Tissue aspiration using a highly articulated microcatheter and an electrically activated guidewire.

Abstract

To provide a transseptal puncture system.SOLUTION: A microcatheter with a guidewire therein can be steered to target tissue, then the target tissue can be punctured with the guidewire to create a transseptal puncture. The microcatheter can have a diameter substantially smaller than known sheaths which are typically used to guide a needle to a target puncture site in known transseptal puncture treatments. The guidewire can have an atraumatic, electrically conductive distal end that can be electrically energized to puncture the target tissue. Once the guide wire is thereacross, ancillary devices such as a dilator and a sheath can be delivered onto the guide wire across the transseptal puncture. A sensor can include one or more sensors. A navigation module can use the electrically conductive distal end as a reference electrode to the location sensors of the microcatheter.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of priority under 35 U.S.C. § 119 to U.S. Provisional Patent Application No. 63 / 190,865, filed on May 20, 2021, which is incorporated herein by reference in its entirety as if fully set forth herein.

[0002] (Field of the Invention) The present invention relates to methods and devices for performing diagnostic and / or therapeutic procedures on tissues and organs. More specifically, it relates to methods and devices for perforation procedures such as transseptal perforation procedures.

Background Art

[0003] In medical procedures involving a patient's heart, there are many diagnostic and therapeutic procedures, including transseptal left - heart catheterization, i.e., catheterization through the left atrium. The transseptal approach provides access for both interventional cardiologists performing antegrade mitral balloon valvuloplasty and cardiac electrophysiologists ablating left - sided accessory conduction pathways or performing catheter - based atrial fibrillation treatment strategies.

[0004] Currently, transseptal puncture generally includes (1) positioning a guidewire in the right atrium, (2) advancing a transseptal sheath containing a dilator into the right atrium on the guidewire, (3) delivering the needle through the dilator until the distal end of the needle is within a short distance of the dilator's distal end, (4) manipulating the sheath and dilator until the distal end of the dilator is pressed against the target tissue, (5) moving the distal end of the needle through the tissue from the dilator to puncture the tissue, and (6) moving the dilator and sheath into the left atrium through the punctured tissue. In this process, the dilator, transseptal sheath, and / or needle may have some predefined curvature at their respective distal ends to assist in positioning the system for puncture. Procedures using simpler systems typically rely on fluoroscopy to visualize the system's position and mechanical feedback to verify the position before puncture (e.g., feeling a "click" when the dilator tip crosses a tissue ridge). More advanced systems, with navigation sensors that can be reshaped during positioning and sheaths with distal curvature (e.g., CARTO VIZIGO® bidirectional guide sheaths), can reduce reliance on fluoroscopy and provide greater mechanical control of the system.

[0005] U.S. Patent Publication No. 2004 / 0220471 (which is disclosed in its entirety and incorporated herein as adjunct to its priority application, U.S. Patent Application No. 63 / 190,865) discloses a method and apparatus for transseptal accelerating using a position system. During transseptal puncture, once the fossa ovale is located, a penetration device, such as a HEARTSPAN® transseptal needle, is delivered to the fossa ovale through the vascular system via a sheath, such as a PREFACE® sheath. The penetration device then exits the sheath and punctures the fossa ovale. HEARTSPAN® transseptal needles and PREFACE® sheaths are available from Biosense Webster, Johnson and Johnson Company.

[0006] In many current procedures, the needles used in the aforementioned procedures are mechanical needles with sharp ends, and structures that rely on electrical energy for puncture are an option. U.S. Patent Publication No. 2012 / 0232546, U.S. Patent No. 8,235,986, U.S. Patent No. 10,065,032, and U.S. Provisional Patent Application No. 63 / 046,266, filed July 7, 2020 (each of which is disclosed in its entirety herein and is attached to the priority application U.S. Patent Application No. 63 / 190,865), each disclose a puncture device that relies on electrical energy (e.g., high frequency) for puncture. [Overview of the project] [Means for solving the problem]

[0007] A system and method for transseptal puncture is disclosed herein, comprising maneuvering a microcatheter having a guidewire inside to a target puncture site, and then puncturing the target puncture site with the guidewire. The microcatheter may have a substantially smaller diameter than known sheaths typically used to guide a needle to a target puncture site in known procedures. The guidewire may have a non-traumatic conductive distal end that can be energized to puncture tissue for transseptal puncture. As the guidewire traverses, auxiliary devices such as dilators and sheaths may be delivered on the guidewire across the transseptal puncture. Alternatively, the microcatheter may have a tapered distal end to function as a dilator, and the sheath may be delivered directly on the microcatheter. The microcatheter may further include one or more position sensors. In some examples, a mapping / navigation module may utilize the conductive distal end of the guidewire as a reference electrode for the microcatheter's position sensor.

[0008] An exemplary transseptal puncture system may include a maneuverable microcatheter, a guidewire, and a generator. The maneuverable microcatheter may include an elongated member having a lumen extending through its interior to define a longitudinal axis, a deflectable distal portion, and a position sensor positioned adjacent to the deflectable distal portion. The guidewire may be positioned within the lumen of the microcatheter. The guidewire may have a conductive core, a conductive distal end, a conductive proximal end, and an outer diameter smaller than, and approximately equal to, the inner diameter of the lumen of the elongated member of the microcatheter. The generator may be in electrical contact with the conductive proximal end of the guidewire. The generator may be configured to provide sufficient electrical energy to the distal end of the guidewire to puncture tissue, so that tissue is punctured without requiring the sharp end of a needle.

[0009] An exemplary transseptal puncture system may further include a navigation module electrically connected to a position sensor. The navigation module may be configured to determine the position of the distal end of a microcatheter in the heart, at least partially based on the position sensor with reference to the conductive distal end of a guidewire.

[0010] An exemplary transseptal puncture system may further include a dilator and a sheath. The dilator may have a lumen that is larger than and approximately equal to the inner diameter of the lumen of the microcatheter. The sheath may be configured to advance over the dilator. Alternatively, the microcatheter may have a tapered distal end and function as a dilator. When the system is configured in this way, the tapered distal end of the microcatheter may have a distal outer diameter that is larger than and approximately equal to the outer diameter of the guidewire, and a proximal outer diameter that is smaller than and approximately equal to the inner diameter of the lumen of the sheath.

[0011] A maneuverable microcatheter may further include one or more pull wires connected to its distal portion. At least one of the pull wires can be pulled to deflect the distal portion relative to the longitudinal axis.

[0012] An exemplary transseptal puncture system may further include an impedance monitoring module that communicates with a generator, which is electrically connected to the proximal end of the guidewire and configured to measure impedance at the distal end of the guidewire. The generator may be configured to supply electrical energy to the distal end of the guidewire based at least in part on the impedance measured by the impedance monitoring module.

[0013] An exemplary transseptal puncture system may further include a mapping module configured to generate a map of at least a portion of the atrial septum using a position sensor. The position sensor may include a magnetic coil. Additionally or alternatively, the position sensor may include an exposed electrode, the system may include one or more body patches, and the navigation module may be configured to determine the position of the distal end of a microcatheter in the heart based at least in part on the impedance between the body patch and the exposed electrode of the position sensor.

[0014] Another exemplary transseptal puncture system may include a maneuverable microcatheter, a guidewire, and a navigation module. The maneuverable microcatheter may have an elongated tubular member having a longitudinal axis, a deflectable distal portion, and a lumen extending through it to define a position sensor positioned close to the distal portion along the longitudinal axis. The guidewire may have a portion positioned within the lumen of the microcatheter. The guidewire may have a conductive core, a conductive distal end, and a conductive proximal end. The navigation module may be configured to determine the position of the distal end of the microcatheter, at least partially based on the position sensor with reference to the distal end of the guidewire.

[0015] The guidewire can have an outer diameter that is smaller than the inner diameter of the lumen of the microcatheter and approximately equal to it.

[0016] An exemplary transseptal puncture system may further include a dilator having a lumen larger than and approximately equal to the inner diameter of the lumen of the microcatheter. An exemplary transseptal puncture system may further include a sheath configured to advance over the dilator. Alternatively, the microcatheter may have a tapered distal end and function as a dilator. When the system is configured in this way, the tapered distal end of the microcatheter may have a distal outer diameter larger than and approximately equal to the outer diameter of the guidewire, and a proximal outer diameter smaller than and approximately equal to the inner diameter of the lumen of the sheath.

[0017] An exemplary transseptal puncture system may further include a generator in electrical contact with the conductive proximal end of a guidewire. The generator may be configured to supply electrical energy to the conductive core of the guidewire through the conductive core of the guidewire, sufficient to puncture the tissue without requiring the sharp end of a needle.

[0018] An exemplary transseptal puncture system may further include an impedance monitoring module that communicates with a generator, which is electrically connected to the proximal end of the guidewire and configured to measure impedance at the distal end of the guidewire. The generator may be configured to supply electrical energy to the distal end of the guidewire based at least in part on the impedance measured by the impedance monitoring module.

[0019] A maneuverable microcatheter may further include a pull wire configured to deflect a deflectable distal portion.

[0020] The position sensor may include a magnetic coil.

[0021] The position sensor may include exposed electrodes. The system may include one or more body patches. The navigation module may be configured to determine the position of the distal end of a microcatheter in the heart, at least partially based on the impedance between the body patch and the exposed electrodes of the position sensor.

[0022] Exemplary methods for transseptal puncture may include one or more of the following steps, performed in various sequences with additional steps, as can be understood by those skilled in the art: A maneuverable microcatheter and guidewire may be positioned in the right atrium such that the conductive distal end of the guidewire is positioned close to the distal end of the maneuverable microcatheter and exposed to blood. The position of the distal end of the microcatheter may be determined at least in part on the position sensor of the microcatheter. The distal end of the microcatheter may be steered toward the target tissue so that the distal end of the guidewire can be brought into contact with the target tissue. While the distal end of the guidewire is in contact with the target tissue, electrical energy may be applied into the target tissue through the conductive core of the guidewire and through the distal tip of the guidewire. While applying electrical energy, the guidewire may be advanced through the target tissue so that its distal end is in the left atrium.

[0023] This method may further include advancing the dilator and sheath over a guidewire and through target tissue while the sheath is over the dilator. Alternatively, a microcatheter may be advanced over a guidewire, an opening through target tissue may be dilated by the microcatheter, and the sheath may be advanced through the opening while the sheath is over the microcatheter.

[0024] An exemplary method may further include using a position sensor to map at least a portion of the atrial septum.

[0025] The exemplary method can further include determining the position of the distal end of the microcatheter at least partially based on the position sensor of the microcatheter with reference to the distal end of the guidewire.

[0026] The exemplary method can further include measuring impedance at the distal end of the guidewire. The exemplary method can further include determining the position of the distal end of the guidewire at least partially based on the impedance. The exemplary method can further include detecting contact with tissue at least partially based on the impedance. The exemplary method can further include initiating the application of electrical energy at least partially based on the impedance. The exemplary method can further include terminating the application of electrical energy at least partially based on the impedance.

[0027] The exemplary method can further include advancing the distal end of the microcatheter across the target tissue into the left atrium.

[0028] The exemplary method can further include measuring the pressure in the left atrium through the lumen of the microcatheter.

[0029] The exemplary method can further include injecting a fluoroscopic contrast agent through the lumen of the microcatheter.

[0030] The exemplary method can further include operating the pull wire of the microcatheter to deflect the compression coil, thereby maneuvering the distal end of the microcatheter.

[0031] The position sensor can include an electromagnetic sensor. The position sensor can include three electromagnetic sensors.

[0032] An exemplary method may further include determining the position of the distal end of a microcatheter in the heart based at least partially on the impedance between a body patch and the exposed electrode of a position sensor. [Brief explanation of the drawing]

[0033] The above and further aspects of the present invention are further discussed below with reference to the accompanying drawings, where similar figures in various drawings indicate similar structural elements and features. The drawings are not necessarily to scale and are primarily intended to illustrate the principles of the present invention. The figures depict one or more implementations of the device of the present invention, not as limitations but merely as examples. [Figure 1] This is a diagram illustrating an exemplary transseptal puncture system according to an embodiment of the present invention. [Figure 2A] This is a diagram of an exemplary transseptal puncture system component having an alternative, maneuverable microcatheter shape according to an aspect of the present invention. [Figure 2B] Figure 2A is a cross-sectional view of the components of an exemplary transseptal puncture system. [Figure 3A] These are a series of diagrams illustrating exemplary methods for transseptal puncture according to aspects of the present invention. [Figure 3B] These are a series of diagrams illustrating exemplary methods for transseptal puncture according to aspects of the present invention. [Figure 3C] These are a series of diagrams illustrating exemplary methods for transseptal puncture according to aspects of the present invention. [Figure 3D] These are a series of diagrams illustrating exemplary methods for transseptal puncture according to aspects of the present invention. [Figure 3E] These are a series of diagrams illustrating exemplary methods for transseptal puncture according to aspects of the present invention. [Figure 3F] These are a series of diagrams illustrating exemplary methods for transseptal puncture according to aspects of the present invention. [Figure 3G] These are a series of diagrams illustrating exemplary methods for transseptal puncture according to aspects of the present invention. [Figure 3H]These are a series of diagrams illustrating exemplary methods for transseptal puncture according to aspects of the present invention. [Figure 3I] These are a series of diagrams illustrating exemplary methods for transseptal puncture according to aspects of the present invention. [Figure 4A] This is a series of diagrams illustrating alternative steps for an exemplary method of transseptal puncture according to an aspect of the present invention. [Figure 4B] This is a series of diagrams illustrating alternative steps for an exemplary method of transseptal puncture according to an aspect of the present invention. [Figure 4C] This is a series of diagrams illustrating alternative steps for an exemplary method of transseptal puncture according to an aspect of the present invention. [Figure 5] This is a flowchart outlining the steps of an exemplary method for transseptal puncture according to an aspect of the present invention. [Figure 6] This is a diagram of a transseptal perforation procedure according to an embodiment of the present invention. [Modes for carrying out the invention]

[0034] As used herein, the terms “about” or “approximately” for any number or range of numbers indicate a suitable dimensional tolerance that enables a part or set of components to function in accordance with its intended purpose as described herein. More specifically, “about” or “approximately” may refer to a range of values ​​within ±20% of the listed values, for example, “about 90%” may refer to a range of values ​​between 71% and 99%.

[0035] As used herein, the terms “component,” “module,” “system,” “server,” “processor,” and “memory” are intended to include one or more computer-related units, such as hardware, firmware, hardware-software combinations, software, or running software, but are not limited to these. For example, a component may be a process, object, executable execution thread, program, and / or computer running on a processor, but is not limited to these. Exemplary examples include applications and computing devices running on computing devices, both of which can be components. One or more components may reside within a running process and / or thread, and components may be localized on one computer and / or distributed across two or more computers. Furthermore, these components may be executed from various computer-readable media having various data structures stored thereon. Components may communicate by local and / or remote processes according to signals having one or more data packets, such as data from one component interacting with another component in a local system, in a distributed system, and / or across a network such as the Internet with other systems via signals. Computer-readable media may be non-transient. Non-temporary computer-readable media include, but are not limited to, random-access memory (RAM), read-only memory (ROM), electronically erasable programmable ROM (EEPROM), flash memory or other memory technologies, compact disk ROM (CD-ROM), digital multipurpose disk (DVD) or other optical storage devices, magnetic cassettes, magnetic tapes, magnetic disk storage devices or other magnetic storage devices, or any other tangible physical media that can be used to store computer-readable instructions and / or data.

[0036] As used herein, the term “computing system” is intended to include standalone machines or devices, and / or combinations of machines, components, modules, systems, servers, processors, memory, detectors, user interfaces, computing device interfaces, network interfaces, hardware elements, software elements, firmware elements, and other computer-related units. For example, a computing system may include, but is not limited to, one or more general-purpose computers, dedicated computers, processors, portable electronic devices, portable electronic medical devices, fixed or semi-fixed electronic medical devices, or other electronic data processing devices.

[0037] As used herein, the term "microcatheter" refers to a catheter with a smaller diameter compared to catheters used in cardiovascular applications, i.e., a diameter of 8 French or less.

[0038] As used herein, the term “needle” refers to a structure having a sharp, pointed end designed to puncture tissue.

[0039] As used herein, the term “non-transient computer-readable medium” includes, but is not limited to, random-access memory (RAM), read-only memory (ROM), electronically erasable programmable ROM (EEPROM), flash memory or other memory technologies, compact disk ROM (CD-ROM), digital purpose disc (DVD) or other optical storage devices, magnetic cassettes, magnetic tapes, magnetic disk storage devices or other magnetic storage devices, or any other tangible physical medium that can be used to store computer-readable information.

[0040] As used herein, the term "radiofrequency" (RF) is used to refer to alternating current flowing through a conductor.

[0041] As used herein, the terms “tubular” and “tube” shall be interpreted broadly and shall not be limited to a right cylindrical structure, a structure with a strictly circular cross-section, or a structure with a uniform cross-section over its entire length. For example, a tubular structure or tubular system is generally illustrated as a substantially right cylindrical structure. However, a tubular system may have a tapered or curved outer surface without departing from the scope of this disclosure.

[0042] In current transseptal puncture procedures, achieving the desired precision in puncture location and angle can be difficult. Large sheaths and dilators can be difficult to position precisely, and rigid needles can deflect the sheath and dilator as the needle moves distally through the sheath and dilator and is forced against the tissue. In some examples illustrated herein, exemplary transseptal puncture systems are used to perform transseptal puncture more safely and / or accurately. In some examples, transseptal puncture systems may require larger, faster, and / or less puncture force than many current transseptal puncture systems.

[0043] Figure 1 shows an exemplary transseptal puncture system 100. The system 100 includes a guidewire 110, a microcatheter 130, a generator 180, a return pad 198, a mapping / navigation module 160, and an intraluminal module 170.

[0044] The guidewire 110 may have a solid conductive core 116 and an insulating jacket 118. The distal end 114 and proximal end 112 of the guidewire 110 do not necessarily have to be insulated, and as a result, an electrical contact can be formed from the proximal end 112 through the conductive core 116 to the distal end 114. Alternatively, the guidewire 110 does not need to include an insulating jacket 118.

[0045] The generator 180 can be electrically connected to the proximal end 112 of the guidewire 110 via an easily attachable connector / cable, and can use RF energy to provide an electrical signal via the core 116 of the guidewire to the distal end 114 of the guidewire sufficient to puncture tissue without requiring a needle or sharp end. The generator 180 can provide an RF signal to the distal end 114 of the guidewire 110 that spreads from the distal end 114 through the patient's body to the return pad 198. To help facilitate use cases, the generator 180 may include an impedance monitoring module 181 configured to measure impedance at the distal end 114 of the guidewire 110. The generator 180 can be configured to provide electrical energy to the distal end 114 of the guidewire 110 based at least in part on the impedance measured by the impedance monitoring module 181. Additionally or alternatively, the generator 180 may be configured to provide electrical energy to the distal end 114 of the guidewire 110 based on a fixed predetermined time.

[0046] The microcatheter 130 has a lumen 138 in which the guidewire 110 is positioned. The microcatheter 130 is aligned along the longitudinal axis LL. The microcatheter 130 may have a deflectable distal portion near the distal end 134 of the microcatheter 130. The microcatheter 130 may have one or more position sensors 136 positioned on the distal portion. The position sensors 136 may include one or more magnetic coils and / or one or more impedance sensors.

[0047] The mapping / navigation module 160 can be electrically contacted with the position sensor 136, for example, via one or more conductors extending longitudinally through the microcatheter 130 from the position sensor 136 to the proximal end 132 of the microcatheter 130. The navigation module 160 can be configured to determine the position and / or orientation of the distal portion of the microcatheter 130 based at least in part on the electrical signal from the position sensor 136 of the microcatheter 130. The navigation module 160 can function in standalone or hybrid modes as described in U.S. Patent No. 8,456,182 incorporated herein by reference and may include an electrical tracking subsystem and / or a magnetic position tracking subsystem, as stipulated in priority application U.S. Patent No. 63 / 190,865 or as understood by those skilled in the art. The navigation module 160 can be further electrically contacted with the proximal end 112 of the guidewire 110, and the distal end 114 of the guidewire can be used as a reference electrode for the position sensor 136.

[0048] Additionally or alternatively, the guidewire 110 may include one or more position sensors configured as described in relation to position sensor 136.

[0049] The intraluminal module 170 can communicate with the lumen 138 of the microcatheter 130. The intraluminal module 170 can be configured to perform intraluminal steps as understood by those skilled in the art, such as sensing pressure and / or supplying fluid through the lumen 138 of the microcatheter 130.

[0050] Figure 2A is a diagram of the components of the exemplary transseptal puncture system 100 shown in Figure 1, except that the maneuverable microcatheter 130a has a tapered distal portion 135. The microcatheter 130a shown in Figure 2A is molded to function as a dilator, or it may otherwise be configured.

[0051] Figure 2B is a cross-sectional view of the system 100 shown in Figure 2A.

[0052] Referring together to Figures 2A and 2B, the microcatheter 130a may have a distal outer diameter (DODC) that is larger than and approximately equal to the outer diameter (ODG) of the guidewire. The microcatheter 130a may have a proximal outer diameter (PODC) that is smaller than and approximately equal to the inner diameter (IDS) of the sheath. The microcatheter 130 shown in Figure 1 can be configured similarly to the microcatheter 130a shown in Figures 2A and 2B, except that the proximal outer diameter (PODC) is smaller, as the microcatheter 130 does not need to function as a dilator in some applications. The microcatheters 130 and 130a may include a pull wire 131 that can be used to pull the distal portion of the microcatheter 130 and 130a so as to deflect it from the longitudinal axis LL. The pull wire 131 can be fixed to the body of the microcatheter 130a by a pull wire anchor 139. The microcatheters 130 and 130a may include one or more sensor wires 137 electrically connected to a position sensor 136. The microcatheters 130 and 130a may include a braided layer 140. The microcatheters 130 and 130a may include one or more fluid / irrigation ports 133. The tapered distal end 135 of the microcatheter 130a may be fused to the shaft of the microcatheter 130a.

[0053] The guidewire 110 may include an insulating jacket 118 over most of the conductive core 116 of the guidewire 110. The insulating jacket 118 can define the outer diameter (ODG) of the guidewire 110. When the guidewire 110 lacks the insulating jacket 118, the conductive core 116 can define the outer diameter (ODG) of the guidewire 110. The microcatheters 130, 130a may have an inner diameter (IDC) in the lumen 138 of the microcatheters 130, 130a that is larger than and approximately equal to the outer diameter (ODG) of the guidewire 110. The lumen 138 of the microcatheters 130, 130a can be tapered such that the inner diameter (IDC) of the microcatheters 130, 130a becomes smaller at the distal end of the microcatheters 130, 130a. The outer diameter (ODG) of the guidewire 110 and the inner diameter (IDC) of the microcatheters 130, 130a can be sized so that the guidewire 110 is held snugly in the lumen 138 of the microcatheters 130, 130a, so that the manipulation of the microcatheters 130, 130a accurately controls the positioning of the distal end 114 of the guidewire 110. Preferably, the outer diameter (ODG) of the guidewire 110 and the inner diameter (IDC) of the microcatheters 130, 130a are sized to allow longitudinal translation of the guidewire 110 within the lumen 138 of the microcatheters 130, 130a. The microcatheters 130, 130a may have an outer diameter (ODG) of about 8 French or less. The guidewire 110 preferably has an outer diameter (ODG) of about 0.032 inches (0.81 mm) to about 0.014 inches (0.36 mm). The microcatheters 130 and 130a preferably have an inner diameter (IDC) of about 0.036 inches (0.91 millimeters) to about 0.04 inches (1 millimeter).

[0054] Figures 3A to 3H are a series of diagrams illustrating exemplary methods for transseptal puncture. Figures 3A to 3H are shown with a low-profile maneuverable microcatheter 130, as shown in Figure 1. Figures 3A to 3G can also be performed in a similar manner to the maneuverable microcatheter 130a having a tapered distal portion 135, as shown in Figures 2A and 2B.

[0055] Figure 3A shows the microcatheter 130 and guidewire 110 traversing the inferior vena cava 22 so that the distal portion of the microcatheter 130 and the guidewire 110 are positioned within the right atrium 12. The distal end 114 of the guidewire 110 is exposed to blood.

[0056] Figure 3B shows the distal portion of the deflected microcatheter 130. In some procedures, the microcatheter 130 can be deflected around the right atrium 12 and moved to map the right atrium. The navigation / mapping module 160 can receive electrical signals from the microcatheter position sensor 136 to map portions of the right atrium 12. For example, the microcatheter 130 can be maneuvered to map a portion of the septal wall 18 of the right atrium 12 to locate the fossa ovalis 16, and the ideal placement of the puncture site is specific to the procedure being performed. In some examples, the navigation / mapping module 160 can receive electrical signals from the conductive distal end 114 of the guidewire 110 and from the position sensor 136, so that the distal end 114 of the guidewire 110 is used as a reference electrode for the position sensor 136.

[0057] Figure 3C shows a microcatheter 130 being maneuvered so that the conductive distal end 114 of the guidewire 110 is positioned in the target tissue, namely the septal wall 18 in the fossa ovalis 16.

[0058] Figure 3D shows a magnified view of the conductive distal end 114 of the guidewire 110 approaching the fossa ovalis 16. As oriented in the figure, the fossa ovalis 16 is aligned with the parallel axis PP and perpendicular to the transverse axis TP. The distal portion of the microcatheter 130 can be positioned and deflected at a desired location on the fossa ovalis 16 at a desired approach angle with respect to the parallel axis PP, allowing it to traverse axis TP.

[0059] As the conductive distal end 114 of the guidewire 110 approaches the tissue of the fossa ovalis 16, the impedance at the distal end 114 can be monitored by the impedance monitoring module 181. When the distal end 114 of the guidewire is sufficiently far from the tissue, the pre-contact impedance can be detected by the impedance monitoring module 181 when it is known to be in contact with blood via mapping, fluoroscopy, or other means. When the distal end 114 of the guidewire 110 is in contact with the tissue, the tissue impedance can be detected by the impedance monitoring module 181. Contact of the distal end 114 of the guidewire 110 with the tissue can be detected by the impedance monitoring module 181 as a change in impedance from pre-contact impedance to tissue impedance, and as impedance after penetration of the fossa ovalis tissue 16.

[0060] Figure 3E shows the distal end 114 of the guidewire 110 positioned within the tissue. Electrical energy is applied by the generator 180 to the conductive distal end 114 of the guidewire 110 to ablate or otherwise shape the damaged tissue 17 around the distal end 114 of the guidewire 110.

[0061] Mechanically, the distal end 114 of the guidewire can be non-traumatic. That is, it can lack a traumatic or sharp end so that there is no application of electrical energy from the generator 180, and the guidewire 110 cannot puncture tissue. The system 100 does not need a needle to puncture tissue. The distal end 114 of the guidewire 110 can have a hemispherical, flat, dome-shaped, or other such non-traumatic shape as illustrated. In contrast, U.S. Patent No. 10,413,707 (incorporated herein by reference and attached to priority application U.S. Patent No. 63 / 190,865) discloses a guidewire having a puncture end configured to mechanically puncture tissue without the application of electrical energy. The guidewire 110 of this disclosure does not need to have such a puncture end for puncturing tissue because tissue puncture can be achieved by applying electrical energy to the distal end 114 of the guidewire 110.

[0062] Figure 3F shows the distal end 114 of the guidewire 110 exiting the tissue and entering the left atrium 14. In some examples, the tissue impedance can be monitored by the impedance monitoring module 181, while the distal end 114 of the guidewire 110 moves through the tissue. The change in impedance from tissue impedance to post-contact impedance detected by the impedance monitoring module 181 can indicate that the distal end 114 has entered the left atrium 14. The generator 180 can stop applying electrical energy in response to the change in impedance detected by the impedance monitoring module 181 when the distal end 114 enters the left atrium 14.

[0063] Additionally or alternatively, the generator 180 may stop applying electrical energy in response to the time elapsed from the start time. The time when the distal end 114 of the guidewire first contacts the tissue of the fossa ovale 16 is detected by the impedance monitoring module 181 and can be recorded or otherwise used as the start time, which is used as a reference for when to terminate the application of electrical energy from the generator 180. Alternatively, the start time can be determined based on the initial application of electrical energy from the generator 180 to the distal end 114 of the guidewire 110. The supply of electrical energy from the generator 180 can be terminated when a predetermined time has elapsed after the start time. In some examples, the predetermined time can be set to a height of about 2 seconds. However, during most procedures, the crossover can be completed within 1 millisecond, and therefore the predetermined time can be set to about 1 to 10 milliseconds.

[0064] Figure 3G shows the guidewire 110 moving further distally into the left atrium 14. In the illustrated example, the electrical energy from the generator 180 is preferably stopped due to a change in impedance and / or the passage of time as disclosed above. However, in a procedure in which electrical energy remains applied from the generator 180, the insulating jacket 118 on the guidewire 110 can suppress further damage to the tissue of the fossa ovalis 16. Alternatively, the energy from the generator 180 can be precisely controlled and interrupted before the tissue is excessively damaged, in which case the insulating jacket 118 is not necessary to suppress further damage to the tissue.

[0065] Figure 3H shows an arbitrary step in which the microcatheter 130 crosses the fossa ovalis 16. While positioned as shown, the intraluminal module 170 can perform intraluminal steps as understood by those skilled in the art, such as pressure sensing, and / or deliver fluid through the lumen 138 of the microcatheter 130.

[0066] Figure 3I shows the dilator 150 and sheath 155 being moved distally on the guidewire 110 to a transseptal puncture through the fossa ovalis 16. The microcatheter 130 may be removed before this step (as shown), or alternatively, the microcatheter 130 may be left in place so that the dilator 150 and sheath 155 can be moved distally on the microcatheter 130. The dilator 150 and sheath can be moved through the transseptal puncture, and the procedure within the left atrium 14 may proceed according to a variety of methods as will be understood by those skilled in the art.

[0067] Figures 4A to 4C are a series of diagrams that can be performed instead of the steps illustrated in Figures 3H and 3I when the maneuverable microcatheter 130a is tapered and functions as a dilator, as shown in Figure 2A.

[0068] Figure 4A shows a tapered dilator fully positioned within the right atrium 12, so that its distal end 134 is positioned in the fossa ovalis immediately after the steps described in relation to Figure 3G.

[0069] Figure 4B shows the sheath 155 being moved over the microcatheter 130a.

[0070] Figure 4C shows the microcatheter 130a expanding the opening of the fossa ovale 16 as its distal end 134 enters the left atrium 14. While positioned as shown, the intraluminal module 170 can perform intraluminal steps as understood by those skilled in the art, such as pressure sensing, and / or supply fluid through the lumen 138 of the microcatheter 130.

[0071] Figure 5 is a flowchart outlining the steps of an exemplary method 300 for transseptal puncture. In step 302, the maneuverable microcatheter and guidewire can be positioned in the right atrium, thereby positioning the conductive distal end of the guidewire near the distal end of the maneuverable microcatheter and exposing it to blood. The microcatheter and guidewire can be configured similarly to the microcatheter 130 and guidewire 110, their variations, and alternative examples disclosed herein, as will be understood by those skilled in the art.

[0072] In step 304, at least a portion of the atrial septum can be mapped using a microcatheter position sensor. The position sensor can be configured similarly to the position sensor 136 disclosed herein, its modifications, and alternatives thereof, as will be understood by those skilled in the art.

[0073] In step 306, the position of the distal end of the microcatheter can be determined using a position sensor.

[0074] In step 308, the distal end of the microcatheter is manipulated to guide the distal end of the guidewire to the target tissue.

[0075] In step 310, contact between the distal end of the guidewire and the tissue can be detected at least partially based on impedance measurements at the distal end of the guidewire.

[0076] In step 312, while the distal end of the guidewire is in contact with the tissue, electrical energy can be applied to the distal end of the guidewire to cause tissue puncture.

[0077] In step 314, the guidewire can be advanced through the target tissue. The microcatheter can also be advanced through the target tissue, preferably after the electrical energy to the guidewire has been exhausted.

[0078] In step 316, the electrical energy at the distal end of the guidewire can be determined at least in part based on the impedance measurement at the distal end of the guidewire.

[0079] In step 318, the guidewire can be held throughout the target tissue such that its distal end is within the left atrium. The microcatheter may also be held across the target tissue.

[0080] In step 320, the dilator and sheath can be advanced on the guidewire across the target tissue and into the left atrium. If the microcatheter is held across the target tissue, the dilator and sheath can be advanced on the microcatheter across the target tissue and into the left atrium.

[0081] Figure 6 shows a transseptal perforation procedure using a computer-assisted system 20. The system 20 can be used during a medical procedure on the heart 10 of a patient 24 to perform a transseptal perforation. The procedure can be performed by one or more operators, including a medical professional 26. The system 20 can be configured to present images of lumens, such as the lumen of the heart 10, allowing the operator 26 to visualize the features of the lumens. The system 20 can be further configured to present images of a microcatheter 130 and / or a guidewire 110. The system 20 can further include and / or be configured to control the components of the transseptal perforation system 100 shown in Figure 1.

[0082] System 20 can be controlled by a system processor 30, which can be implemented as a general-purpose computer. The processor 30 can be mounted on a console 40. The console 40 may include operational controls 42, such as a keypad, and a pointing device, such as a mouse or trackball, which an operator 26 can use to interact with the processor 30. The results of calculations performed by the processor 30 can be provided to the operator on a display 44 connected to the processor 30. The display 44 may further present the operator with a graphical user interface that enables the operator to control System 20. The operator 26 may use the controls 42 to input values ​​for parameters used by the processor 30 in the operation of System 20.

[0083] The processor 30 operates the system 20 using computer software. This software can be downloaded to the processor 30 in electronic form, for example, via a network, or alternatively or additionally, provided and / or stored on a non-temporary, tangible computer-readable medium such as magnetic, optical, or electronic memory.

[0084] Operator 26 can insert the microcatheter 130 and guidewire 110 into patient 24, so that the distal ends of the microcatheter 130 and guidewire 110 enter the right atrium 12 of the patient's heart via the inferior vena cava 22. Processor 30 can be configured to track both the position and orientation of the distal ends 134 of the microcatheter and the distal end 114 of the guidewire 110, typically while they are in the heart 10. If the sensor 136 of the microcatheter 130 includes one or more magnetic coils, processor 30 can utilize a magnetic tracking system such as that provided by the Carto® system manufactured by Biosense Webster. System 20 can include a magnetic field transmitter 66 near patient 24, so that the magnetic field from the transmitter interacts with the magnetic coil near the distal end 134 of the microcatheter 130. The coil interacting with the magnetic field generates a signal that is transmitted to the processor 30, which analyzes the signal to determine the position and orientation of the guidewire 110 and the microcatheter 130.

[0085] Additionally or alternatively, system 20 may include a body patch (not shown) for an impedance-based electrical tracking subsystem, also known as an advanced current localization (ACL) tracking subsystem. In the ACL subsystem, current is delivered to an impedance sensor located in the patient's body, the current diffuses from the impedance sensor through the body to a body patch, and the location of the impedance sensor is calculated based on the current distribution at the body patch. The sensor 136 of the microcatheter 130 may include one or more impedance sensors, and / or the conductive distal end 114 of the guidewire 110 may function as an impedance sensor.

[0086] System 20 may include a magnetic tracking subsystem and / or ACL subsystem configured similarly to that disclosed in U.S. Patent No. 8,456,182, which is incorporated herein by reference and annexed to priority application U.S. Patent No. 63 / 190,865.

[0087] Console 40 may be further configured to monitor the impedance and / or control electrical energy to the guide wire 110, as illustrated and described elsewhere in this specification.

[0088] The descriptions contained herein are examples of embodiments of the present invention and do not limit the scope of the invention in any way. As described herein, the present invention intends to provide many variations and modifications of system components, including alternative tip shapes, alternative number of electrodes, alternative position sensors, combinations of components shown in separate figures, alternative materials, geometric shapes of alternative components, and arrangements of alternative components. Modifications and modifications that are obvious to those skilled in the art relating to the teachings of this disclosure are intended to be within the scope of the following claims.

[0089] [Implementation Method] (1) A transseptal puncture system, A maneuverable microcatheter comprising: an elongated member having a lumen extending through its interior to define a longitudinal axis; a deflectable distal portion; and a position sensor disposed adjacent to the deflectable distal portion; A guidewire disposed within the lumen of the microcatheter, comprising a conductive core, a conductive distal end, a conductive proximal end, and an outer diameter smaller than and approximately equal to the inner diameter of the lumen of the microcatheter, A system comprising: a generator that electrically contacts the conductive proximal end, configured to provide the distal end of the guidewire with sufficient electrical energy to puncture tissue without requiring a sharp end. (2) The system according to Embodiment 1, further comprising: a navigation module configured to determine the position of the distal end of the microcatheter in the heart, at least partially based on the position sensor with reference to the conductive distal end of the guidewire. (3) A dilator having a lumen passing through the inside, which is larger than and approximately equal to the inner diameter of the lumen of the microcatheter, The system according to Embodiment 1, further comprising a sheath configured to advance on the expander. (4) further comprising a sheath configured to advance along the microcatheter, The microcatheter has a tapered distal end, The system according to Embodiment 1, wherein the tapered distal end has a distal outer diameter that is larger than and approximately equal to the outer diameter of the guidewire, and a proximal outer diameter that is smaller than and approximately equal to the inner diameter of the lumen of the sheath. (5) The system according to Embodiment 1, wherein the maneuverable microcatheter further comprises a pull wire connected to the distal portion to deflect the distal portion with respect to the longitudinal axis.

[0090] (6) Further comprising an impedance monitoring module configured to communicate with the generator, to be electrically connected to the proximal end of the guide wire, and to measure the impedance at the distal end of the guide wire, The system according to Embodiment 1, wherein the generator is configured to provide the electrical energy to the distal end of the guidewire based at least in part on the measured impedance. (7) The system according to Embodiment 1, further comprising a mapping module configured to generate a map of at least a portion of the atrial septum using the position sensor. (8) The system according to Embodiment 1, wherein the position sensor comprises a magnetic coil. (9) The system according to Embodiment 1, wherein the position sensor includes an exposed electrode. (10) Body patches and, The system according to embodiment 9, further comprising: a navigation module configured to determine the position of the distal end of the microcatheter in the heart based at least partially on the impedance between the body patch and the exposed electrode of the position sensor.

[0091] (11) Transseptal puncture system, A maneuverable microcatheter comprising: an elongated tubular member having a lumen extending through its interior to define a longitudinal axis; a deflectable distal portion; and a position sensor disposed adjacent to the distal portion along the longitudinal axis; A guidewire having a portion positioned within the lumen of the microcatheter, comprising a conductive core, a conductive distal end, and a conductive proximal end, A system comprising: a navigation module configured to determine the position of the distal end of the microcatheter based at least partially on the position sensor by referring to the distal end of the guidewire. (12) The system according to embodiment 11, wherein the guidewire has an outer diameter that is smaller than and approximately equal to the inner diameter of the lumen of the microcatheter. (13) A dilator having a lumen passing through the inside, having an inner diameter substantially equal to the inner diameter of the lumen of the microcatheter, The system according to embodiment 12, further comprising a sheath configured to advance on the expander. (14) further comprising a sheath configured to advance along the microcatheter, The microcatheter has a tapered distal end, The system according to embodiment 11, wherein the tapered distal end has a distal outer diameter that is larger than and approximately equal to the outer diameter of the guidewire, and a proximal outer diameter that is smaller than and approximately equal to the inner diameter of the lumen of the sheath. (15) The system according to embodiment 11, further comprising a generator that is in electrical contact with the conductive proximal end, wherein the generator is configured to provide sufficient electrical energy to the distal end of the guidewire to puncture tissue.

[0092] (16) Further comprising an impedance monitoring module configured to communicate with the generator, to be electrically connected to the proximal end of the guide wire, and to measure the impedance at the distal end of the guide wire, The system according to embodiment 15, wherein the generator is configured to provide the electrical energy to the distal end of the guidewire based at least in part on the measured impedance. (17) The system according to embodiment 11, wherein the maneuverable microcatheter further comprises a pull wire configured to deflect the deflectable distal portion. (18) The system according to embodiment 11, wherein the position sensor comprises a magnetic coil. (19) The system according to embodiment 11, wherein the position sensor comprises an exposed electrode. (20) Body patches and, The system according to embodiment 19, further comprising: a navigation module configured to determine the position of the distal end of the microcatheter in the heart based at least partially on the impedance between the body patch and the exposed electrode of the position sensor.

Claims

1. Transseptal puncture system, A maneuverable microcatheter comprising: an elongated member having a lumen extending through its interior to define a longitudinal axis; a deflectable distal portion; and a position sensor disposed adjacent to the deflectable distal portion; A guidewire disposed within the lumen of the microcatheter, comprising a conductive core, a conductive distal end, a conductive proximal end, and an outer diameter smaller than and approximately equal to the inner diameter of the lumen of the microcatheter, A generator that electrically contacts the conductive proximal end, configured to provide sufficient electrical energy to the distal end of the guidewire to puncture tissue without requiring a sharp end, The system includes an impedance monitoring module configured to communicate with the generator, electrically communicate with the proximal end of the guidewire, and measure impedance at the distal end of the guidewire, The generator is configured to provide the electrical energy to the distal end of the guidewire, at least in part, based on the measured impedance. The generator is configured to stop supplying electrical energy to the distal end of the guidewire in response to a change in impedance when the distal end of the guidewire enters the left atrium.

2. The system according to claim 1, further comprising a navigation module configured to determine the position of the distal end of the microcatheter in the heart, at least partially based on the position sensor with reference to the conductive distal end of the guidewire.

3. A dilator comprising a lumen through which the dilator passes, having an inner diameter that is larger than and substantially equal to the inner diameter of the lumen of the microcatheter, The device further comprises a sheath configured to advance on the expander, The system according to claim 1, wherein the expander is configured to be advanced over one or both of the guidewire and the microcatheter.

4. The device further comprises a sheath configured to advance along the microcatheter, The microcatheter has a tapered distal end, The system according to claim 1, wherein the tapered distal end has a distal outer diameter that is larger than and approximately equal to the outer diameter of the guidewire, and a proximal outer diameter that is smaller than and approximately equal to the inner diameter of the lumen of the sheath.

5. The system according to claim 1, wherein the maneuverable microcatheter further comprises a pull wire connected to the distal portion to deflect the distal portion with respect to the longitudinal axis.

6. The system according to claim 1, further comprising a mapping module configured to generate a map of at least a portion of the atrial septum using the position sensor.

7. The system according to claim 1, wherein the position sensor comprises a magnetic coil.

8. The system according to claim 1, wherein the position sensor comprises an exposed electrode.

9. Body patches and, The system according to claim 8, further comprising: a navigation module configured to determine the position of the distal end of the microcatheter in the heart based at least partially on the impedance between the body patch and the exposed electrode of the position sensor.

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