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

Abstract

To provide a medical dilator.SOLUTION: A medical dilator includes an elongate member having a proximal end portion, an opposed distal end portion, and a lumen, and the lumen extends 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 2

Description

[Technical field]

[0001] This document relates to medical dilation, such as dilation of surgically created perforations in cardiac tissue. More particularly, 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 is not intended to define or define the scope of any invention. 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 to an electroanatomical mapping system.

[0003] In some examples, the first electrode is disposed between the first end of the dilator tip and the second end of the dilator tip, hi some examples, the first electrode is disposed proximal to the first end of the dilator tip.

[0004] In some examples, the extended tip has a tip outer periphery having a circumferential groove defined therein, and the electrode is annular and seated within the groove. In some examples, the dilator tip has a distal outer periphery, a distal inner periphery, and a distal sidewall extending between the distal inner periphery and the distal outer periphery, and the electrical conductor extends from the electrode through the distal sidewall and into the lumen.

[0005] In some examples, the elongate member has an outer circumferential surface, an inner circumferential surface, and a sidewall extending along the length of the elongate member between the inner and outer circumferential surfaces, with the conductor embedded in the sidewall and extending from the electrode to the proximal end portion. The outer circumferential surface may have a longitudinal groove defined therein and extending from the first electrode to the proximal end portion, with the conductor seated within the longitudinal groove. Alternatively, the elongate member may include an outer tube defining an outer circumferential surface, and an inner liner within the outer tube defining an inner circumferential surface, with the conductor disposed between the outer tube and the inner liner. The conductor may be a tubular braid.

[0006] In some examples, the first electrode is removable from the elongate member. In some examples, the medical dilator further includes a second electrode attached to the elongate member and spaced apart from the first electrode.

[0007] In some examples, the extended tip includes a proximal piece having a distally facing shoulder surface and a neck extending distally from the shoulder surface, the electrode being annular and received on the neck and abutting the shoulder surface, and the extended tip further includes a distal piece received on the neck distal to the electrode and abutting the electrode.

[0008] In some examples, the first electrode forms the dilator tip. The medical dilator can include a metal member having a first section and a second section, the first section can join the metal member to the elongated member, and the second section can provide the first electrode and the dilator tip.

[0009] In some instances, the electrode is radiopaque, hi some instances, the electrode comprises platinum-iridium. In some instances, the electrode has an echogenic profile, hi some instances, the electrode includes a coil.

[0010] According to some embodiments, 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, the 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 portion for electrical connection to an electroanatomical mapping system. The sheath is for receiving the medical dilator. The drilling device is receivable in the lumen.

[0011] In some examples, the kit of parts further includes 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.

[0012] In some examples, the sheath has a tip and the medical dilator further includes a second electrode electrically connectable to an electroanatomical mapping system, wherein the second electrode is proximate to the tip of the sheath when the medical dilator is fully inserted into the sheath.

[0013] 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.

[0014] In some examples, the electroanatomical mapping system is a dielectric open source system. According to some aspects, 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.

[0015] In some examples, the method further includes, after step c., the step of: d. advancing a perforation device from the medical dilator and forming a perforation at the first target anatomical location using the perforation device.

[0016] In some examples, the method further includes determining a location of the punching device relative to the dilator tip. In some examples, the method further includes, after step d., the step of e. advancing an electrode and a dilator tip through the perforation to dilate the perforation.

[0017] In some examples, the method further includes, after or during step e., f. receiving a second electroanatomical mapping signal, 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 examples, the first target anatomical location is the atrial septum.

[0018] In some examples, the method further includes determining a position of the dilation tip relative to the left atrial wall. In some examples, step a. includes placing 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.

[0019] In some examples, the method further includes receiving a second electroanatomical mapping signal from the electrode and generating an anatomical map using the second electroanatomical mapping signal. The anatomical map can include at least one of a map of the superior vena cava, a map of the right atrium, and a map of the pulmonary veins. [Brief description of the drawings]

[0020] 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. [Figure 1] FIG. 1 is a perspective view of an exemplary surgical drilling system. [Diagram 2] 2 is a perspective view of a dilator of the surgical drilling system of FIG. 1. FIG. [Figure 3A] 3A is an enlarged view of the dilator tip of the dilator of FIG. 2. FIG. [Figure 3B] FIG. 3B is an end view of the dilator tip of FIG. 3A. [Figure 3C] FIG. 3C is a cross-sectional view taken along line 3C-3C of FIG. 3B. [Figure 4A]FIG. 4A is a close-up view of another exemplary dilator tip. [Figure 4B] FIG. 4B is an end view of the dilator tip of FIG. 4A. [Figure 4C] FIG. 4C is a cross-sectional view taken along line 4C-4C of FIG. 4B. [Figure 5A] FIG. 5A is a close-up view of another exemplary dilator tip. [Figure 5B] FIG. 5B is a cross-sectional view taken along line 5B-5B of FIG. 5A. [Figure 5C] FIG. 5C is an end view of the dilator tip of FIG. 5A. [Figure 5D] FIG. 5D is a cross-sectional view taken along line 5D-5D of FIG. 5C. [Figure 6A] FIG. 6A is a close-up view of another exemplary dilator tip. [Figure 6B] FIG. 6B is an end view of the dilator tip of FIG. 6A. [Figure 6C] FIG. 6C is a cross-sectional view taken along line 6C-6C of FIG. 6B. [Figure 7] FIG. 7 is a partial perspective view of a sheath, dilator, and drilling device of another exemplary surgical drilling system. [Figure 8] FIG. 8 is a schematic diagram illustrating a first step of an exemplary method for creating and dilating a transseptal puncture. [Figure 9] FIG. 9 is a schematic diagram illustrating a second step of an exemplary method for creating and expanding the transseptal puncture of FIG. [Figure 10] FIG. 10 is a schematic diagram illustrating a third step of the exemplary method for creating and expanding the transseptal puncture of FIG. [Figure 11] FIG. 11 is a schematic diagram illustrating a fourth step of the exemplary method for creating and expanding the transseptal puncture of FIG. [Figure 12] FIG. 12 is a schematic diagram illustrating a fifth step of an exemplary method for creating and expanding the transseptal puncture of FIG. [Figure 13] FIG. 13 is a schematic diagram illustrating a second step of an exemplary method for creating and expanding the transseptal puncture of FIG. [Figure 14A] FIG. 14A is a partial side view of another exemplary dilator. [Figure 14B] FIG. 14B is a cross-sectional view taken along line 14B-14B of FIG. 14A. [Figure 14C] FIG. 14C is a perspective view of the metal member of the dilator of FIG. 14A. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] Various devices or processes or compositions are described below to provide examples of embodiments of the claimed subject matter. The examples described below do not limit any of the claims, and any of the claims may encompass processes or devices or compositions different from those described below. The claims are not limited to devices or processes or compositions having all of the features of any one device or process or composition described below, or to features common to more than one or all of the devices or processes or compositions described below. The devices or processes or compositions described below may not be embodiments of any exclusive rights conferred by the issuance of this patent application. Any subject matter described below to which no exclusive rights are conferred by the issuance of this patent application may be the subject matter of another means of protection, for example, a continuing patent application, and the applicant, inventor, or owner does not intend to abandon, disclaim, or offer to the public any such subject matter by its disclosure in this document.

[0022] Generally disclosed herein is a medical dilator (also referred to herein simply as a "dilator") that can be used to dilate an anatomical opening, such as a surgical perforation. For example, the dilator may be used in a transseptal puncture procedure, where a perforation is formed in the atrial septum of the heart, optionally using a radiofrequency perforation device, and then dilated using the dilator. Such a procedure may be performed, for example, to gain access to the left atrium for treatment.

[0023] Generally, the dilators disclosed herein are configured to allow non-fluoroscopic 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 instruments (e.g., relative to a punching 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 to and from the EAM electrode (directly or via a pad), and can determine the location of the EAM electrode, and thus the tip of the dilator, within the body or relative to other surgical instruments based on the EAM signals received from the EAM electrode. This can, for example, allow the user to visualize the dilator tip to determine whether the tip is properly positioned relative to the target tissue, allow the user to confirm that the punching device is covered within the dilator before punching, and / or allow the user to confirm that the dilator tip is sufficiently spaced away from non-target tissue.

[0024] 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 (e.g., three or more) of 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, 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 are not described in detail herein and may optionally be sold by Baylis Medical Company, Inc. (Montreal, Canada), for example, under the trade names NRG® Transseptal Platform, or SupraCross® Transseptal Platform.

[0025] Additionally, in the alternative, another type of perforation device, such as a mechanical perforation device, may be used in place of the RF perforation device. Optionally, some or all of the components of surgical perforation system 100 may be sold or provided together as a kit, either assembled or unassembled.

[0026] 2, the dilator 102 is shown in more detail. In the illustrated example, the dilator 102 includes an elongate member 118 having a proximal end portion 120 that, in use, is generally oriented toward a user, such as a surgeon, and an opposing distal end portion 122 that, in use, is generally oriented toward a target location within a patient. 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 an outer circumferential surface 126 and an inner circumferential surface 128 (shown in FIGS. 3B and 3C). The inner circumferential 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. In use, the lumen 130 can receive an RF perforation device 112.

[0027] The elongated member may be made from a variety of materials, including, but not limited to, plastics such as high density polyethylene (HDPE). 2, in the example shown, a handle 132 is attached to the proximal end portion 120. The handle 132 can include various hubs and / or ports and / or connection points (not shown) for connecting to various external devices.

[0028] Still referring to Figure 2, the dilator 102 includes a dilator tip 134 at the distal end portion 122. The dilator tip 134 is shown in greater detail in Figures 3A-3C. All or a portion of the dilated tip 134 may be integral with the elongate member 118. That is, the distal end portion 122 of the elongate member 118 may include the dilated tip 134, as shown in Figures 3A-3C. Alternatively, the dilated tip 134 may be a separate piece from the elongate member 118 and may be joined to the distal end portion 122 of the elongate member 118, as described below with respect to Figures 14A-14C.

[0029] In the illustrated example, the dilating tip 134 includes a first end 136 and a second end 138 spaced distally from the first end 136. The dilating tip 134 tapers in cross-sectional area 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 dilating tip 134 passes through an opening, the expansion of the cross-sectional area causes the opening to expand.

[0030] In the illustrated example, the second end 138 of the dilator tip 134 forms the distal end 140 of the dilator 102. In an alternative example (not shown), the dilator tip may be spaced proximally from the distal end of the dilator.

[0031] 3A-3C, in the illustrated example, the extended tip 134 has a sidewall 142 (also referred to herein as the "tip sidewall") that extends longitudinally between a first end 136 of the extended tip 134 and a second end 138 of the extended tip 134, and extends radially between an outer circumferential surface 144 of the extended tip 134 (also referred to herein as the "tip outer circumferential surface") and an inner circumferential surface 146 of the extended tip 134 (also referred to herein as the "tip inner circumferential surface"). The tip sidewall 142, the tip outer circumferential surface 144, and the tip inner circumferential surface 146 form portions of the sidewall 124 of the elongated member 118, the outer circumferential surface 126 of the elongated member 118, and the inner circumferential surface 128 of the elongated member 118, respectively.

[0032] 3A-3C, the dilator further includes an EAM electrode 148 associated with the dilator tip 134. As described above, the EAM electrode 148 can allow for determining the location of the dilator tip 134, such as 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 can be, for example, annular and can be formed of or include stainless steel or platinum-iridium. In some examples, the EAM electrode can additionally be radiopaque, which can allow for visualization of the electrode using fluoroscopy, if desired. In a further example, the EAM electrode can have an echogenic profile, which can allow for visualization of the electrode using ultrasound, if desired. For example, the EAM electrode can include a coil. In some examples, the EAM electrode 148 can be made of conductive paint.

[0033] As discussed above, the EAM electrode 148 is associated with the extended tip 134. The term "associated" refers to the EAM electrode 148 being positioned to allow for determination of the position of the extended tip 134, whether directly (e.g., when the EAM electrode 148 forms all or part of the extended tip or 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).

[0034] In the illustrated example, the EAM electrode 148 is annular and extends circumferentially around the extended tip 134 and is disposed between the first end 136 of the extended tip 134 and the second end 138 of the extended tip 134. In alternative examples (e.g., as shown in FIGS. 5A-5D ), the EAM electrode may be disposed proximal to the extended tip or distal to the extended tip. In such examples, extrapolation may be performed to determine the position of the extended tip based on the position of the EAM electrode, as described above.

[0035] 3C, in the example shown, the outer circumferential surface 144 of the extended tip 134 has a circumferential groove 150 defined therein, and the EAM electrode 148 is seated within 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 example shown, the EAM electrode 148 has a profile that matches the taper of the extended tip 134, such that the outer surface of the EAM electrode 148 is flush with the outer circumferential surface 144 of the extended tip 134. This may be achieved, for example, by swaging, which may allow for a smooth transition as the extended tip 134 passes through an opening.

[0036] In the illustrated example, the dilator tip 134 is of one-piece construction. In an alternative example, the dilator tip may be of multi-piece construction, as described below with reference to Figures 4A-4C. 3A-3C , electrical conductors 152 are connected to the EAM electrodes 148 and extend proximally from the EAM electrodes 148 toward a proximal end portion 120 (not shown in FIGS. 3A-3C ) of the elongate member 118 for connection to an EAM signal generator 106 of the EAM system 104 (not shown in FIGS. 3A-3C ). The electrical conductors 152 are electrically insulated between the EAM electrodes 148 and their connection to the EAM signal generator 106 such that electrical signals may be communicated between the EAM electrodes 148 and the EAM system 104. For example, the electrical conductors 152 may include a polyimide insulation layer.

[0037] The end of the 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 conductor 152, and the end of the 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 conductor 152. The system end portion 156 of the conductor 152 may be connected or connectable to the EAM signal generator 106 in a variety of ways. In the illustrated example, a connector 158 is attached to the system end portion 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 conductor to the EAM system (not shown).

[0038] 3A-3C, in the illustrated example, electrical conductors 152 extend from the EAM electrode 148, through the distal sidewall 142, and into the lumen 130. The electrical conductors 152 then extend through the lumen 130 to the proximal end portion 120 of the elongate member 118. In an alternative example, the electrical conductors may be embedded within the sidewall of the elongate member, as described below.

[0039] As mentioned above, in the illustrated example, 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, by passing electrical signals from the EAM signal generator 106 to the EAM pads 108, from the EAM pads 108 to the EAM electrodes 148, and from the EAM electrodes 148 back to the EAM signal generator 106 (or in the reverse order, i.e., from the EAM signal generator 106 to the EAM electrodes 148, from the EAM electrodes 148 to the EAM pads 108, and from the EAM pads 108 back to the EAM signal generator 106), the EAM electrodes 148 can be visualized, and thus the position of the extension tip 134 can be determined. In some examples, the EAM system 104 can be a dielectric open-source EAM system (e.g., available under the brand name KODEX-EPD). In addition to allowing determination of the position of the dilator's dilator tip, such a system can allow the dilator to be used for anatomical mapping (e.g., to map the geometry of the heart chambers) without necessarily contacting cardiac tissue, as described in further detail below.

[0040] In the illustrated example, the perforation electrode 113 of the RF perforation device 112 can also be used as an additional EAM electrode, i.e., the perforation electrode 113 of the RF perforation device 112, along with the EAM electrode 148 of the dilator 102, can be electrically connected to the EAM system 104 and its position can be determined by the EAM system 104.

[0041] 4A-4C, an alternative embodiment of a dilator tip is shown. In FIG. 4, features similar to those of FIGS. 1-3 are referenced with similar reference numerals, but increased by 300. The dilator tip 434 of FIG. 4 is similar to the dilator tip 134 of FIGS. 1-3, except that the dilator tip 434 is a multi-piece construction. Specifically, in the illustrated embodiment, 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 abuts the shoulder surface 466. The distal piece 464 is received on the neck 468 distal to the EAM electrode 448 and abuts the EAM electrode 448. The proximal piece 462, the EAM electrode 448, and the distal piece 464 may be secured to one another in a variety of ways, such as by adhesion and / or friction.

[0042] 5A-5D, another alternative embodiment of a dilator tip is shown. In FIG. 5, features similar to those of FIGS. 1-3 are referenced with similar reference numbers, but increased by 400. The dilator tip 534 of FIG. 5 is similar to the dilator tip 134 of FIGS. 1-3, except that the electrical conductors 552 are embedded in the sidewall 524 of the elongated member 518. Specifically, the outer circumferential 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 conductors 552 are seated within the groove 570, and a strip of material 572 (e.g., plastic or adhesive) fills the groove 570 to cover the electrical conductors 552.

[0043] 6A-6C, another alternative embodiment of a dilator tip is shown. In FIG. 6, features similar to those of FIGS. 1-3 are referenced with like reference numerals increased by 500. The dilator tip 634 of FIG. 6 is similar to the dilator of FIGS. 1-3, except that the elongate member 618 includes an outer tube 674 defining an outer circumferential surface 626 and an inner liner 676 within the outer tube 674 defining an inner circumferential surface 628. The inner liner 676 may be, for example, a polyimide or polytetrafluoroethylene liner, and the outer tube 674 may be formed of a plastic such as HDPE.

[0044] In the example of FIG. 6, electrical conductors 652 are defined by a tubular braid of metal wires disposed between an outer tube 674 and an inner liner 676 . Optionally, to manufacture the dilator of FIG. 6, the outer tube 674, conductors 652, EAM electrode 648, and inner liner 676 can be first assembled together, and the EAM electrode 648 can be swaged to form an electrical connection between the EAM electrode 648 and the conductors 652. The material of the outer tube 674 can then be reflowed (e.g., by application of heat) to bond the outer tube 674, conductors 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 conductor 652 can then be exposed for connection to the EAM system 104, optionally by skiving.

[0045] Referring now to FIG. 7, another example of a surgical perforation system is shown. In FIG. 7, features similar to those in FIG. 1 are referenced with similar reference numbers, but with the addition of 600. In FIG. 7, only the dilator 702, sheath 710, and RF perforation device 712 of the system 700 are shown, with the remaining portions of the system 700 being the same or similar to those 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. In addition, the system includes a second EAM electrode 748b on the dilator 702 and spaced apart from the first EAM electrode 748a, a third EAM electrode 748c, a fourth EAM electrode 748d, and a fifth EAM electrode 748e on the sheath 710, and a sixth EAM electrode 748f on the RF perforation device 712. The second through sixth EAM electrodes (748b-748f) are connectable to an EAM signal generator via additional conductors (not shown). The use of additional EAM electrodes may allow 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 also 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 pointed.

[0046] In another example (not shown), the dilator may be similar to dilator 702 of FIG. 7, but the second EAM electrode may be positioned such that the second EAM electrode is proximate (e.g., flush or nearly flush with) the tip of the sheath when the dilator is fully inserted into the sheath. In such an example, the second EAM electrode of the dilator may be used to determine the location of the tip of the sheath when the dilator is fully inserted into the sheath, even if the sheath itself does not include any EAM electrode. For example, the second EAM electrode of the dilator may be used to determine whether the tip of the sheath has entered the left atrium during a transseptal puncture procedure.

[0047] 14A-14C, another example of a dilator is shown. In FIGS. 14A-14C, features similar to those of FIGS. 1-3 are referenced with similar reference numbers, but with the addition of 1300. In dilator 1402, dilator tip 1434 is similar to dilator tip 134 of FIGS. 1-3, but with an EAM electrode 1448 forming dilator tip 1434. That is, a metal member 1458 (shown in isolation in FIG. 14C) is provided that includes a first section 1460 and a second section 1462. First section 1460 secures metal member 1458 to elongate member 1418, and second section 1462 functions as EAM electrode 1448 and also forms dilator tip 1434. The first section 1460 includes ribs 1464 embedded in the elongate member 1418 to secure the metal member 1458 to the elongate member 1418. The second section 1462 extends distally from the first section 1460 and tapers in cross-sectional area from its first end 1436 to its second end 1438 to form the dilator tip 1434. In this example, the EAM electrode 1448 forms the distal end 1440 of the dilator 1402 and thus can enable tissue contact with the EAM electrode.

[0048] In a further alternative 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 piercing device. The EAM electrode may be advanced through the lumen of the elongate member until it reaches the distal end of the dilator. The assembly may be calibrated so that it knows how far the EAM electrode should be advanced to reach the distal end.

[0049] 8-13, a method for medical dilation, specifically for the formation and dilation of a transseptal perforation, will now be described. As will be described in more detail, at various points in the method, the EAM electrodes and EAM system can be activated to determine the location of the dilator dilator tip. That is, an EAM signal is received from the EAM electrode of the dilator, and based on the EAM signal, the location of the dilator dilator tip can be determined, and optionally mapped and tracked. This can increase the safety of the procedure. Although the method will be described with reference to the system 100 and dilator 102 shown in FIGS. 1-3, the method is not limited to being performed with the system 100 and dilator 102, and the system 100 and dilator 102 are not limited to use with the described method.

[0050] With reference to FIG. 8, a guidewire 800 may be advanced towards the heart 802 via the femoral vein and “placed” within the superior vena cava (SVC) 804. 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 may be advanced over the guidewire 800 toward the SVC 804. The guidewire 800 can then be removed and the 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 is proximate to the distal end 140 of the dilator 102.

[0051] 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 can function as an additional EAM electrode. After the RF perforation device 112 is 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 placement of the perforation device 112 can be confirmed using the EAM system 104. Specifically, the EAM system 104 can be activated to 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 perforating electrode 113 protrudes from the dilator tip 134, it may be determined that the perforating electrode 113 has been advanced too far into the dilator 102. Alternatively, if the perforating electrode 113 cannot be detected by the EAM system, it may be concluded that the perforating electrode 113 is encased within the dilator tip 134 and is therefore correctly positioned. Additionally, by providing both the perforating electrode 113 and the EAM electrode 148, the relative positioning between the two may be mapped, allowing the orientation of the combined assembly to be determined.

[0052] In some examples, the system 100 may be further configured to provide an alert if the perforating electrode 113 advances distally of the distal end 140 of the dilator 102. Optionally, at this point, the user can refer to CT or MRI data if anatomical data is desired.

[0053] 10 , with the EAM electrode 148 and EAM system 104 actuated 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 can be advanced toward a target anatomical location to place the dilator tip 134 at the target location. The target anatomical location can be, for example, the fossa ovalis 806 of the atrial septum 808. The EAM electrode 148 and EAM system 104 can be used to confirm placement of the dilator tip 134 relative to the fossa ovalis 806, and also to confirm that the piercing electrode 113 is flush with the distal end 140 of the dilator 102.

[0054] With reference to FIG. 11, the perforation device 112 may then be actuated and advanced from the dilator 102 to form a perforation in the atrial septum 808. 12, the dilator tip 134 can then be advanced through the perforation to dilate the perforation. Specifically, the dilator tip 134 can be advanced through the perforation along with the EAM electrode 148. Prior to, during, and / or after advancement of the dilator tip 134 and EAM electrode 148, the EAM electrode 148 and EAM system 104 can be actuated to determine the position of the dilator tip 134. This can help ensure that the perforation is sufficiently dilated while also helping to ensure that the dilator tip 134 does not contact and thereby damage non-target tissue (e.g., the position of the dilator tip relative to the left atrial wall can be visualized).

[0055] Following dilation of the perforation, various procedures can be performed. At a desired point, the dilator 102 and sheath 110 can be withdrawn from the heart 802, as shown in FIG. 13. Optionally, during withdrawal, the EAM electrode 148 and EAM system 104 can be actuated to determine the position of the dilator tip 134.

[0056] Optionally, throughout the method, the dilator 1402 and the EAM system 104 can be used to perform anatomical mapping. That is, as described above, if the EAM system 104 is a dielectric open-source EAM system, the dilator 102 and the EAM system 104 can be used for cardiac mapping without necessarily contacting cardiac tissue. For example, during advancement of the dilator 102, when the dilator 102 is in the inferior vena cava, the EAM system 104 can be actuated (i.e., electroanatomical signals can be received from the EAM electrodes 148) to map the SVC 804. As a further example, when the dilator 102 is in the right atrium 808, the EAM system 104 can be actuated to map the right atrium 808. As a further example, after the dilator 102 has crossed the atrial septum 808, the EAM system 104 can be actuated to map the pulmonary veins. This can be facilitated by rotating the dilator 102. In such an example, more detail and greater resolution can be achieved as the dilator 102 advances towards the location to be mapped. Additionally, in examples where the EAM electrode is at the distal end of the dilator, the EAM system may be capable of providing an alert if tissue is contacted by the distal end of the dilator.

[0057] 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.

[0058] To the extent that any modifications, characterizations, or other assertions previously made (in this application or in any related patent application or patent, including any parent, sibling, or progeny) regarding prior art or other art may be construed as a disclaimer of any subject matter supported by the disclosure of this application, Applicant hereby cancels and withdraws such disclaimer. Applicant also respectfully submits that it may be necessary to reconsider any prior art previously discussed in any related patent application or patent, including any parent, sibling, or progeny. The technical ideas contained in this disclosure are described below as appendices. (Appendix 1) A medical dilator, comprising: an elongate member having a proximal end portion, an opposed distal end portion, and a lumen, the lumen extending through the elongate member from the proximal end portion to the distal end portion; a dilated tip at the distal end portion, the dilated tip having a first end of enlarged cross-sectional area and tapering distally to a second end of 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 towards the proximal end portion for electrical connection to an electroanatomical mapping system; A medical expander comprising: (Appendix 2) 2. The medical dilator of claim 1, wherein the first electrode is disposed between the first end of the dilator tip and the second end of the dilator tip. (Appendix 3) 2. The medical dilator of claim 1, wherein the first electrode is disposed proximal to the first end of the dilator tip. (Appendix 4) 4. The medical dilator of claim 1, wherein the dilator tip has a distal outer peripheral surface, the distal outer peripheral surface having a circumferential groove defined therein, and the electrode is annular and seated within the groove. (Appendix 5) 5. The medical expander of claim 4, wherein the electrode has an outer electrode surface, the outer electrode surface being flush with the outer tip surface. (Appendix 6) The medical expander described in any one of appendix 1 to 3, wherein the expansion tip portion has a distal outer peripheral surface, a distal inner peripheral surface, and a distal side wall extending between the distal inner peripheral surface and the distal outer peripheral surface, and the conductor extends from the electrode through the distal side wall into the lumen. (Appendix 7) The medical expander of any one of claims 1 to 3, wherein the elongated member has an outer peripheral surface, an inner peripheral surface, and a sidewall extending along the length of the elongated member between the inner peripheral surface and the outer peripheral surface, and the conductor is embedded in the sidewall and extends from the electrode to the proximal end portion. (Appendix 8) 8. The medical dilator of claim 7, wherein the outer surface has a longitudinal groove defined therein and extending from the first electrode to the proximal end portion, the electrical conductor being seated within the longitudinal groove. (Appendix 9) 8. The medical dilator of claim 7, wherein the elongated member includes an outer tube defining the outer circumferential surface and an inner liner within the outer tube and defining the inner circumferential surface, the electrical conductor being disposed between the outer tube and the inner liner. (Appendix 10) 10. The medical dilator of claim 9, wherein the electrical conductor is a tubular braid. (Appendix 11) 11. The medical expander according to any one of claims 1 to 10, wherein the first electrode is detachable from the elongated member. (Appendix 12) 12. The medical expander according to any one of claims 1 to 11, further comprising a second electrode attached to the elongated member and spaced apart from the first electrode. (Appendix 13) the dilator tip includes a proximal piece having a distally facing shoulder surface and a neck extending distally from the shoulder surface; the electrode is annular and is received on the neck and abuts the shoulder surface; 2. The medical dilator of claim 1, wherein the dilator tip further includes a distal piece that is received on the neck distal to the electrode and abuts the electrode. (Appendix 14) 2. The medical dilator of claim 1, wherein the first electrode forms the dilator tip. (Appendix 15) 15. The medical dilator of claim 14, further comprising a metal member having a first section and a second section, the first section joining the metal member to the elongated member and the second section providing the first electrode and the dilator tip. (Appendix 16) 16. The medical expander according to any one of claims 1 to 15, wherein the electrodes are radiopaque. (Appendix 17) 17. The medical expander according to any one of claims 1 to 16, wherein the electrode comprises platinum-iridium. (Appendix 18) 18. The medical expander according to any one of claims 1 to 17, wherein the electrode has an echogenic profile. (Appendix 19) 19. The medical dilator of claim 18, wherein the electrode comprises a coil. (Appendix 20) 1. A kit of parts for a medical drilling system, comprising: a medical dilator comprising: 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 dilator tip at the distal end portion 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; and an electrical conductor electrically connected to the first electrode and extending proximally from the first electrode to the proximal end portion for electrical connection to an electroanatomical mapping system; a sheath for receiving the medical dilator; a piercing device receivable in said lumen; A parts kit comprising: (Appendix 21) 21. The kit of parts of claim 20, further comprising at least a second electrode, the second electrode secured to the sheath. (Appendix 22) 21. The kit of parts of claim 20, further comprising at least a second electrode, the second electrode being secured to the elongate member. (Appendix 23) 21. The kit of parts of claim 20, further comprising at least a second electrode, the second electrode being fixed to the drilling device. (Appendix 24) The sheath has a distal end, the medical dilator further comprises a second electrode electrically connectable to the electroanatomical mapping system; 21. The kit of parts of claim 20, wherein the second electrode is adjacent to the tip of the sheath when the medical dilator is fully inserted into the sheath. (Appendix 25) 1. A medical expansion system, comprising: a medical dilator comprising: 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 dilator tip at the distal end portion 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; and an electrical conductor electrically connected to the first electrode and extending proximally from the first electrode to the proximal end portion; and an electroanatomical mapping system 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. A medical expansion system comprising: (Appendix 26) 26. The medical expansion system of claim 25, wherein the electroanatomical mapping system is a dielectric open source system. (Appendix 27) 1. A method for medical dilation, 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; A method comprising: (Appendix 28) 28. The method of claim 27, further comprising, after step c., the step of: d. advancing a perforation device from the medical dilator and using the perforation device to form a perforation at the first target anatomical location. (Appendix 29) 29. The method of claim 27 or 28, further comprising determining a position of the perforation device relative to the dilator tip. (Appendix 30) 30. The method of any one of claims 27 to 29, further comprising, after step d., the step of e. advancing the electrode and the dilator tip through the perforation to dilate the perforation. (Appendix 31) 31. The method of claim 30, further comprising, after or during step e., the steps of: f. receiving a second electroanatomical mapping signal; and g. determining a second position of the dilator tip relative to the first target anatomical location based on the second electroanatomical mapping signal. (Appendix 32) 32. The method of any one of claims 27-31, wherein the first target anatomical location is the atrial septum. (Appendix 33) 33. The method of any one of claims 27-32, further comprising determining a position of the extension tip relative to a left atrial wall. (Appendix 34) 34. The method of any one of claims 27-33, wherein step a. includes placing the dilator within a sheath and advancing the dilator and the sheath toward the first target anatomical location, the method further including determining a position of the dilator tip relative to a tip of the sheath. (Appendix 35) 35. The method of any one of claims 27-34, further comprising the steps of receiving a second electroanatomical mapping signal from the electrode and creating an anatomical map using the second electroanatomical mapping signal. (Appendix 36) 36. The method of claim 35, wherein the anatomical map includes at least one of a map of the superior vena cava, a map of the right atrium, and a map of pulmonary veins.

Claims

1. A medical dilator comprising: an elongate member having a proximal end portion, an opposed distal end portion, and a lumen, the lumen extending through the elongate member from the proximal end portion to the distal end portion; a dilated tip at the distal end portion, the dilated tip having a first end of enlarged cross-sectional area and tapering distally to a second end of 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 towards the proximal end portion for electrical connection to an electroanatomical mapping system; A medical expander comprising:

2. 10. The medical dilator of claim 1, wherein the first electrode is disposed 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 disposed proximal to the first end of the dilator tip.

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

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

6. The medical dilator of any one of claims 1 to 3, wherein the dilator tip has a distal outer peripheral surface, a distal inner peripheral surface, and a distal sidewall extending between the distal inner peripheral surface and the distal outer peripheral surface, and the conductor extends from the electrode through the distal sidewall into the lumen.

7. 4. The medical dilator of claim 1, wherein the elongated member has an outer circumferential surface, an inner circumferential surface, and a sidewall extending along the length of the elongated member between the inner and outer circumferential surfaces, 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 outer circumferential surface has a longitudinal groove defined therein and 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 includes an outer tube defining the outer circumferential surface and an inner liner within the outer tube and defining the inner circumferential surface, the electrical conductor being disposed 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 any one of claims 1 to 10, wherein the first electrode is detachable from the elongate member.

12. The medical dilator of any one of claims 1 to 11, further comprising a second electrode attached to the elongate member and spaced apart from the first electrode.

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

14. The medical dilator of claim 1 , wherein the first electrode forms the dilator tip.

15. 15. The medical dilator of claim 14, further comprising a metal member having a first section and a second section, the first section joining the metal member to the elongated member and the second section providing the first electrode and the dilator tip.

16. The medical dilator of any one of claims 1 to 15, wherein the electrodes are radiopaque.

17. The medical dilator of any one of claims 1 to 16, wherein the electrodes comprise platinum-iridium.

18. The medical dilator of any one of claims 1 to 17, wherein the electrode has an echogenic profile.

19. 20. The medical dilator of claim 18, wherein the electrode comprises a coil.

20. 1. A kit of parts for a medical drilling system, comprising: a medical dilator comprising: 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 dilator tip at the distal end portion 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; and an electrical conductor electrically connected to the first electrode and extending proximally from the first electrode to the proximal end portion for electrical connection to an electroanatomical mapping system; a sheath for receiving the medical dilator; a piercing device receivable in said lumen; A parts kit comprising:

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

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

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

24. The sheath has a distal end, the medical dilator further comprising a second electrode electrically connectable to the electroanatomical mapping system; 21. The kit of parts of claim 20, wherein the second electrode is adjacent the tip of the sheath when the medical dilator is fully inserted into the sheath.

25. 1. A medical expansion system, comprising: a medical dilator comprising: 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 dilator tip at the distal end portion 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; 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 conductors and configured to receive electroanatomical mapping signals from the electrodes and determine a position of the dilator tip based on the electroanatomical mapping signals; A medical expansion system comprising:

26. 26. The medical dilation system of claim 25, wherein the electroanatomical mapping system is a dielectric open source system.

27. 1. A method for medical dilation, 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; A method comprising:

28. 28. The method of claim 27, further comprising, after step c), the step of: d) advancing a punching device from said medical dilator and forming a punch at said first target anatomical location using said punching device.

29. 29. The method of claim 27 or 28, further comprising determining a position of the punching device relative to the dilator tip.

30. 30. The method of any one of claims 27-29, further comprising, after step d), the step of: e) advancing the electrode and the dilator tip through the perforation to dilate the perforation.

31. 31. The method of claim 30, further comprising, after or during step e., f. receiving a second electroanatomical mapping signal, and g. determining a second position of the dilator tip relative to the first target anatomical location based on the second electroanatomical mapping signal.

32. The method of any one of claims 27 to 31, wherein the first target anatomical location is the atrial septum.

33. The method of any one of claims 27 to 32, further comprising determining a position of the dilation tip relative to the left atrial wall.

34. 34. The method of any one of claims 27-33, wherein step a. comprises disposing the dilator within a sheath and advancing the dilator and the sheath towards the first target anatomical location, the method further comprising determining a position of the dilator tip relative to a tip of the sheath.

35. 35. The method of any one of claims 27 to 34, further comprising receiving a second electroanatomical mapping signal from the electrode and generating an anatomical map using the second electroanatomical mapping signal.

36. 36. The method of claim 35, wherein the anatomical map includes at least one of a map of the superior vena cava, a map of the right atrium, and a map of the pulmonary veins.

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