Reinforcement for an infusion electrophysiology balloon catheter with a flexible circuit electrode

Abstract

"Reinforcement for an Infused Electrophysiology Balloon Catheter with Flexible Circuit Electrodes". The present invention provides a balloon of a balloon catheter that must be able to withstand fatigue caused to its components by multiple cycles of repetitive motion, such as deploying from the lumen of the catheter, inflating the balloon, collapsing the balloon, and withdrawing the balloon back into the lumen. The catheter balloon may include a plurality of electrode substrates, each electrode substrate including a plurality of tails. A reinforcement member may be disposed over at least some of the plurality of tails and attached to the membrane, and the reinforcement member may be part of another balloon. If tails are provided on the proximal and distal ends of the balloon, two reinforcement mechanisms may be used.

Description

Technical Field

[0001] The subject matter disclosed herein relates to electrophysiological catheters, and more particularly to those electrophysiological catheters capable of ablating cardiac tissue via electrodes disposed on the surface of a balloon. Background Art

[0002] Ablating cardiac tissue has been used to treat arrhythmias. Ablation energy is typically provided to cardiac tissue by a distal portion that can deliver ablation energy along the tissue to be ablated. Some of these catheters apply ablation energy through various electrodes disposed in or incorporated into a three-dimensional structure (e.g., a wire cage and a balloon). Summary of the Invention

[0003] The balloon of a balloon catheter must be able to withstand the fatigue caused to its components by multiple cycles of repeated movement, such as deploying from the lumen of the catheter, inflating the balloon, deflating the balloon, and withdrawing the balloon back into the lumen. Such a catheter balloon may include a membrane that includes a proximal end and a distal end. A plurality of bases may be disposed around the membrane, each base including a plurality of tails. A reinforcement may be disposed over at least some of the plurality of tails and attached to the membrane. The reinforcement may include a part of the unassembled catheter balloon. Alternatively or additionally, the reinforcement may have a flared shape. In any of the embodiments, the membrane may comprise polyethylene terephthalate, polyurethane, Pellethane, or PEBAX.

[0004] Additionally, in any of the embodiments, the plurality of tails may include a plurality of proximal tails and a plurality of distal tails. The plurality of proximal tails may be disposed adjacent the proximal end of the balloon, and the plurality of distal tails may be disposed adjacent the distal end of the balloon. The reinforcement may be disposed over the plurality of proximal tails or over the plurality of distal tails. First and second reinforcements may be provided such that the first reinforcement may be disposed over the plurality of distal tails and the second reinforcement may be disposed over the plurality of proximal tails. In the case of using two reinforcements, they may be symmetric with each other.

[0005] In any of the foregoing embodiments, the membrane may further include perfusion holes disposed therein. Additionally, the membrane may further include a plurality of ablation electrodes. These electrodes may be disposed on the bases. Further, filaments may be disposed between the membrane and at least one of the plurality of tails. The filaments may comprise a liquid crystal polymer, such as Vectran.

[0006] The balloon may be coupled or attached to the distal end of the catheter. The catheter may include a shaft having a first shaft portion and a second shaft portion at least partially disposed within the first shaft portion. One or more rings may be disposed around at least a portion of the first reinforcement, the second reinforcement (if present), or both to assist in attaching the balloon to the catheter. Additionally, the catheter shaft may have a telescoping function such that the second shaft portion may be disposed within the first shaft portion.

[0007] The catheter can be used according to various methods and variations. For example, after receiving the catheter, a balloon can be deployed from the lumen of the catheter. The balloon can then be inflated, deflated, and withdrawn back into the lumen. These steps of deployment, inflation, deflation, and withdrawal can be repeated five to twenty times. Additionally, ablation electrodes can be activated. Generally, the ablation electrodes can be activated after each inflation step and before each deflation step. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Although the claims that particularly point out and clearly claim the subject matter described herein are provided after the specification, it is believed that the subject matter can be better understood from the following description of certain examples in conjunction with the drawings, in which like reference numerals represent like elements, and in the drawings:

[0009] Figure 1 is a schematic diagram of an invasive medical procedure;

[0010] Figure 2 is a top view of a catheter with a balloon in an inflated state for use with a snare catheter;

[0011] Figure 3 is Figure 2 a perspective view of the distal end of the catheter of

[0012] Figure 4 is Figure 3 a perspective detail view of a flexible circuit electrode assembly on the balloon of

[0013] Figure 5 is Figure 3 a perspective view of the reinforcing member of

[0014] Figure 6 is a side view of an unassembled balloon component; and

[0015] Figure 7 is Figure 3 a detail view of the distal end of the catheter of DETAILED DESCRIPTION

[0016] The following detailed description should be read in conjunction with the drawings, in which the same reference numerals are used for like elements in different drawings. The drawings (not necessarily to scale) illustrate selected embodiments and are not intended to limit the scope of the invention. The detailed description shows, by way of example and not limitation, the principles of the invention. This description will clearly enable those skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives, and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.

[0017] As used herein, the term "about" or "approximately" in reference to any numerical value or range indicates a suitable dimensional tolerance that allows a set of components or elements to achieve its intended purpose as described herein. More specifically, "about" or "approximately" can refer to a range of values of ±10% of the recited value, e.g., "about 90%" can refer to a range of values from 81% to 99%. Additionally, as used herein, the terms "patient", "host", "user", and "subject" refer to any human or animal subject, and are not intended to limit the system or method to human use, although use of the subject invention in human patients represents a preferred embodiment.

[0018] Overview

[0019] The use of cardiac tissue ablation to correct cardiac dysfunctions is a well-known procedure. Generally, for successful ablation, it is necessary to measure cardiac electrode potentials at various locations in the myocardium. Additionally, temperature measurements during ablation provide data that enables the efficacy of ablation to be measured. Generally, for an ablation procedure, electrode potentials and temperatures are measured before, during, and after the actual ablation.

[0020] An ablation catheter may include a lumen, and a balloon may be deployed through the catheter lumen. A multi-layer flexible metal structure is attached to the outer wall or membrane of the balloon. The structure includes a plurality of electrode groups circumferentially arranged around a longitudinal axis, where each electrode group includes a plurality of ablation electrodes typically arranged longitudinally.

[0021] Each electrode group may further include at least one microelectrode that is physically and electrically insulated from the ablation electrodes in the group.

[0022] Each electrode group may further include at least one thermocouple.

[0023] In some embodiments, each electrode group has a microelectrode and a thermocouple formed at the same location.

[0024] Using a single catheter with the three functions of performing ablation, electrode potential measurement, and temperature measurement simplifies the cardiac ablation procedure.

[0025] System Description

[0026] Figure 1 Is a schematic diagram of an invasive medical procedure using device 12 according to one embodiment. The procedure is performed by a medical professional 14, and by way of example, it is assumed that the procedure in the following description includes ablating a portion of the myocardium 16 of the heart of a human patient 18. However, it should be understood that the embodiments disclosed herein are not limited to this particular procedure and may include substantially any procedure for biological tissue or non-biological materials.

[0027] To perform ablation, medical professional 14 inserts probe 20 into sheath 21 that has been pre-positioned in the patient's body cavity. Sheath 21 is positioned such that the distal end 22 of probe 20 enters the patient's heart. Referring hereinafter to Figure 2 the diagnostic / therapeutic catheter 24 (e.g., balloon catheter) detailed in

[0028] is deployed through the lumen 23 of probe 20 and exits from the distal end of probe 20. Figure 1 As shown, device 12 is controlled by system processor 46, which is located in the operation console 15 of the device. Console 15 includes controls 49 used by professional 14 to communicate with the processor. During the procedure, processor 46 typically uses any method known in the art to track the position and orientation of the distal end 22 of probe 20. For example, processor 46 may use magnetic tracking methods, where magnetic emitters 25X, 25Y, and 25Z outside patient 18 generate signals in coils located in the distal end of probe 20. The system (purchased from Biosense Webster, Inc. of Irvine, California) uses such tracking methods.

[0029] Software for processor 46 may be downloaded electronically to the processor, for example, via a network. Alternatively or additionally, the software may be provided via a non-transitory tangible medium such as an optical, magnetic, or electronic storage medium. Tracking of the distal end 22 may be displayed on the three-dimensional representation 60 of the heart of patient 18 on screen 62. However, it may be displayed in two dimensions, for example, by fluoroscopy or MRI.

[0030] To operate device 12, processor 46 communicates with memory 50, which has multiple modules used by the processor to operate the device. Thus, memory 50 includes a temperature module 52, an ablation module 54, and an electrocardiogram (ECG) module 56, the functions of which are described below. Memory 50 typically includes other modules, such as a force module for measuring the force on distal end 22, a tracking module for operating the tracking method used by processor 46, and a perfusion module that allows the processor to control the perfusion provided to distal end 22. For simplicity, Figure 1Such other modules are not shown. The module can include hardware elements as well as software elements. For example, module 54 can include a radio frequency generator having at least one output or output channel (e.g., ten outputs or ten output channels). Each of the outputs can be individually and selectively activated or deactivated by a switch. That is, each switch can be disposed between the signal generator and the corresponding output. Thus, a generator having ten outputs will include ten switches. These outputs can each be individually coupled to an electrode on an ablation catheter, such as ten electrodes 33 on balloon 80, as described in further detail below. Such electrical connection can be achieved by establishing an electrical path between each output and each electrode. For example, each output can be connected to the corresponding electrode by one or more wires or suitable electrical connectors. Thus, in some embodiments, the electrical path can include at least one wire. In some embodiments, the electrical path can further include an electrical connector and at least a second wire. Thus, the electrodes 33 can be selectively activated and deactivated with the switches to receive radio frequency energy independently of each of the other electrodes.

[0031] Figure 3 is a schematic perspective view of an inflatable diagnostic / therapeutic catheter 24 in its inflated configuration in the form of a balloon according to one embodiment. The diagnostic / therapeutic catheter 24 is supported by a tubular shaft 70 having a proximal shaft portion 82 and a distal shaft end 88. The shaft 70 can include a first shaft portion and a second shaft portion telescopically related thereto and at least partially disposed within the first shaft portion such that the proximal shaft portion 82 is a part of the first shaft portion and the distal shaft end 88 is the distal end of the second shaft. The shaft 70 includes a hollow central tube 74 that permits a catheter to pass therethrough and past the distal shaft end 88. The catheter can be a linear lesion catheter or a snare catheter 72, as shown. The snare catheter 72 can be inserted into a pulmonary vein to properly position the diagnostic / therapeutic catheter 24 relative to the ostium prior to ostial ablation. The distal snare portion of the catheter 72 is typically formed of a shape memory retaining material such as nitinol. It should be understood that the diagnostic / therapeutic catheter 24 can also be used with a linear or lesion catheter 99 (such as Figure 3for use in the PV or other parts of the heart as shown by the dashed lines therein. The lesion catheter 99 may include a force sensor at its distal end. Suitable force-transmitting distal ends are disclosed in U.S. Patent 8,357,152 to Govari et al. titled "CATHETER WITH PRESSURE SENSING" issued on January 22, 2013, and U.S. Patent Application 2011 / 0130648 to Beeckler et al. titled "CATHETER WITH PRESSURE MEASURING TIP" filed on November 30, 2009, the entire contents of which are incorporated herein by reference. Any catheter used with a diagnostic / therapeutic catheter may have feature structures and functions including, for example, pressure sensing, ablation, and diagnosis (such as manipulation and pacing).

[0032] The balloon 80 of the diagnostic / therapeutic catheter 24 has an outer wall or membrane 26 of a biocompatible material (e.g., a material formed of a plastic such as polyethylene terephthalate (PET), polyurethane, or ). The shaft 70 and the distal shaft end 88 define the longitudinal axis 78 of the balloon 80. The balloon 80 is deployed through the lumen 23 of the probe 20 in a collapsed configuration and can be inflated to an inflated configuration after being extended from the distal end 22 by telescoping the first shaft portion relative to the second shaft portion. The membrane 26 of the balloon 80 is formed with perfusion pores or holes 27 ( Figure 4 as shown), through which fluid (e.g., saline) can be discharged from the interior of the balloon 80 to the outside of the balloon to cool the tissue ablation site at the nozzle. Although Figure 2 fluid is shown exiting the balloon 80 as a jet, it should be understood that the fluid can exit the balloon at any desired flow rate or pressure, including the rate at which the fluid oozes from the balloon.

[0033] The membrane 26 supports and carries a combined electrode and temperature detection member constructed as a multi-layer flexible circuit electrode assembly 84. The "flexible circuit electrode assembly" 84 can have many different geometric configurations. In the illustrated embodiment, the flexible circuit electrode assembly 84 has a plurality of radiating bases or strips 30. The bases 30 are evenly distributed around the membrane 26 of the balloon 80. Each base has a wider proximal portion that tapers to a narrower distal portion.

[0034] Each base 30 has a proximal tail 31P proximal to the wider proximal portion and a distal tail 31D distal to the narrower distal portion. The proximal tail 31P can be tucked under and fastened to the catheter 24 by a proximal ring 28P mounted on the proximal shaft portion 82 of the shaft 70. The distal tail 31D can be tucked under and fastened to the catheter 24 at the distal shaft end 88 by a distal ring or cap 28D.

[0035] For simplicity, only one of the substrates 30 of the flexible circuit electrode assembly 84 is described, as Figure 4 shown, but it should be understood that the following description can be applied to each substrate of the assembly. The flexible circuit electrode assembly 84 includes a flexible and elastic sheet substrate 34 constructed of a suitable biocompatible material (e.g., polyimide). In some embodiments, the sheet substrate 34 has a higher heat resistance (or higher melting temperature) compared to the balloon membrane 26. In some embodiments, the substrate 34 is constructed of a thermosetting material having a decomposition temperature that is about 100 °C or higher than the melting temperature of the balloon membrane 26.

[0036] The substrate 34 is formed with one or more perfusion pores or holes 35 that are aligned with the perfusion holes 27 of the balloon member 26 such that fluid passing through the perfusion holes 27 and 35 can be delivered to the ablation site on the nozzle tip.

[0037] The substrate 34 has a first or outer surface 36 remote from the balloon membrane 26 and a second or inner surface 37 facing the balloon membrane 26. On its outer surface 36, the substrate 34 supports and carries a contact electrode 33 adapted to contact the ostial tissue. On its inner surface 37, the substrate 34 supports and carries a wiring electrode 38. The contact electrode 33 delivers RF energy to the ostium during ablation or is connected to a thermocouple junction for temperature sensing of the ostium. In the illustrated embodiment, the contact electrode 33 has a longitudinally elongated portion 40 and a plurality of thin, transverse, straight portions or fingers 41 that extend perpendicularly from each side of the elongated portion 40 generally between an enlarged proximal end 42P and a distal end 42D and are spaced apart therefrom generally evenly. The elongated portion 40 has a greater width, and each finger has a generally equal, smaller width. Thus, the configuration or trace of the contact electrode 33 may resemble a "fishbone", but it should be noted that the present invention is not limited to such a configuration. Contrary to area or "patch" ablation electrodes, the fingers 41 of the contact electrode 33 advantageously increase the circumferential or equatorial contact surface of the contact electrode 33 with the ostium, while the void regions 43 between adjacent fingers 41 advantageously allow the balloon 80 to collapse inwardly or expand radially at positions along its equator as needed. In the illustrated embodiment, the fingers 41 have different lengths, some longer and some shorter. For example, the plurality of fingers includes distal fingers, proximal fingers, and fingers therebetween, with each finger therebetween having shorter adjacent fingers. For example, each finger has a length different from that of its immediately adjacent distal or proximal neighbor such that the length of each finger generally follows the tapered configuration of each substrate 30. In the illustrated embodiment, there are 22 fingers extending across the elongated portion 40 (through each side), with the longest finger being the third finger from the enlarged proximal end 42P. In some embodiments, the contact electrode 33 includes gold 58B having a seed layer located between the gold 58B and the membrane 26. The seed layer may include titanium, tungsten, palladium, silver, or a combination thereof.

[0038] One or more discharge zones 47 are formed within the contact electrode 33, each discharge zone surrounding an irrigation hole 35 formed in the substrate 34. The discharge regions 47 are voids intentionally formed in the contact electrode 33, as further detailed below, to avoid positional and functional damage to the contact electrode 33 during the construction of the electrode assembly 84 when accommodating the irrigation holes 35.

[0039] One or more conductive blind vias 48 are also formed in contact electrode 33, the blind vias being conductive formations or metal-containing formations that extend through through-holes in substrate 34 and being configured as cables that connect contact electrode 33 on outer surface 36 and wiring electrode 38 on inner surface 37. It should be understood that in all relevant instances, "conductive" may be used interchangeably with "metal-containing" herein.

[0040] In the illustrated embodiment, contact electrode 33 measures approximately 0.1 inches to 1.0 inches longitudinally, preferably approximately 0.5 inches to 0.7 inches, more preferably approximately 0.57 inches, and has four discharge zones 47 and nine blind vias 48.

[0041] On inner surface 37 of substrate 34, wiring electrode 38 is generally configured as an elongate body that is generally similar in shape and size to elongate portion 40 of contact electrode 33. Wiring electrode 38 loosely resembles a "ridge" and also serves as a ridge in providing a predetermined degree of longitudinal stiffness to each substrate 30 of electrode assembly 84. Wiring electrode 38 is positioned such that each blind via 48 is in conductive contact with both contact electrode 33 and wiring electrode 38. In the illustrated embodiment, the two electrodes 33 and 38 are longitudinally aligned with other electrodes and all nine blind vias 48 are in conductive contact with the two electrodes 33 and 38. In some embodiments, wiring electrode 38 has an inner portion of copper 57 and an outer portion of gold 58.

[0042] Wiring electrode 38 is also formed with a discharge zone 59 surrounding perfusion hole 35 in substrate 34. Wiring electrode 38 is also formed with pad portions 61, at least one active pad portion 61A, and one or more inactive pad portions 61B may be present. Pad portions 61A and 61B are extensions of the sides of the elongate body of wiring electrode 38. In the illustrated embodiment, active pad portion 61A is formed at approximately the mid-position along the elongate body and corresponding inactive pad portions 61B are provided at each of enlarged distal end 42D and enlarged proximal end 42P.

[0043] A wire pair (e.g., constantan wire 51 and copper wire 53) is attached to active pad portion 61A, for example by soldering 63. Copper wire 53 provides a lead to wiring electrode 33, and copper wire 53 and constantan wire 51 provide a thermocouple where the joint is at soldering 63. The wire pair 51 / 53 passes through through-hole 29 formed in membrane 26. It should be understood that in other embodiments, in the absence of through-hole 29, the wire pair 51 / 53 may extend between membrane 26 and substrate 34 and also extend proximally between membrane 26 and proximal tail 31P until the wire pair 51 / 53 enters tubular shaft 70 via another through-hole (not shown) formed in the sidewall of the tubular shaft closer to proximal ring 28P.

[0044] A flexible circuit electrode assembly 84 including a base 30 and tails 31P and 31D is attached to the balloon membrane 26 such that the outer surface 36 of the base 34 is exposed and the inner surface 37 of the base 34 is attached to the balloon membrane 26, wherein the wiring electrodes 38 and the wire pairs 51 / 53 are sandwiched between the base 34 and the balloon membrane 26. The perfusion holes 35 in the base 34 are aligned with the perfusion holes 27 on the balloon membrane 26. The discharge regions 59 in the wiring electrodes 38 and the discharge regions 47 in the contact electrodes 33 are concentrically aligned with each other and are respectively concentrically aligned with the perfusion holes 27 and 35 in the balloon 26 and the base 34.

[0045] More details regarding the construction of the diagnostic / therapeutic catheter according to the foregoing disclosure can be found in U.S. Patent Application No. 15 / 360,966, which was published as U.S. Patent Application Publication No. 2017 / 0312022, the entire disclosure of which is incorporated herein by reference.

[0046] Enhancement

[0047] Through ongoing research and product development efforts regarding the above subject matter, the applicant has determined that the balloon 80 must be able to withstand multiple cycles as follows: deployment from the lumen 23 of the probe 20 from a collapsed configuration, expansion to an expanded configuration, return to the collapsed configuration and withdrawal back into the lumen 23 of the probe 20. The number of cycles can range from about five to about twenty. That is, the connection between the base 30 and the membrane 26 of the balloon 80 and the overall integrity of the assembled balloon must withstand at least five to twenty fatigue cycles and any additional frictional stresses experienced during five to twenty deployments from and five to twenty withdrawals into the lumen 23. The applicant believes that there is a very small possibility of potential delamination of the proximal tail 31P and the distal tail 31D from the membrane 26, which may be caused by repeated fatigue, and has achieved a solution that will prevent or at least significantly further reduce the possibility of any such delamination. The applicant has also determined that any such solution will need to accommodate various design constraints, such as: 1) minimizing any attendant safety issues caused by any solution; 2) minimizing any increase in the diameter of the various parts of the balloon 80 to which the distal tail 31D and the proximal tail 31P adhere, such that the balloon 80 in the collapsed configuration can be easily deployed from and withdrawn into the lumen 23 with little or no increase in friction therebetween (or especially in extreme cases, avoiding the need to increase the diameter of the lumen 23); 3) minimizing any increase in the stiffness of the balloon 80, any increase in stiffness that may impede the establishment of contact between the electrode 30 and the tissue during the procedure; 4) not impeding the electrical contact between the electrode 33 and the tissue during the procedure; and 5) minimizing any increase in the number of assembly steps.

[0048] Disclosed herein is an enhancement or enhancement component 100 that helps prevent delamination problems without violating design constraints. The enhancement component 100 may have a shape similar to and thus conformable to the proximal or distal portion of the membrane 26. For example, the enhancement component 100 may include a portion of the unassembled catheter balloon 80, i.e., the balloon 80 that has not yet been assembled to any other component of the catheter 24 such as the base 30. That is, the balloon 80 may have a portion separated from it by cutting the membrane 26 along one of the lines 86, as Figure 6 shown. In embodiments where the balloon 80 is symmetric about the centerline, two portions of the balloon 80 may be removed to produce two enhancement components 100. In embodiments where the membrane 26 is asymmetric about the centerline, its distal portion may be used as the enhancement component 100 for the distal tail 31D, and its proximal portion may be used as the enhancement component 100 for the proximal tail 31P.

[0049] Thus, the enhancement component 100 may be configured to have a flared (e.g., bell-mouthed) shape as Figure 5 shown. The membrane 26 with the flexible circuit assembly 84 adhered thereto may have its proximal portion disposed within the enhancement component 100 such that the enhancement component 100 covers the proximal tail 31P or a portion thereof. Alternatively or additionally, the membrane 26 with the flexible circuit assembly 84 adhered thereto may have its distal portion disposed within the enhancement component 100 such that the enhancement component 100 covers the distal tail 31D or a portion thereof. The enhancement component 100 may then be adhered to the membrane 26 via, for example, epoxy or mechanical or heat fusion. Thus, the tail is sandwiched between the balloon 80 and the enhancement component 100. In this configuration, the enhancement component 100 may absorb the stress caused by the expanding and collapsing balloon 80, thereby reducing the fatigue on the tail. Additionally, the tail is shielded from the friction between the enhancement component 100 and the wall of the lumen 23 (which would otherwise exist between the tail and the wall of the lumen 23 during deployment and retraction), thereby further reducing the stress on the tail.

[0050] In additional embodiments, the likelihood of delamination may be further reduced by supporting one or more (e.g., all) of the tails with filaments of a certain length between the membrane 26 and the respective tail 31P or 31D. Ideally, the filament material is a filament material that is easily bondable to both the base material and the membrane material such that the filaments can increase the robustness of the connection between the tail and the membrane. Suitable materials include liquid crystal polymers such as VECTRAN TM , or preferably include ultra-high molecular weight polymers such as Honeywell SPECTRA TM .

[0051] According to the embodiments shown and described herein, the applicant has devised a method of using a diagnostic / therapeutic catheter having a balloon on which various components suitable for ablating tissue are provided, the method including repeated steps of tensioning the connection between the balloon and the catheter. Specifically, a user may receive the catheter, such as the catheter previously described (e.g., catheter 24). The user may deploy the balloon from the catheter, inflate the balloon, deflate the balloon, and retract the balloon back into the catheter. These steps may be repeated between five and fifteen times, for example ten times. Additionally, the user may ablate tissue using electrodes provided on the balloon, typically between the steps of inflating and deflating the balloon.

[0052] Any of the examples or embodiments described herein may also include various other features in addition to or as alternatives to those described above. The teachings, expressions, embodiments, examples, etc. described herein should not be considered in isolation from one another. With reference to the teachings herein, various suitable ways in which the teachings herein may be combined will be apparent to those skilled in the art.

[0053] Exemplary embodiments of the subject matter contained herein have been shown and described, and further improvements to the methods and systems described herein may be achieved with suitable modifications without departing from the scope of the claims. Additionally, where the above methods and steps represent specific events occurring in a particular order, it is intended herein that certain specific steps need not necessarily be performed in the order described, but may be performed in any order, so long as the steps enable the embodiment to achieve its intended purpose. Accordingly, if there are variations of the present invention and such variations fall within the substantial scope of the disclosure or equivalents of the present invention found in the claims, this patent is intended to cover such variations as well. Many such modifications will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, ratios, steps, etc. described above are illustrative. Accordingly, the claims should not be limited to the specific details of the structures and operations shown in this written description and the drawings.

Claims

1. A catheter balloon, the catheter balloon comprising: A membrane, the membrane including a proximal end and a distal end; A plurality of bases, the plurality of bases being disposed around the membrane, each of the plurality of bases including a respective proximal tail and a respective distal tail, the respective proximal tail being disposed over and in contact with the proximal end of the membrane, and the respective distal tail being disposed over and in contact with the distal end of the membrane; A first reinforcement, the first reinforcement including a first portion of the unassembled catheter balloon, which is disposed over and in contact with the respective proximal tail of each of the plurality of bases, and the first reinforcement being attached to the proximal end of the membrane; And A second reinforcement, the second reinforcement including a second portion of the unassembled catheter balloon, which is disposed over and in contact with the respective distal tail of each of the plurality of bases, and the second reinforcement being attached to the distal end of the membrane.

2. The catheter balloon according to claim 1, wherein the first reinforcement has a flared shape.

3. The catheter balloon according to claim 2, wherein the membrane comprises polyethylene terephthalate, polyurethane or PEBAX.

4. The catheter balloon according to claim 2, wherein the membrane comprises Pellethane.

5. The catheter balloon according to claim 3, wherein the first reinforcement is symmetric with the second reinforcement.

6. The catheter balloon according to claim 5, wherein the membrane further includes irrigation holes therethrough.

7. The catheter balloon according to claim 5, the catheter balloon further comprising a plurality of ablation electrodes.

8. The catheter balloon according to claim 7, wherein at least one of the ablation electrodes is disposed on each of the plurality of bases.

9. The catheter balloon according to claim 5, the catheter balloon further comprising filaments disposed between at least one of the membrane and the respective distal tail.

10. The catheter balloon according to claim 9, wherein the filaments comprise liquid crystal polymer.

11. A catheter, the catheter comprising: A shaft, the shaft having a first shaft portion and a second shaft portion at least partially disposed within the first shaft portion; A catheter balloon, the catheter balloon having a membrane including a proximal end and a distal end, the proximal end being disposed over and connected to the first shaft portion, and the distal end being disposed over and connected to the second shaft portion; A plurality of bases, the plurality of bases being disposed around the membrane, each of the plurality of bases including a respective proximal tail and a respective distal tail, the respective proximal tail being disposed over and attached to the first shaft portion, and the respective distal tail being disposed over and attached to the second shaft portion; A first reinforcement member, the first reinforcement member including a first portion of an unassembled catheter balloon, which is disposed over and in contact with the respective proximal tails of each of the plurality of substrates, and the first reinforcement member is attached to the proximal end of the membrane; and A second reinforcement member, the second reinforcement member including a second portion of the unassembled catheter balloon, which is disposed over and in contact with the respective distal tails of each of the plurality of substrates, and the second reinforcement member is attached to the distal end of the membrane.

12. The catheter according to claim 11, the catheter further comprising a first ring and a second ring, the first ring attaching the first reinforcement member to the first shaft portion, the second ring attaching the second reinforcement member to the second shaft portion.

13. The catheter according to claim 12, wherein the first reinforcement member has a flared shape.

14. The catheter according to claim 13, wherein the membrane comprises polyethylene terephthalate, polyurethane or PEBAX.

15. The catheter according to claim 13, wherein the membrane comprises Pellethane.

16. The catheter according to claim 13, wherein the second shaft portion is disposed within the first shaft portion in a telescoping relationship.

17. The catheter according to claim 13, the catheter further comprising a plurality of ablation electrodes.

18. The catheter according to claim 17, wherein at least one of the plurality of ablation electrodes is disposed on each of the plurality of substrates.

19. The catheter according to claim 17, the catheter further comprising a lead wire, the lead wire being at least partially disposed within the shaft and the catheter balloon and connected to at least one of the plurality of ablation electrodes.

20. The catheter according to claim 13, the catheter further comprising a filament disposed between at least one of the membrane and the respective distal tail.

21. The catheter according to claim 20, wherein the filament comprises one of ultra-high molecular weight polymer or liquid crystal polymer.

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