Method and apparatus for optimizing a therapy

• US 8,112,292 B2
• Filed: 04/21/2006
• Issued: 02/07/2012
• Est. Priority Date: 04/21/2006
• Status: Active Grant

• Current Assignee: Medtronic Navigation Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Navigation Incorporated (Medtronic Plc)
• Inventors: Simon, David A.
• Primary Examiner(s): O'Connor, Gerald J.
• Assistant Examiner(s): Holcomb, Mark
• Application Number:
  US11/409,499
• Publication Number:
  US 20070249911A1
• Time in Patent Office: 2,118 Days
• Field of Search: 705 2- 3, 128/898
• US Class Current: 705/3
• 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 2034/2055 Optical tracking systems
• CPC Class Codes: A61B 2034/256 having a database of accessory information, e.g. including context sensitive help or scientific articles
• CPC Class Codes: A61B 2090/0818 Redundant systems, e.g. using two independent measuring systems and comparing the signals
• CPC Class Codes: A61B 2090/3983 Reference marker arrangements for use with image guided surgery
• CPC Class Codes: A61B 2090/3995 Multi-modality markers
• 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 90/14 Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins
• CPC Class Codes: A61B 90/36 Image-producing devices or illumination devices not otherwise provided for
• CPC Class Codes: A61M 2005/14292 Computer-based infusion planning or simulation of spatio-temporal infusate distribution
• CPC Class Codes: A61N 2005/1041 using a library of previously administered radiation treatment applied to other patients
• CPC Class Codes: G16H 30/20 for handling medical images, e.g. DICOM, HL7 or PACS
• CPC Class Codes: G16H 70/20 relating to practices or guidelines

Abstract

A method and apparatus to perform a procedure that can include a processor assisted surgical procedure. During the procedure patient space and image space can be registered to allow for tracking of various tracking sensors. An instrument can be placed relative to patient space based upon a plan.

Claims

1. A method of determining an optimized plan for performing a procedure on a selected patient, comprising:

acquiring patient specific information of the selected patient;

selecting a therapy protocol from a plurality of therapy protocols based upon a determined therapy to be applied to the selected patient based at least in part on the acquired patient specific information;

operating a hardware processor to execute instructions to determine optimized candidate plans based on the selected therapy protocol and the acquired patient specific information;

wherein the therapy protocol is stored in a computer accessible database,

wherein the therapy protocol includes optimization criteria, constraints, and search strategies for determining a trajectory for moving an instrument for delivery of a therapy that is based on information acquired from sources other than from the selected patient;

wherein the patient specific information comprises image data and configurations of the instrument available for the therapy delivery;

wherein the image data includes a working area;

wherein the configurations of the instrument include at least one of a turning radius of the instrument, a size of the instrument, a type of the instrument, a shape of the instrument, and a number of instruments;

wherein the therapy includes a delivery of a material.

2. The method of claim 1, where acquiring patient specific information further includes acquiring image data of the selected patient, acquiring an age of the selected patient, acquiring a gender of the selected patient, acquiring a mass of the selected patient, acquiring a prior medical history of the selected patient, or combinations thereof.

3. The method of claim 1, wherein the therapy protocol includes guidelines for performing the selected therapy;

and

executing a program of instructions with a hardware processor to determine an optimized plan that optimizes the selected therapy protocol for performing the determined therapy in the selected patient based on a combination of the provided patient specific information and the information and criteria stored in the computer accessible database.

4. The method of claim 1, wherein the optimization criteria and constraints includes at least one of selecting a location of interest in the selected patient, selecting a material to be delivered to the location of interest, determining anatomical features to be avoided when providing the therapy to the selected location, selecting the parameters for a position of an instrument relative to the selected location, or combinations thereof.

5. The method of claim 4, further comprising:

forming the therapy protocol by integrating data from a plurality of related procedures performed on patients other than the selected patient to determine an optimal position of an instrument for performing a therapy within a patient population.

6. The method of claim 5, further comprising:

accessing optimization criteria and constraints based upon the selected therapy protocol;

wherein executing the instructions further comprises,

determining plurality of candidate plans including a path to reach a selected location in the selected patient based upon the accessed optimization criteria and constraints and the provided information relating to the selected patient;

rating each of the plurality of candidates plan based upon the optimization criteria and constraints; and

outputting to a human viewable display at least the candidate plan and rating for at least a sub-plurality of the determined plurality of candidate plans; and

determining a proposed plan by a human user based upon the outputted sub-plurality of candidate plans.

7. The method of claim 5, further comprising:

processing image data provided as information relating to the selected patient including locating anatomical structures of the patient in the image data, locating a target site in the image data of the patient, locating an entry point for instruments in the image date of the patient, or combinations thereof.

8. The method of claim 7, wherein the processing of the image data is performed by a computer processor to determine at least one of a target location for the selected therapy, a physiological structure in the image data, and an anatomical structure in the image data.

9. The method of claim 8, further comprising:

wherein executing the instructions further comprises determining a candidate plan including a path to reach the target location in the selected patient based upon the accessed optimization criteria and constraints and the provided information relating to the selected patient;

rating the candidate plans based upon the accessed optimization criteria and constraints; and

determining the optimized plan based upon the candidate plans.

10. The method of claim 9, further comprising:

implementing the optimized plan manually, navigated, automatically, or combinations thereof.

11. The method of claim 9, wherein the candidate plans includes determining a plurality of candidate plans;

wherein rating the candidate plans includes determining a candidate plan rating for each of the plurality of candidate plans;

wherein the determined optimized plan is the candidate plan of the plurality of candidate plans with a selected rating and selected by a user from at least a sub-plurality of the plurality of candidate plans; and

performing a therapy on the selected patient based upon the optimized plan based upon the processor executing the program of instructions.

12. The method of claim 10, wherein implementing the optimized plan with navigation includes:

tracking an instrument relative to the selected patient in patient space;

displaying the position of the instrument in image space; and

providing feedback to a user.

13. The method of claim 11, further comprising selecting a selected rating;

wherein selecting the selected rating is performed by a human user.

14. The method of claim 11, wherein the optimization criteria and constraints further includes a selected location of a delivery device relative to a malady of the selected patient, drug delivery rates, a period of drug delivery, or pharmokinetics;

wherein performing a therapy on the selected patient includes delivering a pharmaceutical to the selected patient.

15. The method of claim 12, wherein tracking the instruments in patient space includes tracking the instrument via an acoustic tracking system, an optical tracking system, a radar tracking system, an electromagnetic tracking system, or combinations thereof.

16. The method of claim 12, further comprising:

providing a catheter as the instrument that is to be tracked with tracking sensors relative to a distal end of the catheter;

wherein tracking the instrument includes tracking the catheter by tracking the tracking sensors.

17. A system to determine an optimized therapy for a selected patient, comprising:

a first input system operable to input image data of the selected patient;

a second input system operable to input information regarding the selected patient including an instrument configuration;

a third input system operable to input a recalled and predetermined general therapy protocol including optimization criteria and constraints generated from performing a selected therapy on a population of patients other than the selected patient;

a computer processor unit operable to execute instructions including a search strategy to form a proposed plan based on the inputs from the first input system, the second input system, and the third input system including;

determining a selected location in the image data;

determining an entry point to the selected patient; and

determining a path to reach the selected location from the entry point; and

a therapy delivery system operable to deliver a therapy including a material to the selected patient based upon the proposed plan;

a navigation system including;

a tracking system having a tracking sensor;

an instrument including the tracking sensor to be tracked by the tracking system;

a feedback system operable to provide feedback to a user based upon the tracked position of the instrument relative to the determined path;

a display operable to display an instrument icon representing a location of the instrument relative to the image data displayed on the display and a path icon representing the determined path;

wherein the proposed plan is a patient specific plan for the selected patient;

wherein the display is operable to illustrate a therapy icon illustrating a real time therapy delivery for comparison to the recalled and predetermined general therapy protocol;

wherein the instrument configuration includes at least one of a turning radius of the instrument, a size of the instrument, a type of the instrument, a shape of the instrument, and a number of instruments.

18. The system of claim 17, wherein the instrument is operable to be moved relative to the determined path to reach the selected location;

wherein the instrument icon on the display is operable to display the tracked position of the instrument relative to the path icon illustrating the determined path displayed on the display.

19. The system of claim 17, wherein the second input system includes a keyboard, a touch screen, a mouse, or a memory system, or combinations thereof.

20. The system of claim 17, further comprising:

a robotic manipulation system operable to manipulate an instrument relative to the path determined by the processor.

21. The system of claim 17, wherein the tracking system includes an electromagnetic tracking system including a coil array operable to transmit signals, wherein the tracking sensor is operable to receive and transmit signals based upon the signals transmitted by the coil array.

22. The system of claim 17, wherein the first input system includes an imaging system operable to image the selected patient to form the image data.

23. The system of claim 17, wherein the instructions further include constraints that must be met by the proposed plan to have the proposed plan perform a procedure on the selected target including identified anatomical features, clearance distances of the identified anatomical features, prior procedures of the selected patient, or combinations thereof.

24. The system of claim 21, further comprising:

a dynamic reference frame positioned relative to the selected patient and operable to assist the navigation system in maintaining a registration between a patient space of the selected patient and an image space of the image data.

25. The system of claim 22, wherein the imaging system includes at least one of an MRI, an SPECT, a PGS, a CT scanner, an x-ray system, a PET, or combinations thereof.

26. The system of claim 22, wherein the imaging system includes a first imaging system to provide image data of a first type and a second imaging system operable to provide image data of a second type;

wherein the first input system is operable to form a composite image data of the first image data type and the second image data type;

whereby an image computer processor unit is operable to identify at least one selected location in the image data of the first type or the composite image data.

27. The system of claim 23, wherein the processor is operable to execute instructions based upon a delivery protocol included as a part of the general therapy protocol for a therapy.

28. The system of claim 27, further comprising:

a human viewable output display to display a plurality of proposed plans and an associated plan goodness value to each of the displayed plurality of proposed plans;

wherein the delivery protocol is operable to provide both constraints which cannot be breached and optimization criteria to assist in determining a proposed plan that has a higher plan goodness value than a plurality of candidate plans.

29. The system of claim 27, wherein the determination of a proposed plan includes determining a path in a exhaustive method.

30. A method to determine an optimization of a selected therapy for a selected patient, comprising:

inputting patient specific image data of the selected patient;

inputting non-image patient specific information regarding the selected patient different than the input patient specific image data;

selecting a general therapy based at least in part on the input patient specific image data of the selected patient and the input non-image patient specific information regarding the selected patient different than the input patient specific image data;

recalling from a memory system a general therapy protocol including specific guidelines for performing the selected general therapy based on performing the selected therapy on a population of patients other than the selected patient, wherein the specific guidelines include at least one of an optimization criteria and a constraint criteria; and

executing instructions including a search strategy with a computer processor to form a proposed optimized plan based on the input patient specific image data, the input non-image patient specific information, and the recalled general therapy protocol, wherein executing the instructions includes;

determining a selected working area in the image data;

determining an entry point to the selected patient; and

determining a path to reach the selected working area from the determined entry point;

wherein the proposed optimized plan is a patient specific plan for the selected patient;

wherein the inputted non-image patient specific information includes at least one of a turning radius of the instrument, a size of the instrument, a type of the instrument, a shape of the instrument, and a number of instruments;

wherein the selected therapy includes a delivery of a material.

31. The method of claim 30, wherein the constraint criteria must be met by the proposed optimized plan including identified anatomical features, clearance distances of the identified anatomical features, prior procedures of the selected patient, or combinations thereof.

32. The method of claim 31, further comprising:

delivering a drug with a drug delivery system to the selected patient based upon the proposed plan;

navigating an instrument based on the proposed plan at least by tracking the instrument with a tracking sensor associated with the instrument;

receiving feedback based upon the tracked position of the instrument relative to the determined path;

displaying an instrument icon, a path icon, the input patient specific image data, and a therapy icon;

wherein the instrument icon is illustrated relative to both the path icon and the input patient specific image data to represent a location of the instrument relative to the image data and the path icon representing the determined path;

wherein the therapy icon illustrates a real time therapy delivery for comparison to the recalled general therapy protocol.

33. The method of claim 32, further comprising:

wherein executing the program further comprises,

determining plurality of candidate plans including a path to reach a selected location in the selected patient based upon the optimization criteria and a constraint criteria and the input patient specific image data of the selected patient and the input non-image patient specific information regarding the selected patient different than the input patient specific image data;

rating each of the determined plurality of candidate plans based upon the optimization criteria and a constraint criteria; and

outputting to a human viewable display at least the candidate plan and rating for a sub-plurality of the determined plurality of candidate plans; and

selecting the proposed plan by a human user from the outputted sub-plurality of candidate plans.

34. A method of automatically determining an optimized therapy for a selected patient based upon general therapy protocols and patient specific information, comprising:

selecting a general therapy to be applied to the selected patient to treat a malady of the selected patient;

instructing a processor to recall a stored general therapy protocol relating to performing the selected general therapy to treat the malady, wherein the general therapy protocol is stored in a computer accessible storage system and includes optimization criteria and constraints based on integrating data from previously performed selected therapies to treat the malady in previous patients other than the selected patient;

instructing the processor to recall image data of the selected patient;

inputting an instrument configuration of an instrument including at least one of a turning radius of the instrument, a size of the instrument, a type of the instrument, a shape of the instrument, and a number of instruments;

inputting a therapy material information;

selecting a candidate plan that includes a trajectory for the instrument that was outputted by the processor, where the trajectory is determined with search strategies based upon the recalled general therapy protocol and the recalled image data to determine an optimal plan of therapy for the selected patient; and

moving an instrument based upon the determined plan.

35. The method of claim 34, wherein the optimization criteria includes criteria that can be weighted to provide a plan goodness value for determining the optimal plan in the selected patient based upon the general therapy protocol.

36. The method of claim 34, wherein the selected candidate plan includes determining the highest plan goodness value of a plurality of determined candidate plans that are found during a search of the accessed image data of the selected patient based upon the general therapy protocol.

37. The method of claim 34, wherein recalling a general therapy protocol includes accessing previously collected information relating to a standard therapy procedure protocol and accessing previously collected information relating to the therapy material type.

38. The method of claim 36, further comprising:

delivering a pharmaceutical to the selected patient based upon the selected plan;

wherein the accessed general therapy protocol includes a selected location of a delivery device relative to a malady of the selected patient, drug delivery rates, a period of drug delivery, or pharmokinetics.

39. The method of claim 37, wherein the recalled general therapy protocol can include pharmacokinetics, drug delivery rates, drug toxicity, drug interactions, delivery devices, optimal position of a delivery device, portions of the anatomy of a patient in a patient population to be avoided, or combinations thereof.

40. The method of claim 37, further comprising:

providing an image pre-processor operable to process the image data of the selected patient.

41. The method of claim 37, further comprising:

searching the recalled image data of the selected patient based upon the accessed general therapy protocol to form a candidate plan; and

wherein determining a candidate plan includes applying an optimization criteria and a constraint to determine a plan goodness value of the candidate plan.

42. The method of claim 39, further comprising:

inputting patient specific information of the selected patient to be used by the processor executing a program to determine the candidate plan;

wherein the patient specific information includes sex, mass, age, prior medical history, volume, or combinations thereof.

43. The method of claim 40, further comprising:

pre-processing the image data of the selected patient with the provided image pre-processor, wherein the image pre-processor includes a computer processor system operable to execute instructions to identify anatomical structures, identify anatomical surfaces, identify target locations, or combinations thereof.

44. The method of claim 41, further comprising:

outputting a plurality of the candidate plans based upon the search of the image data.

45. The method of claim 43, wherein moving an instrument includes moving the instrument from an entry point to the identified target location based upon the optimal plan.

46. The method of claim 44, further comprising:

selecting by a human user the optimal plan based upon the plan goodness value of the outputted plurality of the candidate plans.

47. The method of claim 46, wherein the optimal plan includes at least an entry point, a target location, and a path to be followed when moving the instrument.

48. The method of claim 47, further comprising:

tracking the instrument with a navigation system;

displaying the image data on a display; and

displaying an icon representing the location of the instrument relative to the image data of the selected patient.