# US 8,784,290 B2 · Heart treatment kit, system, and method for radiosurgically alleviating arrhythmia

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- Number: US 8,784,290 B2
- Document ID: US8784290B2
- Status: Granted
- Kind: B2
- Application number: 12/838,113
- Filed: 2010-07-16
- Published: 2011-07-07
- Granted: 2014-07-22
- Earliest claimed: 2009-07-17
- Assignees: CyberHeart, Inc.
- Applicants: Thilaka Sumanaweera; Ed Gardner; Oliver Blanck; Tao Cai; Darrin Uecker; Patrick Maguire
- Inventors: Thilaka Sumanaweera; Ed Gardner; Oliver Blanck; Tao Cai; Darrin Uecker; Patrick Maguire
- Web page: https://patentgrep.com/patent/US8784290B2

## CPC

- A61N 5/1037: {taking into account the movement of the target, e.g. 4D-image based planning}
- A61B 5/287: Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
- A61B 6/037: {Emission tomography}
- A61N 5/1039: {using functional images, e.g. PET or MRI}
- A61N 5/1049: {for verifying the position of the patient with respect to the radiation beam}
- A61N 5/1077: {Beam delivery systems}
- A61B 5/7207: {of noise induced by motion artifacts}
- 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}
- A61B 6/03: Computed tomography [CT]
- A61B 6/503: {for diagnosis of the heart}
- A61B 6/504: {for diagnosis of blood vessels, e.g. by angiography}
- A61B 8/0883: {for diagnosis of the heart}
- A61B 8/0891: {for diagnosis of blood vessels}
- A61B 90/39: {Markers, e.g. radio-opaque or breast lesions markers}
- A61B 2034/2051: {Electromagnetic tracking systems}
- A61B 2034/2063: {Acoustic tracking systems, e.g. using ultrasound}
- A61N 5/1067: {in real time, i.e. during treatment}
- A61N 2005/1061: {using an x-ray imaging system having a separate imaging source}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## 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

### Claim 1

A radiosurgical method for treating a patient body having a heart, the heart having a non-tumorous 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 by advancing at least one elongate flexible body through a blood vessel and coupling the surrogate to tissue so that the surrogate exhibits movement induced by a heart beat;
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;
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 surrogate in response to the monitored heart beat cycle while directing the planned radiation to the target region using the time series of image data sets.

### Claim 2 (depends on 1)

The method of claim 1, wherein:
the implanting of the surrogate,
the remodeling 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.

### Claim 3 (depends on 2)

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.

### Claim 4 (depends on 1)

The method of claim 1, 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 region can be determined from an image of the fiducial markers.

### Claim 5 (depends on 1)

The method of claim 1, wherein implanting of the surrogate comprises screwing a helical structure of the elongate body into the tissue.

### Claim 6 (depends on 1)

The method of claim 1, wherein implanting of the surrogate comprises expanding a body within a lumen or cavity bordered by the tissue.

### Claim 7 (depends on 1)

The method of claim 1, wherein implanting of the surrogate comprises affixing an active three-dimensional position indicator to the tissue.

### Claim 8 (depends on 7)

The method of claim 7, wherein a position indicating signal from the position indicator is used to register a location of the implanted surrogate with the planning image data.

### Claim 9 (depends on 8)

The method of claim 8, 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.

### Claim 10 (depends on 9)

The method of claim 9, 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.

### Claim 11 (depends on 7)

The method of claim 7, wherein the position indicator comprises a sensor or signal generator used with an ultrasound or electromagnetic position indicating system.

### Claim 12 (depends on 11)

The method of claim 11, 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.

### Claim 13 (depends on 1)

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 remodeling of the target region, the registration data encompassing the heart and the implanted surrogate.

### Claim 14 (depends on 13)

The method of claim 13, 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 first imaging modality.

### Claim 15 (depends on 13)

The method of claim 13, 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.

### Claim 16 (depends on 13)

The method of claim 13, wherein the registration data comprises an ultrasound or electromagnetic position signal from an active position indicator of the surrogate.

### Claim 17 (depends on 13)

The method of claim 13, 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.

### Claim 18 (depends on 1)

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 remodeled.

### Claim 19 (depends on 1)

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.

### Claim 20 (depends on 13)

The method of claim 13, further comprising aligning a radiation treatment source with the implanted surrogate by acquiring alignment image data of the surrogate, wherein the tissue of the target region is not sufficiently discernible in the alignment image data for the alignment.

### Claim 21 (depends on 1)

The method of claim 1, wherein the implanting of the surrogate comprises 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.

### Claim 22 (depends on 21)

The method of claim 21, wherein the time average offset is determined for the heart beat 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 beat cycle so that tissue deformation between the surrogate and the target region during the heart beat cycle is untracked.

### Claim 23 (depends on 22)

The method of claim 22, wherein the time average offset is further determined by selecting an image data set from among the time series of image data sets as corresponding to a calculated average of the identified series of three dimensional offsets so that the selected image data set does not necessarily correspond to a quiescent phase of the heart cycle.

### Claim 24 (depends on 22)

The method of claim 22, wherein the time average offset comprises a calculated time average of the identified series of three dimensional offsets.

### Claim 25

A radiosurgical method for treating a patient body having a heart, the heart having a non-tumorous 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 by advancing at least one elongate flexible body through a blood vessel and coupling the surrogate to tissue so that the surrogate exhibits movement induced by a heart beat;
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;
registering the planning image data with the implanted surrogate by acquiring registration data between the implanting of the surrogate and the remodeling of the target region, the registration data encompassing the heart and the implanted surrogate, wherein the registration data comprises three dimensional image data; and
segmenting a surface of the heart in the planning image data, segmenting the surface of the heart in the registration data, and registering the planning image data with the implanted surrogate using the surface segments.

### Claim 26

A radiosurgical method for treating a patient body having a heart, the heart having a non-tumorous 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 by advancing at least one elongate flexible body through a blood vessel and coupling the surrogate to tissue so that the surrogate exhibits movement induced by a heart beat;
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;
registering the planning image data with the implanted surrogate by acquiring registration data between the implanting of the surrogate and the remodeling of the target region, the registration data encompassing the heart and the implanted surrogate; and
wherein 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 blood/tissue interface surface.

### Claim 27

A radiosurgical system for treating a patient body with a heart, the heart having a non-tumorous disease, the system comprising:
an image capture device for acquiring three dimensional planning image data from the heart;
an implantable position surrogate having a tissue affixation surface for releasable coupling of the surrogate with a tissue of the heart within the body so that the surrogate exhibits movement induced by a heart beat;
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 configured to generate 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;
a planning image heart beat cycle sensor coupled with the image capture device and the processor system, the planning image data comprising a time series of three dimensional image data sets distributed throughout a heart beat cycle so as to indicate heart tissue movement with the heart beat cycle;
wherein the planning module is configured for planning of the radiation beams 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 system 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 system is configured to direct the desired radiation dose to the target region by tracking at least a portion of the movement of the surrogate with the robot in response to the monitored heart beat cycle while directing the radiation to the target region.

### Claim 28 (depends on 27)

The system of claim 27, 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.

### Claim 29 (depends on 28)

The system of claim 28, wherein the planning module graphically superimposes an estimated lesion of the heart on the heart image based on the planned radiation beams.

### Claim 30 (depends on 27)

The system of claim 27, 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.

### Claim 31 (depends on 30)

The system of claim 30, wherein the surrogate comprises a set of discrete fiducial markers having a non-colinear configuration so that a three-dimensional offset orientation between the surrogate and the target region can be determined from the fiducial markers in the planning image data.

### Claim 32 (depends on 30)

The system of claim 30, wherein the affixation surface comprises a helical structure positioned for screwing into the tissue.

### Claim 33 (depends on 30)

The system of claim 30, wherein the affixation 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.

### Claim 34 (depends on 30)

The system of claim 30, wherein the surrogate comprises an active three-dimensional position indicator.

### Claim 35 (depends on 34)

The system of claim 34, wherein the processor system registers a location of the implanted surrogate with the planning image data in response to a position indicating signal from the position indicator.

### Claim 36 (depends on 35)

The system of claim 35, wherein the position indicating signal indicates an offset between the surrogate and a position sensor or transmitter outside the body, wherein the processor system is configured to calibrate the position indicating signal in response to the planning image data, the planning image data encompassing the sensor or transmitter.

### Claim 37 (depends on 35)

The system of claim 35, 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 toward the target region in response to the position indicating signal.

### Claim 38 (depends on 35)

The system of claim 35, 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.

### Claim 39 (depends on 27)

The system of claim 27, wherein the processor 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.

### Claim 40 (depends on 39)

The system of claim 39, wherein the registration data comprises three dimensional image data, the registration image data and the planning imaging data acquired using the same imaging modality.

### Claim 41 (depends on 39)

The system of claim 39, 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.

### Claim 42 (depends on 39)

The system of claim 39, wherein the registration data comprises an ultrasound or electromagnetic position signal from an active position indicator of the surrogate.

### Claim 43 (depends on 39)

The system of claim 39, 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.

### Claim 44 (depends on 39)

The system of claim 39, further comprising an alignment image acquisition device coupled to the processor system so as to facilitate aligning the radiation source with the implanted surrogate.

### Claim 45 (depends on 27)

The system of claim 27, 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 system configured to determine a time average offset between the surrogate and the target region using the time series of three dimensional 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.

### Claim 46 (depends on 45)

The system of claim 45, wherein the processor system determines the time average offset for the heart beat 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 beat cycle so that tissue deformation between the surrogate and the target region during the heart beat cycle is untracked.

### Claim 47 (depends on 46)

The system of claim 46, wherein the processor system determines the time average offset by selecting an image data set from among the time series of three dimensional image data sets as corresponding to a calculated average of the identified series of three dimensional offsets so that the selected image data set does not necessarily correspond to a quiescent phase of the heart beat cycle.

### Claim 48 (depends on 46)

The system of claim 46, wherein the time average offset comprises a calculated time average of the identified series of offsets.

### Claim 49

A radiosurgical system for treating a patient body with a heart, the heart having a non-tumorous disease, the system comprising:
an image capture device for acquiring three dimensional planning image data from the heart;
an implantable position surrogate having a tissue affixation surface for releasable coupling of the surrogate with a tissue of the heart within the body so that the surrogate exhibits movement induced by a heart beat;
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 configured to generate 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;
wherein the processor 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; and
wherein the registration data comprises three dimensional image data, and wherein the processor system is configured to segment a surface of the heart in the planning image data, segment the surface of the heart in the registration data, and register the planning image data with the implanted surrogate using the surface segments.

### Claim 50

A radiosurgical system for treating a patient body with a heart, the heart having a non-tumorous disease, the system comprising:
an image capture device for acquiring three dimensional planning image data from the heart;
an implantable position surrogate having a tissue affixation surface for releasable coupling of the surrogate with a tissue of the heart within the body so that the surrogate exhibits movement induced by a heart beat;
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 configured to generate 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;
wherein the processor 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; and
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 system is configured to register the surrogate with reference to the blood/tissue interface surface.