Catheter handle with compliant circuitry

Abstract

A catheter can include a catheter shaft, an electrical conductor, a catheter handle, and a compliant circuit. The catheter shaft can include a proximal end and a distal end having at least one electrode or sensor. The electrical conductor can be coupled to the catheter shaft. The electrical conductor can be communicatively coupled to the electrode or sensor at the distal end of the catheter shaft. The handle can be coupled to the proximal end of the catheter shaft and can include a non-planar surface. The compliant circuit can be configured to communicate with an electronic control unit and to conform to the non-planar surface. In one example, the compliant circuit can be electrically coupled to the electrode or sensor through the electrical conductor. In various examples, the compliant circuit can include material properties that stretch and conform to the non-planar surface.

Description

TECHNICAL FIELD

[0001] The present disclosure relates to catheters, such as catheter handles. In one example, the present disclosure relates to a catheter handle comprising a compliant circuit. BACKGROUND

[0002] Catheters have been used for cardiac medical procedures for many years. For example, catheters can be used to diagnose and treat cardiac arrhythmias. A catheter can be placed at a particular location within the body that would otherwise not be accessible without a more invasive procedure. Typically, the catheter can be in communication with a control unit to receive signals from electrodes or sensors of the catheter. The signals can be transmitted through one or more insulated leads. The insulated leads can pass through a handle of the catheter. The leads can terminate in connectors or welds to complete the electrical connection between the electrodes, sensors, and the control unit. The size and shape of the handle can be configured to fit an operator’s hand and provide proper control of the catheter by the operator.

[0003] In many cases, catheters are used in a surgical operating room. The surgical operating room can be a noisy electrical environment. For example, electronic components within the surgical operating room can be exposed to electromagnetic interference from other devices within the surgical operating room. In one example, an electric field-based positioning system can generate an electric field that is used to identify a location of a medical device, such as a catheter, within a patient. The electric field can cause electromagnetic interference.

[0004] The foregoing discussion is merely provided for illustration and shall not be considered to bind in any way to the scope of the claims. SUMMARY

[0005] The present disclosure relates to catheters, such as high-density mapping catheters, mapping catheters for diagnosis, or catheters for medical treatment. For example, catheters can be used to treat cardiac arrhythmias, for example, via ablation. Some examples of catheters can include irrigation. In particular, the present disclosure relates to handles of catheters, such as handles comprising a compliant circuit configured to be disposed on a non-planar surface of the handle. As used herein, the term compliant layer or circuit should be understood to mean a layer or circuit that closely conforms to the shape of an adjacent proximal surface, including a non-planar surface.

[0006] In one example, a catheter can include a catheter shaft, an electrical conductor, a catheter handle, and a compliant circuit. The catheter shaft can include a proximal end and a distal end having at least one electrode or sensor. The electrical conductor can be coupled to the catheter shaft. The electrical conductor can be communicatively coupled to the electrode or sensor located at the distal end of the catheter shaft. The handle can be coupled to the proximal end of the catheter shaft and can include a non-planar surface. The compliant circuit can be configured to communicate with an electronic control unit and to conform to the non-planar surface. In one example, the compliant circuit can be electrically coupled to the electrode or sensor through the electrical conductor. In various examples, the compliant circuit can include material properties that stretch and conform to the non-planar surface. In other examples, the compliant circuit can include at least one dielectric layer and at least one conductive layer. At least one of the dielectric layer and at least one of the conductive layer can include respective material properties. In one example, the conductive layer can include a printable conductive polymer, such as a conductive ink.

[0007] In some examples, the compliant circuit can include a logic component embedded within the compliant circuit. The logic component can be electrically coupled to at least one of the conductive layers. In various examples, the logic component can be configured as one of an analog-to-digital converter, a multiplexer, a filter, an amplifier, or a combination thereof. In one example, the logic component can include a semiconductor. For example, the logic component can include a p-type material or an n-type material.

[0008] In one example, a method of manufacturing a catheter handle can include disposing a compliant circuit along a non-planar surface of the catheter handle. The method can further include conforming the compliant circuit to the non-planar surface. In some examples, the compliant circuit includes a dielectric layer, a plurality of conductive layers, a first connection interface, and a second connection interface. The dielectric layer can include dielectric material properties and each of the plurality of conductive layers can include conductive material properties. The first connection interface can be electrically coupled to at least one of the conductive layers. The second connection interface can be electrically coupled to at least one of the conductive layers. In certain instances, at least one of the conductive layers can include a strain relief feature. In one example, at least one of the conductive layers can be a printed conductive layer, such as a printed conductive polymer, a conductive ink, or the like. In other examples, a logic component can be formed within the compliant circuit. The logic component can include a semiconductor. For example, the logic component can include a p-type material, an n-type material, or both.

[0009] The foregoing and other aspects, features, details, utilities, and advantages of the present disclosure will be better understood from the following description and drawings, wherein: BRIEF DESCRIPTION OF DRAWINGS

[0010] Figure 1 is an example of a system for navigating a medical device in vivo in accordance with the present description, the system including a catheter.

[0011] Figure 2 is an example of a handle of a catheter having a conformal circuit disposed on a non-planar surface of the handle according to the present description.

[0012] Figure 3 is an example of a handle of a catheter having a conformal circuit disposed on a non-planar surface of the handle according to the present description.

[0013] Figure 4 is an example of a cross-section of a conformal circuit including at least one logic component according to the present description.

[0014] Figure 5 is an example of a method for manufacturing a catheter assembly including a conformal circuit disposed on a handle according to the present description. DETAILED DESCRIPTION

[0015] The present disclosure relates to catheters, such as high-density mapping catheters, mapping catheters for diagnosis, or catheters for medical treatment. For example, catheters can be used to treat cardiac arrhythmias, for example, via ablation. In some examples, catheters of the present disclosure can include irrigation catheters configured to irrigate tissue during an ablation procedure. In particular, the present disclosure relates to handles of catheters, such as handles including conformal circuits configured to be disposed on a surface of the handle, such as a non-planar surface. Details of various examples of the present disclosure are described below with specific reference to the drawings.

[0016] Figure 1 One example of a system 100 for navigating a medical device within a body 112 is shown. In the example shown, the medical device includes a catheter 114 that is shown schematically entering a heart that has been dissected away from the body 112. In this example, the catheter 114 is depicted as an irrigated radiofrequency (RF) ablation catheter for treating cardiac tissue 116 in the body 112. However, it should be appreciated that the system 100 can find application in relation to various medical devices for diagnosis or treatment within the body 112. For example, the system 100 can be used to navigate an electrophysiology mapping catheter, an intracardiac echocardiography (ICE) catheter, or an ablation catheter using different types of ablation energy (e.g., cryoablation, ultrasound, etc.). Further, it should be appreciated that the system 100 can be used to navigate medical devices for diagnosis or treatment of portions of the body 112 other than the cardiac tissue 116. Further description of the system and components is contained in U.S. Patent Application 13 / 839,963, filed March 15, 2013, which is incorporated by reference herein in its entirety as if fully set forth herein.

[0017] Still referring to Figure 1The ablation catheter 114 is connected to a fluid source 118 for delivering a biocompatible flushing solution, such as saline, via a pump 120, which may include, for example, a fixed-rate roller pump or a variable-volume syringe pump, having a gravity-feed supply from the fluid source 118 as shown. The catheter 114 is also electrically connected to an ablation generator 122 for delivering RF energy. The catheter 114 may include a handle 124, a cable connector or interface 126 at the proximal end of the handle 124, and a shaft 128. The shaft 128 may include a proximal end 130, a distal end 132, and one or more electrodes 134. The connector 126 provides mechanical, fluid, and electrical connections for tubing or cables extending from the pump 120 and the ablation generator 122. The catheter 114 may also include other conventional components not shown here, such as temperature sensors, additional electrodes, and corresponding conductors or leads.

[0018] Handle 124 provides a physician with a means of holding catheter 114 in place and may further provide means for manipulating or guiding shaft 128 within body 112. For example, handle 124 may include means for changing the length of one or more drawstrings extending from handle 124 through catheter 114 to the distal end 132 of shaft 128. The construction of handle 124 can vary. In various examples, handle 124 may be configured to fit within the user's hand, for example, to provide control over the manipulation of catheter 114. Therefore, the size and shape of handle 124 may be important for the functionality and usability of catheter 114.

[0019] The shaft 128 may be made of a conventional material such as polyurethane and may define one or more cavities configured to receive and / or transport an electrical conductor 156, fluid, or surgical instrument. The shaft 128 may be introduced into a blood vessel or other structure within the body 112 using a conventional introducer. The shaft 128 may then be manipulated or guided through the body 112 to a desired location, such as tissue 116, using a guide wire or drawstring or other methods known in the art, including a remote guidance system. The shaft 128 may also allow the transport, delivery, and / or removal of fluids (including irrigation fluids and bodily fluids), drugs, and / or surgical instruments or apparatus. It should be noted that a variety of methods may be used to introduce the shaft 128 into the area within the body 112. This may include introducers, sheaths, guide sheaths, guide members, guide wires, or other similar devices. For ease of discussion, the term introducer will always be used.

[0020] System 100 may include an electric field-based positioning system 136, a magnetic field-based positioning system 138, a display 140, and an electronic control unit (ECU) 142 (e.g., a processor). Each exemplary system component is further described below.

[0021] An electric field-based positioning system 136 and a magnetic field-based positioning system 138 are provided to determine the position and orientation of the catheter 114 and similar devices within the body 112. The position and orientation of the catheter 114 and similar devices within the body 112 can be determined by the system 136 and / or the system 138. The system 136 can include, for example, the EnSite® NavX® system sold by St. Jude Medical, Inc., of St. Paul, MN, and described in, for example, U.S. Patent No. 7,263,397, entitled "Method and Apparatus for Catheter Navigation and Location Mapping in the Heart," the entire disclosure of which is incorporated herein by reference as if fully set forth herein. The systems 136 and 138 can include, for example, the EnSite Precision® system sold by St. Jude Medical, Inc., of St. Paul, MN. The system 136 operates on the principle that when a low-amplitude electrical signal is passed through the thorax, the body 112 acts as a voltage divider (or potentiometer or rheostat) such that the potential or field strength measured at one or more electrodes 134 on the catheter 114 can be used to determine the position of the electrodes, and thus the catheter 114, relative to a pair of external patch electrodes using Ohm's law and the relative position of the reference electrode (e.g., in the coronary sinus). TM NavX TM system, and described in, for example, U.S. Patent No. 7,263,397, entitled "Method and Apparatus for Catheter Navigation and Location Mapping in the Heart," the entire disclosure of which is incorporated herein by reference as if fully set forth herein. The systems 136 and 138 can include, for example, the EnSite Precision TM system sold by St. Jude Medical, Inc., of St. Paul, MN. The system 136 operates on the principle that when a low-amplitude electrical signal is passed through the thorax, the body 112 acts as a voltage divider (or potentiometer or rheostat) such that the potential or field strength measured at one or more electrodes 134 on the catheter 114 can be used to determine the position of the electrodes, and thus the catheter 114, relative to a pair of external patch electrodes using Ohm's law and the relative position of the reference electrode (e.g., in the coronary sinus).

[0022] In Figure 1 the illustrated configuration, the electric field-based positioning system 136 also includes three pairs of patch electrodes 144 provided to generate electrical signals used to determine the position of the catheter 114 within a three-dimensional coordinate system 146. The electrodes 144 can also be used to generate electro-physiological (EP) data about the tissue 116. To create axis-specific electric fields within the body 112, patch electrodes are placed on opposite surfaces of the body 112 (e.g., the chest and back, the left and right sides of the thorax, and the neck and leg) and form generally orthogonal X, Y, and Z axes. A reference electrode / patch (not shown) is typically placed near the abdomen and provides a reference value and serves as the origin of the coordinate system 146 for the navigation system.

[0023] According to this exemplary system 136 as shown in Figure 1 , the patch electrodes include a right side patch 144 X1 , a left side patch 144 X2 , a neck patch 144 Y1 , a leg patch 144 Y2 , a chest patch 144 Z1 , and a back patch 144 Z2and each patch electrode is connected to a switch 148 (e.g., a multiplexing switch) and a signal generator 150. The patch electrodes 144 X1 , 144 X2 are placed along a first (X) axis; the patch electrodes 144 Y1 , 144 Y2 are placed along a second (Y) axis, and the patch electrodes 144 Z1 , 144 Z2 are placed along a third (Z) axis. A sinusoidal current is driven through each pair of patch electrodes, and voltage measurements are obtained for one or more position sensors associated with the catheter 114 (e.g., ring electrodes 134 or tip electrodes located near the distal end 132 of the catheter shaft 128). The measured voltage is a function of the distance between the position sensors and the patch electrodes. The measured voltage is compared to the potential at the reference electrode, and the position of the position sensors within the coordinate system 146 of the navigation system is determined.

[0024] In this example, the magnetic field-based positioning system 138 employs magnetic fields to detect the position and orientation of the catheter 114 within the body 112. The system 138 can include a GMP S system provided by MediGuide, Ltd., which is generally shown and described in, e.g., U.S. Patent No. 7,386,339, entitled "Medical Imaging and Navigation System," the entire disclosure of which is incorporated by reference as if fully set forth herein. In such a system, a magnetic field generator 152 can be used, which has three orthogonally arranged coils (not shown) to create magnetic fields within the body 112 and control the strength, direction, and frequency of the magnetic fields. The magnetic field generator 152 can be located above the patient or below (e.g., under a patient bed) or another suitable location. Magnetic fields are generated by the coils, and current or voltage measurements are obtained for one or more position sensors (not shown) associated with the catheter 114. The measured current or voltage is proportional to the distance of the sensors from the coils, allowing the position of the sensors within the coordinate system 154 of the system 138 to be determined.

[0025] A display 140 is provided to convey information to the physician to aid in diagnosis and treatment. The display 140 can include one or more conventional computer monitors or other display devices. The display 140 can present a graphical user interface (GUI) to the physician. The GUI can include various information, including, e.g., images of the geometry of the tissue 116, electrophysiological data related to the tissue 116, plots showing voltage levels of various electrodes 134 over time, and images of the catheter 114 and other medical devices, and related information indicating the position of the catheter 114 and other devices relative to the tissue 116.

[0026] The ECU 142 provides a means for controlling the operation of various components of the system 100, including the catheter 114, the ablation generator 122, and the magnetic generator 152 of the magnetic field-based positioning system 138. The ECU 142 can also provide a means for determining the geometry of the tissue 116, the electrophysiological properties of the tissue 116, and the position and orientation of the catheter 114 relative to the tissue 116 and the body 112. The ECU 142 also provides a means for generating display signals for controlling the display 140.

[0027] As the catheter 114 moves within the body 112 and within the electric field generated by the electric field-based positioning system 136, the voltage readings from the electrodes 134 change, indicating the position of the catheter 114 within the electric field and within the coordinate system 146 established by the system 136. The ring electrodes 134 can be adapted to transmit the position signals to the ECU 142.

[0028] Figure 2is an example of a flexible circuit (e.g., a compliant circuit 200). The compliant circuit 200 can route signals between the ECU 142 and electrodes or sensors of the shaft 128. For example, the signals can include electrophysiology signals. The compliant circuit 200 can include dielectric layers 202, conductive layers 204, a first connection interface 208, and a second conductive interface 210. The compliant circuit 200 can include a plurality of routing traces configured to communicate signals between the ECU 142 and electrodes 134 or sensors of the shaft 128. One or more conductive layers 204 can be disposed on one or more dielectric layers 202 to communicate signals within the compliant circuit 200. For example, the conductive layers 204 can be configured to include a plurality of routing traces 214 to communicate various signals within the compliant circuit 200. The catheter typically uses insulated wires to communicate electrical signals between the ECU 142 and various electrodes 134 or sensors. The traces 214 can include a thickness, width, spacing, or a combination thereof of the traces to provide a dense circuit routing. For example, the plurality of traces 214 of the compliant circuit 200 can have a higher density than the insulated wires. In an example, the width of the traces 214 can be 0.01 to 0.25 mm, and the spacing of the traces 214 can be 0.01 to 0.25 mm. Other thickness, width, and spacing of the traces can also be considered. The various conductive layers 204 can be electrically coupled through one or more conductive vias. In some cases, the size of the handle 124 can limit the number of insulated wires that can be disposed therein for communicating signals with the various electrodes 134 and sensors. Due to the relatively higher density of the traces 214, the compliant circuit 200 can have a relatively smaller size compared to the corresponding number of insulated wires. Thus, the compliant circuit 200 can communicate a higher number of signal traces 214 through the limited size and shape of the handle 124 compared to the insulated wires. For example, the compliant circuit 200 can communicate signals from a plurality of electrical conductors 156 (such as 10, 50, 100, 200, 250), or other number of signals corresponding to the number of electrical conductors 156.

[0029] In some examples, the dielectric layers 202 and the conductive layers 204 can be compliant. For example, the conductive layers 204 can be compliant (also referred to herein as compliant conductive layers), and the dielectric layers 202 can be compliant (also referred to herein as compliant dielectric layers). The compliant conductive layers 204 and the compliant dielectric layers 202 can be used independently or in combination with less compliant materials (e.g., copper foil, polyimide, FR4, etc.).

[0030] In various examples, the material of the compliant dielectric layer (dielectric material) can include, but is not limited to, silicone, polydimethylsiloxane (PDMS), polyethylene terephthalate (PET), polyurethane [e.g., thermoplastic polyurethane (TPU)], poly(p-phenylene terephthalate) polymer, poly(methyl methacrylate) (PMMA), poly[styrene-b-(ethylene-co-butylene)-b-styrene] triblock copolymer (SEBS), ionic liquid [1-butyl-3-methylimidazolium bis(trifluoromethylsulfonyl) imide (BMITFSI)], fluorine-containing copolymer, fluorine-containing rubber, silicone, cellulose fiber, polyester fiber, poly(styrene-co-ethylene butylene-co-styrene), graphene, polyacrylamide hydrogel with sodium chloride (NaCl) electrolyte, poly(2-methacryloyloxyethyltrimethylammonium chloride) (PMETAC), silicon dioxide (Si02), poly(tert-butyl acrylate-co-acrylic acid), poly(TBA-co-AA) film (bistable electroactive polymer), polytetrafluoroethylene (PTFE), and the like.

[0031] In some examples, the material of the compliant conductive layer (conductive material) can include, but is not limited to, conductive stretchable polymer, printable conductive polymer, conductive stretchable ink, indium tin oxide (ITO), single-walled carbon nanotube, multi-walled carbon nanotube, carbon nanotube ribbon, carbon nanotube aerogel, poly[styrene-b-(ethylene-co-butylene)-b-styrene] triblock copolymer complexed with single- or multi-walled carbon nanotubes, polyaniline (PANI) covalently bonded to poly(styrene-co-ethylene butylene-co-styrene), poly(3,4-ethylenedioxythiophene): poly(styrene sulfonate) (PEDOT:PSS), poly(3,4-ethylenedioxy-thiophene): p-toluenesulfonate (PEDOT), polyacrylic acid (PAA) infused with gold (Au) or titanium (Ti) or palladium (Pd) ions, copper (e.g., copper nanoparticles), gold (e.g., gold nanoparticles), silver (e.g., silver nanoparticles), zinc (e.g., zinc nanoparticles), spherical citrate-stabilized gold nanoparticles, gold nanowires, gallium arsenide (GaAs) nanoribbons, silicon (Si) nanoribbons, silicon nanowires, graphene, and silver nanowire hybrid foam, and the like. In instances where the compliant conductive layer includes a rigid material such as gold, titanium, palladium, copper, silver, zinc, and the like, the conductive material can be combined with a material that is more compliant to form a composite material. In another example, the conductive material can include at least one strain relief feature 206 (described below) to increase the malleability and compliance of the conductive material to form a compliant conductive material.

[0032] The dielectric layer 202, conductive layer 204, or both may each include their respective material properties (e.g., elastic properties), such as dielectric material properties and conductive material properties. For example, the compliant circuit 200 may be compliant along its length and width based on the respective dielectric and conductive material properties of the individual layers (e.g., dielectric layer 202 and conductive layer 204), other elements of the compliant circuit 200, and the compliant circuit 200 as a whole. In examples, the compliant circuit 200 may be bent or stretched simultaneously along a first axis (e.g., X-axis 216), a second axis (e.g., Y-axis 218), or any combination thereof, based on the respective material properties of the compliant circuit 200. For example, the compliant circuit may be stretched or bent along the first and second axes while conforming to a non-planar surface. In some examples, the conductive material properties, dielectric material properties, or both may include an elastic modulus less than that of steel, aluminum, ceramics, glass, polycarbonate, polyimide, etc. For example, the elastic modulus of the material can be from 0.1 GPa to 2.0 GPa, 0.1 GPa to 1.5 GPa, 0.1 GPa to 1.0 GPa, or 0.1 GPa to 0.5 GPa. In another example, based on the corresponding material properties, a material such as a dielectric or conductive material can be permanently deformed when stretched or compliant with a non-planar surface. For example, when stretched or compliant, in some examples, the dielectric or conductive material will not return to its original shape. Therefore, the compliant circuit 200 can be arranged along the non-planar surface. Figure 3 As shown and described herein, the compliant circuit 200 can conform to a non-planar surface. In the example, the compliant circuit 200 can take a shape corresponding to the shape of the non-planar surface. In other words, the compliant circuit 200 can conform to a non-planar surface. The non-planar surface can include any non-planar shape, such as arcs, angles, irregular shapes, or other non-planar shapes.

[0033] In the example, conductive layer 204 may include strain relief feature 206. Strain relief feature 206 can increase the flexibility of one or more traces of conductive layer 204 (such as trace 214). Strain relief feature 206 may include, but is not limited to, serrated, horseshoe-shaped, wavy, open-loop, or other geometries that can mitigate damage to conductive layer 204 under stress. For example, strain relief feature 206 can increase the extendable length of trace 214. In some examples, conductive layer 204 may be a metallic layer, such as copper or a copper alloy. Strain relief feature 206 can provide compliant properties to conductive layer 204, thus making conductive layer 204 compliant. For example, the material properties of conductive layer 204 may be at least partially based on strain relief feature 206.

[0034] like Figure 2As shown in the example, the compliant circuit 200 may include at least one connection interface, such as a first connection interface 208 at the distal end of the compliant circuit 200 or a second connection interface 210 at the proximal end of the compliant circuit 200. The first connection interface 208 or the second connection interface 210 may include, but is not limited to, pads, electrical connectors, springs, probe contacts, etc. Figure 2 In the example, the first connection interface 208 and the second connection interface 210 are pads. The first connection interface 208 can provide an electrical connection to one or more electrical conductors 156 of the shaft 128. The second connection interface 210 can provide an electrical connection to the ECU 142 or the ablation generator 122. Therefore, the compliant circuit 200 can (e.g., by means of one or more electrical conductors 156) be electrically coupled to one or more electrodes 132 or sensors and the ECU 142, the ablation generator 122, or any combination thereof.

[0035] like Figure 2 As further shown, the compliant circuit 200 may include at least one logic component 212. For example, the logic component 212 may be included in or configured as a logic circuit or integrated circuit. In various examples, the logic component 212 may include, but is not limited to, amplifiers, multiplexing circuits, transistors, diodes, switches, analog-to-digital converters, isolators (filters), memory, or other logic elements. An electric field generated by the electric field-based positioning system 136 or a magnetic field generated by the magnetic field-based positioning system 138 may interfere with one or more signals transmitted through the electrical conductor 156. The logic component 212 may modulate the signal to mitigate interference from electromagnetic radiation. For example, signal modulation may include, but is not limited to, reducing interference, improving the signal-to-noise ratio, amplifying signal power, filtering the signal, or providing other signal conditioning. The logic component 212 may increase the signal-to-noise ratio or strength of the signal received at the ECU 142. For example, positioning the logic component 212 in the handle 124 may reduce the length of one or more electrical conductors 156 exposed to interference. As a result, the signal received at the handle 124 may have less interference than the corresponding signal transmitted all the way to the ECU 142. Therefore, applying signal conditioning using logic unit 212 at handle 124 is more effective than at ECU 142. Thus, signal integrity can be increased by positioning logic unit 212 within handle 124.

[0036] In another example, logic unit 212 can convert signals between analog and digital. In some cases, digital signals may be less sensitive to interference than analog signals. For example, interference is often analog. Analog interference can be filtered out from digital signals to reduce the signal-to-noise ratio.

[0037] In another example, the logic component 212 can multiplex signals to reduce the number of electrical conductors used to communicate with the ECU 142. Accordingly, the size of the compliant circuit can be reduced. In turn, the size of the handle 124 can be reduced, for example, to provide an ergonomic shape.

[0038] Figure 3 An exploded view of an example of the catheter 300 is shown, including a portion 316 of the handle 324, the compliant circuit 314, the shaft 302, and the electrical cable 318. The handle 324 can include a non-planar surface, such as the non-planar surface 322. For example, at least a portion of the interior of the handle 324 can include the non-planar surface 322. In some examples, the catheter handle can include a combination of planar and non-planar surfaces. In another example, the catheter handle can have a flat side surface and a curved edge that joins the side surface with an adjacent surface. The non-planar surface 322 can include, but is not limited to, any non-planar shape, such as an arc, an angle, an irregular shape, or other non-planar shape. As shown in the example of FIG. 3, the non-planar surface 322 is a curved surface. In another example, the non-planar surface 322 can be a flat surface with a curved edge that joins the flat surface with an adjacent surface. Figure 3 In the example shown in FIG. 3, the portion 316 of the handle 324 is a lower half of the handle 324. The compliant circuit 314 can be disposed in the handle 324, for example, along the non-planar surface 322. For example, depending on the material properties of the compliant circuit 314, the compliant circuit 314 can stretch and conform to the non-planar surface 322. A portion of the compliant circuit 314 or the entire compliant circuit 314 can be disposed along the non-planar surface 322. In some examples, the compliant circuit 314 can include the logic component 312 (e.g., the logic component 212 as shown in and described herein). The logic component 312 can be electrically coupled to the compliant circuit 314 by various interconnects, such as surface mount leads, through-hole leads, ball grid array, wire bonds, conductive adhesive, etc. In another example, the logic component 312 can be embedded into the compliant circuit 300, as shown in and described herein. Figure 2 Figure 4

[0039] By having the compliant circuit 300 conform to the non-planar surface 322 (e.g., the interior surface of the handle 324), an interior volume within the handle 324 can remain unobstructed by the compliant circuit 314. Accordingly, the compliant circuit 314 can conserve space within the handle 324, for example, to accommodate a flush tube, a pull wire, etc.

[0040] ​​In some examples, the conformal circuit 314 can be sized and shaped to conform to the non-planar surface 322. Adapting the shape of the conformal circuit 314 to fit along the non-planar surface 322 can increase the size of the conformal circuit 314 to be mounted to the handle 324. For example, a planar circuit can be positioned across the width (e.g., diameter) of the handle 324. The conformal circuit 314 can conform to the non-planar surface 322 (e.g., along the cross-sectional perimeter or circumference of the handle 324), which provides a greater surface area for the conformal circuit 314 to be mounted within the handle 324. Thus, the surface area of the conformal circuit 314 mounted in the handle 324 can be increased when sized and shaped to the non-planar surface 322. Accordingly, the area for routing signals (e.g., for traces) and for logic components 312 can be increased.

[0041] In some examples, at least a portion of the conformal circuit 314 can be attached to the non-planar surface 322. For example, the conformal circuit 314 or at least a portion thereof can be bonded to the non-planar surface 322 by an adhesive. The adhesive can include, but is not limited to, a pressure sensitive adhesive, a heat activated adhesive, a light activated adhesive, or other adhesive. In another example, at least a portion of the conformal circuit 314 can be insert molded into the non-planar surface 322. In another example, the conformal circuit 314 can be heat formed or heat bonded to the non-planar surface 322.

[0042] The catheter 300 can be communicatively coupled with the shaft 302 and the cable 318. In Figure 3 examples, the shaft 302 and the cable 318 are shown in exploded view and decoupled from the conformal circuit 314. The shaft 302 can include a plurality of electrical conductors 306 and a plurality of electrical contacts 304 communicatively coupled to the one or more electrical conductors 306. In Figure 3 examples, the shaft 302 can include a flexible circuit. The electrical conductors 306 can be traces along the flexible circuit, and the electrical contacts 304 can be solder pads or exposed conductive pads. In some examples, the flexible circuit can be folded or formed into a cylindrical shape. A proximal end of the flexible circuit can be transitioned to a more planar shape to couple the electrical contacts 304 with the conformal circuit 314. For example, the electrical contacts 304 of the shaft 302 can be electrically coupled to a connection interface of the conformal circuit 314, such as the first connection interface 308. In some examples, the electrical contacts 304 can be soldered to the first connection interface 308, bonded to the first connection interface by a conductive adhesive, or communicatively coupled by other methods. Accordingly, the one or more electrical conductors 306 can be communicatively coupled with the conformal circuit 314.

[0043] At a proximal end, the handle 324 can be communicatively coupled with the cable 318. The cable 318 can include a plurality of electrical conductors 320. The cable 318 can include or can be electrically coupled to one or more flexible circuits 326. InFigure 3 In the example, cable 318 includes three flexible circuits 326. Electrical conductor 320 may be a trace of the flexible circuit 326 and may include solder pads or exposed conductive pads. Electrical conductor 320 may be electrically coupled to a connection interface of compliant circuit 314, such as a second connection interface 310. In some examples, electrical conductor 320 may be soldered to the second connection interface 310, bonded to the second connection interface 310 by conductive adhesive, or communicatively coupled by other methods. Therefore, compliant circuit 314 can transmit signals between electrical conductor 306 and ECU 142 or ablation generator 122. In some examples, connection interfaces 308, 310, electrical contacts 304, flexible circuits, electrical conductors 320, 306, 320, etc., may be compliant, such as... Figure 3 As shown in the example. Accordingly, electrical conductors 306, 320 can be communicatively coupled to connection interfaces 308, 310 along a non-planar surface (e.g., non-planar surface 322).

[0044] Figure 4 This is an example of a cross-section of a compliant circuit 400 including at least one embedded logic component 418. The compliant circuit 400 may include at least one dielectric layer 402, multiple conductive layers, and at least one semiconductor 410. For example, the compliant circuit 400 may include a first conductive layer 404, a second conductive layer 406, and a third conductive layer 408. Conductive layers 404, 406, or 408 may include, but are not limited to, metal foil, conductive ink, conductive polymers (e.g., printable conductive polymers), or other conductive materials. Various conductive layers, such as the first conductive layer 404, the second conductive layer 406, the third conductive layer 408, or combinations thereof, may be configured as a circuit. For example, various combinations of conductive layers 404, 406, and 408 may be electrically connected using one or more conductive vias within the compliant circuit 400.

[0045] exist Figure 4 In some examples, the first conductive layer 404 can be configured as a source conductor, and the second conductive layer 406 can be configured as a drain conductor. The first conductive layer 404 and the second conductive layer 406 can be separated by a semiconductor 410 (e.g., a semiconducting material disposed above the first conductive layer 404 and the second conductive layer 406). The semiconductor 410 can be configured to switch between a conductive material and an electrically insulating material based on the presence or absence of an electric field. In some examples, the semiconductor can include p-type or n-type semiconductor materials. A dielectric material 402 can separate the third conductive layer 408 from the first conductive layer 404 and the second conductive layer 406. In some examples, the compliant circuit 400 can include another dielectric layer 412 to electrically isolate the third conductive layer 408 from other conductors within the compliant circuit 400. Figure 4In the example of FIG. 4, the third conductive layer 408 can be configured as a gate. The charge at the gate can switch the semiconductor 410 between a conductive mode and an insulative mode. Thus, the logic component 418 can be a transistor, such as a thin-film transistor (TFT) or an organic thin-film transistor (OTFT). In some examples, one or more semiconductors (e.g., the semiconductor 410) or logic components (e.g., the logic component 418) can be separated by a storage body 420. The storage body 420 can electrically isolate various logic components or semiconductors or mitigate the migration of charge between different materials.

[0046] In some examples, the logic component 418 can be conformable. For example, the logic component 418 can include material properties that can stretch and conform to non-planar shapes. The semiconductor can include, but is not limited to, organic polymers (e.g., poly(3-hexylthiophene), polydimethylsiloxane, poly(triarylamine)-poly(bis(tetra butylphenyl-N,N-bisphenyl)phenylamine), ionic gels (e.g., (poly(3-hexylthiophene)), triblock polymers (e.g., poly(styrene-b-methyl methacrylate-b-styrene), conductive polymers (e.g., poly[(4,8-bis-(2-ethylhexyloxy)-benzo(1,2-b:4,5-b')dithiophene)-2,6-diyl-alt-(4-(2-ethylhexanoyl)- thieno[3,4-b]thiophene)-2-6-diyl)] (PBDTTT-c) doped with the dopant tris-[1-(trifluoroacetyl)-2- (trifluoromethyl)ethane-1,2-dithiolylidene] (Mo(tfd-COCF3)3), PMMA, polyvinyl alcohol, polydimethylsilazane, polyacrylate, acrylate monomers and oligomers, mercapto ester and methyl methacrylate tetrahydrofurfuryl, pentacene, a-hexathiophene, dihexylpentathieno, copper phthalocyanine, hexafluorocopper phthalocyanine, poly(3-hexylthiophene), or other semiconductive materials. Thus, the conformable circuit 400 in which the logic component 418 is included can be conformable to stretch and conform to non-planar surfaces.

[0047] The logic component 418 can be included in or configured as a logic circuit or integrated circuit. In various examples, the logic component 418 can include, but is not limited to, amplifiers, multiplexer circuitry, transistors, diodes, switches, analog-to-digital converters, isolators (filters), or other logic elements. Thus, the logic component 418 can be embedded within the conformal circuit 400. In some examples, the logic component 418 can be embedded within the conformal circuit 400, and other logic components (e.g., surface mount electronic components) can be attached (e.g., soldered) to the conformal circuit 400. In further examples, multiple logic components 418 can be stacked within various layers (e.g., conductive layers and dielectric layers) of the conformal circuit 400. For example, one or more logic components 418 can be located within an inner layer or an outer layer of the conformal circuit 400. Thus, the logic component 418 can be located above, below, or between other logic components. By positioning one or more logic components 418 within an inner layer of the conformal circuit 400, the overall size (e.g., surface area) of the conformal circuit 400 can be reduced, as not all logic components need to be located on an outer layer of the conformal circuit 400.

[0048] In another example, embedding the logic component 418 within the conformal circuit 400 can occupy less of the internal volume of the handle (e.g., the handle 124, 324) than an integrated circuit component attached to an outer layer of the conformal circuit 400. For example, logic components such as surface mount integrated circuits can typically include a connection interface (e.g., solder connections), an overmold, a substrate, leads, and sometimes other components that can facilitate the particular application of the logic component. By embedding the logic component 418 in the conformal circuit 400, the size of the logic component can be reduced. For example, the conductive layers 404, 406, 408 of the conformal circuit 400 can be used to electrically couple the logic component 418 to various circuits within the conformal circuit 400, reducing or eliminating the need for leads, connection interfaces, or additional signal routing. In another example, an overmold or cover is not needed, as the logic component 418 can be supported by the substrate 414. For example, the substrate 414 can provide mechanical structure for the logic component 418 or the entire conformal circuit 400. In another example, the encapsulation 416 can protect the logic component 418, such as the semiconductor 410 and the conductive layers 404, 406. In some examples, only the desired elements of the logic component 418 can be included in the conformal circuit 400, and unnecessary or redundant elements can be omitted. Thus, the size of the conformal circuit 400 can be reduced, or a greater number of logic components 418 can be included in the conformal circuit 400.

[0049] Figure 5 is an example of a method 500 of manufacturing a handle of a catheter including a conformal circuit, such as previously described in examples herein and, for example, in U.S. Patent Application No. 16 / 209, 1 13, filed December 4, 2018, which is incorporated by reference in its entirety.Figures 1-4 The handle 124, the handle 324, the conformal circuit 200, the conformal circuit 314, or the conformal circuit 400 shown in FIGS. 1-3. In describing the method 500, reference is made to one or more of the components, features, functions, and processes previously described herein. Where convenient, reference is made to components, features, processes, etc. having reference numerals. The reference numerals provided are exemplary and are non-exclusive. For example, the features, components, functions, processes, etc. described in the method 500 include, but are not limited to, the corresponding numbered elements provided herein. Other corresponding features (numbered and unnumbered) described herein, and equivalents thereof, are also contemplated.

[0050] At 502, a conformal circuit can be disposed along a non-planar surface of a catheter handle. The non-planar surface can include the non-planar surface 522 as described herein. For example, the conformal circuit can include any of the conformal circuits 200, 314, or 400 described herein. In some examples, the conformal circuit can include a dielectric layer having dielectric material properties, such as the dielectric layer 202, 402. The conformal circuit can include a plurality of conductive layers, such as the conductive layers 204, 404, 406, 408. For example, each conductive layer can include conductive material properties. In various examples, the conductive layers can include a printable conductive polymer (e.g., a conductive ink), such as a conformal conductive ink having material properties (e.g., the conductive material properties previously described herein). For example, the conductive layers can be disposed on the dielectric layer using processes including, but not limited to, aerosol jet printing, inkjet printing, screen printing, valve jet, photolithography and chemical treatment, vapor deposition, fused deposition, stereolithography, digital light processing, etc. In one example, for example, a first layer including at least one dielectric layer or at least one conductive layer can be printed directly on the non-planar surface. A second layer of at least one dielectric layer or at least one conductive layer can be printed on the first layer or a subsequent layer.

[0051] In another example, the conductive layers can include strain relief features, such as the strain relief features 206 described herein. In another example, the conformal circuit can include a first connection interface electrically coupled to at least one of the conductive layers and a second connection interface electrically coupled to at least one of the conductive layers.

[0052] In some examples, the conformal circuit can include one or more logic components, such as one or more of the logic components 212, 312, or 418 as shown and described herein. In examples, the logic components can include semiconductors, such as the semiconductor 410 shown in FIG. 4 and discussed herein. The logic components can be attached to the conformal circuit or embedded within the conformal circuit. Figure 4 In some examples, the conformal circuit can include one or more logic components, such as one or more of the logic components 212, 312, or 418 as shown and described herein. In examples, the logic components can include semiconductors, such as the semiconductor 410 shown in FIG. 4 and discussed herein. The logic components can be attached to the conformal circuit or embedded within the conformal circuit.

[0053] Arranging the conformal circuit on the non-planar surface can include, but is not limited to, insert molding the conformal circuit onto the non-planar surface or bonding the conformal circuit to the non-planar surface. For example, insert molding can include insert molding a catheter handle (e.g., the non-planar surface) onto the conformal circuit. In some examples, bonding the conformal circuit to the non-planar surface can include, but is not limited to, attaching the conformal circuit to the non-planar surface with a pressure sensitive adhesive, a heat activated adhesive, a light activated adhesive, or other adhesive. In another example, the conformal circuit can be thermoformed or thermo bonded to the non-planar surface.

[0054] At 504, the conformal circuit can conform to the non-planar surface. The non-planar surface can include any non-planar shape, such as an arc shape, an angular shape, an irregular shape, or other non-planar shape. As previously described herein, the conformal circuit can be conformable along a length and a width of the conformal circuit 200 based on respective material properties of the individual layers and elements of the conformal circuit 200 and the conformal circuit 200 as a whole. In one example, the conformal circuit 200 can bend or stretch along a first axis (e.g., the X-axis 216), a second axis (e.g., the Y-axis 218), or any combination thereof based on the respective material properties of the conformal circuit 200. Accordingly, the conformal circuit 200 can conform to the non-planar surface. For example, the conformal circuit can stretch and conform to the non-planar surface to assume a shape corresponding to the shape of the non-planar surface. In other words, the conformal circuit can conform to the non-planar surface. In some examples, a form can be used to arrange the conformal circuit on the non-planar surface. For example, the form can include a shape corresponding to the non-planar shape. The form can be used to stretch and conform the conformal circuit to the non-planar shape in an original position or prior to arranging the conformal circuit on the non-planar shape. For example, the conformal circuit can conform to the non-planar shape and then be attached to the non-planar surface of the catheter handle. In another example, where the non-planar shape is insert molded onto the conformal circuit, conforming the conformal circuit to the non-planar surface can include positioning the conformal circuit within a mold (e.g., prior to injection molding the catheter handle).

[0055] In other examples, the method 500 can include manufacturing the conformal circuit. For example, manufacturing the conformal circuit can include arranging a conductive layer having conductive material properties on a dielectric layer having dielectric material properties. As previously described herein, manufacturing the conformal circuit can include printing (e.g., aerosol jet printing) one or more dielectric layers or one or more conductive layers.

[0056] While several examples have been described above, it should be apparent that a wide variety of modifications, changes and alternatives can be made to the examples described without departing from the spirit of the disclosure. It is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative only and not limiting. Changes in detail or structure can be made without departing from the spirit of the present teachings. The foregoing description and the appended claims are intended to cover all such modifications and alterations.

[0057] Various examples of various devices, systems, and methods are described herein. Numerous specific details are set forth in order to provide a thorough understanding of the examples described in the specification and illustrated in the accompanying drawings. However, it will be understood by those skilled in the art that the examples can be practiced without these specific details. In other instances, well-known operations, components, and elements have not been described in detail so as not to obscure the examples described in the specification. Those of ordinary skill in the art, with the benefit of this description, will appreciate the examples described herein and illustrated in the accompanying

[0058] Throughout this specification, the use of the expressions "various examples", "some examples", "one example", "an example", etc. mean that a particular feature, structure, or characteristic described in connection with the example is included in at least one example. Thus, appearances of the phrases "in various examples", "in some examples", "in one example", "in an example", etc. throughout this specification are not necessarily all referring to the same example. Furthermore, the particular features, structures, or characteristics can be combined in any suitable manner in one or more examples. Therefore, appearances of a particular feature, structure, or characteristic in

[0059] It will be understood that the terms "proximal" and "distal" can be used throughout this specification with reference to a clinician manipulating an instrument used to treat a patient. The term "proximal" refers to the portion of the instrument closest to the clinician and the term "distal" refers to the portion of the instrument furthest from the clinician. It will be further understood that, for the sake of brevity, the spatial terms "vertical", "horizontal", "up", and "down", can be used herein with respect to the illustrations. However, surgical instruments can be used in many orientations and positions, and these terms are not intended to be limiting and absolute.

[0060] Any patent, publication, or other disclosure material described herein as being incorporated by reference is hereby incorporated by reference in its entirety unless otherwise explicitly indicated, which is the case herein with any such reference only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material expressly set forth in this disclosure. As such, and to the extent necessary, the disclosure herein expressly incorporates by reference the entire text of any and all patents, publications, or other disclosure material for which mention is made herein. To the extent that any material incorporated by reference contradicts or conflicts with this disclosure, the latter prevails.

Claims

1. A catheter comprising: a catheter shaft comprising a proximal end and a distal end having at least one electrode or sensor; an electrical conductor coupled to the catheter shaft, the electrical conductor communicatively coupled to the electrode or the sensor at the distal end of the catheter shaft; a catheter handle, an interior of a lower half of the catheter handle comprising a non-planar surface, the catheter handle coupled to the proximal end of the catheter shaft; a conformal circuit conforming to and attached to the non-planar surface of the catheter handle, wherein the conformal circuit follows a cross-sectional perimeter of the catheter handle, wherein the conformal circuit comprises: a first connection interface at a distal end of the conformal circuit, wherein the first connection interface is within the non-planar surface, wherein the first connection interface is configured to be in electrical communication with the electrode or sensor of the catheter shaft, and a second connection interface at a proximal end of the conformal circuit, wherein the second connection interface is within the same non-planar surface as the first connection interface, wherein the second connection interface is configured to be in electrical communication with an electronic control unit, wherein the conformal circuit is electrically coupled to the electrode or sensor by the electrical conductor and configured to be in communication with an electronic control unit.

2. The catheter of claim 1, wherein, the conformal circuit comprises a material configured to stretch and conform to the non-planar surface.

3. The catheter of claim 1, wherein, the conformal circuit comprises at least one dielectric layer and at least one conductive layer, wherein at least one of the dielectric layer and at least one of the conductive layer each comprise a respective material configured to stretch and conform to the non-planar surface.

4. The catheter of claim 3, wherein, the conductive layer comprises a printable conductive polymer.

5. The catheter of claim 1, further comprising a logic component embedded within the conformal circuit.

6. The catheter of claim 5, wherein, the logic component is configured to be one of an analog-to-digital converter, a multiplexer, a filter, an amplifier, or a combination thereof.

7. The catheter of claim 5, wherein, the logic component comprises a semiconductor.

8. The catheter of claim 7, wherein, the logic component comprises a p-type material, an n-type material, or both.

9. A handle configured to be used with a catheter system, the handle comprising: a lower half, an interior of the lower half comprising a non-planar surface; a distal end configured to be coupled with a catheter shaft; a proximal end configured to be coupled with an electrical cable to be in communication with an electronic control unit; and a conformal circuit disposed on the non-planar surface, wherein the conformal circuit conforms to the non-planar surface, wherein the conformal circuit follows a cross-sectional perimeter of the handle, and wherein the conformal circuit comprises: a first connection interface at a distal end of the conformal circuit, wherein the first connection interface is within the non-planar surface, the first connection interface configured to be in electrical communication with an electrode or sensor of the catheter shaft, and a second connection interface at a proximal end of the conformal circuit, wherein the second connection interface is within the same non-planar surface as the first connection interface, the second connection interface configured to be in electrical communication with the electronic control unit. the conformal circuit comprises a material configured to stretch and conform to the non-planar surface.

10. The handle of claim 9, wherein, ​ 11. The handle of claim 9, wherein, The compliant circuit includes at least one dielectric layer and at least one conductive layer, wherein at least one of the dielectric layers and at least one of the conductive layers each include a respective material configured to stretch and conform to the non-planar surface.

12. The handle of claim 11, wherein, The conductive layer includes a printable conductive polymer.

13. The handle of claim 9, further comprising a logic component embedded within the compliant circuit.

14. The handle of claim 13, wherein, The logic component is configured as one of an analog-to-digital converter, a multiplexer, a filter, an amplifier, or a combination thereof.

15. The handle of claim 13, wherein, The logic component includes a semiconductor including a p-type material, an n-type material, or both.

16. The handle of claim 15, wherein, The compliant circuit is insert molded to the non-planar surface.

17. A method of manufacturing a catheter handle, comprising: arranging a compliant circuit along a non-planar surface of an inner surface of the catheter handle, wherein the compliant circuit includes: a dielectric layer having a dielectric material configured to stretch and conform to the non-planar surface, a plurality of conductive layers each having a conductive material configured to stretch and conform to the non-planar surface, a first connection interface electrically coupled to at least one of the conductive layers, wherein the first connection interface is located within the non-planar surface, and a second connection interface electrically coupled to at least one of the conductive layers, wherein the second connection interface is located within the same non-planar surface as the first connection interface; and conforming at least a portion of the compliant circuit to the non-planar surface, wherein the compliant circuit is arranged along a cross-sectional perimeter of the catheter handle.

18. The method of claim 17, wherein, arranging the compliant circuit along the non-planar surface includes printing a first layer including at least one dielectric layer or at least one conductive layer directly on the non-planar surface, and printing a second layer of at least one dielectric layer or at least one conductive layer on the first layer.

19. The method of claim 17, wherein, The compliant circuit conforms to a shape of the non-planar surface and is then arranged and attached to the non-planar surface.

20. The method of claim 17, wherein, conforming the compliant circuit to the non-planar surface includes positioning the compliant circuit within a mold, and wherein arranging the compliant circuit along the non-planar surface includes insert molding a non-planar surface of the catheter handle to the compliant circuit.

21. The method of claim 17, further comprising fabricating the compliant circuit, wherein, manufacturing the compliant circuit includes arranging the conductive layers on the dielectric layer.

Images