Printed electronics based catheters

Abstract

This invention relates to catheters and methods of manufacturing the catheters based on printed electronics and printed electronics processing. The catheter comprises a steerable sheath including an anchor ring and pull wires connected to the anchorring, printed traces printed onto the steerable sheath using printed electronics processes, and printed components printed onto the steerable sheath and connected to the steerable sheath and the printed traces using the printed electronics processes.

Description

PRINTED ELECTRONICS BASED CATHETERSTECHNICAL FIELD

[0001] This disclosure relates to catheters and in particular, use of printed electronics to manufacture catheters.BACKGROUND

[0002] Catheters are medical devices that can be inserted into the body for diagnostic and therapeutic purposes, to perform a surgical procedure, deliver a therapy through the vasculature, remove fluids from the body, or provide fluids to the body, for example. There are a variety of catheters, including but not limited to, electrophysiology (EP) catheters, mapping electrode catheters, steerable catheters, guiding catheters, balloon catheters, and / or dialysis catheters. An EP catheter is a catheter that is a thin, flexible tube augmented with electronics such as sensors and electrodes. Catheters currently use components that are discretely manufactured and assembled together using a variety of bonding, welding, and soldering methods. For example, electrodes are crimped onto or bonded to catheter tubing. Filars or very fine gauge wires are welded or soldered to the electrodes. These devices are labor intensive and inefficient to manufacture. Moreover, these devices may have limited miniaturization capability, customization capability, and / or usability.SUMMARY

[0003] Disclosed herein are implementations of catheters and methods of manufacturing catheters based on printed electronics, integration of non-printed components, i.e., flexible hybrid electronics, and printed electronics processing.BRIEF DESCRIPTION OF THE DRAWINGS

[0004] The disclosure is best understood from the following detailed description when read in conjunction with the accompanying drawings and are incorporated into and thus constitute a part of this specification. It is emphasized that, according to common practice, the various features of the drawings are not to-scale. On the contrary, the dimensions of the various features are arbitrarily expanded or reduced for clarity.

[0005] FIG. 1 is a cross-sectional view of a catheter in accordance with certain implementations.

[0006] FIG. 2 is a top view of the catheter of FIG. 1 in accordance with certainimplementations .

[0007] FIG. 3 is a top view of a balloon catheter in accordance with certain implementations.

[0008] FIG. 4 is a top view of a balloon catheter in accordance with certain implementations .

[0009] FIG. 5 is a partial cross-sectional view of a catheter with a printed image sensor in accordance with certain implementations.

[0010] FIG. 6 is a flow diagram of an example of a method for manufacturing a catheter using printed electronics processes.

[0011] FIG. 7 is a side view of a catheter in accordance with certain implementations.

[0012] FIG. 8 is a side view of a catheter in accordance with certain implementations.

[0013] FIG. 9 is a partial front perspective view of the catheter of FIG. 8 of in accordance with certain implementations.

[0014] FIG. 10 is a side view of a catheter in accordance with certain implementations.

[0015] FIG. 11 is a front view of the catheter of FIG. 10 in accordance with certain implementations.

[0016] FIG. 12 is a side view of a catheter in accordance with certain implementations.

[0017] FIG. 13 is a top view of a photograph of a printed strain gage for the catheter ofFIG. 12 in accordance with certain implementations.DETAILED DESCRIPTION

[0018] The figures and descriptions provided herein may be simplified to illustrate aspects of the described embodiments that are relevant for a clear understanding of the herein disclosed processes, devices, machines, manufactures, and / or compositions of matter, while eliminating for the purpose of clarity other aspects that may be found in typical similar devices, systems, compositions, and methods. Those of ordinary skill may thus recognize that other elements and / or steps may be desirable or necessary to implement the devices, systems, compositions, and methods described herein. However, because such elements and steps are well known in the art, and because they do not facilitate a better understanding of the disclosed embodiments, a discussion of such elements and steps may not be provided herein. However, the present disclosure is deemed to inherently include all such elements, variations, and modifications to the described aspects that would be known to those of ordinary skill in the pertinent art in light of the discussion herein.

[0019] Embodiments are provided throughout so that this disclosure is sufficientlythorough and fully conveys the scope of the disclosed embodiments to those who are skilled in the art. Numerous specific details are set forth, such as examples of specific aspects, devices, and methods, to provide a thorough understanding of embodiments of the present disclosure. Nevertheless, it will be apparent to those skilled in the art that certain specific disclosed details need not be employed, and that embodiments may be embodied in different forms. As such, the exemplary embodiments set forth should not be construed to limit the scope of the disclosure.

[0020] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. For example, as used herein, the singular forms “a”, “an” and “the” may be intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms “comprises,” “comprising,” “including,” and “having,” are inclusive and therefore specify the presence of stated features, steps, operations, 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.

[0021] The steps, processes, and operations described herein are thus not to be construed as necessarily requiring their respective performance in the particular order discussed or illustrated, unless specifically identified as a preferred or required order of performance. It is also to be understood that additional or alternative steps may be employed, in place of or in conjunction with the disclosed aspects.

[0022] Yet further, although the terms first, second, third, etc. may be used herein to describe various elements, steps, or aspects, these elements, steps, or aspects should not be limited by these terms. These terms may be only used to distinguish one element or aspect from another. Thus, terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, step, component, region, layer, or section discussed below could be termed a second element, step, component, region, layer, or section without departing from the teachings of the disclosure.

[0023] As used herein, the terminology “determine" and "identify," or any variations thereof includes selecting, ascertaining, computing, looking up, receiving, determining, establishing, obtaining, or otherwise identifying or determining in any manner whatsoever using one or more of the devices and methods are shown and described herein.

[0024] As used herein, the terminology "example," "the embodiment," "implementation," "aspect," "feature," or "element" indicates serving as an example, instance, or illustration. Unless expressly indicated, any example, embodiment, implementation, aspect, feature, orelement is independent of each other example, embodiment, implementation, aspect, feature, or element and may be used in combination with any other example, embodiment, implementation, aspect, feature, or element.

[0025] As used herein, the terminology "or" is intended to mean an inclusive "or" rather than an exclusive "or. " That is unless specified otherwise, or clear from context, "X includes A or B" is intended to indicate any of the natural inclusive permutations. That is if X includes A; X includes B; or X includes both A and B, then “X includes A or B” is satisfied under any of the foregoing instances. In addition, the articles “a” and “an” as used in this application and the appended claims should generally be construed to mean “one or more” unless specified otherwise or clear from the context to be directed to a singular form.

[0026] As used herein, the terminology “computer” or “computing device” includes any unit, or combination of units, capable of performing any method, or any portion or portions thereof, disclosed herein. For example, the “computer” or “computing device” may include at least one or more processor(s).

[0027] As used herein, the terminology “processor” indicates one or more processors, such as one or more special purpose processors, one or more digital signal processors, one or more microprocessors, one or more controllers, one or more microcontrollers, one or more application processors, one or more central processing units (CPU)s, one or more graphics processing units (GPU)s, one or more digital signal processors (DSP)s, one or more application specific integrated circuits (ASIC)s, one or more application specific standard products, one or more field programmable gate arrays, any other type or combination of integrated circuits, one or more state machines, or any combination thereof.

[0028] As used herein, the terminology “memory” indicates any computer-usable or computer-readable medium or device that can tangibly contain, store, communicate, or transport any signal or information that may be used by or in connection with any processor. For example, a memory may be one or more read-only memories (ROM), one or more random access memories (RAM), one or more registers, low power double data rate (LPDDR) memories, one or more cache memories, one or more semiconductor memory devices, one or more magnetic media, one or more optical media, one or more magnetooptical media, or any combination thereof.

[0029] As used herein, the terminology “instructions” may include directions or expressions for performing any method, or any portion or portions thereof, disclosed herein, and may be realized in hardware, software, or any combination thereof. For example, instructions may be implemented as information, such as a computer program, stored inmemory that may be executed by a processor to perform any of the respective methods, algorithms, aspects, or combinations thereof, as described herein. Instructions, or a portion thereof, may be implemented as a special purpose processor, or circuitry, that may include specialized hardware for carrying out any of the methods, algorithms, aspects, or combinations thereof, as described herein. In some implementations, portions of the instructions may be distributed across multiple processors on a single device, on multiple devices, which may communicate directly or across a network such as a local area network, a wide area network, the Internet, or a combination thereof.

[0030] The non- limiting embodiments described herein are with respect to catheters or devices and methods for making and using the catheters or devices. The catheters or devices and method for making the catheters or devices may be modified for a variety of applications and uses while remaining within the spirit and scope of the claims. The embodiments and variations described herein, and / or shown in the drawings, are presented by way of example only and are not limiting as to the scope and spirit. The descriptions herein may be applicable to all embodiments of the device and the methods for making the devices.

[0031] Disclosed herein are implementations of catheters manufactured with processes used for printing electronics on flexible materials such as, but not limited to fabrics and / or polymers. Additive manufacturing processes such as additive printing, for example, may be used to print electrodes, electronic components, sensors, and / or other components (collectively “printed components”), traces, and circuit traces, (collectively “printed traces”) (collectively “printed electronics”) onto or in tubing or a sheath to form the catheters. In implementations, the printed electronics may be printed on any surface of the tubing or sheath or may be embedded in the tubing or sheath. The use of printed electronics may lend to a very small catheter. In implementations, the catheter may be in the approximately sub 2 millimeter range. In implementations, the catheter may be in the approximately 1 millimeter range. As such, the use of printed electronics may enable greater integration of a greater number of sensors, electronics, and / or actuators such as, but not limited to, irrigation, ultrasonics, laser ablation, cryoablation, optics and / or imaging devices, and / or graspers. That is, the number of catheters needed or to be inserted or used for a patient for a diagnostic or therapeutic application can be smaller relative to conventional catheters. The tubing or sheath maybe hollow, partially hollow, solid, single lumen, multi-lumen, multi-layered, multilayered with multiple printed electronics layers therein, and / or combinations thereof. In implementations, the tubing may be braided tubing to provide flexibility.

[0032] In implementations, the printed electronics catheters may be steerable or fixed.The use of printed electronics may enable or provide for steerable printed electronics catheters without the larger size disadvantage associated with steerable catheters.

[0033] In implementations, the use of printed electronics may eliminate the labor intensive assembly of electrodes. Printed traces, for example, may eliminate manual welding of filars to electrode rings and the use of other processes such as, but not limited to, wire stuffing, laser welding, and / or resistance welding.

[0034] In implementations, the use of printed electronics may enable the use of a variety of materials including, but not limited to, conductive, dielectric, and / or functional sensing materials.

[0035] In implementations, the use of printed electronics may facilitate coating of the printed electronics with specialized or functional materials, such as Iridium Oxide, for example, which may reduce electrical impedance to a power source, enable a better electrical connection, and reduce energy consumption.

[0036] In implementations, printed electronics may be printed on balloons in a variety of shapes and / or patterns depending on the application.

[0037] In implementations, the use of printed electronics may enable customization. For example, printed electrodes on a catheter or on a balloon may be low power to break up plaque or high power for a renal denervation application. In another example, the dimensions of the printed electronics may be customized depending on the application. In yet another example, the height and / or cross-sectional shape of the printed electronics may be customized depending on the application. That is, the height or thickness and / or cross-sectional shape of the printed electronics can vary to implement a variety of structural and / or functional properties or characteristics. In still another example, the sensing functionality of the printed electronics may be customized depending on the application. In a further example, the diameter sizes and lengths of the printed electronics may be customized depending on the application. In yet a further example, the printed electronics may be ablation electrodes. In still a further example, the printed electronics may be mapping electrodes.

[0038] In implementations, additive or 3D printing of printed electronics may enable fully functional catheters with silicon or organic semiconductor components. Integration of thin flexible semi-conductor devices may be enabled by wrapping the thin flexible semiconductor devices around a circumference of the tubing and connecting the thin flexible semi-conductor devices to the printed traces. In implementations, the semiconductor components can be directly printed on the printed traces. In implementations, the thin profile of the printed traces enables the ability to integrate thin flexible silicon or organicsemiconductor devices directly onto the tubing to bring about or produce the benefits of a fully integrated thin profile functional catheter. For example, the printed electronics may enable a fully integrated thin profile image sensor. In implementations, an encapsulation layer may be printed. For example, the encapsulation layer may be an optically clear or opaque layer across a variety of wavelengths and / or spectrums which may be added on top of the image sensors. In another example, thin film antennas, thin radio frequency identification (RFID) chips, near field communication (NFC) chips, other short-range radio signaling chips, or other thin electronics (e.g., thin, flexible batteries, memory devices, heaters, etc) may be deposited onto the tubing. In implementations, thin electronics may be embedded into the tubing and connected using printed traces.

[0039] In implementations, wireless power coils may be included for energy transfer.

[0040] In implementations, the printed electronics may be printed on an internal surface, an external surface, or embedded in the tubing or sheath. In implementations, vias may be used to connect printed traces or circuit traces to printed electrodes, grounding, or combinations thereof.

[0041] In implementations, the printing processes may include, but is not limited to, inkjet printing, auto-dispensing, screen printing, pad printing, and / or deposition.

[0042] In implementations, surface- mount technology (SMT) devices or components, such as but not limited to, capacitors, resistors, or connectors may be attached directly to printed traces or circuit traces using a variety of materials such as but not limited to, conductive adhesives. Some of these adhesives can be removed through immersion in water or chemicals or through mechanical processes that preserve the integrity of the attached components. Such processes can enable the recovery of materials and components from these devices for reuse.

[0043] FIG. 1 is a cross-sectional view of a catheter 1000 in accordance with certain implementations and FIG. 2 is a top view of the catheter 1000 of FIG. 1 in accordance with certain implementations. The catheter 1000 and the components therein may include other elements which may be desirable or necessary to implement the devices, systems, and methods described herein. However, because such elements and steps do not facilitate a better understanding of the disclosed embodiments, a discussion of such elements and steps may not be provided herein.

[0044] The catheter 1000 may include a tube or sheath (collectively “tubular member”) 1100. The tubular member 1100 may include or have a braided layer 1200. In implementations, the tubular member 1100 may be hollow, partially hollow, and / or solid. In implementations,the tubular member 1100 may include one or more lumens (e.g., single lumen or multi-lumen). In implementations, the lumens may carry fluid for irrigation, cooling and / or for balloon expansion. In implementations, the catheter 1000 may include an anchor ring 1300 connected to pull or guide wires 1400 and 1410 which enable steering or guiding of the catheter 1000. In implementations, the pull or guide wires 1400 and 1410 can have a variety of cross-sections including, but not limited to, flat, round, and / or shaped (where shaped may include a star shape, polygon-shape and the like). The tubular member 1100, the anchor ring 1300, and the pull or guide wires 1400 and 1410 may be collectively referred to as a steerable sheath. In implementations, there can be multiple pull wires arranged in a way to steer the catheter in more than one plane. That is, the pull wires can be connected at different points on the anchor ring to provide a greater degree of freedom in controlling the catheter. In implementations, additive manufacturing processes may be used to selectively add material at certain sections or portions of the tubular member 1100 to control the degree of steerability. That is, a thickness of the tubular member 1100 at these certain sections or portions may be greater than other sections or portions. In implementations, multiple anchor rings can be placed at a variety of sections along the tubing to allow for steering along the length of the sheath.

[0045] In implementations, printed electronics processes including, but not limited to, inkjet printing processes, auto-dispensing processes, screen printing processes, pad printing processes, and / or deposition processes, may be used to print traces and circuit traces, (collectively “printed traces”) 1500 onto an outer surface of the tubular member 1100. In implementations, sheet-to-sheet, roll-to-roll processing techniques can be used to print the electronics. In implementations, a variety of materials may be used for the traces including, but not limited to, metals, conductive inks, and / or combinations thereof. Some of these inks can be removed through immersion in water or chemicals or through mechanical processes that preserve the integrity of the attached components. Such processes may allow the recovery of materials and components from these devices for reuse. In implementations, the printed traces 1500 may be printed on an internal surface of the tubular member 1100 and vias, through holes, and / or other techniques may be used for electronic connectivity as described herein. In implementations, the printed traces 1500 may be connected to a power source, controller, and / or other component. In implementations, the printed traces 1500 may be circuit traces to implement an electronic functionality such as, but not limited to, a resistor, a capacitor, and / or a driver circuit.

[0046] In implementations, the printed electronics processes may be used to print electrodes, electronic components, sensors, and / or other components (collectively “printedcomponents”) 1600 onto an outer surface of the tubular member 1100 and which is electrically, and mechanically connected (collectively “connected” herein) to the printed traces 1500. In implementations, the term connected may include direct and indirect connectivity as applicable and appropriate. For example, this can be implemented through the use of vias and other techniques as applicable and appropriate. In implementations, each printed component of the printed components 1600 may be connected to a printed trace of the printed traces 1500. In implementations, one or more printed components of the printed components 1600 may be connected to a printed trace of the printed traces 1500. In implementations, the size, shape, type, and number of printed components 1600 may be configurable or customized depending on the application or requirements needs. In implementations, a variety of materials may be used for the printed components dependent on the type of printed component. For example, a printed electrode may be printed using metals, conductive inks, and / or combinations thereof.

[0047] In implementations, SMT components and other similar components may be attached to the printed traces using bonding and / or other techniques. In implementations, SMT components and other similar components may be embedded in the tubular member 1100 and connected to the printed traces using vias, through holes, and / or other techniques.

[0048] In implementations, the tubular member 1100 may include multiple layers which may be manufactured using co-extrusion, reflow techniques, and / or other processes. Printed electronics processes may be used to print electronics on each layer of the tubular member 1100. The layers may be connected using vias, through holes, and / or other techniques. In implementations, thin electronics may be added to one or more layers and may be connected using vias, through holes, and / or other techniques.

[0049] In implementations, an encapsulation layer may be printed or deposited around the catheter 1000 using deposition techniques, printed electronics processes, and / or combinations thereof.

[0050] FIG. 3 is a top view of a balloon catheter 3000 in accordance with certain implementations. The balloon catheter 3000 and the components therein may include other elements which may be desirable or necessary to implement the devices, systems, and methods described herein. However, because such elements and steps do not facilitate a better understanding of the disclosed embodiments, a discussion of such elements and steps may not be provided herein.

[0051] The balloon catheter 3000 may be or include the catheter of FIG. 1 and FIG. 2. The balloon catheter 3000 may include a steerable sheath 3100 as described herein. A printed trace 3200 is printed on the steerable sheath 3100 using the printed electronics processes as describedherein. The balloon catheter 3000 includes a balloon 3300 connected to the printed trace 3200 and to the steerable sheath 3100 using a variety of techniques. Printed electronics processes may be used to print a printed trace 3310 onto the balloon 3300 in an inflated state (non- compliant balloons) and / or in a deflated state (compliant balloons). The printed trace 3310 may be printed in a meandering pattern to enable stretchability when the balloon 3300 is inflated. In some implementations, the printed trace 3310 may be printed in a coil configuration around the balloon 3300. In implementations, stretchable inks and / or materials may be used. In implementations, the printed trace 3310 may be printed on an outside or periphery of the balloon 3300.

[0052] FIG. 4 is a top view of a balloon catheter 4000 in accordance with certain implementations. The balloon catheter 4000 and the components therein may include other elements which may be desirable or necessary to implement the devices, systems, and methods described herein. However, because such elements and steps are well known in the art, and because they do not facilitate a better understanding of the disclosed embodiments, a discussion of such elements and steps may not be provided herein.

[0053] The balloon catheter 4000 may be or include the catheter of FIG. 1 and FIG. 2. The balloon catheter 4000 may include a steerable sheath 4100 as described herein. One or more printed traces 4200 may be printed on the steerable sheath 4100 using the printed electronics processes as described herein. The balloon catheter 4000 includes a balloon 4300 connected to the printed traces 4200 and to the steerable sheath 4100 using a variety of techniques. Printed electronics processes may be used to print printed traces 4310 onto the balloon 4300 in an inflated state or a deflated state. The printed traces 4310 may be printed in in a parallel longitudinal pattern. In implementations, stretchable inks and / or materials may be used. In implementations, the printed traces 4310 may be printed on an outside or periphery of the balloon 3300.

[0054] In implementations, printed traces can be arranged to form a heater to provide localized heat or to form an antenna for communication as well as wireless power transfer.

[0055] FIG. 5 is a diagram of a catheter 5000 with a printed image sensor in accordance with certain implementations. The catheter 5000 and the components therein may include other elements which may be desirable or necessary to implement the devices, systems, and methods described herein. However, because such elements and steps do not facilitate a better understanding of the disclosed embodiments, a discussion of such elements and steps may not be provided herein.

[0056] The catheter 5000 may be or include the catheter of FIGS 1-4, and / or combinationsthereof. The catheter 5000 may include a steerable sheath 5100 as described herein. A printed trace 5200 may be printed on the steerable sheath 5100 using the printed electronics processes as described herein. A thin flexible silicon or organic semiconductor component such as an image sensor 5300 may be connected to the printed trace 5200 and the steerable sheath 5100 using for example, but not limited to, deposition techniques, bonding techniques, printed electronics processes, and / or combinations thereof. An optical lens 5400 may be connected to the printed trace 5200, the steerable sheath 5100, and the image sensor 5300 using for example, but not limited to, deposition techniques, bonding techniques, printed electronics processes, and / or combinations thereof.

[0057] FIG. 6 is a flow diagram of an example of a method 6000 for manufacturing a catheter using printed electronics processes. The method 6000 may be used to make the catheters of FIGS 1-5 and 7-13. The method 6000 includes forming 6100 a steerable sheath and / or a catheter; printing 6200 a printed trace onto the steerable sheath and / or the catheter using printed electronics processing; and printing 6300 a printed component onto the steerable sheath and / or catheter using printed electronics processing and connected to the printed trace and the steerable sheath. The method 6000 may use printed electronics processing as described herein. In implementations, the printed trace may be on outer surface, inner surface, embedded, and / or combinations thereof. In implementations, components may be bonded to the printed trace using bonding techniques as described herein. In implementations, the method 6000 may use batch processing, reflow techniques, coextrusion, extrusions, and / or other techniques to form the catheter using multiple layers, where each layer may include printed traces, printed components, printed components, SMT components, and / or combinations thereof. In implementations, vias may be used for connectivity between the layers.

[0058] FIG. 7 is a side view of a catheter 7000 in accordance with certain implementations. The catheter 7000 and the components therein may include other elements which may be desirable or necessary to implement the devices, systems, and methods described herein. However, because such elements and steps do not facilitate a better understanding of the disclosed embodiments, a discussion of such elements and steps may not be provided herein. In implementations, the catheter 7000 can include and / or be implemented with one or more of the catheters described in FIGS 1-5 and the method of FIG. 6.

[0059] The catheter 7000 may include a tubular member 7050. The tubular member 7050 may have a core 7100 and one or more layers 7200. A printed trace 7300 may be deposited on onto an outer surface of the core 7100 using printed electronics processes as described herein.A layer of the one or more layers 7200 can be placed on the printed trace 7300 and the core 7100 such that the printed trace 7300 becomes embedded between the core 7100 and the layer of the one or more layers 7200. In implementations, the layers can be added using lamination processes or techniques, reflow processes or techniques, and / or similar processes or techniques. In these processes or techniques, annular or circular heaters traverse the catheter length at a specific speed and temperature and melt the polymer tube on the layer beneath via heat shrink tubing. The heat shrink tubing provides the force necessary, as it shrinks with the melting heat, to laminate a layer over another. Layer addition can be repeated as needed. Printed components, mounted components, hybrid components, and / or combinations thereof can he placed on the tubular member 7050 and / or the catheter 7000 to connect to the one or more printed traces. In implementations, a printed component such as a printed electrode 7400 can be deposited on the tubular member 7050 and / or the catheter 7000 to connect to the printed trace 7300. Another printed component such as a printed electrode 7410 can be deposited on the tubular member 7050 and / or the catheter 7000 to connect to a printed trace 7310.

[0060] FIG. 8 is a side view of a catheter 8000 in accordance with certain implementations. FIG. 9 is a partial front perspective view of the catheter 8000 of FIG. 8 of in accordance with certain implementations. The catheter 8000 and the components therein may include other elements which may be desirable or necessary to implement the devices, systems, and methods described herein. However, because such elements and steps do not facilitate a better understanding of the disclosed embodiments, a discussion of such elements and steps may not be provided herein. In implementations, the catheter 8000 can include and / or be implemented with one or more of the catheters described in FIGS 1-5 and 7 and the method of FIG. 6.

[0061] The catheter 8000 may include a core 8100. A printed trace 8200 may be deposited on onto an outer surface of the core 8100 using printed electronics processes as described herein. Printed components, mounted components, hybrid components, and / or combinations thereof can he placed on the core 8100 and / or the catheter 8000 to connect to the printed trace 8200. In implementations, a printed component such as a printed electrode 8300 can be deposited on the core 8100 and / or the catheter 8000 to connect to the printed trace 8200.

[0062] The core 8100 may be hollow, partially hollow, solid, and / or include a central lumen 8500 and one or more lumens 8600 (e.g., single lumen or multi-lumen). In implementations, the core 8100 can include ports 8700 which can each be connected to one of the one or more lumens 8600. The ports 8700 can be punctured through the core 8100 to a respective lumen of the lumens 8600. In implementations, the central lumen 8500 can carry a device for diagnostic or therapeutic purposes. For example, a center lumen of a catheter can be used for a guidewire,inject contrast media, inject therapies, and / or combinations thereof. A guidewire can assist in positioning or placement at a defined location and then contrast media can be delivered to the location to be able to see it through fluoroscopy and / or for other uses. In implementations, a fewer number of devices may be needed for various diagnostic or therapeutic applications compared to conventional techniques.

[0063] In implementations, the lumens 8600 can carry fluid for irrigation, cooling and / or for balloon expansion. In implementations, the fluid can exit via the ports 8700. Implementation of the printed electronics can reduce use of catheter real estate for electronics and permit inclusion of the ports. The printed traces and ports are physically separated.

[0064] FIG. 10 is a side view of a catheter 10000 in accordance with certain implementations. FIG. 11 is a front view of the catheter 10000 of FIG. 10 in accordance with certain implementations. The catheter 10000 and the components therein may include other elements which may be desirable or necessary to implement the devices, systems, and methods described herein. However, because such elements and steps do not facilitate a better understanding of the disclosed embodiments, a discussion of such elements and steps may not be provided herein. In implementations, the catheter 10000 can include and / or be implemented with one or more of the catheters described in FIGS 1-5 and 7-9 and the method of FIG. 6.

[0065] The catheter 10000 can be a balloon catheter which includes a core 10100 and a balloon 10200 connected to the core 10100. A printed trace 10300 may be deposited on onto an outer surface of the balloon 10200 using printed electronics processes as described herein. In implementations, the printed trace 10300 can have a pointed, rounded, shaped, substantially pointed, substantially rounded, substantially shaped, and / or combinations thereof form or shape. In implementations, the printed trace 10300 can have an apex. In implementations, the shape of the printed trace 10300 can enable directed or focused radio frequency (RF) emissions or energy at a target location to dislodge plaque and / or other therapeutic activity, for example.

[0066] FIG. 12 is a side view of a catheter 12000 in accordance with certain implementations and FIG. 13 is a top view of a photograph of a printed strain gauge 13000 for use with the catheter 12000 of FIG. 12 in accordance with certain implementations. The catheter 12000 and the components therein may include other elements which may be desirable or necessary to implement the devices, systems, and methods described herein. However, because such elements and steps do not facilitate a better understanding of the disclosed embodiments, a discussion of such elements and steps may not be provided herein. In implementations, the catheter 12000 can include and / or be implemented with one or more of the catheters described in FIGS 1-5 and 7-11 and the method of FIG. 6.

[0067] The catheter 12000 may include a tubular member 12050. The tubular member 12050 may have a core 12100 and one or more layers 12200. A pair of printed traces 12300 and 12310 may be deposited onto different portions of an outer surface of the core 12100 using printed electronics processes as described herein. A printed electronic such as a strain gauge 12400 can be deposited onto a portion of the outer surface of the core 12100 using printed electronics processes as described herein. The strain gauge 12400 is connected to the pair of printed traces 12300 and 12310. A printed electronic such as a printed electrode 12500 can be deposited as a cap for the catheter 12000. The printed electrode 12500 can be connected to the strain gauge 12400. In implementations, the strain gauge 12400 can be the strain gauge 13000. A layer of the one or more layers 12200 can be placed on the printed traces 12300 and 12310, the strain gauge 12400, and the core 12100 such that the printed traces 12300 and 12310 and the strain gauge 12400 become embedded between the core 12100 and the layer of the one or more layers 12200.

[0068] In implementations, the strain gauge 12400 can be used to measure the flex of the catheter 12000 as it touches or engages a cardiac vessel inside a ventricle or other internal area. As the catheter 12000 bends, the strain gauge 12400 measures the change in resistance. For example, in an ablation catheter, increased pressure results in greater ablation. Accordingly, measurements from the strain gauge 12400 can be used to determine amount of force being applied. This can be used in a feedback loop to control pressure.

[0069] In implementations, a temperature probe 12600 can be provided via a lumen in the core 12100 as described herein. Measurements from the temperature probe 12600 can be used in a feedback loop to control amount of cooling via lumens (as described for FIGS. 8 and 9) that can be provided at a site.

[0070] Described herein are catheters and methods of manufacturing catheters based on printed electronics, integration of non-printed components, i.e., flexible hybrid electronics, and printed electronics processing. In implementations, a catheter includes a steerable sheath including an anchor ring and pull wires connected to the anchor ring, printed traces printed onto the steerable sheath using printed electronics processes, and printed components printed onto the steerable sheath and connected to the steerable sheath and the printed traces using the printed electronics processes.

[0071] In implementations, the catheter is a diagnostic catheter. In implementations, the catheter is a therapeutic catheter. In implementations, the printed components include at least printed electrodes. In implementations, the printed components include at least printed electrodes and printed electronics. In implementations, the catheter further includes mountableelectronics mounted to the catheter and the printed traces. In implementations, the catheter is a balloon catheter including a balloon section, the balloon catheter further including printed components printed onto an outside or periphery of the balloon. In implementations, the balloon catheter further includes printed traces printed onto an outside or periphery of the balloon in a variety of shapes and sizes to implement different applications. In implementations, diagnostic or therapeutic application is achieved using a smaller number of devices inserted into a patient. In implementations, the steerable sheath includes a core, a layer on the printed components printed onto the steerable sheath, additional printed traces printed onto the layer using the printed electronics processes, and additional printed components printed onto the layer and connected to the layer and the additional printed traces using the printed electronics processes. In implementations, the core includes one or more lumens. In implementations, the core includes one or more ports, each port connected to a lumen of the one or more lumens. In implementations, the catheter is a balloon catheter including a balloon section, the balloon catheter further including printed traces printed onto an outside or periphery of the balloon, wherein a printed trace has a shaped apex. In implementations, the shaped apex enables directed radio frequency (RF) emissions at a target. In implementations, the one of the printed components is a strain gauge and another of the printed components is an electrode cap, the strain gauge connected to the electrode cap and the printed traces. In implementations, the catheter further including a temperature probe provided via a lumen in the catheter. In implementations, information from the printed components or attached components enable a feedback loop to control the printed components, the catheter, cooling at a target site, irrigation at the target site, or combinations thereof.

[0072] In implementations, a method for manufacturing a catheter includes forming a steerable sheath, the steerable sheath including an anchor ring and pull wires connected to the anchor ring, printing a trace onto the steerable sheath using printed electronics processing, and printing a printed component onto the steerable sheath using the printed electronics processing and connected to a printed trace and the steerable sheath.

[0073] The construction and arrangement of the methods as shown in the various exemplary embodiments are illustrative only. Although only a few embodiments have been described in detail in this disclosure, many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, use of materials and components, colors, orientations, etc.). For example, the position of elements may be reversed or otherwise varied and the nature or number of discrete elements or positions may be altered or varied. Accordingly, all such modificationsare intended to be included within the scope of the present disclosure. The order or sequence of any process or method steps may be varied or re-sequenced according to alternative embodiments. Other substitutions, modifications, changes, and omissions may be made in the design, operating conditions, and arrangement of the exemplary embodiments without departing from the scope of the present disclosure.

[0074] Although the figures may show a specific order of method steps, the order of the steps may differ from what is depicted. Also two or more steps may be performed concurrently or with partial concurrence. Such variation will depend on the software and hardware systems chosen and on designer choice. All such variations are within the scope of the disclosure. Likewise, software implementations could be accomplished with standard programming techniques with rule-based logic and other logic to accomplish the various connection steps, processing steps, comparison steps, and decision steps.

[0075] While the disclosure has been described in connection with certain embodiments, it is to be understood that the disclosure is not to be limited to the disclosed embodiments but, on the contrary, is intended to cover various modifications and equivalent arrangements included within the scope of the appended claims, which scope is to be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures as is permitted under the law.

Claims

What is claimed is:

1. A catheter comprising : a steerable sheath including an anchor ring and pull wires connected to the anchor ring; printed traces printed onto the steerable sheath using printed electronics processes; and printed components printed onto the steerable sheath and connected to the steerable sheath and the printed traces using the printed electronics processes.

2. The catheter of claim 1 , wherein the catheter is a diagnostic catheter.

3. The catheter of claim 1 , wherein the catheter is a therapeutic catheter.

4. The catheter of claim 1, wherein the printed components include at least printed electrodes.

5. The catheter of claim 1, wherein the printed components include at least printed electrodes and printed electronics.

6. The catheter of claim 1 , further comprising: mountable electronics mounted to the catheter and the printed traces.

7. The catheter of claim 1, wherein the catheter is a balloon catheter including a balloon section, the balloon catheter further comprising: printed components printed onto an outside or periphery of the balloon.

8. The catheter of claim 7, wherein the balloon catheter further comprising: printed traces printed onto an outside or periphery of the balloon in a variety of shapes and sizes to implement different applications.

9. The catheter of any of claims 2, 3, 7, and 8, wherein diagnostic or therapeutic application is achieved using a smaller number of devices inserted into a patient.

10. The catheter of any of claims 1-9, wherein the steerable sheath comprising: a core; a layer on the printed components printed onto the steerable sheath; additional printed traces printed onto the layer using the printed electronics processes; and additional printed components printed onto the layer and connected to the layer and the additional printed traces using the printed electronics processes.

11. The catheter of any of claims 10, wherein the core includes one or more lumens.

12. The catheter of any of claims 11, wherein the core includes one or more ports, each port connected to a lumen of the one or more lumens.

13. The catheter of claim 1, wherein the catheter is a balloon catheter including a balloon section, the balloon catheter further comprising: printed traces printed onto an outside or periphery of the balloon, wherein a printed trace has a shaped apex.

14. The catheter of claim 13, wherein the shaped apex enables directed radio frequency (RF) emissions at a target.

15. The catheter of any of claims 1-14, wherein one of the printed components is a strain gauge and another of the printed components is an electrode cap, the strain gauge connected to the electrode cap and the printed traces.

16. The catheter of any of claims 1-15, further comprising: a temperature probe provided via a lumen in the catheter.

17. The catheter of any of claims 1-16, wherein information from the printed components or attached components enable a feedback loop to control one or more of the printed components, the catheter, cooling at a target site, or irrigation at the target site.

18. A method for manufacturing a catheter comprising: forming a steerable sheath, the steerable sheath including an anchor ring and pullwires connected to the anchor ring; printing a trace onto the steerable sheath using printed electronics processing; and printing a printed component onto the steerable sheath using the printed electronics processing and connected to a printed trace and the steerable sheath.

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