Electrical coupling-based electroanatomical mapping compatible expander and sheath

Abstract

The medical system includes a sheath having a long body. The long body includes a proximal portion and a distal portion. One or more sheath electrodes are located on the distal portion. A handle is attached to the proximal portion. The handle includes one or more first couplers that can be electrically coupled to a control system. The medical system includes a dilator having a long body having a proximal portion and a distal portion. One or more dilator electrodes are located on the distal portion. A hub is attached to the proximal portion of the dilator. The hub includes one or more second couplers electrically coupled to one or more dilator electrodes. One or more first couplers are configured to electrically couple with one or more second couplers.

Description

Technical Field

[0001] The present invention generally relates to methods and devices that can be used within a patient's body. More specifically, the present invention relates to devices associated with an electroanatomical mapping-enabled dilator and sheath having an integrated electrical coupling. This application claims priority to U.S. Provisional Patent Application No. 63 / 507,373, filed on June 9, 2023, entitled "ELECTROANATOMICAL MAPPING ENABLED DILATOR AND SHEATH WITH ELECTRICAL COUPLING," the entire contents of which are incorporated herein by reference.

Background Art

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

[0003] Typically, each EAM device requires a cable to connect to an EAM system. This can result in cumbersome handling of the device and a difficult workspace to manage with several cables for that procedure's devices.

Summary of the Invention

[0004] Example 1 is a medical system comprising a sheath having a long body. The long body comprises a proximal portion and a distal portion. One or more sheath electrodes are located on the distal portion. A handle is attached to the proximal portion. The handle includes one or more first couplers that can be electrically coupled to a control system. The medical system comprises an expander comprising a long body having a proximal portion and a distal portion. One or more expander electrodes are located on the distal portion of the expander. A hub is attached to the proximal portion of the expander. The hub includes one or more second couplers electrically coupled to the one or more expander electrodes. The one or more first couplers are configured to electrically couple with the one or more second couplers.

[0005] Example 2 is the medical system of Example 1, wherein the elongated body of the sheath includes a lumen extending from the proximal portion to the distal portion and is configured to receive the dilator.

[0006] Example 3 is the medical system of Example 1 or 2, wherein the hub includes an upper surface and the one or more second couplings extend from the upper surface. Example 4 is a medical system according to any one of Examples 1 to 3, wherein the one or more first couplers and the one or more second couplers have corresponding shapes.

[0007] Example 5 is a medical system from any one of Examples 1 to 3, wherein the cross-sections of the one or more first fusers and the one or more second fusers are symmetrical. Example 6 is a medical system from any one of Examples 1 to 3, wherein the cross-sections of the one or more first couplers and the one or more second couplers are asymmetrical.

[0008] Example 7 is the medical system of Example 6, wherein the cross-section includes one or more recesses and one or more protrusions. Example 8 is a medical system according to any one of Examples 1 to 7, wherein an electrical connection is formed between the one or more expander electrodes and the control system by coupling the one or more first couplers with the one or more second couplers.

[0009] Example 9 is a medical system from any one of Examples 1 to 8, wherein one or more first couplers or one or more second couplers include a conductive surface. Example 10 is a medical system from any one of Examples 1 to 9, wherein the one or more first couplers or the one or more second couplers include an insulating housing configured to enclose a brush.

[0010] Example 11 is a medical system from any one of Examples 1 to 9, wherein the one or more first couplers or the one or more second couplers include contacts protruding from an insulating surface.

[0011] Example 12 is a medical system from any one of Examples 1 to 11, wherein the one or more first couplers or the one or more second couplers include a plurality of insulating regions.

[0012] Example 13 is a medical system according to any one of Examples 1 to 12, wherein the control system is configured to determine the position of the expander relative to the sheath.

[0013] Example 14 is one of Examples 1 to 13, further comprising a display for displaying one or more anatomical images, parameters, and positioning information.

[0014] Example 15 is a medical system from any one of Examples 1 to 14, wherein the one or more sheath electrodes include four sheath electrodes and the one or more expander electrodes include two electrodes.

[0015] Example 16 is a medical system having a sheath including a long body. The long body of the sheath includes a proximal portion and a distal portion. One or more sheath electrodes are located on the distal portion. A handle is attached to the proximal portion. The sheath includes one or more first couplers that can be electrically coupled to a control system. The medical system includes an expander having a long body. The long body of the expander includes a proximal portion and a tapered distal portion. One or more expander electrodes are located on the tapered distal portion. A hub is attached to the proximal portion of the expander. One or more second couplers are located on the hub. One or more first couplers are configured to be electrically coupled to one or more second couplers.

[0016] Example 17 is the medical system of Example 16, wherein the elongated body of the sheath includes a lumen extending from the proximal portion to the distal portion and is configured to receive the dilator.

[0017] Example 18 is the medical system of Example 16, wherein the hub includes an upper surface, and one or more second couplings extend from the upper surface. Example 19 is the medical system of Example 16, wherein the one or more first couplers and the one or more second couplers have corresponding shapes.

[0018] Example 20 is the medical system of Example 16, wherein the cross-sections of the one or more first couplers and the one or more second couplers are symmetrical. Example 21 is the medical system of Example 16, wherein the cross-sections of the one or more first couplers and the one or more second couplers are asymmetrical.

[0019] Example 22 is the medical system of Example 21, wherein the cross-section includes one or more recesses and one or more protrusions. Example 23 is a medical system of Example 16 in which one or more first couplers are coupled with one or more second couplers to form an electrical connection between one or more expander electrodes and the control system.

[0020] Example 24 is the medical system of Example 16, wherein one or more first couplers or one or more second couplers include a conductive surface. Example 25 is a medical system of Example 16, wherein the one or more first couplers or the one or more second couplers include an insulating housing configured to enclose a brush.

[0021] Example 26 is the medical system of Example 16, wherein one or more first couplers or one or more second couplers include contacts protruding from an insulating surface. Example 27 is the medical system of Example 16, wherein the one or more first couplers or the one or more second couplers include a plurality of insulating regions.

[0022] Example 28 is the medical system of Example 16, wherein the control system is configured to determine the position of the expander relative to the sheath. Example 29 is a medical system of Example 16, further comprising a display for displaying one or more anatomical images, parameters, and positioning information.

[0023] Example 30 is the medical system of Example 16, wherein the one or more sheath electrodes include four sheath electrodes and the one or more expander electrodes include two electrodes. Example 31 is a medical system having a sheath including an elongate body. The elongate body of the sheath includes a proximal portion and a distal portion. One or more sheath electrodes are located on the distal portion. A handle is attached to the proximal portion. The handle includes one or more first couplers. The medical system includes a dilator having an elongate body. The elongate body of the dilator includes a proximal portion and a distal portion. One or more dilator electrodes are located on the distal portion of the dilator. A hub is attached to the proximal portion of the dilator. One or more second couplers extend from the hub. The one or more first couplers are configured to receive the one or more second couplers. The medical system is configured to determine the position of the dilator relative to the sheath.

[0024] Example 32 is the medical system of Example 31, wherein the one or more first couplers or the one or more second couplers include a conductive surface. Example 33 is the medical system of Example 32, wherein the one or more first couplers or the one or more second couplers include an insulating housing configured to confine a brush.

[0025] Example 34 is the medical system of Example 33, wherein the one or more first couplers or the one or more second couplers include contacts protruding from an insulating surface. Embodiment 35 is a medical system including a sheath having an elongate body. The elongate body includes a proximal portion and a distal portion. One or more sheath electrodes are located on the distal portion. A handle is attached to the proximal portion. The sheath includes one or more sockets. The medical system includes a dilator including an elongate body having a proximal portion and a distal portion. One or more dilator electrodes are located on the distal portion of the dilator. A hub is attached to the proximal portion of the dilator. One or more plugs extend from the hub. The one or more sockets are configured to receive the one or more plugs. The medical system includes a display for displaying one or more anatomical images, parameters, and positioning information.

[0026] Although multiple embodiments are disclosed, further additional embodiments of the present invention may become apparent to those skilled in the art from the following detailed description showing and describing exemplary embodiments of the present invention. Therefore, the drawings and the detailed description should be considered to be illustrative in nature and not restrictive.

Brief Description of the Drawings

[0027] [Figure 1] FIG. 1 is a diagram showing an exemplary clinical device for treating a patient and treating a patient's heart using an electrophysiological system according to an embodiment of the subject matter of the present disclosure. [Figure 2] FIG. 2 shows a sheath according to an embodiment of the present disclosure. [Figure 3] FIG. 3 shows a bottom view of the sheath of FIG. 2 according to an embodiment of the present disclosure. [Figure 4] FIG. 4 shows a dilator according to the present disclosure. [Figure 5] FIG. 5 shows the sheath of FIG. 2 and the dilator of FIG. 4 assembled according to the present disclosure. [Figure 6] FIG. 6 shows an electrical path according to an embodiment of the present disclosure. [Figures 7A-7B] FIGS. 7A and 7B show the configuration of a sliding electrical connection according to the present disclosure. [Figure 8A] Figure 8A shows the configuration of a sliding electrical connection according to one embodiment of the present disclosure. [Figure 8B] Figure 8B shows the impedance measured by the electrical connection shown in Figure 8A. [Figures 9A-9C] Figures 9A to 9C show the configuration of a sliding electrical connection according to one embodiment of the present disclosure. [Figure 9D] Figure 9D shows the impedance measured by the electrical connections in Figures 9A to 9C. [Modes for carrying out the invention]

[0028] While various modifications and alternative forms are possible with respect to the present invention, specific embodiments are shown in the drawings as examples and described in detail below. However, the present invention is not intended to be limited to the specific embodiments described. Rather, the present invention is intended to encompass all modifications, equivalents, and alternative forms that fall within the scope of the present invention as defined by the appended claims.

[0029] Figure 1 shows an exemplary clinical apparatus 10 for treating a patient 20 and the patient 20's heart 30 using an electrophysiological system 50, according to embodiments of the subject matter of this disclosure. The electrophysiological system 50 includes an access system 60 and an electroanatomical mapping (EAM) system 70, the EAM system 70 including a local field generator 80, a mapping and navigation controller 90, and a display 92. The clinical apparatus 10 also includes additional equipment such as an imaging device 94 (represented by a C-arm) and various controller elements such as a foot controller 96, configured to allow an operator to control various aspects of the electrophysiological system 50. As can be understood by those skilled in the art, the clinical apparatus 10 may have other components and configurations of components not shown in Figure 1.

[0030] The access system 60 includes an expander 100 having a proximal portion 102 and a distal portion 105, an introducer sheath 110, and a console 130. In some embodiments, the distal portion 105 includes a tapered region. The access system 60 also includes various connecting elements, such as cables and umbilicals, that operate to functionally connect the components of the access system 60 to each other and to the components of the EAM system 70. The arrangement of such connecting elements is not critically important to the disclosure, and those skilled in the art will recognize that the various components described herein can be interconnected in various ways.

[0031] In some embodiments, the introducer sheath 110 is operable to provide a delivery conduit capable of deploying all or part of the dilator 100, particularly the distal portion 105 of the dilator 100, to a specific target site within the patient's heart 30. The dilator 100 is configured to include a lumen into which a guide device (e.g., a guidewire) or a puncture device (e.g., an RF puncture device) can be inserted. In some embodiments, a puncture device may be used to perform a transseptal puncture procedure within the heart 30.

[0032] Console 130 is configured to control the functional features of the access system 60. In embodiments, Console 130 includes one or more controllers, microprocessors, and / or computers that execute code from memory to control and / or perform the functional features of the access system 60. In embodiments, memory may be part of one or more controllers, microprocessors, or computers, and / or part of memory capacity accessible via a network such as the World Wide Web. In embodiments, Console 130 may include pulse generator hardware, software, and / or firmware configured to generate electrical pulses of a predetermined waveform that can be transmitted to electrodes positioned on the expander 100, guide device, or drilling device to generate an electric field sufficient to achieve a desired clinical effect, e.g., resection of target tissue by irreversible electroporation. In embodiments, Console 130 may deliver pulse waveforms in unipolar or bipolar operating modes, as described in further detail herein.

[0033] The EAM system 70 is capable of tracking the locations of various functional components of the access system 60 and generating high-fidelity three-dimensional anatomical and electroanatomical maps of the target cardiac chambers. In embodiments, the EAM system 70 may be the RHYTHMIA HDx® mapping system, commercially available from Boston Scientific Corporation. In embodiments, the mapping and navigation controller 90 of the EAM system 70 may include one or more controllers, microprocessors, and / or computers that control and / or execute the functional features of the EAM system 70 by executing code from memory, in which case the memory may be part of one or more controllers, microprocessors, and / or computers, and / or part of a memory capacity accessible via a network such as the World Wide Web.

[0034] As can be understood by those skilled in the art, the electrophysiological system 50 shown in Figure 1 is intended to provide an overall overview of the various components of the system 50, and is not intended to suggest that this disclosure is limited to any set of components or arrangement of components. For example, those skilled in the art will readily recognize that additional hardware components, such as breakout boxes, workstations, etc., may or are likely to be included in the electrophysiological system 50.

[0035] The EAM system 70 defines a local volume around the heart 30 by generating a local field via a field generator 80, and one or more tracking devices, such as one or more position sensors or sensing elements on an expander 100, track the position of the sensors, i.e., the position of the corresponding devices, within the local volume by generating outputs that can be processed by a mapping and navigation controller 90. In the illustrated embodiment, device tracking is achieved using a magnetic tracking method, so that the field generator 80 is a magnetic field generator that generates a magnetic field that defines the local volume, and the position sensors on the tracking devices are magnetic field sensors.

[0036] In other embodiments, impedance tracking methods may be employed to track the positions of various devices. In such embodiments, the localized field is an electric field generated by an internal device or an intracardiac device (e.g., an intracardiac catheter) or both, for example, by an external field generator device (e.g., surface electrodes). In these embodiments, the position sensing element may constitute a group of electrodes on a tracking device that generates outputs to be received and processed by a mapping and navigation controller 90 to track the positions of various position sensing electrodes within a localized volume.

[0037] In some embodiments, the EAM system 70 includes both magnetic tracking and impedance tracking capabilities. In such embodiments, impedance tracking accuracy can be improved in some cases by first creating a map of the electric fields induced by the electric field generator in the target cardiac chamber using a probe equipped with a magnetic position sensor, as made possible with the RHYTHMIA HDx® mapping system described above. One exemplary probe is the INTELLAMAP ORION® mapping catheter, commercially available from Boston Scientific.

[0038] Regardless of the tracking method employed, the EAM system 70 utilizes the positional information of various tracking devices, along with the cardiac electrical activity acquired, for example, by an expander 100 or other catheter or probe equipped with sensing electrodes, to generate an electroanatomical map in which the target cardiac electrical activity is superimposed on a geometric anatomical map, along with a detailed three-dimensional geometric anatomical map or representation of the cardiac chambers, and displays it through the display 92. Furthermore, the EAM system 70 can generate graphic representations of the various tracking devices within the geometric anatomical map and / or electroanatomical map.

[0039] Figure 2 shows a sheath 200 according to one embodiment of the present disclosure. The sheath 200 includes a hollow elongated body 202 having a proximal portion 208 and a distal portion 204. The distal portion 204 includes one or more electrodes 211 located on the distal portion 204 and terminates at a distal tip 206. In one embodiment, one or more electrodes 211 may include four electrodes. One or more electrodes 211 may be evenly spaced or arranged at uneven intervals. One or more electrodes 211 may be configured as surface electrodes capable of contacting tissue or fluid within a patient. One or more electrodes 211 may be configured as part of an EAM system 70 for detecting parameters when in contact with tissue or fluid, or for delivering energy, such as RF energy, to tissue for tissue excision.

[0040] The proximal portion 208 includes a proximal end 210 that is detachably coupled to the handle 214. The handle 214 includes a fixed portion 216 configured to be held by the user's hand and a rotatable knob 212 configured to adjust the shape of the distal portion 204. The rotatable knob 212 is connected to at least one control wire configured to deflect the distal portion 204 in a first direction when the knob 212 is rotated clockwise and deflect the distal portion 204 in a second direction when the knob 212 is rotated counterclockwise. The lumen 222 extends from the proximal end 217 of the handle through the knob 212 and through the hollow body 202 to the distal tip 206. The lumen 222 is configured to receive a dilator or other elongated medical device.

[0041] The fixed portion 216 includes a cable 218 configured to couple with a system, such as an EAM system 70 or an RF energy generator. The cable 218 includes a connector 220 that releasably engages with a connector for the system. The fixed portion 216 also includes a conduit 224, which includes a fitting 226, such as a Luer connector. The conduit 224 is configured to allow the introduction of fluid into the lumen 222 or an additional lumen within the sheath 200. The fitting 226 is configured to releasably connect to a syringe or other container for delivering fluid through the conduit 224.

[0042] Figure 3 shows a bottom view of the proximal end 217 of the sheath 200 of Figure 2 according to an embodiment of the present disclosure. The bottom of the proximal end 217 of the sheath 200 includes one or more first couplers 230 for connection to one or more second couplers associated with a dilator or other medical device. In some embodiments, one or more first couplers 230 may include one or more recesses, sockets, openings, holes, apertures, protrusions, rods, shafts, plugs, surfaces, magnets, or other elements that can be coupled to a second coupler. An electrical connection is formed when the corresponding second coupler is coupled to the first coupler 230.

[0043] As shown in Figure 3, two couplings 230, 231, configured as sockets, are positioned on either side of a hemostatic valve 232 that closes the proximal end of a lumen 222 extending into the sheath 200. The hemostatic valve 232 is configured to form a liquid-tight seal while allowing a fluid or medical device, such as an expander, to be aligned and introduced into the sheath 200. The sockets 230, 231 are electrically isolated from the lumen to avoid the risk of signal interference or short circuits. Although two sockets 230, 231 are shown, more or fewer sockets may be used to electrically connect more or fewer electrodes associated with the connected medical device to an external system, such as an energy generator or EAM system 70.

[0044] Figure 4 shows an expander 400 according to one embodiment of the present disclosure. The expander 400 is configured to be inserted into and coupled with a sheath 200. The expander 400 includes a hollow elongated body 402 having a proximal portion 408 and a distal portion 404. The distal portion 404 includes a tapered portion 407 containing one or more electrodes 411 located on the distal portion. In the embodiment shown in Figure 4, two electrodes 411 are included on the tapered portion 407. In some embodiments, the expander 400 may not include a tapered portion.

[0045] The hollow elongated body 402 is terminated at a distal tip 406. One or more electrodes 411 may be evenly spaced or arranged at uneven intervals. One or more electrodes 411 may be configured as surface electrodes capable of contacting tissue or fluid within the patient. One or more electrodes 411 may be configured to detect parameters when in contact with tissue or fluid, or to deliver energy, such as RF energy, to tissue for tissue excision.

[0046] The proximal portion 408 includes a proximal end 410 that is detachably coupled to the hub 412. The hub 412 is attached to the handle 414. The handle 414 includes an extension 418 that assists in the operation of the dilator 400 and serves as a reference for positioning the dilator 400. The connector 416 is located on the proximal portion of the handle 414. The connector 416 may include a Luer connector configured to detachably connect to a syringe or other container. The connector 416 also allows for the introduction of a medical device, such as a guidewire or RF drilling device, into the lumen 422 that extends from the connector 416 to the distal tip portion 406.

[0047] The hub 412 includes one or more second couplers 430. In some embodiments, one or more second couplers 430 take the form of plugs extending from the upper surface 431. In some embodiments, one or more second couplers 230 may include one or more recesses, sockets, openings, holes, apertures, protrusions, rods, shafts, plugs, surfaces, magnets, or other elements that can be coupled to the first coupler.

[0048] One or more second couplers 430 may include one or more plugs configured to mate with one or more sockets 230 on the sheath 200 when the expander 400 is inserted into the sheath 200. The insertion of one or more plugs 430 into one or more sockets 230 forms an electrical connection between them. This connection couples one or more electrodes 411 to a system coupled to the sheath 200 and the electrodes 211, such as an EAM system 70 or an energy generator. Furthermore, when one or more plugs 430 are positioned in one or more sockets 230, relative rotation between the sheath 200 and the expander 400 is blocked or prevented; that is, a rotation lock is formed between the sheath 200 and the expander 400. Thus, by rotating either the sheath 200 or the expander 400, the sheath 200 and the expander 400 can be rotated together.

[0049] In some embodiments, a snap or locking feature may be associated with the hub 412 or the bottom surface of the proximal end 217 of the sheath 200. The snap or locking feature can ensure a mechanical connection between the sheath 200 and the expander 400. In some embodiments, the snap or locking feature may be associated with one or more plugs 430 or one or more sockets 230.

[0050] One or more plugs 430 include a shape corresponding to one or more sockets 230. One or more plugs 430 are elongated and have a cross-section substantially similar to the opening of one or more sockets 230. In some embodiments, one or more plugs 430 may have a rectangular or square cross-section. In other embodiments, this cross-section may be configured such that there is only one possible insertion position. For example, one or more sockets 230 or one or more plugs 430 may include an asymmetric cross-section such that only one or more plugs 430 can be received in one or more sockets 230 in only one position. In some embodiments, the asymmetric cross-section may include one or more recesses or one or more protrusions.

[0051] Figure 5 shows the sheath 200 of Figure 2 and the expander 400 of Figure 5 assembled according to this disclosure. In Figure 5, the expander 400 is coupled to the sheath 200. The tapered portion 407 of the expander 400 extends from the distal end of the sheath 200. In this configuration, one or more electrodes 411 are exposed. One or more electrodes 211 of the sheath are also exposed. When coupled to each other, each electrode is electronically coupled to a control system 600. The control system 600 may be an EAM system 70 or an energy generator for excision.

[0052] In some embodiments, the control system 600 includes a display. The display is configured to show anatomical images, such as a diagram of the heart, measured parameters, and / or positioning or orientation information related to the sheath 200 and the dilator 400. The positioning or orientation information may include relative distances between components, end positions, curvature or shape information, or other positioning or orientation information. The positioning or orientation information may include images or illustrations of the sheath 200 and / or the dilator 400. In some embodiments, the control system 600 is configured to recognize the sheath 200 and the dilator 400 as a single device with known distances between electrodes. This makes it possible to display a representative image of the position or orientation of the bonded sheath 200 and dilator 400. In this configuration, the display may display information about all electrodes, for example, a total of six electrodes. In some embodiments, the control system 600 is configured to recognize that the sheath 200 and the dilator 400 are not bonded when the dilator 400 is removed from the sheath 200. In this configuration, the display may show information only about the electrodes associated with the sheath 200, for example, a total of four electrodes.

[0053] Figure 6 shows an electrical path according to one embodiment of the present disclosure. The electrical path may include other conductors such as wires or thin film wiring. In Figure 6, the sheath 200 and the expander 400 are not coupled. In the embodiment of Figure 6, the sheath 200 is shown having a single distal electrode 211, and the expander 200 is shown having a distal electrode 411 and a proximal electrode 413.

[0054] The sheath 200 is connected to a control system 600, which may be an EAM system 70 or an energy generator. A first path 701 connects the distal electrode 211 to the system 600. A second path 702 connects the first socket 230 to the system 600. A third path 703 connects the second socket 231 to the system 600. When the expander 400 is inserted into the sheath 200, an electrical coupling (indicated as 704) is formed between the first socket 230 and the first plug 430 of the expander 400, and between the second socket 231 and the second plug 431 of the expander 400. A fourth path 705 connects the proximal electrode 413 to the second plug 431. A fifth path 706 connects the distal electrode 411 to the first plug 430. Therefore, electrical coupling between the distal electrode 411 and the control system 600, and between the proximal electrode 413 and the control system 600, is achieved by inserting the expander 400 into the sheath 200 such that the first plug 430 and the second plug 431 are mated with the first socket 430 and the second socket 231, respectively.

[0055] Figures 7A and 7B illustrate the configuration of a sliding electrical connection 800 between concentric members (e.g., between the plug of an expander and the socket of a sheath) according to the present disclosure. Figure 7A shows the sliding electrical connection 800 having a spring 806 and a brush 808 in a constrained state. An insulating housing 804 constrains the spring 806 and the brush 808 to restrict their movement when the plug is inserted into the socket. The housing 804 restricts the horizontal movement of the spring 806 and the brush 808 while allowing them to move freely in the vertical direction. The brush 808 may include an inclined edge 810 to facilitate sliding along the conductive surface 802. In one embodiment, the conductive surface 802 may form part of the plug. In another embodiment, the conductive surface 802 may form part of the socket. A conductor 807 extends from the brush 808 for electrical connection between the components.

[0056] Figure 7B shows a sliding electrical connection 800 having a fixed raised contact 814. The contact 814 may be made of a conductive material such as metal. The contact 814 is fixed within an insulating surface 812. In some embodiments, a spring may be attached to the contact 814. The contact 814 forms an electrical connection with the conductive surface 802 as it moves across the conductive surface 802. In one embodiment, the conductive surface 802 may form part of the plug. In another embodiment, the conductive surface 802 may form part of the socket. A conductor 807 extends from the contact 814 for electrical connections between components.

[0057] Figure 8A shows the configuration of a sliding electrical connection 900 according to one embodiment of the present disclosure, configured to detect the position of the sheath relative to the expander. Figure 8A shows an insulating housing 804 that restrains a spring 806 and a brush 808, similar to that in Figure 7A. However, in Figure 8A, the conductive surface 802 includes a plurality of insulating regions 809, or regions having an electrical impedance different from the electrical impedance of the conductive surface 802.

[0058] Figure 8B shows the impedance measured by the brush 808 as it passes over the conductive surface 802 and the insulating region 809. As shown in Figure 8B, a low impedance is measured at 922 when the brush 808 is in contact with the conductive surface 802. A high impedance is measured at 920 as the brush 808 passes over the insulating region 809. Thus, as the brush 808 moves along the conductive surface 802 in the direction of arrow 901, a series of high impedance 920 and low impedance 922 are measured. By using the measured impedances and the known distance between the insulating regions 809, the position of the expander relative to the sheath can be determined. This allows for indication of whether the tapered end of the expander is fully exposed, partially exposed, or not exposed at all from the end of the sheath.

[0059] Figures 9A to 9C show another configuration of a sliding electrical connection according to an embodiment of the present disclosure that enables detection of the positioning of the expander relative to the sheath. Figures 9A to 9C show a first insulating housing 804 that restrains a first spring 806 and a first brush 808, and a second insulating housing 904 that restrains a second spring 806 and a second brush 908. In a first embodiment, the first insulating housing 804 and the second insulating housing 904 are associated with a plug. In a second embodiment, the first insulating housing 804 and the second insulating housing 904 are associated with a socket.

[0060] The first brush 808 and the second brush 908 are configured to move relative to the conductive surface 802 and the insulating region 809. As the first brush 808 and the second brush 908 translate along the surface, changes in impedance can be monitored, as shown in Figure 9D. In one embodiment, the first insulating housing 804 and the second insulating housing 904 remain stationary while the conductive surface 802 and the insulating region 809 are moved. In another embodiment, the conductive surface 802 and the insulating region 809 remain stationary while the first insulating housing 804 and the second insulating housing 904 are translated.

[0061] In Figure 9A, both the first brush 808 and the second brush 908 are located on the insulating region 809. Therefore, Figure 9D shows that both brushes measure high impedance at 1001. In Figure 9B, the first brush 808 is located on the conductive surface 802, and the second brush 908 is located on the insulating region 809. Therefore, Figure 9D shows that both high and low impedances are measured at 1002. In Figure 9C, both the first brush 808 and the second brush 908 are located on the conductive surface 802. Therefore, Figure 9D shows that both brushes measure low impedance at 1003. By using the measured impedances and the lengths of the conductive surface 802 and the insulating region 809, the position of the expander relative to the sheath can be determined.

[0062] In some embodiments, the sheath 200 and dilator 400 are packaged as a kit and can be prepared for immediate use from the package. Alternatively, the kit may include an RF puncture or puncture device 110. Or, the kit may comprise multiple sheaths or dilators. Each sheath or dilator has different pre-formed parts for use in various procedures.

[0063] In some embodiments, the sheath 200 or expander 400 may include one or more markers along a portion thereof to identify a position or location while in use with an imaging modality.

[0064] In some embodiments, the sheath 200 or expander 400 may include multiple notches machined into the wall, for example by laser cutting. The shape and arrangement of the notches may allow for a transition of flexibility from the proximal to the distal portion. The notches may include a discontinuous helical configuration. Alternatively, the notches may be arranged substantially perpendicular to the longitudinal axis of the sheath 200 or expander 400. In some embodiments, there may be a single notch formed around the axis with wider spacing between loops in the proximal portion and larger spacing in the distal portion. The spacing and size of the notches may be modified to achieve different flexibility along the length of the sheath 200 or expander 400.

[0065] In some embodiments, the sheath 200 or expander 400 may be formed from a shape memory material such as a shape memory polymer or shape memory metal. This allows the sheath 200 or expander 400 to have a first shape at a first temperature and a second shape at a second temperature. The shape change may be initiated by inserting a heated solution into the sheath 200 or expander 400, or by using electricity to heat a portion of the sheath 200 or expander 400.

[0066] In some embodiments, the sheath 200 may be electrically and mechanically coupled, instead of to a dilator, to a catheter, sheath, wire, needle, or other stretching medical device including a hub with one or more second couplings as described above.

[0067] Various modifications and additions can be made to the exemplary embodiments described without departing from the scope of the present invention. For example, while the embodiments described above refer to specific features, the scope of the invention also includes embodiments having different combinations of features, and embodiments that do not include all of the features described. Accordingly, the scope of the invention is intended to encompass all such alternative forms, modifications, and variations included in the claims, along with all their equivalents.

Claims

1. It is a medical system, A sheath including a long body having a proximal portion and a distal portion, One or more sheath electrodes located on the distal portion, A handle attached to the aforementioned proximal portion, having one or more first couplers that can be electrically coupled to a control system, A dilator including a long body having a proximal portion and a distal portion, One or more expander electrodes located on the distal portion of the expander, A hub attached to the proximal portion of the expander, comprising a hub including one or more second couplers electrically coupled to one or more expander electrodes, A medical system in which one or more first couplers are configured to be electrically coupled to one or more second couplers.

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

3. The medical system according to claim 1 or 2, wherein the hub includes an upper surface, and one or more second couplings extend from the upper surface, and a rotational lock is formed between the sheath and the expander when one or more first couplings are coupled with one or more second couplings.

4. The medical system according to any one of claims 1 to 3, wherein the one or more first couplings and the one or more second couplings have corresponding shapes.

5. The medical system according to any one of claims 1 to 3, wherein the cross-sections of the one or more first couplings and the one or more second couplings are symmetrical.

6. The medical system according to any one of claims 1 to 3, wherein the cross-sections of the one or more first couplings and the one or more second couplings are asymmetrical.

7. The medical system according to claim 6, wherein the cross-section includes one or more recesses and one or more protrusions.

8. The medical system according to any one of claims 1 to 7, wherein an electrical connection is formed between the one or more expander electrodes and the control system by coupling the one or more first couplers with the one or more second couplers.

9. The medical system according to any one of claims 1 to 8, wherein the one or more first couplers or the one or more second couplers include a conductive surface.

10. The medical system according to any one of claims 1 to 9, wherein the one or more first couplers or the one or more second couplers include an insulating housing configured to enclose a brush.

11. The medical system according to any one of claims 1 to 9, wherein the one or more first couplers or the one or more second couplers include contacts protruding from an insulating surface.

12. The medical system according to any one of claims 1 to 11, wherein the one or more first couplers or the one or more second couplers include a plurality of insulating regions.

13. The medical system according to any one of claims 1 to 12, wherein the control system is configured to determine the position of the expander relative to the sheath.

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

15. The medical system according to any one of claims 1 to 14, wherein the one or more sheath electrodes include four sheath electrodes, and the one or more expander electrodes include two electrodes.

16. It is a medical system, A sheath including a long body having a proximal portion and a distal portion, One or more sheath electrodes located on the distal portion, A handle attached to the aforementioned proximal portion, One or more first couplers that can be electrically coupled to a control system, A dilator comprising a long body having a proximal portion and a tapered distal portion, One or more expander electrodes located on the tapered distal portion, A hub attached to the proximal portion of the expander, A plurality of second couplers located on the hub, A medical system comprising, wherein one or more first couplers are configured to be electrically coupled with one or more second couplers.

17. The medical system according to claim 16, wherein the elongated portion of the sheath includes a lumen extending from the proximal portion to the distal portion and is configured to receive the dilator.

18. The medical system according to claim 16, wherein the hub includes an upper surface, and one or more second couplings extend from the upper surface, and when one or more first couplings are coupled with one or more second couplings, a rotational lock is formed between the sheath and the expander.

19. The medical system according to claim 16, wherein the one or more first couplings and the one or more second couplings have corresponding shapes.

20. The medical system according to claim 16, wherein the cross-sections of the one or more first couplings and the one or more second couplings are symmetrical.

21. The medical system according to claim 16, wherein the cross-sections of the one or more first couplings and the one or more second couplings are asymmetrical.

22. The medical system according to claim 21, wherein the cross-section includes one or more recesses and one or more protrusions.

23. The medical system according to claim 16, wherein one or more first couplers are coupled with one or more second couplers to form an electrical connection between one or more expander electrodes and the control system.

24. The medical system according to claim 16, wherein the one or more first couplers or the one or more second couplers include a conductive surface.

25. The medical system according to claim 16, wherein the one or more first couplers or the one or more second couplers include an insulating housing configured to enclose a brush.

26. The medical system according to claim 16, wherein one or more first couplers or one or more second couplers include contacts protruding from an insulating surface.

27. The medical system according to claim 16, wherein the one or more first couplers or the one or more second couplers include a plurality of insulating regions.

28. The medical system according to claim 16, wherein the control system is configured to determine the position of the expander relative to the sheath.

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

30. The medical system according to claim 16, wherein the one or more sheath electrodes include four sheath electrodes, and the one or more expander electrodes include two electrodes.

31. It is a medical system, A sheath including a long body having a proximal portion and a distal portion, One or more sheath electrodes located on the distal portion, A handle attached to the aforementioned proximal portion, One or more first couplers, A dilator including a long body having a proximal portion and a distal portion, One or more expander electrodes located on the distal portion of the expander, A hub attached to the proximal portion of the expander, One or more second couplers extending from the hub, wherein the one or more first couplers are configured to receive the one or more second couplers, A medical system comprising, wherein the medical system is configured to determine the position of the expander relative to the sheath.

32. The medical system according to claim 31, wherein the one or more first couplers or the one or more second couplers include a conductive surface.

33. The medical system according to claim 32, wherein the one or more first couplers or the one or more second couplers include an insulating housing configured to enclose a brush.

34. The medical system according to claim 33, wherein one or more first couplers or one or more second couplers include contacts protruding from an insulating surface.

35. It is a medical system, A sheath including a long body having a proximal portion and a distal portion, One or more sheath electrodes located on the distal portion, A handle attached to the aforementioned proximal portion, One or more sockets, A dilator including a long body having a proximal portion and a distal portion, One or more expander electrodes located on the distal portion of the expander, A hub attached to the proximal portion of the expander, One or more plugs extending from the hub, wherein the one or more sockets are configured to receive the one or more plugs, A display for showing one or more anatomical images, parameters, and positioning information, A medical system equipped with these features.

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