Orthovoltage radiosurgery

• US 7,953,203 B2
• Filed: 05/16/2008
• Issued: 05/31/2011
• Est. Priority Date: 04/09/2007
• Status: Active Grant

• Current Assignee: Carl Zeiss Meditec Incorporated (Carl-Zeiss-Stiftung)
• Original Assignee: Oraya Therapeutics, Inc.
• Inventors: Gertner, Michael, Hansen, Steven D., Chell, Erik
• Primary Examiner(s): KAO, CHIH CHENG G
• Application Number:
  US12/122,640
• Publication Number:
  US 20090003525A1
• Time in Patent Office: 1,110 Days
• Field of Search: 378/65
• US Class Current: 378/65
• CPC Class Codes: A61B 6/506 for diagnosis of nerves
• CPC Class Codes: A61B 6/508 for non-human patients
• CPC Class Codes: A61N 2005/1019 Sources therefor
• CPC Class Codes: A61N 2005/1022 Generators, e.g. X-ray tubes
• CPC Class Codes: A61N 2005/105 using a laser alignment system
• CPC Class Codes: A61N 2005/1051 using an active marker markers in general A61B90/39
• CPC Class Codes: A61N 2005/1059 using cameras imaging the patient
• CPC Class Codes: A61N 2005/1091 Kilovoltage or orthovoltage range photons
• CPC Class Codes: A61N 2005/1097 Means for immobilizing the patient
• CPC Class Codes: A61N 5/10 X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy A61N5/01 takes precedence
• CPC Class Codes: A61N 5/1001 using radiation sources introduced into or applied onto the body; brachytherapy
• CPC Class Codes: A61N 5/1017 Treatment of the eye, e.g. for "macular degeneration"
• CPC Class Codes: A61N 5/1045 using a multi-leaf collimator, e.g. for intensity modulated radiation therapy or IMRT
• CPC Class Codes: A61N 5/1048 Monitoring, verifying, controlling systems and methods
• CPC Class Codes: A61N 5/1049 for verifying the position of the patient with respect to the radiation beam
• CPC Class Codes: A61N 5/1064 for adjusting radiation treatment in response to monitoring
• CPC Class Codes: A61N 5/1065 Beam adjustment
• CPC Class Codes: A61N 5/1067 in real time, i.e. during treatment
• CPC Class Codes: A61N 5/1077 Beam delivery systems
• CPC Class Codes: A61N 5/1084 for delivering multiple intersecting beams at the same time, e.g. gamma knives

Abstract

A radiosurgery system is described that is configured to deliver a therapeutic dose of radiation to a target structure in a patient. In some embodiments, inflammatory ocular disorders are treated, specifically macular degeneration. In some embodiments, other disorders or tissues of a body are treated with the dose of radiation. In some embodiments, the target tissues are placed in a global coordinate system based on ocular imaging. In some embodiments, the target tissues inside the global coordinate system lead to direction of an automated positioning system that is directed based on the target tissues within the coordinate system. In some embodiments, a treatment plan is utilized in which beam energy and direction and duration of time for treatment is determined for a specific disease to be treated and/or structures to be avoided. In some embodiments, a fiducial marker is used to identify the location of the target tissues. In some embodiments, an eye is held with force and in alignment with the system. In some embodiments, the device automatically turns off with excessive movement outside of alignment along an axis of the eye. In some embodiments, radiodynamic therapy is described in which radiosurgery is used in combination with other treatments and can be delivered concomitant with, prior to, or following other treatments.

Claims

1. A method of treating tissue at a target zone deep to a surface of a patient'"'"'s body by emitting, from an x-ray source having a system axis defined in a global coordinate system, a collimated x-ray beam having a beam axis defined in the global coordinate system, said method comprising:

(a) determining a reference axis defined relative to the patient'"'"'s body, the reference axis having a known position and orientation in the global coordinate system;

(b) determining a treatment axis that intersects the target zone, the treatment axis having a known position and orientation with respect to the reference axis and with respect to the system axis in the global coordinate system;

(c) positioning the x-ray source to a first position with respect to the system axis, such that the beam axis intersects the treatment axis at (i) a first treatment site within the target zone and (ii) a first incident angle with respect to the treatment axis, and such that the beam axis intersects the surface of the patient'"'"'s body at a first location;

(d) emitting an x-ray beam toward the target zone along the beam axis, to irradiate the target zone with a first radiation dose;

(e) rotating the x-ray source about the system axis to a second position with respect to the system axis, such that the beam axis intersects the treatment axis at (i) a second treatment site within the target zone and (ii) at a second incident angle with respect to the treatment axis, and such that the beam axis intersects the surface of the patient'"'"'s body at a second location that is separated from the first location by a first distance; and

(f) emitting an x-ray beam toward the target zone along the beam axis, to irradiate the target zone with a second radiation dose.

2. The method of claim 1, wherein the first treatment site is separated from the second treatment site by a second distance.

3. The method of claim 1, wherein the treatment axis is substantially parallel to the reference axis, and wherein the treatment axis is offset in one or both of an “

x”

direction and a “

y”

direction, both of which directions are perpendicular to the reference axis.

4. The method of claim 1, wherein rotating step (e) comprises rotating the x-ray source about the system axis while keeping substantially constant both (i) an incident angle of the beam axis with respect to the treatment axis, and (ii) a distance from the x-ray source to the target zone.

5. The method of claim 1, further comprising repeating steps (e) and (f) until a predetermined total radiation dose has been applied to the target zone.

6. The method of claim 1, wherein the emitting steps (d) and (f) are effective to irradiate the target zone with a dose of radiation of from about 1 Gy to about 40 Gy.

7. The method of claim 1, wherein positioning step (c) and rotating step (e) comprise selecting orientations and/or positions of the x-ray source such that the beam axis, during emitting steps (d) and (f), does not intersect at least one region of the body near the target zone, such that a radiation dose applied to a vulnerable structure within the region is limited.

8. The method of claim 7, wherein the target zone comprises retinal tissue of the patient'"'"'s eye, and the vulnerable structure comprises at least one of an optic nerve and a lens of the eye.

9. The method of claim 1, wherein said target zone comprises a tumor.

10. The method of claim 1, wherein said target zone comprises breast tissue.

11. The method of claim 1, wherein said target zone comprises a prostate.

12. The method of claim 1, wherein said target zone comprises tissue exposed during an operative procedure.

13. The method of claim 1, wherein the target zone of the patient'"'"'s body lies at a depth of from about 10 mm to about 50 mm from the surface.

14. The method of claim 13, wherein the collimated x-ray beam has an energy spectrum configured to propagate through tissue to the target zone, such that a ratio of an exterior dose of radiation, to which the surface is exposed, to an interior dose of radiation, to which tissue at the target zone is exposed, is between about 2:

1 and about 5;

1.

15. The method of claim 13, wherein the x-ray beam is collimated to have a penumbra at the target zone of less than about 20%.

16. The method of claim 13, wherein, during the emitting steps (d) and (f), the x-ray source produces x-ray beams with a source anode positioned within about 200 mm from the target zone.

17. The method of claim 1, wherein:

(i) the target zone comprises tissue of the patient'"'"'s eye;

(ii) the reference axis comprises a central axis of the eye; and

(iii) at least one of the first location and the second location comprises a surface of the sclera of the eye that is separated from a sclera-cornea boundary.

18. The method of claim 17, wherein the collimated x-ray beam has an energy spectrum configured to penetrate the sclera of the eye to propagate to the target zone adjacent the retina, such that a ratio of a scleral dose of radiation, delivered to the sclera of the eye, to a target dose of radiation, delivered to tissue at the target zone, is between about 2:

1 and about 5;

1.

19. The method of claim 17, wherein the x-ray beam is collimated to have a penumbra at a target zone adjacent the retina of less than about 20%.

20. The method of claim 17, wherein, during the emitting steps (d) and (f), the x-ray source produces x-ray beams with a source anode positioned within about 200 mm from a target zone adjacent the retina.

21. The method of claim 17, wherein at least one of the first and second incident angles is selected such that the beam axis intersects the sclera of the eye at a determined minimum distance from a sclera-cornea boundary.

22. The method of claim 17, wherein at least one of the first and second incident angles is selected such that the beam axis intersects the sclera of the eye adjacent a pars plana of the eye.

23. The method of claim 17, wherein the tissue at the target zone comprises the macula, and wherein the method is directed to treat macular degeneration.

24. The method of claim 17, wherein the reference axis determined in step (a) approximates a geometric axis of the eye.

25. The method of claim 17, wherein the reference axis determined in step (a) approximates a visual axis of the eye.

26. The method of claim 17, further comprising stabilizing the eye during a treatment period, such that the eye remains in a substantially fixed position and/or orientation with respect to the system axis.

27. The method of claim 17, further comprising tracking a motion of the eye during a treatment period to detect at least one of a change of position and a change of orientation of the eye with respect to the global coordinate system, and interrupting said emission of radiation when a detected change exceeds a threshold.

28. The method of claim 17, wherein the target zone comprises the macula of the eye.

29. An x-ray treatment system for treating tissue at a target zone, deep to a surface of a patient'"'"'s body, by emission of a collimated x-ray beam, the system comprising:

(a) an alignment assembly operative to determine a reference axis defined relative to the patient'"'"'s body, which axis has a position and orientation in a global coordinate system,

(b) an x-ray source positionable in relation to a system axis defined in the global coordinate system, and operative to emit a collimated x-ray beam having a beam axis defining a beam path;

(c) a beam-positioning assembly operative to move the beam source to place the beam axis at selected positions with respect to the system axis, and

(d) a control unit operatively connected to the alignment assembly, x-ray source, and beam-positioning assembly, the control unit operating to;

(d1) determine, from information received from the alignment assembly related to an anatomical representation of the body, a treatment axis having a position and orientation with respect to the reference axis in the global coordinate system;

(d2) direct the beam-positioning assembly to move the x-ray source to a first position with respect to the system axis, at which the beam axis intersects the treatment axis at the target zone at an incident angle with respect to the treatment axis, such that the beam axis intersects a surface of the body at a first position;

(d3) direct the x-ray source to emit the x-ray beam toward the target zone along the beam axis, to irradiate the target zone with a radiation dose;

(d4) direct the beam-positioning assembly to move the x-ray source with respect to the system axis to a second position, at which the beam axis intersects the treatment axis at the target zone at an incident angle with respect to the treatment axis, so that the beam axis intersects the surface of the body at a second position, different from the first position; and

(d5) direct the x-ray source to emit the x-ray beam toward the target zone along the beam axis, to irradiate the target zone with a radiation dose.

30. The x-ray treatment system of claim 29, wherein the x-ray beam is generated by a linear accelerator.

31. The x-ray treatment system of claim 29, wherein the x-ray beam is less than 500 keV maximum photon energy.

32. The x-ray treatment system of claim 29, wherein the x-ray beam is less than 150 keV maximum photon energy.

33. The x-ray treatment system of claim 29, wherein the collimated x-ray beam further comprises a pointer light beam that identifies a trajectory of the x-ray beam in the global coordinate frame.

34. The x-ray treatment system of claim 29, wherein said beam positioning assembly is configured to move about at least one rotational axis such that an x-ray flux at the target, from beams emitted from the x-ray source at a plurality of positions about the at least one rotational axis, is constant.

35. The x-ray treatment system of claim 29, wherein said beam positioning assembly is configured to move about at least one rotational axis such that a distance between the x-ray source, at a plurality of positions about the at least one rotational axis, and the target is constant.

36. The x-ray treatment system of claim 29, wherein said beam positioning assembly is configured to move between the first position and the second position by movement in a single mechanical degree of freedom.

37. The x-ray treatment system of claim 36, wherein a range of motion of the single mechanical degree of freedom is mechanically limited so as to minimize error of positioning.

38. The x-ray treatment system of claim 29, wherein said beam positioning assembly is configured to move between the first position and the second position by rotation about the system axis, so that the beam axis in both the first and second positions lies within a cone defined by the target zone as an apex and by the selected incidence angle as a cone angle, so that the x-ray source remains a substantially constant distance from the target zone.

39. The x-ray treatment system of claim 29, wherein the alignment assembly further comprises an eye holder device configured to stabilize the eye of the patient during treatment so that the eye remains in a substantially fixed position and/or orientation in relation to the global coordinate system.

40. The x-ray treatment system of claim 29, wherein the alignment assembly further comprises a system configured to:

(i) track motion of the eye of the patient during treatment so as to detect a change of at least one of a position and orientation of the eye with respect to the global coordinate system;

(ii) determine whether the change exceeds a threshold of position and/or orientation; and

(iii) in an event that the change exceeds the threshold, prevent or reduce emission of radiation from the x-ray source.

41. The x-ray treatment system of claim 29, wherein each of a plurality of mechanical degrees of freedom of the positioning assembly, when operatively controlled by the control unit, is mechanically limited in range of motion so as to minimize error of positioning during treatment.