel infusion pump is described hereinfor infusing substances into a patient, other pumping means areenvisioned, such as multiple single channel infusion pumps, gravitysystems and combinations of any of these infusion pumpingtechniques.

[0062] Other embodiments will be evident to those of skill in theart. It should be understood that the foregoing detaileddescription is provided for clarity only and is merely exemplary.The spirit and scope of the present invention are not limited tothe above examples, but are encompassed by the followingclaims.

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