Electroanatomical mapping device with internal electrodes

Abstract

A medical system for forming a communication channel between two anatomical structures comprises an outer member having a proximal portion, a distal portion, and a lumen extending from the proximal portion to the distal portion. At least a portion of the lumen has a conductive surface extending to the distal end of the distal portion. The system comprises an inner member having a proximal portion and a distal portion. The inner member is configured to move within the lumen and deliver treatment to target tissue. The distal portion of the inner member includes a conductive distal tip configured to electrically connect to the conductive surface of the outer member. The inner member includes a proximal portion adapted to electrically connect the conductive distal tip to an auxiliary device.

Description

Technical Field

[0001] The present invention generally relates to methods and devices that can be used within a patient's body. More specifically, the present invention relates to devices having internal electrodes that can be visualized using an electroanatomical mapping (EAM) system.

Background Art

[0002] Electroanatomical mapping (EAM) is a technique that is useful during in vivo procedures and is becoming increasingly popular. EAM enables a physician to identify anatomical regions and electrical activation patterns of the heart. This is particularly useful when treating arrhythmias. Multiple devices compatible with an EAM system enable an operator to localize multiple devices and more easily target specific regions for treatment, thereby enabling a better workflow, better treatment efficacy, and shorter procedure times.

[0003] Typically, each EAM device requires a cable for connection to an EAM system. This can complicate the operation of the device and make it difficult to manage the working space with several cables for multiple devices used in the procedure.

[0004] Multiple devices can interface with multiple EAM systems having multiple electrodes incorporated on the surface of the device. The multiple electrodes enable tracking of the position of the device on the EAM system via impedance measurements. However, multiple electrodes embedded on the surface of a long device create transitions. These transitions increase the risk of causing damage when guiding the vasculature. Furthermore, the transitions can potentially impede the ability of the device to traverse through a narrow opening such as a hole created by a transseptal puncture or an entry through a hemostatic valve.

[0005] Furthermore, positioning electrodes at the distal end of long devices with lumens presents additional manufacturing challenges, and the risk of exposed edges at the electrode interface is even higher. Annular electrodes on lumen devices are typically positioned a few millimeters from the tip to ensure proper fixation and provide a sufficiently smooth material transition. [Overview of the project]

[0006] Example 1 is a medical system for forming a channel between two anatomical structures, comprising an outer member having a proximal portion, a distal portion, and a lumen extending from the proximal portion to the distal portion. At least a portion of the lumen has a conductive surface extending to the distal end of the distal portion. The system comprises an inner member having a proximal portion and a distal portion. The inner member is configured to move within the lumen and deliver treatment to target tissue. The distal portion of the inner member includes a conductive distal tip configured to be electrically connected to the conductive surface of the outer member. The inner member includes a proximal portion adapted to electrically connect the conductive distal tip to an auxiliary device.

[0007] Example 2 is the same system as Example 1, but the outer member is a hypotube. Example 3 is the system of Example 1, wherein the conductive surface includes a coating. Example 4 is a system according to any one of Examples 1 to 3, wherein the conductive surface extends from the proximal portion of the outer member to the distal end of the distal portion.

[0008] Example 5 is a system according to any one of Examples 1 to 4, wherein the treatment delivered by the inner member is to puncture the target tissue. Example 6 is a system according to any one of Examples 1 to 5, wherein the outer member includes an insulating layer surrounding the conductive surface.

[0009] Example 7 is a system according to any one of Examples 1 to 6, wherein the auxiliary device is an EAM system adapted to identify and indicate the position of the distal end. Example 8 is a system according to any one of Examples 1 to 7, wherein the distal portion of the outer member includes a tapered portion.

[0010] Example 9 is a system according to any one of Examples 1 to 8, wherein the distal portion of the outer member includes an electrode. Example 10 is the system of Example 9, wherein the electrode is formed by the conductive surface.

[0011] Example 11 is the system of Example 9, wherein the electrode is flush with the outer surface of the outer member. Example 12 is a system according to any one of Examples 1 to 11, wherein the inner member includes a proximal contact configured to be electrically connected to the conductive surface.

[0012] Example 13 is the system of Example 12, wherein the proximal contact includes an enlarged portion. Example 14 is the system of Example 12, wherein the proximal contact includes a reversed wire. Example 15 is a system according to any one of Examples 1 to 14, wherein the distal portion of the outer member includes a distal tip, and the conductive surface extends beyond the distal tip.

[0013] Example 16 is a medical system for forming a channel between two anatomical structures, such as traversing the atrial septum in a patient's heart, and comprises an outer member having a proximal portion and a tapered distal portion. The outer member has a lumen extending from the proximal portion to the tapered distal portion. At least a portion of the lumen has a conductive surface extending to the distal end of the tapered distal portion. The system comprises an inner member having a proximal portion and a distal portion. The inner member is configured to move within the lumen and deliver treatment to target tissue. The distal portion of the inner member includes a conductive distal tip configured to be electrically connected to the conductive surface of the outer member. The inner member includes a proximal portion adapted to electrically connect the conductive distal tip to an auxiliary device.

[0014] Example 17 is the system of Example 16, wherein the outer member is a hypotube. Example 18 is the system of Example 16, wherein the conductive surface includes a coating. Example 19 is the system of Example 16, wherein the conductive surface extends from the proximal portion of the outer member to the distal end of the tapered distal portion.

[0015] Example 20 is the system of Example 16, wherein the treatment delivered by the inner member is to puncture the target tissue. Example 21 is the system of Example 16, wherein the outer member includes an insulating layer surrounding the conductive surface.

[0016] Example 22 is the system of Example 16, wherein the auxiliary device is an EAM system adapted to identify and indicate the position of the distal end. Example 23 is the system of Example 16, wherein the distal portion of the outer member includes an electrode.

[0017] Example 24 is the system of Example 23, wherein the electrode is formed by the conductive surface. Example 25 is the system of Example 23, wherein the electrode is flush with the outer surface of the outer member.

[0018] Example 26 is the system of Example 16, wherein the inner member includes a proximal contact configured to be electrically connected to the conductive surface. Example 27 is the system of Example 26, wherein the proximal contact includes an enlarged portion.

[0019] Example 28 is the system of Example 26, wherein the proximal contact includes a reversed wire. Example 29 is the system of Example 16, wherein the distal portion of the outer member includes the distal tip, and the conductive surface extends beyond the distal tip.

[0020] Example 30 is a medical system for forming a channel between two structures, such as traversing the atrial septum in a patient's heart, and comprises an outer member having a proximal and distal portion. The lumen extends from the proximal portion to the tapered distal portion. A conductive surface is located along at least a portion of the lumen. The conductive surface extends to the tapered distal portion. An insulating layer surrounds the conductive surface. The system comprises an inner member having a proximal and distal portion. The inner member is configured to move within the lumen. The distal portion of the inner member comprises a distal tip configured to be electrically connected to the conductive surface and a proximal end configured to be electrically connected to the EAM system.

[0021] Example 31 is the system of Example 30, wherein the outer member includes a hypo tube. Example 32 is the system of Example 30, wherein the conductive surface includes a coating. Example 33 is the system of Example 30, wherein the inner member includes a proximal contact configured to be electrically connected to the conductive surface.

[0022] Example 34 is the system of Example 33, wherein the proximal contact includes an enlarged portion or a reversed wire. Example 35 is a method of performing a medical procedure, including inserting an inner member into a lumen of an outer member having a conductive surface. The procedure includes electrically connecting the conductive surface to the distal tip of the inner member. The procedure includes visualizing the distal tip of the outer member using an EAM system.

[0023] Although multiple embodiments are disclosed, further other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description that illustrates and describes exemplary embodiments of the present invention. Therefore, the drawings and the detailed description should be considered to be illustrative in nature and not restrictive.

Brief Description of the Drawings

[0024] [Figure 1] A diagram showing an exemplary clinical setting for treating a patient and treating a patient's heart using an electrophysiological system according to an embodiment of the subject matter of the present disclosure. [Figure 2A] A mapping device with an internal electrode and an inner member according to an embodiment of the present disclosure is shown. [Figure 2B] A mapping device with an internal electrode and an inner member according to an embodiment of the present disclosure is shown. [Figure 2C] A cross-section of the device and the inner member of FIG. 2A is shown. [Figure 3] A mapping device with an internal electrode and an inner member having a proximal contact according to an embodiment of the present disclosure is shown. [Figure 4A] A mapping device with an internal electrode and an inner member according to an embodiment of the present disclosure is shown. [Figure 4B] A mapping device with an internal electrode and an inner member according to an embodiment of the present disclosure is shown. [Figure 5] An arrangement of an inner member having a proximal contact according to an embodiment of the present disclosure is shown.

[0025] While the present invention can accept various modifications and alternative forms, certain embodiments are shown as examples in the drawings and described in detail below. However, the intention is not to limit the invention to the specific embodiments described. Rather, the invention is intended to encompass all modifications, equivalents, and alternative forms that fall within the scope of the invention as defined by the appended claims. [Modes for carrying out the invention]

[0026] Figure 1 shows an exemplary clinical setting 10 for treating a patient 20 and the patient 20's heart 30, using an electrophysiological system 50 according to an embodiment of the subject matter of this disclosure. The electrophysiological system 50 comprises an access system 60 and auxiliary devices such as an EAM system 70, the EAM system 70 including a localization field generator 80, a mapping and navigation controller 90, and a display device 92. The clinical setting 10 also includes additional equipment such as an imaging device 94 (represented by a C-arm) and various controller elements such as a foot controller 96, configured to allow the operator to control various aspects of the electrophysiological system 50. As will be understood by those skilled in the art, the clinical setting 10 may have other components and arrangements of components not shown in Figure 1.

[0027] The access system 60 includes a dilator 100 having a proximal portion 102 and a distal portion 105, an introducer sheath 110, and a console 130. In some embodiments, the distal portion 105 includes a tapered region. Furthermore, the access system 60 includes various connecting elements, such as cables and umbilicals, that operate to functionally connect multiple components of the access system 60 to each other and to functionally connect to components of the EAM system 70. This arrangement of connecting elements is not critically important to the disclosure, and those skilled in the art will recognize that the various components described herein can be interconnected in various ways.

[0028] In several embodiments, the introducer sheath 110 is operable to provide a delivery conduit that allows all or part of the dilator 100, particularly the distal portion 105 of the dilator 100, to be positioned at a specific target site within the patient's heart 30. The dilator 100 is configured with a lumen to allow insertion of a guide device, such as a guidewire, or a puncture device, such as an RF puncture device. In some embodiments, the use of a puncture device allows for transseptal transverse procedures within the heart 30.

[0029] Console 130 is configured to control a functional aspect of the access system 60. In some embodiments, Console 130 includes one or more controllers, microprocessors and / or computers that execute code from memory to control and / or implement a functional aspect of the access system 60. In some embodiments, memory may be part of one or more controllers, microprocessors and / or computers, and / or part of a memory capacity accessible through a network such as the World Wide Web. In some embodiments, Console 130 may include pulse generator hardware, software and / or firmware configured to generate electrical pulses with a predetermined waveform, which are transmitted to electrodes positioned on the dilator 100, guide device or puncture device. This generates an electric field sufficient to achieve a desired clinical effect, such as ablation of target tissue via irreversible electroperforation. In some embodiments, Console 130 can deliver pulse waveforms in unipolar or bipolar operating mode, as described in further detail herein.

[0030] The EAM system 70 is operable to track the locations of various functional components of the access system 60 and to generate high-precision three-dimensional anatomical and electroanatomical maps of cardiac chambers of interest. In some embodiments, the EAM system 70 may be the RHYTHMIA® HDx mapping system sold by Boston Scientific Corporation. In some embodiments, the mapping and navigation controller 90 of the EAM system 70 includes one or more controllers, microprocessors and / or computers, which control and / or execute functional aspects of the EAM system 70 by executing code from memory. Here, the memory in some embodiments may be part of one or more controllers, microprocessors and / or computers, and / or part of memory capacity accessible through a network such as the World Wide Web.

[0031] As will be understood by those skilled in the art, the depiction of the electrophysiological system 50 shown in Figure 1 is intended to provide a general overview of the various components of the system 50, and this disclosure is not intended to be limited to any set of components or configuration of components. For example, those skilled in the art will readily recognize that additional hardware components, such as breakout boxes, workstations, etc., may and likely be included in the electrophysiological system 50.

[0032] The EAM system 70 defines a localization space around the heart 30 by generating a localization field via a field generator 80. One or more position sensors or sensing elements on a device being tracked, such as a dilator 100, generate outputs that can be processed by the mapping and navigation controller 90, allowing the mapping and navigation controller 90 to track the position of the sensors in the localization space, and therefore the position of the corresponding devices. In the shown embodiment, device tracking is achieved using a magnetic tracking technique, in which case the field generator 80 is a magnetic field generator that generates a magnetic field that defines the localization space, and the position sensors on the device being tracked are magnetic field sensors.

[0033] In other embodiments, impedance tracking methods may be employed to track the positions of various devices. In such embodiments, the localization field is an electric field generated by an internal or intracardiac device, such as an intracardiac catheter, or both, by an external field generator arrangement, such as a plurality of surface electrodes. In these embodiments, the plurality of localization elements may constitute a plurality of electrodes on the plurality of devices being tracked, and the plurality of electrodes generate an output that is received and processed by the mapping and navigation controller 90. This allows tracking of the positions of various localization electrodes in the localization space.

[0034] In several embodiments, the EAM system 70 possesses both magnetic tracking and impedance tracking capabilities. In such embodiments, impedance tracking accuracy can be improved in some cases by first generating a map of the electric field induced by an electric field generator within the anatomical structure of interest, and by using a probe equipped with a magnetic position sensor, as is possible with the aforementioned RHYTHMIA HDx® mapping system. One exemplary probe is the INTELLAMAP ORION® mapping catheter, sold by Boston Scientific Corporation.

[0035] Regardless of the tracking method employed, the EAM system 70 utilizes the positional information of various tracked devices along with cardiac electrical activity acquired, for example, by a dilator 100 or another catheter or probe equipped with a sensing electrode. This generates a detailed three-dimensional geometric anatomical map or representation of the cardiac chambers, as well as an electroanatomical map in which the cardiac electrical activity of interest is superimposed on the geometric anatomical map, and displays these via the display device 92. Furthermore, the EAM system 70 can generate graphic representations of the various tracked devices within the geometric anatomical map and / or electroanatomical map.

[0036] To reduce the number of cables or wires in the clinical setting 10, the outer component, such as a dilator 100, may include an internal electrode. In addition to helping to reduce the number of cables or wires, the electrode positioned inside the lumen of the long device addresses the issue of migration to the material on the surface of the device. By shrouding the electrode from the external environment, the outer surface of the device can be made of a single, uniform material. In some embodiments, the internal electrode may be achieved by incorporating a hypotube along at least a portion of the lumen. The distal tip of the hypotube effectively acts as a conductor that can be visualized by the EAM system 70, while the rest of the body of the hypotube is covered by the outer component, effectively preventing the rest of the body from being visualized by impedance tracking.

[0037] The internal electrodes can be electrically connected to the EAM system 70 via an internal component (such as a guidewire or drilling device) inserted into the lumen, thus reducing the number of cables or wires. Therefore, the external component does not require a dedicated connector and cable for communication with the EAM system 70. The distal portion of the internal component may include exposed metal that contacts the internal electrodes while the connector is attached to the proximal portion of the internal component. This forms a circuit to the EAM system 70. In some embodiments, the internal component is completely insulated except for a small section at the proximal end and the exposed tip.

[0038] During use, as the inner member advances through the lumen of the outer member, its exposed tip contacts the internal electrode, and the EAM system 70 indicates the position of the distal tip of the internal electrode corresponding to the tip of the outer member. As the inner member advances beyond the distal opening of the outer member, the EAM system 70 is no longer connected to the internal electrode; instead, the EAM system 70 tracks the position of the exposed tip of the inner member. To allow the EAM system 70 to visualize the distal tips of both the outer and inner members, the inner member may include a secondary contact point located proximal to the tip. This contact point will maintain contact with the internal electrode after the exposed tip has advanced out of the outer member.

[0039] Figures 2A and 2B show a system 200 including an outer member 210 and an inner member 220 according to one embodiment of the present disclosure. The outer member 210 includes an elongated hollow body 202 having a proximal portion 205 and a distal portion 204. The distal portion 204 includes a tapered section 207 whose diameter decreases toward a distal tip portion 209.

[0040] The outer member 210 is an elongated device such as a catheter, dilator, sheath, or other hollow elongated member. The outer member 210 defines a lumen 211 extending from a proximal portion 205 to a distal tip portion 209. The lumen 211 is configured to allow fluid or an inner member 220 to be introduced through the outer member 210. The proximal portion may include a hemostatic valve through which the fluid or inner member 220 enters the lumen 211. In some embodiments, the fluid may include a drug, contrast agent, or biological fluid. The proximal portion 205 may include a fitting such as a Luer connector to which a container such as a syringe for delivering fluid through the lumen 211 can be detachably connected. In various embodiments, the inner member 220 is a puncture device such as an RF puncture wire or needle.

[0041] The lumen 211 is formed at least partially of a conductive material 225 to allow current to flow. The conductive material 225 forms a conductive surface along the lumen and forms internal electrodes. In some embodiments, the outer member 210 is formed from a hypo tube with an electrically insulating coating, for example, a stainless steel hypo tube. The inner surface of the hypo tube forms the conductive material 225. In other embodiments, the outer member 210 includes a conductive coating installed on the inner wall of the lumen 211. The elongated hollow body 202 can be formed of an insulating material surrounding the conductive material 225.

[0042] The conductive material 225 extends toward the distal tip 209 and is positioned to be visible for impedance tracking by the EAM system 70. The conductive material 225 may extend from the proximal portion 205 to the distal tip 206. In some embodiments, the conductive material 225 extends beyond the distal tip 209. In some embodiments, the conductive material 225 is flush with the distal tip 209. In other embodiments, the conductive material 225 is maintained proximal to the distal tip by a distance of, for example, less than 3 mm.

[0043] The inner member 220 is configured to pass through the lumen 211 of the outer member 210. In some embodiments, the device inserted into the lumen 211 may include a drilling device such as a mechanical or RF drilling device, or a guide member such as a guide wire. The inner member 220 includes a proximal portion 215 having a proximal end 216 and a distal portion 214 including a distal tip 219. In some embodiments, the distal portion 214 includes a pre-formed shape such as a J-shape or pigtail shape that facilitates the distal tip 219 to move away from the longitudinal axis of the outer member 210, thereby advancing the inner member 220 through the lumen 211 so that the distal tip 219 comes into contact with the conductive material 225.

[0044] The inner member 220 includes a conductive core at least partially surrounded by an insulator. The proximal end 216 is not insulated and is configured to connect to the EAM system 70. In addition, the distal tip 219 is not insulated and can form an electrode that can be used to puncture or measure tissue. In some embodiments, the distal tip 219 is used to deliver therapy to target tissue, for example, by ablating the tissue, by puncturing the septum of the patient's heart to create a channel from one part of the heart to another, or to create a channel from one anatomical structure to another. In some embodiments, it is possible to create a channel between the right atrium and the left atrium of the heart by perforating the septum. In some embodiments, the channel can provide access to or communication from one anatomical structure to another for the advancement or delivery of a medical device, fluid, or therapeutic device.

[0045] The non-insulated distal tip 219 is configured to electrically connect the conductive material 225 to the EAM system 70 as the inner member 220 passes through the lumen 211. This allows for different EAM visualizations of the inner member 220 and the outer member 210 depending on the situation. In Figure 2A, the distal tip 219 of the inner member 220 is located inside the lumen 211 and is in contact with the conductive material 225. Therefore, the inner member 220 acts as a conductor that transmits signals received at the distal portion 204 where the conductive material 225 is exposed. In Figure 2B, the inner member 220 protrudes from the lumen 211, disconnecting the conductive material 225 from the EAM system 70. In this way, the EAM system tracks the non-insulated distal tip 219 of the inner member 220.

[0046] In some embodiments, access for directly electrically connecting the EAM system 70 to the conductive material 225 is included on the outer member 210. Figure 2B shows a side port 213 that allows access to the conductive material 225. Conductors such as wires or leads can be inserted through the side port 213 to connect the EAM system 70 to the conductive material 225. This allows exposed portions of the conductive material 225 to be used as electrodes without requiring the inner member 220. In other embodiments, access may take the form of a plug, patch, connector, clip or other structure that allows electrical connection between the conductive material 225 and the EAM system 70 or other control system. In other embodiments, a raised feature associated with a clip, cap or other connector can be used to penetrate the outer layer surrounding the conductive material 225, thereby making contact with the conductive material 225. For example, teeth associated with an alligator clip can be used to perforate the outer layer, thereby electrically connecting the EAM system 70 to the conductive material 225. Furthermore, the raised threads of the screw-in connector allow the outer layer to be cut through, thereby electrically connecting the EAM system 70 to the conductive material 225.

[0047] Figure 2C shows cross-sections of the outer member 210 and inner member 220 of Figures 2A and 2B. The outer member 210 includes a conductive material 225 that forms at least partially a lumen 211. The elongated hollow body 202 is formed of an insulating material. The inner member 210 includes a covering or sheath of insulating material 217 surrounding a conductive core or wire 221.

[0048] Figure 3 shows an embodiment of an outer member 210 having internal electrodes and an inner member 220 having a proximal contact 230. The proximal contact 230 is an extended portion of the inner member 220 and is configured to contact the conductive material 225, electrically connecting the conductive material 225 to the EAM system 70. The proximal contact 230 is configured to at least contact the conductive material 225 after the distal tip 219 of the inner member 220 has protruded from the lumen 215. The proximal contact 230 is positioned sufficiently far from the distal tip 219 so that it does not extend outward from the outer member 210 during use. The proximal contact 230 is positioned so that it contacts the conductive material 225 before the distal tip 219 leaves the outer member 210. This allows the EAM system 70 to track both the distal tip 209 of the outer member 210 and the distal tip 219 of the inner member 220.

[0049] Figures 4A and 4B show embodiments of system 400 having an outer member 220 and an inner member 210 similar to system 200. However, the outer member 220 includes an electrode 402 on its distal portion 204. The electrode 402 is flush with the outer surface of the tapered section 207 and is electrically continuous with the conductive material 225. In some embodiments, the electrode 402 is integrally formed by the conductive surface 225. In other embodiments, the electrode 402 is formed of a first conductive material and the conductive surface 225 is formed of a second conductive material. During use, the EAM system 70 visualizes and displays the position of the electrode 402 when the distal tip 219 of the inner member is electrically in communication with the conductive surface 225 as described above.

[0050] Figure 5 shows the arrangement of an inner member 210 having a proximal contact 230 according to an embodiment of the present disclosure. As shown in Figure 5, the proximal contact 230 includes a retrograde wire. As the inner member 210 advances through the lumen 211, the retrograde wire 232 contacts the conductive surface 225, electrically connecting the conductive surface 225 to the EAM system 70. The retrograde wire 232 extends backward in the proximal direction away from the inner member 232.

[0051] The retrograde wire 232 is connected to the contact 235 via the conductor 231 for detachable connection to the EAM system 70 via a connector and / or cable. The retrograde wire 232, the contact 235, and the conductor 231 are insulated from the conductive core 221. As described above, the proximal contact 230 allows the EAM system 70 to visualize both the distal tip 219 of the inner member 210 and the distal portion of the outer member 220 after the distal tip 219 of the inner member 210 extends from the lumen 211.

[0052] In some embodiments, the outer member 210 or inner member 220 includes a plurality of cuts machined into the wall, for example by laser cutting. The shape and positioning of the plurality of cuts will allow for a transition of flexibility from the proximal to the distal portion. The plurality of cuts may include a fracture helical configuration, or the plurality of cuts may be positioned substantially perpendicular to the longitudinal axis of the outer member 210 or inner member 220. In some embodiments, there is a single cut that winds around the axis, with wider spacing between the plurality of loops in the proximal portion and larger spacing in the distal portion. The spacing and size of the plurality of cuts may be varied to achieve different flexibility along the length of the outer member 210 or inner member 220.

[0053] In some embodiments, the outer member 210 or inner member 220 is formed from a shape memory material such as a shape memory polymer or shape memory metal. This would allow the outer member 210 or inner member 220 to have a first shape at a first temperature and a second shape at a second temperature. The shape transition may be initiated by inserting a heated solution into the outer member 210 or inner member 220, or by heating a portion of the outer member 210 or inner member 220 using electricity.

[0054] Various modifications and additions may be made to the exemplary embodiments described without departing from the scope of the present invention. For example, while the embodiments described above refer to specific features, the scope of the invention also includes embodiments having different combinations of features, and embodiments that do not include all of the described features. Accordingly, the scope of the invention is intended to encompass all such substitutes, modifications, and changes included in the claims, as well as all their equivalents.

Claims

1. A medical system for forming a channel between two anatomical structures, An outer member having a proximal portion, a distal portion, and a lumen extending from the proximal portion to the distal portion, wherein at least a portion of the lumen has a conductive surface extending to the distal end of the distal portion, An inner member having a proximal portion and a distal portion, configured to move within the lumen and deliver treatment to target tissue, comprising: A system wherein the distal portion of the inner member includes a conductive distal tip configured to be electrically connected to the conductive surface of the outer member, and the proximal portion is adapted to electrically connect the conductive distal tip to an auxiliary device.

2. The system according to claim 1, wherein the outer member is a hypotube.

3. The system according to claim 1, wherein the conductive surface includes a coating.

4. The system according to any one of claims 1 to 3, wherein the conductive surface extends from the proximal portion of the outer member to the distal end of the distal portion.

5. The system according to any one of claims 1 to 4, wherein the treatment delivered by the internal member is to puncture the target tissue.

6. The system according to any one of claims 1 to 5, wherein the outer member includes an insulating layer surrounding the conductive surface.

7. The system according to any one of claims 1 to 6, wherein the auxiliary device is an EAM system adapted for identifying and indicating the position of the distal end.

8. The system according to any one of claims 1 to 7, wherein the distal portion of the outer member includes a tapered portion.

9. The system according to any one of claims 1 to 8, wherein the distal portion of the outer member includes an electrode.

10. The system according to claim 9, wherein the electrode is formed by the conductive surface.

11. The system according to claim 9, wherein the electrode is flush with the outer surface of the outer member.

12. The system according to any one of claims 1 to 11, wherein the inner member includes a proximal contact configured to be electrically connected to the conductive surface.

13. The system according to claim 12, wherein the proximal contact includes an enlarged portion.

14. The system according to claim 12, wherein the proximal contact includes a reverse-flow wire.

15. The system according to any one of claims 1 to 14, wherein the distal portion of the outer member includes a distal tip, and the conductive surface extends beyond the distal tip.

16. A medical system for forming a channel between two anatomical structures, An outer member having a proximal portion, a tapered distal portion, and a lumen extending from the proximal portion to the tapered distal portion, wherein at least a portion of the lumen has a conductive surface extending to the distal end of the tapered distal portion, An inner member having a proximal portion and a distal portion, configured to move within the lumen and deliver treatment to target tissue, comprising: A system wherein the distal portion of the inner member includes a conductive distal tip configured to be electrically connected to the conductive surface of the outer member, and the proximal portion is adapted to electrically connect the conductive distal tip to an auxiliary device.

17. The system according to claim 16, wherein the outer member is a hypotube.

18. The system according to claim 16, wherein the conductive surface includes a coating.

19. The system according to claim 16, wherein the conductive surface extends from the proximal portion of the outer member to the distal end of the tapered distal portion.

20. The system according to claim 16, wherein the treatment delivered by the internal member is to puncture the target tissue.

21. The system according to claim 16, wherein the outer member includes an insulating layer surrounding the conductive surface.

22. The system according to claim 16, wherein the auxiliary device is an EAM system adapted for identifying and indicating the position of the distal end.

23. The system according to claim 16, wherein the distal portion of the outer member includes an electrode.

24. The system according to claim 23, wherein the electrode is formed by the conductive surface.

25. The system according to claim 23, wherein the electrode is flush with the outer surface of the outer member.

26. The system according to claim 16, wherein the inner member includes a proximal contact configured to be electrically connected to the conductive surface.

27. The system according to claim 26, wherein the proximal contact includes an enlarged portion.

28. The system according to claim 26, wherein the proximal contact includes a reverse-flow wire.

29. The system according to claim 16, wherein the distal portion of the outer member includes a distal tip, and the conductive surface extends beyond the distal tip.

30. A medical system for forming a channel between two anatomical structures, An outer member having a proximal portion, a distal portion, and a lumen extending from the proximal portion to the tapered distal portion, A conductive surface along at least a portion of the lumen, extending to the tapered distal portion, An insulating layer surrounding the conductive surface, An inner member having a proximal portion and a distal portion, configured to move within the lumen and deliver treatment to target tissue, comprising: The system comprises a distal tip configured to be electrically connected to the conductive surface and a proximal end configured to be electrically connected to the EAM system.

31. The system according to claim 30, wherein the outer member comprises a hypotube.

32. The system according to claim 30, wherein the conductive surface includes a coating.

33. The system according to claim 30, wherein the inner member includes a proximal contact configured to be electrically connected to the conductive surface.

34. The system according to claim 33, wherein the proximal contact includes an enlarged portion or a reversed wire.

35. A method for performing medical procedures, Inserting the inner member into the lumen of the outer member, which has a conductive surface, The conductive surface is electrically connected to the distal tip of the inner member, A method comprising visualizing the distal tip of the outer member using an EAM system.

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