06826423 - US006826423B1(12 United States Patent(10 Patent...

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Unformatted text preview: US006826423B1 (12) United States Patent (10) Patent No.: US 6,826,423 B1 Hardy et al. (45) Date of Patent: Nov. 30, 2004 (54) WHOLE BODY STEREOTACTIC 4,791,934 A 12/1988 Brunnett LOCALIZATION AND [MMOBILIZATION 4,838,265 A * 6/1989 Cosman et a1. .............. .. 606/1 SYSTEM 4,905,267 A * 2/1990 Miller et a1. .............. .. 378/208 5,099,846 A 3/1992 Hardy (75) Inventors: Tyrone L. Hardy, Del Mar, CA (US); 5’143’076 A 9/1992 Hardy et al' Laura R Demin San Die 0 CA 5’176’689 A “1993 Hardy ' g’ g ’ 5,299,253 A * 3/1994 Wessels .................... .. 378/163 (Us) 5,354,314 A 10/1994 Hardy et a1. . _ _ 5,398,684 A 3/1995 Hardy (73) ASSlgHeei MIDCO-MEdlcal Instrumentatl9n and 5,442,674 A * 8/1995 Picard et a1. ............... .. 378/20 Diagnostics Corporation, San Diego, 5,531,229 A 7/1996 Dean et a1. CA (US) 5,553,112 A 9/1996 Hardy et a1. 5,566,681 A 10/1996 Manwaring et a1. ( * ) Notice: Subject to any disclaimer, the term of this 5,681,326 A * 10/1997 Lax .......................... .. 606/130 patent is extended or adjusted under 35 596829890 A 11/1997 KOTmOS et a1- Us’C. 154(b) by 0 days. 5,794,628 A 8/1998 Dean 5,908,410 A 6/1999 Weber et 211. 6,011,828 A 1/2000 Hardy et a1. (21) Appl-N0~110/029,305 6,143,003 A 11/2000 Cosman . . 6,148,058 A * 11/2000 Dobbs ....................... .. 378/19 (22) Flled‘ Dec' 20’ 2001 6,533,794 B2 * 3/2003 Chakeres .................. .. 606/130 Related US. Application Data OTHER PUBLICATIONS (63) Continuation—in—part of application No. 09/477,397, filed on Bentel, G~C-> Chapter: Treatment Geometry, P “tier” P 05i' Jan. 4, 2000, now abandoned. tioning and Immobilization in Radiation Oncology, (60) Provisional application No. 60/114,942, filed on Jan. 4, McGraw—Hfll publishers, pp 1—10(1999). 1999. (51) Int Cl 7 A61B 5/05 (List continued on next page.) (52) US. Cl. ..................... .. 600/429; 606/130; 600/426; Primary Examiner—Eleni Mantis Mercader 600/417; 600/414 (74) Attorney, Agent, or Firm—Peacock, Myers & Adams (58) Field of Search ............................... .. 600/407, 411, 600/414, 417, 426, 427, 429, 415, 378/205, (57) ABSTRACT 208, 209; 606/130; 5/601 An apparatus and method for aligning and imaging a body part which immobilizes the body part Within a stereotactic (56) References Cited body localization system having an imaging resolver fiducial Us. PATENT DOCUMENTS localizer for precise imaging and localization of the body parts Within the apparatus. Both anterior and posterior 396929023 A 9/1972 Phillips et a1~ immobilization methods can be used. A continuous array of 377837251 A “1974 PaVkOViCh coupled fiducials is employed With at least one pair formed 4,341,220 A 7/1982 Perfy in a 313/2 horizontal linked sine and cosine wave fiducial 4,583,538 A 4/1986 Onlk et a1. pattern. 4,608,977 A 9/1986 Brown 4,618,978 A 10/1986 Cosman 4,638,798 A 1/1987 Shelden et a1. 21 Claims, 12 Drawing Sheets CA I) Marker Fiducial US 6,826,423 B1 Page 2 OTHER PUBLICATIONS Bentel, G.C., Chapter: Treatment Accuracy and Precision, Patient Positioning and Immobilization in Radiation Oncol- ogy, McGraw—Hill publishers, pp 11—22 (1999). Bentel, G.C., Chapter: General Consideration of Positioning and Immobilization, Patient Positioning and Immobilization in Radiation Oncology, McGraw—Hill publishers, pp 23—37 (1999). Bentel, G.C., Chapter: Central Nervous System, Patient Positioning and Immobilization in Radiation Oncology, McGraw—Hill publishers, pp 71—91 (1999). Bentel, G.C., et al., Comparison of Two Repositioning Devices Used During Radiation Therapy for Hodgkin’s Disease, Int. J. Radiation Oncology Biol. Phys., vol. 38, No. 4, pp. 791—795 (1997). Bentel, G.C., et al., “Impact of Cradle Immobilization Setup Reproducibility During External Beam Radiation Therapy for Lung Cancer,” Int. J. Radiation Oncology Biol. Phys., vol. 38, No. 3, pp 527—531 (1997). Bertolina, J.A., et al., “Quality Assurance Testing for an Extracranial Stereotactic Device: Methods and Results,” Poster No. 129 Int’l Stereotactic Radiosurgery Society, p. 233 (1999). Blomgren, H., et al., “Radiosurgery for Tumors in the Body: Clinical Experience Using a New Method,” Journal of Radiosurgery, vol. 1, No. 1, pp 63—74 (1998). Blomgren, H., et al., “Stereotactic High Dose Fraction Radiation Therapy of Extracranial Tumors Using an Accel- erator,”Acta Oncologica, vol. 34, No. 6, pp 861—870 (1995). Dryzmala, R.E., “Quality Assurance for LINAC—based Ste- reotactic Radiosurgery,”. MED—TEC, Inc. “UNI—FRAME® Head Immobilization System” Advertisement (1996). Smithers Medical Products Inc., Product Catalog exclu- sively featuring: ALPHA CRADLE® Brand Patient Repo- sitioning Systems Advertisement (1995). Izi Medical Products Corp. World Wide Web Page featuring “Multi—Modality Radiographic Marker” and Multi—Modal- ity Radiographic Markers (Sep. 1999). Magellan—Biosense ® “Image—Guidance for Brain, Spine and Sinus Surgery,” (date unknown). CIRS Computerized Imaging Reference Systems, Inc. “Dimensional Anthropomorphic Skull Phantom” Biosence® Nov. 1999). MED—TEC, Inc., VAC—LOKTM Patient Immobilization Sys- tem (1996). Lattanzi, J .P., et al., “A Comparison of Daily C T Localiza- tion to a Daily Ultrasound Based System (BATTM) in Pros- tate Carcinoma—Will BAT Fly?”, I.J. Radiation Oncology Bio.Phys., vol. 42, No. 1, p 215 (Suppl. 1998). Lax, I., et al., “Stereotactic Radiotherapy of Malignancies in the Abdomen,”Acta Oncologica, vol. 33, No. 6, pp 677—683 (1994). Lax, I, et al., “Stereotactic Radiotherapy of Extracranial Targets,” Z. Med. Phys., vol. 4, pp 112—113 (1994). Lax, I., et al., “Extracranial Stereotactic Radiosurgery of Localized Targets,” Journal of Radiosurgery, vol. 1, No. 2, pp 135—148 (1998). Lederman, G., et al., Editors: “Body Radiosurgery Results,” J. of Radiosurgery, www.siuh.edu.radoncology/results, 1998a. Lederman, G., et al., Editors: “Fractionated Stereotactic Body Radiosurgery at Staten Island University Hospital,”. of Radiosurgery, www.siuh.edu.radoncology/bodyrs, 1998c. Lederman, G., et al., Editors: “Innovative Treatment for Pancreas Cancers,” J. of Radiosurgery, www.siuh.edu.ra- doncology/pancancer, 1998d. Lederman, G., et al., Editors: “Fractionated Stereotactic Body Radiosurgery, an Innovative and Effective New Treat- ment Method,” J. of Radiosurgery, www.siuh.edu.radoncol- ogy/bodyrad, 1998e. Lederman, G., et al., Editors: “Stereotactic Radiosurgery (BSR) for Extracranial Metastases,” J. of Radiosurgery, www.siuh.edu.radoncology/estracran, 1998g. Lederman, G., et al., Editors: “Body Stereotactic Radiosur- gery (BSR) for Primary Extracranial Tumors,” J. of Radio- surgery, www.siuh.edu.radoncology/extracrantumor, 1998. Lederman, G., et al., Editors: “Body Radiosurgery Treat- ment Procedure,” J. ofRadiosurgery, www.siuh.edu.radon- cology/bradprocedure, 1998. Naslund, I., et al., “New Prostate Repositioning Para- digm—a Whole Body Frame for Conformal Radiotherapy Techniques, with Vertical Patient Alignment and Rotation to a Horizontal Position,” I.J. Radiation Oncology/Biology/ Physics, vol. 39, No. 2, Suppl Abstract No. 2176 (1997). Onik, G., et al., “CT Body Stereotaxic Systems for Place- ment of Needles Arrays,” Int. J. Radiation Oncology Biol. Phys., vol. 14, pp 121—128 (1987). Sato, M., et al., “Feasibility of Fameless Stereotactic High— Dose Radiation Therapy for Primary or Metastatic Liver Cancer,” J of Radiosurgery, vol. 1, No. 3, pp 233—238 (1998). Stea, B., et al., “Spinal Stereotactic Radiosurgery: a Phase—1 Study,” 1. J. Radiation Oncology Bio. Phys., vol. 42, No. 1, p 214 (Supplement 1998), Abstract No. 1011. Wulf, J., et al., “Hypofractionated, High—Dose Radiation Under Stereotactic Conditions in the Stereotactic Body Frame: Accuracy of Repositioning at 11 CT—Simulations and 37 Applications at the LINAC,” I .J . Radiation Oncology Bio. Phys., vol. 42, No. 1, p 215 (Supplement 1998) Abstract No. 1013. BIONIX Co., “Reusable/Disposable Frame Head Immobi- lizer,” Advertisement (Apr. 1996). BIONIX Co., “Pelvis/Belly Board Immobilizer,” Advertise- ment (Apr. 1996). BIONIX Co., “3—D Pelvis Board Immobilizer,” Advertise- ment (Apr. 1996). MED—TEC, Inc. “HipFix® Hip & Pelvic Immobilization System” Advertisement (1996). MED—TEC, Inc. “REDI—FOAM Foam Immobilization Sys- tem” Advertisement (1996). Precision Therapy International Stereotactic Body FrameTM Dose escalation by Precision Conformal Radiotherapy, Advertisement (Sep. 1995). Pfizer—Leibinger® Extracranial Radiosurgery, Advertise- ment (1997). Ferrero, R., “Consider Using Resolvers and Synchros,” Electronic Design, vol. 17, pp70—72 (1975). Goldberg, A., et al., “Hypofractionated Body Radiosurgery (HBR) as Treatment of Primary Pancreas Cancers,” J. RadiosurgeryI, vol. 1, No. 1, pp 63—74 (1998) Abstract siuh.edu.radoncology/hypocancer. Hamilton, Allan J., “Preliminary Clinical Experience with Linear Accelerator—Based Spinal Stereotactic Radiosur- gery,” Neurosurgery, vol. 36, No. 2, pp 311—319 (1995). US 6,826,423 B1 Page 3 Lutz, W., et al., “A System for Stereotactic Radiosurgery With a Linear Accelerator,” Int. J. Radiation Oncology Biol. Phys, vol. 14, pp 373—381 (Feb. 1988). Hamilton, A.J., “LINAC—Based Spinal Stereotactic Radio- surgery,” Amer Soc. for Stereotactic and Functional Neuro- surgery, p. 69 (Mar. 10, 1995) Abstract. Hamilton, A.J., et al., “Phase 1 Prototype Device for Sinal Stereotactic Radiosurgery,” LINAC Radiosurgery—Z 995, p 83, paper No. 49, Dec. 6—10, 1995. Hamilton, A.J., et al., “Spinal Stereotactic Radiosurgery: A Viable Treatment Strategy for Spinal Neoplasms Failing Standard Fractionated Radiotherapy?” Int’l Stereotactic Radiosurgery Society, 3’“ Congress, p. 55, paper No. 29 Abstract (Jun. 27, 1997). Hamilton, A.J., Chapter 92: Linear Accelerator (LINAC)— Based Stereotactic Spinal Radiosurgery, Textbook of Ster- eotactic and Functional Neurosurgery, McGraW—Hill pp 857—869 (1998). Hanselman, D.C., “Resolver Signal Requirements for High Accuracy Resolver—to—Digital Conversion,” IEEE T ransac- tions on Industrial Electronics, vol. 37, No. 6, pp 556—561 (Dec. 1990). Herfarth, K.K., et al., “Extracranial Stereotactic Conformal Radiation Treatment of Tumors in the Liver and the Lung,” I. J. Radiation Oncology Bio Phys, vol. 42, No. 1, p 214 (Suppl. 1998). * cited by examiner US. Patent Nov. 30, 2004 Sheet 1 0f 12 US 6,826,423 B1 Place patient in body localizer and form body mold by the use of a vacuum lock or foam system Fixate thermoplastic sheet to further restrain a body part Determine stereotactic coordinates, areas or volumes (structures) within imaged body part using resolver algorithm Perform trajectories and treatment volumetric calculations Determine treatment plan to effectively treat volume or structure. e.g., biopsy. radiation, or beam therapy Transport patient to linear accelerator and align patient in body localizer Align body locatizer with patient in radiation treatment tield according to determined stereotactic coordinates Treat patient according to radiation plan Biopsy . . . or surgery Patient may be returned on repeat occasrons, realigned and retreated according to treatment plan FIG-1 US. Patent Nov. 30, 2004 Sheet 2 0f 12 US 6,826,423 B1 FIG-2d FIG-2b FIG-20 FIG-2a US. Patent Nov. 30, 2004 Sheet 3 0f 12 US 6,826,423 B1 QA I) Marker Fiducial W=592 L=-42 US. Patent Nov. 30, 2004 Sheet 4 0f 12 US 6,826,423 B1 ‘ or HiSpeed Adv svngpzc Se:4 OM 32.0 lmz26 DFDV 480C!“ 3?th \ kV120‘» a . mA ‘250 $32.21... -. Large ‘* 1.0mm 1.511 T+1 0.0 1fié/HE 07220231 PM/02.00 0 w 30 *- L:4OO FIG-4 US. Patent Nov. 30, 2004 Sheet 5 0f 12 US 6,826,423 B1 3" O D 9 LL // OwO-r .vae-v-x-W'Mmu— . .. Janna?” wk ‘ 0 POINTS FIG-5 US. Patent Nov. 30, 2004 Sheet 6 0f 12 US 6,826,423 B1 US. Patent Nov. 30, 2004 Sheet 7 0f 12 US 6,826,423 B1 FiG-Q US. Patent Nov. 30, 2004 Sheet 8 0f 12 US 6,826,423 B1 TOP z FIDUCIALS x = 120 - 0.08z . 403mm +360°} / - “I gnmn-I—I HHS FIDUCIAL StNE FIDUCIAL I I ' I I l XO L : I I So % t : s T A .’ . Wnom r T '2— C0 ' ' : : C 9 I , X I ' < I I I I x Lat—J DIAGONAL P1 FIDUCIAL CDSINE LHS FIDUCIAL FIDUCIAL FIG-11 US. Patent Nov. 30, 2004 Sheet 9 0f 12 US 6,826,423 B1 .-._.~.-—-—._._._.—-_-....-..._._. nu.«.~.~.--_._-_.—.........-....-—.-. __._—__—..—.._-__.. -—--._--.-.-~.—.—-_.~..—.-.-.-.—.. ........-_...-.---.--.—.._._._._.—‘ FIG-12a FIG-12b FlG-12C 0‘ I120I 1240 I01 1 so 180 300 360 60 FlG-12e US 6,826,423 B1 1 WHOLE BODY STEREOTACTIC LOCALIZATION AND IMMOBILIZATION SYSTEM CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation-in-part application of US. patent application Ser. No. 09/477,397, entitled “Whole Body Stereotactic Localization System,” filed on Jan. 4, 2000, now abandoned, which application claimed the benefit of the filing of US. Provisional Patent Application Ser. No. 60/114,942, entitled “A Whole Body Stereotactic Localiza- tion System With Imaging Resolver Apparatus and Method for Stereotactic Alignment,” filed on Jan. 4, 1999, and the specifications thereof are incorporated herein by reference. BACKGROUND OF THE INVENTION 1. Field of the Invention (Technical Field) The present invention relates to medical equipment and methods, more particularly to equipment and methods for radiation therapy including stereotactic localization and immobilization systems and methods. 2. Background Art Fractionated radiation therapy to a target lesion within the body is the primary method used for radiation therapy. This method requires precise immobilization and repositioning of the patient for other treatment sessions. Stereotactic local- ization and procedures on cranial and extra-cranial body parts have a similar requirement. Note that the following discussion refers to a number of publications by author(s) and year of publication, and that due to recent publication dates certain publications are not to be considered as prior art vis-a-vis the present invention. Discussion of such publications herein is given for more complete background and is not to be construed as an admission that such publications are prior art for patentabil- ity determination purposes. The need for effective patient immobilization techniques for radiation therapy has recently inspired the development and use of many immobilization devices in that field. The ability to reposition the patient and the patient’s ability to maintain the position during treatment may be improved with the use of immobilization devices (see Bentel 1999). Immobilization reduces “normal tissue” complication rate, allows increased irradiation, and improves tumor control rate. “A modest increase of the treatment and isodose margin can have a significant effect on the volume of normal tissue exposed” (see Bentel 1999). Historically, skin marks, or marker systems (see US. Pat. No. 4,583,538, to Onik, et al.), have been used to aid in target localization and reposition- ing. Skin marks used for patient repositioning may migrate as they are re-marked and markings can shift with respect to underlying deeper tissues. They also tend to smear and fade. Markings on a body immobilization device do not move with respect to the target, they do not smear or fade, hence the problems of re-marking and migration are eliminated (see Bentel 1999). Markings on the immobilization device may also be matched to skin markings (see Bentel 1999). Patient comfort, ability to easily maintain the position for extended periods of time, reproducibility of the patient’s “prescription” position, and anticipated beam orientation are essential in successful repeat radiotherapy treatments (see Bentel 1999). Comfort allows the patient to relax in a position throughout the treatment period, discouraging body movement caused by fatigue or discomfort. Patient move- 10 15 20 25 30 35 40 45 50 55 60 65 2 ment could invalidate target localization and expose healthy tissue to unwanted radiation. Some patients, especially children, may move as much as 5 mm (or more) during treatment (due to pain or an uncomfortable position or because they are uncooperative, demented or restless) (see Bentel 1999). Goitein and Busse studied the theoretical effect of under dosage at the perimeter of the treatment field caused by random immobilization errors. They found that as much as a 12% improvement of tumor control probability could be achieved by good Immobilization techniques (see Bentel 1999). In addition, a cost reduction is realized over traditional radiation therapy because the number of port films as well as setup time is reduced which allows for more patient throughput (see Bentel 1999). Because body fixation is essential for controlled radiation therapy during cancer treatment (Lederman, et al. 1998), emphasis has been placed on non-invasive and comfortable means of body immobilization and repositioning (see Bentel 1999). New techniques for precision radiation to extracra- nial targets of the body have been developed for highly successful treatment of lesions. External fixation systems are used to localize the body for exact repositioning during repeat treatments. The concept of stereotactic localization has been used to localize and aid in the target positioning for radiotherapy (see Lax, et al. 1994 and Hamilton, et al 1995). Bentel (Bentel 1999) references a concept of three- dimensional localization (stereotactic localization) when she states that “The coordinate system allows one to describe the location of any point with respect to another known point (origin). Three axes (x,y,z) transect this known point. The location of any point with respect to the origin is described by the distance measured along each axis and by indicating on which side of the axis the point is located.” These concepts are fundamental to the principles of stereotactc localization, which is to determine the location of deep body structures which are invisible from the surface but their location can be determined by a knowledge of their three- dimensional coordinates in space relative to known anatomi- cal and topographical landmarks in a volumetric space defined by a stereotactic instrument. The stereotactic tech- nique seeks to avoid disturbance to surrounding structures during therapeutic interventions by the use of minimally invasive precision localization Instruments. Guiot, G. and Derome, P., “The principles of stereotactic thalamotomy”, Correlative Neurosurgery, edited by Kahn, E J et al., Springfield, Ill., 2”“ Edition, Chapter 18, pp. 376—401, 1969. As noted by Bentel and Marks (Bentel, et al. 1997) and Bentel (Bentel 1999), a number of methods have been historically used for patient immobilization during radiation therapy. More recently the concept of stereotactic localization, which has previously been successfully applied to radiotherapy/radiosurgery of the brain (see Lutz, et al. 1988), has been applied to extracranial radiotherapy target areas. (Lax 1994, Lederman 1998, and Hamilton, et al., 1995 and 1997). This method of patient immobilization and stereotactic localization has been found to be more effective than pre- vious localization methods for radiation therapy. Lax, et al. (Lax, et al. 1994), found a high degree of target reproduc- ibility when using a stereotactic body frame. They found, from repeat CT examinations of patients in the body frame, a 5 mm range (i.e., a 2—7 mm range of error) of target volume positioning for targets in the liver and lungs. In addition, local tumor control of 90% was possible using this technique (see Blomgren, et al. 1995). The clinical use of a stereotactic body frame is increasing because it can be used to treat lesions over a wide variety of body areas (see Lederman, et al. 1998a—g). US 6,826,423 B1 3 Additional references providing important background to the present invention include the following US. Pat. No. 3,783,251, to Pavkovich, et al.; US. Pat. No. 4,583,538, to Onik, et al.; US. Pat. No. 4,638,798, to Shelden, et al.; US. Pat. No. 4,341,220, to Perry; US. Pat. No. 4,608,977, to 5 Brown, et al.; US. Pat. No. 4,618,978, to Cosman, et al.; US. Pat. No...
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