BACKGROUND OFTHF INVENTION

1. FIELD OF THE INVENTION

The present invention relates to the field of localization and treatment of disease, tumors, and the like and specifically relates to localization and treatment of disease through use of ultrasonic or similar energy waves.

2. DESCRIPTION OF THE RELATED ART

Use of ultrasound for diagnosis of conditions in humans and other animals is well known in the art However, only recently have ultrasound and other energy waves been employed to localize and treat conditions as well as to provide for the diagnosis of those conditions.

One example of a system combining localization and treatment is given by United States Patent Number 4,932,414 titled SYSTEM OF THERAPEUTIC ULTRASOUND AND REAL-TIME ULTRASONIC SCANNING (the '414 patent). The '414 patent describes a system for obtaining, in real-time, cross-sectional and 3-dimensional images of a body using ultrasonic energy. The imaging system of the '414 patent is combined with a therapeutic transducer for treatment. However, and importantly, the '414 patent describes a system in which two separate transducer assemblies are utilized — a first for imaging and a second for therapeutic applications. Use of separate transducers, one for imaging and one for therapy, leads to certain disadvantages including the requirement to co-ordinate data manipulation to overlap the therapy beam on the imaged plane. Secondly, use

of two transducers is likely to lead to increased size of the transducer assembly which is undesirable, especially for some applications.

Another example of such a combined localization and treatment system is given by United States Patent Number 4,955,365 titled LOCALIZATION AND THERAPY SYSTEM FOR TREATMENT OF SPATIALLY ORIENTED DISEASE (the '365 patent). The '365 patent describes a system in which a transducer assembly is provided for visualization and treatment of sites in a body where the transducer assembly comprises separate visualization and treatment transducers.

For example, in Figure 5 of the '365 patent and with reference to the accompanying description at column 8, lines 51, et seq., a probe 240 is shown which includes a therapy transducer 248 and a visualization transducer 254. The arrangement of Figure 5 of the '365 patent is understood to be useful for providing for the localization and treatment of prostate cancer. Therapy transducer 248 is moveable linearly along the axis of probe 240 (and with respect to visualization transducer 254, see col.9, lines 50 et seq.), in addition to being movable rotationaEy relative to arm elements 249. Separate means are provided to allow for linear movement of visualization transducer 254 (see col.9, lines 11, et seq.)

In summary, the '365 reference is understood to teach a localization and therapy system, including separate visualization and therapy transducers, wherein a first linear movement means is provided to allow for linear movement of the visualization transducer and a second linear movement means is provided to allow for linear movement of the therapy transducer. The '365 reference is not understood to teach coordinated linear movement of the separate visualization and therapy transducers.

The '365 patent is a continuation of United States Patent Number 4,858,613 titled LOCALIZATION AND THERAPY SYSTEM FOR TREATMENT OF SPATIALLY ORIENTED FOCAL DISEASE (the "613 reference) which similarly teaches use of separate visualization and therapy transducers.

United States Patent Number 4,484,569 titled ULTRASONIC DIAGNOSTIC AND THERAPEUTIC TRANSDUCER ASSEMBLY AND METHOD FOR USING (the '569 reference) also teaches use of a two transducer assembly which provides for therapeutic radiation from transducer 20 and diagnostic radiation from transducer 22. The '569 reference is understood to have particular applicability to ophthalmic therapy.

As can be seen, each of the '365, '163 and '569 references teach devices which employ dual transducers leading to, among other shortcomings, complications in coordinating localization signals received from the localization transducer with therapeutic radiation transmitted from the therapeutic transducer and increased manufacturing expense and complications in order to provide for two transducers in a single device.

Now, therefore, as one object of the present invention, it is desired to provide for a single transducer device capable of both therapeutic and localization operations.

As is well known in the art of acoustic imaging, it is possible to produce an image transducer signal wherein the transducer is mounted to provide for scanning the signal through a sector of a rotation about an axis. Such scanning is commonly referred to as a sector scan. An example of a system employing such a sector scanning technique may be found with reference to United States Patent Number 4,231,373 titled ULTRASONIC IMAGING APPARATUS (the '373 reference).

A second example of such a system may be found with reference to United States Patent Number 4,756,313 titled ULTRASONIC PROBE (the '313 reference).

More recently, devices have been developed which employ a linear scan in which a transducer is mounted for linear movement An example of such a system is found with reference to United States Patent Number 4,917,096 titled PORTABLE ULTRASONIC PROBE (the '096 reference). The '096 reference contends that such a linear scan arrangement overcomes certain disadvantages of sector scan devices such as by providing for an increased scan area through mechanical movement of the transducer with respect to the body being investigated. This is said to provide for a more predetermined and uniform movement as opposed to physical movement of the transducer housing itself. The '096 reference illustrates a system which provides for linear, but not sector, scanning of the transducer.

Also of interest is United States Patent Number 4,455, 872 titled ROTATING ULTRASONIC SCANNER (the '872 reference) which illustrates a transducer which may be linearly moved along a rotating apparatus. In the '872 reference, the transduceris positioned to transmit pulses of ultrasonic energy upward along a first axis. The transducer is mounted to provide for linear movement of the transducer along a second axis which is generally perpendicular to the first axis and is further mounted to provide for rotational movement of the transducer about a third axis which is generally parallel to the first axis and generally perpendicular to the second axis.

As a second object of the present invention, it is desired to develop a device which provides for advantages of linear scanning of a transducer while also

providing for advantages of sector scanning of the transducer. Such combined linear and sector scanning results in an advantageously increased scan volume.

In this regard, it is desired to provide for a transducer capable of emitting (and at least in the case of localization, receiving) energy along a first axis relative to the transducer while providing for relative linear movement of the transducer along a second axis which is generally perpendicular to the first axis and further providing for relative sector rotation about a third axis which is generally perpendicular to the first axis and parallel to the second axis. The linear movement provides for linear scanning of the transducer while the sector movement provides for sector scanning. As will be understood with reference to the below detailed description of the preferred embodiment of the present invention such linear and sector scanning provides for scanning in perpendicular planes and results in an advantageously increased scan volume.

Now, it has been discovered as another aspect of the present invention that use of perpendicular linear and sector scanned planes allows for the ability to describe in three-dimensional space a volume. The volume may be described for example during localization scanning of the transducer. Then, after defining the volume, the transducer may be used in a therapeutic mode to ablate the described volume. As will be seen, the transducer of the present invention may be controlled by adjusting the time on, intensity and spatial position of the transducer with respect to the described volume in order to adjust the depth of a lesion created by the transducer during the therapeutic ablation process.

These and other aspects of the present invention will be better understood with reference to the below detailed description of the preferred embodiment of the present invention as well as the accompanying drawings.

SUMMARY OF THE INVENTION

A localization and treatment system is described which utilizes wave energy, such as ultrasound, for both the localization and treatment steps. In the present invention, a transducer is utilized to provide wave energy which is directed into a body, such as a human undergoing examination and/or treatment The transducer is provided with means for providing sector movement as well as means for providing linear movement of the transducer yielding an improved ability to scan and treat areas in a body.

The present invention further provides for the transducer to be of a design which is capable of transmitting wave energy at a first level for purposes of localization and examination of the body and which is further capable of transmitting wave energy at a second level for purposes of treatment of disease in the body.

Still further, the present invention describes apparatus for maintaining a fixed relationship between the body being examined and treated and probe for housing the transducer. Such a fixed relationship is important in order to provide for treatment of the desired area within the body after completing the examination process.

Still further, the present invention defines an examination and treatment method in which a body is first examined to determine the desired area within the body for treatment The system displays on a display device an image of an area within the body and the user of the system of the present invention defines an area of the image to be treated. The system then provides for calculation and control of the necessary movements of the transducer in order to accomplish the treatment

These and other aspects of the present invention will be apparent to one of ordinary skill in the art with further reference to the below Detailed Description of the Preferred Embodiment and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is an overall block diagram of components of the present invention.

Figure 2 is an illustration of a display device as may be utilized by the present invention.

Figure 3 is an overall illustration of a control means as may be utihzed by the present invention.

Figure 4 is a perspective view of a probe as may be utilized by the present invention.

Figure 5 is a more detailed side view of the probe of the present invention.

Figure 6 is a detailed top view of the probe of the present invention.

Figure 7 is a back view of the probe of the present invention.

Figure 8 is a side cross-sectional view of the probe housing of the present invention.

Figure 9 is a cross-sectional view of a housing front part of the probe housing of the present invention.

Figure 10 is a cross-sectional view of a cap of the probe housing of the present invention.

Figure 11 is a cross-sectional view of a transducer assembly and shaft of the present invention.

Figure 12 is a cross-sectional view of a probe tip of the present invention.

Figure 13 illustrates a sector rotate assembly of the present invention.

Figure 14 illustrates a linear drive assembly of the present invention.

Figure 15 illustrates a coupling as may be utihzed by the sector rotate assembly and linear drive assembly of the present invention.

Figure 16 illustrates a collar as may be used in conjunction with the coupling of Figure 15 in the sector rotate assembly and hnear drive assembly of the present invention.

Figure 17 illustrates a spur gear as may be utihzed by the sector rotate assembly of the present invention.

Figure 18 illustrates a drive block as may be utilized by the linear drive assembly of the present invention.

Figure 19 is a flow diagram illustrating steps of a typical treatment process as may be carried out by the present invention.

Figure 20 is a diagram illustrating axial scanning as may be utihzed by the present invention.

Figure 21 is a diagram illustrating transverse scanning as may be utihzed by the present invention.

Figure 22 is a diagram illustrating display of a linear image as may be implemented by the present invention.

Figure 23 is a diagram illustrating display of a sector image as may be implemented by the present invention.

For ease of reference, it might be pointed out that reference numerals in ah of the accompanying drawings typically are in the form "drawing number" foUowed by two digits, xx; for example, reference numerals on Figure 1 may be numbered lxx; on Figure 9, reference numerals may be numbered 9xx. In certain cases, a reference numeral may be introduced on one drawing, e.g., reference numeral 201, and the same reference numeral may be utihzed on other drawings to refer to the same item.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

An improved device for providing for locahzation and therapeutic irradiation of a body is described. In the foUowing description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. It will be obvious, however, to one skilled in the art that the present invention may be practiced without these specific details. In other instances, well-known circuits, structures and techniques have not been shown in detail in order not to unnecessarily obscure the present invention.

OVERVIEW OF THE PRESENT INVENTION Figure 1 illustrates in simplified block diagram form the overall construction of the system of the present invention. The system of the present invention may be thought of as comprising three separately describable components, namely: (1) a display means 101; (2) a probe 103 or other device for housing a transducer as will be described in greater detail below; and (3) control means 102 coupled for controlling said display 101 and further coupled for controlling said probe 103. Each of these components will be described in greater detail below. Specifically, Figure 2 relates to display 101; Figure 3 relates to control means 102; and Figures 4-18 relate to probe 103. Figure 19 relates to a method of operating the system of the present invention. Figures 20 and 21 are useful in further describing the hnear and sector scan modes of me present invention as well as further describing the steps in accomplishing locahzation and treatment utilizing the system of the present invention.

DISPT- AY MEANS 101

The display means 101 may be any of a number of conventional displays capable of high resolution graphical display of information. Such displays are well-known in the art In the preferred embodiment the display means 101 is capable of displaying information under control of control means 102 in a format as illustrated with respect to Figure 2.

Figure 2 illustrates the screen of display means 101 in the format of the preferred embodiment in which the name and patient identifier of a patient being examined and treated by the system may be entered and displayed at area 201, the time and date of treatment may be displayed at area 202, a list of available functions may be displayed at area 203, messages such as prompts and error messages may be displayed at area 217, status information may be displayed in area 218, parameters as currently set for the system may be displayed in area 208 and images may be displayed in areas 212 and 213. In the linear image display window 213, an image produced by a linear mode scan may be displayed. Images produced by linear mode scans are better understood with reference to Figure 20. In the sector image window 212, an image produced by the sector mode scan may be displayed. Images produced by sector mode scans are better understood with reference to Figure 21.

As will be seen with reference to Figure 3, the system of the preferred embodiment further comprises a keyboard or other alphanumeric input device which may be used, for example, to enter the patient's name and other patient identifying information in area 201. The keyboard may further include function keys or other means for selecting one of the list of functions shown in the menu listed in area 203.

In the preferred embodiment, five functions are listed in area 203: (1) Fl - Imaging, (2) F2 - Analysis, (3) F3 - Treatment, (4) F4 - Patient Information, and (5) FIO - Exit Each of these functions are described in greater detail with reference to Appendix I. However, it will be useful here to briefly describe these functions.

The imaging function is utilized during a locahzation mode of the system and allows the user to select and adjust certain parameters of the system to provide for enhanced display of a portion of the patient's body. The parameters are displayed in area 208. After a satisfactory display of the portion of the patient's body is achieved, the imaging function further provides for saving of images and further provides for retrieval of saved images.

The Analysis function provides for certain analysis of the displayed image. The analysis includes allowing for selection of two points within the displayed image and calculation of distances between two selected points on the image. The analysis further provides for selection an portion of the displayed image and calculation of the area of the selected portion. In selecting points for such calculations, a pointing device such as trackball 304 is utihzed.

The Treatment function is used prior to and during treatment of a portion of the patient's body corresponding to a portion of the displayed image. The Treatment function provides for setting of certain parameters such as the intensity and on and off times of the acoustic wave used for treatment of the body as well as other, less often edited, parameters. These parameters are also displayed in area 208.

The user is also allowed to define the treatment volume by selecting an "area" from the displayed image for treatment (It is noted that this selected "area" is a two-dimensional area and not, technically, a three-dimensional "volume". However, the two-dimensional area is used to define the treatment volume as will

be described and, generally for ease of reference, the term volume will be used herein to describe both the three-dimensional volume within the body and the two-dimensional area defined on a display.) The treatment volume is defined by using a pointing device, such as trackball 304, to define a volume in the linear image display window 213 or the sector image display window 212. The area from the displayed image corresponds with a volume from the patient's body and, in the normal course of a treatment using the system of the present invention, the tissue in that volume of the patient's body will be treated with relatively high intensity acoustic waves resulting in destruction or alteration of the tissue in that volume. The treatment step is better descibed in connection with Figure 19 and, especially, in connection with step 1906 of that Figure.

The Patient Information function is utilized to allow entry of the patient's name and patient identifying information. In addition, die Patient Information function may be utilized to set the system date and time in certain embodiments of the present invention. (It might be noted that in the system of the preferred embodiment standard operating system commands are available to set the system date and time; therefore, it is not necessary to provide separate functions within the system of the preferred embodiment to set the data and time.)

Finally, the Exit function provides for exiting or terminating the computer program of the preferred embodiment and returning to control to the operating system. As will be discussed in greater detail below, the system of the preferred embodiment is implemented utilizing a standard, known microprocessor executing a standard operating system.

It has not yet been explicitly stated, but it is now noted that each of the above-described data entry steps may be accomphshed using a data input device such as keyboard 301.

Preferably, the display 101 is a color graphics monitor and, as is understood from a reading of Appendix I, should preferably support display of at least three colors in addition to gray scale display — white, yellow and red. As is discussed in Appendix I, white tinted portions of image indicate such portions are not being treated; yellow tinted portions indicate such portions are to be treated but are not yet treated; and red portions indicate treated areas. Of course, in alternative embodiments, other colors may be utilized. In other alternative embodiments, other indicators may be provided to indicate portions of the image not involved in the treatment, portions not yet treated and treated portions.

Finally, prompt window 217 is provided to allow display of prompts and error messages by the system. For example, upon selecting a function to enter the patient's name, a message stating "ENTER PATIENT'S NAME" may be displayed.

CONTROL MEANS 102 Turning now to Figure 3, the control means 102 of the system of the present invention is shown in greater detail. As illustrated, the display 101 is located on top of a cabinet 306 housing components of control means 102. As was discussed in connection with Figure 1, the display 101 is electrically coupled with the control means 102 although such coupling is not illustrated by Figure 3. Coupling of displays to processors and the like is well-known in the art and the particulars of such coupling will not be described here in any greater detail.

As was mentioned, control means 102 comprises a keyboard 301 which may be utilized for entering certain information into the system. Some of such information was described previously and in connection with Appendix I; other information may include, for example, program commands to initialize the system or commands to the operating system executing on processor 312. The control means further includes a cursor control device illustrated as trackball 304. The cursor control device is useful for performing certain functions previously described and described in connection with Appendix I.

The control means 102 further comprises a central processor and associated components shown as computer 312. Although any of a number of processors may be utilized without departure from the spirit and scope of the present invention, the preferred embodiment utilizes an IBM AT-compatible computer system having an Intel® 80386® 20MHz processor with five available expansion slots, 2 megabytes random access memory, a 40 megabyte hard disk drive, a floppy disk drive, a 200 watt power supply, at least two serial ports, one parallel port, a color video graphics processor, a math coprocessor and a real-time clock and calendar. The computer 312 is controlled under an IBM compatible BIOS-based DOS operating system.

The computer 312 serves as an image display processor, a controller for the probe 103, and a controllei coordinator for imaging and therapy electronics of the control means 102.

The trackball 304 is coupled to the computer 312 through one of the serial ports; the keyboard 301 is coupled to the computer 312 through a keyboard port; and the display is coupled to the computer 312 through the color video graphics

controller card. In addition, a printer (not shown) may optionally be coupled to the computer 312 through the parallel port

In addition to the above-described components, the computer 312 comprises a 40 MHz digitizer utihzed for RF data digitization. The digitizer receives A-mode signals from a transceiver 313. The transceiver 313 is coupled to receive signals from the probe 103 which is coupled to the control means 102 through probe connector 314. The digitizer is coupled with the computer 312 in one of the five expansion slots. The digitizer is utihzed to provide digital data to the computer 312 which is in turn provided to the color graphics controller card.

Another slot in the computer 312 is occupied by a digital/analog I/O interface card. The I/O interface card is provided for use as a motor driver interface for controlling a motor driver controller 316, for relay control of the probe in image/therapy mode, and for providing preamplifier control signals.

Finally, a third slot in the computer 312 is occupied a frequency synthesizer and control circuit board. Although the system of the present invention, in its intended commercial implementation uses a custom-designed board for frequency synthesizing and control, it is noted that in earlier versions of the system, an IEEE-488 programmable interface card was utihzed for programming of a function generator 315. The function generator 315 utihzed was a Tektronix TM5003 function generator available from Tektronix, Inc. of Beaverton, Oregon. The TM5003 function generator 315 is a stable RF source, programmable via the programmable interface card for selection of frequency, amplitude and burst mode. Of course, one of ordinary skill in the art may choose to use either a custom designed circuit board or off-the-shelf components.

The function generator provides RF signals, under program control of from the programmable interface card, the RF amplifier 318. The RF amplifier 318 in turn provides amplified RF signals to transducers in probe 103. As was described above, parameters of the probe may be selected by the user for use during the therapy portion of a treatment cycle. The programmable interface card is used to program the function generator responsive to the user selecting the desired parameters such as power shutdown limit, frequency, intensity, and on/off times.

It is now appropriate to turn to the motor driver controller 316. The motor controller driver 316 is a proprietary architecture motor control driver which provides for interfacing of motors within the probe 103 to the computer 312. The motors will be described in greater detail below. The main functions of the motor driver controller 316 are: (1) to maintain constant speed of the motors during scanning procedures; (2) to detect end positions of the scanning probe 103; and (3) to provide position information of a transducer within the probe 103. In order to maintain constant motor speed, closed-loop feedback control is utihzed.

End positions are detected through use of Hall effect switches and a magnet which is incorporated in the drive mechanism of the probe 103. The end position signals are utilized for gating and triggering of numerous functions in the system including (1) determination of the direction of travel of the transducer, (2) position counting, (3) display direction, and (4) digitizing sequence.

Finally, transducer position information is provided by a counting dividing encoder pulses received from the motor shaft of the probe 103. In the preferred embodiment, the motor shaft includes an optical encoder which generates 24 pulses for each revolution of the motor. The position information is used during imaging therapeutic modes of the probe.

As is seen, the control means 102 further comprises a probe connector 314 for coupling of the probe 103 with the control means 102, power supplies 321 and an isolation transformer 322.

PROBE 103 The probe 103 will now be described in greater detail. First it may be useful to refer to Figure 4 which illustrates an overall perspective view of the probe 103. The probe 103 includes a probe housing 400, as illustrated, which comprises a handle area 401 at what will be referred to as the proximal end of the probe 103 and a transducer housing area 402 at what will be referred to as the distal end of the probe 103. The proximal end of me probe 103 is coupled to the control means 102 by cabling exiting from the proximal end of the probe 103 and coupling with the probe connector 314 of the control means 102. Now, at the extreme distal end of probe 103, an opening is provided in the housing to allow for imaging and treatment of tissue with a transducer. Both the opening and transducer will be discussed in greater detail below; however, Figure 4 is useful for illustrating the scan area which may be achieved using the present invention. As can be seen with reference to area 403, a scan area is formed which includes both a sector scan component and a linear scan component As will be seen with the reference to the below description this is preferably accomplished by utilizing a single transducer which produces a signal plane when the transducer is moved along a first axis to produce the hnear scan component The transducer may be caused to partially rotate about the first axis, thus producing the sector component of the scan. In operation, the device may perform a first hnear scan in order to provide a first scan plane, followed by a rotation of the transducer about the axis and performing a second linear scan,

followed by additional rotations of the transducer and linear scans until a sufficient number of scans have been performed to, for example, display a volume of the scanned area on display 101. Linear and sector scanning in the present invention is better described in connection with Figures 20 and 21 and their accompanying description, below.

Figure 5 is a more detailed side view of die probe 103 illustrating opening 501 in the transducer housing area 402. The opening 501 is provided to allow imaging waves to be emitted from and received by a transducer 601 located in the transducer housing area 402 and to allow treatment waves to be emitted from the transducer 601.

The transducer 601 is shown in Figure 6, which figure illustrates a top view of the probe 103. The transducer 601 is further described below with reference to United States Patent Application Serial Number 07/750,691, titled "Curved Rectangular/Elhptical Transducer" filed August 20, 1991 which is a continuation of United States Patent Application Serial Number 07/585,981 titled "Curved Rectangular/Elhptical Transducer" filed September 21, 1990, now abandoned. The transducer of the preferred embodiment provides selectable power output.

Now, as can be envisioned, the transducer may move linearly along an axis projecting from the distal end 621 to the proximal end 622 of the probe 103. Means for providing such linear movement will be described in greater detail below. When transmitting waves, the transducer 601 projects such waves along an axis which projects outward from the surface of the sheet of paper of Figure 6. This may also be understood with reference to Figure 5 from which perspective the transducer 601 will project waves generahy downward from the transducer housing area 402 in the direction indicated by arrow 520. As has been described, in

additional to providing for hnear movement of transducer 601, the present invention also provides for a sector scanning component through partially rotating the transducer 601 about an axis which also extends from the distal end 621 to the proximal end 622 of the probe 103. It is through this movement of the probe to provide for both a linear component and sector component in the scan that a scan area such as area 403 of Figure 4 may be generated.

POSITIONING OF PROBE 103 RELATIVE TO THE PATIENT Before moving on to a more detailed discussion of the mechanics of the probe 103, it may be useful to discuss how the probe 103 is positioned in a fixed relationship to the patient undergoing examination and treatment It is important in the present invention that the patient remains in a fixed relationship with the probe 103 during the examination and treatment process. Therefore, in the preferred embodiment a table is provided on which the patient may lay. Preferably, the table is equipped with stirrups or other means to accommodate and support the patient's feet so that the patient is in an appropriate position for examination and treatment. Now, such tables are well known in the art and further description of such tables is not necessary here. In the preferred embodiment, the probe 103 is attached in a fixed relationship with the table by attaching support 604 to the table at an appropriate position — the positioning of the probe 103 relative to the table allowing for positioning of the probe 103 relative to the patient during treatment The support 604 includes an arm member 608 for at least partially surrounding the circumference of the handle area 401.

Locking means 603 is provided to lock handle area 401 in a fixed rotational relationship with arm 608. During the localization phase of the treatment process, the probe 103 may be rotated about an axis running from distal end 621 to

proximal end 622 until the probe 103 is correctly positioned within the patient by placing the locking means 604 in an unlocked position. The locking means 603 is then placed in a locked position after the probe 103 is correctly positioned within the patient. Now, the probe 103 is locked relative to rotational movement about the described axis. It should be noted that as shown with reference to Figure 7, locking means 603' is also provided in the preferred embodiment on an opposite side of arm 608.

Locking means 602 is provided to lock handle area 401 in a fixed linear relationship with arm 608. A sleeve 606 is provided to accommodate handle area 401 and, when locking means 602 is in an unlocked position, the probe 103 may be freely moved along the axis extending from the distal end 621 to the proximal end 622. Thus, the probe 103 may be placed in an appropriate position with respect to a linear relationship along the described axis within the patient's body. Once the desired relationship is achieved, locking means 602 is placed in a locked position.

It should be noted that the above sequence of positioning and locking the probe 103 with respect to a rotational position followed by positioning and locking the probe 103 with respect to a linear position may be reversed and, in fact, repeated numerous times until the desired relationship between the probe 103 and the patient's body is achieved. Use of the imaging mode to determine the position of the probe within the patient's body facilitates placement of the probe during this process.

PROBE HOUSING

Figure 8 is a side cut-away view of the probe 103 and is useful for describing certain components of the probe in greater detail. As has been described, the probe 103 comprises the handle area 401 at the proximal end 622 of the probe and the

transducer housing area 402 at the distal end 621 of the probe 103. Housed within transducer housing area 402 is transducer 601.

Transducer 601 is coupled with a shaft 801. Shaft 801 is positioned to run along an axis drawn between the distal end 621 and the proximal end 622 of the probe 103. The shaft 801 is preferably 7.77 inches long and 0.1875 inches in diameter and is constructed from stainless steel seamless tubing. As will be seen, it is this shaft 801 which provides, under the control of motors which will be described, for the sector scanning as well as the linear scanning components of the scan of transducer 601. Figure 11 is a side view of shaft 801 and transducer 601 showing couphng of shaft 801 to a housing 1101 which holds the transducer 601. Coupled in this way, transducer 601 moves (either in a scanning direction or a hnear direction) in relation to movements of shaft 801.

Before further describing the sector and linear scanning capabilities of probe 103, coupling of the transducer housing 402 to the handle 401 will be discussed. The transducer housing 402 is coupled to the handle 401 through use of housing front part 802 and cap 803.

Initially, housing front part 802 is coupling within and at the front of the handle 401 and includes a portion which protrudes through an opening 804 in the distal end of the handle 401. The couphng of housing front part 802 within handle 401 is accomphshed by placing housing front part 802 within an opening 815 formed in handle base part 814 and securing housing front part 802 to handle base part 814 by couphng sleeve 816 over housing front part 802 to handle base part 814. The coupling is accomplished in a manner similar, with respect to use of grooves for the couphng and use of o-rings to provide for a water-tight coupling, to couphng of

transducer housing 402 to housing front part 802 which will be discussed in greater detail below.

Figure 9 illustrates the housing front part 802 is greater detail and shows that housing front part includes grooved portion 901. Grooved portion 901 provides for coupling with cap 803 as will be seen. Figure 9 also illustrates thru-hole 902 formed to accommodate the shaft 801. As was illustrated by Figure 11 and Figure 8, one end of shaft 801 is coupled with transducer 601. The other end of shaft 801 is coupled within the handle 401 to provide for sector and linear movement of the shaft 801. This couphng and the components which provide for the sector and linear movement will be described in greater detail below.

Before moving from the description of housing front part 802, it may be worth noting tube 811 which is provided to allow for transmission of a transmissive fluid into the chamber created by couphng of transducer housing 402 with handle 401. The transmissive fluid is provided to allow for effective transmission of wave energy from transducer 601 into the patient's body. The transmissive fluid is preferably water. As can be seen with reference to Figure 8, a thru-hole is provided through housing front part 802 to accommodate tube 811. O-ring slots 904 and 905 are provided on housing front part 802 to provide for a water tight seal when coupling transducer housing 402 with handle 401.

As can be seen with reference to Figure 8, transducer housing 402 is coupled around neck area 903 of the housing front part 802. Cap 803 is then placed over transducer housing 402 and grooves 1003 (shown with reference to Figure 10) are used to couple cap 803 with housing front part 802 which provides for stationary fastening of transducer housing 402 to housing front part 802. It might be noted

that cap 803 defines opening 1004 to accommodate placement of the cap 803 over transducer housing 402.

Figure 12 illustrates housing 402 is greater detail including illustrating collar area 1201 for couphng with neck area 903 of housing front part 802.

Before moving onto the means for providing sector and linear translation of the transducer 601, it is pointed out that handle 401 further comprises rear cap 822. Rear cap 822 has defined therein a thru-hole 821 to accommodate electrical cabling for providing communication between probe 103 and control means 102. It is this electrical cable which is coupled with probe connector 314.

Further, rear cap 822 defines a thru-hole to accommodate tube 823. A water-tight seal is formed between rear cap 822 and the main portion of handle 401 through use of o-ring 824.

MEANS FOR PROVIDING SECTOR TRANSLATION OF THE TRANSDUCER

Now, it is appropriate to turn to the means for providing sector and hnear translation of the transducer 601. It will be described that the preferred embodiment of the present invention provides for a first motor to cause sector translation of the transducer 601 and a second motor to provide for hnear translation of the transducer 601. The first motor will be referred to herein as the sector motor or the sector rotate motor or similar name while the second motor will be referred to as the hnear motor or the linear drive motor or similar name.

Still with reference to Figure 8, sector motor support plate 831 is illustrated located toward the proximal end 622 of handle 401 and is provided to support the sector motor. Sector motor support 831 is coupled by support shafts 832 with rear cap 822. Sector motor support plate 831 is provided to support the sector motor and it is beheved that the illustration of the sector motor support plate 831 in Figure

8 is helpful for an understanding of the overall design of the system. Although not illustrated in Figure 8, a front support plate is also provided to support the sector rotate and linear drive assembhes. The front support plate is located inside the probe handle 401 and next to housing front part 802. The front support plate, sector motor and sector motor support plate 831 will now be described in greater detail with reference to Figure 13.

Figure 13 is a side view of the drive assembly for sector rotate drive assembly. The sector rotate drive assembly fits within probe handle 401 in a manner as can be appreciated from the above discussion. The sector rotate assembly comprises the sector rotate motor 1302, the sector rotate motor support plate 831 and the front support plate 1301 as has been discussed.

The sector rotate motor 1302 is coupled with and supported by the sector motor support plate 831 and is further coupled, through a thru-hole in plate 831, with coupling assembly 1311. The preferred sector rotate motor 1302 is available from Micro-mo Electronics, Inc. of Saint Petersburg, Florida as part number 1331-125-122 and has a 262:1 ratio with a tag encoder.

Coupling assembly 1311 comprises slotted couphng member 1313 which is coupled through a first slot with shaft 1306 of motor 1302 and secured in place with first collar 1312. Coupling assembly 1311 is further coupled with gear 1326 by coupling of shaft 1327 of gear 1326 with slotted coupling member 1313 with a second slot of slotted coupling member 1313; the slotted coupling member 1313 is secured in place in its couphng with shaft 1327 by collar 1314.

Figure 15 illustrates slotted coupling member 1313 in greater detail including illustrating first slot 1501 and second slot 1502. Slotted coupling member 1313 is

preferably available from Servometer Corp. of Cedar Grove, NJ. as part number SHSC/7.

Figure 16 illustrates a collar 1601; collar 1615 is the type of collar shown in Figure 13 as collar 1312 and collar 1313. Collar 1601 defines therein thru-hole 1602 which is used to accommodate slots (either slot 1501 or 1502, as the case may be) of slotted couphng member 1313. Collar 1601 further defines therein screw hole 1603 for accommodating a screw which is utihzed to secure collar 1601 with slotted couphng member 1313.

Shaft 1327 of gear 1326 is supported by front sector support 1331. Front sector support 1331 defines a thru-hole 1334 through which shaft 1327 is placed and then coupled on the other side with coupling member 1311, as described. Shaft 1327 is supported in thru-hole 1334 on bearings to allow for free rotation of gear 1326. Gear 1326 is supported on the opposite end by front support plate 1301, again on bearings to allow for free rotation of gear 1326.

Finally, the sector rotate assembly comprises spur gear 1341 which is coupled with gear 1326 to provide for sector rotation of spur gear 1341 responsive to rotational movement of gear 1326.

Spur gear 1341 is illustrated in greater detail with reference to Figure 17. As can be seen, spur gear 1341 defines a thru-hole 1701 through which shaft 801 is placed. Spur gear 1341 further defines teetii 1702 which are coupled with teeth of gear 1326 which provides for causing movement of spur gear 1341 as gear 1326 sectorally rotates. Thus, and importantly, as spear gear 1341 is moved in a sector rotation manner responsive to movements of gear 1326, shaft 801 is also moved in a sector rotation manner. As is appreciated from a study of Figure 13 and Figure 8, the movement of shaft 801 results in sector rotation movement of transducer 601

(as is recalled, transducer 601 is coupled with shaft 801). Thus, it is seen that the sector rotate assembly illustrated by Figure 13 causes sector rotation of transducer 601 and the resulting sector imaging.

MEANS FOR PROVIDING LINEAR TRANS ATTON OF THE TRANSDUCER

Now, it is has been stated that as one aspect of the present invention, linear movement of transducer 601 is provided in addition to the above-described sector movement The means for producing hnear movement of transducer 601 is described in greater detail with reference to Figure 14.

Figure 14 is a side view of the hnear drive assembly. The linear drive assembly fits within probe handle 401 and is coupled with and supported by sector motor support plate 831 through use of hnear motor support plate 1403.

The linear drive assembly comprises a hnear drive motor 1402 which is coupled with and supported by linear motor support plate 1403 and is further coupled, through a thru-hole in plate 1403 with couphng assembly 1411. The preferred linear drive motor 1402 is available from Micro-mo Electronics, Inc. of Saint Petersburg, Florida as part number 1331-125-123 and has a 6.3:1 ratio with a tag encoder.

Coupling assembly 1411 is of the design described in connection with coupling assembly 1311 and comprises slotted member 1413 which is coupled through a first slot with shaft 1406 of motor 1402 and secured in place with first collar 1412. Coupling assembly 1411 is further coupled with self-reversing screw 1426 by coupling of shaft 1427 of screw 1426 with slotted coupling member 1413; the slotted coupling member 1413 is secured in place in its couphng with shaft 1427 by collar 1414. Front linear support 1431 provides thru-hole 1434 which

accommodates and allows for additional support of shaft 1427. Shaft 1427 is supported on bearings in thru-hole 1434 to allow for free rotation of screw 1426.

Finally, the linear drive assembly comprises drive block 1441. Drive block 1441 is moveably coupled with screw 1426 so as to allow for movement of block 1441 along the length of screw 1426 as screw 1426 is rotated by motor 1402.

Screw 1426 is of a self-reversing design which design causes block 1441 to move along the length of screw 1426 in a first linear direction as screw 1426 initially rotates and, when block 1441 reaches a first end of screw 1426, the direction of movement of block 1441 is automatically reversed due to the sinusoidal grooves on screw 1426 and, therefore, the block 1441 is caused to move in a second, opposite, direction along the length of screw 1426. Screw 1426 is preferably obtained from Shimano Corp. of Irvine, California as part number TRN-0096.

Screw 1426 is further supported (on the end opposite from the end supported by front linear support 1431) by front support plate 1301, again on bearings to allow for free rotation of screw 1426. Shafts 1451 and 1452 are further provided between supports 1431 and 1301 to provide additional support for screw 1426, and to provide support for drive block 1441 as will be seen.

Now, Figure 18 is useful for illustrating how the hnear drive assembly works linear movement of the transducer 601. Figure 18 illustrates drive block 1441 in greater detail. Block 1441 defines thru-hole 1801 to accommodate screw 1426. Block 1441 further defines thru-holes 1802 and 1802 to accommodate shafts 1451 and 1452, respectively. As shown by Figure 18, drive block 1441 comprises travel pin pawl 1817. Pawl 1817 is provided to allow for moveable coupling of block 1441 with screw 1426 when screw 1426 is inserted in thru-hole 1801. Finally,

drive block 1441 provides thru-hold 1812 to allow for coupling with shaft 801. Thus, as drive block 1441 is caused to move in a linear direction by turning of screw 1426 under control of motor 1402, linear movement is imparted to shaft 801 and, in turn, to transducer 601. It is appreciated that as drive block 1441 is moved in a linear direction along screw 1426, spur gear 1341 is also moved along gear 1326 in a linear direction as a result of the common coupling of spur gear 1341 and drive block 1441 with shaft 801.

Thus, what has been described herein is a probe capable of both linear and sector movement and further capable of both imaging and therapeutics utilizing a single transducer.

CONSTRUCTION AND FOCUS OF THE TRANSDUCER 601 The transducer 601 of the preferred embodiment and its preferred construction is described with reference to United States Patent Application Serial Number 07/750,691 titled "Curved Rectangular/Elhptical Transducer" filed August 20, 1991 which is a continuation of filed United States Patent Application Serial Number 07/585,981 titled "Curved Rectangular Elhptical Transducer" filed September 21, 1990, now abandoned. The preferred transducer provides variable output power. In the system of the preferred embodiment the transducer housing area 402 is enclosed in a liquid-filled condom. The amount of liquid in the liquid filled condom may be adjusted during use of the system of the preferred embodiment resulting in increased or decreased pressure against the area of the body being treated. This results in effectively allowing up to approximately a 0.5 cm adjustment in the focus area of the transducer without requirement of unlocking the transducer, repositioning it and relocking the transducer.

POSITION INFORMATION

Now, it has previously been noted that the control means includes means for controlling and utilizing transducer position information. Specifically, it was noted above that motor driver controller 316 provides for interfacing of the motors 1302 and 1402 to the computer 312 by maintaining constant speed of the motors 1302 and 1402 during scanning procedures, by detecting end positions of the scanning probe 103 and by providing position information of the transducer 601. Position information is detected through use of Hall effect switches and magnets which are incorporated in the drive mechanism of the probe 103 and are shown with reference to Figures 13, 14 and 18.

Figure 13 illustrates the position of a magnet and HaU effect switch 1355 which are located on coUar 1312 and an arm adjacent to the coUar 1312, respectively. This combination magnet HaU effect switch is utilized to determine the position of the transducer 601 in its sector sweep. The position of the transducer 601 wiU have a correspondence to the position of collar 1313 as can be appreciated from the above-description.

Figure 14 illustrates magnets 1455 and 1456 which are placed at distal end position and proximal end position, respectively, of the travel of drive block 1441. Drive block 1441 comprises a Hall effect sensor 1813 which is shown with reference to Figure 18. Using the described combination of magnets 1455, 1456 and HaU effect sensor 1813, drive block 1441 is detected as it reaches the distal and proximal end positions of its linear travel along screw 1426.

OPERATION OF THE YSTEM OF THE PRESENT INVENTION

It is worthwhUe to now describe the typical operation of the system of the present invention. Such typical operation may be described with reference to

Figure 19 which iUustrates a flow diagram of the steps involved in a typical localization and treatment of disease in a human, as may be utihzed by the preferred embodiment It should be noted that although Figure 19 represents typical steps in the treatment process, in actual practice, alterations in the described process may occur. For example, the step of positioning the probe, block 1902 and imaging, block 1903, may be repeated until the patient is correctly positioned. The step of defining treatment parameters, block 1905, may be explicitly omitted where default treatment parameters are to be utihzed; however, in such a case, this step is implicitly carried out as the treatment parameters are implicitly selected as the default parameters. Still further, the step of defining treatment parameters, block 1905, and selecting the treatment volume, block 1904, may be readUy reversed. Of course, the above-mentioned variations are merely representative of the variations which may be employed. It is important to the present invention that the user selects an area of a displayed image which is to be treated and, that the system is capable of performing the required treatment on the selected area.

Figure 20 is useful for Ulustrating a typical display of the area of the body which is visible to the user of the system.

Turning now to Figure 19, initiaUy, the patient is positioned on the treatment table, block 1901 and the probe 103 is positioned within the patient block 104. The probe may then be locked in place as has been described — alternatively, the user may carry out some initial imaging, block 1903, before locking the probe in place so that the probe may be correctly positioned. Of course, if the probe is initiaUy locked in place and must be repositioned, it may be unlocked, moved, and then relocked.

Next, imaging of the patient is started. The apparatus for carrying out such imaging has been well-described above and it is not necessary to elaborate here further on such apparatus. The image is displayed on display device 101. During imaging, the user may adjust certain imaging parameters as is described in greater detail in Appendix I and may save images for later recall. In addition, the user may analyze the imaged area such as by measuring the size (both area and length/width) of suspected diseased areas. This process of analyzing the image is also described in greater detaU with reference to Appendix I.

As one important inventive aspect of the system of the present invention, after imaging and analysis of the image, the user then selects a treatment volume, block 1904. As is described in Appendix I, the user defines the treatment volume by using the track bah to outline the treatment volume on the displayed image. It might be noted that this selection of the treatment volume by the user, through defining an area on a display screen using a cursor control device, offers significant ease-of-use advantages in operation of the system of the preferred embodiment.

It should be noted that the image is displayed on display 101 in grey-scale — areas which are defined as being within the treatment volume are tinted yeUow by the system after the treatment volume is defined by the user. As wiU be seen, during treatment, the system wiU highlight treated areas with red tint giving a substantiaUy real-time view of the treatment process.

It should further be noted that that preferred embodiment of the present invention allows the user to select multiple treatment volumes before actuaUy beginning the treatment process. Thus, the step of selecting the treatment volume, block 1904, may be repeated for each of the desired treatment volumes. The user

may effectively define a three-dimensional volume for treatment through defining multiple treatment volumes.

The user then may modify treatment parameters, block 1906. Again, the treatment parameters which may be modified in the system of the preferred embodiment are described in greater detail in Appendix I. These treatment parameters include frequency, shutdown limits, error tolerance limits, and dosage (intensity, on time interval and off time interval) information.

The user then selects a function to begin treatment of the treatment volume, block 1906. Responsive to instructing the system to begin treatment, the system causes the probe to scan the transducer through the treatment volume defined by the user in a manner which wiU now be described. InitiaUy, during the treatment cycle, either the linear image or the sector image is displayed in window 213. The particular image displayed is user selectable. In any event, the image displayed in window 213 remains displayed during die entire treatment process and is static (i.e., is not updated during the treatment process). In addition, die image is also displayed in window 212. However, the image displayed in window 212 is updated during the treatment process so that a comparison may be made by the system operator between the untreated tissue and die treated tissue as the treatment progresses. The image displayed in window 212 is updated as wiU be described.

As has been stated, die system of the preferred embodiment aUows the position of the transducer to be controUed botii in a linear and sector direction. During treatment, the transducer is focused at a zone witiiin the treatment volume in a first plane ø and RF power is applied to d e entire transducer for a first predetermined period of time and, ti en the RF power is turned off, except power is applied to an imaging portion of the transducer, for a second predetermined period of time. The

transducer is tiien used to perform imaging, in either its sector or linear scan mode (depending on die mode selected by die user). The image in window 212 is updated during this period. After a second predetermined period of time, die transducer is then be moved to a position within plane ø which is linearly offset by a distance d from the first position and treatment of a second second zone within the treatment volume is carried out by again applying RF power to the entire treatment area for a first predetermined period and men turning the RF power off (again, except to an imaging portion of the transducer) for a second predetermined period.

This process of turning on RF power to the transducer for a predetermined period of time, turning it off, imaging and moving the transducer linearly within plane ø is repeated under control of the control means untU the entire treatment volume within plane ø has been treated. Treatment is then carried out in a second plane ø+l, again by treating, imaging, moving the transducer linearly within the plane, treating, etc. Treatment is then carried out in this manner in a third plane ø-l, then in a plane ø+2, then in a plane ø-2, etc., until all planes in the defined treatment volume have been treated.

It is noted tiiat the use of the transducer of the present invention for botii imaging and treatment wiU be better understood with reference to co-pending application Serial Number 07/585,981.

As the transducer treats each zone, the display is updated by highlighting treated zones with a red-tint Thus, witiiin the treatment volume, untreated areas wiU be highlighted in yeUow and treated areas will be highlighted in red.

It is noted that die RF power to the transducer is turned alternatively on and off for two important reasons in the system of the preferred embodiment. First, turning the transducer off for periods of time aUows for heat dissipation within the

body and prevents excessive heat bm d up. Second, although the transducer has been described as being turned off, in fact it may be placed in a low-power imaging mode which aUows for substantiaUy real-time imaging of the treatment volume during the period of time when treatment is taking place. If the user desires, based on the real-time imaging or otherwise, treatment can be terminated at any point

In a typical treatment in the preferred embodiment d e transducer variable output power, for example, produces 400-500 watts cm^ during treatment and die on time is set at 4 seconds whUe the off time is set at 8- 12 seconds. In the preferred configuration, die transducer has a focal spot size of approximately 0.5 mm and spacing between focal spots is adjusted to be approximately 0.2 to 0.5 mm. Li tiiis configuration, one cycle of on/off will produce a lesion having an ellipsoid shape measuring approximately 3-5 mm on its major axis and 0.5 to 1.0 mm on its minor axis.

TypicaUy, it is required to produce a lesion measuring approximately 1cm x lcm x 2cm, or greater. The total time to create a lesion volume depends on die time on for the transducer (tl), time off (t2), intensity at the focal site, focal spot size, and spacing between the focus of the separate "shots". Adjustment of each of tiiese factors is influenced significantiy by the temperature gradient of the tissue because the temperature rise of the tissue during any particular consecutive shot is influenced by die temperature rise of the previous shots. The temperature gradient of die tissue of any particular body is a function of botii the tissue and blood flow characteristics. Presendy, it is expected tiiat a typical treatment may take approximately 40 minutes.

As an example, assume a treatment cycle takes 14 seconds, 4 seconds on and 10 seconds off, to create a 1.0 mm^ lesion and it is desired to treat a 2cm, or 200mm, square area it will take 200mm/1.0mm treatment cycles times 14 seconds per cycle equals 2800 seconds equals approximately 47 minutes. Of course, the above-stated example has been simplified for calculation purposes at least because, as has been discussed, the system of the preferred embodiment does not create square lesion, but rather creates elliptical-shaped lesions.

It is important to note that as one inventive aspect of the present invention, it is recognized that each of the parameters of focal spot size, focal spot spacing, intensity, time on, and time off are combined to produce appropriate lesions. Variations in any one of these parameters may lead to requirements to alter other of the parameters. For example, if intensity can be increased, time on may be reduced.

DESCRIPTION OF LINEAR AND SECTOR MODE SCANNING

It is now worthwhhe to further describe the scanning system of the present invention. The below description wiU be provided witii particular reference to prostate scanning applications. As has been described, die present invention provides for scanning with two degrees of freedom — axial scanning (or linear mode) and transverse scanning (or sector mode). Axial scanning is better described with reference to Figure 20 while transverse scanning is better described with reference to Figure 21. As can be seen from a review of these figures, scanning in eidier of these two modes allows definition of a "volume" on a display, such as display 101 using known graphical display techniques.

Figure 20 iUustrates axial scanning of die prostate 2001 in a human body and includes view of the rectal waU 2002 and urethra 2003. When performing axial scanning, the transducer 601 is moved linearly as has been described in order to effect scanning of a first plane A 2011. The direction of hnear movement of the transducer is shown along line 2015. It is noted tiiat linear movement of the transducer is bidirectional, as shown by double-arrowed line 2015. After completing me first linear scan and, as a result imaging plane A 2011, a second linear scan may be performed after rotating the transducer. The second hnear scan results in obtaining a second scan plane, plane B 2012. Additional rotations of the transducer and subsequent linear scans, such as a hnear scan resulting in obtaining the third scan plane C 2013 may be performed. As can be seen, this results in obtaining a "three dimensional" view of slices of the prostate or other portion of a body being examined.

Figure 21 iUustrates transverse scanning, again specificaUy iUustrating scanning of the prostate. When performing transverse scanning, the transducer is scanned in a sector sweep about an axis 2016 in order to provide a first sector scan plane, plane A 2021. The transducer may tiien be moved linearly along axis 2016 and again swept in a sector scan in order to provide a second sector scan plane, plane B 2022. Additional linear movements, foUowed by sector scans of the transducer wiU, of course, produce additional sector scan planes, such as plane C 2023. As can be seen, this transverse scanning produces a view of slices of die prostate or other portion of a body being examined which view is perpendicular to the view produced by die axial scan.

DESCRIPTION OF CONTROL OF LINEAR AND SECTOR SCANNING It is now appropriate to discuss in greater detail user control of linear and sector scanning in the system of the present invention. As has been described, d e present invention provides for display of two images on display 101, a linearly scanned image in window 213 and a sector image in window 212. The user of the system may select which scan (linear or sector) is performed first. As a default, a linear scan is performed first and die resultant image is displayed in window 213. The user may tiien, using a cursor control device, such as trackbaU 304, select lines along which sector scans should be taken. In the example Ulustrated by Figure 20, three lines, 2041-2043, are selected. Sector scanning is then performed by first linearly positioning the transducer at the location indicated by line 2041 and performing sector scanning; then moving the transducer linearly to die position indicated by hne 2042 and performing sector scanning and, finally, moving the transducer linearly to the position indicated by line 2043 and performing sector scanning.

As can be seen with reference to Figure 21, the scan imaged resulting from die sector scan when the transducer was positioned along line 2041 resulted in imaging of plane A 2021; the scan image resulting from the sector scan while the transducer was positioned along line 2042 resulted in imaging of plane B 2022; and the scan image resulting from the sector scan while the transducer was positioned along hne 2043 resulted in imaging of plane C 2023.

SimUarly, the user may select lines in the sector scan, such as hnes 2051, 2052 and 2053 in order to control the rotational positioning of the transducer as linear images are obtained. A hnear scan taken along line 2051 corresponds with die image shown as plane A 2011; A linear scan taken along line 2052 corresponds

with the image shown as plane B 2012; and A linear scan taken along line 2053 corresponds with die image shown as plane C 2013.

After completing imaging, the user tiien may select a treatment volume as has been described, step 1904; the user may define treatment parameters, step 1005; and die treatment step may begin, step 1906.

SELECTION OF THE TREATMENT VOLUME

The steps involved in selection of the treatment volume are Ulustrated witii reference to Figures 22 and 23, as well as witii reference to the Appendix I, and especiaUy the description of die treatment planning function widiin the treatment submenu.

Figure 22 illustrates linear image display window 213 showing a subject's prostate 2001, rectal waU 2002, and urethra 2003. The system of die present invention provides a visible indication 2201 on die display window 213 of d e upper limit of the focal zone and an indication 2202 of the lower limit of the focal zone. There also is displayed a cursor control indicator 2203 which may be used to define die volume for treatment. The selected volume 2204 is shaded, for example in the preferred system it is tinted green, after selection by die user.

Figure 23 iUustrates selection of a volume in me sector image display window 212. It is noted tiiat in die presently developed system, selection in die sector window 212 has not been yet been implemented.

After selection of die volume 2204, the transducer is rotated to provide treatment waves in a first plane ø, and as has been described, is energized for time tl. The transducer is then moved linearly distance d and, after time t2, is again energized for time tl. This process continues until the selected area 2204 is treated

in plane ø along the entire linear lengdi of die area 2204. The transducer is then rotated and die process of energizing

and moving the transducer is repeated in a different plane with a preselected angulation. This process continues for n planes producing a large volume lesion which is a composite of several smaU lesions.

Thus, what has been described is a system for locahzation and treatment of focal disease widiin a body.

APPENDIX I FUNCTION KEY DESCRIPTION

Function keys in the system of the preferred embodiment are provided in a hierarchical format wherein a first level of function keys provides access to a set of functions including imaging, analysis, treatment, patient information and exit Each of tiiese functions (except for exit) utilize their own sets of function keys to provide action to subfunctions or sets of subfunctions.

Each of the function keys will be described below.

Main Menu

Fl Imaging Provides access to die imaging function including ability to set imaging parameters and to store images.

F2 Analysis Provides access to the analysis function including ability to analyze die size of areas in the displayed image.

F3 Treatment Provides access to die treatment function including abUity to define treatment parameters, to define treatment volumes, and to begin and terminate treatment

F4 Patient Information Provides access to the patient information function including the ability to enter the patient name and identifying information.

FIO Exit Provides ability to exit back to the computers operating system.

Imaging Sub-menu

Fl TGC This mode aUows the user to change the time gain compensation curve. The current TGC curve is output on the left side of die image, and the user is allowed to edit die curve using die trackbaU. The left trackball button selects a starting point on the TGC curve, and die right trackbaU button selects an ending point The trackball is tiien moved horizontally to adjust die amplitude of die curve between these points.

F2 GAIN This mode aUows the user to change the overall image gain. The user may enter a new gain value (0-100%), or use the left or right arrows keys to ramp the gain up or down.

F3 LUT This mode aUows the user to edit die output lookup table. The output lookup table is graphed in a manner simtiar to the TGC and is edited in the same way.

F4 Image Save A fuU-screen menu of image slots is displayed. Each line contains a date, time, patient ID, and comment. The user may change the comment string by typing alpha characters after the menu slot is selected using die F-Keys (to select the slot from the menu).

F5 Image RecaU The same menu which was presented above is selected, and die user selects an image slot to restore the image from using one of the F-Keys.

F6 Freeze This option causes die image to be frozen or restarted. Note: space is an alias for freeze which works from aU menus except die treatment menu.

FIO Main Menu Return to main menu.

i -m n

Main Menu Go back to the main menu. Distance Go to the distance sub-menu.

Area Go the area sub-menu. Grid Display dotted 1 cm grid around cursor.

Selects distance calculation number 1. Selects distance calculation number 2. Clear the selected distance calculation off the Return to die analysis menu.

Whfle in the distance calculation mode, die trackbaU is used to move die electronic calipers. The left mouse button selects one cursor, and die right trackbaU button selects the otiier cursor. The center mouse button selects both cursors. Moving the trackbaU moves selected cursors, and causes the distance readout at die bottom of the screen to be changed. Pressing '0' exists distance code.

Distance calculation #1 is displayed as X's and distance calculation #2 is distance is displayed as '+'s.

Selects area calculation number 1. Selects area calculation number 2. Clear the selected are calculation. Return to the analysis menu.

WhUe in die area mode, die trackbaU is used to move a cursor which directs die drawing of an outline around die section of the image to take the area of. Initially we are in "move" mode. The trackball is used to place die cursor at the position to draw die outiine. Pressing the left trackball button causes the system to enter trace mode. In trace mode, a outiine is left behind at die cursor position as die trackball is moved. Pressing the left trackball button again closes the outiine and causes the area to be computed and displayed at die bottom of die screen.

In area mode, die right trackball button enters an undo mode. The outiine is slowly erased in the reverse order in which it was drawn. Erasing the entire outline causes the system to exit draw mode, and re-enter move mode.

Treatment Sub-menu

Fl Set parameters Allows the user to set seldom altered treatment parameters. A form is presented to the user, containing die foUowing:

Frequency: nnn

Power Shutdown Limit: Low: nnn

High: nnn

Probe position error tolerance: nnn%

The user selects a field using die arrow keys, and may change diem by entering new values.

F2 Dosage AUows the user to set treatment amplitude and on/off times. The user is presented die foUowing form, and is permitted to edit values:

F3 Treatment Planning This mode allows the user to define treatment volumes using the trackball. The user moves die cursor within a

predefined transducer focal zone outlined by two paraUel lines on the displayed image to a starting point, presses the left trackbaU button, tiien moves die cursor to die end of the treatment volume and presses the left trackbaU button again. As the user selects treatment volumes, the grey scale image information is tinted yeUow/orange.

The user may delete treatment volumes by moving the cursor close to an already colored region and pressing the right trackbaU button.

F4 Clear Zones This option erases aU the planned treatment sites. AU the color coding of treatment volumes are restored to gray scale (indicating not involved in treatment).

F5 Begin treatment Starts treatment The probe is positioned over each site, and. treatment is performed at tiiat sire using the parameters in the dosage menu. The image is color coded by tinting the gray scale information with die foUowing:

White - Not involved in treatment

YeUow - To be treated, but not yet treated.

Red - Treated.

F6 Stop treatment Used to stop treatment.

Treatment may be resumed by selecting die start treatment option.

Patient name, id and die system time are always displayed at die top of die image. Options [F3] and [F4] need not be implemented, since these items may edited using standard DOS commands, and only need to be set at system configuration time.