Renovascular treatment device, system, and method for radiosurgically alleviating hypertension

Abstract

A radiosurgical method for treating cardiorenal disease of a patient, the method including directing radiosurgery radiation from outside the patient towards one or more target treatment regions encompassing sympathetic ganglia of the patient so as to inhibit the cardiorenal disease. In an exemplary embodiment, the method further includes acquiring three dimensional planning image data encompassing the first and second renal arteries, planning an ionizing radiation treatment of first and second target regions using the three dimensional planning image data so as to mitigate the hypertension, the first and second target regions encompassing neural tissue of or proximate to the first and second renal arteries, respectively, and remodeling the target regions by directing the planned radiation from outside the body toward the target regions.

1 . A radiosurgical method for treating cardiorenal disease of a patient, the method comprising:
 directing radiosurgery radiation from outside the patient towards one or more target treatment regions encompassing a periarterial space of the renal artery of the patient so as to inhibit the cardiorenal disease.   
     
     
         2 . The method of  claim 1 , wherein target treatment region encompasses a sympathetic ganglia of the patient, and wherein the action of directing the radiation is part of a renal denervation procedure, the resulting renal denervation inhibiting hypertension. 
     
     
         3 . The method of  claim 1 , wherein the action of directing the radiation towards the target treatment regions substantially reduces the ability of a central nervous system of the patient to communicate with at least one kidney of the patient. 
     
     
         4 . The method of  claim 1 , wherein the action of directing the radiation towards the target treatment regions at least one of blocks or down-regulates sympathetic impulses between at least one kidney of the patent and a central nervous system of the patient. 
     
     
         5 . The method of  claim 1 , wherein the target treatment region envelops renal nerves of the patient, wherein the renal nerves are located about a renal artery of the patient, and wherein an inner diameter of the artery proximate the target treatment region is at least substantially the same six months after the action of directing the radiation as prior to directing the radiation. 
     
     
         6 . The method of  claim 1 , wherein the action of directing the radiation results in the destruction of substantially much, but not all, of a segment of renal nerves surrounding a renal artery of the patient. 
     
     
         7 . The method of  claim 1 , wherein the action of directing the radiation results in the destruction of renal nerves in a toroidal arc-segment. 
     
     
         8 . The method of  claim 20 , wherein the action of directing the radiation results in the destruction of renal nerves in an area having a cross-section, when taken normal to the longitudinal axis of a renal artery about which the destroyed renal nerves are arrayed, in the general shape of a “C”. 
     
     
         9 . The method of  claim 1 , further comprising, prior to the action of directing the radiation:
 evaluating the state of a renovasucular system of the patient; and   determining that the renovasucular system is not afflicted with a tumor.   
     
     
         10 . The method of  claim 1 , further comprising:
 prior to the action of directing the radiation, initially evaluating at least one of a systolic or a diastolic blood pressure of the patient and determining, as a result of the evaluation, that the respective pressure correspond to a pressure indicative of hypertension;   wherein the radiation is directed in response to the initial evaluation;   after the action of directing the radiation, reevaluating at least one of a systolic or a diastolic blood pressure of the patient and determining, as a result of the reevaluation, whether the respective reevaluated pressures correspond to a pressure indicative of hypertension,   wherein the reevaluated at least one of the systolic or diastolic blood pressure is lower than the respective initially evaluated systolic or diastolic blood pressure.   
     
     
         11 . A radiosurgical method for treating a patient body having a renovascular system including a first and second renal arteries, the patient having hypertension, the method comprising:
 acquiring three dimensional planning image data encompassing the first and second renal arteries;   planning an ionizing radiation treatment of first and second target regions using the three dimensional planning image data so as to mitigate the hypertension, the first and second target regions encompassing neural tissue of or proximate to the first and second renal arteries, respectively; and   remodeling the target regions by directing the planned radiation from outside the body toward the target regions.   
     
     
         12 . The method of  claim 11 , further comprising:
 prior to the planning of the treatment, implanting a position surrogate within the body,   wherein the action of remodeling the target regions of the renovascular system includes directing the planned radiation from outside the body toward the target regions with reference to the implanted surrogate.   
     
     
         13 . The method of  claim 12 , wherein the position surrogate remains implanted in the body for at least a year or until dissolution. 
     
     
         14 . The method of  claim 11 , wherein the treatment comprises a bilateral treatment, the target regions comprising two spatially separated non-contiguous regions, and wherein the remodeling of the target regions inhibits the hypertension. 
     
     
         15 . The method of  claim 14 , wherein the radiation is directed to the two regions in a single treatment procedure on a single day. 
     
     
         16 . The method of  claim 14 , wherein the radiation is sequentially directed to the two regions in separate treatment procedures on separate days. 
     
     
         17 . The method of  claim 11 , wherein the planning of the treatment further comprises determining an estimated lesion of the renovascular system based on the planned radiation, and reviewing a graphical representation of the estimated lesion. 
     
     
         18 . The method of  claim 11 , wherein the radiation is directed from a radiation source, and wherein the action of remodeling the target regions of the renovascular system includes moving the radiation source about the body. 
     
     
         19 . The method of  claim 1 , wherein the radiation is directed from a plurality of fixed radiation sources arrayed about the body. 
     
     
         20 . The method of  claim 14 , wherein the radiation is sequentially directed to the two regions in separate treatment procedures on separate days. 
     
     
         21 . The method of  claim 11 , wherein the planning of the treatment further comprises determining an estimated lesion of the renovascular system based on the planned radiation, and reviewing a graphical representation of the estimated lesion. 
     
     
         22 . The method of  claim 11 , wherein the radiation is directed from a radiation source, and wherein the action of remodeling the target regions of the renovascular system includes moving the radiation source about the body. 
     
     
         23 . The method of  claim 11 , wherein the radiation is directed from a plurality of fixed radiation sources arrayed about the body. 
     
     
         24 . The method of  claim 11 , wherein the target regions includes a distinct region that is generally cylindrical in shape. 
     
     
         25 . The method of  claim 11 , wherein the target regions substantially surrounds a majority of respective perimeters of the first and second renal arteries of the patient, the target regions having two sections separated by a space into which a therapeutic level of radiation is not directed. 
     
     
         26 . The method of  claim 12 , wherein the action of implanting a position surrogate within
 the body includes locating a fiducial in one or more of the renal artery, renal vein, aorta, inferior vena cava, side branch of the aorta or side branch of the vena cava.   
     
     
         27 . The method of  claim 12 , wherein the action of implanting a position surrogate within the body includes implanting passive fiducial seeds within the body. 
     
     
         28 . The method of  claim 12 , wherein the fiducial seeds comprise substantially non-toxic seeds, with respect to the dosages used in the method, with an electron density visible on CT and/or guidance imaging. 
     
     
         29 . The method of  claim 12 , wherein the action of implanting a position surrogate within the body includes inserting a needle tip percutaneously to a position where the surrogate is to be implanted, and implanting one or more surrogates by ejecting the one or more surrogates out of the needle tip. 
     
     
         30 . The method of  claim 11 , wherein the action of remodeling the target regions by directing the planned radiation from outside the body toward the target regions results in renal denervation, wherein the renal denervation results in the reduction of a cardiac infarct size expansion. 
     
     
         31 . The method of  claim 12 , further comprising monitoring movement of at least one of the first and second renal arteries due to a heart beat cycle of the patient, 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 tissue of the at least one first and second renal arteries due to the heart beat cycle while directing the radiation to the target region while compensating for the movement.   
     
     
         32 . The method of  claim 12 , 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 renovascular 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. 
   
     
     
         33 . The method of  claim 11 , wherein the action of directing the planned radiation from outside the body toward the targets regions results in respective absorbed radiation dose distributions of the target regions of at least one unit dose of absorbed radiation and absorbed radiation dose distributions of respective first outer regions outside of and proximate to the target regions of at least ⅔rds of the unit dose of absorbed radiation, the first outer region having a volume of about 1.5 to 4.0 times the volume of a corresponding target region. 
     
     
         34 . The method of  claim 11 , wherein the first target region surrounds a majority of a perimeter of the first renal artery of the patient, wherein the first renal artery has a first lumen adjacent the perimeter, the first lumen defined by a first wall of the first renal artery, and wherein a collateral dose of the radiation in the first wall adjacent the first lumen is sufficiently less than a dose of the radiation in the target region so as to inhibit tissue response-induced occlusion of the first renal artery. 
     
     
         35 . The method of  claim 11 , further comprising:
 implanting a position surrogate from within an inferior vena cava of the body prior to acquiring of the planning image data;   monitoring a breathing cycle from the body while acquiring the planning image data;   monitoring the breathing cycle from the body while directing the planned radiation to the target regions; and   controlling the directing of the planned radiation in response to the monitored breathing cycle;
 wherein no position surrogate is implanted within at least the first renal artery; and 
 wherein the directing of the planned radiation is performed without tracking movement of at least the first renal artery in response to a heartbeat cycle of the body. 
   
     
     
         36 . The method of  claim 12 , wherein the fiducial seeds comprise gold seeds. 
     
     
         37 . The method of  claim 12 , further comprising monitoring movement of at least one of the first and second renal arteries due to a blood pressure component and/or a displacement component of the heart beat cycle of the patient, 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 tissue of the at least one first and second renal arteries.   
     
     
         38 . A radiosurgical system for treating a patient body with a renal artery and hypertension and/or congestive heart failure, the system comprising:
 an image capture device for acquiring three dimensional planning image data from the renal artery and/or a location proximate the renal artery;   a radiation source for transmitting a plurality of beams of ionizing radiation from outside the body; and   a processor system configured to direct the ionizing radiation beams toward a target region of the renal artery and/or a target region at the location proximate the renal artery such that the radiation beams remodel the target region and the hypertension and/or congestive heart failure is mitigated.   
     
     
         39 . The system of  claim 38 , wherein the processor system is configured to control the direction of the radiation to account for heartbeat-induced movement of the renal artery and/or the location proximate the renal artery. 
     
     
         40 . The system of  claim 38 , wherein the processor system is configured to control the direction of the radiation to account for breathing-induced movement of the renal artery and/or the location proximate the renal artery. 
     
     
         41 . The system of  claim 38 , wherein the processor system is configured to direct the ionizing radiation beams to impinge upon renal nerves proximate the renal artery to deliver one or more doses of radiation to the renal nerves, the collective delivered doses being sufficient to destroy at least a portion of the renal nerves upon which the radiation beams impinge. 
     
     
         42 . The system of  claim 38 , wherein the processor system is configured to direct the ionizing radiation beams such that the beams do not impart a collective radiation dose to a wall of the renal artery that destroys a substantial amount of tissue of the wall. 
     
     
         43 . They system of  claim 38 , wherein the processor system is configured to direct the ionizing radiation beams to provide a therapeutic dose of radiation to a periarterial space of a renal artery of the patient. 
     
     
         44 . The system of one of  claim 38 , wherein the processor is configured to control the direction of the radiation to account for breathing-induced movement of the renal artery and/or the location proximate the renal artery, wherein the processor is configured to control the direction of the radiation without tracking heartbeat-induced movement of the renal artery and/or the location proximate the renal artery. 
     
     
         45 . The system of any one of  claims 38 - 44 , further comprising a position surrogate configured for implantation within an inferior vena cava of the body. 
     
     
         46 . The system of  claim 45 , wherein the processor is configured to control the direction of the radiation in response to the position surrogate within the inferior vena cava and without a position surrogate disposed within the renal artery. 
     
     
         47 . The system of any one of  claim 44 , wherein the processor is configured to provide a margin of less than 2 mm to account for heartbeat-induced movement of the renal artery and/or the location proximate the renal artery. 
     
     
         48 . The system of  claim 47 , wherein the processor is configured to provide a margin of less than 0.5 mm to account for heartbeat-induced movement of the renal artery and/or the location proximate the renal artery.