JP6445834B2 - Deploying electrode device having a plurality of longitudinal electrode segments - Google Patents

Description

CROSS REFERENCE This application is filed on October 21, 2014, and is filed on October 21, 2014, in the United States Patent Application No. 14 / 519,409, filed on October 21, 2014, entitled "UNFURLING ELECTRODE DEVICES WITH THE MULTIPLE LONGITUDINAL ELECTRODE SEGMENTS". US Patent Application No. 14 / 519,950 of the invention name “UNFURLING ELECTRODE DEVICES WITH SPRING” and the name of the invention “UNFURLING ELECTRODE DEVICES WITH THE PROTECTION ELECTRONIC” filed on October 21, 2014. Claims the benefit of U.S. Patent Application No. 14 / 520,028, as well as priority to the U.S. Patent Application, The above-mentioned U.S. patent application was filed on Oct. 25, 2013, and was filed with U.S. Provisional Application No. 61 / 895,501 of Oct. 25, 2013, entitled “UNFURLING ELECTRODE DEVICES WITH THE MULTIIPLE LONGITUDINAL ELECTRODE SEGMENTS”. US Provisional Application No. 61 / 895,514 filed with the title of the invention “UNFURLING ELECTRODE DEVICES WITH SPRING” and the name of the invention “UNFURLING ELECTRODE DEVICES WITH THE PROTECTION ELECTRONE” filed on October 25, 2013. Claiming priority to US Provisional Application No. 61,895,530, each of which is incorporated herein for all purposes. The entire Luo is incorporated by reference.

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

  The internal body lumens can have different sizes with respect to each other or with respect to 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 with a single intubation It may be unintentional, cost-effective or unsafe.

  Another problem may exist when treating a target site that is larger than the surface area of the treatment device. Traditional ablation approaches often included more than three repositioning steps to treat the target site. Such repositioning activity may be prone to a reduction in the accuracy of treatment after excision of the subregion of the target site, or during excision of the subregion of the target site, or both. Furthermore, the relocation activity can be ad hoc with respect to the number of relocation steps and the physical processes associated with the actual relocation of the device. Such lack of consistency 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 coupled to the distal portion of the catheter and an ablation structure support coupled to the ablation structure, wherein the ablation structure expands when the expansion member expands and contracts. It is configured to at least partially wrap around and unfold the member. The expansion member may include a non-compliant balloon, a compliant balloon, or a high compliant balloon. The ablation structure support may include one or more longitudinal electrodes, longitudinal electrode zones, and / or longitudinal electrode regions. In some embodiments, the system can include one or more protective elements, the one or more protective elements being distal to the ablation structure, proximal to the ablation structure, or both, Positioned along the catheter.

  In accordance with some embodiments of the present disclosure, an ablation device is provided for the treatment of tissue in body lumens 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 deploying or wrapping around the expansion member when the expansion member expands or contracts. Can be configured to do.

  In some embodiments, the ablation device further includes one or more springs coupled to the ablation structure support, the one or more springs at least partially around the expansion member, the ablation structure support. 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 protective elements, which are positioned along the catheter at least distally or proximally with respect 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 can be controlled or wired separately. In certain embodiments, the longitudinal electrode region includes at least two longitudinal electrode regions having different widths. The ablation device may include at least one bipolar electrode array in some embodiments. In certain examples, the expansion member is a balloon, and the balloon can be compliant in some embodiments.

  In accordance with some embodiments of the present disclosure, a method of treatment of tissue in body lumens having various sizes is provided. The method generally includes inserting an ablation structure coupled to the ablation structure support and an expansion member into the body lumen. The ablation structure and the ablation structure support may be configured to at least partially deploy or wrap around the expansion member when the expansion member expands or contracts. The method includes expanding the dilation member to at least partially deploy the ablation structure to engage a peripheral section of the body lumen and one or more of the plurality of longitudinal electrode regions of the ablation structure. And delivering energy to a surrounding section of the body lumen.

  In some examples, delivering energy to the surrounding section of the 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 contracting the expansion member to facilitate removal of the ablation structure from the body lumen. In some embodiments, the one or more springs cause the ablation structure to wrap at least partially around the expansion member when the expansion member contracts. The one or more springs may include one or more constant load springs in some examples.

  In certain embodiments, the method includes, relative to at least a distal or proximal portion of the ablation structure during insertion of the ablation structure coupled to the ablation structure support and the expansion member into the body lumen. Further utilizing one or more protective elements. In some embodiments, the method further includes moving the one or more protective elements away from the ablation structure after positioning the ablation structure in the body lumen. In certain examples, the method includes determining an impedance for each of a plurality of longitudinal electrode regions of the ablation structure and comparing the determined impedance to one or more of the longitudinal electrode regions. Determining whether or not is at least partially covered by the electrode segments.

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

  In accordance with some embodiments of the present disclosure, an ablation device is provided for the treatment of tissue in body lumens having various sizes. The ablation device generally includes an expansion member coupled to the distal portion of the catheter and an ablation structure that is at least partially around the expansion member when the expansion member expands or contracts. It is configured to perform deployment or wrapping. The ablation device further includes one or more springs coupled to the ablation structure, wherein the one or more springs expand the ablation structure around the expansion member when the expansion member expands or contracts, or It is configured to provide a force that causes wrapping.

  In some embodiments, the one or more springs of the ablation device include one or more strips of material that are transverse to the longitudinal axis of the ablation structure. Connected to the ablation structure. In certain examples, the one or more springs of the ablation device may have a density of one or more pieces of material proximal to the free end of the ablation structure such that the density of one or more distal to the free end of the ablation structure One or more pieces of material are included so as to be less than the density of the pieces of material. In still other embodiments, the one or more springs of the ablation device may have a density of one or more pieces of material proximal to the free end of the ablation structure and close to an installed end of the ablation structure. One or more pieces of material are included such that the density of the one or more pieces of material in the position is less than the density of the one or more pieces of material in the middle portion of the ablation structure. One or more pieces of material may comprise a metallic material or a polymeric material. The one or more pieces of material may include a shape memory polymer material in some embodiments.

  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 that is different from the first length. . The first length may be longer than the second length, and a second spring having the second length may be positioned distal to the free end of the ablation 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 material pieces includes one or more openings, and the one or more openings are in 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, the one or more slots configured in at least one end of the at least one piece of material.

  In certain embodiments, the ablation structure of the ablation device includes a number of longitudinal electrode regions that are configured to be activated sequentially. In some embodiments, the ablation structure includes multiple longitudinal electrode regions, the longitudinal electrode region being continuous starting from a first electrode region adjacent to the free end of the ablation structure. Are configured to be activated. In yet some other embodiments, the ablation structure includes multiple longitudinal electrode regions, each longitudinal electrode region being configured to be selectively operable or inoperable. The longitudinal electrode region 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 to the free end of the ablation structure and a second longitudinal electrode region; The first longitudinal electrode region has a width greater than the width of the second longitudinal electrode region.

  In some embodiments, the longitudinal electrode region of the ablation device includes at least three longitudinal electrode regions having different widths, wherein the at least three longitudinal electrode regions are relative to the 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 to the free end of the ablation structure And a longitudinal electrode region. The first longitudinal electrode region may have a width that is greater than the width of the second longitudinal electrode region, and the second longitudinal electrode region is greater than the width of the third longitudinal electrode region. 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.

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

  In some examples, the one or more protective elements include one or more cones, 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 base circumference that is larger than the circumference 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 facilitates moving the 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. Yes. The one or more protective elements may 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 protective elements include one or more bumpers, and the one or more bumpers are coupled to one or more edges of the ablation structure. One or more bumpers may overlie the edge of the ablation structure inwardly toward the catheter.

  In accordance with various embodiments, the one or more protective elements proximal to the ablation structure can include a raised 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 the body lumen.

  In various embodiments, the ablation device further includes an expansion member coupled to the catheter, and the ablation structure is wrapped around the expansion member. In such embodiments, the one or more protective elements distal to the ablation structure may include a portion of the expansion member that is unexpanded when the expansion member is unexpanded. As a result, the diameter of the lumped portion is configured to exceed the diameter of the wound ablation structure. The massed portion of the expansion member can be configured to prevent the ablation structure from expanding in the distal direction along the catheter during removal from the body lumen.

  In certain examples, 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 elements.

  In accordance with some embodiments of the present disclosure, a method of treatment of tissue in body lumens having various sizes is provided. The method generally includes inserting an ablation structure coupled to the catheter into the 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 ablation structure to engage the body lumen. The protective element may include one or more cones, the one or more cones 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 the body lumen. The method may further include utilizing one or more tethers coupled to the one or more protective elements to facilitate moving the one or more protective elements relative to the ablation structure. .

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

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

  In certain instances, the one or more protective elements distal to the ablation structure may include a portion of the expansion member that is a mass when the expansion member is unexpanded, and As a result, the diameter of the grouped portion is configured to exceed the diameter of the wound cutting structure. The massed portion of the expansion member can be configured to prevent the ablation structure from expanding in the distal direction along the catheter during removal from the body lumen.

  In some embodiments, the one or more protective elements are positioned proximal to the ablation structure relative to the catheter and a first protection element positioned distal to the ablation structure relative to the catheter. A second protection element.

  The foregoing has outlined rather broadly the features and technical advantages of the examples according to 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 specific examples can be readily utilized as a basis for modifying or designing other structures for carrying out the same purposes of the present disclosure. Such equivalent constructions do not depart from the spirit and scope of the appended claims. Features considered to be characteristic of the concepts disclosed herein, together with their associated advantages, together with their associated advantages, when taken in conjunction with the accompanying drawings, from the following description 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 coupled to the distal portion of the catheter;
An ablation structure including a plurality of longitudinal electrode regions;
An ablation structure support coupled to the ablation structure, wherein the ablation structure and the ablation structure support expand at least partially around the expansion member when the expansion member expands or contracts A device that is configured to do or wrap.
(Item 2)
And further comprising one or more springs coupled to the ablation structure support, the one or more springs configured to wrap the ablation structure support at least partially around the expansion member. The ablation device according to the above item.
(Item 3)
The ablation device according to any one of the preceding items, wherein the one or more springs include one or more constant load springs.
(Item 4)
Any of the preceding items further comprising 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 The ablation device according to one item.
(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 one of the preceding items, wherein each of the longitudinal electrode regions is separately controlled or wired.
(Item 7)
The ablation device according to any one of the preceding items, wherein the plurality of longitudinal electrode regions includes at least two longitudinal electrode regions having different widths.
(Item 8)
The ablation device according to any one of the preceding items, wherein the expansion member comprises a balloon.
(Item 9)
The ablation 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 coupled to the distal portion of the catheter;
An ablation 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 ablation structure support, the one or more springs deploying the ablation structure around the expansion member when the expansion member expands or contracts A device that is configured to provide a force that causes that or wrapping.
(Item 12)
The item or items, wherein the one or more springs include one or more pieces of material, the one or more pieces of material being coupled to the ablation structure transversely to a longitudinal axis of the ablation structure. An ablation device according to any one of the above.
(Item 13)
The one or more springs include one or more pieces of material, wherein the density of the one or more pieces of material proximal to the free end of the ablation structure is determined by the density of the free end of the ablation structure. The ablation device of any one of the preceding items, wherein the ablation device 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 proximal to the free end of the ablation structure and the ablation structure is installed. The density of the one or more pieces of material proximal to the end of the abutment is less than the density of the one or more pieces of material in an intermediate portion of the ablation structure according to any one of the preceding items. The ablation device described.
(Item 15)
The ablation device according to any one of the preceding items, wherein the one or more pieces of material comprise at least a metallic material or a polymeric material.
(Item 16)
The ablation device according to any one of the preceding items, wherein the one or more pieces of material comprise at least a shape memory polymer material.
(Item 17)
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. The ablation device according to any one of the above.
(Item 18)
The first length is longer than the second length, and the second spring having the second length is positioned distal to the free end of the ablation structure; The ablation device according to any one of the above items.
(Item 19)
The ablation device according to any one 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 material pieces includes one or more openings, the one or more openings configured in at least one end of the at least one rectangular piece. The ablation device according to any one of the items above.
(Item 21)
The ablation device according to any one of the preceding items, wherein at least one of the pieces of material includes at least a tapered portion.
(Item 22)
At least one of the material pieces includes one or more slots, wherein the one or more slots are configured in at least one end of the at least one piece of material. The ablation device according to any one of the above.
(Item 23)
The ablation structure according to any one of the preceding items, wherein the ablation structure includes a plurality of longitudinal electrode regions, the plurality of longitudinal electrode regions configured to be activated sequentially. Ablation device.
(Item 24)
The ablation structure includes a plurality of longitudinal electrode regions, the plurality of longitudinal electrode regions being continuously active starting from a first electrode region adjacent to the free end of the ablation structure. The ablation device according to any one of the items above, wherein the ablation device is configured to be
(Item 25)
Any one of the preceding items, wherein the ablation structure includes a plurality of longitudinal electrode regions, each longitudinal electrode region being configured to be selectively operable or inoperable. The ablation device described in.
(Item 26)
The ablation device according to any one of the preceding items, wherein the plurality of longitudinal electrode regions includes 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 to the free end of the ablation structure and a second longitudinal electrode region, the first longitudinal electrode region The ablation device according to any one 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 to the free end of the ablation structure. A longitudinal electrode region, a second longitudinal electrode region adjacent to the first longitudinal electrode region, and a third longitudinal direction distal to the free end of the ablation structure The first longitudinal electrode region has a width wider than that of the second longitudinal electrode region, and the second longitudinal electrode region has the second longitudinal electrode region The ablation device according to any one of the preceding items, wherein the ablation device has 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 ablation device according to any one of the preceding items, wherein the expansion member comprises 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 coupled 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 with respect 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 item or items, wherein the one or more protective elements includes one or more cones, the one or more cones configured to protect one or more edges of the ablation structure. An ablation device according to any one of the above.
(Item 34)
Any of the preceding items, wherein the one or more protective elements includes one or more cones, each cone having a base diameter greater than the diameter of the ablation structure when not expanded. An ablation device according to claim 1.
(Item 35)
The one or more conical portions are configured to move away from the ablation structure when the ablation structure is deployed and engages the tissue. The ablation device described in.
(Item 36)
Of the above items, further comprising one or more tethers, wherein the one or more tethers are configured to facilitate moving the one or more cones relative to the ablation structure. The ablation device according to any one of the above.
(Item 37)
The one or more protective elements are configured to prevent the ablation structure from inflating along the catheter at least during deployment into or removal from the body lumen. The ablation device according to any one of the above 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. The ablation device according to any one of the preceding items, wherein:
(Item 39)
The one or more protective elements includes one or more bumpers, wherein the one or more bumpers are coupled to one or more edges of the ablation structure. The ablation device 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 includes an elevated ledge coupled 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. The ablation device according to one item.
(Item 43)
The ablation device according to any one of the preceding items, further comprising an expansion member coupled to the catheter, wherein the ablation structure is wrapped around the expansion member.
(Item 44)
The one or more protective elements distal to the ablation structure includes a portion of the expansion member, the portion of the expansion member becoming a mass when the expansion member is unexpanded. The ablation device according to any one of the preceding items, wherein the mass of the massed portion is configured to exceed the diameter of the wrapped ablation structure.
(Item 45)
The mass of the expansion member is configured to prevent the ablation structure from expanding distally along the catheter during removal from a body lumen. The ablation device according to any one of the above.
(Item 46)
The one or more protective elements include a first protective element positioned distal to the ablation structure with respect to the catheter and a second protection positioned proximal to the ablation structure with respect to the catheter. An ablation device according to any one of the preceding items, comprising an element.

(Summary)
Methods, systems, and devices for providing treatment to tissue in a body lumen are described. The system can include a catheter, an expansion member coupled to the distal portion of the catheter, an ablation structure including one or more longitudinal electrode segments, and an ablation structure support coupled to the ablation structure. The ablation structure is configured to be at least partially deployed when the expansion member is expanded and wound 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, so that each longitudinal electrode Or, the longitudinal electrode zones can be selectively enabled or disabled. In some examples, one or more springs are coupled to the ablation structure that 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 further understanding of the nature and advantages of the embodiments may be realized by reference to the following drawings. In the accompanying drawings, similar components or features may have the same reference signs. In addition, various components of the same type can be distinguished by following a reference indicator with a second indicator that distinguishes between dashes and similar components. When only the first reference label is used herein, the description is for any one of the similar components having the same first reference label regardless of the second reference label. It 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 view of a portion of the upper gastrointestinal tract in humans. FIG. 3A is a schematic illustration of an ablation device in a wound / deflated mode within the esophagus. FIG. 3B is a schematic illustration of the ablation device in the deployed / expanded mode within the esophagus. FIG. 4 is a perspective view of the ablation device in a wound mode / deflated mode coupled with a plurality of separately wired longitudinal electrode zones. FIG. 5 is a perspective view of the ablation device in a deployed mode / expanded mode coupled with a plurality of separately wired longitudinal electrode zones. 6 is a perspective view of the partially deployed ablation 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 a plurality of longitudinal electrode regions 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 regions of uniform narrow width. FIG. 9 is a partially deployed distal view of the ablation device of FIG. 2 having a single spring and a longitudinal electrode region that can be a plurality of different 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 mode / 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 an electrode pattern of the ablation device of FIG. 13 is a cross-sectional view of the ablation structure of the ablation device of FIG. FIG. 14 is a plan view of the ablation structure of the ablation device of FIG. 2 with springs that can be of various lengths. FIG. 15 is a plan view of the slotted spring of the cutting structure of FIG. 16A is a plan view of a tapered spring of the ablation structure of FIG. FIG. 16B is a plan view of the ablation structure of the ablation device of FIG. 2 having a tapered spring. FIG. 17 is a plan view of a metal spring including a pinning hole of the cutting structure of FIG. 18 is a plan view of the ablation structure of the ablation device of FIG. 2 with metal springs that can be of various lengths pinned. FIG. 19A is a perspective view of the ablation device of FIG. 4 in a wound / collapsed mode with 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 with a proximal protective cone element and a distal protective cone element. 20A is a perspective view of the ablation device of FIG. 4 in a wound / collapsed 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 deployed / expanded mode with a distal protective cone element anchored with a tether. FIG. 22 is a perspective view of the ablation device of FIG. 20B in an expanded mode with proximal and distal protective cone elements anchored with a tether. FIG. 23A is a perspective view of the ablation device of FIG. 4 in a wound / collapsed mode with a proximal raised ledge 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 wound / 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 for 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 for 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 is a flow diagram illustrating a method for providing treatment to a target site area using an expansion member that includes one or more moveable 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 can include an expansion member, which can be coupled to the distal portion of the catheter. The ablation structure can be wrapped around the dilation member so as to engage various sized body lumens by dilating the dilation member.

  An ablation structure support coupled to the ablation structure may be positioned at the distal end of the catheter. The ablation structure can include a flexible circuit that can be wrapped and deployed around the expansion member, over which the ablation structure can be disposed. Various aspects of the flexible circuit may be similar to typical integrated circuits and microelectronic devices. The flexible circuit may include a plurality of separately wired longitudinal electrodes or separately controlled longitudinal electrodes, longitudinal electrode zones, or both, which are aligned parallel to the axis And the ablation structure transitions between this 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 purposes of this application, enabling an electrode or electrode zone has the same meaning as activating the electrode or electrode zone. In some examples, the ablation structure includes an electrode array (eg, a bipolar electrode array, etc.).

  The ablation structure support may be coupled to one or more springs. The spring can be made from a variety of materials, such as a metal material or a polymer material. The positional density of the spring relative to the ablation structure support can vary so that the clawing effect is reduced at the location of one or more ablation structures. 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 protective elements prevent them from rubbing the lumen or expanding the ablation support structure during insertion and removal by covering the edges of the ablation 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 during deployment of the expansion member, removing the cones so as not to interfere with the winding and deployment transition . In some cases, a flexible distal protective bumper element that is smaller than the circumference of the wrapped ablation structure is coupled to the longitudinal edge of the distal side portion of the ablation structure. A wound ablation structure that includes a protective bumper element may resemble the well-known tubular shape of an endoscope. In addition, the catheter may include an elevated ledge positioned proximal to the ablation structure, the raised ridge being positioned along the catheter during insertion of the ablation structure into the body lumen. It is comprised so that it may prevent swelling. Further, the expansion member may include a portion that is distal to the ablation structure, the portion becoming a mass when the expansion member is unexpanded, so that the mass of the expansion member that is massed is ablated. The structure prevents swelling along the catheter during removal of the ablation structure from the body lumen.

  Referring to FIG. 1A, a general system 100 for delivering treatment to a target treatment area is shown in accordance with various embodiments. The system 100 can be designed to provide treatment to a target area within the body, such as an organ wall or a lumen in the gastrointestinal tract. System 100 can include a power source 105, a catheter 115, and an expansion member 120. The expansion member 120 can generally be configured to support the ablation structure 160, which can be used to deliver therapy to the 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 can be delivered to a target treatment site within the body. The power source 105 can then be used to power the ablation structure 160 disposed 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 with tapered geometries, and sac. In some embodiments, the power source 105 is configured to inflate the expansion member 120, for example, by incorporating an auxiliary expansion mechanism therein. The deflated configuration can generally be used when the expansion member 120 is inserted into and removed from the body lumen. If the expansion member 120 obtains the desired ablation position, the expansion member 120 is inflated from a collapsed state (ie, a collapsed configuration) to a substantially inflated state (ie, an expanded configuration). It can be expanded by such as.

  The expansion member 120 can be configured to support the ablation 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 the target treatment area). Some ablation structures 160 may be designed so that they are in direct contact with the target treatment area, which includes pushing the ablation structure 160 against the target site.

  The dilation member 120 can be coupled to the catheter 115 such that the dilation member 120 can be manipulated through a body channel (eg, the esophagus) at the target treatment area. The catheter 115 may be coupled to the power / inflation device 105 at the proximal end 145 of the catheter 115. The expansion member 120 can be positioned between the distal end 140 of the catheter 115 and the 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 so that the catheter 115 is in the guide assembly 165. On the other hand, it can move slidably. The guide assembly entry point 175 may typically be located outside the catheter 115 and closest to the power source 105.

  The power source 105 may provide power to the ablation structure 160 disposed on the 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 115 channels are accommodated.

  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, with a rounded distal shape. Including the end. The expansion member 120 can be tapered at its proximal end and can be coupled to the catheter 115 near the portion 150 of the catheter 115.

  Located 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 may include a single electrode that includes multiple electrode zones, or a series of electrodes 169 that are laterally adjacent to each other, the series of electrodes 169 being the longitudinal axis of the ablation structure 160 and the expansion member 120. Is parallel to. One or more electrodes 169 may be combined with about half of the electrodes extending from the first bus bar and about half of the electrodes extending from the second bus bar. The first busbar or the second busbar can be connected to the positive terminal and the other of the first busbar or the second busbar can be connected to the negative terminal or the ground terminal, thereby providing a bipolar electrode configuration. . When connected to power source 105-a, one or more electrodes 169 may provide ablation energy to the target treatment area.

  The expansion member 120 may be coupled to the portion 150 of the catheter 115 that is closest to the distal end 140 of the catheter 115. The ablation structure support 180 can be wrapped at least partially around the outer periphery of the expansion member 120 so that when the expansion member 120 expands, the ablation structure support 180 conforms to the changing periphery 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 the power source 105-a and / or from the switching printed circuit board, which is configured to drive one or more additional channels.

  Referring now to FIG. 1C, a power source 105-b is schematically illustrated according to various embodiments. The power source 105-b may be an example of the power source 105 or 105-a described with reference to FIG. 1A or FIG. 1B. In general, the power source 105-b may include a power switching mechanism 190 configured to switch on the longitudinal electrode region and switch off the longitudinal electrode region. 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 may include an RF generating element 181 that may be configured to transmit RF energy to the power switching element 192 by one or more output channels 186, and then Such power switching element 192 reroutes RF energy 198 to a plurality of longitudinal electrode regions. In some implementations, the power switching mechanism 190 is an external component that is communicatively coupled to the power source 105-b and the 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 regions of the ablation structure 160 is less than or equal to the number of RF channels 186 supported by the power source 105-b, each defined The longitudinal electrode region is coupled to a single RF channel 186. In such a configuration, the switching mechanism 190 may be communicatively coupled with a channel adjustment module 183 that is integral with the power source 105-b. The channel adjustment module 183 can include a microprocessor 184 and a memory 182. The switching mechanism 190 can also include a microprocessor 195 and a memory 194. The channel adjustment module 183 may direct the switching mechanism 190 to make the RF channel 186 either operational or non-operational, which RF channel 186 follows one or more algorithms stored in the memory 182. Associated with one or more electrode regions. In some examples, the switching mechanism 190 may communicate ablation parameters (eg, impedance, etc.) to the power source 105-b for use in algorithmic determination.

  In certain implementations, the number of electrode regions defined exceeds the number of RF channels 186 supported by the power source 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 regions. In such a case, the RF generating element 181 may be configured to transmit RF energy to the power switching element 192 by only one output channel 186, which in turn may be configured to transmit the RF energy. Are rerouted into a plurality of longitudinal electrode regions. Alternatively, the RF generating element 181 can be configured to transmit RF energy through a plurality of output channels 186 to the inverse multiplexer 191, where such inverse multiplexer 191 can provide a common return of, for example, a bipolar system. Extend the number of channels 197 by re-routing.

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

  In some examples, the switching mechanism 190 monitors current and / or interprets other signals communicated from the power source 105-b to partially determine when to switch the channel on or off. To do. Additionally or alternatively, the power supply 105-b can switch the switching mechanism 190 via a one-way or two-way communication channel 185 that couples the power supply logic element 184 and the switching mechanism logic element 195. Can be controlled. In certain implementations, the power source 105-b receives feedback from the switching mechanism 190 (eg, a notification that a switching instruction has been received and / or a notification that the indicated switching behavior has been performed, etc.). 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 a change to the impedance of the tissue when compared to the tissue that has not been excised. A 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 a different region 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 appreciated by those skilled in the art that these and other automated selection algorithms can be implemented in one or more computing devices that are communicatively coupled outside of power supply 105-b. For example, additional computer software (eg, image analysis software) overlaps previously resected areas and / or overlaps as part of an algorithm that adjusts activation and / or energy delivery profiles of associated electrode areas Can be used to identify electrode segments.

  Referring now to FIG. 2, certain abnormalities can cause a retrograde flow of stomach 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 is a secondary anomaly that requires a very different treatment from this procedure, independent of the treatment appropriate for the primary anomaly (eg, an abnormality in the lower esophageal sphincter 216). For example, Barrett's esophagus). Barrett's esophagus is an inflammatory abnormality in which gastric acid, bile acids, and enzymes that reflux 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 the esophageal epithelial cells 218. In some cases, the damage can result in changes in squamous cells, turning them into taller specialized columnar epithelial cells 220. This metaplasia 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 result in adenocarcinoma.

  In some embodiments, the described methods, systems, and devices are configured to treat columnar epithelium at selected sites of the esophagus through tissue resection. 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 a desired treatment effect that does not reach resection (e.g., some level of agitation that can be imparted to the tissue to ensure the desired change in tissue cellular organization, rather than tissue necrosis). It will be appreciated by those skilled in the art that it may have damage). In some examples, as described below, a variety of different energy delivery devices are utilized to cause treatment effects in the shallow layers of tissue while preserving the full function of the deeper layers.

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

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

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

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

  The ablation structure 160 can be operated in direct contact with the wall of the tissue site. This can be achieved by coupling the ablation structure 160 to the dilation member 120, which is dilatable in a shape that matches the size of the inner lumen of the treatment site (eg, the human lower esophageal canal). It has a possible configuration. The ablation structure 160 can be positioned so that energy can be uniformly applied to the inner circumference of the lumen where treatment is desired. This may be accomplished by first positioning the expansion member 120 at the treatment site in a collapsed configuration where the ablation structure 160 is wrapped around the expansion member 120. When 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 inner 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 around all or part of the inner lumen of the esophagus or other tissue sites. 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 is expanded and the ablation structure 160 is deployed, 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 divided, and thus the power supply Accommodate specific power limits, thereby providing the organization with the appropriate energy density. The ablation structure 160 may extend a longer arc length than the periphery of the dilation member 120 so that a clear circumferential ablation is achieved for various sized body lumens when the dilation member 120 is dilated.

  The ablation structure 160 can be positioned and energy can be applied to the inner circumference of the treatment site in the body lumen. This can be accomplished by first positioning the expansion member 120 at the treatment site in a collapsed configuration. When the ablation structure 160 is advanced to the appropriate treatment site, the expansion member 120 can be expanded to advance the ablation structure 160 and engage the internal wall of the body lumen. The desired treatment energy can 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 may be longitudinal electrodes adjacent to the free or overlapping edge 181 of the ablation structure 160 and Starting from the longitudinal electrode zone 161 is enabled continuously. Detection of a fully shielded longitudinal electrode and / or longitudinal electrode zone may be achieved if the further longitudinal electrode and / or longitudinal electrode zone is not in contact with the tissue of the body lumen. Energy delivery to the electrodes and / or longitudinal electrode zones may be stopped in an uncontacted order.

  In certain embodiments, the ablation structure 160 delivers a variety of different types of energy, including radio frequency, microwave, ultrasound, resistive heating, chemical, heatable fluid, optical However, the optical material includes, but is not limited to, ultraviolet light, visible light, infrared light, parallel or non-parallel, coherent or non-coherent, or other light energy.

  Referring now to FIG. 4, the distal portion of the general system 400 for delivering treatment to the target treatment area is shown in a collapsed configuration, according to various embodiments. The system 400 may 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 coupled to the catheter 115, and around the expansion member 120. And a wound ablation structure 160. To engage the inner surface of the body lumen that is larger than the deflated diameter of the expansion member 120, the expansion member 120 can be expanded until the desired pressure is exerted on the inner wall of the lumen (see, eg, FIG. 5). See The expansion member 120 can be expanded so that the pressure applied to the body lumen is less than the pressure that causes damage, for example, by tearing or piercing 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 operable are constant electrodes across the surface of the ablation structure 160. The density can be maintained. The energy delivered to the electrode or electrode zone (including but not limited to an RF signal) can provide a uniform treatment within each region to the exact depth of the tissue. After the procedure is 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 uniform width or varying widths. One electrode is configured to reduce the degree of overlap of the ablation regions and thus reduce the degree of over-ablation. The longitudinal electrode zones 161, 162 can be selectively enabled via a plurality of transmission lines 170, which are connected to the power source 105 (see, eg, FIG. 1A) and the longitudinal direction. It extends between the electrode zones 161 and 162. The ablation structure 160 can include an electrode array 163 etched on its surface and can 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 in accordance with various embodiments. When the expansion member 120 is inflated or otherwise expanded, the ablation structure 160 deploys and reveals 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 that are connected to the power source 105 (see, eg, FIG. 1A). ) And the longitudinal electrodes 502, 504, 506. For example, insulated transmission wires 170-a, 170-b, 170-c may be individually wired to the electrodes or electrode zones 502, 504, 506. The wires can be individually insulated along the entire length of the catheter 115 using heat shrink tubing material. Each of the wires may terminate in a mini connector plug of power supply 105 or a switched printed circuit board controller, which is configured to drive a transmission channel in addition to the channel of power supply 105. . Power can be selectively delivered to one or more electrodes or electrode zones under this configuration so that treatment 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 source 105, or within the power source 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 that is wider than the width of the remaining longitudinal electrode or longitudinal electrode segment closer to the end (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 periphery of this minimum size is one that is positioned adjacent to 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 overall 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 minimum lumen size arc length (16 * pi = 50 mm) is defined as two electrode regions (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 that delivers treatment to a target treatment area is shown in a collapsed configuration, according to various embodiments. System 600 may be an example of system 100, 100-a, or 400 described with reference to FIG. 1A, FIG. 1B, FIG. 4, or FIG. Member 120 and ablation structure 160 may be included. The ablation structure 160 is shown in a partially deployed configuration to illustrate the underside of the ablation structure 160. The ablation structure 160 may be coupled to an ablation structure support 180 that is coupled to the expansion member 120 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 ablation structure 160 and the expansion member 120. In certain instances, adhesion 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 coupled 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 ablation structure 160. It is configured. The ablation structure 160 may include a single electrode that is divided into one or more variable width longitudinal segments 502, 504, 506, 610. The longitudinal electrode segment 502 adjacent to the free edge 181 of the ablation structure 160 may have a width that is wider than the width of the other longitudinal electrode segments 504, 506, 610. Each longitudinal electrode segment 502, 504, 506, 610 is separated by a wiring structure that is insulated from the wiring structures 170-a, 170-b, 170-c, 170-d for the other longitudinal electrode segments. , Can be coupled to a power source 105 (see, eg, FIG. 1A).

  In some embodiments, the ablation structure 160 includes a large single electrode that is divided into adjacent longitudinal electrode zones of uniform width to overlap the ablation region. It is configured to reduce the extent and thus reduce the extent of over-ablation. Such a uniform width configuration may be useful when the minimum size lumen is not known (eg, when the ablation system is used for a variety of different body lumens). Referring now to FIG. 7, the distal portion of the general system 700 for delivering treatment to the target treatment area is shown in a collapsed configuration, according to various embodiments. System 700 may be an example of system 100, 100-a, 400, or 600 described with reference to FIG. 1A, FIG. 1B, or FIGS. Expansion member 120 and ablation structure 160 may be included. The ablation structure 160 is shown in a partially deployed configuration to illustrate the underside of the ablation structure 160. The ablation structure 160 may be coupled to the ablation structure support 180 that is coupled to the expansion member 120 or otherwise to the expansion member 120 along the edge 722 to which it is coupled. It is attached. 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 can 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 is a wiring structure 170-a, 170-b, 170-c, 170 for the other longitudinal electrode segment. A wiring structure that is insulated from -d can be coupled to a power source 105 (see, eg, FIG. 1A) (no further insulated wiring structures are shown).

  In some embodiments, the ablation structure 160 includes a large single electrode that is adjacent to a uniform narrow width (eg, having a width of less than 10 mm) adjacent longitudinal lengths. Divided into electrode zones and configured to reduce the extent of ablation region overlap and thus reduce the extent of over-ablation in regions where there is overlap. Referring now to FIG. 8, the distal portion of the general system 800 for delivering treatment to the target treatment area is shown in a collapsed configuration, according to various embodiments. System 800 may be an example of system 100, 100-a, 400, 600, or 700 described with reference to FIG. 1A, FIG. 1B, or FIGS. Expansion member 120 and ablation structure 160 may be included. The ablation structure 160 is shown in a partially deployed configuration to illustrate the underside of the ablation structure 160. The ablation structure 160 may be coupled to the ablation structure support 180 that is coupled to the expansion member 120 or otherwise to the expansion member 120 along the edge 812 to which it is coupled. It is attached. The lower surface of the cutting structure 160 may include a single spring 820 that extends from the coupled edge 812 of the cutting structure 160 and is relative to the longitudinal axis of the expansion member 120. And vertical. A single electrode can be divided into longitudinal zones 802, 804, 806, 808, 810 of uniform width. Each longitudinal electrode zone 802, 804, 806, 808, 810 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 source 105 (see, eg, FIG. 1A) (no further insulated wiring structure is shown).

  In some embodiments, the ablation structure 160 includes a large single electrode that is divided into adjacent longitudinal electrode zones of varying widths to overlap the ablation region. It is configured to reduce the extent and thus reduce the extent of over-ablation. Referring now to FIG. 9, the distal portion of the general system 900 for delivering treatment to the target treatment area is shown in a collapsed configuration, according to various embodiments. System 900 may be an example of system 100, 100-a, 400, 600, 700, or 800 described with reference to FIG. 1A, FIG. 1B, or FIGS. And an ablation structure 160. The ablation structure 160 is shown in a partially deployed configuration to illustrate the underside of the ablation structure 160. The ablation structure 160 may be coupled to the ablation structure support 180 that is coupled to the expansion member 120 or otherwise to the expansion member 120 along the edge 914 to which it is coupled. It is attached. The lower surface of the cutting structure 160 may include a single spring 916 that extends from the coupled 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 varying 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. Depending on the wiring structure present, it can be coupled to a power source 105 (see, eg, FIG. 1A) (no further insulated wiring structure is shown).

  Referring now to FIGS. 10A and 10B, cross-sectional views of the ablation structure 160 and the expansion member 120 are shown in accordance with 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 the first end 1012 (adhesion not shown). The free end 181 of the ablation structure 160 can be wrapped around the expansion member 120 and overlaps the joined end 1012 one or more times. When the expansion member 120 expands, the ablation structure 160 expands to further reveal additional electrodes or electrode zones that were previously shielded by the overlapping portion 181 of the ablation structure 160.

  At any given expanded diameter, one or more electrodes or electrode zones can be in contact with a region of the treated tissue, and the one or more electrode segments can be an island-like backing of the ablation structure 160 or the ablation structure support 180 Can come in contact with. The electrode traces can be connected with a conductive material, such as saline, mucus, or a tissue clot. These materials can come into contact with the island backing of the ablation structure 160 without the presence of structures or procedures to relax. This can cause loss of energy intended for tissue treatment, both where a single electrode is used and / or where the ablation zone is oriented circumferentially. Energy delivery, thereby reducing 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, so that each longitudinal electrode or longitudinal direction is The electrode zone may be unaffected by the presence or absence of an electrode region covered by the ablation structure and / or an electrode region coated with a conductive material (eg, fluid or tissue). The total energy delivered to each longitudinal electrode or longitudinal electrode zone is the total active surface area of the longitudinal electrode according to the ablation parameters developed in the art (eg, parameters 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 fully or partially overlaps one or more longitudinal electrode regions. 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 therefore 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 backing of the ablation structure 160, which results in an energy delivery profile that deviates from the intended energy delivery profile. And an excessive amount of energy is delivered to the treated tissue region. The longitudinal electrode so that the width of the innermost partially exposed longitudinal electrode or longitudinal electrode zone does not exceed a predetermined percentage (eg, about 20%) around the treatment area Alternatively, this effect can be reduced by forming longitudinal electrode segments.

  To limit the degree to which energy can be overdelivered to a tissue treatment area in contact with a partially shielded longitudinal electrode or longitudinal electrode zone (eg, electrode zone 1006 in FIG. 10A), a variety of The method can be used. The channel adjustment module (eg, see FIG. 1C) may include computer instructions that are received from a longitudinal electrode or longitudinal electrode zone 1008 adjacent to the free edge 181 of the ablation structure 160. Starting sequentially, each adjacent longitudinal electrode or longitudinal electrode zone is configured to be operable. Computer instructions can be further provided to perform impedance measurements and calculations so that the extent of ablation can be controlled in real time. A partially shielded longitudinal electrode or longitudinal electrode zone 1006 often has a higher impedance than an unshielded longitudinal electrode or longitudinal electrode zone (eg, zone 1010 shown in FIG. 10B). Can have. The impedance of each longitudinal electrode or longitudinal electrode zone can be compared to the impedance measurements obtained for the previous zone before enabling each longitudinal electrode or longitudinal electrode zone. Detection of higher impedance may be partially occluded (eg, 1006 in FIG. 10A) electrode or electrode zone, or fully occluded (eg, 1007 in FIG. 10B) electrode or electrode. It may indicate a zone. When determined by detection of a higher onset impedance, computer instructions reduce ablation time and / or lower the voltage delivered to partially or fully occluded electrodes or electrode zones 1006, 1007. Can be further provided. Computer instructions may be further provided that stop the continuous operability of the electrodes or electrode zones 1014, 1016 after detection of the first, partially or fully plugged electrode or electrode zones 1006, 1007. In addition to having a starting impedance that is greater than the impedance of the unshielded longitudinal electrode or longitudinal electrode zone 1010, the blocked electrodes or electrode zones 1006, 1007 are often unshielded longitudinally. When compared to directional electrodes or longitudinal electrode zones 1010, an increase in the rate of change of impedance can occur. Computer instructions may be provided to compare the rate of impedance change during ablation with the rate of impedance change from before ablation in the same patient or previous patient, and detection of a higher rate of impedance change may be performed with 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 electrode or electrode zone that is blocked.

  Referring now to FIGS. 11A-11C, in the case of the esophagus, the electrode pattern varies at the site of treatment depending on the length of the site to be treated, the depth of the mucosa and submucosa, and other factors. It can be. Electrode patterns 1102-1208 may be examples of electrode patterns included with electrode array 163 of FIGS. 4 and 5. The electrode array pattern can be composed of specific electrode elements that can be arranged in a variety of configurations (eg, circumferential orientation, longitudinal orientation, etc.). An electrode element is a conductive element of an 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. A pattern of longitudinal electrodes or longitudinal electrode zones can be aligned axially or transversely 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 can be coupled to various locations of the ablation structure 160. For example, an electrode array such as that shown in FIGS. 11A-11C may have a bipolar axially combined finger electrode 1102, a monopolar rectangle 1104 separated by 1 mm, or six bipolar rings separated by 2 mm. 1106 patterns may be included. Other suitable RF electrode patterns can be used, including, without limitation, the patterns shown in FIGS. 12A-12D. The pattern may be, for example, a bipolar axially combined finger electrode 1202 separated by 0.3 mm, a bipolar band 1204 separated by 0.3 mm, a bipolar ring 1208 separated by 0.3 mm, and / or It may include corrugated electrodes 1206 that are separated by 0.2548 mm.

  The depth of treatment can be controlled by selection of appropriate treatment parameters by an operator, as described in the examples described herein. One parameter that can affect the depth of treatment is the density of the electrode elements. As the spacing between the electrode elements decreases, the treatment depth of the affected tissue also decreases when RF energy is delivered across the electrodes in a bipolar manner. The very close spacing of the electrode elements can limit the current to shallow depth and the resulting ohmic heating so that injury and heating of the submucosa layer is minimized. To treat esophageal tissue 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 controlled depth ablation. Examples of electrode configurations for controlled depth ablation are described in US Pat. Nos. 6,551,310 (Ganz et al.), 7,150,745 (Stern et al.), 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, 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 are for all purposes Is incorporated herein by reference. In various embodiments, a generator and / or channel conditioning module (see, eg, FIG. 1C) uses the ablation structure 160 to achieve energy ablation to achieve ablation of tissue to a controlled depth. It is comprised so that application of may be controlled.

  Although described with respect to an electrode array for RF ablation, those skilled in the art will recognize that an ablation structure suitable for use with the embodiments described herein is configured to perform other forms of treatment 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 motion member can include a sensor element overlying an 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 by other formats.

  In various embodiments, the ablation structures described herein are configured for ablation of abnormal tissue in the esophagus. In some examples, the ablation structures described herein are configured for ablation of abnormal tissue in the lower esophageal sphincter. In certain implementations, the ablation structures described herein are configured to ablate Barrett's esophageal tissue and / or precancerous tissue in the epithelium without damaging the underlying muscalaris. Yes. In some embodiments, the ablation structures described herein are configured for use in a variety of body lumens and organs, including gastrointestinal (GI) tracts (eg, esophagus or duodenum). ), Gastrointestinal tract, digestive system (eg, bile duct), cardiovascular system, endocrine system (eg, pancreas), and 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 excise mucosal tissue without damaging the underlying submucosa. In certain instances, the ablation structures described herein are configured to excise mucosal tissue without damaging the underlying muscle layer. In some implementations, the ablation structure described herein applies an appropriate level of energy to the tissue to achieve an ablation depth that does not extend beyond the submucosal layer of the esophagus. Is configured to do. In some embodiments, the ablation structures described herein are configured to control the ablation depth to the epithelium. In some examples, the ablation structures described herein are configured for superficial ablation. For example, various embodiments of the ablation structure can be configured to bake the tissue surface. In certain cases, the ablation structures described herein are configured to deliver sufficient energy to initiate tissue regrowth, eg, in the mucosal layer.

  Controlling the depth of ablation may be based on several factors (eg, power and treatment time). In various embodiments, the power source activates the longitudinal electrode or longitudinal electrode zone 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 / cm 2 and about 50 J / m 2, between about 10 J / m 2 and about 40 J / m 2, about 15 J / m 2 and about 105 J / m 2. cm, between about 25 J / square cm and about 105 J / square cm, between about 30 J / square cm and about 105 J / square cm, between about 35 J / square cm and about 105 J / square cm, Or one or more longitudinal electrodes or longitudinal electrode zones with sufficient power and length of time required to deliver between about 40 J / square cm and about 105 J / square cm. Activate. Other energies per unit area quantity may be utilized in some embodiments.

  In various embodiments, the power source 105-a (see, eg, FIG. 1B) is between about 10 Watts / square cm and about 50 Watts / square cm, between about 10 Watts / square cm and about 40 Watts / square. Between square centimeters, between about 10 watts / square centimeter and about 30 watts / square centimeter, between about 15 watts / square centimeter and about 30 watts / square centimeter, or between about 15 watts / square centimeter and about 40 It can be configured to deliver between watts per square centimeter. Other energies per unit area quantity may be utilized in some embodiments.

  In some examples, the power source 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. For a period of between about 100 ms and about 1 second, or between about 300 ms and about 800 ms. In certain embodiments, the generator is configured to activate the electrode for less than 1 second, less than 500 ms, or less than 300 ms. In some implementations, the power source 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 / square cm to about 15 J / square cm for a duration of about 300 ms to about 800 ms. Other energy per unit area amount and time amount may be utilized in some embodiments.

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

  One or more constant load springs 1304, 1306 can be attached to the flexible backing 1302 by application of an adhesive material 1308. A polytetrafluoroethylene film can be etched on one side and adhered to the spring side of the ablation structure 160. The entire ablation structure 160 can be laminated as a flat sheet, providing friction reduction during the transition between the wound configuration and the deployed configuration, and is therefore required for the 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 shape memory polymer spring is a polymeric thermoplastic (eg, an amorphous thermoplastic polyetherimide, or from the polyaryletherketone family). Made from organic polymer thermoplastics). The entire laminated ablation structure support 180 can be heat treated to achieve a permanent and final helical structure. In alternative embodiments, 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.

  14-17, various structures for local reduction of spring density are shown in accordance with various embodiments. Referring now to FIG. 14, four springs 1402, 1404, 1406, 1408 of varying lengths are attached to the electrically isolated inner surface of the ablation structure support 180. The ablation structure support 180 may be an example of the ablation structure support 180 of FIGS. 1B, 6, 7, 8, 9, and / or 13. The springs 1402, 1404, 1406, 1408, which can be of various lengths, ensure that one or more distal ends 1410, 1412 of the springs 1404, 1406 do not border the free end 181 of the ablation structure support 180. Is arranged. In some embodiments, a set of four springs is more than the length of two equal length longer springs 1402, 1408, one shorter length spring 1406, and longer springs 1402, 1408. One spring 1404 having a short 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 that of 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 near the free end 181 of the ablation structure support 180 may be directly related to the degree of crawling that appears, where crawling is the initial spring Refers to the tendency of the free end 181 of the ablation structure support 180 back towards the radius.

  Referring now to FIGS. 15-17, local spring density reduction can 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 one or more examples of the springs described with reference to FIGS. 6-9 and / or 13-14. For example, referring to FIG. 15, a slot 1504 can be included at the distal portion of the spring 1506 to reduce the cloaking force of the spring 1506 at or near the slotted region 1504. Referring to FIG. 16A, in some examples, local spring density reduction is achieved by tapering the distal portion 1604 of the spring 1602. 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 (ie, springs that may be of varying widths, tapered springs, slotted springs, and perforated springs) may allow a particular local spring density to be achieved. 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 and are electrically isolated from the ablation structure support 180. Can be attached to an internal surface. The ablation structure support 180 may be an example of the ablation structure support 180 of FIGS. 1B, 6, 7, 8, and / or 9. The springs 1600-a and 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 ablation 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 ablation 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 to 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 join 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 intermediate portion 1616 of the ablation structure support 180 or the spring near the intermediate 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 of the ablation structure support 181 and the mounted end 1610. In certain embodiments, each tapered portion 1608 of the spring 1600-b tapers to a defined density and extends to a fixed end 1610 of the ablation structure support 180 at the defined density. ing. The spring density at the free end 181 and the installed end 1610 of the ablation structure support 180 or near the free end 181 and the installed end 1610 of the ablation structure support 180 is directly related to the degree of clawing that appears. May be related.

  Referring now to FIG. 18, an ablation structure support 180 including metal springs 1802, 1804, 1806 is shown in accordance with various embodiments. The three metal springs 1802, 1804, 1806 shown may each include holes 1814, 1816, 1818 at the distal end of the spring near the free edge 181 of the ablation structure support 180. The metal springs 1802, 1804, 1806 may include one or more of the springs 602, 604, 606, 608, FIG. 7, 720, FIG. 8, 820, FIG. 9, 916, FIG. 13, 1304, 1305, and / or FIG. Or it may be an example of 1402, 1404, 1406, 1408 of FIG. Fixing pins 1808, 1810, 1812 may pass through spring holes 1814, 1816, 1818, each having a smaller shaft circumference than spring holes 1814, 1816, 1818, and in some examples, spring holes 1814, 1816, may have an outer head circumference that is larger than the inner circumference of 1818. The fixation pins 1808, 1810, 1812 may pass through the spring holes 1814, 1816, 1818 so that the ablation structure support 180 can spread into a flat configuration during the lamination procedure. Such a procedure is generally not utilized for shape memory polymer springs that are heat treated after lamination.

  Referring now to FIGS. 19A and 19B, the distal portion of the general system 1900 for delivering treatment to the target treatment area is in a collapsed configuration (FIG. 19A) and an expanded configuration (FIG. 19B), according to various embodiments. Is shown in System 1900 can be an example of system 100, 100-a, 400, 600, 700, 800, or 900 described with reference to FIG. 1A, FIG. 1B, or FIGS. An expansion member 120 (shown only in FIG. 19B) coupled to the catheter 115 and an ablation structure 160 may be included. Conical protective elements 1902, 1904 can be positioned along the catheter 115 at the lateral edges 1906, 1908 of the ablation structure 160. The conical structures 1902, 1904 can be made, for example, from a flexible, smooth polymer (eg, high density polyethylene). Larger openings 1910, 1912 in the conical structures 1902, 1904 can be positioned opposite the 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 expanding during removal and / or rubbing the lumen during insertion. The small diameter end 1914 of the conical structure 1904 may have an inner perimeter that is slightly larger than the outer perimeter of the distal portion 140 of the catheter 115, so that the conical structure 1904 is a distal portion 140 of the catheter 115. Can be slidably movable along. In some embodiments, the small diameter end 1916 of the conical structure 1902 has an inner perimeter that is smaller than the outer perimeter of the portion 150 of the catheter 115, so that the conical structure 1902 has a portion 150 of the catheter 115. May not be slidable along. Referring now to FIG. 19B, the distal portion of the system 1900 for delivering treatment to the target treatment area is shown in an expanded configuration, according to various embodiments. The conical structure 1904 is moved slightly away from the ablation structure 160 so that the ablation structure 160 deploys in response to the 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 the target treatment area is in a collapsed configuration (FIG. 20A) and an expanded configuration (FIG. 20B), according to various embodiments. It is shown in System 2000 may be an example of system 100, 100-a, 400, 600, 700, 800, 900, or 1900 described with reference to FIG. 1A, FIG. 1B, FIG. 4-9, or FIG. , Catheter 115, expansion member 120 coupled to catheter 115, and ablation structure 160. The structure 2002 overlying the bumper may be coupled to a portion of the distal side edge 2004 of the ablation structure 160. The bumper overlying structure 2002 can be made from a highly flexible material so that the structure does not significantly interfere with the deployment of the ablation structure 160 in response to expansion of the expansion member 120. The overlying bumper structure 2002 comprises an arcuate portion 2008 that is coplanar with the surface of the ablation structure 160 and is 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 and radially toward the distal portion 140 of the catheter 115. The arc length of the arcuate portion 2008 may prevent a sufficient portion of the edge 2004 of the ablation structure 160 from being covered to swell during removal of the lumen and / or rub the lumen during insertion. It can be something.

  Referring now to FIG. 21, the distal portion of a general system 2100 that delivers treatment to a target treatment area is shown in an expanded configuration, according to various embodiments. The system 2100 may be the system 100, 100-a, 400, 600, 700, 800, 900, 1900, or 2000 described with reference to FIG. 1A, FIG. 1B, FIG. 4-9, FIG. And may include a catheter 115, an expansion member 120 coupled to the catheter 115, and an ablation structure 160. In some embodiments, a tether anchoring structure 2102 extends inward 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 attached to a slidably movable protective 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 the opening 165 near the proximal portion 145 of the catheter 115 so that the operator can manipulate the tether 2102 and slidably moveable protection The repositioning of element 1904-a may be controlled.

  Referring now to FIG. 22, the distal portion of a general system 2200 that delivers treatment to a target treatment area is shown in an expanded configuration, according to various embodiments. The system 2200 is a system 100, 100-a, 400, 600, 700, 800, 900, 1900, 2000, described with reference to FIGS. 1A, 1B, 4-9, or 19-21. Or it may be an example of 2100 and may include a catheter 115, an expansion member 120 coupled to the catheter 115, and a cutting structure 160. In some embodiments, the tether anchoring structure 2202 extends outside all or part of the length of the proximal portion of the catheter 115 and the distal end 2204 of the tether 2202 is proximally slidably movable. It is attached to the protective 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 anchoring structure 2202 can be secured to the catheter 115 by, for example, one or more ring-shaped structures 2206 that are mounted to the catheter 115, such ring-shaped structures 2206 from the periphery of the tether anchoring structure 2202. Has a slightly larger internal perimeter, allowing the tether anchoring structure 2202 to slide freely in one or more rings 2206. The distal end 2204 of the tether anchoring structure 2202 may be accessible to the operator at the proximal portion 145 (not shown) of the catheter 115 so that the operator manipulates the tether 2202 and moves slidably. Possible repositioning of the protective element 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 is a system 100, 100-a, 400, 600, 700, 800, 900, 1900, 2000, described with reference to FIGS. 1A, 1B, 4-9, or 19-22. Examples of 2100 or 2200 may include a catheter 115, an expansion member 120 coupled 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 positioned near the proximal end 2310 of the expansion member 120. The raised ledge 2305 can be made from any suitable polymeric material and can be glued 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, esophagus). Accordingly, the height of the raised ledge 2305 is greater than the ablation structure 160 when the raised ledge 2305 is further away from the catheter 115 when the expansion member 120 is in a collapsed or unexpanded configuration. As such, it can be large enough. 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 the 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 is a system 100, 100-a, 400, 600, 700, 800, 900, 1900, 2000, described with reference to FIGS. 1A, 1B, 4-9, or 19-23. Examples of 2100, 2200, or 2300 may include a catheter 115, an expansion member 120 coupled to the catheter 115, and an ablation structure 160. As shown, the expansion member 120 can include a lumped portion 2405 that is positioned near the distal end 140 of the catheter 115. The chunked portion 2405 of the expansion member 120 can be configured to prevent the ablation structure 160 from expanding in the distal direction along the catheter 115 while the ablation structure 160 is removed from the body lumen. Thus, the chunked portion 2405 can be configured to have an average diameter that is greater than the diameter of the ablation structure 160 in an unexpanded or deflated configuration. The chunked 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 chunked 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 mass of the distal portion of the expansion member 120 to lumps while being unexpanded, thus forming a lumped portion 2405. Additionally or alternatively, the expansion member 120 may include multiple layers of material near the distal end to form a lumped portion 2405. Accordingly, the distal portion of the expansion member 120 can be thicker than the remainder of the expansion member 120. The multiple layers of expansion member 120 can be fused together by heat or can be 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 severing the distal end of the balloon. This detached 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 a mold so as to overlap the distal portion of the second balloon when the second balloon is formed. By overlapping the cut off 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 contracted 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 you get.

  With reference to FIG. 25, a general method 2500 using various embodiments of the systems and / or devices described herein is illustrated in accordance with various embodiments. For example, the method 2500 may include the system 100, the power source 105, the handheld compressor 112, the expansion member 120, the ablation structure 160, the ablation structure support 180, the protective elements 1902, 1904, 2002 and / or other devices and / or components. It can be implemented utilizing 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 the body lumen. The ablation structure 160 coupled to the ablation structure support 180 may be combined and deployed in response to expansion of the expansion member 120 and wound around in response to contraction of the expansion member 120. The guide assembly 165 can be used such that the expansion member 120 is threaded through the guide assembly 165 to deliver the ablation structure 160 to a target treatment area within the body lumen.

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

  At block 2515, energy may be delivered through the ablation structure 160 to the 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 varying 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, the ablation structure 160 includes a bipolar electrode array.

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

  With reference to FIG. 27, a general method 2700 using various embodiments of the systems and / or devices described herein is illustrated 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 can be examples of the methods 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 expansion member 120 into the 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, protection elements 1902, 1904, 2002, and / or others. Various embodiments of the devices and / or components may be implemented. One or more protective elements are positioned at the distal portion, proximal portion, or both of the ablation structure 160. These protective elements may include, for example, a cone-shaped structure, a bumper-shaped structure, a raised ledge 2305 coupled to the catheter 115, or a portion 2405 of the expansion member 120 that is bundled together, Are each positioned to prevent the ablation structure 160 from bulging and / or to prevent the leading edge of the ablation structure from rubbing the lumen wall during insertion. . In some embodiments of the above method, one or more of the protection elements are moved away from the ablation structure after the ablation structure is positioned.

  Referring to FIG. 28, a general method 2800 using various embodiments of the systems and / or devices described herein is illustrated in accordance with various embodiments. The method 2800 may be an example of the method 2500 described with reference to FIG. For example, blocks 2805, 2810, and 2815 may be examples of the methods 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 the lateral edges 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 expanding and / or the earliest edge of the ablation structure 160 rubs the lumen wall during insertion. This facilitates the combined deployment of the ablation structure 160 coupled with the ablation structure support 180 without being obstructed.

  Referring to FIG. 29, a general method 2900 using various embodiments of the systems and / or devices described herein is illustrated in accordance with 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 methods 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, protection elements 1902, 1904, 2002, and / or others. Various embodiments of the devices and / or components may be implemented. In some examples, the measured value is a longitudinal electrode or longitudinal electrode adjacent to the free edge of the ablation structure before enabling a given longitudinal electrode or longitudinal electrode zone. Starting from the zone, it is acquired continuously. In another embodiment, the rate of impedance change is measured during ablation. In some examples, at block 2925, the starting impedance of the current longitudinal electrode or longitudinal electrode zone in the electrode or electrode zone series is the longitudinal electrode or earlier electrode in the electrode or electrode zone series. It is compared to the starting impedance level of the impedance previously obtained for the longitudinal electrode zone. In some examples, the rate of impedance change during ablation for the current longitudinal electrode or longitudinal electrode zone may be a previously obtained impedance change rate for the current patient and / or from a previous patient. To be compared.

  With reference to FIG. 30, a general method 3000 using various embodiments of the systems and / or devices described herein is illustrated in accordance with various embodiments. For example, the method 3000 utilizes various embodiments of the system 100, the expansion member 120, the ablation structure 160, the ablation structure support 180, the 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 expansion member 120 are inserted into the body lumen. One or more protective elements may be positioned at the distal portion, proximal portion, or both of the ablation structure 160. These protective elements may include, for example, a conical shaped structure, an overlying bumper shaped structure, a raised ledge 2305 coupled to the catheter 115, or a portion 2405 of the expansion member 120 that is grouped together. Each of which may prevent the ablation structure 160 from bulging and / or prevent the foremost edge of the ablation structure 160 from rubbing the lumen wall during insertion; Is positioned. In certain examples, the ablation structure 160 includes a wound bipolar electrode array.

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

  Referring to FIG. 31, a general method 3100 using various embodiments of the systems and / or devices described herein is illustrated in accordance with various embodiments. The method 3100 may be an example of the 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 moved distally from the lateral edge of the ablation structure 160 after positioning the ablation structure within the body lumen. For example, the method 3100 may be performed utilizing various embodiments of the system 100, the expansion member 120, the ablation structure 160, the ablation structure support 180, the protective elements 1902 and 1904, and / or other devices and / or components. obtain. 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 leading edge of the ablation structure rubs the lumen wall during insertion. This facilitates the combined deployment of the ablation structure 160 coupled with the ablation structure support 180 without being obstructed.

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

  The foregoing description provides examples and is not intended to limit the scope, applicability, or configuration of various embodiments. Rather, the description and / or drawings provide those skilled in the art with a description that enables various embodiments to be practiced. 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 appreciated that the above methods can be performed in a different order than the order described, and that various steps can be added, omitted, or combined. Also, aspects and elements described with respect to particular embodiments can be combined in various other embodiments. It should also be appreciated that the following systems, methods, and devices may be components of a larger system, either individually or collectively, where other procedures may be prioritized or otherwise. Their application can be modified in the same way.

  The foregoing descriptions of specific embodiments are presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise form disclosed, and obviously many modifications and variations are possible in view of the above teachings. Embodiments are selected and described to illustrate the principles of the various embodiments and their practical application, so that those skilled in the art will have various modifications when suitable 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 (10)

An ablation device for treatment of tissue in a body lumen having various sizes, the device comprising:
A catheter;
An expansion member coupled to the distal portion of the catheter;
An ablation structure including a plurality of longitudinal electrode regions;
A cut structural support coupled to該切dividing structure, the ablative structure and該切dividing structural support, when the expansion member expands or contracts, at least partially deployed about the expansion member it, or are configured to perform the winding around,該切dividing structure supports an edge coupled to said expansion member, the free edge opposite to the edge that is coupled to the extension member The ablation structure support at least partially overlaps the ablation structure support itself around the expansion member and completely shields at least one of the plurality of longitudinal electrode regions; An ablation structure support;
The plurality of longitudinal electrode regions sequentially starting with a longitudinal electrode region adjacent to a free edge of the ablation structure support; and the at least one longitudinal electrode region completely shielded A power supply configured to selectively enable and stop at
An ablation device. And further comprising one or more springs coupled to the ablation structure support, the one or more springs configured to wrap the ablation structure support at least partially about the expansion member. The ablation device according to claim 1.   The ablation device according to claim 2, wherein the one or more springs include one or more constant load springs.   The ablation according to claim 1, further comprising 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. device.   The ablation device according to claim 1, wherein each of the longitudinal electrode regions is configured to be selectively enabled or disabled. Said longitudinal each electrode region, ablation devices which separately are being or separately wires are controlled, according to claim 5.   The ablation device according to claim 1, wherein the plurality of longitudinal electrode regions includes at least two longitudinal electrode regions having different widths.   The ablation device according to claim 1, wherein the expansion member comprises a balloon.   The ablation device according to claim 8, wherein the balloon comprises a compliant balloon.   The ablation device according to claim 1, wherein the ablation structure includes at least one bipolar electrode array.