Through-electrodes, devices and systems including through-electrodes, and methods for making and using such devices

Abstract

A pass-through electrode device includes a tubular member including a proximal end, a distal end sized for introduction into a patient, a lumen extending between the proximal end and the distal end, and one or more pass-through electrodes on the distal end. Each through electrode includes an outer portion on an outer wall of the tubular member, an inner portion exposed within an inner wall of the lumen, and is passive, e.g., electrically isolated from and / or not connected to other electrodes or components of the device. A system is also provided that includes an outer tubular member including one or more through electrodes, and a surgical device that can be introduced and deployed from the tubular member for performing a procedure, such as mapping and / or ablation. The surgical device includes one or more active electrodes that can be aligned with the through electrode when the device is at least partially positioned within the outer member.

Description

[0001] Relevant application data This application claims the benefit of co-pending U.S. Provisional Applications Serial Nos. 63 / 534580 (filed August 25, 2023), 63 / 633834 (filed April 14, 2024), and 63 / 647623 (filed May 15, 2024), the entire disclosure of which is expressly incorporated herein by reference. Technical Field

[0002] This application relates generally to medical devices, and more specifically, to pass-through electrodes for sheaths, guiding catheters or other tubular devices (e.g., to enhance the functionality of mapping and ablation systems) and methods for manufacturing and using such pass-through electrodes, tubular devices and systems. Background Technology

[0003] Anatomical mapping is ubiquitous in cardiac electrophysiology (EP) kits. The use of magnetically and impedance-based position sensing elements, with or without electrical mapping, has transformed EP operations, improving outcomes and workflows. The value they provide is so significant that even the most innovative new products must incorporate them or risk losing market share. Their use has not only revolutionized conventional ablation and mapping catheters, but for over a decade, their application in traditionally simple systems such as deflectable sheaths and introducers has been a focus of attention and the subject of numerous product trials.

[0004] In the specific case of inlet sleeves (fixed curve or deflectable sleeves), the field is flooded with failed sleeve products equipped with position sensors (primarily impedance-based electrodes). The reasons for these failures are easy to summarize; they are not only expensive in terms of components (e.g., connectors, pigtails, more complex packaging, etc.), but more seriously, due to low yield rates, they are prone to breakage during use and failures during manufacturing, all of which contribute significantly to the cost of ownership and must ultimately be factored into the overall cost of use.

[0005] The underlying reason for the low yield is also simple; binding the conductor from the electrode back to the handle / connector through the thin wall of the sheath shaft is challenging, and even in basic use of the introducer system, stress (bending, torsion, compression, etc.) causes uneven changes in the path length between the sheath and the conductor, leading to conductor and / or conductor-electrode joint breakage. In classic EP ablation or mapping catheters, this binding is much easier, where the main lumen is used for conductor passage (rather than as a channel for delivery), thus protecting them from substantial changes in path length during bending.

[0006] Furthermore, electrical connectors and the required cables are also expensive. For example, connectors are often the most expensive single component on a sheath or guide tube. Ongoing efforts to develop and roll out sheaths and guide tubes with calibration capabilities have continuously demonstrated the value of this feature.

[0007] The ablation and mapping catheters, widely used throughout EP procedures, incorporate magnetically and impedance-based position sensors over a large portion of the distal end of the device. This provides the ability to visualize the location and / or one or more bends within the catheter closer to the typical therapeutic element, further distally. This aids in measuring the true location, contact angle, and / or force, as well as the surgeon's general intuition about what is happening. The sensing electrodes function as intended when the introducer system (e.g., a deflectable sheath, a fixed-curve sheath, or others) is fully extended beyond the distal tip. However, when retracted into the introducer system, the sensing electrodes do nothing.

[0008] Furthermore, with the EP catheter fully extended, the need for further visualization from the introducer system is of little or no value. However, in many common cases, preferred delivery of the treatment or mapping system requires the EP catheter to be substantially retracted into the sheath, which again renders the impedance-based elements proximal to the distal end of the introducer system ineffective.

[0009] Therefore, it is clear that apparatuses, systems, and methods capable of providing calibration functions without the cost or performance issues of the current state of the prior art would be useful. Summary of the Invention

[0010] This application relates to medical devices, and more specifically, to perforated electrodes for use in sheaths, guiding catheters or other tubular devices (e.g., to enhance the functionality of mapping and ablation systems) and methods for manufacturing and using such perforated electrodes, tubular devices and systems.

[0011] To address the aforementioned problems and utilize the aforementioned clinical situations, this application discloses designs and methods for using "penetrating" and / or "mapping" electrodes, which may be included on a sheath or other tubular device for introduction into a patient. Perforating electrodes are typically "passive" electrodes, e.g., without conductors and / or otherwise electrically isolated from other electrodes and / or components of the means on which they are provided. In one instance, the simplest function of a perforating electrode on a sheath or other tubular member is to allow electrical signals from a larger pool of blood through an impedance-based "active" electrode positioned within the tubular member, in a manner substantially the same as when the tubular member surrounding the active electrode is not present. In other words, from an electrical perspective, including a perforating electrode on another tubular member of the sheath or introducer system and its method of use (e.g., basic alignment of the active electrode within the perforating electrode) makes the introducer system electrically transparent to the active electrode positioned within the sheath.

[0012] Furthermore, in one instance, passive (penetrating) electrodes can be used in conjunction with expander devices or systems, for example, by providing one or more active (mapping) electrodes on the expander, which can be covered by an introducer sheath including one or more pipette electrodes. Such mapping electrodes on the expander, when covered by the introducer sheath, would be useless without the surrounding pipette electrodes. Moreover, including active electrodes coupled to conductors extending through the expander body may be much simpler than incorporating such electrodes into conventional introducer systems (e.g., introducers, sheaths, or deflectable sheaths).

[0013] In another example, the sheath or tubular member including the through-electrode may also include one or more active electrodes. Thus, the sheath may include both passive and active electrodes, which may be used individually or in combination during surgery. In another example, the tubular member including multiple through-electrodes may include a dedicated passive electrode and one or more passive electrodes, which may be coupled to a conductor if desired to allow the electrode(s) to function as active electrodes. For example, a device including a mapping electrode may also include an electrode that can be used as an example of the “through” electrode described above, except that the electrode is now coupled to a conductor to allow it to also be used as an active mapping electrode. The conductor may be triaxially positioned along a braided axis and connected at a handle, for example, as disclosed in U.S. Patent Nos. 9,427,551, 1,007,1222, 10,124,145, and 11,305,092, the entire disclosure of which is expressly incorporated herein by reference.

[0014] Various configurations and arrangements of through-electrodes can be provided on sheaths or other tubular members. For example, through-electrodes can be configured as rings or other annular shapes, point electrodes or point electrodes, and / or combinations of both. Alternatively, the sheath, introducer, or guide can be constructed partially or substantially of a conductive material to provide electrotransparency. Typically, each through-electrode includes an external portion on the outer wall of the tubular member and an internal portion on the inner wall of the tubular member, for example, exposed within the instrument lumen of the tubular member. In one example, the internal portion can be a point electrode or a point-like electrode, and the external portion can be an annular electrode or annular member extending around the outer wall of the tubular member.

[0015] Perforated electrodes configured as point electrodes and annular electrodes have different advantages and disadvantages, depending on the purpose of the surgical catheter or other device introduced through a sheath or other tubular member incorporated into the perforated electrode. Generally, point electrodes or annular electrodes for the internal portion minimize disruption to the low-friction lining / surface / coating provided on the instrument lumen, for example, to facilitate the introduction of the surgical catheter. For the external portion, annular electrodes or ring surfaces can provide greater symmetry and / or a more uniform distribution of electrical energy delivered from an active electrode aligned with or near the perforated electrode. Alternatively, point electrodes or annular electrodes can be provided for the external portion, for example, circumferentially and / or axially offset from each other along the length of the sheath or tubular member, which can provide additional orientation / position feedback regarding the surgical device positioned within the tubular member.

[0016] According to one example, a device for performing surgery in a patient is provided, the device comprising: a tubular member including a proximal end, a distal end sized for insertion into the patient, and a longitudinal axis extending between the proximal and distal ends; a main lumen extending between the proximal and distal ends; and one or more through electrodes at the distal end, each through electrode including an external portion exposed on an outer wall of the tubular member and an internal portion exposed within an inner wall of the main lumen.

[0017] According to another example, a device for performing surgery within a patient is provided, the device comprising: a tubular member including a proximal end, a distal end sized for insertion into the patient, and a longitudinal axis extending between the proximal and distal ends; a main lumen extending between the proximal and distal ends; and a plurality of through electrodes spaced apart from each other at the distal end, each through electrode including an external portion exposed on an outer wall of the tubular member and an internal portion exposed within an inner wall of the main lumen, thereby providing a conductive path between the external and internal portions.

[0018] Optionally, the first through-electrode can be coupled to a conductor extending from the distal end to the proximal end, such that when the conductor is isolated, the only conductive path is between the outer and inner portions, and the at least one through-electrode is configured to function as an active electrode when power is supplied through the conductor to the at least one through-electrode. Therefore, when the conductor is inactive, the only conductive path of the first through-electrode lies between the outer and inner portions. Thus, the first through-electrode can be a combination of passive and active electrodes, depending on whether the conductor is on or off relative to an electrical energy source. In one example, the conductor can be a dedicated conductor of a connector extending from the first through-electrode to the proximal end, for example, such that the first through-conductor can be coupled to a controller similar to other active electrodes. Alternatively, the conductor can be a wire or other element with other functions, but can also be used as a conductor for the first through-conductor, such as a traction wire or steering wire, reinforcing wire, etc.

[0019] According to another example, an expander is provided for entry into a patient's body cavity, for example, through a diaphragm or other tissue barrier, comprising: a tubular member including a proximal end and a distal end, the distal end being sized for insertion into the patient and terminating at a tapered distal tip for advancing the distal end through an opening in the tissue; a lumen extending between the proximal and distal ends; and one or more active electrodes on the distal end configured for performing diagnostic or therapeutic procedures. In one example, multiple electrodes may be spaced apart from each other on the distal end, and the distal end may be configured to be introduced into a sheath or other tubular member including one or more through electrodes that may be aligned with or positioned in proximity to electrodes on the distal end of the expander.

[0020] According to another example, a system for performing surgery within a patient is provided, the system comprising: a tubular member including a proximal end, a distal end sized for insertion into the patient to a target site, a lumen extending between the proximal and distal ends, and one or more perforating electrodes on the distal end, each perforating electrode including an external portion exposed on an outer wall of the tubular member and an internal portion exposed within an inner wall of the lumen; and a surgical device including a distal portion capable of being inserted through the lumen to deploy one or more active electrodes on the distal portion within the target site for diagnostic or therapeutic surgery, wherein the one or more electrodes are configured to align with the one or more perforating electrodes when the distal portion is at least partially located within the distal end of the tubular member.

[0021] According to another example, a system for performing surgery within a patient is provided, the system comprising: a tubular member including a proximal end, a distal end sized for insertion into the patient to a target site, a lumen extending between the proximal and distal ends, and a conductive region on the distal end; and a surgical device including a distal portion capable of being inserted through the lumen to deploy one or more active electrodes on the distal portion within the target site for diagnostic or therapeutic surgery, wherein the one or more electrodes are configured to align with the conductive region when the distal portion is at least partially located within the distal end of the tubular member to allow mapping or sensing through the conductive region using the active electrodes.

[0022] According to another example, a method for fabricating a through electrode on a tubular member is provided, the method comprising: providing a tubular body including a wall surrounding a lumen; positioning a rivet-like member within the lumen, the rivet-like member including a conductive head and a shaft extending from the head; inserting the shaft through an opening extending through the wall until the shaft is exposed at an outer surface of the wall and the head is positioned against an inner surface of the wall; and forming an outer portion on the outer surface electrically connected to the head.

[0023] According to another example, a method for manufacturing a through electrode on a tubular member is provided, the method comprising: providing a first segment and a second segment of a tubular body, the tubular body including a wall surrounding a lumen; providing an annular electrode including a central region and a collar extending from an opposite end of the central region; and attaching the collar to the first segment and the second segment to provide a central region between the first segment and the second segment.

[0024] According to another example, a method for manufacturing a through electrode on a tubular member is provided, the method comprising: providing a tubular body including a wall surrounding a lumen; inserting a wire through an opening extending through the wall such that a first end of the wire is exposed at an outer surface of the wall and a second end of the wire is exposed at an inner surface of the wall within the lumen; forming an outer portion of the through electrode on the outer surface using the first end of the wire; and forming an inner portion of the through electrode on the inner surface using the second end of the wire.

[0025] According to another example, a method for performing a medical procedure is provided, the method comprising: introducing a distal end of a tubular member into a body cavity within a patient, the distal end including one or more perforating electrodes providing a conductive path between an outer surface of the distal end and an inner surface of a lumen within the tubular member; introducing a distal end of a surgical device into the lumen such that one or more active electrodes on the distal end of the surgical device are positioned within the distal end of the tubular member; positioning the surgical device such that the one or more active electrodes are aligned with or proximate with corresponding one or more perforating electrodes on the tubular member; and transmitting an electrical signal to the one or more active electrodes, the perforating electrodes transmitting the signal to tissue surrounding the distal end of the tubular member.

[0026] According to another example, a method for performing a medical procedure is provided, the method comprising: introducing a distal end of a tubular member into a body cavity within a patient, the distal end including a plurality of through electrodes providing a conductive path between an outer surface of the distal end and an inner surface of a lumen within the tubular member, the through electrodes being axially and / or circumferentially offset relative to each other; introducing a distal end of a surgical device into the lumen such that one or more active electrodes on the distal end of the surgical device are positioned within the distal end of the tubular member; and positioning the surgical device such that the one or more active electrodes are aligned or proximate with corresponding through electrodes on the tubular member to determine the position of the surgical device within the patient.

[0027] According to another example, a method for performing a medical procedure is provided, the method comprising: introducing a distal end of a tubular member into a body cavity within a patient, the distal end including a plurality of through electrodes providing a conductive path between an outer surface of the distal end and an inner surface of a lumen within the tubular member, the through electrodes being axially and / or circumferentially offset relative to each other; introducing a distal end of an expander into the lumen such that one or more active electrodes on a distal end of a surgical device are positioned within the distal end of the tubular member, and a distal tip of the expander extends from the distal end of the tubular member; and manipulating the expander and the tubular member together to insert the distal tip of the expander into an opening through tissue, while simultaneously sending signals to and receiving signals from one or more active sensors to provide positional information about the expander within the patient, the one or more through electrodes sending signals between the one or more active electrodes and tissue adjacent to the distal end of the tubular member.

[0028] Other aspects and features of the invention will become apparent from the following description taken in conjunction with the accompanying drawings. Attached Figure Description

[0029] The invention will be better understood through the following description of certain examples taken in conjunction with the accompanying drawings, wherein like reference numerals denote like elements, and wherein: Figure 1A An example of a system for performing medical procedures is shown, which includes a surgical catheter comprising multiple electrodes and an outer sheath comprising one or more through electrodes.

[0030] Figure 1B yes Figure 1A The system is shown in a longitudinal cross-sectional view taken along 1B-1B, in which the surgical catheter is positioned inside the sheath to align the electrodes on the catheter with the through electrodes on the sheath.

[0031] Figure 2A This is a detailed view of the distal portion of the introducer sheath, which includes a plurality of through-ring electrodes spaced axially from each other.

[0032] Figure 2B yes Figure 2B The cross-sectional view of the inlet sheath through plane 2B-2B.

[0033] Figure 2C yes Figure 2A The longitudinal cross-sectional view of the sheath shows the construction of the through-electrode mounted on the sheath.

[0034] Figure 2D yes Figure 2A The longitudinal cross-sectional view of the sheath shows the alternative construction of the through-electrode.

[0035] Figure 3A This is a detailed view of the distal portion of another introducer sheath, which includes a plurality of point electrodes or dot electrodes that are axially spaced apart from and axially aligned with each other.

[0036] Figure 3B yes Figure 3A The cross-sectional view of the inlet sheath through plane 3B-3B.

[0037] Figure 3C yes Figure 3A The longitudinal cross-sectional view of the inlet sheath shows an alternative construction of a point electrode or a point-type electrode.

[0038] Figure 4A This is a detailed view of the distal portion of another introducer sheath, which includes a plurality of point electrodes or dot-shaped electrodes that are axially spaced apart from each other and circumferentially offset from each other.

[0039] Figure 4B yes Figure 4A The cross-sectional view of the inlet sheath through plane 4B-4B.

[0040] Figure 5 This is a detailed view of the distal portion of another introducer sheath, which includes a plurality of point electrodes or dot-shaped electrodes spaced axially from each other.

[0041] Figures 6A-6D An exemplary method for mounting a through-point electrode to a tubular body is shown.

[0042] Figure 7A Another example of a system is shown, including a deflectable sheath and an expander that can be introduced through the sheath. The deflectable sheath includes through-electrodes, and the expander includes multiple active electrodes.

[0043] Figure 7B yes Figure 7A The system is shown in a longitudinal cross-sectional view, in which the expander is positioned within the sheath to align the electrodes on the catheter with the through electrodes on the sheath.

[0044] Figure 8 This is a perspective view of an exemplary single-piece electrode that can be used as a through-electrode.

[0045] Figures 9A-9C Showing the method for using Figure 8 An alternative method for mounting electrodes to a sheath or other tubular component.

[0046] Figure 10 Another exemplary monolithic electrode that can be used for through-electrodes is shown.

[0047] Figure 11A and Figure 11B It is a cross-sectional view of a sheath or tubular component comprising multiple integrated electrodes, the integrated electrodes being similar to those attached to the tubular component. Figure 10 The electrodes shown.

[0048] Figure 12A and Figure 12B These are perspective and side views of an example of a ring electrode that can be used as a through electrode.

[0049] Figure 13 The distal end of the sheath is shown, which includes annular electrodes mounted between segments of the sheath, such as... Figure 12A and Figure 12B The electrodes shown.

[0050] Figure 14 This is a cross-sectional view of another example of annular electrodes attached between sections of the sheath.

[0051] Figure 15 This is a cross-sectional view of another example of annular electrodes attached between sections of the sheath.

[0052] The accompanying drawings are not intended to be limiting in any way, and it is conceivable that various embodiments of the invention may be implemented in various other ways, including those not necessarily depicted in the drawings. The accompanying drawings, which are incorporated in and form part of this specification, illustrate several aspects of the invention and, together with the specification, serve to explain the principles of the invention; however, it should be understood that the invention is not limited to the precise arrangements shown. Detailed Implementation

[0053] The following description of certain examples of the invention is not intended to limit the scope of the invention. Other examples, features, aspects, implementations, and advantages of the invention will become apparent to those skilled in the art from the following description, which provides, in an illustrative manner, one of the best modes of carrying out the invention. As will be appreciated, the invention can have other different and obvious aspects, all of which do not depart from the invention. Therefore, the drawings and description should be considered illustrative in nature, not restrictive.

[0054] Before describing the examples, it should be understood that the invention is not limited to the specific examples described, although these examples can vary. It should also be understood that the terminology used herein is for describing specific examples only and is not intended to be limiting, as the scope of the invention will be limited only by the appended claims.

[0055] Where a range of values ​​is provided, it is understood that, unless the context explicitly specifies otherwise, each intermediate value (to one-tenth of the lower limit unit) between the upper and lower limits of the range is also specifically disclosed. Every smaller range between any specified value or intermediate value within the range and any other specified value or intermediate value within the range is included in this invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range, and each range in which one limit, both limits are included, or neither limit is included is also included in this invention, subject to any specific exclusions within the range. Where the range includes one or two limits, this invention also includes ranges that exclude one or both of these included limits.

[0056] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Although any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of this invention, some potential and exemplary methods and materials are now described.

[0057] It must be noted that, unless the context clearly specifies otherwise, the singular forms “a,” “an,” and “the” used herein and in the appended claims include plural references. Thus, for example, reference to “compound” includes a variety of such compounds, and reference to “polymer” includes reference to one or more polymers and their equivalents known to those skilled in the art, and so on.

[0058] This article presents certain ranges of numerical values ​​preceded by the term "approximately". The term "approximately" is used here to provide textual support for the exact number that follows it, as well as numbers that are close to or approximate to the number following the term. In determining whether a number is close to or approximates a specifically listed number, an unlisted number that is close to or approximates a number that is substantially equal to the specifically listed number in its presented context.

[0059] Switch to the attached image. Figure 1A and Figure 1B Examples of devices or systems 8 for performing medical procedures (such as mapping and / or ablation) inside a patient are shown. Typically, such as Figure 1AAs shown, system 8 includes an outer sheath, an introducer, a guide or other tubular component 10, and a surgical catheter or device 40 that can be introduced through the sheath 10 to perform surgery, as further described elsewhere herein.

[0060] Typically, the sheath 10 includes a proximal end 12, a distal end 14 sized for insertion into a body cavity, and defines a longitudinal axis 16 extending between the proximal end 12 and the distal end 14. Furthermore, the sheath 10 includes one or more lumens 18 extending at least partially between the proximal end 12 and the distal end 14. See also, for example, [further details omitted]. Figure 1B The sheath 10 may include a central lumen or main lumen 18a extending from the proximal end 12 to the distal end 14 into an outlet 17. The main lumen 18a may be sized to receive a surgical catheter 40 and / or other devices. Optionally, the sheath 10 may include one or more additional lumens (not shown), for example, for receiving one or more steering elements, wires, or other electrical conductors (also not shown).

[0061] In addition, such as Figure 1A and Figure 1B As shown, the sheath 10 includes one or more "through" electrodes 20, i.e., electrodes comprising an outer surface or external portion 22 exposed on the outer surface 11 of the sheath 10 and an inner surface or internal portion 24 exposed within the main tube cavity 18a, the external portion 22 and the internal portion 24 being electrically connected to each other, for example, by a wire or other conductor 26 extending through the wall of the sheath 10. In the example shown, the sheath 10 includes three through electrodes 20 axially spaced apart from each other, although the sheath may include fewer (one or two) or more (four or more) through electrodes. As further described elsewhere herein, the through electrodes 18 may be annular electrodes, point electrodes, or combinations thereof, or have other geometric configurations, for example, depending on the intended application of the system 8.

[0062] The through-electrodes 20 are typically “passive,” meaning they are electrically isolated from each other and from other parts of the sheath 10, for example, such that the only conductive path for each through-electrode lies between the outer portion 22 and the inner portion 24. For example, while the outer portion 22 and the inner portion 24 are electrically connected by a conductor 26, the conductor 26 may be electrically insulated to prevent contact with wires or braided elements (not shown) within the walls of the sheath 10, thereby enhancing the isolation of the through-electrodes 20. Therefore, the through-electrodes 20 are not connected to any wires or conductors within the sheath 10, unlike “active” electrodes that may be provided on the surgical catheter 40, as further described elsewhere herein.

[0063] Typically, the through-electrode 20 can be formed of highly conductive materials, such as gold, tungsten, and platinum. However, given the short path between the active electrode on the surgical device within the sheath and the blood pool, and the relatively high resistance of blood compared to typical conductive materials, the electrode can alternatively be made of various metals with lower conductivity, such as stainless steel and / or conductive polymers. Optionally, the through-electrode may include a coating to reduce impedance at the interface with blood or tissue, for example, as known in the art.

[0064] Back Figure 1B The distal end 14 may include a distal tip 15 of a conical, round, or other shape, for example, to provide a substantially non-invasive tip and / or facilitate advancement or navigation through various anatomical structures. Optionally, the distal end 14 may include one or more therapeutic and / or diagnostic elements, such as one or more active electrodes, sensors, etc. (not shown), depending on the specific intended application of the system 8. Furthermore, additionally or alternatively, the distal end 14 may include one or more markers or other features to enhance transmissivity and / or visibility under ultrasound, MRI, or other imaging modalities by, for example, mounting one or more platinum elements on the distal end 14, doping one or more areas of the distal end 14 with tungsten or barium sulfate, and / or other known methods.

[0065] Continue to refer to Figure 1A The sheath 10 may include a handle or hub 30 on the proximal end 12, for example, the handle or hub 30 being configured and / or sized to hold and / or manipulate the sheath 10 from the proximal end 12. Furthermore, the handle 30 may include one or more ports, such as port 32a communicating with the main lumen 18a or other corresponding lumen (not shown). Optionally, port 32a may include one or more valves, such as a hemostatic valve (also not shown), which can provide a substantially fluid-impermeable seal while being adapted to insert the surgical catheter 40 or one or more other instruments or fluids into the main lumen 18a. Optionally, as Figure 1A As shown, a side port 32b may be provided on the handle 30, for example for delivering fluid into and / or aspirating fluid from the main lumen 18a, such as around the catheter 40 or other instruments inserted into the main lumen 18a through the first port 32a. Optionally, the side port 32b may include one or more connectors, such as Luer lock connectors (not shown), for connecting other devices to the side port 32b, such as syringes or other fluid sources (also not shown).

[0066] In addition, the handle 30 may include one or more actuators, such as sliders, buttons, switches, rotary actuators, etc., for example, to activate and / or manipulate components on the distal end 14 (also not shown) or otherwise operate the sheath 10. For example, as Figure 1AAs shown, if the distal end 14 is deflectable, an actuator 34 may be provided, which is coupled to the proximal end of the steering element within the steering lumen (not shown) extending from within the wall of the sheath 10 to the distal end 14. The actuator 34 may be movable, such as axially sliding, rotatable about axis 16, etc., to apply axial, such as proximal tension, to the steering element, for example, to deflect the distal end 14, as described elsewhere herein.

[0067] Typically, the sheath 10 is a tubular body configured to include: an inner liner, for example, at least partially or entirely surrounding or otherwise defining the main tube lumen 18a; a reinforcing layer surrounding the inner liner; and an outer sheath surrounding and / or encasing the reinforcing layer (not shown; for example, see examples of such multi-layered constructions). Figure 2C , Figure 2D and Figure 3C Each layer may extend at least partially between the proximal end 12 and the distal end 14 of the sheath 10. In one example, the liner may be formed of a lubricating material (e.g., PTFE or a fluoropolymer) to provide a lubricated inner surface for the main tube lumen 18a. Alternatively, the liner 40 may be formed of one or more layers of thermoplastic or other polymeric materials, including one or more coatings on the inner surface having desired properties, such as hydrophilic and / or lubricating coatings, similar to the liners disclosed in U.S. Patent Nos. 7,550,053 and 7,553,387 and U.S. Publication No. 2009 / 0126862, the disclosures of which are expressly incorporated herein by reference.

[0068] One or more layers of the sheath 10 may have a substantially uniform construction between the proximal end 12 and the distal end 14. For example, a reinforcing layer may be applied substantially continuously between the proximal end 12 and the distal end 14. Alternatively, the construction may vary along the length of the sheath 10 to provide desired properties, such as variation between a proximal portion, a middle portion, and a distal portion (not shown). For example, the proximal portion of the sheath 10 adjacent to the proximal end 12 may be substantially rigid or semi-rigid, for example, providing sufficient pillar strength to allow the distal end 14 of the sheath 10 to be pushed from or otherwise manipulated from the proximal end 12, while the distal portion, for example, carrying the through electrodes 18, 4, may be substantially flexible to accommodate bending and / or be introduced into tortuous anatomical structures.

[0069] Back Figure 1AThe surgical catheter 40 may be an elongated member including a proximal end 42 and a distal end 44 sized to be inserted and pass through the main lumen 18a of the sheath 10. The catheter 40 may include one or more “active” electrodes 46, 48 on the distal end 40 for performing medical procedures within a patient, such as mapping and / or ablation procedures within a patient’s heart (not shown), as described elsewhere herein. For example, as shown, the catheter 40 includes a tip electrode 46a located at the distal tip of the catheter 40 and a plurality of annular electrodes 46b, 48 spaced apart from each other proximal to the tip electrode 46a.

[0070] As used herein, unlike "passive" through-electrodes, "active" electrodes are electrically connected to one or more wires or other conductors, which in turn are connected to a controller that supplies signals or energy to the electrodes for diagnostic and / or therapeutic procedures. For example, Figure 1A The electrodes 46 and 48 shown can be coupled to a lead (not shown) extending proximally from the distal end 44 of the catheter 40 to the proximal end 42, where the lead can be coupled to a controller 60. The controller 60 can be coupled to the electrodes 46 and 48 for transmitting and receiving signals to map conductive pathways within the heart chamber (in which the distal end 34 is introduced) and / or to deliver electrical energy to tissue to ablate it. As shown, the catheter 40 may include a handle or hub 50 on the proximal end 42, which may include one or more connectors (not shown) for connection to a cable 62 to electrically connect the electrodes 46 and 48 to the controller 60.

[0071] The controller 60 can be configured to deliver and receive signals from electrodes 46, 48, and process the signals to identify conductive pathways in adjacent tissues and / or otherwise identify desired anatomical structures. As further described elsewhere herein, the perforating electrode 20 is positioned on the distal end 14 of the sheath 10 such that when the active annular electrode 48 is positioned within the distal end 14 and aligned or proximates with the corresponding perforating electrode 20 (e.g., as...), Figure 1B As shown), the through electrode 20 can be electrically connected to the corresponding active electrode 48 to send / receive signals to / from the controller 60, thereby enabling mapping and / or ablation even without extending the active electrode 48 distally from the distal end 14 of the sheath 10.

[0072] In one example, the inner portion 24 of the through electrode 20 may extend from the inner wall 19 of the lumen 18a, for example, to define a dome or other convex shape, or it may be concave, for example, conforming to the curvature of the inner wall 19. The distal end 44 of the catheter 40 and the lumen 18a may have sufficiently close corresponding diameters such that the inner portion 24 slidably contacts the outer surface of the catheter 40. Thus, when the through electrode 20 is axially aligned with the active electrode 48, a slight interference fit may exist between the electrodes 20, 48, for example, to provide direct electrical contact for transmitting and receiving signals, and / or to center or otherwise stabilize the catheter 40 within the lumen 18a. Alternatively, the relative diameters may be such that when at least some of the inner portions 24 are axially aligned with the corresponding active electrode 48, at least some of the inner portions 24 are spaced apart from the corresponding active electrode 48. In this alternative, blood or other fluid (e.g., saline) within the main lumen 18a surrounding the catheter 40 may provide sufficient conductive pathway between the through electrode 20 and the nearest active electrode 48.

[0073] In any alternative, the signal received by controller 60 can be used to identify when the active electrode 48 is adequately axially aligned with the corresponding through electrode 20. For example, if the active electrode 48 is axially offset from the through electrode 20, the signal received by controller 60 may not correspond to the expected signal when the active electrode 48 receives a signal from adjacent tissue (e.g., if the distal end 44 of catheter 40 unfolds from sheath 10). Once the electrodes 20, 48 are sufficiently close, the signal received by controller 60 can provide an alignment indication, allowing mapping to continue even with the active electrode 48 within sheath 10. In one example, the signal received by controller 60 can be displayed on a monitor (not shown) connected to controller 60, and the operator can visually monitor the signal to determine when the electrodes 20, 48 are adequately aligned. Alternatively or additionally, controller 60 can automatically analyze the signal to determine when the electrodes 20, 48 are adequately aligned and provide an output, for example, on a monitor or other output device, to notify the operator.

[0074] Alternatively or concurrently, one or more of the active electrodes 46, 48 may be configured to deliver electrical energy to adjacent tissue, for example, to perform ablation on tissue in contact with or sufficiently close to the through electrode 20. For example, the controller 60 may include an electrical energy source (not shown) configured to deliver energy to one or more of the active electrodes 46, 48. When the through electrode 20 is adequately aligned with and positioned adjacent to the target tissue, the controller 60 may be activated to deliver energy to ablate the target tissue, as described elsewhere herein.

[0075] In one example, catheter 40 may be a bipolar ablation catheter, and the proximal electrode 48 may serve as a return path for the current. In typical ablation cases, this proximal electrode may frequently be pulled back into the sheath 10. In this application, a perforation electrode on the sheath (e.g., the electrode closest to the distal tip 15) may be aligned with the retracted proximal return electrode to allow the return current to be conducted through the perforation electrode to the return electrode. Optionally, in this example, the sheath may include one or more additional perforation electrodes, for example for ablation perforation and / or for sensing perforation. Using this configuration, operations can be performed with a shorter length of ablation catheter extending from the sheath, such as shaping or deflection, which in turn can provide greater maneuverability, for example, within the chambers of the patient's heart.

[0076] Alternatively, catheter 40 can be a combined mapping and ablation device, for example, an annular electrode 48 is configured to provide mapping, and a tip electrode 46a and a distal annular electrode 46b are configured to perform ablation. For example, the distal annular electrode 46b can use the tip electrode 46a to provide a return electrode for bipolar ablation.

[0077] In another example, the sheath 10 may be a cuttable or peelable sheath (such as a sheath for lead delivery) and includes one or more through electrodes 20. Similar to mapping or ablation catheters, many leads have electrodes on their distal portions that are used for sensing, becoming useless when the outer sheath is retracted. In this case, retraction is normal because the lead itself is optimized for mechanical and electrical implantation (not positioning). Furthermore, many of these leads have fixing or retractable screws that, if they extend even partially from the end of the delivery system, would prevent desired navigation and movement of the sheath (when locating ideal anatomical or electrical sites for implantation). Therefore, using a sheath 10 positioned around the lead (with the lead only slightly retracted to the distal end 14), the through electrodes (one or more) can be aligned with the lead electrodes (one or more) at a spacing corresponding to a typically preferred location, and the lead can be used for sensing, mapping, etc., while remaining within the sheath 10.

[0078] Furthermore, including conventional electrodes in a peelable / cuttable sheath presents even greater challenges, as all the previously described difficulties, as well as other difficulties related to maintaining the peelable / cuttable nature of the device, apply. Ideally, in this case, each through-electrode could be formed as a point / dot-shaped electrode or a ring-shaped electrode of a cuttable soft metal, or, in the case of a peelable sheath, at least partially pre-cut.

[0079] Refer again Figure 1A and Figure 1BThe number and placement of the perforating electrodes 20 can be optimized based on the intended surgical catheter or device to be introduced through the sheath 10. For example, the spacing between the perforating electrodes 20 can substantially match the spacing between the active electrodes 46 on the catheter 40. Optionally, the distal perforating electrode 20 can be offset proximally from the outlet 17 of the sheath 10, for example, corresponding to the intended offset of the active electrodes 46 of the surgical catheter or device 40 when the catheter 40 is retracted to a typical clinically used position.

[0080] Impedance electrodes on surgical catheter 40 (or dilator, for example, such as...) Figure 6A and Figure 6B As shown, when fully inserted into the sheath 10, in the presence of multiple ideal retracted positions, one or more additional through electrodes can be provided on the sheath 10 at the same spacing to fully enable the through function in two or more retracted positions.

[0081] In another alternative, for example, such as Figure 5 As shown, a set of substantially continuous through electrodes 320 may be provided on the distal end 314 of the sheath or other tubular member 310. The sheath 310 may include a plurality of through electrodes 320 spaced apart by a distance shorter than the spacing of the active electrodes on the surgical device. For example, the through electrodes 320 may be uniformly spaced at a distance that is a fraction (e.g., half, one-third, one-quarter, etc.) of the active electrode spacing, such that at multiple locations, the active electrodes will be aligned with or close to a subset of the through electrodes 320. For example, the spacing of the through electrodes may ensure that at any given retracted position of the surgical device, there are through electrodes sufficiently close to each active electrode, for example, to provide effective position sensing of the surgical device relative to surrounding anatomy.

[0082] Optionally, in any sheath or tubular device that includes a through-hole electrode herein, the device may also include one or more “active” electrodes, such as one or more “hard-wired” conventional electrodes, coupled to one or more conductors (not shown) extending from the distal end of the device to the proximal end. In one example, the sheath may include multiple impedance-based mapping electrodes (e.g., three electrodes aligned in a deflection region of the sheath with mapping electrodes of common mapping and ablation catheters (such as the Biosense Smarttouch device), and a fourth electrode near the distal tip of the sheath, which is a combination of hard-wired and through-hole electrodes. This through-hole electrode may be configured for ablation, for example, configured to be aligned with the proximal electrode of a bipolar ablation electrode assembly provided on a surgical device introduced through the sheath. Thus, the fourth electrode can be used for through-hole ablation of the surgical device within the sheath and can also be used as a reference mapping electrode to provide mapping without requiring precise alignment of its internal mapping / ablation catheter with the through-hole electrode. In a variation of this configuration, the combined electrode can alternatively serve as the farthest of the three electrodes, leaving the farthest through-electrode dedicated to conducting ablation energy from the internally aligned active ablation electrode.

[0083] While multiple hardwired electrodes can be provided on a sheath or tubular device that includes through-electrodes, it may often be desirable to include only a single combined electrode or a single hardwired electrode. This is because in electrophysiology or catheterization labs, physicians, nurses, scrub technicians, field engineers, and others are familiar with using alligator clips or other simple methods to attach to lab equipment. This means that very simple pins or tabs can be added to the sheath's handle (which connects to a single hardwired electrode) at a convenient location that the operator can connect to. This eliminates expensive connectors and cables, maintaining device cost and manufacturability.

[0084] Go to Figures 2A-2C In one example, each through-electrode 20 may include an annular or annular outer portion 22 and a dotted or dotted inner portion 24. This configuration can be suitable for applications where an electric field needs to be distributed around the sheath 10, such as during an ablation procedure. For example, the dotted or dotted inner portion 24 may provide sufficient surface area to electrically connect an active electrode aligned axially with the through-electrode 20 to the annular outer portion 22 (via a wire or conductor 26).

[0085] The outer portion 22 may be a closed ring, secured at a desired location on the distal end 14, for example, by one or more of the following methods surrounding the outer wall 11 of the sheath 10: interference fit, adhesive bonding, acoustic welding, melting, etc. Optionally, an annular groove or other recess may be provided in the outer wall 11 such that the ring 22 is at least partially recessed into the outer surface 11 and / or the sheath material may be softened or recirculated to position the ring 22 within the outer wall 11, for example, making the ring 22 flush with the outer surface 11. Figure 2B and Figure 2C As best shown, the inner portion 24 may be a rivet-shaped dot electrode (or electrode array) placed on the inner surface of the lumen 18a, having a dome or other head defining the inner portion 24 and a body or shaft 26 extending through the wall of the sheath 10 to electrically connect the head / inner portion 24 to the ring / outer portion 22.

[0086] In one approach, a rivet-shaped dot electrode 24 may first be positioned within the lumen 18a, and the body or shaft 26 may be inserted through the wall until it is exposed from the outer wall 11. An annular electrode (or electrode array) may then be placed on or within the outer wall 11, contacting the body or shaft 26, and the component may then be secured in place in a manner that maintains electrical contact between the outer portion 22 and the inner portion 24 (e.g., forging, pressing, gluing, melting, etc.). The shaft 26 may be electrically insulated between the outer portion 22 and the inner portion 24 (i.e., to isolate the shaft 26 from wires or other components within the wall of the sheath 10), while simultaneously electrically connecting the outer portion 22 and the inner portion 24.

[0087] exist Figure 2D In another method shown, shaft 26' may be provided on the inner surface of annular electrode portion 22', and shaft 26' may be received through an opening in the wall of sheath 10. The tip 24' of shaft 26' may extend into the lumen 18 of sheath 10, or may be substantially flush with the inner wall 19, to provide a through-hole portion of electrode 20'. Shaft 26' may be attached to annular electrode 22' before being installed into sheath 10, or alternatively, may be separately formed and inserted through the opening to contact annular electrode 22', and permanently attached to sheath 10 and / or annular electrode 22' to provide a through-hole electrode 20'.

[0088] In another approach, one or more linear insulated conductors may be placed through the wall of the tubular member to provide conductor 26 extending through the wall of the sheath 10, and the inner ends of the conductor(s) may be bent over the inner surface of the lumen 18a and fixed to the wall, for example, by one or more of adhesives, fusion, etc. The inner surface of the conductor(s) may then be abrade or otherwise treated to expose the conductive material of the conductor(s), thereby creating an internal portion or point electrode. Optionally, if additional surface area is required for the internal portion 24, a larger surface point electrode may be attached to the inner surface and coupled to the inner ends of the conductor(s).

[0089] Then, one or more annular electrodes can be placed over the passage point of the conductor(s) and mechanically and electrically secured to the appropriate position on the conductor(s) to provide the outer portion 22. Alternatively, the conductor(s) can be wound one or more times around the outer surface 11 of the sheath 10, for example, within an annular groove (not shown) formed in the outer wall, to form a ring. The outer insulating surface of the resulting ring(s) can be polished or otherwise treated to complete the through electrode 20. Optionally, if desired, additional conductive material can be applied over the ring(s) to enhance the conductivity of the outer portion.

[0090] In yet another example, the sheath may include one or more through electrodes formed as a ring, the thickness of which is substantially the same as the wall thickness of the distal end 14 of the sheath, for example, as Figure 12A and Figure 12B As shown. In one method, one or more extrusions defining the distal end can flow back to the proximal and distal ends of each through-electrode, for example, to attach the electrode and / or electrically insulate the electrode from components within the wall (e.g., braided elements of the reinforcing layer and / or traction wires (one or more)). In one example, one or more mechanical holes or slots (not shown) may be provided in the annular electrode to conduct electricity from the center of the electrode from the outer portion 22 to the inner portion 24. Optionally, one or more flushing holes may be provided at the center of the electrode, or otherwise communicated between the outer portion 22 and the inner portion 24, to allow fluid to pass through the electrode 20 from the lumen 18a.

[0091] Alternatively, the annular electrode for the through-hole electrode can be electrically connected to one or more conductors within the distal end. For example, the conductor can be coupled to the electrode and pass axially along the wall of the sheath, for example, triaxially woven into a reinforcing member in the wall and / or non-triaxially woven between the lumen liner and the extrusion. In another alternative, one or more semi-continuous through-hole electrodes can be provided, grounded to a common central conductor (such as a wire or other member of the sheath reinforcement). In yet another alternative, the outer surface of the sheath 10 can be conductive over at least a portion of its length, enabling impedance-based mapping of the surgical device within the sheath when positioned in a blood pool within the patient's body.

[0092] Go to Figure 3A and Figure 3B In another example, a sheath 110 is provided, which includes a plurality of dot-shaped or point-through electrodes 120. In this example, both the outer portion 122 and the inner portion 124 can abut against the outer surface 111 and the inner surface 119 of the sheath 110 to form relatively small conductive areas, for example, having circular, elliptical, square, or other cross-sectional surface areas. Figure 3A As shown, the through electrodes 120 can be axially aligned with each other, i.e., a linear array substantially parallel to the longitudinal axis 116. Optionally, multiple linear arrays (not shown) circumferentially spaced apart from each other around the distal end 114 of the sheath 116 can be provided. In this option, each array can include electrodes at the same axial position, such that the array also defines a circumferential array. Alternatively, one or more arrays can be axially offset from each other, such that the electrodes of at least some linear arrays are axially offset from the other linear arrays.

[0093] In another alternative, such as Figure 4A and Figure 4B As shown, a sheath 210 can be provided comprising a plurality of through electrodes 220 offset from each other axially and circumferentially. For example, as Figure 4A As shown, the electrodes 220 can be arranged in a spiral array along the length of the distal end 214.

[0094] Go to Figures 6A-6D This illustrates an exemplary method for forming a through-hole electrode 120, which includes point electrodes or point-type electrodes for both the outer portion 122 and the inner portion 124, such as... Figure 3A and Figure 3B As shown. First, a wall 113 is provided for the distal end 114 of the sheath or other tubular member 110. The wall 113 may be part of the entire sheath 110 that has already been manufactured, or it may be a relatively short extrusion or other tubular body that may be formed separately and attached to another longer tubular body to provide the distal end 114.

[0095] like Figure 6A As shown, a hole or other opening 113a through the wall 113 can be formed, for example, by one or more of stamping, drilling, cutting, etc. Alternatively, if the wall 113 is part of an extrusion or other separate tubular body, the opening 113a can be formed, for example, by molding, casting, 3D printing, etc., during the formation of the tubular body. A rivet-like member 123 may be provided, comprising a circular or other shaped head 123a corresponding to the inner portion 124 and a tubular shaft 123b extending from the head 123a and corresponding to the conductor 126.

[0096] Go to Figure 6B The shaft 123b of the rivet-like member 123 can be inserted from inside the lumen 118 through the opening 113a to position the head 123a against the inner wall 119, for example, such that the shaft 123b extends around the outer surface 111 of the sheath 110. Then, as Figure 6C As shown, a riveting die or other tool 106 can be used to fold the exposed shaft 123b and / or otherwise deform the shaft 123b to provide the outer portion 122 of the electrode 120. The tool 106 can be further actuated as needed to press the outer portion 122 and the inner portion 124 against the outer surface 111 and the inner surface 119 to provide a completed through-electrode 120, for example as... Figure 6D As shown.

[0097] Alternatively, such as Figure 3C As shown, a rivet-like member 123' can be provided, comprising a head 124' and a shaft 123a' extending from the head 124'. When the rivet-like member 123' is within the lumen 118 of the sheath 110, the shaft 123a' can be inserted through an opening created in the wall of the sheath 110, such that the tip 122' of the shaft 123a' is exposed from the outer surface 111 of the sheath 110. In this alternative, the shaft 123a' can have a rounded or flattened tip 122' that extends from or remains flush with the outer surface 111 to provide an outer portion of the electrode 120'. The head 124' can be permanently attached to the inner surface 119 of the sheath 110, for example, by adhesive bonding, acoustic welding, reflowing sheath material, etc.

[0098] Go to Figure 7A and Figure 7B This shows another example of a system 708 for performing medical procedures, which includes an outer sheath or other tubular member 10, which may be similar to... Figure 1A and Figure 1BThe sheath 10 shown, or alternatively, any other sheath or tubular member herein, includes one or more through electrodes 20. Furthermore, system 708 includes a dilator 740 comprising a proximal end (not shown), a distal or distal portion 744 sized for insertion into a lumen 18 of the sheath 10, and a plurality of active electrodes 746 spaced apart from each other. As shown, electrodes 746 may be spaced proximally from the tapered distal tip 745 of the dilator 740, for example, sized and / or shaped to facilitate advance of the dilator 740 through an opening in tissue (not shown), for example, to dilate the opening and / or otherwise facilitate the introduction of one or more instruments or devices through the tissue. Optionally, the dilator 740 may include a lumen 748 extending from its proximal end to an opening 749 in the distal tip 745, for example, to slidably receive a guidewire or other track. The size and shape of the distal tip 15 of the sheath 10 can provide a substantially smooth transition to the tapered distal tip 745 of the expander 740, for example, so that the entire system 708 can be pushed together through an opening in the tissue, wherein the distal tip 745 causes the tissue to expand to accommodate the sheath 10.

[0099] In one instance, the active electrode 746 can be used for mapping or other sensing. When the expander 746 is positioned within the sheath 10 and the active electrode 746 is aligned with the through electrode 20, the expander 746 can be used for mapping or other sensing, as if the sheath 10 were not present, similar to other devices and systems described herein.

[0100] Alternatively, other devices including one or more active electrodes may be provided instead of the dilator 740. These other devices may be introduced into the sheath 10 and deployed from the distal end 14 for surgical procedures and / or withdrawn from the sheath 10 to align the active electrodes on the device with the perforating electrode 20. For example, a central line catheter or PIC line catheter may be provided, including one or more mapping or sensing electrodes (not shown), which may be introduced through the lumen 18a of the sheath 10. The electrodes on the catheter may be deployed from the distal end 14 during surgery or positioned within the distal end 14 to align the electrodes on the catheter with the perforating electrode 20.

[0101] In other alternatives, it may be desirable to keep the construction of the through-electrode as simple as possible. For example, it may be desirable to construct each through-electrode as a single piece. In a monolithic construction variant, "tongue-shaped," "foot-shaped," or "leg-shaped" portions cut from the classic annular electrode are particularly valuable.

[0102] For example, Figure 8 An example of an integral electrode 820 is shown, which can be formed and mounted onto a sheath or other tubular component, such as... Figures 9A-9C The sheath 810 is shown. As shown, the electrode 820 includes an annular sleeve 822, which includes one or more tabs 824 formed in the wall. In one method, the sleeve 822 may be formed from a flat sheet in which the tabs 824 are formed (e.g., by one or more of stamping, laser cutting, etching, etc.), and the sheet may then be rolled up and the edges of the sheet may be attached together, for example by welding, melting, adhesive bonding, etc., to provide the sleeve 822. Alternatively, the electrode 820 may be formed into a tubular shape, for example by one or more of extrusion, molding, casting, etc., and the tabs 824 may be formed in the tubular shape, for example by one or more of laser cutting, etching, etc.

[0103] like Figure 8 As shown, electrode 820 includes, for example, four tabs 824 spaced apart from each other in a substantially uniform manner around the circumference of sleeve 822. Alternatively, sleeve 822 may include other arrangements of tabs, such as one or more tabs spaced evenly or circumferentially and / or a plurality of tabs positioned adjacent to each other at the same circumferential location between opposite edges of sleeve 822.

[0104] To incorporate the electrode 820 into the sheath or other tubular member 810, one or more slots or other openings 813 may be created through the sheath 810, for example, circumferentially spaced around the sheath wall at a spacing corresponding to the spacing of the tabs 824. A sleeve 822 may be positioned around the sheath 10, and the tabs 824 may be bent or otherwise guided through the openings 813 such that the tabs 824 extend into the lumen 818 of the sheath 810. Alternatively, if the electrode 820 is formed of a flat plate, the flat plate may be wound around the sheath 810, and the tabs 824 may be inserted into the openings 813. The opposite ends of the flat plates may then be attached together or simply positioned adjacent to each other on the outer wall of the sheath 810. The electrode 820 may be permanently attached to the sheath 810, for example, by one or more of the following methods: interference fit, adhesive bonding, reflow of sheath material, melting, ultrasonic welding, etc.

[0105] The tab 824 may have sufficient length to extend through the wall of the sheath 810, such that the tip of the tab 824 provides a through-hole portion of the electrode 820. For example, as Figure 9A As shown, the length of the tab 824 can correspond to the thickness of the wall of the sheath 810 to provide an internal portion of the electrode 820 flush with the inner surface 819 of the sheath 810. Alternatively, as Figure 9B and Figure 9C As shown, the tab 824 can extend into the lumen 818 and then deform against the inner wall 819. For example, in Figure 9BIn the middle, the tip of the protrusion 824 can abut against the inner wall 819 or flatten or become mushroom-shaped within the inner wall 819, while... Figure 9C In this case, the tip of the tab 824 is bent against the inner wall 619. Optionally, the surface of the tab 824 may be at least partially electrically insulated between the sleeve 822 and the tip to isolate the tab 824 from wires or other components within the wall of the sheath 810.

[0106] In another example, the proximal and distal perforating electrodes of the two main bipolar ablation electrodes are aligned, and then all other electrodes are offset based on this position and alignment with the remaining electrodes of the surgical catheter. Electrodes with tongue-shaped incisions (one or more) can then be aligned with the corresponding openings through the sheath wall, and the tongue-shaped incisions (one or more) are pressed into the openings (one or more) (combined with rotation as needed) until the tongue-shaped incisions (foot-shaped / leg-shaped, etc.) encounter a mandrel (not shown) positioned within the lumen of the sheath. In another example, the foot-shaped incisions (or alternatively, holes or openings through the sheath wall) are electrically insulated or otherwise isolated from the braid through which the holes pass. The electrode assembly is then secured in place by one of many common methods, including 1) forging, 2) gluing (hole and edge glue), and the process is repeated for the other electrodes.

[0107] Alternatively, the tongue-shaped / foot-shaped portion can be cut into a more support-like structure with a total cutting path length much greater than the radial arc length, allowing it to be pressed down / extended into the hole without rotation, etc.

[0108] Alternatively, each electrode may include multiple tongue-shaped / foot-shaped / leg-shaped portions (entering into multiple holes) to increase the stability of the electrode and / or the surface area of ​​the internal contacts and / or the uniformity / integrity of signal or ablation transmission.

[0109] In another alternative, the through-electrodes (one or more) can be made using a "tack"-shaped element. The base of the "tack" rests against the inner wall of the sheath, and the "shank" of the tack passes through the shaft. The shank itself (at its exit point on the shaft) can be an effective electrode, or alternatively, an annular electrode can be placed around the exit point (e.g., forged, glued, etc.) while in contact with the annular electrode.

[0110] For example, go to Figure 10An exemplary electrode 920 is shown, comprising a central pint region 924 and a pair of tabs 922 extending from the opposite side of the pint region 924. The tabs 922 may be bent or otherwise shaped and then inserted through a corresponding hole or opening (which penetrates the wall of a sheath or tubular member 910), for example, until exposed on the outer wall 911 of the sheath 910. The tabs 924 and / or the pint region 924 may be attached to the sheath 910, for example, by one or more of interference fit, adhesive bonding, melting, etc., to permanently attach the electrode 920 to the sheath 910. Figure 11A In the example shown, two electrodes 920 are provided on the sheath 910, wherein the pin region 924 is spaced apart from the inner wall 919 of the sheath 910, and the tab 922 extends through the wall, while Figure 11B The middle part provides four electrodes 920.

[0111] The outer end of the tab 922 may extend from the outer wall and / or be pressed or otherwise positioned flush with the outer wall. The exposed outer end may be sufficient to provide the outer portion of the electrode 920, or alternatively, additional electrode components or conductive material may be applied to the outer surface 911 electrically coupled to the end of the tab 922. For example, an annular component (not shown) may be attached around the outer surface 911 and coupled to the tab 922, or one or more point-like or dot-shaped electrodes may be attached to the outer surface 911, for example, a single point electrode coupled to each pair of tabs, or a separate point electrode coupled to each tab (also not shown).

[0112] Go to Figure 12A and Figure 12B This shows another example of the annular electrode 1020, which can be attached to a sheath or other tubular component, such as... Figure 13 The sheath 1010 is shown. At least a portion of the electrode 1020 may have a thickness substantially the same as the wall thickness of the distal end 1014 of the sheath 1010. For example, as Figure 12A and Figure 12B As shown, electrode 1020 may include a central annular region 1021, which includes an outer surface 1022 and an inner surface 1024. When electrode 1020 is mounted or otherwise attached to a sheath, the outer surface 1022 may be exposed or flush with the outer surface of the sheath, and the inner surface 1024 may be exposed or flush with the inner surface of the sheath.

[0113] In the illustrated example, electrode 1020 includes a collar 1023 located on the opposite side of central region 1021, the thickness of collar 1023 being less than the thickness of central region 1021, for example, such that a sheath can be attached to collar 1023, for example, received on collar 1023 and then flowed back or otherwise attached to collar 1023. For example, as shown, each collar 1023 may include one or more holes, recesses or other features 1023a into which material from adjacent sheath segments 1020a, 1020b may flow or otherwise engage collar 1023 to permanently attach collar 1023 to adjacent sheath segments, for example, by making outer surface 1022 and inner surface 1024 flush with the outer / inner wall of the sheath. Optionally, the central region 1021 may include one or more holes or other channels 1025 extending therethrough, i.e., between the outer surface 1022 and the inner surface 1024. The channels 1025 allow fluid to flow through them; for example, fluid introduced through the lumen of the sheath flows out through the channels 1025, which can be used to cool the electrode 1020 and / or enhance the electrical connection of the electrode 1020 to adjacent tissues.

[0114] Alternatively, such as Figure 14 As shown, the annular electrode 1020' may include a collar 1023' flush with the outer surface 1022' on the opposite side of the central region 1021'. The thickness of the collar 1023' is less than the thickness of the central region 1021, for example, such that the electrode 1020' can be attached to adjacent sections 1010a, 1010b of the sheath 1010 via an overlap attachment. Similar to the previous example, the overlap attachment can be reflowed or otherwise attached to the collar 1023'.

[0115] exist Figure 15 In another alternative shown, a ring electrode 1020 can be provided (e.g., similar to...). Figure 12A and Figure 12B The electrode 1020 shown, and the sheath 1010” may include a plurality of extrusions or other segments 1020a”-1020d”, which may be attached to a collar 1023” to attach the electrode 1020” to the sheath 1010. Optionally, the plurality of segments 1010a”-1010d” may allow conductors (e.g., wires, etc.) to be coupled to the electrode 1020”, for example, a combination of passive / active electrodes may be provided if desired, as described elsewhere herein.

[0116] For illustrative and descriptive purposes, various examples of the above disclosure have been provided. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. In view of the above disclosure, many variations and modifications of the embodiments described herein will be apparent to those skilled in the art.

[0117] Furthermore, in describing representative embodiments, the specification may have presented methods and / or processes as a specific sequence of steps. However, the method or process should not be limited to the specific sequence of steps described herein, where the method or process does not depend on it. Other sequences of steps are possible, as will be understood by those skilled in the art. Therefore, the specific order of steps set forth in the specification should not be construed as a limitation of the claims.

[0118] While the invention is readily adaptable to various modifications and alternatives, specific examples have been shown in the accompanying drawings and described in detail herein. However, it should be understood that the invention is not limited to the specific forms or methods disclosed, but rather, on the contrary, it is intended to cover all modifications, equivalents, and alternatives falling within the scope of the appended claims.

Claims

1. A device for performing surgery inside a patient, comprising: A tubular member comprising a proximal end, a distal end sized for insertion into a patient, and a longitudinal axis extending between the proximal end and the distal end; The main cavity extends between the proximal end and the distal end; and One or more through electrodes on the distal end, each through electrode including an outer portion exposed on the outer wall of the tubular member and an inner portion exposed within the inner wall of the main tube lumen.

2. The device of claim 1, wherein each through-electrode is passive.

3. The device of claim 2, wherein a unique conductive path for each through electrode is between the outer portion and the inner portion.

4. The device of claim 2, wherein each through electrode is electrically isolated from other electrodes or components on the tubular member.

5. The device of claim 2, wherein each through electrode is not connected to any wire or conductor on the tubular member.

6. The device of claim 1, wherein each through electrode includes a wire or conductor extending through the sheath between the outer portion and the inner portion.

7. The device of claim 6, wherein the wire or conductor is electrically isolated from the surrounding material of the sheath.

8. The device of claim 6, wherein the wire or conductor extends radially through the sheath between the outer portion and the inner portion.

9. The device according to any one of claims 1-8, wherein the one or more through electrodes comprise a plurality of through electrodes spaced apart from each other on the distal end.

10. The device of claim 9, wherein the through electrodes are axially spaced apart from each other.

11. The device of claim 10, wherein the through-electrode comprises a plurality of point electrodes axially aligned with each other.

12. The device of claim 10, wherein the through-electrode comprises a plurality of point electrodes spaced apart from each other in a circumferential direction.

13. The device of claim 12, wherein the point electrode is arranged in a helical configuration on the distal end.

14. The device according to any one of claims 1-8, wherein each through electrode includes an annular outer portion extending circumferentially around the outer wall of the sheath.

15. The device of claim 14, wherein each through electrode includes an annular inner portion extending circumferentially around the inner wall.

16. The device of claim 15, wherein each through-electrode comprises an annular electrode.

17. The device of claim 16, wherein the radial thickness of the annular electrode is substantially the same as the radial thickness of the tubular member between the outer wall and the inner wall.

18. The device of claim 14, wherein each through-electrode includes a point electrode defining the internal portion.

19. The device of claim 18, further comprising a wire or conductor extending between the outer portion and the inner portion.

20. The device of claim 18, wherein each through-electrode comprises only a single point electrode defining the internal portion.

21. The device of claim 18, wherein each through-electrode includes a plurality of point electrodes defining the inner portion, each of the point electrodes being electrically connected to the outer annular portion.

22. The device according to any one of claims 1-8, wherein each through electrode comprises a point electrode or a point-type electrode defining the outer portion.

23. The device of claim 2, wherein each through-electrode comprises a point electrode or a point-type electrode defining the internal portion.

24. The device of claim 23, further comprising a wire or conductor extending between the outer portion and the inner portion.

25. The device according to any one of claims 1-8, wherein the tubular member includes a distal portion that defines a curved shape in a relaxed state.

26. The device of claim 25, wherein the distal portion is deflectable to at least partially straighten the distal portion from the relaxed state.

27. The device according to any one of claims 1-8, further comprising: A steering element that extends at least partially from the proximal end toward the distal end; and The actuator on the proximal end is coupled to the steering element to guide the steering element to deflect the distal portion of the tubular member adjacent to the distal end.

28. The device of claim 27, wherein the tubular member includes an auxiliary lumen extending along the distal portion adjacent to the main lumen, and wherein the steering element is slidably disposed within the auxiliary lumen.

29. The device of claim 28, wherein the actuator is coupled to the proximal end of the steering element such that actuation of the actuator applies axial tension or compression to the steering element, thereby deflecting the distal portion.

30. The device according to any one of claims 1-8, further comprising one or more markers on the distal end for identifying the distal end using external imaging.

31. The device according to any one of claims 1-8, further comprising one or more active electrodes at the distal end and one or more conductors extending from the distal end toward the proximal side, the one or more conductors being coupled to the one or more active electrodes.

32. The device according to any one of claims 1-8, wherein one or more of the through electrodes are connected to ground.

33. An expander for providing access to a patient's body cavity, comprising: A tubular member comprising a proximal end, a distal end sized for insertion into a patient and terminating at a distal conical tip, and a lumen extending between the proximal end and the distal end, the distal conical tip being used to advance the distal end through an opening in the tissue. and One or more active electrodes on the distal end are configured to perform diagnostic or therapeutic procedures.

34. The expander of claim 33, wherein the one or more active electrodes comprise a plurality of electrodes spaced apart from each other along the length of the distal end.

35. The expander of claim 34, wherein the electrodes comprise a plurality of annular electrodes.

36. A central venous catheter or PIC catheter, comprising: A tubular member comprising a proximal end, a distal end sized for insertion into a patient and terminating at a distal conical tip, and a lumen extending between the proximal end and the distal end, the distal conical tip being used to advance the distal end through an opening in the tissue. and One or more active electrodes on the distal end are configured to perform diagnostic or therapeutic procedures.

37. The expander of claim 36, wherein the one or more active electrodes comprise a plurality of electrodes spaced apart from each other along the length of the distal end.

38. The expander of claim 37, wherein the electrodes comprise a plurality of annular electrodes.

39. A device for performing surgery in a patient, comprising: A tubular member comprising a proximal end, a distal end sized for insertion into a patient, and a longitudinal axis extending between the proximal end and the distal end; The main cavity extends between the proximal end and the distal end; and A plurality of through electrodes spaced apart from each other at the distal end, each through electrode including an outer portion exposed on the outer wall of the tubular member and an inner portion exposed within the inner wall of the main tube lumen, thereby providing a conductive path between the outer portion and the inner portion.

40. The device of claim 39, wherein at least one through electrode is coupled to a conductor extending from the distal end toward the proximal end such that when the conductor is isolated, the only conductive path is the conductive path between the outer portion and the inner portion, and when electricity is supplied to the at least one through electrode through the conductor, the at least one through electrode is configured to function as an active electrode.

41. A system for performing surgery in a patient, comprising: A tubular member comprising a proximal end, a distal end sized for insertion into a patient to a target site, a lumen extending between the proximal end and the distal end, and one or more perforating electrodes on the distal end, each perforating electrode comprising an external portion exposed on an outer wall of the tubular member and an internal portion exposed within an inner wall of the main lumen. and A surgical device comprising a distal portion capable of being introduced through the lumen to deploy one or more active electrodes on the distal portion within the target site for diagnostic or therapeutic surgery, wherein the one or more electrodes are configured to be aligned with the one or more through electrodes when the distal portion is at least partially located within the distal end of the tubular member.

42. The system of claim 41, wherein the one or more through electrodes comprise a plurality of through electrodes spaced apart from each other on the distal end.

43. The system of claim 42, wherein the one or more active electrodes comprise a plurality of active electrodes spaced apart from each other along the distal portion.

44. The system of claim 43, wherein the number of active electrodes is equal to or less than the number of through electrodes.

45. The system of claim 43, wherein the active electrode comprises a calibration electrode.

46. ​​The system of claim 45, further comprising a controller coupled to the mapping electrode for transmitting and receiving signals to map conductive pathways within the cardiac chamber, the distal portion extending within the cardiac chamber.

47. The system of claim 46, wherein the through-electrode is disposed on the distal end such that when the active electrode is positioned within the distal end and aligned with the corresponding through-electrode, the through-electrode is electrically connected to the corresponding active electrode to transmit and receive the signal to characterize the conductive path.

48. The system of claim 46, wherein the controller is configured to provide an output indicating when the active electrode is aligned with a corresponding punch-through electrode.

49. The system of claim 48, further comprising a display coupled to the controller, such that the controller displays a signal received from the active electrode to allow an operator to visually identify changes in the displayed signal to confirm when the active electrode is aligned with the through electrode.

50. The system of claim 48, wherein the controller is configured to analyze signals from the active electrode to determine when the active electrode is aligned with a corresponding through electrode.

51. The system of claim 50, further comprising an output device coupled to the controller for providing an output when the controller determines that the active electrode is aligned with the corresponding through electrode.

52. The system of claim 43, wherein the active electrode comprises one or more ablation electrodes.

53. The system of claim 52, further comprising a controller coupled to the one or more ablation electrodes for delivering electrical energy to the one or more ablation electrodes to ablate tissue adjacent to the one or more ablation electrodes.

54. The system of claim 53, wherein the through-hole electrode is disposed on the distal end such that when the one or more ablation electrodes are positioned within the distal end and aligned with the respective through-hole electrode, the through-hole electrode is electrically connected to the respective ablation electrode to deliver electrical energy to tissue adjacent to the through-hole electrode to ablate the tissue.

55. The system according to any one of claims 41-54, further comprising a tip electrode located at the distal tip of the surgical device.

56. The system according to any one of claims 41-44, wherein the surgical device includes a dilator having a tapered distal tip for advancing the dilator through an opening in the tissue.

57. The system of claim 56, wherein the dilator further includes a lumen extending between the proximal and distal portions for receiving one or more instruments.

58. The system according to any one of claims 41-44, wherein the surgical device comprises a central venous catheter.

59. The system according to any one of claims 41-44, wherein the surgical device comprises a peripherally inserted central venous catheter (PICC).

60. The system of claim 59, wherein the catheter includes a lumen extending between the proximal and distal portions for receiving one or more instruments.

61. A system for performing surgery in a patient, comprising: A tubular member comprising a proximal end, a distal end sized for insertion into a patient to a target site, a lumen extending between the proximal end and the distal end, and a conductive region on the distal end; and A surgical device comprising a distal portion capable of being introduced through the lumen to deploy one or more active electrodes on the distal portion within the target site for diagnostic or therapeutic surgery, wherein the one or more electrodes are configured to align with the conductive region when the distal portion is at least partially located within the distal end of the tubular member to allow mapping or sensing through the conductive region using the active electrodes.

62. An apparatus for performing surgery in a patient, comprising: A tubular member comprising a proximal end, a distal end sized for insertion into a patient, and a longitudinal axis extending between the proximal end and the distal end; A lumen extending between the proximal end and the distal end; One or more through electrodes on the distal end, each through electrode including an outer portion exposed on the outer wall of the tubular member and an inner portion exposed within the inner wall of the main tube lumen, thereby providing a conductive path between the outer portion and the inner portion; and One or more active electrodes on the distal end.

63. The device of claim 62, wherein the one or more through electrodes comprise a plurality of through electrodes spaced apart from each other on the distal end.

64. The device of claim 63, wherein the first through electrode is coupled to a conductor extending from the distal end toward the proximal end such that when the conductor is isolated, the only conductive path is the conductive path between the outer portion and the inner portion, and the at least one through electrode is configured to function as an active electrode when electricity is supplied to the at least one through electrode through the conductor.

65. The device of claim 64, wherein the unique conductive path of all through electrodes other than the first through electrode is located between the outer portion and the inner portion.

66. The device of claim 62, wherein the one or more through electrodes comprise a plurality of passive electrodes spaced apart from each other on the distal end.

67. The device of claim 62, wherein the one or more active electrodes comprise a plurality of mapping electrodes spaced apart from each other on the distal end.

68. The device of claim 67, further comprising a controller coupled to the mapping electrode for transmitting and receiving signals to map conductive pathways within the cardiac chamber, the distal portion extending within the cardiac chamber.

69. The device of claim 62, wherein the one or more active electrodes comprise one or more ablation electrodes located at the distal end.

70. The device of claim 69, further comprising a controller coupled to the one or more ablation electrodes for delivering electrical energy to the one or more ablation electrodes to ablate tissue adjacent to the one or more ablation electrodes.

71. A method for fabricating a through-electrode on a tubular member, comprising: Provides a tubular body comprising a wall surrounding the lumen; A rivet-like component is positioned within the cavity, the rivet-like component comprising a conductive head and a shaft extending from the head; The shaft is inserted through an opening extending through the wall until it is exposed on the outer surface of the wall, and the head is positioned against the inner surface of the wall. and An external portion electrically connected to the head is formed on the outer surface.

72. The method of claim 71, wherein forming the outer portion on the outer surface comprises positioning a conductive annular member around the outer surface such that the annular member is electrically connected to the tip of the shaft.

73. The method of claim 71, wherein forming the outer portion on the outer surface comprises deforming the tip of the shaft against the outer surface to provide the outer portion.

74. The method of claim 73, wherein a crimping device is used to deform the tip of the shaft, the crimping device simultaneously pressing the head against the inner surface and deforming the tip of the shaft against the outer surface.

75. The method according to any one of claims 71-74, wherein the shaft is at least partially electrically insulated along its length to isolate the shaft from wires or other components within the wall of the tubular body.

76. The method according to any one of claims 71-74, wherein the shaft is at least partially electrically insulated along its length such that a single conductive path between the outer portion and the head passes through the shaft.

77. A method for fabricating a through-electrode on a tubular member, comprising: Provides a tubular body comprising a wall surrounding the lumen; A wire is inserted through an opening extending through the wall, such that a first end of the wire is exposed on the outer surface of the wall, and a second end of the wire is exposed on the inner surface of the wall within the lumen; The first end of the wire forms an outer portion of the through electrode on the outer surface; and The second end of the wire is used to form the inner portion of the through electrode on the inner surface.

78. The method of claim 77, wherein the outer portion and the inner portion are formed by bending the first end and the second end of the conductor against the outer surface and the inner surface, respectively.

79. The method of claim 77, wherein forming the outer portion comprises positioning a conductive material against the outer surface of the first end electrically connected to the wire.

80. The method of claim 79, wherein the conductive material comprises an annular member.

81. The method according to any one of claims 77-80, wherein the conductor is at least partially electrically insulated between the first end and the second end to isolate the conductor from conductors or other components within the wall of the tubular body.

82. The method according to any one of claims 77-80, wherein the conductor is at least partially electrically insulated along its length such that a single conductive path between the outer portion and the inner portion passes through the conductor.

83. A method for fabricating a through-electrode on a tubular member, comprising: A first segment and a second segment of a tubular body are provided, the tubular body including a wall surrounding a lumen; A ring electrode is provided, the ring electrode including a central region and a collar extending from the opposite end of the central region; and The collar is attached to the first segment and the second segment to provide the central region between the first segment and the second segment.

84. The method of claim 83, wherein the thickness of the central region is substantially the same as the thickness of the wall, such that the inner surface of the central region is substantially flush with the inner surface of the wall, and the outer surface of the central region is substantially flush with the outer surface of the wall.

85. The method of claim 84, wherein the thickness of the collar is less than the thickness of the central region, and wherein the collar is attached to the first segment and the second segment using an overlap attachment, wherein material from the first segment and the second segment flows back into the collar.

86. The method of claim 85, wherein the collar includes a recess or other feature to receive reflow material, thereby attaching the collar to the first segment and the second segment.

87. A method for performing a medical procedure, comprising: The distal end of a tubular member is introduced into a body cavity within a patient, the distal end including one or more through electrodes that provide a conductive path between an outer surface of the distal end and an inner surface of a lumen within the tubular member. The distal end of the surgical device is introduced into the lumen, such that one or more active electrodes on the distal end of the surgical device are positioned within the distal end of the tubular member. Position the surgical device such that the one or more active electrodes are aligned or close to the corresponding one or more through electrodes on the tubular member; and Electrical signals are delivered to the one or more active electrodes, and the through-electrode transmits the signals to tissue surrounding the distal end of the tubular member.

88. The method of claim 87, wherein the electrical signal comprises electrical energy sufficient to ablate tissue adjacent to the distal end of the tubular member.

89. The method of claim 87, wherein the electrical signal includes a mapping signal, and wherein the one or more through electrodes send a return signal to a corresponding one or more active electrodes to map a conductive pathway in the tissue surrounding the distal end of the tubular member.

90. The method of claim 87, wherein positioning the surgical device comprises axially moving the surgical device within the distal end of the tubular member, the method further comprising analyzing the return signal to determine when the one or more active electrodes are aligned with or approach a corresponding one or more through-electrodes.

91. The method of claim 90, wherein information about the return signal is presented on a display to allow an operator moving the surgical device to observe the return signal to determine when the one or more active electrodes are aligned with or near a corresponding one or more through-electrodes.

92. The method of claim 90, wherein the return signal is analyzed by a controller coupled to the one or more active signals to determine when the one or more active electrodes are aligned with or near a corresponding one or more through-electrodes, thereby the controller providing an output to an operator moving the surgical device.

93. A method for performing a medical procedure, comprising: The distal end of a tubular member is introduced into a body cavity within a patient, the distal end including a plurality of through electrodes that provide a conductive path between an outer surface of the distal end and an inner surface of a lumen within the tubular member, the through electrodes being axially and / or circumferentially offset relative to each other. The distal end of the surgical device is introduced into the lumen, such that one or more active electrodes on the distal end of the surgical device are positioned within the distal end of the tubular member. and Position the surgical device such that the one or more active electrodes are aligned or close to corresponding through electrodes on the tubular member to determine the location of the surgical device within the patient's body.

94. A method for performing a medical procedure, comprising: The distal end of a tubular member is introduced into a body cavity within a patient, the distal end including a plurality of through electrodes that provide a conductive path between an outer surface of the distal end and an inner surface of a lumen within the tubular member, the through electrodes being axially and / or circumferentially offset relative to each other. The distal end of the dilator is introduced into the lumen such that one or more active electrodes on the distal end of the surgical device are positioned within the distal end of the tubular member, and the distal tip of the dilator extends from the distal end of the tubular member. and The expander and the tubular member are manipulated together to insert the distal tip of the expander into an opening through the tissue, while simultaneously sending and receiving signals to and from the one or more active sensors to provide information about the position of the expander within the patient's body. The one or more perforating electrodes transmit the signals between the one or more active electrodes and the tissue adjacent to the distal end of the tubular member.

95. The method of claim 94, wherein the location information is used to identify the location of the expander relative to one or more anatomical structures.

96. The method of claim 95, wherein the anatomical structure comprises one of the patient's esophagus and the patient's aorta.

97. The method of claim 94, wherein the location information is used to identify the location of the dilator in the atrial septum.

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