Catheter with vapor deposition features on the tip

Abstract

A method for manufacturing a surgical instrument is disclosed. The surgical instrument includes a catheter and an end effector extending distally from the catheter. The method includes forming at least one electrode, sensor, or thermocouple onto the catheter or end effector of the surgical instrument by etching or vapor depositing a three-dimensional structure onto a non-conductive material layered over a super-elastic material.

Description

Background Technology

[0001] Cardiac arrhythmias, such as atrial fibrillation, occur when areas of cardiac tissue abnormally conduct electrical signals. Treatment protocols for these arrhythmias involve surgically disrupting the conduction pathways used for such signals. By selectively ablating cardiac tissue with energy (e.g., radiofrequency (RF) energy), it is possible to stop or alter the propagation of unwanted electrical signals from one part of the heart to another. The ablation process can provide a blockage of unwanted electrical pathways by forming an electrically insulating lesion or scar tissue that effectively blocks the communication of abnormal electrical signals across tissues.

[0002] Cardiac arrhythmias, such as atrial fibrillation, occur when areas of cardiac tissue abnormally conduct electrical signals. Treatment protocols for these arrhythmias involve surgically disrupting the conduction pathways used for such signals. By selectively ablating cardiac tissue with energy (e.g., radiofrequency (RF) energy), it is possible to stop or alter the propagation of unwanted electrical signals from one part of the heart to another. The ablation process can provide a blockage of unwanted electrical pathways by forming an electrically insulating lesion or scar tissue that effectively blocks the communication of abnormal electrical signals across tissues.

[0003] In some procedures, catheters with one or more RF electrodes can be used to deliver ablation within the cardiovascular system. The catheter may be inserted into a major vein or artery (e.g., the femoral artery) and then advanced to position the electrodes within the heart or in cardiovascular structures adjacent to the heart (e.g., the pulmonary veins). One or more electrodes may be positioned to contact cardiac or other vascular tissue and then activated using RF energy to ablate the contacted tissue. In some cases, the electrodes may be bipolar. In other cases, a monopolar electrode may be used in conjunction with a grounding pad or other reference electrode in contact with the patient. Flushing may be used to absorb heat from the ablation components of the ablation catheter and to prevent blood clots from forming near the ablation site.

[0004] Examples of ablation catheters are described in U.S. Publication 2013 / 0030426, published January 31, 2013, entitled “Integrated Ablation System using Catheter with Multiple Irrigation Lumens,” the disclosure of which is incorporated herein by reference; U.S. Publication 2017 / 0312022, published November 2, 2017, entitled “Irrigated Balloon Catheter with Flexible Circuit Electrode Assembly,” the disclosure of which is incorporated herein by reference; U.S. Publication 2018 / 0071017, published March 15, 2018, entitled “Ablation Catheter with a Flexible Printed Circuit Board,” the disclosure of which is incorporated herein by reference; and Catheter with Bipole Electrode Spacer and Related…, published March 1, 2018. U.S. Publication 2018 / 0056038, entitled "Catheter with Bipolar Electrode Pads and Related Methods," is incorporated herein by reference; U.S. Patent 10,130,422, entitled "Catheter with Soft Distal Tip for Mapping and Ablating Tubular Region," published November 20, 2018, is incorporated herein by reference; U.S. Patent 8,956,353, entitled "Electrode Irrigation Using Micro-Jets," published February 17, 2015, is incorporated herein by reference; and U.S. Patent 9,801,585, entitled "Electrocardiogram Noise Reduction," published October 31, 2017, is incorporated herein by reference.

[0005] Some catheter ablation procedures can be performed after electrophysiological (EP) mapping to identify tissue areas that should be targeted for ablation. Such EP mapping may involve the use of sensing electrodes on a catheter (e.g., the same catheter used to perform the ablation or a dedicated mapping catheter). These sensing electrodes monitor electrical signals emanating from conductive endocardial tissue to precisely locate the site of abnormally conductive tissue leading to arrhythmias. Examples of EP mapping systems are described in U.S. Patent 5,738,096, entitled “Cardiac Electromechanics,” published April 14, 1998, the disclosure of which is incorporated herein by reference. Examples of EP mapping catheters are described in U.S. Patent 9,907,480, published March 6, 2018, entitled "Catheter Spine Assembly with Closely-Spaced Bipole Microelectrodes," the disclosure of which is incorporated herein by reference; U.S. Patent 10,130,422, published November 20, 2018, entitled "Catheter with Soft Distal Tip for Mapping and Ablating Tubular Region," the disclosure of which is incorporated herein by reference; and U.S. Publication 2018 / 0056038, published March 1, 2018, entitled "Catheter with Bipole Electrode Spacer and Related Methods," the disclosure of which is incorporated herein by reference.

[0006] When using an ablation catheter, it may be desirable to ensure that one or more electrodes of the ablation catheter make adequate contact with the target tissue. For example, it may be desirable to ensure that one or more electrodes contact the target tissue with sufficient force to effectively apply RF ablation energy to the tissue; but not to apply a force that may tend to undesirably damage the tissue. For this purpose, it may be desirable to include one or more force sensors or pressure sensors for detecting adequate contact between one or more electrodes of the ablation catheter and the target tissue.

[0007] In addition to force sensing or EP mapping, some catheter ablation procedures can be performed using image-guided surgery (IGS) systems. IGS systems allow physicians to visually track the catheter's position within the patient's body in real time, relative to images of the patient's anatomy. Some systems offer a combination of EP mapping and IGS functionality, including CARTO from Biosense Webster, Inc., Irvine, California. The system. An example of a catheter configured for use with an IGS system is disclosed in U.S. Patent 9,480,416, published November 1, 2016, entitled “Signal Transmission Using Catheter Braid Wires,” the disclosure of which is incorporated herein by reference; as well as various other references cited herein.

[0008] Although several catheter systems and methods have been manufactured and used, it is believed that no one had manufactured or used the inventions described, shown and claimed herein before the inventors. Attached Figure Description

[0009] The following figures and detailed descriptions are intended to be illustrative only and are not intended to limit the scope of the invention as contemplated by the inventors.

[0010] Figure 1 A schematic diagram depicts a medical procedure for inserting a catheter assembly into a patient's body.

[0011] Figure 2 Depicting Figure 1 A perspective view of the catheter assembly, with additional components shown schematically;

[0012] Figure 3 Depicting Figure 1 A perspective view of the distal portion of the catheter, with additional components shown schematically;

[0013] Figure 4 Depicting Figure 1 A perspective view of the distal portion of the catheter, with the outer sheath omitted to show the internal components;

[0014] Figure 5 Depicting Figure 1 Exploded perspective view of the distal portion of the catheter;

[0015] Figure 6 Depicting Figure 1 A schematic perspective view of the distal portion of an alternative catheter, wherein the catheter includes an elongated flexible sheath and the end effector includes a distal end member, wherein the additional components are shown schematically.

[0016] Figure 7 Depicting Figure 6 A schematic exploded perspective view of the distal portion of the catheter;

[0017] Figure 8 Depicting the cross Figure 6 The line 8-8 cut Figure 6 A schematic cross-sectional view of the elongated flexible sheath of the catheter, wherein a force sensor is disposed on the outer surface of the elongated flexible sheath.

[0018] Figure 8A Depicting something similar to Figure 8 An exemplary schematic cross-sectional view of an alternative elongated flexible sheath, wherein the force sensor is disposed on the inner surface of the elongated flexible sheath.

[0019] Figure 9 Depicting the cross Figure 6 The line 9-9 was cut off Figure 6 A schematic cross-sectional view of a cylindrical body, wherein microelectrodes and thermocouples are disposed on the outer surface of the distal end member;

[0020] Figure 9A Depicting the cross Figure 6 The line 9-9 is similar to the cut. Figure 6 An exemplary schematic cross-sectional view of an alternative cylindrical body, wherein the microelectrodes and thermocouples are disposed on the inner surface of the distal end member.

[0021] Figure 10 Depicting the use of etching or vapor deposition Figure 6 A schematic side front view of an exemplary structure of a conduit or end effector; and

[0022] Figure 11 Describes the formation Figure 10 An exemplary method for the structure. Detailed Implementation

[0023] The following description of certain examples of the invention is not intended to limit the scope of the invention. The accompanying drawings (not necessarily drawn to scale) depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates the principles of the invention by way of example and not by way of limitation. Other examples, features, aspects, embodiments, and advantages of the invention will be apparent to those skilled in the art from the following description, which is shown by way of example, and a best mode is contemplated for carrying out the invention. It will be appreciated that the invention can have other different or equivalent aspects, all of which do not depart from the invention. Therefore, the drawings and descriptions should be considered substantially illustrative and not restrictive.

[0024] Any one or more of the teachings, expressions, types, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, types, examples, etc. Therefore, the following teachings, expressions, types, examples, etc., should not be considered separate from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the art, referring to the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0025] As used herein, the term “about” or “approximately” for any numerical value or range indicates a suitable dimensional tolerance that allows a collection of parts or elements to achieve the intended purpose as described herein. More specifically, “about” or “approximately” may refer to a range of values ​​±10% of the listed values; for example, “about 90%” may refer to a range of values ​​from 81% to 99%. Additionally, as used herein, the terms “patient,” “host,” “user,” and “subject” refer to any human or animal subject and are not intended to limit the system or method to human use, but the use of the subject matter invention in human patients represents a preferred embodiment.

[0026] I. Overview of Exemplary Ablation Catheter Systems

[0027] Figure 1 An exemplary medical protocol and associated components are shown for a cardiac ablation catheter system that can be used to deliver the cardiac ablation procedures mentioned above. Specifically, Figure 1 The image shows the handle (110) of the catheter assembly (100) being gripped by a physician (PH), wherein the end actuator (140) of the catheter (120) of the catheter assembly (100) is located in... Figures 2 to 3 Shown but not in Figure 1 (As shown) is placed inside the patient (PA) to ablate tissue in or near the patient's (PA) heart (H). Figure 2 As shown, the catheter assembly (100) includes a handle (110), a catheter (120) extending distally from the handle (110), an end actuator (140) located at the distal end of the catheter (120), and a deflection drive assembly (200) associated with the handle (110).

[0028] As will be described in more detail below, the end effector (140) includes various components configured to deliver RF energy to a target tissue site, provide EP mapping functionality, track external forces applied to the end effector (140), track the position of the end effector (140), and disperse flushing fluid. Also as will be described in more detail below, the deflection drive assembly (200) is configured to deflect the distal portion of the end effector (140) and the catheter (120) away from the central longitudinal axis (LL) defined by the proximal portion of the catheter (120). Figures 3 to 5 ).

[0029] like Figure 3 As shown, the catheter (120) includes an elongated flexible sheath (122) with an end effector (140) positioned at the distal end of the elongated flexible sheath (122). The end effector (140) and various components housed within the elongated flexible sheath (122) will be described in more detail below. The catheter assembly (100) is coupled to the guidance and actuation system (10) via a cable (30). The catheter assembly (100) is also coupled to a fluid source (42) via a fluid conduit (40). A set of field generators (20) is positioned below the patient (PA) and coupled to the guidance and actuation system (10) via another cable (22). The field generators (20) are optional only.

[0030] The boot and drive system (10) of this example includes a console (12) and a display (18). The console (12) includes a first drive module (14) and a second drive module (16). The first drive module (14) is coupled to the conduit assembly (100) via a cable (30). In some variations, the first drive module (14) is operable to receive EP mapping signals obtained via microelectrodes (138) of an end effector (140), as described in more detail below. The console (12) includes a processor (not shown) that processes such EP mapping signals and thereby provides EP mapping as known in the art.

[0031] The first actuator module (14) of this example is also operable to provide RF power (as will be described in more detail below) to the distal end member (142) of the end effector (140) to ablate tissue. The second actuator module (16) is coupled to the field generator (20) via a cable (22). The second actuator module (16) is operable to activate the field generator (20) to generate an alternating magnetic field around the heart (H) of the patient (PA). For example, the field generator (20) may include coils that generate the alternating magnetic field within a predetermined working volume accommodating the heart (H).

[0032] The first driver module (14) is also operable to receive a position indication signal from the position sensor assembly (150) in the end effector (140). In this type, the processor of the console (12) is also operable to process the position indication signal from the position sensor assembly (150) to determine the position of the end effector (140) within the patient (PA). As will be described in more detail below, the position sensor assembly (150) includes a pair of coils on a respective panel (151) operable to generate a signal indicating the position and orientation of the end effector (140) within the patient (PA). The coils are configured to generate an electrical signal in response to the presence of an alternating electromagnetic field generated by the field generator (20). Other components and techniques that may be used to generate real-time position data associated with the end effector (140) may include wireless triangulation, acoustic tracking, optical tracking, inertial tracking, etc. Alternatively, the end effector (140) may not have a position sensor assembly (150).

[0033] The display (18) is coupled to the processor of the console (12) and is operable to present images of the patient's anatomy. Such images may be based on a set of images obtained before or during surgery (e.g., CT or MRI scans, 3D mapping, etc.). The view of the patient's anatomy provided by the display (18) may also be dynamically changed based on signals from the position sensor assembly (150) of the end effector (140). For example, as the end effector (140) of the catheter (120) moves within the patient (PA), corresponding position data from the position sensor assembly (150) may cause the processor of the console (12) to update the view of the patient's anatomy in the display (18) in real time to depict the area of ​​the patient's anatomy around the end effector (140) as the end effector (140) moves within the patient (PA). Furthermore, the processor of the console (12) can drive the display (18) to show the location of abnormally conductive tissue sites detected via electrophysiological (EP) mapping using an end effector (140) or otherwise (e.g., using a dedicated EP mapping catheter). By way of example only, the processor of the console (12) can drive the display (18) to overlay the location of the abnormally conductive tissue sites onto an image of the patient's anatomy with some other form of visual indication, such as by overlaying illuminated points, crosshairs, or other forms of visual indication of the abnormally conductive tissue sites.

[0034] The processor of the console (12) can also drive the display (18) to overlay the current position of the end effector (140) onto an image of the patient's anatomy in a manner such as by overlaying illuminated points, crosshairs, a graphical representation of the end effector (140), or some other form of visual indication. As the physician moves the end effector (140) within the patient (PA), such overlaid visual indications can also move in real time within the image of the patient's anatomy on the display (18), thus providing the operator with real-time visual feedback on the position of the end effector (140) within the patient (PA) as it moves. Therefore, the image provided by the display (18) can effectively provide video tracking of the position of the end effector (140) within the patient (PA) without the need for any optical instruments (i.e., cameras) for viewing the end effector (140). In the same view, the display (18) can simultaneously visually indicate the location of abnormally conductive tissue sites detected by EP mapping. Therefore, the physician (PH) can view the display (18) to observe the real-time positioning of the end effector (140) relative to the mapped abnormal conductive tissue sites and relative to images of adjacent anatomical structures within the patient (PA).

[0035] The fluid source (42) in this example comprises a bag containing brine or some other suitable flushing fluid. The conduit (40) includes a flexible tube further coupled to a pump (44) operable to selectively drive fluid from the fluid source (42) to the conduit assembly (100). As described in more detail below, such flushing fluid may be discharged through an opening (158) in the distal end member (142) of the end actuator (140). Such flushing can be provided in any suitable manner that will be apparent to those skilled in the art, taking into account the teachings herein.

[0036] II. Exemplary end actuator of the catheter assembly

[0037] As described above, the end effector (140) includes various components configured to deliver RF energy to target tissue sites, provide EP mapping functionality, track external forces applied to the end effector (140), track the position of the end effector (140) within the patient (PA), and disperse flushing fluid. Figures 3 to 5Exemplary components of the end effector (140) and other components of the distal portion of the conduit (120) are shown in more detail. The end effector (140) includes a distal end member (142), a distal end base (144), a distal circuit disc (146), a force sensor assembly (148), a position sensor assembly (150), a distal spacer stack (152), and a pair of proximal spacers (154). The distal end member (142), distal end base (144), distal circuit disc (146), force sensor assembly (148), position sensor assembly (150), distal spacer stack (152), and proximal spacers (154) are coaxially aligned with each other and stacked longitudinally, such that these components (144-154) define a stacked circuit. A pair of push-pull cables (160, 170) and a flushing tube (180) extend along the length of the conduit (120) to reach the end effector (140). Each of the aforementioned components will be described in more detail below. A flexible sheath (122) surrounds all of the aforementioned components except for the distal end member (142).

[0038] like Figures 4 to 5 As shown, the distal end member (142) of this example includes a cylindrical body (156) with a domed end. The cylindrical body (156) and the domed end may be formed of a conductive material, such as metal. A plurality of openings (158) are formed through the cylindrical body (156) and communicate with the hollow interior of the distal end member (142). Thus, the openings (158) allow flushing fluid to be delivered from the interior of the distal end member (142) through the cylindrical body (156). The cylindrical body (156) and the domed end are also operable to apply RF electrical energy to tissue, thereby ablating the tissue. Such RF electrical energy may be delivered from the first driver module (14) to the proximal spacer (154) via a cable (30). The distal end member (142) may also include one or more thermocouples configured to provide temperature sensing capability.

[0039] like Figures 3 to 4As shown, the distal end member (142) of this example also includes one or more EP mapping microelectrodes (138) mounted to the cylindrical body (156). The EP mapping microelectrodes (138) are configured to pick up potentials from tissues in contact with the EP mapping microelectrodes (138). Thus, the EP mapping microelectrodes (138) can be used to determine the location of abnormal electrical activity in tissues within cardiovascular anatomy structures (e.g., pulmonary veins, etc.). The signals picked up by the EP mapping microelectrodes (138) can be transmitted via through-holes or other structures located in layers proximal to the force sensor assembly (148), ultimately reaching the first driver module (14) of the console (12) via cable (30). Based on the teachings of the various references cited herein, the first driver module (14) can process the EP mapping signals and provide corresponding feedback to the physician (PH) indicating the location of abnormal electrical activity.

[0040] In a configuration where the cylindrical body (156) is formed of a conductive material to provide RF power for tissue ablation, an electrically insulating material may be inserted between the cylindrical body (156) and the EP mapping microelectrode (138), thereby electrically isolating the EP mapping microelectrode (138) from the cylindrical body (156). The EP mapping microelectrode (138) may be constructed and operated in accordance with the teachings of the various patent references cited herein. Although only one EP mapping microelectrode (138) is shown, the distal end member (142) may include two or more EP mapping microelectrodes (138). Alternatively, the distal end member (142) may be completely devoid of EP mapping microelectrodes (138).

[0041] The distal end base (144) defines a central aperture configured to provide a path for conveying flushing fluid into the hollow interior of the distal end member (142). The distal end base 144 forms an annular shoulder that is adjacent to the proximal edge of the distal end member (142). The distal end member (142) also defines a lateral notch configured to receive a proximally extending tab of the distal end member (142). Figures 3 to 4 As shown, the distal circuit disk (146) is positioned proximal to the distal end base (144). The distal circuit disk (146) includes circuitry operable to transmit RF power to the distal end member (142) via tabs extending proximally from the distal end member (142). In a configuration that includes one or more EP mapping electrodes (138), the distal circuit disk (146) may also include circuitry operable to transmit EP mapping signals from the EP mapping electrodes (138).

[0042] In some configurations, the distal circuit disk (146) also includes one or more transmitting coils. Such transmitting coils can provide wireless communication of signals (e.g., EP mapping signals from the microelectrode (138)) to one or more complementary coils located proximal to the distal circuit disk (146). Additionally or alternatively, such transmitting coils can provide wireless communication of RF power from one or more complementary coils located proximal to the distal end member (142). In configurations where coils are integrated into the distal circuit disk (146) and one or more other layers proximal to the force sensor assembly (148), such coils can thus enable wireless communication of electrical signals across the force sensor assembly (148) without requiring wires, vias, or other conductive structures to longitudinally penetrate the force sensor assembly (148).

[0043] In some configurations, the distal circuit disk (146) includes at least one transmitting coil (TX) paired with the receiving coil (RX) of the position sensor assembly (150) to detect strain applied to the force sensor assembly (148) in order to determine the contact force applied to the distal end (142). In some other configurations of the distal circuit disk (146), the TX coil may be omitted.

[0044] A force sensor assembly (148) is positioned proximal to the distal circuit disk (146) and configured to sense external forces impacting the distal end member (142). When the distal end (142) encounters an external force (e.g., when the distal end (142) presses against tissue), those forces are transmitted from the distal end (142) to the distal end base (144), to the distal circuit disk (146), and to the force sensor assembly (148), enabling the strain gauge to generate an appropriate signal corresponding to the magnitude and direction of the external force. The signal from the force sensor assembly (148) can be transmitted via a via or other structure in a layer proximal to the force sensor assembly (148), ultimately reaching the first actuator module (14) of the control console (12) via a cable (30). Referring to the teachings herein, the first actuator module (14) can process the strain signal in any suitable manner that will be apparent to a person skilled in the art. By way of example only, when the force sensor assembly (148) indicates that the distal end member (142) has encountered a force exceeding a predetermined threshold, the console (12) can provide auditory feedback to alert the physician (PH) to prevent the physician (PH) from unintentionally damaging the cardiovascular anatomy with the distal end member (142).

[0045] The position sensor assembly (150) can generate signals indicating the position and orientation of the end effector (140) in three-dimensional space with substantially accurate precision. The position sensor assembly (150) includes a plurality of panels (151), each panel including an RX coil operable to generate an electrical signal indicating position in response to an alternating magnetic field generated by a field generator (20). Each RX coil may be formed by electrical traces to define an electrical coil or antenna to receive radio frequency signals emitted by an external transmitter TX coil (e.g., three TX coils provided by a field generator (20) positioned outside the patient's (PA) body and emitting discrete radio frequencies), such that the position and orientation of each RX coil can be determined relative to the TX coil provided by the field generator (20). Signals from the position sensor assembly (150) can be transmitted through through-holes or other structures in a layer located proximal to the strain position sensor assembly (150), ultimately reaching the first driver module (14) of the console (12) via a cable (30).

[0046] The central annular body of the position sensor assembly (150) defines a central aperture configured to provide a path for conveying flushing fluid to the hollow interior of the distal end member (142). In a configuration in which the central annular body of the position sensor assembly includes a wireless communication coil, such a wireless communication coil may also be coupled to a through-hole or other structure in a layer proximal to the strain position sensor assembly (150), thereby providing a path for electrical communication with a first driver module (14) of the console (12) via a cable (30).

[0047] In this example, each distal spacer (153) is generally shaped like a disc, with a pair of thoracic cutouts offset at an angle of 90 degrees from each other. The size and configuration of these cutouts are set to accommodate a corresponding panel (151) of the position sensor assembly (150), thereby allowing the panel (151) to be radially inserted between the distal spacer stack (152) and the sheath (122). Each distal spacer (153) also includes a pair of cable recesses offset at an angle of 180 degrees from each other. These cable recesses are configured to receive corresponding distal end portions (174, 164) of push-pull cables (160, 170). Each distal spacer (153) also includes a central aperture configured to provide a path for conveying flushing fluid to the hollow interior of the distal end member (142).

[0048] Each proximal spacer 154 is formed in a disc shape, through which three holes are formed. The central hole is configured to provide a path for conveying flushing fluid to the hollow interior of the distal end member (142). The side holes are sized and configured to receive the proximal portions (162, 172) of the corresponding push-pull cables (160, 170).

[0049] As stated above and as Figure 1 and Figure 3 As shown, cable (30) couples the conduit assembly (100) to the drive system (10). Figure 4 As shown, the wire (32) of the cable (30) extends along the length of the conduit (120) to reach the proximal spacer (154) on the nearest side. Therefore, the wire (32) can be accommodated within the sheath (122). The wire (32) can be physically and electrically coupled to the proximal spacer (154) on the nearest side in any suitable manner.

[0050] As described above, the conduit assembly (100) is configured such that flushing fluid can be delivered from the fluid source (42) to the conduit (120) via the fluid conduit (40), thereby providing discharge of the flushing fluid through an opening (158) in the distal end member (142). In this example, the fluid path for the flushing fluid includes a flushing tube (180) which... Figures 4 to 5 As shown in the diagram, the proximal end of the flushing tube (180) is coupled to a fluid conduit (40), for example, at the handle (110) of the conduit assembly (100). The flushing tube (180) extends along the length of the conduit (120) to reach the end actuator (140). In some configurations, flushing fluid may be delivered from the distal end of the flushing tube (180) through a central passage formed by the aligned central bore described above, ultimately reaching the interior of the distal end member (142) via a hole (218) in the distal end base (144).

[0051] III. Exemplary alternative catheters and catheter assembly end actuators

[0052] Flexible circuit technology can include complex manufacturing methods for converting two-dimensional structures into three-dimensional structures, precise adhesive application, complex tooling, or one or more curing processes. Traditional flexible circuit technologies can be difficult and sporadic for structures such as openings (158) or for achieving seamless transitions during assembly, especially when using scales smaller than approximately 0.010 inches. Integrating sensing and therapeutic technologies into a single manufacturing process, overlaid onto a shape-holding substrate, can significantly simplify the manufacturability of complex structures associated with sensing and therapeutic technologies. Such a single manufacturing process may be desirable and surpasses traditional flexible circuit technologies.

[0053] Exemplary alternative conduits (310) and exemplary alternative end effectors (312) are described in more detail below. The conduits (310) and end effectors (312) may be provided as alternatives to the conduits (120) and end effectors (140) described above. The conduits (310) and end effectors (312) can provide advantages over conventional two-dimensional flexible circuits, which are typically assembled in separate stages to obtain a three-dimensional configuration. For example, the assembly of conventional two-dimensional flexible circuits can typically utilize a number of components to be formed before the elongated flexible sheath (122) slides over these components to form the conduit (120).

[0054] A. Exemplary alternative catheters and end actuators

[0055] Figure 6 It shows surgical instruments (e.g., such as) Figures 1 to 2 Perspective view of the distal portion of the catheter (310) and end effector (312) of the catheter assembly (100) shown. (See previous references) Figures 1 to 3 As described, the catheter assembly (100) may include a handle (110) and a deflection drive assembly (200) associated with the handle (110). In this example, the catheter assembly (100) includes a catheter (310) and an end effector (312), wherein the catheter (310) extends distally from the handle (110). Figure 6 As shown, the catheter (310) includes an elongated flexible sheath (314). An end effector (312) is disposed at the distal end of the elongated flexible sheath (314) of the catheter (310). (See reference...) Figures 6 to 11 In more detail, the catheter (310) is generally similar to the catheter (120) and the end effector (312) is generally similar to the reference. Figures 1 to 2 The end effector (140) shown and described, with the differences described below. Figure 7 It shows Figure 6 An exploded perspective view of the distal portion of the catheter (310), wherein the catheter (310) defines the longitudinal axis (LL).

[0056] Figures 6 to 7Exemplary components of the end effector (312) and other components of the distal portion of the conduit (310) are shown in more detail. The end effector (312) includes a distal end member (316) similar to a distal end member (142), a distal end base (318) similar to a distal end base (144), a distal circuit disk (320) similar to a distal circuit disk (146), a distal spacer stack (322) including a distal spacer (323) similar to a distal spacer stack (152), and a pair of proximal spacers (324) similar to a pair of proximal spacers (154). As shown, the distal end member (316), distal end base (318), distal circuit disk (320), distal spacer stack (322), and proximal spacers (324) are coaxially aligned with each other and stacked longitudinally, such that these components (316-324) define a stacked circuit. Push-pull cables (160, 170) and flushing tubes (180) extend along the length of the conduit (310) to reach the end actuator (312).

[0057] The distal end member (316) includes a cylindrical body (330) with a domed end (332). The domed end (332) or the entire cylindrical body (330) may be formed of a conductive material such as metal. The cylindrical body (330) with the domed end (332) is operable to apply RF electrical energy to tissue, thereby ablating the tissue. Such RF electrical energy may be transmitted from the first driver module (14) to the nearest-side spacer (324) via a cable (30). A plurality of openings (334) are formed through the cylindrical body (330) and communicate with the hollow interior of the distal end member (316). The openings (334) allow flushing fluid to be delivered from the interior of the distal end member (316) through the cylindrical body (330) of the distal end member (316).

[0058] The deflection drive assembly (200) is configured to deflect the distal portion of the end effector (312) and the catheter (310) away from the central longitudinal axis (LL) defined by the proximal portion of the catheter (310) (see [link]). Figures 6 to 7 ).like Figure 6 As shown, the conduit (310) includes an elongated flexible sheath (314), with an end effector (312) disposed at the distal end of the elongated flexible sheath (314). The end effector (312) and various components housed within the elongated flexible sheath (314) will be described in more detail below. The conduit assembly (100) is coupled to the guiding and actuation system (10) via a cable (30). The conduit assembly (100) is also coupled to a fluid source (42) via a fluid conduit (40).

[0059] As described above and see below Figures 8 to 9AIn more detail, the end effector (312) includes various components configured to perform one or more of the following: deliver RF energy to a target tissue site; provide EP mapping functionality; track external forces applied to the end effector (312); track the position of the end effector (312) within the patient (PA); or disperse flushing fluid. For this reason, the end effector (312) may include one or more electrodes, sensors, or thermocouples (336). Electrodes may include at least one sensing electrode (e.g., an EP mapping electrode (338)), at least one ablation electrode (339), or at least one reference electrode (not shown). Individually, sensors may include at least one force sensor assembly (326) or at least one position sensor assembly (328). For example, unlike the end effector (140), the end effector (312) may include at least one etched or vapor-deposited force sensor assembly (326) which may replace or be used in addition to the force sensor assembly (148); or at least one etched or vapor-deposited position sensor assembly (328) which may replace or be used in addition to the position sensor assembly (150).

[0060] Figure 8 and Figure 9 It shows Figure 6 Two cross-sectional views. More specifically, Figure 8 Showing cross Figure 6 The line cut from 8-8 Figure 6 A cross-sectional view of the elongated flexible sheath (314) of the conduit (310), wherein the force sensor assembly (326) and the position sensor assembly (328) are disposed on the outer surface (340) of the wall (342) of the elongated flexible sheath (314) of the conduit (310). Figure 8A It shows something similar to Figure 8 An exemplary cross-sectional view of an alternative elongated flexible sheath (314), wherein the force sensor assembly (326) is disposed on the inner surface (344) of the wall (342) of the elongated flexible sheath (314) of the conduit (310).

[0061] The force sensor assembly (326) is configured to sense an external force impacting the distal end member (316). When the distal end member (316) encounters an external force (e.g., when the distal end member (316) presses against tissue), that external force is transmitted from the distal end member (316) to the distal end base (318), to the distal circuit disk (320), and to the force sensor assembly (326), such that the force sensor assembly (326) can generate an appropriate signal corresponding to the magnitude and direction of the external force. The signal from the force sensor assembly (148) can be transmitted through a via or other structure in a layer proximal to the force sensor assembly (326), ultimately reaching the first driver module (14) of the console (12) via a cable (30).

[0062] The force sensor assembly (326) may include multiple force sensors. For example, the force sensor assembly (326) may include a first, second, and third force sensor (346a-c). Figure 8 As shown, the first, second, and third force sensors (346a-c) can be etched or vapor-deposited onto the outer surface (340) of the elongated flexible sheath (314) of the conduit (310). Alternatively, as Figure 8A As shown, the first, second, and third force sensors (346a-c) can be etched or vapor-deposited onto the inner surface (344) of the elongated flexible sheath (314) of the conduit (310). It is also envisioned that the force sensor assembly (326) (e.g., the first, second, and third force sensors (346a-c)) can be directly etched or vapor-deposited onto the outer surface (340) of the elongated flexible sheath (314) or directly etched or vapor-deposited onto the inner surface (344) of the elongated flexible sheath (314). The first, second, and third force sensors (346a-c) of the force sensor assembly (326) can be formed as rose-shaped strain gauges (e.g., triaxial rose-shaped strain gauges) vapor-deposited onto the outer surface (340) or inner surface (344) of the elongated flexible sheath (314). Alternatively, it will be apparent to those skilled in the art, with reference to the teachings herein, that the force sensors (346a-c) can take any other suitable form.

[0063] The position sensor assembly (328) is operable to generate signals indicative of the position and orientation of the end effector (312) in three-dimensional space within the patient's (PA) body. The position sensor assembly (328) may include one or more position sensors (e.g., position coils). For example, the position sensor assembly (328) may include first, second, and third position coils (348a-c). Figure 8 As shown, the first, second, and third position coils (348a-c) can be etched or vapor-deposited onto the outer surface (340) of the elongated flexible sheath (314). Alternatively, as Figure 8AAs shown, the first, second, and third position coils (348a-c) can be etched or vapor-deposited onto the inner surface (344) of the elongated flexible sheath (314). Each position coil (348a-c) can be oriented about an axis orthogonal to the axes of the other position coils (348a-c). The position sensor assembly (328) (e.g., the first, second, and third position coils (348a-c)) can be directly etched or vapor-deposited onto the outer surface (340) of the elongated flexible sheath (314) or directly etched or vapor-deposited onto the inner surface (344) of the elongated flexible sheath (314). The first, second, and third position coils (348a-c) of the position sensor assembly (328) can replace or be used in addition to the reference reference. Figures 4 to 5 Used outside of the multiple panels (151) of the position sensor assembly (150) shown and described.

[0064] The force sensor assembly (326) can be formed together with the position sensor assembly (328) or separately. Figure 8 A first force sensor (346a) combined with a first position coil (348a), a second force sensor (346b) combined with a second position coil (348b), and a third force sensor (346c) combined with a third position coil (348c) are shown. For example, the force sensor assembly (326) can be formed together with the position sensor assembly (328) as a single integral structure, such that the first, second, and third force sensors (346a-c) are formed as integral parts with the first, second, and third position coils (348a-c), respectively. Alternatively, Figure 8A A first force sensor (346a) formed separately from a first position coil (348a), a second force sensor (346b) formed separately from a second position coil (348b), and a third force sensor (346c) formed separately from a third position coil (348c) are shown. Although not shown, it is envisioned that the first, second, and third force sensors (346a-c) may be separate from the first, second, and third position coils (348a-c) on the outer surface (340) of the elongated flexible sheath (314); or the first, second, and third force sensors (346a-c) may be combined with the first, second, and third position coils (348a-c) on the inner surface (344) of the elongated flexible sheath (314).

[0065] Each position coil (348a-c) can be configured to generate an electrical signal in response to the presence of an alternating electromagnetic field generated by the field generator (20). Each position coil (348a-c) can be coupled to a corresponding trace (not shown) or other cable on the elongated flexible sheath (314) of the catheter (310), such that the signal generated by the position coil (348a-c) can be transmitted back to the console (12) via a cable (not shown) in the catheter (310), which can process the signal to identify the position of the end effector (312) within the patient (PA). For example, each position coil (348a-c) can be formed by an electrical trace to define an electrical coil or antenna to receive radio frequency signals emitted by an external transmitter TX coil (e.g., three TX coils provided by a field generator (20) positioned outside the patient (PA) and emitting discrete radio frequencies), such that the position and orientation of each TX coil can be determined relative to the TX coil provided by the field generator (20). Signals from the position sensor assembly (328) can be transmitted via through-holes or other suitable structures in a layer located near the position sensor assembly (328), ultimately reaching the first driver module (14) of the console (12) via cable (30). Although not shown, other components and techniques that can be used to generate real-time position data associated with the end effector (312) may include wireless triangulation, acoustic tracking, optical tracking, inertial tracking, etc.

[0066] Figure 9 Showing cross Figure 6 The line 9-9 was cut off Figure 6 A cross-sectional view of the cylindrical body (330) of the distal end member (316), wherein the mapping electrode (338) (e.g., similar to the EP mapping microelectrode (138)), the ablation electrode (339) and the thermocouple (336) are disposed on the outer surface (350) of the wall (352) of the cylindrical body (330) of the distal end member (316). Figure 9A Showing cross Figure 6 The line 9-9 is similar to the cut. Figure 6 An exemplary alternative cylindrical body (330) is shown in cross-section, wherein the mapping electrode (338), the ablation electrode (339), and the thermocouple (336) are disposed on the inner surface (354) of the cylindrical body (330) of the distal end member (316). The thermocouple (336) (shown schematically) is configured to provide temperature sensing capability.

[0067] Although Figures 9 to 9AOnly one mapping electrode (338) is shown, but more than one mapping electrode (338) can be combined. For example, a pair of mapping electrodes (338) can be used, and the pair of mapping electrodes can be collectively referred to as a single “sensor.” Each mapping electrode (338) can be coupled to a corresponding trace or other cable on the elongated flexible sheath (314) of the catheter (310), so that the signal picked up by the mapping electrode (338) can be transmitted back to the console (12) via a cable (not shown) in the catheter (310), which can process the signal to provide EP mapping, thereby identifying the location of abnormal electrical activity within the cardiac anatomy. This, in turn, allows the physician (PH) to identify the most suitable area of ​​cardiac tissue to be ablated (e.g., with RF energy, cryoablation, etc.), thereby preventing or at least reducing the propagation of abnormal electrical activity across cardiac tissue. Such contact can be further facilitated by providing a large number of mapping electrodes (338) on the cylindrical body (330) of the distal end member (316), such as Figures 9 to 9A As shown. Having a large number of mapping electrodes (338) enables the end effector (312) to provide high-density EP mapping through all four chambers of the heart (H), because several pairs of mapping electrodes (338) can simultaneously provide electrocardiogram signal sensing at multiple regions of the heart tissue.

[0068] At least one ablation electrode (339) can be used to apply RF energy to tissue in contact with the ablation electrode (339), thereby ablating the tissue. Each ablation electrode (339) can be coupled to a corresponding trace or other cable on the cylindrical body (330) of the distal end member (316), thereby enabling the console (12) to transmit RF energy via a cable (not shown) in the conduit (120) to the trace or other cable on the cylindrical body (330) of the distal end member (316) to reach the ablation electrode (339). Similar to the mapping electrode (338), as Figures 9 to 9A The number and location of the ablation electrodes (339) shown are merely exemplary. Any other suitable number or location may be used for the ablation electrodes (339). As yet another illustrative variation, the ablation electrodes (339) may be omitted from the end effector (312). In some such variations, the mapping electrodes (338) may still be included on the end effector (312).

[0069] B. Exemplary structures formed by etching or vapor deposition

[0070] Figure 10 The exemplary structure (410) is adapted to Figure 6At least one electrode, at least one sensor, or at least one thermocouple is formed by etching or vapor deposition. For example, the force sensor assembly (326), position sensor assembly (328), thermocouple (336), mapping electrode (338), and ablation electrode (339) can be etched or vapor-deposited onto the elongated flexible sheath (314) of the conduit (310) or the cylindrical body (330) of the distal end member (316) in the manner described below with reference to structure (410). For example, the force sensor (346a-c) or position coil (348a-c) can be vapor-deposited onto the outer surface (340) or inner surface (344) of the wall (342) of the elongated flexible sheath (314) of the conduit (310), thereby reducing or completely eliminating the need for a separate force sensor or position coil. For example, thermocouples (336), calibration electrodes (338), or ablation electrodes (339) can be vapor-deposited onto the outer surface (350) or inner surface (354) of the wall (352) of the cylindrical body (330) of the distal end member (316), thereby reducing or completely eliminating additional structures.

[0071] As shown, the structure (410) may include a first layer (412) having an upper surface and a lower surface (414, 416). The first layer (412) is at least partially formed of a hyperelastic material, as described in more detail below. The hyperelastic material may include a hyperelastic alloy. For example, the hyperelastic alloy may include nitinol. Nitinol may be provided as a thin film (e.g., one or more nitinol strips or other nitinol structures). In this example, even to the extent that the material forming the first layer (412) is conductive, the first layer (412) may be primarily used for structural purposes rather than for electrical or conductive purposes.

[0072] A second layer (418) having upper and lower surfaces (420, 422) is disposed above the first layer (412). As shown, the upper surface (414) of the first layer (412) directly contacts the lower surface (422) of the second layer (418). The second layer (418) is at least partially formed of a non-conductive planar material. The non-conductive material provides electrical insulation properties between the first layer (412) and the third layer (424). A third layer (424) having upper and lower surfaces (426, 428) is disposed above the second layer (418). As shown, the upper surface (420) of the second layer (418) directly contacts the lower surface (428) of the third layer (424). The third layer (424) comprises a conductive etched or vapor-deposited material. In a configuration where the third layer (424) is formed in several discrete regions separated from each other, the second layer (418) electrically isolates these discrete regions of the third layer (424) from each other (in addition to the second layer (418) electrically isolating the regions of the third layer (424) from the first layer (412). For example only, the third layer (424) may include several discrete electrodes, pressure sensors, or other suitable features for ablation or EP mapping. All layers (412, 418, 424) may also include other features, such as fluid paths.

[0073] By way of example only, the first layer (412) may include one or more nitinol strips or other nitinol structures. One or more nitinol strips may be applied to the substrate (430). A suitable substrate (430) may include, for example, an elongated flexible sheath (314) of a conduit (310) or a cylindrical body (330) of a distal end member (316). In other words, the sheath (314) or the cylindrical body (330) may provide Figure 10The substrate (430) includes an upper surface and a lower surface (432, 434). As shown, the lower surface (416) of the first layer (412) directly contacts the upper surface (432) of the substrate (430). The representation of the upper and lower surfaces is for illustrative purposes only, and it is conceivable that the first layer (412) may directly contact the inner or outer surface of the substrate (430). In the form in which the marking and ablation electrodes (338, 339) are disposed on the outer surface (350) or inner surface (354) of the cylindrical body (330) of the distal end member (316), a nitinol strip or other elastic member may be inserted between layers of a flexible material (e.g., polyimide, polyetheretherketone, etc.) that forms an elongated flexible sheath (314) or a cylindrical body (330). Alternatively, a nitinol strip or other elastic member may be positioned along the elongated flexible sheath (314) or cylindrical body (330) in areas where the measuring and ablation electrodes (338, 339) are absent. While the first layer (412) is applied to the substrate (430) layer in the aforementioned example, other types may omit the substrate (430) entirely. In other words, the first layer (412) itself may serve as a suitable substrate for other layers (418, 424). In some of these types, the first layer (412) may be formed in a cylindrical shape (a cylinder with flaps folded to form a dome-shaped end) or any other suitable shape.

[0074] As yet another illustrative example, the mapping and ablation electrodes (338, 339) and the position coils (348a-c) can be applied directly to an electrically insulating layer disposed above the nitinol of the cylindrical body (330) of the distal end member (316). In this type, the end effector (312) may not have polyimide, polyetheretherketone, or other flexible materials used as conventional flexible circuit substrates. Other methods may also be used to place the mapping and ablation electrodes (338, 339), conductive traces, or other circuit components, including but not limited to sputtering deposition, thermal deposition, etc., on the outer and inner surfaces (340, 344) of the elongated flexible sheath (314) of the conduit (310) or on the outer and inner surfaces (350, 354) of the cylindrical body (330) of the distal end member (316).

[0075] The end effector (312) may include any suitable number and arrangement of thermocouples such as thermocouples (336). Alternatively, the end effector (312) may include any suitable number and arrangement of mapping electrodes (338). Alternatively, the end effector (312) may include any suitable number and arrangement of ablation electrodes such as ablation electrodes (339). Alternatively, the catheter (310) may include any suitable number and arrangement of force sensors such as force sensors (346a-c). Alternatively, the catheter (310) may include any suitable number and arrangement of position sensors such as position coils (348a-c). Other suitable ways in which the catheter (310) and the end effector (312) may be formed with reference to the teachings herein will be apparent to those skilled in the art.

[0076] C. Exemplary Manufacturing Method

[0077] Figure 11 It shows the manufacture of surgical instruments (e.g.) Figures 1 to 2 An exemplary method (510) of the catheter assembly (100) shown herein may include steps (512, 514, 516). As previously described, the catheter assembly (100) includes a catheter (310) and an end effector (312) extending distally from the catheter (310).

[0078] At step (512), method (510) may include forming at least one electrode, at least one sensor, or at least one thermocouple (336) by etching or vapor deposition of a three-dimensional structure (e.g., a third layer (424)) onto a non-conductive material (e.g., a second layer (418)) stacked above a hyperelastic material (e.g., a first layer (412)). The at least one electrode may include at least one sensing electrode (e.g., an EP mapping electrode (338)), or at least one ablation electrode (339), or at least one reference electrode (not shown). Individually, the at least one sensor may include at least one force sensor assembly (326) or at least one position sensor assembly (328).

[0079] For example, vapor deposition can be physical vapor deposition. Physical vapor deposition (PVD) (sometimes considered a thin film process) is an atomic deposition process in which material is evaporated from a solid or liquid source into atoms or molecules and transported as vapor through a vacuum or low-pressure gas (or plasma) environment to a substrate, where the vapor condenses. The main categories of PVD processes are vacuum deposition (evaporation), sputtering deposition, arc vapor deposition, and ion plating. Alternatively, vapor deposition is chemical vapor deposition. Chemical vapor deposition (CVD) is a process in which a film of material is deposited from the vapor phase by decomposing chemicals on the surface of a substrate. This process is typically thermally driven, light-assisted, or plasma-assisted. The deposition of the film is controlled by a chemical reaction. For example, PVD or CVD machines (518) can be used.

[0080] The first, second, and third layers (412, 418, 424) can form a single structure compatible with MRI machines that have both diagnostic and therapeutic capabilities. Step (512) may include etching or vapor deposition of domes, barrels, combinations of domes and barrels, or barrels with dome ends. Magnetic material (e.g., the third layer (424)) may be vapor-deposited onto a non-conductive material (e.g., the second layer (418)) to form structure (410).

[0081] At step (514), the method (510) may include heat-treating the structure (410) after the forming step to shape the structure (410). For example, a heating device (520) may be used. This heat treatment step is merely optional. Hyperelastic materials (such as, but not limited to, nitinol) allow the structure (410) to be shaped using one or more heat treatments to provide manufacturing consistency.

[0082] At step (516), method (510) may include laser welding a seam or joint structure (410) to form a closed shape. For example, welding equipment (522) may be used. This laser welding step is merely optional. Existing microstructures (e.g., openings (334)) may remain unaffected. As previously described, openings (334) allow flushing fluid to be delivered from the interior of the distal end member (316) through the cylindrical body (330) of the distal end member (316). Furthermore, traces and bonding pads may be deposited along appropriate layers, with wires connected to the bonding pads, to provide a path for electrical communication between the end effector (312) and the guidance and drive system (10).

[0083] IV. Exemplary Combinations

[0084] The following examples illustrate various non-exhaustive ways in which the teachings herein can be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claims that may be provided at any time in this patent application or a subsequent filing thereof. No disclaimer is intended. The following examples are provided merely for illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in a variety of other ways. It is also contemplated that some variations may omit certain features mentioned in the following examples. Therefore, none of the aspects or features mentioned below should be considered definitive unless otherwise expressly indicated, for example, by the inventor or a successor of the inventor of interest, at a later date. If any claim set forth in this patent application or a subsequent filing related to this patent application includes additional features beyond those mentioned below, such additional features should not be presumed to have been added for any reason related to patentability.

[0085] Example 1

[0086] A method of manufacturing a surgical instrument, the surgical instrument including a catheter and an end effector extending distally from the catheter, the method comprising: forming at least one electrode, sensor or thermocouple onto the catheter or the end effector of the surgical instrument by etching or vapor deposition of a three-dimensional structure onto a non-conductive material stacked on top of a hyperelastic material.

[0087] Example 2

[0088] According to the method described in Example 1, the non-conductive material is planar.

[0089] Example 3

[0090] According to any one or more of the methods described in Examples 1 to 2, the superelastic material includes a superelastic alloy.

[0091] Example 4

[0092] According to the method described in Example 3, the superelastic alloy comprises nickel-titanium.

[0093] Example 5

[0094] According to the method described in Example 4, the nickel-titanium is in the form of a thin film.

[0095] Example 6

[0096] According to the method of Embodiment 1, the step of forming at least one electrode, sensor or thermocouple onto the conduit or the end effector further includes forming at least one electrode by etching or vapor deposition.

[0097] Example 7

[0098] According to the method described in Example 6, the at least one electrode is selected from the group consisting of a sensing electrode, an ablation electrode, and a reference electrode.

[0099] Example 8

[0100] According to any one or more of the methods in Examples 1 to 7, the step of forming at least one electrode, sensor or thermocouple onto the conduit or the end effector further includes forming at least one thermocouple by etching or vapor deposition.

[0101] Example 9

[0102] According to any one or more of the methods described in Examples 1 to 8, the forming step further includes forming a single structure having both diagnostic and therapeutic capabilities.

[0103] Example 10

[0104] According to any one or more of the methods in Examples 1 to 9, the step of forming at least one electrode, sensor or thermocouple onto the conduit or the end effector further includes forming at least one sensor by etching or vapor deposition.

[0105] Example 11

[0106] According to any one or more of the methods described in Examples 1 to 10, the sensor is at least one position sensor assembly or at least one force sensor assembly.

[0107] Example 12

[0108] According to the method of Embodiment 11, the catheter has an inner surface and an outer surface, the end effector has an inner surface and an outer surface, the position sensor assembly includes at least one position coil, and the forming step further includes etching or vapor-depositing the at least one position coil onto at least one of the inner surface of the catheter, the inner surface of the end effector, the outer surface of the catheter, or the outer surface of the end effector.

[0109] Example 13

[0110] According to the method of Embodiment 11, the position sensor assembly includes at least one position coil, and the forming step further includes etching or vapor-depositing the at least one position coil onto the inner surface of the conduit or the inner surface of the end effector.

[0111] Example 14

[0112] According to the method of Embodiment 11, the position sensor assembly includes at least one position coil, and the forming step further includes etching or vapor-depositing the at least one position coil onto the outer surface of the conduit or the outer surface of the end effector.

[0113] Example 15

[0114] According to the method of Embodiment 11, the at least one force sensor includes a first force sensor, and the forming step further includes etching or vapor-depositing the first force sensor onto the inner surface of the conduit or the inner surface of the end effector.

[0115] Example 16

[0116] According to the method of embodiment 15, the at least one force sensor further includes a second force sensor, and the forming step further includes etching or vapor-depositing the second force sensor onto the inner surface of the conduit or the inner surface of the end effector.

[0117] Example 17

[0118] According to the method of embodiment 16, the at least one force sensor further includes a third force sensor, and the forming step further includes etching or vapor-depositing the second force sensor onto the inner surface of the conduit or the inner surface of the end effector.

[0119] Example 18

[0120] According to the method of embodiment 11, the at least one force sensor includes a first force sensor, and the forming step further includes etching or vapor-depositing the first force sensor onto the outer surface of the conduit or the end effector.

[0121] Example 19

[0122] According to the method of embodiment 18, the at least one force sensor further includes a second force sensor, and the forming step further includes etching or vapor-depositing the second force sensor onto the outer surface of the conduit or the end effector.

[0123] Example 20

[0124] According to the method of embodiment 19, the at least one force sensor further includes a third force sensor, and the forming step further includes etching or vapor-depositing the second force sensor onto the outer surface of the conduit or the end effector.

[0125] Example 21

[0126] According to any one or more of the methods in Examples 11 to 20, the at least one force sensor further includes a rose strain gauge, and the force sensor further includes vapor deposition of the rose strain gauge onto the conduit or the end effector.

[0127] Example 22

[0128] According to the method described in Example 21, the rose strain gauge is a triaxial rose strain gauge, and the vapor deposition of the rose strain gauge further includes vapor deposition of the triaxial rose strain gauge onto the conduit or the end effector.

[0129] Example 23

[0130] According to any one or more of the methods described in Examples 1 to 22, the vapor deposition is physical vapor deposition.

[0131] Example 24

[0132] According to any one or more of the methods described in Examples 1 to 22, the vapor deposition is chemical vapor deposition.

[0133] Example 25

[0134] The method according to any one or more of Examples 1 to 24 further includes vapor-depositing a magnetic material onto the non-conductive material to form the three-dimensional structure.

[0135] Example 26

[0136] The method according to any one or more of Embodiments 1 to 25 further includes heat treatment of the three-dimensional structure after the formation step to shape the three-dimensional structure.

[0137] Example 27

[0138] According to any one or more of the methods described in Examples 1 to 26, the forming step further includes etching or vapor deposition of a dome, a barrel, or a combination of both, or a barrel having a dome end.

[0139] Example 28

[0140] The method according to any one or more of Examples 1 to 27 further includes laser welding of seams or joints to form a closed shape.

[0141] Example 29

[0142] A method of manufacturing a surgical instrument, the surgical instrument including a catheter and an end effector extending distally from the catheter, the method comprising: forming at least one sensing electrode, ablation electrode, thermocouple, reference electrode or sensor onto the catheter or the end effector of the surgical instrument by etching or vapor deposition of a structure onto a non-conductive material stacked above a thin film structure to form a single structure.

[0143] Example 30

[0144] The method according to Embodiment 29 further includes heat-treating the structure after the formation step to shape the structure.

[0145] Example 31

[0146] According to any one or more of the methods in Examples 29 to 30, the forming step further includes etching or vapor deposition of a dome, a barrel, or a combination of both, or a barrel having a dome end.

[0147] Example 32

[0148] The method according to any one or more of Examples 29 to 31 further includes laser welding of seams or joints to form a closed shape.

[0149] Example 33

[0150] A surgical instrument includes: (a) a handle; (b) a catheter extending distally from the handle, a proximal portion of the catheter defining a longitudinal axis; and (c) an end effector extending distally from the catheter, the end effector including at least one sensing electrode, an ablation electrode, a reference electrode, a force sensor assembly, a position sensor assembly, or a thermocouple, the end effector including: (i) a first layer comprising a hyperelastic material; (ii) a second layer comprising a non-conductive material in contact with the hyperelastic material; and (iii) a third layer in contact with the non-conductive material.

[0151] Example 34

[0152] According to the surgical instrument of embodiment 33, the catheter has an inner surface and an outer surface, the end effector has an inner surface and an outer surface, and at least one sensing electrode, ablation electrode, reference electrode, force sensor assembly, position sensor assembly or thermocouple is disposed on at least one of the inner surface of the catheter, the inner surface of the end effector, the outer surface of the catheter or the outer surface of the end effector.

[0153] Example 35

[0154] According to the surgical instrument of embodiment 33, the catheter has an inner surface and an outer surface, the end effector has an inner surface and an outer surface, and at least one sensing electrode, ablation electrode, reference electrode, force sensor assembly, position sensor assembly or thermocouple is disposed on the inner surface of the catheter or the inner surface of the end effector.

[0155] Example 36

[0156] According to the surgical instrument of embodiment 33, the catheter has an inner surface and an outer surface, the end effector has an inner surface and an outer surface, and at least one sensing electrode, ablation electrode, reference electrode, force sensor assembly, position sensor assembly or thermocouple is disposed on the outer surface of the catheter or the outer surface of the end effector.

[0157] Example 37

[0158] According to any one or more of the surgical instruments described in 33 to 36, the non-conductive material is selected from the group consisting of polyimide and polyetheretherketone.

[0159] Example 38

[0160] According to any one or more of the surgical instruments described in Examples 33 to 37, the non-conductive material is planar.

[0161] Example 39

[0162] According to one or more of the surgical instruments described in Examples 33 to 38, the superelastic material includes a superelastic alloy.

[0163] Example 40

[0164] According to the surgical instrument of Example 39, the superelastic alloy is nickel-titanium.

[0165] Example 41

[0166] According to the surgical instrument of Example 39, the superelastic alloy comprises a shape memory material.

[0167] Example 42

[0168] According to the surgical instrument of embodiment 41, the shape memory material includes a temperature-sensitive material, such that the temperature-sensitive material is configured to change from a first shape to a second shape in response to a change in temperature.

[0169] Example 43

[0170] The surgical instrument according to any one or more of Embodiments 33 to 42 further includes a position sensor operable to generate a signal indicating the position of at least a portion of the catheter or at least a portion of the end effector in three-dimensional space.

[0171] Example 44

[0172] According to one or more of the surgical instruments described in Examples 33 to 43, the position sensor assembly is located on a portion of the catheter.

[0173] Example 45

[0174] According to any one or more of the surgical instruments described in Examples 33 to 44, the catheter further includes a flexible elongated sheath, and the position sensor assembly is located on the inner or outer surface of the flexible elongated sheath of the catheter.

[0175] V. Miscellaneous

[0176] Any of the devices described herein may be cleaned and sterilized before and / or after the procedure. In one sterilization technique, the device is placed in a closed and sealed container such as a plastic bag or a TYVEK bag. The container and device can then be placed in a radiation field that can penetrate the container, such as gamma radiation, X-rays, or high-energy electrons. The radiation kills bacteria on the device and in the container. The sterilized device can then be stored in a sterile container for later use. Any other techniques known in the art may also be used to sterilize the device, including but not limited to beta or gamma radiation, ethylene oxide, hydrogen peroxide, peracetic acid, and gas-phase sterilization (with or without gas plasma or vapor).

[0177] It should be understood that any example described herein may also include various other features besides or in lieu of those described above. By way of example only, any example described herein may also include one or more features disclosed in any of the various references incorporated herein by reference.

[0178] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc., described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc., described herein. Therefore, the aforementioned teachings, expressions, embodiments, examples, etc., should not be considered in isolation from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the art upon reference to the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0179] It should be understood that any patent, patent publication, or other public material allegedly incorporated herein by reference, whether in whole or in part, is incorporated only to the extent that the incorporated material does not conflict with any existing definitions, statements, or other public material set forth in this disclosure. Therefore, and to the extent necessary, the disclosures expressly listed herein replace any conflicting material incorporated herein by reference. Any material, or part thereof, allegedly incorporated herein by reference that conflicts with any existing definitions, statements, or other public material set forth herein will be incorporated only to the extent that the incorporated material does not conflict with any existing public material.

[0180] While various embodiments of the invention have been shown and described, further improvements to the methods and systems described herein can be achieved by suitable modifications made by those skilled in the art without departing from the scope of the invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the examples, types, geometries, materials, dimensions, ratios, steps, etc., discussed above are exemplary and not essential. Therefore, the scope of the invention should be considered in accordance with the following claims and should be understood as not being limited to the details of the structures and operations shown and described in the specification and drawings.

Claims

1. A method of manufacturing a surgical instrument, the surgical instrument comprising a catheter and an end effector extending distally from the catheter, the catheter comprising an elongated flexible sheath, the method comprising: At least one electrode, sensor, or thermocouple is formed onto the elongated flexible sheath of the catheter of the surgical instrument by etching or vapor deposition of a three-dimensional structure onto a non-conductive material stacked on top of a superelastic material, wherein the superelastic material is applied to the sheath.

2. The method according to claim 1, wherein the non-conductive material is planar.

3. The method according to claim 1, wherein the superelastic material comprises a superelastic alloy.

4. The method according to claim 3, wherein the superelastic alloy comprises nickelitanol.

5. The method of claim 1, wherein the step of forming at least one electrode, sensor or thermocouple onto the sheath further comprises forming at least one electrode by etching or vapor deposition.

6. The method according to claim 5, wherein the at least one electrode is selected from the group consisting of a sensing electrode, an ablation electrode, and a reference electrode.

7. The method of claim 1, wherein the step of forming at least one electrode, sensor or thermocouple onto the sheath further comprises forming at least one thermocouple by etching or vapor deposition.

8. The method of claim 1, wherein the step of forming at least one electrode, sensor or thermocouple onto the sheath further comprises forming at least one sensor by etching or vapor deposition.

9. The method according to claim 1, wherein the sensor is at least one position sensor assembly or at least one force sensor assembly.

10. The method of claim 9, wherein the sheath has an inner surface and an outer surface, the position sensor assembly includes at least one position coil, and the forming step further includes etching or vapor-depositing the at least one position coil onto at least one of the inner surface of the sheath or the outer surface of the sheath.

11. The method of claim 9, wherein the at least one force sensor assembly includes a first force sensor, and the forming step further includes etching or vapor-depositing the first force sensor onto the inner surface of the sheath.

12. The method of claim 9, wherein the at least one force sensor assembly further comprises a rose-shaped strain gauge, and the at least one force sensor assembly further comprises vapor-depositing the rose-shaped strain gauge onto the sheath.

13. The method of claim 1, further comprising vapor-depositing a magnetic material onto the non-conductive material to form the three-dimensional structure.

14. The method of claim 1, further comprising subjecting the three-dimensional structure to heat treatment after the forming step to shape the three-dimensional structure.

15. The method of claim 1, further comprising laser welding of the seam or joint to form a closed shape.

16. The method according to claim 1, wherein the superelastic material is a thin film structure.

17. The method of claim 1, wherein the forming step further comprises etching or vapor deposition of a dome, a barrel, or a combination thereof.

18. The method of claim 17, wherein the combination of the dome and the barrel comprises a barrel having a dome end.

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