Abstract:
A structurally integrated biopsy system includes a movable base having wheels to facilitate movement of the structurally integrated biopsy system. On the movable based there is mounted a tissue removal system, an ultrasound imaging system, and a controller. The tissue removal system includes a probe connector configured to connect to a tissue removal probe. The ultrasound imaging system is configured to generate an ultrasound image of a body region of a patient, and has an image display system having an image display screen to display ultrasound images taken by the ultrasound imaging system. The controller is configured to be in communication with each of the tissue removal system and the ultrasound imaging system to both provide control information for the ultrasound imaging system and provide control information for the tissue removal system in the structurally integrated biopsy system.

Description:
RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 11/810,425, filed Jun. 5, 2007, now U.S. Pat. No. 8,622,907, which is related to provisional application Ser. No. 60/810,906, filed on Jun. 5, 2006, each of which is incorporated herein in its entirety and which is relied upon for priority. 
    
    
     FIELD OF THE INVENTION 
     This invention is directed to systems and methods for imaging and removing tissue from a location within a patient and particularly to a biopsy system which has an integrated imaging system. 
     BACKGROUND OF THE INVENTION 
     Currently, to find suspicious areas or lesions, one or more imaging systems are used to locate the area or lesion of interest and may be used to guide the biopsy probe of a biopsy systems to and/or near the area or lesion of interest. Subsequently, tissue samples are removed and often, particularly in the case of breast biopsy, markers are placed at the site of the lesion removal. 
     Existing biopsy systems such as the EnCor® biopsy system manufactured by SenoRx, Inc. (the present assignee) and other commercially available systems are “stand alone” biopsy systems. Diagnostic imaging systems such as an ultrasound, x-ray, MRI, PET, CT, Thermal, etc. are separate devices frequently requiring substantial “floor space” in patient treatment and/or diagnosis rooms in clinical settings such as clinician offices, breast centers, hospitals, etc. Portable imaging systems are available but they can require additional operators other than the physician or other medical practitioner who is performing the biopsy. 
     SUMMARY OF THE INVENTION 
     A biopsy system embodying features of the invention includes a tissue removal system, an imaging system, an image display system and a common input console for the tissue removal system, the imaging system and the image display system. 
     The tissue removal system is suitable for use with one or more tissue removal probes. The imaging system is preferably an ultrasonic imaging system. The imaging system is configured to display images taken by the imaging system. The common input console is configured for imputing control or operational data to the tissue removal system, the imaging system and the image display system. 
     The tissue removal system has a programmable control module (microprocessor), at least one peripheral module for providing a vacuum to the tissue removal system and a plurality of connecting modules configured to receive one or more tissue removing probes. The individual probes preferably have software scripts stored in a memory device within the probe for operating the probe, controlling the functionalities of the probe and to provide pertinent information to the control module when connected thereto. 
     The imaging system has a programmable control module (microprocessor) for controlling the imaging system providing imaging data to a main computer module for the image display system. Preferably the imaging system has a plurality of connecting modules which allow for use of a plurality of different imaging probes (e.g ultrasound probes). For example, the ultrasound probes may have different sized or different shaped, e.g. flat or curved, ultrasonic transducer surfaces. 
     The biopsy system preferably has a main computer module which has communication links with the tissue removal system and the imaging system. 
     The common input console typically includes a key board and/or a touch screen display which allows a single operator to handle the tissue removal system the imaging system and the image display system. Moreover, the tissue removal system and the imaging system may be used alone. 
     The biopsy system preferably has the tissue removal system, the imaging system and the image display system mounted on a movable base such as a wheeled cart, so as to be easily transported to different locations. The biopsy system is small enough to provide a small foot-print in treatment rooms. 
     A number of potential diagnostic ultrasound systems are available commercially that can be used in a biopsy system embodying features of the invention, including: Sonosite, Alora, Toshiba, Siemens, GE, Philips, Acuson, ATL, HP, Medison, Shimadzu, HDAC and Hitachi. One particularly suitable ultrasound imaging system which can be packaged in a much smaller housing yet provides a high resolution, high image quality capability that may be readily adaptable to a combined biopsy system is available from the ULTRASONIX MEDICAL CORPORATION OF BRITISH COLUMBIA (Burnaby) Canada. Details of the ULTRASONIX imaging system can be found in the following patents and published applications which are incorporated herein in their entirety: 
     
       
         
               
               
             
           
               
                   
                   
               
             
             
               
                   
                 U.S. Pat. No. 6,558,326 
               
               
                   
                 U.S. Pat. No. 6,911,008 
               
               
                   
                 U.S. Pat. No. 6,325,759 
               
               
                   
                 U.S. Pat. Pub. No. 2002/000719 A1 
               
               
                   
                 U.S. Pat. Pub. No. 2004/0193047 A1 
               
               
                   
                 U.S. Pat. Pub. No. 2004/0122314 A1 
               
               
                   
                   
               
             
          
         
       
     
     A particularly suitable tissue removal system is the EnCor® and SenoCor 360® biopsy systems available from SenoRx, Inc. (the present assignee) of Aliso Viejo, Calif. Details of the EnCor® and SenoCor® biopsy systems can be found in the following U.S. Patent and published applications: 
     
       
         
               
               
             
           
               
                   
                   
               
             
             
               
                   
                 U.S. Pat. No. 6,620,157 
               
               
                   
                 U.S. Pat. Pub. No. 2004/0138653 
               
               
                   
                 U.S. Pat. Pub. No. 2005/0004559 
               
               
                   
                 U.S. Pat. Pub. No. 2005/0159677 
               
               
                   
                 U.S. Pat. Pub. No. 2006/0149162 
               
               
                   
                   
               
             
          
         
       
     
     With the present biopsy system the clinician can identify the outline of the ultrasound image and then determine the path of tissue removal probe, e.g. an RF cutter or mechanical cutter (see listed publications and patents) on the image display. Additionally, the common input console allows the clinician to input information to the tissue control system, the imaging system and the image display system. These and other advantages will become more apparent from the following detailed description of embodiments. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a front perspective view of a biopsy system which has a tissue removal system and an ultrasonic imaging system embodying features of the invention. 
         FIG. 2  is a rear perspective view of the biopsy system shown in  FIG. 1  showing one side of the system. 
         FIG. 3  is a rear perspective view of the biopsy system shown in  FIG. 1  showing the side opposite to that shown in  FIG. 2 . 
         FIG. 4  is a side view of the biopsy system shown in  FIG. 1 . 
         FIG. 5  depicts a touch-display screen which allows operation of both the tissue removal system and the imaging system of the biopsy system shown in  FIG. 1 . 
         FIG. 6  is a general block diagram of a biopsy system embodying features of the invention. 
     
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
       FIGS. 1-5  illustrate a biopsy system  10  that embodies features of the invention. The system  10  has a tissue removal system  11 , an imaging system  12 , display screen  13  and a common input console  14  with a keyboard  15  and a touch-screen display  16 . The biopsy system  10  is mounted on a cart  17  which has wheels  18  at each corner for portability. The input console  14  has probe holders  20  for holding ultrasonic probes and tissue removal probes (not shown). 
     The tissue removal system  11  has connecting modules  21  and  22  that are configured to receive tissue removal probes (not shown) such as the probes for EnCor® and SenoCor 360® probes which are available from SenoRx, Inc., the present assignee. The imaging system  12  has connecting modules  23 ,  24  and  25  for connecting with different suitable ultrasonic probes, such as broadband transducers L 14-5/38, L 14-5W/60 and C 5-2/60 available from Ultrasonix Medical Corporation. The first two are linear array type transducers and the latter is a curved array type transducer. 
       FIG. 6  is a general block diagram of the biopsy system  10  shown in  FIG. 1  which has a tissue removal system  11 , an ultrasonic imaging system  12  and a main computer module  30  and an image display screen. The tissue removal system  11  of system  10  has a tissue removal control module  31 , a vacuum module  32  for vacuum operations and tissue removal connector module  33  probe connectors  21  and  22 . The vacuum module  32  has a vacuum line, a valve operated by the tissue removal control module  31  and a vacuum source (e.g. a connection to a vacuum line or a vacuum pump) which are not shown. The imaging system  12  has an ultrasound control module  34  for ultrasonic emission and reception and an interface with the main computer module  30 . An ultrasound connector module  35  is in communication with the ultrasound control module and has ultrasound probe connectors  23 ,  24  and  25 . Output from the main computer module  30  related to the imaging input data thereto from the ultrasound control module is directed through a communication link to the image display screen  13  to display ultrasonic diagnostic images from an ultrasonic probe (not shown) connected to one of the ultrasound probe connectors  23 ,  24  or  25 . 
     The input console  14  is connected via a communication link to the main computer module  30  which in turn has communication links to the tissue removal control module  31  and the ultrasound control module  34 . This allows the single input console  14  to be employed to control both the tissue removal system  11  and the imaging system  12 . The main display screen  13  is positioned right above the input console  14  so that a single operator may easily operate both the tissue removal system  11  and the ultrasound imaging system  12  from a single console. Further details of the tissue removal system can be found in patents and published applications of SenoRx, Inc. previously referred to and incorporated herein. 
     The ultrasound imaging system  12  for producing ultrasound images has ultrasound control module  34  is coupled to a ultrasound connector module  35  has probe connectors  23 ,  24  and  24  to which may be connected an ultrasound probe (not shown) The probe generates and receives acoustic signals. The acoustic signals that are generated by the probe are directed towards a body region of a patient, e.g. breast, and some of the acoustic signals are reflected back to the probe as echo signals. The echo signals obtained by the probe are sent back to the ultrasound control module  34  which processes the echo signals to extract data that is sent to the main computer module  30 . The main computer module  30  performs a display data processing in real-time which is sent to the ultrasound display screen  13  where an ultrasound diagnostic image is displayed. See U.S. Pat. No. 6,325,759, for example, which is incorporated herein by reference. Input console  14  allows the user to interact with the main computer module and modify the ultrasound configuration. Further details of the ultrasound imaging system can be found in the patents and published applications of Ultrasonix previously referred to and incorporated herein. 
     In the embodiment shown in  FIG. 6 , only the vacuum control module  32  and the tissue removal control modules  32  are shown. However, additional modules may be provided, for example modules for a temperature probe, a heart rate monitor device, a drug infusion tools, anesthesia tools, or other surgical or medical devices that may operate with the biopsy system  10 . They may be connected to the tissue removal control module  31  or directly to the main computer module  30 . The tissue removal devices connected to the tissue removal connector module  33  may have mechanical tissue cutting members or radio frequency (RF) powered electrosurgical cutting members for performing the surgery. It is to be understood that other peripheral modules can be of different forms and functions, and they may not be required to be physically connected to the tissue removal control module  31  or the ultrasound control module  34  or directly to the main computer module  30  so as to communicate therewith. 
     The tissue removal control module  31  is a microprocessor-based electrical device with built-in software functions necessary to operate various handheld devices for both tissue removal. Each handheld device preferably contains a software script, stored in a memory device within the handheld device, for operating that particular device when connected to the tissue removal control module. For example, the said software script may be stored in non-volatile memories such as erasable programmable read only memories (EPROMs), electrically erasable programmable read only memories (EEPROMs) or flash memories. When a handheld device is indirectly connected to the tissue removal control module  31 , the software script within the handheld device will be downloaded into the tissue removal control module. This software script will enable the tissue removal control module  31  to control the functionalities of a particular handheld device. Connection to the main computer module  30  allows the touch screen  14  to display its pertinent information and allow control input through either the touch screen or the keyboard  15 . During the operation of a handheld device, a graphical user interface (GUI) software will display information on the touch screen  14  relevant to the operation of the tissue removal control module  31  and the handheld device to the operator. It is understood by those skilled in the art that the information displayed may vary depending upon the type of handheld device connected, the operational state of the handheld device as well as other environmental factors affecting the operation of both the handheld device and the main computer module  30 . 
     It is understood that although the various modules and the handheld devices for either the tissue removal system  11  or the ultrasound image system  12  may be interconnected through wired connections (including connector modules and wires) for their operations, the communication links can be easily implemented through wireless communications. However, the conventional wired connections have certain advantages such as low signal interferences, but the wireless technology can turn the operation of the handheld device to a more mobile operation, which benefits the operator as well. For example, almost all the control signals can be sent through a predetermined wireless communication channel using technologies such as Bluetooth or 802.11 compliant wireless technologies. When the handheld device is battery powered, then the operation may be completely mobile. It is also practical that the wired communication channels may be used together with the wireless communication channels so that the tissue removal control module can take advantage of the available wireless technologies for providing convenience to the operator, while still benefiting from using some conventional wired technologies. In short, while the examples provided herein illustrate embodiments having features of the invention, it should be understood that communications between devices can take various forms and the main computer module  30 , the tissue removal control module  31  and the ultrasound control module  33  are designed to use the most practical technologies for fulfilling the need of the operators. 
     The biopsy system may be powered by a single power source (not shown) or can have multiple power sources for various functions. For example, the tissue removal system  11  and the ultrasound imaging system  12  may have separate power sources. 
     While particular forms of the invention have been illustrated and described herein, it will be apparent that various modifications and improvements can be made to the invention. For example, the discussion herein has focused on ultrasound imaging. Those having ordinary skill in the art will recognize that other imaging systems may be employed, for example x-ray or mammographic imaging. To the extent not previously described, the various elements of the biopsy system may be made from conventional materials used in similar devices. Moreover, individual features of embodiments of the invention may be shown in some drawings and not in others, but those skilled in the art will recognize that individual features of one embodiment of the invention can be combined with any or all the features of another embodiment. Accordingly, it is not intended that the invention be limited to the specific embodiments illustrated. It is therefore intended that this invention be defined by the scope of the appended claims as broadly as the prior art will permit. 
     Terms such as “element”, “member”, “component”, “device”, “means”, “manufacture”, “portion”, “section”, “steps” and words of similar import when used herein shall not be construed as invoking the provisions of 35 U.S.C. §112(6) unless the following claims expressly use the terms “means for” or “step for” followed by a particular function without reference to a specific structure or action. All patents and all patent applications referred to above are hereby incorporated by reference in their entirety.