Balloon catheter for organ protection during thermal ablation

Abstract

A balloon catheter, comprising an elongate body having a proximal end and a proximal opening, a distal end and a distal opening, the proximal and distal openings defining an inner lumen therebetween, wherein the body defines an inner surface and an outer surface, a first internal channel positioned within the inner lumen and fluidly connected to at least one balloon positioned on the outer surface of the body at the distal end, wherein the balloon is configurable between an inflated state and a deflated state, and a second internal channel positioned within the inner lumen.

Description

Attorney Docket No : 206030-0318-00WOBALLOON CATHETER FOR ORGAN PROTECTION DURING THERMAL ABLATIONCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 733,086, filed on December 12, 2024, the contents of which are incorporated by reference herein in is entirety.BACKGROUND

[0002] Currently, thermal ablation of the liver, renal, or any abdominal tumors cannot be safely performed if the tumor is sub-capsular and abuts the gastrointestinal tract, with the main complication injury to bowel resulting in perforation. Hydro-infusion into the free peritoneal cavity (artificial ascites) may be sufficient to separate bowel but it is not completely reliable as free fluid accumulates at low pressure locations, and it fails in many locations where it cannot overcome the pressure between two organs. Further, the large amount of fluid that needs to be infused just to separate two organs at a specific location may cause unwanted side effects such as fluid overload, electrolyte imbalance, and symptomatic pleural effusions. The most common scenario where free peritoneal fluid is utilized is when a sub-capsular left lobe liver tumor requires percutaneous ablative treatment, but it is immediately adjacent to the stomach.

[0003] Using a balloon catheter to separate a bowel loop from the liver has been described and can be effective. However, it is not a commonly practiced technique and instead many eligible tumors are considered not good candidates for thermal ablation. The main issue is that the catheters that were used were designed for other purposes, mostly for angiographic procedures, with balloons that are rounded in axial expansion, and are not very practical for separation of two structures in a planar fashion.

[0004] Thus, there is a need in the art for a catheter of practical length and caliber, with easy maneuverability to facilitate intraperitoneal positioning, and with temperature resistant balloon(s) that expands in a planar, or sheet-like configuration to effectively separate the structures.Attorney Docket No : 206030-0318-00WOSUMMARY

[0005] Aspects of the present disclosure relate to a balloon catheter, comprising an elongate body having a proximal end and a proximal opening, a distal end and a distal opening, the proximal and distal openings defining an inner lumen therebetween, wherein the body defines an inner surface and an outer surface, a first internal channel positioned within the inner lumen and fluidly connected to at least one balloon positioned on the outer surface of the body at the distal end, wherein the balloon is configurable between an inflated state and a deflated state, and a second internal channel positioned within the inner lumen.

[0006] In some embodiments, in the inflated state, the at least one balloon has a bilobal shape. In some embodiments, the body comprises one or more balloon restricting members configured to compress the at least one balloon along one or more axes to form the bilobal shape. In some embodiments, in the inflated state, the at least one balloon has a thickness ranging between 1 cm and 3.5 cm. In some embodiments, in the inflated state, the at least one balloon has a length ranging between 2 cm and 5 cm and a width ranging between 2 cm and 5 cm.

[0007] In some embodiments, the at least one balloon comprises a material selected from the group consisting of: biocompatible materials, flexible materials, substantially flexible materials, heat resistant materials, polymers, polyvinyl chloride (PVC), polyethylene terephthalate (PET), nylon, polypropylene, polyurethane, polyetheretherketone (PEEK), polycarbonate, polyester, high-density polyethylene (HDPE), thermoplastic polyurethane (TPU), pellethane, carbothane, silicone, latex, rubber, and any combination thereof. In some embodiments, the at least one balloon comprises a heat-resistant material. In some embodiments, the elongate body comprises an at least partially flexible material selected from the group consisting of: plastics, stainless steel, titanium, nickel-titanium alloys (e.g. Nitinol), polymers, polyvinyl chloride (PVC), rubber, nylon, polyethylene, polyurethane, polytetrafluoroethylene (PTFE), ePTFE, silicone, polyethylene terephthalate, polyamide, polyether block amide (Pebax), polyether ether ketone (PEEK), or polyvinyl chloride (PVC).Attorney Docket No : 206030-0318-00WO

[0008] In some embodiments, the first internal channel and the second internal channel are discrete channels positioned within the inner lumen of the body. In some embodiments, the first internal channel and the second internal channel are coaxial. In some embodiments, the elongate body further comprises a third internal channel configured to deliver a lubricating fluid to the exterior surface of the balloon. In some embodiments, the elongate body has a diameter of ranging between about 6 to 10 French. In some embodiments, the second internal channel is sized to fit a removable stylet or guidewire. In some embodiments, the balloon catheter further comprises an electrode positioned on the outer surface of the at least one balloon. In some embodiments, the balloon catheter further comprises a temperature sensor positioned on the outer surface of the body or the at least one balloon. In some embodiments, the balloon catheter further comprises one or more radiopaque markers positioned to on the body and proximate to the at least one balloon.

[0009] Aspects of the present disclosure relate to a method of using a balloon catheter, comprising the steps of providing the balloon catheter, advancing a guidewire into the second internal channel of the elongate body, inserting the balloon catheter into the body and using the guidewire to maneuver the balloon catheter to a desired location, and inflating the at least one balloon by delivering a fluid via the first internal channel. In some embodiments, the method further comprises the step of delivering a fluid to the external surface of the at least one balloon to lubricate the external surface and facilitate optimal positioning of the device.

[0010] Aspects of the present disclosure relate to a balloon catheter, comprising an elongate body having a proximal end and a proximal opening, a distal end and a distal opening, the proximal and distal ends defining an inner lumen therebetween, and further comprising one or more internal channels within the inner lumen, a first balloon positioned at a distal portion of the elongate body, a second balloon positioned proximal to the first balloon at the distal portion of the elongate body, and a third balloon positioned proximal to the second balloon at the distal portion of the elongate body, wherein the distal portion of the elongate body is flexible and has a straight configuration and a coiled configuration. In some embodiments, the first, second, and third balloon each have an inflated state and a deflated state. In some embodiments, when the distal potion is in the straight configuration, the first, second, and third balloons are arranged linearly along the distal portion. In some embodiments, when the distal portion is in the coiledAttorney Docket No : 206030-0318-00WO configuration, the first, second, and third balloons, when inflated, are coplanar and form a clover shape.

[0011] Aspects of the present disclosure relate to a method of using a balloon catheter, comprising the steps of providing the balloon catheter, inserting a rigid wire into an internal channel of the elongate body to move the distal portion of the tube into the straight configuration, inserting the balloon catheter into a body cavity between two organs, removing the rigid wire from the internal channel of the elongate body to move the distal portion of the tube to the coiled configuration, and inflating the first, second and third balloons.BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The foregoing purposes and features, as well as other purposes and features, will become apparent with reference to the description and accompanying figures below, which are included to provide an understanding of the invention and constitute a part of the specification, in which like numerals represent like elements, and in which:

[0013] Fig. 1 is a schematic of an exemplary balloon catheter with one balloon.

[0014] Fig. 2 is a schematic of an exemplary balloon catheter with two balloons.

[0015] Fig. 3 is a schematic of an exemplary balloon catheter with three balloons.

[0016] Fig. 4A is a schematic of an exemplary balloon catheter with three balloons in an undeployed state.

[0017] Fig. 4B is a schematic of the exemplary balloon catheter of Fig. 4A in a deployed state.

[0018] Fig. 5 A depicts an exploded view of an exemplary balloon catheter.

[0019] Fig. 5B depicts an exemplary balloon catheter with the components assembled.

[0020] Fig. 5C depicts an exemplary balloon catheter with the components assembled.Attorney Docket No : 206030-0318-00WO

[0021] Fig. 6A depicts a cross-sectional view of an exemplary balloon catheter and a side view of the balloon catheter.

[0022] Fig. 6B depicts a cross-sectional view of an exemplary balloon catheter and a side view of the balloon catheter.

[0023] Fig. 6C depicts a cross-sectional view of an exemplary ballon catheter.

[0024] Fig. 6D depicts a cross-sectional view of an exemplary balloon catheter and a side view of the balloon catheter.

[0025] Fig. 7A depicts a side view of an exemplary balloon catheter.

[0026] Fig. 7B depicts multiple views of an exemplary bilobal balloon.

[0027] Fig. 8A depicts a close-up view of an exemplary balloon.

[0028] Fig. 8B depicts close-up views of exemplary balloons.

[0029] Fig. 9 depicts a close-up view of the proximal end of an exemplary balloon.

[0030] Fig. 10A depicts an exemplary prototype of the balloon catheter.

[0031] Fig. 10B depicts the balloon catheter being used during an ablation procedure.DETAILED DESCRIPTION

[0032] The following discussion omits or only briefly describes conventional features of balloon catheters that are apparent to those skilled in the art. Those of ordinary skill in the pertinent arts may thus recognize that other elements may be desirable and / or necessary to implement the devices, systems, and / or methods described herein. It is noted that various examples are described in detail with reference to the drawings. Reference to these various examples does not limit the scope of the claims attached hereto. Additionally, any examples set forth in this specification are intended to be non-limiting and merely set forth some of the many possible implementations for the appended claims. Further, particular features described herein can beAttorney Docket No : 206030-0318-00WO used in combination with other described features in each of the various possible combinations and permutations. As such, it is understood that this detailed description is exemplary and explanatory only and is not restrictive of the broad inventive concepts upon which the examples disclosed herein are based.

[0033] Unless otherwise specifically defined herein, all terms are to be given their broadest reasonable interpretation. This includes meanings implied from the specification as well as meanings understood by those skilled in the art and / or as defined in dictionaries, treatises, etc.

[0034] It is noted that, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless otherwise specified. The term “includes” and / or “including,” when used in this specification, specify the presence of stated features, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof.

[0035] Relative terms such as “horizontal,” “vertical,” “up,” “down,” “top,” and “bottom” as well as derivatives thereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should be construed to refer to the orientation as then-described or as shown in the drawing figure under discussion. These relative terms are for convenience of description and normally are not intended to require a particular orientation in actuality. Terms including “inwardly” versus “outwardly,” “longitudinal” versus “lateral,” and the like are to be interpreted relative to one another or relative to an axis of elongation, or an axis or center of rotation, as appropriate. Terms concerning attachments, coupling and the like, such as “connected” and “interconnected,” refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise. The phrases “operatively” or “operably connected” indicates such an attachment, coupling, or connection that allows the pertinent structures to operate as intended by virtue of that relationship.

[0036] Reference throughout the specification to “one embodiment,” “an embodiment,” or “some embodiments” means that a particular feature, structure, or characteristic described in connection with at least one embodiment of the subject matter is included in at least one embodiment of the subject matter disclosed. Thus, the appearance of the phrases “in oneAttorney Docket No : 206030-0318-00WO embodiment,” “in an embodiment,” or “in some embodiments” in various places throughout the specification is not necessarily referring to the same embodiment. Further, the particular features, structures, or characteristics of “one embodiment,” “an embodiment,” or “some embodiments” may be combined in any suitable manner with each other to form additional embodiments of such combinations. It is intended that embodiments of the disclosed subject matter cover modifications and variations thereof. Terms such as “first,” “second,” “third,” etc., merely identify one of a number of portions, components, steps, operations, functions, and / or points of reference as disclosed herein, and likewise to not necessarily limit embodiments of the present disclosure to any particular configuration or orientation.

[0037] Moreover, throughout this disclosure, various aspects can be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the disclosure. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as individual numbers within that range, for example, 1, 2, 2.7, 3, 4, 5, 5.3, 6, and any whole and partial increments therebetween. This applies regardless of the breadth of the range. As used herein, the term “about” in reference to a measurable value, such as an amount, a temporal duration, and the like, is meant to encompass the specified value and / or variations of plus or minus 20%, plus or minus 10%, plus or minus 5%, plus or minus 1%, and plus or minus 0.1% of the specified value, as such variations are appropriate and fit within the confines of a functional system.

[0038] The terms “proximal,” “distal,” “anterior,” “posterior,” “medial,” “lateral,” “superior,” and “inferior” are defined by their standard usage indicating a directional term of reference. For example, “proximal” refers to a position that is situated nearer to the center of a body or point of attachment or interest. In another example, “anterior” refers to the front of a body or structure, while “posterior” refers to the rear of a body or structure, in relation to a relative viewpoint. In another example, “medial” refers to the direction towards the midline of a body or structure, and “lateral” refers to the direction away from the midline of a body or structure. In some examples,Attorney Docket No : 206030-0318-00WO“lateral” or “laterally” may refer to any sideways direction. In another example, “superior” refers to the top of a body or structure, while “inferior” refers to the bottom of a body or structure. It should be understood, however, that the directional term of reference may be interpreted within the context of a specific body or structure, such that a directional term referring to a location in the context of the reference body or structure may remain consistent as the orientation of the body or structure changes.

[0039] The terms “patient,” “subject,” “individual,” and the like are used interchangeably herein and refer to any human, animal, or other living organism amenable to the systems, devices, and methods described herein.

[0040] Described herein a balloon catheter device for organ protection during thermal ablation. The device is capable of separating organ structures within the body such that thermal ablation performed on a target organ does not affect or damage an adjacent healthy organ. The device is further capable of resisting high temperatures during the ablation process and can maintain its rigidity to continually separate organs during the procedure. The device is generally configured to be positioned at the ablation site for optimal organ separation where necessary. The device generally comprises an elongate tube having a proximal end and a proximal opening, a distal end and a distal opening, wherein the proximal and distal openings define an inner lumen extending therebetween, and comprising one or more internal channels therethrough, and one or more balloons disposed on the distal end of the elongate tube. In some embodiments, the distal end of the elongate tube is configured to be inserted percutaneously within a body cavity of a subject. In some embodiments, the proximal end of the tube may remain external to the subject.

[0041] In some embodiments and referring to Fig. 1, the device 100 comprises an elongate tube 102 having a distal end 101 and a proximal end 103, one or more internal channels therethrough, and a balloon 104 disposed on the distal end of the tube 102. In some embodiments, the balloon has an expanded and a non-expanded state or a deployed and an undeployed state. In some embodiments, balloon 104 has a generally elongated shape when inflated. In some embodiments, the elongate tube 102 comprises at least a first internal channel and a second internal channel. In some embodiments, the first internal channel is fluidly connected to the balloon 104 and is configured for inflation / deflation of the balloon 104. In some embodiments, the second internalAttorney Docket No : 206030-0318-00WO channel is configured for the insertion of guidewires or stylets within the elongate tube 102 for precise control and maneuverability of the device 100.

[0042] In some embodiments, and referring now to Fig. 2, the device 100 comprises an elongate tube 102 having a distal end 101 and a proximal end 103, one or more internal channels extending through an inner lumen of the elongate body 102, a first balloon 204 and a second balloon 206 disposed on opposing sides of the distal end of the tube 102. In some embodiments, the first and second balloons 204 and 206 have a generally elongated configuration when inflated, each extending outward radially from opposing sides of the distal end of elongate tube 102. In some embodiments, the first and second balloons 204 and 206 form a planar or sheet-like configuration when inflated for effective force distribution across the balloons. In some embodiments, the balloons 204, 206 when inflated have a total width ranging between about 2 - 4 cm, and a thickness ranging between about 1 - 2 cm. In some embodiments, the balloons 204, 206 may have any desired shape, for example but not limited to, spherical, rounded, cuboidal, conical, cylindrical, frustoconical, polygonal, or any combination thereof. In some embodiments, the one or more internal channels of the elongate tube 102 may be configured for inflation / deflation of the balloons, for fluid delivery, or for insertion of guidewires or stylets.

[0043] In some embodiments, and referring now to Fig. 3, the device 100 comprises an elongate tube 102 having a distal end 101, a proximal end 103 and one or more internal channels therethrough, a first balloon 304, a second balloon 306, and a third balloon 308. In some embodiments, the first balloon 304, second balloon 306, and third balloon 308 are positioned at the distal end of the elongate tube 102. In some embodiments, balloon 304 is positioned at the distal tip of the elongate tube 102. In some embodiments, balloons 306 and 308 are positioned at opposing sides of the distal end of the elongate tube, and adjacent balloon 304 such that the balloons 304, 306, and 308 form a clover shape and have a planar configuration (as depicted in Fig. 3, balloons 304, 306, and 308 are positioned on the same vertical plane). The planar configuration of the balloons 304, 306, and 308 allows effective separation of the organs by effectively distributing forces throughout the surfaces of each balloon. In some embodiments, the balloons 304, 306, and 308 (when inflated) have a total width ranging between about 2 - 4 cm, and each have a thickness or diameter ranging between about 1 - 2 cm. In some embodiments, the balloons 304, 306, and 308 may have any desired shape, for example but not limited to,Attorney Docket No : 206030-0318-00WO spherical, rounded, cuboidal, conical, cylindrical, frustoconical, polygonal, or any combination thereof. In some embodiments, the one or more internal channels of the elongate tube may be configured for inflation / deflation of the balloons, for fluid delivery, or for insertion of guidewires or stylets.

[0044] In some embodiments, and referring now to Fig. 4, the device 100 comprises an elongate tube 102 having a distal end 101 and a proximal end 103, and one or more internal channels therethrough, a first balloon 404 positioned at a distal portion 410 of the elongate tube, a second balloon 406 positioned proximal to the first balloon 404 at the distal portion 410, and a third balloon 408 positioned proximal to the second ballon 406 at the distal portion 410. In some embodiments, the distal portion 410 is flexible and has a straight configuration, and a coiled configuration (for example the distal portion 410 may comprise a pigtail). In some embodiments, the distal portion 410 may be moved to the straight configuration via the insertion of a rigid wire through at least one internal channel of elongate tube 102. In such a configuration, the balloons 404, 406, and 408 are arranged linearly at the distal portion 410 of the distal end of tube 102. In some embodiments, the distal portion 410 of the elongate tube may be returned to the coiled configuration via removing the rigid wire from the elongate tube 102. In the coiled configuration, the balloons 404, 406, and 408 (when inflated) form a clover shape wherein the first, second, and third balloons have a planar configuration. In some embodiments, the balloons 404, 406, and 408 (when inflated) have a total width ranging between about 2 - 4 cm, and each balloon has a thickness or diameter ranging between about 1 - 2 cm. In some embodiments, the balloons 404, 406, and 408 may have any desired shape, for example but not limited to, spherical, rounded, cuboidal, conical, cylindrical, frustoconical, polygonal, or any combination thereof. In some embodiments, the one or more internal channels of the elongate tube 102 may be configured for inflation / deflation of the balloons, for fluid delivery, or for insertion of guidewires or stylets.

[0045] In some embodiments, the elongate tube 102 further comprises openings in the walls of the elongate tube fluidly connected to at least one internal channel of the elongate tube 102 and configured for fluid delivery to the organ separation site. In some embodiments, the fluid may be an irrigation fluid configured to facilitate the organ separation process or to increase maneuverability of the device 100 within the body cavity of the subject.Attorney Docket No : 206030-0318-00WO

[0046] Aspects of the present invention relate to materials for the elongate tube 102. Example materials considered suitable to form tube 102 may include, but are not limited to biocompatible materials, flexible materials, metals such as stainless steel, titanium, nickel-titanium alloys (e.g. Nitinol), polymers, polyvinyl chloride (PVC), rubber, nylon, polyethylene, polyurethane, polytetrafluoroethylene (PTFE), ePTFE, silicone, rubber, coiled materials, or any other material known to one of skill in the art. It should be appreciated that the elongate tube 102 must be at least partially flexible to ensure maneuverability of the device 100 within the body cavity such that an optimal placement is achieved at the organ separation site. In some embodiments, the elongate tube 102 may have straight portions and coiled portions. In some embodiments, the elongate tube 102 may have a size ranging between 6 - 10 French. In some embodiments, the elongate tube 102 may have a length ranging between 15 cm and 40 cm. In some embodiments, the elongate tube 102 may have a closed distal tip.

[0047] Aspects of the present invention relate to materials for the one or more balloons. Example materials considered to form the one or more balloons include, but are not limited to biocompatible materials, flexible materials, substantially flexible materials, heat resistant materials, polymers, polyvinyl chloride (PVC), polyethylene terephthalate (PET), nylon, polypropylene, polyurethane, polyetheretherketone (PEEK), polycarbonate, polyester, high- density polyethylene (HDPE), thermoplastic elastomer (TPE), silicone, latex, rubber, or any combinations thereof. It should be appreciated that the one or more balloons must have substantial rigidity to withstand the forces exerted between two organs. In some embodiments, the one or more balloons may comprise flexible portions and rigid portions. In some embodiments, the one or more balloons further comprise a coating applied to the outer surface of the one or more balloons. In some embodiments, the coating may be a hydrophilic coating. In some embodiments, each balloon can be described as having at least a first and second configuration, at least an inflated and deflated configuration, or at least a deployed and nondeployed state. It should be appreciated that the one or more balloons must each be at least partially deflated when the device 100 is inserted into or removed from the subject to prevent organ damage. In some embodiments any disclosed balloon may comprise a substantially inelastic, non-distensible or rigid material and one or more pleats and / or folds such that when balloon is configured to the first or deflated configuration the balloon lays flat against tube 102.Attorney Docket No : 206030-0318-00WO

[0048] Aspects of the present invention relate to the attachment of the one or more balloons to the tube 102. In some embodiments, the one or more balloons may be attached to the tube 102 via any suitable method known to one of skill in the art. For example, in some embodiments, the one or more balloons may be attached to the tube 102 via a compression fit, adhesives, a tab and groove, a retaining portion or flange on the tube 102, heat bonding, laser welding, and the like.

[0049] Aspects of the present invention relate to a method of using the balloon catheter 100, comprising the steps of: providing the balloon catheter device described above, inserting a rigid wire into at least one internal channel of the elongate tube to move the distal portion of the tube into the straight configuration, inserting the device into a body cavity between two organs, removing the rigid wire from the at least one internal channel of the elongate tube to move the distal portion of the tube to the coiled configuration, and inflating the first, second and third balloons. In some embodiments, the method further comprises the step of delivering a fluid to the external surface of the tube to lubricate the external surface of the device and facilitate optimal positioning of the device.

[0050] Referring now to Fig. 5A, shown is an exploded view of an exemplary balloon catheter 500. In some embodiments, the balloon catheter device 500 comprises an elongate body 502 having a distal end 504 and a distal end opening, a proximal end 506 and a proximal end opening, the distal and proximal openings defining an inner lumen therebetween. In some embodiments, the body 502 comprises at least a first internal channel 508 and a second internal channel 510, each channel positioned within the inner lumen of the body 502 and extending at least partially along its length. The device 500 further comprises a balloon 512 positioned at the distal end 504 and in fluid communication with the first internal channel 508, and configurable between an inflated and a deflated configuration. Figs. 5B and 5C show perspective views of embodiments of the balloon catheter 500 with all components assembled.

[0051] In some examples, the body 502 is a generally elongate and tubular member. The body 502 may be at least partially flexible. In some embodiments, the body 502 may comprise any biocompatible material known to one of skill in the art. For example, the body 502 may be formed from materials including, but not limited to, biocompatible materials, flexible materials, plastics, stainless steel, titanium, nickel -titanium alloys (e.g. Nitinol), polymers, polyvinylAttorney Docket No : 206030-0318-00WO chloride (PVC), rubber, nylon, polyethylene, polyurethane, polytetrafluoroethylene (PTFE), ePTFE, silicone, polyethylene terephthalate, polyamide, polyether block amide (Pebax), polyether ether ketone (PEEK), or polyvinyl chloride (PVC), or any other material known to one of skill in the art. In some embodiments, the body 502 may have a length ranging between 15 cm and 40 cm. In some embodiments, the body 502 may have an outer diameter ranging between 6- 10 French.

[0052] In some embodiments, the first internal channel 508 is configured as an inflation lumen, fluidly connecting the balloon 512 and a fluid source or reservoir. The fluid may be any liquid, gas, gel, or solution suitable for the inflation of the balloon 512. For example, sterile water or saline solutions may be used. The first internal channel 508 may have a diameter ranging between 0.5 mm and 2 mm. In some embodiments, the second internal channel 510 is configured as a guidewire lumen and sized to fit a removable stylet 511 or guidewire for the manipulation of the balloon catheter 500 within the body. For example, the second internal channel 510 may be sized to fit guidewires having diameters ranging between 0.5 mm and 1 mm. The second internal channel 510 may have an inner diameter ranging between 0.5 mm and 1.5 mm.

[0053] In some examples, and referring now to Fig. 6A, the first and second internal channels 508 and 510 may be discrete channels disposed within the inner lumen of body 502. In some embodiments, the first internal channel 508 may have a diameter larger than the inner diameter of the second internal channel 510. In some examples, the first internal channel 508 may have an inner diameter smaller than the inner diameter of the second internal channel 510. In some embodiments, the first internal channel 508 and the second internal channel 510 may have equal diameters. In some embodiments, the first internal channel 508 may have one or more openings fluidly connecting the first internal channel 508 to the interior of balloon 512. In some embodiments, the second internal channel 510 may have a closed distal end.

[0054] In some examples, and referring to Figs. 6B and 6C, the first and second internal channels may be disposed coaxially, wherein the second internal channel 510 is positioned within the first internal channel 508. A gap is defined between the outer surface of the second internal channel 510 and the inner surface of the first internal channel 508, wherein the gap is fluidly connected to the balloon 512. The second internal channel 510 may have a closed distalAttorney Docket No : 206030-0318-00WO end to securely hold a stylet or guidewire. In some embodiments, the body 502 may further comprise a third internal channel 516 disposed coaxially with the first and second internal channels 508 and 510. The third internal channel 516 may be the outermost channel in the coaxial configuration.

[0055] In some examples, and referring to Fig. 6D, the body 502 may comprise any number of discrete internal channels within the inner lumen. For example, the body 502 may comprise a third internal channel 516. In some embodiments, a fourth, or fifth internal channel may be configured for the insertion of medical instruments, including but not limited to, ablation catheters, injection needles, stylets, guidewires, or any other medical instrument as would be known by one of skill in the art. For example, a third internal channel may be configured as lubrication lumen, having one or more openings and configured to deliver a lubrication fluid to the exterior surface of the balloon 512.

[0056] In some embodiments and referring back to Fig. 5A, the proximal end 506 of the body 502 may further comprise connectors 518 fluidly connected to the first internal channel 508 and / or the second internal channel 510. The connectors 518 may comprise any fittings known to one of skill in the art to fluidly connect the first internal channel 508 to a fluid source and to facilitate the insertion of a guidewire into the second internal channel 510. For example, the connectors 518 may include Luer lock connectors, Luer slip connectors, Y-connectors, duallumen catheter hubs, coaxial hubs, valves, Tuohy Borst valves, and the like. In some embodiments, the proximal end 506 may further comprise a Y-connector 519, fluidly connected to the inner lumen of the body 502 or the first internal channel 508 and having a side port that may be used as a flush port. In some embodiments, the proximal end 506 may further comprise a handle, configured for secure ergonomic gripping and maneuvering of the balloon catheter 500.

[0057] In some examples, and referring now to Fig. 7A, the balloon 512 is positioned along a distal portion of the body 502 and fluidly connected to the first internal channel 508. In some embodiments, the balloon 512 is configurable between an inflated configuration and a deflated configuration. In the deflated configuration the balloon 512 may lie substantially flat against the exterior surface of the body 512 or may be disposed within the inner lumen of body 502. In the inflated configuration the balloon 512 extends outwards from the outer surface of the body 502.Attorney Docket No : 206030-0318-00WOIn some embodiments, and in the inflated state, the balloon 512 may have a length ranging between 2 cm and 5 cm. In some embodiments, and in the inflated state, the balloon 512 may have a width or diameter ranging between 2 cm and 5 cm. In some embodiments, the balloon 512 may have a thickness of at least 1 cm, at least 1.5 cm, at least 2 cm, or at least 2.5 cm. That is, once inflated, the balloon may provide a separation distance of at least 1 cm between anatomical structures in the body. In some embodiments, the balloon 512 may have a generally elongated shape, for example but not limited to, spherical, rounded, cuboidal, conical, oblong, cylindrical, frustoconical, polygonal, or any combinations thereof.

[0058] Referring now to Fig. 7B, the balloon 512 may have a bilobal geometry in the inflated state. That is, the balloon 512 may remain compressed along a midline axis 513, as depicted in Fig. 6B, and expand into two substantially equal and diametrically opposing lobes 514a and 514b when inflated. The bilobal shape may be achieved via balloon restricting members positioned on the distal end of the body 502. The balloon restricting members are configured to compress the balloon 512 along one or more axes to achieve non-uniform expansion of the balloon 512. For example, the distal portion of the body 502 may comprise longitudinal openings, with the balloon 512 positioned within the inner lumen of the body 502 such that the balloon 512 expands via the openings into the bilobal shape when inflated. Figs. 8A and 8B depict exemplary configurations of the balloon 512.

[0059] In some embodiments, the balloon 512 may be configured to inflate in any custom shape suitable for a particular application. For example, the balloon 512 may be configured to inflate into a dog-bone shape, a trilobal shape, a flower shape, a star shape, a multi-chambered shape, and the like. In some embodiments, the balloon restricting members may be any other structure or feature configured to configured to produce any suitable balloon shape. In other embodiments, the balloon 512 may comprise one or more regions having different thicknesses or elasticities to create different expansion profiles. In some embodiments, a plurality of balloons may be used, each balloon being independently inflatable, thereby forming an expandible regions or pockets that expand independently to create customizable balloon profiles. In some embodiments, the plurality of balloons may be positioned concentrically around the cross-section of the body 502. In some embodiments, the plurality of balloons may be positioned along the length of the bodyAttomey Docket No : 206030-0318-00WO502. In some embodiments, the plurality of balloons may be positioned in a pattern along the body 502, for example in a linear pattern, a staggered pattern, or a spiral pattern.

[0060] In some embodiments, the balloon 512 is configured to withstand temperatures ranging between 80°C and 150°C, or at least 80°C, at least 90°C, at least 100°C, at least 110°C, at least 120°C, at least 130°C, at least 140°C, or at least 150°C. In some embodiments, the balloon 512 is configured to withstand high temperatures for a period of time ranging between 5 minutes and 15 minutes, or at least 5 minutes, at least 6 minutes, at least 7 minutes, at least 8 minutes, at least 9 minutes, at least 10 minutes, at least 11 minutes, at least 12 minutes, at least 13 minutes, at least 14 minutes, or at least 15 minutes. In some embodiments, the balloon 512 is configured to withstand an applied force and distribute forces throughout the surface of the balloon.

[0061] Referring now to Fig. 9, the body 502 comprises a third internal channel 516 configured to deliver an irrigation fluid or lubricant to the exterior surface of the balloon 512. In some embodiments, the third internal channel may be a third discrete channel within the inner lumen of the body 502. In some embodiments, the third internal channel 516 may be an outermost coaxial channel within the body 502. In some embodiments, the third internal channel may comprise a plurality of openings 515 configured to fluidly connect the third internal channel 516 to the exterior surface of the balloon. In some embodiments, the openings 515 may be positioned at least at the distal and proximal ends of the balloon 512. In some embodiments, an irrigation or lubrication fluid may be delivered to the exterior surface of the balloon 512 via the plurality of openings 515. In some embodiments, the lubrication fluid may comprise sterile water, a saline solution, or a dextrose solution. In some embodiments, the lubrication fluid is configured to decrease frictional forces on the exterior surface of the balloon. In other embodiments, the exterior surface of the balloon 512 or the body 502 may comprise a coating, which may be a hydrophilic or a heat-resistant coating. Exemplary coatings may include, but are not limited to, hydrogels, silicone elastomers, polytetrafluoroethylene (PTFE), or poly imide (PI).

[0062] In some embodiments, the balloon 512 may comprise any flexible, biocompatible, and heat-resistant material known to one of skill in the art. Exemplary materials may include, but are not limited to, polymers, polyvinyl chloride (PVC), polyethylene terephthalate (PET), nylon, polypropylene, polyurethane, polyetheretherketone (PEEK), polycarbonate, polyester, high-Attorney Docket No : 206030-0318-00WO density polyethylene (HDPE), thermoplastic polyurethane (TPU), pellethane, carbothane, silicone, latex, rubber, or any combinations thereof. In some embodiments, the balloon 512 may be configured to inflate to a maximum volume.

[0063] In some embodiments, the balloon 512 may be attached to the body 502 via any suitable method known to one of skill in the art to form a fluid-tight seal between the balloon interior and the first internal channel 508. For example, in some embodiments, the balloon 512 may be attached to the body 502 via adhesives, UV-curable adhesives, epoxy or polyurethane-based adhesives, cyanoacrylate adhesives, thermal bonding, laser bonding, chemical bonding, mechanical securing elements such as polymeric collars, bands and retention sleeves, and the like.

[0064] In some embodiments, the outer surface of the balloon 512 may further comprise a conducting element, configured to return the RF current from the body or tissue. In some embodiments, the conducting element may be an electrodes, conductive inks, metallic films, conductive meshes, and the like. In some embodiments, the conducting element may be positioned on the outer surface of the balloon 512, embedded within the balloon wall layer, or disposed on an inner surface of the balloon 512. In some embodiments, one or more conducting elements may be used, disposed in one or more regions of the balloon 512, for example in rings, bands, or circumferential arrays. The conducting element may allow for focused bipolar energy delivery around tumors thereby improving precision and reducing collateral damage.

[0065] In some embodiments, the ballon catheter 500 further comprises a temperature sensor configured to track real-time temperatures of organs or tissue during the ablation procedure. The temperature sensor may be disposed on the outer surface of the balloon 512, on the outer surface of the body 502, or embedded in the body 502. Exemplary temperature sensors may include but are not limited to thermistors, resistance temperature detectors (RTDs), thermocouples, fiberoptic temperature sensors, or thin-film sensors. Continuous temperature-tracking allows for realtime temperature feedback during ablation, control and regulation of energy delivery, safety mechanism such as automatic shut-off thresholds, and monitoring of therapeutic effect.

[0066] In some embodiments, the balloon catheter 500 further comprises radiopaque markers positioned on the body 502 and in proximity to the balloon 512. In some embodiments, theAttorney Docket No : 206030-0318-00WO radiopaque markers may be positioned distal and proximate to the balloon 512 to delineate the balloon’s working length. In some embodiments, the radiopaque markers may comprise Barium Sulfate (BaSCh), metallic coatings including tungsten, platinum, platinum-iridium, or gold coatings, or any other radiopaque material known to one of skill in the art.

[0067] Aspects of the present invention relate to a method of using the balloon catheter 500, comprising the steps of: providing the balloon catheter 500, advancing a guidewire into the second internal channel of the elongate body, inserting the balloon catheter into the body and using the guidewire to maneuver the balloon catheter to a desired location, and inflating the balloon by delivering a fluid via the first internal channel. In some embodiments, the method further comprises the step of delivering a fluid to the external surface of the balloon to lubricate the external surface and facilitate optimal positioning of the device.

[0068] The disclosures of each and every patent, patent application, and publication cited herein are hereby incorporated herein by reference in their entirety. While this invention has been disclosed with reference to specific embodiments, it is apparent that other embodiments and variations of this invention may be devised by others skilled in the art without departing from the true spirit and scope of the invention. The appended claims are intended to be construed to include all such embodiments and equivalent variations.

Claims

Attorney Docket No : 206030-0318-OOWOCLAIMSWhat is claimed is:

1. A balloon catheter, comprising: an elongate body having a proximal end and a proximal opening, a distal end and a distal opening, the proximal and distal openings defining an inner lumen therebetween, wherein the body defines an inner surface and an outer surface; a first internal channel positioned within the inner lumen and fluidly connected to at least one balloon positioned on the outer surface of the body at the distal end; wherein the balloon is configurable between an inflated state and a deflated state; and a second internal channel positioned within the inner lumen.

2. The balloon catheter of claim 1, wherein in the inflated state, the at least one balloon has a bilobal shape.

3. The balloon catheter of claim 2, wherein the body comprises one or more balloon restricting members configured to compress the at least one balloon along one or more axes to form the bilobal shape.

4. The balloon catheter of claim 1, wherein in the inflated state, the at least one balloon has a thickness ranging between 1 cm and 3.5 cm.

5. The balloon catheter of claim 1, wherein in the inflated state, the at least one balloon has a length ranging between 2 cm and 5 cm and a width ranging between 2 cm and 5 cm.

6. The balloon catheter of claim 1, wherein the at least one balloon comprises a material selected from the group consisting of: biocompatible materials, flexible materials, substantially flexible materials, heat resistant materials, polymers, polyvinyl chloride (PVC), polyethylene terephthalate (PET), nylon, polypropylene, polyurethane,Attorney Docket No : 206030-0318-00WO polyetheretherketone (PEEK), polycarbonate, polyester, high-density polyethylene (HDPE), thermoplastic polyurethane (TPU), pellethane, carbothane, silicone, latex, rubber, or combinations thereof.

7. The ballon catheter of claim 1, wherein the at least one balloon comprises a heat-resistant material.

8. The balloon catheter of claim 1, wherein the elongate body comprises an at least partially flexible material selected from the group consisting of: plastics, stainless steel, titanium, nickel -titanium alloys (e.g. Nitinol), polymers, polyvinyl chloride (PVC), rubber, nylon, polyethylene, polyurethane, polytetrafluoroethylene (PTFE), ePTFE, silicone, polyethylene terephthalate, polyamide, polyether block amide (Pebax), polyether ether ketone (PEEK), or polyvinyl chloride (PVC), or combinations thereof.

9. The balloon catheter of claim 1, wherein the first internal channel and the second internal channel are discrete channels positioned within the inner lumen of the body.

10. The balloon catheter of claim 1, wherein the first internal channel and the second internal channel are coaxial.

11. The balloon catheter of claim 1, wherein the elongate body further comprises a third internal channel configured to deliver a lubricating fluid to the exterior surface of the balloon.

12. The balloon catheter of claim 1, wherein the elongate body has a diameter of ranging between about 6 to 10 French.

13. The balloon catheter of claim 1, wherein the second internal channel is sized to fit a removable stylet or guidewire.

14. The balloon catheter of claim 1, further comprising an electrode positioned on the outer surface of the at least one balloon.Attorney Docket No : 206030-0318-00WO15. The balloon catheter of claim 1 , further comprising a temperature sensor positioned on the outer surface of the body or the at least one balloon.

16. The balloon catheter of claim 1, further comprising one or more radiopaque markers positioned to on the body and proximate to the at least one balloon.

17. A method of using a balloon catheter, comprising the steps of: providing the balloon catheter of claim 1; advancing a guidewire into the second internal channel of the elongate body; inserting the balloon catheter into the body and using the guidewire to maneuver the balloon catheter to a desired location; and inflating the at least one balloon by delivering a fluid via the first internal channel.

18. The method of claim 18, further comprising the step of: delivering a fluid to the external surface of the at least one balloon to lubricate the external surface and facilitate optimal positioning of the device.

19. A balloon catheter, comprising: an elongate body having a proximal end and a proximal opening, a distal end and a distal opening, the proximal and distal ends defining an inner lumen therebetween, and further comprising one or more internal channels within the inner lumen; a first balloon positioned at a distal portion of the elongate body; a second balloon positioned proximal to the first balloon at the distal portion of the elongate body; and a third balloon positioned proximal to the second balloon at the distal portion of the elongate body; wherein the distal portion of the elongate body is flexible and has a straight configuration and a coiled configuration.

20. The balloon catheter of claim 20, wherein the first, second, and third balloon each have an inflated state and a deflated state.Attorney Docket No : 206030-0318-00WO21. The balloon catheter of claim 20, wherein when the distal potion is in the straight configuration, the first, second, and third balloons are arranged linearly along the distal portion.

22. The balloon catheter of claim 20, wherein when the distal portion is in the coiled configuration, the first, second, and third balloons, when inflated, are coplanar and form a clover shape.

23. A method of using a balloon catheter, comprising the steps of: providing the balloon catheter of claim 20; inserting a rigid wire into an internal channel of the elongate body to move the distal portion of the tube into the straight configuration; inserting the balloon catheter into a body cavity between two organs; removing the rigid wire from the internal channel of the elongate body to move the distal portion of the tube to the coiled configuration; and inflating the first, second and third balloons.

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