Methods and devices for detecting, controlling, and predicting radiation delivery

• US 8,848,869 B2
• Filed: 08/02/2013
• Issued: 09/30/2014
• Est. Priority Date: 12/23/2007
• Status: Active Grant

• Current Assignee: Carl Zeiss Meditec Incorporated (Carl-Zeiss-Stiftung)
• Original Assignee: Oraya Therapeutics, Inc.
• Inventors: Gertner, Michael, Arnoldussen, Mark, Chell, Erik, Hansen, Steven D., Herron, Matt, Koruga, Igor, Liang, Junzhong
• Primary Examiner(s): Kao, Glen
• Application Number:
  US13/958,475
• Publication Number:
  US 20130315374A1
• Time in Patent Office: 424 Days
• Field of Search: 378/65
• US Class Current: 378/65
• CPC Class Codes: A61F 2009/00844 Feedback systems
• CPC Class Codes: A61F 2009/00863 Retina
• CPC Class Codes: A61F 9/008 using laser
• CPC Class Codes: A61N 2005/1059 using cameras imaging the patient
• CPC Class Codes: A61N 2005/1072 taking into account movement of the target
• CPC Class Codes: A61N 2005/1091 Kilovoltage or orthovoltage range photons
• CPC Class Codes: A61N 5/1017 Treatment of the eye, e.g. for "macular degeneration"
• 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

Abstract

Embodiments provide method and systems for determining alignment of a patient'"'"'s body part, such as an eye, in an external coordinate system of a treatment or diagnostic device, such as a radiotherapy device, so as to define a reference axis for guiding device operation. Additional embodiments provide image-based methods and systems for aligning, tracking and monitoring motion of a body part and a treatment target in relation to a radiation beam axis. Particular ophthalmic embodiments provide method and systems including an eye-contact guide device and imaging system for aligning and tracking motion of an eye and ocular treatment target in relation to an orthovoltage X-ray beam axis, so as to monitor application of radiation to a lesion, such as a macular lesion of the retina. Particular methods for controlling radiation in response to motion of the target during treatment are described, such as algorithms for gating or interrupting radiation emission, both to ensure treatment goals and to avoid exposure to sensitive structures.

Claims

1. Non-transitory machine-readable medium operable with an electronic computer, in treating a lesion on or adjacent the retina of an eye of a patient with an external-beam radiation device, to execute instructions effective to perform the steps comprising:

(a) placing the eye in alignment with a known system axis in an external three-dimensional coordinate system, and measuring an axial length of the eye;

(b) from a known position of the system axis and from the measured axial length, determining coordinates of the lesion to be treated in the external coordinate system;

(c) directing a collimated x-ray radiation beam along a known beam axis in the external coordinate system at the lesion to be treated;

(d) during said directing, tracking a position of the eye with respect to the known system axis, thus to track a position of the lesion to be treated in the external coordinate system; and

(e) based on the known beam axis of the collimated beam in the external coordinate system, and the tracked position of the lesion to be treated in the external coordinate system, as determined at least in part by the tracked position of the eye, calculating a total radiation equivalent received at the lesion to be treated during the treatment.

2. The medium of claim 1, wherein:

step (b) further includes determining the coordinates of at least one radiation-sensitive structure in the external coordinate system;

step (d) further includes tracking a position of the at least one radiation-sensitive structure in the external coordinate system; and

step (e) further includes, based on the tracked position of the at least one radiation-sensitive structure in the external coordinate system, calculating a total radiation equivalent received at the at least one radiation-sensitive structure during the treatment;

the instructions are further effective to perform the step of (f) based on the calculated radiation equivalent from step (e), controlling the radiation beam to insure that the at least one radiation-sensitive structure does not receive more than a preselected radiation equivalent during the treatment.

3. The medium of claim 2, wherein step (a) includes measuring the axial length of the eye by ultrasound imaging, and step (b) includes scaling the measured axial length from step (a) to a standard human-eye model, and determining the coordinates of the lesion to be treated and the at least one radiation-sensitive structure from the eye model.

4. The medium of claim 3, wherein step (a) includes determining a patient-eye geometric axis that extends through the center of the limbus and contains the corneal reflection of the eye, and aligning the geometric axis with the known system axis;

and wherein step (d) includes tracking the angular deviation of the geometric axis of the eye with the known system axis.

5. The medium of claim 4, wherein the instructions are further effective to perform the step of attaching an eye guide to the eye, centered thereon so that the geometric axis of the eye corresponds approximately to an axis of the eye guide, and aligning the axis of the eye guide with the known system axis.

6. The medium of claim 5, wherein step (b) includes using the measured axial length of the eye to place the patient'"'"'s eye in registry with the eye model, and using the coordinates of the lesion to be treated and the at least one radiation-sensitive structure in the model to determine the coordinates thereof in the external coordinate system.

7. The medium of claim 6, wherein step (d) includes tracking the position of the eye guide axis with respect to the system axis, thus to track the positions of the lesion and radiation-sensitive structures in the external coordinate system.

8. The medium of claim 7, wherein the eye model includes a virtual medium by which the attenuation of a radiation beam along a known path through the model can be determined;

and step (e) includes determining a spatial accumulation of radiation received at the macular region of the eye based on the known intensity of the collimated beam, the instantaneous positions of the eye, and the attenuation of the beam through the virtual medium along known pathways within the eye.

9. The medium of claim 8, wherein step (f) includes directing the beam against a macular region of the patient until the spatial accumulation of radiation mapped at the macula of the eye model reaches a predetermined dose level.

10. The medium of claim 7, wherein step (e) includes mapping a spatial quantity indicative of a distribution of total radiation onto the eye model, based on the tracked position of the eye during a period of directing a radiation beam at the retinal region of the eye.

11. The medium of claim 2, wherein the lesion to be treated is the macula, the at least one radiation-sensitive structure includes at least a portion of the optic nerve or optic disk of the eye, and step (e) includes calculating the total radiation equivalent received at the macula and at the optic disk during the treatment.

12. The medium of claim 2, wherein step (f) of controlling the radiation beam includes controlling the radiation beam to do one or more of:

(i) achieve a desired dose of radiation at the lesion;

(ii) avoid exceeding a selected level of radiation dose at the radiation-sensitive structure; and

(iii) avoid exceeding a selected threshold based on a spatial quantity, the threshold indicative of eye-motion-based departure of the beam axis from the selected target.

13. The medium of claim 2, wherein step (e) of calculating total radiation equivalent received at the lesion and the at least one radiation-sensitive structure includes determining a time-increment vector summation of a parameter indicative of an eye-motion-based departure of the beam axis from the selected target lesion to be treated.

14. The medium of claim 2, wherein step (e) of calculating total radiation equivalent received at the lesion and the at least one radiation-sensitive structure includes modulating a pre-determined radiation distribution model representing predicted radiation dose distribution to be received by tissue of the patient from the collimated radiation beam in the absence of eye motion, the modulating being based on tracked eye motion during treatment, so as to determine a radiation dose distribution accounting for actual eye motion during treatment.

15. The medium of claim 2, wherein step (e) of calculating total radiation equivalent received at the lesion and the at least one radiation-sensitive structure further includes modulating a pre-determined radiation distribution model for a plurality of successive time increments during radiation treatment so as to determine a cumulative dose distribution during the course of treatment;

and wherein step (f) includes (i) comparing the cumulative dose received by a selected non-target anatomical structure with a pre-determined dose threshold quantity to determine whether the threshold has been exceeded and (ii) in the event that the threshold has been exceeded, controlling the radiation beam or beam axis to reduce or eliminate further radiation dose to the selected non-target anatomical structure.

16. The medium of claim 2, wherein step (e) of calculating total radiation equivalent received at the lesion to be treated and the at least one radiation-sensitive structure further includes sequentially modulating a pre-determined radiation distribution model for a plurality of successive time increments during radiation treatment so as to determine a cumulative dose distribution during the course of treatment;

and wherein step (f) includes (i) comparing the cumulative dose received by a selected anatomical target region with a pre-determined dose threshold quantity to determine whether the threshold has been reached, and (ii) in the event that the threshold has been reached, controlling the radiation beam or beam axis to reduce or eliminate further radiation dose to the selected anatomical target region.

17. The medium of claim 2, wherein the lesion is a macular lesion and step (c) includes determining the position of a macula of the patient in a treatment coordinate system from the known position of the eye and the coordinates of the macula in the external coordinate system, and determining a treatment axis in the external coordinate system that intersects the patient macula.

18. The medium of claim 17, wherein step (c) includes directing the collimated X-ray beam along each of at least two different known treatment axes in the treatment coordinate system at a region of the macular region of a retina of the patient.

19. The medium of claim 18, wherein step (f) includes controlling the X-ray beam to deliver approximately equal doses of radiation at the macula along each of the different known treatment axes.

20. The medium of claim 17, wherein step (f) includes turning off the beam being directed onto the eye when the position of the macula, as tracked in step (c), relative to the axis of the beam, is greater than a predetermined threshold distance.

21. Non-transitory machine-readable medium operable with an electronic computer in a treatment system, for treating a target area in a patient with an irradiation beam, operably connected to (a) a tracking assembly for tracking a position of a patient body region containing the target area and at least one radiation-sensitive area with respect to a known reference axis in an external coordinate system and (b) a beam source for directing an x-ray irradiation beam at the patient target area along a known treatment axis in the external coordinate system, to execute instructions effective to perform the steps comprising:

(i) determining, from a known position of body region in the external coordinate system, the coordinates of the target area to be treated and the coordinates of the at least one radiation-sensitive patient structure;

(ii) during a period when the irradiation beam is being directed along the treatment axis at the target area, and based on information received from the tracking assembly, tracking positions of the target area to be treated and the at least one radiation-sensitive structure;

(iii) based on the known beam axis of the collimated beam in the external coordinate system, and the instantaneous positions of the target area to be treated and the at least one radiation-sensitive structure, calculating a total radiation equivalent received at the target area and at least one radiation-sensitive structure; and

(iv) based on the calculated radiation equivalents from step (iii), controlling the irradiation beam to insure that the at least one radiation-sensitive structure does not receive more than a preselected radiation equivalent during the treatment.