Medical dilator, and system, method, and kits for medical dilation

Abstract

To provide a medical dilator, and a system, a method and kits for the medical dilator.SOLUTION: A medical dilator includes an elongate member having a proximal end portion, an opposed distal end portion, and a lumen extending through the elongate member from the proximal end portion to the distal end portion. A dilating tip is at the distal end portion. The dilating tip has a first end of an enlarged cross-sectional area and tapers going in the distal direction to a second end of a reduced cross-sectional area. At least a first electrode is associated with the dilating tip. An electrical conductor is electrically connected to the first electrode and extends proximally from the first electrode towards the proximal end portion for electrical connection with an electro-anatomical mapping system.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] This document relates to medical dilation, such as dilation of surgically created perforations in cardiac tissue. More specifically, this document relates to medical dilators and associated systems, methods, and kits. Summary of the Invention

[0002] The following summary is intended to introduce the reader to various aspects of the detailed description, but does not define or delimit any invention.

[0003] According to some aspects, a medical dilator includes an elongate member having a proximal end portion, an opposing distal end portion, and a lumen extending through the elongate member from the proximal end portion to the distal end portion. A dilator tip is at the distal end portion. The dilator tip has a first end of an enlarged cross-sectional area and tapers distally to a second end of a reduced cross-sectional area. At least a first electrode is associated with the dilator tip. An electrical conductor is electrically connected to the first electrode and extends proximally from the first electrode toward the proximal end portion for electrical connection with an electroanatomical mapping system.

[0004] In some embodiments, the first electrode is positioned between the first end of the dilator tip and the second end of the dilator tip, hi some embodiments, the first electrode is positioned proximal to the first end of the dilator tip.

[0005] In some embodiments, the enlarged tip has a tip circumferential outer surface with a circumferential groove defined therein, and the electrode is annular and seated within the groove.

[0006] In some embodiments, the dilating tip has a tip circumferential outer surface, a tip circumferential inner surface, and a tip sidewall extending between the tip circumferential inner surface and the tip circumferential outer surface, and an electrical conductor extends from the electrode through the tip sidewall and into the lumen.

[0007] In some examples, the elongate member has a circumferential outer surface, a circumferential inner surface, and a sidewall extending along the length of the elongate member between the circumferential inner surface and the circumferential outer surface, and the electrical conductor is embedded in the sidewall and extends from the electrode to the proximal end portion. The circumferential outer surface may have a longitudinal groove defined therein and extending from the first electrode to the proximal end portion, and the electrical conductor may be seated within the longitudinal groove. Alternatively, the elongate member may include an outer tube defining a circumferential outer surface and an inner liner within the outer tube, defining a circumferential inner surface, and the electrical conductor may be positioned between the outer tube and the inner liner. The electrical conductor may be a tubular braid.

[0008] In some embodiments, the first electrode is detachable from the elongate member.

[0009] In some embodiments, the medical dilator further includes a second electrode attached to the elongate member and spaced apart from the first electrode.

[0010] In some embodiments, the extended tip includes a proximal part having a distally facing shoulder surface and a neck extending distally from the shoulder surface, the electrode is annular and received on the neck and adjacent the shoulder surface, and the extended tip further includes a distal part received on the neck distal from the electrode and adjacent the electrode.

[0011] In some embodiments, the electrode is radiopaque, hi some embodiments, the electrode comprises platinum iridium.

[0012] In some embodiments, the electrode has an echogenic profile, hi some embodiments, the electrode comprises a coil.

[0013] According to some aspects, a kit of parts for a medical drilling system includes a medical dilator, a sheath, and a drilling device. The medical dilator has an elongate member having a proximal end portion, an opposing distal end portion, and a lumen extending through the elongate member from the proximal end portion to the distal end portion. The medical dilator further has a dilator tip at the distal end portion, the dilator tip having a first end of an enlarged cross-sectional area and tapering distally to a second end of a reduced cross-sectional area. The medical dilator further has at least a first electrode associated with the dilator tip and an electrical conductor electrically connected to the first electrode and extending proximally from the first electrode to the proximal end for electrically connecting with an electroanatomical mapping system. The sheath is for receiving the medical dilator. The drilling device is receivable within the lumen.

[0014] In some embodiments, the kit of parts further comprises at least a second electrode, which may be secured to the sheath, or may be secured to the elongate member, or may be secured to the punching device.

[0015] According to some aspects, a medical dilation system includes a medical dilator and an electroanatomical mapping system. The medical dilator includes an elongate member having a proximal end portion, an opposing distal end portion, and a lumen extending through the elongate member from the proximal end portion to the distal end portion. A dilator tip is at the distal end portion. The dilator tip has a first end of an enlarged cross-sectional area and tapers distally to a second end of a reduced cross-sectional area. At least a first electrode is associated with the dilator tip, and an electrical conductor is electrically connected to the first electrode and extends proximally from the first electrode to the proximal end portion. The electroanatomical mapping system is electrically connectable to the electrical conductor and configured to receive electroanatomical mapping signals from the electrode and determine a position of the dilator tip based on the electroanatomical mapping signals.

[0016] According to some embodiments, a method for medical dilation includes: a. advancing a dilation tip of a medical dilator toward a first target anatomical location; b. receiving a first electroanatomical mapping signal from an electrode associated with the dilation tip; and c. determining a first position of the dilation tip relative to the first target anatomical location based on the first electroanatomical mapping signal.

[0017] In some embodiments, after step c., the method further includes d. advancing a perforation device from the medical dilator and creating a perforation at the first target anatomical location using the perforation device.

[0018] In some embodiments, the method further includes determining a position of the punching device relative to the dilator tip.

[0019] In some embodiments, after step d., the method further comprises: e. advancing an electrode and a dilator tip through the fenestration to dilate the fenestration.

[0020] In some embodiments, after or during step e., the method further includes: f. receiving a second electroanatomical mapping signal from the electrode; and g. determining a second position of the dilator tip relative to the first target anatomical location based on the second electroanatomical mapping signal. In some embodiments, the first target anatomical location is the atrial septum.

[0021] In some embodiments, the method further includes determining a position of the dilation tip relative to the left atrial wall.

[0022] In some embodiments, step a. includes positioning a dilator within a sheath and advancing the dilator and sheath toward the first target anatomical location, and the method further includes determining a position of the dilator tip relative to the tip of the sheath. [Brief description of the drawings]

[0023] The accompanying drawings are intended to illustrate examples of the articles, methods, and apparatus of the present disclosure and are not intended to be limiting.

[0024] [Figure 1] FIG. 1 is a perspective view of an exemplary surgical drilling system.

[0025] [Diagram 2] 2 is a perspective view of a dilator of the surgical drilling system of FIG. 1.

[0026] [Figure 3A] FIG. 3 is a close-up view of the dilator tip of the dilator of FIG. 2.

[0027] [Figure 3B] FIG. 3B is an end view of the dilator tip of FIG. 3A.

[0028] [Figure 3C] FIG. 3C is a cross-sectional view taken along line 3C-3C of FIG. 3B.

[0029] [Figure 4A] FIG. 13 is a close-up view of another exemplary dilator tip.

[0030] [Figure 4B] FIG. 4B is an end view of the dilator tip of FIG. 4A.

[0031] [Figure 4C] FIG. 4C is a cross-sectional view taken along line 4C-4C of FIG. 4B.

[0032] [Figure 5A] FIG. 13 is a close-up view of another exemplary dilator tip.

[0033] [Figure 5B] FIG. 5B is a cross-sectional view taken along line 5B-5B of FIG. 5A.

[0034] [Figure 5C] FIG. 5B is an end view of the dilator tip of FIG. 5A.

[0035] [Figure 5D] FIG. 5D is a cross-sectional view taken along line 5D-5D of FIG. 5C.

[0036] [Figure 6A] FIG. 13 is a close-up view of another exemplary dilator tip.

[0037] [Figure 6B] FIG. 6B is an end view of the dilator tip of FIG. 6A.

[0038] [Figure 6C] FIG. 6C is a cross-sectional view taken along line 6C-6C of FIG. 6B.

[0039] [Figure 7] 1 is a partial perspective view of a sheath, a dilator, and a drilling device of another exemplary surgical drilling system.

[0040] [Figure 8] 1 is a schematic diagram showing a first step of an exemplary method for creating and dilating a transseptal puncture.

[0041] [Figure 9] 9 is a schematic diagram illustrating a second step of an exemplary method for creating and dilating the transseptal puncture of FIG. 8.

[0042] [Figure 10] 9 is a schematic diagram illustrating a third step of an exemplary method for creating and dilating the transseptal puncture of FIG. 8.

[0043] [Figure 11] 9 is a schematic diagram illustrating a fourth step of an exemplary method for creating and dilating the transseptal puncture of FIG. 8.

[0044] [Figure 12] FIG. 9 is a schematic diagram illustrating a fifth step of an exemplary method for creating and dilating the transseptal puncture of FIG.

[0045] [Figure 13] 9 is a schematic diagram illustrating a second step of an exemplary method for creating and dilating the transseptal puncture of FIG. 8. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0046] Various devices or processes or configurations are described below to provide examples of embodiments of the claimed subject matter. The examples described below do not limit any claim, and any claim may cover a process or device or configuration different from those described below. The claims are not limited to all features of any one device or process or configuration described below, or to devices or processes or configurations having features common to more than one or all of the devices or processes or configurations described below. The devices or processes or configurations described below may not be embodiments of any exclusive rights granted by the issuance of this patent application. Any subject matter described below for which no exclusive rights are granted by the issuance of this patent application may be the subject matter of another protected document, e.g., a continuing patent application, and the applicant, inventor, or owner does not intend to relinquish, abdicate, or make available to the public such subject matter by its disclosure in this document.

[0047] In general, disclosed herein are medical dilators (also referred to herein simply as "dilators") that can be used to dilate an anatomical opening, such as a surgical perforation. For example, the dilators can be used in a transseptal puncture procedure, where a perforation is created in the atrial septum of the heart, optionally using a radiofrequency puncture device, and then dilated using the dilator. Such a procedure can be performed, for example, to gain access to the left atrium for a medical procedure.

[0048] In general, the dilators disclosed herein are configured to allow non-fluorescent visualization and determination of the location of the tip of the dilator (also referred to herein as the "dilator tip") within the body, or relative to other surgical tools (e.g., relative to a drilling device or relative to a sheath in which the dilator is housed). More specifically, the dilators disclosed herein can include at least one electrode associated with its tip. The electrode can be an electroanatomical mapping (EAM) electrode. The EAM electrode can be connected to an EAM system, which can communicate EAM signals (either directly or via a pad) to and from the EAM electrode, and can determine the location of the EAM electrode based on the EAM signals received from the EAM electrode, and therefore the location of the tip of the dilator within the body, or relative to other surgical tools. This may, for example, allow the user to visualize the dilator tip and determine if the tip is properly positioned relative to the target tissue, allow the user to ensure that the perforation device is enclosed within the dilator prior to perforation, and / or allow the user to ensure that the dilator tip is sufficiently spaced from non-target tissue.

[0049] 1, an exemplary surgical drilling system 100 is shown. The surgical drilling system 100 includes a dilator 102, an EAM system 104 including an EAM signal generator 106, and a set of (e.g., three or more) EAM pads 108 (only two of which are shown in FIG. 1), a sheath 110, a radio frequency (RF) drilling device 112 having a drilling electrode 113 at its distal tip, and an RF generator 114, and a grounding pad 116. The sheath 110, the RF drilling device 112, the RF generator 114, and the grounding pad 116 may not be described in detail herein and may, if desired, be those sold by Baylis Medical Company, Inc. (Montreal, Canada), for example, under the trade names NRG® Transseptal Platform, or Supracross® Transseptal Platform. Additionally, in alternative embodiments, another type of drilling device, such as a mechanical drilling device, may be used in place of the RF drilling device. If desired, some or all of the components of the surgical drilling system 100 may be sold or provided together in a kit, either assembled or unassembled.

[0050] 2, the dilator 102 is shown in more detail in the illustrated embodiment, which includes an elongate member 118 having a proximal end portion 120 that is generally oriented toward a user, such as a surgeon, during use, and an opposing distal end portion 122 that is generally oriented toward a target location on a patient during use. The elongate member 118 includes a sidewall 124 that extends longitudinally between the proximal end portion 120 and the distal end portion 122, and radially between a circumferential outer surface 126 and a circumferential inner surface 128 (shown in FIGS. 3B and 3C). The circumferential inner surface 128 defines a lumen 130 (shown in FIGS. 3B and 3C) that extends through the elongate member 118 from the proximal end portion 120 to the distal end portion 122. During use, the lumen 130 may receive an RF perforation device 112.

[0051] The elongated member may be made from a variety of materials, including, but not limited to, plastics such as high density polyethylene (HDPE).

[0052] 2, in the illustrated embodiment, a handle 132 is attached to the proximal end portion 120. The handle 132 may include various hubs and / or ports and / or connection points (not shown) for connecting to various external devices.

[0053] 2, the dilator 102 includes a dilator tip 134 at the distal end portion 122. The dilator tip 134 is shown in more detail in FIGS. 3A-3C. In the embodiment shown, the dilator tip 134 includes a first end 136 and a second end 138 spaced distally from the first end 136. The dilator tip 134 tapers in cross-sectional area going from the first end 136 to the second end 138 such that the first end 136 has an enlarged cross-sectional area relative to the second end 138, and the second end 138 has a reduced cross-sectional area relative to the first end 136. As the dilator tip 134 passes through an opening, the enlargement of the cross-sectional area dilates the opening.

[0054] In the embodiment shown, the second end 138 of the dilator tip 134 forms the distal end 140 of the dilator 102. In an alternative embodiment (not shown), the dilator tip can be spaced proximally from the distal end of the dilator.

[0055] 3A-3C, in the embodiment shown, the dilated tip 134 has a sidewall 142 (also referred to herein as the "tip sidewall") extending longitudinally between a first end 136 of the dilated tip 134 and a second end 138 of the dilated tip 134 and extending radially between a circumferential outer surface 144 of the dilated tip 134 (also referred to herein as the "tip circumferential outer surface") and a circumferential inner surface 146 of the dilated tip 134 (also referred to herein as the "tip circumferential inner surface"). The tip sidewall 142, the tip circumferential outer surface 144, and the tip circumferential inner surface 146 form portions of the sidewall 124 of the elongated member 118, the circumferential outer surface 126 of the elongated member 118, and the circumferential inner surface 128 of the elongated member 118, respectively.

[0056] 3A-3C, the dilator further includes an EAM electrode 148 associated with the dilator tip 134. As described above, the EAM electrode 148 may allow for determining the location of the dilator tip 134, for example, the location of the dilator tip 134 within the body or relative to other portions of the surgical drilling system 100. The EAM electrode 148 may be, for example, annular and may be made of or include stainless steel or platinum-iridium. In some embodiments, the EAM electrode may additionally be radiopaque, allowing visualization of the electrode using fluoroscopy, if desired. In further embodiments, the EAM electrode may have an echogenic profile that may allow visualization of the electrode using ultrasound, if desired. For example, the EAM electrode may include a coil. In some embodiments, the EAM electrode 148 may be made of conductive paint.

[0057] As noted above, the EAM electrode 148 is associated with the extended tip 134. The term "associated" indicates that the EAM electrode 148 is positioned to allow for the position of the extended tip 134 to be determined, either directly (e.g., when the EAM electrode 148 is directly attached to the extended tip 134) or indirectly (e.g., when the EAM electrode 148 is spaced apart from the extended tip 134 and an extrapolation is performed to determine the position of the extended tip 134 based on the position of the EAM electrode 148).

[0058] In the embodiment shown, the EAM electrode 148 is annular and extends circumferentially around the dilated tip 134 and is positioned between the first end 136 of the dilated tip 134 and the second end 138 of the dilated tip 134. In alternative embodiments (e.g., as shown in FIGS. 5A-5D ), the EAM electrode may be positioned proximal to the dilated tip or distal to the dilated tip. In such embodiments, extrapolation may be performed to determine the position of the dilated tip based on the position of the EAM electrode, as discussed above.

[0059] 3C, in the embodiment shown, the circumferential outer surface 144 of the extended tip 134 has a circumferential groove 150 defined therein, with the EAM electrode 148 seated in the groove 150. The EAM electrode 148 may be secured within the groove 150 in a variety of ways, such as by gluing, welding, soldering, and / or friction. Further, in the embodiment shown, the EAM electrode 148 is contoured to match the taper of the extended tip 134, such that the outer surface of the EAM electrode 148 is flush with the circumferential outer surface 144 of the extended tip 134. This may be accomplished by swaging, for example, which may allow for a smooth transition as the extended tip 134 passes through the opening.

[0060] In the embodiment shown, the dilator tip 134 is of unitary construction. In alternative embodiments, the dilator tip may be of assembled construction, as described below with reference to Figures 4A-4C.

[0061] 3A-3C , electrical conductor 152 is connected to EAM electrode 148 and extends proximally from EAM electrode 148 toward proximal end portion 120 (not shown in FIGS. 3A-3C ) of elongate member 118 for connection to EAM signal generator 106 (not shown in FIGS. 3A-3C ) of EAM system 104. Electrical conductor 152 is electrically isolated between EAM electrode 148 and its connection with EAM signal generator 106 such that electrical signals may be communicated between EAM electrode 148 and EAM system 104. For example, electrical conductor 152 may include a layer of polyimide insulation.

[0062] The end of the electrical conductor 152 connected to the EAM electrode 148 may be referred to herein as the "electrode end portion 154" (shown in FIG. 3C) of the electrical conductor 152, and the end of the electrical conductor 152 connectable to the EAM system 104 may be referred to herein as the "system end portion 156" (shown in FIGS. 1 and 2) of the electrical conductor 152. The system end 156 of the electrical conductor 152 may be connected or connectable to the EAM signal generator 106 in a variety of ways. In the embodiment shown, a connector 158 is attached to the system end 156. The connector 158 is mateable with a connector 160 of the EAM signal generator 106. Alternatively, a clip (e.g., an alligator clip) may be used to connect the system end portion of the electrical conductor to the EAM system (not shown).

[0063] 3A-3C , in the embodiment shown, the electrical conductor 152 extends from the EAM electrode 148, through the tip sidewall 142, and into the lumen 130. The electrical conductor 152 then extends through the lumen 130 to the proximal end portion 120 of the elongate member 118. In an alternative embodiment, as described below, the electrical conductor may be embedded within the sidewall of the elongate member.

[0064] As mentioned above, in the illustrated embodiment, the EAM system 104 includes an EAM signal generator 106 and a pair of EAM pads 108. Such systems are commercially available, for example, under the brand names ENSITE PRECISION™ and CARTO®, and will not be described in detail herein. Briefly, the path of the electrical signal from the EAM signal generator 106 to the EAM pads 108, from the EAM pads 108 to the EAM electrode 148, and from the EAM electrode 148 back to the EAM signal generator 106 (or the reverse path, i.e., from the EAM signal generator 106 to the EAM electrode 148, from the EAM electrode 148 to the EAM pads 108, and from the EAM pads 108 back to the EAM signal generator 106) allows the EAM electrode 148 to be visualized, and thus the position of the extension tip 134 to be determined.

[0065] In the embodiment shown, the perforation electrode 113 of the RF perforation device 112 can also be used as an additional EAM electrode. That is, the perforation electrode 113 of the RF perforation device 112 together with the EAM electrode 148 of the dilator 102 can be electrically connected to the EAM system 104, so that its position can be determined by the EAM system 104.

[0066] 4A-4C, an alternative embodiment of a dilator tip is shown. In FIG. 4, features like those in FIGS. 1-3 may be referenced with similar reference numerals incremented by 300. The dilator tip 434 of FIG. 4 is similar to the dilator tip 134 of FIGS. 1-3. However, the dilator tip 434 is an assembled structure. Specifically, in the embodiment shown, the dilator tip 434 includes a proximal piece 462 and a distal piece 464. The proximal piece 462 is stepped to define a distally facing shoulder surface 466 and has a neck 468 extending distally from the shoulder surface 466. The EAM electrode 448 is annular and is received on the neck 468 and adjacent the shoulder surface 466. The distal piece 464 is received on the neck 468 distal to the EAM electrode 448 and adjacent the EAM electrode 448. The proximal piece 462, the EAM electrode 448, and the distal piece 464 may be secured together in a variety of ways, such as by adhesion and / or friction.

[0067] 5A-5D, another alternative embodiment of a dilator tip is shown. In FIG. 5, features like those in FIGS. 1-3 may be referenced with similar reference numerals incremented by 400. The dilator tip 534 of FIG. 5 is similar to the dilator tip 134 of FIGS. 1-3. However, an electrical conductor 552 is embedded in the sidewall 524 of the elongated member 518. Specifically, the circumferential outer surface 526 of the elongated member 518 has a longitudinal groove 570 defined therein. The groove 570 extends from the EAM electrode 548 to a proximal end portion (not shown) of the elongated member 518. The electrical conductor 552 is seated within the groove 570, and a strip of material 572 (e.g., plastic or adhesive) fills the groove 570 across the electrical conductor 552.

[0068] 6A-6C, another alternative embodiment of a dilator tip is shown. In FIG. 6, features like those in FIGS. 1-3 may be referenced with like reference numerals incremented by 500. The dilator tip 634 of FIG. 6 is similar to the dilator of FIGS. 1-3. However, the elongate member 618 includes an outer tube 674 that defines a circumferential outer surface 626 and an inner liner 676 within the outer tube 674 that defines a circumferential inner surface 628. The inner liner 676 may be, for example, a polyimide or polytetrafluoroethylene liner, and the outer tube 674 may be made of a plastic such as HDPE.

[0069] In the embodiment of FIG. 6, electrical conductor 652 is defined by a tubular braid of metal wires positioned between an outer tube 674 and an inner liner 676 .

[0070] Optionally, to manufacture the dilator of FIG. 6, the outer tube 674, electrical conductor 652, EAM electrode 648, and inner liner 676 can be assembled together, and the EAM electrode 648 can be swaged to form an electrical connection between the EAM electrode 648 and the electrical conductor 652. The material of the outer tube 674 can then be reflowed (e.g., by application of heat) to bond the outer tube 674, electrical conductor 652, and inner liner 676. The distal piece 664 of the dilator tip 634 can then be bonded to the assembly. The system end (not shown) of the electrical conductor 652 can then be exposed for connection to the EAM system 104, if desired, by skiving.

[0071] Referring now to FIG. 7, another embodiment of a surgical drilling system is shown. In FIG. 7, features like those in FIG. 1 may be referenced with similar reference numbers incremented by 600. In FIG. 7, only the dilator 702, sheath 710, and RF drilling device 712 of the system 700 are shown. The remaining parts of the system 700 may be the same or similar to the parts shown in FIG. 1. The system 700 of FIG. 7 includes additional EAM electrodes. Specifically, the system 700 includes a first EAM electrode 748a associated with the dilator tip, as described above with respect to FIGS. 1-3. Additionally, the system includes a second EAM electrode 748b on the dilator 702 and spaced apart from the first EAM electrode 748a, a third 748c, a fourth 748d, and a fifth 748e EAM electrodes on the sheath 710, and a sixth EAM electrode 748f on the RF drilling device 712. The second through sixth EAM electrodes (748b-748f) are connectable to an EAM signal generator via additional electrical conductors (not shown). The use of additional EAM electrodes may allow for additional position data to be determined. For example, the position of the sheath 710, or the position of the dilator tip 734 relative to the sheath 710, may be determined. Furthermore, by providing additional electrodes, the orientation of the sheath or dilator may be determined. For example, providing at least two electrodes on each of the sheath and dilator allows for the determination of the direction in which the device is oriented.

[0072] In a further alternative embodiment of the dilator (not shown), the EAM electrode may be detachable from the elongate member. For example, the elongate member of the dilator may be a standard dilator (e.g., as known in the art). The EAM electrode connected to the electrical conductor may be separate from the elongate member. For example, the EAM electrode may be fixed to a punching device. The EAM electrode may be advanced through the lumen of the elongate member until it is at the distal end of the dilator. The assembly may be calibrated so that the extent to which the EAM electrode should be advanced to reach the distal end is known.

[0073] 8-13, a method for medical dilation, particularly for the creation and dilation of a transseptal perforation, may be described. As described in more detail, at various points during the method, an EAM electrode and an EAM system may be engaged to determine the position of the dilator dilator tip, i.e., an EAM signal may be received from the EAM electrode of the dilator, and based on the EAM signal, the position of the dilator dilator tip may be determined, and optionally mapped and tracked. This may increase the safety of the procedure. The method may be described with reference to a system 100 and a dilator 102, as shown in FIGS. 1-3. However, the method is not limited to being performed with the system 100 and the dilator 102, and the system 100 and the dilator 102 are not limited to being used in accordance with the described method.

[0074] With reference to FIG. 8, a guidewire 800 may be advanced towards the heart 802 via the femoral vein and “dwell” in the superior vena cava (SVC) 804 .

[0075] 9, with the dilator 102 within the sheath 110 and the dilator tip 134 extending protruding from the sheath 110, the dilator 102 and sheath 110 can be advanced over the guidewire 800 toward the SVC 804. The guidewire 800 can then be removed and an RF perforation device 112 (not shown in FIG. 9) can be advanced through the dilator 102 until the perforation electrode 113 (not shown in FIG. 9) of the RF perforation device 112 just clears the distal end 140 of the dilator 102.

[0076] In addition to the EAM electrode 148 of the dilator 102 being connected to the EAM system 104 (not shown in FIGS. 8-13 ) as described above, the perforation electrode 113 of the RF perforation device 112 may be connected to the EAM system 104 and function as an additional EAM electrode. After the RF perforation device 112 has been advanced through the dilator 102, and the perforation electrode 113 is exposed from the dilator 102, or the distal tip of the perforation device 112 is flush with the distal tip of the dilator 102, the EAM system 104 may be used to confirm the positioning of the perforation device 112. Specifically, the EAM system 104 may be engaged and may determine the position of the perforation electrode 113 relative to the dilator tip 134 based on the EAM signals received from the EAM electrode 148 and the perforation electrode 113. For example, if the EAM system indicates that the perforated electrode 113 protrudes from the dilator tip 134, it may be determined that the perforated electrode 113 has been advanced too distally into the dilator 102. Alternatively, if the perforated electrode 113 cannot be detected by the EAM system, it may be concluded that the perforated electrode 113 is covered within the dilator tip 134 and is therefore correctly positioned. Additionally, by providing both the perforated electrode 113 and the EAM electrode 148, the relative position between the two may be mapped to allow for determination of the orientation of the combined assembly.

[0077] In some embodiments, the system 100 can be further configured to provide a warning if the perforating electrode 113 is advanced distally of the distal end 140 of the dilator 102 .

[0078] Optionally, at this point the user may query for CT or MRI data if anatomical data is desired.

[0079] 10 , with the EAM electrode 148 and EAM system 104 engaged to track the position of the dilator tip 134 and the piercing electrode 113 (not shown in FIG. 10 ), the sheath 110, dilator 102, and piercing device 112 may be advanced toward the target anatomical location to position the dilator tip 134 at the target location. The target anatomical location may be, for example, the fossa ovalis 806 of the atrial septum 808. The EAM electrode 148 and EAM system 104 may be used to confirm the positioning of the dilator tip 134 relative to the fossa ovalis 806 and to confirm that the piercing electrode 113 is flush with the distal end 140 of the dilator 102.

[0080] With reference to FIG. 11, the perforation device 112 may then be engaged and advanced from the dilator 102 to create a perforation in the atrial septum 808 .

[0081] 12 , the dilator tip 134 may be advanced through the perforation to dilate the perforation. Specifically, the dilator tip 134 may be advanced through the perforation along with the EAM electrode 148. Before, during, and / or after advancement of the dilator tip 134 and the EAM electrode 148, the EAM electrode 148 and the EAM system 104 may be engaged to determine the position of the dilator tip 134. This may help ensure that the perforation is sufficiently dilated while not contacting and thereby damaging non-target tissue (e.g., the position of the dilator tip relative to the left atrial wall may be visualized).

[0082] Following dilation of the perforation, various procedures may be performed. At the desired time, the dilator 102 and sheath 110 may be withdrawn from the heart 802, as shown in FIG. 13. Optionally, during withdrawal, the EAM electrode 148 and EAM system 104 may be engaged to determine the position of the dilator tip 134.

[0083] Although the above description provides examples of one or more processes or devices or configurations, it will be understood that other processes or devices or configurations may be within the scope of the following claims.

[0084] To the extent that any amendment, characterization, or other statement previously made (in this patent, or in any related patent application or patent, including parent, sibling, or progeny patents) with respect to any technology, prior art, or otherwise, may be construed as a disclaimer of any subject matter supported by the present disclosure of this application, Applicant hereby cancels and revokes such disclaimer. Applicant also respectfully submits that any prior art previously considered may need to be re-referenced in any related patent application or patent, including any parent, sibling, or progeny patents.

Claims

1. A medical dilator comprising: an elongate member having a proximal end portion, an opposing distal end portion, and a lumen extending through the elongate member from the proximal end portion to the distal end portion; an expanded tip at the distal end portion, the distal tip having an enlarged cross-sectional area at a first end and tapering distally to a reduced cross-sectional area at a second end; and at least a first electrode associated with the expanded tip. an electrical conductor electrically connected to the first electrode and extending proximally from the first electrode towards the proximal end portion for electrical connection with an electroanatomical mapping system.

2. 10. The medical dilator of claim 1, wherein the first electrode is positioned between the first end of the dilator tip and the second end of the dilator tip.

3. The medical dilator of claim 1 , wherein the first electrode is positioned proximal to the first end of the dilator tip.

4. 10. The medical dilator of claim 1, wherein the dilator tip has a tip circumferential outer surface having a circumferential groove defined therein, the electrode being annular and seated within the groove.

5. 5. The medical dilator of claim 4, wherein the electrode has an outer electrode surface, the outer electrode surface being flush with the outer tip circumferential surface.

6. 2. The medical dilator of claim 1, wherein the dilator tip has a circumferential outer tip surface, a circumferential inner tip surface, and a tip sidewall extending between the circumferential inner tip surface and the circumferential outer tip surface, and the electrical conductor extends from the electrode through the tip sidewall and into the lumen.

7. 2. The medical dilator of claim 1, wherein the elongated member has a circumferential outer surface, a circumferential inner surface, and a sidewall extending along the length of the elongated member between the circumferential inner surface and the circumferential outer surface, and the electrical conductor is embedded in the sidewall and extends from the electrode to the proximal end portion.

8. 8. The medical dilator of claim 7, wherein the circumferential outer surface has a longitudinal groove defined therein extending from the first electrode to the proximal end portion, the electrical conductor being seated within the longitudinal groove.

9. 8. The medical dilator of claim 7, wherein the elongated member comprises an outer tube defining the circumferential outer surface, and an inner liner within the outer tube defining the circumferential inner surface, the electrical conductor being positioned between the outer tube and the inner liner.

10. 10. The medical dilator of claim 9, wherein the electrical conductor is a tubular braid.

11. The medical dilator of claim 1 , wherein the first electrode is detachable from the elongate member.

12. 10. The medical dilator of claim 1, further comprising a second electrode attached to the elongate member and spaced from the first electrode.

13. the dilator tip comprises a proximal part having a distally facing shoulder surface and a neck extending distally from the shoulder surface; 10. The medical dilator of claim 1, wherein the electrode is annular and is received on the neck and adjacent the shoulder, and the dilator tip further comprises a distal part received on the neck distal to and adjacent the electrode.

14. 10. The medical dilator of claim 1, wherein the electrode is radiopaque.

15. 15. The medical dilator of claim 14, wherein the electrode comprises platinum iridium.

16. The medical dilator of claim 1 , wherein the electrode has an echogenic profile.

17. 20. The medical dilator of claim 16, wherein the electrode comprises a coil.

18. 1. A kit of parts for a medical drilling system, said kit of parts comprising: an elongate member having a proximal end portion, an opposing distal end portion, and a lumen extending through the elongate member from the proximal end portion to the distal end portion; a medical dilator; a dilator tip at the distal end portion, the distal tip having a first end of an enlarged cross-sectional area and tapering distally to a second end of a reduced cross-sectional area; at least a first electrode associated with the dilator tip; an electrical conductor electrically connected to the first electrode and extending proximally from the first electrode to the proximal end portion for electrical connection with an electroanatomical mapping system; and a sheath for receiving the medical dilator. a piercing device receivable within said lumen.

19. 20. The kit of parts of claim 18, further comprising at least a second electrode, said second electrode being secured to said sheath.

20. 20. The kit of parts of claim 18, further comprising at least a second electrode, said second electrode being secured to said elongate member.

21. 20. The kit of parts of claim 18, further comprising at least a second electrode, said second electrode being fixed to said punching device.

22. 1. A medical expansion system, comprising: a medical dilator comprising an elongate member having a proximal end portion, an opposing distal end portion, and a lumen extending through the elongate member from the proximal end portion to the distal end portion; a dilator tip at the distal end portion, the distal tip having a first end of an enlarged cross-sectional area tapering distally to a second end of a reduced cross-sectional area; at least a first electrode associated with the dilator tip; and an electrical conductor electrically connected to the first electrode and extending proximally from the first electrode to the proximal end portion. an electroanatomical mapping system electrically connectable to the electrical conductor and configured to receive electroanatomical mapping signals from the electrodes and determine a position of the dilation tip based on the electroanatomical mapping signals.

23. 1. A method for medical expansion, comprising: a. advancing a dilator tip of a medical dilator towards a first target anatomical location; b. receiving a first electroanatomical mapping signal from an electrode associated with the dilator tip; c) determining a first position of the dilator tip relative to the first target anatomical location based on the first electroanatomical mapping signal.

24. 24. The method of claim 23, further comprising, after step c., d. advancing a perforation device from said medical dilator and creating a perforation at said first target anatomical location using said perforation device.

25. 25. The method of claim 24, further comprising determining a position of the punching device relative to the dilator tip.

26. 25. The method of claim 24, further comprising, after step d., e. advancing the electrode and the dilator tip through the fenestration to dilate the fenestration.

27. 27. The method of claim 26, further comprising, after or during step e., f. receiving a second electroanatomical mapping signal from the electrode, and g. determining a second position of the dilator tip relative to the first target anatomical location based on the second electroanatomical mapping signal.

28. 24. The method of claim 23, wherein the first target anatomical location is the atrial septum.

29. 30. The method of claim 28, further comprising determining a position of the dilation tip relative to a left atrial wall.

30. 24. The method of claim 23, wherein step a. comprises positioning the dilator within a sheath and advancing the dilator and the sheath toward the first target anatomical location, and further comprises determining a position of the dilator tip relative to a tip of the sheath.

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