Medical dilators

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] The present document relates to medical dilation, for example dilation of a surgically created perforation in cardiac tissue. More specifically, the present document relates to a medical dilator, and related systems, methods, and kits.

Summary of the Invention

[0002] The following summary is intended to introduce the reader to various aspects of embodiments of the invention, and is not intended to define any invention or delimit the scope thereof.

[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. An expansion tip is at the distal end portion. The expansion tip has a first end with an enlarged cross-sectional area and tapers distally toward a second end with a reduced cross-sectional area. At least a first electrode is associated with the expansion 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 expansion tip and the second end of the expansion tip. In some embodiments, the first electrode is positioned proximal to the first end of the expansion tip.

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

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

[0007] In some embodiments, the elongated member has a circumferential outer surface, a circumferential inner surface, and side walls extending along the length of the elongated member between the circumferential inner surface and the circumferential outer surface, with the electrical conductor embedded in the side walls and extending from the electrode to the proximal end portion. The circumferential outer surface may have a longitudinal groove defined therein, extending from the first electrode to the proximal end portion, and the electrical conductor may be seated within the longitudinal groove. Alternatively, the elongated member may include an outer tube defining the circumferential outer surface and an inner liner within the outer tube, defining the 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 elongated member.

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

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

[0011] In some embodiments, the electrodes are radiopaque. In some embodiments, the electrodes contain platinum-iridium.

[0012] In some embodiments, the electrodes have an echo-generating profile. In some embodiments, the electrodes include a coil.

[0013] According to several embodiments, a kit of components for a medical puncture system includes a medical dilator, a sheath, and a puncture device. The medical dilator has an elongated member having a proximal end portion, an opposing distal end portion, and a lumen extending through the elongated member from the proximal end portion to the distal end portion. The medical dilator further has a dilation tip at the distal end portion, the dilation 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 dilation tip, and an electrical conductor electrically connected to the first electrode and extending proximal to the proximal end from the first electrode for electrical connection to an electroanatomical mapping system. The sheath is for receiving the medical dilator. The puncture device is receivable within the lumen.

[0014] In some embodiments, the parts kit further includes at least a second electrode, which may be fixed to a sheath, or to an elongated member, or to a drilling device.

[0015] In some embodiments, a medical dilation system includes a medical dilator and an electroanatomical mapping system. The medical dilator includes an elongated member having a proximal end portion, an opposing distal end portion, and a lumen extending through the elongated member from the proximal end portion to the distal end portion. The dilation tip is located at the distal end portion. The dilation 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 dilation tip, and an electrical conductor is electrically connected to the first electrode and extends proximal from the first electrode to the proximal end portion. The electroanatomical mapping system is electrically connectable to the electrical conductor and is configured to receive electroanatomical mapping signals from the electrode and to determine the position of the dilation tip based on the electroanatomical mapping signals.

[0016] According to some embodiments, a method for medical dilation includes: a. advancing the 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 advancing the perforating device from the medical dilator and using the perforating device to create a perforation at a first target anatomical location.

[0018] In some embodiments, the method further includes determining the position of the drilling device relative to the expanded tip.

[0019] In some embodiments, after step d, the method further includes e. advancing the electrode and the expanded tip through the perforation to expand the perforation.

[0020] In some embodiments, after or during step e, the method further includes f. receiving a second electroanatomical mapping signal from the electrodes, and g. determining a second position of the dilated tip relative to a 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 the position of the dilated tip relative to the left atrial wall.

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

[0023] The accompanying drawings are for purposes of illustrating examples of the articles, methods, and devices of the present disclosure, and are not intended to be limiting. In the drawings,

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

[0025] [Figure 2] is a perspective view of a dilator of the surgical puncture system of Figure 1.

[0026] [Figure 3A] is an enlarged view of the dilated distal end of the dilator of Figure 2.

[0027] [Figure 3B] is an end view of the dilated distal end of Figure 3A.

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

[0029] [Figure 4A] is an enlarged view of another exemplary dilated distal end.

[0030] [Figure 4B] is an end view of the dilated distal end of Figure 4A.

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

[0032] [Figure 5A] is an enlarged view of another exemplary dilated distal end.

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

[0034] [Figure 5C] is an end view of the dilated distal end of Figure 5A.

[0035] [Figure 5D] This is a cross-sectional view along the line 5D-5D in Figure 5C.

[0036] [Figure 6A] This is a magnified view of another exemplary extended tip.

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

[0038] [Figure 6C] This is a cross-sectional view along line 6C-6C in Figure 6B.

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

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

[0041] [Figure 9] Figure 8 is a schematic diagram showing the second step of an exemplary method for creating and expanding a transseptal perforation.

[0042] [Figure 10] Figure 8 is a schematic diagram showing the third step of an exemplary method for creating and expanding a transseptal perforation.

[0043] [Figure 11] Figure 8 is a schematic diagram showing the fourth step of an exemplary method for creating and expanding a transseptal perforation.

[0044] [Figure 12] Figure 8 is a schematic diagram showing the fifth step of an exemplary method for creating and expanding a transseptal perforation.

[0045] [Figure 13] Figure 8 is a schematic diagram showing the second step of an exemplary method for creating and expanding a transseptal perforation. [Modes for carrying out the invention]

[0046] To provide examples of embodiments of the claimed subject matter, various apparatuses, processes, or configurations are described below. The embodiments described below are not intended to limit any claim, and any claim may encompass processes, apparatuses, or configurations different from those described below. The claims are not limited to all features of any one apparatus, process, or configuration described below, or to apparatuses, processes, or configurations having features common to several or all of the apparatuses, processes, or configurations described below. The apparatuses, 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 exclusive rights are not granted by the issuance of this patent application may be subject matter in another protective document, for example, a continuation patent application, and the applicant, inventor, or owner does not intend to abandon, waive, or make public such subject matter by its disclosure in this document.

[0047] Generally, disclosed herein are medical dilators (also referred to herein simply as “dilaters”) that can be used to dilate anatomical openings such as surgical perforations. For example, a dilater may be used in a transseptal perforation procedure, where a perforation is optionally made in the atrial septum of the heart using a radiofrequency perforation device, and then dilated using a dilater. Such a procedure may be performed, for example, to obtain access to the left atrium for a medical procedure.

[0048] Generally, the dilators disclosed herein are configured to enable non-fluorescent visualization and determination of the position of the tip of the dilator within the body (also referred to herein as the “dilation tip”), or the position of the tip of the dilator relative to other surgical tools (e.g., relative to a piercing device or to a sheath in which the dilator is housed). More specifically, the dilators disclosed herein may include at least one electrode associated with its tip. The electrode may be an electroanatomical mapping (EAM) electrode. The EAM electrode may be connected to an EAM system that can communicate EAM signals to and from the EAM electrode (either directly or via a pad), and can determine the position of the EAM electrode based on the EAM signals received from the EAM electrode, and thus can determine the position of the tip of the dilator within the body, or the position of the tip of the dilator relative to other surgical tools. This allows, for example, the user to visualize the tip of the dilator to determine whether the tip is properly positioned relative to the target tissue, to confirm that the puncturing device is covered within the dilator before puncture, and / or to confirm that the dilator tip is sufficiently spaced away from the non-target tissue.

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

[0050] Referring here to Figure 2, the expander 102 is shown in more detail in the given embodiment, and the expander 102 generally includes an elongated member 118 having a proximal end portion 120 directed toward a user such as a surgeon during use, and an opposing distal end portion 122 directed toward a target location on the patient during use. The elongated member 118 includes side walls 124 extending 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 Figures 3B and 3C). The circumferential inner surface 128 defines a lumen 130 (shown in Figures 3B and 3C) extending through the elongated member 118 from the proximal end portion 120 to the distal end portion 122. During use, the lumen 130 can receive an RF puncture device 112.

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

[0052] Referring further to Figure 2, in the illustrated embodiment, the 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] Referring further to Figure 2, the expander 102 includes an expanded tip 134 at the distal end portion 122. The expanded tip 134 is shown in detail in Figures 3A to 3C. In the shown embodiment, the expanded tip 134 includes a first end 136 and a second end 138 distally spaced from the first end 136. The expanded tip 134 tapers in the cross-sectional area extending from the first end 136 to the second end 138, so 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 expanded tip 134 passes through the opening, the enlargement of the cross-sectional area expands the opening.

[0054] In the shown embodiment, the second end 138 of the expansion tip 134 forms the distal end 140 of the expander 102. In an alternative embodiment (not shown), the expansion tip may be spaced proximal to the distal end of the expander.

[0055] Referring further to Figures 3A to 3C, in the shown embodiment, the extended tip 134 has a side wall 142 (also referred to as the "tip side wall") that extends longitudinally between the first end 136 and the second end 138 of the extended tip 134 and extends radially between the circumferential outer surface 144 (also referred to herein as the "tip circumferential outer surface") of the extended tip 134 and the circumferential inner surface 146 (also referred to herein as the "tip circumferential inner surface") of the extended tip 134. The tip side wall 142, the tip circumferential outer surface 144, and the tip circumferential inner surface 146 form part of the side wall 124, the circumferential outer surface 126, and the circumferential inner surface 128 of the elongated member 118, respectively.

[0056] Referring further to Figures 3A to 3C, the dilator further includes an EAM electrode 148 associated with the dilation tip 134. As described above, the EAM electrode 148 may enable the determination of the position of the dilation tip 134, for example, the position of the dilation tip 134 within the body, or the position of the dilation tip 134 relative to other parts of the surgical puncture system 100. The EAM electrode 148 may be, for example, annular and may be made of stainless steel or platinum-iridium, or may include such materials. In some embodiments, the EAM electrode may be additionally radiopaque and, if desired, enable visualization of the electrode using fluoroscopy. In further embodiments, the EAM electrode may have an echogenic profile that, if desired, enables visualization of the electrode using ultrasound. For example, the EAM electrode may include a coil. In some embodiments, the EAM electrode 148 may be made of conductive paint.

[0057] As described above, the EAM electrode 148 is associated with the extended tip 134. The term “associated” means that the EAM electrode 148 is positioned either directly (for example, if the EAM electrode 148 is directly attached to the extended tip 134) or indirectly (for example, if the EAM electrode 148 is spaced apart from the extended tip 134 and extrapolation is performed to determine the position of the extended tip 134 based on the position of the EAM electrode 148) to enable the position of the extended tip 134 to be determined.

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

[0059] Referring to Figure 3C, in the shown embodiment, the circumferential outer surface 144 of the extended tip 134 has a defined circumferential groove 150 therein, and the EAM electrode 148 is seated in the groove 150. The EAM electrode 148 can be fixed in the groove 150 by various methods such as adhesive, welding, soldering, and / or friction. Furthermore, in the shown embodiment, the EAM electrode 148 is contoured to coincide with the tapered portion of the extended tip 134, so that the outer surface of the EAM electrode 148 is coplanar with the circumferential outer surface 144 of the extended tip 134. This can be achieved, for example, by swaging. This can allow for a smooth transition as the extended tip 134 passes through the opening.

[0060] In the embodiments shown, the extended tip 134 is a single-piece structure. In alternative embodiments, the extended tip may be an assembled structure, as described below with reference to Figures 4A to 4C.

[0061] Referring further to Figures 3A to 3C, the electrical conductor 152 is connected to the EAM electrode 148 and extends proximal to the proximal end portion 120 of the elongated member 118 (not shown in Figures 3A to 3C) for connection to the EAM signal generator 106 (not shown in Figures 3A to 3C) of the EAM system 104. The electrical conductor 152 is electrically insulated between the EAM electrode 148 and its connection to the EAM signal generator 106, thereby allowing electrical signals to be communicated between the EAM electrode 148 and the EAM system 104. For example, the 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 herein to as the “electrode end portion 154” of the electrical conductor 152 (shown in Figure 3C), and the end of the electrical conductor 152 connectable to the EAM system 104 may be referred herein to as the “system end portion 156” of the electrical conductor 152 (shown in Figures 1 and 2). The system end portion 156 of the electrical conductor 152 may be connected to or connectable to the EAM signal generator 106 in various ways. In the shown embodiment, a connector 158 is attached to the system end portion 156. The connector 158 is matable with the connector 160 of the EAM signal generator 106. Alternatively, the system end portion of the electrical conductor may be connected to the EAM system (not shown) using a clip (e.g., an alligator clip).

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

[0064] As described 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®, which are not described in detail herein. Briefly, the EAM electrode 148 may be visualized by the electrical signal path from the EAM signal generator 106 to the EAM pad 108, from the EAM pad 108 to the EAM electrode 148, and back from the EAM electrode 148 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 pad 108, and back from the EAM pad 108 to the EAM signal generator 106), and thus the position of the extended tip 134 can be determined.

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

[0066] Referring here to Figures 4A to 4C, alternative embodiments of the extended tip are shown. In Figure 4, features similar to those in Figures 1 to 3 can be referred to by similar reference numbers incremented by 300. The extended tip 434 in Figure 4 is similar to the extended tip 134 in Figures 1 to 3. However, the extended tip 434 is an assembled structure. Specifically, in the embodiment shown, the extended 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 to the shoulder surface 466. The distal piece 464 is received distal to the EAM electrode 448 on the neck 468 and adjacent to the EAM electrode 448. The proximal piece 462, the EAM electrode 448, and the distal piece 464 can be fixed together by various methods, such as by adhesion and / or friction.

[0067] Referring here to Figures 5A to 5D, another alternative embodiment of the extended tip is shown. In Figure 5, features similar to those in Figures 1 to 3 can be referred to by similar reference numbers incremented by 400. The extended tip 534 in Figure 5 is similar to the extended tip 134 in Figures 1 to 3. However, the electrical conductor 552 is embedded in the side wall 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 the 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] Referring here to Figures 6A to 6C, another alternative embodiment of the expanded tip is shown. In Figure 6, features similar to those in Figures 1 to 3 may be referred to by similar reference numbers incremented by 500. The expanded tip 634 in Figure 6 is similar to the expanders in Figures 1 to 3. However, the elongated member 618 includes an outer tube 674 defining a circumferential outer surface 626 and an inner liner 676 within the outer tube 674 defining 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 shown in Figure 6, the electrical conductor 652 is defined by a tubular braid of metal wire positioned between the outer tube 674 and the inner liner 676.

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

[0071] Referring here to Figure 7, another embodiment of the surgical puncture system is shown. In Figure 7, features similar to those in Figure 1 may be referred to by similar reference numbers incremented by 600. In Figure 7, only the expander 702, sheath 710, and RF puncture device 712 of system 700 are shown. The remaining parts of system 700 may be the same as or similar to the parts shown in Figure 1. System 700 in Figure 7 includes additional EAM electrodes. Specifically, system 700 includes a first EAM electrode 748a associated with the expanded tip, as described above with respect to Figures 1 to 3. Furthermore, the system includes a second EAM electrode 748b located on the expander 702 and spaced apart from the first EAM electrode 748a, third 748c, fourth 748d, and fifth 748e EAM electrodes on the sheath 710, and a sixth EAM electrode 748f on the RF puncture device 712. The second to sixth EAM electrodes (748b to 748f) can be connected to the EAM signal generator via additional electrical conductors (not shown). The use of additional EAM electrodes may allow for the determination of additional positional data. For example, the position of the sheath 710 or the position of the extension tip 734 relative to the sheath 710 may be determined. Furthermore, the orientation of the sheath or extension may be determined by providing additional electrodes. For example, by providing at least two electrodes on both the sheath and the extension, it is possible to determine the direction in which the device is oriented.

[0072] In a further alternative embodiment of the expander (not shown), the EAM electrode may be detachable from the elongated member. For example, the elongated member of the expander may be a standard expander (e.g., one well known in the art). The EAM electrode, connected to an electrical conductor, may be separated from the elongated member. For example, the EAM electrode may be fixed to a drilling device. The EAM electrode may be advanced through the lumen of the elongated member until the EAM electrode reaches the distal end of the expander. The assembly may be calibrated so that the extent to which the EAM electrode should advance to reach the distal end is well known.

[0073] Referring here to Figures 8 to 13, a method for medical dilation, particularly for the creation and expansion of transseptal perforations, can be described. As will be described in more detail, at various points in the method, EAM electrodes and EAM systems can be engaged to determine the position of the dilation tip of the dilator; that is, EAM signals can be received from the EAM electrodes of the dilator, and based on the EAM signals, the position of the dilation tip of the dilator can be determined, optionally mapped, and tracked. This can enhance the safety of the procedure. The method can be described by referring to system 100 and dilator 102 as shown in Figures 1 to 3. However, the method is not limited to being performed with system 100 and dilator 102, and system 100 and dilator 102 are not limited to being used in accordance with the described method.

[0074] Referring to Figure 8, the guidewire 800 can be advanced through the femoral vein toward the heart 802 and "retain" in the superior vena cava (SVC) 804.

[0075] Referring to Figure 9, the expander 102 and the expander tip 134 within the sheath 110 can be advanced toward the SVC 804 on the guidewire 800, with the expander 102 and the expander tip 134 extending outward from the sheath 110. The guidewire 800 can then be removed, and the RF drilling device 112 (not shown in Figure 9) can be advanced through the expander 102 until the drilling electrode 113 (not shown in Figure 9) of the RF drilling device 112 just clears the distal end 140 of the expander 102.

[0076] As mentioned above, in addition to the EAM electrode 148 of the expander 102 being connected to the EAM system 104 (not shown in Figures 8 to 13), the piercing electrode 113 of the RF piercing device 112 may also be connected to the EAM system 104 and function as an additional EAM electrode. After the RF piercing device 112 advances through the expander 102, the piercing electrode 113 is exposed from the expander 102, or the distal tip of the piercing device 112 is coplanar with the distal tip of the expander 102, and the positioning of the piercing device 112 can be confirmed using the EAM system 104. Specifically, the EAM system 104 can be engaged and, based on EAM signals received from the EAM electrode 148 and the piercing electrode 113, can determine the position of the piercing electrode 113 relative to the expander tip 134. For example, if the EAM system indicates that the piercing electrode 113 is protruding from the expanded tip 134, it can be determined that the piercing electrode 113 has advanced too distally into the expander 102. Alternatively, if the piercing electrode 113 cannot be detected by the EAM system, it can be concluded that the piercing electrode 113 is covered within the expanded tip 134 and therefore correctly positioned. Furthermore, by providing both the piercing electrode 113 and the EAM electrode 148, it may be possible to map the relative positions between the two to enable the determination of the orientation of the combined assembly.

[0077] In some embodiments, the system 100 may be further configured to provide a warning if the piercing electrode 113 advances distal to the distal end 140 of the expander 102.

[0078] If desired, the user may request CT or MRI data at this point if anatomical data is required.

[0079] Referring here to Figure 10, with the EAM electrode 148 and EAM system 104 engaged to track the positions of the dilated tip 134 and the puncturing electrode 113 (not shown in Figure 10), the sheath 110, dilator 102, and puncturing device 112 can be advanced toward the target anatomical location to position the dilated tip 134 at the target location. The target anatomical location may be, for example, the fossa ovale 806 of the atrial septum 808. The positioning of the dilated tip 134 relative to the fossa ovale 806 can be confirmed using the EAM electrode 148 and EAM system 104, and it can also be confirmed that the puncturing electrode 113 is coplanar with the distal end 140 of the dilator 102.

[0080] Referring to Figure 11, the perforating device 112 can then engage with the dilator 102 and be advanced to create a perforation in the atrial septum 808.

[0081] Referring to Figure 12, the dilator tip 134 may advance through the perforation to dilate it. Specifically, the dilator tip 134 may advance through the perforation together with the EAM electrode 148. The position of the dilator tip 134 may be determined by engaging the EAM electrode 148 and the EAM system 104 before, during, and / or after the advancement of the dilator tip 134 and the EAM electrode 148. This may help ensure that the perforation is sufficiently dilated, while at the same time ensuring that non-target tissue is not damaged by the dilator tip 134 not making contact (for example, the position of the dilator tip relative to the left atrial wall may be visualized).

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

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

[0084] To the extent that any amendments, feature determinations, or other representations made previously with respect to any art, prior art, or otherwise (in this Patent, or any related patent application or patent including any parent, sibling, or child patents) may be construed as a withdrawal of any subject matter supported by the disclosure of this application, the applicant hereby cancels and withdraws such withdrawals. The applicant also respectfully raises the possibility that any prior art previously considered may need to be re-examined in any related patent application or patent including any parent, sibling, or child patents. The technical concepts included in this disclosure are described below. (Note 1) A medical dilator, An elongated member having a proximal end portion, an opposing distal end portion, and a lumen extending through the elongated member from the proximal end portion to the distal end portion; an expanded tip portion at the distal end portion, wherein the distal tip portion has a first end of an enlarged cross-sectional area and tapers distally to a second end of a reduced cross-sectional area; and at least a first electrode associated with the expanded tip portion. A medical dilator comprising: an electrical conductor electrically connected to the first electrode and extending proximal to the proximal end portion from the first electrode for electrical connection to an electroanatomical mapping system. (Note 2) The medical dilator according to Appendix 1, wherein the first electrode is positioned between the first end of the dilated tip and the second end of the dilated tip. (Note 3) The medical dilator according to Appendix 1, wherein the first electrode is positioned proximal to the first end of the dilated tip. (Note 4) The medical dilator according to Appendix 1, wherein the dilated tip has an outer surface in the circumferential direction of the tip having a defined circumferential groove therein, and the electrode is annular and seated in the groove. (Note 5) The medical dilator according to Appendix 4, wherein the electrode has an outer electrode surface, and the outer electrode surface is in the same plane as the outer surface in the circumferential direction of the tip portion. (Note 6) The medical dilator according to Appendix 1, wherein the expanded tip portion has an outer surface in the circumferential direction of the tip portion, an inner surface in the circumferential direction of the tip portion, and a tip side wall extending between the inner surface in the circumferential direction of the tip portion and the outer surface in the circumferential direction of the tip portion, and the electrical conductor extends from the electrode through the tip side wall into the lumen. (Note 7) The medical dilator according to Appendix 1, wherein the elongated member has a circumferential outer surface, a circumferential inner surface, and a side wall 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 side wall and extends from the electrode to the proximal end portion. (Note 8) The medical dilator according to Appendix 7, wherein the circumferential outer surface has a longitudinal groove defined therein that extends from the first electrode to the proximal end portion, and the electrical conductor is seated in the longitudinal groove. (Note 9) The medical dilator according to Appendix 7, wherein the elongated member comprises an outer tube defining the outer surface in the circumferential direction and an inner liner located within the outer tube defining the inner surface in the circumferential direction, and the electrical conductor is positioned between the outer tube and the inner liner. (Note 10) The medical dilator described in Appendix 9, wherein the electrical conductor is a tubular braid. (Note 11) The medical dilator according to Appendix 1, wherein the first electrode is detachable from the elongated member. (Note 12) The medical dilator according to Appendix 1, further comprising a second electrode attached to the elongated member and spaced apart from the first electrode. (Note 13) The extended tip portion comprises a proximal part having a shoulder surface facing distally and a neck portion extending distally from the shoulder surface, The medical dilator according to Appendix 1, wherein the electrode is annular, received on the neck portion and adjacent to the shoulder portion, and the expanded tip portion further comprises a distal component received on the neck portion distal to the electrode and adjacent to the electrode. (Note 14) The medical dilator described in Appendix 1, wherein the electrode is radiopaque. (Note 15) The medical dilator described in Appendix 14, wherein the electrode contains platinum-iridium. (Note 16) The medical dilator described in Appendix 1, wherein the electrode has an echo generation profile. (Note 17) The medical dilator described in Appendix 16, wherein the electrode comprises a coil. (Note 18) A component kit for a medical puncture system, wherein the component kit comprises, It comprises a proximal end portion, an opposing distal end portion, and an elongated member having a lumen that extends through the elongated member from the proximal end portion to the distal end portion. A medical dilator; a dilating 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 dilating tip; an electrical conductor electrically connected to the first electrode and extending proximal to the proximal end portion for electrical connection to an electroanatomical mapping system; A sheath for receiving the aforementioned medical dilator, A parts kit comprising a drilling device that can be received within the lumen. (Note 19) The component kit according to Appendix 18, further comprising at least a second electrode, wherein the second electrode is fixed to the sheath. (Note 20) The component kit according to Appendix 18, further comprising at least a second electrode, wherein the second electrode is fixed to the elongated member. (Note 21) The component kit according to Appendix 18, further comprising at least a second electrode, wherein the second electrode is fixed to the drilling device. (Note 22) A medical augmentation system, A medical dilator comprising a proximal end portion, an opposing distal end portion, and an elongated member having a lumen extending through the elongated member from the proximal end portion to the distal end portion; a dilation tip portion at the distal end portion, wherein the distal tip portion 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 associated with the dilation tip portion; and an electrical conductor electrically connected to the first electrode and extending proximal from the first electrode to the proximal end portion. A medical augmentation system comprising: an electroanatomical mapping system that is electrically connectable to the electrical conductor and configured to receive an electroanatomical mapping signal from the electrode and to determine the position of the augmented tip based on the electroanatomical mapping signal. (Note 23) A method for medical extension, a. To advance the dilated tip of the medical dilator toward the first target anatomical location, b. Receiving a first electroanatomical mapping signal from an electrode associated with the extended tip, c. A method comprising determining a first position of the extended tip relative to a first target anatomical location based on the first electroanatomical mapping signal. (Note 24) The method according to Appendix 23, further comprising, after step c, d. advancing the perforating device from the medical dilator and using the perforating device to create a perforation at the first target anatomical location. (Note 25) The method according to Appendix 24, further comprising determining the position of the drilling device relative to the expanded tip. (Note 26) The method according to Appendix 24, further comprising, after step d, e. advancing the electrode and the expanded tip through the perforation in order to expand the perforation. (Note 27) The method according to Appendix 26, further comprising: f. receiving a second electroanatomical mapping signal from the electrode after or during step e.; and g. determining a second position of the extended tip relative to the first target anatomical location based on the second electroanatomical mapping signal. (Note 28) The method according to Appendix 23, wherein the first target anatomical location is the atrial septum. (Note 29) The method according to Appendix 28, further comprising determining the position of the dilated tip relative to the left atrial wall. (Note 30) The method according to Appendix 23, wherein step a. includes positioning the dilator within the sheath and advancing the dilator and the sheath toward the first target anatomical location, and further includes determining the position of the dilator tip relative to the tip of the sheath.

Claims

1. A medical dilator, An elongated member having a proximal end portion, an opposing distal end portion having a distal end, and a lumen extending through the elongated member from the proximal end portion to the distal end, The extended tip portion at the distal end, wherein the extended tip portion has a shoulder surface and a neck portion facing distally, and the neck portion extends distally from the shoulder surface facing distally to the distal end, A first annular electrode is received on the neck portion and contacts the distally facing surface of the shoulder portion, An electrical conductor electrically connected to the first annular electrode and extending proximal to the proximal end portion from the first annular electrode for electrical connection to the electroanatomical mapping system, A medical dilator comprising: a distal piece having a first end of an enlarged cross-sectional area and tapering distally toward a second end of a reduced cross-sectional area, the distal piece being received on the neck and in contact with the first annular electrode.

2. The medical dilator according to claim 1, wherein the expanded tip portion has an outer surface in the circumferential direction of the tip portion, an inner surface in the circumferential direction of the tip portion, and a tip side wall extending between the inner surface in the circumferential direction of the tip portion and the outer surface in the circumferential direction of the tip portion, and the electrical conductor extends from the first annular electrode through the tip side wall into the lumen.

3. The medical dilator according to claim 1, wherein the elongated member has a circumferential outer surface, a circumferential inner surface, and a side wall 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 side wall and extends from the first annular electrode to the proximal end portion.

4. The medical dilator according to claim 3, wherein the circumferential outer surface has a longitudinal groove defined therein that extends from the first annular electrode to the proximal end portion, and the electrical conductor is seated in the longitudinal groove.

5. The medical dilator according to claim 4, further comprising a strip of material for filling the longitudinal grooves across the electrical conductor.

6. The medical dilator according to claim 3, wherein the elongated member comprises an outer tube defining the outer surface in the circumferential direction and an inner liner located within the outer tube defining the inner surface in the circumferential direction, and the electrical conductor is positioned between the outer tube and the inner liner.

7. The medical dilator according to claim 6, wherein the electrical conductor is a tubular braid.

8. The medical dilator according to claim 1, wherein the first annular electrode is detachable from the elongated member.

9. The medical dilator according to claim 1, further comprising a second electrode attached to the elongated member and spaced apart from the first annular electrode.

10. The medical dilator according to claim 1, wherein the first annular electrode is radiopaque.

11. The medical dilator according to claim 10, wherein the first annular electrode contains platinum-iridium.

12. The medical dilator according to claim 1, wherein the first annular electrode has an echo-generating profile.

13. The medical dilator according to claim 12, wherein the first annular electrode comprises a coil.

14. The medical expander according to claim 1, wherein the elongated member is made of high-density polyethylene.

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