Heart Treatment Kit, System, and Method For Radiosurgically Alleviating Arrhythmia

• US 20110166407A1
• Filed: 07/16/2010
• Published: 07/07/2011
• Est. Priority Date: 07/17/2009
• Status: Active Grant

• Current Assignee: Varian Medical Systems Incorporated (Siemens AG)
• Original Assignee: Cyberheart, Inc. (Siemens AG)
• Inventors: Maguire, Patrick, Sumanaweera, Thilaka, Gardner, Ed, Uecker, Darrin, Cai, Tao, Blanck, Oliver
• Granted Patent: US 8,784,290 B2
• Time in Patent Office: Days
• US Class Current: 600/1
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2063 Acoustic tracking systems, e.g. using ultrasound
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/7207 of noise induced by motion artifacts
• CPC Class Codes: A61B 5/7289 Retrospective gating, i.e. associating measured signals or images with a physiological event after the actual measurement or image acquisition, e.g. by simultaneously recording an additional physiological signal during the measurement or image acquisition
• CPC Class Codes: A61B 6/03 Computed tomography [CT] echo-tomography A61B8/14
• CPC Class Codes: A61B 6/037 Emission tomography
• CPC Class Codes: A61B 6/503 for diagnosis of the heart
• CPC Class Codes: A61B 6/504 for diagnosis of blood vessels, e.g. by angiography
• CPC Class Codes: A61B 8/0883 for diagnosis of the heart
• CPC Class Codes: A61B 8/0891 for diagnosis of blood vessels
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61N 2005/1061 using an x-ray imaging system having a separate imaging source
• CPC Class Codes: A61N 5/1037 taking into account the movement of the target, e.g. 4D-image based planning
• CPC Class Codes: A61N 5/1039 using functional images, e.g. PET or MRI
• CPC Class Codes: A61N 5/1049 for verifying the position of the patient with respect to the radiation beam
• CPC Class Codes: A61N 5/1067 in real time, i.e. during treatment
• CPC Class Codes: A61N 5/1077 Beam delivery systems

Abstract

Radiosurgical treatments of tissues of the heart mitigate arrhythmias and treat other tumerous and non-tumerous disease using an implanted fiducial positioned in or near the heart using cardiac catheterization techniques. The fiducials may be implanted after diagnostic and planning images of the target tissues have been acquired. Fiducial implantation may take place the day of a scheduled radiosurgical treatment. Techniques to accommodate post-planning fiducial implantation may include registration of the implanted fiducial location with the treatment plan, and active fiducials may limit collateral imaging radiation exposure while enhancing tracking accuracy.

Claims

1. A radiosurgical method for treating a patient body having a heart, the heart having a non-tumerous disease, the method comprising:

acquiring three dimensional planning image data from the heart;

planning an ionizing radiation treatment of a target region of the heart using the three dimensional planning image data so as to mitigate the disease;

after the planning of the treatment, implanting a position surrogate within the body;

remodeling the target region of the heart by directing the planned radiation from outside the body toward the target region with reference to the implanted surrogate.

2. The method of claim 1, wherein:

the implanting of the surrogate,

the treating of the target region, and

explanting of the surrogate from the body,

are performed on a treatment day, and wherein;

the acquiring of the planning image data of the heart, and

the planning of the treatment,

are performed prior to the treatment day.

3. The method of claim 2, wherein the planning of the treatment further comprises determining an estimated lesion of the heart based on the planned radiation, and reviewing a graphical representation of the estimated lesion.

4. The method of claim 1, wherein the implanting of the surrogate comprises advancing at least one elongate flexible body through a blood vessel and coupling the surrogate to tissue so that the surrogate exhibits heartbeat-induced movement of the tissue.

5. The method of claim 4, wherein the surrogate comprises a non-colinear set of discrete fiducial markers so that a three-dimensional offset orientation between the surrogate and the target area can be determined from an image of the fiducial markers.

6. The method of claim 4, wherein implanting of the surrogate comprises screwing a helical structure of the elongate body into the tissue.

7. The method of claim 4, wherein implanting of the surrogate comprises expanding a body within a lumen or cavity bordered by the tissue.

8. The method of claim 4, wherein implanting of the surrogate comprises affixing an active three-dimensional position indicator to the tissue.

9. The method of claim 8, wherein a position indicating signal from the position indicator is used to register a location of the implanted surrogate with the planning image data.

10. The method of claim 9, wherein the position indicating signal indicates an offset between the surrogate and a position transmitter outside the body, and further comprising calibrating the position indicating signal using image data encompassing the heart and the position transmitter.

11. The method of claim 10, wherein the image data used for calibrating the position indicating signal comprises post-planning calibration image data, and further comprising generating a calibration position sensing signal while a catheter tip engages a heart tissue, wherein a positional relation established between the transmitter and the body is maintained during acquisition of the calibration image data and the generation of the position sensing signal.

12. The method of claim 8, wherein the position indicator comprises a sensor or signal generator used with an ultrasound or electromagnetic position indicating system.

13. The method of claim 12, wherein the target region is treated by directing the planned radiation using a position indicating signal from the position indicator between intermittent tracking verification images.

14. The method of claim 1, further comprising registering the planning image data with the implanted surrogate by acquiring registration data between the implanting of the surrogate and the treating of the target region, the registration data encompassing the heart and the implanted surrogate.

15. The method of claim 14, wherein the registration data comprises three dimensional image data acquired using a first imaging modality, wherein the planning image data is also acquired with the same imaging modality.

16. The method of claim 14, wherein the registration data comprises three dimensional image data acquired using a first imaging modality, wherein the planning image data is acquired using a second imaging modality different than the first image modality.

17. The method of claim 14, wherein the registration data comprises three dimensional image data, and further comprising segmenting a surface of the heart in the planning image data, segmenting the surface of the heart in the registration image data, a registering the planning image data with the implanted surrogate using the surface segmentations.

18. The method of claim 14, where the planning image data and the registration data are each acquired while contrast is disposed in a chamber or vessel bordered by a blood/tissue interface surface, and wherein the surrogate is registered with reference to the interface blood/tissue interface surface.

19. The method of claim 14, wherein the registration data comprises an ultrasound or electromagnetic position signal from an active position indicator of the surrogate.

20. The method of claim 14, wherein the surrogate comprises a plurality of discrete image-able markers implanted so that the markers are sufficiently non-colinear to define a three-dimensional offset orientation.

21. The method of claim 1, wherein a location of the target region of the heart relative to adjacent high-contrast tissue structures of the body moves significantly after the planning image data is acquired and before the target region is treated.

22. The method of claim 1, further comprising registering a location of the implanted surrogate with the planning image data by implanting one or more image-able fiducial markers of the surrogate at one or more associated heart tissue-defined locations, and by identifying the one or more heart-tissue defined locations in the planning image data.

23. The method of claim 14, further comprising aligning a radiation treatment source with the implanted fiducials by acquiring alignment image data of the surrogate, wherein the tissue of the target region is not sufficiently discernable in the alignment image data for the alignment.

24. The method of claim 1,

further comprising monitoring a heart beat cycle from the body while acquiring the planning image data, and acquiring a time series of three dimensional image data sets distributed throughout the heart beat cycle so as to indicate heart tissue movement with the heart beat cycle;

wherein the planning of the treatment comprises;

identifying radiation sensitive collateral tissue, and

determining a series of radiation beams suitable for providing a desired radiation dose in the target region without excessively irradiating the collateral tissue; and

wherein the remodeling of the target region is performed by;

monitoring the heart beat cycle of the body, and

tracking at least a portion of the movement of the tissue in response to the monitored heart beat cycle while directing the radiation to the target region using a time series of datasets.

25. The method of claim 24, wherein the implanting of the surrogate comprises advancing at least one elongate flexible body through a blood vessel and coupling the surrogate to the heart so that the surrogate moves with the heart beat cycle, and further comprising determining a time average offset between the surrogate and the target region using the time series of image data sets, wherein the tracking of the target region is performed by:

determining a position of the surrogate;

monitoring the heart beat cycle of the body; and

directing the radiation beams to the target region using the monitored heart beat cycle, the determined position of the surrogate, and the time average offset.

26. The method of claim 25, wherein the time average offset is determined for the heart cycle by identifying a series of three dimensional offsets from the time series of image data sets, and wherein the time average offset is applied throughout the heart cycle so that tissue deformation between the surrogate and the target region during the heart beat cycle is untracked.

27. The method of claim 26, wherein the time average offset is further determined by selecting an image data set from among the time series of datasets as corresponding to a calculated average of the measured series of offsets so that the selected offset does not necessarily correspond to a quiescent phase of the heart cycle.

28. The method of claim 26, wherein the offset comprises a calculated time average of the identified series of offsets.

29. A radiosurgical system for treating a patient body with a heart, the heart having a non-tumerous disease, the system comprising:

an image capture device for acquiring three dimensional planning image data from the heart;

an implantable position surrogate coupleable with a tissue of the heart within the body;

a radiation source for transmitting a plurality of beams of ionizing radiation from outside the body; and

a processor system comprising a planning module having an input for identifying a target region of the heart, the planning module generating a plan of the radiation beams in response to the target region and the planning image data, the processor system coupled with the radiation source so as to direct the radiation beams toward the target region with reference to the implanted surrogate such that the radiation beams mitigate the disease by remodeling the target region of the heart.

30. The system of claim 29, further comprising a display of the planning module configured to output a planning image of the heart, wherein the input of the planning module designates a three-dimensional location of the heart image, the heart image comprising a three dimensional heart image.

31. The system of claim 30, wherein the planning module graphically superimposes an estimated lesion of the heart on the heart image based on the planned radiation beams.

32. The system of claim 29, wherein the surrogate is supported by an elongate flexible body having a proximal end disposable outside the body during use, a distal end supporting the surrogate and insertable through a blood vessel, and a tissue affixation surface for releasable coupling the surrogate to tissue so that the surrogate exhibits heartbeat-induced movement of the tissue.

33. The system of claim 32, wherein the surrogate comprises set of discrete fiducial markers having a non-colinear configuration so that a three-dimensional offset orientation between the surrogate and the target area can be determined from the fiducial markers in the heart image.

34. The system of claim 32, wherein the fixation surface comprises a helical structure positioned for screwing into the tissue.

35. The system of claim 32, wherein the fixation surface is disposed on an expandable body having a first configuration for insertion into a lumen or cavity bordered by the tissue and a second expanded configuration for fixedly engaging the tissue.

36. The system of claim 32, wherein the surrogate comprises an active three-dimensional position indicator.

37. The system of claim 36, wherein the processor registers a location of the implanted surrogate with the planning image data in response to a position indicating signal from the position indicator.

38. The system of claim 37, wherein the position indicating signal indicates an offset between the surrogate and a position sensor or transmitter outside the body, wherein the processor is configured to calibrate the position indicating signal in response to the planning image data, the planning image data encompassing the sensor or transmitter.

39. The system of claim 32, wherein the position indicator comprises a sensor or signal generator included within an ultrasound or electromagnetic position indicating system coupled to the processor system, wherein the processor system directs the radiation beam toward the target area in response to the position indicating signal.

40. The system of claim 32, further comprising a tracking verification image acquisition system coupled to the processor system so that the processor system directs the planned radiation using the position indicating signal between intermittent verification images from the verification image system, and verifies and refines the directing of the planned radiation using the intermittent verification images.

41. The system of claim 29, wherein the processing system is configured to register the planning image data with the implanted surrogate in response to registration data acquired after implanting of the surrogate, the registration data encompassing the heart and the implanted surrogate.

42. The system of claim 41, wherein the registration data comprises three dimensional image data, the registration image data and the planning imaging data acquired using the same imaging modality.

43. The system of claim 41, further comprising a registration image acquisition system, wherein the registration data comprises three dimensional image data acquired using a first imaging modality, wherein the planning image data is acquired using a second imaging modality different than the first image modality.

44. The system of claim 41, wherein the registration data comprises three dimensional image data, and wherein the processor is configured to segment a surface of the heart in the planning image data, segment the surface of the heart in the registration image data, and register the planning image data with the implanted surrogate using the surface segmentations.

45. The system of claim 41, further comprising imaging contrast, the planning image data and the registration data each being acquired while the contrast is disposed in a chamber or vessel bordered by a blood/tissue interface surface, wherein the processor is configured to register the surrogate with reference to the blood/tissue interface surface.

46. The system of claim 41, wherein the registration data comprises an ultrasound or electromagnetic position signal from an active position indicator of the surrogate.

47. The system of claim 41, further comprising a registration image acquisition system, wherein the surrogate comprises a plurality of discrete image-able markers supported by an elongate flexible intravascular body so that the markers are sufficiently non-colinear to define a three-dimensional offset orientation in the registration data.

48. The system of claim 41, further comprising an alignment image acquisition device coupled to the processor so as to facilitate aligning the radiation treatment source with the implanted fiducials.

49. The system of claim 29,

further comprising a planning image heart beat cycle sensor coupled with the planning image capture device and the processor, the planning image data comprising a time series of three dimensional image data sets distributed throughout the heart beat cycle so as to indicate heart tissue movement with the heart beat cycle;

wherein the processor comprises a planning module configured for planning of the treatment by identifying radiation sensitive collateral tissue, and by determining a series of radiation beams suitable for providing a desired radiation dose in the target region without excessively irradiating collateral tissue; and

further comprising a treatment heart beat cycle sensor coupled with the processor so as to monitor the heart beat cycle of the body while remodeling the target region, and a robot for altering alignment between the body and the radiation source;

wherein the processor is configured to direct the radiation dose to the target region by tracking at least a portion of the movement of the tissue with the robot in response to the monitored heart beat cycle while directing the radiation to the target region.

50. The system of claim 49, wherein the implanting of the surrogate is supported by at least one elongate flexible body insertable through a blood vessel so as to couple the surrogate with the heart so that the surrogate moves with the heart beat cycle, the processor configured to determine a time average offset between the surrogate and the target region using the time series of image data sets, and for tracking of the target region by determining a position of the surrogate and directing the radiation beams to the target region using the heart beat cycle, the determined position of the surrogate, and the time average offset.

51. The system of claim 50, wherein the processor determines the time average offset for the heart cycle by identifying a series of three dimensional offsets from the time series of image data sets, and wherein the time average offset is applied throughout the heart cycle so that tissue deformation between the surrogate and the target region during the heart beat cycle is untracked.

52. The system of claim 51, wherein the processor determines the time average offset by selecting an image data set from among the time series of datasets as corresponding to a calculated average of the measured series of offsets so that the selected offset does not necessarily correspond to a quiescent phase of the heart cycle.

53. The system of claim 51, wherein the time average offset comprises a calculated time average of the identified series of offsets.

54. A treatment kit for use with a radiosurgical system to treat a patient body with a heart, the heart having a non-tumerous disease, the radiosurgical system having a radiation source for transmitting a plurality of beams of ionizing radiation from outside the patient body per a plan so as to mitigate the disease, the radiosurgical system having a plurality of tracking inputs for synchronizing the radiation beams with movement of a target region of the heart, the kit comprising:

an electrode coupleable to the patient so as to transmit a heart cycle signal of the patient to a first tracking input of the radiosurgical system;

an elongate flexible body having a proximal end and a distal end insertable though a blood vessel of the patient; and

a position surrogate supported by the distal end of the flexible body so as to be insertable into operational engagement with the heart such that the surrogate moves with the heart suitably for generating a second tracking input of the radiosurgical system.

55. The treatment kit of claim 54, further comprising a package containing the electrode, flexible body, and surrogate.

56. The treatment kit of claim 55, the second input of the radiosurgical system including a remote imaging system, wherein the surrogate comprises a set of passive high-contrast fiducial markers having a sufficiently non-colinear configuration when deployed for defining a three-dimensional offset between the surrogate and the target region.

57. The treatment kit of claim 56, wherein the set of fiducials have a linear insertion configuration.

58. The treatment kit of claim 55, wherein the surrogate comprises an active ultrasound or electromagnetic component included within an ultrasound or electromagnetic system, the second input comprising an ultrasound or electromagnetic signal-based position input.

59. The treatment kit of claim 55, further comprising a fixation surface for affixing the distal end of the elongate body to a tissue of the heart, the fixation surface defined by a radially expandable body, a vacuum seal body, or a helical fixation screw.

60. The treatment kit of claim 55, further comprising a body surface marker affixable to an exposed surface of the body so as to allow imaging of a respiration movement of the body.

61. The treatment kit of claim 55, wherein the electrode comprises a set of electrocardiogram electrodes.

62. The treatment kit of claim 55, further comprising an adhesive patch suitable for affixing an ultrasound imaging transducer to a skin of the patient.

63. The treatment kit of claim 55, further comprising an introducer sheath having a proximal end affixable to skin of the patient during the radiation beams, a distal end insertable into the patient, and a lumen therebetween, the lumen sealingly receiving the elongate body.

64. The treatment kit of claim 55, further comprising one or more of a cardiac guidewire, imaging contrast deliverable through a lumen of the elongate body to a lumen or chamber of the heart, anesthetic skin cleansing solution, a locator needle, or a guidewire.

65. A radiosurgical system for treating a patient body with a heart, the heart having a non-tumerous disease, the system comprising:

an implantable position surrogate retrievably affixable to a tissue of the heart within the body from within a blood vessel;

an image capture device for acquiring three dimensional planning image data from the heart;

a radiation source for transmitting a plurality of beams of ionizing radiation from outside the body;

a tracking system for generating position data in response to a position of the surrogate; and

a processor system comprising a planning module having an input for identifying a target region of the heart, the planning module generating a plan of the radiation beams in response to the target region and the planning image data, the processor system coupling the tracking system with the radiation source so as to direct the radiation beams toward the target region with reference to the implanted surrogate such that the radiation beams mitigate the disease by remodeling the target region of the heart.