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`a2) United States Patent
`US 9,814,826 B2
`(0) Patent No.:
`*Nov. 14, 2017
`(45) Date of Patent:
`Hidem et al.
`
`(54)
`
`INTEGRATED STRONTIUM-RUBIDIUM
`RADIOISOTOPE INFUSION SYSTEMS
`
`(71) Applicant: Bracco Diagnostics Inc., Monroe
`Township, NJ (US)
`
`(72)
`
`Inventors: Stephen E. Hidem, Edina, MN (US);
`Aaron M.Fontaine, Minneapolis, MN
`(US); Janet L. Gelbach, Schaumburg,
`IL (US); Patrick M. McDonald,
`Omaha, NE (US); Kathryn M. Hunter,
`Knoxville, TN (US); Rolf E. Swenson,
`Silver Spring, MD (US); Julius P.
`Zodda, Mercerville, NJ (US)
`
`(58) Field of Classification Search
`CPC .. A61M 5/007; A61M 5/1001; A61M 5/1002;
`A61M 5/1007;
`
`(Continued)
`
`(56)
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`
`CA
`CN
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`(*) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`This patent is subject to a terminal dis-
`claimer.
`
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`(22)
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`Filed:
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`Prior Publication Data
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`US 2017/0274138 Al
`
`Sep. 28, 2017
`
`Related U.S. Application Data
`
`(63) Continuation of application No. 15/389,200, filed on
`Dec. 22, 2016, now Pat. No. 9,750,869, which is a
`(Continued)
`
`(51)
`
`Int. Cl.
`AGIM 5/00
`AGIM 5/14
`
`(2006.01)
`(2006.01)
`(Continued)
`
`(52) U.S. Cl.
`CPC wees A6IM 5/007 (2013.01); A61B 6/037
`(2013.01); A6IB 6/107 (2013.01), A6IB 6/481
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`OTHER PUBLICATIONS
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`Alvarez-Diezetal. “Manufacture of strontium-82/rubidium-82 gen-
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`(Continued)
`
`Primary Examiner — Charles A Marmor, II
`Assistant Examiner — Carrie R Dorna
`
`(74) Attorney, Agent, or Firm — Fredrikson & Byron,
`PA.
`
`ABSTRACT
`(57)
`Methods for setting up, maintaining and operating a radio-
`pharmaceutical infusion system,that includes a radioisotope
`generator, are facilitated by a computer of the system. The
`computer may include pre-programmed instructions and a
`computer interface, for interaction with a user of the system,
`for example, in order to track contained volumes of eluant
`and/or eluate, and/or to track time from completion of an
`elution performed by the system, and/or to calculate one or
`more system and/or injection parameters for quality control,
`and/or to perform purges of the system, and/or to facilitate
`diagnostic imaging.
`
`(Continued)
`
`30 Claims, 27 Drawing Sheets
`
`
`
`JUBILANT EXHIBIT 1036
`Jubilant v. Bracco, IPR2018-01449
`
`JUBILANT EXHIBIT 1036
`Jubilant v. Bracco, IPR2018-01449
`
`
`
`US 9,814,826 B2
`
`Page 2
`
`PPPPPEEPSEEEPEPEEEEESPPEESPPEEEEEPSEPPEEEPPEPrPPEPEPPS
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`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2016.01)
`(2006.01)
`(2006.01)
`(2013.01)
`(2006.01)
`(2016.01)
`(2006.01)
`(2006.01)
`
`Int. Cl.
`A6IB 90/00
`AGIM 5/145
`G21F 3/00
`AGIM 5/158
`G21F 7/00
`AGIM 5/168
`G21G 1/00
`AGIB 6/00
`AGIB 6/03
`G21G 4/08
`AGIB 50/13
`AGIM 5/142
`A6IK 51/00
`GO6F 21/31
`AGIB 6/10
`A6IB 50/10
`AGIN 5/10
`B62B 3/00
`(52) U.S. Cl
`CPC veeceecceseee A6IB 6/507 (2013.01); A6IB 50/13
`(2016.02); A6IB 90/39 (2016.02); A6LK 51/00
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`(58) Field of Classification Search
`CPC A61M 5/1014—-5/1017; A61M 5/1027; A61M
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`See application file for complete search history.
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`
`
`U.S. Patent
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`Nov. 14, 2017
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`Sheet 1 of 27
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`1
`INTEGRATED STRONTIUM-RUBIDIUM
`RADIOISOTOPE INFUSION SYSTEMS
`
`US 9,814,826 B2
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`CROSS REFERENCE TO RELATED
`APPLICATIONS
`FIG. 1A isafirst perspective view of an infusion system,
`according to some embodiments of the present invention.
`This application is a continuation of U.S. patent applica-
`FIG. 1B is another perspective view of a portion of a
`tion Ser. No. 15/389,200, filed Dec. 22, 2016, which is a
`cabinet structure of the system shownin FIG. 1A, according
`continuation of U.S. patent application Ser. No. 12/808,467,
`to some embodiments.
`filed Jun. 16, 2010, now U.S. Pat. No. 9,607,722, issued
`Mar. 28, 2017, which is a 371 National Stage of Interna-
`tional Application No. PCT/US09/47031,
`filed Jun. 11,
`2009, which in turn is a continuation of the following four
`patent applications: U.S. patent application Ser. No. 12/137,
`356,filed Jun. 11, 2008, now U.S. Pat. No. 8,317,674, issued
`Nov. 27, 2012; U.S. patent application Ser. No. 12/137,363,
`filed Jun. 11, 2008, now U.S. Pat. No. 7,862,534, issued Jan.
`4, 2011; U.S. patent application Ser. No. 12/137,364, filed
`Jun. 11, 2008, now U.S. Pat. No. 9,597,053, issued Mar. 21,
`2017; and U.S. patent application Ser. No. 12/137,377, filed
`Jun. 11, 2008, now U.S. Pat. No. 8,708,352, issued Apr. 29,
`2014. The entire contents of all of these applications are
`incorporated herein by reference.
`
`2
`scale (unless so stated) and are intended for use in conjunc-
`tion with the explanationsin the following detailed descrip-
`tion. Embodiments of the present invention will hereinafter
`be described in conjunction with the appended drawings,
`wherein like numerals denote like elements.
`
`FIG. 1C is a second perspective view of the system shown
`in FIG. 1A, according to some embodiments.
`FIG. 1D is a schematic of an infusion circuit, according to
`some embodiments of the present invention.
`FIG. 1Eis a perspective view of exemplary sample vial
`shielding that may be employed in conjunction with the
`infusion system of FIG. 1A.
`FIG.2A is a perspective view of a shielding assembly for
`an infusion system, such as that shown in FIGS. 1A-C,
`according to some embodiments of the present invention.
`FIG. 2B is a perspective view of a framework of the
`system, according to some embodiments, and FIG. 2B-1 is
`an enlarged detailed view of a component of the system,
`according to some embodiments.
`FIG. 3A is another perspective view of the shielding
`assembly shown in FIG. 2A.
`FIG. 3B is a perspective view of the infusion circuit,
`shown in FIG. 1C, configured and routed, according to some
`embodiments.
`FIG. 3C is a perspective view of a disposable infusion
`circuit subassembly, according to some embodiments.
`FIG. 3D is a frame for the subassembly shownin FIG.3C,
`according to some embodiments.
`FIG. 4 is a main menu screen shot from an interface of a
`computer, which may be included in systemsof the present
`invention, according to some embodiments.
`FIG. 5A is a schematic showinga first group of successive
`screen shots from the computerinterface, according to some
`embodiments.
`FIG. 5B is a pair of screen shots from the computer
`interface, which provide indicationsrelated to eluant volume
`levels in a reservoir of the system, according to some
`embodiments.
`
`FIG. 5C is a schematic showing a second group of
`successive screen shots from the computer interface, accord-
`ing to some embodiments.
`FIG.6 is a schematic showing a third group of successive
`screen shots from the computerinterface, according to some
`embodiments.
`
`FIGS. 7A-C are schematics showing a fourth group of
`successive screen shots from the computer interface, accord-
`ing to some embodiments.
`FIGS. 8A-B are schematics showing a fifth group of
`successive screen shots from the computer interface, accord-
`ing to some embodiments.
`FIGS. 9A-C are schematics showing a sixth group of
`successive screen shots from the computer interface, accord-
`ing to some embodiments.
`FIG. 10 is a schematic showing a seventh group of
`successive screen shots from the computer interface, accord-
`ing to some embodiments.
`FIG. 11 is an exemplary report which may be generated
`by the computer included in infusion systems, according to
`some embodiments.
`FIGS. 12A-B are schematics of alternative infusion cir-
`cuits that may be employed by embodiments of the present
`invention.
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`TECHNICAL FIELD
`
`The present invention pertains to systems that generate
`and infuse radiopharmaceuticals, and, more particularly, to
`systems including computer-facilitated maintenance and/or
`operation.
`
`BACKGROUND
`
`for
`radioactive material
`Nuclear medicine employs
`therapy and diagnostic imaging. Positron emission tomog-
`raphy (PET)
`is one type of diagnostic imaging, which
`utilizes doses of radiopharmaceuticals, for example, gener-
`ated by elution within a radioisotope generator, that are
`injected, or infused into a patient. The infused dose of
`radiopharmaceuticalis absorbed by cells of a target organ, of
`the patient, and emits radiation, which is detected by a PET
`scanner, in order to generate an image of the organ. An
`example of a radioactive isotope, which may be used for
`PET, is Rubidium-82 (produced by the decay of Strontium-
`82); and an example of a radioisotope generator, which
`yields a saline solution of Rubidium-82, via elution, is the
`CardioGen-82® available from Bracco Diagnostics Inc.
`(Princeton, N.J.). A PET scanner in combination with
`infused doses of
`radiopharmaceuticals may also be
`employed to quantify blood flow rate, for example, through
`the coronary arteries of a patient.
`Set up, maintenance and operational procedures for infu-
`sion systems that both generate and inject doses of radiop-
`harmaceuticals are relatively involved in order to assure the
`safety and efficacy of each injected dose for the patient.
`Efficiency in carrying out these procedures is highly desir-
`able for technical personnel, who work with these systems
`on a routine basis and would like to avoid unnecessarily
`prolonged exposure to radioactive radiation. Thus there is a
`need for new system configurations that facilitate more
`efficient set up, maintenance and operation.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`The following drawings are illustrative of particular
`embodiments of the present invention and therefore do not
`limit the scope of the invention. The drawings are not to
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`US 9,814,826 B2
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`3
`FIG. 12C is a schematic illustrating exemplary activity
`profiles of injected doses of a radiopharmaceutical.
`
`DETAILED DESCRIPTION
`
`The following detailed description is exemplary in nature
`and is not
`intended to limit the scope, applicability, or
`configuration of the invention in any way. Rather,
`the
`following description provides practical
`illustrations for
`implementing exemplary embodiments. Utilizing the teach-
`ing provided herein, those skilled in the art will recognize
`that manyof the examples have suitable alternatives that can
`be utilized.
`FIG. 1A is a first perspective view of an infusion system
`10, according to some embodiments of the present inven-
`tion, wherein system 10 is shown supported by a cabinet
`structure, which includes a platform 113 (seen better in FIG.
`2B) and a shell 13; shell 13 extends upward from a skirt 11,
`that surrounds platform 113, to surround an interior space in
`which a portion of infusion system 10 is contained (seen in
`FIG. 1C). Shell 13 may be formed from panels of injection-
`molded polyurethane fitted together according to methods
`known to those skilled in the art. FIG. 1A illustrates the
`
`cabinet structure of system 10 including a grip or handle 14,
`which extends laterally from shell 13, in proximity to an
`upper surface 131 thereof, and a post 142, which extends
`upward from shell 13, and to which a work surface, or tray
`16 and a computer 17 are, preferably, attached, via an
`ergonomic, positionable mount. According to some embodi-
`ments, computer 17 is coupled to a controller of system 10,
`which is mounted within the interior space surrounded by
`shell 13; and, a monitor 172 of computer 17 not only
`displays indications of system operation for a user of system
`10, but also serves as a device for user input (e.g. touch
`screen input). However, according to alternate embodi-
`ments, another type of user input device, known to those
`skilled in the art, may be employed by computer 17. Other
`types of user input devices may be included, for example, a
`keyboard, a series of control buttons or levers, a bar code
`reader (or other reader of encoded information), a scanner,
`a computer readable medium containing pertinent data, etc.
`The user input device may be mounted on the cabinet
`structure of system 10, as shown, or maybetethered thereto;
`alternatively the user input device may be remote from
`system 10, for example, located in a separate control room.
`According to some additional embodiments, another user
`input device, for example, in addition to a touch screen of
`computer 17, may be remote from system 10 and used to
`start and stop infusions, as well as to monitor system
`operation both during quality control infusions and during
`patient infusions. Operation of system 10, which is facili-
`tated by computer 17, will be described below, in conjunc-
`tion with FIGS. 4-9C.
`FIG. 1A further illustrates two pairs of wheels 121, 122,
`mounted to an underside of platform 113, to make system 10
`mobile; handle 14 is shown located at an elevation suitable
`for a person to grasp in order to maneuver system 10, from
`one location to another, upon pairs of wheels 121, 122.
`According to some preferred embodiments, one or both
`pairs of wheels 121, 122, are casters, allowing for rotation
`in a horizontal plane (swivel), in order to provide additional
`flexibility for maneuvering system 10 in relatively tight
`spaces.
`FIG.1B is a perspective view of a portion of system 10,
`on a side 111 of the cabinet structure, which is in proximity
`to wheels 121, 122. FIG. 1B illustrates a lever or pedal 125,
`whichis located for activation by a foot of the person, who
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`In a neutral
`grasps handle 14 to maneuver system 10.
`position, pedal 125 allows wheels 121, 122 to rotate, and,if
`embodied as casters, to swivel freely. Pedal 125 may be
`depressed to a first position which prevents a swiveling of
`wheels 121, 122, according to those embodiments in which
`wheels 121, 122 are casters, and may be further depressed to
`brake wheels 121, 122 from rolling and swiveling, upon
`reaching a desired location. According to some embodi-
`ments, braking may be designed to slow system 10, for
`example, when rolling down an incline, and, according to
`yet further embodiments, system 10 may include a motorto
`power movementthereof.
`FIG. 1B further illustrates: a rear access panel 174 ofshell
`13, for example, providing access to circuit boards of the
`aforementioned controller contained within the interior
`space that is surrounded by shell 13; an optional lock 184,
`to secure panel 174; a power jack 118, for connecting system
`10 to a power source; and a printer 117 for providing
`documentation of each patient infusion carried out by sys-
`tem 10, and of system quality control test results. In some
`embodiments, system