Ablation in the gastrointestinal tract to achieve hemostasis and eradicate lesions with a propensity for bleeding

(Cross-reference of related applications) This application claims priority under US Provisional Application No. 60 / 958,566 by Utley, Wallace and Gerberding, entitled "Subjects to Ablation Diseases of Non-Barrett Mucosa," filed July 6, 2007. is there.

This application was jointly transferred, filed on February 19, 2003, and published as US Patent Publication No. 2003/0158550 on August 21, 2003, "Treatment of Abnormal Tissues in the Human Edo". US Patent Application No. 10 / 370,645 entitled "Methods to Do" and "Precision Ablation Method" filed on November 23, 2005 and published as US Patent Publication No. 2007/0118106 on May 24, 2007. It incorporates the entire US Patent Application No. 11 / 286,444 entitled. In addition, the following jointly transferred US patent application is incorporated herein by reference in its entirety: US Patent Application No. 1 entitled "Systems and Methods for Treating Obesity and Other Gastrointestinal Conditions." 10 / 291,862, US Patent Application No. 10 / 370,645 entitled "How to Treat Abnormal Tissues in the Human Edo", US Patent Application No. 11 / 286,257 entitled "Precision Ablation Device", "Automatic Alignment" US Patent Application No. 11 / 275,244 entitled "Ablation Device and Its Usage", US Patent Application No. 11 / 286,444 entitled "Precision Ablation Device", US Patent Application No. 11 / entitled "System for Tissue Ablation" 420,712, US Patent Application No. 11 / 420,714 entitled "Methods for Low Temperature Tissue Ablation", U.S. Patent Application No. 11 / 420,719 entitled "Methods for Vacuum Auxiliary Tissue Ablation", "Methods for Tissue Ablation" US Patent Application No. 11 / 420,722 entitled "Methods for" and US Patent Application No. 11 / 469,816 entitled "Surgical Instruments and Techniques for Treating Gastroesophageal Reflux Disease". This application is further filed in US Patent Application No. 12 / 114,628 entitled "Gastrointestinal Ablation for the Treatment of Obesity" filed May 2, 2008, and filed June 20, 2008. It incorporates the entire US Patent Application No. 12 / 143,404, such as Wallance, entitled "Electrical Means for Standardizing Ablation Energy Transfer to the Surface of Variable Size Cavity Tissue."

(Built-in by reference) All publications, patents and patent applications mentioned herein are referenced to the same extent that individual publications, patents or patent applications are incorporated by reference, specifically and individually. It is incorporated here by doing.

(Field of invention) The present invention provides, for example, a device for treating a portion of the gastrointestinal tract of a patient with a bleeding condition in the gastrointestinal tract to control bleeding (ie, achieve hemostasis) and / or to cure a site of injury that is prone to bleeding. The present invention relates to an endoscopic treatment device and a treatment method, such as a method.

Bleeding may occur from the blood vessels contained in the wall of the gastrointestinal tract into the lumen of the gastrointestinal tract. Such bleeding is abnormal and may be associated with certain disease states and anatomical abnormalities. Bleeding can lead to an emergency with hematemesis or rectal drainage. In these cases, emergency endoscopic or surgical intervention is often required, along with blood transfusions, to avoid patient morbidity and death. Hemorrhagic varicose veins in the esophagus associated with portal venous pressure, exposed blood vessels in gastric or duodenal ulcers, or ruptured arteriovenous malformations (disordered collection of blood vessels) in the internal organs, etc. Included as an example.

There may be other sites of bleeding with chronic, less severe bleeding that result in chronic anemia and the need for continuous endoscopic intervention to cauterize visible abnormalities. .. In such cases, long-term transfusion therapy is often required because endoscopic interventions are not ideal for permanent hemostasis. Gastric Antral Vascular Ectasia (GAVE), radiation-induced proctopathy and colon disease, portal hypertensive, known as watermelon stomach because of its unique appearance of gastric lesions. Examples include portal hypertensive gastropathy (PHG), vascular dysplasia, small arteriovenous malformation (AVM), and small hemorrhagic ulcers. A common finding in many of these more chronic anomalies is the presence of blood vessels within the walls of the gastrointestinal tract, especially in the mucosal and submucosal layers, which are larger than normal and standard. It is more superficial, entangled, disordered, and / or exposed in the gastrointestinal tract, and is therefore more vulnerable to food and stool excretion than normal. Due to the combination of these features, these vessels tend to chronically bleed into the lumen of the gastrointestinal tract, which requires chronic management.

The onset of significant symptoms of acute bleeding, where the patient vomits or drains from the rectum and affects the cardiovascular system, is usually urgent with endoscopic or surgical treatment and blood transfusions. It is processed. Typically, these events are associated with large blood vessels that have ruptured and are bleeding heavily into the lumen. These sites are visualized endoscopically and adrenaline (registered trademark) can be injected to relieve bleeding, followed by a small probe that comes into direct contact with the blood vessels. It can be cauterized using or can be cauterized using an electrified argon gas stream. These probes provide radio-frequency energy that rapidly heats blood vessels and tissues of targeted focus, causing the blood vessels to constrict and stop bleeding. Surgery is reserved for patients with life-threatening bleeding for whom endoscopic treatment is not suitable.

<p> The development of chronic bleeding symptoms causes long-term illness and requires repeated treatment and blood transfusions, but typically does not require imminent life-saving intervention. Rather, these sites of disability typically come to mind after endoscopic examination when the patient presents with unexplained anemia symptoms. As described above, these impaired sites can be identified and targeted using an endoscope. Cauterization is a standard treatment that can be expected to permanently eliminate the risk of bleeding. Unfortunately, in many cases, current ablation techniques do not permanently cure these lesions, resulting in recurrent bleeding. Factors affecting the unsatisfactory results of using currently available ablation methods include gastric antral capillary dilatation (GAVE), radiation-induced proctopathy and colonic disease, and portal venous pressure hyperactivity. Includes the fact that gastric disorders and damaged sites such as vascular dysplasia tend to appear as large, widespread sites that are not suitable for ablation techniques that use small probes to press against the site. .. Balanced (even) arteriovenous malformations tend to have high flow rates and large surface areas, which makes treatment with small probes difficult. Another similar reason for the problematic and inconsistent results of using conventional ablation is related to the presence of blood in the vasculature when ablation is performed. Improvements in systems and methods, especially non-surgical methods or conventional ablation techniques, will be appreciated in the field of treatment for acute and chronic bleeding in the gastrointestinal tract.</p>

<p>(Outline of the invention) Addressing these and other needs, the present invention provides a larger ablation surface, which compresses blood vessels prior to supplying cauterizing energy and contains bleeding blood vessels. By controlling the depth of ablation to include layers, to provide a more permanent solution to predominantly chronic bleeding occurring in the gastrointestinal tract and to provide a more permanent cure for the disorders that lead to such bleeding. , Provide various embodiments of endoscopic devices and methods. For this purpose, the device is a balloon-based endoscopic catheter attached to the end of the endoscope, or an operating channel or ancillary channel of the endoscope. It is equipped with an endoscopic catheter that passes through. The device controls the depth of ablation for the targeted tissue through parameters such as energy density, electrode pattern, power density, number of applications and pressure acting on the tissue. In this way, it has an electrical array on at least one surface to supply radio frequency energy or other energy source. Ablation energy is supplied to the catheter by an energy generator connected to the catheter by an electric wire (cable).</p><p> The method is described in conjunction with existing visualization endoscopes to visualize areas of the gastrointestinal tract that include disorders that are actively bleeding or causing chronic recurrent bleeding. Includes the use of. The device is positioned in contact with the obstacle, deployed according to an embodiment of the device, and the blood vessel is compressed. Ablation energy is then supplied to the device and to the disorder, resulting in hemostasis and eradication of the disorder.</p><p> Compression prior to the supply of coagulation energy blocks or reduces blood flow within the targeted blood vessels. Then, when energy is supplied, coaptive coagulation occurs more easily, and the walls of the blood vessel are sealed against itself. If blood flow is occurring during coagulation, the failure rate will be higher due to the blood that keeps the blood vessels open and the heat sink effect that the blood flow brings.</p><p> The therapeutic parameter may be the achievement of a uniform level of ablation in all or part of the targeted disorder. For example, for superficial disorders, the desired ablation depth may be mucosa or part of the mucosa. For deeper disorders, the desired ablation depth may be the deeper mucosa and all or part of the submucosa. Depth control and uniformity of the ablation effect is achieved through the characteristics of the device and the characteristics of the therapeutic parameters, including electrode pattern, pressure for targeted obstacles, energy density, power density and number of applications.</p><p> Embodiments of the invention include systems and methods that allow the system to be implemented for methods of treating bleeding areas in the gastrointestinal tract. This method of treatment includes the step of identifying the bleeding area; the step of positioning the treatment device in the gastrointestinal tract close to the target site in the bleeding area; and the step of reducing the blood volume in the blood vessels in the bleeding area. , A step of applying pressure to the bleeding area; a step of performing non-surgical hemostasis treatment while continuing to pressurize the area. In some embodiments of this method, the identifying step is performed endoscopically. Also, in some embodiments, the identifying step, the positioning step, the pressure applying step and the performing step are performed during a single endoscopic treatment. In another embodiment, the device having the hemostatic treatment device mounted on it is inserted into the gastrointestinal tract before the identifying step, and after the step of performing the hemostatic treatment, the device is inserted. It may also have a removal step.</p><p> In some embodiments of the method, the step of performing the non-surgical hemostatic treatment comprises applying energy, such as radio frequency energy, to the site of interest. In various embodiments, the step of applying energy to the target site comprises controlling the energy supply across the tissue surface within the target site. Also, in some embodiments, the step of applying energy to the target site comprises controlling the depth of energy supply into the panniculus within the target site. Further, in some embodiments, the step of applying energy to the target site comprises applying more than one energy, and in some embodiments, the step of applying energy to the target site. Includes applying energy to more than one target site within the bleeding area.</p><p> In some embodiments of the method, the step of applying non-surgical hemostatic treatment to the target site comprises applying cryotherapy to the target site. In some embodiments where the cryotherapy is applied, such treatment comprises spraying a cold fluid onto the subject site, and in other embodiments, the cryotherapy is administered from the subject area. Includes drawing heat to the cold fluid contained in the device.</p><p> In some embodiments of the method, the positioning step comprises moving the ablation structure of the device to bring it into therapeutic contact with a site of interest within the bleeding area. In some of these embodiments, moving the ablation structure is either inflating the balloon member, expanding the flexible member, moving the flexible member, or expanding the expandable member. Includes.</p><p> The step of applying pressure to the bleeding area, which forms the basis of the junctional aspect of the ablation treatment, involves applying a pressure of about 1 psig to about 15 psig, and in various embodiments, the pressure applied is from about 3 psig to about 3 psig. It is in the range of 7 psig, and in certain embodiments, the applied pressure is about 4 psig.</p><p> In another aspect of the invention, the method is focused on treating the site of interest in the bleeding area in the gastrointestinal tract with ablation. Such a method involves applying pressure to the bleeding area to reduce blood volume in the blood vessels within the bleeding area; wirelessly to the tissue surface within the area of interest, which is an adjacent radial site of the gastrointestinal tract. It comprises a step of supplying frequency energy; and a step of controlling the supply of radio frequency energy across the tissue surface in the target area and deep into the tissue in the target area. The bleeding area may be any of an acute bleeding site, a chronic bleeding site, or a site identified as prone to bleeding. In particular, the acute bleeding site may include either hemorrhagic varicose veins in the esophagus, exposed bleeding blood vessels in a gastric or duodenal ulcer, or arteriovenous malformations in the intestine. The chronic bleeding sites include gastric antral capillary dilatation (GAVE), radiation-induced proctopathy and colon disease, portal hypertension gastric disease (PHG), and vascular dysplasia. It may include either a small arteriovenous malformation (AVM) or a small hemorrhagic ulcer.</p><p> In some embodiments of this method, the step of controlling the supply of radiofrequency energy across the tissue surface within the target area to the depths of the tissue within the target area ablates a portion of the surface of the target tissue. It involves providing sufficient radio frequency energy to achieve and insufficient energy to achieve ablation to other parts of the surface of the tissue of interest. Also, in some embodiments of the method, controlling the supply of radiofrequency energy deep into the tissue provides sufficient energy to one or more tissue layers near the surface to achieve ablation. It involves controlling the supply of radiofrequency energy from the tissue surface so that the other deeper layers are supplied with insufficient energy to achieve ablation.</p><p> In some embodiments of the method, controlling the supply of radiofrequency energy across the surface of the area of interest is sufficient to allow the spacing between certain electrodes to allow sufficient energy transfer to perform ablation. It involves configuring the electrode pattern so that it is in close proximity to the other electrodes and the spacing between the other electrodes is inadequately close enough to allow the transfer of sufficient energy to perform ablation. Also, in other embodiments of the method, controlling the supply of radiofrequency energy across the surface of the area of interest is sufficient for the energy supplied between certain electrodes to perform ablation, and certain electrodes. In between, it involves manipulating the electrode pattern so that not enough energy is supplied to perform the ablation.</p><p> In some embodiments of the method, controlling the supply of energy that begins at the mucosal surface and dissipates into the walls of the organ involves ablating certain parts of the blood vessels within the epithelial layer. In various embodiments of the method, controlling the supply of energy that begins at the mucosal surface and gradually dissipates deeper into the layers of the organ wall ablates some parts of the blood vessels within the epithelial and lamina propria. Including that. In yet another embodiment, some parts of the blood vessel may be ablated within the epithelial layer, the lamina propria and the muscularis mucosae, or within the epithelial layer, the lamina propria, the lamina propria and Ablation may be applied within the submucosa, or within the epithelial layer, within the lamina propria, within the lamina propria, within the submucosa and within the lamina propria. Further, in various embodiments, the step of controlling the delivery of radiofrequency energy across the tissue surface within the target area to the deeper part of the tissue within the target area is partial ablation within the tissue layer of the gastrointestinal tract. Includes achieving.</p><p> In some embodiments of the method, the step of supplying radiofrequency energy is by means of an electrode pattern constructed 360 degrees around the ablation structure. In another embodiment, supplying energy from the ablation structure transfers energy asymmetrically through the 360 degree perimeter so that the ablation is focused within an arc that is smaller than 360 degrees. Includes doing. Also, in another embodiment, the step of supplying radiofrequency energy is by means of an electrode pattern configured circumferentially around the ablation structure through an arc that is smaller than 360 degrees. Regardless of the pattern of ablation, in various embodiments, the energy supply step may be performed more than once and for more than one location.</p><p> In some embodiments, the method further comprises the step of evaluating the area of interest in order to measure the state of the area of interest at some time point after the step of supplying energy. In various embodiments, in order to assess the condition immediately after treatment of the site, the assessment step is performed within a close time after the supply of energy. Also, in another embodiment, the evaluation step may be performed at least one day after the energy supply.</p><p> In various embodiments, the method further comprises the step of obtaining energy for transfer from an energy source controlled by a control system. In some of these embodiments, the energy source is a generator. In some embodiments operated by the control system, the method feedback-controls energy transfer to provide either specific power, power density, energy, energy density, circuit impedance, or tissue temperature. Is further equipped.</p><p> Some embodiments of the method of treating a bleeding area with ablation are steps of advancing an ablation structure into the gastrointestinal tract, which has a non-penetrating electrode pattern on the structure, which is an instrument. Supported by the step; the step of positioning the ablation close to the area of interest; the subject to bring the ablation structure into therapeutic contact on the area of interest prior to supplying energy. It may further include a step of moving towards the surface of the area. The moving step may include variously either inflating the balloon member, expanding the flexible member, moving the flexible member, or expanding the expandable member.</p><p> Some embodiments of the method of treating a bleeding area with ablation further include a positioning step following the moving step; an example of creating a suction between the structure and the ablation site. Including that. In addition, the method may further include a step of evaluating the target area and measuring the state of the target area prior to the positioning step. In another variation of the method, when a large number of target areas are treated, the first target area is provided with the positioning step, the moving step, and the energy transfer step. It comprises a step of positioning, a step of moving, and a step of transmitting energy to another target area without removing the ablation structure from the patient.</p><p> Some embodiments of the present invention include an ablation system that treats a site of interest within a hemorrhagic region within the gastrointestinal tract, such a system with an electrode pattern comprising multiple electrodes; a longitudinal supporting the electrode pattern. A directional support member; a computer controller connected to a generator that has a programming that directs the generator to supply energy to multiple electrodes, which programming directs energy delivery to a subset of the electrodes. The patterned electrodes receive energy from the generator and, when in therapeutic contact with the target area of the tissue, traverse the surface of the target area from the tissue surface to the deep tissue layer. It includes a computer controller, which is configured to control the energy supply.</p><p> Various embodiments of the system treat bleeding areas, including either hemorrhagic varicose veins in the esophagus, exposed bleeding blood vessels in gastric or duodenal ulcers, or arteriovenous malformations in the intestine. May be devoted to. Other embodiments include gastric antral capillary dilatation (GAVE), radiation-induced proctopathy and colonic disease, portal hypertensive gastric disease (PHG), vascular dysplasia, and minor movements. You may be focused on treating the bleeding area, including either a venous malformation (AVM) or a small hemorrhagic ulcer.</p><p> The electrode patterns of some embodiments of the ablation system that treat the site of interest in the bleeding area in the gastrointestinal tract have a longitudinal axis and, alongside the feeder, are perfectly circumferential perpendicular to this longitudinal axis. The pattern is sized to contact the tissue of the area of interest inside the gastrointestinal tract. In another embodiment, the electrode pattern forms a partially circumferential surface orthogonal to its longitudinal axis, and the pattern is sized to contact tissue in the area of interest within the gastrointestinal tract. ing. Also, in various embodiments of these latter, the electrode pattern may form an arcuate portion of about 90 degrees or about 180 degrees.</p><p> In some embodiments of the ablation system, when programming directs the generator to supply energy to all electrodes, the electrode pattern will contact the tissue area therapeutically and the tissue within the area of interest. The electrode elements are distributed in a pattern so that ablation is applied to a part of the above-mentioned area, but the other part of the tissue in the target area is not ablated. Also, in another embodiment of the ablation system, the programming ablates a portion of the tissue within the target area upon therapeutic contact with the target tissue area, while the other portion of the tissue within the target area. Is instructed to supply energy to a subset of the electrode elements that form the unablated pattern. In various embodiments of the system, whether the electrode pattern is fully driven to feed the split ablation pattern or partially driven to feed the split ablation pattern. Instead, the system ensures that the ablated tissue is at least partially dysfunctional and the other parts that are substantially unablated thus maintain its functionality.</p><p> Some embodiments of the present invention are an ablation structure supported by an instrument; a non-invasive electrode pattern on the ablation support structure, with a radio frequency sufficient for a portion of the surface of the tissue of interest to achieve ablation. With an electrode pattern configured to control the energy supply to the target tissue so that it receives energy and the rest of the surface of the target tissue receives insufficient energy to achieve ablation; by the instrument. An ablation system for vascular tissue at a site of interest in a patient's gastrointestinal tract, which is a supported means of bringing the ablation structure into therapeutic contact with tissue in the area of interest. Includes.</p>

<figref num="1A">Schematic representation of a cross section of the wall of a portion of the gastrointestinal tract with bleeding blood vessels, with branched capillaries, mainly located in the lamina propria and epithelial tissue, blood vessels, arterioles or venuole. It is a figure which shows a part of).</figref><figref num="1B">Schematic representation of a cross section of the wall of a portion of the gastrointestinal tract with bleeding blood vessels, a portion of a blood vessel, arteriole or veneole with branched capillaries located primarily in the submucosa and lamina propria. It is a figure which shows.</figref><figref num="2A">It is a figure which shows a specific example of the condition which can become the source of acute or chronic bleeding in the gastrointestinal tract, and is the figure which shows the arteriovenous malformation (AVM).</figref><figref num="2B">It is a figure which shows the specific example of the state which can become the source of acute or chronic bleeding in the gastrointestinal tract, and is the figure which shows typically the telangiectasia with the significantly dilated capillaries.</figref><figref num="2C">Pylorus of a patient with a watermelon gastric region that is characteristic of gastric antral capillary dilatation (GAVE) and is a diagram showing a specific example of a condition that can be a source of acute or chronic bleeding in the gastrointestinal tract. It is an endoscopic view of the stomach as seen toward.</figref><figref num="3">A flow chart showing the overall picture of the method, which determines the appropriate site for intervention by ablation for the treatment of acute or chronic bleeding sites in the gastrointestinal tract, the level of debilitating treatment, and at least for local limitation. It is a flow diagram which provides preliminary information and makes a favorable clinical judgment about the embodiment of the present invention.</figref><figref num="4">It is a flow diagram showing a method after the site of ablation in the acute or chronic bleeding site of the gastrointestinal tract is locally limited and a preferable ablation device is selected, and the method is the details of the position and stage. Includes site evaluation, site number and sizing determination, and the method also involves instrument insertion and ablation treatment target tissue local movement of the device, ablation therapy to produce therapeutic contact. It is a flow chart that continuously performs more precise movement of the structure, release of ablation radiation, and subsequent post-treatment evaluation.</figref><figref num="5">It is a figure which shows one Embodiment of the ablation apparatus provided with the operating radius of a completely circumferential shape.</figref><figref num="6">It is a figure which shows one Embodiment of the ablation apparatus which has the balloon-like (balloon) member of an inflated form, and has a completely circumferential operational radius.</figref><figref num="7A">It is a figure which shows an example of the electrode pattern of the apparatus of FIG.</figref><figref num="7B">It is a figure which shows an example of the electrode pattern of the apparatus of FIG.</figref><figref num="7C">It is a figure which shows an example of the electrode pattern of the apparatus of FIG.</figref>

<figref num="8A">It is a figure which shows an example of the electrode pattern which can be used in the embodiment of the ablation apparatus provided with the operation radius of a perfect circumference, or in the embodiment of any of the apparatus described herein.</figref><figref num="8B">It is a figure which shows an example of the electrode pattern which can be used in the embodiment of the ablation apparatus provided with the operation radius of a perfect circumference, or in the embodiment of any of the apparatus described herein.</figref><figref num="8C">It is a figure which shows an example of the electrode pattern which can be used in the embodiment of the ablation apparatus provided with the operation radius of a perfect circumference, or in the embodiment of any of the apparatus described herein.</figref><figref num="8D">It is a figure which shows an example of the electrode pattern which can be used in the embodiment of the ablation apparatus provided with the operation radius of a perfect circumference, or in the embodiment of any of the apparatus described herein.</figref><figref num="9">It is a figure which shows the ablation apparatus of this invention with a partially circumferential operational radius.</figref><figref num="10">It is an end view of the embodiment of the ablation apparatus of FIG.</figref><figref num="11">It is an end view which shows the apparatus of FIG. 9 in one extended form.</figref><figref num="12">FIG. 5 is an end view showing the device of FIG. 9 in an alternative extended form.</figref><figref num="13">FIG. 5 is an end view showing the device of FIG. 9 in an alternative extended form.</figref><figref num="14">FIG. 5 is an end view showing the device of FIG. 9 in an alternative extended form.</figref><figref num="15">It is a figure which shows the ablation apparatus of this invention in a non-expanded form.</figref><figref num="16">It is a figure which shows the ablation apparatus of this invention in an extended form.</figref><figref num="17">It is an end view of the apparatus shown in one extended form.</figref><figref num="18">It is an end view of the apparatus shown in one extended form.</figref><figref num="19A">It is a figure of the ablation apparatus of this invention which shows the deflection (deflation) member mechanism.</figref><figref num="19B">It is a figure of the ablation apparatus of this invention which shows the alternative deflection member in the extended form of the apparatus.</figref><figref num="20">It is a figure which shows the apparatus of FIG. 19 in the non-expanded form of a deflation member.</figref><figref num="21">(I) It is an end view of the device shown in a non-expanded form.</figref><figref num="22">It is an end view of the apparatus shown in FIG. 21 in an extended form.</figref><figref num="23">It is a figure of the ablation apparatus of this invention which shows the mechanism of the rotating ablation structure.</figref><figref num="24">It is explanatory drawing of the ablation apparatus of this invention combined with an endoscope system.</figref><figref num="25">It is a figure which shows typically the cross section which passes through the tube wall of a part of the digestive tract.</figref><figref num="26">It is a figure of the ablation apparatus of this invention including the extension sheath (sheath) mechanism.</figref><figref num="27">It is a figure of the apparatus in which the extending sheath mechanism is optically transparent.</figref><figref num="28">It is an enlarged view of the optically transparent mechanism of a device.</figref><figref num="29">FIG. 2 is a cross-sectional view of the optically transmissive sheath mechanism of the apparatus shown in FIGS. 27 and 28.</figref>

<figref num="30">It is a figure which shows the device including the alternative optically transparent mechanism and the expansion member mechanism in an extended form.</figref><figref num="31">It is explanatory drawing of the ablation device of FIG. 30 located in the esophagus.</figref><figref num="32">It is a figure of the ablation apparatus of this invention including the sheath tube (slit sheath) mechanism with a slit.</figref><figref num="33A">It is an end view of the sheath mechanism with a slit of an apparatus shown in the non-expanded form of a sheath.</figref><figref num="33B">It is an end view of the sheath mechanism with a slit of an apparatus and an endoscope which shows the expanded form of a sheath.</figref><figref num="34A">FIG. 5 is a cross-sectional view of a device located within the internal working channel of an endoscope, showing the inflatable member mechanism in a non-expandable position.</figref><figref num="34B">FIG. 3 is a diagram of the device shown in FIG. 34A, showing the inflatable member mechanism in the expanded position.</figref><figref num="35A">FIG. 5 is a cross-sectional view of a device located within an internal working channel of an endoscope, showing the expandable member mechanism in a non-expandable position.</figref><figref num="35B">FIG. 5 is a diagram of the device shown in FIG. 35A, showing the expandable member mechanism in the extended position.</figref><figref num="36A">FIG. 5 is a cross-sectional view of a device located within an internal working channel of an endoscope, showing an alternative expandable member mechanism in a non-expandable position.</figref><figref num="36B">FIG. 6 is a diagram of the device shown in FIG. 36A, showing the expandable member mechanism in the extended position.</figref><figref num="37">It is a figure of the ablation apparatus of this invention including an alternative deflection member.</figref><figref num="38">It is explanatory drawing of the ablation apparatus of this invention including the alternative deflection member located in the non-deflation position in the bleeding site of the acute or chronic gastrointestinal tract.</figref><figref num="39">It is explanatory drawing of the apparatus shown in FIG. 38 in the state which the deflection member is in a deflection position.</figref><figref num="40">It is sectional drawing of the ablation apparatus of this invention which shows the internal coupling mechanism.</figref><figref num="41">FIG. 5 is a cross-sectional view of the ablation apparatus of the present invention showing an alternative internal coupling mechanism and a rolled sheath mechanism.</figref><figref num="42">It is explanatory drawing which shows the cross section of the ablation apparatus of this invention located in the lumen at the bleeding site of the acute or chronic gastrointestinal tract.</figref><figref num="43">It is explanatory drawing of the ablation apparatus of this invention located in the esophagus which shows the rotation mechanism.</figref><figref num="44">It is explanatory drawing of the ablation apparatus of this invention located in the esophagus which shows the rotation mechanism combined with the expansion member in an expanded form.</figref><figref num="45A">It is a figure of the ablation apparatus of this invention which shows an example of an alternative rotation mechanism.</figref><figref num="45B">It is a figure of the ablation apparatus of this invention which shows an example of an alternative rotation mechanism.</figref><figref num="45C">It is a figure of the ablation apparatus of this invention which shows an example of an alternative rotation mechanism.</figref>

<figref num="46A">It is a figure which shows the endoscope.</figref><figref num="46B">It is a figure of the ablation apparatus of this invention including a catheter mechanism.</figref><figref num="46C">It is a figure which shows the sheath mechanism of the said device.</figref><figref num="47">It is a figure of the ablation apparatus of this invention which includes the features shown in FIG. 46A-FIG. 46C in an assembly.</figref><figref num="48A">It is a figure which shows an example of the electrode arrangement of the striped pattern for fractional ablation.</figref><figref num="48B">It is a figure which shows the example of the ablation pattern (ablation pattern) on the tissue which can be created from an electrode pattern.</figref><figref num="48C">It is a figure which shows the example of the ablation pattern on the tissue which can be created from an electrode pattern.</figref><figref num="48D">It is a figure which shows the example of the ablation pattern on the tissue which can be created from an electrode pattern.</figref><figref num="49A">It is a figure which shows the electrode arrangement of the concentric pattern for split ablation.</figref><figref num="49B">It is a figure which shows the ablation pattern on the tissue which can be created from the electrode pattern of FIG. 49A.</figref><figref num="50A">It is a figure which shows the electrode arrangement of the grid pattern for division ablation.</figref><figref num="50B">It is a figure which shows the ablation pattern on the tissue which can be created from the electrode pattern of FIG. 50A.</figref><figref num="51A">It is a figure which shows the electrode arrangement of the grid pattern which operates in a non-divided manner.</figref><figref num="51B">It is a figure which shows the ablation pattern on the tissue created from such an operation pattern.</figref><figref num="52A">It is a figure which shows the electrode arrangement of the lattice pattern which operates in the division mode.</figref><figref num="52B">It is a figure which shows the ablation pattern on the tissue created from such an operation pattern.</figref><figref num="53A">It is a figure which shows the electrode arrangement of the anode and the cathode of the striped AC which operates in the undivided mode.</figref><figref num="53B">It is a figure which shows the ablation pattern on the tissue which can be created from such an operation pattern.</figref><figref num="54A">It is a figure which shows the electrode arrangement of the anode and the cathode of the striped alternating current which operates in a split mode.</figref><figref num="54B">It is a figure which shows the ablation pattern on the tissue which can be created from such an operation pattern.</figref><figref num="55">FIG. 6 is a schematic three-dimensional diagram showing a target region of the radial portion of the gastrointestinal tract at an acute or chronic bleeding site in the state after ablation treatment.</figref>

<figref num="56A">An ablation surface is included on the hinge structure or on a flexing mechanism similar to that shown in FIG. 43, and the hinge is free to rotate on the ablation surface between its longitudinal axis and the longitudinal axis of the endoscope. It is a figure which shows the ablation device (similar to the device of FIG. 38 and FIG. 39) which allows, and shows the device in the state which the ablation surface is oriented parallel to the endoscope.</figref><figref num="56B">Including an ablation surface on the hinge structure or on a flexure mechanism similar to that shown in FIG. 43, the hinge is free to rotate on the ablation surface between its longitudinal axis and the longitudinal axis of the endoscope. A device showing an ablation device (similar to the device in FIGS. 38 and 39), in which the longitudinal axis of the ablation surface is oriented substantially perpendicular to the longitudinal axis of the endoscope. It is a figure which shows.</figref><figref num="57A">Overlapping around an expandable balloon A 360-degree circumferential ablation surface is provided on the electrode support, and in the expanded state, the operative element includes the balloon and the electrode support. In order to clearly show that a part and an edge of the support are attached to the balloon and the other part and the edge are not attached to the balloon. , It is a figure which shows the support which is pulled out from a balloon.</figref><figref num="57B">FIG. 6 illustrates an ablation device with a 360 degree circumferential ablation surface on an electrode support that is wrapped around and overlaps an expandable balloon, and in the expanded state the operating element includes the balloon and the electrode support. It is a diagram showing an operating element of an apparatus which comprises a non-adhesive portion of a support wrapped around a balloon in a deployable manner, the non-adhesive portion and an edge portion thereof overlapping around the adhesive portion. is there.</figref><figref num="57C">FIG. 6 illustrates an ablation apparatus with a 360 degree circumferential ablation surface on an electrode support that is wrapped around and overlaps an expandable balloon, and in the expanded state the operating element includes the balloon and the electrode support. Yet, in the figure showing the apparatus of FIGS. 57A and 57B, with one or more more elastic bands wrapped around the electrode support as an optional feature of the operating element. is there.</figref><figref num="57D">A diagram illustrating an ablation device with a 360 degree circumferential ablation surface on an electrode support that is wrapped around and overlaps an expandable balloon, and in the expanded state the operating element includes the balloon and the electrode support. After supplying ablation energy as well as the state of the device when the device is deployed in the lumen and positioned at the target site, with the balloon portion non-inflated (or contracted). It is a figure which shows the state of the device which is taken out from a lumen.</figref><figref num="58A">It is applied to create an ablation surface at a recessed or inwardly sloping target site, such as a stoma or pylorus, at the distal end of the endoscope. It is a figure which shows the embodiment of the ablation apparatus which includes the ablation surface arranged in the circumferential shape in the distal part of the expandable member attached around, and is the figure which shows the apparatus in the expanded form.</figref><figref num="58B">An extension mounted around the distal end of the endoscope, applied to create an ablation surface at a recessed or inwardly sloping target site, such as a pit or pylorus. It is a figure which shows the embodiment of the ablation apparatus which includes the ablation surface arranged in a circumferential shape in the distal part of a possible member, and is suitable for deploying the apparatus on a target tapered surface, or ablation. FIG. 5 shows the device of FIG. 58A in which the expandable member is in an unexpanded or deflated state so as to be suitable for removing the device from the site.</figref><figref num="58C">An extension mounted around the distal end of the endoscope, applied to create an ablation surface at a recessed or inwardly sloping target site, such as a pit or pylorus. A diagram illustrating an embodiment of an ablation apparatus comprising a circumferentially arranged ablation surface in the distal portion of a possible member to an inclined or recessed target site, such as a pylorus. It is a figure which shows the device of FIG. 58A which can be deployed.</figref><figref num="58D">An extension mounted around the distal end of the endoscope, applied to create an ablation surface at a recessed or inwardly inclined target site, such as a sphincter or pylorus. A diagram illustrating an embodiment of an ablation apparatus comprising a circumferentially arranged ablation surface in the distal portion of a possible member, facing the proximal side and, for example, of the lower esophageal sphincter. The device of FIG. 58A in an alternative form, with electrodes bearing the faces of the inverted device so that it can be pulled backwards towards an inclined or recessed portion, such as. It is a figure which shows.</figref>

<figref num="59A">It is a diagram showing an ablation device that can be deployed through an operating channel of an endoscope configured to exhibit a wide range of ablation planes that are approximately orthogonal or approximately perpendicular to the longitudinal axis of the delivery endoscope and are fully deployed. It is a figure which shows the said apparatus in the said form.</figref><figref num="59B">FIG. 5 shows an ablation apparatus that can be deployed through the operating channel of an endoscope configured to exhibit a wide range of ablation planes that are approximately orthogonal or substantially perpendicular to the longitudinal axis of the delivery endoscope. It is a figure which shows the said device in the form which can be pulled into the actuating channel of.</figref><figref num="60">FIG. 6 illustrates an embodiment of an ablation device deployable through an operating channel of an endoscope applied to exhibit an ablation plane substantially parallel to the longitudinal axis of the delivery endoscope, the two parallel collapsible. Includes a shape memory rib and an ablation electrode that is stretched across both ribs and is configured to be taut across the space between the ribs in the unfolded state. It is a figure which shows one Embodiment of the device.</figref><figref num="61A">An ablation device that can be deployed through the operating channel of the endoscope applied to exhibit an ablation surface approximately parallel to the longitudinal axis of the delivery endoscope, the ablation surface of the device being tilted at the proximal end. It also has a laterally-curved bias that is substantially flat but rollable, does not roll when pushed out of the working channel, and is pulled back into the working channel. It is a figure which shows one embodiment of the device which sometimes rolls around itself, and shows the device in the form which it unfolded after coming out of an actuating channel.</figref><figref num="61B">An ablation device that can be deployed through the operating channel of the endoscope applied to exhibit an ablation surface approximately parallel to the longitudinal axis of the delivery endoscope, the ablation surface of the device being tilted at the proximal end. It also has a laterally curved bias that is substantially flat but rollable, does not roll when pushed out of the working channel, and revolves around itself when pulled back into the working channel. It is a figure which shows one Embodiment of the device which rolls, and is the figure which shows the device which remains configured in the working channel prior to deployment, or after being pulled back into a working channel.</figref><figref num="62">An endoscope similar to the device of FIG. 61, except that it exhibits an ablation surface that is approximately orthogonal to the longitudinal axis of the sending endoscope due to the flexible bends in close proximity to the ablation surface. It is a diagram showing an embodiment of an ablation device that can be deployed through the working channel of a mirror, wherein the ablation surface of the device is inclined at the proximal end and is substantially flat but rollable. It is a figure which shows one Embodiment of the apparatus which provided the curved surface bias in the sideways direction, does not roll when pushed out from a working channel, and rolls around itself when pulled back into the working channel.</figref><figref num="63">FIG. 5 illustrates an embodiment of an ablation device deployable through an operating channel of an endoscope applied to exhibit a circular or spiral ablation surface oriented outwardly and circumferentially. The circular or spiral portion is uncoiled as it emerges from the operating channel of the endoscope and is coiled into a linear form when pulled back into the operating channel. It is a figure which shows.</figref><figref num="64">It is a detailed view of the perspective and cross section of the circuit layer of the ablation surface common to the apparatus shown in FIGS. 59 to 63.</figref><figref num="65A">It is a figure which shows one Embodiment of the ablation apparatus which provided a partially circumferential ablation surface including a hydraulic cleaning mechanism, and is the side view of the apparatus which provided the hydraulic pressure line connected to the ablation surface.</figref><figref num="65B">It is a figure which shows one Embodiment of the ablation apparatus provided with a partially circumferential ablation surface including a hydraulic cleaning mechanism, and is a more detailed perspective view of an ablation surface, a hydraulic pressure intake part, and multiple outlet holes. Is.</figref>

Utilization of fully circumferential and partially circumferential ablation structures, some in combination with inflatable balloons to position the ablation structure relative to the target tissue, use of ablation techniques Has been mentioned in US patents and US patent applications. Devices and methods that utilize a partially circumferential ablation structure include, for example, the following US patent applications: 11 / 286,257, 11 / 286,444 and 11 / 275,244. In addition, devices and methods that utilize a completely circumferential ablation structure include U.S. Patents: 6,551,310 and 7,150,745, and U.S. Patent Applications: 11 / 557,445, 10 / 370,645, 10 /. It is described in 416,923, 11 / 420,722, 11 / 420,719, 11 / 420,714, 11 / 420,712, 11 / 469,816 (Shadduck), and US Pat. No. 6,872,206.

The devices and methods may provide an immediate hemostatic effect, or may eliminate or repair a disorder that tends to bleed in the future, and the therapeutic effect may provide an extended time in association with wound healing. Therefore, it may gradually lead to a more effective hemostatic effect. This therapeutic effect can be achieved over a wide range, typically coaptive in nature, uniform in depth, controllable to the desired depth, and quickly. Will be sent. For some embodiments of the invention, the wide-field aspect of ablation therapy is due to the large surface area of the device and the ability to repeatedly rearrange the device to treat adjacent and non-proximal areas. It is a thing. Cooperative ablation of blood vessels is considered to be an advantageous method (approach) for several reasons. First, as blood is removed or reduced from the site, the tissue heatsink. sink) Capacity (ability to absorb heat) is reduced, producing a more effective hemostatic effect. Second, prior to applying therapy, the treatment anneals the vascular wall together by compressing or crushing the vessel wall together with the pressure applied by the device itself. Bringing blood flow can be stopped. Thus, method steps that favor co-coagulation, such as application of appropriate pressure, are beneficial to the method. Due to the pressure applied to the tissue targeted by the ablation device or the blood vessels contained therein, the hemostatic effect is inherently co-operative. For embodiments of the invention, a level of pressure, typically applied by an expandable member of the device when in close proximity to the site of interest, or on which the device is mounted, or device. The pressure level applied by the physical movement of the endoscope through which it is inserted ranges from about 1 pound to about 15 pounds per square inch (pound square inches: psig). In particular, the co-operative pressure is about 3 to about 7 psig. An even more cohesive pressure is about 4 psig.

The therapeutic parameter may be that a uniform level of ablation is achieved in all or part of the targeted site of injury. For example, for superficial disorders, the desired depth of ablation may be mucosa or part of the mucosa. For deeper disorders, the depth of ablation may be deeper mucosa and all or part of the submucosa. Depth control and uniformity of the ablation effect is achieved through device features and therapeutic parameters, including electrode patterns, pressure on the target site of injury, energy density, power density and number of applications.

The choice of embodiments of methods and devices used to treat a particular bleeding site or site of injury includes the size of the organ in which the bleeding is occurring, endoscopic access, and the site of bleeding. And the size of the disorder, as well as the degree of involvement of the inner layer of the organ. For example, within the gastric antrum of a patient with GAVE, the site of bleeding failure is narrow, straight (like spokes radiating from the wheel) or confluent and circumferential. May. In the former case, focal ablation and hemostatic devices, such as, for example, an ablation catheter with a partially circumferential ablation surface, or other localized devices disclosed herein. May be preferable. In the latter case, a completely circumferential ablation and hemostatic device is preferred. Both types of devices (ie, localized or non-circumferential and circumferential devices) insert the endoscope over the endoscope, or along the length of the endoscope. , Can be attached in various ways. In addition, the device may include balloon or non-balloon methods of expansion and compression of the tissue of interest.

Embodiments of methods and devices for carrying out the method can be applied to acute or chronic bleeding sites in the gastrointestinal tract. 1A and 1B schematically show a cross section of the wall of a portion of the gastrointestinal tract where the bleeding vessel 4 is located. FIG. 1A shows a portion of a blood vessel, arteriole or veneole with branched capillaries, located primarily in the lamina propria and epithelial tissue. FIG. 1B also shows a portion of a blood vessel, arteriole or benuole with branched capillaries, located primarily in the submucosa and lamina propria. The point of these figures is that fragile and bleeding blood vessels may be present in certain layers of the gastrointestinal tract. In some cases, due to the known properties of a particular condition, the histological layers involved may be known. In other cases of acute or chronic bleeding, the patient's specific information from the patient's medical history, biopsy (biopsy), preliminary to treatment, or endoscopic observation during treatment. Are available, they can provide signs of preferentially localizing problematic blood vessels to a particular tissue depth. In the example given by FIG. 1A, it would be preferable to supply the energy of the depth controlled ablation so that the ablation occurs in the epithelial tissue and in the lamina propria. Also, in the example given by FIG. 1B, it would be preferable to provide depth-controlled ablation energy such that ablation occurs within the submucosa, muscularis mucosae and lamina propria.

2A-2C are diagrams showing specific examples of conditions that are sources of acute or chronic bleeding in the gastrointestinal tract and can be the subject of hemostatic ablation according to embodiments of the methods and devices of the invention. is there. FIG. 2A shows an arteriovenous malformation (AVM) 4avm as an entanglement of blood vessels located between the upstream artery 4a and the downstream vein 4v. FIG. 2B schematically shows telangiectasia with significantly dilated capillaries 4c located between the upstream arteriole 4a and the downstream venuole 4v. Figure 2C also shows the endoscopic distance of the stomach, as seen towards the pylorus of a patient with a wide pattern of 4 wm of watermelon gastric site, which is characteristic of gastric antral capillary dilatation (GAVE). It is a figure in the position direction. Since these vascular disorders 4l are visualized by an endoscope, they can be visually recognized not only externally but also internally on the skin covering the stomach.

Looking back on one aspect of the therapeutic ablation method given here (aspect), that is, determining the suitable site for ablation treatment (Figure 3) as well as the amount of ablation energy applied during such treatment. Such a decision is derived from the total amount of clinical information that a clinician can collect for a particular patient. In some embodiments, as well as an assessment of the approximate dimensions of the patient's gastrointestinal tract, a preliminary of acute or chronic gastrointestinal bleeding sites so that features specific to any patient can be precisely planned. A good endoscopy may be preferable. Such information can be obtained by direct visual observation by endoscopic methods, optionally with intramucosal staining agents, and also non-narrow band imaging such as narrow band imaging from an endoscope. Further can be achieved by other diagnostic methods, including invasive transmission imaging methods, or by using any conventional method known in the art. On one side, the evaluation of a site involves identifying the location of the site, including its dimensions. On the other side, the assessment of the tissue of interest involves identifying the multiplicity of the sites in the case of one or more sites, as well as identifying those locations and their respective dimensions. .. On the other side, assessing the site of interest involves identifying or grading any lesion or injury or specific feature of the site of acute or chronic gastrointestinal bleeding, and is particularly targeted for ablation. Includes identifying any clinically meaningful or problematic area that overlaps or is in close proximity to the area of interest.

Once the target site for ablation has been identified, the target tissue for acute or chronic gastrointestinal bleeding sites should be treated with an original ablation device and related methods, as described herein. Can be done. The assessment of the condition of the ablation target tissue is also, for example, in close coordination with the ablation, immediately before and / or immediately after the application of ablation energy (eg, radiant energy), especially by visualization, ablation therapy (Figure 3). ) Is usefully executed as part of. In addition, any diagnostic method when clinically appropriate after ablation treatment, for example, a few days, weeks, months, or whenever clinically indicated following ablation treatment. Alternatively, the treatment site can be evaluated by a visual method. If any follow-up evaluation indicates that the treatment has been inadequately completed or that the cell population targeted for ablation is recovering, repeated ablation treatment is instructed.

As described in detail here, looking back at the aspects of the ablation device that can direct the ablation modification of the injured bypass treatment, the ablation device is arranged with energy transfer elements such as electrodes. It has an ablation structure. In some embodiments, depending on the type of ablation energy used in the treatment, it can be mounted on or supported by some instrument, which provides the appropriate movement of the ablation surface to the location of the target site. Tolerate. Such devices, in their form and dimensions, are well adapted to reach the site of interest and may include a purpose-appropriate simple catheter; insertable. The (insertive) device includes an endoscope, which, in addition to its supporting role, also provides visualization capabilities. Also, in some embodiments of the method, an endoscope separate from the supporting device can participate in the ablation treatment by providing visual information.

Illustrative embodiments of creative devices, as described herein, typically utilize electrodes that transmit radio frequency energy, but this form of energy transfer is non-limiting. Yes, embodiments of the present invention include other forms of energy, as well as other forms of energy transfer hardware. As provided by embodiments of the present invention, ablation energy is transmitted from, for example, microwave energy radiated from an antenna, light energy radiated from a photonic element, and the surface of a heated ablation structure. As brought about by heat transfer or heated gas or liquid, by heat sink heat absorption of energy, by freezing or cryogenic cooling of the surface of the ablation structure, or by the structure of cold gas or spray fluid or mist. It contains thermal energy that is transferred to the tissue as applied by direct contact with or by absorbing heat through the walls of a device that separates a cold gas or fluid from the tissue.

Embodiments of the ablation apparatus include variations with respect to the extent of the entire circumference of the ablation surface being handled, some embodiments providing a perfect perimeter-like ablation surface, and other embodiments described above. As such, it gives an ablation surface that is smaller than the perfect peripheral surface. Choosing the right device, as shown in Figure 3, is a step within the scope of a given treatment method. These and other variants provide unique advantages, depending on the nature, extent, location and dimensions of one or more of the walls of the gastrointestinal tract. One embodiment of the present invention is a full radial zone within a lumen organ. It includes a device with an ablation surface that surrounds a completely circumferential, or 360 degree radial range, so that the zone) is ablated. Within this zone, depending on the energy output and the pattern of ablation elements (such as electrodes), ablation is performed to vary the angle, but with substantial uniformity within the ablation zone. To. This embodiment is particularly suitable for treating extensive or diffuse sites within an acute or chronic gastrointestinal bleeding site. In other embodiments of the device, the ablation surface of the original device is partially circumferential and engages the entire inner perimeter or portion of the inner perimeter of the lumen organ. Fragmented portions of the perimeter that are ablated on the inner surface of the lumen organ are the size and placement of the lumen organ to be treated (radius, diameter or all circumference or slope, as described in more detail below. ) And the dimensions of the ablation surface. For smaller and more discrete treatment sites, the smaller and more discrete ablation planes provided by the latter embodiment may be advantageous.

This type of operational control of an all-around subset of ablation energy elements around a 360-degree all-around array is a section entitled "Controlling Electrode Patterns and Ablation Patterns Across Surface Areas of Tissues" (Section: As described later in section), it resembles the fragmentary manipulation of a patterned subset of electrode arrays. In a partially circumferential operation of an array, a specific arc is driven to supply energy to the arc around the entire circumference. In a fragmentary pattern manipulation of an array, energy is delivered to one part of the tissue in the area of interest, while the other part receives insufficient energy to achieve ablation. In some embodiments, these operational variations can be combined, i.e., a patterned subset of all-around arcs can be driven.

Both FIGS. 3 and 4 are flow charts of an embodiment of a method of ablating (melting) tissue at a bleeding site in the acute or chronic gastrointestinal tract. These figures show the method produced by two embodiments of the device, one having a 360-degree all-around ablation structure and the other having an ablation structure with arcs smaller than 360 degrees. It represents a common aspect of the embodiment.

FIG. 3 is a flow chart showing the overall picture of the method, focusing on patient evaluation and determination of clinically suitable sites for ablative treatment in the gastrointestinal tract. In another step, the responsible clinician was placed on a suitable example to treat the patient: device 100A with a 360 degree electrode arrangement or an arc smaller than 360 degrees. An informed choice is made for any of the devices 100B equipped with electrodes. When selected to use device 100A, treatment choices are made to operate the electrodes over a 360 degree circumference or to operate a subset of the radial structure of the electrode array. In the other step, the clinician reviews and decides on the ablation procedure, taking into account the amount of energy to be supplied, the energy density, and the duration of energy supply. These studies take into account the surface area to be fused, the depth of tissue to be treated and the characteristics of the electrode arrangement, eg, whether the electrodes should be fragmented and what pattern is desirable. .. Regardless of the device choice, another preliminary step to the implementation of the method can include a more in-depth assessment of the site of interest in the gastrointestinal tract. Evaluation of such sites also provides a detailed examination of some visualization characteristics, or the number, dimensions, exact location, and / or its clinical condition, apparently normal or abnormal of individual target tissue sites. May include diagnostic methods. This step is shown following instrument selection, but can occur at any time, simply in connection with diagnosis, or after diagnosis of the tissue of interest and approximate location. In any case, as outlined in the process operation step, the evaluation step is typically performed prior to ablation, as shown in the flow diagram of FIG. In the following description, reference numeral 100 is generally used to refer to an ablation apparatus, whether its ablation surface 101 is completely circumferential or partially circumferential.

FIG. 4 is a flow chart showing a method after the target site in the acute or chronic bleeding site of the gastrointestinal tract is locally limited and a preferable ablation device is selected. The method includes an evaluation of the site, which, as described above, includes location identification, stage, determination of the number and dimensions of the site, and the references mentioned in the background section. The method described in detail in the above and / or any method known to practitioners in the art is used. The method also continues the insertion of the instrument and the local movement of the instrument to the tissue of interest for ablation treatment. Subsequent, more precise movements of the ablation therapeutic structure can be performed that produce a more therapeutic contact between the ablation structure and the site of interest. If a 360 degree embodiment of device 100A is selected, therapeutic contact is made by inflating a balloon underneath the electrode array. In the case of 100B, which is a device with an electrode surface that extends to an arc-shaped part smaller than 360 degrees, the movement that brings the ablation surface to therapeutic contact is any expansion or deflection of the balloon. It may include the expansion of the (deflation) member and / or the operation of the deflection member, all of which are further described below.

Subsequent steps include the release of ablation energy from the device, depending on the device Example 100A or 100B and, depending on what type of operation was performed, after the therapeutic contact has been made. Changes in the release of ablation energy include not only ablation of a single site, but also the movement of the instrument to a second site or subsequent site identified during the evaluation step. Following an ablation-like event, subsequent steps can include an assessment of the treated site; alternative, an assessment of the results of ablation may include collecting and observing clinical data of the patient. Absent. If the endoscope is included during the procedure, as an instrument to support the ablation structure, or as a separate instrument, such an assessment will be very early during the procedure, immediately or after ablation, if the instrument is already in place. Will be done. In other embodiments of the method, the treated site can be evaluated at any time clinically appropriate after the procedure, eg, the next day or the next week or months later. If any of these evaluations show ablation that is only partially completed, or if it shows unwanted regeneration of the cells of interest, the method has just been described and is also shown in FIG. It appropriately includes the repetition of the steps performed.

&lt;Devices and methods for 360-degree circumferential ablation&gt; The method according to the invention for achieving ablation of vascular tissue at an acute or chronic bleeding site in the gastrointestinal tract comprises releasing radiant energy at a level that achieves ablation of the bleeding site in the gastrointestinal tract. .. In the typical embodiment described in this section, the distribution element of radiant energy is constructed in a 360-degree circular shape. Instead of using the release of RF energy from the ablation structure, other energy sources can be used with the ablation structure to achieve tissue ablation and without the need for electrodes. Such alternative energy sources are ultraviolet light, microwave energy, ultrasonic energy, thermal energy transmitted from a heated fluid medium, thermal energy transmitted from a heated element, steam heating an ablation structure. Alternatively, a heated gas (gas) such as steam that directly heats the tissue through contact between the steam and the tissue, parallel or non-parallel light energy, a cooled fluid around or inside the ablation structure or Includes low temperature energy transmitted by gas or directly cooling the tissue through contact of the fluid / gas with the tissue, and the like. The embodiments of systems and methods that utilize these forms of ablation energy include structures, control systems, power supply systems and all other ancillary support systems and methods for the type of ablation energy supplied. Includes modification as appropriate.

In some embodiments of a fully circumferential ablation device, the flexible shaft comprises a cable surrounded by an electrical insulating layer and radiant energy at its distal end. It has a distribution element of. In one embodiment of the invention, the positioning and expansion device around the distal end of the device is located internally, not only on the sides of the energy distribution element, but also on the front of the energy distribution element. It is of sufficient size to contact and dilate the walls of the gastrointestinal tract (eg, stomach, pylorus, small intestine, rectum or anus) at the site of acute or chronic bleeding. For example, the distal head of the instrument (distal The head) can be supported by an inflatable balloon, or inflatable member, at a controlled distance from the wall of the gastrointestinal tract at the site of acute or chronic bleeding, resulting in energy through the electrodes. A therapeutic contact is made between the ablation structure and the target tissue to allow regulation and control of the amount of energy transferred to the tissue within the lumen when added. The balloon is preferably attached to a portion of the flexible shaft at a point away from the distal head element.

Some embodiments of a fully circumferential ablation device include an expandable or inflatable balloon as a means of transport for delivering ablation energy. Also, one feature of this embodiment includes means by which energy is transferred from the distal head portion of the present invention to the membrane constituting the balloon member. For example, one type of energy distribution that is suitable and incorporated herein by itself is set forth in US Pat. No. 5,713,942. There, the inflatable balloon is connected to a power source that provides radio frequency power with the desired properties to selectively heat the tissue of interest to a desired temperature. According to embodiments of the present invention, balloons can be made of electrically conductive elastomers, for example a mixture of polymers, elastomers and electrically conductive particles. Alternatively, a non-expandable air bag (bladder) having a shape and size that extends to the tissue to be contacted in a fully inflated form can be constructed. In another embodiment, the electrically conductive member is made of an electrically conductive elastomer, where an electrically conductive material, such as copper, is deposited on the surface and electrodes are deposited on the material. The pattern is etched and then this electrically conductive member is attached to the outer surface of the balloon member. In certain embodiments, the electrically conductive member, eg, the balloon member, is shaped to fit the dimensions of the dilated (unbroken) inner surface of the human gastrointestinal tract at the site of acute or chronic bleeding. Has an inflatable form. Further, such an electrically conductive member can consist of a plurality of electrode segments arranged on an ablation structure 101 having one or more thermistors, said thermistor. It is connected to each electrode segment, whereby the temperature from each of the plurality of electrode segments is monitored and controlled by a feedback mechanism. In another embodiment, the electrically conductive member can have means to allow the transfer of microwave energy to the ablation site. In yet another embodiment, the expanding member or the inflatable balloon member may have a means of carrying or transmitting a heatable fluid into one or more parts of the member, said. The thermal energy of a heatable fluid is used as an ablation energy source.

Some embodiments of the fully circumferential ablation apparatus include variable and directional control means, means for accurately detecting the depth of cauterization, and suitable alternative embodiments that are inflatable. Even if it is desired not to place an electrically conductive element within the membrane forming the balloon member, for example, with an energy distribution head on the distal side, while maintaining the energy release means at a position within the volume of the inflatable balloon member. Balloon members can be utilized for placement and positioning control.

In embodiments of the present invention, an ablation device, such as a fully circumferential ablation device, is used to treat a site of acute or chronic bleeding at a site within the gastrointestinal tract. After determining the part or multiple parts of the gastrointestinal tract wall at the site of acute or chronic bleeding with tissue subject to complete or partial ablation, the patient should implement the device to be used. Treatment is prepared in an appropriate manner according to the morphology. Then, in certain embodiments, the practitioner inserts the ablation device presented and discussed herein into the patient through the access and control of the endoscope. In addition, positioning and visualization of parts of the device, performed in the proper position, identifies the site of ablation at the site of acute or chronic gastrointestinal bleeding. The selection and activation of the quadrant or part / fragment on the ablation catheter member is performed by the physician, including the appropriate power setting according to the desired cauterization depth. Additional configuration is required when further ablation is required at different locations and / or different depths in the gastrointestinal tract at the patient's acute or chronic bleeding site. Following ablation, the patient is given appropriate follow-up procedures known in the art during and after removal of the device from the acute or chronic bleeding site of the gastrointestinal tract.

In yet another method of the invention, the practitioner first determines the length of the acute or chronic bleeding site portion of the gastrointestinal tract that requires ablation, and then each catheter is coupled to a balloon member. One ablation catheter is selected from a plurality of ablation catheters of the present invention having different lengths of electrode members. For example, if the practitioner determines that a 1 cm surface of an acute or chronic bleeding site in the gastrointestinal tract requires ablation, an ablation catheter with a 1 cm electrode member may be used in the ablation. Is selected for. The length of the electrode member connected to the balloon member varies from 1 to 10 cm, for example.

In yet another embodiment, a plurality of ablation catheters are provided in which the radiant energy distribution element is linked to the balloon member, where the diameter of the balloon member when inflated varies from 12 mm to 40 mm. In this method, the practitioner has a diameter that, when inflated, stretches the acute or chronic bleeding site of the gastrointestinal tract to thin the mucosal layer and thus reduces and occludes blood flow at the site of ablation. An ablation catheter will be selected. By reducing blood flow in the ablation area, the heat generated by the radiant energy is less likely to dissipate to other areas of the tissue of interest and therefore concentrates on the ablation site.

One approach that practitioners use to determine the appropriate diameter ablation catheter for a particular patient is to use a highly flexible balloon coupled to a pressure sensing mechanism in the first step. The balloon is inserted into a luminal organ within the acute or chronic bleeding site of the gastrointestinal tract, positioned at the desired site of ablation and inflated until an appropriate pressure value is obtained. The ablation apparatus of the present invention, which has a balloon inflated to a defined diameter and can be expanded to that diameter, is selected for therapeutic use. In the method of the invention, it is desirable to fully dilate an expandable electrically conductive member, such as a balloon, until it occludes the submucosal vasculature, including arterial, capillary or venule vessels.

In other embodiments of the method, electronic means are used to measure the area of interest in the lumen of the gastrointestinal features formed by obesity surgery, and energy is adequately standardized for the surface area of the tissue of interest. Will be done. These aspects of this method were filed on June 20, 2008, entitled "Electrical Means for Standardizing Ablation Energy Transfer to the Surface of Vessel Tissue of Variable Size", in its entirety. Is incorporated herein in detail in US Patent Application No. 12 / 143,404, such as Wallance et al.

In addition to a typical embodiment of an ablation apparatus with a fully circumferential ablation surface that can be pressed against the area of interest to achieve therapeutic contact by the expandable member shown in FIG. Other representative examples are given in FIGS. 57A-57D and 58A and 58B. A specific example, shown in Figures 57A through 57D, was entitled "Electrical Means for Standardizing Ablation Energy Transfer to the Surface of Vessel Tissue of Variable Size" on June 20, 2008. It is described in detail in US Patent Application No. 12 / 143,404, such as Wallance, which has been filed and incorporated herein by itself. Specific examples of devices with a 360 degree ablation surface are described in detail in the above application and are also shown in FIGS. 57A-57D of this application. Pressure detectors are used to measure the size of cavities in preparation for ablation treatment, as described in Jackson's US Patent Application No. 11 / 244,385, published as US Patent Publication No. 2006/0095032. Used.

Specific examples of devices disclosed in U.S. Patent Application No. 12 / 143,404, such as Wallance, provide a 360 degree ablation surface placed on an overlapping support that inflates according to a balloon confined within the periphery of the support. Therefore, it is briefly explained here. The periphery of the device expands with the balloon as a whole, but the ablation surface itself is non-expanding and maintains its electrode density. 57A-57D are perspective views of an ablation device with an overlapping electrode support wrapped around an expandable balloon. An array of ablation energy supply elements 101, such as radio frequency electrodes, is located on the outer surface of the electrode support. An operative element is attached to the distal end of the ablation catheter, the distal portion of its axis 41 is visible, and a balloon 105 is constructed around it. FIG. 57A clearly shows that one part of the support and the inner edge 362 are glued to the balloon and the other part and its outer edge 364 are not bound to the balloon 105. The electrode support 360 drawn from is shown. FIG. 57B shows the non-adhesive portion of the electrode support 360 wrapped around the balloon 105 in a deployable form, showing the non-adhesive portion and its edges overlapping around the non-adhesive portion. FIG. 57C shows an optional feature of device 100A, one or more more elastic band 380 wrapped around the electrode support 360. In some embodiments, the elastic band material is a conductive elastomer that can be included in a size sensing circuit that provides information about the degree of expansion of the operating element, as described in more detail below. FIG. 57D shows the device of FIG. 57C in which the balloon portion is in a non-inflated (or contracted) state and is in a folded state, in which the device is deployed in the lumen and positioned at the target site. Not only the state of the device when it is done, but also the state of being removed from the lumen after supplying ablation energy.

Other embodiments of the ablation apparatus with a fully circumferential ablation surface are given in FIGS. 58A and 58B. Specific Example 400 of this particular device is recessed or tilted inward, for example, in the distal portion of the gastric cavity or in the pylorus, which is the site of vascular lesions typical of the watermelon stomach. It is applied to make an ablation surface exist at the target site marked with. The device includes a circumferentially arranged ablation surface in the distal portion of the expandable member 105, which is mounted around the distal end 110 of the axis of the endoscope 111. FIG. 58 shows the device in the deployed form. FIG. 58B shows a device in which the expandable member is in an unexpanded or deflated state, suitable for deploying the device on a target tapered surface or for removing the device from the ablation site. .. A device of FIG. 58A is shown that can be deployed to a slanted or recessed target site, such as the pylorus 9. FIG. 58D is reversed so that it faces the proximal side and can be pulled backwards towards a sloped or depressed area, such as the lower esophageal sphincter 10. An alternative form of the device of FIG. 58A is shown with electrodes supporting the surface of the device.

&lt;Electrode pattern and control of ablation pattern across the surface area of tissue&gt; Some embodiments of the ablation apparatus and method used will be described with particular attention to the electrode patterns present on the ablation structure. The devices used are schematically shown in FIGS. 5-7. As shown in FIG. 6, the extended flexible shaft 41 of the device 100 with a fully circumferential ablation surface is connected to a multi-pin electrical connector 94. This connector includes a male luer connector 96 for connecting to a power source and for attaching to a fluid source useful for expanding the expandable member. The extended flexible shaft has an electrode 98 wound around its circumference. The expandable members shown in FIGS. 5 and 6 contain three different electrode patterns, the patterns of which are more detailed in FIGS. 7A-7C. Typically, the apparatus of the present invention uses only one electrode pattern, but can include more than one electrode pattern. In the device shown in FIG. 5, the extended flexible shaft 41 has six bipolar rings 62 (first electrode pattern) with a separation of about 2 mm at one end of the shaft. Close to the bipolar ring, it has six unipolar bands or rectangles 65 (second electrode pattern) with a separation of about 1 mm, and the other end of the shaft is axially combined. Another pattern of bipolar finger electrodes 68 (third electrode pattern) is located. In this device, a null-space is located between the last of the unipolar bands and the bipolar axial electrodes. The catheter used in this study was prepared using a flat sheet made of polyimide with a thickness of about 1 mil (mil: 0.001 inch) coated with copper. The desired electrode pattern was etched into copper.

Alternative electrode patterns are shown in FIGS. 8A-8D as reference numerals 80, 84, 88 and 92, respectively. Pattern 80 is a pattern of axially combined bipolar finger electrodes with a separation of about 0.3 mm. Pattern 84 contains a unipolar band with a 0.3 mm separation. Pattern 88 is an electrode pattern in a wavy electrode pattern with a separation of about 0.25 mm. Pattern 92 includes a bipolar ring with a separation of about 0.3 mm. In this case, the electrodes are attached to the outer surface of the balloon, which has a diameter of about 18 millimeters. The device can be adapted to utilize radio frequencies by attaching wires to the electrodes to connect the electrodes to the power supply, as shown in FIG.

The morphology of the electrode arrangement described above has been described in relation to an ablation structure with a perfect 360 degree ablation plane, but such a pattern or deformation thereof supplies energy across a plane that is completely smaller than the circumference. Ablation structure, for example, a structure that ablates (ablates) any part of the peripheral surface smaller than 360 degrees, or ablates over a range of about 90 degrees or about 180 degrees. Can be done.

The embodiments of the ablation system provided herein are generally characterized as having a substantially flat electrode pattern on the surface of the ablation support structure, which is impermeable to the ablated tissue. The electrode pattern forms a continuous therapeutic area with a substantially radial aspect of the luminal organ; this area is distinct from the ablation pattern left by electrical filaments, filament sprays or single wires. To. In some embodiments of the invention, the radial portion may be completely circumferential; the radial portion of the luminal organ ablated by the embodiments of the present invention is (1) in the case of the stomach. Is a function of the combination of the perimeter of the organ and (2) the dimensions of the electrode pattern, which is relatively large and small in the case of the area within the small intestine or anus. Therefore, at the upper limit, the radial extent of the therapeutic area is as large as 360 degrees and as small as about 5 to 10 degrees, as is the case with the therapeutic area in the stomach.

Embodiments of ablation energy supply systems and methods are also characterized by non-penetration for the tissue of interest. Ablation radio frequency energy is supplied from the electrode pattern when the flat electrode pattern makes therapeutic contact with the tissue surface of the therapeutic area, as described elsewhere in the application; From the point of surface contact, energy is delivered directly inward towards the underlying panniculus.

Some embodiments of the ablation systems and methods provided herein can be further characterized by electrode patterns configured to achieve partial or fractional ablation, resulting in tissue. Only one part of the surface receives enough radiofrequency energy to achieve ablation, and the other part of the tissue surface receives insufficient energy to achieve ablation. The system and method can be further configured to control the supply of radiofrequency energy from the tissue surface to the inward, resulting in the depth of the tissue layer providing sufficient energy for ablation. Be controlled.

Controlling a fraction of the target area on the surface of the tissue to be ablated allows, at least to some extent, a small portion of the tissue to be ablated and the surface within the target area to emerge from the treatment. A small portion of is substantially free from ablation. The ability to control the ratio of ablated to non-ablated surfaces is beneficial for treatment. According to embodiments of the present invention, ablation-like treatments aim to ablate vascular tissue and have minimal or recoverable or transient effects on surrounding tissue. There is. Therefore, what is desired is a well-controlled and regulated ablation that results in a varying degree of therapeutic effect without substantially damaging the organ or its particular layer. In other words, for the health of the organs in which the vascular tissue of interest is located, and for the health of the individual as a whole, some normal functioning after ablation. Is generally desirable to remain in the surrounding and intervening tissues.

To some extent, split ablation can be as functionally effective as complete ablation with respect to the effects of methods involving split ablation of cells within a region of interest, including vascular cells, on vascular tissue. Vascular cells, especially the endothelial cells that form blood vessels, grow in an arboreal manner. It is generally believed that an isolated vascular system is not adjacent to any other part of the isolated vascular system. Thus, the vessels that survive the split ablation procedure, however, remain isolated from the upstream and downstream connections and are left behind, thereby destined to be biologically absorbed. ing. Thus, based on the above considerations, small-scale ablation of tissues within the area of interest, especially tissue within the area of interest of blood vessels, effectively ablates blood vessels during acute or chronic bleeding (ablation). ), And it can be understood that the tissue can be beneficially left in good and healthy condition over a wide area within the target area. Embodiments of the method thus include controlling the supply of radiofrequency energy up to a certain depth across the surface of the tissue within the area of interest, thereby, in a portion of the tissue within the area of interest. It provides sufficient radio frequency energy to achieve ablation, yet provides insufficient radio frequency energy to other parts of the surface to achieve ablation.

Furthermore, for the purpose of providing an example useful for explaining what is provided by the present invention, an organ having an ablation target region inside can be evaluated as a cell population in the non-vascular tissue of the target region, and its health. Based on the above, it is possible to work in a poor condition, for example, with a low threshold functional capacity of 20%, and in the best condition, with 100% functional capacity. The purpose of the ablation therapy provided herein may be to work at 50% capacity without dysfunctional the entire population of cells within the scope of this example by analogy. Also, the purpose of treatment is to maintain a small portion of the population in a fully functional state that works at about 100% capacity and a remaining small portion to work at a lower range of abilities after ablation treatment. It may be to do.

According to embodiments of the present invention, control of a small portion of the ablated tissue surface target area is provided by a variety of exemplary techniques: (1) spacing in relatively non-dense electrode patterns. It is brought about by the physical form of the open electrode pattern, (2) by partial manipulation of the relatively dense electrode pattern, in a billboard-like manner. In general, the creation of a small portion of ablation by the physical form of the electrode pattern allows a given level of energy transfer between the electrodes, with some spacing between the electrodes close enough to allow the tissue to be ablated. On the other hand, the spacing between the other electrodes involves configuring the electrode pattern so that it is not close enough to allow the transfer of enough level of energy to ablate. An exemplary electrode pattern embodiment demonstrating this approach to the creation of a small portion of ablation is described below and is also depicted in FIGS. 48-55. The creation of an ablation pattern by activating a small population (subset) of electrodes represents the operation of an original system and method similar to the description above, in which the ablation structure with all-around pattern electrodes. However, it can be operated in such a way that only a small portion of the electrode in the radial direction is operated.

The ablation system of the present invention includes an electrode pattern with a plurality of electrodes and a longitudinal support member that supports the electrode patterns, as described herein in a number of embodiments. Energy is sent from a generator to an electrode, and the operation of the generator is controlled by a computer controller connected to the generator. This computer controller controls the operating parameters of the electrodes. The computer controller has the function of supporting all electrodes or a subset of electrodes to supply energy. The controller also has the ability to control the timing of energy supply so that the electrodes are driven simultaneously or in a subset, non-simultaneously. Moreover, as described elsewhere, the electrodes can be operated in unipolar mode, bipolar mode, or multiplexing mode. These various modes of actuation ablate a portion of the tissue within the area of interest, especially when the pattern is in therapeutic contact with the surface of the object, with the aim of activating a subset of electrodes within the pattern. Allows pattern formation, leaving some of the tissue within the area of interest unablated.

In general, in the creation of split ablation by operational techniques with a relatively dense electrode array, the energy supplied between some electrodes is sufficient to perform the ablation, while between some electrodes. In, it involves manipulating the electrode pattern so that sufficient energy is not supplied to perform the ablation. An exemplary electrode pattern embodiment illustrating this technique of producing split ablation is described below and is also depicted in FIGS. 48-55.

According to embodiments of the present invention, another aspect of tissue division ablation control relates to controlling the depth of ablation into layers of tissue within a region of interest. Energy is supplied inward from the surface, so the level of ablation can be controlled with a gradual increase in energy supply. As a result, for example, the ablated tissue may consist solely of tissue within the epithelial layer, or may consist of tissue within the epithelial layer and lamina propria, or the epithelial layer, lamina propria and muscularis mucosae. It may consist of tissues within, or it may consist of tissues within the epithelial layer, lamina propria, muscularis mucosae and submucosa, or it may consist of epithelial layer, propria, muscularis mucosae, submucosa and lamina propria. It may consist of an internal organization. In no case is ablation energy delivered to the serosal layer at the site of acute or chronic bleeding in the gastrointestinal tract.

Embodiments of the invention include a pattern of RF electrode sequences that ablate a small portion of tissue within a given single ablation region, with typical split sequence patterns being shown in FIGS. 48A, 49A and FIGS. Shown at 50A. As described above, the arrangement of these divided ablation electrodes is an ablation structure focused on a completely circumferential target region, or a perfect circumferential surface such as a 90 degree radial surface or a 180 degree radial surface. It can be applied to ablation structures that focus on every part. FIG. 48A shows a pattern 180 of linear electrodes 60 arranged in parallel as a striped pattern on the support surface. When the electrodes are well separated and pressed against the tissue in therapeutic contact, the burns left by the distribution of energy through the electrodes are striped on the target tissue, as seen in Figure 48B. Presents a pattern. FIG. 48B corresponds to this electrode pattern, with a striped pattern of burned or ablated tissue 3a alternating with unburned or substantially unaffected tissue 3b. In some embodiments of the method, focus is on a target surface of about 180 degrees around the inner circumference of the lumen, particularly a target area smaller than a 360 degree radial angle, such as a target surface of about 90 degrees. Ablation can be repeated with ablation structures located at different angles. For example, Figure 48C depicts a tissue burn pattern 191 created by a second ablation event following a second ablation event after the ablation structure has rotated about 90 degrees in the horizontal plane after the first ablation event. .. As another example, Figure 48D depicts a tissue burn pattern 192 created by a second ablation event following a second ablation event after the ablation structure has rotated about 45 degrees in the horizontal plane after the first ablation event. There is.

The effect of the ability to ablate tissue surfaces in this way adds another level of fine control over tissue ablation and the depth of tissue ablation, beyond parameters such as total energy distributed. The level of control provided by the split ablation, especially when combined with repeated ablation, as described in FIGS. 48C and 48D, is the highest local maximum ablation level. Adjust the existing surface area where a small portion of the tissue is distributed. The split ablation provided by such a split electrode pattern is not intended to be a complete and complete ablation effect and a functional compromise of tissue or cells within the tissue is desired. Is especially beneficial. Therefore, in some therapeutic examples, a partial reduction in the overall function of the subject area may be a preferable result rather than an overall loss of the overall function of the subject area. For example, in the split ablation of the area of interest at the wall of an acute or chronic bleeding site in the gastrointestinal tract, a favorable result may be, for example, a temporary compromise for non-vascular tissue. In an ablation pattern involving a burned area 3a and a non-burned area 3b, cells from the non-burned area can give rise to cells that migrate or colonize exposed areas within the burned area. , Should be understood.

Figures 49A and 50A depict other examples of electrode patterns on the ablation structure that are split and ablated, and FIGS. 49B and 50B are respective splits on the tissue treated with these electrode patterns. It shows a burn pattern. In FIG. 49A, the concentric pattern 182 is formed by the wire electrodes forming the +-++-pattern (from the center to the outside). When activated, the tissue between the + and-electrodes is burned, and the tissue between the ++ electrode pairs or-the tissue between the electrode pairs is not burned. Therefore, the concentric pattern 192 of FIG. 49B is formed. An embodiment of a split and ablated electrode pattern, such as that in FIG. 49A, does not need to include a perfect circle, and a circle (incomplete circle or ellipse) is around its common center. It does not have to be completely concentric.

Similarly, FIG. 50A shows a grid pattern 184 of + and-electrodes that, when activated, creates a burn pattern 194 as seen in FIG. 50B. The tissue between adjacent + and-electrodes is burned, and the tissue between adjacent ++ electrode pairs or-between electrode pairs remains unburned. FIG. 50B includes representations of the positions of the + and-electrodes from the ablation structure to clarify the relative positions of the burned region 3a and the region 3b that remains substantially unburned.

Embodiments of the present invention include a pattern of RF electrode sequences that ablate a small portion of tissue within a given single ablation region by a manipulative approach, thereby causing an ablation event to occur on the region of interest. During this time, some electrodes of the pattern are activated and some electrodes are not activated. Typical split sequences are shown in FIGS. 51A, 52A, 53A and 54A. As described above, the arrangement of these divided ablation electrodes is an ablation structure focused on a completely circumferential target region, or a perfect circumferential surface such as a 90 degree radial surface or a 180 degree radial surface. It can be applied to ablation structures that focus on every part.

FIG. 51A shows a grid-like electrode pattern during an ablation event in which all electrode squares of actuation pattern 186A are actuated, as depicted by a sparkle line surrounding each electrode . Activating the electrode pattern 186A in this manner creates the ablation pattern 196A, which is the tissue 3a in which the entire surface of the tissue within the treatment area is ablated, as seen in FIG. 51B. On the other hand, FIG. 52A shows a grid-like electrode pattern during the ablation event in which only every other electrode square of the working pattern 186B is working, as depicted by the flash rays surrounding each working electrode. There is. Activating the electrode pattern 186B in this manner creates an ablation pattern 196B, where the dispersed pattern of the ablated square tissue 3a is the square region of the unablated tissue 3b, as seen in Figure 52B. It is a grid-like, divided and ablated pattern that appears alternately with.

Figure 53A shows the alternating + and-electrode streaks during the ablation event in which all the electrode squares of working pattern 188A are working, as depicted by the flash rays surrounding each linear electrode. A linear electrode pattern is shown. Activating the electrode pattern 188A in this manner creates an ablation pattern 198A, as seen in FIG. 53B, where all surfaces of the tissue within the treatment area are ablated tissue 3a.

On the other hand, FIG. 54A shows the alternating + and-during the ablation event in which the alternating electrode pairs of the linear electrode pairs are operating, as depicted by the flash of light surrounding the working linear electrodes. The linear electrode pattern 188B of the striped pattern of the electrode is shown. Activating the electrode pattern 188B in this manner creates an ablation pattern 198B, as seen in Figure 54B, where the streaks of ablated tissue within the therapeutic area are striped of the non-ablated tissue 3b. It appears alternately with the pattern.

FIG. 55 is a schematic representation of the target region of the radial portion of the gastrointestinal tract at an acute or chronic bleeding site, as shown after ablation treatment according to embodiments of the present invention3. It is a diagram of dimensions. The ablated area 3a is represented as an area distributed through the area of interest within the wide sea portion of the non-ablated tissue 3b. In this schematic, these areas are depicted as slightly conical portions, but in practice the ablated areas may have a more columnar shape. Area 3a is approximately the same depth, as described herein, by control acting over the depth of the ablation region into the layer of the wall of the gastrointestinal tract. With such control, the area 3a can be varied with respect to the layer in which the area extends continuously from the upper surface to which the ablation energy is applied. The conical areas are of approximately the same width or diameter and are evenly distributed throughout the tissue, with control over the area of the ablation plane, as described herein. In this particular example, the therapeutic target is actually a particular type of cell 4b (open irregular sphere), eg, a nerve cell or a secretory cell of the endocrine gland; these cells Is distributed over the entire target area. The target cells 4a (dark, irregular spheres) after ablation treatment happened to be contained within the ablated conical area 3a. Post-ablated cells 4a may be more or less dysfunctional, may be completely dysfunctional, and to some extent, only on average 50% functional, just for explanatory illustrations. It may, and its functionality may fluctuate over a certain range. However, according to embodiments of the present invention, it should be evaluated that cells 4b not contained within the cone of ablated tissue are fully functional.

&lt;Ablation control from the viewpoint of tissue depth of ablation effect&gt; In addition to controlling the surface region distribution of ablation, the ablation structure treats the tissue and treatment as achieved by the use of split ablation electrodes as described above, or as controlled by the surface region of the electrode dimensions. Ablation can be controlled with respect to the depth of ablation below the level of the tissue surface making the above contact. Appropriate energy supply parameters to provide controlled ablation with respect to depth within the tissue can be determined experimentally. An experimental set of exercises was performed, for example, on normal young pigs to understand the relationship between electrode-driven electrical parameters and the resulting level of ablation in esophageal tissue. .. The data are available in US Patent Application No. 10 / 370,645 by Ganz et al., Filed February 19, 2003, and in US Patent Application Publication No. 2003/0158550, published August 21, 2003. It is detailed in A1 and in particular in Table 1-4 of the application. Such techniques can determine appropriate parameters for ablation of other tissues within the acute or chronic bleeding site of the gastrointestinal tract. The parameters applied by the ablation electrode pattern on the ablation structure with a 360 degree working surface oriented to the esophageal tissue are, for example, a closely spaced bipolar electrode array (less than 250 microns) within 300 ms. Contains 300W supplied to. 8-12J / cm²The ablation depth, which is related to the energy density supplied by, results in complete removal of the epithelium. The parameters applied by the ablation electrode pattern on the ablation structure with an working radial surface of about 90 degrees include a number of narrow band-shaped electrodes with 250 micron wide spacing, where the generator 12- 15J / cm²Provides a very high power energy density of 40 W / cms at the energy dose of. In general, depth changes are achieved by ablation time, energy dose, number of energy applications and electrode spacing.

FIG. 25 is a schematic representation of the tissue structure of the gastrointestinal tract at acute or chronic bleeding sites, as found in various lumen organs, such as the esophagus, stomach, pylorus, duodenum and cavity. Is provided. The relative presence, depth and composition of the layers shown in FIG. 25 vary from organ to organ, but the basic structure is similar. The layer of acute or chronic bleeding site of the gastrointestinal tract faces the site of the acute or chronic bleeding cavity of the gastrointestinal tract, from innermost to outermost; also as seen in Figure 25. And from the point of view of the direction in which the ablation structure approaches the tissue. It can be understood that the innermost layer can be referred to as the surface (epithelial tissue) and the subsequent layers are below or below the "above" layer. The innermost layer of the gastrointestinal tract at the site of acute or chronic bleeding, which is the layer that comes into direct contact with nutrients and processed nutrients as it travels through the gastrointestinal tract, is the layer of epithelial tissue 12. .. This layer secretes mucus that protects the lumen from abrasion and against the corrosive effects of acidic environments. Below the epithelial tissue is the layer known as the lamina propria 13, and below it is the layer known as the muscularis mucosae 14. The epithelial tissue 12, the lamina propria 13 and the muscularis mucosae 14 together form the mucosa 15.

Below the mucosal layer 15 is the submucosal layer 16 that forms the separation boundary between the upper mucosal layer 15 and the lower lamina propria 17. The lamina propria 17 contains various different layers of smooth muscle that wrap the organ in different orientations, including diagonal, circular and longitudinal layers. Surrounding this lamina propria 17 is the serosa 18, which is the outer boundary of the organ.

The entire gastrointestinal wall is highly vascular and nerve-distributed. The mucosal layer is also rich in secretory glands and cells that secrete the contents into the lumen and secrete hormones into the bloodstream. All of these cells, including the vasculature, exocrine gland cells, endocrine gland cells and neurons, are potential targets for ablation when the ablation energy is directed to the area in which they reside. As a result of receiving energy, cells are either killed, damaged to the point of no longer functioning, or partially damaged with some function remaining. In addition, all of these cells are within the population, and partial ablation is such that some cells in the population are damaged to the extent that there is no hope of removal or salvation, and some cells are virtually unaffected and complete. It should be understood to reveal a statistical distribution of damage that remains functional. In such partial or divided ablation events, residual levels of function after therapeutic ablation may include a range of dysfunction and dysfunction.

As provided by embodiments of the present invention, the ablation applied to wall cells at the site of acute or chronic bleeding in the gastrointestinal tract can be depth controlled, so that only epithelial tissue 12 Alternatively, only the mucosal layer is ablated and the deeper layers remain virtually unaffected. In other embodiments, the ablated cells begin in the epithelial tissue and further into the submucosa and, in some cases, into the lamina propria, if necessary to achieve the desired therapeutic effect. Spread deeply.

&lt;Devices and methods for partially circumferential ablation&gt; One embodiment of the method of ablating the tissue of the gastrointestinal tract at an acute or chronic bleeding site is an ablation with an ablation structure supported by a conventional endoscope 111, as shown in FIG. Includes the use of equipment. As described herein, in particular, the tissue targeted for ablation by the ablation device and method embodiments is therefore on the wall of the gastrointestinal tract at the site of acute or chronic bleeding. An example of a commercially available conventional endoscope 111 is the Olympus "gastrovideoscope" model number GIF-Q160. Although the special construction of certain commercially available endoscopes may differ, most endoscopes have a shaft 164 with a maneuverable distal end 110, as shown in FIG. , Hub or handle 162, which is a visual channel for connection to the video screen 160. It includes a channel) and a port 166 that provides access to the internally actuated channel inside the shaft 164. As is well known in the field of endoscopy technology, the handle 162 typically has a dial, lever so that the operator can selectively steer the distal end 110 of the endoscope 111. Alternatively, another mechanism (not shown) may be provided. According to the present invention, the ablation apparatus, including the ablation structure, is advanced in the gastrointestinal tract towards an acute or chronic bleeding site while being supported by the distal end of the endoscope. The ablation structure is deflectable towards the tissue surface and the ablation structure is actuated to ablate the tissue surface. Within the gastrointestinal tract at the site of acute or chronic bleeding, tissue surface portions of various sizes are ablated using the device. As further described, the ablation structure of the embodiments described in this section does not enclose a complete 360 degree, but encloses a portion of the 360 degree as further described below.

Generally speaking, in some embodiments, a method of ablating the tissue of the gastrointestinal tract at an acute or chronic bleeding site is provided. The method involves advancing the ablation structure into the gastrointestinal tract at an acute or chronic bleeding site while supporting the ablation structure at the distal end of the endoscope. In certain embodiments, the advancement of the ablation structure to the acute or chronic bleeding site of the gastrointestinal tract is provided by positioning the ablation structure of the device close enough proximal to achieve therapeutic contact. May be enough. In other embodiments, subsequent steps may be performed to achieve the appropriate level of therapeutic contact. This voluntary step is generally understood as moving the ablation structure towards the site of interest. Thus, the method involves moving at least a portion of the ablation structure with respect to the endoscope and towards the tissue surface; and activating the ablation structure to ablate the tissue surface. And may be included further. Moving at least a portion of the ablation structure with respect to the endoscope may include moving towards or away from the endoscope along the endoscope. Moving the ablation structure towards the surface of the target tissue can be performed in a manner specific to the structure. For example, the structure can be moved by expanding the balloon member, expanding the deflation member, or moving the deflation member. The function of such movement is to establish a therapeutically effective contact between the ablation structure and the site of interest. The therapeutically effective contacts described above include substantially uniform contact, where highly controlled electrical parameters of radiation emission from the electrodes result in similarly highly controlled tissue ablation. .. Some embodiments of the invention further include structures and methods for locking or restraining such therapeutically effective contacts once established. Thus, some of these embodiments include, for example, a positioning step that uses a suction force to secure the bond between the ablation structure and the tissue site.

As shown in FIGS. 9, 10, 11 and 26, one embodiment of the method of ablating tissue in the gastrointestinal tract at an acute or chronic bleeding site is to ablate the tissue surface 3. Includes an ablation device 100 for the purpose, which device 100 includes an ablation structure such as, for example, an ablation structure 101 supported by an endoscope 111. The method involves (1) advancing the ablation structure 101 into the luminal organ; (2) bending the ablation structure 101 toward the tissue surface 3; and (3) ablating the tissue surface 3. The step of activating the ablation structure involves ablating the tissue within the walls of the gastrointestinal tract organs at the site of acute or chronic bleeding. As shown in FIG. 9, the device 100 may additionally include a housing 107, an electrical connection 109, an expansion line 113, and an expansion member or balloon 105.

In certain embodiments, the ablation structure 101 is an electrode configured and arranged to deliver energy, including radio frequency energy, to the mucosal layer of the organ wall at the site of acute or chronic bleeding in the gastrointestinal tract. It is a structure. It is assumed that such an ablation structure 101 may include a plurality of electrodes. For example, two or more electrodes may be part of the ablation structure. While substantially protecting the muscularis tissue, the appropriate level to achieve ablation of the mucosal or submucosal level of the tissue, or, alternative, to cause therapeutic damage to these tissues. Can supply energy with. Here, the term "ablation" is commonly used to refer to thermal damage that causes some of the tissue's characteristic loss of function or tissue necrosis. The thermal damage can be achieved through heating the tissue or cooling the tissue (ie, freezing).

As provided by embodiments of the present invention, radio frequency energy is one particular form of energy for ablation, while other embodiments include, for example, microwave energy, perhaps improved sensitizing. Other forms of energy may be utilized, including light or sources such as infrared or ultraviolet light combined with agent). Photonic sources can include semiconductor emitters, lasers and other such sources. The light energies may be parallel or non-parallel. Other embodiments of the invention may utilize a heatable fluid, or alternative, a cooling medium as the ablation energy medium, which cooling medium is liquid nitrogen, Freon®, non-CFC. Refrigerant, CO₂Or N₂It includes non-limiting examples such as O. For ablation with warm or cold fluids or gases, the ablation system circulates a heating / cooling medium from outside the patient to a heating / cooling balloon or other element and then returns it back to the outside of the patient. Can include. The mechanism by which the medium is circulated in a cryosurgery probe is well known in the field of ablation. For example, suitable circulation mechanisms are US Pat. No. 6,182,666 granted to Dobak, US Pat. No. 6,193,644 granted to Dobak, US Pat. No. 6,237,355 granted to Li, and US Pat. No. 6,572,610 granted to Kovalcheck. It is disclosed in the issue and they are incorporated herein by reference.

In certain embodiments, the energy delivered to the walls of the organ at the site of acute or chronic bleeding in the gastrointestinal tract includes radio frequency energy that can be delivered from the energy supply device 100. Radio frequency energy can be supplied in a number of ways. Typically, radio frequency energy is bipolarized from a bipolar array of electrodes located on the ablation structure 101. In some cases, inflatable structures such as balloons, frames, cages, etc., with controlled levels of therapeutic contact between the electrodes and the tissue of interest (eg,). A structure that can be expanded and deployed directly or in immediate proximity to the mucosal tissue to establish contact via direct contact, or through a dielectric membrane or other layer). It is supplied from the electrode located above. Alternatively, the electrode structure comprises a unipolar electrode structure that is typically energized by a radio frequency power supply combined with a counter electrode located on the patient's skin, eg, on a depression in the back. You may be. In any case, radio frequency energy is used to damage or ablate only the mucosal or submucosal level tissue without substantially heating the muscularis tissue or otherwise damaging it. Typically, it is supplied with a high energy bundle over a very short period of time. In embodiments where the ablation structure comprises multiple electrodes, one or more electrodes are bipolar or unipolar, and in some embodiments a combination of bipolar and unipolar electrodes is included.

The ablation structure 101 can be configured and arranged in any of a number of ways in terms of shape and size. Typically, the array is about 0.5 cm²About 9.0cm from²It has an area in the range of. Typical shapes will include rectangles, circles and ovals. In some embodiments, the ablation structure is about 4 cm.²It has an area of about 2 cm x 2 cm.

The housing 107 of the ablation device 100 is configured and arranged to support the ablation structure 101. The housing 107 can be made of any suitable material as long as it can withstand the high energy flux created by the ablation structure 101. As shown in FIGS. 9-14, 17, 18, 21, and 22, in some embodiments, the housing 107 is when the ablation device 100 is supported by the endoscope 111. It is sandwiched between the ablation structure and the endoscope 111. One end of the ablation structure 101 can be further separated from the endoscope than the other end in order to improve the ease of contact with the target tissue (not shown). For example, the proximal end of the electrode may be supported by a slanted housing member 107 to ensure that the proximal end of the ablation structure 101 is in contact with the tissue of interest.

The electrical connection 109 of the ablation device connects the ablation structure 101 to a power source. The electrical connection 109 may optionally include a single wire or a plurality of wires to provide a controlled energy supply via the ablation structure 101. In certain embodiments, the electrical connector 109 comprises a low electrical loss wire, such as a litz wire.

The expansion line 113 is configured and arranged to transport the expansion medium, typically a suitable fluid or gas, to and from the expansion member. In some embodiments, the expansion line is a flexible tube. The expansion line 113 may be made of a polymer or a copolymer, for example, a non-limiting example such as polyimide, polyurethane, polyethylene terephthalate (PET), or polyamide (nylon). Can be done. The expansion member 105 is designed to bend the ablation device 100 with respect to the target tissue surface 3. The expansion member 105 can be reversibly expanded to an enlarged outer contour.

In certain embodiments, the inflatable member 105 also serves as a mounting portion for supporting the ablation device 100 by the endoscope 111. As shown in FIGS. 9-14, 17, 18, 21, and 22, the expansion member 105 uses an expansion medium to form or structure a small contour (see FIGS. 10 and 20). ) Can be expanded to the shape or structure of the outer contour (see FIGS. 11 to 14 and 17 to 194). When preparing for ablation, the deflection of the ablation device 100 with respect to the tissue surface 3 can be achieved when the expansion member 105 is sufficiently inflated. As shown in FIGS. 11, 31, 42 and 44, in certain embodiments, the deflection of the device 100 is a therapeutic level of contact between the ablation structure 101 and the subject tissue surface 3, ie. Provides virtually direct, uniform and sustainable contact. For example, as shown in FIGS. 31, 42 and 44, when the inflatable member 105 is sufficiently inflated, the resulting contour of the inflatable member 105 comes into contact with the tissue surface 3 and the gastrointestinal tract. It results in flexion contact between the inner wall of the luminal organ and the ablation structure 100 at the site of acute or chronic bleeding. In these embodiments, suction can be applied in combination with the inflatable member 105 to achieve contact between the ablation structure 101 and the tissue surface 3. Aspiration can be achieved via the endoscope 111 or via an ablation device and helps to crush the subject tissue surface 3 around the ablation structure 101.

In various embodiments, the inflatable member 105 may be flexible, inflexible or semi-flexible. The inflatable member 105 is a thin, flexible air bag made of, for example, a non-limiting example, a material such as a polymer such as polyimide, polyurethane or polyethylene terephthalate (PET). Can be manufactured with. In some embodiments, the inflatable member is a balloon. Expansion of the expansion member 105 can be achieved, for example, via an expansion line 113 with a controlled supply of fluid or gas expansion medium. The expansion medium can include a compressible gaseous medium such as air. Alternatively, the expansion medium can include an incompressible medium, such as water or saline solution.

As shown in FIGS. 12, 13 and 14, the inflatable member 105 can be configured and arranged in various ways to facilitate the deflection of the ablation device 100 with respect to the tissue surface 3. For example, as shown in FIG. 12, the inflatable member 105 can be eccentrically positioned with respect to the supporting endoscope 111, as with the housing 107 and the ablation structure 101. Instead, as shown in FIG. 13, for example, the inflatable member 105 can be concentrically positioned with respect to the supporting endoscope 111, and the ablation structure 101 is inward with respect to the inflatable member 105. It can be attached distal to the endoscope 111. In another embodiment, as shown in FIG. 12, the inflatable member 105 can be located between the supporting endoscope 111 and the ablation structure 101. The ablation structure 101 shown in FIGS. 12-14 can cover a range of circumferential spans of the endoscope 111, for example from about 5 degrees to 360 degrees, when the expansion member 105 is deployed and deployed. ..

One method of ablating tissue within a luminal organ at an acute or chronic bleeding site in the gastrointestinal tract involves the first step of advancing the ablation structure 101 to an acute or chronic bleeding site in the gastrointestinal tract. There is. In the second step, the ablation structure 101 is supported by the endoscope 111 at the site of acute or chronic bleeding in the gastrointestinal tract. In the third step, the ablation structure 101 is flexed towards the tissue surface 3. In the fourth step, energy is applied to the ablation structure 101 to ablate the tissue surface 3.

In another method, the step of advancing the endoscopically supported ablation structure 101 is to advance the endoscope 111 into the luminal organ at the site of acute or chronic bleeding in the gastrointestinal tract. It can include advancing the ablation structure 101 beyond the endoscope 111. For example, the endoscope 111 can be located with respect to the ablation target tissue surface 3, after which the ablation structure 101 is advanced beyond the outside of the endoscope 111 to ablate the target tissue surface 3. Can be

In yet another method, the step of supporting the ablation structure 101 with the endoscope 111 involves inserting the endoscope 111 into the ablation structure 101 (see, eg, FIGS. 1A-2B). In one related method, the ablation structure 101 is supported by a sheath 103 (see FIGS. 26-26, 30, 31, 32 and 37) and the endoscope 111. The step of inserting into the ablation structure 101 involves inserting the endoscope 111 into the sheath 103. In yet another related method, the step of inserting the endoscope 111 into the sheath 103 comprises creating an opening (not shown) in the sheath 103.

In certain methods, the distal portion of the sheath 103, which has an outer diameter smaller than the proximal portion of the sheath 103, is adapted to be dilated when the endoscope 111 is inserted into it. ..

Alternatively, the step of advancing the ablation structure 101 into the gastrointestinal tract at the site of acute or chronic bleeding is endoscopic (as discussed below for FIGS. 34A, 35A and 36A). It involves advancing the ablation structure 101 from either the proximal end or the distal end through the channel of the endoscope 111. In yet another method, the step of supporting the ablation structure 101 is ablated with a groove in endoscope 111 (as discussed below for FIGS. 34A, 35A, 36A, 37-39). Includes supporting structure 101. In a further method, the flexible structure or flexible member 150 is advanced through the groove of the endoscope 111, and the step of bending the ablation structure 101 toward the tissue surface 3 is the flexible structure or flexible member 150. It involves bending the ablation structure 101.

As shown in FIGS. 34A, 35A and 36A, the variously adapted and configured ablation structures 101 are fitted into and transferred through the endoscope's internal working channel 211. Can be done. In each case, the ablation structure 101 and the ablation structure 101 and in the dimensionally miniaturized first form, which can be extended to a second form that extends radially out of the distal end 110 of the endoscope 111. The paralyzed flexing mechanism can be transferred through the internal actuation channel 211 (see, eg, FIG. 34A, FIG. 34B, FIG. 35A, FIG. 35B, FIG. 36A and FIG. 36B).

As shown in FIG. 34B, in some embodiments, the flexing mechanism is an expanding member 105, whereas the ablation structure 101 is integrated, for example, by etching, attachment or gluing. Or can be mounted / mounted. The inflatable member 105 is, for example, a flexible, inflexible or semi-flexible balloon.

As shown in FIGS. 35B and 36B, in another embodiment, the flexing mechanism is an expandable member 209 that can be extended to a second desired form and arrangement. As shown in FIG. 35B, the expandable member 209 is an expandable stent, frame or cage device on which the ablation structure 101 is mounted or integrated. is there. For example, the expandable member 209 is a wire cage, which may be a component of a bipolar circuit that characterizes the ablation structure 101. Instead, the cage can be glued with a flexible electrode circuit or attached to the outer or inner surface of the cage to provide the electrode ablation structure 101. As shown in FIG. 35B, the expandable member 209 contains or has an attached ablation structure 101 that expands upon exiting the distal end 110 of the endoscope 111, folded or rolled. It may be a series of ring-shaped bodies (hoop).

Further, as shown in FIGS. 37-39, the ablation structure 101 can be supported by the groove of the endoscope 111. As shown in FIGS. 37-39, in certain embodiments, the ablation device 100 includes an attached housing 107 and a flexible member 150 that supports the ablation structure 101. As shown in FIG. 39, the endoscope 111 includes an internal actuating channel 211 suitable for advancing or retreating the flexing member 150 connected to the internal coupling mechanism 215 of the ablation device 100. Both FIGS. 37 and 39 show the bending member 150 including the bending region of the bending member 150 at the deployment position, and at the deployment position, the bending region of the bending member 150 is the distal end 110 of the endoscope. It is located outside of. FIG. 38 shows the bending member 150 in the non-deployed position, and in the non-deployed position, the bending region of the bending member 150 is located inside the endoscope 111. As described above, the ablation structure 101 is supported by the groove portion of the endoscope 111 (internal operating channel 211 of the endoscope 111) by the flexible member 150 and the connected internal coupling mechanism 215 of the ablation device 100. There is.

Further, when the flexing member 150 is advanced, i.e., moved in the proximal or distal direction within the internal working channel 211 of the endoscope, the flexing member 150 is therefore the endoscope 111. It will be advanced through the channel (groove) of. In another embodiment, the expansion line 113 is as shown in FIG. 42, where the deflection mechanism is an inflatable member 105 (shown in a deployed and deployed form) coupled to the expansion line 113. , Can be placed within the internal working channel 211 of the endoscope. In yet another embodiment, both the inflatable member 105 (in the undeployed form) and the inflatable line 113 act internally in either the proximal or distal direction with respect to the endoscope 111. It can proceed within channel 211. As shown in FIG. 37, the conductive wire 109 can be routed through or outside the working channel (not shown).

In another embodiment, as shown in FIG. 41, an internal working channel 211 suitable for supporting the ablation housing 107 and the ablation structure 101 connected to the internal coupling mechanism 215 of the ablation device 100. Includes. The ablation structure 101 connected in this way is supported in the groove of the endoscope 111. In addition, as shown in FIG. 41, the housing 107 and the ablation structure 101 can be further supported by the outer region of the endoscope 111, where the internal coupling mechanism 215 contains the housing 107. It is adapted and configured to be in contact with the external region of the endoscope 111. The internal coupling mechanism 215 can be inserted into a cannula to facilitate the use of working channels for suction and flow in fluid or air (not shown).

In other ablation methods, an additional step involves moving the ablation structure 101 with respect to the endoscope 111 within the luminal organ at the site of acute or chronic bleeding in the gastrointestinal tract. As shown in FIGS. 27, 28, 30, 32 and 47 and discussed below, the sheath 103 of the ablation device 100 to which the ablation structure 101 is attached moves the ablation structure 101 with respect to the endoscope 111. Allows you to. In addition, an endoscope shown in FIGS. 34A, 35A, 36A, 37, 38, 39 and 41, through which at least a portion of the ablation device 100 is placed, as previously discussed. The internal actuation channel 211 of the 111 allows the ablation structure 101 to be moved with respect to the endoscope 111.

With reference to FIGS. 11, 31, 42 and 44, in yet another embodiment, the step of bending the ablation structure 101 towards the tissue surface 3 is the site of acute or chronic bleeding in the gastrointestinal tract. Includes inflating the inflating member 105 of the ablation device 100 within the luminal organ in. The expansion member 105 can be reversibly inflatable and arranged. The inflatable member 105 can be inserted into the gastrointestinal tract along the ablation structure 101 in a collapsed form and is expanded when positioned in a preselected processing area. In one embodiment, the inflatable member 105 is a balloon. For example, in FIGS. 11, 31, 42 and 44, how is it achieved to bend the ablation structure 101 towards the tissue surface 3 when the inflatable member 105 is inflated or deployed and deployed? It is shown whether it will be done. As shown in FIGS. 11, 31, 42 and 44, when fully expanded, the inflatable member 105 contacts the tissue surface 3 and thus the ablation structure 101 in contact with the opposing tissue surface 3. Bend.

As shown in FIGS. 19B, 20, 35, 36 and previously discussed, in a further method, the step of flexing the ablation structure 101 involves expanding the flexing structure or flexing member 150. I'm out. In one embodiment, as shown in FIG. 19A, the ablation device 100 includes a sheath 103, which sheath 103 is configured and arranged to receive the flexing member 150, the endoscope 111 and the ablation. The structure 101 is internally received by the sheath 103. In one embodiment, the flexing member 150 is a shape memory alloy such as Nitinol. The flexible extension of the flexible member 150 in this embodiment can be applied to any part of the device 100, including the endoscope, the elastic sheath 115 of the ablation device 100 (shown in FIG. 19A), or the ablation housing 107. Can be combined.

As shown in FIGS. 34, 35, 36, 37, 38 and 39 and previously discussed, in a further method, the step of flexing the ablation structure 101 is the flexing structure or flexing member 150. Includes moving.

Briefly, in each case, moving the flexible member 150 is used to change the flexible member 150 from the non-deployed form to the expanded form. As shown in FIG. 23, in certain embodiments, bending the ablation structure 101 includes a bending point within the ablation structure 101, where, for example, when in contact with the tissue surface 3. The ablation structure can flex in response to the resistance encountered.

In another method, the step of flexing the ablation structure 101 is parallel to each of them with respect to the endoscope 111, as shown in FIGS. 43, 44 and 45A-45C and discussed in more detail below. Includes rotating, rotating, turning, or turning the ablation structure 101 along a vertical axis. The deflection of the ablation structure 101 with respect to the endoscope 111 is combined with the distal end 110 of the endoscope 111, which is flexing with respect to the site of interest on the wall of the lumen at the site of acute or chronic bleeding in the gastrointestinal tract. Can occur. Also, the ablation structure 101 can be flexed in combination with the expansion member 105 used to achieve the addition of the ablation device 100 to the tissue. In certain embodiments, the step of flexing the ablation structure 101 may further include any combination of the flexing steps disclosed above.

As shown in Fig. 19, Fig. 20, Fig. 21, Fig. 22, Fig. 34A, Fig. 34B, Fig. 35A, Fig. 35B, Fig. 36A, Fig. 36B, Fig. 46B and Fig. 47, in another ablation method, An additional step involves operating the ablation structure 101 from the first form to the second form, which is radially extended. Details regarding the radial expansion of the ablation structure 101 shown in FIGS. 19, 20, 21 and 22 are described below, while FIGS. 34A, 34B, 35A, 35B, 36A and 36B. Details for are given earlier. Further, as shown in FIGS. 46B and 47, the ablation structure 101 can be arranged in a first form, in which the ablation structure 101 is directly or housing 107. It is coupled to an inflatable member 105 attached to the catheter 254 via (not shown). In the undeployed form, the non-expanded inflatable member 105 and the ablation structure 101 have a relatively small contour with respect to the endoscope 111, as shown in FIGS. 46B and 47. When the expansion member 105 is deployed and deployed, the ablation structure 101 is operated in a second form (not shown) expanded in the radial direction.

In a further method, an additional step is the ablation structure 101, as shown in FIGS. 15, 16, 40, 43, 44, 45A-45C, 46B and 47. Includes attachment to endoscope 111. As shown in FIGS. 15 and 16, the attachment of the ablation structure 101 to the endoscope 111 can also be performed by the elastic sheath 115. The elastic sheath 115 can removably hold the ablation structure 101 in a desired position on the endoscope 111. The elastic sheath 115 can be configured and arranged to fit beyond the distal end 110 of the endoscope. As shown in FIGS. 15 and 16, the inflatable member 105 can be attached to the elastic sheath 115, or instead, the inflatable member 105 can also act as an "elastic sheath" (not shown). ..

In another method, the step of attaching the ablation structure 101 to the endoscope 111 comprises attaching the ablation structure 101 to the outer surface of the endoscope. Alternatively, the mounting step can include, for example, mounting on the inner surface of the endoscope, mounting on a mechanism inside or outside the endoscope, or any combination of the above. Water, IPA, jelly or oil may be used for the purpose of attaching and detaching the ablation device to the endoscope.

As shown in FIG. 41, in a further method, the step of attaching the ablation structure 101 to the endoscope 111 comprises the ablation structure 101 having an attached rolled sheath 116, wherein the ablation structure 101 has an attached rolled sheath 116. Attaching the ablation structure 101 to the endoscope 111 includes unwinding the sheath 116 over the entire outer surface of the endoscope 11. The winding sheath 116 can further cover the electrical connection 109 of the ablation device 100 along the length of the endoscope 111. In a related method, the ablation structure 101 is attached to the endoscope 111 by a step involving unwinding the rotary sheath 116 over the entire outer surface of the endoscope 111 and a portion of the ablation structure 101.

In another method, as shown in FIG. 40, the step of attaching the ablation structure 101 to the endoscope 111 involves attaching the ablation structure 101 to the groove of the endoscope. As shown in FIG. 40, in one embodiment, the housing 107 and the ablation structure 101 are coupled to an internal coupling mechanism 215 that may be located within the internal working channel 211 of the endoscope 111. The internal coupling mechanism 215 in FIG. 40 is shown to be attached to the internal working channel 211 at the distal end 110 of the endoscope. In this embodiment, the housing 107 and the ablation structure 101 are shown to be aligned and coupled to the outer surface of the endoscope near the distal end 110 of the endoscope 111.

In some methods of ablating the tissue of the gastrointestinal tract, the tissue surface 3 comprises a first treated region and the driving step of the ablation structure 101 comprises driving the ablation structure 101 to ablate the first region. Includes moving the ablation structure 101 to a second region without removing the ablation structure 101 from the patient and driving the ablation structure 101 to ablate the second region. In this sense, moving refers to moving the ablation structure to a specific location on the site of interest, after which further movement to a therapeutically effective location has been described in detail elsewhere. As described above, various operations can be performed by inflating the balloon member or by bending or inflating the flexible member. For example, two or more areas of the tissue surface 3 of the area of interest in the wall of the lumen at the site of acute or chronic bleeding in the gastrointestinal tract direct the ablation structure 101 to the first area of interest and then the tissue. Ablation can be performed by driving the ablation structure 101 to ablate the surface 3. Then, for ablation of the appropriate area of the tissue surface 3 without removing the ablation structure 101 from the patient. The ablation structure 101 is directed to a second area of interest within the wall of the organ.

In general, in other embodiments, the ablation structure 101 is detachably attached to the distal end 110 of the endoscope and is adapted and configured to move the ablation structure 101 towards the tissue surface 3. An ablation device 100 including a deflection mechanism is provided (eg, FIGS. 5-19,22,22,27-29,30-32,34A,35A,36A,37,38,39,42,44 and 47). reference).

In a related embodiment, the ablation device 100 further comprises an ablation structure moving mechanism adapted to move the ablation structure 101 with respect to the endoscope 111. As discussed below and shown in FIGS. 26-28 and 30-32, the ablation structure moving mechanism may be the sheath 103 to which the ablation structure 101 is attached, where the sheath 103 is the subject. It is configured and arranged to move the ablation structure 101 with respect to the endoscope 111 received within the sheath 103. Alternatively, the ablation structure transfer mechanism may be in the form of the internal coupling mechanism 215 of the ablation structure 100, as previously discussed and shown in FIGS. 34A, 35A, 36A and 37-39. There, the ablation structure is connected to the internal coupling mechanism 215, at least a portion of the internal coupling mechanism 215 is internally disposed in the endoscope.

In another embodiment, the ablation apparatus 100 further comprises a coupling mechanism designed to fit the entire outer surface of the endoscope 111 in order to couple the ablation structure 101 to the endoscope 111. .. As previously discussed, the spiral sheath 104, elastic sheath 115, wound sheath 116 and internal coupling mechanisms as shown in FIGS. 15, 16, 40 and 41 are examples of such coupling mechanisms, respectively. In certain embodiments, the coupling mechanism comprises a sheath 103 capable of supporting the ablation structure 101. The sheath 103 is a tube, catheter, or suitable extension member. The sheath 103 is configured and arranged so that it can be moved independently of the connecting endoscope.

As shown in FIG. 41, in other embodiments, the sheath 103 can be configured and arranged as a wound sheath 116 that can be unwound over the outer surface of the endoscope. In use, for example, the winding sheath 116 connected to the ablation device 100 substantially near the proximal end (from the device operator's point of view) of the housing 107 is unwound from this position and close to the endoscope 111. Continue to unwind towards the end 112 (see Figure 47). In this method, the winding sheath 116 causes contact and cover with all or part of the length of endoscope 111 (not shown). Further, when the winding sheath 116 is unwound along the endoscope 111, an electrical connector 109 can be sandwiched between the winding sheath 116 and the endoscope 111 (see FIG. 41 overall).

In another embodiment, as shown in FIGS. 30 and 31, the sheath 103 can be configured and arranged to support a flexing mechanism, where the flexing mechanism is a flexing structure or flexing member. Contains 150. As shown in FIGS. 30 and 31, when the flexing member 150 is an expanding member 105, the expanding member 105 can be attached directly to the sheath 103. As shown in each case, the inflatable member 105 is placed opposite the placement position of the ablation structure 101, which is also attached to the sheath 103. The configuration of the sheath 103 provides support for the inflating member 105 and the ablation structure 101, which are independent of the positioning of the distal end 110 of the endoscope. For example, as shown in FIG. 30, the distal end 110 of the endoscope is the distal end 110 of the endoscope and the distal end of the sheath 103 on which the ablation structure 101 and the inflatable member 105 are located. It can be arranged so as to provide a gap between them. In contrast, as shown in FIG. 31, the distal end 110 of the endoscope can extend through and beyond the distal end of the sheath 103.

In other embodiments, the sheath 103 can be extended, as shown in FIG. FIG. 26 depicts a sheath containing an electrical connector 109 and an expansion line 113. The sheath 103 may include pneumatic and / or extruded wires that have entered the sheath 103. Upon use, the sheath 103 can first be introduced into the gastrointestinal tract, where the sheath 103 serves as a catheter-like guide for the introduction of the endoscope 111 within the sheath 103. Instead, the endoscope 111 may be introduced first, thereby acting as a guide to the sheath 103 to be introduced. FIG. 26 also shows the attachment of the expansion member 105 to the sheath 103 in an arrangement structure in which the ablation structure 101 is attached to the expansion member 105 on the side opposite to the attachment point of the sheath 103.

In the embodiments shown in FIGS. 27 and 28, the sheath 103 comprises an optically transmissive portion 158 adapted and configured to work with the visual channel of the endoscope 111. For example, the sheath 103 can be made of a transparent translucent or transparent polymer tube containing PCV, acrylic and Pebax® (registered trademark: polyether block amide). As shown in FIG. 24, one component of endoscope 111 is a visual channel that provides a visual image of tissue surface 3 imaged from the distal end 110 of the endoscope. For example, the permeation portion 158 allows visualization of the wall portion of the esophagus 3 through the permeation portion 158 of the sheath 103. As shown in the cross-sections given in FIGS. 28 and 29, the sheath 103 shown in FIGS. 27 and 28 is said to be the sheath with the help of an internally placed endoscope 111 having a visual channel 161. It comprises an optically transmissive portion 158 configured and arranged to provide a display of tissue surface 3 through the walls of 103. Also shown in FIG. 29 is a portion of the sheath 103 through which the electrical connection 109 and the expansion line 113 can pass. These features can be incorporated into the inner wall of the sheath 103 or attached to the inner wall of the sheath 103. As shown in FIG. 27, the sheath 103 containing the transmission portion 158 can extend past the distal end 110 of the endoscope. Instead, as shown in FIGS. 27, 28 and 31, the distal end 110 of the endoscope can extend distally past the permeation portion 158 of the sheath 103.

In another embodiment, the permeation portion 158 of the sheath 103 is coiled or braided therein to prevent ellipticization and / or collapse of the sheath 103, especially while flexing the ablation device 100. It can be structurally reinforced with the elements.

In a further embodiment, the sheath 103 comprises a slit 203 formed in the proximal portion of the sheath 103, wherein the distal end 110 of the endoscope enters the sheath 103. Designed to open to allow. As shown in FIG. 32, the proximal portion of the sheath 103 can include a perforation area or slit 203. The slit 203 can extend to a part of the total length along the length of the sheath 103. The slit 203 allows the sheath 103 to be pulled back, or allows the sheath 103 to be opened, for example, when the endoscope 111 is introduced into the sheath 103. In one embodiment, as shown in FIG. 32, the sheath 103 further comprises a fixing collar 205 to secure the sheath 103 in a desired position with respect to the endoscope 111. ing.

As shown in FIGS. 33A and 33B, the distal portion of the sheath 103 can have a smaller outer diameter than the proximal portion of the sheath 103, and the distal portion of the sheath 103 is the endoscope 111. Is adapted and configured to expand (not shown) when inserted into it. This embodiment can help access the endoscope 111 when the sheath 103 is first advanced to a site of interest in the gastrointestinal tract. Since the distal end of the sheath 103 is smaller in diameter but contains the slit 203, the sheath 103 allows expansion of the sheath 103 when the endoscope 111 is advanced because the slit 203 of the sheath 103 allows expansion of the sheath 103. It can accept endoscopes 111 with larger outer diameters.

In general, in another aspect, the method of ablating tissue in the gastrointestinal tract comprises advancing the ablation structure 101 into the gastrointestinal tract while supporting the ablation structure 101 with an endoscope 111. The distal end 110 of the endoscope can be bent to move the ablation structure 101 into contact with the tissue surface, driving the ablation structure 101 to ablate the tissue surface 3 (see, eg, FIG. 43). However, it follows. In certain embodiments, the ablation structure 101 comprises a plurality of electrodes, the drive step comprising applying energy to the electrodes.

Generally, in other embodiments, the coupling mechanism is, for example, the entire outer surface of the endoscope 111 to bind the ablation structure 101 to the endoscope 111, rather than being a sheath (as previously discussed). It is designed to fit into, and is designed to be fitted and configured to give the ablation structure 101 some degree of freedom of movement. The freedom of movement includes, but is not limited to, bending and / or rotation and / or swivel with respect to the endoscope 111 when coupled to the endoscope 111. The freedom of movement is for one, two or three axes, thereby providing one, two or three axes of freedom. Non-limiting examples of suitable coupling mechanisms include flex joints (flex joints), pin joints, U-joints, spherical joints (ball joints) or any combination thereof. Embodiments of the coupling mechanism described below benefit from a substantially uniform additional force between the supporting endoscope 111 and the ablation structure 101 when locating on the tissue surface 3 of interest. It brings to.

As shown in FIGS. 43, 44, 45A and 45B, the coupling mechanism is a ring 250 attached to the housing 107 and the endoscope 111, where the housing 107 is a ring. It is adapted and configured to bend, rotate or swivel around 250. For example, acute or chronic bleeding of the gastrointestinal tract when the ablation device 100 is connected by a ring 250 to the flexible distal end 110 of the endoscope 111, as depicted in FIG. When the device is flexed towards the tissue surface 3 of the wall of the lumen at the site, the housing 107 brings the ablation structure 101 into contact with the tissue surface 3 by flexing, rotating or swirling around the ring 250. In these embodiments, both the endoscope and the housing supporting the ablation structure have their own longitudinal axes, which are arranged parallel to each other. The coupling mechanism that attaches the housing to the endoscope allows for swiveling motion between the longitudinal axis of the housing and the longitudinal axis of the endoscope. Conveniently, the sufficient contact pressure provided by the deflection of the distal end 110 of the endoscope 111 is sufficient, regardless of the precise alignment of the distal end 112 with respect to the plane of the tissue surface 3 to be treated. The desired degree of contact can be created between the ablation structure 101 and the tissue surface 3.

For the purposes of this disclosure, the "desired degree of contact", "desired contact", "therapeutic contact" or "therapeutically effective contact" between the ablation structure 101 and the tissue surface 3 is , Between all or part of a given subject on tissue surface 3 (eg, a site on the wall of a luminal organ at an acute or chronic bleeding site of the gastrointestinal tract) and all or part of ablation structure 101 Includes complete or substantially complete contact. Therapeutic contact is typically ablation on the device, as described in this disclosure, by expansion of an expandable member, such as a balloon, or by expanding, moving or flexing a flexural structure. It should be understood that the surface results from being moved into such a contact state. With all of these approaches, bringing such movements, or therapeutic contacts, involves the action or application of pressure. Such pressurization is a factor affecting coaptive ablation, and the pressure acting through the tissues of the blood vessels causes them to partially or substantially empty the blood, while at the same time due to blood pressure. It acts as a back pressure to block the normal influx of blood. As described above, it can be understood that any event of moving or expanding the member in order to bring the ablation surface to the target tissue also pressurizes the tissue.

In a different but still related embodiment, as shown in FIG. 44, when the flexing mechanism of the ablation device 100 is an inflatable member 105, the ring 250 coupling is of the housing 107 and the ablation structure 101. Allows bending, rotation or turning. As in the previous case, the sufficient contact pressure provided by the inflatable member 105, through flexure, creates the desired degree of contact between the ablation structure 101 and the tissue surface 3. Again, fortunately, due to the flexion, rotation or swivel provided by the ring 250 coupling, despite the precise arrangement of the distal end 110 of the flexed endoscope 111 with respect to the plane of the tissue surface 3 to be treated. However, the desired contact can be achieved.

As shown in FIG. 45A, in one related embodiment, the coupling mechanism between the ablation device 100 and the endoscope 111 is an elastic band 252, where the housing of the device 100 107 is flexibly attached to the elastic band 252. For example, at the site of acute or chronic bleeding in the gastrointestinal tract, where the ablation device 100 is attached to the distal end 110 of the endoscope 111 by an elastic band 252, as depicted in FIG. 45C. As the device 100 is flexed towards the tissue surface 3 of the wall of the lumen, the flexion around the elastic band 252 results in a precise arrangement between the housing 107 and, therefore, the ablation structure 101 and the tissue surface 3. Can be achieved. Fortunately again, due to the flexion function provided by the elastic band 252 coupling, regardless of the precise arrangement of the distal end 110 of the flexed endoscope 111 with respect to the plane of the tissue surface 3 to be treated. The desired contact can be achieved.

As shown in FIG. 45A, in another related embodiment, the coupling mechanism between the ablation device 100 and the endoscope 111 is a combination of the ring 250 and the elastic band 252, where the device 100 Housing 107 is coupled to elastic band 252. For example, as depicted in FIG. 45A, when the ablation device 100 is attached to the distal end 110 of the endoscope 111 by an elastic band 252, the gastrointestinal tract (not shown) is acute or chronic. As the device 100 is flexed towards the tissue surface 3 of the wall of the lumen at the site of bleeding, the housing 107 and thus ablation by flexion, rotation or swivel around the ring 250 and the coupling of the elastic band 252. An arrangement can be achieved between the structure 101 and the tissue surface 3. Again, fortunately, the flexion, rotation or swirl provided by the elastic band 252 coupling results in a precise arrangement of the distal end 110 of the flexed endoscope 111 with respect to the plane of the tissue surface 3 to be treated. Regardless, the desired contact can be achieved.

In another embodiment, the ablation device 100 further comprises an alternative coupling mechanism between the ablation device 100 and the endoscope 111, which is configured and arranged to fit within the groove of the endoscope 111. There is. The coupling mechanism is an internal coupling mechanism 215, which is configured and arranged to couple the ablation structure 101 within the internal working channel 211 of the endoscope 111 (see FIG. 37 and the discussion above).

As shown in FIGS. 34A, 34B, 35A, 35B, 36A and 36B, in certain embodiments of such coupling mechanisms, the ablation structure 101 is configured to fit within the internal working channel 211 of the endoscope. And are arranged. Further, as shown in FIGS. 34A, 34B, 35A, 35B, 36A and 36B, in a related embodiment, the deflection mechanism is also configured and arranged to fit within the internal working channel 211 of the endoscope. ..

In each of the embodiments described above and shown in FIGS. 34A, 34B, 35A, 35B, 36A and 36B, after expansion of inflatable member 105 or inflatable member 209 and subsequent treatment of subject tissue 3, binding. The means can further serve as a means of pulling back, pulling back or regaining the ablation structure 101 and the flexing mechanism into the internal working channel 211 of the endoscope. Moreover, in addition to providing a coupling between the ablation structure 101 and the endoscope's internal working channel 211, the coupling mechanism can also include an electrical connector 109 that supplies energy to the ablation structure 101.

In certain related embodiments, the ablation device 100 further comprises a coupling mechanism configured and arranged to fit within the groove of the endoscope 111, which coupling mechanism can include a shape memory member and is a flexing mechanism. Can include a bend in the shape memory member. As shown in FIGS. 37-39, the internal coupling mechanism 215 is located within the internal working channel 211 of the endoscope and extends beyond the distal end 100 of the endoscope. Further, the internal coupling mechanism 215 can be connected to a bending mechanism which is a bending member 150. The flexing member 150 can include a bend and can be connected to the housing 107. As shown in FIG. 38 and previously discussed, the bend of the flexing member 150 can be placed within the endoscope's internal actuation channel 211, causing the ablation structure 101 to move to a non-deployment position. .. As the internal coupling mechanism 215 is advanced towards the distal end 110 of the endoscope, the shape memory properties of the flexing member 150 facilitate the deployment of the ablation structure 101 in a position suitable for ablation.

In general, in some embodiments, the ablation structure 101 of the ablation device 100 comprises an optical transmissive portion 158 adapted and configured to cooperate with the visible channel of the endoscope 111. As shown in FIGS. 27-31 and previously discussed, the optical transmission portion 158 may be the sheath 103 of the ablation device 100.

In certain embodiments, the ablation structure 101 of the ablation apparatus 100 is further adapted and configured to move from a first form to a second form that extends in the radial direction. As shown in FIGS. 19-22, the ablation structure 101 and housing 107 extend radially from the first form (see FIGS. 20 and 21), which does not extend much in the radial direction, and are useful for ablation. It can be designed to move reversibly to the second form. The foldable or flexible morphology that results in the reversible radial expansion of the housing 107 and the ablation structure 101 can facilitate access to the tissue surface due to its reduced size. In addition, the foldable or flexible form is useful for cleaning, introduction, restoration and repositioning of the device within the luminal organ at the site of acute or chronic bleeding of the gastrointestinal tract.

The ablation apparatus 100 shown in FIGS. 19B and 20 is configured to move the ablation structure 101 from a first form (see FIG. 20) to a second form (see FIG. 21) that extends radially. It comprises an arranged ablation structure actuator 152. As illustrated (in FIGS. 19B and 20), the actuator 152 shall be designed to work with a receiver 154 that is extended and configured to receive the actuator 152. Can be done. The actuator 152 may be a wire, rod or other suitable extension structure. Instead, the actuator 152 may be a hydraulic actuating means with or without a balloon. In certain embodiments, the actuator 152 is a stiffening wire.

As shown in FIG. 20, both the housing 107 and the ablation structure 101 have a first form before the actuator 152 is placed within a portion of the receiver 154 attached to the housing 107. In position. As shown in FIG. 21, after the actuator 152 is partially or completely introduced into the receiver 154, the housing 107 and the ablation structure 101 are, as a result, radial as compared to the first embodiment. It can be transformed into an expanded second form. The introduction of the actuator 152 into the receiver 154 forces the housing 107 and the ablation structure 101 to be laterally located on the side of the receiver 154 and expands in the radial direction (see FIG. 19). In certain embodiments, the housing 107 is a heat set in a contracted first form suitable for locating the ablation apparatus 100 near the surface 3 of the tissue of interest. After the tissue surface 3 of interest has been reached, the actuator 152 can be introduced into the receiver 154 to achieve a second radial extension that is useful for ablation of the tissue surface 3.

In a related alternative embodiment, the housing 107 and the ablation structure 101 include a radially extended unconstrained shape, which unconstrained shape is at the distal end 110 of the endoscope 111. One or more flexible points to allow crushed or reduced radial expansion when placed distally towards and compressed by the polymer sheath 115 (not shown). Includes.

In another embodiment, as shown in FIGS. 21 and 22, the ablation structure 101 of the ablation apparatus 100 is adapted and configured to move from a first form to a second form that extends radially. The ablation device 100 further comprises an expandable member 156. The expandable member 156 can be located between the housing 107 and the endoscope 111, and in the non-expanded shape, the ablation structure 101 is therefore configured in the first form. When the expandable member 156 expands, the form of the ablation structure 101 is changed to a second form (see FIG. 21) that expands in the radial direction.

In certain embodiments, the flexing mechanism of the ablation device 100 comprises an inflatable inflatable member 105. As shown in FIGS. 11,21,22,25B,27,2830,31,34A,34B,42,44,46 and 47 and previously discussed, the inflatable member 105 is of device 100 with respect to tissue surface 3. Bending can be facilitated.

In another embodiment, the flexing mechanism comprises an expandable member 156 (discussed in detail earlier, see FIGS. 35B and 36B). As shown in FIG. 35B, the expandable member 209 may be an expandable stent, frame or cage device. Also, as shown in FIG. 35B, the expandable member 209 may be a series of connected hoops that can be folded or wound prior to expansion.

In another beneficial embodiment, the ablation device 100 transmits torque from the proximal end of the endoscope 111 to the ablation structure 101 in order to rotate the ablation device 100 around the central axis of the endoscope 111. It is further equipped with a torque transmission member adapted and configured as described above. In certain embodiments, the torque transfer member is a first and second interlocking member adapted to resist relative motion between the endoscope 111 and the ablation structure 101 around the central axis. member) is included. As shown in FIGS. 46B, 46C and 47, in some embodiments, the first connecting member is a key 258 and the second connecting member is a key way 256. In certain embodiments, the first connecting member is attached to the sheath 103 surrounding the endoscope 111 and the second connecting member is attached to the catheter 254 supporting the ablation structure 101. For example, as shown in FIGS. 46B, 46C and 47, the key 258 can be attached to the sheath 103 surrounding the endoscope 111 and the keyway 256 can be attached to the catheter 254 supporting the ablation structure 101. Can be done. In one more related embodiment, the catheter 254 and the sheath 103 are configured and arranged for relative movement along the central axis of the endoscope 111. The sheath 103 is, for example, a polymer sheath, and a key 258 may be attached to the outside of the sheath 103 substantially along the longitudinal axis of the sheath 103. In use, this embodiment provides one-to-one torque transfer between the ablation device 100 and the endoscope assembly 111 when the proximal end 112 of the endoscope is operated, while in-situ. It results in the positioning of the ablation structure 101 either proximally or distally to the distal end 110 of an endoscope. Further, the sheath 103 can be pre-incorporated into the catheter 254 or can be incorporated separately.

In general, in some embodiments, the ablation apparatus 100 is adapted to detachably attach the ablation structure 101 and the ablation structure 101 to the distal end 110 of the endoscope 111 and to the endoscope. It is provided with a coupling mechanism adapted to allow the ablation structure 101 to rotate and / or rotate with respect to the endoscope when coupled to it. Various related embodiments are set in detail below. For example, an embodiment in which the coupling mechanism comprises a ring 250 and the ablation structure 101 is adapted to rotate and / or swivel around the ring 250; the coupling mechanism comprises an elastic band 252 adapted to bend and ablation. Embodiments that allow the structure 101 to rotate and / or swivel; an embodiment in which the ablation apparatus 100 further comprises a flexing mechanism adapted and configured to move the ablation structure 101 towards the tissue surface 3. Embodiment; Also, an embodiment in which such a flexing mechanism comprises an inflatable member.

56A and 56B provide a diagram of an ablation device with an ablation surface on the hinge 159, the hinge operating in a manner similar to the mechanism shown in FIG. 43, with its longitudinal axis on the ablation surface. It allows a free swivel movement with the longitudinal axis of the endoscope. FIG. 56A shows a device with an ablation surface 101 oriented parallel to the endoscope, which is in contact with the inner surface of the gastrointestinal luminal wall 5 at the desired target area. .. The ablation surface 101 is supported by a flexing member 150 that can be delivered from and pulled back into the working channel within the endoscope. FIG. 56B shows a device with the longitudinal axis of the ablation surface 101 oriented at approximately right angles to the longitudinal axis of the endoscope. It swivels as a passive response to the ablation surface 101 as it easily rotates on the hinge 159 over a bending range of about 170 degrees from 0 (zero) degrees (parallel to endoscope 111). As shown in the figure, the surface angle is about 90 degrees with respect to the endoscope.

Most embodiments described herein have utilized radio frequency energy as exemplary ablation energy and electrodes as energy transfer elements, but these examples are energy sources and energy supply or transfer elements. It should be noted that there are no restrictions on. Also, as described herein, not only the cryoablation technique, but also other forms of energy, where the ablation is fragmentary or partial, and as described herein, there is some tissue in the area of interest. It may be supplied for ablation of the area of interest in such a way that the portions are ablated and some parts of the tissue of the area of interest are not ablated.

&lt;Embodiment of a device that can be deployed through an endoscope&gt; As mentioned above, the ablation device can be deployed or positioned at the site of chronic or acute bleeding in a variety of ways associated with an endoscope that gives the physician visual ability. For example, some endoscopic catheters can be positioned in therapeutic contact with a balloon or other form of expandable member, or the flexing member can be moved or flexed, and embodiments are endoscopic. It can be attached to the end of the mirror or a suitable alternative site, or the ablation device can pass through the operating channel or ancillary channel of the endoscope. The ablation device that can pass through the working channel of the endoscope is that the operation of the endoscope is not hindered and complicated by the characteristics of the external device, and the doctor practitioner can use the working channel device. It is very friendly and reassuring, so it brings practical benefits. However, the limitation is that the device housed inside the working channel must typically have a collapsed form that fits within the dimensions of the channel with a diameter of 2-5 mm. In addition, such in-channel devices need to be able to easily move back and forth between contained or deployable forms and operating or deployed forms. Some examples of in-channel devices are given in FIGS. 59A-64 and are described below.

Figures 59A and 59B show ablation devices that can be deployed through the operating channels of the endoscope configured to exhibit a wide range of ablation planes that are generally orthogonal or substantially perpendicular to the longitudinal axis of the delivery endoscope. It is a figure. FIG. 59A shows the device in a fully deployed form. FIG. 59A also shows the device in an intermediate form between the deployed and deployed form and the collapsed form to be accommodated within the operating channel of the endoscope. The device 400 is supported at the distal end of a shaft 41 that supports the internal coaxial rod 410. At the coupling 412, the coaxial rod is associated with a plurality of struts 420 that support the ablation energy supply surface 101. A wire 430 also extends from the coupling portion 412 to reach the center of the back surface 101b of the ablation energy supply surface further supported by the frame element 440. Pushing the coaxial rod distally causes the coaxial rod to project forward from the working channel, opening the ablation surface and providing a wide range of ablation energy supply surfaces. When the coaxial rod is pulled in the proximal direction, the ablation energy supply surface is retracted by itself in a foldable manner and is in a form that can be pulled into the working channel. In an alternative embodiment, the ablation energy supply surface 101 and its supporting frame element 440 are adapted to provide a convex rather than flat front surface for better contact with the wide lumen surface. The device and ablation surface are maneuverable thanks to their endoscopic support, and also have the ability of the operating physician to manually apply pressure to make effective therapeutic contact with the area of interest. You can see that. It is also found that the ablation supply element can be placed on the ablation surface 101 in any form described anywhere in this disclosure.

FIG. 60 shows an embodiment of an ablation apparatus 400 deployable through the working channel 112 of the endoscope 111, which is adapted to exhibit an ablation surface 111 substantially parallel to the longitudinal axis of the delivery endoscope 111. The device comprises an ablation structure with two parallel foldable shape memory ribs 415 to which the ablation electrodes are laid (eg, made of Nitinol), the laid electrodes being unfolded. In this state, it is stretched over the space between the ribs to form the ablation surface 101. When the distal end of the support shaft 41 is pushed out of the working channel of the endoscope 111, the support rib 415 expands according to its preferred form. When the support shaft is pulled back into the endoscope, the proximally beveled portion of the rib 415 pulls the rib together as it passes through the opening of the working channel. The ablation surface 101 is adapted to provide the focal point of ablation within the area of interest.

Figures 61A and 61B show embodiments of the ablation apparatus 400 deployable through the actuation channel 112 of the endoscope 111, which is applied to exhibit an ablation surface 101 substantially parallel to the longitudinal axis of the delivery endoscope. The proximal end 416 of the support of the ablation surface 101 of the device is beveled and has a laterally-curved bias that is substantially flat but rollable. , Does not rotate when pushed out of the working channel of the endoscope 111, but when pulled back into the working channel of the endoscope 111, the beveled proximal end 416 is the edge of the working channel 112. It rotates about itself by the force acting on the inclined proximal end 416 when it is brought through. The ablation surface 101 is adapted to provide a focal point for ablation within the area of interest, especially for the walls of a relatively narrow lumen. FIG. 61A shows the device in a deployed form protruding forward from the actuation channel. Figure 61B shows a device that will be seen retracted within the working channel; the distal end of the device contains the proximal portion of support 416 and the ablation surface 101 is around itself. Wrapped around or coiled around.

FIG. 62 is adapted to exhibit an ablation plane that is approximately orthogonal to the longitudinal axis of the delivery endoscope, thanks to the flexible bends 418,419 in close proximity to the ablation plane 101. It shows an embodiment of an ablation device that is similar to the device of FIG. 61 and can be deployed through the actuation channel 112 of the endoscope 111. The support 416 with respect to the ablation surface of the device is beveled at its proximal end and also has a substantially flat but rollable lateral curved bias that rotates when extruded from the working channel. It does not move, and when it is pulled back into the operating channel, it rotates around itself.

FIG. 63 is one of the ablation devices 400 deployable through the actuation channel 112 of the endoscope 111, adapted to exhibit a circular or spiral ablation surface 101 oriented outwardly and circumferentially. An embodiment is shown. The circular or spiral portion becomes uncoiled when it emerges from the operating channel of the endoscope and is coiled into a linear form when pulled back into the operating channel.

FIG. 64 is a detailed perspective and cross-sectional view of the ablation plane circuit layer and exemplary materials common to the devices shown in FIGS. 60-63. The material of the ablation surface support 416 has superelastic shape memory properties, such as those of Nitinol. A circuit backing 417 is laminated on the upper end of the support layer, and on the upper surface of the backing layer is a copper wiring provided with a radio frequency energy supply element of the device.

&lt;Characteristics that bring about hydraulic cleaning of the ablation surface&gt; During the radiofrequency coagulation of blood and / or blood vessels, coagulated blood as well as other fluids, such as extracellular fluids and cytoplasmic fluids, may stick to the electrodes, making subsequent ablation more effective. Will be lower and more difficult to control. Several techniques are used to minimize the risk of blood or coagulation sticking to the electrodes (risk). And in some embodiments, a non-adhesive surface is used on the electrode and / or adjacent surface to prevent sticking of the coagulated product. This non-adhesive surface is provided by a material such as silicon, PTFE, FEP for the material adjacent to the conductive electrode element. Alternatively, the conductive element and / or adjacent material of the electrode may be silicone (in cured or uncured form), PTFE, other fluorepolymers, lecithin, oils, glycolipids, or other lubricants. It will be coated with a thin layer of a lecithin organic or non-organic coating. To minimize the effect of these coatings on the electrical circuit between the electrodes and the ablation site, the coatings are chosen to have minimal impedance and / or resistance to the circuit. High impedance coatings result in power loss and prevent efficient power transfer to tissue sites. For example, a cured silicone coating in the range of 0.1 to 100 μm may be suitable for this application. Also, in another embodiment, a significant amount of coating burns out the conductive element after the initial slight ablation, but the coating still remains on the adjacent material.

In another more aggressive cleaning embodiment, fluid cleaning is performed to prevent or remove coagulation on the electrode surface. Therefore, FIGS. 65A and 65B depict an embodiment of the ablation apparatus 100 provided with a partially circumferential ablation surface 101 including the feature of hydraulic cleaning. The device as a whole is similar to that depicted in FIG. 56 and has a mechanism for longitudinally swiveling similar to that depicted in FIG. 43. Two lines extend distally from the proximal end of the device to serve the ablation surface 101, one of which is an electrical connection that provides ablation energy for distribution. The other is a hydraulic line 121 that carries the cleaning fluid to the ablation surface. FIG. 65B shows a more detailed perspective view of the ablation surface 101 and the hydraulic lines 121 leading to the cleaning channel system 122 and numerous outlet holes 123. The ablation surface 101 contains any form of electrode arrangement described elsewhere here, but is not shown to focus on the cleaning element. The cleaning system may carry a physiologically appropriate solution and may be manually manipulated by a physician, or it may be automatically controlled by a controller that provides cleaning at appropriate intervals and rates following the supply of radio frequency energy. Maybe.

&lt;Terms and conventions&gt; Unless otherwise specified, all technical terms used herein are in the field of ablation techniques and metabolic conditions and diseases, as commonly understood by those skilled in the art of ablation treatment surgery. Has the same meaning as commonly understood by those skilled in the art. Although specific methods, devices and materials are described in this application, any method and material similar to or equivalent to those described herein can be used in the practice of the present invention. Although embodiments of the present invention are described by some detailed and exemplary drawings, such drawings are for the purpose of clarity of understanding only and are not intended to be limiting. Although various terms have been used in the description to convey an understanding of the invention; these various terms may extend to their usual linguistic or grammatical variants or forms. Will be understood. Also, if the terminology refers to a device, device or drug designated by a trade name, brand name, or generic name, these terms or names are now provided as the latest examples, and the invention is in this language. It will be understood that it is not limited by scope. Any technical term that will be introduced at a later date that can be reasonably understood as a derivative of the current term or as a specification of a hierarchical subset accepted by the current term is the current term. Will be understood as described by. Further, for example, some theoretical considerations have been presented in facilitating an understanding of the benefits of mechanistic or conjunctive therapeutic ablation, but the claims of the invention are bound by such theory. is not it. Furthermore, one or more features of any other embodiment can be combined with one or more other features of any other embodiment without departing from the scope of the invention. Furthermore, the present invention is not limited to the embodiments described for illustrative purposes, and each element of the invention is attached to the present patent application to include the entire range of qualified equivalence. It should be understood that it is stipulated only by a fair interpretation of the claim.