PRIORITY CLAIM This application is a Divisional application of U.S. patent application Ser. No. 09/603,886 filed on Jun. 26, 2000 entitled “Apparatus and Method for Performing a Tissue Resectioning Procedure”. The entire disclosure of this prior application is considered as being part of the disclosure of the accompanying application and hereby expressly incorporated by reference herein.
BACKGROUND OF THE INVENTION 1. Field of the Invention
The present invention relates generally to an apparatus and method for performing a medical procedure. More specifically, the invention provides for identifying target tissue margins and for guiding a tissue resection device to the target tissue in a tissue resection procedure.
2. Description of the Related Art
An endoluminal procedure is a medical procedure that takes place in one of the many tubes, or lumens, within the human body. The endoluminal procedures may take place in vascular, gastrointestinal, or air exchange lumens, and may involve disease diagnosis and/or treatment. Millions of endoluminal procedures are performed each year in hospitals around the world.
A procedure that is often carried out endoluminally is the removal of “suspect” or diseased tissue. The purpose of such tissue removal, or resection, may be to provide tissue samples for histological analysis or removal of diseased tissue as a treatment means. Today, endoluminal resection of tissue is often done using only the subjective judgment of the clinician to determine where tissue should be removed. As disease tissue margins are sometimes difficult to determine visually, tissue resection guided solely by visual cues can be inaccurate and even dangerous. The danger arises when resectioning cancerous tissues that are prone to metastasize. In this case, a tissue resection that occurs without sufficient buffer of healthy tissue risks leaving behind cancerous tissue requiring repeated resectioning procedures, or worse, causing the cancerous lesion to “seed”, or metastasize, to other parts of the body.
FIGS. 1 and 2 illustrate a prior artendoluminal device100 that could be used in the harvesting of diseased tissue from within a body lumen. The device is comprised of aflexible catheter body110 with aproximal end112 anddistal end114. At theproximal end112 there is a suction adjustknob120, acoupler130, avacuum hose140, head-actuating handle150, and anelectrical interconnect160. Thevacuum hose140 makes connection from avacuum pump142, through thecoupler130, to acentral lumen170 within thecatheter body110 to draw a suction on tissue-harvesting chamber190. Theelectrical interconnect160 is comprised ofelectrical leads161 that pass from theexternal electronics162, through thecoupler130 at theproximal end112 of thecatheter body110 to acavity116 outside thecentral lumen170 but within thecatheter body110. Some of theelectrical leads161 supply electrical energy to alight source163 and avision chip164 situated at thedistal end114 of thecatheter110, while another group of theelectrical leads161 bring electrical signals from thevision chip164 to a video processor and adisplay device165. The head-actuating handle connects to a cable (not shown) that travels the length of thecatheter body110 within thecentral lumen170 to control the operation of the endoluminal device'shead assembly180.
FIG. 2 is a detailed view of thedistal end114 of thedevice100 ofFIG. 1. At thedistal end114 of thecatheter body110 there is ahead assembly180, a tissue-harvesting chamber190, acutting device192, and thelight source163 and thevision chip164. The tissue-harvesting chamber190 is connected to thecentral lumen170 of thecatheter body110. Thecentral lumen170 is connected to theexternal vacuum pump142. Thehead assembly180 is movable with respect to thecatheter body110 and, thus, can be extended or retracted using the cable that is attached to the head-actuating handle150 at theproximal end112 of thedevice100 and to thehead assembly180 at thedistal end114 of thedevice100. Thecutting device192 is a sharpened blade that severs thetissue200 as the retractinghead assembly180 presses thetissue200 against thecutting device192 to remove thesuspect tissue area210.Distal end114 also includesstaples194 andanvil surface196 which are utilized to staple the site. Thevision chip164 is connected to the external video processor anddisplay device165 via theelectrical leads161 within thecatheter body110, but outside of thecentral lumen170.
FIG. 2 also illustrates thedistal end114 of the prior art tissue-resectioning device100 as it would appear having been inserted into a body lumen. Extended into the body lumen, the Endoscopist would guide thedistal tip114 of the device into close proximity with thetissue200 to be resected. By adjusting the suction at thetip114 with the suction adjustknob120, the clinician can then increase the suction at thetip114 until thetissue200 is drawn into thetissue harvesting chamber190 through a distal opening114A and into thetissue harvesting chamber190. Once the tissue is in position, the clinician can then retract thehead assembly180 to perform the resection. Thesuspect tissue210 is removed and the site is stapled with the staples contained in thehead assembly180. With thetissue sample210 enclosed within the tissue-harvesting chamber190, thedevice100 can be removed from the body lumen and thetissue sample210 removed.
Today, a tissue-resectioning procedure such as described above would be guided by the clinician based upon whatever limited visual information could be obtained through thevision chip164 at thedistal end114 of thecatheter110. Whereas histological staining may be used to assist in tissue margin identification, guiding theresection device100 in the procedure in this manner is still a very subjective process and prone to error. There is a high probability that either too much or too little tissue will be resected. Both of the outcomes are undesirable, and even dangerous.
Therefore, it would be desirable to provide an improved system and method for assisting a practitioner in accurately identifying target tissue margins and guiding the practitioner to the target tissue.
SUMMARY OF THE INVENTION An apparatus and a method for performing a medical procedure is provided. In an embodiment for an apparatus of the present invention, the apparatus includes a positioning system and a resection device disposed within the positioning system. The positioning system includes an imaging device, a video processor coupled to the imaging device, a computer coupled to the video processor, and a video display coupled to the computer. In an embodiment for a method of practicing the present invention, the method includes the steps of creating an image of a lesion within a patient's body on an imaging device. Data representative of the lesion image is processed by a video processor. Tissue margins around the lesion are defined by a processor based on the processed data representative of the lesion image and a resection device is operated during a resection procedure within the patient's body based upon the defined tissue margins.
BRIEF DESCRIPTION OF THE DRAWINGS The various features of the invention will best be appreciated by simultaneous reference to the description which follows and the accompanying drawings, in which:
FIG. 1 illustrates a known endoluminal device;
FIG. 2 is a detailed view of the distal end of the device ofFIG. 1; and
FIG. 3 is an embodiment of a system for performing a medical procedure in accordance with the principles of the present invention.
DETAILED DESCRIPTIONFIG. 3 illustrates an embodiment of a system for performing a medical procedure in accordance with the principles of the present invention. As can be seen inFIG. 3, thesystem30 includes apositioning system300 and aresection device100. In the illustrated embodiment, thepositioning system300 includes afluoroscope310, anx-ray imaging sensor320,video processing electronics330, acomputer340, avideo display350, and analarm360. As can be further seen inFIG. 3, thesystem30 further includes aresection device100 that is positionable within thepositioning system300.Resection device100, as is well-known in the art, can be utilized to remove aninternal lesion420 from atubular organ410 within abody wall400 of a patient and resect the tissue of thetubular body organ410 from whichlesion420 is removed. As will be further explained later in this specification,fluoroscope310 generates x-rays that are detected by thex-ray imaging sensor320. The x-rays generated byfluoroscope310 pass through the patient andlesion420 to be collected onx-ray imaging sensor320. A radiopaque die, having selectively been absorbed bylesion420, creates an image of the boundaries oflesion420 onx-ray imaging sensor320. Image information fromx-ray imaging sensor320 related tolesion420 is communicated tovideo processing electronics330 where the video processing electronics processes the image information fromsensor320 and provides digitized image data tocomputer340.Computer340 utilizes the digitized image data to identify atissue margin420A aroundlesion420. Thetissue margin420A is provided tovideo display350 where the tissue margin can be displayed relative tolesion420.
In addition tocomputer340 receiving position image data forlesion420 fromx-ray imaging sensor320,computer340 is also able to receive position image data forresection device100. Thus,computer340 is able to provide relative positioning data forresection device100,lesion420, and the definedtissue margin420A.
Through use of thepresent system30, if, during the resection procedure, the resection device, through operation by the surgeon, is in danger of severing tissue outside oftissue margin420A or is in danger of not removing a sufficient amount oftissue surrounding lesion420, as defined bytissue margin420A,computer340 is able to provide an alarm to alarmdevice360 to alert the physician that is performing the procedure of the particular situation.
Thus, through utilization ofsystem30, the physician is able to objectively determine the amount of tissue that is to be removed when preforming the procedure. This provides advantages over the currently known methods and apparatuses that are utilized by surgeons who perform these procedures. As discussed previously, today, a tissue-resectioning procedure is guided by the surgeon based on whatever limited visual information is obtainable through the vision system located at the distal end of the resection catheter. Guiding the resection procedure in this manner is a very subjective process and prone to error, with a danger of taking either too much or too little tissue from around the lesion to be removed.
In further describing the present invention, as described previously,fluoroscope310 is utilized to generate x-rays that are directed through the patient's body and, thus, throughlesion420. Whereas the present invention is described as utilizing an imaging device which consists of afluoroscope310 and anx-ray imaging sensor320, any of a variety of different imaging devices may be utilized in practicing the principles of the present invention. For example, a magnetic resonance imaging device (MRI) could be utilized in the present invention to provide an image oflesion420 andresection device100. Thus, the present invention is not limited to utilizing a fluoroscope and x-ray energy in practicing the present invention.
As described previously,lesion420 absorbs a radiopaque die which creates an image of the lesion on thex-ray imaging sensor320 whenlesion420 is radiated by the x- rays emitted fromfluoroscope310. The radiopaque die may be administered tolesion420 through any of a variety of procedures and the present invention is not limited to any particular procedure for introducing the radiopaque die withinlesion420. For example, the die could be administered either intravenously or topically to the lesion site. Similarly, the operating end, or distal end, ofresection device100 could also contain a radiopaque die on it. This would also allow for the position of the resection device to be detected by thex-ray imaging sensor320 when radiated byfluoroscope310.
X-ray imaging sensor320 detects the x-rays generated byfluoroscope310 and is thus able to create an image oflesion420 andresection device100. Image information detected byx-ray imaging sensor320 for bothlesion420 andresection device100 is provided tovideo processing electronics330.Video processing electronics330 processes the image information received fromimaging sensor320 and provides this processed, digitized image data tocomputer340.
Computer340 may be any of a variety of processing devices that are capable of processing electronic information, either in a digital or analog format. For example,computer340 could be a personal computer.Computer340 contains software that is able to define atissue margin420A aroundlesion420. As described previously,tissue margin420A defines a sufficient area of tissue aroundlesion420 such that if the surgeon removeslesion420 and thetissue surrounding lesion420 defined bytissue margin420A, enough tissue is removed from aroundlesion420 to help ensure that all of the diseased tissue is removed frombody organ410. Additionally, removal of the surrounding tissue defined bytissue margin420A also helps to ensure that too much healthy tissue is not removed frombody organ410. Thus,computer340 defines the tissue margin that is to be removed from a tubular body organ when removing a lesion from the tubular organ during a resection procedure.
As described previously,computer340 is provided with digitized image data oflesion420 withinbody organ410 such thatcomputer340 is able to determine the position, and thus the boundaries, oflesion420 withintubular body organ410. By knowing the position oflesion420 withinbody organ410,computer340 is able to definetissue margin420A aroundlesion420. Any number of different methodologies may be utilized to definetissue margin420A aroundlesion420 and the present invention is not limited to any particular methodology. All that is required is that an objectively determined tissue margin is defined around the lesion to be removed such that the surgeon performing the procedure is able to perform the procedure while considering the defined tissue margin.
An exemplary methodology for determiningtissue margin420A aroundlesion420 is to utilize a pre-selected absolute measure of tissue. For example,computer340 could definetissue margin420A such that the tissue margin consists of a one-inch boundary of tissue extending from the outer boundaries oflesion420. Alternatively,computer340 could definetissue margin420A as being a measure of tissue that is a pre-selected percentage of a physical dimension oflesion420. For example, iflesion420 has a thickness of one-inch,computer340 could define thetissue margin420A such that the margin extends 100% of the thickness oflesion420 from the outer boundaries oflesion420, which in this example would result in a one-inch tissue margin. Thus,tissue margin420A would be defined to encompass a boundary of one-inch of tissue that surroundedlesion420.
Whereas two alternative methodologies for definingtissue margin420A are provided above, as stated previously, any number of methodologies can be utilized for definingtissue margin420A and the present invention is not limited to any particular methodology.Computer340 may utilize any methodology for defining a tissue margin around a lesion based on the image data of the lesion received from the video processing electronics. The surgeon performing the procedure may selectively set the parameters for defining the tissue margin, based upon considerations of the particular procedure being performed, by inputting the parameters' definitions intocomputer340.
Oncecomputer340 has definedtissue margin420A aroundlesion420,computer340 provides this definedtissue margin420A tovideo display350.Video display350 displays thelesion420, the definedtissue margin420A around the lesion, and the position ofresection device100. Thus,video display350 provides a visual presentation that the surgeon can monitor while performing the resection procedure and can utilize to operate theresection device100 such that sufficient tissue defined bytissue margin420A is removed when removinglesion420. Whereasvideo display350 is illustrated as being a separate element fromcomputer340, the video display may be integrated into the computer and, thus, separate structural elements are not required for these components.
One methodology that the surgeon can utilize when practicing the present invention is to visually observe the definedtissue margin420A aroundlesion420 when operatingresection device100. The surgeon is able to remove the proper amount of tissue fromtubular organ410 by visually observing thelesion420, the definedtissue margin420A, and theresection device100 when performing the resection procedure. By visually observing the position of theresection device100 relative to thelesion420 andtissue margin420A during the procedure, the surgeon can ensure that the proper amount of tissue, as defined bytissue margin420A, is removed from the tubular organ.
Becausecomputer340 is also detecting the position ofresection device100 asresection device100 is performing the procedure, if theresection device100 is operated by the surgeon such that the surgeon is either taking too much tissue or not taking enough tissue, as defined bytissue margin420A,computer340 can provide an alarm to alert the surgeon of the error.Computer340 is coupled toalarm device360 and may provide either an audible alarm that will sound onalarm device360 or could provide a signal to alarmdevice360 which would be visually displayed onvideo display350. Thus, as the surgeon is watching the video presentation of the procedure onvideo display350, if the surgeon is operatingresection device100 such that it is not removing tissue as defined bytissue margin420A, an alarm can be provided to alert the physician of this error.
Whereas the above embodiment describes a component for generating an alarm, i.e.,alarm device360, that is a separate component, it is not required that the alarm function be performed by a component separate from eithercomputer340 orvideo display350. The principles of the present invention may be practiced by including the functionality of the alarm device in eithercomputer340 and/orvideo display350. Thus, the alarm function can be performed by a software module contained in any of the other components of the present invention.
In continuing with the description of the methodologies of the present invention, as described above, the surgeon performing the procedure may visually monitorvideo display350 to control his or her operation ofresection device100. Alternatively, as is illustrated inFIG. 3,computer340 can also be directly coupled toresection device100. Thus,computer340 can directly controlresection device100. For example, rather than having to rely on the surgeon visually monitoring the position ofresection device100 with respect to the definedtissue margin420A onvideo display350, ifcomputer340 detects an error in the physician's positioning ofresection device100 outside of definedtissue margin420A, i.e., too much tissue is being removed,computer340 could be programmed to disableresection device100 in this situation. Thus, ifcomputer340 determines thatresection device100 is being operated such that tissue outside of definedtissue margin420A is being removed,computer340 can provide a signal toresection device100 to disableresection device100. For example, the resection device could be disabled such that its head assembly could not be opened to receive tissue within it, and/or the cutting blade could be retracted such that it could no longer cut tissue, and/or the suction could be disabled, and/or head-actuating handle150 could be disabled. These, or any of a variety of other methodologies, could be utilized to disableresection device100. Thus, due tocomputer340 disablingresection device100 if the resection device is mis-positioned, the physician is not physically able to remove too much tissue from aroundlesion site420. In addition to disablingresection device100 in this circumstance where too much tissue is about to be removed,computer340 could also provide the visual and/or audible alarms as previously described.
Whereas it was described above thatcomputer340 disablesresection device100 if too much tissue was being removed,computer340 could also disableresection device100 if too little tissue was also being removed.
As described above, in an embodiment of the present invention,computer340 is able to control the operation ofresection device100 by monitoring the positions of theresection device100, thelesion420, and the definedtissue margin420A aroundlesion420.
As is further illustrated inFIG. 3,computer340 can also be coupled tofluoroscope310. Thus, based on the quality of the image data received bycomputer340 fromvideo processing electronics330,computer340 may controlfluoroscope310 in order to receive a better quality of image data.Computer340 can controlfluoroscope310 in order to attempt to obtain better quality image data by any of a variety of different methodologies. For example,computer340 could physically alter the positioning offluoroscope310 such that better quality image data is received orcomputer340 could alter the x-ray dosage delivered byfluoroscope310. Thus,computer340 is able to controlfluoroscope310 in order to provide image data of a higher quality than that possibly originally received fromvideo processing electronics330.
Thus, as described above, the apparatuses and methods of the present invention can be utilized by a surgeon to guide the surgeon in the resectioning procedure. With knowledge of the objectively-defined tissue margins of the lesions, the system monitors the position of the resectioning catheter relative to the tissue margins and warns the surgeon, through either audible alarms and/or visual queues on a video monitor, if either too much or too little healthy tissue is being taken. In another embodiment of the invention, as described above, the system is able to control the resectioning catheter, preventing it from cutting unless proper tissue margins are being maintained.
Whereas fluoroscopy has been previously known in assisting surgeons to visualize a treatment site during orthopedic surgery, it is not known to use such a system with a resection procedure. The present invention is able to safely reduce the amount of healthy tissue that is resected with the diseased tissue while it increases the chances of resecting the entire lesion in a single procedure so that repeat procedures are not necessary. This reduces cost and discomfort to the patient as well as reducing the chances for metastasis of cancerous tissue by reducing the amount of damage to the lesion during its resection.
Whereas the previously described embodiments of the present invention would possibly provide a two-dimensional image, it is also possible within the present invention to add a secondary imaging device, e.g., a second x-ray source, and combine the data of the two x-ray sources to create 3-D imagery. U.S. Pat. Nos. 5,772,594 and 5,799,055 describe fluoroscopy in medical procedures and are incorporated herein by reference.
The apparatuses and methods of the present invention can be utilized with any of a variety of different resection devices and the present invention is not limited to any particular resection device in practicing the present invention, including the embodiment described inFIGS. 1 and 2 with or without the vision chip and light source. For example, a resection device as described in U.S. Pat. No. 5,868,760, which is incorporated herein by reference, may be utilized when practicing the present invention. Additionally, the resection device described in U.S. patent application Ser. No. 09/100,393 filed on Jun. 19, 1998, now issued as U.S. Pat. No. 6,126,058, which is also incorporated herein by reference, could also be utilized when practicing the present invention. Again, any of a variety of known resection devices can be utilized in the present invention.
More specifically, the present invention may be utilized with a flexible endoscopic resection system including a flexible endoscope slidably received through at least a portion of a stapling mechanism comprising an anvil and a stapling head mounted to the anvil so that the anvil and the stapling head are moveable with respect to one another between a tissue receiving position and a stapling position. A position adjusting mechanism is provided for moving the anvil and the stapling head between the tissue receiving and stapling positions and a staple firing mechanism sequentially fires a plurality of staples from the stapling head across the gap against the anvil and through any tissue received in the gap and a knife cuts a portion of tissue received within the gap. A control unit which remains outside the body is coupled to the stapling mechanism for controlling operation of the position adjusting mechanism and the staple firing mechanism. The endoscope is inserted into a naturally-occurring body orifice to locate a lesion, for example, in a tubular organ under visual observation (usually while insufflating the organ). Once the lesion has been located, a working head assembly including a stapling mechanism and an anvil is slidably advanced along the endoscope into the tubular organ until the working head assembly is in a desired position adjacent to the lesion. Alternatively, the working head assembly may be detachably coupled to a distal end of the endoscope, and the entire arrangement may then be inserted into the body orifice under visual observation.
The disclosed embodiments are illustrative of the various ways in which the present invention may be practiced. Other embodiments can be implemented by those skilled in the art without departing from the spirit and scope of the present invention.