US20070093879A1 - Systems and methods for monitoring and controlling use of medical devices - Google Patents

Abstract

A device carries a use monitoring element that possesses a state or condition that changes in response to use of the device and that is sensed when the device is presented for use. Reuse of the device is not permitted, if the use monitoring element indicates a prior use.

Description

RELATED APPLICATIONS
• This application is a divisional of co-pending U.S. patent application Ser. No. 10/792,423, filed 3 Mar. 2004, which is a divisional of U.S. patent application Ser. No. 10/070,465, filed 14 Aug. 2002, now U.S. Pat. No. 6,733,495, which claims the benefit of provisional U.S. Patent Application Ser. No. 60/152,749, filed 8 Sep. 1999, and entitled “Systems and Methods for Monitoring and Controlling Use of Medical Devices,” and which is also a continuation-in-part of U.S. patent application Ser. No. 09/495,390, filed 31 Jan. 2000, and entitled “Systems and Methods for Monitoring and Controlling Use of Medical Devices, now abandoned, and a continuation-in-part of U.S. patent application Ser. No. 09/574,704, filed 18 May 2000, and entitled “Graphical User Interface for Monitoring and Controlling Use of Medical Devices, now U.S. Pat. No. 6,464,689,” and a continuation-in-part of U.S. patent application Ser. No. 09/639,910 filed 16 Aug. 2000, and entitled “Unified Systems and Methods for Controlling Use and Operation of a Family of Different Treatment Devices,” now abandoned.
FIELD OF THE INVENTION
• The invention is directed to systems and methods for monitoring and controlling use of medical devices.
BACKGROUND OF THE INVENTION
• Use of medical devices intended to treat or diagnose conditions of the body can sometimes generate stress on the material or materials from which the devices are made. The material stress can alter the physical characteristics of the devices, making future performance of the devices unpredictable.
• In addition, exposure to blood and tissue during use can entrap biological components on or within many medical devices. Despite cleaning and subsequent sterilization, the presence of entrapped biological components can lead to unacceptable pyrogenic reactions.
• The effects of material stress and damage caused during a single use of a medical device, coupled with the possibility of pyrogen reactions even after resterilization, reasonably justify imposing a single use restriction upon many medical devices.
SUMMARY OF THE INVENTION
• The invention provides systems and methods for monitoring and controlling use of a device for treating a tissue region. The systems and methods provide the device and an element carried by the device for retaining use monitoring information. The systems and methods employ a reader to download from the element the use monitoring information to a controller for the device. The systems and methods cause the controller to process the use monitoring information by pre-programmed rules to either enable or disable operation of the device.
• According to one aspect of the invention, the element retains use monitoring information as an identification code unique to the device. The pre-programmed rules cause the controller to create a table by registering unlike identification codes in memory as they are downloaded by the reader and to enable operation of the device when a new identification code is registered in the table. The pre-programmed rules cause the controller to disable operation of the device when the given identification code matches an identification code in the table.
• The element can express the identification code using, e.g., a magnetic core element, or a bar code strip, or a RFID tag, or by Hall effect, or by an array of fiber optics.
• According to another aspect of the invention, the element retains use monitoring information as a value reflecting time period of use of the device. The pre-programmed rules cause the controller to enable operation of the device only when the value reflects a time period of use less than a prescribed maximum time period of use.
• The element can express the value using, e.g., a magnetic core element, or a bar code strip, or a RFID tag, or a stepper motor.
• According to another aspect of the invention, the element includes a magnetic core carried by the device having a logic state that changes in response to use of the device. In one embodiment, magnetic flux in one direction about the core represents a logic one state and magnetic flux in another direction about the core represents a logic zero state. The core, when initially installed in the device, possesses a logic one state. Use of the device changes the logic state to a logic zero state. When the device is presented for use, the state of the core is sensed. If the core indicates a prior use (logic zero state), reuse of the device is not permitted.
• According to another aspect of the invention, the element includes a latching relay carried by the device having a relay condition that changes in response to use of the device. In one embodiment, the relay is biased toward an electrically open condition. The relay can be moved and latched into an electrically closed condition. Prior to use, the relay is located in the electrically open condition. During use, the relay is moved and latched to the electrically closed condition. When the device is presented for use, the position of the relay is sensed. If the position indicates a prior use (latched closed condition), reuse of the device is not permitted.
• According to another aspect of the invention, the element includes a use register carried by the device that retains a digital value that changes in response to use of the device. In one embodiment, when the device is presented for use, the value contained in the use register is sensed. If the value indicates a prior use, reuse of the device is not permitted.
• 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 system for treating body sphincters and adjoining tissue regions, which embodies features of the invention;
• FIG. 2 is a perspective view, with portions broken away, of a device usable in association with the system shown inFIG. 1 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 an enlarged view of the operative element shown inFIG. 4, with the electrodes extended for use;
• FIG. 6 is a schematic view of a module that uses magnetic core memory to monitor and control incidence of use of the device shown inFIG. 2;
• FIG. 7 is a schematic view of a module that uses a latching relay to monitor and control incidence of use of the device shown inFIG. 2;
• FIG. 8 is a schematic view of a module that uses a micro-chip register to monitor and control incidence of use of the device shown inFIG. 2; and
• FIG. 9 is a schematic view of a module that uses an identification code to monitor and control incidence of use of the device shown inFIG. 2.
• 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
• FIG. 1 shows one embodiment of a system10, which monitors and controls the use of anoperative element12. The system10 is well adapted for association with single use, catheter-based devices. Therefore, in the illustrated embodiment, theoperative element12 is part of a catheter-basedtreatment device26. It should be appreciated, however, that the system10 is also adaptable for use with devices and methods that are not necessarily catheter-based.
• A. The Treatment Device
• In the illustrated embodiment, thedevice26 includes ahandle28 made, e.g., from molded plastic. Thehandle28 is sized to be conveniently held by a physician, to introduce thecatheter tube30 into the targeted tissue region.
• Thehandle28 carries aflexible catheter tube30. Thecatheter tube30 can be constructed, for example, using standard flexible, medical grade plastic materials. Thecatheter tube30 has adistal end34, which carries theoperative element12.
• Theoperative element12 can support, for example, a device for imaging body tissue, such as an endoscope, or an ultrasound transducer. Theoperative element12 can also support a device to deliver a drug or therapeutic material to body tissue. Theoperative element12 can also support a device for sensing a physiological characteristic in tissue, such as electrical activity, or for transmitting energy to stimulate or form lesions in tissue.
• In the illustrated embodiment, thedevice26, in use, is intended to treat dysfunction of sphincters and adjoining tissue regions in the upper gastrointestinal tract, e.g., in the lower esophageal sphincter and adjacent cardia of the stomach, as well as in the lower gastrointestinal tract, e.g., in the intestines, rectum and anal canal. Still, it should be appreciated that the system10 can be used in association with other devices and methods used to treat other dysfunctions elsewhere in the body, which are not necessarily sphincter-related. For example, the various aspects of the invention have application in procedures requiring ablation of tissue throughout the body, or treatment of hemorrhoids, or restoring compliance to or otherwise tightening interior tissue or muscle regions.
• In the illustrated embodiment, one function that theoperative element12 is to perform is to apply energy in a selective fashion to a targeted body region, which, for the purpose of illustration, can be the lower esophageal sphincter, or cardia, or both. The applied energy creates one or more lesions, or a prescribed pattern of lesions, below the mucosal surface of the esophagus or cardia. The subsurface lesions are formed in a manner that preserves and protects the mucosal surface against thermal damage.
• It has been discovered that natural healing of the subsurface lesions leads to a physical tightening of the sphincter and/or adjoining cardia. 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 the sphincter.
• The structure of theoperative element12 to achieve this result can vary. A representative embodiment is shown in FIGS.2 to4, in which theoperative element12 comprises 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 esophagus10.
• Thecatheter 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 force upon the tissue surrounding thebasket56.
• 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 esophageal or cardia20 wall. The desired depth can range from about 4 mm to about 5 mm.
• In this arrangement (seeFIG. 1), the system10 includes agenerator38 to supply the treatment energy to theelectrodes66. 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.
• Acable40 extending from the proximal end of thehandle28 terminates with anelectrical connector42. Thecable40 is electrically coupled to theoperative element12, e.g., by wires that extend through the interior of thehandle28 andcatheter tube30. Theconnector42 plugs into thegenerator38, to convey the generated energy to theoperative element12.
• 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. 5), an electrical insulatingmaterial70 is coated about the proximal end of eachelectrode66. When the distal end of theelectrode66 penetrating the smooth muscle of the esophageal sphincter18 or cardia20 transmits radio frequency energy, thematerial70 insulates the mucosal surface of the esophagus10 or cardia20 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 illustrate embodiment (seeFIG. 5), 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 muscosal surface when theballoon structure72 is inflated.
• The system10 (seeFIG. 1) can also include certain auxiliary processing equipment, e.g., an externalfluid delivery apparatus44 for supplying cooling liquid to the targeted tissue, e.g., through holes in the spines, and anexternal aspirating apparatus46 for conveying liquid from the targeted tissue site, e.g., through other holes in the spine or elsewhere on thebasket56.
• The system10 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 delivery of processing fluid and, if desired, the removal of aspirated material.
• Thecontroller52 also governs the power levels, cycles, and duration that the radio frequency energy is distributed to theelectrodes66, to achieve and maintain power levels appropriate to achieve the desired treatment objectives. 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 (not shown) 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 another electrode comprises the return for the transmitted energy. The bipolar electrode pairs canelectrodes66 on adjacent spines, orelectrodes66 spaced more widely apart on different spines.
• 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 thetemperature sensors80, 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.
• B. Monitoring and Control of Reuse
• Thehandle28 and thecatheter tube30 form an integrated construction intended for a single use and subsequent disposal as a unit. Alternatively, thehandle28 can comprise a nondisposable component intended for multiple uses. In this arrangement, thecatheter tube30, and components carried at the end of thecatheter tube30 comprise a disposable assembly, which the physician releasably connects to thehandle28 at time of use and disconnects and discards after use. The catheter tube-30 can, for example, include a male plug connector that couples to a female plug receptacle on thehandle28.
• 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, thecontroller54 includes amodule48 that monitors incidence of use of the device and prevents multiple use.
• The module and its interaction with thedevice26 can take various forms.
• 1. Magnetic Core Memory
• In one embodiment (seeFIG. 6), thedevice26 carries within its handle28 amagnetic core82 comprising, e.g., a toroidal-shaped piece of ferrite magnetic material. Magnetic flux in one direction about thecore82 represents a logic one state and magnetic flux in another direction about thecore82 represents a logic zero state. Thecore82, when initially installed in thedevice26, possesses a logic one state. The logic one state therefore indicates the absence of prior use of thedevice26.
• Whenever adevice26 is coupled to thegenerator38, thecontroller52 operates themodule48 to sense the state of thecore82 prior to enabling the conveyance of radio frequency energy to theelectrodes66. In the illustrated embodiment, themodule48 includes atransformer84 comprising a primary winding86, which passes through thecore82, and a secondary winding88, which is located outside thecore82.
• Thetransformer84 is coupled to acurrent source90. Themodule48, when activated, passes current through the primary winding86 in a direction that will set the core82 to a logic zero state. If the core82 initially contained a logic one state, a pulse of voltage occurs at the terminals of the secondary winding88. The determination of whether the core82 memory was set at a logic one state or logic zero state prior to sampling by themodule48 is therefore indicated, respectively, by the presence or absence of a pulse in the secondary winding88.
• Thecontroller52 is coupled to themodule48. When adevice26 is coupled to thegenerator38, thecontroller52 causes current to flow from the source through the primary winding86 to set the core82 to logic zero state. Thecontroller52 senses the presence or absence of a voltage pulse in the secondary winding88. In the presence of a sensed voltage pulse, thecontroller52 enables the conveyance of radio frequency energy to thedevice26.
• After a specified time period of use (e.g., at the end of a treatment cycle or after a prescribed time out period), thecontroller52 causes current to flow from thegenerator38 through anamplifier92 to the core82 in the direction that assures that thecore82 retains the logic zero state. The logic zero state of the core82 therefore indicates that thedevice26 has been used.
• Should adevice26 having the core82 set at the logic zero state be again coupled to thegenerator38, operation ofmodule48 to cause current to pass from thesource90 through the primary winding86 will this time result in the absence of a sensed pulse in the secondary winding88 (because thecore82 is already set at logic zero state). This condition identifies adevice26 that has been previously been used.
• In the absence of a sensed pulse, thecontroller52 does not permit radio frequency energy to be conveyed to thedevice26. Thecontroller52 can also generate an output to thedisplay device54, that results in a visual or audible alarm, informing the operator that thedevice26 has been previously used and cannot be used again. Thecontroller52 also causes current to flow from thegenerator38 through the amplifier to the core82 in the direction that assures that thecore82 of thedevice26 remains in a logic zero state.
• 2. Latching Relay
• In another embodiment (seeFIG. 7), thedevice26 carries within its handle28 a latchingrelay94. The latchingrelay94 includes a switch arm96 and acontact98 coupled to ground. The switch arm96 is biased toward an electrically open condition, away from thecontact98. The switch arm96 can be moved, into an electrically closed condition, against thecontact98.
• In the illustrated embodiment, the latchingrelay94 also includes acoil100. When energized, thecoil100 moves the switch arm96 to the electrically closed condition. The latchingrelay94 further includes apermanent magnet102 that, once the switch arm96 is moved into the electrically closed condition, retains the switch arm96 in the electrically closed condition.
• When initially installed in thedevice26, the switch arm96 is located in the electrically open condition. This is treated as a logic one state. The logic one state indicates that thedevice26 has not been used.
• Whenever adevice26 is coupled to thegenerator38, thecontroller52 operates themodule48 to sense the position of the switch arm96 prior to enabling the conveyance of radio frequency energy to theelectrodes66.
• In the illustrated embodiment, themodule48 includes afirst circuit104 that applies current from asource106 through aresistor108 to the switch arm96. The presence or absence of current flow depends whether the switch arm96 is in the electrically open condition (i.e., the logic one state) or in the electrically closed condition (which is treated as a logic zero state).
• Themodule48 also includes asecond circuit110 that applies current from asource112 thecoil100. The application of this current moves the switch arm96 to the electrically closed condition, which thepermanent magnet102 maintains.
• Thecontroller52 is coupled to themodule48. When adevice26 is coupled to thegenerator38, thecontroller52 senses the presence of current flow through thefirst circuit104. The absence current flow in the first circuit104 (i.e., the logic one state) indicates that the switch arm96 is in the electrically open condition. This condition identifies adevice26 that has not been previously used. Thecontroller52 thereby enables the conveyance of radio frequency energy from thegenerator38 to thedevice26.
• After a specified time period of use (e.g., at the end of a treatment cycle or after a prescribed time out period), thecontroller52 also causes current to flow in thesecond circuit110. This current moves the switch arm96 to the electrically closed condition, which is the logic zero state, to indicate that thedevice26 has been used.
• In the illustrated embodiment, thecontroller52 then resamples the current flow through thefirst circuit104, to confirm that the switch arm96 has been successfully moved to the electrically closed condition. If, after current flow through thesecond circuit110, no current flow is sensed in the first circuit104 (indicating that the switch arm96 is still in the electrically open condition), thecontroller52 generates an error signal.
• Should adevice26 having the switch arm96 set at the logic zero state be again coupled to thegenerator38, thecontroller52 will sense the presence of current flow in thefirst circuit104. This indicates prior use of thedevice26. In the presence of a current flow in thefirst circuit104, thecontroller52 does not permit radio frequency energy to be conveyed to thedevice26. Thecontroller52 can also generate an output to thedisplay device54 that results in a visual or audible alarm, informing the operator that thedevice26 has been previously used and cannot be used again.
• 3. Use Register
• In another embodiment (seeFIG. 8), thedevice26 carries within its handle28 a use register144. Theuse register114 contains a digital value that changes upon use of thedevice26.
• Theuse register114 can comprise a solid state micro-chip, ROM, EEROM, EPROM, or non volatile RAM carried within thehandle28. Theuse register114 is initially programmed by the manufacturer of thedevice26, e.g., with a digital value of zero. Theuse register114 includes anoutput116 that generates this digital value upon prompting. Theuse register114 also includes aninput118 which increments the digital value upon use of thedevice26 to apply radio frequency energy.
• Whenever adevice26 is coupled to thegenerator38, prior to enabling the conveyance of radio frequency energy to theelectrodes66, thecontroller52 operates amodule48 to prompt theuse register114 to output the then resident digital value.
• Thecontroller52 compares the digital value output to a set value indicating no prior use, i.e., a zero value. A resident value of zero identifies adevice26 that has not be previously used. Thecontroller52 thereby enables the conveyance of radio frequency energy from thegenerator38 to thedevice26.
• After a specified time period of use (e.g., at the end of a treatment cycle or after a prescribed time out period), thecontroller52 also generates an input to theuse register114, which increments the resident value to a value above zero, to indicate that thedevice26 has been used.
• Should adevice26 with ause register114 having a resident value greater than zero be again coupled to thegenerator38, thecontroller52 will sense the incremented digital value. This indicates prior use of thedevice26. In the presence of an incremented resident value greater than zero, thecontroller52 does not permit radio frequency energy to be conveyed to thedevice26. Thecontroller52 can also generate an output to thedisplay device54 that results in a visual or audible alarm, informing the operator that thedevice26 has been previously used and cannot be used again.
• Theuse register114 can take other forms and retain a more detailed history of use. For example, theuse register114 can be configured to retain a value reflecting the actual period of time during which energy has been applied to thedevice26. For example, theuse register114 can comprise an array of magnetic cores, which are embedded by thecontroller54 with a pattern of magnetic states that, together, express in binary terms the time-of-use. In this arrangement, themodule48 includes sense amplifiers to determine the magnetic states of the array and, from that, derive the time-of-use history. Alternatively, theuse register114 can comprise a material, e.g., relatively high coercive square loop material, which can be incrementally saturated by pulses of magnetism by thecontroller54 over time, such that the magnitude of the charge bears a linear relationship with time-of-use. In this arrangement, themodule48 includes a sense amplifier to determine the magnitude of the charge and, from that, the time-of-use history.
• As another example, theuse register114 can comprises a handle-resident magnetic strip. One or more analog magnetic recording heads can be used to record information on the strip during use. Themodule48 can comprise a bar-code reader, that reads the code in conventional fashion, e.g., as the user swipes the strip on the handle across the reader. Alternatively, the same heads in the handle can also be employed to read information from the strip for processing by themodule48.
• As yet another example, theuse register114 can comprise a miniature stepper or DC motor carried in the handle. The stepper motor operates as thedevice26 is used, e.g., to incrementally advance an arm in succession across an array of electrical contacts. The stepper motor advances the arm serially from one contact to another in proportion to the length of time thedevice26 is in use. The alignment between the arm and a particular electrical contact is electrically sensed by themodule48, from which the time-of-use can be ascertained.
• As yet another embodiment, theuse register114 can comprise a conventional RFID tag element carried within the handle. In this arrangement, themodule48 includes an RFID transponder. The user scans the tag element with the transponder before use, to ascertain time-of-use information, and then scans the tag element with the transponder after use to update the time-of-use information.
• In these embodiments, thecontroller54 can ascertain whether the time period of previous use or uses retained by theuse register114 is less than a prescribed maximum time period, e.g., 45 minutes. If so, thecontroller54 enables operation of thegenerator38 in association with thedevice26, but only for the time period remaining. If thecontroller54 ascertains that the time period of previous use or uses equals or exceeds the prescribed maximum time period, thecontroller54 does not enable use of thegenerator38.
• 4. Device Identification Code
• In another embodiment (seeFIG. 9), thedevice26 carries within itshandle28 anelement200 that holds a value that constitutes aunique identification code214 capable of being read by themodule48 and registered by thecontroller54. Theidentification code214 is created to be unique to eachdevice26. That is, eachdevice26 contains its ownunique identification code214. No twodevices26 share thesame identification code214. Theunique identification code214 can comprise, e.g., a serial number uniquely assigned to theparticular device26, or any other unique code that is not repeated for anyother device26. Thecode214 itself can comprise letters, numbers, or combinations thereof.
• AsFIG. 9 shows, when thedevice26 is coupled to thecontroller54, themodule48 reads theidentification code214 for input to thecontroller54. 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 thecontroller54. These identification codes will be called the “registered identification codes.”
• Following pre-programmed rules, thecontroller54 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, thecontroller54 updates the table, i.e., the controller registers the instant identification code by adding it to the table216. Upon registering the usage key card202, thecontroller54 also enables use ofgenerator38 in association with the device.
• The presence of a match between the instant identification code and any registered identification code indicates a prior use of thedevice26. In this circumstance, thecontroller54 does not add the duplicative identification code to the table216 and does not enable use of thegenerator38 in association with anydevice26. Preferably, thecontroller54 outputs to the display device54 a visual or audible alarm providing notice of prior use.
• Theelement200 can take various forms. For example, theelement200 can comprise an array of magnetic cores, which are embedded with a pattern of magnetic states that, together, express a multiple bit binary value expressing the identification code. In this arrangement, themodule48 includes sense amplifiers to determine the magnetic states of the array and, from that, derive the binary value.
• As another example, theelement200 can comprise a strip containing a magnetic or optical bar code that expresses the identification code. In this arrangement, themodule48 comprises a bar-code reader, that reads the code in conventional fashion, e.g., as the user swipes the strip on the handle across the reader. Alternatively, the identification code can be expressed by conventional RFID tag element carried within the handle. In this arrangement, themodule48 includes an RFID transponder, which scans the tag element to read the code.
• The binary bits of the identification code can also be-expressed by Hall effect. In this arrangement, themodule48 can comprise either an array of Hall effect sensors, which read the multiple-bit identification code in parallel, or by a single, mechanically movable Hall effect sensor, which reads and processes the code bit-by-bit in a serial swiping motion.
• Alternatively, theelement200 can generate the identification code can be expressed in a binary fashion using an array of fiber optics, each fiber expressing a bit of the code. In this arrangement, themodule48 can comprise an array of photo diodes, which read the multiple-bit optical code in parallel, or by a single, mechanically movable photo diode, which reads and processes the optical code bit-by-bit in a serial swiping motion.
• Thecontroller54 can also maintain 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, thecontroller54 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, thecontroller54 enables a subsequent operation of thegenerator38 in association with thedevice26, but only for the time period remaining. Thecontroller54 updates thetime record218 as further use occurs. Thecontroller54 preferably outputs to the display device the time period of permitted use remaining.
• If thecontroller54 ascertains that the time period of previous use equals or exceeds the prescribed maximum time period, thecontroller54 does not enable use of thegenerator38. Preferably, thecontroller54 outputs to the display device notice of prior use.
• Each embodiment of themodule48, as above described, assures that thedevice26, once used, cannot be used a second time. Thedevice26, when supplied to a customer, can also be accompanied by a floppy disk. The disk, when read by a disk drive associated with thecontroller52, identifies the type of catheter in 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). The disk can also condition the graphical user interface to display the desired images and data formats, which change depending upon the treatment procedure using the device (e.g., treatment of GERD, fecal incontinence, or urinary incontinence).
• Various features of the invention are set forth in the following claims.

Claims (11)

1. A system for treating a tissue region comprising

a device including a usage regulating mechanism having a logic state being operable to be set to either a logic state of one or a logic state of zero, and

a reader to sense the logic state and enabling operation of the device if the sensed logic state is a pre-established one of the logic state of one and the logic state of zero, the reader further operating, in response to enabling operation of the device, to change the sensed logic state to the other one of the logic state of one and the logic state of zero to prevent subsequent operation of the device.

2. A system as inclaim 1

wherein the usage regulating mechanism is a magnetic core.

3. A system as inclaim 1

wherein the use regulating mechanism is a latching relay.

4. A system as inclaim 3

wherein the latching relay includes a switch arm operable to be set to a first position corresponding to a logic state of one or a second position corresponding to a logic state of zero.

5. A system as inclaim 1

wherein the device is adapted to apply radio frequency energy to the tissue region.

6. A system for treating a tissue region comprising

a controller, and

a device including a use register that senses time-of-use of the device and inputs the time-of-use to the controller,

the controller including a processing function for processing the time-of-use to enable operation of the device if the time-of-use is less than a prescribed maximum time period and to disable operation of the device if the time-of-use equals or exceeds the prescribed maximum time period.

7. A system as inclaim 6

wherein the use register comprises an array of magnetic cores.

8. A system as inclaim 6

wherein the use register comprises a magnetic strip.

9. A system as inclaim 6

wherein the use register comprises a stepper motor.

10. A system as inclaim 6

wherein the use register comprises a RFID tag element.

11. A system as inclaim 6

wherein the device is adapted to apply radio frequency energy to the tissue region.

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