Molding dilator for transseptal puncture and electroanatomical mapping

Abstract

The medical system includes a sheath and a dilator. The sheath includes an elongated body having a proximal and distal portion, and a lumen extending from the proximal to the distal portion. The dilator is movable within the lumen. The dilator includes an elongated body having a proximal portion, a preformed distal portion, and a tapered distal tip. One or more electroanatomical mapping electrodes are positioned in the preformed distal portion. One or more electroanatomical mapping electrodes are configured to be electrically connected to an electroanatomical mapping system. The preformed distal portion has a substantially linear morphology when confined within the sheath and an arcuate morphology when unconstrained.

Description

Technical Field

[0001] The present invention generally relates to methods and devices usable within a patient's body. More specifically, the present invention relates to an apparatus and method for creating an electroanatomical map of a cardiac structure using an electroanatomical mapping compatible dilator that can also be used for performing a transseptal puncture.

Background Art

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

[0003] As efforts to reduce fluoroscopy in the cardiac catheterization laboratory are intensified, EAM is playing an increasingly important role. To perform a transseptal puncture without using fluoroscopy, physicians can create a quick map of the right atrium in conjunction with the use of ultrasound-based imaging (such as intracardiac echocardiography). To create a quick map of the right atrium, the user currently inserts a device that can be integrated with an EAM system into the patient's body to create a map representing the anatomical structure of the patient's right atrium. After the map of the right atrium is created, the user needs to remove the mapping device and insert a device or series of devices capable of performing a transseptal puncture. The repeated insertion and removal of devices is inefficient from both a workflow efficiency and safety perspective because each insertion / removal increases the procedure time and creates the potential to introduce air and / or particulate matter into the patient's bloodstream.

Summary of the Invention

[0004] Example 1 is a medical system including a sheath and a dilator. The sheath includes an elongated body having a proximal and distal portion, and a lumen extending from the proximal to the distal portion. The dilator is movable within the lumen. The dilator includes an elongated body having a proximal portion, a preformed distal portion, and a tapered distal tip. One or more electroanatomical mapping electrodes are positioned in the preformed distal portion. One or more electroanatomical mapping electrodes are configured to be electrically connected to an electroanatomical mapping system. The preformed distal portion has a substantially linear morphology when confined within the sheath and an arcuate morphology when unconstrained.

[0005] Example 2 is the system of Example 1, wherein the sheath or dilator includes a steering mechanism. Example 3 is a system of either Example 1 or 2, wherein the preformed distal portion includes a first curved portion, a second curved portion, and an intermediate portion between the first and second curved portions, and when the preformed distal portion is in an arc shape, the axis of the tapered distal tip is offset from the axis of the intermediate portion.

[0006] Example 4 is a system of any of Examples 1 to 3 in which, when the preformed distal portion is in an arc shape, the preformed distal portion and the tapered distal tip are located in the same plane. Example 5 is a system of any of Examples 1 to 3, wherein when the preformed distal portion is in an arc shape, the preformed distal portion and the tapered distal tip are located in different planes.

[0007] Example 6 is a system of any of Examples 1 to 5, wherein the sheath has greater rigidity than the rigidity of the preformed distal portion. Example 7 is a system that is any of the systems in Examples 1 to 6, further comprising a guide member configured to be inserted into the lumen of the dilator.

[0008] Example 8 is a system that is any of the systems in Examples 1 to 7, further comprising a puncture member configured to be inserted into the lumen of a dilator. Example 9 is a system of Example 8, wherein the puncture member is an RF puncture device or a needle.

[0009] Example 10 is a system of any of Examples 1 to 9, comprising one or more conductors extending from one or more electroanatomical mapping electrodes to the proximal portion of a long dilator body.

[0010] Example 11 is a system of any of Examples 1-10, wherein the tapered distal tip is tapered over a length of approximately 10 mm, with an outer diameter of approximately 0.111 inches (2.8194 mm) to approximately 0.060 inches (1.524 mm).

[0011] Example 12 is a system of any of Examples 1 to 11, wherein the dilator is formed from one or more low-density polyethylene, high-density polyethylene, shape memory polymer, or shape memory metal.

[0012] Example 13 is a system that is any of the systems from Examples 1 to 12, further comprising a proximal electrode positioned proximal to the preformed distal portion and configured to identify the stem of a dilator on an electroanatomical mapping system.

[0013] Example 14 is a system of any of Examples 1 to 13, wherein the electroanatomical mapping system includes a display for displaying one or more anatomical images, parameters, and positioning information.

[0014] Example 15 is a system of any of Examples 1 to 14, wherein one or more electroanatomical mapping electrodes include three electrodes. Example 16 is a medical system including a sheath and a dilator. The sheath includes an elongated body having a proximal and distal portion, and a lumen extending from the proximal to the distal portion. The dilator is movable within the lumen. The dilator includes an elongated body having a proximal portion, a preformed distal portion, a tapered distal tip, and a lumen extending from the proximal to the tapered distal tip. One or more electroanatomical mapping electrodes are positioned in the preformed distal portion. One or more electroanatomical mapping electrodes are configured to be electrically connected to an electroanatomical mapping system. The preformed distal portion has a substantially linear morphology when confined within the sheath and an arcuate morphology when unconstrained.

[0015] Example 17 is a system of Example 16, wherein the sheath or dilator includes a steering mechanism. Example 18 is a system of Example 16 in which the preformed distal portion includes a first curved portion, a second curved portion, and an intermediate portion between the first and second curved portions, and when the preformed distal portion is in an arc shape, the axis of the tapered distal tip is offset from the axis of the intermediate portion.

[0016] Example 19 is a system of Example 16 in which the preformed distal portion and the tapered distal tip are located in the same plane when the preformed distal portion is in an arc shape. Example 20 is a system of Example 16 in which the preformed distal portion and the tapered distal tip are located in different planes when the preformed distal portion is in an arc shape.

[0017] Example 21 is a system of Example 16 in which the sheath has greater rigidity than the rigidity of the preformed distal portion. Example 22 is the system of Example 16, further comprising a guide member configured to be inserted into the lumen of the dilator.

[0018] Example 23 is the system of Example 16, further comprising a puncture member configured to be inserted into the lumen of the dilator. Example 24 is a system of Example 23, wherein the puncture member is an RF puncture device or a needle.

[0019] Example 25 is a system of Example 16, comprising one or more conductors extending from one or more electroanatomical mapping electrodes to the proximal portion of a long dilator body.

[0020] Example 26 is a system of Example 16 in which the tapered distal tip is tapered over a length of approximately 10 mm, from an outer diameter of approximately 0.111 inches (2.8194 mm) to approximately 0.060 inches (1.524 mm).

[0021] Example 27 is a system of Example 16 in which the dilator is formed from one or more low-density polyethylene, high-density polyethylene, shape memory polymer, or shape memory metal.

[0022] Example 28 is the system of Example 16, further comprising a proximal electrode positioned proximal to the pre-formed distal portion and configured to identify the stem of a dilator on an electroanatomical mapping system.

[0023] Example 29 is a system of Example 16 in which the electroanatomical mapping system comprises a display for displaying one or more anatomical images, parameters, and positioning information.

[0024] Example 30 is a system of Example 16, wherein one or more electroanatomical mapping electrodes include three electrodes. Example 31 is a medical system including a sheath and a dilator. The sheath includes an elongated body having a proximal portion and a distal portion, and a lumen extending from the proximal portion to the distal portion. The dilator is movable within the lumen. The dilator includes an elongated body having a proximal portion, a preformed distal portion, and a distal tip. A plurality of electroanatomical mapping electrodes are disposed on the preformed distal portion. The plurality of electroanatomical mapping electrodes are configured to be electrically connected to an electroanatomical mapping system. The preformed distal portion has a substantially linear form when constrained within the sheath and has an arcuate form when unconstrained.

[0025] Example 32 is the system of Example 31, wherein the preformed distal portion includes a first curved portion, a second curved portion, and an intermediate portion between the first curved portion and the second curved portion, and when the preformed distal portion is in an arcuate form, the axis of the tapered distal tip is offset from the axis of the intermediate portion.

[0026] Example 33 is the system of Example 31, wherein the preformed distal portion and the distal tip are located in the same plane when the preformed distal portion is in an arcuate form. Example 34 is the system of Example 31, wherein the preformed distal portion and the distal tip are located in different planes when the preformed distal portion is in an arcuate form.

[0027] Example 35 is a medical method. The method includes inserting a sheath and a dilator into the right atrium. The dilator is advanced from the distal tip of the sheath to a mapping configuration. The method includes moving the dilator around the right atrium to generate an electroanatomical map of the right atrium. The dilator is retracted into the sheath to apply a transseptal crossing configuration. The fossa ovalis is punctured by a puncture device inserted through the hollow lumen of the dilator. The method includes advancing the sheath and the dilator into the left atrium of the heart.

[0028] While several embodiments are disclosed, further embodiments of the present invention will become apparent to those skilled in the art from the following detailed description illustrating and explaining exemplary embodiments of the invention. Accordingly, the drawings and detailed description should be considered illustrative and not limiting. [Brief explanation of the drawing]

[0029] [Figure 1A] This is a schematic diagram of a medical procedure performed inside a patient's heart using a transseptal access system according to an embodiment of the present disclosure. [Figure 1B] This is a schematic diagram of a medical procedure performed inside a patient's heart using a transseptal access system according to an embodiment of the present disclosure. [Figure 1C] This is a schematic diagram of a medical procedure performed inside a patient's heart using a transseptal access system according to an embodiment of the present disclosure. [Figure 2] This figure shows a sheath and molded dilator equipped with an EAM electrode according to an embodiment of the present disclosure. [Figure 3A] This figure shows various configurations for a molding dilator according to embodiments of the present disclosure. [Figure 3B] This figure shows various configurations for a molding dilator according to embodiments of the present disclosure. [Figure 4] This figure shows the sheath and molded dilator shown in Figure 2 set up in a mapping configuration within the left atrium according to an embodiment of the present disclosure. [Figure 5] This figure shows the state in which the sheath and molded dilator of Figure 2 are set in a transseptal configuration, pressed against the atrial septum, according to an embodiment of the present disclosure. [Figure 6] This figure shows the sheath and molded dilator shown in Figure 2 set up in a mapping configuration within the right atrium according to an embodiment of the present disclosure. [Modes for carrying out the invention]

[0030] While the present invention can be adapted to various modifications and alternative forms, specific embodiments are shown in the drawings as examples and described in detail below. However, the intention is not to limit the present invention to the specific embodiments described. Rather, the present invention is intended to encompass all modifications, equivalents, and alternative forms that fall within the scope of the invention as defined by the appended claims.

[0031] Figures 1A to 1C are schematic diagrams of a medical procedure 10 performed in a patient's heart 20 using a transseptal access system 50 according to an embodiment of the present disclosure. As is well known, the human heart 20 has four chambers: the right atrium 55, the left atrium 60, the right ventricle 65, and the left ventricle 70. The atrial septum 75 separates the right atrium 55 from the left atrium 60, and the ventricular septum 80 separates the right ventricle 65 from the left ventricle 70. Furthermore, as is well known, deoxygenated blood from the patient's body is returned to the right atrium 55 via the inferior vena cava (IVC) 85 or the superior vena cava (SVC) 90.

[0032] Various medical procedures have been developed to diagnose or treat physiological disorders occurring within the left atrium 60 and related structures. Examples of such procedures include, but are not limited to, the deployment of a diagnostic or mapping catheter within the left atrium 60 for use in generating an electroanatomical map or diagnostic image of the left atrium 60. Other exemplary procedures include endocardial catheter-based ablation (e.g., radiofrequency ablation, pulsed-field ablation, cryoablation, laser ablation, radiofrequency ultrasound ablation, etc.) of target sites within the cardiac chambers or adjacent vessels (e.g., pulmonary veins and their orifices) to terminate cardiac arrhythmias such as atrial fibrillation and atrial flutter. Further exemplary procedures may include the deployment of a left atrial appendage (LAA) closure device. Naturally, the foregoing examples of procedures within the left atrium 60 are merely illustrative and are not limiting in any way to the present disclosure.

[0033] The medical procedure 10 shown in Figures 1A to 1C is an exemplary embodiment for the subsequent deployment of the aforementioned diagnostic and / or therapeutic devices within the left atrium 60, by providing access to the left atrium 60 using a transseptal access system 50. As shown in Figures 1A to 1C, the target tissue site may be formed by tissue on the atrial septum 75. In the illustrated embodiment, the target site is accessed via the IVC 85, for example, through the femoral vein, according to conventional catheter insertion techniques. In other embodiments, access to the target site on the atrial septum 75 may be achieved using an upward approach in which the transseptal access system 50 is advanced into the right atrium 55 via the SVC 90.

[0034] In the illustrated embodiments, the transseptal access system 50 includes an introducer sheath 100, a dilator 105 having a dilator body 107 and a tapered distal end 108, and a radiofrequency (RF) puncture device 110, also known as a puncture device, having a distal end 112 terminated by a tip electrode 115. As illustrated, in the assembled and used configuration shown in Figures 1A-1C, the RF puncture device 110 may be located within the dilator 105, and the dilator 105 itself may be located within the sheath 100. In one embodiment in which the transseptal access system 50 is deployed into the right atrium 55 via the IVC 85, the user introduces a guidewire (not shown) into the femoral vein, typically the right femoral vein, and advances it toward the heart 20. The sheath 100 is then introduced into the femoral vein on the guidewire and advanced toward the heart 20. In one embodiment, the guidewire and the distal end of the sheath 100 are then located within the SVC 90. These steps may be performed using an imaging system (e.g., fluoroscopy or ultrasound imaging). The dilator 105 is then introduced into the sheath 100 and advanced along the guidewire through the sheath 100 into the SVC 90. Alternatively, the dilator 105 may be fully inserted into the sheath 100 before entering the body, and both may be advanced simultaneously toward the heart 20. Once the guidewire, sheath 100, and dilator 105 are positioned within the superior vena cava, the guidewire is removed from the body, and the sheath 100 and dilator 105 are retracted so that their distal ends are positioned within the right atrium 55. The RF puncture device 110 described above may then be introduced into the dilator 105 and advanced toward the heart 20. In some embodiments, the guidewire may include an RF electrode itself to function as an RF puncture device.

[0035] Next, the user can press the distal end of the dilator 105 against the atrial septum 75, which may be done under imaging guidance. The RF puncture device 110 is then positioned so that the electrode 115 aligns with the distal end of the dilator 105 or protrudes slightly from it. The dilator 105 and the RF puncture device 110 are moved along the atrial septum 75 and may be positioned, for example, to press against the fossa ovale of the atrial septum 75 under imaging guidance. Various additional steps may be performed, such as measuring one or more characteristics of the target site, e.g., electrogeography or ECG (electrocardiogram) trace and / or pressure measurement, or delivering a substance to the target site, e.g., delivering a contrast agent. Such steps may enable the positioning of the tip electrode 115 at the desired target site. In addition, tactile feedback provided by the medical RF puncture device 110 can be used to enable the positioning of the tip electrode 115 at the desired target site.

[0036] With the tip electrode 115 and dilator 105 positioned at the target site, energy is delivered from an energy source, such as an RF generator, to the tip electrode 115 and the target site through an RF perforation device 110. In some embodiments, the energy is delivered with a voltage of at least about 200 V RMS (565 V peak-to-peak) and a power of at least about 5 W, which functions to vaporize cells near the tip electrode 115, thereby creating a void or perforation that penetrates the tissue at the target site. The user then applies force to the RF perforation device 110 to advance the tip electrode 115 at least partially through the perforation. In these embodiments, energy delivery is stopped when the tip electrode 115 has passed through the target tissue, i.e., when it has reached the left atrium 60. In some embodiments, the energy delivery step takes place over a period of about 1 second to about 5 seconds.

[0037] With the tip electrode 115 of the RF perforation device 110 crossing the atrial septum 75, the dilator 105 can be advanced forward, and the tapered distal tip 107 operates to gradually enlarge the perforation, allowing the distal end of the sheath 100 to advance into the left atrium 60.

[0038] In some embodiments, the distal end 112 of the RF puncture device 110 may be pre-formed to take on a non-traumatic shape, such as a J-shape, a pigtail shape (as shown in Figures 1B-1C), or other shape selected to direct the tip electrode 115 away from the endocardial surface of the left atrium 60. Examples of such RF puncture devices can be found, for example, in U.S. Patent Application No. 16 / 445,790 and U.S. Patent Application No. 16 / 346,404, assigned to Baylis Medical Company, Inc. The aforementioned pre-formed shapes can advantageously function to minimize the risk of unintended contact between the tip electrode 115 and tissue within the left atrium 60, and can also function to anchor the distal end 112 within the left atrium 60 during subsequent treatment steps. For example, in embodiments, the RF puncture device 110 may be structurally configured to function as a delivery rail for deploying a relatively large-bore therapeutic delivery sheath and associated dilators. In such embodiments, after the distal end 112 of the RF perforation device 110 is deployed into the left atrium 60, the dilator 105 and sheath 100 are withdrawn. The anchoring function of the preformed distal end 112 prevents unintended retraction of the distal end 112 and loss of access to the perforation site in the atrial septum 75 during such withdrawal.

[0039] The transseptal access system 50 can be configured to achieve multiple different curvatures. This is useful in enabling the system 50 to be introduced and positioned at a desired location within the heart 20. For example, the various curvatures allow the dilator 105 and the RF puncture device 110 to be positioned at a desired location along a portion of the atrial septum 75.

[0040] In some embodiments, the RF puncture device 110 may be replaced with a mechanical puncture device such as a needle having a sharp distal tip. The needle may be configured such that its sharp distal tip is positioned on the atrial septum 75 and, when pressure is applied to its proximal end, punctures the atrial septum 75.

[0041] In some embodiments, it may be desirable for the dilator 105, sheath 100, or RF puncture device 110 to include one or more surface electrodes. One or more surface electrodes may be positioned distal to the dilator 105, sheath 100, or RF puncture device 110 for use in ablation, mapping, puncture, or parameter sensing within a portion of the heart 20. One or more surface electrodes may be connected to an electroanatomical mapping (EAM) system, generator, or other diagnostic system.

[0042] Figure 2 shows a system 200 including a sheath 201 and a molding dilator 205 according to one embodiment of the present disclosure. The sheath 201 includes an elongated hollow body 202 having a proximal portion 208 and a distal portion 204. The distal portion 204 terminates at a distal tip 209.

[0043] The proximal section 208 includes a proximal end 210 detachably connected to a handle 214. The handle 214 includes a fixed section 216 configured to be held by the user's hand and a rotatable knob 212 configured to adjust the shape of the distal section 204. The rotatable knob 212 is connected to at least one control wire configured to deflect the distal section 204 in a first direction when the knob 212 is rotated clockwise, and to deflect the distal section 204 in a second direction when the knob 212 is rotated counterclockwise. In some embodiments, instead of the rotatable knob 212, a dial, plunger, or sliding mechanism may be used to control one or more pull wires or push rods to deflect a portion of the sheath 201.

[0044] Lumen 207 extends from the proximal end 227 of the handle through the knob 212 and through the hollow body 202 to the distal tip 209. Lumen 207 is configured to receive a dilator 205, other elongated medical devices, or fluid.

[0045] The fixed section 216 includes a conduit 224, which includes a fitting 226, such as a Luer connector. The conduit 224 is configured to allow the introduction of fluid into the lumen 207 or additional lumens within the sheath 201. The fitting 226 is configured to be detachably connected to a syringe or other container for delivering fluid through the conduit 224. In some embodiments, the sheath 201 may include one or more electrodes. In this configuration, the fixed section 216 may include a cable configured to connect to a system, such as an EAM system or an RF energy generator. The cable includes a connector that detachably engages with a connector for the system.

[0046] The molding dilator 205 is configured to be movable within the lumen 207. The molding dilator 205 includes an elongated hollow body 206 having a proximal and distal portion. The proximal portion includes a proximal end 230 detachably connected to a hub or handle 231. In some embodiments, the hub or handle 231 may include a steering mechanism that allows the shape of the distal portion to be changed. The hub or handle 231 allows the user to extend the molding dilator 205 from the sheath 201 or retract it into the sheath 201.

[0047] The distal portion includes a tapered section 217, a distal end 213, and an arcuate section 220. The tapered section 217 is tapered over a length of approximately 10 mm, with an outer diameter ranging from approximately 0.111 inches (2.8194 mm) to approximately 0.060 inches (1.524 mm). The arcuate section 220 is preformed such that, when projecting from the sheath 201 in mapping configuration, the tapered section 217 and the distal end 213 generally point towards the elongated hollow body 206. The arcuate section 220 is more flexible than the elongated hollow body 202 of the sheath, and as a result, when confined within the lumen 207 of the sheath 201, the arcuate section 220 remains substantially linear and takes the shape of the elongated hollow body 202.

[0048] In various embodiments, the arc-shaped portion 220 has a circular shape such that its distal end 213 is positioned substantially adjacent to the hollow body 206. The arc-shaped portion 220 includes an intermediate portion 240 located between the first curved portion 221 and the second curved portion 223. In some embodiments, the arc length and radius of the first curved portion 221 and the second curved portion 223 are set such that, in mapping configuration, the axis 243 of the tapered portion 217 is offset from the axis 241 of the intermediate portion 240. In some embodiments, the arc length and radius of the first curved portion 221 and the second curved portion 223 are set such that the tapered portion 217 and its distal end 213 roughly point to the elongated hollow body 206 when in mapping configuration. It is understood that the respective arc lengths and radii of the first curved portion 221 and the second curved portion 223 may be adjusted to change the configuration of the arc-shaped portion 220 when in mapping configuration. For example, in one embodiment, the arc-shaped portion 220 may have a consistent curvature and be substantially circular in shape. In another embodiment, the arc-shaped portion 220 may include various curvatures and may be substantially elliptical or substantially spiral in shape.

[0049] Figure 4 shows the mapping configuration of the sheath 201 and molded dilator 205 in the patient's right atrium. Figure 6 shows the mapping configuration of the sheath 201 and molded dilator 205 in the patient's left atrium.

[0050] The distal portion of the arcuate portion 220, located immediately proximal to the tapered portion 217, is substantially linear to ensure an appropriate shape when the dilator is in a transseptal configuration. Figure 5 illustrates the sheath 201 and molded dilator 205 in a transseptal configuration pressed against the atrial septum 75 according to an embodiment of the present disclosure. In the transseptal configuration, the arcuate portion 220 of the molded dilator 205 is retracted into the sheath 201 such that only the substantially linear portion and the tapered portion 217 are exposed.

[0051] In one embodiment shown in Figure 3A, the distal portion of the forming dilator 205, when extended from the sheath 201, remains within a single plane indicated by 301. In this configuration, the arcuate portion 220 and the tapered portion 217 share a common plane. In another embodiment shown in Figure 3B, the distal portion of the forming dilator 205 extends into two or more planes. For example, the arcuate portion 220 may remain within a first plane indicated by 301, and the tapered portion 217 may extend into a second plane indicated by 303. Although two planes are shown, it should be understood that the distal portion of the forming dilator 205 may extend into three or more planes when not constrained by the sheath 201. In some embodiments, one or more control wires or push rods may be used to change the shape of the arcuate portion 220. In other embodiments, the arcuate portion 220 may have a preformed curve that causes the distal portion to extend into three or more planes. In some embodiments, the arcuate portion 220 may include an embedded nitinol-formed wire or a laser-cut hypo tube, allowing the arcuate portion 220 to obtain a preformed curve when not constrained by the sheath 201.

[0052] The distal portion includes one or more electrodes 211. The one or more electrodes 211 can be evenly spaced or arranged at uneven intervals. The one or more electrodes 211 may be configured as surface electrodes capable of contacting tissue or fluid within the patient. The one or more electrodes 211 may be formed from a single conductive material or as ring electrodes formed from multiple materials. The one or more electrodes 211 may be solid, formed by doping, electroplating, or other methods for forming conductive electrodes. The one or more electrodes 211 may be configured to detect parameters when in contact with tissue or fluid, or to deliver energy, such as RF energy, to tissue for ablation. The one or more electrodes 211 may be electrically connected to a control system, such as an electroanatomical mapping system or an energy generator.

[0053] In some embodiments, one or more electrodes 211 may have a width of 1 mm or more and a width of 5 mm or less. Although multiple electrodes are illustrated, in some applications, only a single electrode may be required to create a basic map of the patient's heart. One or more electrodes 211 are connected to a wire or conductor that traverses the entire length of the molded dilator 205 to interface with a control system such as an electroanatomical mapping system. The molded dilator 205 may include one or more lumens for housing the wire or conductor for each of the one or more electrodes 211.

[0054] One or more electrodes 211 include a proximal electrode 215 and a tip electrode 219. The proximal electrode 215 is located proximal to the first curved portion 221. This allows the mapping system to identify the starting position of the arc-shaped portion 220 and display the configuration of the shaping dilator 205 on the display. Visualization of the proximal electrode 215 ensures that the arc-shaped portion 220 extends completely from the sheath 201. The tip electrode 219 is located at the distal end 213 of the shaping dilator 205.

[0055] The molded dilator includes a lumen extending from the hub or handle 231 through a long, hollow body 206 to the distal end 213. The lumen is configured to receive a long medical device such as a guidewire or a puncture or drilling device. Fluid can also be introduced into the lumen from the hub or handle 231.

[0056] The molding dilator 205 may have a lumen diameter in the range of approximately 0.032 inches (0.8128 mm) to 0.060 inches (1.524 mm) and may be formed from a variety of materials, including low-density polyethylene (LDPE) and high-density polyethylene (HDPE).

[0057] The proximal portion of the molding dilator 205 may include one or more indicators 235. One or more indicators 235 provide an indication of whether the dilator 205 is in mapping mode or trans-septal transverse mode. One or more indicators 235 may be visual (e.g., visual markers) and / or tactile (e.g., raised / grooved) means configured to indicate to the user whether the molding dilator 205 is in mapping mode or trans-septal transverse mode. One or more indicators 235 may also indicate when the molding dilator 205 is fully retracted into the sheath 201.

[0058] Figure 4 shows the sheath 201 and molded dilator 205 of Figure 2 configured in a mapping configuration within the right atrium 55 of a patient's heart 20, according to one embodiment of the present disclosure. In Figure 4, the sheath 201 and molded dilator 205 are positioned within the right atrium 55 using a guidewire or other guide member. The molded dilator 205 is shown advanced from the distal end of the sheath 20 into the mapping configuration. In the mapping configuration, the arcuate portion 220 of the molded dilator 205 takes on a pre-formed arcuate configuration. One or more electrodes 211 are connected to an electroanatomical mapping system and are used to create an electroanatomical map of the right atrium 55 as the system 200 moves throughout the right atrium 55. The sheath 201 and / or dilator 205 may be equipped with a steering system to improve the movement of the dilator 205 in order to create the electroanatomical map.

[0059] Following the creation of an electroanatomical map of the right atrium 55, the molded dilator 205 can be retracted into the sheath 201 until the pre-formed curve of the arcuate portion 220 that was present in the mapping configuration fits into the sheath 201. This configuration is useful for performing a transseptal puncture. Figure 5 shows the sheath 201 and molded dilator 205 of Figure 2, set in a transseptal transverse configuration with the distal end of the dilator 205 pressed against the atrial septum 75, according to one embodiment of the present disclosure. Once positioning is complete, the puncture device can be advanced through the lumen of the dilator 205 to perform a transseptal puncture immediately after creating a map of the right atrium 55. Figure 5 shows the tip electrode 115 of the puncture device before puncturing the atrial septum 75.

[0060] Figure 6 shows the sheath 201 and molded dilator 205 of Figure 2, configured in a mapping configuration within the left atrium 60, according to one embodiment of the present disclosure. Following transseptal puncture, the sheath 201 and molded dilator 205 are advanced into the left atrium 60. The molded dilator 205 is then advanced again from the distal end of the sheath 201 into a mapping configuration. At this position, one or more electrodes 211 of the dilator 205 can be used to move the dilator 205 around the left atrium to create an electroanatomical map of the left atrium 60.

[0061] In some embodiments, the control system, such as an EAM system or energy generator, may include a display for showing one or more anatomical images, parameters, positioning information, a 3D anatomical rendering of the relevant cardiac chambers, and medical device information.

[0062] In some embodiments, the sheath 201 and the pre-formed dilator 205 are packaged as a kit and ready for immediate use after being removed from the package. The kit may also include an RF piercing device or puncture device 110. Alternatively, the kit may comprise multiple sheaths or dilators, each having different pre-formed portions for use in various procedures.

[0063] In some embodiments, the sheath 201 or the molding dilator 205 may include one or more markers along its distal portion for identifying position or location during use with an imaging modality.

[0064] In some embodiments, the sheath 201 or dilator 205 may include a number of notches machined into its walls, for example by laser cutting. The shape and arrangement of the notches can allow for a transition of flexibility from the proximal to the distal end. The notches may include a discontinuous helical configuration or may be arranged substantially perpendicular to the longitudinal axis of the sheath 201 or dilator 205. In some embodiments, there may be a single notch winding around the axis, with wider loop spacing at the proximal end and wider spacing at the distal end. The spacing and size of the notches may be modified to achieve different flexibility along the length of the sheath 201 or dilator 205.

[0065] In some embodiments, the sheath 201 or dilator 205 may be formed from a shape memory material such as a shape memory polymer or shape memory metal. This allows the sheath 201 or dilator 205 to have a first shape at a first temperature and a second shape at a second temperature. The shape transition can be initiated by inserting a heating solution into the sheath 201 or dilator 205, or by heating a portion of the sheath 201 or dilator 205 using electricity.

[0066] Various modifications and additions can be made to the exemplary embodiments described without departing from the scope of the present invention. For example, while the embodiments described above refer to specific features, the scope of the invention also includes embodiments having different combinations of features, and embodiments that do not include all of the described features. Accordingly, the scope of the invention is intended to encompass all such alternative forms, modifications, and variations included in the claims, along with all their equivalents.

Claims

1. It is a medical system, A sheath comprising a long body having a proximal and distal portion, and a lumen extending from the proximal portion to the distal portion, A dilator movable within the lumen, comprising a long body having a proximal portion, a preformed distal portion, and a tapered distal tip, The system comprises one or more electroanatomical mapping electrodes disposed on the preformed distal portion, configured to be electrically connected to an electroanatomical mapping system, A medical system in which the preformed distal portion has a substantially linear shape when confined within the sheath and an arc shape when not confined.

2. The system according to claim 1, wherein the sheath or the dilator includes a steering mechanism.

3. The system according to claim 1 or 2, wherein the preformed distal portion includes a first curved portion, a second curved portion, and an intermediate portion between the first curved portion and the second curved portion, and when the preformed distal portion is in the arc shape, the axis of the tapered distal tip is offset from the axis of the intermediate portion.

4. The system according to any one of claims 1 to 3, wherein the preformed distal portion and the tapered distal tip are located in the same plane when the preformed distal portion is in the arc shape.

5. The system according to any one of claims 1 to 3, wherein the preformed distal portion and the tapered distal tip are located in different planes when the preformed distal portion is in the arc shape.

6. The system according to any one of claims 1 to 5, wherein the sheath has greater rigidity than the rigidity of the preformed distal portion.

7. The system according to any one of claims 1 to 6, further comprising a guide member configured to be inserted into the lumen of the dilator.

8. The system according to any one of claims 1 to 7, further comprising a puncture member configured to be inserted into the lumen of the dilator.

9. The system according to claim 8, wherein the puncture member is an RF puncture device or a needle.

10. The system according to any one of claims 1 to 9, comprising one or more conductors extending from one or more electroanatomical mapping electrodes to the proximal portion of a long dilator body.

11. The system according to any one of claims 1 to 10, wherein the tapered distal tip is tapered over a length of about 10 mm from about 0.111 inches (2.8194 mm) in outer diameter to about 0.060 inches (1.524 mm).

12. The system according to any one of claims 1 to 11, wherein the dilator is formed from one or more low-density polyethylene, high-density polyethylene, shape memory polymer, or shape memory metal.

13. The system according to any one of claims 1 to 12, further comprising a proximal electrode positioned proximal to the preformed distal portion and configured to identify the stem of the dilator on the electroanatomical mapping system.

14. The electroanatomical mapping system according to any one of claims 1 to 13, wherein the electroanatomical mapping system comprises a display for displaying one or more anatomical images, parameters, and positioning information.

15. The system according to any one of claims 1 to 14, wherein the one or more electroanatomical mapping electrodes include three electrodes.

16. It is a medical system, A sheath comprising a long body having a proximal and distal portion, and a lumen extending from the proximal portion to the distal portion, A dilator movable within the lumen, comprising a long body having a proximal portion, a preformed distal portion, a tapered distal tip, and a lumen extending from the proximal portion to the tapered distal tip, The system comprises one or more electroanatomical mapping electrodes disposed on the preformed distal portion, configured to be electrically connected to an electroanatomical mapping system, A medical system in which the preformed distal portion has a substantially linear shape when confined within the sheath and an arc shape when not confined.

17. The system according to claim 16, wherein the sheath or the dilator includes a steering mechanism.

18. The system according to claim 16, wherein the preformed distal portion includes a first curved portion, a second curved portion, and an intermediate portion between the first curved portion and the second curved portion, and when the preformed distal portion is in the arc shape, the axis of the tapered distal tip is offset from the axis of the intermediate portion.

19. The system according to claim 16, wherein the preformed distal portion and the tapered distal tip are located in a single plane when the preformed distal portion is in the arc shape.

20. The system according to claim 16, wherein the preformed distal portion and the tapered distal tip are located in different planes when the preformed distal portion is in the arc shape.

21. The system according to claim 16, wherein the sheath has greater rigidity than the rigidity of the preformed distal portion.

22. The system according to claim 16, further comprising a guide member configured to be inserted into the lumen of the dilator.

23. The system according to claim 16, further comprising a puncture member configured to be inserted into the lumen of the dilator.

24. The system according to claim 23, wherein the puncture member is an RF puncture device or a needle.

25. The system according to claim 16, comprising one or more conductors extending from one or more electroanatomical mapping electrodes to the proximal portion of a long dilator body.

26. The system according to claim 16, wherein the tapered distal tip is tapered over a length of about 10 mm from about 0.111 inches (2.8194 mm) in outer diameter to about 0.060 inches (1.524 mm).

27. The system according to claim 16, wherein the dilator is formed from one or more low-density polyethylene, high-density polyethylene, shape memory polymer, or shape memory metal.

28. The system according to claim 16, further comprising a proximal electrode positioned proximal to the preformed distal portion and configured to identify the stem of the dilator on the electroanatomical mapping system.

29. The system according to claim 16, wherein the electroanatomical mapping system comprises a display for displaying one or more anatomical images, parameters, and positioning information.

30. The system according to claim 16, wherein the one or more electroanatomical mapping electrodes include three electrodes.

31. It is a medical system, A sheath comprising a long body having a proximal and distal portion, and a lumen extending from the proximal portion to the distal portion, A dilator that is movable within the lumen, comprising a long body having a proximal portion, a preformed distal portion, and a distal tip, A plurality of electroanatomical mapping electrodes arranged on the preformed distal portion, wherein the plurality of electroanatomical mapping electrodes are configured to be electrically connected to an electroanatomical mapping system, A medical system in which the preformed distal portion has a substantially linear shape when confined within the sheath and an arc shape when not confined.

32. The system according to claim 31, wherein the preformed distal portion includes a first curved portion, a second curved portion, and an intermediate portion between the first curved portion and the second curved portion, and when the preformed distal portion is in the arc shape, the axis of the tapered distal tip is offset from the axis of the intermediate portion.

33. The system according to claim 31, wherein the preformed distal portion and the distal tip are located in a single plane when the preformed distal portion is in the arc shape.

34. The system according to claim 31, wherein the preformed distal portion and the distal tip are located in different planes when the preformed distal portion is in the arc shape.

35. It is a medical method, The steps include inserting the sheath and dilator into the right atrium, The steps include advancing the dilator from the distal tip of the sheath into a mapping configuration, The steps include moving the dilator around the right atrium to generate an electroanatomical map of the right atrium, The steps include retracting the dilator into the sheath to apply a trans-septal transverse configuration, The steps include puncturing the fossa ovalis via a perforation device inserted through the hollow lumen of the dilator, A method comprising the step of advancing the sheath and the dilator into the left atrium of the heart.

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