System for carrying out surgery, biopsy and ablation of a tumor or other physical anomaly

The The present invention relates generally to a system for carrying out a surgical procedure on a body structure (eg. as breast, Liver, pancreas, kidney, uterus or other solid organ), and in particular a system for tracking an instrument within a body structure, marking the location of a tumor and biopsy or destruction of Tumor.

background the invention

currently, Breast biopsies using an apparatus carried out, the known as core biopsy system. The core biopsy system wins first a stereo mammogram of the breast of a patient, while the Breast by compressing between two plates is fixed, and uses these two images, to the 3-D coordinates of suspected tumor to calculate. Then a needle is in the kick breast and with biopsy of the suspected tumor. If the biopsy is positive, the patient for the surgical removal of the tumor is provided. It should be noted that before the start of the biopsy procedure the tumor must be identified manually by a radiologist.

Of the surgical process runs generally from in the following manner. A patient is a Mammogram subjected in several levels, a radiologist examines the film and leads subsequently a wire in the chest one, so that it punctured the tumor. This Procedure is visualized using repetitive x-ray images. In the recent past the stereotactic breast imaging system has been used to the to localize the tumor more precisely and assist the insertion of the wire. Of the Patient is then brought into the operating room and the chest by Applying a local sterilizing agent for the surgical procedure prepared. The surgeon opens subsequently the chest and follows the wire until the lesion found and removed is.

one of unwanted Factors in the above-described process is the presence a long wire through the breast for many hours while the Surgical intervention is expected. This is highly traumatic for the patient and undesirable. Second, the surgeon must while the surgery to follow the wire into the breast. As this possibly is not the optimal path, would the surgeon ideally prefer the input path regardless of to plan the wire or to dispense altogether with the wire. This is only feasible when the site of the lesion identified within the breast using a system can be that takes into account the existing deformability of the breast tissue. It is understood that with the deformability of breast tissue problem associated alike for others easily deformable body structures, such. as the liver, is considered.

On Another approach stereotactic surgery is described in European Patent Publication No. <patcit><text>EP 0728446 A1</text></patcit> described. This publication shows a stereotactic system and procedures with special application for the Breast Surgery on. The patient is a magnetic resonance or other imaging device tested to a 3-D image display to produce on a monitor for display. Under the use of visible under magnetic markers on the way for the Tissue adjacent exoskeletalen material are attached, a Hand reading head with transmitters and receivers, and a processor for the Relationships of the coordinate system is the relationship between a Coordinate system of the patient and a coordinate system of the determined on a monitor image displayed. A path for a biopsy, Resection or the like is planned using a Stereotaxieführung, which is fixed to a patient support structure. At the transmitter guide are activated to an appropriate human-readable web display to be generated by the image displayed on the monitor. A suitable Rail and depth is selected from the human-readable display and web a medical instrument. is inserted along the guide to perform the medical procedure.

the current Problem that the use of stereotactic breast surgery restricts is the great Difference between the position and the shape of the breast during the Mammography and surgery. From this viewpoint, be during mammography images taken for stereotactic positioning while the surgical procedure useless. Stereotactic Surgery While it can be carried out with a compressed breast, with the patient lying on the stereotactic table, but this is not desirable. The ideal way to carry out This surgical procedure is in the supine patient, such as this is done routinely.

The <patcit><text>US 5515853</text></patcit> describes a Apparatus and method for simultaneous measurement of several Distances through networked piezoelectric transducer. A rigid external reference frame is provided to the movements of instruments relatively to monitor this.

The overcomes present invention These and other disadvantages of the systems according to the prior &lt;?page 3?&gt;of the technique and creates a system that significantly improved accuracy has and better comfort for the patient has.

Summary the invention

According to the present Invention is a system for performing stereotactic surgery improved accuracy and improved comfort created.

It An object of the present invention, a system for carrying out a surgical procedure on a body structure in minimally invasive creating way.

It is a further object of the present invention, a system to perform to provide a surgical procedure on a body structure naturally deformable is.

It is a further object of the present invention, a system to perform a surgical procedure to create, in which an increased precision in the localization of a tumor is present, resulting in a more accurate surgical Engagement allows.

It is a further object of the present invention, a system to perform a surgical procedure to create, wherein a constant 3-D reference frame is established.

It is a further object of the present invention, a system to perform a surgical procedure to create, in which a deformation the respective body structure a 3-D reference frame does not change.

It is a further object of the present invention, a system to perform to provide a surgical procedure at the breast, in which a greatly reduced risk of distortion or change the shape of the breast given is.

It is a further object of the present invention, a system to perform a surgical procedure on the liver or another internal creating institution in which the location of a tumor more precisely takes place.

It is a further object of the present invention, a system to perform surgery to the liver or other organ create, in the need for more accurate positioning of a surgical instrument is.

More Objects and advantages of the invention will occur to those skilled in after studying and understanding the following detailed description, the accompanying drawings and the appended claims apparently.

Summary tHE dRAWINGS

The Invention may in certain parts and arrangement of parts take physical form, the preferred embodiment and methods in this specification described in detail and in the accompanying drawings which form a part thereof, will be explained.

<figref idrefs="S24">1</figref> shows a three-dimensional tracking and imaging system in accordance with an preferred embodiment, of the present invention.

<figref idrefs="S25">2</figref> shows a breast, in which a Referenztransducer is deposited, while the Breast is compressed.

<figref idrefs="S25">3</figref> shows a transducer assembly in accordance with a preferred embodiment, of the present invention.

<figref idrefs="S26">4A</figref> and <figref idrefs="S26">4B</figref> show the progression of a probe by a breast, shown against the original Stereo mammograms.

<figref idrefs="S27">5A</figref> shows Referenztransducer and a "homing tag" transducer field, the are arranged on a breast.

<figref idrefs="S27">5B</figref> shows the scene <figref idrefs="S27">5A</figref> in the 3-D representation on a Display unit.

<figref idrefs="S28">6A</figref> shows a probe having a transducer in contact with the in <figref idrefs="S26">4A</figref> shown Chest.

<figref idrefs="S28">6B</figref> shows the scene <figref idrefs="S28">6A</figref> in the 3-D representation on a Display unit.

<figref idrefs="S29">7</figref> shows a liver, at several Referenztransducer attached.

<figref idrefs="S29">8</figref> shows a process for producing a 3-D scene, including a 2-D ultrasound image in the <figref idrefs="S29">7</figref> shown Liver.

<figref idrefs="S30">9</figref> shows the insertion a locatable tube in the in <figref idrefs="S29">7</figref> Liver shown; and

<figref idrefs="S30">10</figref> shows the insertion a cryoprobe into a trackable sleeve which at the site of a tumor is arranged.

Detailed Description of Preferred Embodiment

It it is known that it using &lt;?page 4?&gt;the runtime principle of high frequency sound waves is possible, Distances in an aqueous Medium, such as inside the body of a living being, while a surgical procedure to measure accurately. High frequency sound or ultrasonic vibration energy is defined as that in a Frequency range of 100 kHz to 10 MHz. The apparatus for obtaining three-dimensional measurements using Sound waves is used, is known as a sonomicrometer. Typically, a sonomicrometer consists of a pair of piezoelectric Transducer (ie, a transducer operates as a transmitter, while the other transducer as a receiver is working).

The Transducers are implanted into a medium and with electronic Circuits connected. For measuring the distance between the transducers the transmitter is supplied with electrical energy so that it ultrasonic generated. The resulting sound wave then propagates through the Medium continues until it is detected by the receiver.

Of the Transmitter typically takes the form of a piezoelectric crystal, by a high voltage spike or impulse function with a Duration is supplied under a microsecond with energy. This causes the piezoelectric crystal, with its own characteristic swinging resonant frequency. The envelope of the transmitter signal decays rapidly over the Time and usually produces a set of six or more periods, which are characterized by the aqueous medium propagate from the transmitter off. The sound energy is also each interface, to which it applies, steamed.

Of the receiver also is typically in the form of a piezoelectric Crystal before (with similar Characteristics as the transmitter piezoelectric crystal), the detected by the transmitter generated acoustic energy and in response to this begins to vibrate. This vibration produces an electronic Signal in the order of millivolts, which are amplified by appropriate receiver circuits can.

The Propagation velocity of ultrasound in an aqueous medium is well documented. The of an ultrasonic pulse distance traveled can therefore simply by recording the time delay between the moment in which the sound is transmitted and the time at which it received will be measured. Three-dimensional coordinates of the distance measurement can be determined.

In the drawings, which showings are for purposes of illustration a preferred embodiment, of the invention and not for purposes of limiting the same shows <figref idrefs="S24">1</figref> a three-dimensional (3-D) tracking and imaging system <figref>1000</figref> for use in connection with the process according to the present invention. the 3-D tracking and imaging system <figref>1000</figref> generally has a computer system <figref>1010</figref>, Mobile transducer <figref>1032</figref>. Referenztransducer <figref>1034</figref>, an instrument <figref>1030</figref> and an optional robot subsystem <figref>1040</figref> on.

the computer system <figref>1010</figref> generally has a 3-D tracking system <figref>1012</figref>. an image processing Modalitätssystem <figref>1014</figref>. an image registration system <figref>1016</figref>, A Verziehungs- and Geometry transformation system <figref>1018</figref> ( "Delay system"), a user interface <figref>1020</figref> and an ad <figref>1022</figref> on. It is understood that the 3-D tracking system<figref>1012</figref> the Form of a system based on sound or a system on electromagnetism base can accept. Preferably, the 3-D tracking system is <figref>1012</figref> as a 3-D Ultraschallnachverfolgungssystem before, the WO in US Pat. No. 5,515,853 and PCT application no. 96/31753 is described, which are both incorporated herein by reference are.

the instrument <figref>1030</figref> may take the form of a catheter, a probe (Z. B. a cryoprobe), a sensor, a needle, a scalpel, pliers or other means or other instrument present that in a surgical or diagnostic procedure is used. The mobile Transducer<figref>1032</figref> and Referenztransducer <figref>1034</figref> can in Form an ultrasound transducer or an electronic transducer present. For purposes of illustration a preferred embodiment, the present invention, the transducer <figref>1032</figref> and <figref>1034</figref> in Form of ultrasonic transducers (ie, piezoelectric crystals) before.

Several mobile transducer <figref>1032</figref> are attached to the instrument <figref>1030</figref> available. One or more Referenztransducer <figref>1034</figref> provide a reference position relative to mobile transducers <figref>1032</figref>, in view of can the Referenztransducer <figref>1034</figref> be arranged so that they an internal reference frame inside a patient's body or on the surface a patient's body arise to create an external reference frame.

As indicated above, the Referenztransducer <figref>1034</figref> its transmitter, transceiver or receiver, that can generate ultrasound or electromagnetic radiation from the mobile transducers <figref>1032</figref> can be detected.

the 3-D tracking system <figref>1012</figref> converts the multiple distance measurements between all transducers <figref>1032</figref>. <figref>1034</figref> in XYZ coordinates vorste relative to a reference axis, as described in detail&lt;?page 5?&gt;described starting. It is understood that the of the Referenztransducern <figref>1034</figref> created Framework must be self-determining, that is, if the reference frame is distorted, this distortion of the Referenztransducern <figref>1034</figref> must be recorded. The detection is typically carried out using transceivers that the Distance between any combination of two transducers and thus their spatial Relative coordinates to determine the 3-D space. In this connection, the position of the transducer in 3-D from the of the body structure (Z. B. tissue or organ) received captured images that show "dots" where the transducers are arranged, and also from the transducers themselves when they in of the body structure are. If a discrepancy of distances between all combinations present of transducers, the body structure has deformed (ie "warped") who, after the images were recorded. A mathematical coordinate transformation can be used to determine exactly how the picture setting is correct and the delay can be compensated. The Distance between any combination of two transducers is determined by having each transducer is caused, a signal be sent to all other transducers. In this way, all known distances between the transducers. From these distances can the XYZ coordinates be calculated by reference to a transducer as the origin.

the Image processing Modalitätssystem <figref>1014</figref> detected 2-D, 3-D or 4-D image data sets from an imaging source, such. as fluoroscopy, MRI (magnetic resonance imaging), CT (computed tomography) or 2-D or 3-D ultrasound device, to a "template" to create, through which or against which the shape, position and movement of the tracked Instruments <figref>1030</figref> can be displayed. The template has Typically, the form of an image of the instrument surrounding Environment (eg. As a body structure). It should be noted that if multiple (3-D) volumes in different are recorded time intervals, a 4-D image is obtained (ie an over the time-varying 3-D image).

the Image Registration System <figref>1016</figref> registers the position the instrument <figref>1030</figref> within the spatial coordinates of the of the image processing Modalitätssystem <figref>1014</figref> provided Image data set. The position of the instrument<figref>1030</figref> is of the 3-D tracking system <figref>1012</figref> provided. The image registration system <figref>1016</figref> provides an indication the instrument <figref>1030</figref> at its actual 3-D location within of the body structure and its alignment with the body structure itself. It goes relatively that the registration system <figref>1016</figref> user-assisted or completely can be automated if image processing algorithms implemented are to the spatial Places of transducers (typically the Referenztransducer) in the Image data set to automatically detect.

the delay system <figref>1018</figref> is a software-based system that the image data sets transformed to the appropriate values, or "warp" so that they correspond to a deformation, in the reference frame between the time at which the image data set has been detected, and the time at which the operation during the surgical procedure is implemented, has occurred. correspondingly , the default system <figref>1018</figref> typically a matrix transformation routine on that maps the deformed geometry onto the original image data set and distorts it appropriately.

The User interface <figref>1020</figref> allows the user to interact to computer system <figref>1010</figref> including the programming of the computer Systems <figref>1010</figref> for carrying out a desired Function. For example, a particular view for display selected will. instruments<figref>1030</figref> (For example, tubes or catheters) can using the user interface <figref>1020</figref> activated will. The display<figref>1022</figref> shows the user registered Images received from the image registration system <figref>1016</figref> to be provided.

the optional robotic system <figref>1040</figref> generally includes a robot control system <figref>1042</figref> and a robotic manipulator system <figref>1044</figref> on. The robot control system<figref>1042</figref> controls the robot manipulator system <figref>1044</figref>So that it a programmed follows path based on shifting, warping or deformation a body structure are changed at the time of the surgical procedure appropriately can. The robot manipulator system<figref>1044</figref> physically moved the instrument <figref>1030</figref> according to the instructions of the robot control system <figref>1042</figref>,

the above 3-D Nachverfolgungs and imaging system <figref>1000</figref> can be used to provide both stereotactic localization during Biopsy and surgery that is more interactive than Stereotaxietischsysteme existing, as well as the marking of a enabling tumor, so he then during the usual surgical procedure can be localized. It is understood, that although the present invention with reference to the biopsy and ablation of a tumor is described, but also for use is suitable in connection with other physical anomalies.

the Marking a present in a breast tumor is below with reference to <figref idrefs="S25">2</figref> described. Several external reference Trans&lt;?page 6?&gt;ducer <figref>20</figref> be on the surface of chest <figref>10</figref> appropriate. The Referenztransducer<figref>20</figref> offer a stereotactic external reference frame for the interactive 3-D display the movement of a probe <figref>40</figref> during insertion of the internal transducer <figref>30</figref>As will be described below. The tumor <figref>12</figref> is by introducing an internal ultrasound transducer <figref>30</figref> in the tumor <figref>12</figref> while the conventional marked mammography, the breast <figref>10</figref> under use of compression plates <figref>8</figref> is compressed. The transducer<figref>30</figref> occurs in place of the Lokalisiernadel, the currently according to the methods of the prior introduced the technology into the tumor is.

The Referenztransducer <figref>20</figref> can formed as a single Aufklebelemente or parts of an adhesive strip be. <figref idrefs="S25">3</figref> shows an exemplary embodiment an arrangement for attaching Referenztransducern <figref>20</figref> among Using an adhesive. The Referenztransducer<figref>20</figref> becomes of a piece of adhesive tape <figref>24</figref> carried. A Anpassungsgel <figref>26</figref> is on the tape piece <figref>24</figref> applied and Referenztransducer <figref>20</figref> disposed therein. the gel <figref>26</figref> ensures the acoustic coupling. Electrical leads<figref>22</figref> of Referenztransducers <figref>20</figref> pass through an opening in the piece of tape <figref>24</figref> out.

It understood that the Referenztransducer <figref>20</figref> on the two Mammograms appear that obtained from two slightly different angles be, and can be used, to fiducials for stereographic determination of the 3-D coordinates with respect to to produce these markings. Further, the movement of the probe<figref>40</figref> also this mammograms in two levels using the transducer <figref>30</figref> based will. Accordingly, a user can change the movement of the probe<figref>40</figref> both in a 3-D viewing environment as well as against the original X-ray images while of depositing the transducer <figref>30</figref> track, the following during Biopsy or the surgical procedure as a "homing tag" for the tumor serves. The progression is an instrument by a breast against mammograms <figref idrefs="S26">4A</figref> and <figref idrefs="S26">4B</figref> shown.

After this the transducer <figref>30</figref> in the tumor <figref>12</figref> was used and the probe <figref>40</figref> from the breast <figref>10</figref> was removed, the patient can comfortably walk around, as the transducer <figref>30</figref> associated electrical leads <figref>32</figref> are very flexible and with tape on the skin the patient may be fastened. It is understood that the transducer <figref>30</figref> the site of the tumor <figref>12</figref> during the can designate subsequent surgery reliable because it using small prongs that while of introducing intervene in the tumor <figref>12</figref> remains attached.

The Procedure described above provides a significant Improvement over the conventional Stereotactic. As between mammography and surgical Engaging a very strong change the breast form occurs, the tumor can in a completely different Place are as previously during mammography detected. This has the result that any stereotactic registration external breast form on internal breast images is meaningless. However, since the tumor with the transducer <figref>30</figref> is selected, may place during the following operations are always determined.

After the above-described procedure, the patient goes to the operating room, the breast is for the surgery and preparing new adhesive with it embedded ultrasonic transducers is attached to the skin. The transducer <figref>20</figref> and <figref>30</figref> are above the described 3-D tracking and imaging system connected. It is understood that the transducer <figref>20</figref> and <figref>30</figref> the Tracking of additional Transducers allow, during the the subsequent surgical procedure used in the breast can be.

<figref idrefs="S27">5A</figref> shows a breast <figref>10</figref>, The one with an internal transducer <figref>30</figref> highlighted tumor <figref>12</figref> having. The attachment of the external Referenztransducer<figref>20</figref> and the presence of internal transducer <figref>30</figref> in the tumor <figref>12</figref> allows Generating a 3-D viewing environment in which the tumor <figref>12</figref> in With respect to the chest <figref>10</figref> can be localized (<figref idrefs="S27">5B</figref>). This means for visualizing the spatial location of the tumor <figref>12</figref> relative to the outside breast <figref>10</figref> is for the planning of the surgical procedure to remove the cancer important. conventional Technology is simply a previously introduced in the breast wire to follow. This is not desirable, as this may not cosmetically preferable way is to be taken. By analyzing einer3-D display, such as in <figref idrefs="S27">5B</figref> shown, can decide from which direction he cuts a surgeon starts.

If the cuts are set, a secondary probe <figref>50</figref> in the wound be held to determine whether the train should be modified. <figref idrefs="S28">6A</figref> shows the probe <figref>50</figref> in touch with the breast <figref>10</figref>, It is noted that the probe<figref>50</figref> a arranged at its tip transducer <figref>52</figref> has. correspondingly can in <figref idrefs="S28">6B</figref> generated 3-D display shown will. Once on the sample<figref>50</figref> Inappropriate Transducer <figref>52</figref> With the tissue in contact comes, he will appear in 3-D display and can relative to the transducer <figref>30</figref> (D. the "homing tag") are localized h.. correspondingly allows the 3-D display, the surgi&lt;?page 7?&gt;visualize logical way and correct as needed. Because of the Referenztransducer<figref>20</figref> formed Reference frame on the outer surface of the chest <figref>10</figref> is fixed, it is not important if the breast tissue deformed after Mammografieabbildung. Among to this aspect, the transducer <figref>30</figref> always relative to the new configuration on the outer surface of the breast <figref>10</figref> fortified transducer <figref>20</figref> shown. Further, since the outer Referenztransducer<figref>20</figref> communicate with each other, set them a new, changing coordinate frame independently thereof, the extent to which the Breast tissue is manipulated. In any case, the relative position the transducer <figref>30</figref> within this coordinate system displayed.

The Approach described above offers numerous advantages and overcomes the current restrictions stereotactic surgery that fixed on a coordinate system based. From the viewpoint of clinical benefits, a surgery on the chest are much less performed invasive. In a further development, it may be possible to significantly tumors less invasive manner by introducing small catheters remove the remove the tumor by ablation, vacuum or destroy otherwise, without the breast for visual inspection open must become. This substantially reduces the risk of the chest deface or alter its shape. Another important clinical advantage is the increased precision in the location of the tumor, resulting in a more precise surgical Engagement allows. The theoretical precision the above-described 3-D tracking system is 20 microns. In the Practice is the spatial 3-D precision less than 1 mm, and due to geometrical transformation errors this may rise to 2 mm. This is apparently still better than the currently precision achievable using the Drahteinführtechnik or usual stereotactic tables. Such increased precision improve the success rate of tumor removal without greater, more radical Lumpectomies are required. Another clinical advantage is that the above-described procedure without Another both Biopsies, open surgery or fully closed, Minimally invasive surgical procedures can be used. you provides a user-assisted Device in real time on the approximation to tumors within the breast and is much less costly than conventional stereotactic Devices.

The present invention may according to a further embodiment of the present invention are also used to an instrument placing at the site of a tumor. <figref idrefs="S29">7</figref> shows liver <figref>60</figref>That a tumor <figref>14</figref> having. On three-dimensional frame of reference of the liver <figref>60</figref> is generated, by several Referenztransducer <figref>90</figref> on the outer surface of the liver <figref>60</figref> be attached. Thereby, the transducer<figref>90</figref> among laparoscopic guidance be attached. subsequently is the site of the tumor <figref>14</figref> using two-dimensional guided Ultrasonic <figref>110</figref> determines a 2-D ultrasound imaging plane <figref>112</figref> generated. A 2-D ultrasound imaging plane is within the 3-D reference frame displayed, to form a 3-D scene. If the tumor<figref>14</figref> from the ultrasound imaging plane <figref>112</figref> is cut, is the user a cursor mark in the 3-D scene to the center the tumor <figref>14</figref> to identify. The 3-D-consistent overview and imaging system determines the 3-D coordinates of the tumor <figref>14</figref> within the 3-D scene, relative to that of the transducers <figref>90</figref> created 3-D reference frame. It will be appreciated that, since the transducers<figref>90</figref> at the liver <figref>60</figref> are fixed, the site of the tumor <figref>14</figref> relative to the 3-D reference frame remains fixed, even when the liver <figref>60</figref> even manipulated is and deformation of the liver <figref>60</figref> caused.

As <figref idrefs="S30">9</figref> and <figref idrefs="S30">10</figref> show, A cryoprobe <figref>100</figref> (Or other instrument) at the tumor <figref>14</figref> placed. Here is an ultrasonically localizable bracket shell <figref>70</figref> in the liver <figref>60</figref> imported and positioned so that an end to the tumor site <figref>14</figref> equivalent. The bracket shell <figref>70</figref> Has preferably the form of a hollow rigid shell or a tube, to the transducer <figref>80</figref> are attached. A preferred holder Case<figref>70</figref> is in the Detail in US-A-5868673 described. The transducer <figref>80</figref> allow it, the position of the bracket shell <figref>70</figref> among Using the above-described 3-D tracking and imaging system to pursue.

As soon as the mounting sleeve <figref>70</figref> at the The tumor site <figref>14</figref> is placed, the cryoprobe <figref>100</figref> in the mounting sleeve <figref>70</figref> introduced so that they at the mouth the envelope stops. According to at the cryoprobe <figref>100</figref> made any physical modifications in order for them at the tumor site <figref>14</figref> is placed. subsequently is the holder shell <figref>70</figref> along the shaft of cryoprobe <figref>100</figref> withdrawn. Then, the cryoprobe <figref>100</figref> for ablation of the tumor <figref>14</figref> in a known Way powered.

alternative , the operation described above by introducing a trackable blunt instrument guide with attached ultrasonic transducers and by placing the guide instrument performed at the tumor site will. Then, a tube or sleeve is placed at the tumor site, by the pipe on the guide instrument is pushed. &lt;?page 8?&gt;Then, the guide instrument is removed, leaving only the shell remains. A cryoprobe (or other instrument) is then carried the case imported characterized so that the cryoprobe is placed at the tumor site.

The Invention has been described with reference to a preferred embodiment described. It is obvious that other modifications and variations after studying and understanding This description will clearly. All such modifications and amendments should be included insofar as they depart from the scope the accompanying claims fall.