Mapping and transseptal puncture catheter

Abstract

A medical system for performing procedures within a patient's heart includes an elongated member having a proximal portion and a pre-formed distal portion. The pre-formed distal portion is configured to contact a portion of the fossa ovale of the heart. The elongated member includes a lumen extending from the proximal portion to the proximal position of the pre-formed distal portion. The system includes a puncture device having a proximal portion and a distal portion including a puncture tip. The puncture device is configured to translate within the lumen. The puncture tip is substantially centered within the pre-formed distal portion when the pre-formed distal portion is in contact with the fossa ovale.

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 a device having electroanatomical mapping (EAM) and transseptal crossing capabilities. [Background Art]

[0002] Electroanatomical mapping (EAM) is an increasingly popular technique that is useful during in vivo procedures. This technique allows physicians to identify anatomical regions of the heart and patterns of electrical activation. This is particularly useful when treating arrhythmia. Devices compatible with EAM systems allow operators to localize the device and more easily target specific regions for treatment, enabling better workflow, better therapeutic efficacy, and shorter procedure times.

[0003] In the treatment of atrial fibrillation and other electrophysiology (EP) procedures, physicians typically need to gain access to the left side of the heart by puncturing and crossing the fossa ovalis (FO) under fluoroscopic image guidance. The introduction of electroanatomical mapping (EAM) technology can reduce or eliminate the use of fluoroscopy. However, this comes at the cost of increased complexity of devices and workflow. Mainly, for EAM-guided transseptal puncture (TSP), a map of the right atrium must first be generated before the puncture device can be positioned with high reliability. The need for a mapping catheter and additional exchanges to access the left atrium is a major obstacle to the adoption of EAM for TSP. [Summary of Invention]

[0004] Example 1 is a medical system for performing a procedure within a patient's heart. The system includes an elongated member having a proximal portion and a pre-formed distal portion. The pre-formed distal portion is configured to contact a portion of the fossa ovale of the heart. The elongated member includes a lumen extending from the proximal portion to the proximal position of the pre-formed distal portion. The system includes a puncture device having a proximal portion and a distal portion including a puncture tip, the puncture device being configured to translate within the lumen. The puncture tip is substantially centered on the pre-formed distal portion when the pre-formed distal portion is in contact with the fossa ovale.

[0005] Example 2 is the system of Example 1, wherein the pre-formed distal portion includes a loop, arch, or spiral. Example 3 is the system of Example 1, which includes a magnetic sensor in which an elongated member is configured to be electrically coupled to the EAM system.

[0006] Example 4 is a system of any of Examples 1 to 3, comprising a plurality of electrodes configured such that an elongated member is electrically coupled to the EAM system for mapping or locating the tissue surface.

[0007] Example 5 is the system of Example 4, wherein multiple electrodes are uniformly spaced apart along a pre-formed distal portion. Example 6 is the system of Example 4, in which multiple electrodes are positioned in pairs along a pre-formed distal portion.

[0008] Example 7 is a system of any of Examples 1 to 6, wherein the proximal portion of the elongated member is configured to connect to the EAM system. Example 8 is a system of any of Examples 1 to 7, wherein a pre-formed distal portion remains substantially linear in a constrained state and forms a loop, arch, or spiral in an unconstrained state.

[0009] Example 9 is a system of any of Examples 1 to 8, wherein the puncture tip is an RF electrode or a needle tip. Example 10 is a system of any of Examples 1 to 9, further comprising a dilator including a proximal dilator portion, a tapered distal portion, and a dilator lumen extending between the proximal dilator portion and the tapered distal portion.

[0010] Example 11 is the system of Example 10, wherein the dilator lumen is configured to restrain a pre-formed distal portion of an elongated member. Example 12 is a system of any of Examples 1 to 11, further comprising an outer hollow member configured to restrain a pre-formed distal portion of an elongated member.

[0011] Example 13 is a system of any of Examples 1 to 12, wherein the distal portion of the drilling device includes a curve. Example 14 is a system of any of Examples 1 to 13, wherein the pre-formed distal portion is configured to identify the fossa ovalis.

[0012] Example 15 is a system of any of Examples 1 to 14, wherein a pre-formed distal portion forms a loop, arch, or helix in an unconstrained state, and the loop, arch, or helix lies in a single plane.

[0013] Example 16 is a medical system for performing procedures within a patient's heart, comprising an elongated member having a proximal portion and a pre-formed distal portion. The pre-formed distal portion is configured to contact a portion of the fossa ovale of the heart. Multiple electrodes are positioned along the pre-formed distal portion, and the lumen extends from the proximal portion to a position proximal to the pre-formed distal portion. The system includes a puncture device having a proximal portion and a distal portion including a puncture tip. The puncture device is configured to translate within the lumen. The puncture tip is positioned substantially at the center of the pre-formed distal portion when the pre-formed distal portion is in contact with the fossa ovale.

[0014] Example 17 is the system of Example 16, wherein the pre-formed distal portion includes a loop, arch, or spiral. Example 18 is the system of Example 16, which includes a magnetic sensor in which an elongated member is configured to be electrically coupled to the EAM system.

[0015] Example 19 is the system of Example 16, wherein multiple electrodes are configured to be electrically coupled to the EAM system. Example 20 is the system of Example 19, wherein multiple electrodes are uniformly spaced along a pre-formed distal portion to map or locate the tissue surface.

[0016] Example 21 is the system of Example 19, in which multiple electrodes are positioned in pairs along a pre-formed distal portion. Example 22 is the system of Example 16, wherein the proximal portion of the elongated member is configured to connect to the EAM system.

[0017] Example 23 is the system of Example 16, wherein the pre-formed distal portion remains substantially linear in a constrained state and forms a loop, arch, or spiral in an unconstrained state.

[0018] Example 24 is the system of Example 16, wherein the puncture tip is an RF electrode or a needle tip. Example 25 is the system described in Example 16, further comprising a dilator including a proximal dilator portion, a tapered distal portion, and a dilator lumen extending between the proximal dilator portion and the tapered distal portion.

[0019] Example 26 is the system of Example 25, wherein the dilator lumen is configured to restrain a pre-formed distal portion of an elongated member. Example 27 is the system of Example 16, further comprising an outer hollow member configured to restrain a pre-formed distal portion of an elongated member.

[0020] Example 28 is the system of Example 16, wherein the distal portion of the piercing device comprises a curve. Example 29 is the system of Example 16, wherein the pre-formed distal portion is configured to identify the fossa ovalis.

[0021] Example 30 is the system of Example 16, wherein the pre-formed distal portion forms a loop, arch, or helix in an unconstrained state, and the loop, arch, or helix lies within a single plane.

[0022] Example 31 is a method for providing access to the left atrium of the heart. The method comprises advancing an elongate member having a pre-formed distal portion into the right atrium of the heart. A portion of the fossa ovalis of the heart is contacted with the pre-formed distal portion. A piercing device is advanced through a lumen of the elongate member, and the puncture tip of the piercing device is positioned substantially centrally within the pre-formed distal portion when the pre-formed distal portion is in contact with the fossa ovalis. The method comprises puncturing the fossa ovalis with the puncture tip.

[0023] Example 32 is the method of Example 31, further comprising mapping the right atrium using a plurality of electrodes on the pre-formed distal portion of the elongate member, wherein the plurality of electrodes are electrically coupled to an EAM system.

[0024] Example 33 is the method of Example 31, further comprising dilating the punctured fossa ovalis. Example 34 is a medical system for performing a procedure within a patient's heart, comprising an elongate member having a proximal portion and a preformed distal portion. The preformed distal portion forms a loop, an arch, or a spiral, and is configured to contact a portion of the fossa ovalis of the heart. A lumen extends from the proximal portion to a position proximal of the preformed distal portion. The system includes a piercing device having a proximal portion and a distal portion including a piercing tip. The piercing device is configured to translate within the lumen. The system includes a dilator having a dilator proximal portion, a tapered distal portion, and a lumen extending between the dilator proximal portion and the tapered distal portion. The piercing tip is located substantially at the center of the preformed distal portion when the preformed distal portion is in contact with the fossa ovalis.

[0025] Example 35 is the system of Example 34, wherein the dilator lumen is configured to constrain the preformed distal portion of the elongate member. While multiple embodiments have been disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following Detailed Description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and the Detailed Description are to be regarded as illustrative in nature rather than restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] [Figure 1] FIG. 1 illustrates an exemplary clinical setting for treating a patient and treating the patient's heart using an electrophysiology system, in accordance with an embodiment of the presently disclosed subject matter. [Figure 2A] FIG. 2A illustrates a device having EAM and transseptal crossing capabilities, in accordance with an embodiment of the present disclosure. [Figure 2B] FIG. 2B illustrates a device having EAM and transseptal crossing capabilities, in accordance with an embodiment of the present disclosure. [Figure 3] FIG. 3 shows the device of FIGS. 2A and 2B positioned within the right atrium of a patient's heart. [Figure 4]Figures 2A and 2B show a device during a portion of a transseptal passage procedure according to one embodiment of the present disclosure. [Figure 5] This describes a part of a transseptal passage procedure according to one embodiment of the present disclosure. [Figure 6] This describes a part of a transseptal passage procedure according to one embodiment of the present disclosure. [Figure 7] This disclosure shows a device having EAM and transseptal passage capabilities during a portion of a transseptal passage procedure, according to one embodiment of this disclosure. [Figure 8] This describes a part of a transseptal passage procedure according to one embodiment of the present disclosure. [Figure 9] This describes a part of a transseptal passage procedure according to one embodiment of the present disclosure. [Figure 10] This describes a part of a transseptal passage procedure according to one embodiment of the present disclosure. [Modes for carrying out the invention]

[0027] While the present invention is applicable to various modifications and alternative forms, specific embodiments are shown as examples in the drawings and described in detail below. However, the intention is not to limit the present invention to the specific embodiments described. On the contrary, the present invention is intended to encompass all modifications, equivalents, and alternative forms within the scope of the invention as defined by the appended claims.

[0028] Figure 1 shows an exemplary clinical setup 10 for treating a patient 20 and the patient 20's heart 30 using an electrophysiology system 50 according to an embodiment of the subject matter of this disclosure. The electrophysiology system 50 includes an access system 60 and an EAM system 70, the EAM system 70 including a localization field generator 80, a mapping and navigation controller 90 and a display 92. The clinical setup 10 also includes additional equipment such as an imaging device 94 (represented by a C-arm) and various controller elements such as a foot controller 96 configured to allow an operator to control various aspects of the electrophysiology system 50. As will be understood by those skilled in the art, the clinical setup 10 may have other components and arrangements of components not shown in Figure 1.

[0029] The access system 60 includes an expander 100 having a proximal portion 102 and a distal portion 105, an introducer sheath 110, and a console 130. In some embodiments, the distal portion 105 includes a tapered region. Furthermore, the access system 60 includes various connecting elements, such as cables and umbilicals, which operate to functionally connect the components of the access system 60 to each other and to the components of the EAM system 70. This arrangement of connecting elements is not critically important to the disclosure, and those skilled in the art will recognize that the various components described herein can be interconnected in various ways.

[0030] In some embodiments, the introducer sheath 110 is operable to provide a delivery conduit that can deploy the dilator 100, in whole or in part, its distal portion 105, to a specific target site within the patient's heart 30. In some embodiments, the sheath 110 provides a delivery conduit for medical devices other than the dilator 100. The dilator 100 is configured to have a lumen into which a guide device, such as a guidewire, or a puncture device, such as an RF puncture device, can be inserted. In some embodiments, a puncture device can be used to perform a transseptal passage procedure within the heart 30. It should be understood that different workflows may involve different operating sequences when positioning components such as the introducer sheath 110, dilator 100, and puncture device within the body at any given time. For example, in some procedures, the dilator 100 may or may not be present during access to the patient's heart 30.

[0031] Console 130 is configured to control the functional aspects of the access system 60. In embodiments, Console 130 includes one or more controllers, microprocessors, and / or computers that execute code from memory to control and / or perform the functional aspects of the access system 60. In embodiments, memory may be part of one or more controllers, microprocessors, and / or computers, and / or part of memory capacity accessible via a network such as the World Wide Web. In embodiments, Console 130 may include pulse generator hardware, software, and / or firmware configured to generate electrical pulses with a predetermined waveform, which can be transmitted to electrodes positioned on the expander 100, guide device, or puncture device to generate an electric field sufficient to achieve a desired clinical effect, such as ablation of target tissue by irreversible electroporation. In embodiments, Console 130 may deliver pulse waveforms in unipolar or bipolar operating modes, as will be described in further detail herein.

[0032] The EAM system 70 can operate to track the locations of various functional components of the access system 60 and generate high-fidelity three-dimensional anatomical and electroanatomical maps of the cardiac chambers of interest. In embodiments, the EAM system 70 may be the RHYTHMIA® HDx mapping system, which is commercially available from Boston Scientific Corporation. Also in embodiments, the mapping and navigation controller 90 of the EAM system 70 includes one or more controllers, microprocessors, and / or computers that execute code from memory to control and / or perform the functional aspects of the EAM system 70, and the memory may, in embodiments, be part of one or more controllers, microprocessors, and / or computers, and / or part of a memory capacity accessible via a network such as the World Wide Web.

[0033] As those skilled in the art will understand, the depiction of the electrophysiological system 50 shown in Figure 1 is intended to provide an overall overview of the various components of the system 50, and is not intended in any way to imply that this disclosure is limited in any way to any set of components or arrangement of components. For example, those skilled in the art will readily recognize that additional hardware components, such as breakout boxes, workstations, etc., may and likely be included in the electrophysiological system 50.

[0034] The EAM system 70 generates a localization field via a field generator 80 to define a localization volume around the heart 30, and one or more tracked devices, such as one or more position sensors or sensing elements on an expander 100, generate outputs that can be processed by a mapping and navigation controller 90 to track the position of the sensors in the localization volume and, consequently, the position of the corresponding devices. In the illustrated embodiment, device tracking is achieved using magnetic field tracking techniques, thereby the magnetic field generator 80 is a magnetic field generator that generates a magnetic field that defines the localization volume, and the position sensors on the tracked devices are magnetic field sensors.

[0035] In another embodiment, an impedance tracking method may be used to track the location of various devices. In such embodiments, the location field is an electric field generated, for example, by an external field generator array (e.g., surface electrodes), by an intracellular or intracardiac device (e.g., an intracardiac catheter), or both. In these embodiments, the location sensing element may constitute an electrode on the tracked device that generates an output received and processed by a mapping and navigation controller 90 in order to track the location of various location sensing electrodes within a location volume.

[0036] In some embodiments, the EAM system 70 has both magnetic tracking and impedance tracking capabilities. In such embodiments, impedance tracking accuracy can be improved by first creating a map of the electric fields induced by the electric field generator in the target cardiac chamber using a probe equipped with a magnetic position sensor, as is possible in some cases using the aforementioned RHYTHMIA HDx® mapping system. One exemplary probe is the INTELLAMAP ORION® mapping catheter, commercially available from Boston Scientific Corporation.

[0037] Regardless of the tracking method used, the EAM system 70 utilizes the positional information of various tracked devices, along with cardiac electrical activity acquired, for example, by the dilator 100 or another catheter or probe equipped with sensing electrodes, to generate a detailed three-dimensional geometric anatomical map or representation of the cardiac chambers, as well as an electroanatomical map in which the cardiac electrical activity of interest is superimposed on the geometric anatomical map, and displays these via the display 92. Furthermore, the EAM system 70 can generate graphic representations of various tracked devices within the geometric anatomical map and / or electroanatomical map.

[0038] Figures 2A and 2B show a system 200 having EAM and transseptal passage capability according to one embodiment of the present disclosure. The system 200 includes a catheter 205 comprising an elongated body having a pre-formed distal portion 207 and a proximal portion 209. The proximal portion 209 includes a connector 211 that allows the catheter 205 to be electrically connected to an EAM system 70.

[0039] The pre-formed distal portion 207 is configured to form a loop or a circle when unconstrained. In some embodiments, the pre-formed distal portion 207 is configured to form a helix. In some embodiments, the pre-formed distal portion 207 is configured to form an arch. The pre-formed distal portion 207 remains substantially linear when constrained, for example, by a lumen. In some embodiments, the shape of the pre-formed distal portion 207 can be changed or modified by one or more steering wires or push rods. For example, the size of the loop, circle, arch, or helix may be adjustable by acting on one or more steering wires or push rods.

[0040] The pre-formed distal portion 207 includes a distal tip portion 213. Multiple electrodes 215 are arranged along the pre-formed distal portion 207. In some embodiments, the multiple electrodes 215 are arranged in uniformly spaced pairs along the pre-formed distal portion 207. In some embodiments, the multiple electrodes 215 are evenly spaced along the pre-formed distal portion 207. In some embodiments, the multiple electrodes 215 extend proximal to the pre-formed distal portion 207 along the elongated body of the catheter 205. The multiple electrodes 215 are configured to be electrically connected to the EAM system 70 via a connector 211 for mapping portions of the patient's heart. In some embodiments, the connector 211 may include a cable or be configured to connect to a cable. The catheter 205 also includes a magnetic sensor 217 located proximal to the pre-formed distal portion 207.

[0041] The pre-formed distal portion 207 is configured to press against the flexible wall of the FO to distinguish it from the surrounding rigid tissue. This allows for a high level of reliability in determining the location of the FO. The loop of the pre-formed distal portion enables easily identifiable FO tenting on the EAM system 70. The EAM system 70 can map various surfaces of the heart.

[0042] The catheter 205 includes a lumen, which extends from a proximal portion 209 to an opening 219 located proximal to a pre-formed distal portion 207. The lumen is configured to allow fluid or a medical device to be discharged from or advanced out of the opening 219. The opening 219 is positioned to be centered in the pre-formed distal portion 207. Thus, while the pre-formed distal portion 207 presses against the FO and tentates the tissue, the medical device extending from the opening 219 is positioned at the geometric center of the structure formed by the pre-formed distal end 207. In some embodiments, the opening 219 is positioned off-center in the pre-formed distal portion 207. In this configuration, while the pre-formed distal portion 207 presses against the FO and tentates the tissue, the medical device extending from the opening 219 is positioned away from the geometric center of the structure formed by the pre-formed distal end 207.

[0043] In one embodiment, the puncture device 210 is configured to advance through a lumen and outward from an opening 219. The puncture device 210 includes a distal RF electrode 212 configured to be energized to puncture tissue, e.g., the patient's FO, during a transseptal puncture procedure. The puncture device 210 includes a proximal portion that can be electrically connected to an RF system to selectively energize the distal RF electrode 212. In some embodiments, the lumen includes an expandable nose to help support the puncture device 210 (e.g., an RF puncture wire) during FO puncture. This may include, for example, a hypotube that can extend outward from the lumen to support the puncture device 210. In some embodiments, the expandable hypotube is configured to have a sharp tip that can puncture tissue. In some embodiments, the puncture device 210 may include a needle having a sharp tip, in contrast to the distal RF electrode 212.

[0044] In some embodiments, the pre-formed distal portion 207 is formed as a balloon. The balloon may include a shape configured to press against the FO and to position one or more electrodes relative to the FO. The balloon is configured to have a central lumen, through which the puncture device 210 extends to puncture the target tissue.

[0045] Figures 3 to 6 are schematic diagrams of a medical procedure 100 in a patient's heart 30 utilizing a system 200 according to an embodiment of the present disclosure. As is known, the human heart 30 has four chambers: the right atrium 55, the left atrium 60, the right ventricle 65, and the left ventricle 70. The right atrium 55 and the left atrium 60 are separated by the atrial septum 75, and the right ventricle 65 and the left ventricle 67 are separated by the ventricular septum 82. As is also 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) 87.

[0046] The medical procedure 10 shown in Figures 3 to 6 is an exemplary embodiment for providing access to the left atrium 60 using a system 200 for subsequent deployment of a diagnostic and / or therapeutic device within the left atrium 60. As shown in Figures 3 to 6, the target tissue site may be defined by tissue on the atrial septum 75. In the illustrated embodiment, the target site is accessed via the IVC 85, for example, via the femoral vein, according to conventional catheterization techniques. In another embodiment, access to the target site on the atrial septum 75 may be achieved using an above approach, in which the system 200 is advanced into the right atrium 55 via the SVC 87.

[0047] In the illustrated embodiment, the system 200 includes an introducer sheath 110, a dilator 100 having a tapered distal tip portion 108, a radiofrequency (RF) puncture device 210, also known as a puncture device, having a distal end portion terminated with a tip electrode 212, and a catheter 205 having a pre-formed distal portion 207. As illustrated, in the assembled and used state shown in Figures 3 to 6, the RF puncture device 210 can be positioned within the catheter 205. In one embodiment in which the system 200 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 30. The sheath 110 can then be introduced into the femoral vein on the guidewire and advanced toward the heart 30. In one embodiment, the distal ends of the guidewire and sheath 110 are then positioned within the SVC 87. These steps can be performed using an imaging system, for example, fluoroscopy or ultrasound imaging. Next, the catheter 205 may be introduced into the sheath 110 and then into the SVC 87 through the sheath 110. Alternatively, the catheter 205 may be fully inserted into the sheath 110 before entering the body, and both may be advanced simultaneously toward the heart 30.

[0048] Subsequently, the user may extend the catheter 205 from the sheath 110 so that the pre-formed distal portion 207 achieves an unconstrained mapping configuration, such as a loop, arch, or spiral. A map of the right atrium can be created using multiple electrodes 215. The user may then position the pre-formed distal portion 207 relative to the atrial septum 75 for the purpose of locating the fossa ovalis for puncture or for mapping the tissue surface. The user may tent tissue using the pre-formed distal portion 207. The RF puncture device 210 is then extended outward through the lumen of the catheter 205 from the opening 219, so that the electrode 212 is substantially centered on the pre-formed distal portion 207 and aligned with the target site for puncture.

[0049] Once the tip electrode 212 is positioned at the target site, energy is delivered from an energy source, such as an RF generator, to the tip electrode 212 and the target site through the RF perforation device 210. In some embodiments, the energy is delivered with a voltage of at least about 75V (peak-to-peak) and a power of at least about 5W, which functions to vaporize cells in the vicinity of the tip electrode 212, thereby creating a void or perforation that penetrates the tissue at the target site. The user then applies force to the RF perforation device 210 to advance the tip electrode 212 through the perforation, at least partially. In these embodiments, energy delivery is stopped when the tip electrode 212 has passed through the target tissue, i.e., when the tip electrode 212 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.

[0050] With the tip electrode 212 of the RF puncture device 210 traversing the atrial septum 75, the catheter 205 can be withdrawn from the sheath 110. In some embodiments, the catheter 205 may include features such as score lines or perforations that allow the catheter to be detached from the RF puncture device 210. After the catheter 205 is removed, the dilator 100 can be advanced through the sheath 110 into the right atrium 55. The dilator 100 can then be advanced forward as indicated by the arrows in Figure 5, and the tapered distal tip portion 108 operates to gradually enlarge the perforation formed by the tip electrode 212, allowing the distal end of the sheath 110 to advance into the left atrium 60.

[0051] In some embodiments, the distal end portion of the RF puncture device 210 may be pre-formed to take on a non-traumatic shape, such as a J-shape (as shown in Figures 3–6), a pigtail shape, or other shape selected to guide the tip electrode 212 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 212 and tissue within the left atrium 60, and can also act to fix the distal end portion within the left atrium 60 during subsequent procedure steps. For example, in embodiments, the RF puncture device 210 may be structurally configured to function as a delivery rail for the deployment of a relatively large bore therapeutic delivery sheath and associated dilators (one or more). In such embodiments, the dilator 100 and sheath 110 are withdrawn following the deployment of the distal end portion of the RF puncture device 210 into the left atrium 60. A pre-formed fixation feature of the distal end portion prevents unintended retraction of the distal end portion and corresponding loss of access to the puncture site on the atrial septum 75 during such retraction.

[0052] Figures 7 to 10 show a system 320 having EAM and transseptal passage capability according to one embodiment of the present disclosure. The system 320 includes an introducer sheath 310, a dilator 300 having a tapered portion 308, and a catheter 305 having a preformed distal portion 307. The catheter 305 includes a plurality of electrodes 315 configured to be electrically connected to the EAM system 70 as described above, as well as a distal RF electrode 312. The dilator 300 includes a lumen 302 through which the catheter 305 is configured to translate. The lumen 302 is configured to restrain the preformed distal portion 307 of the catheter 305 while the system 320 advances through the patient's vascular system.

[0053] Figure 7 shows the system 320 in a mapping configuration. In Figure 7, the system 320 can be positioned at a desired location within the patient's heart, such as the right atrium. In one embodiment, the system 320 can be advanced together to the desired position. In another embodiment, the sheath 310 can be advanced along a guidewire or other guide member to the desired position. Following the removal of the guidewire or guide member, the dilator 300 can be advanced through the sheath 310 to that position, with or without the catheter 305. If not advanced together with the dilator 300, the catheter 305 can then be advanced through the lumen 302 of the dilator 300 to that position.

[0054] Once it reaches a desired location, for example, the right atrium, the catheter 305 extends from the dilator 300 and sheath 310, thereby causing the pre-formed distal portion 307 to take on a pre-formed curve. In a mapping configuration, the pre-formed distal portion 307 can be positioned relative to the target tissue to locate a portion of the target tissue or to map various tissue surfaces. In one embodiment, the target tissue is the fovea ovale (FO), as described above.

[0055] Figure 8 shows how the introducer sheath 310 is advanced after the FO is identified by the catheter 305. The introducer sheath 310 can help provide force for tenting the tissue of the atrial septum 75 and ensure that the identified tissue is not lost.

[0056] When the distal end of the introduction sheath 310 is pressed against the target tissue, the catheter 305 can be retracted into the dilator 300. Figure 9 shows the catheter 305 being retracted into the introduction sheath 310 and the dilator 300. The pre-formed distal portion 307 is constrained by the lumen 302 so that the pre-formed distal portion 307 is substantially straight. The catheter 305 is retracted until the distal RF electrode 312 can be positioned against the target tissue.

[0057] While keeping the sheath 310 stationary, the dilator 300 is advanced to the target tissue. As shown in Figure 10, the dilator 300 is advanced simultaneously with, or immediately after, the delivery of energy to the distal RF electrode 312. This allows the distal RF electrode 312 to puncture the FO and the tapered portion 308 of the dilator 300 to widen the puncture, thus enabling the sheath 310 to be advanced into the left atrium.

[0058] In some embodiments, the sheath 310, dilator 300, and / or catheter 305 include a number of notches machined into the wall, for example by laser cutting. The shape and positioning of the notches can allow for a flexible transition from the proximal to the distal portion. The notches may include a fractured helical shape or may be positioned substantially perpendicular to the longitudinal axis of the sheath 310, dilator 300, and / or catheter 305. In some embodiments, there is a single notch that wraps around the axis such that the spacing between loops is wider in the proximal portion and wider in the distal portion. The spacing and size of the notches can be varied to achieve different flexibility along the length of the sheath 310, dilator 300, and / or catheter 305.

[0059] In some embodiments, the pre-formed distal portion 307 of the catheter 305 is adjustable. The shape of the pre-formed distal portion 307 is altered by using one or more pull wires or push wires, or by forming the pre-formed distal portion 307 of a shape memory material such as a shape memory polymer or shape memory metal. This allows the pre-formed distal portion to have a first shape at a first temperature and a second shape at a second temperature. The shape transition may be initiated by inserting a heated solution into the catheter 305, or by heating a portion of the catheter 305 using electricity.

[0060] 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 present 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 present invention is intended to encompass all such alternative forms, modifications, and variations that fall within the claims, along with all their equivalents.

Claims

1. A medical system for performing procedures within a patient's heart, An elongated member having a proximal portion and a pre-formed distal portion, wherein the pre-formed distal portion is configured to contact a part of the fossa ovalis of the heart, and the lumen extends from the proximal portion to the proximal position of the pre-formed distal portion, A puncture device having a proximal portion and a distal portion including a puncture tip, configured to translate within the lumen, Equipped with, When the puncture tip is in contact with the fossa ovalis, the pre-formed distal portion is located substantially in the center of the pre-formed distal portion. Healthcare system.

2. The system according to claim 1, wherein the pre-formed distal portion includes a loop, an arch, or a spiral.

3. The system according to claim 1, wherein the elongated member includes a magnetic sensor configured to be electrically coupled to the EAM system.

4. The system according to any one of claims 1 to 3, wherein the elongated member includes a plurality of electrodes configured to be electrically coupled to the EAM system for mapping or locating the tissue surface.

5. The system according to claim 4, wherein the plurality of electrodes are uniformly spaced apart along the pre-formed distal portion.

6. The system according to claim 4, wherein the plurality of electrodes are positioned in pairs along the pre-formed distal portions.

7. The system according to any one of claims 1 to 6, wherein the proximal portion of the elongated member is configured to connect to the EAM system.

8. The system according to any one of claims 1 to 7, wherein the pre-formed distal portion remains substantially straight in a restrained state and forms a loop, arch, or spiral in an unrestrained state.

9. The system according to any one of claims 1 to 8, wherein the puncture tip is an RF electrode or a needle tip.

10. The system according to any one of claims 1 to 9, further comprising a dilator including a proximal dilator portion, a tapered distal portion, and a dilator lumen extending between the proximal dilator portion and the tapered distal portion.

11. The system according to claim 10, wherein the dilator lumen is configured to restrain the pre-formed distal portion of the elongated member.

12. The system according to any one of claims 1 to 11, further comprising an outer hollow member configured to restrain the pre-formed distal portion of the elongated member.

13. The system according to any one of claims 1 to 12, wherein the distal portion of the drilling device includes a curve.

14. The system according to any one of claims 1 to 13, wherein the pre-formed distal portion is configured to identify the fossa ovalis on an electroanatomical map.

15. The system according to any one of claims 1 to 14, wherein the pre-formed distal portion forms a loop, arch, or spiral in an unconstrained state, and the loop, arch, or spiral lies in a single plane.

16. A medical system for performing procedures within a patient's heart, An elongated member having a proximal portion, a pre-formed distal portion configured to contact a part of the fossa ovalis of the heart, a plurality of electrodes positioned along the pre-formed distal portion, and a lumen extending from the proximal portion to the proximal position of the pre-formed distal portion, A puncture device having a proximal portion and a distal portion including a puncture tip, configured to translate within the lumen, Equipped with, When the puncture tip is in contact with the fossa ovalis, the pre-formed distal portion is located substantially in the center of the pre-formed distal portion. system.

17. The system according to claim 16, wherein the pre-formed distal portion includes a loop, an arch, or a spiral.

18. The system according to claim 16, wherein the elongated member includes a magnetic sensor configured to be electrically coupled to the EAM system.

19. The system according to claim 16, wherein the plurality of electrodes are configured to be electrically coupled to an EAM system for mapping or locating a tissue surface.

20. The system according to claim 19, wherein the plurality of electrodes are uniformly spaced apart along the pre-formed distal portion.

21. The system according to claim 19, wherein the plurality of electrodes are positioned in pairs along the pre-formed distal portions.

22. The system according to claim 16, wherein the proximal portion of the elongated member is configured to connect to the EAM system.

23. The system according to claim 16, wherein the pre-formed distal portion remains substantially linear in a constrained state and forms a loop, arch, or spiral in an unconstrained state.

24. The system according to claim 16, wherein the puncture tip is an RF electrode or a needle tip.

25. The system according to claim 16, further comprising a dilator including a proximal dilator portion, a tapered distal portion, and a dilator lumen extending between the proximal dilator portion and the tapered distal portion.

26. The system according to claim 25, wherein the dilator lumen is configured to restrain the pre-formed distal portion of the elongated member.

27. The system according to claim 16, further comprising an outer hollow member configured to restrain the pre-formed distal portion of the elongated member.

28. The system according to claim 16, wherein the distal portion of the drilling device includes a curve.

29. The system according to claim 16, wherein the pre-formed distal portion is configured to identify the fossa ovalis.

30. The system according to claim 16, wherein the pre-formed distal portion forms a loop, arch, or helix in an unconstrained state, and the loop, arch, or helix lies in a single plane.

31. A method for providing access to the left atrium of the heart, The process involves advancing an elongated member having a pre-formed distal portion into the right atrium of the heart, The aforementioned distal portion is brought into contact with a part of the fossa ovale of the heart, The method involves advancing the puncture device through the lumen of the elongated member such that the puncture tip of the puncture device is positioned substantially at the center of the pre-formed distal portion when the pre-formed distal portion is in contact with the fossa ovalis. The puncture tip is used to puncture the fossa ovalis, Methods that include...

32. The method according to claim 31, further comprising mapping the right atrium using a plurality of electrodes on the pre-formed distal portion of the elongated member, wherein the plurality of electrodes are electrically coupled to an EAM system.

33. The method according to claim 31, further comprising expanding the punctured fossa ovalis.

34. A medical system for performing procedures within a patient's heart, An elongated member having a proximal portion, a pre-formed distal portion, and a puncture tip, wherein the pre-formed distal portion is configured to form a loop, arch, or spiral and contact a portion of the fossa ovalis of the heart, A dilator comprising a proximal portion, a tapered distal portion, and a lumen extending between the proximal portion and the tapered distal portion, Equipped with, The dilator lumen is configured to restrain the pre-formed distal portion of the elongated member. system.

35. The system according to claim 34, wherein the puncture tip includes an RF electrode.

Images