US20050033271A1 - Unified systems and methods for controlling use and operation of a family of different treatment devices - Google Patents

Abstract

Unified systems and methods enable control of the use and operation of a family of different treatment devices, to treat dysfunction in different regions of the body.

Description

RELATED APPLICATIONS
• This application is a divisional of co-pending U.S. patent application Ser. No. 10/212,311, filed Aug. 5, 2002, which is a continuation of co-pending U.S. patent application Ser. No. 09/639,910, filed Aug. 16, 2000, now abandoned, which is a continuation-in-part of U.S. patent application Ser. No. 09/305,123, filed May 4, 1999, now U.S. Pat. No. 6,358,245, and which is also a continuation-in-part of U.S. patent application Ser. No. 09/574,704, filed May 18, 2000, now U.S. Pat. No. 6,464,689.
FIELD OF THE INVENTION
• In a general sense, the invention is directed to systems and methods for treating interior tissue regions of the body. More specifically, the invention is directed to systems and methods for treating dysfunction in body sphincters and adjoining tissue.
BACKGROUND OF THE INVENTION
• The gastrointestinal (GI) tract, also called the alimentary canal, is a long tube through which food is taken into the body and digested. The alimentary canal begins at the mouth, and includes the pharynx, esophagus, stomach, small and large intestines, and rectum. In human beings, this passage is about 30 feet (9 meters) long.
• Small, ring-like muscles, called sphincters, surround portions of the alimentary canal. In a healthy person, these muscles contract or tighten in a coordinated fashion during eating and the ensuing digestive process, to temporarily close off one region of the alimentary canal from another region of the alimentary canal.
• For example, a muscular ring called the lower esophageal sphincter (or LES) surrounds the opening between the esophagus and the stomach. Normally, the lower esophageal sphincter maintains a high-pressure zone between fifteen and thirty mm Hg above intragastric pressures inside the stomach.
• In the rectum, two muscular rings, called the internal and external sphincter muscles, normally keep fecal material from leaving the anal canal. The external sphincter muscle is a voluntary muscle, and the internal sphincter muscle is an involuntary muscle. Together, by voluntary and involuntary action, these muscles normally contract to keep fecal material in the anal canal.
• Dysfunction of a sphincter in the body can lead to internal damage or disease, discomfort, or otherwise adversely affect the quality of life. For example, if the lower esophageal sphincter fails to function properly, stomach acid may rise back into the esophagus. Heartburn or other disease symptoms, including damage to the esophagus, can occur. Gastrointestinal reflux disease (GERD) is a common disorder, characterized by spontaneous relaxation of the lower esophageal sphincter.
• Damage to the external or internal sphincter muscles in the rectum can cause these sphincters to dysfunction or otherwise lose their tone, such that they can no longer sustain the essential fecal holding action. Fecal incontinence results, as fecal material can descend through the anal canal without warning, stimulating the sudden urge to defecate. The physical effects of fecal incontinence (i.e., the loss of normal control of the bowels and gas, liquid, and solid stool leakage from the rectum at unexpected times) can also cause embarrassment, shame, and a loss of confidence, and can further lead to mental depression.
SUMMARY OF THE INVENTION
• The invention provides unified systems and methods for controlling use and operation of a family of different treatment devices.
• One aspect of the invention provides systems and method for controlling operation of a family of treatment devices comprising at least first and second different treatment devices. In use, the different treatment devices are intended to be individually deployed in association with different tissue regions. According to this aspect of the invention, the systems and methods make use of a single, unified controller to which a selected one of the first or second treatment device is coupled for use. A reader downloads information to the controller to identify the selected treatment device that is coupled to the connector. The controller enables a first control function when the reader identifies the first treatment device as the selected treatment device. The controller enables a second control function when the reader identifies the second treatment device as the selected treatment device.
• The single, unified controller further includes an operating system to execute on a display screen different graphical interfaces, each tailored to the configuration and treatment objectives of the particular treatment device selected for use. A first graphical interface tailored for the first treatment device is executed when the first control function is enabled. A second graphical interface tailored for the second treatment device and different, at least in part, from the first graphical interface, is executed when the second control function is enabled.
• The single, unified controller thereby makes possible the treatment of different regions of the body by different treatment devices.
• Another aspect of the invention provides systems and methods for controlling operation of a treatment device. The systems and methods confirm by different mechanisms the identity of the treatment device intended to be used, before enabling such use. In one embodiment, the systems and methods provide a usage key card for the treatment device. The usage key card is adapted to be handled separate from the treatment device. The usage key card contains a storage medium formatted to contain an identification code that identifies the treatment device. The identification code is communicated by a reader to a controller to which the treatment device is coupled for use. The systems and methods also provide an electrical identification signal that is communicated by the treatment device itself to the controller when the treatment device is coupled to the controller for use. Before enabling use of the treatment device, the systems and methods cross-check the identity of the treatment device based upon the identification code and based upon the electrical identification signal. The systems and methods enable use of the treatment device only when the identity of the treatment device based upon identification code and the electrical identification signal corresponds. The systems and methods thereby provide a failsafe means for identifying the treatment device, using both software (i.e., the identification code on the usage key card) and hardware (i.e., the electrical identification signal provided by the device itself).
• Features and advantages of the inventions are set forth in the following Description and Drawings, as well as in the appended Claims.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a diagrammatic view of a unified system usable in association with a family of different treatment devices for treating body sphincters and adjoining tissue regions in different regions of the body, which embodies features of the invention;
• FIG. 2 is a perspective view, with portions broken away, of one type of treatment device usable in association with the system shown inFIG. 1 to treat tissue in the upper gastro-intestinal tract, the treatment device having an operative element for contacting tissue shown in a collapsed condition;
• FIG. 3 is a perspective view, with portions broken away, of the device shown inFIG. 2, with the operative element shown in an expanded condition;
• FIG. 4 is a perspective view, with portions broken away, of the device shown inFIG. 2, with the operative element shown in an expanded condition and the electrodes extended for use;
• FIG. 5 is a perspective view of another type of treatment device usable in association with the system shown inFIG. 1 to treat tissue in the lower gastro-intestinal tract, the treatment device having an array of electrodes shown in a retracted position;
• FIG. 6 is a perspective view of the device shown inFIG. 5, with the array of electrodes shown in their extended position;
• FIG. 7 is a perspective view of a kit containing a device, such as shown in FIGS.2 or5, and a usage key card;
• FIG. 8 is an enlarged, mainly schematic view of the usage key card shown inFIG. 7, embodied as a floppy disk, and also showing the pre-formatted files it contains;
• FIG. 9 is a schematic view of a controller, which the system shown inFIG. 1 incorporates, showing the pre-programmed rules by which information contained on the usage key card shown inFIGS. 7 and 8 is read and processed;
• FIG. 10 is a schematic view of another processing device that reads information from the usage key card shown inFIG. 7, for further processing;
• FIGS. 11A and 11B are, respectively, left and right perspective views of one embodiment of an integrated device incorporating features of the system shown inFIG. 1 and usable with either treatment device shown inFIG. 2 or5 for treating body sphincters and adjoining tissue regions, and also having a graphical user interface;
• FIG. 12 is a front view of the device shown inFIGS. 11A and 11B showing the components of the graphical user interface;
• FIG. 13 is a flow chart showing further details of the pre-programmed rules by which information contained on the usage key card shown inFIGS. 7 and 8 is read and processed to set up use of a selected treatment device with the device shown inFIGS. 11A, 11B, and12;
• FIG. 14 is a representative SETUP display that can be implemented by the graphical user interface of the device shown inFIGS. 11A, 11B, and12, following the pre-programmed rules shown inFIG. 13, as part of monitoring and controlling the use of a selected treatment device;
• FIG. 15 is a flow chart showing further details of the pre-programmed rules implemented in concert with the pre-programmed rules shown inFIG. 13, by which information contained on the usage key card and provided by a selected treatment device is read and processed to enable use of the selected treatment device in association with the device shown inFIGS. 11A, 11B, and12;
• FIG. 16 is a representative EXCHANGE display that can be implemented by the graphical user interface of the device shown inFIGS. 11A, 11B, and12, following the pre-programmed rules shown inFIGS. 13 and 15, as part of monitoring and controlling the use of a selected treatment device;
• FIGS.17 to24 are views of a graphical user interface that can be implement by the device shown inFIGS. 11A, 11B, and12, for controlling the use and operation of the treatment device shown in FIGS.2 to4;
• FIGS.25 to30 are views of a graphical user interface that can be implement by the device shown inFIGS. 11A, 11B, and12, for controlling the use and operation of the treatment device shown inFIGS. 5 and 6;
• FIGS. 31 and 32 are side views, with portions broken away and in section, showing deployment of the treatment device shown in FIGS.2 to4 in the upper gastro-intestinal tract to treat dysfunction of the lower esophageal sphincter; and
• FIG. 33 is a side view, with portions broken away and in section, showing deployment of the treatment device shown inFIGS. 5 and 6 in the lower gastro-intestinal tract to treat sphincter dysfunction in the anal canal.
• The invention may be embodied in several forms without departing from its spirit or essential characteristics. The scope of the invention is defined in the appended claims, rather than in the specific description preceding them. All embodiments that fall within the meaning and range of equivalency of the claims are therefore intended to be embraced by the claims.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• This Specification discloses various systems and methods for treating dysfunction of sphincters and adjoining tissue regions in the body. The systems and methods are particularly well suited for treating these dysfunctions in the upper and lower gastrointestinal tract, e.g., gastro-esophageal reflux disease (GERD) affecting the lower esophageal sphincter and adjacent cardia of the stomach, or fecal incontinence affecting the internal and external sphincters of the anal canal. For this reason, the systems and methods will be described in this context.
• Still, it should be appreciated that the disclosed systems and methods are applicable for use in treating other dysfunctions elsewhere in the body, and dysfunctions that are not necessarily sphincter-related. For example, the various aspects of the invention have application in procedures requiring treatment of hemorrhoids, or urinary incontinence, or restoring compliance to or otherwise tightening interior tissue or muscle regions. The systems and methods that embody features of the invention are also adaptable for use with systems and surgical techniques that catheter-based and not necessarily catheter-based.
I. Overview of the System
• FIG. 1 shows aunified system24 for diagnosing and/or treating dysfunction of sphincters and adjoining tissue in different regions of the body. In the illustrated embodiment, thesystem24 is configured to diagnose and treat dysfunction in at least two distinct sphincter regions within the body.
• The targeted sphincter regions can vary. In the illustrated embodiment, one region comprises the upper gastrointestinal tract, e.g., the lower esophageal sphincter and adjacent cardia of the stomach. The second region comprises the lower gastrointestinal tract, e.g., in the intestines, rectum and anal canal.
• Thesystem24 includes a family oftreatment devices26aand26b. Eachdevice26aand26bcan be specifically configured according to the physiology and anatomy of the particular sphincter region which it is intended to treat. The details of construction of eachdevice26aand26bwill be generally described later for purposes of illustration, but are not material to the invention.
• Eachdevice26a/26bcarries anoperative element36aand36b. Theoperative element36aand36bcan be differently configured according to the physiology and anatomy of the particular sphincter region which it is intended to treated. Still, if the anatomy and physiology of the two treatment regions are the same or similar enough, the configuration of theoperative elements36a and36bcan be same or essentially the same.
• In the illustrated embodiment, theoperative elements36aand36bfunction in thesystem10 to apply energy in a selective fashion to tissue in or adjoining the targeted sphincter region. The applied energy creates one or more lesions, or a prescribed pattern of lesions, below the surface of the targeted region. The subsurface lesions are desirably formed in a manner that preserves and protects the surface against thermal damage.
• Natural healing of the subsurface lesions leads to a physical tightening of the targeted tissue. The subsurface lesions can also result in the interruption of aberrant electrical pathways that may cause spontaneous sphincter relaxation. In any event, the treatment can restore normal closure function to thesphincter region18.
• Thesystem24 includes agenerator38 to supply the treatment energy to theoperative element36a/36bof thedevice26a/26bselected for use. In the illustrated embodiment, thegenerator38 supplies radio frequency energy, e.g., having a frequency in the range of about 400 kHz to about 10 mHz. Of course, other forms of energy can be applied, e.g., coherent or incoherent light; heated or cooled fluid; resistive heating; microwave; ultrasound; a tissue ablation fluid; or cryogenic fluid.
• A selecteddevice26a/26bcan be individually coupled to thegenerator38 via acable10 to convey the generated energy to the respectiveoperative element36a/36b.
• Thesystem24 preferably also includes certain auxiliary processing equipment. In the illustrated embodiment, the processing equipment comprises an externalfluid delivery apparatus44 and anexternal aspirating apparatus46.
• A selecteddevice26a/26bcan be connected viatubing12 to thefluid delivery apparatus44, to convey processing fluid for discharge by or near theoperative element36a/36b. A selecteddevice26a/26bcan also be connected viatubing14 to the aspiratingapparatus46, to convey aspirated material from or near from theoperative element36a/36bfor discharge.
• Thesystem24 also includes acontroller52. Thecontroller52, which preferably includes a central processing unit (CPU), is linked to thegenerator38, thefluid delivery apparatus44, and the aspiratingapparatus46. Alternatively, the aspiratingapparatus46 can comprise a conventional vacuum source typically present in a physician's suite, which operates continuously, independent of thecontroller52.
• Thecontroller52 governs the power levels, cycles, and duration that the radio frequency energy is distributed to the particularoperative element36a/36b, to achieve and maintain power levels appropriate to achieve the desired treatment objectives. In tandem, thecontroller52 also desirably governs the delivery of processing fluid and, if desired, the removal of aspirated material.
• Thecontroller52 includes an input/output (I/O)device54. The I/O device54 allows the physician to input control and processing variables, to enable the controller to generate appropriate command signals. The I/O device54 also receives real time processing feedback information from one or more sensors associated with the operative element (as will be described later), for processing by thecontroller52, e.g., to govern the application of energy and the delivery of processing fluid.
• The I/O device54 also includes a graphical user interface (GUI), to graphically present processing information to the physician for viewing or analysis. Further details regarding the GUI will be provided later.
II. The Treatment Devices The structure of theoperative element36 can vary. Various representative embodiments will be described.
• A. For Treatment of Upper Gastro-Intestinal Tract
• FIGS.2 to4 show a catheter-baseddevice26afor treating sphincter regions in the upper gastro-intestinal tract, and more particularly, the lower esophageal sphincter and adjoining cardia of the stomach to treat GERD. In the embodiment shown, thedevice26aincludes aflexible catheter tube30 that carries ahandle28 at its proximal end. The distal end of thecatheter tube30 carries theoperative element36a.
• In the illustrated embodiment, theoperative element36acomprises a three-dimensional basket56. Thebasket56 includes one ormore spines58, and typically includes from four to eightspines58, which are assembled together by adistal hub60 and aproximal base62.
• In the illustrated embodiment, anexpandable structure72 comprising a balloon is located within thebasket56. Theballoon structure72 can be made, e.g., from a Polyethylene Terephthalate (PET) material, or a polyamide (non-compliant) material, or a radiation cross-linked polyethylene (semi-compliant) material, or a latex material, or a silicone material, or a C-Flex (highly compliant) material.
• Theballoon structure72 presents a normally, generally collapsed condition, asFIG. 2 shows. In this condition, thebasket56 is also normally collapsed about theballoon structure72, presenting a low profile for deployment into the esophagus.
• Acatheter tube30 includes an interior lumen, which communicates with the interior of theballoon structure72. A fitting76 (e.g., a syringe-activated check valve) is carried by thehandle28. The fitting76 communicates with the lumen. The fitting76 couples the lumen to a syringe78 (seeFIG. 3). Thesyringe78 injects fluid under pressure through the lumen into theballoon structure72, causing its expansion.
• Expansion of theballoon structure72 urges thebasket56 to open and expand (seeFIG. 3). The force exerted by theballoon structure72, when expanded, is sufficient to exert an opening or dilating force upon the tissue surrounding the basket56 (seeFIG. 31).
• Eachspine58 carries an electrode66 (seeFIG. 4). In the illustrated embodiment, eachelectrode66 is carried within thetubular spine58 for sliding movement. Eachelectrode66 slides from a retracted position, withdrawn in the spine58 (shown inFIG. 3) and an extended position, extending outward from the spine58 (seeFIG. 4) through a hole in thespine58. A push-pull lever68 on thehandle28 is coupled by one or more interior wires to the slidingelectrodes66. Thelever68 controls movement electrodes between the retracted position (by pulling rearward on the lever68) and the extended position (by pushing forward on the lever68).
• Theelectrodes66 have sufficient distal sharpness and strength, when extended, to penetrate a desired depth into tissue the smooth muscle of the loweresophageal sphincter18 or the cardia of the stomach16 (seeFIG. 32). The desired depth can range from about 4 mm to about 5 mm.
• Theelectrodes66 are formed of material that conducts radio frequency energy, e.g., nickel titanium, stainless steel, e.g.,304 stainless steel, or a combination of nickel titanium and stainless steel.
• In the illustrated embodiment (seeFIG. 4), an electrical insulatingmaterial70 is coated about the proximal end of eachelectrode66. When the distal end of theelectrode66 penetrating the smooth muscle of theesophageal sphincter18 orcardia20 transmits radio frequency energy, thematerial70 insulates the mucosal surface of theesophagus10 orcardia20 from direct exposure to the radio frequency energy. Thermal damage to the mucosal surface is thereby avoided. The mucosal surface can also be actively cooled during application of radio frequency energy, to further protect the mucosal surface from thermal damage.
• In the illustrated embodiment (seeFIG. 4), at least onetemperature sensor80 is associated with each electrode. Onetemperature sensor80 senses temperature conditions near the exposed distal end of theelectrode66, asecond temperature sensor80 is located on the correspondingspine58, which rests against the mucosal surface when theballoon structure72 is inflated.
• The externalfluid delivery apparatus44 is coupled via tubing12 (seeFIG. 1) to connector48 (seeFIG. 4), to supply cooling liquid to the targeted tissue, e.g., through holes in the spines. Theexternal aspirating apparatus46 is coupled via tubing14 (seeFIG. 1) to connector50 (seeFIG. 4), to convey liquid from the targeted tissue site, e.g., through other holes in the spine or elsewhere on thebasket56. Thecontroller52 can govern the delivery of processing fluid and, if desired, the removal of aspirated material.
• Thecontroller52 can condition theelectrodes66 to operate in a monopolar mode. In this mode, eachelectrode66 serves as a transmitter of energy, and an indifferent patch electrode (described later) serves as a common return for allelectrodes66. Alternatively, thecontroller52 can condition theelectrodes66 to operate in a bipolar mode. In this mode, one of the electrodes comprises the transmitter and an other electrode comprises the return for the transmitted energy. The bipolar electrode pairs canelectrodes66 on adjacent spines, orelectrodes66 spaced more widely apart on different spines.
• Further details of the construction and use of thedevice26aand other devices intended to be deployed to treat sphincter regions in the upper gastro-intestinal tract are disclosed in copending U.S. patent application Ser. No. 09/305,123, filed May 4, 1999, and entitled “Graphical User Interface for Association with an Electrode Structure Deployed in Contact with a Tissue Region,” which is incorporated herein by reference.
• B. For Treatment of Lower Gastro-Intestinal Tract
• FIGS. 5 and 6 show a representative embodiment fordevice26b, which takes the form of a hand manipulateddevice302 for treating sphincter regions in the lower gastro-intestinal tract, and more particularly, the internal and/or external sphincter muscles in the anal canal to treat fecal incontinence. Thedevice302 includes ahand grip304 that carries theoperative element36b.
• In the illustrated embodiment, theoperative element36btakes the form of a hollow,tubular barrel306 made from a transparent, molded plastic material. Thebarrel306 terminates with a blunt, roundeddistal end308 to aid passage of thebarrel306 through the anal canal, without need for a separate introducer. Thehand grip304 includes aviewing port312 for looking into the transparent, hollow interior of thebarrel306, to visualize surrounding tissue.
• An array ofneedle electrodes316 are movably contained in a side-by-side relationship along an arcuate segment of thebarrel306. In the illustrated embodiment, theneedle electrodes316 occupy an arc of about 67.5 degrees on thebarrel306. Theneedle electrodes316 are mechanically linked to a finger-operatedpull lever318 on thehand grip304. By operation of thepull lever318, the distal ends of theneedle electrodes316 are moved between a retracted position (FIG. 5) and an extended position (FIG. 6). An electrical insulatingmaterial344 is coated about the needle electrodes316 (seeFIG. 6), except for a prescribed region of the distal ends, where radio frequency energy is applied to tissue. Thegenerator38 is coupled via thecable10 to aconnector352, to convey radio frequency energy to theelectrodes316.
• In use (seeFIG. 33), the physician grasps thehand grip304 and guides thebarrel306 into theanal canal320. Thepull lever318 is in the neutral position and not depressed, so theneedle electrodes316 occupy their normal retracted position. Looking through theviewing port312, the physician visualizes the pectinate (dentate) line through thebarrel306. Looking through thebarrel306, the physician positions the distal ends of theneedle electrodes316 at a desired location above the pectinate (dentate) line. A fiberoptic can also be inserted into thebarrel306 to provide local illumination, or the physician can wear a headlamp for this purpose. Once the distal end of thebarrel306 is located at the targeted site, the physician depresses the pull lever318 (asFIG. 33 shows). Theneedle electrodes316 advance to their extended positions. The distal ends of theelectrodes316 pierce and pass through the mucosal tissue into the muscle tissue of the target sphincter muscle. InFIG. 33, the distal end of theelectrodes316 are shown penetrating the involuntary,internal sphincter muscle322. The physician commands thecontroller52 to apply radio frequency energy through theneedle electrodes316. The energy can be applied simultaneously by allelectrodes316, or in any desired sequence.
• The externalfluid delivery apparatus44 is coupled viatubing12 to aconnector348 to convey a cooling liquid, e.g., through holes in thebarrel306, to contact tissue at a localized position surrounding theelectrodes316. Theexternal aspirating apparatus46 is coupled viatubing14 to aconnector350 to convey liquid from the targeted tissue site, e.g., through anaspiration port358 in thedistal end308 of the barrel306 (seeFIGS. 5 and 6).
• The barrel306 (seeFIG. 6) also preferably carries temperature sensor364, one of which is associated with eachneedle electrode316. The sensors364 sense tissue temperature conditions in the region adjacent to eachneedle electrode316. Preferably, the distal end of eachneedle electrode316 also carries a temperature sensor372 (seeFIG. 6).
• Further details of the construction and use of thedevice26band other devices that can be deployed to treat sphincter regions in the lower gastro-intestinal tract are disclosed in copending U.S. patent application Ser. No. 09/305,123, filed Apr. 21, 2000, and entitled “Systems and Methods for Treating Dysfunctions in the Intestines and Rectum,” which is incorporated herein by reference.
III. Monitoring and Controlling Use of the Devices
• Eachdevice26aand26bpreferably forms an integrated construction intended for a single use and subsequent disposal as a unit. To protect patients from the potential adverse consequences occasioned by multiple use, which include disease transmission, or material stress and instability, or decreased or unpredictable performance, thecontroller52 includes amodule64 that controls use of eachdevice26aand26b.
• In the illustrated embodiment (seeFIG. 7), eachdevice26a/26bis supplied as part of akit200 that includes, together with the device26, a usagekey card202. Thekit200 packages thedevice26a/26band usagekey card202 as a unitary, single use item in a sterile fashion within peripherally sealed sheets of plastic film material that are torn or peeled away at the instance of use.
• The presence of thedevice26a/26band userkey card200 packaged together in thekit200 verifies to the physician or user thatdevice26a/26bis sterile and has not be subjected to prior use. The physician or user is thereby assured that thedevice26a/26bmeets established performance and sterility specifications. Nounused device26a/26bis supplied in thekit200 without a usagekey card202, and vice versa.
• The usagekey card202 for eachdevice26a/26bincorporates astorage medium204 that is readable by themodule64. Thestorage medium204 contains information that enables at least three use control and monitoring functions.
• The first use control and monitoring function of the usagekey card202 occurs prior to use of the selecteddevice26a/26bin association with thegenerator38. To enable use of thegenerator38 in association with the selecteddevice26a/26b, the physician must first present the usagekey card202 for reading by themodule64. To enable use of the selecteddevice26a/26b, thecontroller52 must then find that the usagekey card202 meets the criteria necessary for its registration by thecontroller52. The criteria are designed to indicate the absence of a prior use, either in absolute terms or in terms of a period of use outside a predetermined time period. If the criteria are not met, thecontroller52 will not register the usagekey card202, and thecontroller52 will also not enable use of thegenerator38 in association with the selecteddevice26a/26b. Further details of the registration function of thecontroller52 will be described later.
• The second use control and monitoring function occurs if the criteria are met and registration of the usagekey card202 occurs. The second use control and monitoring function identifies the particular type ofdevice26a/26bthat has been selected for use. The second use and control function conditions thecontroller52 to implement only those control algorithms and operator interface displays particular to the selecteddevice26a/26b. Further details of this control aspect will be described later.
• The third use control and monitoring function of the usagekey card202 occurs during permitted use of the selected device26//26bin association with thegenerator38. During permitted use, thestorage medium204 of the usagekey card202 remains in themodule64 and receives, via themodule64, data generated by thecontroller52 recording operating parameters and performance of the selecteddevice26a/26b. Thestorage medium204 of the usagekey card202 retains and organizes the data for further off-line storage and processing. Further details of the data retention function will be described later.
• The usagekey card202 can be variously configured. In the illustrated embodiment (seeFIG. 8), the usagekey card202 comprises a computer-readable storage medium204 housed within a conventional 3.5inch floppy disk206. In this arrangement, themodule64 comprises a conventional floppy disk drive208 (seeFIG. 9) capable of reading data from and downloading data to thestorage medium204 of thedisk206.
• Alternatively, the usagekey card202 can take the form of a PC card, flash memory device, or magnetic card. In these alternative embodiments, themodule64 comprises a data reading and writing device compatible with the storage medium of thecard202.
• AsFIG. 8 shows, thestorage medium204 of the usagekey card202 contains at least threepre-formatted files210,226, and212. Thefirst file210 contains aunique identification code214 capable of being read by themodule64 and registered by thecontroller52. Thesecond file226 contains another identification code that specifies the particular type ofdevice26a/26bthat has been selected, which thereby indicates the desired treatment protocol that has been selected. Thethird file212 is formatted to receive and retain operational and performance data generated by thecontroller52 to create from it aprocedure log220.
• Theidentification code214 contained in thefirst file210 is created to be unique to the particular usagekey card202. That is, each usagekey card202 contains its ownunique identification code214. No two usage key cards share thesame identification code214. Theunique identification code214 can comprise, e.g., a serial number uniquely assigned to theparticular device26a/26bfound in thekit200, or any other unique code that is not repeated for any other usagekey card202. Thecode214 itself can comprise letters, numbers, or combinations thereof.
• AsFIG. 9 shows, themodule64 reads theidentification code214 off the usagekey card202 for input to thecontroller52. This identification code will be called the “instant identification code.”
• Following pre-programmed rules, thecontroller54 constructs and maintains in non-volatile memory a use table216. The use table216 contains all prior identification codes that meet the criteria to be registered by thecontroller52. These identification codes will be called the “registered identification codes.”
• Following pre-programmed rules, thecontroller52 compares theinstant identification code214 to all registered identification codes contained in the table216. In the absence of a match between the instant identification code and any registered identification code, thecontroller52 updates the table, i.e., the controller registers the instant identification code by adding it to the table216. Upon registering the usagekey card202, thecontroller52 also enables use ofgenerator38 in association with the selecteddevice26a/26b.
• The presence of a match between the instant identification code and any registered identification code indicates the usagekey card202 has been previously read by themodule64, which reflects a prior use of the selecteddevice26a/26bor another device not packaged with thecard202. In this circumstance, thecontroller52 does not add the duplicate identification code to the table216 and does not enable use of thegenerator38 in association with any device26. Preferably, thecontroller52 outputs to theGUI54 notice of prior use.
• In an alternative arrangement, thecontroller52 maintains for each registered identification code in the table216 atime record218. Thetime record218 contains a value reflecting the period of time during which energy was applied by thegenerator38 during the previous permitted use. In this embodiment, when a match occurs between the instant identification code and a registered identification code, thecontroller52 ascertains whether the time period of previous use contained in therecord218 is less than a prescribed maximum time period, e.g., 45 minutes. If so, thecontroller52 enables a subsequent operation of thegenerator38 in association with the device26, but only for the time period remaining. Thecontroller52 updates thetime record218 as further use occurs. Thecontroller52 preferably outputs to the GUI the time period of permitted use remaining.
• If thecontroller52 ascertains that the time period of previous use equals or exceeds the prescribed maximum time period, thecontroller52 does not enable use of thegenerator38. Preferably, thecontroller52 outputs to the GUI notice of prior use.
• AsFIG. 8 shows, thesecond file226 contained in thestorage medium204 of the usagekey card202 is created to uniquely identify the particular configuration and intended use of thedevice26aor26bthat has been selected. Thefile226 contains afirst identification code228aifdevice26ahas been selected. Thefile226 contains asecond identification code228bifdevice26bhas been selected. Thecodes228aand228bcan comprise letters, numbers, or combinations thereof.
• Thecodes228a/228bcan identify the type ofdevice26a/26bin terms of its operational characteristics, the inclusion of temperature sensing, and reuse criteria (e.g., no reuse after a single use, or multiple uses permitted up a prescribed maximum number of uses, or multiple uses permitted up to a maximum time period of use, or multiple uses permitted up to a maximum application of RF energy). In one arrangement, thecontroller52 can compare the device characteristics with the operational characteristics of thecontroller52 andgenerator38, and disable operation of the device26 should the characteristics of the device26 be incompatible with the characteristics of thecontroller52 and/orgenerator38.
• Once the criteria for registration of the usagekey card202 are met, themodule64 reads theidentification code228aor228boff the usagekey card202 for input to thecontroller52. Following pre-programmed rules, thecontroller54 implements only those particular control algorithms intended for the selecteddevice26a/26b. As will be described in greater detail later, thecontroller52 can, in response to reading theidentification code228aor228balso condition theGUI54 to display the desired images and data formats, which change depending upon the treatment procedure using the selecteddevice26a/26b(e.g, treatment of GERD using thedevice26aor the treatment of fecal incontinence using thedevice26b). Thus, thesystem10 accommodates different control schemes and different graphical interfaces in support of different treatment protocols.
• AsFIG. 8 shows, thethird file212 contained on thestorage medium204 of the usagekey card202 is formatted to receive, via themodule64, data that is generated by thecontroller52 during permitted use of the selecteddevice26a/26bin association with thegenerator38. Thefile212 retains the data in a formatted array according to pre-programmed rules to create a procedure log220 (seeFIG. 10).
• The content of the formattedlog220 can vary. For example, thelog220 can document, by date of treatment and number of treatments, the coagulation level (i.e., the depth at which the electrodes are inserted), the time duration of energy application, the magnitude of energy delivered by each electrode, and the coolant flow rate. Theprocedure log220 can also record at pre-established intervals (e.g., every 5 seconds) the temperatures of the electrodes and surrounding tissue, along other parameters, e.g., sensed impedance and power delivered by each electrode.
• Theprocedure log220 preferably records these values in a pre-formatted data base format, to enable import of the values as data base items for storage, processing, and retrieval by an off-linedata processing device222 having a compatible data base processing application. The off-linedata processing device222 reads processing log data from the usage key card202 (via afloppy disk drive230 or otherwise compatible reading device).
• Thedevice222 can process the data in various ways according to the rules of the data processing application. Thedevice222 can, e.g., create a print-formatted record of the procedure log220 for printing in a hard copy version. Thedevice222 can also, e.g., process the procedure logs for multiple devices and patients, to create historical patient treatment records, patient reimbursement records, and the like for storage or retrieval. Thedevice222 thereby makes possible the establishment and maintenance of an archival patient data base by processing individual procedure logs.
• AsFIG. 7 shows, thekit200 can also include alabel224 that is pre-applied or that can be applied by the physician to the usagekey card202. Thelabel224 receives manually transcribed, visually readable information pertaining to the usagekey card202, e.g., the name of the patient being treated by the device26, the date of treatment, and the like. In this way, usagekey cards202 can itself be physically stored and indexed.
• AsFIG. 7 also shows, thekit200 can also includeinstructions232 for using the usagekey card202 in the fashion described. For example, theinstructions232 can instruct the physician as to the need for having the usagekey card202 read by themodule64, in order to enable use of the device26 in association with thegenerator38. Theinstructions232 can also instruct the physician regarding the content of the procedure log and the subsequent off-line processing options that are available.
• Further details regarding the usagekey card202 can be found in co-pending U.S. patent application Ser. No. 09/574,704, filed May 18, 2000, and entitled “Graphical User Interface for Monitoring and Controlling Use of Medical Devices,” which is incorporated herein by reference.
IV. System Operation
• In the illustrated embodiment (seeFIGS. 11A and 11B), theradio frequency generator38, thecontroller52 with I/O device54, and the fluid delivery apparatus44 (e.g., for the delivery of cooling liquid) are integrated within asingle housing400. The I/O device54 includesinput connectors402,404, and406. Theconnector402 accepts anelectrical connector408, to which the selectedtreatment device26a/26bis electrically coupled for use. Theconnector404 accepts anelectrical connector410 coupled to a patch electrode412 (for mono-polar operation). Theconnector406 accepts anpneumatic connector414 coupled to aconventional foot pedal416, when, when depressed, causes the delivery of radio frequency energy to theelectrodes66 on the device26. Theseconnectors402,404, and406 couple these external devices to thecontroller52.
• The I/O device54 also couples thecontroller52 to an array ofmembrane keypads422 and other indicator lights on thehousing400, for entering and indicating parameters governing the operation of thecontroller52.
• In the illustrated embodiment, as shown inFIG. 12, thekeypads422 and indicators include:
• 1. Standby/Ready Button430, which allows switching from one mode of operation to another, as will be described later.
• 2. Standby/Ready Indicator432, which displays a green light after thedevice400 passes a self test upon start up.
• 3.RF On Indicator434, which displays a blue light when radio frequency energy is being delivered.
• 4.Fault Indicator436, which displays a red light when an internal error has been detected. No radio frequency energy can be delivered when theFault Indicator436 is illuminated.
• 5.Target Duration Keys438, which allow increases and decreases in the target power duration at the start or during the course of a procedure.
• 6.Target Temperature Keys440, which allow increases and decreases in the target temperature at the start or during the course of a procedure.
• 7.Maximum Power Keys442, which allow increases and decreases in the maximum power setting at the start or during the course of a procedure.
• 8.Channel Selection Keys444, which allow selection of any or all power channels.
• 9.Coagulation Level Keys446, which manually increases and decreases the magnitude of the indicated depth of insertion of the electrodes of thedevice26awithin the esophagus. This depth is determined, e.g., by visually gauging the measured markings along the length of the catheter tube of thetreatment device26a. Alternatively, the coagulation level can be automatically detected by, e.g., placing optical, mechanical, or magnetic sensors on an associated mouth piece inserted into the esophagus, which detect and differentiate among the measured markings along the catheter tube of thetreatment device26ato read the magnitude of the depth of insertion.
• 10. Flow Rate andPriming Keys448, which allow for selection of three internally calibrated flow rates, low (e.g., 15 ml/min), medium (e.g., 30 ml/min), and high (e.g., 45 ml/min). Pressing and holding the “Up” key activates the pump at a high flow rate for priming, overruling the other flow rates until the “Up” key is released.
• The I/O device54 also couples thecontroller52 to a display microprocessor474 (seeFIG. 11A). In the illustrated embodiment, themicroprocessor474 comprises, e.g., a dedicated Pentium7□based central processing unit.
• Thecontroller52 transmits data to themicroprocessor474, and themicroprocessor474 acknowledges correct receipt of the data and formats the data for meaningful display to the physician. In the illustrated embodiment, thededicated display microprocessor474 exerts no control over thecontroller52.
• In the illustrated embodiment, thecontroller52 comprises an 68HC11 processor having an imbedded operating system. Alternatively, thecontroller52 can comprise another style of processor, and the operating system can reside as process software on a hard drive coupled to the CPU, which is down loaded to the CPU during system initialization and startup.
• Thedisplay microprocessor474 is coupled to a graphics display monitor420 in thehousing400. Thecontroller52 implements through thedisplay microprocessor474 the graphical user interface, or GUI, which is displayed on thedisplay monitor420.
• The GUI can be realized, e.g., as a VISUAL BASICJ language program implemented by themicroprocessor474 using the MS WINDOWSJ or NT application and the standard WINDOWS 32 API controls, e.g., as provided by the WINDOWSJ Development Kit, along with conventional graphics software disclosed in public literature.
• Thedisplay microprocessor474 is also itself coupled to thefloppy disk drive426, previously described as floppy disk module208 (FIG. 9). Thedisplay microprocessor474 can also be coupled to a keyboard, printer, and include one or more parallel port links and one or more conventional serial RS-232C port links or Ethernet™ communication links.
• The graphics display monitor420 can comprise an active matrix LCD display screen located between themembrane keypads422 and other indicators on the front panel. TheGUI424 is implemented by showing on themonitor420 basic screen displays.
• In the illustrated embodiment, these displays signify four different operating modes: Start-Up, Standby, Ready, RF-On, and Pause.
• A. Start-up: Monitoring and Controlling Reuse
• Upon boot-up of the CPU (seeFIG. 13), the operating system implements the START-UP function510 for theGUI424. TheGUI424 displays an appropriate start-up logo and title image (not shown), while thecontroller52 performs a self-test.
• Upon completion of the START-UP function (seeFIG. 13), thecontroller52 conducts a CHECK function512. The function512 checks for the presence of a usagekey card202 in thefloppy disk drive426. As before described, a valid usagekey card202 is a prerequisite for using a given treatment device26.
• The absence of a usagekey card202 causes thecontroller52 to command thedisplay microprocessor474 to generate aSETUP prompt500 on thegraphics display monitor420.FIG. 14 shows arepresentative SETUP prompt500. When graphically implemented, as shown inFIG. 14, the SETUP prompt500 leads the operator in a step-wise fashion through the tasks required to enable use of thegenerator38. A first graphic field displays one or more icons and/or alpha-numeric indicia502 that prompt the operator to connect theelectrical connector42 of the treatment device26 to theconnector cable408. A second graphic field displays one or more icons and/or alpha-numeric indicia504 that prompt the operator to insert a valid user key card202 (i.e., floppy disk). A third graphic field displays one or more icons and/or alpha-numeric indicia506 that prompt the user to select the standby-ready button430 on the housing400 (seeFIG. 12).
• With the selectedtreatment device26a/26bconnected and a userkey card202 inserted in thefloppy disk drive426, and the standby-ready button430 pressed, thecontroller52 reads thedevice identification code228aor228bon the userkey card202. In this way, thecontroller52 ascertains whichdevice26aor26bhas been selected for use. Based upon this input, thecontroller52 proceeds to execute the preprogrammed control and graphical GUI command functions for thedevice26aand26bthat the userkey card202 indicates has been selected.
• If theidentification code228ais registered, theGUI424 displays an appropriate start-up logo and title image for thedevice26a. Likewise, if theidentification code228bis registered, theGUI424 displays an appropriate start-up logo and title image for thedevice26b.
• After the start-up logo and title image for the selecteddevice26a/26bhas been displayed, thecontroller52 remains in the STAND-BY mode508 (seeFIG. 15). In the STAND-BY mode508, thecontroller52 performs a DEVICEHARDWARE CHECK function540. The same DEVICEHARDWARE CHECK function540 is performed regardless of thedevice26a/26bselected. The DEVICEHARDWARE CHECK function540 looks for the presence or absence of a preestablished electrical identification signal from thedevice26a/26bitself, to confirm by a different mechanism the identity of thedevice26a/26bindicated by the userkey card202.
• The DEVICEHARDWARE CHECK function540 can be accomplished is various ways. For example, thedevice26aand26bcan include within its handle an analog electrical element (e.g., a capacitor or resistor) or a solid state element (micro-chip, ROM, EEROM, EPROM, or non volatile RAM) that generates an electrical value that differs depending upon thedevice26aor26bis present. Thecontroller52 reads this electrical value through theelectrical connector408, to which the selectedtreatment device26a/26bis coupled for use. The DEVICEHARDWARE CHECK function540 provides a redundant, fail safe confirmation of the identification of thedevice26a/26bprovided by the userkey card202. If the identity of thedevice26a/26bbased upon the DEVICEHARDWARE CHECK function540 does not correspond with the identity of thedevice26a/26bbased upon the userkey card202, thecontroller52 returns to the SETUP prompt500 (FIG. 14) described earlier, to repeat the identification process.
• If the identification of thedevice26a/26bbased upon the userkey card202 and DEVICEHARDWARE CHECK function540 correspond, thecontroller52 executes theREGISTRATION function514 for thedevice26a/26b(seeFIG. 15), to determine whether the userkey card202 inserted in thedrive426 contains avalid identification code214. Thesame REGISTRATION function514 is performed regardless of thedevice26a/26bselected.
• Theidentification code214 will not be deemed valid when the code already exists in the use table216 of thecontroller52 with atime record218 equal to or greater than the prescribed maximum, thereby indicating a completed prior use of the selecteddevice26a/26b. When theidentification code214 is not valid, theREGISTRATION function514 commands thedisplay microprocessor474 to generate anEXCHANGE prompt516 on thegraphics display monitor420.FIG. 16 shows arepresentative EXCHANGE prompt516. When graphically implemented, as shown inFIG. 16, the EXCHANGE prompt516 leads the operator in a step-wise fashion through the tasks of replacing the previously used selecteddevice26a/26band itskey card202 with a new selecteddevice26a/26band its associatedkey card202.
• As shown inFIG. 16, a first graphic field displays one or more icons and/or alpha-numeric indicia518 that prompt the operator to disconnect theelectrical connector42 of the previously usedtreatment device26a/26band to connect anew treatment device26a/26b. A second graphic field displays one or more icons and/or alpha-numeric indicia520 that prompt the operator to remove the old userkey card202 and insert the newkey card202 that accompanied the new selectedtreatment device26a/26bin thekit200. A third graphic field displays one or more icons and/or alpha-numeric indicia522 that prompt the user to again select the standby-ready button430 on thehousing400.
• With the new treatment device26 connected and the new userkey card202 inserted in thefloppy disk drive426, selection of the standby-ready button430 causes thecontroller52 to again enter the STAND-BY mode508, and again execute the DEVICEHARDWARE CHECK function540 and the REGISTRATION function514 (seeFIG. 15).
• Successful completion of the DEVICEHARDWARE CHECK function540 and theREGISTRATION function514, confirming the type ofdevice26a/26band indicating the presence of avalid identification code214 on theuser card202, causes thecontroller52 to enter theREADY mode524.
• B. Controlling Deployment and Use of the Selected Device
• Upon completion of the START-UP operation, and successful registration of the usagekey card202, thecontroller52 proceeds to condition the generator and ancillary equipment to proceed step-wise through a sequence of operational modes. The operational modes have been preprogrammed to achieve the treatment protocol and objective of the selecteddevice26a/26b. The conduct of these operational modes and the appearance of the graphical user interface that guides and informs the user during the course of the selected procedure can differ betweendevices26aand26b.
• For ease of description, the GUI displays for the upper gastro-intestinal procedure (i.e., for thedevice26a) will in shorthand be generally called UGUI (which are shown inFIGS. 12 and 17 to24). Likewise, the GUI displays for the lower gastro-intestinal procedure (i.e., for thedevice26b) will in shorthand be generally called LGUI (which are shown in FIGS.25 to30).
1. Standby
• When thedevice identification code228ais read on the usage key card202 (i.e., indicating selection of thedevice26afor use in the upper gastro-intestinal tract), thecontroller52 conditions the UGUI to display the Standby screen shown inFIG. 17. When thedevice identification code228bis read on the usage key card202 (i.e., indicating selection of thedevice26bfor use in the lower gastro-intestinal tract), thecontroller52 conditions the LGUI to display the Standby screen shown inFIG. 25.
• No radio frequency energy can be delivered while the Standby screen is displayed.
• There are various icons common to the Standby, Ready, RF-On, and Pause screens for both UGUI and LGUI.
• In the Standby screen for UGUI, aScreen Icon450 appears in the upper left hand corner to indicate the operating condition of thetreatment device26a. In the UGUI, theicon450 also indicates the position of the treatment device inside or outside the esophagus. In the Standby screen for the LGUI (seeFIG. 25), theScreen Icon450 is displayed in the lower left hand corner, to indicate the operating condition of thetreatment device26b.
• While in the Standby Mode, the physician can couple the source of cooling liquid to the appropriate port on the handle of thedevice26a/26b(as previously described) and load the tubing leading from the source of cooling liquid (e.g., a bag containing sterile water) in thepump rotor428. The physician can also couple theaspiration source46 to the appropriate port on the handle of thetreatment device26a/26b(as also already described). The physician can also couple thepatch electrode412 andfoot pedal416.
• In UGUI(FIG. 17), there are also parameter icons designatingtarget duration452,target temperature454,maximum power456,channel selection458,coagulation level460, and flow rate/priming462. These icons are aligned with, respectively, the correspondingTarget Duration Keys438,Target Temperature Keys440,Maximum Power Keys442,Channel Selection Keys444,Coagulation Level Keys446, and Flow Rate andPriming Keys448. Theicons452 to462 indicate current selected parameter values. The flow rate/priming icon462 shows the selected pump speed by highlighting a single droplet image (low speed), a double droplet image (medium speed), and a triple droplet image (high speed).
• In LGUI (FIG. 25), comparable parameter icons appear, except thatcoagulation level icon460 in the UGUI is replaced in the LGUI by a RFcycle counter icon461. Theicon461 displays a value that counts the number of RF cycles applied to thedevice26bduring use. Knowing the number of electrodes that thedevice26bcarries, this value is indicative of the number of lesions that are being formed.
• Pressing the “Up” priming key448 in the Standby mode, to cause cooling liquid to flow through thetreatment device26a, causes an animated priming stream PS to be displayed in the icon450 (shown inFIG. 21) of the UGUI. An animated priming stream PS (seeFIG. 26) is displayed in the flow rate/priming icon462 of the LGUI when thedevice26bis primed in the Standby mode. In other modes, animated priming streams PS are displayed in theScreen Icon450 in UGUI (seeFIGS. 21, 22, and23) and LGUI (seeFIGS. 28 and 29) whenever thepump rotor428 is operating, to indicate the supply of cooling fluid through therespective treatment device26aand26b.
• In both UGUI (FIG. 17) and LGUI (FIG. 25), there is also afloppy disk icon464. Theicon464 is illuminated when a floppy disk is inserted in thedrive426. When the floppy disk (e.g., the usage key card202) is inserted in thedrive426 data can be saved automatically after each application of radio frequency energy (as will be described later).
• There is also anElectrode Icon466 in each display UGUI and LGUI. TheElectrode Icon466 comprises an idealized graphical image, which spatially models the particular multiple electrode geometry of thetreatment device26a/26bselected to be deployed. The form of theElectrode Icon466 is another way thecontroller52 differentiates the UGUI and LGUI.
• AsFIG. 17 shows, in the UGUI, four electrodes are shown in the graphic image of theIcon466, which are spaced apart by 90 degrees. This graphic image is patterned after the geometry of the four-electrode configuration of thedevice26a, as shown inFIG. 4.
• AsFIG. 25 shows, in the LGUI, the four electrodes are shown in the graphic image ofIcon466 in a circumferentially spaced relationship along a partial arcuate sector. This graphic image is patterned after the arrangement of electrodes on thetreatment device26b, as shown inFIG. 6.
• For each electrode, theIcon466 presents in a spatial display the magnitude of tip temperature as actually sensed in outside box B1 in UGUI (FIG. 17) and in outside oval O1 in LGUI (FIG. 25). The magnitude of tissue temperatures as actually sensed are also displayed in inside box B2 in UGUI (FIG. 17) and in inside oval O2 in LGUI (FIG. 25). Until afunctional treatment device26a/26bis connected, two dashes will appear in the boxes B1/B2 (seeFIG. 17) and the ovals O1/O2. Thecontroller52 prohibits advancement to the Ready screen until numeric values register in the boxes B1/B2 or ovals O1/O2, asFIG. 18 andFIG. 25 show, respectively. The display of numeric values indicate that afunctional treatment device26a/26bis present.
• No boxes B1/B2 or ovals O1/O2 will appear in theIcon466 for a given electrode if the corresponding electrode/channel has been disabled using theChannel Selection Keys444, asFIG. 19 shows. In the illustrated embodiment, the physician is able to manually select or deselect individual electrodes using theSelection Keys444 in the Standby or Ready Modes, but not in the RF-On Mode. However, thecontroller52 can be configured to allow electrode selection while in the RF-On Mode, if desired.
• The physician can now deploy thetreatment device26a/26bto the targeted tissue region. Once deployed, the physician extends the electrodes through mucosal tissue and into underlying smooth muscle, asFIG. 32 shows for thedevice26aandFIG. 33 shows for thedevice26b.
• Once thetreatment device26a/26bis located at the desired location and the electrodes are deployed, the physician presses the Standby/Ready Button430 to advance thecontroller52 from Standby to Ready Mode.
2. Ready
• In the Ready Mode, thecontroller52 commands thegenerator38 to apply bursts of low level radio frequency energy through each electrode selected for operation. Based upon the transmission of these low level bursts of energy by each electrode, thecontroller52 derives a local impedance value for each electrode. The impedance value indicates whether or nor the given electrode is in desired contact with submucosal, smooth muscle tissue.
• AsFIG. 20 shows, the Ready screen updates theScreen Icon450 of the UGUI to indicate that thetreatment device26ais connected and deployed in the patient's esophagus. The Ready screen of the UGUI also intermittently blinks the RF On Indicator434 (seeFIG. 12) to indicate that bursts of radio frequency energy are being applied by the electrodes. The Ready screen also updates theElectrode Icon466 to spatially display in the inside and outside boxes B1 and B2 the actual sensed temperature conditions. The Ready screen also adds a further outside box B3 to spatially display the derived impedance value for each electrode.
• In the LGUI (seeFIG. 27), the Ready screen intermittently blinks a portion of the image in theicon450 to indicate that bursts of radio frequency energy are being applied by the electrodes. The Ready screen also updates theElectrode Icon466 to spatially display in the inside and outside ovals O1 and O2 the actual sensed temperature conditions. The Ready screen also adds a further outside oval O3 to spatially display the derived impedance value for each electrode.
• On the Ready screen for both UGUI and LGUI, instantaneous, sensed temperature readings from the tip electrode and tissue surface, as well as impedance values, are continuously displayed in spatial relation to the electrodes (in the boxes B1, B2, and B3 in UGUI (FIG. 20) and in the ovals O1, O2, and O3 in LGUI (FIG. 27)). An “acceptable” color indicator (e.g., green) is also displayed in the background of box B1/oval O1 as long as the tip temperature reading is within the desired pre-established temperature range (e.g., 15 to 120 C). However, if the tip temperature reading is outside the desired range, the color indicator changes to an “undesirable” color indicator (e.g., to white), and two dashes appear in box B1/oval O1 instead of numeric values.
• Thecontroller52 prevents the application of radio frequency energy if any temperature reading is outside a selected range (e.g., 15 to 120 degrees C.).
• By touching theTarget Duration Keys438, theTarget Temperature Keys440, theMaximum Power Keys442, theChannel Selection Keys444, theCoagulation Level Keys446, and the Flow Rate and Priming Keys448 (seeFIG. 12), the physician can affect changes to the parameter values for the intended procedure. Thecontroller52 automatically adjusts to take these values into account in its control algorithms. The correspondingtarget duration icon452,target temperature icon454,maximum power icon456,channel selection icon458,coagulation level icon460, and flow rate/priming icon462 change accordingly in the UGUI and LGUI to indicate the current selected parameter values.
• When the physician is ready to apply energy to the targeted tissue region to begin treatment, the physician presses thefoot pedal416. In response, thecontroller52 advances from Ready to RF-On Mode, provided that all sensed temperatures are within the selected range.
3. RF-On
• When thefoot pedal416 is pressed, thecontroller52 activates thepump rotor428. Cooling liquid is conveyed through thetreatment device26a/26binto contact with mucosal tissue at the targeted site. At the same time, cooling liquid is aspirated from thetreatment device26a/26bin an open loop. During a predetermined, preliminary time period (e.g. 2 to 5 seconds) while the flow of cooling liquid is established at the site, thecontroller52 prevents the application of radio frequency energy.
• After the preliminary time period, thecontroller52 applies radio frequency energy through the electrodes. The RF-On screen is displayed in the UGUI (FIG. 22) and LGUI (FIG. 28).
• The RF-On screen in both the UGUI (FIG. 22) and LGUI (FIG. 28) displays theScreen Icon450, indicate that thetreatment device26a/26bis connected and deployed. In the LGUI (FIG. 28), theScreen Icon450 also shows the extension of electrodes, to differentiate the RF-On Screen from the Ready Screen (FIG. 27). The flow drop animation PS also appears in both UGUI (FIG. 22) and LGUI (FIG. 28), indicating that cooling is taking place. A flashing radio wave animation RW also appears in both UGUI (FIG. 22) and LGUI (FIG. 28), indicating that radio frequency energy is being applied. The RF On Indicator434 (FIG. 12) is also continuously illuminated to indicate that radio frequency energy is being applied by the electrodes.FIG. 12 shows the RF-On screen of the UGUI.
• In both UGUI (FIG. 22) and LGUI (FIG. 28), the RF-On screen also updates theElectrode Icon466 to display in the boxes B1/ovals O1 the actual sensed tip temperature conditions. In both UGUI and LGUI, the RF-On screen also displays the derived impedance value for each electrode in the boxes B3/ovals O3.
• In both UGUI (FIG. 22) and LGUI (FIG. 28), unlike the Ready or Standby screens, the surface temperature is no longer displayed in a numerical format in boxes B2/ovals O2. Instead, a circle C1 is displayed in both UGUI and LGUI, which is color coded to indicate whether the surface temperature is less than the prescribed maximum (e.g., 45 degrees C.). If the surface temperature is below the prescribed maximum, the circle C1 is colored an “acceptable” color, e.g., green. If the surface temperature is exceeds the prescribed maximum, the color of the circle C1 changes to an “not acceptable” color, e.g., to red.
• Likewise, in addition to displaying numeric values in UGUI (FIG. 22) and LGUI (FIG. 28), the boxes B1 and B3/ovals O1 and O3 are also color coded to indicate compliance with prescribed limits. If the tip temperature is below the prescribed maximum (e.g., 100 degrees C.), the box B1/oval O1 is colored, e.g., green. If the tip temperature is exceeds the prescribed maximum, the box border thickens and the color of the box B1/oval O1 changes, e.g., to red. If the impedance is within prescribed bounds (e.g., between 25 ohms and 1000 ohms), the box B3/oval O3 is colored, e.g., grey. If the impedance is outside the prescribed bounds, the box border thickens and the color of the box B3/oval O3 changes, e.g., to red.
• If desired, in either or both UGUI and LGUI, theElectrode Icon466 can also display in a box or circle the power being applied to each electrode in spatial relation to the idealized image.
• In both UGUI (FIG. 22) and LGUI (FIG. 28), the RF-On screen displays thetarget duration icon452,target temperature icon454,maximum power icon456,channel selection icon458, coagulation level icon460 (or, in LGUI, the RF cycle icon461), and flow rate/priming icon462, indicating the current selected parameter values. The physician can alter the target duration or target temperature or maximum power and pump flow rate through thecorresponding selection keys438,440,442, and448 (seeFIG. 12) on the fly, and thecontroller52 and respective UGUI and LGUI instantaneously adjust to the new parameter settings. As before mentioned, in the illustrated embodiment, thecontroller52 does not permit change of the channel/electrode while radio frequency energy is being applied, and, for this reason, thechannel selection icon458 is dimmed.
• Unlike the Standby and Ready screens, the RF-On screen in both UGUI (FIG. 22) and LGUI (FIG. 28) also displays a realtime line graph468 to show changes to the temperature profile (Y-axis) over time (X-axis). In both UGUI (FIG. 22) and LGUI (FIG. 28), the RF-On screen also shows a runningclock icon470, which changes appearance to count toward the target duration. In the illustrated embodiment, a digital clock display CD is also shown, indicating elapsed time.
• Theline graph468 in both UGUI (FIG. 22) and LGUI (FIG. 28) displays four trending lines to show the minimum and maximum surface and tip temperature readings from all active electrodes. In the illustrated embodiment, the time axis (X-axis) is scaled to one of five pre-set maximum durations, depending upon the set target duration. For example, if the target duration is 0 to 3 minutes, the maximum time scale is 3:30 minutes. If the target duration is 3 to 6 minutes, the maximum time scale is 6:30 seconds, and so on.
• Theline graph468 displays two background horizontal bars HB1 and HB2 of different colors. The upper bar HB1 is colored, e.g., green, and is centered to the target coagulation temperature with a spread of plus and minus 10 degrees C. The lower bar HB2 is colored, e.g., red, and is fixed at a prescribed maximum (e.g., 40 degrees C.) to alert potential surface overheating.
• In both UGUI (seeFIG. 23) and LGUI (seeFIG. 29), theline graph468 also displays a triangle marker TM of a selected color (e.g., red) and with a number corresponding to the channel/electrode that is automatically turned off by thecontroller52 due to operation outside the selected parameters. As before described, the circle C1 and boxes B1 and B3/ovals O1 and O3 for this electrode/channel are also modified in theelectrode icon466 when this situation occurs.
• TheElectrode Icon466 can graphically display other types of status or configuration information pertinent to thetreatment device26a/26b. For example, theElectrode Icon466 can display a flashing animation in spatial relation to the idealized electrodes to constantly remind the physician that the electrode is extended into tissue.
• The flashing animation ceases to be shown when the electrode is retracted. The flashing animation reminds the physician to retract the electrodes before removing thetreatment device26a/26b. As another example, theElectrode Icon466 can display another flashing animation when the expandable structure of thetreatment device26ais expanded. The flashing animation reminds the physician to collapse the electrodes before removing thetreatment device26a.
4. Pause
• For the UGUI (FIG. 24) and the LGUI (FIG. 30), thecontroller52 terminates the conveyance of radio frequency ablation energy to the electrodes and the RF-On screen changes into the Pause screen, due to any of the following conditions (i) target duration is reached, (ii) all channels/electrodes have an erroneous coagulation condition (electrode or surface temperature or impedance out of range), or (iii) manual termination of radio frequency energy application by pressing thefoot pedal416 or the Standby/Ready Button430.
• Upon termination of radio frequency ablation energy, the runningclock icon470 of the Pause screen of the UGUI (FIG. 24) and the LGUI (FIG. 30) stops to indicate total elapsed time. Thecontroller52 commands the continued supply of cooling liquid through thetreatment device26a/26binto contact with mucosal tissue at the targeted site. At the same time, cooling liquid is aspirated from thetreatment device26a/26bin an open loop. This flow of cooling liquid continues for a predetermined time period (e.g. 2 to 5 seconds) after the supply of radio frequency ablation energy is terminated, after which thecontroller52 stops thepump rotor428.
• The Pause screen for the UGUI (FIG. 24) and LGUI (FIG. 30) is in most respects similar to the RF-On screen for therespective device26a/26b. In the UGUI (FIG. 24), the Pause screen displays theScreen Icon450, to indicate that thetreatment device26ais connected and deployed in the patient's esophagus. However, the flashing radio wave animation is not present, indicating that radio frequency energy is no longer being applied. In the LGUI (FIG. 30), theScreen Icon450 is blanked.
• The Pause screen for the UGUI (FIG. 24) also updates theElectrode Icon466 to display in the boxes B1 and B3 the actual sensed tip temperature and impedance conditions. However, no background color changes are registered on the Pause screen, regardless of whether the sensed conditions are without or outside the prescribed ranges. In the LGUI (FIG. 30), no values are displayed in the ovals O1 and O3.
• The Pause screen for the UGUI (FIG. 24) and the LGUI (FIG. 30) continues to display thetarget duration icon452,target temperature icon454,maximum power icon456,channel selection icon458, coagulation level icon460 (or, in LGUI, the RF cycle icon461), and flow rate/priming icon462, indicating the current selected parameter values.
• In the UGUI (FIG. 24) and LGUI (FIG. 30), the real timetemperature line graph468 continues to display the four trending lines, until the target duration is reached and five additional seconds elapse, to show the drop off of electrode temperature.
• If further treatment is desired, pressing the Standby/Ready button430 returns thedevice400 from the Pause back to the Ready mode.
V. The Procedure Log
• When the floppy disk (i.e., usage key card) is inserted in thedrive426, data is saved automatically after each application of radio frequency energy.
• When the floppy disk is inserted, thecontroller52 downloads data to the disk each time it leaves the RF-On screen, either by default or manual termination of the procedure. The downloaded data creates a procedure log. The log documents, by date of treatment and number of treatments, the coagulation level, the coagulation duration, energy delivered by each electrode, and the coolant flow rate. The procedure log also records at pre-established intervals (e.g., every 5 seconds) the temperatures of the electrode tips and surrounding tissue, impedance, and power delivered by each electrode. The procedure log preferably records these values in a spreadsheet format.
• Thecontroller52 includes an UPDATE function526 (seeFIG. 15). TheUPDATE function526 registers the time period during which radio frequency energy is applied using thedevice26a/26b. The time is entered into thetime record218 of the use table216 maintained by thecontroller52. After a prescribed maximum period of use is registered (e.g., sixty minutes), theUPDATE function526 interrupts application of radio frequency energy to theelectrodes66, and prevents further delivery by thegenerator38 to the particular device26.
• In this circumstance, theUPDATE function526 causes thecontroller52 to generate theEXCHANGE prompt516. As previously described, the EXCHANGE prompt516 (seeFIG. 16) requires the operator to replace the existing device26 and itskey card200 with a new device26 and its associatedkey card200.
• Thehousing400 can carry an integrated printer, or can be coupled through the I/O device54 to an external printer. The printer prints a procedure log in real time, as the procedure takes place.
• Other details of the GUI during operation of a givendevice26a/26bcan be found in co-pending U.S. patent application Ser. No. 09/305,123, filed May 4, 1999 and entitled “Graphical User Interface for Association with an Electrode Structure Deployed in Contact with a Tissue Region,” which is incorporated herein by reference.
• Various features of the invention are set forth in the following claims.

Claims (15)

1. A system for controlling operation of a family of treatment devices comprising

a family of treatment devices comprising at least first and second different treatment devices which are intended to be individually deployed,

a controller including a connector to which a selected one of the first or second treatment device is coupled for use, and

a reader to download information to the controller to identify the selected treatment device coupled to the connector, the information comprising first data containing an identification code unique to the selected treatment device and second data containing a functional code identifying a functional characteristic of the selected device, the identification codes and the functional codes for the first and second treatment devices being different, the controller including a usage monitoring function comprising a first data state prior to downloading of the identification code and operating to process the identification code and enabling operation of the selected device if the identification code correlates in a pre-established manner with the first data state, the usage monitoring function further operating, in response to enabling operation of the selected device, to change the first data state to a second data state that prevents subsequent operation of the selected device in response to downloading of the identification code,

the controller also including a first or second control function enabled only if the usage monitoring function enables operation of the selected device, the first control function being enabled in response to downloading the functional code of the first treatment device and the second control function being enabled in response to downloading of the functional code of the second treatment device.

2. A system according toclaim 1 further including

a first usage key card for the first treatment device and a second usage key card for the second treatment device, each usage key card adapted to be handled separate from the respective treatment device and comprising a storage medium formatted to contain, for the respective treatment device, the identification code and the functional code that, upon reading by the reader, is downloaded to the controller.

3. A system according toclaim 1

wherein the usage monitoring function causes the controller to create a table by registering unlike identification codes in memory as they are downloaded by the reader and to enable the control function for the selected treatment device when a new identification code is registered in the table.

4. A system according toclaim 3

wherein the usage monitoring function causes the controller to disable the first or second control function for the selected treatment device when the given identification code matches an identification code in the table.

5. A system according toclaim 3

wherein the usage monitoring function causes the controller to register in the table, a time period of use of the device.

6. A system according toclaim 5

wherein the usage monitoring function causes the controller to disable the control function for the selected treatment device when the time period of use exceeds a prescribed period.

7. A system according toclaim 1

wherein the reader downloads through the connector an electrical identification signal that varies according to the identification and functional codes of the selected treatment device.

8. A system according toclaim 1

wherein the controller includes an input adapted to be attached to a sensor carried by the selected treatment device to monitor an operating condition.

9. A system according toclaim 8

wherein the sensor monitors tissue temperature.

10. A system according toclaim 8

wherein the sensor monitors impedance.

11. A system according toclaim 8

wherein the controller includes an output to process the monitored operating condition as data for storage or manipulation.

12. A system according toclaim 11

wherein the output communicates with a storage medium to save the data.

13. A system according toclaim 11

wherein the output communicates with a printer to print the data.

14. A method for controlling operation of a family of treatment devices comprising the steps of

providing a family of treatment devices comprising at least first and second different treatment devices which, in use, are intended to be individually deployed in association with different tissue regions,

selecting one of the first or second treatment device for use,

connecting the selected treatment device to a unified controller having a first control function for the first treatment device and a second control function for the second treatment device,

communicating to the controller through a reader information relating to the selected treatment device coupled to the connector, the information comprising first data containing an identification code unique to the selected treatment device and second data containing a functional code identifying a functional characteristic of the selected device, the identification codes and the functional codes for the first and second treatment devices being different,

executing a usage monitoring function having a first data state prior to downloading of the identification code and operating to process the identification code and enabling operation of the selected device only if the identification code correlates in a pre-established manner with the first data state, the usage monitoring function further operating, in response to enabling operation of the selected device, to change the first data state to a second data state that prevents subsequent operation of the selected device in response to downloading of the identification code,

enabling either the first or second control function only if the usage monitoring function enables operation of the selected device, the first control function being enabled in response to downloading the functional code of the first treatment device and the second control function being enabled in response to downloading of the functional code of the second treatment device, and

enabling execution on a display screen of a first graphical interface guiding and monitoring use of the first treatment device when the first control function is enabled.

15. A method according toclaim 14

wherein the communicating step includes providing a first usage key card for the first treatment device and a second usage key card for the second treatment device, each usage key card adapted to be handled separate from the respective treatment device and comprising a storage medium formatted to contain, for the respective treatment device, the identification code and the functional code that, upon reading by the reader, is downloaded to the controller.

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