Patent Description:
Endoscopic devices and procedures may be used to diagnose, monitor and treat various conditions by close examination of the internal organs. By way of background, a conventional endoscope generally is an instrument having an imaging device for visualizing the interior of an internal region of a body and a lumen for inserting one or more treatment devices therethrough. A wide range of applications have been developed for the general field of endoscopes including by way of non-limiting example the following: arthroscope, angioscope, bronchoscope, choledochoscope, colonoscope, cytoscope, duodenoscope, enteroscope, esophagogastro-duodenoscope (gastroscope), laparoscope, laryngoscope, nasopharyngo-neproscope, sigmoidoscope, thoracoscope, and utererscope (individually and collectively, "endoscope").

By way of non-limiting example, millions of people suffer from progressive gastroesophageal reflux disease (GERD), which is characterized by frequent episodes of heartburn, typically on at least a daily basis. Without adequate treatment, GERD can cause erosion of the esophageal lining as the lower esophageal sphincter (LES), a segment of smooth muscle located at the junction of the stomach and the esophagus, gradually loses its ability to function as the barrier that prevents stomach acid reflux. Chronic GERD can also cause metaplasia to the inner lining of the esophagus where the normal squamous mucosa changes to columnar mucosa, also known as Barrett's esophagus. Barrett's esophagus can progress to esophageal cancer if left untreated.

Endoscopic treatment of Barrett's esophagus includes endoscopic mucosal resection (EMR). One method of performing EMR involves ablation of the mucosal surface by heating the surface until the surface layer is no longer viable. The dead tissue is then removed.

Treatment devices for performing EMR have been developed using bipolar ablation technology that includes attaching an ablation cap to the distal end of an endoscope, then positioning a probe associated with the cap against the target tissue and delivering energy to the tissue to ablate the tissue in contact with the probe. In some devices, as a safety precaution, if the probe does not make sufficient contact with tissue to be ablated, the probe may not be energized. Thus, to ensure adequate contact between the probe and the target tissue during the procedure, a vacuum associated with the endoscope may supply a suction force within the ablation cap in order to draw the tissue to be ablated into contact with the probe. A consequence of this suction force, however, is that tissue may be drawn into the cap, thereby blocking or obscuring direct endoscopic visualization (e.g., via the imaging device of the endoscope), thereby limiting or preventing accurate positioning of the probe for tissue ablation.

In other devices, a preset amount of energy may be delivered to the probe, regardless of the surface area of the probe in contact with tissue, relative to the surface area of the probe not in contact with tissue. In those situations, the amount of energy delivered to the tissue in contact with the probe may exceed a desired level, for example, as compared to the same amount of energy delivered to and distributed among tissue in contact with the entire surface area of the probe. Those situations may present additional safety or other operational concerns.

<CIT> relates to an energy delivery system including an overtube the proximal portion of which is adapted to be positioned over a distal portion of an endoscope.

<CIT> discloses a tissue ablation system including a plurality of electrode pairs and a viewing window between each pair of adjacent electrodes.

What is needed in the art is an ablation treatment device that is simple to use, that may be coupled to an endoscope, that minimizes the number of steps and time required for a treatment procedure, and that provides treatment under direct endoscopic visualization.

The present embodiments provide systems suitable for ablation treatment using an endoscope, while i) maintaining suitable visibility of the target treatment site and surrounding environment, and ii) supplying a vacuum or suction force to draw tissue to be ablated into contact with a probe. Any methods of treatment of the human or animal body by surgery or therapy which are described herein do not fall within the scope of the claims.

In one aspect, an ablation device includes a body having a lumen for receiving a distal end of an endoscope, a cover portion extending from a side of the body, the cover portion defining a recess between the cover portion and the body, and an electrode platform having at least one electrode positioned thereon, the electrode platform movable between a covered position, where the at least one electrode is covered by the cover portion, and an exposed position, where the at least one electrode is at least partially exposed beyond the cover portion. At least one vacuum port is formed in the electrode platform.

The at least one vacuum port may include a plurality of vacuum ports arranged about a periphery of the electrode platform. The at least one vacuum port may include a plurality of vacuum ports arranged about a periphery of the at least one electrode. The at least one vacuum port may be surrounded by the at least one electrode. The at least one vacuum port may include a plurality of vacuum ports surrounded by the at least one electrode.

A vacuum port of the at least one vacuum port may be circular. A vacuum port of the at least one vacuum port may have a diameter of <NUM> to <NUM>, or less. A vacuum port of the at least one vacuum port may be square. A vacuum port of the at least one vacuum port may have a maximum dimension of <NUM> to <NUM>, or less. A vacuum port of the at least one vacuum port may be rectangular. A vacuum port of the at least one vacuum port may have a maximum width of <NUM> to <NUM>, or less. A vacuum port of the at least one vacuum port may be a longitudinal slot extending along a length of the at least one electrode. A width of the longitudinal slot may be between <NUM> to <NUM>, or less. A vacuum port of the at least one vacuum port may be a transverse slot extending along a width of the at least one electrode. A width of the transverse slot may be between <NUM> to <NUM>, or less. A vacuum port of the at least one vacuum port may include a longitudinal slot extending along a length of the at least one electrode, and a transverse slot extending along a width of the at least one electrode. A width of the longitudinal slot and the transverse slot may be between <NUM> to <NUM>, or less.

In some embodiments, a drive catheter extends proximally from the electrode platform. The drive catheter may include at least one lumen. At least one wire may extend from the at least one electrode through a lumen of the at least one lumen. A first lumen of the at least one lumen may be in fluid communication with a first vacuum port of the at least one vacuum port, and a second lumen of the at least one lumen may be in fluid communication with a second vacuum port of the at least one vacuum port.

In some embodiments, the electrode platform may include an internal cavity, the at least one vacuum port being in fluid communication with the internal cavity. A drive catheter may extend proximally from the electrode platform, the drive catheter having at least one lumen in fluid communication with the internal cavity.

The ablation device may include any one or more of the features above.

In another embodiment, an ablation device system includes an endoscope having an imaging device for capturing images at a distal end of the endoscope and one or more fluid lumens extending through at least a portion of the endoscope between a proximal end of the endoscope and the distal end. The system further includes an ablation cap with a body having a lumen for receiving the distal end of the endoscope, and a cover portion extending from a side of the body, the cover portion defining a recess between the cover portion and the body. An electrode platform includes at least one electrode positioned thereon, the electrode platform movable between a covered position, where the at least one electrode is covered by the cover portion, and an exposed position, where the at least one electrode is at least partially exposed beyond the cover portion. At least one vacuum port formed in the electrode platform.

The system may include at least one vacuum pump, wherein the at least one vacuum port formed in the electrode platform of the ablation cap and the one or more fluid lumens of the endoscope are in fluid communication with the at least one vacuum pump. The at least one vacuum pump may supply a suction force to the at least one vacuum port formed in the electrode platform of the ablation cap independent of a suction force supplied to the one or more fluid lumens of the endoscope.

In some embodiments, the at least one vacuum port may include a plurality of vacuum ports arranged about a periphery of the electrode platform. The at least one vacuum port may include a plurality of vacuum ports arranged about a periphery of the at least one electrode. The at least one vacuum port may be surrounded by the at least one electrode. The at least one vacuum port may include a plurality of vacuum ports surrounded by the at least one electrode.

In some embodiments, a vacuum port of the at least one vacuum port may be circular. A vacuum port of the at least one vacuum port may have a diameter of <NUM> to <NUM>, or less. A vacuum port of the at least one vacuum port may be square. A vacuum port of the at least one vacuum port may have a maximum dimension of <NUM> to <NUM>, or less. A vacuum port of the at least one vacuum port is rectangular. A vacuum port of the at least one vacuum port may have a maximum width of <NUM> to <NUM>, or less. A vacuum port of the at least one vacuum port may have a longitudinal slot extending along a length of the at least one electrode. A width of the longitudinal slot may be between <NUM> to <NUM>, or less. A vacuum port of the at least one vacuum port may be a transverse slot extending along a width of the at least one electrode. A width of the transverse slot may be between <NUM> to <NUM>, or less. A vacuum port of the at least one vacuum port may include a longitudinal slot extending along a length of the at least one electrode, and a transverse slot extending along a width of the at least one electrode. A width of the longitudinal slot and the transverse slot may be between <NUM> to <NUM>, or less.

The ablation device system may include any one or more of the features above.

In yet another embodiment, an ablation device includes an electrode platform having at least one electrode positioned thereon, a drive catheter extending from the electrode platform, the drive catheter having at least one lumen, and, at least one vacuum port formed in the electrode platform, the at least one vacuum port in fluid communication with the at least one lumen. The at least one vacuum port and the electrode platform are movable in unison via movement of the drive catheter.

In some embodiments, the at least one vacuum port may incldue a plurality of vacuum ports arranged about a periphery of the electrode platform. The at least one vacuum port may include a plurality of vacuum ports arranged about a periphery of the at least one electrode. The at least one vacuum port may be surrounded by the at least one electrode. The at least one vacuum port may include a plurality of vacuum ports surrounded by the at least one electrode.

In some embodiments, a vacuum port of the at least one vacuum port may be circular. A vacuum port of the at least one vacuum port may have a diameter of <NUM> to <NUM>, or less. A vacuum port of the at least one vacuum port may be square. A vacuum port of the at least one vacuum port may have a maximum dimension of <NUM> to <NUM>, or less. A vacuum port of the at least one vacuum port may be rectangular. A vacuum port of the at least one vacuum port may have a maximum width of <NUM> to <NUM>, or less. A vacuum port of the at least one vacuum port may be a longitudinal slot extending along a length of the at least one electrode. A width of the longitudinal slot may be between <NUM> to <NUM>, or less. A vacuum port of the at least one vacuum port may be a transverse slot extending along a width of the at least one electrode. A width of the transverse slot may be between <NUM> to <NUM>, or less. A vacuum port of the at least one vacuum port may include a longitudinal slot extending along a length of the at least one electrode, and a transverse slot extending along a width of the at least one electrode. A width of the longitudinal slot and the transverse slot may be between <NUM> to <NUM>, or less.

In some embodiments, at least one wire extends from the at least one electrode through a lumen of the at least one lumen. A first lumen of the at least one lumen may be in fluid communication with a first vacuum port of the at least one vacuum port, and a second lumen of the at least one lumen may be in fluid communication with a second vacuum port of the at least one vacuum port. The electrode platform may include an internal cavity, the at least one vacuum port being in fluid communication with the at least one lumen through the internal cavity.

In some embodiments, the ablation device further includes a body having a lumen for receiving a distal end of an endoscope, wherein the at least one vacuum port and the electrode platform are movable relative to the body in unison via movement of the drive catheter.

In some embodiments, the ablation device further includes a cover portion extending from a side of the body, the cover portion defining a recess between the cover portion and the body, wherein the electrode platform is movable between a covered position, where the at least one electrode is covered by the cover portion, and an exposed position, where the at least one electrode is at least partially exposed beyond the cover portion.

Other systems, methods, features and advantages of the described embodiments will be, or will become, apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features and advantages be within the scope of the disclosure.

The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the disclosure.

In the present application, the term "proximal" refers to a direction that is generally towards a physician during a medical procedure, while the term "distal" refers to a direction that is generally towards a target site within a patient's anatomy during a medical procedure. As used herein to describe example embodiments, the term "fluid" may refer to a gas or a liquid.

<FIG> illustrate an embodiment of an ablation cap <NUM> in accordance with the present disclosure. As shown, the ablation cap <NUM> includes a tubular body <NUM> having a lumen <NUM> formed therein. The ablation cap <NUM> includes a proximal portion <NUM> and a distal portion <NUM>. As shown in, the proximal portion <NUM> of the cap <NUM> is sized to fit on a distal end <NUM> of an endoscope <NUM> (shown in <FIG>). In some embodiments, the proximal portion <NUM> of the ablation cap <NUM> may include a flexible portion <NUM> that is connected to the tubular body <NUM> and that fits over the distal end <NUM> of the endoscope <NUM> to secure the cap <NUM> to the endoscope <NUM>, for example, by friction fit. In some embodiments, the proximal portion <NUM> may be made of a hard material that is sized and shaped to fit over the distal end <NUM> of the endoscope <NUM> by friction fit.

The distal portion <NUM> of the ablation cap <NUM> may extend beyond the distal end <NUM> of the endoscope <NUM>. The distal portion <NUM> may be cylindrical. In some embodiments, the distal portion <NUM> may be formed from a material having sufficient transparency so that the operator using an imaging device <NUM> of the endoscope <NUM> may observe a portion of the tissue to be treated by viewing the tissue through a wall <NUM> of the distal portion <NUM> of the ablation cap <NUM>. The distal portion <NUM> may also include a portion that is formed from a material for magnifying the tissue under observation. The cap <NUM> may further include a hood or a cover portion <NUM> that includes a recess <NUM> formed as part of the ablation cap <NUM>. The cover portion <NUM> may be integrally formed with the cap <NUM> or provided as a separate portion and connected to the cap <NUM>. The cover portion <NUM> is at least partially spaced apart from the tubular body to form the recess <NUM>. The recess <NUM> may be sized and shaped to hold an extendable electrode platform <NUM> within the recess <NUM> in a covered position, as shown in <FIG> and <FIG>. The electrode platform <NUM> is slidably positionable within the recess <NUM> of the cover portion <NUM>. In some embodiments, the electrode platform <NUM> may be positioned entirely within the recess <NUM> of the cover portion <NUM> in the covered position so that electrodes positioned on the electrode platform <NUM> are completely covered. As shown in <FIG>, the electrode platform <NUM> may be extended distally from the recess <NUM> so that at least a portion of a surface <NUM> of the electrode platform is exposed and can contact the tissue to be treated. A portion of the wall <NUM> is positioned behind the electrode platform <NUM> when the electrode platform <NUM> is an exposed position and may be used to support the electrode platform <NUM> when the electrode platform <NUM> is pressed against the tissue to be treated. In some embodiments, a distal end <NUM> of the electrode platform <NUM> does not extend beyond a distal end of the distal portion <NUM> of the cap <NUM>.

In some embodiments, a distal end <NUM> of the electrode platform <NUM> is extended less than the extension as shown in <FIG>. By way of non-limiting example, the distal end <NUM> may be extended less than <NUM>% or about <NUM>%, <NUM>%, <NUM>% and <NUM>% of the extension shown in <FIG>. Other extension distances are also possible. In some embodiments, the electrode platform <NUM> may be colored to facilitate viewing the electrode platform <NUM> as it is advanced distally and to determine the amount that the electrode platform <NUM> has been extended. For example, the electrode platform <NUM> may be black or blue or any color that may be seen through an endoscope to help viewing the position of the electrode platform <NUM>. In some embodiments, the cap <NUM> may include a stop to stop the electrode platform <NUM> at a maximum extension and to prevent the electrode platform from extending too far out of the cap <NUM>.

In some embodiments, at least a portion of the electrode platform <NUM> may be viewable through the endoscope. The electrode platform <NUM> may move into and out of the view of the endoscope, for example, when the electrode platform <NUM> has been extended a certain percent relative to the cap <NUM>, the electrode platform <NUM> may be viewed through the endoscope. By way of non-limiting example, the electrode platform <NUM> may be viewed when <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>% or other amount has been extended distally from the retracted position of <FIG>. Electrodes positioned on the electrode platform <NUM> may also be energized when the electrode platform <NUM> is extended distally less than <NUM>%.

A cross-sectional side view of the ablation cap <NUM> is shown in <FIG>. The lumen <NUM> extends through the ablation cap <NUM> between the proximal portion <NUM> and the distal portion <NUM>. The electrode platform <NUM> is shown within the recess <NUM> of the cover portion <NUM>. In the embodiment shown, a beveled portion <NUM> is positioned on a distal edge of the recess <NUM>. The beveled portion <NUM> may be used to help prevent tissue entrapment within the recess <NUM>, for example, by scraping ablated tissue off the electrode platform <NUM>, when the electrode platform <NUM> is retracted in a proximal direction, to a position within the cover portion <NUM>.

As shown in <FIG>, the electrode platform <NUM> may be connected to a drive catheter <NUM> that extends proximally from the electrode platform <NUM>, through an opening <NUM> (see <FIG>) in the rear of the cover portion <NUM>, to a proximal control handle (not shown). The drive catheter <NUM> is distally movable to extend the electrode platform <NUM> from the recess <NUM> of the cover portion <NUM> and proximally movable to re-position the electrode platform <NUM> within the recess <NUM>. Typically, the electrode platform <NUM> is positioned within the recess <NUM> of the cover portion <NUM> when the ablation cap <NUM> is being delivered to a treatment site or being repositioned within a patient's lumen for additional treatment at one or more additional sites. Positioning of the electrode platform <NUM> within the recess <NUM> also helps to prevent accidental energy delivery, for example to healthy tissue. The electrode platform <NUM> is at least partially distally extended from the recess <NUM> of the cover portion <NUM> for treatment at a site and energy is delivered to the tissue to ablate the diseased tissue as described in more detail below.

In some embodiments, the electrode platform <NUM> may include a support member <NUM> upon which one or more electrodes <NUM> are positioned. <FIG> illustrate exemplary support members <NUM>. As shown in <FIG>, the support member <NUM> may be a solid material, such as a plastic material. As shown in <FIG>, the support member <NUM>, may be a mesh. When the solid material or the mesh is formed of a metallic material, a layer of insulation may be provided between the support member <NUM> and the electrodes <NUM>. The support member <NUM> may be moved proximally and distally with the drive catheter <NUM>. The electrodes <NUM> may be secured to the support member <NUM> by any method known to one skilled in the art. By way of non-limiting example, the electrodes may be secured by gluing, bonding, taping, an adhesive backing on the electrodes, crimping, manufacturing the electrodes directly on to the body and the like.

Electrical wires <NUM> may extend through a lumen <NUM> of the drive catheter <NUM> as shown in <FIG> and connect to the electrodes <NUM> to supply the energy for ablation. Alternatively, the electrical wires <NUM> may extend through a lumen of the endoscope <NUM>. Exemplary electrodes <NUM> may be seen in <FIG>. The electrodes <NUM> may be provided separately from the support member <NUM> and in some embodiments may also form the support member <NUM> without providing a separate support member.

As shown In <FIG>, the electrodes <NUM> may include positive electrodes <NUM> and negative electrodes <NUM> in a bipolar device. When provided as a bipolar device, the electrodes <NUM> are provided in pairs, one positive and one negative electrode per pair. The electrodes <NUM> may also be provided as a monopolar device having a single electrode <NUM> or a plurality of electrodes <NUM> with a grounding pad or an impedance circuit additionally provided (not shown). The electrodes <NUM> may be provided in any pattern on the support member <NUM>. The electrodes <NUM> may cover the entire support member <NUM> or a portion thereof. By way of non-limiting example, a space <NUM> between the positive electrode <NUM> and the negative electrode <NUM> may between about <NUM> to about <NUM>. In some embodiments, the energy may be delivered to the tissue for a period of time from about <NUM> second to about <NUM> seconds. In some embodiments, the amount of energy delivered to the tissue may be from about <NUM> watts to about <NUM> watts. Other spacing distances between electrodes, length of time, and energy delivery are also possible and depend on the target tissue, the depth of the lesion, the type of energy, the length of application of the energy to the tissue and the spacing of the electrodes.

The electrodes <NUM> are operably connected to an energy source (not shown). In some embodiments, the energy source may be a radio frequency source. However, other types of energy sources may also be used to provide energy to the electrodes. By way of non-limiting example, additional possible energy sources may include microwave, ultraviolet, cryogenic and laser energies.

In some embodiments, the ablation cap may be made primarily of a substantially transparent or translucent polymer such as polytetrafluorothylene (PTFE). Additional possible materials include, but are not limited to the following, polyethylene ether ketone (PEEK), fluorinated ethylene propylene (FEP), perfluoroalkoxy polymer resin (PFA), polyamide, polyurethane, high density or low density polyethylene, and nylon. In some embodiments, the ablation cap may be formed from a lubricious material such as PTFE and the like for easy slidability within the patient's lumen for delivery to the treatment site. In some embodiments, the ablation cap or a portion thereof may be formed from magnifying or other image enhancing materials. The ablation cap or a portion thereof may also be coated or impregnated with other compounds and materials to achieve the desired properties. Exemplary coatings or additives include, but are not limited to, parylene, glass fillers, silicone hydrogel polymers and hydrophilic coatings.

<FIG> illustrates the distal end <NUM> of an exemplary endoscope <NUM> for use with the ablation caps of the present disclosure. In some embodiments, the endoscope <NUM> may include an imaging device <NUM> extending through at least a portion of endoscope <NUM> between a proximal end of the endoscope <NUM> and the distal end <NUM>. The imaging device <NUM> may include a lens operatively coupled to, e.g., in signal communication with, an external imaging system and is configured to capture images of the target site and transmit signals indicative of the captured images to the imaging system. The endoscope <NUM> may also include an accessory channel <NUM> extending through at least a portion of the endoscope <NUM> between a proximal end of the endoscope <NUM> and the distal end <NUM>. The accessory channel <NUM> may be used to delivery any number of accessories or devices, such as a catheter (not shown), to the distal end <NUM> of the endoscope <NUM>. Endoscope <NUM> may further include one or more light sources <NUM>, such as light-emitting diodes (LEDs), and a water source <NUM> configured to inject water into the target site. Finally, the endoscope <NUM> may include one or more fluid lumens <NUM> extending through at least a portion of the endoscope <NUM> between a proximal end of the endoscope <NUM> and the distal end <NUM>. The one or more fluid lumens <NUM> may be in fluid communication with an external source of a pressurized fluid (e.g., gas such as carbon dioxide or a liquid) to aerate the target site. Alternatively, or additionally, the one or more fluid lumens <NUM> may be in fluid communication with a vacuum pump to withdraw fluid from the target site and/or to supply a suction force within the cap <NUM> in order to draw the tissue to be ablated into contact with the electrodes <NUM>.

<FIG> illustrate additional electrode platforms and drive catheters in accordance with additional embodiments of the present disclosure. The electrode platforms and drive catheters of <FIG> may be used in conjunction with the ablation cap <NUM> of <FIG>, or other ablation caps, and/or in conjunction with the endoscope <NUM> of <FIG>, or other endoscopes. The structure of the electrode platform <NUM> and drive catheter <NUM> of <FIG> is exemplary of the structures of the electrode platforms <NUM>, <NUM>, <NUM>, and <NUM> illustrated in <FIG>, except as described below.

Similar to prior embodiments, <FIG> illustrate an electrode platform <NUM> having one or more electrodes <NUM> arranged in a central portion of the electrode platform <NUM>. A drive catheter <NUM> defining a central lumen <NUM> extends proximally from the electrode platform <NUM>. The drive catheter <NUM> may be movable distally to extend the electrode platform <NUM> from the recess <NUM> of the cover portion <NUM> and movable proximally to re-position the electrode platform <NUM> within the recess <NUM>. Electrical wires <NUM> may extend through the lumen <NUM> of the drive catheter <NUM> and connect to the electrodes <NUM> to supply the energy for ablation.

Unlike prior embodiments, the electrode platform <NUM> comprises one or more vacuum ports <NUM> formed on the surface <NUM> of the electrode platform <NUM>. The vacuum ports <NUM> extend through the surface <NUM> and are in fluid communication with a central cavity <NUM> of the electrode platform <NUM>, as illustrated in the cross-sectional view of <FIG>. In turn, the central cavity <NUM> is in fluid communication with the central lumen <NUM> of the drive catheter <NUM>. The central lumen <NUM> may be in fluid communication with a vacuum pump (not shown) positioned at a proximal end of the drive catheter <NUM>. In this way, the one or more vacuum ports <NUM> may be used to selectively supply a suction force to draw tissue in the vicinity of the of the electrode platform <NUM> toward the one or more electrodes <NUM>, without relying on the fluid port <NUM> of the endoscope <NUM>.

In the embodiment of <FIG>, four vacuum ports <NUM> are arranged about the periphery of the electrode platform <NUM>, and about the periphery of the one or more electrodes <NUM>, in a generally rectangular orientation. In some embodiments, the electrode platform may have fewer than four vacuum ports <NUM>, or more than four vacuum ports <NUM>. In some embodiments, the vacuum ports <NUM> may be circular, and have a diameter of <NUM> to <NUM>, or less. In other embodiments, the vacuum ports <NUM> may have other shapes, such as a square, a rectangle, or other elongated shape. In general, however, the vacuum ports <NUM> will be sized so that no significant amount of ablated and/or loose tissue will be drawn into the vacuum ports <NUM>, where such tissue may build-up and/or clog the cavity <NUM> or lumen <NUM>. In general, such openings will have a dimension (e.g., diameter, width, etc.) in the range of <NUM> to <NUM>, or less.

In the embodiment of <FIG>, the vacuum ports <NUM> are arranged about the periphery of the one or more electrodes <NUM>. Advantageously, this orientation does not disrupt the surface of the one or more electrodes <NUM>, thereby maintaining the surface area thereof for ablation of tissue, while still providing a distributed suction force around the periphery of the electrodes <NUM>. Likewise, vacuum ports <NUM> in the form of multiple small holes or openings distributed about the surface <NUM> of the electrode platform <NUM>, rather than one or more larger openings, helps maintains the rigidity of the electrode platform <NUM>, thereby facilitating the ability to position the electrode platform <NUM>. In this embodiment, the distributed suction force supplied by the vacuum ports <NUM>, about the periphery of the electrodes <NUM>, effectively draws adjacent tissue uniformly into contact across the entire surface area of the electrodes <NUM>.

While the drive catheter <NUM> and electrode platform <NUM> of <FIG> illustrates a single lumen <NUM>, and a single cavity <NUM>, for communication with a vacuum pump (not shown), and/or an energy source (not shown) via wires <NUM>, in other embodiments, the drive catheter <NUM> may have multiple separate lumens, in communication with multiple separate cavities and/or vacuum ports <NUM>. For example, the drive catheter <NUM> may have one lumen for housing the wires <NUM>, a second lumen in communication with a cavity and one or more select vacuum ports <NUM>, and a third lumen in communication with another cavity and one or more other vacuum ports <NUM>, where the second and third lumens are also selectively in communication with one or more vacuum pumps. In this way, a suction force may be selectively delivered to one or more of the vacuum ports <NUM>, as desired, or all of the vacuum ports <NUM>. In some embodiments, the one or more vacuum ports <NUM> may be monitored, individually or collectively, to determine if adequate contact is achieved between the electrode platform <NUM> (and one or more electrodes <NUM> mounted thereon) and target tissue site. For example, the one or more vacuum ports <NUM> may be individually or collectively monitored to determine if a negative pressure is created and maintained within the one or more lumens <NUM> and/or cavities <NUM>, thereby indicating contact between the target tissue and the electrode platform <NUM>, at least in the region of the individual vacuum ports <NUM>.

Additionally, or alternatively, in some embodiments, the one or more vacuum ports <NUM> (and related cavities and lumens) may be in communication with a source of pressurized fluid (e.g., carbon dioxide, or saline solution), for purposes of flushing the lumen <NUM>, cavity <NUM>, and/or vacuum ports <NUM>, for example, to expel ablated tissue. The pressurized fluid may also serve to "rinse" the surface <NUM> of the electrode platform <NUM>, for example, to assist the release of ablated tissue from the surface <NUM>.

<FIG> illustrate an electrode platform <NUM> according to another embodiment of the present disclosure. In the embodiment of <FIG>, one or more vacuum ports <NUM> are arranged along the lateral edges of one or more electrodes <NUM>. In some embodiments, the vacuum ports <NUM> may be formed as longitudinal slots, having a length corresponding to a length of the electrodes <NUM>, and a width of <NUM> to <NUM>, or less. In other embodiments, the length of the longitudinal slots may be greater than or less than the length of the electrodes <NUM>. Advantageously, this orientation does not disrupt the surface of the one or more electrodes <NUM>, thereby maintaining the surface area thereof for ablation of tissue, while still providing a distributed suction force along the entire length and lateral edges of the one or more electrodes <NUM>. In this embodiment, the distributed suction force supplied by the vacuum ports <NUM>, along the lateral edges of the electrodes <NUM>, effectively draws adjacent tissue uniformly into contact across the entire surface area of the electrodes <NUM>.

<FIG> illustrate an electrode platform <NUM> according to another embodiment of the present disclosure. In the embodiment of <FIG>, one or more vacuum ports <NUM> are arranged along the proximal and distal edges of one or more electrodes <NUM>. In some embodiments, the vacuum ports <NUM> may be formed as transverse slots, having a length corresponding to a width of the electrodes <NUM>, and a width of <NUM> to <NUM>, or less. In other embodiments, the length of the transverse slots may be greater than or less than the width of the electrodes <NUM>. Advantageously, this orientation does not disrupt the surface of the one or more electrodes <NUM>, thereby maintaining the surface area thereof for ablation of tissue, while still providing a distributed suction force along the entire width and proximal and distal edges of the one or more electrodes <NUM>. In this embodiment, the distributed suction force supplied by the vacuum ports <NUM>, along the entire width and proximal and distal edges of the one or more electrodes <NUM>, effectively draws adjacent tissue uniformly into contact across the entire surface area of the electrodes <NUM>.

<FIG> illustrate an electrode platform <NUM> according to another embodiment of the present disclosure. In the embodiment of <FIG>, one or more vacuum ports <NUM> are arranged along the lateral edges, and the proximal and distal edges, of one or more electrodes <NUM>. In some embodiments, the vacuum ports <NUM> may be formed as slots, having both a longitudinal portion, extending along a portion of the length of the electrodes <NUM>, and a transverse portion, extending along a the width of the electrodes. Again, the slots may have a width of <NUM> to <NUM>, or less. In some embodiments, the longitudinal portions of the vacuum ports <NUM> may extend substantially the length of the electrodes <NUM>. However, it should be appreciated that the entire periphery of the electrodes are not surrounded by the vacuum ports <NUM>, as at least a portion of the surface of the electrode platform <NUM> must remain to support the electrodes <NUM>. Advantageously, this orientation does not disrupt the surface of the one or more electrodes <NUM>, thereby maintaining the surface area thereof for ablation of tissue, while still providing a distributed suction force along both the length and width, and on all sides of the or more electrodes <NUM>. In this embodiment, the distributed suction force supplied by the vacuum ports <NUM>, along both the length and width of the one or more electrodes <NUM>, effectively draws adjacent tissue uniformly into contact across the entire surface area of the electrodes <NUM>.

<FIG> illustrates an electrode platform <NUM> according to another embodiment of the present disclosure. In the embodiment of <FIG>, one or more vacuum ports <NUM> are arranged within, or are surrounded by, one or more electrodes <NUM>. In some embodiments, the vacuum ports <NUM> may be circular, and have a diameter of <NUM> to <NUM>, or less. In other embodiments, the vacuum ports <NUM> may have other shapes, such as a square, a rectangle, or other elongated shape. Advantageously, this orientation provides a distributed suction force originating in multiple locations within, or surrounded by the one or more electrodes <NUM>, thereby drawing tissue to be ablated to a specific locations within the electrodes <NUM>. In this embodiment, a distributed suction force may be supplied by the vacuum ports <NUM>, depending on the location, number, and shape of the vacuum ports <NUM>, to effectively draw adjacent tissue uniformly into contact across the entire surface area of the electrodes <NUM>.

In other embodiments, an electrode platform may have one or more combinations of the orientations of the vacuum ports <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. For example, an electrode platform may have vacuum ports <NUM> and <NUM>, in the form of circular holes, formed about the periphery of one or more electrodes, and within, or surrounded by, the one or more electrodes. It should be appreciated that the any number of combinations and orientations of vacuum ports may be positioned on an electrode platform without departing from the scope of the present disclosure. The embodiments described and illustrated herein are only exemplary.

Operation of an ablation device using the endoscope <NUM>, the ablation cap <NUM>, and an electrode platform (e.g., <NUM>, <NUM>, <NUM>, <NUM>, and/or <NUM>) of the present disclosure as a non-limiting example will be explained with reference to <FIG> illustrates a patient's esophagus <NUM>, lower esophageal sphincter (LES) <NUM> and stomach <NUM>. Areas of diseased tissue <NUM> within the esophagus <NUM> are also shown. The diseased tissue <NUM> may be columnar mucosa (Barrett's esophagus) that is to be ablated using the ablation cap <NUM>. <FIG> illustrates the ablation cap <NUM> positioned on the distal end <NUM> of the endoscope <NUM> and the cap <NUM> and the endoscope <NUM> being inserted into the patient's esophagus <NUM>. The ablation cap <NUM> is positioned in the esophagus <NUM> near the portion of the diseased tissue <NUM> to be treated. The insertion of the ablation cap <NUM> may be monitored using the imaging device <NUM> of the endoscope <NUM> to help position the cap <NUM> at the diseased tissue. As shown in <FIG>, the ablation cap <NUM> is positioned near the diseased tissue <NUM>. While the ablation cap <NUM> is being positioned, the electrode platform (e.g., <NUM>, <NUM>, <NUM>, <NUM>, and/or <NUM>) is in a covered position <NUM> within the ablation cap <NUM>. Then, when the ablation cap <NUM> is in the desired position, the electrode platform may be advanced distally from the cap <NUM> to an exposed position <NUM>. Once in an exposed position <NUM>, a suction force may be selectively delivered from a vacuum source to one or more vacuum ports (e.g., <NUM>, <NUM>, <NUM>, <NUM>, and/or <NUM>) on the electrode platform to draw nearby tissue in to contact with the electrodes on the electrode platform, as shown in <FIG>. Advantageously, this step may also be may be monitored using the imaging device <NUM> of the endoscope <NUM> to help ensure that the target tissue (and not healthy tissue) is in the desired contact with the electrode platform. When the diseased tissue <NUM> is in sufficient contact with the electrode platform <NUM>, the electrodes <NUM> are in contact with the diseased tissue <NUM> and can deliver energy to the diseased tissue <NUM> to ablate the diseased tissue <NUM>. A power source (not shown) is activated for a sufficient time to ablate the diseased tissue <NUM>. The ablation cap <NUM> may then be repositioned near another portion of diseased tissue <NUM> for treatment and the steps repeated as many times as needed. The electrode platform <NUM> may be extended and viewed through the imaging device <NUM> as the electrode platform <NUM> extends distally. When necessary, a fluid from a fluid source may be delivered to the one or more vacuum ports to flush the vacuum ports and/or "rinse" the surface of the electrode platform. While the procedure has been described with reference to the ablation of diseased tissue in the esophagus using the ablation cap <NUM>, the location of the treatment is not limited to the esophagus. By way of non-limiting example, portions of the stomach, or the gastrointestinal tract may also be treated using the ablation cap <NUM>.

Although the subject matter has been described in language specific to structural features and/or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described. Rather, the specific features and acts are disclosed as illustrative forms of implementing the claims, which solely define the scope of the invention.

One skilled in the art will realize that a virtually unlimited number of variations to the above descriptions are possible, and that the examples and the accompanying figures are merely to illustrate one or more examples of implementations.

In the detailed description above, numerous specific details are set forth to provide a thorough understanding of claimed subject matter. However, it will be understood by those skilled in the art that claimed subject matter can be practiced without these specific details. In other instances, methods, devices, or systems that would be known by one of ordinary skill have not been described in detail so as not to obscure claimed subject matter.

Claim 1:
An ablation device comprising:
a body (<NUM>) having a lumen (<NUM>) for receiving a distal end (<NUM>) of an endoscope (<NUM>);
a cover portion (<NUM>) extending from a side of the body, the cover portion defining a recess (<NUM>) between the cover portion and the body;
an electrode platform (<NUM>) having at least one electrode positioned thereon, the electrode platform movable between a covered position, where the at least one electrode is covered by the cover portion, and an exposed position, where the at least one electrode (<NUM>) is at least partially exposed beyond the cover portion; and,
at least one vacuum port (<NUM>) formed in the electrode platform (<NUM>).