Electrical connection of electroanatomical mapping dilator to sheath

Abstract

A medical system includes a sheath including an elongate body having a proximal portion and a distal portion. One or more sheath electrodes are located at the distal portion. A handle is attached to the proximal portion, the handle including a first connector and a second connector electrically coupleable to a control system. The system includes a dilator having an elongate body including a proximal portion and a distal portion having one or more dilator electrodes. The dilator includes a bushing having a dilator connector electrically coupled to one or more dilator electrodes. The second connector includes a retaining rail having at least one electrical contact. The second connector is configured to mechanically and electrically couple with the dilator connector.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 582,657, filed September 14, 2023, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] This invention generally relates to methods and devices that can be used in a patient's body. More specifically, this invention relates to a device relating to an electroanatomical mapping enabling expander and an electroanatomical mapping sheath having integrated electrical coupling. Background Technology

[0004] Electroanatomical mapping (EAM) is an increasingly popular technique useful during in vivo surgery. It enables physicians to identify anatomical regions and electrical activation patterns of the heart. This is particularly useful in treating arrhythmias. Devices compatible with EAM systems allow operators to locate them and more easily target specific areas for treatment, resulting in better workflow, better treatment outcomes, and shorter procedure times.

[0005] Typically, each EAM device requires a cable to connect to the EAM system. This can lead to cumbersome device operation and challenges in managing the workspace for surgical equipment with multiple cables. Summary of the Invention

[0006] Example 1 is a medical system comprising an expander having an elongated body with a proximal and a distal portion, the distal portion having one or more expander electrodes. The expander has a hub including an expander connector electrically coupled to the one or more expander electrodes. The medical system includes a sheath comprising the elongated body having a proximal and a distal portion; one or more sheath electrodes located on the distal portion; and a handle attached to the proximal portion, the handle having a first connector and a second connector capable of electrically coupling to a control system. The second connector includes a retaining rail having at least one electrical contact, and the second connector is configured for mechanical and electrical coupling with the expander connector.

[0007] Example 2 is a system according to Example 1, wherein the elongated sheath body includes a lumen extending from the proximal portion to the distal portion and is configured to receive the dilator.

[0008] Example 3 is a system according to Example 2, wherein the second connector is coaxial with the lumen.

[0009] Example 4 is the system of any of examples 1-3, wherein the resilient retention track comprises an elliptical body having a width greater than a height.

[0010] Example 5 is the system of example 4, wherein the resilient retention track comprises a first line of symmetry and a second line of symmetry, and the at least one electrical contact intersects the first line of symmetry.

[0011] Example 6 is the system of example 5, wherein the at least one electrical contact is a conductive coating.

[0012] Example 7 is the system of any of examples 1-6, wherein the second connector comprises a hemostasis valve, a cap, and a cover.

[0013] Example 8 is the system of example 7, wherein the cap comprises a retention track guide.

[0014] Example 9 is the system of any of examples 1-8, wherein an electrical connection is made between the one or more dilator electrodes and the control system when the dilator connector is received by the second connector.

[0015] Example 10 is the system of any of examples 1-9, wherein the dilator distal portion is tapered.

[0016] Example 11 is the system of any of examples 1-10, wherein the dilator connector comprises a cylinder having an outer surface and one or more electrical contacts located on the outer surface.

[0017] Example 12 is the system of any of examples 1-11, wherein the dilator connector is configured to mechanically couple with the second connector to hold the dilator in a desired rotational orientation relative to the sheath.

[0018] Example 13 is the system of any of examples 1-12, wherein the dilator connector comprises a distal protrusion.

[0019] Example 14 is the system of any of examples 1-13, further comprising a display for displaying one or more anatomical images, parameters, and positioning information.

[0020] Example 15 is the system of any of examples 1-14, wherein the one or more sheath electrodes comprise four sheath electrodes and the one or more dilator electrodes comprise two electrodes.

[0021] Example 16 is a medical system comprising: a sheath comprising an elongate body having a proximal portion, a distal portion, and a lumen therebetween. One or more sheath electrodes are located on the distal portion. A handle is attached to the proximal portion. The handle comprises a first connector electrically couplable to a control system and a second connector coaxial with the lumen. The system comprises a dilator. The dilator comprises an elongate body having a proximal portion and a distal portion having one or more dilator electrodes. The dilator has a dilator connector electrically coupled to the one or more dilator electrodes. The second connector comprises a retention track having at least one electrical contact. The second connector is configured to mechanically and electrically couple with the dilator connector.

[0022] Example 17 is the system of Example 16, wherein the sheath lumen is configured to receive the dilator.

[0023] Example 18 is the system of Example 17, wherein the dilator comprises a dilator hub and the dilator connector is integral with the dilator hub.

[0024] Example 19 is the system of Example 16, wherein the resilient retention track comprises an elliptical body having a width greater than a height.

[0025] Example 20 is the system of Example 19, wherein the resilient retention track comprises a first line of symmetry and a second line of symmetry, and the at least one electrical contact intersects the first line of symmetry.

[0026] Example 21 is the system of Example 20, wherein the at least one electrical contact comprises a conductive coating.

[0027] Example 22 is the system of Example 16, wherein the second connector comprises a hemostasis valve, a cap, and a cover.

[0028] Example 23 is the system of Example 22, wherein the cap comprises a retention track guide.

[0029] Example 24 is the system of Example 16, wherein an electrical connection is made between the one or more dilator electrodes and the control system when the dilator connector is received by the second connector.

[0030] Example 25 is the system of Example 16, wherein the dilator distal portion is tapered.

[0031] Example 26 is the system of Example 16, wherein the dilator connector comprises a cylinder having an outer surface and one or more electrical contacts located on the outer surface.

[0032] Example 27 is the system of example 16, wherein the dilator connector is configured to self-align with the second connector, and wherein the dilator connector is configured to mechanically couple with the second connector so as to hold the dilator in a desired rotational orientation relative to the sheath.

[0033] Example 28 is the system of example 16, wherein the dilator connector comprises a distal protrusion.

[0034] Example 29 is the system of example 16, further comprising a display for displaying one or more anatomical images, parameters, and positioning information.

[0035] Example 30 is the system of example 16, wherein the one or more sheath electrodes comprise four sheath electrodes, and the one or more dilator electrodes comprise two electrodes.

[0036] Example 31 is a medical system comprising a sheath comprising an elongated body having a proximal portion, a distal portion, and a lumen therebetween. One or more sheath electrodes are located on the distal portion. A handle is attached to the proximal portion. The handle has a first connector that is electrically couplable to a control system and a second connector that is coaxial with the lumen. The system comprises a dilator. The dilator has an elongated body comprising a proximal portion and a distal portion having one or more dilator electrodes. The dilator has a dilator connector that is electrically coupled to the one or more dilator electrodes. The second connector comprises a resilient retention track that is configured to mechanically and electrically couple with the dilator connector. An electrical connection is made between the one or more dilator electrodes and the control system when the dilator connector is received by the second connector.

[0037] Example 32 is the system of example 31, wherein the resilient retention track comprises an elliptical body having a width that is greater than a height.

[0038] Example 33 is the system of example 32, wherein the resilient retention track comprises at least one electrical contact.

[0039] Example 34 is the system of example 33, wherein the at least one electrical contact comprises a conductive coating.

[0040] Example 35 is a medical system comprising a sheath comprising an elongate body having a proximal portion, a distal portion, and a lumen therebetween. One or more sheath electrodes are located on the distal portion. A handle is attached to the proximal portion, the handle comprising a first connector that is electrically couplable to a control system and a second connector that is coaxial with the lumen. The system comprises a dilator comprising an elongate body having a proximal portion and a distal portion. One or more dilator electrodes are located on the distal portion. A dilator connector is electrically coupled to the one or more dilator electrodes. The system comprises a display for displaying one or more anatomical images, parameters, and positioning information. The second connector comprises a resilient retention track having at least one electrically conductive snap. The second connector is configured to receive the dilator elongate body and electrically couple with the dilator connector.

[0041] While several embodiments have been disclosed, other embodiments of the present application will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the present application. As will be realized, the drawings and detailed description are not intended to limit the present application. BRIEF DESCRIPTION OF DRAWINGS

[0042] Figure 1 is a diagram showing an exemplary clinical environment for treating a patient and treating a heart of the patient using an electrophysiology system, in accordance with an embodiment of the subject matter of the present disclosure.

[0043] Figure 2 is shown a sheath, in accordance with an embodiment of the present disclosure.

[0044] Figure 3 is shown a dilator, in accordance with an embodiment of the present disclosure.

[0045] Figure 4 is shown a dilator, in accordance with an embodiment of the present disclosure. Figure 3 insertion of the dilator into the sheath. Figure 2 is shown a dilator, in accordance with an embodiment of the present disclosure.

[0046] Figure 5 is shown an exploded view of a proximal sheath connector, in accordance with an embodiment of the present disclosure.

[0047] Figure 6 is shown a plan view of a retention track, in accordance with an embodiment of the present disclosure.

[0048] Figure 7 is shown a plan view of a proximal sheath connector showing electrical contacts, in accordance with an embodiment of the present disclosure.

[0049] Figure 8 is shown a dilator connector, in accordance with the present disclosure.

[0050] Figure 9A cross-sectional view of the proximal sheath connector and dilator connector according to the present disclosure is shown prior to connection.

[0051] Figure 10 A cross-sectional view of the proximal sheath connector and dilator connector according to the present disclosure is shown after connection.

[0052] While the application is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail in the following description. It should be understood, however, that the intention is not to limit the application to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the application as defined by the appended claims. DETAILED DESCRIPTION

[0053] Figure 1 is a diagram showing an exemplary clinical environment 10 for treating a patient 20 and treating a heart 30 of the patient 20 using an electrophysiology system 50 according to embodiments of the disclosed subject matter. The electrophysiology system 50 includes an access system 60 and an electroanatomical mapping (EAM) system 70, which includes a localization field generator 80, a mapping and navigation controller 90, and a display 92. In addition, the clinical environment 10 includes additional devices, such as an imaging device 94 (represented by a C-arm) and various controller elements, such as a foot controller 96, which are configured to allow an operator to control various aspects of the electrophysiology system 50. Those skilled in the art will appreciate that the clinical environment 10 can have other components and arrangements of components not shown in FIG. 1. Figure 1

[0054] The access system 60 includes a dilator 100 having a proximal portion 102 and a distal portion 105, an introducer sheath 110, and a control console 130. In some aspects, the distal portion 105 includes a tapered region. The introducer sheath 110 includes a plurality of electrodes on a distal portion thereof. The introducer sheath 110 is connected to the EAM system using one or more cables, umbilical cables, or the like, which are used to functionally connect the electrodes to the EAM system 70. The dilator 100 also includes a plurality of electrodes along the distal portion 105 for connection to the EAM system 70. The dilator 100 is not directly connected to the EAM system 70 via a cable or umbilical cable. Rather, the dilator 100 is connected to the EAM system 70 upon insertion into the introducer sheath 110, as discussed in detail below.

[0055] ​In one embodiment, the guide sheath 110 is operable to provide a delivery catheter through which the dilator 100 (partially its distal portion 105) can be deployed to a specific target site within the patient's heart 30. The dilator 100 is configured with a lumen that allows the insertion of a guiding device (e.g., a guidewire) or a perforation device (e.g., an RF perforation device). In some aspects, the perforation device can be used to perform transseptal crossing procedures within the heart 30.

[0056] Console 130 is configured to control functional aspects of access system 60. In embodiments, console 130 includes one or more controllers, microprocessors, and / or computers that execute code in memory to control and / or perform functional aspects of access system 60. In embodiments, memory may be part of one or more controllers, microprocessors, and / or computers, and / or part of a memory capacity accessible via a network, such as the World Wide Web. In embodiments, console 130 may include pulse generator hardware, software, and / or firmware configured to generate electrical pulses of predefined waveforms that can be sent to electrodes located on expander 100, guiding device, or perforation device to generate an electric field sufficient to achieve a desired clinical effect, such as ablation of target tissue via irreversible electroporation. In embodiments, console 130 may deliver pulse waveforms in unipolar or bipolar operating modes, as will be described in further detail herein.

[0057] EAM system 70 is operable to track the position of various functional components of access system 60 and generate high-fidelity three-dimensional anatomical and electroanatomical maps of the cardiac chambers of interest. In an embodiment, EAM system 70 may be a RHYTHMIA system sold by Boston Scientific. TM HDx mapping system. Furthermore, in embodiments, the mapping and navigation controller 90 of the EAM system 70 includes one or more controllers, microprocessors, and / or computers that execute off-memory code to control and / or perform functional aspects of the EAM system 70, wherein, in embodiments, the memory may be part of one or more controllers, microprocessors, and / or computers, and / or part of a memory capacity accessible via a network (such as the World Wide Web).

[0058] Those skilled in the art will understand that Figure 1 The description of the electrophysiological system 50 shown is intended to provide a general overview of the various components of the system 50 and is not intended in any way to imply that this disclosure is limited to any particular set of components or arrangement of components. For example, those skilled in the art will readily recognize that additional hardware components (e.g., junction boxes, workstations, etc.) may and are likely to be included in the electrophysiological system 50.

[0059] The EAM system 70 generates a localization field via the field generator 80 to define a localization volume around the heart 30, and one or more position sensors or sensing elements on one or more tracked devices, such as the dilator 100, generate output that can be processed by the mapping and navigation controller 90 to track the position of the sensors, and thus the corresponding devices, within the localization volume. In the illustrated embodiment, device tracking is implemented using magnetic tracking technology, whereby the field generator 80 is a magnetic field generator that generates a magnetic field defining the localization volume, and the position sensors on the tracked devices are magnetic field sensors. In some aspects, the EAM system 70 can include a display for displaying one or more anatomical images, parameters, and orientation information.

[0060] In other embodiments, impedance tracking methods can be employed to track the position of various devices. In such embodiments, the localization field is an electric field generated, for example, by external field generator arrangements (e.g., surface electrodes), intrabody or intracardiac devices (e.g., intracardiac catheters), or both. In these embodiments, the position sensing elements can constitute electrodes on the tracked devices that generate output received and processed by the mapping and navigation controller 90 to track the position of the various position sensing electrodes within the localization volume.

[0061] In embodiments, the EAM system 70 is equipped with both magnetic and impedance tracking functionality. In such embodiments, impedance tracking accuracy can in some cases be improved by first using a probe equipped with magnetic position sensors to create an electric field map within a cardiac chamber of interest that is sensed by an electric field generator, just like using the RHYTHMIA® mapping system described above. One example probe is the INTELLAMAP ORION® mapping catheter sold by Boston Scientific Corporation. HDx TM The INTELLAMAP ORION® mapping catheter. TM mapping catheter.

[0062] Regardless of the tracking method employed, the EAM system 70 utilizes the position information of the various tracked devices, along with the electrical activity captured by, for example, the dilator 100 or another catheter or probe equipped with sensing electrodes, to generate and display via the display 92 a detailed three-dimensional geometric anatomical map or representation of the cardiac chamber, along with an electroanatomical map in which the electrical activity of interest is superimposed on the geometric anatomical map. In addition, the EAM system 70 can generate graphical representations of the various tracked devices within the geometric anatomical map and / or electroanatomical map.

[0063] Figure 2 A sheath 110 according to embodiments of the present disclosure is shown. The sheath 110 includes a handle 112 configured to be grasped by a user to manipulate the sheath 110. The handle 112 includes a proximal end 114 and a distal end 116. A proximal sheath connector 115 is located at the proximal end 114 of the handle 112 and is configured to mate with a dilator connector, as described below.

[0064] A control knob 118 is located on the handle 112 and is rotatable to control the shape of the elongated hollow body 120 extending from the handle 112. While the control knob 118 is shown proximate to the distal end 116, it should be understood that the control knob 118 can be positioned along any portion of the handle 112. The control knob 118 is configured to manipulate one or more steering wires or rods to change the shape of the elongated hollow body 120 and is configured to move relative to a stationary portion of the handle 112. The control knob 118 is configured to deflect the elongated hollow body 120 in a first direction when the knob 118 is rotated clockwise and in a second direction when the knob 118 is rotated counterclockwise.

[0065] The elongated hollow body 120 includes a proximal end 121 and a distal end 122. The proximal end 121 is detachably connected to the distal end 116 of the handle 112 and the distal end 122 is freely movable. The elongated hollow body 120 includes one or more electrodes 124 positioned along its length. In one aspect, the one or more electrodes 124 include at least four electrodes. The one or more electrodes 124 can be positioned at uniform intervals or at non-uniform intervals. The one or more electrodes 124 can be configured as surface electrodes capable of contacting tissue or fluid within a patient. The one or more electrodes 124 can be configured as part of the EAM system 70 to detect a parameter when in contact with tissue or fluid or to deliver energy, such as RF energy, to tissue to ablate the tissue.

[0066] A lumen 126 extends from the handle proximal end 114 through the knob 118 and through the elongated hollow body 120 to the distal end 122. The lumen 126 is configured to receive a dilator or other elongated medical device in the direction shown by arrow 132. The proximal sheath connector 115 is coaxial with the lumen 126 and is configured to receive a medical device, such as the elongated hollow body 142 of the dilator 100, therein.

[0067] The handle 112 includes a connector 128 configured to couple with a control system, such as the EAM system 70 or an RF energy generator. The connector 128 is configured to releasably engage with the system. The handle 112 also includes a conduit 130 including at least one fitting 131, such as a Luer connector. The conduit 130 is configured to allow fluid to be introduced into the lumen 126 or an additional lumen within the sheath 110. The at least one fitting 131 is configured to detachably connect to a syringe or other container for delivering fluid through the conduit 130.

[0068] Figure 3An expander 100 according to embodiments of the present disclosure is shown. The expander 100 is configured to be inserted into and coupled with a sheath 110. The expander 100 includes a hub 134. The hub 134 includes a knurled surface 135 configured to assist a user in gripping the hub 134. The hub 134 includes a proximal end 136 and an opposite distal end 138. A connector 137 is located at the proximal end 136. The connector 137 can include a luer connector configured to detachably connect to a syringe or other container. The connector 137 also allows for the introduction of a medical device, such as a guidewire or RF perforation device, into a lumen 140 that extends from the connector 137 to a distal tip 141 of the expander 100. The hub 134 includes an extension 139 that aids in the manipulation of the expander 100 and serves as a reference for positioning the expander 100.

[0069] The expander 100 includes an elongated hollow body 142 having a proximal portion 143 and a distal portion 144. The distal portion 144 includes a tapered section 145 that includes one or more electrodes 146, 148 located thereon. In the illustrated embodiment, the tapered section 145 is located at the distal tip 141 of the expander 100. Figure 3 In the illustrated embodiment, two electrodes 146, 148 are included on the tapered section 145.

[0070] The elongated hollow body 142 terminates at the distal tip 141. The one or more electrodes 146, 148 can be positioned in uniform or non-uniform spacing. The one or more electrodes 146, 148 can be configured as surface electrodes capable of contacting tissue or fluid within a patient. The one or more electrodes 146, 148 can be configured to detect a parameter when in contact with tissue or fluid, or to deliver energy, such as RF energy, to tissue to ablate the tissue. The one or more electrodes 146, 148 are configured to be electrically connected to a system, such as the EAM system 70.

[0071] The one or more electrodes 146, 148 can be electrically coupled with a system, such as the EAM system 70, when the expander 100 is inserted into the introducer sheath 110. In one embodiment, the one or more electrodes 146, 148 are electrically coupled with the EAM system 70 when the expander connector 150 is coupled to the proximal sheath connector 115. The expander connector 150 is located at the proximal portion 143 of the elongated hollow body 142, just distal of the hub 134. In one embodiment, the expander connector 150 is integral with and forms a portion of the hub 134. In another embodiment, the expander connector 150 is separate from the hub 134.

[0072] Figure 4 An expander 100 according to embodiments of the present disclosure is shown inserted into an introducer sheath 110 according to embodiments of the present disclosure. Figure 3 In the illustrated embodiment, the expander 100 is inserted into the introducer sheath 110. Figure 2 In the illustrated embodiment, the expander 100 is inserted into the introducer sheath 110. Figure 4In this configuration, each of the one or more electrodes 124 of the introducer sheath and the one or more electrodes 146, 148 of the dilator 100 are electrically coupled to a control system, such as the EAM system 70 or the energy generator. The length of the dilator 100 is such that when the dilator connector 150 is received in the proximal sheath connector 115, the distal portion 144, including at least the tapered section 145 and the one or more electrodes 146, 148, extends from the distal end 122 of the introducer sheath 110.

[0073] Figure 5 An exploded view of the proximal sheath connector 115 is shown, according to embodiments of the present disclosure. The proximal sheath connector 115 is configured to releasably connect with the dilator connector 150. Connecting the dilator 100 with the introducer sheath 110 allows a user to manipulate the dilator 100 and sheath 110 together, as well as electrically connect the one or more electrodes 146, 148 to the system. The proximal sheath connector 115 includes a bushing 152, a hemostatic valve 158, a cap 162, a retention rail 168, and a cover 174.

[0074] The bushing 152 includes an outer surface 154 configured to connect with an inner surface of the cap 162. The outer surface 154 can include elements configured to interact with elements on the inner surface of the cap 162. These elements can be configured to form a snap fit, a friction fit, or a threaded connection. The bushing 152 includes a face that includes a recess or channel 156 configured to fit or hold the hemostatic valve 158. During assembly, the hemostatic valve 158 is placed within the recess or channel 156 and held in place by the cap 162. The hemostatic valve 158 includes an opening 160 that allows medical devices to enter the sheath 110, but prevents fluid from exiting the sheath 110.

[0075] The cap 162 includes a proximally facing surface that includes a retention rail guide 164 and a cover connector 166. The retention rail guide 164 is configured to hold the retention rail 168 in place when assembled. The retention rail guide 164 allows the retention rail 168 to move freely within the cap 162 between a first configuration and a second configuration. The cover connector 166 is configured to connect with a corresponding connector of the cover 174. The connector 166 can be configured to form a snap fit, a friction fit, or a threaded connection with the cover 174.

[0076] The retention track 168 is a flexible or resilient component configured to retain a portion of the dilator 100 when inserted into the dilator 100. The retention track 168 includes a resiliently elliptical body 170 and includes two snaps 172 that grip the dilator 100. The snaps provide the functionality of mechanical and electrical coupling with the dilator 100 via the dilator connector 150. The resiliently elliptical body 170 is formed of a polymeric or metallic material to provide the appropriate force to retain the dilator 100 when inserted into the dilator 100. The snaps 172 are provided with a conductive coating, film, or surface, or are made entirely of a conductive material to create electrical contacts. Each electrical contact of the snaps 172 is electrically connected to the connector 128 via one or more leads such that the snaps 172 can be electrically connected to the EAM system 70 or other energy delivery system.

[0077] The cover 174 includes an opening to allow the dilator 100 or other medical device to be inserted into the sheath 110. The opening includes a beveled surface 176 and a flat surface 177. The beveled surface 176 and the flat surface 177 are configured such that they provide self-alignment with the dilator connector 150 when the dilator 100 is inserted into the sheath 110. In addition, the beveled surface and the flat surface 177 are configured to hold the dilator 100 in a desired rotational orientation relative to the sheath 110 when the dilator connector 150 is coupled with the proximal sheath connector 115.

[0078] Figure 6 A plan view of the retention track 168 is shown. The resilient retention track includes an elliptical body 170 having a width w that is greater than a height h. The elliptical body 170 includes a first curve 171 and a second curve 173 that are separated by snaps 172. The snaps 172 include an arcuate ramp surface 172a that extends toward the center of the elliptical body 170. The resilient retention track 168 includes a first line of symmetry 182 and a second line of symmetry 184. The snaps 172 are disposed along the elliptical body 170 to intersect the first line of symmetry 182. In one embodiment, the snaps 172 can be formed of a conductive material to form electrical contacts. In another embodiment, the snaps 172 can be formed of an electrically insulating material but can include a conductive coating or film to form electrical contacts. In one aspect, the arcuate ramp surface 172a can include a conductive coating or film.

[0079] Figure 7 A plan view of the proximal sheath connector 115 is shown according to an embodiment of the present disclosure. The retention track 168 is shown in a first configuration in which no dilator is inserted into the connector 115. In this configuration, the snaps 172 can be seen extending into the lumen 175 along with a conductive material that forms electrical contacts 172b. The electrical contacts 172b can form only a portion of the snaps 172, or can form the entire snaps 172.

[0080] Figure 7The tilted surface 176 and the flat surface 177 are shown arranged such that the distal tip 141 of the dilator 100 is pointed towards the lumen 175. The hemostatic valve 185 can be seen located within the lumen.

[0081] Figure 8 A dilator connector 150 according to the present disclosure is shown. The dilator connector 150 comprises a cylinder 151 having an outer surface. The cylinder 150 comprises a distal protrusion 179 forming a raised ring. The cylinder comprises two ramped surfaces 180 separated by electrical contacts 178 on the outer surface of each side of the cylinder 151. When the dilator 100 is inserted into the sheath 110, the two ramped surfaces 180 interact with the tilted surface 176 and the flat surface 177 to provide self-alignment with the dilator connector 150.

[0082] In one embodiment, the electrical contacts 178 can be formed from a thin film or coating of conductive material placed on the surface of the dilator connector 150. In another embodiment, a separate piece of conductive material can be formed, for example by stamping, and attached to the surface of the dilator connector 150. In another embodiment, the dilator connector 150 can be formed from a conductive material and covered with an insulating layer, except for the portions forming the electrical contacts 178. The electrical contacts 178 are electrically connected to the one or more electrodes 146, 148 by leads or wires running along the elongate hollow body 142. Thus, when the dilator connector 150 is inserted into the proximal sheath connector 115, the retaining track 168 assumes the second expanded configuration when the distal protrusion 179 is inserted therein. Once the distal protrusion 179 is advanced beyond the retaining track 168, and the catch 172 exerts a compressive force on the electrical contacts 178, the retaining track 168 returns towards the first configuration. Thus, the one or more electrodes 146, 148 are electrically connected to the EAM system 70 or energy delivery system.

[0083] Figure 9 A cross-sectional view of the proximal sheath connector 115 and the dilator connector 150 according to the present disclosure before connection is shown. As Figure 9 It can be seen that the distal protrusion 179 of the dilator connector 150 is located outside of the proximal sheath connector 115. Thus, the electrical contacts 178 of the dilator connector 150 are not in contact with the electrical contacts 172b of the sheath connector 115. Thus, there is no electrical connection between the sheath connector 115 and the dilator connector 150.

[0084] Figure 10 A cross-sectional view of the proximal sheath connector 115 and the dilator connector 150 according to the present disclosure after mechanical and electrical connection is shown. As Figure 10In this configuration, the dilator connector 150 has been inserted into the proximal sheath connector 115. The catch 172 is in the engaged configuration, and the electrical contacts 172b of the sheath connector 115 are in electrical communication with the electrical contacts 178 of the dilator connector 150. In this configuration, the one or more electrodes 146, 148 of the dilator 100 are electrically coupled with the EAM system 70.

[0085] In some aspects, the sheath 110 and dilator 100 can be packaged as a kit and ready for use outside of the package. Alternatively, the kit can include multiple sheaths or dilators each having a different pre-shaped portion for use in various procedures.

[0086] In some aspects, the sheath 110 or dilator 100 can include one or more markers along a portion thereof for identifying an orientation or position during use of an imaging modality.

[0087] In some aspects, the sheath 110 or dilator 100 can include a plurality of cuts machined into the wall, for example by laser cutting. The shape and positioning of the cuts can allow for a transition in flexibility from the proximal portion to the distal portion. The cuts can include a broken helical configuration, or can be positioned substantially perpendicular to the longitudinal axis of the sheath 110 or dilator 100. In some aspects, there can be a single cut wound around the axis, with a wider spacing between the loops of the proximal portion and a greater spacing between the loops of the distal portion. The spacing and size of the cuts can vary to achieve different flexibility along the length of the sheath 110 or dilator 100.

[0088] In some aspects, the sheath 110 or dilator 100 can be formed of a shape- storing material, such as a shape-storing polymer or a shape-storing metal. This would allow the sheath 110 or dilator 100 to have a first shape at a first temperature and a second shape at a second temperature. The shape transition can be initiated by inserting a heated solution into the sheath 110 or dilator 100 or using electrical power to heat a portion of the sheath 110 or dilator 100.

[0089] Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the disclosure. For example, while the embodiments discussed above refer to particular features, the scope of this disclosure also includes embodiments that do not include all of these features. Thus, embodiments of the present disclosure can include only a subset of the features discussed above, and the scope of the present disclosure is intended to encompass all such alternatives, modifications and variations as fall within the scope of the claims, as well as all equivalents thereof.

Claims

1. A medical system comprising a dilator having an elongated body with a proximal portion and a distal portion, the distal portion having one or more dilator electrodes, the dilator having a hub comprising a dilator connector electrically coupled to the one or more dilator electrodes, the medical system comprising: a sheath comprising an elongated body having a proximal portion and a distal portion; one or more sheath electrodes on the distal portion; and a handle attached to the proximal portion, the handle having a first connector and a second connector capable of being electrically coupled to a control system; wherein the second connector comprises a retention track having at least one electrical contact, the second connector configured to mechanically and electrically couple with the dilator connector.

2. The system of claim 1, wherein the elongated body of the sheath comprises a lumen extending from the proximal portion to the distal portion and is configured to receive the dilator.

3. The system of claim 2, wherein the second connector is coaxial with the lumen.

4. The system of any one of claims 1-3, wherein the retention track is resilient and comprises an elliptical body having a width greater than a height.

5. The system of claim 4, wherein the resilient retention track comprises a first line of symmetry and a second line of symmetry, and the at least one electrical contact intersects the first line of symmetry.

6. The system of claim 5, wherein the at least one electrical contact is a conductive coating.

7. The system of any one of claims 1-6, wherein the second connector comprises a hemostasis valve, a cap, and a cover.

8. The system of claim 7, wherein the cap comprises a retention track guide.

9. The system of any one of claims 1-8, wherein an electrical connection is made between the one or more dilator electrodes and the control system when the dilator connector is received by the second connector.

10. The system of any one of claims 1-9, wherein the dilator distal portion is tapered.

11. The system of any one of claims 1-10, wherein the dilator connector comprises a cylinder having an outer surface and one or more electrical contacts on the outer surface.

12. The system of any one of claims 1-11, wherein the dilator connector is configured to mechanically couple with the second connector to hold the dilator in a desired rotational orientation relative to the sheath.

13. The system of any one of claims 1-12, wherein the dilator connector comprises a distal protrusion.

14. The system of any one of claims 1-13, further comprising a display for displaying one or more anatomical images, parameters, and orientation information.

15. The system of any one of claims 1-14, wherein the one or more sheath electrodes comprise four sheath electrodes and the one or more dilator electrodes comprise two electrodes.

16. A medical system comprising: ​ a sheath including an elongated body having a proximal portion, a distal portion, and a lumen therebetween; one or more sheath electrodes on the distal portion; a handle attached to the proximal portion, the handle having a first connector electrically couplable to a control system and a second connector coaxial with the lumen; and a dilator including an elongated body having a proximal portion and a distal portion having one or more dilator electrodes, the dilator having a dilator connector electrically coupled to the one or more dilator electrodes; wherein the second connector includes a retention track having at least one electrical contact, the second connector configured to mechanically and electrically couple with the dilator connector.

17. The system of claim 16, wherein the sheath lumen is configured to receive the dilator.

18. The system of claim 17, wherein the dilator includes a dilator hub, and the dilator connector is integral with the dilator hub.

19. The system of claim 16, wherein the retention track is resilient and includes an elliptical body having a width greater than a height.

20. The system of claim 19, wherein the resilient retention track includes a first line of symmetry and a second line of symmetry, and the at least one electrical contact intersects the first line of symmetry.

21. The system of claim 20, wherein the at least one electrical contact includes a conductive coating.

22. The system of claim 16, wherein the second connector includes a hemostasis valve, a cap, and a cover.

23. The system of claim 22, wherein the cap includes a retention track guide.

24. The system of claim 16, wherein when the dilator connector is received by the second connector, an electrical connection is made between the one or more dilator electrodes and the control system.

25. The system of claim 16, wherein the dilator distal portion is tapered.

26. The system of claim 16, wherein the dilator connector includes a cylinder having an outer surface and one or more electrical contacts on the outer surface.

27. The system of claim 16, wherein the dilator connector is configured to self-align with the second connector, and wherein the dilator connector is configured to mechanically couple with the second connector so as to hold the dilator in a desired rotational orientation relative to the sheath.

28. The system of claim 16, wherein the dilator connector includes a distal protrusion.

29. The system of claim 16, further comprising a display for displaying one or more anatomical images, parameters, and positioning information.

30. The system of claim 16, wherein the one or more sheath electrodes include four sheath electrodes, and the one or more dilator electrodes include two electrodes.

31. A medical system, comprising: a sheath including an elongated body having a proximal portion, a distal portion, and a lumen therebetween; one or more sheath electrodes on the distal portion; a handle attached to the proximal portion, the handle having a first connector electrically couplable to a control system and a second connector coaxial with the lumen; and a dilator including an elongated body having a proximal portion and a distal portion having one or more dilator electrodes, the dilator having a dilator connector electrically coupled to the one or more dilator electrodes; wherein the second connector includes a retention track having at least one electrical contact, the second connector configured to mechanically and electrically couple with the dilator connector. one or more sheath electrodes on the distal portion; a handle attached to the proximal portion, the handle having a first connector electrically couplable to a control system and a second connector coaxial with the lumen; and a dilator including an elongated body having a proximal portion and a distal portion, the distal portion having one or more dilator electrodes, the dilator having a dilator connector electrically coupled to the one or more dilator electrodes; wherein the second connector includes a resilient retention track configured to mechanically and electrically couple with the dilator connector, and wherein when the dilator connector is received by the second connector, an electrical connection is made between the one or more dilator electrodes and the control system.

32. The system of claim 31, wherein the resilient retention track includes an elliptical body having a width greater than a height.

33. The system of claim 32, wherein the resilient retention track includes at least one electrical contact.

34. The system of claim 33, wherein the at least one electrical contact includes a conductive coating.

35. A medical system, comprising: a sheath including an elongated body having a proximal portion, a distal portion, and a lumen therebetween; one or more sheath electrodes on the distal portion; a handle attached to the proximal portion, the handle having a first connector electrically couplable to a control system and a second connector coaxial with the lumen; a dilator including an elongated body having a proximal portion and a distal portion; one or more dilator electrodes on the distal portion; and a dilator connector electrically coupled to the one or more dilator electrodes; and a display for displaying one or more anatomical images, parameters, and positioning information; wherein the second connector includes a resilient retention track having at least one electrically conductive snap, the second connector configured to receive the dilator elongated body and electrically couple with the dilator connector.

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