MRI-guided surgical systems with proximity alerts

• US 9,259,290 B2
• Filed: 06/08/2010
• Issued: 02/16/2016
• Est. Priority Date: 06/08/2009
• Status: Active Grant

• Current Assignee: Clearpoint Neuro, Inc.
• Original Assignee: MRI Interventions, Inc. (Clearpoint Neuro, Inc.)
• Inventors: Jenkins, Kimble L., Piferi, Peter, Guttman, Michael
• Primary Examiner(s): Fernandez, Katherine
• Assistant Examiner(s): MCDONALD, KATHERINE M
• Application Number:
  US12/795,945
• Publication Number:
  US 20100312095A1
• Time in Patent Office: 2,079 Days
• Field of Search: 600/411, 600/424, 600/434, 600/463, 600/439, 601 1- 2, 606/41, 606/34, 703/11
• US Class Current: 1/1
• 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 comprising at least one processor and/or at least one Application Specific Integrated Circuit (ASIC);

an intrabody device comprising a tip with a deflectable distal end portion which has variable curvature, wherein the intrabody device further comprises a plurality of spaced apart tracking coils residing on the deflectable distal end portion; and

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

wherein 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 at least one avoid zone on the at least one volumetric planning map,

wherein the circuit is further configured to define proximity alert locations for an MRI-guided procedure associated with the user selected at least one target site and/or the user selected at least one avoid zone, track the intrabody device by calculating a tip location and orientation of the tracked intrabody device using known physical data regarding the tracking coils and a predictable deflectable behavior of the deflectable distal end portion, and generate at least one audible and/or visual alert during the MRI-guided procedure when the tracked intrabody device is identified as approaching or being in one of the defined proximity alert locations, wherein the predictable deflectable behavior is based on forces applied to the intrabody device;

wherein the circuit is further configured to register the at least one volumetric planning map to MRI 3-D image space associated with the MRI-guided procedure, determine preset scan planes that cover the at least one selected target site and/or avoid zone based on the user selected at least one target site and/or the user selected at least one avoid zone, and wherein, during the MRI-guided procedure, the circuit is configured to determine a location of the tracked intrabody device and automatically select a relevant preset scan plane from one of the determined preset scan planes to obtain an MRI signal.

2. The system of claim 1, wherein the circuit is configured to define the proximity alert locations for the selected at least one target site and the selected at least one avoid zone, wherein the circuit is configured to define boundary limits for the at least one target site for the at least one audible and/or visual alerts, and wherein the boundary limits include boundary limits of different ablation sites for ablation by the tracked intrabody device.

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

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

(b) provide defined boundary limits for the selected at least one 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 selected at least one target site; and

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

4. The system of claim 3, wherein the known configuration data of the tracked intrabody device includes physical data regarding size, shape and position of at least one tracking coil on a distal end portion of the intrabody device including a distance of the at least one tracking coil from a tip of the intrabody device when straight and a known or predictable changeable shape behavior of a distal end portion of the intrabody device, and wherein the at least one tracking coil is configured to connect to an MR Scanner channel.

5. The system of claim 1, wherein the at least one volumetric planning map comprises at least one map of a patient'"'"'s heart, and wherein the UI is configured to allow the user to use the at least one map of the patient'"'"'s heart to define a plurality of avoid zones for the at least one audible and/or visual 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 phrenic nerve, and an atrioventricular (AV) node of the patient'"'"'s heart, and wherein the circuit is configured to provide a proposed overlay of the plurality of avoid zones on the at least one volumetric planning map and allow the user to use the UI to move a location of a proposed avoid zone and/or adjust size and/or shape of the proposed avoid zone for a particular medical procedure.

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

7. The system of claim 1, wherein the UI is configured to allow the 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 at least one volumetric planning map to define one or more of the proximity alert locations.

8. The system of claim 1, wherein the circuit is configured to register the at least one volumetric planning map to the MRI 3D image space prior to or during the MRI-guided procedure to electronically define locations of the at least one selected target site with associated boundary limits and/or the at least one avoid zone in the MRI 3D image space, wherein the circuit automatically generates the at least one audible and/or visual alerts when the deflectable distal end portion of the tracked intrabody 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, wherein the tracking coils are connected to respective MR scanner channels.

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

10. The system of claim 8, wherein the circuit is configured to generate positive proximity alerts when the distal end portion of the tracked intrabody device is within the boundary limits of a respective selected target site, and wherein the warning proximity alerts have a different audible signal than positive proximity alerts.

11. The system of claim 1, wherein each tracking coil of the plurality of spaced apart tracking coils is connected to a MR scanner channel, and wherein the at least one audible and/or visual alert changes to indicate an increase or decrease in distance between the deflectable distal end portion of the tracked intrabody device and a respective target site and/or avoid zone.

12. The system of claim 1, wherein the circuit is configured to generate a UI input to allow the user to affirmatively (i) mark desired treatment sites on the at least one volumetric planning map and (ii) select a preset scan option using the marked sites on the at least one volumetric planning map to determine the preset scan planes.