Abstract:
An ultrasound therapy system utilizes a mechanical positioning assembly to locate and aim an ultrasonic transducer. The positioner provides for roll and pitch control as well as control in the lateral and longitudinal directions. The positioner uses piezo-electric vibrational motors that can effectively operate within the field of an MRI system without interfering with its operation. The motors are capable of providing a breaking force to the drive shafts while de-energized and thus aid in preventing motor slippage or backlash. Since the motors do not affect the operation of an MRI system, the ultrasonic therapy system can be made more compact. Two sets of position encoders are used to align the positioner. Course absolute encoders and fine relative encoders are both coupled to the positioning motors and allow for precise control over the position and orientation of the ultrasonic transducer.

Description:
FIELD OF THE INVENTION 
     The present invention pertains to a mechanical positioning system and more particularly, to a positioning system for an ultrasonic therapy device operating under Magnetic Resonance Imaging guidance. 
     BACKGROUND OF THE INVENTION 
     The use of Magnetic Resonance Imaging (MRI) is well-known. MRI provides a radiologist with detailed internal views of a patient&#39;s anatomy that cannot be visualized with conventional x-ray technology. Images generated by MRI systems provide physicians with a visual contrast between varying tissues that is extremely useful when planning surgical procedures. 
     Ultrasonic therapy uses focused, localized heating to selectively destroy tumors or other tissue anomalies. Heating tissue beyond a critical temperature for a period of time causes necrosis, the destruction of tissue. The use of MRI imaging to guide the focal point of an ultrasonic therapy device is known. For instance, U.S. Pat. Nos. 5,443,068, 5,275,165, and 5,247,935 each describe the use of an ultrasonic transducer, guided by an MRI system, to selectively destroy tissue. The details of these disclosures are hereby incorporated by reference into the present application. 
     The need to accurately position an ultrasonic transducer for use in selective tissue necrosis presents special problems when used in combination with an MRI guidance system. In particular, MRI systems employ large magnets, for creating a homogenous magnetic field, and gradient coils for altering that magnetic field in a uniform manner in time and/or space. This procedure creates magnetic field gradients. MRI systems also employ radiofrequency (RF) coils for applying an RF field to the tissue that is to be imaged, causing the tissue to resonate and create an MR response signal. The MR response signal is then used to construct an image of the tissue that is displayed to an operator. The image can then be printed or otherwise stored for later use and analysis. The degree of homogeneity of the magnetic field and the linearity of a magnetic field gradient over space and time are important in creating a clear undistorted image. Any interference with the RF field will reduce the quality of the image. The best and most consistent imaging typically occurs when surgical equipment or other objects do not interfere with the magnetic and RF fields created by the MRI system. 
     Several situations may affect the performance of MRI systems or other equipment used in conjunction with it. For example, equipment that is constructed from ferro-magnetic materials should not be used near an MRI system since the large magnetic fields generated by the MRI system will physically attract the magnetic equipment. Consequently, MRI performance may suffer. Furthermore, conductive materials disturb and distort the radio frequency electromagnetic fields necessary for resonance imaging. Other problems occur with materials that produce eddy currents when placed in a time-varying magnetic field. The eddy currents in these materials, usually electrical conductors, create their own magnetic field that interferes with the fields used for magnetic resonance imaging. Therefore, materials which exhibit good conductivity, such as aluminum and copper, should not be used within a time-varying magnetic field. 
     In order to accurately position an ultrasonic therapy device under MRI guidance, a precise positioning system must be employed. In addition, the positioning system needs to be able to provide repeatedly predictable control of the ultrasonic transducer in order to accommodate the precision requirements of certain clinical procedures. Tumors that may be small or have irregular shapes require exact positioning of the ultrasonic transducer in order to destroy only the intended tissue while leaving the healthy tissue undamaged. 
     Known positioning systems, such as those described in U.S. Pat. Nos. 5,247,935 and 5,275,165 utilize hydraulic mechanisms to position an ultrasonic transducer beneath a patient. However, these systems rely on placing the transducer directly beneath the object to be treated (e.g., a tumor) and provide positioning only in the linear x, y, and z axes. Due to constraints that may be imposed by the available acoustic passage to the object to be treated, effective therapy may not be possible with this arrangement. Additionally, these known systems have inherent reliability and accuracy problems due to the use of hydraulic positioners which can exacerbate motor backlash, degrading the accuracy of the positioner. 
     Since the motors used in these known systems are formed from materials that interfere with the operation of the MRI system, the motor must be placed at an increased distance from the ultrasonic transducer and the MRI imaging space. Known positioning systems therefore require the use of long motor drive shafts, which increase the physical footprint of the positioning system. Furthermore, the motors used in known systems need to be left engaged and energized in order to minimize slippage due to the backlash problem. Since an energized motor produces an increased electric field that interferes with the operation of a MRI system, the motor cannot be mounted within, or in the vicinity of, the MRI imaging space. For this reason, known systems require the motors to be mounted at a significant distance from the MRI imaging space. 
     U.S. Pat. No. 5,443,068 describes an MRI guided ultrasonic therapy system that uses threaded shafts attached to screw drives through universal joints in order to position the therapy transducer in three linear dimensions. The &#39;068 patent also requires the ultrasonic transducer to be placed directly beneath the object to be treated and only provides positioning in the linear x, y, and z axes. The screw drives, and particularly the universal joints, utilized in this system compound the motor backlash problem described above and therefore further restrict the positional accuracy that the system can achieve. Furthermore, the motor drives of the &#39;068 patent are formed from magnetic material and must also be located at a distance from the imaging space in order to eliminate interference with the MRI system. 
     SUMMARY OF THE INVENTION 
     The foregoing problems are solved by providing a positioning system for magnetic resonance imaging guidance of a therapy device. In a first embodiment, the position system comprises an energy transducer, a first positioner operative to adjust the location of the energy transducer in a lateral direction in a first plane, a second positioner operative to adjust the location of the energy transducer in a longitudinal direction in the first plane, and a third positioner operative to adjust the roll of the energy transducer. 
     Each of the positioners are vibrational motors that comprise a drive shaft and a linear actuator coupled to the drive shaft. The actuators are operative to produce a rotary motion of the drive shaft. The positioning system may further comprise a fourth positioner operative to adjust the pitch of the drive shaft. 
     In a further embodiment a device for positioning an ultrasonic therapy device under magnetic resonance imaging comprises a motor coupled to a drive shaft, a first position encoder coupled to the motor, and a second position encoder coupled to the drive shaft. The first position encoder is operative to measure the amount of motion relative to a predetermined position and the second position encoder is operative to measure the amount of motion relative to an arbitrary position. 
     In another embodiment, a device for positioning an ultrasonic therapy device under magnetic resonance imaging guidance comprises a vibrational motor coupled to a drive shaft, and a positioner assembly that includes a support bracket, a longitudinal slide coupled to the support bracket, and a lateral slide coupled to the longitudinal slide. The device may further comprise a second vibrational motor coupled to a second drive shaft, a third vibrational motor coupled to a third drive shaft, and a fourth vibrational motor coupled to a fourth drive shaft. Each of the vibrational motors controls a specific directional motion of the support bracket. 
     In a still further embodiment, a device for positioning an ultrasonic therapy device under magnetic resonance imaging guidance comprises energy concentrating means for directing energy at a focal point, a first positioning means for adjusting the lateral position of the energy concentrating means, a second positioning means for adjusting the longitudinal position of the energy concentrating means, and a third positioning means for adjusting the roll of the energy concentrating means. The device may further comprise a fourth positioning means for adjusting the pitch of the energy concentrating means. 
     Other and further aspects and advantages of the invention will become apparent hereinafter. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a perspective view of an ultrasound therapy system constructed in accordance with the present invention; 
     FIG. 2 is an isolated perspective view of a positioner used in conjunction with the ultrasound therapy system of FIG. 1; 
     FIG. 3 is another isolated perspective view of a positioner used in conjunction with the ultrasound therapy system of FIG. 1; 
     FIG. 4 is a perspective view of a transducer assembly and transducer holder used in conjunction with the positioner of FIGS. 2 and 3; 
     FIG. 5 is an exploded perspective view of a positioner used in conjunction with the ultrasound therapy system of FIG. 1; 
     FIG. 6 is a perspective view of a case that encloses the positioner; 
     FIG. 7 is a perspective view of a motor bay used in conjunction with the ultrasound therapy system of FIG. 1; 
     FIG. 8 is a detail showing the drive shaft of a positioning motor used in conjunction with ultrasound therapy system of FIG. 1; and 
     FIG. 9 is a detail of a motor used in conjunction with the ultrasound therapy system of FIG.  1 . 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     FIG. 1 shows an ultrasound therapy system  20  constructed in accordance with the present invention. The ultrasound therapy system  20  is used in conjunction with an MRI based guidance system to accurately guide a physician to a desired therapy site. The ultrasound therapy system  20  includes an MRI cradle  32  that supports a positioner  30  and a motor bay  40 . The positioner  30  is used to direct energy from an ultrasound or other energy transducer. The positioner  30  is mounted within a sealed case  34  and the motor bay  40  encloses four positioning motors  42 ,  44 ,  46 , and  48 . The motors  42 ,  44 ,  46 , and  48  each provide rotary motion to a drive shaft and are each responsible for controlling a distinct motion direction of the positioner  30  (i.e., lateral, longitudinal, roll, or pitch). The vertical position of the ultrasonic energy is controlled electronically by altering the focal point of the ultrasonic transducer. Preferably, and as described in more detail below, the motors  42 ,  44 ,  46 , and  48  are made from non-magnetic materials and impart a rotational motion on the respective drive shafts by utilizing piezo-electric vibrational fingers. The motor bay  40  is rigidly attached to the case  34  and forms a modular unit that is placed into and is attached to the MRI cradle  32 . When assembled, the MRI cradle  32 , including the case  34 , the positioner  30 , and the motor bay  40  are enclosed by a cover (best seen in FIG.  6 ). The ultrasound therapy system  20  is constructed so that a patient can be positioned on the cradle while the system is moved through an MRI imaging system. An ultrasonic transducer (not shown) is mounted on the positioner, and with guidance from the MRI system, a tumor or other tissue mass within a patient&#39;s body, can be precisely treated via ultrasonic energy. The ability to accurately position the ultrasonic transducer underneath a patient allows increased accuracy and efficiency of the ultrasonic therapy. 
     Referring to FIGS. 2 through 5, the positioner  30  is shown in further detail. Each component of the positioner  30  is made from an MRI-compliant material. In order to achieve a consistent and predictable ultrasonic energy application, the positioner  30 , including the ultrasonic transducer, is submersed in a water bath during operation. Thus, the positioner components must also be made of a material that has good dimensional stability under water immersion conditions. The case  34  is filled with a degassed water to prevent cavitation of the positioner&#39;s moving parts and to ensure a consistent medium to transfer the ultrasonic energy from the transducer to the patient. All components of the positioner that penetrate the case  34  are appropriately sealed to prevent leakage. 
     The positioner  30  is composed of five main sub-assemblies: a base  50 , a lateral slide  52 , a longitudinal slide  54 , a transducer holder  56 , and a transducer assembly  58 . Each of these subassemblies function together and are each mounted inside the case  34 . 
     The base  50  is a generally flat plate that rigidly mounts the positioner  30  within the case  34 . The base  50  has a front channel  51  and a back channel  53 , both extending along the length of the base. The channels  51  and  53  provide a guide for, and enable precise, low-friction lateral movement (i.e., along the length of the base  50 ) of the remaining sub-assemblies of the positioner  30 . 
     The lateral slide  52  is generally trough shaped and includes L-shaped rails  55  and  57  on its bottom surface that are perpendicular to its length. The rails  55  and  57  engage with the front channel  51  and the back channel  53 , respectively, on the base  50 . As such, the lateral slide  52  moves freely in the lateral direction only (i.e., along the length of the base  50 ). The motion of the lateral slide  52  is accomplished by a screw drive mechanism that includes a lateral positioning shaft  62  engaged with a corresponding nut  69  located inside the lateral slide  52 . The lateral positioning shaft  62  is driven via the motor  46  located inside the motor bay  40  and engages with the lateral slide  52  through an aperture  63 . 
     A roll positioning shaft  60  controls the roll motion of the positioner  30  and engages with the lateral slide  52  through an aperture  61 . The roll positioning shaft  60  is driven via the motor  42 . A longitudinal positioning shaft  64  controls the longitudinal motion of the positioner  30  and engages with the lateral slide  52  through an aperture  65 . The longitudinal positioning shaft  64  is driven via the motor  44 . A pitch positioning shaft  66  controls the pitch motion of the positioner  30  and engages with the lateral slide  52  through an aperture  67 . The pitch positioning shaft  66  is driven via the motor  48 . Each of the roll positioning shaft  60 , the longitudinal positioning shaft  64 , and the pitch positioning shaft  66  engage with the lateral slide  52  without impeding its ability to move laterally along the length of the base  50 . 
     Each of the motors  42 ,  44 ,  46 , and  48  impart a rotary motion on the positioning shafts  60 ,  64 ,  62 , and  66 , respectively, through precision pulley and belt transmissions (best seen in FIG.  8 ). The rotary motion of the shafts is then translated into either a lateral, longitudinal, roll, or pitch movement of the positioner  30 . The transmissions for translating the rotary motion of the shafts  60 ,  62 ,  64 , and  66  into the corresponding movement of the positioner  30  are each within the lateral slide  52 . It is noted that the arrangement of the motors within the motor bay  40 , and their association with a specific positioning shaft, can vary. 
     The rotary motion of the longitudinal positioning shaft  64  is translated into a longitudinal motion of the positioner by a tooth gear  96  and a pair of sliding pins  96   a  and  96   b.  The rotary motion of the pitch positioning shaft  66  is translated into a pitch motion of the positioner by a first worm gear  90  and a spiral gear  90   a,  and the rotary motion of the roll positioning shaft  60  is translated into a roll motion of the positioner by a second worm gear  92  and a spiral gear  92   a.    
     Housed within the lateral slide  53  are the driving transmissions for both the pitch and roll axes. The pitch transmission includes the spiral gear  90   a  that engages with the worm gear  90 , and a round tube  98 . The tube  98  has a shaped hole  98   a  that receives a shaft  99 . The shaft  99  engages with the spiral gear  90   a  and is free to slide in and out of the tube  98  and induce the pitch motion by rotating. The roll transmission includes the spiral gear  92   a  that engages with the worm gear  92  and a shaft tube  103  that engages with the spiral gear  92   a.  A cap  91  closes the worm gear  90  within the lateral slide  52  and a cap  93  closes the worm gear  92  within the lateral slide  52 . The upper portion of the lateral slide  52  includes rails  100  and  102  for engaging the longitudinal slide  54 . 
     The longitudinal slide  54  includes channels  54   a  and  54   b  that engage with the rails  100  and  102  on the lateral slide  52 . This enables the longitudinal slide  54  to move along the length of the lateral slide  52 . The longitudinal motion of the longitudinal slide  54  and the positioner  30  is accomplished by engaging the tooth gear  96  with a tooth bar  97  that is mounted to the bottom surface of the longitudinal slide  54 . The matching level of the tooth bar  97  to the tooth gear  96  is adjustable so that backlash in the movement of the longitudinal slide is minimized. 
     The transducer holder  56  engages with the shaft tube  103  and includes a holding fork  104 . The holding fork  104  is formed from two separate pieces, a sprocket assembly  104   a  and a support bracket  104   b.  The shaft tube  103  engages on its proximal end with an opening  101  in the longitudinal slide  54 , and engages on its distal end with the sprocket assembly  104   a  of the holding fork  104 . The distal end of the shaft tube  103  is the end closer to the transducer assembly. Any longitudinal motion of the longitudinal slide  54  is therefore directly translated to the shaft tube  103  and the holding fork  104 . Similarly, since the holding fork  104  is directly attached to the shaft tube  103 , any roll motion of the shaft is directly applied to the fork. 
     The shaft tube  103  contains a lumen  103   a  formed to receive the tube  98 . The distal end of the tube  98  engages the sprocket assembly  104   a  through the inner passage  103   a  and when so engaged, has a longitudinal axis common to the longitudinal axis of the shaft tube  103 . With this arrangement, the pitch driving mechanism described above, and engaged with the tube  98 , can provide a pitch motion to the positioner  30 , regardless of the orientation of either the longitudinal slide  54  or the transducer holder  56 . A sprocket wheel  106  is mounted on the distal end of the tube  98  and transfers the rotational motion of the shaped hole  98   a  to the sprocket assembly  104   a.    
     The transducer assembly  58  is mounted to the transducer holder  56  by two shafts,  108  and  110 , that fit through holes  105   a  and  105   b  in the support portion  104   b  of the fork  104 . The transducer assembly  58  is preferably a cup-shaped component that is adapted to receive a correspondingly shaped ultrasonic transducer element (not shown). The transducer assembly  58  is also sized to engage with the holding fork  104  and to rotate freely about the shafts  108  and  110 . A sprocket wheel  112  is mounted on the end of the shaft  108  and another sprocket wheel  113  is mounted on the corresponding side of the sprocket assembly  104   a.  The sprocket wheel  113  is formed from two counter-rotating sprockets mounted one on top of each other on a common drive shaft. A chain  114  connects the sprocket wheels  112 ,  113 , and  106 , and translates the rotational motion of the tube  98  into a pitch motion of the transducer assembly  58 . A tensioning mechanism  116  ensures that the chain  114  remains taught and transfers the rotary motion of the tube  98  with minimal backlash. Cables  118  provide power to the transducer element and relay data back to an operator. 
     Referring to FIG. 6, the case  34  that encloses the positioner  30  is shown in greater detail. Since the case is filled with degassed water during operation of the transducer, it is necessary to seal all openings and mounting interfaces. This is preferably accomplished with an O-ring or another type of flexible seal. The case  34  includes a cover  122  that is bolted to the top perimeter of the case and sealed with an O-ring  120 . A mylar panel  124  is embedded in the cover and is positioned over the location of the transducer element. The mylar panel  124  is attached to the cover  122  with a frame  126  and is sealed with an O-ring  130 . The mylar panel  124  ensures a consistent interface to the MRI imaging area and protects the imaging area from damage. 
     Turning to FIGS. 7 through 9, the motor bay  40  is shown in more detail. FIG. 7 depicts the four motors  42 ,  44 ,  46 , and  48  mounted inside the motor bay  40 . Each of the motors produce a rotary motion that is ultimately transferred to the four positioning shafts  60 ,  64 ,  62 , and  66 , respectively, via precision pulley and belt transmissions. Each one of the motors is responsible for a distinct motion direction of the positioner (i.e., lateral, longitudinal, roll, and pitch). FIG. 8 shows a typical detail of a motor drive shaft  148  attached to a precision pulley  149  which in turn engages with a belt  150 . The belt  150  extends along the length of the case  34  and is then attached to one of the positioning shafts extending from the case  34 . A similar pulley is attached to each of the positioning shafts. The rotary motion produced by each of the motors is thus transferred to the positioning shafts, which in turn translate the rotary motion into one of the distinct motion directions of the positioner  30 . 
     Specifically, the motor  42  is coupled to the roll position shaft  60  and is responsible for the roll direction of the positioner  30 . The motor  44  is coupled to the longitudinal position shaft  64  and is responsible for the longitudinal direction of the positioner  30 . The motor  46  is coupled to the lateral position shaft  62  and is responsible for the lateral direction of the positioner  30 . And the motor  48  is coupled to the pitch position shaft  66  and is responsible for the pitch direction of the positioner  30 . 
     Precise control of each positioner motion direction is necessary when aiming an ultrasound or other energy transducer. Particularly when providing therapy to small tissue masses or an area of a patient that is obscured by varying tissue properties. In order to achieve and maintain this precise control, an ultrasonic therapy system constructed in accordance with the present invention utilizes two sets of position encoders. 
     The angular position of each motor is measured by an absolute encoder  130 ,  132 ,  134 , or  136 . One example of such an encoder is model No. A2-S-K-250, manufactured by U.S. Digital Corporation. Each of the motors  42 ,  44 ,  46 , and  48  are based on a pair of linear actuators such as those manufactured by Nanomotion Ltd. Each of the actuators have two piezo-electric vibrational fingers. The actuators are designed to drive the vibrational fingers in a linear direction. 
     Referring to FIG. 9, the motor  42  is shown in greater detail. The motor  42  has two actuators  138  and  140 , fixed on either side of a ring  142 . The ring is preferably made from alumina or another hard, non-magnetic material. The actuators  138  and  140  are positioned 180° apart around the circumference of the ring  142 . A pair of vibrational fingers  144  are attached to the actuator  138  and a pair of vibrational fingers  146  are attached to the actuator  140 . Each pair of vibrational fingers  144  and  146  include tension springs (not shown) that fasten them to the ring  142 . The tension springs produce a high amount of friction between the fingers and the ring and results in the fingers acting as a break for the ring when the fingers are still (i.e., not energized by the actuators). When the fingers vibrate (i.e., energized by the actuators), the linear motion of the fingers translates into a rotary motion of the ring. The rotation of the ring  142  drives the motor shaft  148 , which in turn drives both the transmission (the pulley and belt system described above), and the absolute encoder  130 . All components of the motor assembly are made of non-magnetic materials such as plastic, brass, alumina, etc. so that they can be used within the magnetic field of a MRI system without interfering with its performance. 
     An ultrasonic therapy system constructed in accordance with the present invention further utilizes a second set of encoders, more specifically “relative encoders.” The first set, referred to as “absolute encoders”, and mentioned briefly above, are mounted directly on each of the motor assemblies and measure the absolute amount of motion relative to the origin location of the positioner. The origin is designated as the “home” position. 
     The second set of encoders  160 ,  162 ,  164 , and  166 , (“relative encoders”), are mounted on each of the drive shafts of the motors and measure the amount of motion relative to the position of the system at the time of system power-up. One such example of a relative encoder is model No. HD-9140 manufactured by Hewlett Packard. As can be expected, the position of the system at power-up need not be, and in most cases, is not, the same as the “home” position. Rather, this position is an arbitrary position that was reached during the previous operation and prior to powerdown. The absolute encoders provide a course positioning measurement and the relative encoders provide a fine positioning measurement. Both the relative and the absolute encoders are preferably shielded by a copper cup in order to prevent RFI disturbances induced by the MRI system. 
     The relative encoders provide enough motion resolution to support the accuracy requirements of an ultrasound therapy system. They also have a very compact footprint in order to comply with the slim dimension of the case  34 . It is also preferable to select encoders that support an indexing feature. The index is a point on the encoder that is encountered once per revolution. It should be noted that the encoder typically performs more than one revolution within the positioner&#39;s complete range of motion. 
     In order to bring the system to the home position after power-up and to properly initialize the relative encoders, the positioner is brought to the vicinity of the home position based on the measurements of the absolute encoders. Since these readings are not accurate to the extent that the system demands, the home location is fine tuned by utilizing the higher resolution of the relative encoders. The relative encoders typically have up to 10 times the resolution of the absolute encoders. During an initial calibration procedure, the value of each encoder&#39;s index position around the home position is pre-stored. Once the positioner is in the vicinity of the home position, the positioner is moved until the index position of the associated relative encoder is reached. At that point, the current value of the encoder is reset to the calibrated pre-stored value and the positioner is moved back to the home position based on the relative encoder position readings. 
     Dual positioner readings are further utilized to detect any single failure in the absolute or relative encoders or in the actuator controller by comparing the respective values of the absolute and relative encoder readings. Any discrepancy triggers a safety mechanism that either performs some automatic recovery routine or stops any further motion until human intervention occurs. 
     Each of the motors described above act as a breaking system allowing all power to the positioner to be disconnected while MR imaging is taking place. The breaking feature of the motors holds the transducer position without the risk of positional slip and without the potential for backlash. Known motors used in MR imaging systems require power to be continuously supplied in order to provide a breaking force and therefore require that the motors be located remote from the MRI system so that they do not interfere with the MRI performance. With a positioning system constructed in accordance with the present invention, and since the motors can be de-energized while the MR imaging system is activated, the motors can be located closer to the imaging volume and the entire system can be made more compact. 
     An ultrasonic therapy system constructed in accordance with the present invention thus allows the positioning motors to operate within the MRI imaging space without interfering with the operation of the MRI system. Since inadvertent motor motion at a treatment location due to backlash can be prevented without the need to energize and engage the motors, and since the motors are made from non-magnetic components, the motor bay can be located close to the positioner and within the MRI imaging space. 
     Although the invention has been described and illustrated in the above description and drawings, it is understood that this description is by example only and that numerous changes and modifications can be made by those skilled in the art without departing from the true spirit and scope of the invention. The invention, therefore, is not to be restricted, except by the following claims and their equivalents.