Automatically supplying a pressurizing unit of a medical injection
Contents
1. 65 4 valve may comprise spring biased spool valve but in other embodiments other types of valves including check valves may also be used Patient manifold sensor 114 can detect the manifold valve position and report this position to injector head 104 for safety purposes Device 100 also includes air detector 116 Tubing that runs from device 100 to an external catheter passes through air detector 116 which is capable of detecting air bubbles or air columns within the tubing If air detector 116 detects a mea sureable or otherwise significant amount of air within the tubing it is capable of generating an alarm signal for injector head 104 In such a case a warning or alarm message may be displayed to the operator on control panel 102 indicating that air has been detected In addition in one embodiment device 100 may automatically pause or terminate a fluid injection procedure if air detector 116 has detected air in the tubing such that the air is not delivered to the catheter Because device 100 may be used for many injections and patient procedures injection fluids may need to be continu ously replaced For example when the reservoir held by holder 110 becomes empty it may need to be manually replaced with a new full reservoir by the operator In addi tion the syringe in sleeve 108 may need to be supplied with injection fluid from time to time such that there is sufficient fluid within the syringe to perform injectio2. Air detectors 230A and 236A may comprise acoustic based optical based or other forms of air detectors If either or both of air detectors 230A and 236A detect a measurable amount of air in the input and or output tubing these detectors may propagate signals to injector head 201 of device 200 One or more processors of injector head 201 may process these received signals Injector head 201 may provide a warning message or alert to the operator via control panel 212 such that the operator may take appropriate action Injec tor head 201 may also in one embodiment automatically pause or terminate any injection of fluid from the syringe in sleeve 216A if air has been detected in the input and or output tubing by controlling operation of the motor actuator assem bly driving the syringe Pinch valve 232A controls a flow of fluid from input tubing into the syringe in sleeve 216A Injector head 201 controls the US 8 812 082 2 11 operation of pinch valve 232A When injector head 201 opens pinch valve 232A fluid may flow from the reservoir con nected to holder 202A and into the syringe When pinch valve 232A is closed no fluid flow is permitted within the input tubing For example when injector head 201 is supplying the syringe with fluid it may open pinch valve 232A to allow fluid flow in the input tubing but it may also close pinch valve 234A to prohibit any fluid flow in the output tubing The plunger within the syringe may be move
3. fluid from first fluid reservoir 132 Second fluid reservoir 138 may contain a second fluid such as saline An operator may hang second fluid reservoir 138 on hook 137 In some cases second fluid reservoir 138 may be a plastic reservoir such as a bag The fluid contained within second fluid reservoir 138 may be drawn through tubing 128 through operation of pump 106 FIG 1B also shows that a hand control device 136 is coupled to control panel 102 via a connector 134 In one embodiment hand control device 136 may be connected to another component of device 100 other than control panel 102 As shown in FIG 1B hand control device 136 is coupled to tubing cabling or wiring which connects hand control device 136 to connector 134 Connector 134 may then be connected to or disconnected from control panel 102 An operator may manipulate hand control device 136 to control injection of fluid from device 100 For example the operator may use hand control device 136 as a variable rate control device to variably control the rate of flow of fluid from device 100 e g flow of fluid out of pressurizing unit 130 In one embodiment hand control device 136 may comprise an elec trical device In one embodiment hand control device 136 may comprise a pneumatic device Tubing 128 is coupled to a pressure transducer 126 Pres sure transducer 126 is also coupled to output high pressure tubing 122 which may be connected to a patient line via connect
4. Control panel 212 is located on the top side of example device 200 The operator may interact with control panel 212 to program various injection procedure parameters and or protocols that may be used for injection procedures The operator may also use control panel to set up device 200 for use to begin pause resume or end a procedure or to view various injection related information such as flow rate vol ume pressure rise time procedure type fluid information and or patient information FIG 2A shows various user activated buttons on the side of control panel 212 However in one embodiment control panel 212 may include a touch activated screen one embodiment a separate larger control panel not shown may also be in communication with device 200 In this embodiment the larger control panel provides similar operator functionality to that provided by control panel 212 However the larger control panel may be mounted to a rail of a bed on which a patient is lying or may be mounted to other 0 30 35 40 45 50 55 8 devices separate from device 200 one embodiment the larger control panel looks similar to control panel 102 shown in FIG 1A Device 200 is a dual syringe device that includes two syringes contained within sleeves 216A and 216B Both syringes are capable of delivering medical fluid to a patient In one embodiment the syringe within sleeve 216A is capable of drawing in fluid fr
5. also be removed by an operator For example the operator may unscrew pivot pin 229 and remove it from front end assemblies 218A and 218B After pivot pin 229 has been removed doors 221A and 221B may also be removed from assemblies 218A and 218B For example the operator may choose to remove doors 221A and 221B if the operator wishes to clean or replace doors 221A and 221B FIG 2D is a perspective view of front end assemblies 218A and 218B shown in more detail according to one embodiment Although doors 221A and 221B are not shown in FIG 2D they are made of a transparent or semi transpar ent material such that the contents of assemblies 218A and 218B may be more clearly seen by an operator even when doors 221A and 221B are closed Front end assembly 218A includes a first air detector 230A a first pinch valve 232A a second pinch valve 234A and a second air detector 236A Input tubing from a reservoir on holder 202A runs through air detector 230A and pinch valve 232A and into a syringe in sleeve 216A via a first syringe port according to one embodiment Output tubing coupled to a second syringe port of the syringe in sleeve 216A runs through pinch valve 234A and air detector 236A and is then coupled an external patient line or kit such as the one shown in FIG 4 Air detector 230A is used to detect air bubbles or columns within the input tubing and air detector 236A is used to detect air bubbles or columns within the output tubing
6. from the syringe while connection port 404 may be coupled to tubing running through pump 106 In this embodiment tubing 417 may also be coupled to or run through air detector 116 of device 100 FIG 5 is a flow diagram of an example method that may be performed by device 100 FIG 1A or by device 200 FIG 2A according to one embodiment to initiate an automatic fluid replenishment operation The method includes acts 500 501 503 504 506 and 508 and also includes checkpoint 502 At 500 device 100 or device 200 may obtain user input For example a user or operator of device 100 may specify one or more parameters by interacting with control panel 102 A user may for instance arm or disarm device 100 provide one or more setup parameters or turn on off an auto supply mode Typically device 100 is capable of injecting fluid only when it is armed Device 100 may in one embodiment perform automatic fluid replenishment operations when the auto sup ply mode is turned on At 501 device 100 or device 200 may obtain operational state information for the device One or more processors of injector head 104 or injector head 201 may obtain this infor _ 0 20 40 45 55 16 mation The operational state information may include cur rent or prior state information along with current or prior operational information for device 100 or device 200 At 502 device 100 or device 200 may determine whether the opera tional stat
7. mode when neither syringe is being used to inject fluid For example device 200 may enter standby mode after a patient case has been finished and before the operator has entered parameters or otherwise con figured the device using panel 212 for a new case In one embodiment the examples shown in Table 1 are based upon an assumption that only one of the contrast media or diluent is injected at a time In some cases during an automatic fluid replenishment operation a user or operator may intervene by interacting with the control panel such as control panel 102 FIG 1A or control panel 212 For instance an operator may choose to terminate a fluid replenishment operation or may choose to modify one or more fluid supply parameters FIG 3 is a perspective diagram of an example syringe 301 that may be used within device 200 according to one embodi ment Syringe 301 may be loaded in either sleeve 216A or 216B If syringe 301 is loaded into sleeve 216A it may be coupled to a fluid reservoir connected to holder 202A FIG 2A and may further be coupled to a patient line FIG 4 Syringe 301 is a dual port syringe in the example of FIG 3 Input port 300 is coupled to input tubing 308 and output port 302 15 coupled to output tubing 304 Input tubing is coupled to 35 45 50 55 60 65 saline to syringe in sleeve 216B y contrast media to syringe in sleeve in more detail above while output tubing 304 may run through p
8. second port is used for output tubing that is opera tively coupled to an output patient line through assemblies 218A or 218B Front end assembly 218A is associated with sleeve 216A and front end assembly 218B is associated with sleeve 216B Output tubing from the syringe in sleeve 216A runs through assembly 218A and out to a patient line while output tubing from the syringe in sleeve 216B runs through assembly 218B and out to the patient line Each assembly 218A and 218B includes a door or cover which may be opened and closed by the operator For the example the operator may open the door when loading tubing and may be closed upon loading In one embodiment each door may be made of a transparent or translucent material such that the operator may see inside the contents of the assembly 218A or 218B even when the door is closed In one embodiment each front end assembly 218A and 218B includes air detectors and valve components not shown Air detectors are used to detect air bubbles or air columns within the fluid tubing that is used The valve com ponents are used to allow or restrict fluid flow through tubing For example when pinch valves are used the valves pinch fluid tubing to restrict fluid flow in one state but stay open to allow fluid flow in another state Various different forms of valves may be used within assemblies 218A and 218B In addition various different forms of air detectors e g ultra sonic optical may be
9. the first pressurizing unit after obtaining the additional operational state informa tion determine based on the additional operational state information that the device will no longer per mit the fluid replenishment operation for the first pres surizing unit upon determining that the fluid replenishment operation is no longer permitted automatically terminate with out any manual interaction the fluid replenishment operation for the first pressurizing unit and after terminating the fluid replenishment operation ini tiate the new injection procedure specified by the additional operational state information using the medical fluid of the first pressurizing unit 16 The medical fluid injection device of claim 15 further comprising at least one air detector that during operation of the device is coupled to the first pressurizing unit and at least one valve that during operation of the device is coupled to the first pressurizing unit 17 The medical fluid injection device of claim 15 further comprising a fluid reservoir holder that during operation of the device is coupled to the first pressurizing unit the fluid reser voir holder being configured to holda reservoir of medi cal fluid that is supplied to the first pressurizing unit 18 The medical fluid injection device of claim 15 wherein the first pressurizing unit comprises a syringe and wherein the medical fluid comprises at least one of a contrast medi
10. 08 Nayak etal 604 82 FOREIGN PATENT DOCUMENTS EP 1 847 284 Al 10 2007 WO 01 74421 Al 10 2001 WO 2006 044409 2 4 2006 WO WO 2007 033103 Al 3 2007 WO WO 2007 062315 A3 5 2007 OTHER PUBLICATIONS Communication from European associate regarding responding to the communication dated Jun 14 2011 under Rules 161 162 filed with the European Patent Office for European Patent Application No 09744569 6 2319 dated Dec 21 2011 20 pgs Continued Primary Examiner Tse Chen Assistant Examiner Hien Nguyen 74 Attorney Agent or Firm Shumaker amp Sieffert 57 ABSTRACT In general this disclosure relates to techniques for automati cally supplying a pressurizing unit e g syringe that is used with a powered medical fluid injection device with fluid An example method performed by the medical fluid injection device includes obtaining operational state information of the medical fluid injection device wherein the operational state information includes information other than a fluid delivery amount for a subsequent injection procedure The example method further includes using the operational state informa tion to determine whether the powered medical fluid injection device permits a fluid replenishment operation for the pres surizing unit If the fluid replenishment operation is permit ted the method further includes automatically supplying the pressurizing unit with an amount of med
11. 12 United States Patent Hajicek et al US008812082B2 10 Patent No US 8 812 082 B2 54 75 73 21 22 65 51 52 58 56 AUTOMATICALLY SUPPLYING A PRESSURIZING UNIT OF A MEDICAL INJECTION DEVICE WITH FLUID Inventors David Hajicek Minnetonka MN US Richard Oftedahl Jordan MN US Assignee ACIST Medical Systems Inc Eden Prairie MN US Notice Subject to any disclaimer the term of this patent is extended or adjusted under 35 U S C 154 b by 1413 days Appl No 12 261 713 Filed Oct 30 2008 Prior Publication Data US 2010 0113924 A1 May 6 2010 Int A6IM 5 00 2006 01 A61M 1 00 2006 01 A61M 5 36 2006 01 US A61M 5 36 2013 01 A61M 5 00 2013 01 A61M 1 00 2013 01 461 5 007 2013 01 600 432 604 123 Field of Classification Search 61 5 36 61 5 00 61 1 00 61 5 007 matuta au nai 600 432 See application file for complete search history References Cited U S PATENT DOCUMENTS 5 573 515 11 1996 Wilson et al 6 221 045 Bl 4 2001 Duchon et al 6 626 862 Bl 9 2003 Duchon et al 6 932 242 B2 8 2005 Gerlach et al 7 128 729 B2 10 2006 Duchon et al 45 Date of Patent Aug 19 2014 7 678 072 B2 3 2010 Weber 2003 0028145 1 2 2003 Duchonet al 604 151 2007 0100282 1 5 2007 Small etal 604 151 2008 0161757 1 7 20
12. 4 tubing 408 is coupled to check valve 412 and transducer 414 In one embodiment check valve 412 comprises a bi directional check valve Transducer 414 com prises a pressure transducer in one embodiment that is capable of measuring hemodynamic signals of a patient when patient line 400 is coupled a catheter that has been inserted into the patient Transducer connector 410 may be coupled to device 200 such as by way of port 224 FIG 2B When connected hemodynamic signals generated by transducer 414 may be processed by a processor within device 200 Output tubing 417 is coupled to stopcock 418 and to con nector 420 shown in FIG 4 Stopcock 418 may be manually manipulated by the operator to control fluid flow and may also be connected to other external devices such as a syringe Connector 420 is used to connect patient line 400 to an exter nal catheter that may deliver fluid to a patient In one embodi ment connector 420 comprises a Luer type connector one embodiment patient line 400 may also be used with device 100 shown in FIG 1A When used with device 100 transducer connector 410 is coupled to a mating port within device 100 not shown such that a processor of device 100 may process the hemodynamic signals Assembly 401 may also be coupled in device 100 in this embodiment Patient line 400 may be coupled to a manifold valve that is coupled to patient manifold sensor 114 such that connection port 402 may be coupled to tubing
13. FIG 1A is a perspective diagram of one embodiment of a powered medical fluid injection device that may be used to automatically supply a pressurizing unit with fluid FIG 1B is a perspective diagram of one embodiment of the powered medical fluid injection device of FIG 1A connected to various components including fluid reservoirs and tubing FIGS 2A 2D are various perspective diagrams of another embodiment of a powered medical fluid injection device that may beused to automatically supply one or more pressurizing units with fluid FIG 3 is a perspective diagram of an example syringe that may be used with a powered medical fluid injection device according to one embodiment FIG 4 is a perspective diagram of a patient line that may be used with a powered medical fluid injection device according to one embodiment FIG 5 is a flow diagram of a method that may be performed by a powered medical fluid injection device according to one embodiment FIG 6 is a conceptual diagram illustrating various opera tional states during which time a powered medical fluid injec tion device may initiate an automatic fluid replenishment operation for one or more pressurizing units DETAILED DESCRIPTION FIG 1A 15 a perspective diagram of one embodiment of a powered medical fluid injection device 100 that may be used to automatically supply a pressurizing unit contained within a sleeve 108 with medical fluid In the embodiment of FIG 1A the pressu
14. a fluid replenishment procedure of the syringe if the operational state of device 100 changes such that a replenish ment operation is no longer permitted For example if during a fluid replenishment cycle the operator wishes to initiate an injection of fluid from the syringe injector head 104 may terminate the fluid replenishment cycle and begin an injection procedure for injection of fluid from the syringe Additional examples and embodiments pertaining to automated fluid replenishment operations will be further described in more detail below 20 25 30 35 40 45 50 55 60 65 6 FIG 1B is a perspective diagram of one embodiment of the powered medical fluid injection device 100 of FIG 1A con nected to various components including fluid reservoirs and tubing For example FIG 1B shows a first fluid reservoir 132 and a second fluid reservoir 138 First fluid reservoir 132 contains a first fluid such as contrast media An operator may hang first fluid reservoir 132 on reservoir holder 110 In some cases first fluid reservoir 132 may be a glass reservoir while in other cases it may be a plastic reservoir The fluid con tained within first fluid reservoir 132 may be drawn through tubing and into a pressurizing unit 130 e g a syringe that has been inserted into sleeve 108 during operation During an automatic replenishment operation device 100 may auto matically supply pressurizing unit 130 with an amount of
15. anel of the powered medical fluid injection device wherein the additional operational state information specifies that the powered medical fluid injection device is to ini tiate a new injection procedure using the medical fluid of the first pressurizing unit after obtaining the additional operational state informa tion determine based on the additional operational state information that the powered medical fluid injection device will no longer permit the fluid replen ishment operation for the first pressurizing unit upon determining that the fluid replenishment operation is no longer permitted automatically terminating without any manual interaction the fluid replenish ment operation for the first pressurizing unit and after terminating the fluid replenishment operation ini tiating the new injection procedure specified by the additional operational state information using the medical fluid of the first pressurizing unit 2 The method of claim 1 wherein the first pressurizing unit comprises a syringe and wherein the medical fluid com prises at least one of a contrast medium and a diluent 3 The method of claim 1 further comprising using the operational state information to determine an amount of the medical fluid to be supplied to the first pressurizing unit 4 The method of claim 3 wherein using the operational state information to determine the amount of the medical fluid to be supplied to the first pressurizing
16. atent application No 2011 5347 15 1 page Oct 30 2012 Response to Examiner s Report dated May 10 2012 for correspond ing Australian patent application No 20093 14380 dated May 30 2013 16 pages Response to Examiner Report dated Jan 11 2013 for correspond ing Canadian application No 2 741 702 dated Jul 11 2013 Office Action with English Translation for corresponding Korean patent application No 10 2011 7011092 dated Mar 26 2013 6 pages cited by examiner US 8 812 082 B2 Sheet 1 of 10 Aug 19 2014 U S Patent U S Patent Aug 19 2014 Sheet 2 of 10 US 8 812 082 B2 FIG 1B U S Patent Aug 19 2014 Sheet 3 of 10 US 8 812 082 B2 lt N FIG 2A 208A 206 US 8 812 082 B2 Sheet 4 of 10 Aug 19 2014 U S Patent 92 Sls U S Patent Aug 19 2014 Sheet 5 of 10 US 8 812 082 B2 200 lt 220 218 x 218B 228 lt oan EN Bk D N lI N m lt w N N N N e lt lt N N j tk Q al N je E e Ee lt N N N U S Patent Aug 19 2014 Sheet 6 of 10 US 8 812 082 B2 218B 2308 m N N 236B FIG 2D 218A 236A U S Patent Aug 19 2014 Sheet 7 of 10 US 8 812 082 B2 e LIE 304 306 300 3 U S Patent Aug 19 2014 Sheet 8
17. be connected to connector 306 FIG 3 which 15 coupled to output tubing 304 for the syringe in sleeve 216A Patient line 400 is a disposable kit in one embodiment such that connectors 402 and 404 may be connected to and removed from tubing connectors such as connector 306 by US 8 812 082 2 15 the operator In one embodiment patient line 400 is single use disposable kit such that it is connected to device 200 for one patient use and then subsequently disconnected and dis carded Connector 402 is operatively coupled to tubing 406 and connector 404 is operatively coupled to tubing 408 In one embodiment connector 402 is coupled to the syringe in sleeve 216A which contains contrast media while connector 404 is coupled to the syringe in sleeve 216B which contains a diluent such as saline Thus in this embodiment contrast media is injected into tubing 406 of patient line 400 while diluent is injected into tubing 408 Tubing 406 and 408 are coupled to valve 416 which in one embodiment comprises an elastomeric type valve that allows fluid flow from only one of tubing 406 and 408 to output tubing 417 In one embodi ment valve 416 comprises a one way valve that allows fluid flow only in the direction towards output tubing 417 Guide rod 220 may help in some cases maintain the sterility of connectors 402 and 404 by aligning these connectors during insertion to prevent contact with non sterile items As is shown in FIG
18. ce 200 Similarly front end assembly 218B includes a first air detector 230B a first pinch valve 232B a second pinch valve 234B and a second air detector 236B Input tubing from a reservoir connected to holder 202B runs through air detector 230B and pinch valve 232B and into a first syringe port of the syringe in sleeve 216B Output tubing coupled to a second syringe port of the syringe runs through pinch valve 234B and air detector 236B and may then be coupled to a patient line The components within device 218B function similarly to those contained within device 218A as described above according to one embodiment one embodiment device 200 of FIGS 2A 2D is capable of initiating fluid replenishment cycles for the syringes in sleeves 216A and or 216B during different operational states of device 200 In this embodiment injector head 201 may obtain operational state information for the device such as for example the type of operational state information described with reference to FIGS 1A 1B Injector head 201 then is capable of using the operational state information to determine whether it will permit a fluid replenishment opera tion for one or both of the syringes If a fluid replenishment operation is permitted for one of these syringes injector head 201 then initiates a fluid replenishment operation with a deter mined amount of medical fluid The operational state infor mation includes information other than a fluid deliver
19. contrast media and a syringe that is used to inject the contrast media into the patient The contrast media injection device may be used during certain medical procedures such as an angiographic or computed tomography CT procedure Many medical fluid injection devices include one or more syringes to inject fluid A syringe has a chamber for holding the fluid and a plunger that is moveable within the chamber The fluid is typically drawn into the chamber from a fluid reservoir when the plunger is moved in a first direction The fluid is then expelled from the chamber and into the patient via a catheter when the plunger is moved in a second oppo site direction The fluid is delivered at a rate that may be determined by a speed of movement of the plunger During a given medical procedure a medical fluid injec tion device may need to deliver a determined amount of medical fluid If the pressurizing unit such as a syringe does not contain a sufficient amount of fluid for the procedure a clinician may need to interact with the device to initiate a fluid replenishment operation For example the clinician may push a button or otherwise interact with a graphical user interface GUI provided by the device to partially or com pletely fill the pressurizing unit In other cases the device may be capable of calculating or otherwise determining an amount of fluid remaining within the pressurizing unit and then supplying the pressurizing unit with
20. ctor 410 shown in FIG 4 may be connected to con nection port 224 The pressure transducer connector is opera tively coupled to a pressure transducer which measures patient hemodynamic signals on the patient line By connect ing a pressure transducer to connection port 224 device 200 is capable of utilizing and processing hemodynamic pressure signals of a patient that are detected in the patient line Device 200 also includes connection port 222 which may be connected to a hand control device not shown In one embodiment the hand control device is a disposable compo nent that may be used by the operator for a single patient procedure The hand control device may control the opera tion of one or both of syringes in sleeves 216A and 216B For example the operator may push a button or otherwise interact with the hand control device to cause a motor actuator assem bly to inject fluid from the syringe in sleeve 216A and may push another button or otherwise interact with the hand control device to cause a motor actuator assembly to inject fluid from the syringe in sleeve 216B Thus if the syringe in sleeve 216A contains contrast media and the syringe in sleeve 216B contains a diluent the operator may push one button on the hand control device to inject contrast into the patient line and may push another button to inject saline In one embodiment the hand control device contains variable rate functionality such that the harder the ope
21. d fluid replenishment operation In FIG 2A device 200 US 8 812 082 2 7 includes a first primary reservoir holder 202A a second pri mary reservoir holder 202B an electrical connection inter face 206 a first backup reservoir holder 208A a second backup reservoir holder 208B a control panel 212 a first syringe sleeve 216A a second syringe sleeve 216B a first front end assembly 218A a second front end assembly 218B and a patient connection guide rod 220 In the embodi ment of FIG 2A the pressurizing units that are used to deliver medical fluid are syringes that are contained within sleeves 216A and 216B Injector head 201 includes reservoir holder 202A reservoir holder 202B connection interface 206 res ervoir holder 208A reservoir holder 208B and control panel 212 Injector head 201 further includes one or more proces sors used to control and or monitor the components of injec tor head 201 and other components of device 200 Reservoir holder 202A is capable of holding a first reser voir of medical fluid while reservoir holder 202B is capable ofholding a second reservoir of medical fluid In one embodi ment reservoir holder 202A holds a reservoir of a first type of fluid such as contrast media while reservoir holder 202B holds a reservoir of a second different type of fluid such as a diluent e g saline Different forms of reservoirs e g bottles bags may be used with reservoir holders 202A and 202B Becaus
22. d in a first direction by the motor actuator assembly to supply fluid to the syringe When a fluid injection occurs the motor actuator assembly will move the plunger within the syringe in a sec ond opposite direction Injector head 201 may close pinch valve 232A during an injection procedure to prohibit fluid flow in the input tubing However injector head 201 may open pinch valve 234A to allow fluid flow in the output tubing during such a procedure In such fashion injector head 201 utilizes pinch valves 232A and 234A to control fluid flow in the input and output tubing during various operations e g replenishment and injection operations one embodiment pinch valves 232A and 234A sole noid based pinch valves In other embodiments other forms of pinch valves 232A and 234A may be used such as pneu matic based valves In one embodiment pinch valves 232A and 234A have default states in the closed position Thus when device 200 is neither supplying fluid into nor injecting fluid from the syringe in sleeve 216A both pinch valves 232A and 234A are closed Pinch valves 232A and 234A may then be opened by device 200 when energy is actively applied to pinch valves 232A and or 234A When no energy is applied to pinch valves 232A and or 234A they return to a default closed position Thus if there are any power failures to device 200 valves 232A and 234A will return to closed position This may help improve the safety of devi
23. e device 200 may be used to inject medical fluid over multiple patient procedures the reservoirs held by hold ers 202A and 202B may need to be replaced over time Typi cally an operator of device 200 manually replaces the reser voirs on holders 202A and 202B For operator convenience device 200 additionally includes backup holders 208A and 208B The operator may store backup fluid reservoirs on holders 208A and 208B When a reservoir on primary holder 202A or 202B runs empty and needs to be replaced operator may quickly and easily access a new fluid reservoir from one of backup holders 208A or 208B and attach to primary holder 202A or 202B Device 200 includes electrical connection interface 206 to directly or indirectly couple device 200 to an external medical device such as a medical imaging device Typically device 200 when used as a contrast media injection device works in conjunction with a medical imaging device For example device 200 may work in conjunction with a medical imaging device during an angiographic or CT procedure Connection interface 206 is used to directly or indirectly connect device 200 to such an imaging device In one embodiment device 200 may transmit injection and or control information to an external imaging device via interface 206 and may receive imaging and or control information from the external imag ing device via interface 206 as well FIG 2A shows that device 200 also includes control panel 212
24. e information permits a fluid replenishment opera tion for one or more pressurizing units For example device 100 may determine whether such information permits a fluid replenishment operation of the syringe in sleeve 108 while device 200 may determine whether such information permits a fluid replenishment operation of syringe in sleeve 216A and or 216B In many cases a fluid replenishment operation will be allowed if a given pressurizing unit is not currently being used to inject or purge any fluid Ifa fluid replenishment operation is not permitted such as for example when the pressurizing unit is actively injecting or purging fluid device 100 or 200 terminates if necessary any current fluid replenishment operation for the pressurizing unit at 503 For example if device 200 is currently in the midst of a fluid replenishment operation of the syringe in sleeve 216A but receives operational state information at 501 indicating that the operator wishes to proceed with an injec tion procedure using fluid from the syringe device 200 will terminate the fluid replenishment operation If however device 200 is not currently supplying the syringe in sleeve 216A with fluid no additional action may need to be taken by device 200 Device 100 or 200 may then again obtain addi tional new state information If however a fluid replenishment operation is permitted at checkpoint 502 device 100 or 200 uses the state information at 504 to determ
25. eve 216A or 216B with fluid it continually monitors the state of device 200 according to one embodiment If the state of device 200 changes injector head 201 may pause or abort a fluid replenishment operation that is taking place For example if device 200 is automatically supplying the syringe in sleeve 216A with fluid but detects that the operator now wants to initiate an injection procedure using fluid from this syringe injector head 201 will stop the fluid replenishment operation and initiate an injection operation During any of these operations injector head 201 may utilize one or more of its processors to perform certain operations In one embodiment a fluid replenishment operation may be permitted if at least a determined amount of time has elapsed since a prior injection of medical from one of the pressurizing units e g syringes in sleeve 216A or 216B For example when a syringe delivers fluid to a catheter in a patient a clinician may inject intermittent frequent puffs of contrast media from device 200 during placement of the catheter within the patient In this example it may sometimes be beneficial to avoid or prohibit replenishment operations in between these puff injections Thus a fluid replenish ment operation may in some cases only be permitted if a determined amount of time e g 30 seconds has elapsed since a prior injection or puff of contrast media In some cases a fluid reple
26. fluid ifit determines that this remaining amount is less than the amount that is required to perform an injection procedure for a patient SUMMARY In general this disclosure relates to techniques for auto matically supplying a pressurizing unit e g syringe that is used with a medical fluid injection device with medical fluid If the medical fluid injection device includes multiple pres surizing units the device may initiate an automatic fluid replenishment procedure for one or more of the pressurizing units during operation as will be described in more detail below By automatically supplying a pressurizing unit with fluid at identified times the device is capable of preventing the pressurizing unit from running empty during a medical procedure The device may be capable of initiating a fluid replenishment operation without having to know or calculate an amount of fluid required for an injection procedure As a result a user of the device such as a clinician may not need to interact with the device to initiate a fluid replenishment cycle In addition there may be fewer interruptions during a given medical procedure and there may be opportunities to perform greater number of procedures in a given period due to higher operational efficiency of the device 20 25 30 35 40 45 50 55 60 65 2 In one embodiment example method performed by a powered medical fluid injection device includes obta
27. he first pressurizing unit 30 The medical fluid injection device of claim 15 wherein the injector head is configured to permit the fluid replenish ment operation for the first pressurizing unit if a fluid volume in the first pressuring unit has decreased at least a determined amount since a prior fluid replenishment operation for the first pressurizing unit 20 22
28. he pressurizing unit can only have a value of Yes or No It is possible that some types of operational state information can have more than 2 values for a given opera tional state For example a three position switch may have any of three different state values and a valve having more than two possible positions may also have multiple different state values depending on the position of the valve The operational state information could thus be used to define a logic table e g a set of rules that determines for a given combination of operating states or conditions whether a fluid replenishment operation is permitted and may also automati cally initiate such a replenishment operation Each pressur izing unit e g syringe pump that is used within the device may have its own associated operational state information For example if injector head 104 uses operational state information to determine that device 100 is currently deliv ering fluid from pump 106 but not from the syringe contained in sleeve 108 injector head 104 may use this state information to determine that it is permitted to automatically supply the syringe with medical fluid if necessary provided that the auto fluid supply mode parameter is set to That is if the syringe is not currently delivering fluid injector head 104 may cause the syringe to be supplied with fluid Ifthe syringe is currently full injector head 104 of course would not need to in
29. head 201 may cause the syringe to be completely filled to capacity Or injector head 201 may otherwise use operational state infor mation to determine an amount of fluid to use during the fluid replenishment operation Injector head 201 may determine whether the syringe in sleeve 216B is already full using a number of different approaches For example in one scenario injector head 201 may use operational state information to determine how much fluid remains in the syringe In another scenario injector head 201 may calculate an amount of remaining fluid based upon an amount of fluid that has been injected from the syringe in prior injection procedures which may also be obtained from operational state information of device 200 Operational state information includes current and past state information about device 200 including operational information injection parameters used error messages alert conditions and any other related information Using another example injector head 201 may also gather operational state information indicating that neither of the syringes in sleeves 216A or 216B is being used to inject fluid at a given time This may be the case when an operator is using control panel 212 to set up injection parameters for one or more subsequent procedures to be performed In this case injector head 201 may initiate a fluid replenishment operation for both of the syringes When injector head 201 is supplying the syringe in sle
30. iate a fluid replenishment operation for one or more pressurizing units FIG 6 shows example operational states 600 602 604 606 608 and 610 When obtaining any operational state information device 100 or device 200 may utilize one or more processors such as processors within injector head 104 or 201 to obtain infor mation related to one or more of these operational states For example operational state information may include informa tion about a current operational state for device 100 or 200 along with any other associated information The example states shown in FIG 6 provide examples of common opera tional states for device 100 or 200 US 8 812 082 2 17 In state 600 device 100 or 200 prepares or more fluid lines or pathways for injection For example in this state device 100 or 200 may purge fluid tubing that is used with contrast media or with diluents in anticipation of later per forming an injection procedure Ifa given pressurizing unit is not be used during a given preparation function it may be supplied with fluid For example if device 200 is preparing the fluid line for the output tubing coupled to the syringe in sleeve 216A during a purge cycle injector head 201 may automatically supply the syringe in sleeve 216B with fluid In state 602 the operator may start a new case for device 100 or 200 For example an operator may push a button or otherwise interact with control panel 102 device 100 or co
31. ical fluid If the device includes multiple pressurizing units the device may initiate an automatic fluid replenishment procedure for one or more of the pressurizing units during operation 30 Claims 10 Drawing Sheets US 8 812 082 B2 Page 2 56 References Cited OTHER PUBLICATIONS International Preliminary Report on Patentability for international application No PCT US2009 062384 dated Feb 7 2011 11 pp Office Action from Australian Application No 20093 14380 dated May 10 2012 2 pp Reply to Written Opinion filed with the IPEA EPO in corresponding PCT Application No PCT US2009 062384 on Aug 30 2010 11 pgs Notification of Transmittal of the International Search Report and the Written Opinion of the International Searching Authority or the Declaration from corresponding PCT Application No PCT US2009 062384 mailed Mar 19 2010 12 pages ACIST CVi Contrast Delivery System User Manual ACIST Medi cal Systems Inc Nov 2005 91 pages First Office Action with English Translation and Search Report for corresponding Chinese patent application No 200980144656 8 dated Nov 2 2012 12 pages Examination Report for corresponding Canadian patent application No 2 741 702 dated Jan 11 2013 2 pages Office Action from corresponding Korean Application No 10 2011 7011092 with translation dated Sep 26 2012 7 pp Examiner s Opinion stated in the Office Action for corresponding Japanese p
32. inch valve 234A and air detector 236A In one embodiment syringe 301 along with input tubing 308 con nector 310 output tubing 304 and connector 306 are dispos able multi use components That is these components may be used within device 200 over multiple uses or patient pro cedures before they are disconnected from device 200 and disposed of In another embodiment these components are disposable single use components meaning that they are disposed of after a single patient procedure In one embodiment syringe 301 may also be used in device 100 FIG 1A When used in device 100 connector 310 would be connected to a fluid reservoir on holder 110 and output tubing 304 would run through patient manifold sensor 114 FIG 4 is a perspective diagram of a patient line 400 that may be used with injection device 200 shown in FIGS 2A 2C according to one embodiment Patient line 400 includes an assembly 401 a valve 416 a stopcock 418 anda connector 420 Patient line 400 is used to couple device 200 witha catheter that is used to deliver medical fluid to a patient Assembly 401 includes a first connector 402 and a second connector 404 When assembly 401 is coupled to device 200 connector 402 is connected with a connector for output tubing that is coupled to one of the syringes in sleeves 216A or 216B while connector 404 is connected with a connector for output tubing that is coupled to the other syringe For example connector 402 may
33. ine an amount of fluid replenishment amount to be supplied to the pressurizing unit For example one or more processors of injector head 104 or injector head 201 may determine whether the pressurizing unit such as the syringe in sleeve 216A and or 216B is already full by using the state information If it is full the determined amount would be zero If it is not full device 100 or 200 may deter mine or calculate the amount based upon how much fluid has been injected from the pressurizing unit or how much fluid is currently contained within the pressurizing unit At 506 device 100 or 200 supplies the pressurizing unit with the determined supply amount of fluid Device 100 or 200 activates the motor actuator assembly coupled to the pressurizing unit to initiate the fluid replenishment operation 508 the operational state of device 100 or 200 changes thereby causing the device to repeat the method by obtaining new operational state information at 501 and again determin ing if a fluid replenishment operation is permitted at check point 502 If for example device 100 or 200 had begun a replenishment operation but new operational state informa tion indicated that the pressurizing unit was now to beused for an injection device 100 or 200 would end the fluid replen ishment operation at 503 FIG 6 is a conceptual diagram illustrating various opera tional states during which time device 100 FIG 1A or device 200 FIG 2A may init
34. ining operational state information of the medical fluid injection device wherein the operational state information includes information other than a fluid delivery amount for subse quent injection procedure The example method further includes using the operational state information to determine whether the powered medical fluid injection device will per mit a fluid replenishment operation for a first pressurizing unit If the fluid replenishment operation is permitted the method further includes automatically supplying the first pressurizing unit with an amount of medical fluid In one embodiment an example medical fluid injection device includes a first pressurizing unit and an injector head that is configured to obtain operational state information of the device and use the operational state information to deter mine whether a fluid replenishment operation is permitted for the first pressurizing unit the operational state information including information other than a fluid delivery amount for a subsequent injection procedure If the fluid replenishment operation is permitted the medical fluid injection device sup plies the first pressurizing unit with an amount of medical fluid The details of one or more embodiments are set forth in the accompanying drawings and the description below Other features objects and advantages will be apparent from the description and drawings and from the claims BRIEF DESCRIPTION OF DRAWINGS
35. is moved in a second opposite direction fluid is expelled out of the syringe into the output tubing In one embodiment the syringe is a dual port syringe such that the input tubing is coupled to one port of the syringe and the output tubing is coupled to another port of the syringe FIG 3 shows an example of such a dual port syringe which will be described in more detail below Patient manifold sensor 114 is coupled to a manifold valve not shown according to one embodiment This manifold valve controls flow of fluid from tubing coupled to either the syringe in sleeve 108 or pump 106 In one embodiment the manifold valve is coupled to output tubing from the syringe and also to tubing that runs through pump 106 Tubing also is coupled between the manifold valve and air detector 116 After passing through air detector 116 the tubing is then coupled to a patient line or catheter not shown such that fluid can ultimately be delivered from device 100 to a patient The manifold valve held by the patient manifold sensor 114 is capable of controlling the flow of fluid from the syringe and pump 106 to an external catheter In one embodiment the manifold valve has a first position that allows only fluid from the syringe to be delivered to the catheter The manifold valve has a second position that allows only fluid from pump 106 to be delivered to the catheter In one embodiment the manifold 20 25 30 35 40 45 50 55 60
36. itiate a fluid replenishment procedure But if the syringe is not full injector head 104 may actuate a motor actuator assembly coupled to the syringe to supply the syringe with a determined amount of fluid In one scenario injector head 104 may decide to completely fill the syringe to capacity Thus if the syringe is a 100 milliliter ml syringe and is currently half full of medical fluid injector head 104 may fill syringe to a full 100 ml capacity In one scenario injector head 104 may only partially fill the syringe with fluid In one embodiment a known or determined amount of fluid may be supplied to the syringe during a replenishment operation In one embodiment device 100 may cause replen ishment of the syringe when the amount remaining in the syringe is below the maximum amount of fluid to be delivered during an injection procedure by a threshold amount e g to limit excessive fluid replenishment operations In one embodiment replenishing of the syringe with fluid may occur when the amount of fluid remaining in the syringe is less than a certain level or less than a specified amount of remaining fluid e g when the amount remaining in the syringe is less than a determined percentage of the capacity of the syringe or less than a determined percentage of the maximum amount User selectable parameters may be used to specify threshold amounts or determined percentages one embodiment device 100 may dynamically termi nate
37. izing unit and an injector head comprising one or more processors wherein the injector head is configured to obtain opera tional state information of the device and use the opera tional state information to determine whether an auto matic fluid replenishment operation is permitted for at least one of the first pressurizing unit and the second pressurizing unit the operational state information including information other than a fluid delivery amount for a subsequent injection procedure to describe an operating state or condition of the device wherein if the fluid replenishment operation is permitted for the first pressurizing unit the injector head is further configured to initiate the fluid replenishment operation in order to automatically supply the first pressurizing unit with medical fluid without any manual interaction by a user with the powered medical fluid injection device after initiation of the fluid replenishment operation and while the first pressurizing unit is being supplied with the medical fluid obtain additional operational state information that is generated based on a manual inter action by the user with a control panel of the powered medical fluid injection device wherein the additional operational state information specifies that the pow 20 25 30 35 40 45 50 55 60 65 20 ered medical fluid injection device is to initiate a new injection procedure using the medical fluid of
38. ng that the fluid replenishment operation is permitted for the first pressurizing unit 11 The method of claim 1 wherein automatically supply ing the first pressurizing unit with the amount of medical fluid comprises supplying the first pressurizing unit with the medi cal fluid if the first pressurizing unit contains less than a specified amount of remaining fluid 12 The method of claim 11 wherein the specified amount of remaining fluid comprises a threshold amount that is speci fied by a user selectable parameter 13 The method of claim 1 wherein using the operational state information to determine whether the powered medical fluid injection device permits the fluid replenishment opera tion for the first pressurizing unit comprises permitting the fluid replenishment operation if at least a determined amount of time has elapsed since a prior injection of medical fluid from the first pressurizing unit 14 The method of claim 1 wherein using the operational state information to determine whether the powered medical fluid injection device permits the fluid replenishment opera tion for the first pressurizing unit comprises permitting the fluid replenishment operation if a fluid volume in the first pressuring unit has decreased at least a determined amount since a prior fluid replenishment operation for the first pres surizing unit 15 A powered medical fluid injection device comprising a first pressurizing unit a second pressur
39. nishment operation may be permitted if a US 8 812 082 2 13 fluid volume in the syringe has decreased at least a deter mined amount since a prior replenishment operation was performed Table 1 below shows examples of a number of different states of operation of device 200 during which one or more fluid replenishment operations of the syringes in sleeves 216A and 216B may be initiated From the examples shown in Table 1 itis assumed that the syringe in sleeve 216A is used for injecting contrast media and that the syringe in sleeve 216B is used for injecting saline which is a diluent Addi tional states and or operations to those listed may also be possible TABLE 1 FLUID REPLENISHMENT STATE OF INJECTION DEVICE 200 OPERATION Contrast media purge from syringe in sleeve Supp 216A Saline purge from syringe in sleeve 216B Supp 216A Contrast media injection from syringe in Supp sleeve 216A Saline injection or KVO cycle from syringe in sleeve 216B Injection parameter entry change by operator on control panel 212 Supp 216A Supp sleeve 216B Standby mode for device 200 Supp 14 a connector 310 which may be connected to a fluid reservoir in holder 202A assuming syringe 301 is loaded into sleeve 216A For example if connector 310 is a spike the spike may be inserted into a bottle of medical fluid connected to holder 202A Output tubing 304 is coupled to a connector 306 which couples output tubing 304 to a separa
40. ns for patient pro cedures When an operator detects that a fluid volume within the syringe has decreased or is low the operator may initiate a manual fluid replenishment procedure by touching a button on or otherwise interacting with control panel 102 By doing so the operator may manually supply the syringe with fluid contained in the reservoir either partially or completely In addition device 100 is capable of automatically supply ing the syringe in certain situations with a determined amount of medical fluid In one such situation device 100 may determine a maximum amount of fluid that is to be delivered during an injection procedure For example device 100 may determine this amount based upon volume informa tion input by the operator using control panel 102 Device 100 may further determine an amount of fluid remaining in the syringe such as by making a calculation of remaining fluid volume based upon amounts of fluid injected from the syringe If the amount remaining in the syringe is less than a maximum amount of fluid to be delivered during an injection procedure device 100 can cause injector head 104 to add fluid to the syringe In one embodiment injector head 104 of device 100 uti lizes operational state information for device 100 in deter mining whether or not a fluid replenishment operation is permitted for the syringe in sleeve 108 This operational state information may comprise many different types of state infor ma
41. ntrol panel 212 device 200 to start a new case this state pressurizing units are not typically activated or being used Thus in state 602 device 100 has the opportunity to supply the syringe in sleeve 108 with fluid while device 200 would has the opportunity to supply both syringes in sleeves 216A and 216B with fluid Similarly in state 604 device 100 may supply the syringe in sleeve 108 with fluid while device 200 may supply the syringes in sleeves 216A and 216B with fluid given that the operator is entering injection parameters Typically the operator will enter these parameters using control panel 102 device 100 or control panel 212 device 200 Once the case has begun and the parameters have been entered device 100 or 200 is ready to inject fluid In state 606 device 100 or 200 injects fluid using one or more pressurizing units Ifa given pressurizing unit is not be used to inject fluid it may potentially be supplied with fluid during a replenishment operation Thus for device 100 if fluid is being delivered only through pump 106 for example device 100 may supply the syringe in sleeve 108 with fluid assuming it is not already filled to capacity In device 200 if a syringe in sleeve 216A is being used to deliver fluid for example device 200 may supply syringe in sleeve 216B with fluid assuming it is not already filled to capacity In some cases an injection may be initiated manually be a user In these cases the
42. of 10 US 8 812 082 B2 400 FIG 4 N U S Patent Aug 19 2014 Sheet 9 of 10 US 8 812 082 B2 RECEIVE USER INPUT 503 OBTAIN OPERATIONAL STATE INFORMATION BY A PROCESSOR IF NECESSARY TERMINATE CURRENT REPLENISHMENT OPERATION FOR PRESSURIZING UNIT DOES OPERATIONAL STATE INFORMATIO PERMIT REPLENISHMENT OF PRESSURIZING UNIT USE STATE INFORMATION TO DETERMINE FLUID REPLENISHMENT AMOUNT BY THE PROCESSOR SUPPLY PRESSURIZING UNIT WITH DETERMINED FLUID AMOUNT INJECTOR OPERATIONAL STATE CHANGES FIG 5 US 8 812 082 B2 Sheet 10 of 10 Aug 19 2014 U S Patent 019 359 809 33ON YO 39119 909 01073 LOAPNI 95913 709 53313411 NOILOSPNI 09 3579 MAN LYVLS 009 NOILOAPNI S ANIT 01073 US 8 812 082 2 1 AUTOMATICALLY SUPPLYING PRESSURIZING UNIT OF A MEDICAL INJECTION DEVICE WITH FLUID TECHNICAL FIELD This disclosure generally relates to the use of pressurizing units such as syringes within powered medical fluid injec tion devices BACKGROUND Medical fluid injection devices are typically used to inject medical fluid into a patient These devices often include one or more reservoirs to hold the medical fluid and one or more pressurizing units to inject the medical fluid into the patient For example a contrast media powered injection device may include a reservoir containing
43. om a fluid reservoir coupled to holder 202A and the syringe within sleeve 216B is capable of drawing in fluid from a fluid reservoir coupled to holder 202B For example these syringes may draw in fluid during a fluid replenishment operation Each syringe is coupled to a motor actuator assembly not shown that drives a plunger in one of two directions During a fluid replenishment cycle for example a motor actuator assembly of device 200 may drive a plunger within the syringe in sleeve 216A in one direction to draw fluid from a reservoir coupled to holder 202A into the syringe During an injection cycle the motor actuator assem bly of device 200 may drive the plunger within this syringe in the opposite direction to expel fluid In one embodiment device 200 contains two distinct motor actuator assemblies such that one assembly drives the syringe within sleeve 216A while another drives the syringe within sleeve 216B These motor actuator assemblies are part of injector head 201 and may individually be controlled or monitored by the one or more processors included within injector head 201 Fluid input tubing couples the syringes within sleeves 216A and 216B to the fluid reservoirs and to output lines according to one embodiment In one embodiment the syringes each are dual port syringes such as the dual port syringe shown in FIG 3 In this embodiment one syringe port is used for input tubing that is coupled to a fluid reservoir while the
44. or 120 When high pressure tubing 122 is connected to a patient line within a patient pressure transducer 126 is capable of functioning as a hemodynamic monitor for the patient Pressure transducer 126 converts detected pressures into electrical signals that may be monitored or otherwise used by device 100 or another monitoring device High pres sure tubing 122 also runs through air detector 116 Air detec tor 116 is capable of detecting the presence of air e g air bubbles or columns within fluid that may be flowing through high pressure tubing 122 FIG 1B also shows a manifold valve 124 This manifold valve 124 is connected to high pressure tubing 122 as well as patient manifold sensor 114 Manifold valve 124 is capable of controlling a flow of fluid from pressurizing unit 130 and or through pump 106 to high pressure tubing 122 For example in one embodiment when manifold valve 124 is in a first position fluid may flow from pressurizing unit 130 to high pressure tubing 122 When manifold valve 124 however is in a second position fluid may flow through pump 106 via tubing 128 to high pressure tubing 122 In one embodiment manifold valve 124 may allow fluid flow to high pressure tubing 122 from only one of pressurizing unit 130 or pump 106 at a time FIG 2A is a perspective diagram of another embodiment of a powered injection device 200 that may be used to perform various functions and when operable may initiate an auto mate
45. rator pushes on 20 25 30 35 40 45 50 55 60 65 10 a button actuates a component the greater the flow rate of injected fluid from the syringe in sleeve 216A or 216B FIG 2C is another perspective diagram of device 200 FIG 2C shows a top view of device 200 according to one embodi ment FIG 2C also shows doors 221A and 221B on front end assemblies 218A and 218B respectively As noted above in one embodiment each of assemblies 218A and 218B include a moveable door 221A and 221B respectively Door 221A covers assembly 218A and door 221B covers assembly 218B In the embodiment of FIG 2C doors 221A and 221B are made ofa transparent or semi transparent material such that an operator may see the contents of assemblies 218A and 218B which are shown in more detail in FIG 2D Door 221A includes a handle 219A and door 221B includes a handle 219B The operator may utilize handles 219A and 219B to open and close doors 221A and 221B respectively Doors 221A and 221B are coupled to one or more hinges 228 which allow doors 221A and 221B to be opened and closed Also shown in FIG 2C is a pivot pin 229 Pivot pin 229 is inserted through hinges 228 according to one embodiment to securely allow doors 221A and 221B to be freely opened and closed by an operator Doors 221A and 221B pivot about an axis that runs through pivot pin 229 In one embodiment pivot pin 229 is screwed into place Pivot pin 229 may
46. rizing unit within sleeve 108 is a syringe In other embodiments other forms of pressurizing units may be used including other types of positive displacement pumps Device 100 is in some embodiments used to inject medical fluid such as contrast media or saline into a patient during a medi cal procedure such as an angiographic or computed tomog raphy CT procedure Device 100 includes a control panel US 8 812 082 2 3 102 an injector head 104 sleeve 108 to hold a pressurizing unit a reservoir holder 110 a module 112 a patient manifold sensor 114 and an air detector 116 Injector head 104 includes a pump 106 and also includes one or more processors used to control and or monitor injector head 104 control panel 102 the pressurizing unit within sleeve 108 patient manifold sensor 114 and air detector 116 of device 100 Reservoir holder 110 is capable of holding a fluid reservoir that contains an amount of fluid to be drawn into the syringe during operation of device 100 For example reservoir holder 110 may hold a reservoir of contrast media or diluent A second reservoir holder not shown may hold a diluent e g saline for use in pump 106 FIG 3 shows an example of a syringe that may be used within sleeve 108 according to one embodiment Patient manifold sensor 114 may in some cases be connected to a patient manifold as will be described in reference to FIG 1B An operator of device 100 such as a clinician may
47. s have been described herein These and other embodiments are within the scope of the following claims 20 25 30 35 40 45 50 55 60 65 18 The invention claimed is 1 method comprising obtaining operational state information ofa powered medi cal fluid injection device that is operatively coupled to a first pressurizing unit and also to a second pressurizing unit the operational state information including infor mation other than a fluid delivery amount for a subse quent injection procedure to describe an operating state or condition of the powered medical fluid injection device using the operational state information to determine whether the powered medical fluid injection device per mits an automatic fluid replenishment operation for at least one of the first pressurizing unit and the second pressurizing unit and if the fluid replenishment operation is permitted for the first pressurizing unit the method further comprises initiating the fluid replenishment operation in order to automatically supply the first pressurizing unit with medical fluid without any manual interaction by a user with the powered medical fluid injection device after initiation of the fluid replenishment operation and while the first pressurizing unit is being supplied with the medical fluid obtaining additional operational state information that is generated based on a manual interaction by the user with a control p
48. te patient line In one embodiment connector 306 is a Luer type connector Fluid is drawn from the fluid reservoir into port 300 of syringe 301 via input tubing 308 Fluid is expelled from port 302 of syringe 301 into output tubing 304 Input tubing 308 may run through air detector 230A and pinch valve 232A FIG 2D of front end assembly 218A which was described saline to syringe in sleeve 216B y contrast media to syringe in sleeve y saline to syringe in sleeve 216B y contrast media to syringe in sleeve y contrast media to syringe in sleeve 216A and or supply saline to syringe in y contrast media to syringe in sleeve 216A and or supply saline to syringe in sleeve 216B Contrast media reservoir change by operator Supp such as by replacing reservoir on holder 202A Saline reservoir change by operator such as by replacing reservoir on holder 202B Supp 216A In the examples of Table 1 purge operations from the syringes in sleeves 216A and or 216B occur when device 200 is being primed or prepared for patient use Thus during purge operations device 200 is not yet connected to a patient Conversely during injection operations from the syringes fluids are injected into a patient Device 200 may also be used for or keep vessel open operations A opera tion occurs when small amounts of diluent are repeatedly or continuously injected Also in reference to Table 1 device 200 may be in standby
49. tion but may include information other than an amount or volume of fluid that is to be delivered from the syringe for a subsequent injection procedure That is injector head 104 of device 100 need not necessarily know how much fluid may need to be delivered from the syringe during an injection procedure in order to determine whether or not to initiate a fluid replenishment operation Instead injector head 104 may utilize other operational state information in order to make such a determination Operational state information may include information describing operating states or conditions of various portions of a fluid injection device such as device 100 Examples of operational state information may include but are not limited to information related to any combination of the following operational states 1 currently delivering injecting fluid from a pressurizing unit e g 41101600105 yes no 2 cur rently delivering fluid from a pump yes no 3 armed yes US 8 812 082 2 5 4 setup complete yes no 5 air present yes no 6 valve position e g spool valve set to a specified position positional value 7 pressurizing unit syringe full and 8 auto fluid supply mode on off As these examples illustrate operating state information may in some cases have a finite relatively small number of values associated with certain states For example the state of currently delivering inject ing fluid from t
50. ubing elements of the syringe in sleeve 216A or 216B An example patient line is shown in FIG 4 and will be discussed in more detail below In one embodiment a medical fluid injection device such as device 200 may include a plurality of pressurizing units including three or more pressurizing units Each of these pressurizing units may be included within a separate sleeve during operation In some cases multiple pressurizing units may contain the same type of fluid For example a first pressurizing unit may contain contrast media a second pres surizing unit may contain a diluent e g saline and a third pressurizing unit may contain contrast media In this sce nario the third pressurizing unit may comprise a backup or secondary source of contrast media In this example the first and third pressurizing units may both be coupled to common front end assembly such as a front end assembly similar to 218A or 218B FIG 2B is another perspective diagram of device 200 shown in FIG 2A In FIG 2B sleeves 216A and 216B along with front end assemblies 218A and 218B can be more clearly seen Although the doors of assemblies 218A and 218B are closed in the example of FIG 2B they are made of a semi transparent material such that the interior pinch valve and air detector components may be more clearly seen FIG 2B also shows connection ports 222 and 224 In one embodi ment a pressure transducer connector such as one coupled to conne
51. um and a diluent 19 The medical fluid injection device of claim 15 wherein the injector head further configured to use the operational state information to determine an amount of the medical fluid to be supplied to the first pressurizing unit 20 The medical fluid injection device of claim 19 wherein the injector head is configured to determine whether the first pressurizing unit is already filled to capacity when it uses the operational state information to determine the amount of the medical fluid to be supplied to the first pressurizing unit 21 The medical fluid injection device of claim 20 wherein the determined amount of the medical fluid is equal to zero when the first pressurizing unit is already filled to capacity 22 The medical fluid injection device of claim 15 wherein the injector head is configured to fill the first pressurizing unit to capacity when it supplies the first pressurizing unit with the medical fluid 23 The medical fluid injection device of claim 15 wherein the injector head is configured to partially fill the first pres surizing unit when it supplies the first pressurizing unit with the medical fluid 24 The medical fluid injection device of claim 15 wherein the injector head is configured to determine whether medical fluid is being delivered from the first pressurizing unit when the injector head uses the operational state information to determine whether the powered medical fluid injection device
52. unit comprises deter mining whether the first pressurizing unit is already filled to capacity 5 The method of claim 4 wherein the determined amount of medical fluid is equal to zero when the first pressurizing unit is already filled to capacity 6 The method of claim 1 wherein automatically supplying the first pressurizing unit with the amount of the medical fluid comprises filling the first pressurizing unit to capacity 7 The method of claim 1 wherein automatically supplying the first pressurizing unit with the amount of the medical fluid comprises partially filling the first pressurizing unit 8 The method of claim 1 wherein the fluid replenishment operation is no longer permitted for the first pressurizing unit US 8 812 082 2 19 if the additional operational state information indicates that the powered medical fluid injection device is delivering medi cal fluid from the first pressurizing unit 9 The method of claim 1 wherein using the operational state information to determine whether the powered medical fluid injection device per mits the fluid replenishment operation for the first pres surizing unit comprises determining whether the pow ered medical fluid injection device is delivering medical fluid from the second pressurizing unit 10 The method of claim 9 further comprising if the powered medical fluid injection device is currently delivering medical fluid from the second pressurizing unit determini
53. use control panel 102 to set up various parameters and or proto cols to be used for a given injection procedure For example the operator may interact with control panel 102 to enter injection parameters for flow rate maximum injection vol ume maximum injection pressure rise time or other param eters In one embodiment control panel 102 includes a touch screen panel Pump 106 is capable of pumping fluid In one embodiment pump 106 is a peristaltic pump In this embodiment tubing and a fluid reservoir not shown are coupled to and through pump 106 Pump 106 pumps fluid from the fluid reservoir through the tubing towards module 112 In the example of FIG 1A both pump 106 and the syringe contained within sleeve 108 are capable of delivering fluid from device 100 into acatheter Pump 106 is driven by a motor that is part of pump 106 and the plunger within the syringe is driven by a motor assembly including an actuator that is part of injector head 104 In one embodiment injector head 104 includes a pro cessor that drives the motor assembly In one embodiment reservoir holder 110 holds a fluid reservoir that is coupled to input fluid tubing This input fluid tubing is coupled to the syringe such that when the plunger within the syringe is moved in a first direction by the motor fluid is drawn from the reservoir into the syringe The syringe within sleeve 108 is further coupled to output tubing When the plunger within the syringe
54. used as well In one embodiment the input and output tubing that is coupled to the syringe in sleeve 216A runs through front end assembly 218A and the input and output tubing that is coupled to the syringe in sleeve 216B runs through front end assembly 218B In this embodiment each assembly 218A and 218B contains a first pinch valve and a first air detector coupled to the input tubing for the respective syringe and further contains a second pinch valve and a second air detec US 8 812 082 2 9 tor coupled to the output tubing the respective syringe These components are more clearly shown in FIG 2D and will be discussed in more detail below FIG 2A also shows a patient connection guide rod 220 The output tubing from syringes 216A and 216B run through front end assemblies 218A and 218B respectively and are then coupled to a patient line or kit not shown The patient line is a single use line according to one embodiment that is used for a single patient procedure Each patient line may be connected to and disconnected from the output tubing run ning through front end assemblies 218A and 218B The patient line is connected to the output tubing via connection guide rod 220 according to one embodiment The patient line may slide over connection guide rod 220 in order to become coupled with the output tubing In one embodiment the patient line includes two tubing elements each element cor responding to one of the output t
55. user may manipulate a hand controller such as hand controller 136 shown in FIG 1B to initiate an injec tion In some cases the injection may be initiated by an external system such as an external X ray system that is coupled to device 200 During a case the operator may choose to change one or more injection parameters In state 608 the operator interacts with control panel 102 device 100 or control panel 212 device 200 to make such a change Typically no injections occur when the operator makes changes to injection param eters Thus in state 608 device 100 has the opportunity to supply the syringe in sleeve 108 with fluid and device 200 has the opportunity to supply the syringes in sleeves 216A and 216B with fluid When a procedure is complete the operator ends the case Typically the operator will interact with control panel 102 or control panel 212 to end the case In state 610 when the case has ended device 100 may take the opportunity to automati cally supply the syringe in sleeve 108 with fluid while device 200 may take the opportunity to automatically supply the syringes in sleeves 216A and 216B with fluid given that no injection of fluid is taking place Thus as can be seen in the conceptual diagram of FIG 6 there are multiple states during which device 100 or 200 has the opportunity to supply cor responding pressurizing units with fluid to improve or maxi mize the efficiency of these device Various embodiment
56. will permit the fluid replenishment operation for the first pressurizing unit 25 The medical fluid injection device of claim 15 wherein the injector head is configured to use the operational state information to determine whether the powered medical fluid injection device will permit the fluid replenishment operation for the first pressurizing unit by determining whether the medical fluid injection device is delivering medical fluid from the second pressurizing unit US 8 812 082 2 21 26 The medical fluid injection device of claim 25 wherein if the medical fluid injection device is currently injecting medical fluid from the second pressurizing unit the injector head is further configured to determine that the fluid replen ishment operation of the first pressurizing unit is permitted 27 The medical fluid injection device of claim 15 wherein the injector head is configured to supply the first pressurizing unit with the medical fluid if the first pressurizing unit con tains less than a specified amount of remaining fluid 28 The medical fluid injection device of claim 27 wherein the specified amount of remaining fluid comprises a threshold amount that is specified by a user selectable parameter 29 The medical fluid injection device of claim 15 wherein the injector head is configured to permit the fluid replenish ment operation if at least a determined amount of time has elapsed since a prior injection of medical fluid from t
57. y vol ume for a subsequent injection procedure according to one embodiment such that device 200 need not necessarily need to know an amount of fluid that is to be injected from the syringe in sleeve 216A or 216B for a patient injection proce dure in order to determine whether or not to allow and initiate a fluid replenishment operation This may provide a more effective and efficient way by which to supply the syringes with fluid 20 25 30 40 45 50 55 60 65 12 For example injector head 201 may obtain operational state information at a given point in time to determine that device 200 is injecting fluid from the syringe in sleeve 216A but is not injecting fluid from the syringe in sleeve 216B Given this operational state information injector head 201 may then be able to determine that it can supply the syringe in sleeve 216B with fluid if necessary given that this syringe is not currently being used to inject fluid Injector head 201 may first check to see if this syringe is already full such as by checking additional operational state information or by mak ing a calculation If the syringe is already full injector head 201 need not initiate a fluid replenishment operation since it determines that a supply amount would essentially be equal to zero If however the syringe is not full to capacity injector head 201 may supply the syringe in sleeve 216B with a determined amount of fluid For example injector
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