JP5952008B2

Control methods and devices for energy delivery

Abstract

This record has no abstract on file.

JP5952008B2, drawing sheet 1 — Sheet 1 of 11

Term

Projected expiry 27 January 2032.

7 claims: 1 independent, 6 dependent

1
気道疾患を治療するために肺内の気道にエネルギーを送出するように構成されたエネルギー送出および追跡システムであって、該システムは、近位端および遠位端を有する軸と、無線周波数電極を含む拡張可能部材であって、該拡張可能部材は、該軸の該遠位端に配置され、該電極は、肺の気道壁に接触し、エネルギー治療を適用して該気道を治療するように構成されている、拡張可能部材と、位置決め器具またはセンサアセンブリであって、該位置決め器具またはセンサアセンブリは、該肺の気道の仮想地図またはデータ地図上での該システムの仮想位置を追跡するように、該軸の該遠位端に結合されている、位置決め器具またはセンサアセンブリとを備え、該位置決め器具またはセンサアセンブリが、エネルギー治療が以前に適用された場所か、あるいはエネルギー治療が以前に適用された場所の近くかに位置する場合に、該無線周波数電極は、該エネルギー治療の適用を開始することができない、システム。
2
前記仮想地図は、三次元地図または図式表示を含み、前記データ地図は、データ座標を含む、請求項1に記載のシステム。
3
前記仮想地図を生成するレンダリングシステムをさらに備え、該レンダリングシステムは、超音波イメージング、コンピュータ断層撮影(CT)、磁気共鳴映像法(MRI)、または陽電子放射断層撮影法(PET)を備える、請求項1または請求項2に記載のシステム。
4
前記位置決め器具と通信する位置決めシステムをさらに備える、請求項1~3のいずれか一項に記載のシステム。
5
前記仮想地図を表示する仮想表示部をさらに備える、請求項1~4のいずれか一項に記載のシステム。
6
前記仮想地図に基づいて、各治療部位における前記システムの前記仮想位置の治療履歴プロファイル、該仮想地図上の提案される治療部位、または理想処置プロファイルを生成するように構成された処理部を有する制御器をさらに備える、請求項1~5のいずれか一項に記載のシステム。
7
前記データ地図は、身体内の固定基準点に対する一連のデータ座標を含む、請求項2に記載のシステム。

Independent claims7

64 paragraphs, as filed

0001(Citation of related application) This application claims the benefits of US Provisional Patent Applications Nos. 60 / 674,106 and 60 / 673,876 (both filed April 21, 2005) under 35 U.SC § 119 (e), and the content of each application is Incorporated herein by reference.

0002Various obstructive airway diseases have several reversible components. Examples include COPD and asthma. Asthma is a disease that makes it difficult for asthma patients to breathe by causing excessive mucus production of bronchoconstriction and inflammation and swelling of the airways, causing widespread but variable airway obstruction. Asthma is a chronic disease characterized primarily by persistent airway inflammation. Asthma is further characterized by the acute onset of additional airways that narrow due to the contraction of hypersensitive airway smooth muscle.

0003In susceptible individuals, asthma symptoms include shortness of breath (dyspnea), wheezing, chest tightness and recurrent onset of cough. Currently, asthma is being addressed by a combination of irritant avoidance and pharmacology. Irritation avoidance is achieved by systemic identification and minimizing contact with each type of irritant. However, avoiding all possible irritants is impractical and may not always be useful.

0004Pharmacological management of asthma includes long-term management using anti-inflammatory and long-acting bronchodilators. Short-term pharmacological management of the acute exacerbation phase may be achieved using short-acting bronchodilators. Both of these methods require repeated and habitual use of prescription drugs. High doses of corticosteroid anti-inflammatory drugs have serious side effects that need to be carefully managed. In addition, some patients are resistant to steroid treatment. Problems associated with drug compliance in patients with pharmacological management and the difficulty of avoiding asthma-inducing irritants are common obstacles to successful conventional asthma management. Therefore, it would be desirable to provide a management system and a method that does not require habitual patient compliance with medication.

0005Various energy delivery systems have been developed for intraluminal treatment of anatomical structures by controlling and applying energy to the luminal surface. Such systems include heterogeneous properties of lung tissue, including cartilage, airway smooth muscles, and mucous glands and ducts, in particular variations in the size of the lung tissue lumen due to the branching pattern of the tracheobronchial tree, variations in the vasculature of the lung. , And due to clinical demands due to variations in tissue type in the lung, it may be specifically configured to deliver energy to lung tissue. Therefore, systems designed to deliver energy, and in some specific cases high frequency energy, to lung tissue need to take these variability into account and deliver energy in a controlled manner.

0006Medical procedures involved in controlling and delivering therapeutic energy to patient tissue are often demanding and may require physicians to perform several tasks at the same time. In addition, medical or other procedures may require specific energy delivery parameters. What has been needed as such is a form that regulates and controls energy delivery, blocks operation or energy delivery when the control system detects a failure in the energy delivery system, and is user-friendly. It is an energy delivery system with a user-friendly control system that can be easily analyzed during demanding medical procedures because the information is delivered by.

Although the following disclosure discusses the treatment of asthma and the airways as a variant of the invention, it should be noted that the invention is not limited to such labeling. The present invention may be applicable to almost any medical treatment or therapy in which the information associated with the treatment site is useful. In one embodiment, a system for delivering activation energy to a therapeutic energy delivery device having a temperature detection element and an energy release element comprises an energy generator configured to be coupled with said energy release element. The energy generator has an activated state and a standby state, in which activation energy is delivered to the energy release device in the activated state instead of the standby state. A controller having a user interface surface with a processing unit and a visible indicator is connected to the energy generator, and the processing unit is said to be said when the temperature measured by the temperature sensing element is not within a predetermined temperature range. It is configured to activate the visible indicator. In another embodiment, the energy delivery system comprises a therapeutic energy delivery device having a distal portion configured to be delivered to the treatment site. The distal portion includes a temperature sensing element and an energy releasing element. The energy generator is configured to be connected to the energy release element and has an activated state and a standby state, in which activation energy is delivered to the energy release element in the activated state instead of the standby state. .. A controller having a user interface surface with a processing unit and a visible indicator is configured to activate the visible indicator when the temperature measured by the temperature sensing element is not within a predetermined temperature range. In another embodiment, a system for delivering activation energy to a therapeutic energy delivery device having a temperature sensing element and an energy release element comprises an energy generator configured to be coupled with said energy release element. The energy generator has an activated state and a standby state, in which activation energy is delivered to the energy release device in the activated state instead of the standby state. A controller having a user interface surface with a processing unit and a visible indicator will indicate the visible indicator if the impedance of the energy release circuit between the energy generator, the energy release element, and the patient is not within a predetermined impedance range. It is configured to activate the vessel. In another embodiment, the energy delivery system comprises a therapeutic energy delivery device having a temperature sensing element and an energy releasing element. The energy generator is configured to be connected to the energy release element and has an activated state and a standby state, in which activation energy is delivered to the energy release element in the activated state instead of the standby state. .. A controller having a user interface surface with a processing unit and a visible indicator will indicate the visible indicator if the impedance of the energy release circuit between the energy generator, the energy release element, and the patient is not within a predetermined impedance range. It is configured to activate the vessel. In yet another embodiment, the system for delivering activation energy to a therapeutic energy delivery device having a temperature sensing element and an energy release element comprises an energy generator configured to be coupled with said energy release element. The energy generator has an activated state and a standby state, in which activation energy is delivered to the energy release device in the activated state instead of the standby state. A controller having a processing unit and a user interface surface with a first visible indicator and a second visible indicator can use the first visible indicator if the temperature measured by the temperature sensing element is not within a predetermined temperature range. It is configured to activate and activate the second visible indicator when the impedance of the energy release circuit between the energy generator, the energy release element, and the patient is not within a predetermined impedance range. In another embodiment, the energy delivery system comprises a therapeutic energy delivery device configured to be delivered to the treatment site. The energy delivery device has a temperature detection element and an energy release element. The energy generator is configured to be connected to the energy release element and has an activated state and a standby state, in which activation energy is delivered to the energy release element in the activated state instead of the standby state. .. A controller having a processing unit and a user interface surface with a first visible indicator and a second visible indicator can use the first visible indicator if the temperature measured by the temperature sensing element is not within a predetermined temperature range. It is configured to activate and activate the second visible indicator when the impedance of the energy release circuit between the energy generator, the energy release element, and the patient is not within a predetermined impedance range. In another embodiment, the energy delivery system comprises a therapeutic energy delivery catheter having electrodes and a temperature sensing element located distal to the catheter. The distal portion of the catheter is configured to be delivered to a treatment site adjacent to the patient's target tissue and to deliver the therapeutic RF energy of the treatment cycle to the target tissue. The RF energy generator is configured to be connected to the electrode and has an activated state and a standby state, in which RF energy is delivered to and from the electrode in the activated state instead of the standby state. It is released. A controller having a processing unit and a user interface surface with a first visible indicator and a second visible indicator is the temperature taken by the temperature sensing element prior to activation of the RF energy generator into the activated state. It is configured to process measurements and impedance measurements between the RF energy generator and the target tissue. The processing unit also activates the first visible indicator if the temperature measured by the temperature sensing element is not within a predetermined temperature range, between the RF energy generator and the target tissue adjacent to the electrode. The second visible indicator is activated when the impedance of is equal to or higher than a predetermined value. In embodiments of the invention, the invention includes a method for treating an organ tissue network, such as the airway, having smooth muscle tissue surrounding the airway lumen passage, said method using a rendering system. A step of mapping at least a portion of the organ tissue network; a step of selecting at least one treatment site within the lumen passage of the organ tissue network; and a plurality of the energy therapies applied to each of the treatment sites. Includes the step of applying energy therapy to the treatment site to treat the smooth muscle tissue, as defined by the parameters of. These parameters may include, but are not limited to, treatment time, treatment interval, temperature, energy, rate of change in temperature, rate of change in energy, impedance of said treatment site, and combinations thereof. The parameters may be displayed during or after the treatment. The term luminal passage may include the lumen of a tubular or other organ such as the airway, the esophagus, the gastrointestinal tract, the vascular system, the heart, the kidney, the liver, the bladder, and / or the brain, or it may further include an organ. It may refer to a non-naturally occurring lumen that occurs in the tissue. The map maps computer tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), ultrasonic imaging, or essentially various image or data editing. It may be a virtual map or a compiled map created by another similar rendering system. It should be noted that the map or virtual map may be merely a schematic representation of the movement of the device within the body with respect to a particular reference point. The map may also be just a series of coordinates with respect to a fixed reference point at some location on the body. Although such a map is not represented graphically, the map is useful for identifying said location of the device in said organ. It may also be used to display the location of the device in the light of the location already examined, diagnosed or treated by the device. Once the map is created, it may be useful in correctly positioning the map, which is composed of anatomical features or positions within the body. With such positioning, the position of the map can be correlated with the actual movement of the device within the body. The map may be created prior to the actual initiation of the treatment. For example, the patient may undergo a CT scan and produce the images needed to compose the map. Once completed, the medical procedure may be initiated with a completed or substantially completed diagram. It may be useful to display the map on an image display, such as the image display of an image obtained by a microscope-type device, but the map is on a separate monitor away from the image display. It may be displayed. The monitor may provide a schematic or schematic representation of the organ tissue network and / or may simply provide positioning data. As mentioned above, the present invention may combine several types of positioning systems and locating instruments to detect said location of the device within the organ tissue network (where the term device refers to catheters, Includes access devices, probes, or other items such as). In one embodiment, the positioning device and positioning system described in the patent above may be incorporated into the treatment device or in a separate device. However, variants of the invention may use other positioning systems such as RFID systems. In any case, the positioning device communicates with the positioning system to establish a virtual position of the device on the map. Accordingly, the virtual position may then be impositioned on the real-time image of the luminal passage on the image display. The system of the present invention may also create a diagnosis or treatment history profile, where, when applying the energy therapy, the diagnosis or treatment history profile includes said at the respective diagnosis or treatment location. The virtual position of the device is included. It should be noted that the treatment may be applied in one step (such as exposing the body to a single source of energy (from inside or outside the body), or the division of the organ is a step. (For example, when the organ is treated stepwise to reduce the healing burden on the organ and minimize the time of the patient in a sedated state). Variants of the invention include systems and devices that exist to detect probes such as catheters or endoscopes that pass through the patient's body. Such systems and equipment are entitled 6,188,355; System and method of recording under the title Wireless six-degree-of-freedom locator. and displaying in context of an image a location of at least one point-of-interest in a body during an intra-body medical procedure title 6,226,543; Six-degree of freedom tracking system having a passive 6,380,732; System and method of recording under the title transponder on the object being tracked 6,558,333; Linking of the title of the displaying in context of an image a location of at least one point-of-interest in a body during an intra-body medical procedure an intra-body tracking system to external reference coordinates title 6,574,498; Intrabody navigation system for medical applications title 6,593,884; Object tracking using a single sensor or a pair of sensors title 6,615,155; Steering configuration for catheter with rigid distal 6,702,780; System and method for determining the location of a catheter during an 6,711,429 in the title of intra-body medical procedure; 6,833,814 in the title of Intrabody navigation system for medical applications; and Method and system for displaying cross-sectional It is disclosed in 6,996,430 under the title of images of a body. Each of the above is incorporated by reference in its entirety. These features of the embodiments will become more apparent from the detailed description below, when combined with the accompanying exemplary drawings.For example, the present invention provides the following items.(Item 1) A system for delivering activation energy to a therapeutic energy delivery device having a temperature detection element and an energy release element. An energy generator configured to be coupled to the energy release element and having an activated state and a standby state in which activation energy is delivered to the energy release device in the activated state rather than in the standby state. Energy generator and A controller having a processing unit and a user interface surface with at least one visible indicator, the processing unit activates the visible indicator when the temperature measured by the temperature sensing element is not within a predetermined temperature range. The controller, which is configured as System with.(Item 2) The system of item 1, wherein the processing unit is also configured to render the energy generator inoperable when the temperature measured by the temperature sensing element is not within a predetermined temperature range.(Item 3) The system of item 1, wherein the visible indicator comprises at least one LED.(Item 4) The system of item 3, wherein the LED is located adjacent to at least a portion of the schematic display of the therapeutic energy delivery device on the surface of the user interface.(Item 5) The system of item 1, wherein the user interface surface further comprises an interface coupler for the therapeutic energy delivery device located adjacent to the visible indicator.(Item 6) The processing unit is configured to determine whether the measured temperature of the temperature sensing element violates the predetermined temperature range immediately after the initial connection of the therapeutic energy delivery device to the controller. , The system described in item 1.(Item 7) The system of item 1, wherein the processing unit is further configured to activate an audible error signal when the temperature measured by the temperature sensing element is not within a predetermined temperature range.(Item 8) The system of item 1, wherein the predetermined temperature range is from about 15 ° C to about 35 ° C.(Item 9) 8. The system of item 8, wherein the predetermined temperature range is from about 20 ° C to about 30 ° C.(Item 10) The system of item 1, further comprising an energy delivery device coupled to said system for delivery of activation energy.(Item 11) 10. The system of item 10, wherein the energy delivery device comprises an RF energy delivery catheter, and the energy generator comprises an RF energy generator.(Item 12) The system according to item 1, further comprising an interface connector that communicates with the processing unit and is configured to communicate with the input of the bronchoscopic camera, wherein the processing unit is the state of the system or A system that transmits information to the input of the bronchoscope camera about the treatment cycle performed by the system, and as a result, the information can be displayed within the display of the bronchoscope.(Item 13) Item 1. The user interface surface further comprises a digital display that communicates with the processing unit and is configured to display information about the state of the system or the treatment cycle performed by the system. Described system.(Item 14) A therapeutic energy delivery device with a distal portion configured to be delivered to the treatment site, including a temperature sensing element and an energy releasing element. An energy generator configured to be coupled to the energy release element and having an activated state and a standby state, wherein the activation energy is delivered to the energy release element in the activated state instead of the standby state. With an energy generator A controller having a user interface surface with a processing unit and a visible indicator so that the processing unit activates the visible indicator when the temperature measured by the temperature sensing element is not within a predetermined temperature range. It is composed of controls and An energy delivery system.(Item 15) The energy delivery according to item 14, wherein the processing unit is also configured to make it impossible to start the energy generator when the temperature measured by the temperature sensing element is not within a predetermined temperature range. system.(Item 16) The energy delivery system according to item 14, wherein the visible indicator comprises an LED.(Item 17) 16. The energy delivery system of item 16, wherein the LED is located adjacent to at least a portion of the schematic display of the energy delivery device on the surface of the user interface.(Item 18) The energy delivery system of item 14, wherein the user interface surface further comprises an interface coupler to the therapeutic energy delivery device located adjacent to the visible indicator.(Item 19) The processing unit is configured to determine whether the measured temperature of the temperature sensing element deviates from the predetermined temperature range immediately after the initial connection of the therapeutic energy delivery device to the controller. The energy delivery system according to item 14.(Item 20) The energy delivery system according to item 14, wherein the processing unit is further configured to activate a voice error sound when the temperature measured by the temperature sensing element is not within a predetermined temperature range.(Item 21) The energy delivery system according to item 14, wherein the predetermined temperature range is from about 15 ° C to about 35 ° C.(Item 22) 21. The energy delivery system according to item 21, wherein the predetermined temperature range is from about 20 ° C to about 30 ° C.(Item 23) The therapeutic energy delivery device is arranged on an energy delivery catheter having an elongated shaft with a proximal and a distal section and the proximal section configured to connect to the interface coupler on the surface of the user interface. 14. The energy delivery system of item 14, comprising a proximal coupler and an extended basket electrode located on the distal section that is in telecommunications with the proximal coupler.(Item 24) The system according to item 14, further comprising an interface connector that communicates with the processing unit and is configured to communicate with the input of the bronchoscopic camera, wherein the processing unit is the state of the system or A system that transmits information to the input of the bronchoscope camera about the treatment cycle performed by the system, and as a result, the information can be displayed within the display of the bronchoscope.(Item 25) Item 14. The user interface surface further comprises a digital display that communicates with the processing unit and is configured to display information about the state of the system or the treatment cycle performed by the system. Described system.(Item 26) A system for delivering activation energy to a therapeutic energy delivery device having a temperature detection element and an energy release element. An energy generator configured to be coupled to the energy release element and having an activated state and a standby state, in which the activation energy is delivered to the energy release device in the activated state instead of the standby state. With an energy generator that can A controller having a user interface surface with a processing unit and a visible indicator, the processing unit in which the impedance of the energy release circuit between the energy generator, the energy release element, and the patient is within a predetermined impedance range. When not in the controller, which is configured to activate the visible indicator, System with. (Item 27) 26. The system of item 26, wherein the processing unit is also configured to make it impossible to start the energy generator if the impedance of the energy release circuit is not within a predetermined impedance range.(Item 28) 26. The system of item 26, wherein the visible indicator comprises an LED.(Item 29) 28. The system of item 28, wherein the LED is located adjacent to at least a portion of the schematic display of the therapeutic energy delivery device on the surface of the user interface.(Item 30) 28. The system of item 28, wherein the LED is located adjacent to a schematic representation of at least a portion of the return electrode assembly on the surface of the user interface.(Item 31) 26. The system of item 26, wherein the user interface surface further comprises an interface coupler for the therapeutic energy delivery device located adjacent to the visible indicator.(Item 32) The processing unit is configured to determine if the impedance of the energy release circuit is not within a predetermined impedance range immediately after the initial connection of the therapeutic energy delivery device to the controller, item 26. The system described in.(Item 33) 26. The system of item 26 further comprises a user-operated activation switch that is coupled to the controller and is configured to activate the energy generator in an activated state. A system also configured to determine if the impedance of the energy release circuit is not within a predetermined impedance range after activation of the activation switch.(Item 34) 33. The system of item 33, wherein the activation switch comprises a foot switch.(Item 35) The user interface surface further comprises a schematic display of the foot switch, the foot switch being configured to be coupled to an interface coupler disposed on the user interface surface adjacent to the graphic display of the foot switch. 34. The system of item 34, further comprising a proximal coupler.(Item 36) The controller further comprises a second visible indicator, the processing unit, when the impedance of the energy release circuit is not within a predetermined impedance range after at least two activation cycles of the activation switch. 33. The system of item 33, configured to activate the second visible indicator.(Item 37) 26. The system of item 26, wherein the processing unit is further configured to activate a voice error sound when the impedance of the energy release circuit is not within a predetermined impedance range.(Item 38) 26. The system of item 26, wherein the predetermined impedance range is up to about 1000 ohms.(Item 39) 26. The system of item 26, further comprising an energy delivery device coupled to said system for delivery of activation energy.(Item 40) 39. The system of item 39, wherein the energy delivery device comprises an RF energy delivery catheter and the energy generator comprises an RF energy generator.(Item 41) 26. The system of item 26, further comprising an interface coupler that communicates with the processing unit and is configured to communicate with the input of the bronchoscopic camera, wherein the processing unit is the state of the system or A system that transmits information to the input of the bronchoscope camera about the treatment cycle performed by the system, and as a result, the information can be displayed within the display of the bronchoscope.(Item 42) 26. The user interface surface further comprises a digital display that communicates with the processing unit and is configured to display information about the state of the system or the treatment cycle performed by the system. Described system.(Item 43) A therapeutic energy delivery device with a temperature detection element and an energy release element, An energy generator configured to be coupled to the energy release element and having an activated state and a standby state, wherein the activation energy is delivered to the energy release element in the activated state instead of the standby state. With an energy generator A controller having a user interface surface with a processing unit and a visible indicator, the processing unit in which the impedance of the energy release circuit between the energy generator, the energy release element, and the patient is within a predetermined impedance range. When not in the controller, which is configured to activate the visible indicator, An energy delivery system.(Item 44) 43. The system of item 43, wherein the processing unit is also configured to render the energy generator inoperable if the impedance of the energy release circuit is not within a predetermined impedance range.(Item 45) The energy delivery system according to item 43, wherein the visible indicator is equipped with an LED.(Item 46) 45. The energy delivery system of item 45, wherein the LED is located adjacent to a schematic display of at least a portion of the therapeutic energy delivery device on the surface of the user interface.(Item 47) 46. The system of item 46, wherein the LED is located adjacent to a schematic representation of at least a portion of the counter electrode assembly on the outer surface of the user interface.(Item 48) 43. The system of item 43, wherein the user interface surface further comprises an interface coupler for the therapeutic energy delivery device located adjacent to the visible indicator.(Item 49) The processing unit is configured to determine whether or not the impedance of the energy release circuit is within a predetermined impedance range immediately after the initial connection of the therapeutic energy delivery device to the controller. The system described in.(Item 50) 43. The system of item 43 further comprises a user-operated activation switch that is coupled to the controller and configured to activate the energy generator, the processing unit comprising said activation. A system configured to determine if the impedance of the energy release circuit is within a predetermined impedance range after activation of the switch.(Item 51) The system of item 50, wherein the activation switch comprises a foot switch.(Item 52) 51. The system of item 51, wherein the foot switch further comprises a proximal coupler configured to couple to an interface coupler on the surface of the user interface adjacent to the schematic display of the foot switch.(Item 53) The controller further comprises a second visible indicator, the processing unit, when the impedance of the energy release circuit is not within a predetermined impedance range after at least two activation cycles of the activation switch. 50. The system of item 50, which is configured to activate the second visible indicator.(Item 54) 43. The system of item 43, wherein the processing unit is further configured to activate a voice error sound when the impedance of the energy release circuit is not within a predetermined impedance range.(Item 55) 43. The system of item 43, wherein the predetermined impedance range is up to about 1000 ohms.(Item 56) The therapeutic energy delivery device is an energy delivery catheter having an elongated shaft with a proximal section and a distal section, and a proximal interface coupler arranged on the proximal section configured to connect to the controller. 43. The system of item 43, comprising: and an extended basket electrode located on the distal section that is in telecommunications with the proximal interface coupler.(Item 57) 43. The system of item 43, further comprising an interface connector that communicates with the processing unit and is configured to communicate with the input of the bronchoscopic camera, wherein the processing unit is the state of the system or A system that transmits information to the input of the bronchoscope camera about the treatment cycle performed by the system, and as a result, the information can be displayed within the display of the bronchoscope.(Item 58) Item 43, wherein the user interface surface further comprises a digital display that communicates with the processing unit and is configured to display information about the state of the system or the treatment cycle performed by the system. Described system.(Item 59) A system for delivering activation energy to a therapeutic energy delivery device having a temperature detection element and an energy release element. An energy generator configured to be connected to the energy release element and having an activated state and a standby state, in which the activation energy is delivered to the energy release device in the activated state instead of the standby state. With an energy generator that can A controller having a processing unit and a user interface surface having a first visible indicator and a second visible indicator, the processing unit when the temperature measured by the temperature sensing element is not within a predetermined temperature range. , Activate the first visible indicator and activate the second visible indicator when the impedance of the energy release circuit between the energy generator, the energy release element, and the patient is not within a predetermined impedance range. The controls, which are configured to System with.(Item 60) A therapeutic energy delivery device configured to be delivered to the treatment site and having a temperature detection element and an energy release element. An energy generator configured to be connected to the energy release element and having an activated state and a standby state, in which the activation energy is delivered to the energy release element in the activated state instead of the standby state. With an energy generator A controller having a processing unit and a user interface surface having a first visible indicator and a second visible indicator, the processing unit when the temperature measured by the temperature sensing element is not within a predetermined temperature range. , Activate the first visible indicator and activate the second visible indicator when the impedance of the energy release circuit between the energy generator, the energy release element, and the patient is not within a predetermined impedance range. The controls, which are configured to An energy delivery system.(Item 61) A therapeutic energy delivery catheter with electrodes and temperature sensing elements located distal to it that is delivered to a treatment site adjacent to the patient's target tissue and is configured to deliver therapeutic RF energy to the target tissue. When, An RF energy generator that is configured to be connected to the electrode and has an activated state and a standby state, in which RF energy is delivered to the electrode in the activated state instead of the standby state. When, A controller with a processing unit and a user interface surface with a first visible indicator and a second visible indicator, It is an energy delivery system equipped with The processing unit Prior to activation of the RF energy generator into the activated state, the temperature measurements taken by the temperature sensing element and the impedance measurements between the RF energy generator and the target tissue are processed. If the temperature measured by the temperature sensing element is not within the predetermined temperature range, the first visible indicator is activated. When the impedance between the RF energy generator and the target tissue adjacent to the electrode is equal to or higher than a predetermined value, the second visible indicator is activated. It is configured, system.(Item 62) The energy delivery system according to item 61, wherein the first and second visible indicators include LEDs.(Item 63) 61. The energy delivery system of item 61, wherein the first and second visible indicators are located adjacent to at least a portion of the schematic representation of the energy delivery catheter on the surface of the user interface.(Item 64) 63. The energy delivery system of item 63, wherein the user interface surface further comprises an interface coupler for the energy delivery catheter that is disposed adjacent to the schematic representation of the energy delivery catheter.(Item 65) 61. The energy delivery system of item 61, wherein the processing unit is further configured to activate a voice error sound when either the first or second visible indicator is activated.(Item 66) The energy delivery system of item 61, wherein the predetermined impedance range is up to about 1000 ohms.(Item 67) 61. The system of item 61, wherein the predetermined temperature range is from about 20 ° C to about 30 ° C.(Item 68) The energy delivery catheter comprises an elongated shaft having a proximal section and a distal section and a proximal coupler located on the proximal section configured to connect to an interface coupler on the user interface. 61. The energy delivery system of item 61, wherein the electrode comprises at least a portion of an extended basket electrode located on the distal section that is in telecommunications with the proximal coupler.(Item 69) 61. The system of item 61, further comprising an interface connector that communicates with the processing unit and is configured to communicate with the input of the bronchoscopic camera, wherein the processing unit is the state of the system or A system that transmits information to the input of the bronchoscope camera about the treatment cycle performed by the system, and as a result, the information can be displayed within the display of the bronchoscope.(Item 70) Item 61, the user interface surface further comprises a digital display that communicates with the processing unit and is configured to display information about the state of the system or the treatment cycle performed by the system. The system described in.(Item 71) A method for treating an organ tissue network that has smooth muscle tissue surrounding the luminal passages of an organ. Steps to map at least part of the organ tissue network using a rendering system, With the step of selecting at least one treatment site within the luminal passage of the organ tissue network, A step of applying energy therapy to the treatment site to treat the smooth muscle tissue, wherein the energy therapy applied to an individual treatment site is defined by a plurality of parameters. Including, methods.(Item 72) The method of item 71, wherein the organ tissue network comprises an airway and the smooth muscle tissue comprises an airway smooth muscle tissue.(Item 73) The method of item 71, further comprising the step of correlating the map with a plurality of locations within the organ tissue network.(Item 74) The method of item 71, wherein a substantial portion of the map is created prior to selecting at least one treatment location.(Item 75) 74. The method of item 74, wherein the steps of displaying the actual location of the treatment site and the real-time image of the lumen passage are displayed on the image display.(Item 76) 74. The method of item 74, further comprising the step of using the image display to select the treatment site.(Item 77) The method of item 75, further comprising the step of imposing at least a portion of the map on the image display.(Item 78) The method of item 75, further comprising the step of advancing the device into the organ tissue network, wherein the device communicates with a positioning system to establish a virtual position of the device, at least one positioning. A method with equipment.(Item 79) The method according to item 78, wherein the step of displaying the real-time image of the lumen passage on the image display unit includes a step of imposing the virtual position of the device on the image display unit.(Item 80) 78. The method of item 78, further comprising displaying the map and the virtual position of the device on a monitor.(Item 81) The step of applying the energy therapy is the step of inserting the energy delivery element into the organ tissue network, and the energy delivery element is connected to a control system configured to provide energy for the energy therapy. 78. The method of item 78, comprising the steps to be performed.(Item 82) 81. The method of item 81, wherein the energy delivery element is attached to a therapeutic device.(Item 83) 81. The method of item 81, wherein the energy delivery element is attached to the device.(Item 84) 83. The method of item 83, further comprising applying the energy therapy by the device at a plurality of treatment sites.(Item 85) 84. The method of item 84, wherein the treatment history profile further comprises a step of creating the treatment history profile, the treatment history profile comprising said virtual position of the device at each treatment location when applying the energy therapy.(Item 86) 85. The method of item 85, wherein the treatment history profile is recorded electronically.(Item 87) 85. The method of item 85, wherein the treatment history profile further comprises at least one of the plurality of parameters of each energy therapy associated with said virtual position of the device at each treatment location.(Item 88) The method of item 85, wherein the step of displaying at least a portion of the treatment history profile allows the care provider to avoid duplication of treatment locations when applying one or more energy therapies. ..(Item 89) 88. The method of item 88, wherein the control system is prevented from providing the energy therapy if the medical care provider overlaps treatment locations.(Item 90) 85. The method of item 85, further comprising providing an auditory output to signal the relationship between the current treatment location and said treatment history profile.(Item 91) 85. The method of item 85, further comprising displaying at least a portion of the treatment history profile on either the monitor or the image display.(Item 92) The method of item 91, wherein the step of displaying the treatment history profile includes the step of visually marking a portion of the luminal passage on the image display to identify a previous treatment site. ..(Item 93) 92. The method of item 92, wherein the step of visually marking the portion of the lumen passage comprises coloring the portion of the lumen passage on the image display.(Item 94) The method of item 91, further comprising the step of providing a recommended treatment location on either the image display or the monitor.(Item 95) 94. The method of item 94, wherein the control system is prevented from providing the energy therapy if the medical care provider fails to apply the energy therapy to the recommended treatment location.(Item 96) 94. The method of item 94, wherein the step of providing the recommended treatment location includes a step of visually identifying the location of the lumen passage from a portion of the lumen passage that corresponds to the treatment history profile.(Item 97) The method of item 96, wherein the recommended treatment location does not overlap with the portion of the luminal passage that corresponds to the treatment history profile.(Item 98) 97. The method of item 97, wherein the recommended treatment location is located at a distance from the portion of the luminal passage that corresponds to the treatment history profile.(Item 99) 94. The method of item 94, wherein the step of providing the recommended treatment location includes the step of using the map to calculate the minimum distance to an adjacent organ or anatomical marker.(Item 100) The step of providing the recommended treatment site is a step of displaying the recommended route on either the image display unit or the monitor, and the recommended route is an instruction to reach the recommended treatment site via the organ tissue network. 99. The method of item 99, further comprising steps.(Item 101) The method of item 99, wherein the shortest time is calculated based on an algorithm that minimizes time factors, navigation difficulties, or size differences between organs.(Item 102) 85. The method of item 85, wherein a step of creating an ideal treatment profile based on the map, wherein the ideal treatment profile comprises a plurality of ideal parameters, further comprising a step.(Item 103) 102. The method of item 102, wherein the plurality of ideal parameters comprises at least one ideal virtual treatment site.(Item 104) The method of item 103, wherein the plurality of ideal parameters further comprises at least one ideal energy therapy parameter associated with each ideal virtual treatment location.(Item 105) The ideal energy therapy parameters are selected from a group consisting of ideal time, ideal temperature, ideal energy, ideal temperature change rate, ideal energy change rate, ideal impedance of the treatment site, and a combination thereof. 104. The method of item 104, comprising the parameters to be.(Item 106) 102. The method of item 102, further comprising the step of comparing the ideal treatment profile with the treatment history profile.(Item 107) 106. The method of item 106, wherein the step of comparing the ideal treatment profile with the treatment history profile occurs during the step of applying the energy therapy to the treatment site.(Item 108) The method of item 71, further comprising analyzing the map to determine the anatomical features of the organ tissue network.(Item 109) The anatomical features include lumen passage diameter, organ bifurcation, smooth muscle tissue depth, smooth muscle tissue volume, organ wall thickness, organ proximity to another organ, peri-organ, and intra-organ. The degree of fluid in the organ, the number of folds in the organ, the condition of the epithelium or endothelial layer in the organ, the flow of fluid in the organ, the presence of additional tissue in the organ, the presence of blood vessels, the presence of cartilage, and smooth muscle. 108. The method of item 108, comprising a feature selected from a group consisting of the degree of contraction when stimulated.(Item 110) 10. The method of item 109, wherein the energy therapy is generated by a control system, which adjusts that at least one of the plurality of parameters is adjusted according to the anatomical features.(Item 111) The method according to item 71, wherein the map is a three-dimensional map.(Item 112) The method of item 71, wherein the plurality of parameters comprise time, temperature, energy, rate of change in temperature, rate of change in energy, impedance of said treatment site, and a combination thereof.(Item 113) The method of item 71, further comprising displaying at least one parameter of the energy therapy on the image display.(Item 114) 113. The method of item 113, wherein the step of displaying at least one parameter of the energy therapy occurs in real time during the application of energy.(Item 115) Item 71, wherein the organ tissue network comprises an airway in the lobe, and the method further comprises applying the energy therapy to a plurality of airways.(Item 116) A treatment device having an energy delivery unit is used to apply energy therapy to the treatment site, and the treatment device transmits information to the rendering system while advancing through the organ tissue network and the map. The method of item 71, which creates at least a portion of.(Item 117) The method of item 116, further comprising the step of correlating the portion of the map with a plurality of locations within the organ tissue network.(Item 118) The method of item 116, wherein the therapeutic device further comprises a sensor assembly that communicates with the rendering system to detect movement of the device within an organ to create said portion of the map.(Item 119) The sensor assembly comprises a light source, a sensor, and a digital signal processor, which reflects light at the organ wall towards the sensor, which is directed to the digital signal processor for multiple images. The method of item 118, wherein the digital signal processor determines the movement of the device by comparing images.(Item 120) 119. The method of item 119, wherein the light emitting source comprises a light emitting diode and the sensor comprises a complementary metal oxide semiconductor.(Item 121) The method of item 116, wherein the treatment device further comprises at least one positioning instrument that communicates with an external positioning system to create said portion of the map.(Item 122) A method of mapping within a combined organ tissue network, each with a luminal passage. A step of advancing the device into the organ tissue network, wherein the device comprises a light source, a sensor, and a digital signal processor. In the step of creating data to characterize the movement of the device within the organ tissue network, the luminescent source reflects light at the organ wall towards the sensor, which is digital. A step of transmitting a plurality of images to a signal processing unit, and the digital signal processing unit determines the movement of the device by comparing the images. The step of transmitting the data to the electronic storage means, Including, methods.(Item 123) 122. The method of item 122, wherein the electronic storage means is a memory unit attached to the device.(Item 124) The means according to item 122, wherein the electronic storage means is a computer system.(Item 125) 122. The method of item 122, further comprising the step of creating a schematic representation of the data on an image monitor.(Item 126) 122. The method of item 122, further comprising applying energy to the organ and associating the energy parameters with the data.

0024<figref num="1">FIG. 1 is a schematic representation of a system for delivering energy to the wall tissue of a patient's lungs.</figref><figref num="2">FIG. 2 is an enlarged view of the distal portion of the therapeutic energy delivery device.</figref><figref num="3">FIG. 3 is an enlarged view of the portion 3 circled in FIG. 2 showing a more detailed view of the energy release and temperature detection elements of the therapeutic energy delivery device.</figref><figref num="4">FIG. 4 is an elevational view of the user interface surface of the controller.</figref><figref num="5A">Figures 5A and 5B are flow diagrams that depict the various steps and routine procedures that control user interface surface elements. Figures 5A and 5B are flow diagrams that depict the various steps and routine procedures that control user interface surface elements.</figref><figref num="5B">Figures 5A and 5B are flow diagrams that depict the various steps and routine procedures that control user interface surface elements. Figures 5A and 5B are flow diagrams that depict the various steps and routine procedures that control user interface surface elements.</figref><figref num="6A">FIG. 6A is a schematic representation of a system for delivering energy to the wall tissue of a patient's lungs, along with visible and virtual displays.</figref><figref num="6B">Figure 6B is a depiction of a rendering system for creating a map.</figref><figref num="6C">FIG. 6C is a schematic representation of a system for advancing the device inside the lungs and delivering energy to the wall tissue of the patient's lungs when imaged with visible and virtual displays.</figref><figref num="6D">FIG. 6D is an enlarged view of the distal portion of the therapeutic energy delivery device, along with elements that allow the device to be mapped within the body.</figref><figref num="6E">FIG. 6E is a sample virtual map showing the virtual location of the device, along with a variety of information useful to the practitioner in performing the treatment.</figref>

0025Disclosed embodiments and methods of systems for delivering energy to patient tissue in a controlled manner, in particular systems and methods for controlling the delivery of radio frequency (RF) energy to lung tissue, bronchial tissue, or both. .. Embodiments of the system and method may be configured to enhance relevant information and efficiently communicate to users of the system, with ancillary connections (eg, treatment equipment, foot switches, counter electrode pads, or the like). Includes detecting and serving as an automated troubleshooting guide with user-friendly instruction manuals, information, indicators and equivalents.

0026The system and methods may include various other types of energy delivery forms that achieve the treatment of interest in the tissue. During the procedure, the practitioner applies therapy to the treatment site, where the energy applied to each treatment site is defined by many parameters. Recording of these parameters and their relevance to the treatment site can be important for a number of reasons, including follow-up evaluation, additional treatment, or avoidance of excessive treatment of the area.

0027FIG. 1 shows the RF energy generator 12, the controller 14 connected to the energy generator, the user interface surface 16 communicating with the controller 14, and the user interface surface 16 for delivering therapeutic energy 10 to the patient's tissue. FIG. 6 shows a schematic representation of a system with a therapeutic energy delivery device in the form of an RF energy delivery catheter 18 connected to an interface coupler 20 on the user interface surface 16. The controller 14 connected to the energy generator 12 and the user interface surface 16 is configured to control the energy output of the energy generator 12. The user interface surface 16 may include a switch, a digital display, a visible indicator, a schematic display of system elements, and a sound generator, as well as other features. The controller 14 includes a processing unit 22 configured to receive information from the system and system elements and process the information according to various algorithms that generate control signals to control the energy generator 12. The processing unit 22 also receives information from the system 10 and system elements, processes the information according to various algorithms, and gives the user the system status, element status, treatment status or any other useful information monitored by the system. Also to notify, an information signal may be generated that may be directed to a visible indicator, digital display or user interface audio sound generator. The processing unit 22 of the controller 14 may be a digital IC processing unit, an analog processing unit, or any other appropriate logic or control system that implements the control algorithm. Some of the routine procedures for control alarms, information, feedback and testing are shown in the flow diagrams in Figures 5A and 5B.

0028The system 10 also includes a counter electrode pad 24 and a foot switch 26, both of which are coupled to the respective interface couplers 28 and 30 on the user interface surface 16. The user interface surface 16 also includes a digital display 32 that may be used to display numerical data to the user of system 10. The array of user interface surfaces 16 provides a user-friendly interface with system 10 that provides feedback and system information to the user in an intuitive format. System elements connected to the user interface surface 16 such as the foot switch 26, counter electrode conductive pad 24 and energy delivery catheter 18, and connected to the user interface surface 16 adjacent to the graphical representation of each system element, as well as these. Visible indicators configured to display information about various system elements may be placed adjacent to or inside each graphical display of each system element. This configuration allows the user to easily and intuitively connect system elements to the appropriate interface on the user interface surface 16, and also allows the user to easily and intuitively correlate voice and visible system feedback to the appropriate system elements. Can be made to.

0029With reference to FIG. 1 again, the energy delivery catheter 18 is configured to connect from an elongated shaft 34, a handle 36 fixed to the proximal end of the elongated shaft 34, a handle 36 to an interface coupler 20 on the user interface surface 16. Includes a control cable 38 that extends to the proximal coupler 40. The sliding actuating device 42 at the handle 36 controls the radial expansion and contraction of the distal electrode basket 44 located at the distal end of the elongated shaft 34. The elongated shaft 34 may have a variety of configurations, including rigid, flexible, movable, with respect to distal tip deviation and the like. The elongated shaft 34 and distal portion may also be configured and sized so that the passage of the elongated shaft 34 can pass through the normally functioning lumen of a commercially available bronchoscope. Further, if the processing unit 22 of the controller 14 initiates the treatment cycle by switching the RF energy generator from the standby state to the activated state, the trigger signal is also generated by the controller and of the treatment or treatment cycle. The controller 14 is also coupled to the bronchoscope camera trigger to initiate videotape and display of the image produced by the bronchoscope camera coupled to the bronchoscope used to position the energy delivery catheter 18 in between. Any interface coupler (not shown) configured to do so may be included. Alternatively, the interface connection may be capable of transmitting some or all of the controller output or feedback to the bronchoscopic video processor or monitor. Due to this feature, the information display on the surface of the user interface of the controller can be displayed on any of the bronchoscopic video monitors. In addition, additional controller output information that is not displayed on the surface of the controller user interface can be displayed on any of the displays associated with the bronchoscope. This feature allows the physician to focus on the bronchoscopic display monitor while performing the procedure.

0030The distal electrode basket 44 can be seen in more detail in FIGS. 2 and 3. The distal electrode basket 44 is flexible and elastic, including an energy emitting element in the form of an electrode 46 formed from the exposed compartment of the basket leg 48, which is only slightly coated with an electrical insulator material 50 in the outer region of the exposed compartment. It is an oval basket with a. The distal electrode basket 44 also includes a temperature sensing element in the form of a thermocouple 52 placed on or adjacent to the electrode 46. The thermocouple 52 has a thermocouple end point 56 that is fixed to the lead wire 54 and the exposed compartment 58 or electrode 46 of the basket leg.

0031A conductor (not shown) telecommunications with the lead 54 and electrode 46 of the thermocouple 52 is close to the distal basket 44 to the handle 36 and then through the control cable 38 to the proximal coupler 40. And grow. This configuration allows the electrodes 46 and thermocouple leads 54 to be electrically connected by a user interface surface 16 in a modular array with a controller 14. An interface coupler 20 configured to receive the proximal coupler 40 of the energy delivery catheter 18 is placed adjacent to the schematic representation 60 of the embodiment of the energy delivery catheter 18 printed on the user interface surface 16. This provides a useful visible prompt for users who are configuring System 10. When the proximal coupler 40 is connected to the interface coupler 20 for the energy delivery catheter 18, the electrode 46 immediately telecommunicationss with the RF energy generator 12 and is activated and standby while the RF cannot be delivered. The RF generator 12 may be switched back and forth between and affected by control and modulation by the controller 14. Further, since the lead wire 54 of the thermocouple 52 is also in telecommunications with the controller 14, the controller 14 may monitor the temperature of the tissue adjacent to the electrode 46. In this arrangement, the RF energy generator 12, controller 14, and user interface 16 form a system for controlling and delivering activation energy to the energy delivery catheter 18.

0032The electrode 46 may be unipolar or bipolar, however, if the electrode 46 is a unipolar electrode, the counter electrode element 62 is the electricity between the RF energy generator 12 and the patient (not shown). May be used with system 10 to complete energy release or patient circuitry. The return electrode 62 includes a conductive pad 24, a proximal coupler 64, and a conductive table 66 extending and communicating between the conductive pad 24 and the proximal coupler 64. The conductive pad 24 is configured to be removably attached to the patient's skin and has a sufficiently large surface area to prevent burns or other damage to the patient's skin around the conductive pad 24 during use of the system 10. It may have a conductive adhesive surface to be provided. The proximal coupler 64 is configured to couple to an interface coupler 28 on the user interface surface 16. The interface coupler 28 for the counter electrode 62 is located adjacent to the schematic display 68 of the counter electrode 62 on the user interface surface 16. As before, this provides a useful visible prompt for users configuring System 10.

0033RF energy is applied when the proximal coupler 40 of the energy delivery catheter 18 and the proximal coupler 64 of the counter electrode 62 are coupled to the controller 14 via the respective interface couplers 20 and 28 of the user interface surface 16. Generated by the RF generator 12, ie, the RF generator 12 may be switched to the activated state, and from electrode 46 of the distal basket 44 of the energy delivery catheter 18 to the target tissue of the patient adjacent to electrode 46. May be released. The processing unit 22 then goes through a feedback loop between the thermocouple 52 and the processing unit 22 to adjust the output of the RF generator 12 to maintain a substantially constant temperature of the tissue adjacent to the electrode. May be good. The processing unit 22 may use the control algorithm to process the temperature feedback and also generate a control signal for the RF generator 12. In addition, the control algorithm may be configured to set a predetermined dwell time or start-up time for embodiments of the treatment cycle. Embodiments of control algorithms and system elements that may be used in conjunction with embodiments of control devices and methods discussed herein are "Control System and". It may be found in US Patent Application No. 10 / 414,411, filed April 14, 2003, under the title Process for Application of Energy to Airway Walls and Other Mediums, which may be found in its entirety by reference. Incorporated herein.

0034In addition, a device and method for treating the tracheal wall is entitled METHOD AND APPARATUS FOR TREATING SMOOTH MUSCLES IN THE WALLS OF BODY CONDUITS, US patent application 09 / 095,323 filed June 10, 1998; 10 / 414,253 filed on April 14, 2003 under the title of MODIFICATION OF AIRWAYS BY APPLICATION OF ENERGY; 09 / filed on November 8, 1999 under the title of DEVICES FOR MODIFICATION OF AIRWAYS BY TRANSFER OF ENERGY 436,455; METHOD OF TREATING AN ASTHMA ATTACK, filed October 25, 2001 09 / 999,851; METHOD OF TREATING AIRWAYS IN THE LUNG, filed March 26, 2004, 10 / 810,276; METHODS 10 / 640,967 filed on August 13, 2003 under the title of OF TREATING ASTHMA; 10 / 809,991; and INACTIVATION OF SMOOTH filed on March 26, 2004 under the title of METHODS OF TREATING REVERSIBLE OBSTRUCTIVE PULMONARY DISEASE. 10 / 954,895; filed on September 30, 2004 under the title of MUSCLE TISSUE; and CONTROL SYSTEM AND PROCESS FOR APPLICATION OF It is described in US Pat. No. 6,411,852; entitled ENERGY TO AIRWAY WALLS AND OTHER MEDIUMS and 6,634,363 under the title DEVICES FOR MODIFICATION OF AIRWAYS BY TRANSFER OF ENERGY. Each of the above is incorporated herein by reference in its entirety.

0035In one embodiment, the RF generator 12 has a wattage output sufficient to maintain the target tissue temperature from about 60 ° C to about 80 ° C, particularly from about 60 ° C to about 70 ° C, about 400 kHz. Generates RF energy at a frequency of about 500kHz. The duration of the activated state for embodiments of a single treatment cycle may be from about 5 seconds to about 15 seconds, in particular from about 8 seconds to about 12 seconds. Alternatively, the duration of the activated state of the RF generator is also required to deliver about 150 joules of energy to the target tissue, in particular about 125 joules of RF energy to the target tissue. It may be set so that it does not exceed the desired duration.

0036The activation state of the RF generator 12 is initiated by various devices and methods, however, the embodiment of FIG. 1 includes a user-operated activation switch in the form of a foot switch 26. The conductive table 70 connects to and between the foot switch 26 and the proximal coupler 72, which is located on the user interface surface 16 and is configured to be electrically connected to the respective interface coupler 30. Deploy. The interface coupler 30 for the proximal coupler 72 of the foot switch 26 is located adjacent to the schematic display 74 of the foot switch 26 on the user interface surface 16. Given that all elements of the system 10 are functioning and connected properly, the foot switch 26 may be used in some configurations to initiate the activated state of the RF energy generator 12. This can be defined as a control that goes into a ready state.

0037A more detailed view of the embodiment of the user interface surface 16 is now shown with reference to FIG. The user interface surface 16 may be substantially rectangular and flat as shown in FIG. 4, but may have any other suitable shape, size, or configuration. The user interface surface 16 may, in some embodiments, be any part of the energy delivery system or its elements that the user accesses or sees in order to convey or receive information from it. The controller 14 may have an alternating current (AC) power on / off switch that may be located anywhere on the controller 14 or the user interface surface 16. However, in the embodiment shown in FIG. 4, the user interface surface 16 does not include an AC power on / off switch. The controller 14 or user interface surface 16 provides a sound generator (not shown) that may be used in conjunction with the various visible indicators of the system 10 to warn the user of the status of various elements of the system 10. It may be included. In one embodiment, the sound generator includes a speaker (not shown) that may be attached to any suitable surface of the controller 12 or the user interface surface 16.

0038The user interface surface 16 has a visible indicator in the form of a multicolored LED (light emitting diode) ready indicator light 76 in the upper left corner of the user interface surface 16. When the RF energy generator 12 is ready for use in the standby state, the ready indicator light 76 may be activated or lit by a primary color such as green. Due to the RF energy delivered to the energy release element 46 of the energy delivery catheter 18, when the RF generator 12 transitions from the standby state or the ready state to the activated state, a short voice sound is also heard in the activated state. When the RF energy generator 12 is switched on, the LED indicator 76 may be activated or lit with a second color, such as amber. In addition, the remote LED indicators 92 may be activated or lit by a second color, such as blue, during RF energy delivery. The user typically activates the RF energy generator 12 for the treatment cycle by pressing and releasing the foot switch 26. During the start-up cycle, the step switch 26 of the system 10 is pushed down and released again to trigger the shutoff reaction of the step switch from the processing unit 22 that switches the RF energy generator 12 from the activated state to the standby state. The color of the completion indicator light 76 may be switched back to the first color. The second color or amber color is when the system 10 is in the power-on self-diagnosis test (POST) form for a period of time during which the sound generator may emit a constant single pitch sound. Alternatively, it may be displayed by the ready indicator light 76. In addition, if a failure of the energy delivery catheter 18, such as a broken electrode 46 or a broken thermocouple 52, is detected by the controller 14, the second amber color may also be indicated by the ready indicator. The activation of the second color indicating the failure of the energy delivery catheter 18 may also occur at the same time as the audible first error sound from the audio sound generator. AC power circulation to initialize system 10 during the period when system 10 also produces an audible first error sound. The ready indicator light 76 may emit the first color, green, while running the ring to the controller 14. Basically, the ready indicator light 76 emits the first color when the system 10 is ready to use, and if the system 10 detects a failure in the system 10 and is not ready to use the first. Emits two colors or amber.

0039The following LED preparation indicator 76 is a schematic display 74 of the foot switch 26 printed on the user interface surface 16. Schematic representation 74 of the foot switch 26 is directly above and adjacent to the interface coupler 30 configured to accommodate the proximal coupler 72 of the foot switch 26 assembly. The graphical display 74 of the foot switch 26 adjacent to the interface coupler 30 for the foot switch 26 is intuitive to the user and the user to position the appropriate plug for the foot switch 26 while configuring the system 10. Provide a friendly prompt.

0040Schematic representation 68 of the counter electrode assembly 62 printed on the user interface surface 16 including the conductive pad 24, the conductive table 66 and the proximal coupler 64 is to the right of the schematic representation 74 of the foot switch 26. Schematic representation 78 of the proximal coupler 64 of the counter electrode assembly 62 is directly above and adjacent to the interface coupler 28 for the proximal coupler 64 of the counter electrode assembly 62. A visible indicator in the form of an amber LED light 80 is placed on the user interface surface 16 within the schematic display 82 of the conductive pad 24 of the counter electrode assembly 62. If the system 10 is further initiated by POST, which may occur at the same time as a single pitch audible sound from the audio generator, the visible indicator 80 may be configured to light in steady state. If the controller 14 attempts to activate the RF energy generator three or more times and then measures the impedance in the patient circuit above a predetermined value, the visible indicator 80 also activates and lights up. You may. The second error tone may occur at the same time as the visible indicator is activated in this situation. In some embodiments, the predetermined impedance value for the patient circuit may exceed about 1000 ohms, in particular about 900 ohms. Such high impedance measurements in the patient circuit display an open circuit and also require the user to investigate the patient circuit and try System 10 at another time. The patient circuit includes an electrode 46 and a conductive table 38 of the energy delivery catheter 18, a patient with a conductive pad 24 and an electrode 46 that telecommunications with the patient's body (not shown), and a counter electrode assembly 62. Is done. The visible indicator 80 if the processing unit 22 causes a failure that requires the user to turn off the AC power and turn it back on immediately while the first audible error sound is also generated by the audio sound generator. May also be activated or lit in a blinking manner.

0041To the right of Schematic Display 68 on the counter electrode 62, Schematic Display 60 of the energy delivery catheter 18 is printed on the user interface surface 16 and includes a handle 36, an elongated shaft 34 and a distal electrode basket 44. The interface coupler 20, which is configured to receive the proximal coupler 40 of the energy delivery catheter 18, is located directly below the schematic display 84 of the handle 36 of the energy delivery catheter 18. The first visible indicator in the form of amber LED light 86 is located within the schematic display 88 of the distal electrode basket 44 on the user interface surface 16. The second visible indicator 90, which has a second color different from the first visible indicator and is in the form of a red LED light 90, is located within the schematic display 84 of the handle 36.

0042In some embodiments of system 10, the first visible indicator 86 may be activated and lit if the controller 14 measures impedance in the patient circuit above a predetermined value. In some embodiments, the predetermined impedance value of the patient circuit may be higher than about 1000 ohms, in particular higher than about 900 ohms. The first audible error tone may also be generated during such activation. If the measured impedance of the patient circuit is higher than such a predetermined value while attempting to activate the RF energy generator 12 at least three times, the first visible indicator 86 is also lit. Or you may start it. In this situation, the second audible error sound may also be generated in conjunction with the activation of the first visible indicator 86. If the processing unit 22 of system 10 is further initiated by POST, which may occur simultaneously with a single pitch audible sound from the audio sound generator, the first visible indicator 86 will also light up in steady state. You may. The visible indicator 86 if the processing unit 22 causes a failure that requires the user to turn off the AC power and turn it back on immediately while the first audible error sound is also generated by the audio sound generator. May also be activated or lit in a blinking manner.

0043If the controller 14 detects a failure of the energy delivery catheter 18, such as a broken electrode 46 or a broken thermocouple 52, the second visible indicator 90 may be activated or lit in a lit or intermittent fashion. .. Activation of the second visible indicator 90, which suggests a failure of the energy delivery catheter 18, may also occur at the same time as the audible first error sound from the audio sound generator. If the processing unit 22 of system 10 is further initiated by POST, which may occur simultaneously with a single pitch audible sound from the audio sound generator, the second visible indicator 90 will also light up in steady state. You may. If the processing unit 22 causes a failure that requires the user to turn off the AC power and then turn it back on immediately during the period when the first audible error sound is also generated by the voice sound generator, the second visible instruction is given. The vessel 90 may also be activated or lit in a blinking manner.

0044Another visible indicator 92 in the form of a schematic representation of the radiation electrodes is placed on the user interface surface 16. During the period when the RF energy generator 12 switches to the activated state and delivers RF energy to the energy delivery catheter 18, this RF energy indicator 92, which may be a third color or blue LED, is activated or activated in a blinking form. It may be lit. If the processing unit 22 of system 10 is further initiated by POST, which may occur at the same time as a single pitch audible sound from the audio generator, the RF energy indicator 92 will also light up in steady state. May be good. The RF energy indicator if the processing unit 22 causes a failure that requires the user to turn off the AC power and turn it back on immediately while the first audible error sound is also generated by the audio sound generator. The 92 may also be activated or lit in a blinking manner.

0045The digital display unit 94 is arranged on the user interface surface 16 under the RF energy indicator 92 and is configured to display numerical information. The digital display 94 is controlled or otherwise initialized by a switch 96 located directly below the digital display 94 on the user interface surface 16. In a standard form, the digital display 94 will display the number of successful treatment cycles delivered by system 10 performed by the user of system 10. If Switch 96 is pressed down for less than about 2 to about 4 seconds, the number of unsuccessful or incomplete treatment cycles will be displayed in a short time, such as about 5 seconds. After this short time, the digital display 94 returns to display the number of completed treatment cycles. When the switch 96 is pressed down and held for longer than a short time of about 2 to about 4 seconds, the digital display 94 indicates a short time "0", such as about 1 second. If the switch 96 is pressed and held for this short 1 second, the total number of completed and incomplete treatment cycles is initialized to zero. If the switch 96 is released for this short one second, the digital display 94 returns an indication of the completed or successful treatment cycle without initializing the treatment cycle counter.

0046With reference to FIG. 5, embodiments of various system steps are shown in the form of flow diagrams. Upon use, the system 10 for delivering therapeutic energy may be implemented by a switch (not shown) on the controller 14 or user interface surface 16 as described above, and is first powered. To do. Once AC power is supplied to the controller 14, the processor 22 initiates the POST cycle indicated by the box 100, which verifies the near integrity of the processor 22, the controller 14, and the system 10. If the POST fails, the user starts circulating AC power to restart the controller 14, especially the processing unit 22 of the controller 14. Further, once AC power is supplied to the controller 14, the processing unit 22 continuously activates the first background algorithm displayed by the decision point "uncorrectable error" 102. Checking for uncorrectable errors checks for hardware and processor errors such as CPU settings, COP timeouts, ROMCRC errors, RAM, illegal CPU instructions, software, non-volatile memory, RF current measurement errors. If such an error is detected, the user should start the AC power cycle, as indicated by the box 111, to restart the controller 14, and in particular the processor 22 of the controller 14. is there. During the circulation of AC power, the user will be notified of the circulation status by blinking of all visible indicators on the user interface surface 16 as well as the blinking of the digital display 94 and the simultaneous audible error sound. ..

0047If the POST is successful, the processor 22 will make all connections for system elements such as the energy delivery catheter 18, counter electrode 62 and foot switch 26, respectively, as indicated by the decision point 104, on the user interface surface 16. A test algorithm will be initiated to determine if all of the interface couplers 20, 28 and 30 are properly coupled. If an error is detected during this routine procedure, the ready indicator light 76 will remain in the second or amber state, and the RF energy generator 12 is not ready. Or display that it is in the standby state. Once system elements such as the energy delivery catheter 18, counter electrode 62 and foot switch 26 are properly coupled to the user interface 16, the processor 22 has the temperature sensing element or thermocouple 52 of the energy delivery catheter 18 boxed. Initiate an algorithm that determines if it is functioning properly as displayed by 106.

0048During this test, the processing unit 22 measures the temperature indicated by the thermocouple 52 and also compares the results with a predetermined temperature range including room temperature for some embodiments. For example, the predetermined temperature range for some embodiments may be from about 15 ° C to about 35 ° C, in particular from about 20 ° C to about 30 ° C. If the measured temperature, indicated by the thermocouple 52, does not fall within a predetermined temperature range, the processor 22 sends a red LED second visible indicator 90 on the handle 84 of the schematic display 60 of the energy delivery catheter 18. Flashing Form In addition to initiating activation, the ready indicator light 76 displays a broken thermocouple 52 by initiating an error message to the user, including switching to a second color or amber color. The audible error sound may also occur at the same time as the error message generated by the visible indicators 76 and 90. These error messages inform the user that the energy delivery catheter 18 may need to be replaced with a new one.

0049Once the thermocouple test is successfully performed, the processing unit 22 switches the ready indicator light 76 to the first color or green and the system 10 displays the treatment cycle in the patient as indicated by the box 108. Indicates that you are now ready to run. At this point, the user then places the distal electrode basket 44 of the energy delivery catheter 18 so that at least one release element or electrode 46 is placed adjacent to the patient's target tissue, such as the smooth muscle of the patient's bronchial airways. May be positioned. Once the electrode 46 is properly positioned, the user depresses the foot switch 26 to initiate the treatment cycle, as indicated by the user action / input box 110. When the foot switch 26 is pressed down, the processing unit 22 immediately measures the impedance of the patient circuit, and if the impedance is below a predetermined maximum value or within a predetermined impedance range, the processing unit 22 is an RF energy generator. Twelve is switched from ready or standby to activated, where RF energy is delivered to the patient's target tissue to initiate the treatment cycle.

0050In some embodiments of the standard treatment cycle, the processing unit 22 and the algorithm performed by the processing unit 22, as indicated by the result box 112, is from about 5 seconds to 15 seconds, especially from about 8 seconds. The RF energy generator 12 is configured to remain active for a residence time of up to approximately 12. The duration of the treatment cycle is also suppressed by the total energy delivered to the target tissue during the cycle. For example, the processing unit 22 may execute an algorithm that ends the treatment cycle when the total energy delivered to the target tissue reaches a maximum of about 150 joules, particularly about 125 joules. During the treatment cycle, the processing unit 22 controls the output of the RF energy generator 12 to maintain a substantially constant temperature of the target tissue. The temperature of the target tissue during the embodiments of the treatment cycle may be maintained at a temperature of about 60 ° C to about 80 ° C, particularly from about 60 ° C to about 70 ° C. As mentioned above, the processing unit 22 measures by monitoring the temperature of the target tissue with a temperature measuring element or thermocouple 52, and reducing the output of the RF energy generator 12 if the measured temperature is higher than desired. A substantially constant temperature of the target tissue can be maintained by processing the temperature information in a feedback loop that increases the output of the RF energy generator if the temperature is lower than desired.

0051During the treatment cycle, the processor 22 will switch the blue RF energy visible indicator 92 to the activated identical color or blinking form, and also activate the single voice generator during the treatment cycle. A dual-pitch audible sound is produced from an audible sound generator that repeats high-pitch, then low-pitch audible sounds, followed by a long single-pitch sound at the end of a successful cycle. If an error occurs during the treatment cycle, an audible error will be heard and the visible or indicator indicating the error will be activated as described above. As mentioned above, the treatment cycle may also be interrupted by the user depressing the foot switch 26 during the treatment cycle and initiated to shut off the foot switch, as indicated by the user action box 114. If the user feels that the system 10 is improperly upset for any reason, the user feels that the location of the electrode 46 is improper, or for any other reason do this. May be good. The user's stepping switch shutoff action returns the system 10 to the RF generator ready state, indicated by box 108, but does not record the completed or successful treatment cycle on the digital display 94. If the treatment cycle is successful and complete, the digital display 94 displays the total number "1" and displays one successful and completed treatment cycle.

0052If an error occurs during the treatment cycle, the step switch shutoff option is used and continues to display "0" as shown in result box 116. However, if the display control switch 96 is pressed down for more than about 2 to about 4 seconds, the digital display 94 indicates a "1", indicating one treatment cycle that has not been completed or has been unsuccessful. The user may subsequently place the energy delivery catheter 18 in a new location within the patient's biological structure and activate the RF energy generator 12 in the activated state as many times as desired during the treatment cycle. If an error occurs during the treatment cycle, the user interface 16 will soon display the type of error caused by the appropriate visible and audible indicators, as shown in the result box 116, and also the user. Propose an action policy. After the user attempts a correction, the foot switch 26 may be pressed down again to initiate another treatment cycle, as indicated by the user action / input box 118.

0053If the impedance of the patient circuit is higher than or within the predetermined impedance range at the time the foot switch 26 is pressed down, the result box 120 includes a visible indicator and an audible sound 2 One of the error messages may be created by system 10. In particular, if high impedance is measured at the time of the first depressing of the foot switch 26 or the second depressing of the foot switch 26, the error message "Improve placement", as indicated by box 122. "Please continue" is generated as described above, thereby activating and illuminating the amber visible indicator 86 of the distal basket diagram 88 on the user interface 16 and the first error sound by the audible sound generator. Generated. Further, incomplete treatment cycles are recorded by the digital display 94. Once the correction is attempted, the foot switch 26 may be pressed down again when resuming the treatment cycle, as indicated by the user action / input box 124.

0054If the same error is detected by system 10 at the time of the third or next depressing of the foot switch 26, the error message "Investigate patient circuit" is generated and it, as described above. The amber visible indicator 80 of the counter electrode diagram 82 and the amber visible indicator 86 of the electrode basket diagram 88 on the user interface surface 16 are activated and lit. Such error messages also occur at the same time as the second audible error sound produced by the audible sound generator. Further, incomplete treatment cycles will be recorded by the digital display 94. After attempting to correct the error, the foot switch 26 may be pressed down again to initiate another treatment cycle, as indicated by the user action / input box 126.

0055FIG. 6A shows a schematic system diagram of the system 10 described herein. The system may have any number of image display units 130 to display treatment information, treatment parameters, virtual maps, positioning, or other data useful to the practitioner. For example, many endoscopic procedures include at least one image display 130 that shows a real-time image of the target site (and, in some cases, the tip of the treatment device 18). The map may be displayed on a separate monitor for the virtual display 132 as shown.

0056The virtual display unit 132 may include a virtual map of the entire device, a virtual treatment location, or a virtual location. Alternatively, since the two display units 130 and 132 may be combined, the virtual display unit is superimposed on the image display unit or arranged along the side surface of the image display unit. However, the map may also be shown in numerical form (eg, the display of positioning information 131) on either the display 130 or 132. It should be noted that the image display 130 may be of any type associated with an endoscopic device (in the case of a pulmonary bronchoscopic device). Further, the image display unit may be an alternative real-time image display unit (for example, a fluorescent fluoroscope or a non-invasive real-time imaging means). In another variation of the device, the map may be incorporated into the user interface 16 of the controller 14.

0057The systems and methods described herein are to map at least part of the organ or organ tissue network (lung 2 in this case) that is mapped using the rendering system shown in Figure 6B. Is included. Mapping is a rendering system 128 that includes computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), ultrasound imaging, or other similar rendering systems. May include use. The rendering system may create a schematic / virtual map or a map that may be just a series of coordinates with respect to a fixed reference point at some location on the body.

0058For example, as shown in Figure 6B, the rendering system 128 may be a system outside the body (such as CT, MRI, PET, etc.). Alternatively, the rendering system may have a probe or other element 129, where the tracking system may record the probe / device (eventually the data in some storage device) as it travels through the organ. Good) data or coordination. In such a case, the map is composed only of the data until the map data is shown on the virtual map on the display unit. Such a map will be used in a system that does not have a schematic display, such as the one shown in FIG. Instead, these data-only maps integrate with the user interface 16, generator 12, or controller 14, for example, to show if the technician has already treated in a particular area of therapeutic activity. Send a simple signal (audible, visible, or other) in between.

0059The displays 130 and 132 may also be used to provide a variety of information 131, such as whether the location has been treated so far, treatment parameters, and so on. Further, information 131 also excludes the need for the practitioner to constantly shift focus from user interface 16 to display 130 or 132 by including information from user interface 16 (as described below). FIG. 6A shows an image display connected to the generator and controller, but any number of configurations is possible. They are shown for illustration purposes only.

0060The map may be rendered / constructed prior to treating the patient, or may be rendered while treating the patient. For example, CT equipment may not be available in the same operating room as the treatment equipment. Therefore, the practitioner may use the rendering system to create a map for use in later scheduled procedures.

0061In a variant of the invention, once the map is rendered, it correlates with and / or is correctly positioned at one or more locations in the organ tissue network, as shown in Figure 6C. This correlation matches the map data with the actual physical part. One way to properly position the map is to put device 18 into the lungs and advance it to a known location (eg, the first branch of the main bronchus 142). Once the device 18 is in the proper position, the user then uses the positioning system 138 to correctly position the virtual image of the site (as shown in Figure 6A) on the actual site. This may be repeated for several sites.

0062As shown in FIG. 6C, virtual image 136 shows a virtual map of the airways. As the device 18 advances to the organ, the positioning device (not shown) at the device 18 communicates with the positioning system 138 to provide a region position for the device. As long as the virtual map correlates with the actual structure of the organ, the exact virtual location of device 18 can be displayed on the virtual map. As described herein, when applying device 18 to treatment in lung 2, the practitioner may look at treatment parameters and / or location on system 10 or indicators 130, 132.

0063FIG. 6D shows an example of the positioning instrument 140 connected to the device 18. The positioning device 140 transmits to the positioning system 138 and tracks the device 18 while moving within the organ. Examples of such positioning devices and systems can be found in the references cited and incorporated by reference above.

0064In addition, the treatment system 10, image display 130, virtual display 132, and / or positioning system 138 may be connected to each other so that treatment parameters are associated with each treatment site and create a treatment history profile for the patient. Good. Of course, this information may be recorded electronically within the controller 14, the positioning system 138, or any other element of the system. This previous treatment history profile may be incorporated for use in the next treatment activity. It may be desirable to store treatment history profiles electronically, either in the memory of a computer system or control, or even in a rendering system that may be standalone or integrated into any element of the system.

0065The parameters are time zone or duration of treatment, temperature (such as site, device, or adjacent site), energy, power, average power, status / incomplete activation, location of treatment, applied total. It may include energy, rate of change in temperature, rate of change in applied energy, impedance of treatment site, or a combination thereof. As noted herein, such parameters may be mapped to treatment sites. It is noted that the parameters and possible combinations may include these parameters discussed in the patents described above.

0066The advantages of the systems and methods described herein can improve treatment in organs that require treatment at multiple locations or repeated treatments. For example, by creating a treatment history profile and presenting parameter data as described herein, the practitioner may avoid duplication of treatment locations or extra treatment at a particular location in some cases. it can. In the variants of the invention, the treatment system may be configured to prevent treatment at a particular site if the map and associated parameters indicate that the device is at the previously treated location. .. In such a case, the appropriate audio or visible signal will be shown on either the display 130 or 132.

0067Additional benefits include spacing the treatment sites at the desired intervals and signaling the practitioner about the device being in place. The system of the present invention also allows treatment planning by calculating the shortest distance traveled by the practitioner to indicate the next area to be treated. To achieve this, the system 10 may give appropriate instructions to the displays 130, 132. For example, FIG. 6E illustrates a variation of the virtual display unit 132. The information 131 displayed is intended to be merely an example. Variants of the invention include any display of the parameters discussed in the invention.

0068As shown in FIG. 6E, the virtual map 136 can track the progress of the device 18 as it advances through the organ. The virtual map 136 also visualizes the treated area (eg, shadow area 146) from the untreated area. It is also possible to distinguish between them. In addition, the virtual map 136 can provide visual information to guide the practitioner to the next site. (For example, via arrow 148). The virtual map 136 also provides information 131 regarding parameters based on the position of device 18. Can be shown. For example, moving to shadow portion 18 displays information about such treatment parameters.

0069The system allows users to get information about where they are, where they were, and what they have done in different locations. In addition, to protect from poorly treated areas, the second path of the device, when combined with maps and positioning information, allows evaluation of untreated or poorly treated areas. .. The system can allow post-treatment analysis where the actual treatment is compared to the "ideal treatment".

0070In some variations, the controller and / or power supply should be configured so that the map treatment history profile indicates that the practitioner is unknowingly attempting to treat the site twice and is unable to provide treatment. Can be done. In some variations, the system can be combined with an auditory signal to indicate the relationship between the current treatment location and treatment history profile. For example, the auditory signal can sound a warning if the treatment is incomplete / already done, and the same signal is triggered each time the positioning device passes a particular site. Treatment can also be titrated based on map analysis or analysis of other anatomical data. For example, if the map yields organs with different wall thicknesses, algorithms can be used to adjust treatment parameters (eg, thicker wall parts receive higher energy treatment and thinner parts more. Receives low energy.) Titration can be based on the depth at which the target object is present. For example, if smooth muscle tissue is located deep inside the organ wall, titration can adjust the energy parameters for optimal treatment. In another example, mapping or other analysis showing that the area of interest is in close proximity to other vital organs can reduce energy parameters.

0071The system of the present invention can also provide visible identification of the organ or region to be treated. For example, if the site has already been treated, the organ can be shown in a particular color, and the organ of interest can be shown in another color to signal the untreated area. If the system determines that a particular site should be treated next, this recommended treatment location can also be visually distinguished on image displays 130, 132.

0072The system can also enable the creation of map-based ideal treatments or treatment profiles. For example, the use of maps can allow various features to be determined for a region or organ of interest (eg, passage diameter, amount of smooth muscle tissue, bifurcation, etc.). Based on these characteristics, energy therapy can be adjusted for a set of ideal parameters. Therefore, the practitioner can compare the actual treatment parameters (using the treatment history profile) with the ideal parameters based on the ideal treatment. In case of inconsistency, the practitioner has the option of re-treating the area or simply observing the area where the actual treatment differs from the ideal treatment. The ideal parameters can be of the same type as the parameters described above. For example, they can include ideal treatment time, ideal temperature, ideal energy, ideal rate of change in temperature, ideal rate of change in energy, ideal impedance of treatment site, and combinations thereof. The system can allow comparison of ideal treatment with actual treatment that may occur during or after treatment.

0073As mentioned above, maps can allow analysis of the structure surrounding the body and target area for improved treatment. In one example, the system uses an algorithm to analyze the body and determine the anatomical features of the area being treated so that tailored therapy can be performed for the anatomical features. Can be done. For example, anatomical features include lumen passage diameter, organ bifurcation, smooth muscle tissue depth, smooth muscle tissue volume, organ wall thickness, organ proximity compared to distant organs, and organ perimeter. , The degree of fluid in the organ, the number of folds in the organ, the condition of the epithelium or endothelial layer in the organ, the flow rate in the organ, the presence of additional tissue in the organ, the presence of blood vessels, the presence of cartilage, and smooth muscle Can include the degree of contraction when stimulated. Such anatomical features can be identified during map rendering as shown in Figure 6C.

0074Apart from creating the ideal procedure, the procedure can be adjusted on a real-time basis according to the particular anatomical features identified on the map. When the treatment device is installed at the actual treatment site, the system activates the control system to alert one or more of the energy or other parameters.

0075It should be noted that the map can be configured to be a 3D map (eg, branching of the bronchial passage in many directions requires a 3D map for proper imaging) or. , It may be desired to only create a single-sided map.

0076In another variant of the invention, aspects of the system described herein can be combined with a device having an energy delivery unit used to apply energy therapy to a treatment site, in which case. The treatment device propagates information through the organ tissue network to the rendering system to create at least a portion of the map. In such cases, the rendering system can simply track the movement of the device within the body. For example, the device can include a sensor assembly similar to that used in optical tracking devices (such as optical computer mice). In this method, the map is rendered as the treatment progresses.

0077For example, a sensor assembly on or connected to a therapeutic device can communicate with a rendering system and enable detection of device movement within an organ to create a portion of a map. In one variant, the sensor assembly, as shown by 140 in Figure 6D, comprises a light source, a sensor, and a digital signal processor, which reflects light to the sensor on the organ wall and the sensor. Transmits to a digital signal processor that determines the movement of the device by comparing multiple images, intensities, and / or wavelengths of reflected light. As an example, the light emitting source can include a light emitting diode and the sensor can include a complementary metal oxide semiconductor (CMOS). However, any known structure may be used. In some variants, the structure can allow tracking as the device advances through the organ tissue network. An example of the installation of the sensor assembly can be seen in Figure 6C. In most cases, the sensor assembly and positioning device are located at the distal end of the device.

0078In cases where it is difficult to create a 3D map, the treatment device further includes at least one positioning instrument that communicates with an external positioning system, creating a portion of the map to enable 3D configuration.

0079In yet another variation of the present invention, the present invention is a method of creating a map in a tissue network of connected organs, each having a lumen passage, wherein the device includes a light source, a sensor, and a digital signal processor. In the step of advancing the including device into the organ tissue network, the light source reflects light onto the organ wall to the sensor, which is a digital signal that determines the movement of the device by comparing multiple images. It includes a method comprising a step of creating data to characterize the movement of the device in the tissue network to be transmitted to the processing unit and a step of transmitting the data to the electronic storage means.

0080With respect to the above detailed description, the similar reference numbers used therein refer to similar elements that may have the same or similar dimensions, materials, and structures. While exemplifying and describing certain forms of embodiments, it will be clear that various modifications can be made without departing from the spirit and scope of the embodiments of the present invention. Accordingly, the present invention is not intended to be limited by the detailed description described above.

Citations
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JP2002526188A	Cites	Japan

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AU2006239877A1	Australia	A1	2006-11-02
CA2605360A1	Canada	A1	2006-11-02
US2006247683A1	United States of America	A1	2006-11-02
US2006247746A1	United States of America	A1	2006-11-02
WO2006116198A2	World Intellectual Property Organization (WIPO)	A2	2006-11-02
US2007074719A1	United States of America	A1	2007-04-05
WO2006116198A3	World Intellectual Property Organization (WIPO)	A3	2007-05-31
US2007265639A1	United States of America	A1	2007-11-15
EP1874211A2	European Patent Office (EPO)	A2	2008-01-09
JP2008538524A	Japan	A	2008-10-30
US7594925B2	United States of America	B2	2009-09-29
US7708768B2	United States of America	B2	2010-05-04
US2010268222A1	United States of America	A1	2010-10-21
JP2012106009A	Japan	A	2012-06-07
JP4958896B2	Japan	B2	2012-06-20
EP1874211A4	European Patent Office (EPO)	A4	2012-10-03
US8292882B2	United States of America	B2	2012-10-23
US8298224B2	United States of America	B2	2012-10-30
AU2006239877B2	Australia	B2	2012-11-01
AU2012238242A1	Australia	A1	2012-11-01
AU2012238242A2	Australia	A2	2012-11-08
US2013023873A1	United States of America	A1	2013-01-24
AU2012238242B2	Australia	B2	2014-02-20
EP2727547A2	European Patent Office (EPO)	A2	2014-05-07
US2014330332A1	United States of America	A1	2014-11-06
US9199091B2	United States of America	B2	2015-12-01
US2016038230A1	United States of America	A1	2016-02-11
JP5952008B2This record	Japan	B2	2016-07-13
CA2605360C	Canada	C	2017-03-28
EP2727547A3	European Patent Office (EPO)	A3	2017-04-12
EP1874211B1	European Patent Office (EPO)	B1	2017-05-31
US9808312B2	United States of America	B2	2017-11-07
US10219858B2	United States of America	B2	2019-03-05
US2019151016A1	United States of America	A1	2019-05-23
EP2727547B1	European Patent Office (EPO)	B1	2020-11-18
EP3804647A1	European Patent Office (EPO)	A1	2021-04-14
US11547474B2	United States of America	B2	2023-01-10
US2023082399A1	United States of America	A1	2023-03-16
US12220165B2	United States of America	B2	2025-02-11

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