WO 2007/104133
`
`WE CLAIM:
`
`PCT/CA2007 /000295
`
`- 24 -
`
`1.
`
`A method of controlling an 82Sr/ 82Rb elution system
`
`having a generator valve for proportioning a flow of
`saline solution between an 82Sr/ 82Rb generator and a
`
`bypass line coupled to an outlet of the generator
`
`such that saline solution traversing the bypass line
`
`will merge with eluted saline solution emerging from
`
`the generator to provide an active saline solution,
`
`the method comprising steps of:
`
`during each elution run:
`
`obtaining a plurality of successive concentration
`
`parameter values at predetermined intervals,
`
`each concentration parameter value being
`
`indicative of
`
`a
`
`respective
`
`instantaneous
`
`activity concentration of the active saline
`
`solution;
`
`computing respective error values between each
`
`concentration parameter value and a
`
`target
`
`activity concentration value of the elution
`
`run; and
`
`accumulating error data based on a plurality of
`
`the computed error values; and
`
`between successive elution runs, adjusting at least
`
`one performance parameter of the elution system
`
`based on the accumulated error data.
`
`2.
`
`A method as claimed in claim 1, wherein the step of
`
`adjusting at least one performance parameter of the
`
`elution
`
`system
`
`comprises
`
`a
`
`step of
`
`tuning
`
`a
`
`performance model of the generator valve.
`
`2275 of 2568
`
`

`

`WO 2007/104133
`
`PCT/CA2007 /000295
`
`- 25
`
`3.
`
`A method as
`
`claimed
`
`in claim 2, wherein
`
`the
`
`accumulated error data comprises the computed error
`
`values as a function of an estimated flow ratio.
`
`4.
`
`A method as claimed in claim 3,
`
`wherein the step of
`
`tuning a performance model of
`
`the generator valve
`
`comprises steps of:
`
`calculating a slope of the error data; and
`
`adjusting a response slope parameter of the generator
`
`valve model based on the calculated slope of the
`
`error data.
`
`5.
`
`A method as claimed in claim 2, wherein the error
`
`data comprises one or more error values accumulated
`
`during
`
`a
`
`period
`
`in which
`
`a
`
`target
`
`activity
`
`concentration of an elution exceeds
`
`the predicted
`
`activity concentration of that elution.
`
`6.
`
`A method as claimed in claim 5,
`
`wherein the step of
`
`tuning a performance model of
`
`the generator valve
`
`comprises steps of:
`
`calculating a slope of the error data; and
`
`adjusting an upper limit parameter of the generator
`
`valve based on the calculated slope of the error
`
`data.
`
`7.
`
`A method as claimed
`
`in claim 6, wherein the step of
`
`adjusting the upper
`
`1 imi t parameter comprises steps
`
`of:
`
`if the calculated slope is zero,
`
`reducing the
`
`upper
`
`limit parameter by
`
`a predetermined
`
`increment; and
`
`2276 of 2568
`
`

`

`WO 2007/104133
`
`PCT /CA2007 /000295
`
`- 26 -
`
`otherwise, calculating an adjusted upper limit
`
`parameter value using the calculated slope.
`
`8.
`
`A method as claimed in claim 2, wherein the error
`
`data comprises
`
`a difference between
`
`a predicted
`
`elution duration required to achieve a desired total
`
`activity dose and an actual elution duration.
`
`9.
`
`A method as claimed in claim 8, wherein the step of
`
`tuning a performance model of the generator valve
`
`comprises a step of adjusting a hysteresis factor H
`
`based on the difference between the predicted and
`
`actual elution durations.
`
`10.
`
`A method as claimed in claim 1, further comprising a
`
`step of enforcing
`
`a predetermined delay between
`
`successive elution runs.
`
`11.
`
`A method as claimed in claim 1, further comprising
`
`steps of:
`
`defining
`
`a plurality of operating modes of
`
`the
`
`elution system; and
`
`during each elution run, automatically transitioning
`
`between selected ones of the operating modes, in
`
`accordance with user-input parameters of
`
`the
`
`elution run.
`
`12.
`
`A method as claimed
`
`in claim 11,
`
`wherein
`
`the
`
`plurality of operating modes comprise:
`
`a "Bypass-to-waste" mode in which the entire saline
`
`flow is directed through the bypass line and into
`
`a waste reservoir;
`
`2277 of 2568
`
`

`

`WO 2007/104133
`
`PCT /CA2007 /000295
`
`- 27 -
`
`a "patient line flush" mode in which the saline flow
`
`is directed
`
`through
`
`the bypass
`
`line and out
`
`through a patient outlet;
`
`a "waiting for threshold" mode in which the saline
`
`flow is directed through the generator, and the
`
`active saline solution directed into the waste
`
`reservoir; and
`
`an "elution" mode
`
`in which
`
`the saline
`
`flow
`
`is
`
`proportioned between the generator and the bypass
`
`line, and the active saline solution directed out
`
`through the patient outlet.
`
`13.
`
`A method as claimed in claim 11, wherein the user(cid:173)
`
`input parameters comprise:
`
`at least one of a desired duration of the elution,
`
`and a desired saline flow rate; and
`
`at
`
`least one of
`
`a
`
`target activity concentration
`
`profile, and a total eluted activity dose.
`
`14.
`
`A method as claimed in claim 1, further comprising
`
`steps of:
`
`defining a set of one or more predetermined elution
`
`runs, each having respective set of predetermined
`
`parameters; and
`
`executing the set of predetermined elution runs in
`
`accordance with a predetermined schedule.
`
`15.
`
`A method as claimed
`
`in claim 14, wherein
`
`the
`
`predetermined schedule defines a daily protocol.
`
`16.
`
`A method as claimed in claim 14, wherein the set of
`
`one or more predetermined elution runs comprises a
`
`2278 of 2568
`
`

`

`WO 2007/104133
`
`PCT /CA2007 /000295
`
`- 28 -
`
`calibration elution for calibrating any one or more
`
`of:
`
`a performance of the generator;
`
`a proportionality constant between the concentration
`
`parameter value and
`
`the
`
`instantaneous activity
`
`concentration of the active saline solution.
`
`17.
`
`A method as claimed
`
`in claim 16, wherein
`
`the
`
`calibrated performance of
`
`the generator comprises
`
`either one or both of:
`
`82Rb activity concentration vs. eluted volume; and
`
`82Sr breakthrough.
`
`18.
`
`A positron detector for detecting instantaneous 82Rb
`
`activity concentration of an active saline solution
`generated by an 82 Sr/ 82Rb elution system, the positron
`
`detector comprising:
`
`a scintillation fiber disposed adjacent a feed line
`
`for conveying the active saline solution;
`
`a
`
`photon
`
`counter operatively
`
`coupled
`
`to
`
`the
`
`scintillation
`
`fiber
`
`for
`
`detecting
`
`photons
`
`generated by positron annihilation within
`
`the
`
`scintillation fiber; and
`
`a
`
`radiation shield surrounding
`
`the scintillation
`
`fiber and at least a portion of the feed line,
`
`for shielding at least the scintillation fiber
`
`from spurious radiation.
`
`19.
`
`A positron detector as claimed in claim 18, wherein a
`
`thickness of the radiation shield is on the order of
`
`~ inch.
`
`2279 of 2568
`
`

`

`WO 2007/104133
`
`PCT /CA2007 /000295
`
`- 29 -
`
`20.
`
`A positron detector as claimed in claim 18, wherein
`
`the radiation shield surrounds a
`
`length of the feed
`
`line corresponding to at least five times an outer
`
`diameter or the feed line, in each direction from the
`
`scintillation fiber.
`
`2280 of 2568
`
`

`

`Q g
`~ Q
`~
`~
`""= ~
`
`Ul
`I.cl
`N
`Q
`Q
`
`:::i
`.....
`
`Q ... .....
`~ .....
`
`Q
`Q
`N
`0
`~
`
`(,;,I
`(,;,I
`
`T2
`
`T1
`
`...._ _____ _
`____ _
`
`,:
`... -_ ..................... ..
`
`A
`
`(Prior Art)
`Figure 2b
`
`AM~
`
`A
`
`(Prior Art)
`Figure 2a
`
`Outlet
`Patient
`
`10
`
`Gen
`
`82Sr/Rb
`
`8
`
`~2
`
`6
`
`4
`
`Supply
`Saline
`
`(Prior Art)
`Figure 1a
`
`2281 of 2568
`
`~..._
`

`

`Q g
`~ Q
`~
`~
`""= ~
`
`Ul
`I.cl
`N
`Q
`Q
`
`:::i
`N
`
`Q ... .....
`~ .....
`
`Q
`Q
`N
`0
`~
`
`(,;,I
`(,;,I
`
`Res.
`Waste
`
`26
`
`Outlet
`Patient
`
`10
`
`40
`
`24
`
`33
`
`detect
`
`e+
`
`20
`
`18
`
`8
`
`Gen
`
`..----22
`
`82Sr/Rb
`
`User Interface
`
`Controller
`
`D 44
`
`28
`
`6
`
`30
`
`14~
`
`4
`
`Supply
`Saline
`
`Figure 3
`
`2282 of 2568
`
`

`

`WO 2007/104133
`
`3/7
`
`PCT /CA2007 /000295
`
`0
`
`N \
`
`_J
`_J
`
`a:::
`w
`0 a:::
`I-z
`oo
`I- ()
`
`co
`
`(")
`
`LO
`())
`I....
`:J
`O>
`i.L
`
`a:::
`0
`I-
`<(
`a:::
`w
`z
`ow
`I- CJ
`
`Cl)
`Cl)
`<(
`CL
`>-
`CD
`
`t
`
`i
`
`~ a:::
`oo
`a::: I-
`LL <( a:::
`w
`z
`w
`CJ
`
`...
`
`Cl)
`Cl)
`<(
`
`CL >-CD
`
`co
`
`a:::
`w
`
`_J
`_J
`
`0
`a:::
`~ I-
`oz
`a::: 0
`LL ()
`
`2283 of 2568
`
`

`

`WO 2007/104133
`
`PCT/CA2007 /000295
`
`4/7
`
`Figure 6a
`
`4
`
`Saline
`Supply
`
`Figure 6b
`
`4
`
`Saline
`Supply
`
`Figure 6c
`
`4
`
`Saline
`Supply
`
`16
`
`22
`
`62Sr/Rb
`
`20
`
`e+
`
`8
`
`18
`
`22
`
`62Sr/Rb
`
`e+
`
`8
`
`18
`
`28
`
`Decision
`
`22
`
`62Sr/Rb
`Gen
`
`• •
`:
`8
`-------l~;---·
`
`e+
`
`~14
`
`24
`
`f 10
`40
`__ [ ___ ~Patient
`Outlet
`
`26
`
`Waste
`Res.
`
`~14
`
`Waste
`Res.
`
`~14
`
`20
`
`24
`
`40 r 10
`
`__ [ ___ -c> Patient
`Outlet
`
`[26
`
`Waste
`Res.
`
`2284 of 2568
`
`

`

`WO 2007/104133
`
`PCT/CA2007 /000295
`
`5/7
`
`Figure 6d
`
`Saline
`Supply
`
`4
`
`28
`
`Decision
`
`~42
`
`~14
`
`22
`
`20
`
`82Sr/Rb
`Gen
`
`8
`
`18
`
`e+ 1---411o-....c::::::1--"'"--...-~ Patient
`Outlet
`
`26
`
`Waste
`Res.
`
`2285 of 2568
`
`

`

`WO 2007/104133
`
`Figure ?a
`
`Compute
`CM
`
`617
`
`S2
`
`PCT/CA2007 /000295
`
`No
`change
`
`S8
`
`Yes
`
`Open
`Generator
`Valve
`
`No
`
`S12
`
`Yes
`
`Close
`Generator
`Valve
`
`Figure 7b
`
`cdet
`
`Figure 7c
`
`time
`
`2286 of 2568
`
`

`

`WO 2007/104133
`
`717
`
`PCT /CA2007 /000295
`
`Compute
`CM(t)
`
`Predict
`Flow Ratio,
`Duty Cycle
`
`Get Cdet
`
`S2
`
`S14
`
`S16
`
`S18
`
`Compute
`LlC=CM(t)-Cdet
`
`S22
`
`Yes
`
`Increase
`DutyCycle
`
`No
`
`S26
`
`Yes
`
`Decrease
`DutyCycle
`
`Figure 8a
`
`S28
`
`No
`change
`
`No
`
`Figure 8b
`
`cdet
`
`46
`
`CM-·-·-·- rc.(t)
`
`Figure 8c
`
`r46
`
`CM -
`
`-
`
`-
`
`- . -
`
`- . - - - - " - - - - - - - - - - -
`
`time
`
`time
`
`2287 of 2568
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`International application No.
`PCT JCA2007 /000295
`
`A
`
`CLASSIFICATION OF SUBJECT M"i.TTER
`IPC: A61M 36/06 (2006.01), A61M 36/08 (2006.01), GOIT 1/164 (2006.01), GOJT J/20 (2006.01)
`According to International Patent Classification (IPC) or to both national classification and IPC
`
`B. FIELDS SEARCHED
`Minimum documentation searched (classification system followed by classification symbols)
`IPC(8): A61M All (2006.01) + GOlT All (2006.01)
`
`Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched
`
`Electronic database(s) consulted during the international search (name of database(s) and, where practicable, search terms used)
`QPat, QWeb, Delphion (Keywords used: positron emission tomography, myocard* perfusion, radiation detector, scintillation fibre,
`generator, etc.)
`
`C. DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Category* Citation of document, with indication, where appropriate, of the relevant passages
`
`Relevant to claim No.
`
`A
`
`A
`
`A
`
`A
`
`A
`
`JP 2000131443 A (CHIBA, K. et al.) 12 May 2000 ( 12-05-2000)
`*Figs 1-6; Abstract; Machine translation*
`
`JP 7231884 A (OK.ADA, H. et al.) 5 September 1995 (05-09-1995)
`* Figs. I-7; Abstract *
`
`US 4975583 A (SPOWART, AR.) 4 December 1990 (04-12-1990)
`* Fig. 2; Abstract; Columns 2-3 *
`
`US 6713765 B2 (TESTARDI, LR.) 30 March 2004 (30-03-2004)
`* \Vhole document *
`
`AL V AREZ-DL"i.Z, Teresa M. et al., Manufacture of strontium-82/rubidium-82
`generators and quality control of rubidium-82 chloride for myocardial perfusion
`imaging in patients using positron emission tomography, Applied Radiation and
`Isotopes, vol. 50, no. 6, 1999, pp. 1015-1023
`
`18-20
`
`18-20
`
`18-20
`
`18-20
`
`1-17
`
`[X] Further documents are listed in the continuation of Box C.
`"'
`Special categories of cited documents
`"A"
`
`document defining the general state of the art which is not considered
`to be of particular relevance
`
`"E"
`
`"L ..
`
`"U'
`
`"P"
`
`earlier application or patent but published on or after the international
`filing date
`
`d9cument whi.ch may thro~ 4oubts on priority cla~m(::;) or which is
`c1te4 to estabhsh the P1:1bhcation date of anoL'1er c1tat10n or other
`specrn.1 reason (as specified)
`
`document referring to an oral disclosure, use. exhibi:ion or other means
`
`docun.:i-e~t pubhshe~ pri0r to the international filing date but later flan
`the pnonty date claimed
`
`[X] See patent family annex.
`
`''T"
`
`"X ..
`
`"Y ..
`
`later documept publi:s:hed. after the m~emational :0li~ date or priority
`~~ep;r,~~l~ 1~r ~h~J~\:J~rf~fnith~i~~,~~t?~! c1te
`to understand
`
`docu_11ent of particular relevance; the claime~ invention canno.t be
`considered novel or cannot be considered to mvolve an invenhve
`step when the document is taken alone
`
`docu_11ent of particular re!evance~ the claimed invention cannot be
`consic:lered to mvohre an mventive step when the docu.11ent is
`combmed with one or more other such documents, such combination
`being obvious to a person skilled in the art
`
`"& ..
`
`docu_"'Tient member of the same patent family
`
`Date of the actual completion of the international search
`
`Date of mailing of the international search report
`
`I 3 April 2007 (13-04-2007)
`
`Name and mailing address of the ISA/CA
`Canadian Intellectual Property Office
`Place du Portage I, C 114 - 1st Floor, Box PCT
`50 Victoria Street
`Gatineau, Quebec KIA OC9
`Facsimile No.: 001-819-953-2476
`
`Form PCT/ISA/210 (second sheet) (April 2005)
`
`18 May 2007 (18-05-2007)
`
`Authorized officer
`
`Valerie Dube 819- 934-4261
`
`Page 3 of5
`
`2288 of 2568
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`International application No.
`PCT /CA2007 /000295
`
`Box No. II
`
`Observations where certain claims were found unsearchable (Continuation of item 2 of the first sheet)
`
`This international search report has not been established in respect of certain claims under Article l 7(2)(a) for the following
`reasons :
`
`I.
`
`[
`
`] Claim Nos. :
`because they relate to subject matter not required to be searched by this Authority, namely :
`
`2
`
`[
`
`] Claim Nos. :
`because they relate to parts of the international application that do not comply with the prescribed requirements to such an extent
`that no meaningful international search can be carried out, specifically :
`
`3.
`
`[
`
`] Claim Nos. :
`because they are dependant claims and are not drafted in accordance \Vith the second and third sentences of Rule 6.4(a).
`
`Box No. III
`
`Observations where unity of invention is lacking (Continuation of item 3 of first sheet)
`
`This International Searching Authority found multiple inventions in this international application, as follows :
`
`•
`
`Claims 1-17 pertain to a method of controlling an 82Sr/82Rb elution system, the system comprising a generator valve, an
`82Sr/82Rb generator and a bypass line and providing an active saline solution, the method comprising: during each elution run,
`obtaining concentration values, computing error values between the obtained values and a target value, accumulating error data
`and adjusting a system parameter accordingly.
`Claims 18-20 pertain to a positron detector for detecting 82Rb activity concentration of an active saline solution generated by an
`82Sr/82Rb elution system, the detector comprising a scintillation fibre adjacent a feed line, a photon counter and a radiation
`shield.
`The common feature between aforesaid groups of claims is an 82Sr/82Rb elution system generating an active saline solution. However,
`such a system is already well known in the art and therefore cannot be regarded as constituting a single common inventive feature linking
`
`•
`
`l.
`
`[
`
`] As all required additional search fees were timely paid by the applicant, this international search report covers all
`searchable claims.
`
`2.
`
`[ X] As all searchable claims could be searched without effort justifying additional fees, this Authority did not invite
`payment of additional fees.
`
`3.
`
`[
`
`] As only some of the required additional search fees were timely paid by the applicant, this international search report
`covers only those claims for which fees were paid, specifically claim Nos
`
`4.
`
`[
`
`] No required additional search fees were timely paid by the applicant Consequently, this international search report is
`
`restricted to the invention first mentioned in the claims; it is covered by claim Nos. ·
`
`Remark on Protest
`
`] The additional search fees were ac;:;ompanied by the applicant's protest and, where applicable,
`the payment of a protest fee.
`
`[
`
`] The additional search fees were accompanied by the applicant's protest but the applicable protest
`fee was not paid v.ithin the time limit specified in the invitation.
`
`] No protest accompanied the payment of additional search fees.
`[
`Forni PCT/ISA/210 (continuation of first sheet (2)) (April 2005)
`
`Page2 of 5
`
`2289 of 2568
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`International application No_
`PCT /CA2007 /000295
`
`C (Continuation). DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Category* Citation of document, v.'ith indication, where appropriate, of the relevant passages Relevant to claim No.
`
`A
`
`A
`
`A
`
`A
`
`YANO, Y, et al., A Precision Flow-Controlled Rb-82 Generator for Bolus
`or Constant-Infusion Studies of the Heart and Brain, The Journal of
`Nuclear Medicine, vol. 22, no. 11, 1981, pp. 1006-1010
`
`Y ANO, Y, Essentials of a Rubidium-82 Generator for Nuclear Medicine,
`International journal of radiation applications and instrumentation. Part
`A, Applied radiation and isotopes, vol. 38, no. 3, Great Britain, 1987, pp.
`205-211
`
`KENSETT, M. J. et al., Experience with a 82Sr/82Rb Generator for
`Clinical Use, International journal of radiation applications and
`instrumentation. Part A, Applied radiation and isotopes, vol. 38, no. 3,
`Great Britain, 1987, pp. 227-231
`
`1-17
`
`1-17
`
`1-17
`
`SAHA, G. et al., Use of the 82Sr/82Rb Generator in Clinical PET Studies, 1-17
`International journal of radiation applications and instrumentation. Part
`B, Nuclear medicine and biology, vol. 17, no. 8, Great Britain, 1990, pp.
`763-768
`
`FormPCT/ISA/210 (continuation of second sheet) (April 2005)
`
`Page 4 of5
`
`2290 of 2568
`
`

`

`INTERNATIONAL SEARCH REPORT
`Information on patent family members
`
`International application No_
`PCT /CA2007 /000295
`
`Patent Document
`Cited in Search Report
`
`Publication
`Date
`
`Patent Family
`Member(s)
`
`Publication
`Date
`
`JP 2000131443 A
`
`12-05-2000
`
`JP 7231884 A
`
`05-09-1995
`
`CS 4975583 A
`
`04-12-1990
`
`NONE
`
`NONE
`
`AU1299288 A
`EP0346369 Al
`GB8704074 DO
`JP2502217 T
`W08806297 Al
`
`14-09-1988
`20-12-1989
`25-03-1987
`19-07-1990
`25-08-1988
`
`CS 6713765 B2
`
`30-03-2004
`
`NONE
`
`Form PCT/ISA/210 (patent family annex ) (April 2005)
`
`Page 5 of5
`
`2291 of 2568
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`

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`Electronic Acknowledgement Receipt
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`12137364
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`Title of Invention:
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`INFUSION SYSTEMS INCLUDING COMPUTER-FACILITATED MAINTENANCE
`AND/OR OPERATION AND METHODS OF USE
`
`First Named Inventor/Applicant Name:
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`Stephen E. Hidem
`
`Customer Number:
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`22859
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`Filer:
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`Elisabeth Lacy Belden
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`11-JUN-2008
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`2008140351
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`WO
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`2008-11-20
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`WO 2008/140351
`
`PCT/RU 2008/000211
`
`AUTOMATED STRONTIUM-RUBIDIUM INFUSION SYSTEM
`
`The invention relates to medical engineering, and particularly to means for automation
`
`of a process for producing a diagnostic solution from a radionuclide strontium-rubidium
`
`5
`
`generator and remote carrying out a checked infusion with automatic checking main process
`
`characteristics, such as an introduced activity value, presence of air bubbles as well as a
`
`solution weight and activity in a waste container.
`
`One of the most perspective directions m the nuclear diagnostics is the positron
`
`emission tomography (PET). Such short and ultra-short living isotopes as C-11, 0-15, N-13,
`
`10
`
`and F-18 are used in the PET centers. This obliges to have cyclotrons at the place of
`
`diagnostic for making such isotopes. It is possible to widen the functionality of the PET
`
`diagnostics in use of generator systems having a parent radionuclide lifetime significantly
`
`longer tha