JP6647374B2 - Deployable electrode device having a plurality of longitudinal electrode segments - Google Patents

Description

CROSS-REFERENCE This application is filed on Oct. 21, 2014, U.S. patent application Ser. No. 14 / 519,409, filed on Oct. 21, 2014 and entitled "UNFULLING ELECTRODE DEVICES WITH THE MULTIPLE LONGITUDINAL ELECTRODE SEGMENTS", filed on Oct. 21, 2014. Of the invention "UNFULLING"
US Patent Application No. 14 / 519,950, filed on October 21, 2014, and US Patent Application No. 14 / 519,950, filed on October 21, 2014, US Patent Application No. 14 / 519,950, ELECTRODE DEVICES WITH SPRING. No. 028, as well as priority to the above-mentioned U.S. patent applications, each of which is filed on October 25, 2013, with the title "UNFULLING ELECTRODE DEVICES WITH THE THE MULTIPLE LONGITUDINAL ELECTRODE SEGMENTS". U.S. Provisional Application No. 61 / 895,501, filed Oct. 25, 2013, titled "UNFUURLIN" US Provisional Application No. 61 / 895,514 of "ELECTRODE DEVICES WITH SPRING", and US Provisional Application No. 61, 89, of "UNFULLING ELECTRODE DEVICES WITH THE PROTECTION ELEMENT" filed on October 25, 2013. No. 530, each of which is incorporated by reference in its entirety for all purposes.

BACKGROUND The human body has a number of internal body lumens or cavities, which are located, for example, in different parts of the gastrointestinal tract, many of which have a lining or lining. Body lumens can include, for example, the esophagus, small and large intestines, stomach, remnants after bariatric surgery, rectum, and anus. These linings can be predisposed to disease. In some cases, different ablation techniques have been utilized for the lining to prevent the spread of disease to nearby otherwise healthy tissue.

  The inner body lumens may have different sizes for each other or for different patients. As a result, different sized devices may be utilized to accommodate these different sized lumens. However, this may involve utilizing multiple devices (eg, multiple sizing and / or treatment devices), which is more efficient than a device that can perform both sizing and treatment in a single intubation. Sometimes it is not a target, it is not cost-effective, and it is not secure.

  Another problem may exist when treating a target site that is larger than the surface area of the treatment device. Conventional ablation approaches often included three or more repositioning steps to treat the target site. Such repositioning activity may be likely to result in reduced accuracy of the procedure after excision of a small area of the target site, or during excision of a small area of the target site, or both. Further, the relocation activity may be ad hoc with respect to the number of relocation steps and the physical processes associated with the actual relocation of the device. Such inconsistencies may further reduce treatment accuracy, treatment efficiency, or both.

  Accordingly, there may be a need for systems, devices, and methods that can overcome the above and / or other disadvantages of known systems, devices, and methods.

SUMMARY Methods, systems, and devices for providing treatment to a target site (eg, a site within a body lumen) are described. The system can include an expansion member connected to the distal portion of the catheter and a resection structure support connected to the resection structure, the resection structure expanding when the expansion member expands and contracts. It is configured to at least partially wrap and deploy around the member. The expansion member may include a non-compliant balloon, a compliant balloon, or a highly compliant balloon. The ablation structure support may include one or more longitudinal electrodes, longitudinal electrode zones, and / or longitudinal electrode areas. In some embodiments, the system may include one or more protection elements, one or more protection elements distal to the ablation structure, proximal to the ablation structure, or both. Positioned along the catheter.

  According to some embodiments of the present disclosure, there is provided an ablation device for treatment of tissue in a body lumen having various sizes. The ablation device generally includes an expansion member coupled to the distal portion of the catheter and an ablation structure that includes a number of longitudinal electrode regions. An ablation structure support may be coupled to the ablation structure, the ablation structure and the ablation structure support at least partially deploy or wrap around the expansion member when the expansion member expands or contracts. It can be configured to do so.

  In some embodiments, the ablation device further comprises one or more springs coupled to the ablation structure support, the one or more springs at least partially around the expansion member. It is configured to wrap around the body. The one or more springs may include one or more constant load springs. The ablation device may also include one or more protection elements, wherein the one or more protection elements are positioned along the catheter at least distally or proximal to the ablation structure.

  In some embodiments, each of the longitudinal electrode regions of the ablation device is configured to be selectively enabled or disabled. Each of the longitudinal electrode regions may be separately controlled or wired. In certain embodiments, the longitudinal electrode regions include at least two longitudinal electrode regions having different widths. The ablation device may, in some embodiments, include at least one bipolar electrode array. In certain instances, the dilation member is a balloon, and the balloon may be compliant in some embodiments.

  According to some embodiments of the present disclosure, a method of treating tissue in a body lumen having various sizes is provided. The method generally includes inserting a resection structure coupled to the resection structure support and an expansion member into a body lumen. The ablation structure and the ablation structure support may be configured to at least partially deploy or wrap around the expansion member as the expansion member expands or contracts. The method includes expanding an expansion member to at least partially deploy an ablation structure to engage a perimeter section of a body lumen, and one or more of a plurality of longitudinal electrode regions of the ablation structure. Delivering the energy through the peripheral section of the body lumen.

  In some examples, delivering energy to a peripheral section of a body lumen through one or more of the plurality of longitudinal electrode regions of the ablation structure selectively operates each of the longitudinal electrode regions. Including enabling. The method may further include deflating the dilation member to facilitate removing the resection structure from the body lumen. In some embodiments, the one or more springs cause the cutting structure to at least partially wrap around the expansion member when the expansion member contracts. The one or more springs may, in some examples, include one or more constant load springs.

  In certain embodiments, the method comprises the steps of: And utilizing one or more protection elements. In some embodiments, the method further includes, after positioning the ablation structure within the body lumen, moving one or more protective elements away from the ablation structure. In certain examples, the method includes determining an impedance for each of the plurality of longitudinal electrode regions of the ablation structure and comparing the determined impedance to one or more of the longitudinal electrode regions. Further comprising determining whether at least partially covered by the electrode segment.

  In some embodiments, the longitudinal electrode regions of the ablation structure include at least two longitudinal electrode regions having different widths. The ablation structure may, in certain instances, include at least a bipolar electrode array. The expansion member may be a balloon in some embodiments.

  According to some embodiments of the present disclosure, there is provided an ablation device for treatment of tissue in a body lumen having various sizes. The ablation device generally includes an expansion member coupled to the distal portion of the catheter, and an ablation structure that at least partially surrounds the expansion member when the expansion member expands or contracts. It is configured to unfold or wrap. The ablation device further includes one or more springs coupled to the ablation structure, wherein the one or more springs cause the ablation structure to expand about the expansion member when the expansion member expands or contracts, or It is configured to provide a force that causes winding.

  In some embodiments, the one or more springs of the ablation device include one or more strips of material, the one or more strips being transverse to the longitudinal axis of the ablation structure. Connected to the resection structure. In certain instances, the one or more springs of the ablation device may include a density of one or more pieces of material proximal to the free end of the ablation structure, and one or more materials distal to the free end of the ablation structure. One or more pieces of material such that the density is less than the density of the pieces of material. In still other embodiments, the one or more springs of the ablation device include a density of one or more pieces of material proximal to the free end of the ablation structure and a proximity to an installed end of the ablation structure. The one or more pieces of material are included such that the density of the one or more pieces of material in the order is less than the density of the one or more pieces of material in the middle portion of the ablation structure. The one or more pieces of material may include a metallic or polymeric material. The one or more pieces of material may, in some embodiments, include a shape memory polymer material.

  In certain examples, the one or more springs of the ablation device include at least a first spring having a first length and a second spring having a second length different from the first length. . The first length may be longer than the second length, and a second spring having a second length may be positioned distal to the free end of the cutting structure.

In some embodiments, the one or more pieces of material of the one or more springs include one or more rectangular pieces of material. In certain examples, at least one of the rectangular pieces of material includes one or more openings, wherein the one or more openings are within at least one end of the at least one rectangular piece. It is configured. In some embodiments, at least one of the pieces of material includes at least a tapered portion. In still other embodiments, at least one of the pieces of material includes one or more slots, wherein the one or more slots are configured within at least one end of the at least one piece of material.

  In certain embodiments, the ablation structure of the ablation device includes multiple longitudinal electrode regions, the longitudinal electrode regions configured to be sequentially activated. In some embodiments, the ablation structure includes a number of longitudinal electrode regions, the longitudinal electrode regions being continuous starting from a first electrode region adjacent a free end of the ablation structure. It is configured to be activated. In still some other embodiments, the ablation structure includes multiple longitudinal electrode regions, each longitudinal electrode region configured to be selectively enabled or disabled. The longitudinal electrode regions may include at least two longitudinal electrode regions having different widths. In certain examples, the at least two longitudinal electrode regions of different widths include a first longitudinal electrode region adjacent a free end of the ablation structure and a second longitudinal electrode region; The first longitudinal electrode region has a greater width than the width of the second longitudinal electrode region.

  In some embodiments, the longitudinal electrode regions of the ablation device include at least three longitudinal electrode regions having different widths, wherein the at least three longitudinal electrode regions are relative to a free end of the ablation structure. A proximal first longitudinal electrode region, a second longitudinal electrode region adjacent to the first longitudinal electrode region, and a third distal electrode distal to the free end of the ablation structure. A longitudinal electrode area. The first longitudinal electrode area may have a greater width than the width of the second longitudinal electrode area, and the second longitudinal electrode area may have a greater width than the width of the third longitudinal electrode area. Can also have a wide width.

  In certain embodiments, the ablation structure of the ablation device includes at least a bipolar electrode array. In some embodiments, the expansion member of the ablation device is a balloon.

  According to embodiments of the present disclosure, an ablation device is provided for treatment of tissue in a body lumen having various sizes. The ablation device generally includes an ablation structure coupled to the catheter and includes one or more protection elements, one or more protection elements distal to the ablation structure and proximal to the ablation structure. Or both, along the catheter. In some embodiments, the ablation structure includes a wound bipolar electrode array.

  In some examples, the one or more protection elements include one or more cones, wherein the one or more cones are configured to protect one or more edges of the ablation structure. . The one or more cones may each have a larger basal perimeter than the perimeter of the deflated ablation structure. Further, the one or more cones may be configured to move away from the ablation structure when the ablation structure is deployed and engages tissue. In some embodiments, the ablation device may further include one or more tethers, such that the one or more tethers facilitate moving one or more cones relative to the ablation structure. It is configured.

  In certain instances, the one or more protective elements are configured to prevent the ablation structure from bulging along the catheter at least during deployment into or removal from the body lumen. I have. The one or more protective elements can be configured to prevent the ablation structure from damaging the surface of the body lumen at least during deployment into or removal from the body lumen.

  In some embodiments, the one or more protection elements include one or more bumpers, wherein the one or more bumpers are connected to one or more edges of the ablation structure. One or more bumpers may overlay the edge of the ablation structure inwardly toward the catheter.

  According to various embodiments, one or more protection elements proximal to the ablation structure can include an elevated ledge coupled to the catheter. The raised ledge may be configured to prevent the ablation structure from bulging proximally along the catheter during insertion or deployment into a body lumen.

  In various embodiments, the ablation device further includes an expansion member coupled to the catheter, wherein the ablation structure is wrapped around the expansion member. In such an embodiment, the one or more protective elements distal to the ablation structure may include a portion of the expansion member, the portion of the expansion member being provided when the expansion member is unexpanded. The lump is configured such that the diameter of the lump exceeds the diameter of the wound ablation structure. The lumped portion of the expansion member may be configured to prevent the ablation structure from distending distally along the catheter during removal from the body lumen.

  In certain instances, the one or more protection elements are a first protection element positioned distal to the ablation structure relative to the catheter and a second protection element positioned proximal to the ablation structure relative to the catheter. Protection element.

  According to some embodiments of the present disclosure, a method of treating tissue in a body lumen having various sizes is provided. The method generally includes inserting an ablation structure associated with the catheter into a body lumen. One or more protective elements may be positioned along the catheter, at least distally or proximally, relative to the ablation structure. The method further includes expanding the expansion member and at least partially deploying the resection structure to engage a body lumen. The protection element may include one or more cones, wherein the one or more cones are configured to protect one or more edges of the ablation structure. In some examples, the method further includes transferring one or more cones away from the ablation structure when the ablation structure is deployed to engage a body lumen. The method may further include utilizing one or more tethers associated with the one or more protection elements to facilitate moving one or more protection elements relative to the ablation structure. .

  In some examples, one or more protective elements are configured to prevent the ablation structure from bulging along the catheter during deployment into a body lumen. In certain embodiments, the one or more protection elements include one or more bumpers, wherein the one or more bumpers are connected to one or more edges of the ablation structure. One or more bumpers may overlay the edge of the ablation structure inwardly toward the catheter.

  According to various embodiments, one or more protection elements proximal to the ablation structure can include an elevated ledge, which is coupled to the catheter. The raised ledge may be configured to prevent the ablation structure from bulging proximally along the catheter during deployment or insertion into a body lumen.

  In certain examples, the one or more protective elements distal to the ablation structure can include a portion of the expansion member, which becomes a lump when the expansion member is unexpanded, and As a result, the diameter of the lump is configured to exceed the diameter of the wound resection structure. The lumped portion of the expansion member may be configured to prevent the ablation structure from distending distally along the catheter during removal from the body lumen.

  In some embodiments, the one or more protection elements are positioned first with respect to the catheter distally of the ablation structure, and with one or more protection elements proximal to the ablation structure with respect to the catheter. A second protection element.

  The foregoing has outlined rather broadly the features and technical advantages of the examples in accordance with the present disclosure in order that the detailed description that follows may be better understood. Additional features and advantages are described below. The disclosed concepts and particular examples can be readily utilized as a basis for modifying or designing other structures to perform the same purpose of the present disclosure. Such equivalent arrangements do not depart from the spirit and scope of the appended claims. Features that are believed to be characteristic of the concepts disclosed herein, together with the associated advantages, together with the advantages thereof when taken together with the accompanying drawings, are more fully described below, both in terms of their organization and manner of operation. Well understood. Each of the drawings is for purposes of illustration and description only, and is not provided as a limitation on the scope of the claims.

For example, the present invention provides the following items.
(Item 1)
An ablation device for treatment of tissue in a body lumen having various sizes, the device comprising:
A catheter,
An expansion member connected to the distal portion of the catheter;
An ablation structure including a plurality of longitudinal electrode regions;
A cutting structure support coupled to the cutting structure, wherein the cutting structure and the cutting structure support expand at least partially around the expansion member when the expansion member expands or contracts. A device configured to do, or wrap.
(Item 2)
The device further includes one or more springs coupled to the resection structure support, the one or more springs configured to wrap the resection structure support at least partially around the expansion member. An ablation device according to the preceding item.
(Item 3)
The resection device according to any of the preceding items, wherein the one or more springs comprises one or more constant load springs.
(Item 4)
Any of the preceding items further comprising one or more protection elements, wherein the one or more protection elements are positioned along the catheter, at least distally or proximally to the ablation structure. An ablation device according to claim 1.
(Item 5)
The ablation device according to any one of the preceding items, wherein each of the longitudinal electrode regions is configured to be selectively enabled or disabled.
(Item 6)
The ablation device according to any of the preceding items, wherein each of the longitudinal electrode regions is separately controlled or wired.
(Item 7)
The ablation device according to any of the preceding items, wherein the plurality of longitudinal electrode regions include at least two longitudinal electrode regions having different widths.
(Item 8)
The resection device according to any one of the preceding items, wherein the expansion member includes a balloon.
(Item 9)
The resection device according to any one of the preceding items, wherein the balloon comprises a compliant balloon.
(Item 10)
The ablation device according to any one of the preceding items, wherein the ablation structure comprises at least one bipolar electrode array.
(Item 11)
An ablation device for treatment of tissue in a body lumen having various sizes, the device comprising:
A catheter,
An expansion member connected to the distal portion of the catheter;
A cutting structure configured to at least partially deploy or wrap around the expansion member when the expansion member expands or contracts;
One or more springs coupled to the resection structure support, wherein the one or more springs deploy about the expansion member when the expansion member expands or contracts. Or a device configured to provide a force that causes it to wrap.
(Item 12)
The above item, wherein the one or more springs comprises one or more pieces of material, the one or more pieces of material being coupled to the cutting structure transversely to a longitudinal axis of the cutting structure. An ablation device according to any one of the preceding claims.
(Item 13)
The one or more springs include one or more pieces of material, wherein a density of the one or more pieces of material proximal to a free end of the cutting structure is the free end of the cutting structure. An ablation device according to any one of the preceding items, wherein the density is less than a density of the one or more pieces of material distal to the device.
(Item 14)
The one or more springs include one or more pieces of material, wherein the density of the one or more pieces of material proximate to a free end of the ablation structure and the mounting of the ablation structure The density of the one or more pieces of material proximal to the end of the cut is less than the density of the one or more pieces of material in the middle portion of the ablation structure according to any one of the preceding items. An ablation device as described.
(Item 15)
The ablation device according to any one of the preceding clauses, wherein the one or more pieces of material comprise at least a metallic or polymeric material.
(Item 16)
The ablation device according to any one of the preceding items, wherein the one or more pieces of material include at least a shape memory polymer material.
(Item 17)
Wherein the one or more springs includes at least a first spring having a first length and a second spring having a second length different from the first length. An ablation device according to any one of the preceding claims.
(Item 18)
The first length is greater than the second length, and the second spring having the second length is positioned distal to the free end of the resection structure; An ablation device according to any one of the preceding items.
(Item 19)
The ablation device according to any of the preceding items, wherein the one or more pieces of material comprise one or more rectangular pieces of material.
(Item 20)
At least one of the rectangular pieces of material includes one or more openings, wherein the one or more openings are configured in at least one end of at least one of the rectangular pieces. The ablation device according to any one of the preceding items, wherein:
(Item 21)
The ablation device according to any of the preceding items, wherein at least one of the pieces of material comprises at least a tapered portion.
(Item 22)
At least one of the pieces of material includes one or more slots, wherein the one or more slots are configured within at least one end of the at least one piece of material. An ablation device according to any one of the preceding claims.
(Item 23)
The resection structure of any one of the preceding items, wherein the ablation structure includes a plurality of longitudinal electrode regions, the plurality of longitudinal electrode regions being configured to be sequentially activated. Excision device.
(Item 24)
The ablation structure includes a plurality of longitudinal electrode regions, the plurality of longitudinal electrode regions being sequentially active starting from a first electrode region adjacent a free end of the ablation structure. The ablation device according to any one of the preceding items, wherein the ablation device is configured to be adapted to be ablated.
(Item 25)
The ablation structure may include a plurality of longitudinal electrode regions, wherein each longitudinal electrode region is configured to be selectively enabled or disabled. An ablation device according to claim 1.
(Item 26)
The ablation device according to any of the preceding items, wherein the plurality of longitudinal electrode regions include at least two longitudinal electrode regions having different widths.
(Item 27)
The at least two longitudinal electrode regions of different widths include a first longitudinal electrode region adjacent a free end of the ablation structure and a second longitudinal electrode region; The ablation device according to any of the preceding items, wherein the longitudinal electrode region has a width greater than the width of the second longitudinal electrode region.
(Item 28)
The plurality of longitudinal electrode regions include at least three longitudinal electrode regions having different widths, the at least three longitudinal electrode regions being a first proximal electrode region proximal to a free end of the ablation structure. A longitudinal electrode area, a second longitudinal electrode area adjacent to the first longitudinal electrode area, and a third longitudinal direction distal to the free end of the ablation structure. Wherein the first longitudinal electrode region has a width greater than the width of the second longitudinal electrode region, and wherein the second longitudinal electrode region comprises the second longitudinal electrode region. The ablation device according to any one of the preceding items, having a width greater than the width of the three longitudinal electrode regions.
(Item 29)
The ablation device according to any one of the preceding items, wherein the ablation structure comprises at least a bipolar electrode array.
(Item 30)
The resection device according to any one of the preceding items, wherein the expansion member includes a balloon.
(Item 31)
An ablation device for treatment of tissue in a body lumen having various sizes, the device comprising:
A catheter,
An ablation structure connected to the catheter;
One or more protective elements, wherein the one or more protective elements are positioned along the catheter at least distally or proximally to the ablation structure.
(Item 32)
The ablation device according to any one of the preceding items, wherein the ablation structure comprises a wound bipolar electrode array.
(Item 33)
The above item, wherein the one or more protection elements include one or more cones, wherein the one or more cones are configured to protect one or more edges of the ablation structure. An ablation device according to any one of the preceding claims.
(Item 34)
Any of the preceding items, wherein the one or more protection elements include one or more cones, each cone having a base diameter that, when unexpanded, is greater than the diameter of the ablation structure. An ablation device according to claim 1.
(Item 35)
Any one of the preceding items, wherein the one or more cones are configured to move away from the resection structure when the resection structure is deployed and engages the tissue. An ablation device according to claim 1.
(Item 36)
The above items, further comprising one or more tethers, the one or more tethers configured to facilitate moving the one or more cones relative to the resection structure. An ablation device according to any one of the preceding claims.
(Item 37)
The one or more protective elements are configured to prevent the ablation structure from bulging along the catheter at least during deployment into or removal from a body lumen. An ablation device according to any one of the preceding items.
(Item 38)
The one or more protective elements are configured to prevent the ablation structure from damaging the surface of the body lumen at least during deployment into or removal from the body lumen. An ablation device according to any one of the preceding items, wherein
(Item 39)
The one or more protective elements according to any one of the preceding items, wherein the one or more protective elements include one or more bumpers, wherein the one or more bumpers are connected to one or more edges of the cutting structure. An ablation device as described.
(Item 40)
The ablation device according to any one of the preceding items, wherein the one or more bumpers overlie the edge of the ablation structure inwardly toward the catheter.
(Item 41)
The ablation device according to any one of the preceding items, wherein the one or more protective elements proximal to the ablation structure include an elevated ledge connected to the catheter.
(Item 42)
Any of the preceding items, wherein the raised ledge is configured to prevent the ablation structure from bulging proximally along the catheter during deployment into a body lumen. An ablation device according to claim 1.
(Item 43)
The resection device according to any of the preceding items, further comprising an expansion member coupled to the catheter, wherein the resection structure is wrapped around the expansion member.
(Item 44)
The one or more protection elements distal to the ablation structure include a portion of the expansion member, the portion of the expansion member becoming a lump when the expansion member is unexpanded, and The ablation device according to any of the preceding items, wherein the mass of the lump is configured to exceed the diameter of the wound ablation structure.
(Item 45)
The lump portion of the expansion member is configured to prevent the ablation structure from distending distally along the catheter during removal from a body lumen. An ablation device according to any one of the preceding claims.
(Item 46)
The one or more protection elements are a first protection element positioned distal to the resection structure with respect to the catheter, and a second protection element positioned proximal to the resection structure with respect to the catheter. The ablation device according to any one of the preceding items, comprising:

(Description)
Methods, systems, and devices for providing treatment to tissue in a body lumen are described. The system may include a catheter, an expansion member connected to a distal portion of the catheter, an ablation structure including one or more longitudinal electrode segments, and an ablation structure support connected to the ablation structure. The resection structure is configured to at least partially expand when the expansion member expands and wrap around when the expansion member contracts. The ablation structure may include a plurality of separately wired longitudinal electrodes and / or separately controlled longitudinal electrodes, longitudinal electrode zones, or both, such that each longitudinal electrode Or, the longitudinal electrode zones may be selectively enabled or disabled. In some examples, one or more springs are coupled to the cutting structure, which is configured to facilitate deployment or wrapping around the expansion member. In some examples, one or more protective elements are positioned along the catheter.

  A better understanding of the nature and advantages of embodiments may be realized by reference to the following drawings. In the accompanying drawings, similar components or features may have the same reference sign. Further, various components of the same type may be distinguished by a dash and a second indicator that distinguishes similar components follows the reference indicator. When only a first reference sign is used herein, the description refers to any one of like components having the same first reference sign regardless of the second reference sign. Is applicable.

FIG. 1A is a schematic diagram of a system for delivering treatment to a target treatment area, including components configured in accordance with various embodiments. FIG. 1B is a schematic diagram of one particular embodiment of the system shown in FIG. 1A. FIG. 1C is a schematic diagram of the power supply and switching mechanism of the system shown in FIGS. 1A and 1B. FIG. 2 is a schematic diagram of a portion of the upper gastrointestinal tract in humans. FIG. 3A is a schematic illustration of the ablation device in a wrapped / deflated mode within the esophagus. FIG. 3B is a schematic illustration of the ablation device in a deployed / dilated mode within the esophagus. FIG. 4 is a perspective view of the ablation device in a wrapped / deflated mode coupled to a plurality of separately wired longitudinal electrode zones. FIG. 5 is a perspective view of the ablation device in an expanded / expanded mode coupled to a plurality of separately wired longitudinal electrode zones. FIG. 6 is a perspective view of the partially deployed resection device of FIG. FIG. 7 is a perspective view of a partially deployed distal portion of the ablation device of FIG. 2 having a single spring and multiple longitudinal electrode areas of uniform width. FIG. 8 is a perspective view of a partially deployed distal portion of the ablation device of FIG. 2 having a single spring and a plurality of longitudinal electrode areas of uniform narrow width. FIG. 9 shows a partially deployed distal portion of the ablation device of FIG. 2 with a single spring and a longitudinal electrode area that can be a plurality of various lengths of continuously decreasing width. It is a perspective view of a part. FIG. 10A is a top cross-sectional view of the ablation structure of the ablation device of FIG. 2 in a deployed / expanded mode with partially overlapping electrode regions and fully overlapping electrode regions. FIG. 10B is a top cross-sectional view of the ablation structure of the ablation device of FIG. 2 in a deployed / expanded mode with fully overlapping electrode regions. FIG. 11 is a cross-sectional view of a pattern of an array of linear electrode zones of the ablation device of FIG. FIG. 12 is a schematic diagram of a pattern of electrodes of the ablation device of FIG. FIG. 13 is a cross-sectional view of the resection structure of the resection device of FIG. FIG. 14 is a plan view of the cutting structure of the cutting device of FIG. 2 with a spring that can be of various lengths. FIG. 15 is a plan view of the slotted spring of the cutout structure of FIG. FIG. 16A is a plan view of the tapered spring of the resection structure of FIG. FIG. 16B is a plan view of the resection structure of the resection device of FIG. 2 having a tapered spring. FIG. 17 is a plan view of a metal spring including the pinned hole of the cutout structure of FIG. FIG. 18 is a plan view of the cutting structure of the cutting device of FIG. 2 with a metal spring that can be of various lengths pinned. FIG. 19A is a perspective view of the ablation device of FIG. 4 in a wrapped / deflated mode having a proximal protective cone element and a distal protective cone element. FIG. 19B is a perspective view of the ablation device of FIG. 5 in a deployed / expanded mode having a proximal protective cone element and a distal protective cone element. FIG. 20A is a perspective view of the ablation device of FIG. 4 in a wrapped / deflated mode with a distal protective bumper element. FIG. 20B is a perspective view of the ablation device of FIG. 5 in a deployed / expanded mode with a distal protective bumper element. FIG. 21 is a perspective view of the ablation device of FIG. 20B in an expanded / expanded mode with a distal protective cone element tethered. FIG. 22 is a perspective view of the ablation device of FIG. 20B in an expanded mode having a proximal protective cone element and a distal protective cone element tethered. FIG. 23A is a perspective view of the ablation device of FIG. 4 in a wrapped / deflated mode having a proximal raised element. FIG. 23B is a perspective view of the ablation device of FIG. 5 in a deployed / expanded mode with a proximal raised ledge element. FIG. 24 is a perspective view of the ablation device of FIG. 4 in a wrapped / deflated mode. FIG. 25 is a flow diagram illustrating a method for providing treatment to a target site area, according to various embodiments. FIG. 26 is a flow diagram illustrating a method for providing treatment to a target site area, according to various embodiments. FIG. 27 is a flow diagram illustrating a method of providing treatment to a target site area using an expansion member that includes one or more protective elements, according to various embodiments. FIG. 28 is a flow diagram illustrating a method of providing treatment to a target site area using an expansion member that includes one or more movable protection elements, according to various embodiments. FIG. 29 is a flow diagram illustrating a method for providing treatment to a target site area, according to various embodiments. FIG. 30 is a flow diagram illustrating a method of providing treatment to a target site area using an expansion member that includes one or more protective elements, according to various embodiments. FIG. 31 is a flow diagram illustrating a method for providing treatment to a target site area using an expansion member that includes one or more protective elements, according to various embodiments. FIG. 32 illustrates a flow diagram illustrating a method of providing treatment to a target site area using an expansion member including one or more movable protective elements moored with a tether, according to various embodiments. It is.

DETAILED DESCRIPTION Methods, systems, and devices for providing treatment to a target site (eg, a site within a body lumen) are described. The system may include an expansion member, which may be connected to a distal portion of the catheter. The ablation structure may be wrapped around the expansion member to expand the expansion member to engage body lumens of various sizes.

  An ablation structure support coupled to the ablation structure may be positioned at the distal end of the catheter. The ablation structure may include a flexible circuit that can be wrapped around the expansion member and deployed, over which the ablation structure can be positioned. Various aspects of the flexible circuit can be similar to typical integrated circuits and microelectronic devices. The flexible circuit may include a plurality of separately wired or separately controlled longitudinal electrodes, longitudinal electrode zones, or both, which are aligned parallel to the axis. The ablation structure transitions between the wound configuration and the deployed configuration about this axis.

  The ablation structure may include various widths of the longitudinal electrodes, various widths of the longitudinal electrode zones, or both. Each longitudinal electrode or longitudinal electrode zone may be selectively enabled or selectively disabled. For the purpose of this application, enabling an electrode or an electrode zone has the same meaning as activating an electrode or an electrode zone. In some examples, the ablation structure includes an electrode array (eg, a bipolar electrode array, etc.).

  The resection structure support may be connected to one or more springs. The spring may be made from a variety of materials, such as, for example, metallic or polymeric materials. The density of the springs relative to the cutting structure support may be varied such that the closing effect is reduced at one or more cutting structure locations. The spring density can vary from structure to structure, including, for example, slotted springs, tapered springs, and / or springs that can be of various lengths.

  One or more protective elements may be positioned along the catheter distal to the ablation structure and / or proximal to the ablation structure. Slidably movable conical protection elements prevent them from scraping the lumen or expanding the resection support structure during insertion and removal by covering the edges of the resection structure support To be positioned. The distal end of the tether anchoring structure can be attached to the conical protection element so that the protection element can be moved upon deployment of the expansion member, removing the conical portion so as not to interfere with the winding and deployment transitions . In some cases, a flexible distal protective bumper element smaller than the circumference of the wound cutting structure is connected to the longitudinal edge of the distal side portion of the cutting structure. The wound resection structure including the protective bumper element may resemble the well-known tubular shape of an endoscope. Further, the catheter can include an elevated ledge positioned proximally with respect to the ablation structure, such that the elevated structure allows the ablation structure to move along the catheter during insertion of the ablation structure into a body lumen. It is configured to prevent swelling. Further, the expansion member may include a portion distal to the ablation structure, the portion becoming a lump when the expansion member is unexpanded, such that the material of the lumped expansion member is ablated. The structure prevents bulging along the catheter during removal of the resection structure from the body lumen.

  Referring to FIG. 1A, a general system 100 for delivering treatment to a target treatment area is shown according to various embodiments. System 100 can be designed to provide treatment to a target area within the body, such as a wall of an organ or a lumen in the gastrointestinal tract. System 100 may include a power source 105, a catheter 115, and an expansion member 120. The expansion member 120 may generally be configured to support an ablation structure 160, which may be used to deliver therapy to a target treatment site. System 100 may operate by positioning guide assembly 165 within the body and passing expansion member 120 through guide assembly 165 such that expansion member 120 may be delivered to a target treatment site within the body. The power source 105 can then be used to power the ablation structure 160 located on the expansion member 120 so that the therapy can be applied to the target treatment site.

  The expansion member 120 can be an inflatable device that can transition between a collapsed or unexpanded configuration and an expanded configuration using an auxiliary expansion mechanism. Suitable expansion members 120 include, but are not limited to, balloons, compliant balloons, balloons having a tapered geometry, and bladders. In some embodiments, power supply 105 is configured to inflate expansion member 120, for example, by incorporating an auxiliary expansion mechanism therein. The collapsed configuration may generally be used when the expansion member 120 is inserted into and removed from a body lumen. When the expansion member 120 achieves the desired resection position, the expansion member 120 is expanded from a contracted state (ie, a collapsed configuration) to a substantially expanded state (ie, an expanded configuration). It can be expanded by things.

  The expansion member 120 can be configured to support the cutting structure 160. In some embodiments, the ablation structure 160 is a therapeutic or diagnostic instrument (eg, an ablation element that can provide ablation energy to a target treatment area). Some ablation structures 160 may be designed such that they make direct contact with the target treatment area, which includes pushing the ablation structure 160 against a target site.

  The expansion member 120 can be coupled to the catheter 115 such that the expansion member 120 can be manipulated through a body channel (eg, the esophagus) in the target treatment area. Catheter 115 may be coupled to power / inflation device 105 at a proximal end 145 of catheter 115. The expansion member 120 may be positioned between a distal end 140 of the catheter 115 and a portion 150 of the catheter 115. In some embodiments, the catheter 115 includes an opening 175 that is configured to allow entry and exit of the guide assembly 165 such that the catheter 115 is On the other hand, it can be slidably moved. The entry point 175 of the guide assembly may typically be located outside the catheter 115 and closest to the power source 105.

  Power supply 105 may provide power to ablation structure 160 located on expansion member 120. In some embodiments, power is provided from the power source 105 to the ablation structure 160 via one or more transmission lines 170, the transmission line 170 extending between the power source 105 and the ablation structure 160, and the catheter It is housed in 115 channels.

  FIG. 1B illustrates a system 100-a, which may be an example of the system 100 shown in FIG. 1A, according to various embodiments. The system 100-a includes a generator 105-a, a handheld air compressor 112, a guide assembly 165 having a distal end 166 and a proximal end 167, a catheter 115, an expansion member 120, an ablation structure 160, and / or an expansion. An ablation structure support 180 coupled to member 120 may be included.

  The expansion member 120 can include a balloon on which the ablation structure support 180 can be supported. The expansion member 120 can be a flexible material that can be bent or folded when expanded, and the expansion member 120 can have a generally elongated cylindrical shape and a rounded distal end. Includes digits. The expansion member 120 may be tapered at its proximal end and may couple with the catheter 115 near a portion 150 of the catheter 115.

  Disposed on a portion of the surface of the expansion member 120 may be an ablation structure 160 that is configured to provide treatment to a target treatment area. The ablation structure 160 can include a single electrode that includes a plurality of electrode zones, or a series of electrodes 169 that are laterally adjacent to each other, wherein the series of electrodes 169 is a longitudinal axis of the ablation structure 160 and the expansion member 120. Is parallel to The one or more electrodes 169 may be combined with about half of the electrodes extending from the first bus and about half of the electrodes extending from the second bus. The first bus or the second bus may be connected to a positive terminal, and the other of the first bus or the second bus may be connected to a negative terminal or a ground terminal, thereby providing a bipolar electrode configuration. . When connected to power supply 105-a, one or more electrodes 169 may provide ablation energy to the target treatment area.

  The expansion member 120 may be coupled to a portion 150 of the catheter 115 that is closest to the distal end 140 of the catheter 115. The resection structure support 180 may be at least partially wrapped around the outer perimeter of the expansion member 120 such that when the expansion member 120 expands, the resection structure support 180 adapts to the changing perimeter, and The ablation structure 160 maintains a constant electrode density per unit area. A set of transmission wires 170-a may extend from the power source 105-a to the ablation structure 160 through the channel of the catheter 115. Zone activation may be controlled from power supply 105-a and / or from a switched printed circuit board, which is configured to drive one or more additional channels.

  Referring now to FIG. 1C, a power supply 105-b is schematically illustrated according to various embodiments. The power supply 105-b may be an example of the power supply 105 or 105-a described with reference to FIG. 1A or 1B. In general, power supply 105-b may include a power switching mechanism 190 configured to switch on the longitudinal electrode area and to switch off the longitudinal electrode area. And thus at least partially control the order, timing, and duration of energy delivery at the treatment site. For example, the power switching mechanism 190 can include an RF generation element 181 that can be configured to transmit RF energy to the power switching element 192 via one or more output channels 186; Such a power switching element 192 reroutes RF energy 198 to a plurality of longitudinal electrode areas. In some implementations, power switching mechanism 190 is an external component that is communicatively coupled to power supply 105-b and catheter 115. In other cases, the power switching mechanism 190 is integral to and / or attached to the catheter 115. In certain instances, the combined catheter 115 and switching mechanism 190 components are single-use, disposable components.

  In some cases, the number of defined longitudinal electrode areas of the ablation structure 160 is less than or equal to the number of RF channels 186 supported by the power supply 105-b, each defined. The longitudinal electrode regions are connected to a single RF channel 186. In such a configuration, switching mechanism 190 may be communicatively coupled to a channel adjustment module 183 that is integral with power supply 105-b. The channel adjustment module 183 may include a microprocessor 184 and a memory 182. The switching mechanism 190 may also include a microprocessor 195 and a memory 194. Channel adjustment module 183 may direct switching mechanism 190 to either enable or disable RF channel 186, which follows one or more algorithms stored in memory 182. Associated with one or more electrode regions. In some examples, switching mechanism 190 may communicate ablation parameters (eg, impedance, etc.) to power supply 105-b for use in algorithm determination.

  In certain implementations, the number of defined electrode areas exceeds the number of RF channels 186 supported by power supply 105-b. For example, the RF generating element 181 may support up to three RF channels 186, and the ablation structure 160 (see, eg, FIG. 1) may include six separately wired electrode areas. In such a case, the RF generation element 181 may be configured to transmit RF energy to the power switching element 192 via only one output channel 186, and then such power switching element 192 may Is re-routed to a plurality of longitudinal electrode areas. Alternatively, the RF generating element 181 may be configured to transmit RF energy through a plurality of output channels 186 to an inverse multiplexer 191, wherein such an inverse multiplexer 191 may, for example, provide a common return for a bipolar system. Rerouting extends the number of channels 197.

  Additionally or alternatively, power supply 105-b may be configured to transmit RF energy over one or more channels 186 simultaneously or in a defined order. In some embodiments, switching mechanism 190 switches RF output channel 186 on or off by preventing transmission from RF generating element 181. The switching mechanism 190 may include a power switching element 192 (eg, a metal oxide semiconductor field effect transistor or a relay, etc.). In some examples, an isolation element 193 is positioned between the power switching element 192 and a logic element or microprocessor 195 and memory 194. In some examples, the channel conditioning module 183 communicates the order of the longitudinal electrode area activations to the power switching element 192, which blocks RF transmission or according to the order received. Enables RF transmission, and thus controls the activation, timing, and / or duration of energy transmission in the longitudinal electrode region associated with RF channel 186. Additionally or alternatively, switching mechanism 190 determines the order of activation of the longitudinal electrode regions independently of power supply 105-b based at least in part on an algorithm stored in memory 194. I can do it.

  In some examples, switching mechanism 190 monitors current and / or interprets other signals communicated from power supply 105-b to partially determine when to turn a channel on or off. I do. Additionally or alternatively, power supply 105-b may provide the switching behavior of switching mechanism 190 via a one-way or two-way communication channel 185 coupling power logic 184 and switching mechanism logic 195. Can be controlled. In certain implementations, power supply 105-b receives feedback from switching mechanism 190 (eg, an acknowledgment that a switching command has been received and / or an acknowledgment that the indicated switching behavior has been performed). obtain. Communication between logic element 184 and logic element 195 may implement an established communication protocol (eg, I2C or SPI, etc.).

  Tissue ablation can result in changes to the impedance of the tissue when compared to non-ablated tissue. The probe sensor determines the ablation status of the surrounding treatment site region, for example, by comparing the impedance of the treatment site region with previous impedance data for the same region of the treatment site and / or different regions of the treatment site. Can be used for This data can then be used to select an activation state and / or activation duration for one or more longitudinal electrode regions. It will be recognized by those skilled in the art that these and other automated selection algorithms may be implemented on one or more communication devices that are communicatively coupled, outside of power supply 105-b. For example, additional computer software (e.g., image analysis software) may have previously excised areas and / or overlaps as part of an algorithm that modulates the activation and / or energy delivery profile of the associated electrode area. Can be used to identify electrode segments.

  Referring now to FIG. 2, certain abnormalities can cause retrograde flow of gastric or intestinal contents from the stomach 212 to the esophagus 214, as indicated by arrows A and B. Although the causes of these problems are different, this retrograde flow can be secondary to a procedure that requires a very different procedure (eg, an abnormality of the lower esophageal sphincter 216) that requires a procedure that is very different from this procedure. For example, Barrett's esophagus). Barrett's esophagus is an inflammatory disorder in which gastric acid, bile acids, and enzymes refluxed from the stomach and duodenum enter the lower esophagus and cause damage to the esophageal mucosa. If this type of retrograde flow occurs frequently enough, damage can occur to esophageal epithelial cells 218. In some cases, the damage can result in squamous cell changes, turning them into taller specialized columnar epithelial cells 220. This metaplastic change of the mucosal epithelium from squamous cells to columnar cells is called Barrett's esophagus. Some of the columnar cells can be benign, while others can lead to adenocarcinoma.

  In some embodiments, the described methods, systems, and devices are configured to treat columnar epithelium at a selected site in the esophagus through ablation of tissue. The term “ablation” as used herein refers to thermal damage to tissue that results in necrosis of the tissue or cells. Some therapeutic procedures require the desired treatment effect that does not reach ablation (eg, some level of agitation or tissue that can be given to the tissue to ensure the desired change in cellular organization of the tissue, rather than necrosis of the tissue). It will be appreciated by those skilled in the art that they may have damage. In some examples, as described below, a variety of different energy delivery devices are utilized to cause a treatment effect in a shallow layer of tissue while preserving the full functionality of the deeper layers.

  Cell or tissue necrosis is achieved using energy at an appropriate level (eg, RF energy) to achieve ablation of tissue at the mucosal or submucosal level while substantially preserving muscular tissue. obtain. Such an ablation may be utilized to remove the columnar growth 220 from the portion of the esophagus 214 that affected it.

  Referring now to FIGS. 3A and 3B, the expansion member 120 can be mounted in any of a variety of ways (eg, including placement of the guide assembly 165, endoscope placement, surgery), or other methods. It can be inserted into the body by means. Expansion member 120 may be an example of expansion member 120 of FIGS. 1A and / or 1B. Referring now to FIG. 3A, the expansion member 120 is shown in a collapsed configuration, according to various embodiments. The expansion member 120 may be configured to transition between the collapsed configuration shown and the expanded configuration as shown in FIG. 3B. In the expanded configuration, at least one dimension of expansion member 120 may be increasing. In various embodiments, the expanded configuration is substantially larger than the collapsed configuration, such that the ablation structure 160 contacts a treatment surface (eg, columnar epithelial cells 220-a and / or 220-b). enable. The resection structure 160 may be delivered to a treatment site within a body lumen while in the collapsed state. This low profile configuration may allow for easy access to the treatment site without discomfort or complications for the patient. If an endoscope (not shown) is used, portion 150 of catheter 115 may be positioned along the outside of the endoscope. Alternatively, an endoscope may be used to visualize the path that expansion member 120 should follow during installation. The distal end 166 of the guide assembly 165 can be positioned along the outside of the endoscope and can be left in a body lumen after removal of the endoscope. A proximal end 167 (see, eg, FIG. 1B) of guide assembly 165 may be inserted into distal end 140 of catheter 115 and catheter 115 may be inserted into the esophagus according to a path determined by guide assembly 165. Can be inserted.

  An ablation structure 160 may be provided, and the ablation structure 160 may be coupled to the dilation member 120 and positioned near the portion 150 of the catheter 115. In some examples, expansion member 120 is coupled to portion 150 of catheter 115. Ablation structure 160 may include one or more electrodes 169. One or more electrodes 169 may be disposed within a plurality of longitudinal electrode zones 161, 162 of equal or varying width. The one or more electrodes 169 may be coupled to a power source 105 (see, for example, FIG. 1A), which at a suitable level to provide ablation of the tissue to a predetermined depth of the tissue. It is configured to power one or more electrodes and / or longitudinal electrode zones 161, 162.

  In some embodiments, the ablation structure 160 includes a flexible, non-inflated backing. For example, the ablation structure 160 may include a thin rectangular sheet of a polymeric material (eg, polyimide, polyester, or other flexible thermoplastic or thermoset polymer film). The ablation structure 160 may also include a polymer clad material or other non-conductive material. Further, the backing may include an electrically insulating polymer, wherein an electrically conductive material (eg, copper) has been deposited on the surface so that the electrode pattern is etched into the material to create an electrode array. obtain.

  The resection structure 160 may be operated in direct contact with the tissue site wall. This may be accomplished by connecting the resection structure 160 to an expansion member 120 that is expandable in a shape that matches the dimensions of the inner lumen of the treatment site (eg, the lower esophageal canal of a human). It has a possible configuration. The ablation structure 160 can be positioned such that energy can be uniformly applied to the inner circumference of the lumen where treatment is desired. This may be achieved by first positioning the expansion member 120 at the treatment site in a collapsed configuration where the resection structure 160 is wrapped around the expansion member 120. As the device is advanced to the appropriate site, the expansion member 120 can be expanded, causing the ablation structure 160 to transition from the wrapped state to the deployed state, thereby engaging the interior wall of the lumen.

  Referring to FIG. 3B, the ablation structure 160 uniformly engages the inner wall of the lumen, and the one or more electrode zones 161, 162 are all around a portion of the inner lumen of the esophagus or at all or a portion of another tissue site. It has a constant density so that energy can be applied uniformly. The expansion member 120 can include, for example, a balloon (eg, a compliant balloon and / or a balloon having a tapered shape) that expands to an expanded configuration when inflated.

  In some embodiments, when the expansion member 120 expands and the ablation structure 160 expands, additional electrodes or electrode zones 163 are exposed from beneath the overlapping portion 181 of the ablation structure 160. Selectively enabling one or more longitudinal electrodes 169 and / or longitudinal electrode zones 161, 163 allows the entire surface area of the ablation structure 160 to be split, thus providing a power source. Respond to specific power limitations, thereby providing the appropriate energy density to the tissue. The ablation structure 160 may extend a greater arc length than the circumference of the expansion member 120 such that when the expansion member 120 expands, a solid perimeter resection is achieved for body lumens of various sizes.

  Ablation structure 160 may be positioned and energy may be applied to the inner circumference of the treatment site in the body lumen. This may be achieved by first positioning the expansion member 120 at the treatment site in a collapsed configuration. As the resection structure 160 is advanced to the appropriate treatment site, the expansion member 120 can be expanded to advance the resection structure 160 to engage the interior wall of the body lumen. The desired treatment energy may then be delivered to the tissue by selectively enabling one or more longitudinal electrodes and / or longitudinal electrode zones 161, 162, 163. In some examples, all longitudinal electrodes and / or longitudinal electrode zones 161, 162, 163 are free of longitudinal electrodes and adjacent longitudinal edges 181 of ablation structure 160. And / or continuously enabled starting from the longitudinal electrode zone 161. The detection of the fully shielded longitudinal electrode and / or the longitudinal electrode zone may be performed if the further longitudinal electrode and / or the longitudinal electrode zone is not in contact with the tissue of the body lumen. Energy delivery to the electrodes and / or the longitudinal electrode zones may be stopped in an untouched order.

  In certain embodiments, the ablation structure 160 delivers a variety of different types of energy, including radio frequency, microwave, ultrasonic, resistive heating, chemical, heatable fluid, optical But optical examples include, but are not limited to, ultraviolet, visible, infrared, parallel or non-parallel, coherent or non-coherent, or other light energies.

  Referring now to FIG. 4, a distal portion of a general system 400 for delivering treatment to a target treatment area is shown in a collapsed configuration, according to various embodiments. The system 400 can be an example of the system 100 or 100-a described with reference to FIG. 1A or FIG. 1B, and includes a catheter 115, an expansion member 120 connected to the catheter 115, and a periphery of the expansion member 120. And a cutting structure 160 wound therearound. To engage the inner surface of a body lumen that is larger than the reduced diameter of the expansion member 120, the expansion member 120 may be expanded until a desired pressure is exerted on the inner wall of the lumen (see, for example, FIG. 5). See). The expansion member 120 may be expanded so that the pressure applied to the body lumen is less than the pressure that causes damage, such as by tearing or puncturing the lumen. As the expansion member 120 expands, the exposed surface area of the ablation structure 160 increases, but the electrodes or electrode zones that are individually and continuously enabled are a constant electrode over the surface of the ablation structure 160. Density can be maintained. The energy delivered to the electrodes or electrode zones, including but not limited to RF signals, can provide uniform treatment within each region to the exact depth of the tissue. After the procedure has been performed, the expansion member 120 can be deflated and the system can be removed from the body lumen.

  In some embodiments, the ablation structure 160 includes a large single electrode that is divided into adjacent longitudinal electrode zones 161, 162 of either a uniform width or various widths. One electrode is configured to reduce the degree of overlap of the ablation area, and thus reduce the degree of overablation. The longitudinal electrode zones 161, 162 may be selectively enabled via a plurality of transmission lines 170, wherein the plurality of transmission lines 170 are coupled to the power supply 105 (see, eg, FIG. 1A) and to the longitudinal direction. It extends between the electrode zones 161 and 162. The ablation structure 160 may include an electrode array 163 etched on its surface and may be aligned between the distal end 404 and the proximal end 402 of the expansion member 120.

  Referring now to FIG. 5, the system 400 described with reference to FIG. 4 is shown in an expanded configuration, according to various embodiments. When the expansion member 120 is inflated or otherwise expanded, the ablation structure 160 deploys, revealing the electrodes 504,506. The longitudinal electrodes 502, 504, 506 of the ablation structure 160 may be selectively enabled via a plurality of transmission lines 170, the plurality of transmission lines 170 being connected to the power source 105 (eg, see FIG. 1A). ) And the longitudinal electrodes 502, 504, 506. For example, insulated transmission wires 170-a, 170-b, 170-c can be individually routed to the electrodes or electrode zones 502, 504, 506. The wires can be individually insulated using heat shrink tubing along the entire length of catheter 115. Each of the wires may be terminated to a mini-connector plug of the power supply 105, or to a switched printed circuit board controller, which is configured to drive a transmission channel in addition to the channel of the power supply 105. . Power can be selectively delivered to one or more electrodes or electrode zones under this configuration so that the procedure is performed on a particular area along the ablation structure 160. The switching printed circuit board may be included on the catheter 115, external to the power supply 105, or within the power supply 105.

  In some embodiments, the ablation structure 160 has one or more of the longitudinal electrodes or longitudinal electrode segments positioned at the free end 181 of the ablation structure 160 coupled to the ablation structure 160. It is configured to have a width greater than the width of the remaining longitudinal electrodes or longitudinal electrode segments closer to the edge (not shown). If a minimum lumen size can be expected (eg, about 16 mm in the case of the esophagus), the arc length corresponding to the perimeter of this minimum size is one that is positioned adjacent the free end 181 of the ablation structure 160. It can be used as the width for the wider longitudinal electrodes or longitudinal electrode regions described above. For example, if the maximum lumen size can be 37 mm, the entire arc length of one or more electrodes can be calculated as 37 * pi = 116 mm. In the case of a single electrode with multiple longitudinal electrode zones, an electrode area equal to the arc length of the smallest lumen size (16 * pi = 50 mm) is defined as two electrode areas (each having a width of 25 mm). Can be configured. The remaining area may include a set of narrow electrode zones (eg, seven electrode zones of 10 mm each). This can result in a reduction in the overall number of regions when compared to using a set of fixed width regions, and continues to provide a narrow width region for potential areas of overlap of the ablation structure.

  Referring now to FIG. 6, a distal portion of a general system 600 for delivering treatment to a target treatment area is shown in a collapsed configuration, according to various embodiments. The system 600 may be an example of the system 100, 100-a, or 400 described with reference to FIGS. 1A, 1B, 4, or 5, and includes a catheter 115 and an expansion coupled to the catheter 115. It may include a member 120 and a cutting structure 160. The cutting structure 160 is shown in a partially expanded configuration to illustrate the underside of the cutting structure 160. The cutting structure 160 may be coupled to a cutting structure support 180, which is coupled to or otherwise attached to the expansion member 120. For example, the first end 612 of the ablation structure 160 can be coupled to the expansion member 120 or otherwise attached to the expansion member 120. An adhesive bond may be implemented along the entire or partial length of the contact zone between the first end 612 of the cutting structure 160 and the expansion member 120. In certain instances, bonding occurs when the expansion member 120 is in an expanded configuration. The internal surface of the ablation structure 160 may include springs 602, 604, 606, 608, which may be four different widths, and the springs 602, 604, 606, 608, which may be four different widths, Extending perpendicularly from the joined first edge 612 and perpendicular to the longitudinal axis of the expansion member 120, the local spring density increases linearly toward the free end 181 of the cutting structure 160. Is configured. The ablation structure 160 may include a single electrode that is divided into one or more longitudinal segments 502, 504, 506, 610 of various widths. The longitudinal electrode segment 502 adjacent to the free edge 181 of the ablation structure 160 may have a greater width than the width of the other longitudinal electrode segments 504, 506, 610. Each longitudinal electrode segment 502, 504, 506, 610 has a wiring structure that is insulated from the wiring structures 170-a, 170-b, 170-c, 170-d for the other longitudinal electrode segments. , 105 (see, eg, FIG. 1A).

  In some embodiments, the ablation structure 160 includes a large single electrode, which is divided into adjacent longitudinal electrode zones of uniform width and provides an overlap of the ablation area. It is configured to reduce the extent and, thus, the extent of overablation. Such a uniform width configuration may be useful where the minimum size lumen is not known (eg, where the ablation system is used for a variety of different body lumens). Referring now to FIG. 7, a distal portion of a general system 700 for delivering treatment to a target treatment area is shown in a collapsed configuration, according to various embodiments. The system 700 may be an example of the system 100, 100-a, 400, or 600 described with reference to FIG. 1A, FIG. 1B, or FIGS. May include an expanded member 120 and an ablation structure 160. The cutting structure 160 is shown in a partially expanded configuration to illustrate the underside of the cutting structure 160. The ablation structure 160 may be coupled to an ablation structure support 180 that is coupled to, or otherwise coupled to, the expansion member 120 along an associated edge 722. Installed. The lower surface of the ablation structure 160 may include a single spring 720 that extends from the coupled edge 722 of the ablation structure 160 and is relative to the longitudinal axis of the expansion member 120. And vertical. A single electrode may be divided into longitudinal zones 702, 704, 706, 708, 710, 712, 714, 716, 718 of uniform width. Each longitudinal electrode zone 702, 704, 706, 708, 710, 712, 714, 716, 718 includes a wiring structure 170-a, 170-b, 170-c, 170 for another longitudinal electrode segment. A wiring structure insulated from −d may couple to the power supply 105 (eg, see FIG. 1A) (further insulated wiring structures are not shown).

  In some embodiments, the ablation structure 160 includes a single large electrode that is adjacent to a uniform narrow width (e.g., having a width of less than 10 mm) in the longitudinal direction. Divided into electrode zones and configured to reduce the degree of overlap in the ablation area, and thus reduce the degree of overablation in the area where the overlap exists. Referring now to FIG. 8, a distal portion of a general system 800 for delivering treatment to a target treatment area is shown in a collapsed configuration, according to various embodiments. The system 800 may be an example of the system 100, 100-a, 400, 600, or 700 described with reference to FIG. 1A, FIG. 1B, or FIGS. May include an expanded member 120 and a cutting structure 160. The cutting structure 160 is shown in a partially expanded configuration to illustrate the underside of the cutting structure 160. The ablation structure 160 may be coupled to an ablation structure support 180, which is coupled to, or otherwise connected to, the expansion member 120 along an associated edge 812. Installed. The lower surface of the ablation structure 160 may include a single spring 820 that extends from the coupled edge 812 of the ablation structure 160 and is relative to the longitudinal axis of the expansion member 120. And vertical. A single electrode may be divided into uniform width longitudinal zones 802, 804, 806, 808, 810. Each longitudinal electrode zone 802, 804, 806, 808, 810 is a wire that is insulated from the wiring structures 170-a, 170-b, 170-c, 170-d for the other longitudinal electrode zones. Depending on the structure, it may be coupled to a power supply 105 (see, for example, FIG. 1A) (further isolated wiring structures are not shown).

  In some embodiments, the ablation structure 160 includes a single large electrode, which is divided into adjacent longitudinal electrode zones of various widths to provide an overlap of the ablation area. It is configured to reduce the extent and, thus, the extent of overablation. Referring now to FIG. 9, a distal portion of a general system 900 for delivering treatment to a target treatment area is shown in a collapsed configuration, according to various embodiments. The system 900 may be an example of the system 100, 100-a, 400, 600, 700, or 800 described with reference to FIG. 1A, FIG. 1B, or FIGS. And an ablation structure 160 coupled to the cutting member 160. The cutting structure 160 is shown in a partially expanded configuration to illustrate the underside of the cutting structure 160. The resection structure 160 may be coupled to a resection structure support 180 that is coupled to, or otherwise connected to, the expansion member 120 along an associated edge 914. Installed. The lower surface of the cutting structure 160 may include one spring 916 that extends from the joined edge 914 of the cutting structure 160 and is perpendicular to the longitudinal axis of the expansion member 120. It is. A single electrode can be divided into longitudinal zones 902, 904, 906, 908, 910, 912 of various widths. Adjacent longitudinal electrode zones 912 extending from the free edge 181 of the ablation structure 160 decrease in width linearly until a minimum width (eg, 10 mm, etc.) is reached. Subsequent adjacent longitudinal electrode zones 902, 904, 906, 908, 910 may all have a width equal to the minimum width. Each longitudinal electrode segment 902, 904, 906, 908, 910, 912 is insulated from the wiring structures 170-a, 170-b, 170-c, 170-d for the other longitudinal electrode zones. May be coupled to a power supply 105 (eg, see FIG. 1A) (further isolated wiring structures are not shown).

  Referring now to FIGS. 10A and 10B, cross-sectional views of the ablation structure 160 and the expansion member 120 are shown according to various embodiments. The ablation structure 160 may be an example of the ablation structure 160 described in connection with FIGS. 1A, 1B, 4, and / or 5. As shown, the ablation structure 160 may be attached to the expansion member 120 at a first end 1012 (adhesion not shown). The free end 181 of the ablation structure 160 can be wrapped around the expansion member 120 and overlap the joined end 1012 one or more times. As the expansion member 120 expands, the ablation structure 160 expands, further revealing additional electrodes or electrode zones previously shielded by the overlapping portions 181 of the ablation structure 160.

  At any given inflated diameter, one or more electrodes or electrode zones may be in contact with the area of the treated tissue, and one or more electrode segments may be May come into contact with. The electrode traces can be connected with a conductive material, such as saline, mucus, or tissue clumps. Without the presence of a mitigating structure or procedure, these materials may contact the island backing of the ablation structure 160. This can cause the energy intended for tissue treatment to be lost, both where a single electrode is used and / or where the ablation zone is directed circumferentially, and therefore Energy delivery, thereby reducing the density / depth of tissue ablation below a threshold level. In some embodiments, each longitudinal electrode or longitudinal electrode zone is separately controlled, separately wired, or both, such that each longitudinal electrode or longitudinal electrode zone is May be unaffected by the presence or absence of the electrode area covered by the ablation structure and / or the electrode area coated by a conductive material (eg, fluid or tissue). The total energy delivered to each longitudinal electrode or longitudinal electrode zone is determined by the total active surface area of the longitudinal electrode according to ablation parameters developed in the art, such as those used with ablation catheter systems. Or it can be calculated based on the total active surface area of the longitudinal electrode zone.

  The free end 181 of the ablation structure 160 often completely or partially overlaps one or more longitudinal electrode areas. The electrode segment 1006 is only partially exposed (ie, partially covered by the overlapping portion 181 of the ablation structure 160), as shown in FIG. 10A, and thus only partially with the tissue treatment area. When in contact, energy 1002 can be delivered to the treatment area and energy 1004 can be delivered to the lining of the ablation structure 160, which results in an energy delivery profile that deviates from the intended energy delivery profile. And deliver an excess amount of energy to the treated tissue area. The longitudinal electrodes such that the width of the innermost partially exposed longitudinal electrode or longitudinal electrode zone does not exceed a predetermined percentage (eg, about 20%, etc.) around the treatment area. Alternatively, this effect can be reduced by configuring the electrode segments in the longitudinal direction.

  To limit the degree to which energy can be over-delivered to the tissue treatment area in contact with the partially shielded longitudinal electrode or longitudinal electrode zone (eg, electrode zone 1006 of FIG. 10A), various A method can be used. The channel conditioning module (see, for example, FIG. 1C) may include computer instructions, which may include a longitudinal electrode or longitudinal electrode zone 1008 adjacent to the free edge 181 of the ablation structure 160. Starting sequentially, it is configured to enable each adjacent longitudinal electrode or longitudinal electrode zone. Computer instructions may further be provided to perform impedance measurements and calculations, so that the degree of ablation may be controlled in real time. Partially shielded longitudinal electrodes or longitudinal electrode zones 1006 often have a higher impedance than unshielded longitudinal electrodes or longitudinal electrode zones (eg, zone 1010 shown in FIG. 10B). May be provided. Prior to enabling each longitudinal electrode or longitudinal electrode zone, the impedance of each longitudinal electrode or longitudinal electrode zone may be compared to impedance measurements obtained for a previous zone. The detection of higher impedance may be partially occluded (eg, 1006 in FIG. 10A) or electrode zone, or completely occluded (eg, 1007 in FIG. 10B) electrode or electrode. It may indicate a zone. As determined by the detection of a higher starting impedance, the computer instructions may reduce the ablation time and / or lower the voltage delivered to the partially / fully occluded electrode or electrode zone 1006, 1007. To provide further. After detection of the first, partially or completely occluded electrode or electrode zone 1006, 1007, computer instructions to shut down the continuous operability of the electrode or electrode zone 1014, 1016 may further be provided. In addition to having a starting impedance that is greater than the impedance of the unshielded longitudinal electrode or longitudinal electrode zone 1010, the plugged electrode or electrode zone 1006, 1007 often has an unshielded longitudinal electrode or electrode zone 1006, 1007. When compared to directional electrodes or longitudinal electrode zones 1010, an increase in the rate of change of impedance may occur. Computer instructions may be provided to compare the rate of change of impedance during ablation with the rate of change of impedance from before the ablation in the same patient or a previous patient, wherein detection of a higher rate of change of impedance may be performed on the currently enabled electrode or Indicates that the electrode zone is partially shielded. Computer instructions may further be provided to reduce ablation time and / or lower the voltage delivered to the occluded electrode or electrode zone.

  11A-11C, in the case of the esophagus, the electrode pattern may vary at the site of treatment, depending on the length of the site to be treated, the depth of mucosa and submucosa, and other factors. Can be The electrode patterns 1102-1208 may be examples of electrode patterns included with the electrode array 163 of FIGS. The electrode array pattern can be composed of specific electrode elements that can be arranged in various configurations (eg, circumferential orientation, longitudinal orientation, etc.). The electrode elements are the conductive elements of the electrode array. In some examples, the electrode elements are aligned parallel to each other. The density of the electrode elements can affect the depth of the ablation procedure. The pattern of longitudinal electrodes or longitudinal electrode zones can be axially or transversely aligned over one or more electrodes, or a linear or non-linear parallel matrix, or a series of bipolar pairs or monopolar electrodes. Can be formed. One or more different patterns may be connected to the ablation structure 160 at various locations. For example, an electrode array such as that shown in FIGS. 11A-11C may have bipolar axially interdigitated finger electrodes 1102, a unipolar rectangle 1104 separated by 1 mm, or six bipolar rings separated by 2 mm. 1106 patterns. Other suitable RF electrode patterns may be used, including, but not limited to, the patterns shown in FIGS. 12A-12D. The pattern may be, for example, bipolar axially associated finger electrodes 1202 separated by 0.3 mm, bipolar bands 1204 separated by 0.3 mm, bipolar rings 1208 separated by 0.3 mm, and / or It may include wavy electrodes 1206 separated by 0.2548 mm.

  The depth of the treatment can be controlled by the selection of appropriate treatment parameters by the operator, as described in the examples described herein. One parameter that can affect the depth of the procedure is the density of the electrode elements. As the spacing between the electrode elements decreases, the depth of treatment of the affected tissue also decreases when RF energy is delivered across the electrodes in a bipolar manner. Very close spacing of the electrode elements may limit current to shallow depth and consequent ohmic heating so that damage and heating of the submucosal tissue layer is minimized. To treat tissue of the esophagus with RF energy, (i) 3 mm, (ii) 2 mm, (iii) 1 mm, (iv) 0.5 mm, or (v) 0.3 mm, (vi) 0.1 mm It may be desirable to have a spacing between adjacent electrode elements, such as:

  In various embodiments, the dimensions of the electrodes and the spacing between the electrode elements are selected to allow a controlled depth of ablation. Examples of electrode configurations for controlled depth ablation are described in U.S. Patent Nos. 6,551,310 (Ganz et al.), 7,150,745 (Stern et al.), And 7,344. No. 535 (Stern et al.), No. 7,530,979 (Ganz et al.), No. 7,993,336 (Jackson et al.), No. 8,012,149 (Jackson et al.), No. 8, Nos. 192,426 (Stern et al.), 8,439,908 (Utley et al.), And 8,398,631 (Ganz et al.), The entire contents of each of which is incorporated herein by reference for all purposes. And is incorporated herein by reference. In various embodiments, the generator and / or channel adjustment module (see, for example, FIG. 1C) uses an ablation structure 160 to achieve ablation of tissue to a controlled depth. Is configured to control the application of.

  Although described with respect to electrode arrays for RF ablation, those skilled in the art will appreciate that ablation structures suitable for use with the embodiments described herein may be configured to perform other forms of therapy or diagnosis. Recognize that it can be done. For example, the techniques described above can be applied to form an antenna for microwave ablation. In another example, the operating member may include a sensor element overlying the expandable support device. A monopolar RF configuration may also be used in some embodiments. Some embodiments may utilize a bipolar RF configuration.

  In various embodiments, the ablation structure described herein is an ablation device, and in some embodiments, an RF ablation device. In various embodiments, the ablation structures described herein are configured for thermal ablation. In some embodiments, the ablation structures described herein are configured to heat surrounding tissue by resistive heating or conduction. Embodiments of the ablation structure described herein may be configured to treat or diagnose surrounding tissue in other manners.

  In various embodiments, the resection structures described herein are configured for resection of abnormal tissue in the esophagus. In some examples, the resection structures described herein are configured for resection of abnormal tissue in the lower esophageal sphincter. In certain implementations, the ablation structures described herein are configured to ablate Barrett's esophageal and / or precancerous tissue in the epithelium without damaging the underlying muscalaris. I have. In some embodiments, the resection structures described herein are configured for use in a variety of body lumens and organs, including the gastrointestinal (GI) tract (eg, esophagus or duodenum). ), The gastrointestinal tract, the digestive system (eg, the bile duct), the cardiovascular system, the endocrine system (eg, the pancreas), and the respiratory system.

  In various embodiments, the ablation structures described herein are configured to ablate tissue to a predetermined depth. In some cases, the ablation structures described herein are configured to ablate mucosal tissue without damaging the underlying submucosal tissue. In certain instances, the ablation structures described herein are configured to ablate mucosal tissue without damaging the underlying muscle layer. In some implementations, the ablation structures described herein apply an appropriate level of energy to tissue to achieve a depth of ablation that does not extend beyond the submucosal tissue layer of the esophagus. It is configured to be. In some embodiments, the ablation structures described herein are configured to control the depth of the ablation down to the epithelium. In some examples, the ablation structures described herein are configured for superficial ablation. For example, various embodiments of the ablation structure may be configured to burn tissue surfaces. In certain cases, the ablation structures described herein are configured to deliver sufficient energy to initiate tissue regrowth, for example, in the mucosal layer.

  Controlling the ablation depth can be based on several factors, such as power and treatment time. In various embodiments, the power supply activates the longitudinal electrodes or longitudinal electrode zones for a sufficient amount of time with sufficient power to ablate tissue to a predetermined depth. In an exemplary embodiment, the power source is between about 1 J / sq cm and about 50 J / sq cm, between about 10 J / sq and about 40 J / sq cm, about 15 J / sq cm and about 105 J / sq cm. cm, between about 25 J / sq cm and about 105 J / sq cm, between about 30 J / sq cm and about 105 J / sq cm, between about 35 J / sq cm and about 105 J / sq cm, Or one or more longitudinal electrodes or longitudinal electrode zones with sufficient power and length of time needed to deliver between about 40 J / sq cm and about 105 J / sq cm. Activate. Other energies per unit area may be utilized in some embodiments.

  In various embodiments, power supply 105-a (see, for example, FIG. 1B) is between about 10 watts / square cm and about 50 watts / sq. Cm, about 10 watts / sq. Square cm, between about 10 watts / cm2 and about 30 watts / cm2, between about 15 watts / cm2 and about 30 watts / cm2, or between about 15 watts / cm2 and about 40 watts / cm2. It can be configured to deliver between watts / square cm. Other energies per unit area may be utilized in some embodiments.

  In some examples, the power supply 105-a is between about 10 ms and about 5 minutes, between about 100 ms and about 1 minute, between about 100 ms and about 30 seconds, between about 10 ms and about 1 second. Between about 100 ms and about 1 second, or between about 300 ms and about 800 ms, configured to activate the longitudinal electrode or longitudinal electrode zone. In certain embodiments, the generator is configured to activate the electrodes for less than 1 second, less than 500 ms, or less than 300 ms. In some implementations, the power supply is configured to deliver about 40 W / cm 2 for a duration of about 300 ms to about 800 ms. In some embodiments, the power source is configured to deliver between about 12 J / sq cm to about 15 J / sq cm for a duration of about 300 ms to about 800 ms. Other energies per unit area and amount of time may be utilized in some embodiments.

  In certain cases, the resection structure support 180 is helically wrapped around the longitudinal axis of the expansion member 120. The electrode patterns can be axially or transversely aligned across the backing and can be formed in a linear or non-linear parallel array, or a series of bipolar pairs, or other suitable patterns. Referring now to FIG. 13, a cross-sectional view of the dilation member 120, the resection structure support 180, and the resection structure 160 is shown in accordance with various embodiments. In some embodiments, the ablation structure support 180 includes a flexible, non-expandable backing. For example, the backing may be a thin rectangular sheet of a polymeric material (eg, a polyimide, polyester, or other flexible thermoplastic or thermoset polymer film), a material covered with a polymer, or other non-conductive material. May be included. The backing may also include an electrically insulating polymer, with an electrically conductive material (eg, copper) deposited on the surface. The ablation structure 160 may be formed from a metal layer 1310, which may be etched to include a pattern of electrodes using any known technique (eg, etching with a mask).

  One or more constant load springs 1304, 1306 may be attached to a flexible backing 1302 by application of an adhesive material 1308. A polytetrafluoroethylene film may be etched on one side and adhered to the spring side of the ablation structure 160. The entire ablation structure 160 may be laminated as a flat sheet, providing reduced friction during the transition between the rolled configuration and the deployed configuration, and thus required for transition to the deployed configuration. Reduce pressure. Other methods of constructing the ablation structure 160 and the ablation structure support 180 may also be utilized. In some examples, the ablation structure support 180 includes a shape memory polymer spring, which may be a polymer thermoplastic (eg, such as an amorphous thermoplastic polyetherimide, or from the polyaryletherketone family). Organic polymer thermoplastic). The entire laminated ablation structure support 180 can be heat treated to achieve a permanent and final helical structure. In an alternative embodiment, a metal spring (eg, a spring made from surgical stainless steel) may be used. The metal spring is set in the coil before lamination so that a permanent spiral structure can be retained.

  Referring now to FIGS. 14-17, various structures for local reduction of spring density are shown according to various embodiments. Referring now to FIG. 14, four springs 1402, 1404, 1406, 1408 of various lengths are attached to the electrically insulated inner surface of the ablation structure support 180. The resection structure support 180 may be an example of the resection structure support 180 of FIGS. 1B, 6, 7, 8, 9, and / or 13. Springs 1402, 1404, 1406, 1408, which may be of various lengths, such that one or more distal ends 1410, 1412 of springs 1404, 1406 do not coincide with free end 181 of ablation structure support 180. Are located in In some embodiments, a set of four springs has two equal length longer springs 1402, 1408, one shorter length spring 1406, and a longer spring 1402, 1408 than the length thereof. A single spring 1404 that is short in length but longer than the length of the shorter spring 1406. The spring density near the free end 181 of the ablation structure support 180 may be half the spring density near the joined end 1415. In some examples, the spring density decreases linearly from the joined end 1415 to the free end 181 of the ablation structure support 180. The spring density at the free end 181 of the ablation structure support 180, or the spring density near the free end 181 of the ablation structure support 180, can be directly related to the degree of crawling that appears, where clawing is the initial spring Refers to the tendency of the free end 181 of the ablation structure support 180 to return toward the radius.

  Referring now to FIGS. 15-17, a local reduction in spring density may be obtained by reducing the amount of material at one or more locations along one or more springs. The springs 1506, 1602, 1702 may be examples of one or more of the springs described with reference to FIGS. 6-9 and / or 13-14. For example, referring to FIG. 15, a slot 1504 may be included in a distal portion of the spring 1506 to reduce the closing force of the spring 1506 at or near the slotted region 1504. Referring to FIG. 16A, in some examples, a reduction in local spring density is achieved by tapering the distal portion 1604 of the spring 1602. The material can also be removed from the spring by techniques such as drilling. Referring to FIG. 17, in some examples, one or more holes 1704 are drilled at or near the distal end of one or more springs 1702. One or more of these techniques (i.e., springs that can be of various widths, tapered springs, slotted springs, and perforated springs) are designed to achieve a particular local spring density. Can be combined.

  Referring now to FIG. 16B, in certain embodiments, a plurality of polymer springs 1600-a, 1600-b each have a tapered portion to electrically isolate the ablation structure support 180. Can be attached to an internal surface. The resection structure support 180 may be an example of the resection structure support 180 of FIGS. 1B, 6, 7, 8, and / or 9. The springs 1600-a, 1600-b are aligned with the first set of springs 1600-a adjacent to each other with the end of the tapered portion 1606 abutting the free end 181 of the resected structure support. And the second set of springs 1600-b are aligned adjacent to each other with the end of the tapered portion 1608 abutting the mounted end 1610 of the resection structure support. Can be done. In some examples, the end of the non-tapered spring portion 1612 of the first set of springs 1600-b is joined with the end of the non-tapered portion 1614 of the second set of springs 1600-b. ing. In some embodiments, the location 1616 where the non-tapered ends meet is at or near the middle portion of the ablation structure support 180. The spring density near the free end 181 and the mounted end 1610 of the ablation structure support 180 is the spring density at the middle portion 1616 of the ablation structure support 180 or the spring density near the middle portion 1616 of the ablation structure support 180, respectively. It can be less than half the density. In some examples, the spring density decreases linearly in the direction of the free end 181 and the mounted end 1610 of the ablation structure support 181. In certain embodiments, the tapered portion 1608 of each of the springs 1600-b tapers to a defined density and extends at the defined density to the installed end 1610 of the ablation structure support 180. ing. The spring density at the free end 181 and the installed end 1610 of the ablation structure support 180 or the spring density near the free end 181 and the installed end 1610 of the ablation structure support 180 is directly related to the degree of crawling that appears. Can be relevant.

  Referring now to FIG. 18, an ablation structure support 180 including metal springs 1802, 1804, 1806 is shown according to various embodiments. The three metal springs 1802, 1804, 1806 shown may each include a hole 1814, 1816, 1818 at the distal end of the spring near the free edge 181 of the ablation structure support 180. Metal springs 1802, 1804, 1806 may include one or more of springs 602, 604, 606, 608 of FIG. 6, 720 of FIG. 7, 820 of FIG. 8, 916 of FIG. 9, 1304, 1305 of FIG. Or, it may be an example of 1402, 1404, 1406, 1408 in FIG. Locking pins 1808, 1810, 1812 may pass through spring holes 1814, 1816, 1818, and each may have a smaller shaft circumference than spring holes 1814, 1816, 1818, and in some examples, spring holes 1814, 1816, 1818 may have a larger outer head perimeter than the inner perimeter. The fixation pins 1808, 1810, 1812 can pass through spring holes 1814, 1816, 1818 so that the resection structure support 180 can spread to a flat configuration during the lamination procedure. Such procedures are generally not utilized for shape memory polymer springs that are heat treated after lamination.

  19A and 19B, the distal portion of the general system 1900 for delivering treatment to a target treatment area has a collapsed configuration (FIG. 19A) and an expanded configuration (FIG. 19B), according to various embodiments. Are shown. The system 1900 can be an example of the system 100, 100-a, 400, 600, 700, 800, or 900 described with reference to FIGS. 1A, 1B, or FIGS. An expansion member 120 (only shown in FIG. 19B) coupled to the catheter 115 and an ablation structure 160 may be included. Conical protection elements 1902, 1904 may be positioned along catheter 115 at lateral edges 1906, 1908 of ablation structure 160. The conical structures 1902, 1904 can be made, for example, from a flexible, smooth polymer (eg, high density polyethylene). The larger openings 1910, 1912 of the conical structures 1902, 1904 may be positioned opposite side edges 1906, 1908 of the ablation structure 160. The perimeter at the large diameter ends 1910, 1912 of the conical structures 1902, 1904 may be larger than the perimeter of the deflated ablation structure 160, so that the entire edges 1906, 1908 of the ablation structure 160 are conical. May be insertable into the larger openings 1910, 1912 of the structures 1902, 1904, thus preventing the ablation structure 160 from bulging during removal and / or rubbing the lumen during insertion. The small diameter end 1914 of the conical structure 1904 may have an inner circumference that is slightly larger than the outer circumference of the distal portion 140 of the catheter 115 such that the conical structure 1904 causes the distal portion 140 of the catheter 115 to May be slidably movable along. In some embodiments, the small diameter end 1916 of the conical structure 1902 has a smaller inner perimeter than the outer perimeter of the portion 150 of the catheter 115, such that the conical structure 1902 forms a portion 150 of the catheter 115. May not be slidably movable along. 19B, a distal portion of a system 1900 for delivering treatment to a target treatment area is shown in an expanded configuration, according to various embodiments. The conical structure 1904 moves the resection structure 160 slightly away from the resection structure 160 such that the resection structure 160 deploys in response to expansion of the expansion member 120 without being obstructed by the conical structures 1902, 1904. Can be

  Referring now to FIGS. 20A and 20B, the distal portion of the general system 2000 for delivering treatment to a target treatment area has a collapsed configuration (FIG. 20A) and an expanded configuration (FIG. 20B), according to various embodiments. Indicated by The system 2000 may be an example of the system 100, 100-a, 400, 600, 700, 800, 900, or 1900 described with reference to FIGS. 1A, 1B, 4-9, or 19. , A catheter 115, an expansion member 120 connected to the catheter 115, and an ablation structure 160. The bumper overlying structure 2002 may be coupled to a portion of the distal side edge 2004 of the ablation structure 160. The bumper overlying structure 2002 may be made of a highly flexible material such that the structure does not significantly impede deployment of the ablation structure 160 in response to expansion of the expansion member 120. The overlying bumper structure 2002 is comprised of an arcuate portion 2008 coplanar with and coupled to the surface of the ablation structure 160, and a plurality of adjacent trapezoidal shaped structures 2006. In some cases, a plurality of adjacent trapezoidal shaped structures 2006 extend radially from the arcuate portion 2008 toward the distal portion 140 of the catheter 115. The arc length of the arcuate portion 2008 may be such that a sufficient portion of the edge 2004 of the ablation structure 160 is covered to prevent bulging during removal of the lumen and / or rubbing the lumen during insertion. It can be something.

  Referring now to FIG. 21, a distal portion of a general system 2100 for delivering treatment to a target treatment area is shown in an expanded configuration, according to various embodiments. The system 2100 may be a system 100, 100-a, 400, 600, 700, 800, 900, 1900, or 2000 described with reference to FIGS. 1A, 1B, 4-9, 19, or 20. And may include a catheter 115, an expansion member 120 connected to the catheter 115, and an ablation structure 160. In some embodiments, the tether anchoring structure 2102 extends all or a portion of the length of the catheter 115 and exits through the distal portion 140, and the distal end 2106 of the tether 2102 is It is attached to a slidably movable protection element 1904-a. The conical protection element 1904-a may be an example of the conical protection element 1904 described in connection with FIG. The proximal end 2110 of the tether anchoring structure 2102 extends out of an opening 165 near the proximal portion 145 of the catheter 115 so that an operator can operate the tether 2102 and slidably move the protection. Repositioning of element 1904-a may be controlled.

  Referring now to FIG. 22, a distal portion of a general system 2200 for delivering treatment to a target treatment area is shown in an expanded configuration, according to various embodiments. The system 2200 may be any of the systems 100, 100-a, 400, 600, 700, 800, 900, 1900, 2000, described with reference to FIGS. 1A, 1B, 4-9, or 19-21. Or 2100, which may include a catheter 115, an expansion member 120 connected to the catheter 115, and an ablation structure 160. In some embodiments, the tether anchoring structure 2202 extends all or a portion of the length of the proximal portion of the catheter 115 externally, and the distal end 2204 of the tether 2202 is proximally slidably movable. Attached to protection element 1902-a. The conical protection element 1902-a may be an example of the conical protection element 1902 described with reference to FIG. The tether mooring structure 2202 may be secured to the catheter 115 by, for example, one or more ring-shaped structures 2206 mounted on the catheter 115, such ring-shaped structures 2206 may be less than around the tether mooring structure 2202. Also has a slightly larger internal perimeter, allowing the tether anchoring structure 2202 to slide freely on one or more rings 2206. The distal end 2204 of the tether anchoring structure 2202 can be accessible to an operator at a proximal portion 145 (not shown) of the catheter 115 so that the operator can operate the tether 2202 and slidably move. Repositioning of possible protection elements 1902-a may be controlled.

  Referring to FIG. 23A, a distal portion of a general system 2300 for delivering treatment to a target treatment area is shown in a collapsed / wrapped configuration, according to various embodiments. The system 2300 includes the systems 100, 100-a, 400, 600, 700, 800, 900, 1900, 2000, described with reference to FIGS. 1A, 1B, 4-9, or 19-22. It may be an example of 2100 or 2200, and may include a catheter 115, an expansion member 120 connected to the catheter 115, and an ablation structure 160. As shown, in some embodiments, a raised ledge 2305 is coupled to the catheter 115 and is positioned near the proximal end 2310 of the expansion member 120. The raised ledge 2305 may be made from any suitable polymeric material and may be adhered to the catheter 115 or otherwise attached. The raised ledge 2305 may be configured to prevent the ablation structure 160 from bulging proximally along the catheter 115 during insertion of the ablation structure 160 into a body lumen (eg, the esophagus). Thus, the height of the raised ledge 2305 may be greater than the ablation structure 160 when the expanded ledge 2305 is away from the catheter 115 when the expansion member 120 is in the collapsed or unexpanded configuration. It can be large enough to do so. The raised ledge 2305 may be an example of a protective element as described with reference to FIGS. Referring to FIG. 23B, the expansion member 120 and ablation structure 160 illustrated in FIG. 23A are shown in an expanded / deployed configuration, according to various embodiments.

  Referring to FIG. 24, a distal portion of a general system 2400 for delivering treatment to a target treatment area is shown in a collapsed / wrapped configuration, according to various embodiments. The system 2400 includes the system 100, 100-a, 400, 600, 700, 800, 900, 1900, 2000, described with reference to FIGS. 1A, 1B, 4-9, or 19-23. It may be an example of 2100, 2200, or 2300, and may include a catheter 115, an expansion member 120 connected to the catheter 115, and a cutting structure 160. As shown, the expansion member 120 can include a lumped portion 2405, which is positioned near the distal end 140 of the catheter 115. The chunked portion 2405 of the expansion member 120 may be configured to prevent the ablation structure 160 from bulging distally along the catheter 115 while the ablation structure 160 is being removed from a body lumen. Accordingly, the lumped portion 2405 can be configured to have an average diameter that is greater than the diameter of the ablation structure 160 in the unexpanded or collapsed configuration. The lumped portion 2405 may be an example of a protective element as described with reference to FIGS.

  The expansion member 120 can be modified in a variety of ways to create a united portion 2405. For example, the expansion member 120 can be designed to have a steep taper angle at the distal end of the expansion member 120. The steep taper angle causes the distal portion of the expansion member 120 to become lumped while being unexpanded, thus forming a lumped portion 2405. Additionally or alternatively, the expansion member 120 can include multiple layers of material near the distal end to form a unitized portion 2405. Accordingly, the distal portion of the expansion member 120 can be thicker than the rest of the expansion member 120. The multiple layers of the expansion member 120 can be fused together by heat or joined through an adhesive or mechanical fastener element.

  For example, in various embodiments, the expansion member 120 is a balloon formed from a two-step blow molding process. The first step of the blow molding process may include forming a first balloon and then cutting off the distal end of the balloon. This cutaway portion can then be added back to the balloon mold while the second balloon is being formed. In particular, the detached portion is placed in the mold so as to overlap the distal portion of the second balloon when the second balloon is being formed. By overlapping the detached portion of the first balloon with the distal portion of the second balloon, the distal portion of the second balloon is thicker than the rest of the balloon material. Thus, when the balloon is in a collapsed or unexpanded state, the distal portion may form a lumped portion 2405 due to excess material. The size of the lumped portion 2405 is adjusted by altering the taper angle of the distal portion of the expansion member 120, as well as the number and thickness of additional layers of material near the distal portion of the expansion member 120. It can be appreciated that gains are obtained.

  Referring to FIG. 25, a general method 2500 for using various embodiments of the systems and / or devices described herein is depicted in accordance with various embodiments. For example, the method 2500 may include the system 100, the power supply 105, the handheld compressor 112, the expansion member 120, the ablation structure 160, the ablation structure support 180, the protective element 1902, 1904, 2002 and / or other devices and / or components. It may be implemented using various embodiments. At block 2505, the ablation structure 160 coupled to the ablation structure support 180 and the expansion member 120 may be inserted into a body lumen. The cutting structure 160 coupled to the cutting structure support 180 may, in combination, deploy in response to expansion of the expansion member 120 and wrap in response to contraction of the expansion member 120. Guide assembly 165 may be used such that expansion member 120 is threaded through guide assembly 165 and delivers ablation structure 160 to a target treatment area within a body lumen.

  At block 2510, the expansion member 120 may be expanded such that the cutting structure 160, which is coupled with the cutting structure support 180, deploys in combination and engages a peripheral section of the body lumen. In some examples, expansion member 120 includes a compliant balloon. In some embodiments, power supply 105 and / or handheld compressor 112 may be used to expand expansion member 120.

  At block 2515, energy may be delivered through the ablation structure 160 to a first portion of the surrounding treatment area of the body lumen. In some embodiments, the ablation structure 160 includes two or more longitudinal electrodes or longitudinal electrode zones of various widths. In some embodiments, the ablation structure 160 includes two or more longitudinal electrodes or longitudinal electrode zones, wherein the two or more longitudinal electrodes or longitudinal electrode zones are selectively operable. Alternatively, it is configured to be selectively disabled. In certain examples, ablation structure 160 includes a bipolar electrode array.

  Referring to FIG. 26, a general method 2600 for using various embodiments of the systems and / or devices described herein is depicted in accordance with various embodiments. Method 2600 may be an example of method 2500 described with reference to FIG. For example, blocks 2605, 2610, and 2615 may be examples of the method described in blocks 2505, 2510, and 2515 of method 2500. Further, at block 2620, the expansion member 120 is configured such that the cutting structure 160, which is coupled to the cutting structure support 180 including one or more springs, wraps in combination to disengage the perimeter section of the body lumen. Can be contracted. For example, the method 2600 may include the system 100, the power supply 105, the handheld compressor 112, the expansion member 120, the ablation structure 160, the ablation structure support 180, the springs 1506, 1602, 1702, the protection elements 1902, 1904, 2002, and / or others. May be implemented utilizing various embodiments of the devices and / or components of the present invention. In some examples, expansion member 120 includes a compliant balloon. In some embodiments, a vacuum is used to completely contract expansion member 120. In some examples, the one or more springs include a constant load spring.

  Referring to FIG. 27, a general method 2700 for using various embodiments of the systems and / or devices described herein is depicted in accordance with various embodiments. Method 2700 may be an example of method 2500 described with reference to FIG. For example, blocks 2705, 2710, and 2715 may be examples of the method described in blocks 2505, 2510, and 2515 of method 2500. Further, at block 2720, one or more protective elements may be utilized during insertion of the ablation structure coupled to the ablation structure support 180 and the dilation member 120 into a body lumen. For example, method 2700 may include system 100, power supply 105, handheld compressor 112, expansion member 120, ablation structure 160, ablation structure support 180, springs 1506, 1602, 1702, protective elements 1902, 1904, 2002, and / or others. May be implemented utilizing various embodiments of the devices and / or components of the present invention. One or more protective elements are positioned at a distal portion, a proximal portion, or both of the ablation structure 160. These protection elements may include, for example, a conical shaped structure, a bumper shaped structure, a raised ledge 2305 connected to the catheter 115, or a portion 2405 of the expanded member 120 that is bundled together. Are each positioned to prevent the resection structure 160 from bulging and / or to prevent the earliest edge of the resection structure from rubbing the lumen wall during insertion. . In some embodiments of the above method, one or more of the protective elements are moved away from the ablation structure after the ablation structure is positioned.

  Referring to FIG. 28, a general method 2800 for using various embodiments of the systems and / or devices described herein is depicted in accordance with various embodiments. Method 2800 may be an example of method 2500 described with reference to FIG. For example, blocks 2805, 2810, and 2815 may be examples of the method described in blocks 2505, 2510, and 2515 of method 2500. Further, at block 2820, after positioning the ablation structure 160 within the body lumen, one or more protective elements are moved distally from a lateral edge of the ablation structure 160. For example, method 2800 includes system 100, power supply 105, handheld compressor 112, expansion member 120, ablation structure 160, ablation structure support 180, springs 1506, 1602, 1702, protective elements 1902, 1904, tethers 2102, 2202, and It may be implemented utilizing various embodiments of other devices and / or components. Moving one or more protective elements after positioning of the ablation structure 160 continues to prevent the ablation structure 160 from bulging and / or the foremost edge of the ablation structure 160 rubs the lumen wall during insertion. Facilitates the combined deployment of the ablation structure 160 connected to the ablation structure support 180 without being interrupted.

  Referring to FIG. 29, a general method 2900 that employs various embodiments of the systems and / or devices described herein is illustrated according to various embodiments. Method 2900 may be an example of method 2500 described with reference to FIG. For example, blocks 2905, 2910, and 2915 may be examples of the method described in blocks 2505, 2510, and 2515 of method 2500. Further, at block 2920, an impedance level may be determined for each longitudinal electrode or longitudinal electrode zone. For example, method 2900 may include system 100, power supply 105, handheld compressor 112, expansion member 120, ablation structure 160, ablation structure support 180, springs 1506, 1602, 1702, protective elements 1902, 1904, 2002, and / or the like. May be implemented utilizing various embodiments of the devices and / or components of the present invention. In some examples, the measurements may be performed on a longitudinal electrode or a longitudinal electrode adjacent to a free edge of the ablation structure prior to enabling a given longitudinal electrode or longitudinal electrode zone. Acquired continuously, starting from the zone. In another embodiment, the rate of change in impedance is measured during the ablation. In some examples, at block 2925, the starting impedance of the current longitudinal electrode or longitudinal electrode zone in the series of electrodes or electrode zones is equal to the length of the longitudinal electrode or the earlier longitudinal electrode in the series of electrodes or electrode zones. It is compared to the starting impedance level of the previously acquired impedance for the longitudinal electrode zone. In some examples, the rate of change of impedance during ablation for the current longitudinal electrode or longitudinal electrode zone is the rate of change of impedance previously obtained for the current patient and / or from a previous patient. Be compared.

  Referring to FIG. 30, a general method 3000 that uses various embodiments of the systems and / or devices described herein is illustrated according to various embodiments. For example, method 3000 utilizes various embodiments of system 100, dilation member 120, ablation structure 160, ablation structure support 180, protective elements 1902, 1904, 2002 and / or other devices and / or components. Can be implemented. At block 3005, the ablation structure 160 coupled to the ablation structure support 180 and the dilation member 120 are inserted into a body lumen. One or more protective elements may be positioned at a distal portion, a proximal portion, or both of ablation structure 160. These protective elements may include, for example, a cone-shaped structure, an overlying bumper-shaped structure, a raised ledge 2305 connected to the catheter 115, or a portion 2405 of the expanded member 120 that is bundled. These may each include preventing the ablation structure 160 from bulging and / or preventing the foremost edge of the ablation structure 160 from rubbing the lumen wall during insertion. Is positioned. In certain instances, ablation structure 160 includes a wound bipolar electrode array.

  At block 3010, the expansion member 120 can be expanded so that the cutting structure 160 coupled to the cutting structure support 180 can be deployed in combination and engage a peripheral section of a body lumen. In some examples, expansion member 120 includes a compliant balloon. In some embodiments, power supply 105 and / or handheld compressor 112 are used to expand expansion member 120.

  Referring to FIG. 31, a general method 3100 for using various embodiments of the systems and / or devices described herein is depicted in accordance with various embodiments. Method 3100 may be an example of method 3000 described with reference to FIG. For example, blocks 3105 and 3110 may be examples of the method described in blocks 3005 and 3010 of method 3000. Further, at block 3115, one or more protective elements may be transferred distally from a lateral edge of the ablation structure 160 after positioning the ablation structure within the body lumen. For example, method 3100 is implemented utilizing various embodiments of system 100, dilation member 120, ablation structure 160, ablation structure support 180, protective elements 1902, 1904, and / or other devices and / or components. obtain. Moving one or more protective elements after positioning of the resection structure 160 continues to prevent the resection structure 160 from bulging, and / or the foremost edge of the resection structure rubs the lumen wall during insertion. Facilitates the combined deployment of the ablation structure 160 connected to the ablation structure support 180 without being obstructed.

  Referring to FIG. 32, a general method 3200 for using various embodiments of the systems and / or devices described herein is depicted in accordance with various embodiments. Method 3200 may be an example of method 3000 described with reference to FIG. For example, blocks 3205 and 3210 may be examples of the method described in blocks 3005 and 3010 of method 3000. Further, at block 3215, one or more protection elements may be moved relative to ablation structure 160 through the use of one or more tether anchoring structures coupled to one or more of the protection elements. For example, method 3200 includes various embodiments of system 100, expansion member 120, ablation structure 160, ablation structure support 180, protective elements 1902, 1904, tethers 2102, 2202, and / or other devices and / or components. May be implemented. In some embodiments, the tether anchoring structure extends upward from the protection element along the length of the catheter, such that an operator operates the tether and repositions one or more of the protection elements. Can be controlled.

  The foregoing description provides examples, and is not intended to limit the scope, applicability, or configuration of the various embodiments. Rather, the description and / or drawings provide those skilled in the art with an enabling description for implementing various embodiments. Various changes can be made in the function and arrangement of the elements.

  Thus, various embodiments may omit, substitute, or add various procedures or components as appropriate. For example, it should be recognized that the methods described above can be performed in a different order than described, and that various steps can be added, omitted, or combined. Also, aspects and elements described with respect to certain embodiments can be combined in various other embodiments. It should also be appreciated that the following systems, methods, and devices, individually or collectively, may be components of a larger system, wherein other procedures may take precedence or separate Their application can be modified in a similar manner.

  The foregoing description of certain embodiments has been presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms disclosed, and obviously many modifications and variations are possible in light of the above teaching. Embodiments have been chosen and described to explain the principles of the various embodiments, and their practical application, so that those of ordinary skill in the art may have various modifications where appropriate for the particular use contemplated. Various embodiments can be utilized. It is intended that the scope of the various embodiments be defined by the claims appended hereto, and their equivalents.

Claims (18)

An ablation device for treatment of tissue in a body lumen having various sizes, the device comprising:
A catheter,
An expansion member coupled to a distal portion of the catheter , the expansion member extending longitudinally ;
A cutting structure configured to at least partially deploy, or wrap around the expansion member when the expansion member expands or contracts;
One or more springs coupled to the resection structure, the one or more springs deploying about the expansion member when the expansion member expands or contracts; Alternatively, the one or more springs are configured to provide a force to cause winding, the one or more springs extending perpendicular to the longitudinal direction of the expansion member, and includes one or more pieces of material, the one or more pieces of material is coupled to the ablative structure transversely to the longitudinal axis of the extension member, at least one of said pieces of material One or more springs, including at least a tapered portion. The one or more springs include one or more pieces of material, and a density of the one or more pieces of material near a free end of the ablation structure is greater than a density of the one or more pieces of material near an installed end of the ablation structure. The ablation device according to claim 1, wherein the ablation device is less than a density of the one or more pieces of material.   The ablation device according to claim 2, wherein the one or more pieces of material include at least a shape memory polymer material. The one or more springs include one or more pieces of material, the density of the one or more pieces of material near a free end of the ablation structure, and the density of the one or more pieces of material near an installed end of the ablation structure. The ablation device according to claim 1, wherein the density of the one or more pieces of material is less than a density of the one or more pieces of material in an intermediate portion of the ablation structure.   The ablation device according to claim 1, wherein the one or more pieces of material include at least a metallic or polymeric material.   2. The one or more springs of claim 1, wherein the one or more springs include at least a first spring having a first length and a second spring having a second length different from the first length. Excision device. The first length is greater than the second length, and the second spring having the second length is positioned near an installed end of the cutting structure. Item 7. An ablation device according to Item 6.   The ablation device according to claim 1, wherein the one or more pieces of material comprise one or more rectangular pieces of material. At least one of the one or more rectangular pieces of material comprises one or more openings, said one or more openings, wherein at least one of the one or more rectangular pieces of material one of which is configured in at least one end, ablation device of claim 8.   The at least one of the pieces of material includes one or more slots, and the one or more slots are configured within at least one end of the at least one piece of material. An ablation device according to claim 1. The ablation structure includes a plurality of longitudinal electrode regions extending parallel to the longitudinal axis direction of the expansion member , wherein the plurality of longitudinal electrode regions are configured to be sequentially activated. The ablation device according to claim 1, wherein The ablation structure includes a plurality of longitudinal electrode regions extending parallel to the longitudinal axis of the expansion member , the plurality of longitudinal electrode regions adjacent a free end of the ablation structure. The ablation device according to claim 1, wherein the ablation device is configured to be activated sequentially, starting from the first electrode region. The ablation structure includes a plurality of longitudinal electrode regions extending parallel to the longitudinal axis of the dilation member , each longitudinal electrode region being selectively enabled or disabled. The ablation device according to claim 1, wherein the ablation device is configured.   14. The ablation device according to claim 13, wherein the plurality of longitudinal electrode regions include at least two longitudinal electrode regions having different widths.   The at least two longitudinal electrode regions having different widths include a first longitudinal electrode region adjacent a free end of the ablation structure and a second longitudinal electrode region; 15. The ablation device according to claim 14, wherein one longitudinal electrode region has a width greater than a width of the second longitudinal electrode region. The plurality of longitudinal electrode regions includes at least three longitudinal electrode regions having different widths, wherein the at least three longitudinal electrode regions include a first longitudinal electrode region near a free end of the ablation structure. An electrode region, a second longitudinal electrode region adjacent to the first longitudinal electrode region, and a third longitudinal electrode region near an installed end of the ablation structure. Wherein the first longitudinal electrode region has a width greater than the width of the second longitudinal electrode region, and wherein the second longitudinal electrode region comprises a third longitudinal electrode region. 14. The ablation device according to claim 13, having a width greater than the width of the electrode region.   The ablation device according to claim 1, wherein the ablation structure comprises at least a bipolar electrode array.   The ablation device according to claim 1, wherein the dilation member comprises a balloon.