MRI-GUIDED SURGICAL SYSTEMS WITH PROXIMITY ALERTS

• US 20100312095A1
• Filed: 06/08/2010
• Published: 12/09/2010
• Est. Priority Date: 06/08/2009
• Status: Active Grant

• Current Assignee: Clearpoint Neuro, Inc.
• Original Assignee: MRI Interventions, Inc. (Clearpoint Neuro, Inc.)
• Inventors: Guttman, Michael, Jenkins, Kimble L., Piferi, Peter
• Granted Patent: US 9,259,290 B2
• Time in Patent Office: Days
• US Class Current: 600/411
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00053 Mapping
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/1472 for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2034/101 Computer-aided simulation of surgical operations
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/252 indicating steps of a surgical procedure
• CPC Class Codes: A61B 2090/374 NMR or MRI
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: A61B 5/418 lymph vessels, ducts or nodes

Abstract

Systems to facilitate MRI-guided procedures are configured to generate proximity alerts for an MRI-guided procedure associated with at least one target site and/or at least one avoid zone.

Claims

1. A system to facilitate MRI-guided procedures, comprising:

a circuit; and

a display in communication with the circuit, the display having a User Interface (UI),

the circuit is configured to provide at least one volumetric planning map of relevant patient anatomy to the display, wherein the UI is configured to allow a user to select at least one target site and/or at least one avoid zone on the planning map, wherein the circuit is configured to define proximity alert locations for an MRI-guided procedure associated with the selected at least one target site and/or the selected at least one avoid zone, and wherein the circuit is configured to generate at least one audible and/or visual alert during the MRI-guided procedure when a tracked intrabody device is identified as approaching and/or being in one of the defined proximity alert locations.

2. The system of claim 1, wherein the circuit is configured to define proximity alert locations for the selected at least one target site and the selected at least one avoid zone, and wherein the circuit is configured to define boundary limits for the at least one target site for the proximity alerts.

3. The system of claim 1, wherein the at least one volumetric planning map comprises at least one map of the patient'"'"'s heart, and wherein the UI is configured to allow a user to use the at least one heart planning map to define a plurality of avoid zones for the proximity alerts for the MRI-guided procedure, including at least two of the following:

a portion of an esophagus adjacent a cardiac posterior wall, an aorta, a phernic nerve, and an atrioventricular (AV) node of the patient'"'"'s heart.

4. The system of claim 1, wherein the UI is configured to allow a user to select at least one intrabody target treatment site on the at least one planning map as the at least one target site to identify a respective proximity alert location, wherein the proximity alert for treatment sites is generated as a confirmation proximity alert when an intrabody device is determined to be within and/or approaching defined boundary limits of a respective treatment site and is generated as a warning proximity alert when the intrabody device is determined to be outside the defined boundary limits, and wherein the warning proximity alert has a different audible and/or visible signal than the confirmation proximity alert, and wherein the system is configured to track multiple intrabody device, each having a different audible and/or visible alert signal.

5. The system of claim 2, wherein the UI is configured to carry out at least one of the following:

(a) allow a user to select the boundary limits for the at least one selected site by marking locations on the planning map or by selecting dimensional spacing about a treatment site;

(b) provide defined boundary limits for the at least one selected target site based on pre-defined data regarding a medical device that will be used during the MRI guided procedure to carry out a therapy or a diagnostic procedure at the at least one selected target site;

or (c) provide default boundary limits that can be modified by a user for the at least one target site, wherein the default boundary limits can be defined based on known configuration data regarding the tracked intrabody medical device that will be used during the MRI guided procedure to deliver a therapy to the treatment site.

6. The system of claim 1, wherein the UI is configured to allow a user to select at least one intrabody avoid zone using an electronic list of suggested avoid zones for the MRI-guided procedure provided by the circuit, and wherein the circuit automatically electronically displays the selected at least one avoid zone on the planning map to define one or more of the proximity alert locations.

7. The system of claim 1, wherein the circuit is configured to register the at least one planning map to 3-D MRI imaging space prior to or during an MRI-guided procedure to electronically define locations of the at least one target site with associated boundary limits and the at least one avoid zone in the 3-D MRI imaging space, wherein the circuit automatically generates the proximity alerts when a distal end portion of the tracked medical device used during the MRI-guided procedure is determined to be outside defined boundary limits of a respective selected target site or proximate a selected avoid zone, and wherein location of the distal end of the medical device is based on tracking coil data from at least one tracking coil on the device and a known configuration of the device.

8. The system of claim 7, wherein the circuit is configured to generate warning proximity alerts when the distal end portion of the device is outside the boundary limits of a respective selected target site and also when the device is proximate a selected avoid zone.

9. The system of claim 7, wherein the circuit is configured to generate positive proximity alerts when the distal end portion of the device is within the boundary limits of a respective selected target site, and wherein the warning proximity alerts have a different audible signal than the positive proximity alerts.

10. The system of claim 1, wherein the circuit is configured to track a location of the tracked intrabody medical device using tracking coil signal data and generate proximity alerts during the MRI guided procedure when a distal end portion of the intrabody medical device is proximate or approaching one of the proximity alert locations, and wherein the proximity alert changes to indicate an increase or decrease in distance between the distal portion of the device and a respective target site and/or avoid zone.

11. The system of claim 1, wherein the circuit is configured to track a location of the tracked intrabody catheter using tracking coil signal data and generate proximity alerts during the MRI guided procedure when a distal end portion of the catheter is proximate or approaching one of the proximity alert locations, and wherein the circuit is configured to lock activation of an energy source or delivery on an injectable agent when a proximity alert is generated for an avoid zone and/or when the distal end portion of the catheter is determined to be outside boundary limits of a proximate target treatment site.

12. The system of claim 5, wherein the known configuration data of the medical device includes physical data regarding size, shape and position of at least one tracking coil on a distal end portion of the medical device, and wherein the at least one tracking coil is configured to connect to an MR Scanner channel.

13. An MRI-guided system, comprising:

a circuit adapted to communicate with and/or be integral with an MRI Scanner, the circuit configured to;

(a) identify at least one target intrabody treatment or diagnostic site of a patient and define boundary limits for the at least one site and/or identify at least one avoid zone of the patient;

(b) define proximity alert locations for the identified at least one treatment site and/or the at least one avoid zone; and

(c) generate at least one proximity alert during an MRI guided procedure,

wherein the at least one proximity alert is generated when a distal end portion of an intrabody device is electronically automatically determined to be at least one of the following;

inside or approaching the defined boundary limits of the at least one target intrabody site, outside or exiting the defined boundary limits of the at least one intrabody target site, or proximate the at least one avoid zone.

14. The system of claim 13, wherein the circuit is configured to provide at least one volumetric planning map of relevant patient anatomy, wherein the circuit is in communication with a display with a user interface that is configured to allow user input to define the at least one intrabody target treatment or diagnostic site using the planning map, and wherein the user interface is configured to carry out at least one of the following:

(a) allow a user to select boundary limits for the at least one selected site by marking locations on the planning map or by selecting desired dimensional tolerances for a selected treatment or diagnostic site;

(b) provide defined boundary limits for the at least one selected target site based on pre-defined data regarding a medical device that will be used during the MRI guided procedure;

or (c) provide defined boundary limits as default boundary limits that can be modified by a user for the at least one target site based on pre-defined data regarding a medical device that will be used during the MRI guided procedure to deliver a therapy to the treatment site.

15. The system of claim 13, wherein the circuit is configured to provide at least one volumetric planning map of relevant patient anatomy, wherein the circuit is in communication with a display with a user interface that is configured to allow user input to define the at least one avoid zone using the planning map.

16. The system of claim 13, wherein the circuit is configured to provide at least one patient volumetric planning map of relevant patient anatomy, wherein the circuit is in communication with a display with a user interface that is configured to allow user input to define the at least one intrabody target treatment or diagnostic site and the at least one avoid zone using the planning map,

wherein the circuit is configured to register the at least one patient planning map to 3-D MRI imaging space prior to the MRI guided procedure, wherein the at least one planning map includes the proximity alert locations for the at least one avoid zone and the at least one diagnostic or treatment site, and

wherein the circuit is configured to identify locations of the defined treatment sites and the at least one avoid zone in 3-D MRI imaging space based on the registered at least one planning map.

17. The system of claim 16, wherein the at least one planning map comprises at least one map of at least a portion of the patient'"'"'s heart, and wherein the at least one map is used to define a plurality of avoid zones, including at least two of the following:

a portion of an esophagus adjacent a cardiac posterior wall, an aorta, a phernic nerve, and an atrioventricular (AV) node of the patient'"'"'s heart.

18. The system of claim 13, wherein the circuit is configured to generate warning proximity alerts when the distal end portion of the device is determined to be outside the defined boundary limits of a respective target site or proximate an avoid zone.

19. The system of claim 13, wherein the circuit is configured to generate positive proximity alerts when the distal end portion of the device is determined to be within the defined boundary limits proximate a respective target site.

20. The system of claim 17, wherein the intrabody device is an ablation catheter or an injection catheter, and wherein the circuit is configured to lock activation of the ablation electrode on the ablation catheter or prohibit delivery of a therapeutic agent from the injection catheter when a proximity alert is generated for an avoid zone and/or when the distal end of the catheter is determined to be outside boundary limits of a proximate target treatment site.

21. The system of claim 13, wherein the circuit is configured to generate the proximity alert based on pre-defined data of the distal end portion of the medical device, including physical data regarding size, shape and position of at least one tracking coil on a distal end portion of the medical device, and wherein the at least one tracking coil is configured to connect to an MR Scanner channel.

22. An MRI guided cardiac EP system, comprising:

a clinician workstation; and

a display with a User Interface in communication with and/or integrated into the workstation, the display configured to display at least one volumetric model of at least a portion of a patient'"'"'s heart, wherein the User Interface is configured to allow a user to select target ablation sites on the at least one model on the display, and wherein the User Interface is configured to automatically define boundary limits for target ablation sites and/or allow a user to define associated boundary limits,

wherein the system is configured to automatically generate an audible proximity alert and/or a visual proximity alert on the display when a distal end portion of an ablation catheter is proximate to but at a position that is outside the defined boundary limits of a respective target ablation site.

23. The system of claim 22, wherein the User Interface is configured to allow a user to identify avoid zones on the at least one model, and wherein the system is also configured to generate proximity alerts when a distal end portion of the ablation catheter is proximate the identified avoid zone during an MRI-guided interventional procedure, and wherein the proximity alert can change in a visual and/or audible manner to indicate distance between the distal end of the catheter and the target ablation site.

24. The system of claim 23, wherein the system is configured to register the at least one model to 3-D MRI imaging space prior to or during an MRI-guided procedure to electronically define locations of the at least one ablation site, the associated boundary limits and the at least one avoid zone in the 3-D imaging space, and wherein the circuit automatically generates proximity alerts when a distal end portion of the ablation catheter used during the MRI-guided procedure is determined to be:

outside the boundary limits of a selected ablation site, inside the boundary limits of a selected ablation site, and proximate an avoid zone.

25. The system of claim 22, wherein the system has a circuit that is in communication with and/or integrated into the workstation and is configured to allow a user to generate a drag lesion pattern on the map and electronically define associated pre-set scan planes for the drag lesion pattern.

26. An MRI guided cardiac EP system, comprising:

a clinician workstation; and

a display with a User Interface in communication with or integrated into the workstation, the display configured to display at least one volumetric model of at least a portion of a patient'"'"'s heart, wherein the User Interface is configured to allow a user to select avoid zones on the at least one model on the display, and wherein the system is configured to automatically generate an audible and/or visual alert when a distal end portion of a therapeutic or diagnostic catheter is in a position that is proximate a selected avoid zone during an MRI-guided cardiac interventional procedure.

27. The system of claim 26, wherein the avoid zones include at least two of the following:

a portion of an esophagus adjacent a cardiac posterior wall, an aorta, a phernic nerve, and an atrioventricular (AV) node of the patient'"'"'s heart.

28. The system of claim 26, wherein the circuit is configured to allow a user to generate a drag lesion pattern on the map and electronically define associated pre-set scan planes for the drag lesion pattern.

29. A method for facilitating MRI-guided procedures, comprising:

providing at least one volumetric map of relevant anatomy of a patient;

identifying at least one avoid zone on the at least one volumetric map, the avoid zone associated with sensitive tissue that resides along a tortuous intrabody access path to a target treatment or diagnostic site or that resides proximate a target treatment or diagnostic site;

then

registering the volumetric map with the identified at least one avoid zone to 3-D MRI imaging space;

tracking location of a distal end portion of an intrabody medical device during an MRI guided procedure to determine a location of the device in the 3-D MRI imaging space; and

electronically generating a proximity alert when the distal end portion of the medical device is determined to be proximate the at least one identified avoid zone based on the tracking step.

30. A method according to claim 29, further comprising, before the registering step,

identifying at least one target site on the at least one volumetric map;

and

electronically associating boundary limits for the at least one identified site, and wherein, after the registering step, the method comprises,

electronically generating a confirmation proximity alert when the distal end portion of the medical device is determined to be proximate an identified site; and

electronically generating a warning proximity alert when the distal end portion of the medical device is determined to be outside associated boundary limits of a respective identified site,

wherein the confirmation proximity alert has a different visual indicator and/or different audible output than the warning proximity alert, and wherein the electronically generated proximity alert for the at least one identified avoid zone is a warning proximity alert.

31. A method for carrying out an MRI-guided therapy to treat cardiac disease or disorders, comprising:

displaying at least one volumetric model of at least a portion of a heart of a patient;

allowing a user to mark and/or select target treatment sites on the displayed model;

electronically defining boundary limits for the target treatment sites in response to the marking step;

then

electronically tracking location of a distal end portion of a therapeutic catheter in 3-D MRI imaging space; and

electronically generating an alert when the location of the distal end portion of the catheter is determined to be at least one of;

(i) approaching and/or within the defined boundary limits of a respective selected target treatment site; and

/or (ii) outside or exiting the defined boundary limits of a respective selected target treatment site during an MRI-guided therapy.

32. The method of claim 31, further comprising allowing a user to mark and/or select at least one avoid zone on the at least one volumetric model;

and

electronically generating an alert when the position of the distal end portion of the catheter is determined to be proximate the at least one avoid zone during the MRI-guided therapy.

33. The method of claim 31, further comprising registering the volumetric model to the 3-D imaging space before the monitoring and generating the alert steps.

34. A method according to claim 31, further comprising:

electronically associating preset scan planes for the selected target treatment sites using the at least one model; and

obtaining near real time MR image data using the preset scan planes during the MRI-guided procedure.

35. A method according to claim 31, wherein the step of allowing a user to mark a path on the map is carried out to allow a user to generate a drag catheter lesion formation pattern on the map.

36. A computer program product for facilitating an MRI-guided interventional procedure, the computer program product comprising:

a non-transitory computer readable storage medium having computer readable program code embodied in said medium, said computer-readable program code comprising;

computer readable program code that renders a volumetric map of at least a portion of a patient'"'"'s target anatomy;

computer readable program code that defines at least one avoid zone using the volumetric map;

computer readable program code that defines at least one target treatment site using the volumetric map;

computer readable program code that registers the map with the defined at least one avoid zone and at least one target treatment site in three dimensional MRI imaging space; and

and computer readable program code that generates a proximity alert when an intrabody device is proximate the at least one target treatment site and the at least one avoid zone.

37. The computer program product of claim 36, further comprising computer readable program code that accepts user input to identify the at least one defined target treatment site on the volumetric map and computer readable program code that defines boundary limits for a respective treatment site in response to a user'"'"'s identification of the selected at least one target treatment site.

38. The computer program product of claim 36, wherein the volumetric map comprises a map of a patient'"'"'s heart, and wherein the intrabody device is an ablation catheter or an injection catheter, each with tracking coils that connect to channels of an MRI Scanner, and wherein the computer readable program code that generates the proximity alert comprises computer readable program code that is able to calculate a shape and position of the distal end of the device based on known physical data of the intrabody device and tracking signal data from the tracking coils.

39. The computer program product of claim 38, further comprising computer readable program code that defines pre-set scan planes for the at least one avoid zone and/or the at least one target treatment site in response to a user'"'"'s identification of the at least one avoid zone and/or the at least one target treatment site on the map.

40. A computer program product according to claim 36, wherein the computer readable program code that identifies at least one treatment site comprises computer readable program code that a allows a user to use a GUI in communication with a display to generate a drag catheter lesion formation pattern on the map.

41. A computer program product according to claim 36, wherein the computer readable program code that generates the proximity alert is configured to generate an audio and/or visual alert when a distal end portion of the ablation catheter is in a location that will generate a lesion or injection that is outside the defined boundary limits.

42. An MRI guided cardiac interventional system, comprising:

a display;

a processor in communication with the display and adapted to communicate with an MRI scanner;

electronic memory coupled to the processor; and

computer program code residing in the memory that is executable by the processor for;

obtaining MR image data of a heart of a subject;

rendering at least one 3-D map of at least a portion of the heart of the subject;

displaying a graphical user interface (GUI) containing the at least one map within the display, wherein the GUI allows a user to select at least one target ablation site and at least one avoid zone on the at least one map;

tracking a location of a distal end of an intrabody medical device having at least one tracking coil using tracking coil signal; and

generating at least one proximity alert when the distal end portion of the device is identified as approaching and/or residing proximate the selected at least one target treatment site and/or the at least one avoid zone during an MRI guided procedure based on the tracked location.

43. The system of claim 42, further comprising computer program code residing in the memory that is executable by the processor for:

defining pre-set scan planes for the selected at least one target treatment site; and

defining boundary limits for the at least one selected target treatment site.

44. The system of claim 42, wherein the computer program code configured to generate a proximity alert is configured to generate the proximity alert if the distal end of an ablation or injection catheter is identified as being proximate to a respective treatment site but at a location that is outside the defined boundary limits for that target treatment site.

45. The system of claim 42, wherein the computer program code that allows a user to select at least one target ablation site and at least one avoid zone on the at least one map is configured to allow a user to generate a drag lesion path on the at least one map.

46. An MRI-guided cardiac interventional system, comprising:

a circuit adapted to communicate with an MRI Scanner, the circuit configured to define target therapeutic delivery boundary limits for a defined target therapy delivery site of a patient using a known therapeutic catheter with at least one tracking coil that connects to an MR Scanner channel, and generate an alert during an MRI-guided interventional procedure when the catheter is at a location that is inside and/or outside the defined boundary limits of a defined target delivery site.

47. The system of claim 46, wherein the target therapy delivery path is for delivering a therapeutic agent to tissue of the heart, the circuit configured to generate near-real time MRI images of an active injection into local tissue and show a fluid distribution in the local tissue based on the injection.

48. An MRI-guided cardiac interventional system, comprising:

a circuit adapted to communicate with an MRI Scanner, the circuit configured to define at least one patient avoid zone associated with target anatomical structure proximate a delivery site or associated with a tortuous delivery path and generate an alert during an MRI-guided interventional procedure when a tracked intrabody device is determined to be proximate the avoid zone using tracking coil data.